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UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

JOINT CLAIM CONSTRUCTION BRIEF

Markman Hearing Date: November 18, 2024 Filing Date: November 4, 2024

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I. INTRODUCTION

Plaintiff Apex Surgical Innovations, Inc. ("Apex") and Defendant Solstice Biomedical, Inc. ("Solstice") respectfully submit this Joint Claim Construction Brief pursuant to the Scheduling Order entered by this Court on July 2, 2024 (D.I. 34), and in accordance with the Court's Local Patent Rules, D. Del. L.P.R. 4.1 et seq., in advance of the Markman hearing scheduled for November 18, 2024.

Apex commenced this action on May 9, 2024, by filing a Complaint (D.I. 1) alleging that Solstice infringes three United States utility patents owned by Apex, each directed to components and assemblies used in minimally invasive laparoscopic surgical access devices, commonly known as trocars. The patents-in-suit are:

1. U.S. Patent No. 9,814,237 ("the '237 Patent"), entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," issued on November 14, 2017, with an expiration date of June 22, 2035. Apex asserts Claims 1, 3, 7, and 12 of the '237 Patent.

2. U.S. Patent No. 10,271,884 ("the '884 Patent"), entitled "Retractable Blade Deployment Mechanism for Trocar Systems," issued on April 30, 2019, with an expiration date of September 15, 2036. Apex asserts Claims 1, 2, 5, 9, and 14 of the '884 Patent.

3. U.S. Patent No. 10,932,105 ("the '105 Patent"), entitled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar," issued on March 2, 2021, with an expiration date of January 10, 2038. Apex asserts Claims 1, 4, and 8 of the '105 Patent.

The named inventor on all three patents is Dr. Raymond Szabo, who serves as Vice President of Engineering at Apex. All three patents were assigned to Apex and Apex is the current owner of record of all right, title, and interest therein. Certified copies of the assignment records have been produced in this litigation and are referenced in the parties' Joint Statement of Undisputed Facts filed on September 6, 2024 (D.I. 52).

Apex alleges that three product families manufactured and sold by Solstice in the United States infringe the asserted patents. The accused products are:

• The PrecisionEdge™ PE-5000 Series (5 mm trocar assembly), accused of infringing the '237 and '884 Patents;

• The PrecisionEdge™ PE-12000 Series (12 mm trocar assembly), accused of infringing the '237, '884, and '105 Patents; and

• The PrecisionEdge™ PE-15000 Series (15 mm trocar assembly), accused of infringing the '884 and '105 Patents.

Solstice denies infringement of all asserted claims and has asserted affirmative defenses of invalidity and unenforceability. The parties' respective contentions regarding invalidity and enforceability are not addressed herein, as they are not germane to the claim construction issues presently before the Court.

In accordance with the Court's Scheduling Order, the parties exchanged their respective proposed claim constructions and supporting intrinsic evidence on October 22, 2024. See D. Del. L.P.R. 4.1(b). The parties thereafter met and conferred on October 28, 2024 and October 30, 2024, in an effort to narrow or resolve the disputed claim terms. Despite good-faith efforts, the parties were unable to reach agreement on the construction of any of the disputed terms. As a result, nine (9) claim terms remain in dispute and are presented to the Court for construction.

This Joint Claim Construction Brief sets forth the parties' respective proposed constructions for each of the nine disputed terms, the intrinsic and extrinsic evidence supporting each party's position, and the reasons why each party's construction should be adopted. The brief is organized in a joint format, with Apex's position presented first for each disputed term, followed by Solstice's position, consistent with the Court's standard practice for joint claim construction briefing in this District.

The parties recognize that claim construction is "not an invasive surgical procedure" — but the subject matter of these patents is. The patented technology at issue relates to critical safety features in laparoscopic access devices, including seal mechanisms that maintain the pneumoperitoneum necessary for visualization during laparoscopic surgery, blade retraction systems designed to prevent inadvertent tissue injury, and insufflation valve assemblies that regulate gas flow during the procedure. Proper construction of the disputed terms is essential to framing the infringement and validity issues that will be central to the resolution of this case, whether by summary judgment or trial.

II. LEGAL STANDARD FOR CLAIM CONSTRUCTION

Claim construction is a question of law to be decided by the Court. Markman v. Westview Instruments, Inc., 517 U.S. 370, 372, 388–91 (1996). The construction of patent claims determines the scope of the patent owner's right to exclude and, consequently, is a necessary predicate to the infringement and validity analyses that follow. O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1360 (Fed. Cir. 2008) (holding that where the parties raise an actual dispute regarding the proper scope of a claim term, the court has a duty to resolve it).

The words of a claim "are generally given their ordinary and customary meaning," which is "the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). This inquiry is an objective one, focused on "how a person of ordinary skill in the art understands a claim term" in light of the intrinsic record. Id. at 1313.

The intrinsic evidence is the primary basis for claim construction. Intrinsic evidence consists of three sources: (1) the claims themselves, (2) the patent specification, and (3) the prosecution history. Ridgeway & Co. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). The Federal Circuit has established a hierarchy among these sources, although all three are part of a single, holistic analysis.

The Claims. Claim construction begins — and often ends — with the language of the claims themselves. The context of the surrounding claim language is informative, as "[t]he claim in its entirety provides important context for understanding the meaning of each of its terms." Phillips, 415 F.3d at 1314. In addition, other claims in the patent, both asserted and unasserted, can shed light on the meaning of a disputed term through the doctrine of claim differentiation, which creates a presumption that each claim in a patent has a different scope. Nystrom v. Larkspur Holdings, 424 F.3d 1136, 1143 (Fed. Cir. 2005).

The Specification. The specification is "the single best guide to the meaning of a disputed term." Phillips, 415 F.3d at 1315 (quoting Vitronics, 90 F.3d at 1582). It is always appropriate to consult the specification to determine whether the inventor has used a term in a manner consistent with its ordinary meaning, or has instead given the term a special definition or otherwise limited its scope. Id. at 1316. As the Federal Circuit has cautioned, however, there is "a fine line between reading a claim in light of the specification, and reading a limitation into the claim from the specification." Hill-Rom Servs., Inc. v. Hollowell Industries, 755 F.3d 1367, 1371 (Fed. Cir. 2014) (internal quotation marks omitted). While the specification may be used to interpret what a patentee meant by a particular term, it should not be used to import limitations from particular embodiments into the claims unless the patentee has clearly limited the scope of the claims to that embodiment. Phillips, 415 F.3d at 1323.

The Prosecution History. The prosecution history, consisting of the complete record of proceedings before the United States Patent and Trademark Office ("USPTO"), "provides evidence of how the PTO and the inventor understood the patent." Phillips, 415 F.3d at 1317. The prosecution history includes prior art cited during examination, any rejections or objections by the examiner, amendments to the claims, and the applicant's arguments and remarks submitted in response to the examiner's actions. Statements made by the applicant during prosecution, including arguments distinguishing prior art, may limit the scope of the claims through prosecution history estoppel. Bell Atl. Network Servs., Inc. v. Covad Commc'ns Grp., Inc., 262 F.3d 1258, 1268 (Fed. Cir. 2001). However, the prosecution history "often lacks the clarity of the specification and thus is less useful for claim construction purposes." Phillips, 415 F.3d at 1317.

Extrinsic Evidence. Extrinsic evidence, including expert and inventor testimony, technical dictionaries, learned treatises, and other materials outside the intrinsic record, may be used to assist the Court in understanding the technology at issue and the meaning of terms to a person of ordinary skill in the art. Phillips, 415 F.3d at 1317–18; Teva Pharm. USA, Inc. v. Sandoz, Inc., 574 U.S. 318, 331 (2015). However, extrinsic evidence is "less significant than the intrinsic record in determining the legally operative meaning of claim language" and may not be used to contradict the meaning of claim terms as established by the intrinsic evidence. Phillips, 415 F.3d at 1318 (quoting C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004)).

Lexicography and Disavowal. A patentee is free to act as his or her own lexicographer by providing an explicit definition of a claim term in the specification. Thorner v. Severin Industries, 669 F.3d 1362, 1365 (Fed. Cir. 2012). When the patentee does so, the definition provided controls. Id. However, to invoke this principle, the patentee's definition must be set forth "with reasonable clarity, deliberateness, and precision." Id. Similarly, a patentee may disavow or disclaim claim scope, but such disavowal must be clear and unmistakable, appearing in the specification or prosecution history with sufficient definiteness to put the public on notice of the scope of the claimed invention. Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1117 (Fed. Cir. 2004).

Means-Plus-Function. Where a claim limitation is drafted in means-plus-function format under 35 U.S.C. § 112(f), the limitation is construed to cover the corresponding structure disclosed in the specification and equivalents thereof. Neither party contends that any of the nine disputed terms at issue in this brief should be construed under Section 112(f), and the parties agree that none of the disputed terms are drafted in means-plus-function format.

Avoiding Impermissible Constructions. The Court should not construe claims in a manner that renders them nonsensical or inconsistent with the written description. See 3 Chisum on Patents § 8.04 (2024). Nor should the Court adopt a construction so narrow as to exclude the preferred embodiment, absent clear prosecution history estoppel or lexicography supporting such a result. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002) (noting that "a claim construction that excludes a preferred embodiment is rarely, if ever, correct"). Conversely, the Court should not adopt a construction so broad that it encompasses prior art that the patentee expressly distinguished during prosecution. Abbottott Labs. v. Sandoz, Inc., 566 F.3d 1282, 1289 (Fed. Cir. 2009).

Person of Ordinary Skill in the Art. The parties agree that a person of ordinary skill in the art ("POSITA") at the time of the inventions disclosed in the patents-in-suit would have at least a Bachelor of Science degree in mechanical engineering, biomedical engineering, or a closely related field, and approximately three to five years of professional experience in the design of minimally invasive surgical instruments, specifically including experience with laparoscopic access devices and trocars. This agreed definition of a POSITA applies to all three patents-in-suit and to all nine disputed claim terms.

III. THE ASSERTED PATENTS — OVERVIEW

A. The '237 Patent — "Locking Seal Assembly for Minimally Invasive Surgical Access Device"

U.S. Patent No. 9,814,237, entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," was issued on November 14, 2017 to named inventor Dr. Raymond Szabo. The '237 Patent claims priority to U.S. Provisional Application No. 62/182,456, filed June 20, 2015, through a non-provisional application filed June 22, 2015. Under 35 U.S.C. § 154(a)(2), the '237 Patent has an expiration date of June 22, 2035. A certified copy of the '237 Patent is attached as Exhibit 1 to the Declaration of Victoria Stanton filed concurrently herewith.

The '237 Patent is directed to a locking seal assembly for use in a trocar housing that maintains pneumoperitoneum during laparoscopic surgery. In laparoscopic procedures, the abdominal cavity is insufflated with carbon dioxide gas to create a working space for the surgeon. Trocars — cylindrical access devices inserted through the abdominal wall — serve as conduits for surgical instruments. A critical design challenge for trocars is maintaining the seal around the surgical instrument shaft to prevent gas leakage, which can cause loss of pneumoperitoneum and compromise the surgeon's visualization of the surgical field. The '237 Patent addresses this challenge by disclosing a seal assembly that locks around the instrument shaft to prevent gas leakage while allowing the instrument to be inserted, manipulated, and removed.

As described in the specification, the locking seal assembly of the '237 Patent includes several components. A sealing member is disposed within the trocar housing and is configured to engage the outer surface of a surgical instrument shaft. A locking ring cooperates with the sealing member to secure the seal in a closed position. A biasing element urges the sealing member toward a sealed configuration, ensuring continuous contact with the instrument shaft during the surgical procedure. The specification describes a multi-stage locking mechanism that transitions between open, partially sealed, and fully sealed and locked positions. '237 Patent col. 3, ll. 15–40; col. 4, ll. 1–30. The specification illustrates several embodiments, including one utilizing a radially-compressing seal with a rotating lock ring (FIGS. 2A–2D) and another utilizing an axially-compressing seal with a cam-actuated lock (FIGS. 5A–5C).

Apex asserts Claims 1, 3, 7, and 12 of the '237 Patent. Claim 1 is the sole independent claim, and Claims 3, 7, and 12 are dependent claims. Claim 1, in relevant part, recites:

A locking seal assembly for a minimally invasive surgical access device, the assembly comprising:

a housing defining an interior chamber and configured to receive a surgical instrument therethrough;

a sealing member disposed within the interior chamber, the sealing member in continuous contact with an outer surface of the surgical instrument during use;

a locking ring movably disposed within the housing and configured to engage the sealing member to secure the sealing member in a sealed position; and

a biasing element configured to urge the sealing member toward the sealed position.

The full text of all asserted claims of the '237 Patent is set forth in Appendix A. Three of the nine disputed terms at issue in this Joint Brief arise from the '237 Patent: "locking seal assembly" (Disputed Term No. 1), "sealing member in continuous contact with" (Disputed Term No. 2), and "biasing element configured to urge" (Disputed Term No. 3).

B. The '884 Patent — "Retractable Blade Deployment Mechanism for Trocar Systems"

U.S. Patent No. 10,271,884, entitled "Retractable Blade Deployment Mechanism for Trocar Systems," was issued on April 30, 2019 to named inventor Dr. Raymond Szabo. The '884 Patent claims priority to U.S. Provisional Application No. 62/399,012, filed September 14, 2016, through a non-provisional application filed September 15, 2016. Under 35 U.S.C. § 154(a)(2), the '884 Patent has an expiration date of September 15, 2036. A certified copy of the '884 Patent is attached as Exhibit 2 to the Stanton Declaration.

The '884 Patent is directed to a mechanism for deploying and retracting a cutting blade within a trocar obturator. Trocar obturators are sharp-tipped inner components inserted through the trocar cannula to penetrate the abdominal wall. After the abdominal wall is penetrated, the obturator blade must be retracted or shielded to prevent inadvertent injury to underlying tissue and organs. The '884 Patent discloses a spring-loaded retraction system and a safety shield that addresses this clinical need. The mechanism is designed to automatically retract the blade after tissue penetration, minimizing the risk of injury to intra-abdominal structures.

The specification describes a blade housed within a blade housing that is fixedly secured to the obturator shaft. A spring-loaded retraction assembly stores mechanical energy during the deployment phase and releases it to retract the blade after penetration is detected by a change in resistance at the blade tip. A safety shield extends distally beyond the cutting edge of the blade when the blade is in the retracted position, providing a physical barrier between the sharp edge and surrounding tissue. '884 Patent col. 4, ll. 10–45; col. 5, ll. 1–60. The specification illustrates the preferred embodiment with reference to FIGS. 3A–3D, depicting a tubular shield concentrically surrounding the blade.

Apex asserts Claims 1, 2, 5, 9, and 14 of the '884 Patent. Claim 1 is the sole independent claim, and Claims 2, 5, 9, and 14 are dependent claims. Claim 1, in relevant part, recites:

A retractable blade deployment mechanism for a trocar system, the mechanism comprising:

a blade housing fixedly secured to an obturator shaft;

a cutting blade movably disposed within the blade housing between a retracted position and a deployed position;

a spring-loaded retraction assembly operatively connected to the cutting blade and configured to retract the cutting blade from the deployed position to the retracted position; and

a safety shield extending distally beyond a cutting edge of the cutting blade when the cutting blade is in the retracted position.

The full text of all asserted claims of the '884 Patent is set forth in Appendix A. Four of the nine disputed terms at issue in this Joint Brief arise from the '884 Patent: "retractable blade deployment mechanism" (Disputed Term No. 4), "spring-loaded retraction assembly" (Disputed Term No. 5), "safety shield extending distally beyond" (Disputed Term No. 6), and "blade housing fixedly secured to" (Disputed Term No. 7).

C. The '105 Patent — "Integrated Insufflation Valve and Seal for Laparoscopic Trocar"

U.S. Patent No. 10,932,105, entitled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar," was issued on March 2, 2021 to named inventor Dr. Raymond Szabo. The '105 Patent claims priority to U.S. Provisional Application No. 62/960,118, filed January 10, 2020, through a non-provisional application filed January 11, 2020. Under 35 U.S.C. § 154(a)(2), the '105 Patent has an expiration date of January 10, 2038. A certified copy of the '105 Patent is attached as Exhibit 3 to the Stanton Declaration.

The '105 Patent is directed to an integrated valve and seal structure within a trocar cannula that simultaneously controls the flow of insufflation gas into the abdominal cavity and seals around surgical instruments passed through the trocar. In conventional trocar designs, the insufflation valve (typically a stopcock-type valve) and the instrument seal are separate components, adding to the overall bulk and complexity of the trocar and creating potential leak points. The '105 Patent discloses a unitary approach that combines these two functions into a single structural component, referred to as the "integrated insufflation valve and seal."

The specification describes a valve body containing a flow regulation channel that controls the rate and direction of insufflation gas flow. A deformable seal element, integrated into the valve body, conforms to the outer surface of a surgical instrument to maintain a gas-tight seal. The flow regulation channel is described as being in fluid communication with an insufflation port on the trocar cannula. '105 Patent col. 3, ll. 1–40; col. 4, ll. 5–35. The specification states that "the integrated valve and seal is formed as a single molded component" (col. 3, ll. 5–12) and describes the manufacturing process as involving injection molding of a medical-grade silicone elastomer.

Apex asserts Claims 1, 4, and 8 of the '105 Patent. Claim 1 is the sole independent claim, and Claims 4 and 8 are dependent claims. Claim 1, in relevant part, recites:

An integrated insufflation valve and seal for a laparoscopic trocar, comprising:

a valve body configured to be received within a trocar cannula;

a flow regulation channel disposed within the valve body and in fluid communication with an insufflation port of the trocar cannula, the flow regulation channel configured to regulate a flow of insufflation gas;

a deformable seal element integrally formed with the valve body, the deformable seal element configured to sealingly engage an outer surface of a surgical instrument received through the valve body.

The full text of all asserted claims of the '105 Patent is set forth in Appendix A. Two of the nine disputed terms at issue in this Joint Brief arise from the '105 Patent: "integrated insufflation valve and seal" (Disputed Term No. 8) and "flow regulation channel in fluid communication with" (Disputed Term No. 9).

IV. THE NINE DISPUTED CLAIM TERMS — OVERVIEW TABLE

Pursuant to D. Del. L.P.R. 4.2, the parties have prepared the following summary table identifying each of the nine disputed claim terms, the patent(s) and claim(s) in which each term appears, and the parties' respective proposed constructions. A more detailed Joint Claim Construction Chart is attached as Appendix B.

As the table reflects, the central dispute between the parties concerns the breadth of the patent claims. Apex generally proposes constructions that it contends reflect the plain and ordinary meaning of the claim terms and preserve the full scope of the patent claims as written. Solstice generally proposes narrower constructions that it contends are compelled by the specification and prosecution history, and that properly limit the claims to the inventions actually disclosed and claimed.

V. AGREED CONSTRUCTIONS

Pursuant to D. Del. L.P.R. 4.3, the parties have attempted in good faith to resolve as many claim construction disputes as possible without the need for judicial intervention. The parties exchanged proposed claim constructions on October 22, 2024, and subsequently met and conferred on October 28, 2024 and October 30, 2024. Despite these efforts, the parties were unable to agree on the construction of any of the nine disputed terms identified above. All nine terms remain in dispute and are submitted to the Court for resolution.

The parties do, however, agree on the following matters relevant to claim construction:

1. Person of Ordinary Skill in the Art. The parties agree that a person of ordinary skill in the art ("POSITA") at the time of the inventions disclosed in the patents-in-suit would have at least a Bachelor of Science degree in mechanical engineering, biomedical engineering, or a closely related field, and approximately three to five years of professional experience in the design of minimally invasive surgical instruments, specifically including experience with laparoscopic access devices and trocars. This agreed definition applies to all three patents-in-suit and to all nine disputed terms.

2. No Means-Plus-Function Terms. The parties agree that none of the nine disputed terms at issue in this brief are drafted in means-plus-function format under 35 U.S.C. § 112(f), and that construction under Section 112(f) is not required or appropriate for any of the disputed terms.

3. No Indefiniteness Challenge to Disputed Terms. Solstice does not contend that any of the nine disputed terms at issue in this brief are indefinite under 35 U.S.C. § 112(b). Solstice reserves the right to assert indefiniteness as to other claim terms not at issue in this brief.

Beyond these agreements, the parties' positions diverge as set forth in the term-by-term analysis that follows.

VI. DISPUTED TERM NO. 1: "LOCKING SEAL ASSEMBLY" ('237 Patent, Claims 1, 3, 7, 12)

A. Apex's Proposed Construction

Apex's proposed construction: "An assembly that includes a seal and a locking mechanism that, when engaged, secures the seal in a closed position around a surgical instrument."

Apex contends that its proposed construction faithfully reflects the plain and ordinary meaning of the term "locking seal assembly" as it would be understood by a person of ordinary skill in the art. Each word of the term carries its common meaning: "locking" refers to a mechanism that secures or fixes something in position; "seal" refers to a component that prevents the passage of fluid (here, insufflation gas); and "assembly" refers to a collection of parts that work together. Taken together, the phrase describes an assembly that includes a seal and a locking mechanism, where the locking mechanism secures the seal in a closed position around a surgical instrument.

Apex's construction is fully supported by the intrinsic record. The specification of the '237 Patent describes the "locking seal assembly" in broad terms at multiple points. For example, at column 3, lines 15–40, the specification states:

"The present invention provides a locking seal assembly for a minimally invasive surgical access device. The locking seal assembly comprises a sealing member and a locking mechanism. The locking mechanism may take various forms, including but not limited to a rotating lock ring, a cam-actuated clamp, or a lever-actuated compression collar. The essential function of the locking mechanism is to secure the sealing member in a closed and sealed position around the shaft of a surgical instrument inserted through the trocar."

This passage demonstrates that the specification contemplates range structural configurations for the locking mechanism, and does not limit the "locking seal assembly" to any single embodiment. The specification expressly states that the locking mechanism "may take various forms," including a rotating lock ring (the preferred embodiment illustrated in FIGS. 2A–2D), a cam-actuated clamp, or a lever-actuated compression collar. See '237 Patent col. 3, ll. 22–28.

In addition, the specification describes a second embodiment of the locking seal assembly at column 7, lines 10–35, which utilizes an axially-compressing seal with a cam-actuated lock rather than a radially-compressing seal with a rotating lock ring. The specification states that this alternative embodiment "provides the same locking seal function" as the preferred embodiment, differing only in "the direction of compression applied to the sealing member and the specific mechanical configuration of the locking mechanism." '237 Patent col. 7, ll. 15–20. This further confirms that the claim term "locking seal assembly" is not limited to the radially-compressing, rotating-lock-ring configuration of the preferred embodiment.

Apex's construction also finds support in the claim language itself. Claim 1 recites "a locking seal assembly" as a preamble term and then separately recites the specific structural components of the assembly: "a sealing member," "a locking ring," and "a biasing element." This structure demonstrates that the "locking seal assembly" is a broad, overarching term for the assembly as a whole, and the specific structural components are separately recited in the body of the claim. To construe "locking seal assembly" as requiring a radially-compressing seal and a mechanical lock ring — as Solstice proposes — would improperly conflate the preamble term with the specifically recited structural limitations of the claim body. See Phillips, 415 F.3d at 1314 (claim language provides context); Hill-Rom Servs., 755 F.3d at 1371 (cautioning against importing limitations from the specification into the claims).

Solstice's proposed construction improperly narrows the "locking seal assembly" term in two respects. First, it adds a limitation that the seal must be a "radially-compressing seal element," which is drawn from only one of the multiple embodiments described in the specification. See Ashford Enterprises v. Dunmore Corporation, 358 F.3d 898, 906 (Fed. Cir. 2004) (holding it error to import a limitation from a preferred embodiment when the specification does not limit the invention to that embodiment). The specification expressly contemplates axially-compressing seals in addition to radially-compressing seals. Second, Solstice's construction adds a negative limitation — "as distinguished from a friction-fit or elastomeric seal that does not employ a separate locking component" — that is not found in the claim language itself. While the prosecution history may place some limits on claim scope, those limits must be "clear and unmistakable." See Innova/Pure Water, 381 F.3d at 1117. As discussed further in Section XV.A below, the prosecution history does not compel Solstice's narrow reading.

Apex further notes that even where a patentee makes arguments to distinguish prior art during prosecution, those arguments do not necessarily limit the scope of the claims unless the patentee "clearly and unmistakably" disclaimed the broader construction. Ashford Corporation v. Marposs Società per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998). In this case, the applicant's prosecution arguments focused on the absence of a separate locking mechanism in the prior art, not on the specific structural form of the locking mechanism. The applicant never stated that the claimed "locking seal assembly" required a radially-compressing seal or that it excluded all seals that include elastomeric components. To the contrary, the sealing member in the preferred embodiment of the '237 Patent is itself an elastomeric component (an O-ring seal, '237 Patent col. 4, l. 45), and the "locking" function refers to the additional mechanical mechanism that secures the seal in place — not to the material composition of the seal itself.

For these reasons, Apex respectfully submits that its proposed construction should be adopted.

B. Solstice's Proposed Construction

Solstice's proposed construction: "An assembly comprising a radially-compressing seal element and a mechanical lock ring that physically engages the seal element to maintain the seal in a compressed state, as distinguished from a friction-fit or elastomeric seal that does not employ a separate locking component."

Solstice contends that the proper construction of "locking seal assembly" must be understood in the context of the full intrinsic record, including not only the specification but also the prosecution history, which together compel a construction narrower than the overbroad reading proposed by Apex.

Solstice begins with the specification. While Apex points to language describing multiple possible forms of the "locking mechanism," the specification is far more consistent in its treatment of the "locking seal assembly" as a whole. The specification's detailed description begins at column 3 by distinguishing the claimed invention from the prior art:

"Prior art trocar seal assemblies have relied on friction-fit seals or self-sealing elastomeric gaskets that do not employ a separate locking component. Such seals are prone to gas leakage, particularly when instruments of varying diameters are inserted through the trocar. The present invention overcomes this limitation by providing a locking seal assembly in which a mechanical lock ring physically engages the seal element to maintain the seal in a compressed state around the instrument shaft."

'237 Patent col. 2, ll. 55–65 (emphasis added). This passage establishes the fundamental point of novelty of the "locking seal assembly" — it employs a separate mechanical lock ring that physically engages the seal to maintain compression, as distinguished from prior art friction-fit or self-sealing elastomeric gaskets. The specification thus draws a clear line between the claimed invention and the prior art, and that line runs through the requirement of a separate mechanical locking component.

Solstice further relies on the prosecution history to confirm this understanding. During prosecution of the '237 Patent, the examiner initially rejected Claim 1 under 35 U.S.C. § 102(a)(1) as anticipated by U.S. Patent No. 7,621,886 to Conlon ("the Conlon reference"). The Conlon reference discloses a trocar seal assembly using a self-sealing elastomeric gasket that compresses around the instrument shaft by the elastic properties of the gasket material itself, without a separate mechanical locking component. In response to the Office Action, the applicant (Dr. Szabo, through counsel) amended Claim 1 to add the word "locking" before "seal assembly" and argued:

"The amended claims are patentably distinct from Conlon. Conlon discloses a friction-fit elastomeric seal that relies solely on the compressive elasticity of the gasket material to seal around an instrument shaft. Conlon does not disclose, teach, or suggest a locking seal assembly — i.e., one that includes a separate, mechanically-actuated locking component, such as a lock ring, that physically engages the seal element to maintain the seal in a compressed state. The claims as amended require this distinct structural feature, which is absent from Conlon."

See APEX-004782 (Applicant's Response to First Office Action, dated March 14, 2017) (emphasis in original); Appendix D at D-3. The applicant's amendment and argument constitute a clear and unmistakable disavowal of claim scope. By adding "locking" to distinguish the claims from the friction-fit elastomeric seal of Conlon, and by explicitly arguing that the claims "require" a "separate, mechanically-actuated locking component, such as a lock ring," the applicant surrendered any construction of "locking seal assembly" that would encompass seals without a separate mechanical locking component. See Abbottott Labs., 566 F.3d at 1289 (prosecution history estoppel applies where the applicant makes "clear and unmistakable" arguments to distinguish prior art); CCS Fitness, 288 F.3d at 1367 (arguments made to overcome rejection estop the patentee from later adopting a broader construction).

Solstice further notes that every embodiment in the specification describes the "locking seal assembly" as incorporating a radially-compressing seal element. Even the alternative embodiment described at column 7 of the specification, which uses a cam-actuated lock rather than a rotating lock ring, still employs a radially-compressing seal. The specification does not describe any embodiment in which the seal is not radially compressed when the locking mechanism is engaged. Apex's assertion that the specification contemplates axially-compressing seals conflates the direction of force applied by the locking mechanism (which may be axial, radial, or cam-actuated) with the mode of compression of the seal element itself (which the specification consistently describes as radial). See '237 Patent col. 7, ll. 10–35 (describing the cam-actuated embodiment as producing "radial compression of the seal element through the axial force of the cam mechanism").

Solstice acknowledges that a "locking seal assembly" need not be limited to the exact rotating lock ring of the preferred embodiment — the claim term may encompass other types of mechanical locking components (e.g., cam-actuated locks, lever-actuated compression collars) that physically engage the seal element. But the claim term must, at a minimum, require: (1) a radially-compressing seal element and (2) a separate mechanical locking component that physically engages the seal element, as distinguished from a friction-fit or self-sealing elastomeric seal that achieves sealing through its own inherent elasticity without a separate locking component.

The significance of this construction to the infringement analysis is straightforward. Solstice's PrecisionEdge™ PE-5000 and PE-12000 Series trocar assemblies utilize elastomeric self-sealing gaskets that achieve sealing through the inherent compressive properties of the gasket material. These products do not employ a distinct mechanical lock ring or any other separate locking component that physically engages the seal element. Under Solstice's construction — which is compelled by the specification and prosecution history — these products do not meet the "locking seal assembly" limitation and therefore do not infringe the asserted claims of the '237 Patent. Under Apex's impermissibly broad construction, by contrast, virtually any trocar seal could be characterized as a "locking seal assembly," which would render the "locking" limitation meaningless and extend the claims far beyond the scope of the actual invention. See Glenrock Enterprises v. Adriatic Partners LLC, 242 F.3d 1337, 1341 (Fed. Cir. 2001) (claims must be construed consistently with the specification's description of the invention).

For these reasons, Solstice respectfully submits that its proposed construction should be adopted.

VII. DISPUTED TERM NO. 2: "SEALING MEMBER IN CONTINUOUS CONTACT WITH" ('237 Patent, Claims 1, 7)

A. Apex's Proposed Construction

Apex's proposed construction: "A sealing component that maintains contact with the instrument shaft during use of the device."

Apex contends that the phrase "sealing member in continuous contact with" should be given its plain and ordinary meaning, which requires that the sealing member maintain contact with the instrument shaft during the operative use of the device — that is, during the laparoscopic surgical procedure. Apex's construction is faithful to the claim language, the specification, and the understanding of a person of ordinary skill in the art.

The specification supports Apex's construction. The '237 Patent describes the sealing member as maintaining contact with the instrument shaft "throughout the surgical procedure" to prevent gas leakage. '237 Patent col. 5, ll. 20–28. The specification further explains that the purpose of the "continuous contact" requirement is to ensure maintenance of pneumoperitoneum: "The sealing member maintains continuous contact with the outer surface of the instrument shaft throughout the surgical procedure, thereby preventing escape of insufflation gas from the abdominal cavity." Id. at col. 5, ll. 22–26.

Notably, the specification does not require that the seal maintain contact with the instrument shaft at all times in every conceivable scenario, including during the initial insertion of the instrument through the seal, during instrument exchange, or during removal of the instrument at the conclusion of the procedure. These are transient events during which temporary loss of contact is inherent in the physical operation of any trocar seal. The specification describes "continuous contact" in the context of use of the device — i.e., during the period in which the instrument is positioned within the trocar and the surgeon is performing the procedure. A POSITA would understand "continuous contact" in this practical, functional sense.

Apex's construction is further supported by dependent Claim 7, which adds the limitation that "the sealing member maintains a gas-tight seal around the instrument shaft during manipulation of the instrument." Claim 7 does not add a limitation requiring contact during insertion and removal; rather, it focuses on maintaining a seal "during manipulation." This is consistent with Apex's reading that "continuous contact" in Claim 1 refers to contact during operative use, not at every conceivable moment. Under the doctrine of claim differentiation, Claim 7's additional limitation must add scope beyond what is already required by Claim 1, which would not be the case if Claim 1's "continuous contact" already required uninterrupted contact at all times. See Phillips, 415 F.3d at 1314–15.

Solstice's proposed construction, by contrast, requires "uninterrupted physical contact . . . at all times when the instrument is positioned within the trocar, including during insertion, use, and removal." This construction imposes a requirement that the sealing member never break contact with the instrument shaft from the moment the instrument enters the seal to the moment it is withdrawn. This is an unrealistic physical impossibility for many trocar seal designs — including the preferred embodiment of the '237 Patent itself. As described in the specification, the locking seal assembly transitions through an "open" position to allow instrument insertion, during which the sealing member is not in full contact with the instrument shaft. '237 Patent col. 5, ll. 5–10. Solstice's construction would, paradoxically, exclude the preferred embodiment of the patent, which the Federal Circuit has repeatedly held is a strong indicator of an erroneous construction. See CCS Fitness, 288 F.3d at 1366.

For these reasons, Apex respectfully submits that its proposed construction should be adopted.

B. Solstice's Proposed Construction

Solstice's proposed construction: "A sealing component that maintains uninterrupted physical contact with the outer surface of the instrument shaft at all times when the instrument is positioned within the trocar, including during insertion, use, and removal."

Solstice contends that the plain and ordinary meaning of "continuous contact" requires uninterrupted physical contact — not the intermittent, sometime-during-use contact proposed by Apex. The word "continuous" has a clear and well-understood meaning in both common parlance and technical usage: it means "without interruption." See Sterling Reach Industries Dictionary of Scientific and Technical Terms (7th ed. 2013) (defining "continuous" as "without interruption in time, sequence, or extent"). Apex's construction effectively reads the word "continuous" out of the claim, replacing it with a requirement of merely "some contact" or "contact during parts of the procedure."

The specification confirms this understanding. The passage cited by Apex — "the sealing member maintains continuous contact with the outer surface of the instrument shaft throughout the surgical procedure" ('237 Patent col. 5, ll. 22–26) — uses both "continuous" and "throughout" to describe unbroken, ongoing contact. A POSITA reading this passage would understand it to require that the seal remain in contact with the instrument shaft continuously, without interruption, for the duration of the time the instrument is positioned within the trocar.

Solstice further relies on the prosecution history. During prosecution, the examiner issued a second Office Action citing U.S. Patent No. 8,403,891 to Wenchell ("the Wenchell reference"), which discloses a trocar seal that contacts the instrument shaft intermittently — i.e., the seal makes and breaks contact with the shaft as the instrument is manipulated. In response, the applicant distinguished the Wenchell reference by arguing:

"Unlike Wenchell, the claimed sealing member is in continuous contact with the outer surface of the instrument shaft. Wenchell's seal makes only intermittent contact, breaking and re-establishing contact as the instrument is moved. The present claims require continuous, unbroken contact to ensure a gas-tight seal is maintained at all times."

See APEX-005218 (Applicant's Response to Second Office Action, dated August 22, 2017) (emphasis in original); Appendix D at D-7. This argument constitutes a clear statement by the applicant that "continuous contact" means "continuous, unbroken contact . . . at all times" — precisely the construction Solstice proposes. The applicant's own words during prosecution foreclose Apex's attempt to water down "continuous" to mean merely "during use."

Solstice addresses Apex's claim-differentiation argument based on dependent Claim 7. Apex contends that Claim 7's "gas-tight seal during manipulation" limitation would be superfluous if Claim 1 already required uninterrupted contact. Solstice disagrees. Claim 7 adds a specific functional requirement — that the seal be "gas-tight" — beyond the physical requirement of "continuous contact" in Claim 1. A seal may be in continuous contact with an instrument shaft without necessarily forming a gas-tight seal at every moment (for example, if the contact is not circumferentially complete). Claim 7 thus narrows the claim by requiring not merely continuous contact but continuous gas-tight sealing. The two limitations are distinct, and claim differentiation is therefore satisfied.

The significance of this dispute is material to the infringement analysis. Solstice contends that the PrecisionEdge™ PE-5000 and PE-12000 seal assemblies experience brief interruptions in contact between the seal and the instrument shaft during instrument exchange — a moment when the outgoing instrument is partially withdrawn and the incoming instrument has not yet fully engaged the seal. Under Solstice's construction, which correctly requires uninterrupted contact, these brief interruptions would mean the accused products do not satisfy the "sealing member in continuous contact with" limitation. Under Apex's diluted construction, which requires only contact "during use," these interruptions would be dismissed as irrelevant.

For these reasons, Solstice respectfully submits that its proposed construction should be adopted.

VIII. DISPUTED TERM NO. 3: "BIASING ELEMENT CONFIGURED TO URGE" ('237 Patent, Claims 1, 12)

A. Apex's Proposed Construction

Apex's proposed construction: "A component that applies a force to push or move another element in a particular direction, including but not limited to springs, elastomeric elements, and resilient foam."

Apex contends that "biasing element configured to urge" is a broad functional term that encompasses any component capable of applying a force to push or move another component in a particular direction. The specification of the '237 Patent supports this broad reading by expressly identifying multiple types of biasing elements:

"The biasing element may be any component capable of applying a restoring or urging force to the sealing member. Suitable biasing elements include, but are not limited to, coil springs, leaf springs, wave springs, elastomeric O-rings or pads, resilient foam inserts, and other resilient materials."

'237 Patent col. 6, ll. 30–36. This passage is unambiguous. The specification defines the "biasing element" in terms of its function — applying a restoring or urging force — and expressly states that suitable biasing elements "include, but are not limited to" a list that encompasses both mechanical springs and non-spring components such as elastomeric pads and resilient foam. The phrase "but are not limited to" could not be clearer in indicating that the list is illustrative, not exhaustive.

A POSITA would understand "biasing element" in the same broad sense. The term "biasing element" is widely used in the mechanical engineering arts to refer generically to any component that applies a force to bias another component in a particular direction. See Sterling Reach Industries Dictionary of Scientific and Technical Terms (7th ed. 2013) (defining "bias" in the mechanical context as "a force applied to urge a component in a particular direction"). The term does not inherently connote a mechanical spring, and the specification's express inclusion of non-spring components confirms that no such limitation is warranted.

Dependent Claim 12 further supports Apex's construction. Claim 12 depends from Claim 1 and adds the limitation that "the biasing element comprises a coil spring." Under the doctrine of claim differentiation, the recitation of "a coil spring" in Claim 12 presupposes that the broader term "biasing element" in Claim 1 is not limited to coil springs. If "biasing element" in Claim 1 were already limited to mechanical springs (as Solstice proposes), dependent Claim 12's limitation to a "coil spring" would add very little scope beyond what was already required. The presumption of claim differentiation weighs strongly in favor of Apex's broader construction. See Comark Commc'ns, Inc. v. Harris Corp., 156 F.3d 1182, 1187 (Fed. Cir. 1998).

Solstice's proposed construction — limiting "biasing element" to "mechanical springs (e.g., coil springs, leaf springs)" — is unsupported by the claim language, contradicted by the specification's express "not limited to" language, and would improperly exclude embodiments specifically identified in the specification. A construction that excludes embodiments expressly described in the specification as within the scope of the invention is "rarely, if ever, correct." CCS Fitness, 288 F.3d at 1366.

For these reasons, Apex respectfully submits that its proposed construction should be adopted.

B. Solstice's Proposed Construction

Solstice's proposed construction: "A spring element that applies a restoring force in a predetermined direction, limited to mechanical springs (e.g., coil springs, leaf springs) as described in the specification."

Solstice contends that while the specification includes broad language regarding the types of components that "may" serve as biasing elements, the prosecution history narrowed the scope of this term in a manner that Apex cannot now undo.

During prosecution of the '237 Patent, the examiner cited U.S. Patent No. 8,900,178 to Ortiz ("the Ortiz reference") in a rejection of Claim 1 under 35 U.S.C. § 103. The Ortiz reference discloses a trocar seal assembly in which the seal is urged into a sealed position by the elastic compression of an elastomeric gasket — i.e., the gasket itself serves as both the seal and the biasing force. In response, the applicant argued:

"Ortiz does not disclose a separate 'biasing element configured to urge' the sealing member. In Ortiz, the seal gasket provides sealing force through its own inherent elastomeric compression. The claimed invention requires a distinct biasing element — a spring component — that is separate from the sealing member and that applies a restoring force to urge the sealing member toward the sealed position. Ortiz lacks this separate spring component."

See APEX-005891 (Applicant's Response to Third Office Action, dated November 3, 2017); Appendix D at D-10 (emphasis added). The applicant's argument explicitly characterizes the "biasing element" as "a spring component" that is "separate from the sealing member." This constitutes a clear and unambiguous prosecution history statement that limits the scope of "biasing element" to spring components, excluding elastomeric elements and resilient foam that function through their own inherent compression.

Solstice acknowledges that the specification contains the broad "including but not limited to" language cited by Apex. However, it is well-established that the prosecution history can narrow claim scope even beyond the broader language of the specification. See Ridgeway Holdings AB v. Mutual Pharm. Co., 384 F.3d 1333, 1339–40 (Fed. Cir. 2004) (prosecution history estoppel narrowed claims despite broader specification language). The applicant's own words during prosecution — describing the biasing element as "a spring component" — constitute a binding admission that the claimed "biasing element" is limited to mechanical springs.

Solstice further notes that every working example in the specification implements the "biasing element" as a mechanical spring. The preferred embodiment uses a coil compression spring ('237 Patent col. 5, l. 55); the alternative embodiment uses a leaf spring (col. 7, l. 42). While the specification's introductory passage lists "elastomeric O-rings or pads" and "resilient foam inserts" as potential biasing elements, no working example in the specification actually uses any of these non-spring materials as the biasing element. This disparity between the broad introductory language and the narrow implementation suggests that the specification's list was aspirational rather than enabling, and the prosecution history confirms that the applicant ultimately chose to pursue claims limited to spring biasing elements.

As to claim differentiation, Solstice agrees that dependent Claim 12's recitation of "a coil spring" narrows the type of spring from the broader genus of mechanical springs in Claim 1 (which may encompass coil springs, leaf springs, wave springs, and other mechanical spring types) to the specific species of coil springs. Claim differentiation is thus satisfied even under Solstice's construction: Claim 1 requires a mechanical spring of any type, while Claim 12 requires specifically a coil spring.

The significance of this construction is clear. Solstice's PrecisionEdge™ product line utilizes a molded silicone biasing pad — not a mechanical spring — to apply sealing force to the instrument seal. Under Solstice's construction, this silicone pad does not constitute a "biasing element" as that term is properly construed, and the PrecisionEdge™ products do not satisfy this claim limitation. Under Apex's impermissibly broad construction, any resilient material — including the silicone pad — would qualify, extending the claims far beyond what the applicant actually claimed during prosecution.

For these reasons, Solstice respectfully submits that its proposed construction should be adopted.

IX. DISPUTED TERM NO. 4: "RETRACTABLE BLADE DEPLOYMENT MECHANISM" ('884 Patent, Claims 1, 2, 5, 9, 14)

A. Apex's Proposed Construction

Apex's proposed construction: "A mechanism that deploys a cutting blade for tissue penetration and subsequently retracts or withdraws the blade."

Apex contends that the phrase "retractable blade deployment mechanism" should be given its plain and ordinary meaning. The term describes a mechanism that performs two functions: (1) deploying a cutting blade for the purpose of tissue penetration, and (2) subsequently retracting or withdrawing the blade. The claim language is clear and unambiguous, and the term does not specify or require any particular structural means for accomplishing these functions. Specifically, the claim does not require linear axial blade movement, automatic retraction, or any other structural limitation that Solstice seeks to impose.

The '884 Patent's title — "Retractable Blade Deployment Mechanism for Trocar Systems" — uses the same phrase as the claim term, and it reinforces the broad functional nature of the term. The abstract similarly describes the invention in functional terms: "A retractable blade deployment mechanism for a trocar system includes a cutting blade that is deployed for tissue penetration and subsequently retracted to minimize the risk of inadvertent tissue injury." '884 Patent Abstract. Neither the title nor the abstract limits the mechanism to any particular mode of blade movement.

The specification describes multiple possible modes of blade actuation. While the preferred embodiment utilizes linear axial blade movement (i.e., the blade translates along the longitudinal axis of the obturator), the specification also references alternative actuation modes:

"The blade may be deployed and retracted by any suitable actuation mechanism, including linear translation, rotary actuation, or a combination thereof. The essential feature of the retractable blade deployment mechanism is that the blade is movable between a retracted position and a deployed position."

'884 Patent col. 4, ll. 25–30. This passage explicitly contemplates rotary actuation as a suitable mode of blade deployment and retraction. Solstice's proposed construction, which requires that "the blade moves linearly along the longitudinal axis of the obturator," would exclude rotary actuation — a mode of operation expressly contemplated by the specification. Such a construction improperly imports a limitation from the preferred embodiment into the claims. See Liebel-Flarsheim, 358 F.3d at 906.

Apex further notes that Solstice's construction adds a requirement that the blade be "automatically retracted . . . by a dedicated retraction component." While the claims separately recite a "spring-loaded retraction assembly" (Disputed Term No. 5), the preamble term "retractable blade deployment mechanism" does not itself impose a requirement of automatic retraction or a dedicated retraction component. These additional limitations are addressed by other claim elements and need not be read into the overarching mechanism term. See GE Lighting Sols., LLC v. AgiLight, Inc., 750 F.3d 1304, 1311 (Fed. Cir. 2014) (cautioning against reading structural limitations from the body of a claim into a preamble term).

The construction of this term is significant because Solstice's PrecisionEdge™ PE-5000 and PE-15000 trocar assemblies employ a rotary cam-actuated blade mechanism in which the blade rotates between a deployed position and a retracted position, rather than translating linearly along the longitudinal axis. Under Apex's construction — which correctly encompasses any mechanism that deploys and retracts a blade — these products practice the claimed "retractable blade deployment mechanism." Under Solstice's construction, which would artificially limit the claims to linear axial blade movement, these products would be excluded. The specification's express reference to "rotary actuation" as a suitable alternative forecloses Solstice's attempt to narrow the claims in this manner.

For these reasons, Apex respectfully submits that its proposed construction should be adopted.

B. Solstice's Proposed Construction

Solstice's proposed construction: "A mechanism comprising a blade that is affirmatively advanced from a retracted position to a deployed position for tissue cutting and is then automatically retracted to the retracted position by a dedicated retraction component, where the blade moves linearly along the longitudinal axis of the obturator."

Solstice contends that the intrinsic record, considered as a whole, compels a construction that limits the "retractable blade deployment mechanism" to linear axial blade movement with automatic retraction by a dedicated component. Apex's proposed construction — a generic mechanism that "deploys" and "retracts" a blade — is so broad as to be meaningless, encompassing virtually any trocar obturator with a movable blade, including designs that bear no resemblance to the invention described in the '884 Patent.

Solstice begins with the specification. The detailed description of the '884 Patent devotes the entirety of its discussion of blade movement to linear axial translation. The specification states:

"The cutting blade is disposed within the blade housing and is configured to translate linearly along the longitudinal axis of the obturator between a retracted position and a deployed position. In the deployed position, the cutting edge of the blade extends distally beyond the distal end of the safety shield to penetrate tissue. In the retracted position, the blade is withdrawn proximally into the blade housing and the safety shield extends distally beyond the cutting edge."

'884 Patent col. 4, ll. 35–44. Every figure in the '884 Patent depicting blade movement shows the blade translating linearly along the longitudinal axis. FIGS. 3A–3D illustrate the blade in the retracted position (FIG. 3A), transitioning to the deployed position (FIGS. 3B–3C), and returning to the retracted positi

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
JOINT CLAIM CONSTRUCTION BRIEF
Markman Hearing Date: November 18, 2024 Filing Date: November 4, 2024
TABLE OF CONTENTS
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TABLE OF AUTHORITIES
Cases
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Treatises and Other Authorities
I. INTRODUCTION
Plaintiff Apex Surgical Innovations, Inc. ("Apex") and Defendant Solstice Biomedical, Inc. ("Solstice") respectfully submit this Joint Claim Construction Brief pursuant to the Scheduling Order entered by this Court on July 2, 2024 (D.I. 34), and in accordance with the Court's Local Patent Rules, D. Del. L.P.R. 4.1 et seq., in advance of the Markman hearing scheduled for November 18, 2024.
Apex commenced this action on May 9, 2024, by filing a Complaint (D.I. 1) alleging that Solstice infringes three United States utility patents owned by Apex, each directed to components and assemblies used in minimally invasive laparoscopic surgical access devices, commonly known as trocars. The patents-in-suit are:
1. U.S. Patent No. 9,814,237 ("the '237 Patent"), entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," issued on November 14, 2017, with an expiration date of June 22, 2035. Apex asserts Claims 1, 3, 7, and 12 of the '237 Patent.
2. U.S. Patent No. 10,271,884 ("the '884 Patent"), entitled "Retractable Blade Deployment Mechanism for Trocar Systems," issued on April 30, 2019, with an expiration date of September 15, 2036. Apex asserts Claims 1, 2, 5, 9, and 14 of the '884 Patent.
3. U.S. Patent No. 10,932,105 ("the '105 Patent"), entitled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar," issued on March 2, 2021, with an expiration date of January 10, 2038. Apex asserts Claims 1, 4, and 8 of the '105 Patent.
The named inventor on all three patents is Dr. Raymond Szabo, who serves as Vice President of Engineering at Apex. All three patents were assigned to Apex and Apex is the current owner of record of all right, title, and interest therein. Certified copies of the assignment records have been produced in this litigation and are referenced in the parties' Joint Statement of Undisputed Facts filed on September 6, 2024 (D.I. 52).
Apex alleges that three product families manufactured and sold by Solstice in the United States infringe the asserted patents. The accused products are:
• The PrecisionEdge™ PE-5000 Series (5 mm trocar assembly), accused of infringing the '237 and '884 Patents;
• The PrecisionEdge™ PE-12000 Series (12 mm trocar assembly), accused of infringing the '237, '884, and '105 Patents; and
• The PrecisionEdge™ PE-15000 Series (15 mm trocar assembly), accused of infringing the '884 and '105 Patents.
Solstice denies infringement of all asserted claims and has asserted affirmative defenses of invalidity and unenforceability. The parties' respective contentions regarding invalidity and enforceability are not addressed herein, as they are not germane to the claim construction issues presently before the Court.
In accordance with the Court's Scheduling Order, the parties exchanged their respective proposed claim constructions and supporting intrinsic evidence on October 22, 2024. See D. Del. L.P.R. 4.1(b). The parties thereafter met and conferred on October 28, 2024 and October 30, 2024, in an effort to narrow or resolve the disputed claim terms. Despite good-faith efforts, the parties were unable to reach agreement on the construction of any of the disputed terms. As a result, nine (9) claim terms remain in dispute and are presented to the Court for construction.
This Joint Claim Construction Brief sets forth the parties' respective proposed constructions for each of the nine disputed terms, the intrinsic and extrinsic evidence supporting each party's position, and the reasons why each party's construction should be adopted. The brief is organized in a joint format, with Apex's position presented first for each disputed term, followed by Solstice's position, consistent with the Court's standard practice for joint claim construction briefing in this District.
The parties recognize that claim construction is "not an invasive surgical procedure" — but the subject matter of these patents is. The patented technology at issue relates to critical safety features in laparoscopic access devices, including seal mechanisms that maintain the pneumoperitoneum necessary for visualization during laparoscopic surgery, blade retraction systems designed to prevent inadvertent tissue injury, and insufflation valve assemblies that regulate gas flow during the procedure. Proper construction of the disputed terms is essential to framing the infringement and validity issues that will be central to the resolution of this case, whether by summary judgment or trial.
II. LEGAL STANDARD FOR CLAIM CONSTRUCTION
Claim construction is a question of law to be decided by the Court. Markman v. Westview Instruments, Inc., 517 U.S. 370, 372, 388–91 (1996). The construction of patent claims determines the scope of the patent owner's right to exclude and, consequently, is a necessary predicate to the infringement and validity analyses that follow. O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1360 (Fed. Cir. 2008) (holding that where the parties raise an actual dispute regarding the proper scope of a claim term, the court has a duty to resolve it).
The words of a claim "are generally given their ordinary and customary meaning," which is "the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). This inquiry is an objective one, focused on "how a person of ordinary skill in the art understands a claim term" in light of the intrinsic record. Id. at 1313.
The intrinsic evidence is the primary basis for claim construction. Intrinsic evidence consists of three sources: (1) the claims themselves, (2) the patent specification, and (3) the prosecution history. Ridgeway & Co. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). The Federal Circuit has established a hierarchy among these sources, although all three are part of a single, holistic analysis.
The Claims. Claim construction begins — and often ends — with the language of the claims themselves. The context of the surrounding claim language is informative, as "[t]he claim in its entirety provides important context for understanding the meaning of each of its terms." Phillips, 415 F.3d at 1314. In addition, other claims in the patent, both asserted and unasserted, can shed light on the meaning of a disputed term through the doctrine of claim differentiation, which creates a presumption that each claim in a patent has a different scope. Nystrom v. Larkspur Holdings, 424 F.3d 1136, 1143 (Fed. Cir. 2005).
The Specification. The specification is "the single best guide to the meaning of a disputed term." Phillips, 415 F.3d at 1315 (quoting Vitronics, 90 F.3d at 1582). It is always appropriate to consult the specification to determine whether the inventor has used a term in a manner consistent with its ordinary meaning, or has instead given the term a special definition or otherwise limited its scope. Id. at 1316. As the Federal Circuit has cautioned, however, there is "a fine line between reading a claim in light of the specification, and reading a limitation into the claim from the specification." Hill-Rom Servs., Inc. v. Hollowell Industries, 755 F.3d 1367, 1371 (Fed. Cir. 2014) (internal quotation marks omitted). While the specification may be used to interpret what a patentee meant by a particular term, it should not be used to import limitations from particular embodiments into the claims unless the patentee has clearly limited the scope of the claims to that embodiment. Phillips, 415 F.3d at 1323.
The Prosecution History. The prosecution history, consisting of the complete record of proceedings before the United States Patent and Trademark Office ("USPTO"), "provides evidence of how the PTO and the inventor understood the patent." Phillips, 415 F.3d at 1317. The prosecution history includes prior art cited during examination, any rejections or objections by the examiner, amendments to the claims, and the applicant's arguments and remarks submitted in response to the examiner's actions. Statements made by the applicant during prosecution, including arguments distinguishing prior art, may limit the scope of the claims through prosecution history estoppel. Bell Atl. Network Servs., Inc. v. Covad Commc'ns Grp., Inc., 262 F.3d 1258, 1268 (Fed. Cir. 2001). However, the prosecution history "often lacks the clarity of the specification and thus is less useful for claim construction purposes." Phillips, 415 F.3d at 1317.
Extrinsic Evidence. Extrinsic evidence, including expert and inventor testimony, technical dictionaries, learned treatises, and other materials outside the intrinsic record, may be used to assist the Court in understanding the technology at issue and the meaning of terms to a person of ordinary skill in the art. Phillips, 415 F.3d at 1317–18; Teva Pharm. USA, Inc. v. Sandoz, Inc., 574 U.S. 318, 331 (2015). However, extrinsic evidence is "less significant than the intrinsic record in determining the legally operative meaning of claim language" and may not be used to contradict the meaning of claim terms as established by the intrinsic evidence. Phillips, 415 F.3d at 1318 (quoting C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004)).
Lexicography and Disavowal. A patentee is free to act as his or her own lexicographer by providing an explicit definition of a claim term in the specification. Thorner v. Severin Industries, 669 F.3d 1362, 1365 (Fed. Cir. 2012). When the patentee does so, the definition provided controls. Id. However, to invoke this principle, the patentee's definition must be set forth "with reasonable clarity, deliberateness, and precision." Id. Similarly, a patentee may disavow or disclaim claim scope, but such disavowal must be clear and unmistakable, appearing in the specification or prosecution history with sufficient definiteness to put the public on notice of the scope of the claimed invention. Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1117 (Fed. Cir. 2004).
Means-Plus-Function. Where a claim limitation is drafted in means-plus-function format under 35 U.S.C. § 112(f), the limitation is construed to cover the corresponding structure disclosed in the specification and equivalents thereof. Neither party contends that any of the nine disputed terms at issue in this brief should be construed under Section 112(f), and the parties agree that none of the disputed terms are drafted in means-plus-function format.
Avoiding Impermissible Constructions. The Court should not construe claims in a manner that renders them nonsensical or inconsistent with the written description. See 3 Chisum on Patents § 8.04 (2024). Nor should the Court adopt a construction so narrow as to exclude the preferred embodiment, absent clear prosecution history estoppel or lexicography supporting such a result. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002) (noting that "a claim construction that excludes a preferred embodiment is rarely, if ever, correct"). Conversely, the Court should not adopt a construction so broad that it encompasses prior art that the patentee expressly distinguished during prosecution. Abbottott Labs. v. Sandoz, Inc., 566 F.3d 1282, 1289 (Fed. Cir. 2009).
Person of Ordinary Skill in the Art. The parties agree that a person of ordinary skill in the art ("POSITA") at the time of the inventions disclosed in the patents-in-suit would have at least a Bachelor of Science degree in mechanical engineering, biomedical engineering, or a closely related field, and approximately three to five years of professional experience in the design of minimally invasive surgical instruments, specifically including experience with laparoscopic access devices and trocars. This agreed definition of a POSITA applies to all three patents-in-suit and to all nine disputed claim terms.
III. THE ASSERTED PATENTS — OVERVIEW
A. The '237 Patent — "Locking Seal Assembly for Minimally Invasive Surgical Access Device"
U.S. Patent No. 9,814,237, entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," was issued on November 14, 2017 to named inventor Dr. Raymond Szabo. The '237 Patent claims priority to U.S. Provisional Application No. 62/182,456, filed June 20, 2015, through a non-provisional application filed June 22, 2015. Under 35 U.S.C. § 154(a)(2), the '237 Patent has an expiration date of June 22, 2035. A certified copy of the '237 Patent is attached as Exhibit 1 to the Declaration of Victoria Stanton filed concurrently herewith.
The '237 Patent is directed to a locking seal assembly for use in a trocar housing that maintains pneumoperitoneum during laparoscopic surgery. In laparoscopic procedures, the abdominal cavity is insufflated with carbon dioxide gas to create a working space for the surgeon. Trocars — cylindrical access devices inserted through the abdominal wall — serve as conduits for surgical instruments. A critical design challenge for trocars is maintaining the seal around the surgical instrument shaft to prevent gas leakage, which can cause loss of pneumoperitoneum and compromise the surgeon's visualization of the surgical field. The '237 Patent addresses this challenge by disclosing a seal assembly that locks around the instrument shaft to prevent gas leakage while allowing the instrument to be inserted, manipulated, and removed.
As described in the specification, the locking seal assembly of the '237 Patent includes several components. A sealing member is disposed within the trocar housing and is configured to engage the outer surface of a surgical instrument shaft. A locking ring cooperates with the sealing member to secure the seal in a closed position. A biasing element urges the sealing member toward a sealed configuration, ensuring continuous contact with the instrument shaft during the surgical procedure. The specification describes a multi-stage locking mechanism that transitions between open, partially sealed, and fully sealed and locked positions. '237 Patent col. 3, ll. 15–40; col. 4, ll. 1–30. The specification illustrates several embodiments, including one utilizing a radially-compressing seal with a rotating lock ring (FIGS. 2A–2D) and another utilizing an axially-compressing seal with a cam-actuated lock (FIGS. 5A–5C).
Apex asserts Claims 1, 3, 7, and 12 of the '237 Patent. Claim 1 is the sole independent claim, and Claims 3, 7, and 12 are dependent claims. Claim 1, in relevant part, recites:
A locking seal assembly for a minimally invasive surgical access device, the assembly comprising:
a housing defining an interior chamber and configured to receive a surgical instrument therethrough;
a sealing member disposed within the interior chamber, the sealing member in continuous contact with an outer surface of the surgical instrument during use;
a locking ring movably disposed within the housing and configured to engage the sealing member to secure the sealing member in a sealed position; and
a biasing element configured to urge the sealing member toward the sealed position.
The full text of all asserted claims of the '237 Patent is set forth in Appendix A. Three of the nine disputed terms at issue in this Joint Brief arise from the '237 Patent: "locking seal assembly" (Disputed Term No. 1), "sealing member in continuous contact with" (Disputed Term No. 2), and "biasing element configured to urge" (Disputed Term No. 3).
B. The '884 Patent — "Retractable Blade Deployment Mechanism for Trocar Systems"
U.S. Patent No. 10,271,884, entitled "Retractable Blade Deployment Mechanism for Trocar Systems," was issued on April 30, 2019 to named inventor Dr. Raymond Szabo. The '884 Patent claims priority to U.S. Provisional Application No. 62/399,012, filed September 14, 2016, through a non-provisional application filed September 15, 2016. Under 35 U.S.C. § 154(a)(2), the '884 Patent has an expiration date of September 15, 2036. A certified copy of the '884 Patent is attached as Exhibit 2 to the Stanton Declaration.
The '884 Patent is directed to a mechanism for deploying and retracting a cutting blade within a trocar obturator. Trocar obturators are sharp-tipped inner components inserted through the trocar cannula to penetrate the abdominal wall. After the abdominal wall is penetrated, the obturator blade must be retracted or shielded to prevent inadvertent injury to underlying tissue and organs. The '884 Patent discloses a spring-loaded retraction system and a safety shield that addresses this clinical need. The mechanism is designed to automatically retract the blade after tissue penetration, minimizing the risk of injury to intra-abdominal structures.
The specification describes a blade housed within a blade housing that is fixedly secured to the obturator shaft. A spring-loaded retraction assembly stores mechanical energy during the deployment phase and releases it to retract the blade after penetration is detected by a change in resistance at the blade tip. A safety shield extends distally beyond the cutting edge of the blade when the blade is in the retracted position, providing a physical barrier between the sharp edge and surrounding tissue. '884 Patent col. 4, ll. 10–45; col. 5, ll. 1–60. The specification illustrates the preferred embodiment with reference to FIGS. 3A–3D, depicting a tubular shield concentrically surrounding the blade.
Apex asserts Claims 1, 2, 5, 9, and 14 of the '884 Patent. Claim 1 is the sole independent claim, and Claims 2, 5, 9, and 14 are dependent claims. Claim 1, in relevant part, recites:
A retractable blade deployment mechanism for a trocar system, the mechanism comprising:
a blade housing fixedly secured to an obturator shaft;
a cutting blade movably disposed within the blade housing between a retracted position and a deployed position;
a spring-loaded retraction assembly operatively connected to the cutting blade and configured to retract the cutting blade from the deployed position to the retracted position; and
a safety shield extending distally beyond a cutting edge of the cutting blade when the cutting blade is in the retracted position.
The full text of all asserted claims of the '884 Patent is set forth in Appendix A. Four of the nine disputed terms at issue in this Joint Brief arise from the '884 Patent: "retractable blade deployment mechanism" (Disputed Term No. 4), "spring-loaded retraction assembly" (Disputed Term No. 5), "safety shield extending distally beyond" (Disputed Term No. 6), and "blade housing fixedly secured to" (Disputed Term No. 7).
C. The '105 Patent — "Integrated Insufflation Valve and Seal for Laparoscopic Trocar"
U.S. Patent No. 10,932,105, entitled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar," was issued on March 2, 2021 to named inventor Dr. Raymond Szabo. The '105 Patent claims priority to U.S. Provisional Application No. 62/960,118, filed January 10, 2020, through a non-provisional application filed January 11, 2020. Under 35 U.S.C. § 154(a)(2), the '105 Patent has an expiration date of January 10, 2038. A certified copy of the '105 Patent is attached as Exhibit 3 to the Stanton Declaration.
The '105 Patent is directed to an integrated valve and seal structure within a trocar cannula that simultaneously controls the flow of insufflation gas into the abdominal cavity and seals around surgical instruments passed through the trocar. In conventional trocar designs, the insufflation valve (typically a stopcock-type valve) and the instrument seal are separate components, adding to the overall bulk and complexity of the trocar and creating potential leak points. The '105 Patent discloses a unitary approach that combines these two functions into a single structural component, referred to as the "integrated insufflation valve and seal."
The specification describes a valve body containing a flow regulation channel that controls the rate and direction of insufflation gas flow. A deformable seal element, integrated into the valve body, conforms to the outer surface of a surgical instrument to maintain a gas-tight seal. The flow regulation channel is described as being in fluid communication with an insufflation port on the trocar cannula. '105 Patent col. 3, ll. 1–40; col. 4, ll. 5–35. The specification states that "the integrated valve and seal is formed as a single molded component" (col. 3, ll. 5–12) and describes the manufacturing process as involving injection molding of a medical-grade silicone elastomer.
Apex asserts Claims 1, 4, and 8 of the '105 Patent. Claim 1 is the sole independent claim, and Claims 4 and 8 are dependent claims. Claim 1, in relevant part, recites:
An integrated insufflation valve and seal for a laparoscopic trocar, comprising:
a valve body configured to be received within a trocar cannula;
a flow regulation channel disposed within the valve body and in fluid communication with an insufflation port of the trocar cannula, the flow regulation channel configured to regulate a flow of insufflation gas;
a deformable seal element integrally formed with the valve body, the deformable seal element configured to sealingly engage an outer surface of a surgical instrument received through the valve body.
The full text of all asserted claims of the '105 Patent is set forth in Appendix A. Two of the nine disputed terms at issue in this Joint Brief arise from the '105 Patent: "integrated insufflation valve and seal" (Disputed Term No. 8) and "flow regulation channel in fluid communication with" (Disputed Term No. 9).
IV. THE NINE DISPUTED CLAIM TERMS — OVERVIEW TABLE
Pursuant to D. Del. L.P.R. 4.2, the parties have prepared the following summary table identifying each of the nine disputed claim terms, the patent(s) and claim(s) in which each term appears, and the parties' respective proposed constructions. A more detailed Joint Claim Construction Chart is attached as Appendix B.
As the table reflects, the central dispute between the parties concerns the breadth of the patent claims. Apex generally proposes constructions that it contends reflect the plain and ordinary meaning of the claim terms and preserve the full scope of the patent claims as written. Solstice generally proposes narrower constructions that it contends are compelled by the specification and prosecution history, and that properly limit the claims to the inventions actually disclosed and claimed.
V. AGREED CONSTRUCTIONS
Pursuant to D. Del. L.P.R. 4.3, the parties have attempted in good faith to resolve as many claim construction disputes as possible without the need for judicial intervention. The parties exchanged proposed claim constructions on October 22, 2024, and subsequently met and conferred on October 28, 2024 and October 30, 2024. Despite these efforts, the parties were unable to agree on the construction of any of the nine disputed terms identified above. All nine terms remain in dispute and are submitted to the Court for resolution.
The parties do, however, agree on the following matters relevant to claim construction:
1. Person of Ordinary Skill in the Art. The parties agree that a person of ordinary skill in the art ("POSITA") at the time of the inventions disclosed in the patents-in-suit would have at least a Bachelor of Science degree in mechanical engineering, biomedical engineering, or a closely related field, and approximately three to five years of professional experience in the design of minimally invasive surgical instruments, specifically including experience with laparoscopic access devices and trocars. This agreed definition applies to all three patents-in-suit and to all nine disputed terms.
2. No Means-Plus-Function Terms. The parties agree that none of the nine disputed terms at issue in this brief are drafted in means-plus-function format under 35 U.S.C. § 112(f), and that construction under Section 112(f) is not required or appropriate for any of the disputed terms.
3. No Indefiniteness Challenge to Disputed Terms. Solstice does not contend that any of the nine disputed terms at issue in this brief are indefinite under 35 U.S.C. § 112(b). Solstice reserves the right to assert indefiniteness as to other claim terms not at issue in this brief.
Beyond these agreements, the parties' positions diverge as set forth in the term-by-term analysis that follows.
VI. DISPUTED TERM NO. 1: "LOCKING SEAL ASSEMBLY" ('237 Patent, Claims 1, 3, 7, 12)
A. Apex's Proposed Construction
Apex's proposed construction: "An assembly that includes a seal and a locking mechanism that, when engaged, secures the seal in a closed position around a surgical instrument."
Apex contends that its proposed construction faithfully reflects the plain and ordinary meaning of the term "locking seal assembly" as it would be understood by a person of ordinary skill in the art. Each word of the term carries its common meaning: "locking" refers to a mechanism that secures or fixes something in position; "seal" refers to a component that prevents the passage of fluid (here, insufflation gas); and "assembly" refers to a collection of parts that work together. Taken together, the phrase describes an assembly that includes a seal and a locking mechanism, where the locking mechanism secures the seal in a closed position around a surgical instrument.
Apex's construction is fully supported by the intrinsic record. The specification of the '237 Patent describes the "locking seal assembly" in broad terms at multiple points. For example, at column 3, lines 15–40, the specification states:
"The present invention provides a locking seal assembly for a minimally invasive surgical access device. The locking seal assembly comprises a sealing member and a locking mechanism. The locking mechanism may take various forms, including but not limited to a rotating lock ring, a cam-actuated clamp, or a lever-actuated compression collar. The essential function of the locking mechanism is to secure the sealing member in a closed and sealed position around the shaft of a surgical instrument inserted through the trocar."
This passage demonstrates that the specification contemplates range structural configurations for the locking mechanism, and does not limit the "locking seal assembly" to any single embodiment. The specification expressly states that the locking mechanism "may take various forms," including a rotating lock ring (the preferred embodiment illustrated in FIGS. 2A–2D), a cam-actuated clamp, or a lever-actuated compression collar. See '237 Patent col. 3, ll. 22–28.
In addition, the specification describes a second embodiment of the locking seal assembly at column 7, lines 10–35, which utilizes an axially-compressing seal with a cam-actuated lock rather than a radially-compressing seal with a rotating lock ring. The specification states that this alternative embodiment "provides the same locking seal function" as the preferred embodiment, differing only in "the direction of compression applied to the sealing member and the specific mechanical configuration of the locking mechanism." '237 Patent col. 7, ll. 15–20. This further confirms that the claim term "locking seal assembly" is not limited to the radially-compressing, rotating-lock-ring configuration of the preferred embodiment.
Apex's construction also finds support in the claim language itself. Claim 1 recites "a locking seal assembly" as a preamble term and then separately recites the specific structural components of the assembly: "a sealing member," "a locking ring," and "a biasing element." This structure demonstrates that the "locking seal assembly" is a broad, overarching term for the assembly as a whole, and the specific structural components are separately recited in the body of the claim. To construe "locking seal assembly" as requiring a radially-compressing seal and a mechanical lock ring — as Solstice proposes — would improperly conflate the preamble term with the specifically recited structural limitations of the claim body. See Phillips, 415 F.3d at 1314 (claim language provides context); Hill-Rom Servs., 755 F.3d at 1371 (cautioning against importing limitations from the specification into the claims).
Solstice's proposed construction improperly narrows the "locking seal assembly" term in two respects. First, it adds a limitation that the seal must be a "radially-compressing seal element," which is drawn from only one of the multiple embodiments described in the specification. See Ashford Enterprises v. Dunmore Corporation, 358 F.3d 898, 906 (Fed. Cir. 2004) (holding it error to import a limitation from a preferred embodiment when the specification does not limit the invention to that embodiment). The specification expressly contemplates axially-compressing seals in addition to radially-compressing seals. Second, Solstice's construction adds a negative limitation — "as distinguished from a friction-fit or elastomeric seal that does not employ a separate locking component" — that is not found in the claim language itself. While the prosecution history may place some limits on claim scope, those limits must be "clear and unmistakable." See Innova/Pure Water, 381 F.3d at 1117. As discussed further in Section XV.A below, the prosecution history does not compel Solstice's narrow reading.
Apex further notes that even where a patentee makes arguments to distinguish prior art during prosecution, those arguments do not necessarily limit the scope of the claims unless the patentee "clearly and unmistakably" disclaimed the broader construction. Ashford Corporation v. Marposs Società per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998). In this case, the applicant's prosecution arguments focused on the absence of a separate locking mechanism in the prior art, not on the specific structural form of the locking mechanism. The applicant never stated that the claimed "locking seal assembly" required a radially-compressing seal or that it excluded all seals that include elastomeric components. To the contrary, the sealing member in the preferred embodiment of the '237 Patent is itself an elastomeric component (an O-ring seal, '237 Patent col. 4, l. 45), and the "locking" function refers to the additional mechanical mechanism that secures the seal in place — not to the material composition of the seal itself.
For these reasons, Apex respectfully submits that its proposed construction should be adopted.
B. Solstice's Proposed Construction
Solstice's proposed construction: "An assembly comprising a radially-compressing seal element and a mechanical lock ring that physically engages the seal element to maintain the seal in a compressed state, as distinguished from a friction-fit or elastomeric seal that does not employ a separate locking component."
Solstice contends that the proper construction of "locking seal assembly" must be understood in the context of the full intrinsic record, including not only the specification but also the prosecution history, which together compel a construction narrower than the overbroad reading proposed by Apex.
Solstice begins with the specification. While Apex points to language describing multiple possible forms of the "locking mechanism," the specification is far more consistent in its treatment of the "locking seal assembly" as a whole. The specification's detailed description begins at column 3 by distinguishing the claimed invention from the prior art:
"Prior art trocar seal assemblies have relied on friction-fit seals or self-sealing elastomeric gaskets that do not employ a separate locking component. Such seals are prone to gas leakage, particularly when instruments of varying diameters are inserted through the trocar. The present invention overcomes this limitation by providing a locking seal assembly in which a mechanical lock ring physically engages the seal element to maintain the seal in a compressed state around the instrument shaft."
'237 Patent col. 2, ll. 55–65 (emphasis added). This passage establishes the fundamental point of novelty of the "locking seal assembly" — it employs a separate mechanical lock ring that physically engages the seal to maintain compression, as distinguished from prior art friction-fit or self-sealing elastomeric gaskets. The specification thus draws a clear line between the claimed invention and the prior art, and that line runs through the requirement of a separate mechanical locking component.
Solstice further relies on the prosecution history to confirm this understanding. During prosecution of the '237 Patent, the examiner initially rejected Claim 1 under 35 U.S.C. § 102(a)(1) as anticipated by U.S. Patent No. 7,621,886 to Conlon ("the Conlon reference"). The Conlon reference discloses a trocar seal assembly using a self-sealing elastomeric gasket that compresses around the instrument shaft by the elastic properties of the gasket material itself, without a separate mechanical locking component. In response to the Office Action, the applicant (Dr. Szabo, through counsel) amended Claim 1 to add the word "locking" before "seal assembly" and argued:
"The amended claims are patentably distinct from Conlon. Conlon discloses a friction-fit elastomeric seal that relies solely on the compressive elasticity of the gasket material to seal around an instrument shaft. Conlon does not disclose, teach, or suggest a locking seal assembly — i.e., one that includes a separate, mechanically-actuated locking component, such as a lock ring, that physically engages the seal element to maintain the seal in a compressed state. The claims as amended require this distinct structural feature, which is absent from Conlon."
See APEX-004782 (Applicant's Response to First Office Action, dated March 14, 2017) (emphasis in original); Appendix D at D-3. The applicant's amendment and argument constitute a clear and unmistakable disavowal of claim scope. By adding "locking" to distinguish the claims from the friction-fit elastomeric seal of Conlon, and by explicitly arguing that the claims "require" a "separate, mechanically-actuated locking component, such as a lock ring," the applicant surrendered any construction of "locking seal assembly" that would encompass seals without a separate mechanical locking component. See Abbottott Labs., 566 F.3d at 1289 (prosecution history estoppel applies where the applicant makes "clear and unmistakable" arguments to distinguish prior art); CCS Fitness, 288 F.3d at 1367 (arguments made to overcome rejection estop the patentee from later adopting a broader construction).
Solstice further notes that every embodiment in the specification describes the "locking seal assembly" as incorporating a radially-compressing seal element. Even the alternative embodiment described at column 7 of the specification, which uses a cam-actuated lock rather than a rotating lock ring, still employs a radially-compressing seal. The specification does not describe any embodiment in which the seal is not radially compressed when the locking mechanism is engaged. Apex's assertion that the specification contemplates axially-compressing seals conflates the direction of force applied by the locking mechanism (which may be axial, radial, or cam-actuated) with the mode of compression of the seal element itself (which the specification consistently describes as radial). See '237 Patent col. 7, ll. 10–35 (describing the cam-actuated embodiment as producing "radial compression of the seal element through the axial force of the cam mechanism").
Solstice acknowledges that a "locking seal assembly" need not be limited to the exact rotating lock ring of the preferred embodiment — the claim term may encompass other types of mechanical locking components (e.g., cam-actuated locks, lever-actuated compression collars) that physically engage the seal element. But the claim term must, at a minimum, require: (1) a radially-compressing seal element and (2) a separate mechanical locking component that physically engages the seal element, as distinguished from a friction-fit or self-sealing elastomeric seal that achieves sealing through its own inherent elasticity without a separate locking component.
The significance of this construction to the infringement analysis is straightforward. Solstice's PrecisionEdge™ PE-5000 and PE-12000 Series trocar assemblies utilize elastomeric self-sealing gaskets that achieve sealing through the inherent compressive properties of the gasket material. These products do not employ a distinct mechanical lock ring or any other separate locking component that physically engages the seal element. Under Solstice's construction — which is compelled by the specification and prosecution history — these products do not meet the "locking seal assembly" limitation and therefore do not infringe the asserted claims of the '237 Patent. Under Apex's impermissibly broad construction, by contrast, virtually any trocar seal could be characterized as a "locking seal assembly," which would render the "locking" limitation meaningless and extend the claims far beyond the scope of the actual invention. See Glenrock Enterprises v. Adriatic Partners LLC, 242 F.3d 1337, 1341 (Fed. Cir. 2001) (claims must be construed consistently with the specification's description of the invention).
For these reasons, Solstice respectfully submits that its proposed construction should be adopted.
VII. DISPUTED TERM NO. 2: "SEALING MEMBER IN CONTINUOUS CONTACT WITH" ('237 Patent, Claims 1, 7)
A. Apex's Proposed Construction
Apex's proposed construction: "A sealing component that maintains contact with the instrument shaft during use of the device."
Apex contends that the phrase "sealing member in continuous contact with" should be given its plain and ordinary meaning, which requires that the sealing member maintain contact with the instrument shaft during the operative use of the device — that is, during the laparoscopic surgical procedure. Apex's construction is faithful to the claim language, the specification, and the understanding of a person of ordinary skill in the art.
The specification supports Apex's construction. The '237 Patent describes the sealing member as maintaining contact with the instrument shaft "throughout the surgical procedure" to prevent gas leakage. '237 Patent col. 5, ll. 20–28. The specification further explains that the purpose of the "continuous contact" requirement is to ensure maintenance of pneumoperitoneum: "The sealing member maintains continuous contact with the outer surface of the instrument shaft throughout the surgical procedure, thereby preventing escape of insufflation gas from the abdominal cavity." Id. at col. 5, ll. 22–26.
Notably, the specification does not require that the seal maintain contact with the instrument shaft at all times in every conceivable scenario, including during the initial insertion of the instrument through the seal, during instrument exchange, or during removal of the instrument at the conclusion of the procedure. These are transient events during which temporary loss of contact is inherent in the physical operation of any trocar seal. The specification describes "continuous contact" in the context of use of the device — i.e., during the period in which the instrument is positioned within the trocar and the surgeon is performing the procedure. A POSITA would understand "continuous contact" in this practical, functional sense.
Apex's construction is further supported by dependent Claim 7, which adds the limitation that "the sealing member maintains a gas-tight seal around the instrument shaft during manipulation of the instrument." Claim 7 does not add a limitation requiring contact during insertion and removal; rather, it focuses on maintaining a seal "during manipulation." This is consistent with Apex's reading that "continuous contact" in Claim 1 refers to contact during operative use, not at every conceivable moment. Under the doctrine of claim differentiation, Claim 7's additional limitation must add scope beyond what is already required by Claim 1, which would not be the case if Claim 1's "continuous contact" already required uninterrupted contact at all times. See Phillips, 415 F.3d at 1314–15.
Solstice's proposed construction, by contrast, requires "uninterrupted physical contact . . . at all times when the instrument is positioned within the trocar, including during insertion, use, and removal." This construction imposes a requirement that the sealing member never break contact with the instrument shaft from the moment the instrument enters the seal to the moment it is withdrawn. This is an unrealistic physical impossibility for many trocar seal designs — including the preferred embodiment of the '237 Patent itself. As described in the specification, the locking seal assembly transitions through an "open" position to allow instrument insertion, during which the sealing member is not in full contact with the instrument shaft. '237 Patent col. 5, ll. 5–10. Solstice's construction would, paradoxically, exclude the preferred embodiment of the patent, which the Federal Circuit has repeatedly held is a strong indicator of an erroneous construction. See CCS Fitness, 288 F.3d at 1366.
For these reasons, Apex respectfully submits that its proposed construction should be adopted.
B. Solstice's Proposed Construction
Solstice's proposed construction: "A sealing component that maintains uninterrupted physical contact with the outer surface of the instrument shaft at all times when the instrument is positioned within the trocar, including during insertion, use, and removal."
Solstice contends that the plain and ordinary meaning of "continuous contact" requires uninterrupted physical contact — not the intermittent, sometime-during-use contact proposed by Apex. The word "continuous" has a clear and well-understood meaning in both common parlance and technical usage: it means "without interruption." See Sterling Reach Industries Dictionary of Scientific and Technical Terms (7th ed. 2013) (defining "continuous" as "without interruption in time, sequence, or extent"). Apex's construction effectively reads the word "continuous" out of the claim, replacing it with a requirement of merely "some contact" or "contact during parts of the procedure."
The specification confirms this understanding. The passage cited by Apex — "the sealing member maintains continuous contact with the outer surface of the instrument shaft throughout the surgical procedure" ('237 Patent col. 5, ll. 22–26) — uses both "continuous" and "throughout" to describe unbroken, ongoing contact. A POSITA reading this passage would understand it to require that the seal remain in contact with the instrument shaft continuously, without interruption, for the duration of the time the instrument is positioned within the trocar.
Solstice further relies on the prosecution history. During prosecution, the examiner issued a second Office Action citing U.S. Patent No. 8,403,891 to Wenchell ("the Wenchell reference"), which discloses a trocar seal that contacts the instrument shaft intermittently — i.e., the seal makes and breaks contact with the shaft as the instrument is manipulated. In response, the applicant distinguished the Wenchell reference by arguing:
"Unlike Wenchell, the claimed sealing member is in continuous contact with the outer surface of the instrument shaft. Wenchell's seal makes only intermittent contact, breaking and re-establishing contact as the instrument is moved. The present claims require continuous, unbroken contact to ensure a gas-tight seal is maintained at all times."
See APEX-005218 (Applicant's Response to Second Office Action, dated August 22, 2017) (emphasis in original); Appendix D at D-7. This argument constitutes a clear statement by the applicant that "continuous contact" means "continuous, unbroken contact . . . at all times" — precisely the construction Solstice proposes. The applicant's own words during prosecution foreclose Apex's attempt to water down "continuous" to mean merely "during use."
Solstice addresses Apex's claim-differentiation argument based on dependent Claim 7. Apex contends that Claim 7's "gas-tight seal during manipulation" limitation would be superfluous if Claim 1 already required uninterrupted contact. Solstice disagrees. Claim 7 adds a specific functional requirement — that the seal be "gas-tight" — beyond the physical requirement of "continuous contact" in Claim 1. A seal may be in continuous contact with an instrument shaft without necessarily forming a gas-tight seal at every moment (for example, if the contact is not circumferentially complete). Claim 7 thus narrows the claim by requiring not merely continuous contact but continuous gas-tight sealing. The two limitations are distinct, and claim differentiation is therefore satisfied.
The significance of this dispute is material to the infringement analysis. Solstice contends that the PrecisionEdge™ PE-5000 and PE-12000 seal assemblies experience brief interruptions in contact between the seal and the instrument shaft during instrument exchange — a moment when the outgoing instrument is partially withdrawn and the incoming instrument has not yet fully engaged the seal. Under Solstice's construction, which correctly requires uninterrupted contact, these brief interruptions would mean the accused products do not satisfy the "sealing member in continuous contact with" limitation. Under Apex's diluted construction, which requires only contact "during use," these interruptions would be dismissed as irrelevant.
For these reasons, Solstice respectfully submits that its proposed construction should be adopted.
VIII. DISPUTED TERM NO. 3: "BIASING ELEMENT CONFIGURED TO URGE" ('237 Patent, Claims 1, 12)
A. Apex's Proposed Construction
Apex's proposed construction: "A component that applies a force to push or move another element in a particular direction, including but not limited to springs, elastomeric elements, and resilient foam."
Apex contends that "biasing element configured to urge" is a broad functional term that encompasses any component capable of applying a force to push or move another component in a particular direction. The specification of the '237 Patent supports this broad reading by expressly identifying multiple types of biasing elements:
"The biasing element may be any component capable of applying a restoring or urging force to the sealing member. Suitable biasing elements include, but are not limited to, coil springs, leaf springs, wave springs, elastomeric O-rings or pads, resilient foam inserts, and other resilient materials."
'237 Patent col. 6, ll. 30–36. This passage is unambiguous. The specification defines the "biasing element" in terms of its function — applying a restoring or urging force — and expressly states that suitable biasing elements "include, but are not limited to" a list that encompasses both mechanical springs and non-spring components such as elastomeric pads and resilient foam. The phrase "but are not limited to" could not be clearer in indicating that the list is illustrative, not exhaustive.
A POSITA would understand "biasing element" in the same broad sense. The term "biasing element" is widely used in the mechanical engineering arts to refer generically to any component that applies a force to bias another component in a particular direction. See Sterling Reach Industries Dictionary of Scientific and Technical Terms (7th ed. 2013) (defining "bias" in the mechanical context as "a force applied to urge a component in a particular direction"). The term does not inherently connote a mechanical spring, and the specification's express inclusion of non-spring components confirms that no such limitation is warranted.
Dependent Claim 12 further supports Apex's construction. Claim 12 depends from Claim 1 and adds the limitation that "the biasing element comprises a coil spring." Under the doctrine of claim differentiation, the recitation of "a coil spring" in Claim 12 presupposes that the broader term "biasing element" in Claim 1 is not limited to coil springs. If "biasing element" in Claim 1 were already limited to mechanical springs (as Solstice proposes), dependent Claim 12's limitation to a "coil spring" would add very little scope beyond what was already required. The presumption of claim differentiation weighs strongly in favor of Apex's broader construction. See Comark Commc'ns, Inc. v. Harris Corp., 156 F.3d 1182, 1187 (Fed. Cir. 1998).
Solstice's proposed construction — limiting "biasing element" to "mechanical springs (e.g., coil springs, leaf springs)" — is unsupported by the claim language, contradicted by the specification's express "not limited to" language, and would improperly exclude embodiments specifically identified in the specification. A construction that excludes embodiments expressly described in the specification as within the scope of the invention is "rarely, if ever, correct." CCS Fitness, 288 F.3d at 1366.
For these reasons, Apex respectfully submits that its proposed construction should be adopted.
B. Solstice's Proposed Construction
Solstice's proposed construction: "A spring element that applies a restoring force in a predetermined direction, limited to mechanical springs (e.g., coil springs, leaf springs) as described in the specification."
Solstice contends that while the specification includes broad language regarding the types of components that "may" serve as biasing elements, the prosecution history narrowed the scope of this term in a manner that Apex cannot now undo.
During prosecution of the '237 Patent, the examiner cited U.S. Patent No. 8,900,178 to Ortiz ("the Ortiz reference") in a rejection of Claim 1 under 35 U.S.C. § 103. The Ortiz reference discloses a trocar seal assembly in which the seal is urged into a sealed position by the elastic compression of an elastomeric gasket — i.e., the gasket itself serves as both the seal and the biasing force. In response, the applicant argued:
"Ortiz does not disclose a separate 'biasing element configured to urge' the sealing member. In Ortiz, the seal gasket provides sealing force through its own inherent elastomeric compression. The claimed invention requires a distinct biasing element — a spring component — that is separate from the sealing member and that applies a restoring force to urge the sealing member toward the sealed position. Ortiz lacks this separate spring component."
See APEX-005891 (Applicant's Response to Third Office Action, dated November 3, 2017); Appendix D at D-10 (emphasis added). The applicant's argument explicitly characterizes the "biasing element" as "a spring component" that is "separate from the sealing member." This constitutes a clear and unambiguous prosecution history statement that limits the scope of "biasing element" to spring components, excluding elastomeric elements and resilient foam that function through their own inherent compression.
Solstice acknowledges that the specification contains the broad "including but not limited to" language cited by Apex. However, it is well-established that the prosecution history can narrow claim scope even beyond the broader language of the specification. See Ridgeway Holdings AB v. Mutual Pharm. Co., 384 F.3d 1333, 1339–40 (Fed. Cir. 2004) (prosecution history estoppel narrowed claims despite broader specification language). The applicant's own words during prosecution — describing the biasing element as "a spring component" — constitute a binding admission that the claimed "biasing element" is limited to mechanical springs.
Solstice further notes that every working example in the specification implements the "biasing element" as a mechanical spring. The preferred embodiment uses a coil compression spring ('237 Patent col. 5, l. 55); the alternative embodiment uses a leaf spring (col. 7, l. 42). While the specification's introductory passage lists "elastomeric O-rings or pads" and "resilient foam inserts" as potential biasing elements, no working example in the specification actually uses any of these non-spring materials as the biasing element. This disparity between the broad introductory language and the narrow implementation suggests that the specification's list was aspirational rather than enabling, and the prosecution history confirms that the applicant ultimately chose to pursue claims limited to spring biasing elements.
As to claim differentiation, Solstice agrees that dependent Claim 12's recitation of "a coil spring" narrows the type of spring from the broader genus of mechanical springs in Claim 1 (which may encompass coil springs, leaf springs, wave springs, and other mechanical spring types) to the specific species of coil springs. Claim differentiation is thus satisfied even under Solstice's construction: Claim 1 requires a mechanical spring of any type, while Claim 12 requires specifically a coil spring.
The significance of this construction is clear. Solstice's PrecisionEdge™ product line utilizes a molded silicone biasing pad — not a mechanical spring — to apply sealing force to the instrument seal. Under Solstice's construction, this silicone pad does not constitute a "biasing element" as that term is properly construed, and the PrecisionEdge™ products do not satisfy this claim limitation. Under Apex's impermissibly broad construction, any resilient material — including the silicone pad — would qualify, extending the claims far beyond what the applicant actually claimed during prosecution.
For these reasons, Solstice respectfully submits that its proposed construction should be adopted.
IX. DISPUTED TERM NO. 4: "RETRACTABLE BLADE DEPLOYMENT MECHANISM" ('884 Patent, Claims 1, 2, 5, 9, 14)
A. Apex's Proposed Construction
Apex's proposed construction: "A mechanism that deploys a cutting blade for tissue penetration and subsequently retracts or withdraws the blade."
Apex contends that the phrase "retractable blade deployment mechanism" should be given its plain and ordinary meaning. The term describes a mechanism that performs two functions: (1) deploying a cutting blade for the purpose of tissue penetration, and (2) subsequently retracting or withdrawing the blade. The claim language is clear and unambiguous, and the term does not specify or require any particular structural means for accomplishing these functions. Specifically, the claim does not require linear axial blade movement, automatic retraction, or any other structural limitation that Solstice seeks to impose.
The '884 Patent's title — "Retractable Blade Deployment Mechanism for Trocar Systems" — uses the same phrase as the claim term, and it reinforces the broad functional nature of the term. The abstract similarly describes the invention in functional terms: "A retractable blade deployment mechanism for a trocar system includes a cutting blade that is deployed for tissue penetration and subsequently retracted to minimize the risk of inadvertent tissue injury." '884 Patent Abstract. Neither the title nor the abstract limits the mechanism to any particular mode of blade movement.
The specification describes multiple possible modes of blade actuation. While the preferred embodiment utilizes linear axial blade movement (i.e., the blade translates along the longitudinal axis of the obturator), the specification also references alternative actuation modes:
"The blade may be deployed and retracted by any suitable actuation mechanism, including linear translation, rotary actuation, or a combination thereof. The essential feature of the retractable blade deployment mechanism is that the blade is movable between a retracted position and a deployed position."
'884 Patent col. 4, ll. 25–30. This passage explicitly contemplates rotary actuation as a suitable mode of blade deployment and retraction. Solstice's proposed construction, which requires that "the blade moves linearly along the longitudinal axis of the obturator," would exclude rotary actuation — a mode of operation expressly contemplated by the specification. Such a construction improperly imports a limitation from the preferred embodiment into the claims. See Liebel-Flarsheim, 358 F.3d at 906.
Apex further notes that Solstice's construction adds a requirement that the blade be "automatically retracted . . . by a dedicated retraction component." While the claims separately recite a "spring-loaded retraction assembly" (Disputed Term No. 5), the preamble term "retractable blade deployment mechanism" does not itself impose a requirement of automatic retraction or a dedicated retraction component. These additional limitations are addressed by other claim elements and need not be read into the overarching mechanism term. See GE Lighting Sols., LLC v. AgiLight, Inc., 750 F.3d 1304, 1311 (Fed. Cir. 2014) (cautioning against reading structural limitations from the body of a claim into a preamble term).
The construction of this term is significant because Solstice's PrecisionEdge™ PE-5000 and PE-15000 trocar assemblies employ a rotary cam-actuated blade mechanism in which the blade rotates between a deployed position and a retracted position, rather than translating linearly along the longitudinal axis. Under Apex's construction — which correctly encompasses any mechanism that deploys and retracts a blade — these products practice the claimed "retractable blade deployment mechanism." Under Solstice's construction, which would artificially limit the claims to linear axial blade movement, these products would be excluded. The specification's express reference to "rotary actuation" as a suitable alternative forecloses Solstice's attempt to narrow the claims in this manner.
For these reasons, Apex respectfully submits that its proposed construction should be adopted.
B. Solstice's Proposed Construction
Solstice's proposed construction: "A mechanism comprising a blade that is affirmatively advanced from a retracted position to a deployed position for tissue cutting and is then automatically retracted to the retracted position by a dedicated retraction component, where the blade moves linearly along the longitudinal axis of the obturator."
Solstice contends that the intrinsic record, considered as a whole, compels a construction that limits the "retractable blade deployment mechanism" to linear axial blade movement with automatic retraction by a dedicated component. Apex's proposed construction — a generic mechanism that "deploys" and "retracts" a blade — is so broad as to be meaningless, encompassing virtually any trocar obturator with a movable blade, including designs that bear no resemblance to the invention described in the '884 Patent.
Solstice begins with the specification. The detailed description of the '884 Patent devotes the entirety of its discussion of blade movement to linear axial translation. The specification states:
"The cutting blade is disposed within the blade housing and is configured to translate linearly along the longitudinal axis of the obturator between a retracted position and a deployed position. In the deployed position, the cutting edge of the blade extends distally beyond the distal end of the safety shield to penetrate tissue. In the retracted position, the blade is withdrawn proximally into the blade housing and the safety shield extends distally beyond the cutting edge."
'884 Patent col. 4, ll. 35–44. Every figure in the '884 Patent depicting blade movement shows the blade translating linearly along the longitudinal axis. FIGS. 3A–3D illustrate the blade in the retracted position (FIG. 3A), transitioning to the deployed position (FIGS. 3B–3C), and returning to the retracted positi

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

JOINT CLAIM CONSTRUCTION BRIEF

TABLE OF CONTENTS

TABLE OF AUTHORITIES

I. INTRODUCTION

II. LEGAL STANDARD FOR CLAIM CONSTRUCTION

V. AGREED CONSTRUCTIONS

Record

Parties

Dates

Amounts