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1037-00004 · Solstice Biomedical Devices Ltd · Claim Construction & Invalidity

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PRELIMINARY CLAIM CHART — NON-INFRINGEMENT ANALYSIS

U.S. Patent No. 9,814,237

"Locking Seal Assembly for Minimally Invasive Surgical Access Device"

Date: July 20, 2024

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1. Introduction and Purpose

This memorandum presents a preliminary element-by-element claim chart mapping the asserted claims of U.S. Patent No. 9,814,237 (hereinafter, "the '237 Patent") against Solstice Biomedical's PrecisionEdge™ PE-5000 Series (5 mm trocar assembly) and PrecisionEdge™ PE-12000 Series (12 mm trocar assembly). The purpose of this analysis is threefold: (1) to identify and document non-infringement positions for each asserted claim element on a limitation-by-limitation basis; (2) to guide further technical investigation, expert engagement, and claim construction strategy in advance of the Markman hearing currently scheduled for November 18, 2024; and (3) to provide a working foundation for the litigation team as it prepares for the discovery phase and formulates the overall defense strategy.

This is a preliminary internal work product prepared approximately five weeks after the filing of Solstice Biomedical's Answer, Affirmative Defenses, and Counterclaims on June 14, 2024. It is intended to be a living document that will be revised and updated as additional information becomes available throughout the course of the litigation. The analysis set forth herein reflects the best assessment of the undersigned attorneys as of the date of this memorandum, based on the information then available.

The analysis is based on information currently available from Solstice's internal engineering documentation—including design specifications, bill-of-materials records, manufacturing process instructions, and quality control test reports for the PE-5000 and PE-12000 product lines—as well as the allegations and exhibits contained in Apex Surgical Innovations' Complaint filed on May 9, 2024. This preliminary analysis will be supplemented as discovery proceeds and following several key upcoming milestones, including (a) Apex's document production, which is currently expected on or about October 7, 2024; (b) the exchange of Proposed Claim Constructions scheduled for October 22, 2024; (c) the filing of the Joint Claim Construction Brief due November 4, 2024; and (d) the claim construction proceedings and Markman hearing before Chief Judge Andrews, currently scheduled for November 18, 2024. The Court's Claim Construction Order, which we anticipate will issue in late November or December 2024, will be critical to evaluating the viability of several of the non-infringement positions set forth in this memorandum, particularly those relating to the PE-12000 Series.

This memorandum should be read in conjunction with the companion claim charts prepared for the other two asserted patents in this matter. The claim chart addressing U.S. Patent No. 10,291,884 (the "'884 Patent") is dated July 22, 2024, and the claim chart addressing U.S. Patent No. 11,045,105 (the "'105 Patent") is dated July 25, 2024. Together, these three memoranda provide a comprehensive preliminary mapping of Solstice's non-infringement positions across all patents at issue in this litigation.

2. Background on the '237 Patent

2.1 Patent Identification

The following table summarizes the key identifying information for the '237 Patent:

Dr. Raymond Szabo, the named inventor, is identified in publicly available corporate filings and industry publications as the Vice President of Engineering at Apex Surgical Innovations, Inc. Dr. Szabo holds a Ph.D. in Mechanical Engineering from MIT and has been named as an inventor on more than thirty U.S. patents in the field of minimally invasive surgical devices.

The '237 Patent is part of the broader Apex Trocar Patent Family, which comprises fourteen issued U.S. patents and six pending continuation applications. The family traces its priority to Provisional Application No. 62/183,914, filed on June 24, 2014. The '237 Patent is related to the other two asserted patents in this litigation (the '884 Patent and the '105 Patent) through a chain of continuation and continuation-in-part applications, although the specific priority relationships and their implications for prior art dates will be addressed in detail in the forthcoming Invalidity Contentions — Prior Art Analysis Memorandum, currently scheduled for preparation by September 18, 2024.

The '237 Patent specification describes a surgical access device—commonly referred to as a trocar—that includes a locking seal assembly. The specification identifies problems with prior art trocar seals, including the tendency for seals to become dislodged during surgery, leading to loss of pneumoperitoneum (insufflation gas pressure in the abdominal cavity). The '237 Patent purports to solve this problem through a seal assembly that incorporates a positive locking mechanism to prevent axial displacement of the seal, combined with a release actuator that allows the seal to be removed or replaced during the procedure when desired. The specification describes several embodiments, including a preferred embodiment utilizing radially-arranged pawls, detents, and a rotatable collar for locking and release functions.

2.2 Asserted Claims

Apex has asserted Claims 1, 3, 7, and 12 of the '237 Patent in its Complaint filed on May 9, 2024 (D.I. 1). Of these, Claim 1 is the sole independent claim at issue; Claims 3, 7, and 12 are dependent claims that incorporate the limitations of Claim 1 and add further structural limitations. The claim dependency structure is as follows:

• Claim 1 — Independent claim

• Claim 3 — Depends from Claim 1

• Claim 7 — Depends from Claim 1

• Claim 12 — Depends from Claim 7 (which depends from Claim 1)

Claim 1 is directed to a locking seal assembly for a minimally invasive surgical access device and recites a multi-element combination comprising: (a) a housing defining an interior passage configured to receive a surgical instrument; (b) a seal member disposed within the housing and configured to form a gas-tight seal around the surgical instrument; (c) a locking mechanism configured to engage the seal member in a locked position to prevent axial displacement of the seal member relative to the housing; and (d) a release actuator operatively connected to the locking mechanism, the release actuator being configured to transition the locking mechanism from the locked position to an unlocked position to permit removal or replacement of the seal member. The full text of Claim 1, as well as Claims 3, 7, and 12, is reproduced verbatim in Appendix A to this memorandum.

Claim 3 depends from Claim 1 and adds a limitation specifying that the seal member comprises an elastomeric valve having a self-sealing slit extending across the interior passage. This limitation narrows the broad "seal member" recitation of Claim 1 to a specific type of seal structure commonly used in laparoscopic trocars.

Claim 7 depends from Claim 1 and adds a limitation specifying that the locking mechanism comprises a plurality of radially-arranged pawls configured to engage corresponding detents formed on the seal member. This limitation narrows the broad "locking mechanism" recitation of Claim 1 to a specific mechanical configuration involving discrete pawls and detents.

Claim 12 depends from Claim 7 (and thereby incorporates the limitations of both Claim 7 and Claim 1) and further requires that the release actuator comprises a rotatable collar operatively connected to the plurality of pawls, wherein rotation of the collar causes the pawls to disengage from the detents. This represents the narrowest asserted claim, requiring the specific combination of a rotatable collar, pawls, and detents.

2.3 Accused Products

Apex's Complaint identifies two Solstice Biomedical product lines as allegedly infringing the '237 Patent:

PrecisionEdge™ PE-5000 Series (5 mm Laparoscopic Trocar Assembly). The PE-5000 is a single-use, 5 mm diameter laparoscopic trocar assembly designed for use in minimally invasive surgical procedures. It is accused of infringing Claims 1, 3, 7, and 12 of the '237 Patent, as alleged in paragraphs 34–47 of Apex's Complaint. The PE-5000 was first commercially introduced in the United States in March 2021 and has been sold continuously since that date. The PE-5000 is manufactured at Solstice's facility in San Jose, California, and is distributed through both direct hospital sales and third-party group purchasing organizations.

PrecisionEdge™ PE-12000 Series (12 mm Laparoscopic Trocar Assembly). The PE-12000 is a single-use, 12 mm diameter laparoscopic trocar assembly designed for procedures requiring larger instrument access, including stapler insertion. It is accused of infringing Claims 1, 3, 7, and 12 of the '237 Patent, as alleged in paragraphs 48–61 of Apex's Complaint. The PE-12000 was commercially introduced in the United States in August 2021 and has been sold continuously since that date. In addition to the '237 Patent, the PE-12000 is also accused of infringing the '884 and '105 Patents; those allegations are addressed in the separate companion claim charts referenced in Section 1 above.

The PrecisionEdge™ PE-15000 Series (15 mm) is not accused of infringing the '237 Patent, although it is accused under the '105 Patent and is addressed in the '105 Patent claim chart dated July 25, 2024.

For context, the combined U.S. sales of all accused PrecisionEdge™ products (i.e., those product lines accused across all three asserted patents) for the period from calendar year 2021 through the third quarter of 2024 total approximately $74.6 million. A year-by-year breakdown is as follows:

The weighted average gross margin on the accused products across this period is approximately 61.3%. However, the breakdown of these revenue figures by individual product line (PE-5000, PE-12000, and PE-15000) and the apportionment of damages on a patent-specific basis will be addressed separately in the damages analysis to be prepared by the damages expert, whose retention is currently anticipated for late 2024. These revenue and margin figures are provided here solely for context and to underscore the magnitude of the potential exposure at issue in this litigation.

3. Methodology

The methodology employed in preparing this preliminary claim chart is as follows:

Element-by-Element Decomposition. Each asserted claim has been broken into its constituent elements and limitations. For the independent Claim 1, this decomposition identifies the preamble and four substantive structural limitations. For each dependent claim, the additional limitation added by the dependent claim is analyzed separately, with the understanding that infringement of a dependent claim requires that all limitations of the parent independent claim also be met.

Three-Column Analysis. For each claim element, the chart identifies: (a) the relevant claim language as it appears in the issued patent; (b) a description of the corresponding structure (if any) in each of the two accused products—the PE-5000 and the PE-12000—based on Solstice's internal engineering documentation and physical inspection of production samples; and (c) the preliminary non-infringement position, explaining why the accused product does not literally meet the claim element or, where applicable, why the doctrine of equivalents should not extend infringement liability to encompass the differences between the accused product structure and the claimed element.

Preliminary Claim Constructions. Where the non-infringement analysis turns on the construction of a particular claim term, the chart identifies the disputed term and sets forth Solstice's preliminary proposed construction, as well as the construction that Apex is likely to advance. These preliminary constructions are informed by (a) the intrinsic record, including the claim language, the specification, and the prosecution history; (b) applicable Federal Circuit precedent; and (c) initial input from prosecution counsel, as described below. Formal claim construction positions will be developed and finalized for the Proposed Claim Constructions exchange currently scheduled for October 22, 2024, and the Joint Claim Construction Brief due November 4, 2024.

Prosecution History Analysis. This analysis incorporates initial input from Kendrick & Lau LLP, our co-counsel responsible for patent prosecution analysis in this matter. Dr. Jonathan Kendrick, Lead Partner at Kendrick & Lau, has provided a preliminary prosecution history analysis of the '237 Patent, as well as prior art search results relevant to potential prosecution history estoppel arguments. Dr. Kendrick's analysis has been particularly valuable in identifying at least three narrowing amendments made during prosecution that may support Solstice's narrower claim constructions and limit the scope of the doctrine of equivalents. The prosecution history analysis is ongoing and will be refined as additional documents are obtained through discovery.

Expert Consultation. Dr. Miriam Ostrowski, Professor of Biomedical Engineering at Halford University, has been identified as the technical expert to be retained in this matter. Dr. Ostrowski has extensive experience in the design and development of minimally invasive surgical devices and has previously served as a testifying expert in patent litigation in this technology space. The retention agreement with Dr. Ostrowski is expected to be executed on or about August 20, 2024, at which point she will be consulted to review and refine the non-infringement positions set forth in this memorandum. Dr. Ostrowski's hourly rate is $750. Until Dr. Ostrowski's retention is formalized, the technical analysis set forth herein reflects the understanding of the undersigned attorneys based on their review of Solstice's engineering documentation and discussions with Solstice's internal engineering team.

Scope and Limitations. This analysis addresses literal infringement and, where relevant, the doctrine of equivalents. It does not address indirect infringement theories (induced infringement under 35 U.S.C. § 271(b) or contributory infringement under 35 U.S.C. § 271(c)), which will be analyzed separately if Apex advances such theories. The analysis also does not address invalidity defenses, which are the subject of the forthcoming Invalidity Contentions — Prior Art Analysis Memorandum. Finally, this analysis is preliminary and is based on the information currently available; it will be updated as the record develops through discovery and claim construction proceedings.

4. Claim Chart — Claim 1 (Independent Claim)

Claim 1 is the sole independent claim among the four asserted claims. Because Claims 3, 7, and 12 all depend directly or indirectly from Claim 1, a finding of non-infringement on any element of Claim 1 is dispositive of all four asserted claims. The analysis below addresses each element of Claim 1 in sequence.

4.1 Preamble: "A locking seal assembly for a minimally invasive surgical access device, comprising:"

PE-5000 Analysis. The PE-5000 Series includes a seal assembly that is integrated into the trocar housing and is designed for use with minimally invasive laparoscopic surgical procedures. In a general sense, the PE-5000 is a "surgical access device" that incorporates a "seal assembly." However, the preamble specifically recites a "locking seal assembly," and as discussed in detail in connection with Element 1(c) below, the PE-5000 does not employ a locking mechanism in any conventional sense—it utilizes a friction-retention mechanism rather than a positive lock engagement.

PE-12000 Analysis. Similarly, the PE-12000 Series includes a seal assembly integrated into its trocar housing and is used in minimally invasive surgical procedures. The PE-12000 likewise includes a seal assembly, but the same issue arises as to whether the PE-12000's retention mechanism constitutes a "locking" mechanism within the meaning of the preamble and the claim body.

Non-Infringement Position. Whether the preamble of Claim 1 is limiting is a threshold claim construction issue. Our preliminary position is that the preamble should be treated as limiting because it provides antecedent basis for subsequent limitations in the claim body—specifically, the term "locking" in the preamble is necessary to give life and meaning to the "locking mechanism" recited in Element 1(c) and the "locked position" and "unlocked position" recited in Element 1(d). Moreover, the prosecution history supports treating the preamble as limiting: during prosecution, the applicant relied on the "locking" feature of the claimed seal assembly to distinguish the claimed invention from prior art seal assemblies that used friction-fit or press-fit retention. The applicant specifically argued in the October 23, 2016 Response to Office Action that the prior art failed to disclose a "locking seal assembly" as claimed, thereby importing the "locking" limitation from the preamble into the scope of the claim.

If the preamble is treated as limiting—as we believe it should be—the PE-5000 and PE-12000 seal assemblies use a friction-retention mechanism rather than a "locking" mechanism, and there is no positive lock engagement in either product. This distinction is fundamental and flows through the analysis of the remaining claim elements, particularly Elements 1(c) and 1(d).

If, however, the Court determines that the preamble is not limiting—a risk that must be acknowledged—the non-infringement analysis would rest entirely on the claim body elements analyzed below.

4.2 Element 1(a): "a housing defining an interior passage configured to receive a surgical instrument"

PE-5000 Analysis. The PE-5000 includes a cylindrical polycarbonate housing that defines a 5 mm interior passage. The interior passage is configured to receive standard 5 mm laparoscopic instruments, including graspers, scissors, dissectors, and electrosurgical devices. The housing is a two-piece construction consisting of a main body and a housing cap that are snap-fitted together during assembly. The interior passage extends through the full length of the housing from the proximal (surgeon-facing) end to the distal (patient-facing) end. This element appears to be met by the PE-5000.

PE-12000 Analysis. The PE-12000 includes a cylindrical polycarbonate housing that defines a 12 mm interior passage. The interior passage is configured to receive larger laparoscopic instruments, including endoscopic staplers and clip appliers. Like the PE-5000, the PE-12000 housing is a two-piece construction. This element appears to be met by the PE-12000.

Non-Infringement Position. We do not advance a non-infringement argument on this element standing alone. The housing structure recited in Element 1(a) is conventional and is present in substantially all laparoscopic trocar assemblies on the market, including the PE-5000 and PE-12000. The recitation of "a housing defining an interior passage configured to receive a surgical instrument" is met by both accused products. Our non-infringement positions are focused on the more specific structural limitations of Elements 1(c) and 1(d), as discussed below.

4.3 Element 1(b): "a seal member disposed within the housing and configured to form a gas-tight seal around the surgical instrument"

PE-5000 Analysis. The PE-5000 includes an elastomeric seal component positioned within the housing that provides gas-tight sealing during insufflation (i.e., when the abdominal cavity is inflated with CO₂ gas to create a working space for the surgeon). The seal is manufactured from medical-grade silicone and is designed to conform around instruments of varying diameters (within the 5 mm range) to maintain pneumoperitoneum.

However, our preliminary position is that the PE-5000's seal is a compression-fit gasket that is integrally molded as part of the housing cap, rather than a discrete "seal member disposed within the housing." Specifically, during the PE-5000 manufacturing process, the silicone seal material is overmolded directly onto the inner surface of the polycarbonate housing cap using a two-shot injection molding process. The resulting structure is a unitary housing cap with an integral seal, not a separate seal member that is independently "disposed within" the housing. This distinction is supported by the PE-5000 bill of materials (BOM), which lists the housing cap assembly as a single part number (SBD-PE5-HC-001) rather than listing the housing cap and seal as separate components.

PE-12000 Analysis. The PE-12000 uses a different seal design. It employs a dual-layer silicone seal insert that is separately manufactured as a discrete component (part number SBD-PE12-SI-003) and is subsequently inserted into the housing during assembly. The PE-12000 seal insert is a freestanding component that can be removed from the housing and is held in place by the snap-ring retainer discussed in connection with Element 1(c) below. The PE-12000 seal insert forms a gas-tight seal around 12 mm instruments during insufflation.

Given the PE-12000's use of a separately manufactured and inserted seal component, this element may be more difficult to distinguish for the PE-12000 than for the PE-5000. The PE-12000 seal insert appears to be a "seal member disposed within the housing" within the plain meaning of that claim language.

Non-Infringement Position. PE-5000: The PE-5000's integral compression-fit gasket is not a separate "seal member disposed within the housing" because it is integrally formed with the housing cap through overmolding. The claim language "disposed within" implies a discrete component that is placed or positioned within the housing as a separate element, not one that is integrally molded as part of the housing itself. This interpretation is supported by the '237 Patent specification, which at column 3, lines 15–28, expressly distinguishes "integral seals" from the "discrete seal members" that are the subject of the invention. The specification states: "Prior art devices have employed integral seals molded directly into the housing structure. While such integral seals provide adequate sealing, they cannot be readily removed or replaced during a surgical procedure. The present invention addresses this limitation by providing a discrete seal member that is disposed within the housing and that can be locked in place and released as needed." (Col. 3, ll. 15–28) (emphasis added). This passage makes clear that the "seal member disposed within the housing" limitation excludes integral seals, which is precisely what the PE-5000 employs.

PE-12000: The non-infringement position on this element is weaker for the PE-12000 because its dual-layer silicone seal insert is a separately manufactured component that is inserted into the housing. This structure is more consistent with a "seal member disposed within the housing" as that term is used in the claim and described in the specification. Accordingly, for the PE-12000, our non-infringement arguments are focused on other elements—particularly Elements 1(c) and 1(d)—rather than on this element.

4.4 Element 1(c): "a locking mechanism configured to engage the seal member in a locked position to prevent axial displacement of the seal member relative to the housing"

This element is the centerpiece of our non-infringement analysis for both accused products. The construction of the terms "locking mechanism" and "engage the seal member" will be outcome-determinative for much of this litigation.

PE-5000 Analysis. The PE-5000 uses a friction-fit retention ring to hold the integral gasket in place within the housing cap. The retention ring is a thin polycarbonate ring that is press-fitted into the housing cap during assembly. The retention ring holds the gasket in position through compressive friction—that is, the interference fit between the ring and the housing cap creates sufficient frictional force to prevent the gasket from moving axially during normal use. There is no discrete locking engagement; no positive mechanical interengagement between mating features (such as pawls and detents, latches and catches, or bayonet-style locking features) occurs. The gasket is simply held in place by the compressive force of the press-fit ring.

The friction-fit mechanism in the PE-5000 is fundamentally different from the "locking mechanism" described in the '237 Patent specification. The specification describes locking mechanisms that involve positive mechanical engagement—specifically, pawls that engage detents, creating a locked state that can only be overcome by affirmative actuation of a release mechanism. By contrast, the PE-5000's friction-fit retention ring can be overcome simply by applying sufficient pulling force—there is no "locked position" from which the seal must be affirmatively released.

PE-12000 Analysis. The PE-12000 uses a snap-ring retainer (part number SBD-PE12-SR-002) that clicks into a circumferential groove formed on the interior surface of the housing. The snap-ring is a C-shaped spring steel ring that is compressed during insertion and expands into the housing groove to hold the seal insert in place. Apex will likely argue that the snap-ring constitutes a "locking mechanism" because it prevents the seal insert from being displaced axially under normal conditions.

However, Solstice's position is that the snap-ring is a passive retention device, not a "locking mechanism" that is "configured to engage the seal member" as required by the claim. Critically, the snap-ring engages the housing (by expanding into the circumferential groove on the housing's interior surface), not the seal member itself. The claim requires the locking mechanism to "engage the seal member"—that is, to make direct mechanical contact with and exert a locking force upon the seal member. The PE-12000 snap-ring does not directly engage the seal insert; rather, the snap-ring engages the housing groove, and the seal insert is retained between the snap-ring and a shoulder in the housing. The seal insert is held in place indirectly—by the physical barrier created by the snap-ring and the housing shoulder—not by a locking mechanism that "engages" the seal member.

Non-Infringement Position. PE-5000: This element presents a strong non-infringement argument for the PE-5000. A friction-fit retention mechanism is not a "locking mechanism" under any reasonable construction of that term. The prosecution history of the '237 Patent confirms this: during prosecution, the applicant specifically distinguished prior art friction-fit seals to secure allowance of the claims. In the Response to Office Action dated October 23, 2016, the applicant argued that the claimed "locking mechanism" was patentably distinct from the prior art's friction-fit seal retention because "[t]he prior art's friction-fit arrangement does not constitute a 'locking mechanism' as claimed because it does not positively lock the seal in a locked position—it merely holds the seal through frictional interference, which can be overcome without actuation of any release mechanism." The applicant's own characterization of the distinction between friction-fit retention and a "locking mechanism" directly supports Solstice's non-infringement position with respect to the PE-5000.

PE-12000: The non-infringement argument for the PE-12000 on this element is based on the claim language requiring the locking mechanism to "engage the seal member." The PE-12000 snap-ring engages the housing groove, not the seal member. The claim requires direct mechanical engagement between the locking mechanism and the seal member, not indirect retention of the seal member through engagement with the housing. This construction is supported by (a) the plain language of the claim, which uses the active verb "engage" followed by the direct object "the seal member," indicating direct interaction between the two components; (b) the specification, which describes the locking mechanism as engaging the seal member through pawl-detent interengagement, with the pawls making direct contact with detent features on the seal member itself (col. 5, ll. 42–55); and (c) the prosecution history, which reflects a narrowing amendment made during prosecution to add the "engage the seal member" language specifically to overcome prior art that taught retention mechanisms engaging the housing rather than the seal. This amendment-based estoppel argument is particularly powerful: by amending the claim to require engagement of "the seal member" (rather than the housing or some other structure), the applicant surrendered coverage of mechanisms that engage the housing to indirectly retain the seal—which is precisely what the PE-12000 snap-ring does.

4.5 Element 1(d): "a release actuator operatively connected to the locking mechanism, the release actuator being configured to transition the locking mechanism from the locked position to an unlocked position to permit removal or replacement of the seal member"

PE-5000 Analysis. The PE-5000 has no release actuator of any kind. The friction-fit gasket in the PE-5000 is removed by prying during disassembly using a standard flat-blade tool or similar instrument. The removal process involves physically deforming the retention ring to break the interference fit—there is no actuator, button, lever, collar, tab, or any other user-manipulable feature that functions to release the seal. The PE-5000 is, in practice, not designed for intra-operative seal replacement; the friction-fit gasket is intended to remain in place for the life of the single-use device.

PE-12000 Analysis. The PE-12000 includes a depression tab on the housing cap that, when depressed by the user, deflects the snap-ring outward from the housing groove, thereby allowing the snap-ring (and consequently the seal insert) to be removed. Apex may argue that this depression tab functions as a "release actuator" within the meaning of the claim because it is a user-manipulable feature that, when actuated, allows the seal to be removed.

Solstice's position is that the depression tab does not constitute a "release actuator operatively connected to the locking mechanism" for several reasons. First, the depression tab is a unitary, integral portion of the molded polycarbonate housing cap—it is not a "separately formed component" or a distinct structural element. It is simply a thinned region of the housing cap wall that can be flexed inward by finger pressure. The claim recites "a release actuator operatively connected to the locking mechanism," which implies two distinct components—an actuator and a locking mechanism—that are connected to each other. In the PE-12000, there is no such structural distinction; the tab is part of the housing, and the snap-ring is a separate retention element, but there is no "operative connection" between them in the sense required by the claim. When the tab is depressed, it physically pushes the snap-ring out of the groove through direct contact—there is no linkage, cam, lever, or other operative connection between the tab and the snap-ring.

Second, the depression tab does not "transition the locking mechanism from the locked position to an unlocked position." The concept of transitioning between a "locked position" and an "unlocked position" implies two defined states of the locking mechanism—a locked state in which the seal is secured, and an unlocked state in which the seal is free to be removed. The PE-12000 tab simply deflects the snap-ring outward during intentional disassembly; there is no defined "unlocked position" to which the snap-ring transitions. Once the tab is released, the snap-ring does not remain in an "unlocked position"—it simply springs back to its neutral state. The tab functions as a disassembly aid, not as a release actuator that transitions a locking mechanism between defined positions.

Non-Infringement Position. PE-5000: The absence of any release actuator in the PE-5000 provides a strong literal non-infringement position on this element. The claim requires "a release actuator operatively connected to the locking mechanism," and the PE-5000 simply does not include any such structure. There is no actuator—whether a collar, button, lever, tab, or any other user-operable feature—that functions to release the seal. This is a complete absence of a claimed element, which is dispositive of literal non-infringement. See Becton, Dickinson & Co. v. C.R. Bard, Inc., 922 F.2d 792, 798 (Fed. Cir. 1990) ("To establish literal infringement, every limitation set forth in a claim must be found in an accused product.").

PE-12000: The non-infringement position for the PE-12000 on this element rests on several grounds: (1) the depression tab is an integral, unitary portion of the molded housing cap, not a separate "release actuator" component; (2) the tab is not "operatively connected to" the snap-ring in the manner contemplated by the claim—there is no linkage or connection mechanism between the tab and the snap-ring, only incidental physical contact during disassembly; (3) the tab does not "transition" the snap-ring between a "locked position" and an "unlocked position"—it merely deflects the snap-ring during intentional disassembly, which is a fundamentally different function from the claimed transitioning between two defined positions; and (4) the PE-12000's disassembly process is not analogous to the release mechanism described in the '237 Patent specification, which contemplates a user actuating a dedicated release feature (the rotatable collar) to switch the locking mechanism between two stable states.

5. Claim Chart — Claim 3 (Dependent on Claim 1)

5.1 Claim Language

"The locking seal assembly of claim 1, wherein the seal member comprises an elastomeric valve having a self-sealing slit extending across the interior passage."

Claim 3 depends from Claim 1 and adds a single additional limitation specifying the nature of the seal member: it must be an "elastomeric valve having a self-sealing slit extending across the interior passage." This type of seal—commonly known as a "duckbill" or "flap" valve in the industry—is widely used in laparoscopic trocars to maintain pneumoperitoneum while allowing instruments to be inserted and withdrawn.

PE-5000 Analysis. The PE-5000's integral silicone gasket includes a slit that self-seals around instruments when they are inserted through the trocar. The slit is formed by a laser-cut incision through the silicone material during manufacturing. However, the PE-5000's slit does not extend fully across the interior passage; rather, it extends approximately 60% of the diameter of the passage (approximately 3 mm of the 5 mm diameter). The remaining 40% of the seal surface consists of an uncut annular perimeter that provides structural support for the gasket.

Notwithstanding the question of whether the PE-5000's partial slit satisfies the "extending across the interior passage" limitation, the more fundamental issue is that Claim 3 is a dependent claim that incorporates all limitations of Claim 1. Because the PE-5000 does not meet the "locking mechanism" (Element 1(c)) or "release actuator" (Element 1(d)) limitations of Claim 1, as discussed in detail in Sections 4.4 and 4.5 above, Claim 3 is necessarily not infringed by the PE-5000 regardless of whether the additional limitation of Claim 3 itself is met.

PE-12000 Analysis. The PE-12000's dual-layer silicone seal insert includes a self-sealing slit in the inner layer that extends fully across the 12 mm interior passage. The slit is formed by a precision die-cutting process during manufacturing and extends from edge to edge of the seal insert. The PE-12000's seal structure appears to meet the additional limitation of Claim 3 on its face—the inner layer of the dual-layer seal is an "elastomeric valve having a self-sealing slit extending across the interior passage."

Non-infringement of Claim 3 as to the PE-12000 rests primarily on the non-infringement positions established for the independent Claim 1 elements, particularly Elements 1(c) (locking mechanism) and 1(d) (release actuator). If the Claim 1 limitations are not met—as we contend—then Claim 3, which depends from Claim 1, is likewise not infringed.

Non-Infringement Position. Non-infringement of Claim 3 follows from non-infringement of Claim 1 for both the PE-5000 and the PE-12000. Because a dependent claim cannot be infringed unless the independent claim from which it depends is also infringed, Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1552 n.9 (Fed. Cir. 1989), the non-infringement positions established for Claim 1 in Sections 4.2 through 4.5 above are fully dispositive of Claim 3.

Additionally, with respect to the PE-5000, there exists an independent basis for non-infringement on the additional limitation of Claim 3 itself. The PE-5000's slit extends only approximately 60% of the way across the interior passage (approximately 3 mm of the 5 mm diameter). The claim language "extending across the interior passage" may reasonably be construed to require a slit that extends fully across—i.e., from one side to the other of—the interior passage. The specification supports this reading: the disclosed embodiments show slits that extend fully across the passage diameter (see Figs. 4A–4C), and the specification describes the slit as "extending across the full diameter of the interior passage to permit passage of the surgical instrument" (col. 4, ll. 30–33). While this argument may face resistance if Apex contends that "extending across" does not require full-diameter extension, it provides an additional layer of protection for the PE-5000 non-infringement position on Claim 3.

6. Claim Chart — Claim 7 (Dependent on Claim 1)

6.1 Claim Language

"The locking seal assembly of claim 1, wherein the locking mechanism comprises a plurality of radially-arranged pawls configured to engage corresponding detents formed on the seal member."

Claim 7 depends from Claim 1 and narrows the "locking mechanism" limitation by specifying that the mechanism comprises "a plurality of radially-arranged pawls configured to engage corresponding detents formed on the seal member." This limitation requires three specific structural features: (1) a plurality of pawls (i.e., more than one); (2) the pawls must be "radially-arranged" (i.e., arranged in a radial pattern around the circumference of the assembly); and (3) the pawls must be "configured to engage corresponding detents formed on the seal member" (i.e., the seal member must have discrete detent features that correspond to and mate with the pawls).

PE-5000 Analysis. The PE-5000's friction-fit retention ring has no pawls of any kind—radially arranged or otherwise. The retention ring is a smooth, continuous annular ring with no projecting features, tabs, teeth, or pawl-like elements. Similarly, the PE-5000's integral gasket has no detents—there are no recesses, notches, or other features on the gasket that are designed to receive or interengage with any mating structure on the retention ring. The PE-5000 retention mechanism is purely friction-based, with no mechanical interengagement between discrete features.

This element is entirely absent from the PE-5000. The non-infringement position on this element is exceptionally strong.

PE-12000 Analysis. The PE-12000's snap-ring retainer is a continuous C-shaped spring steel ring. It is not "a plurality of radially-arranged pawls." The snap-ring is a single, unitary element—not a plurality of discrete elements arranged radially. While the snap-ring does have a circumferential profile, it does not comprise multiple discrete pawls that can independently engage corresponding features on the seal member.

Furthermore, the PE-12000 seal insert has a circumferential groove on its outer surface that accommodates the snap-ring, but it does not have discrete "detents." The '237 Patent specification describes detents as discrete recesses—specifically, individual pocket-like formations that are spaced around the circumference of the seal member and that correspond to and receive individual pawls (col. 5, ll. 42–55: "The seal member 120 includes a plurality of detents 125 formed on its outer circumferential surface. Each detent 125 is a discrete recess sized and positioned to receive a corresponding pawl 135."). A continuous circumferential groove is structurally and functionally distinguishable from a plurality of "discrete recesses" (i.e., detents). The PE-12000's circumferential groove is a single continuous channel, not a series of discrete recesses corresponding to individual pawls.

Non-Infringement Position. PE-5000: The complete absence of pawls and detents in the PE-5000 makes literal non-infringement clear and indisputable on this element. There is no structure in the PE-5000 that could reasonably be characterized as a "plurality of radially-arranged pawls" or as "corresponding detents formed on the seal member." This provides an independent basis for non-infringement of Claim 7, in addition to the non-infringement positions on the Claim 1 elements that are incorporated by dependency.

PE-12000: The non-infringement position for the PE-12000 on this element rests on two independent grounds:

(1) The snap-ring is not "a plurality of radially-arranged pawls." The snap-ring is a single continuous element, not a plurality of discrete elements. The claim language "a plurality of radially-arranged pawls" requires at least two (and in the context of the specification, typically three or more) individual pawl elements arranged in a radial pattern. A single continuous snap-ring does not satisfy this limitation. Construing "a plurality of radially-arranged pawls" to encompass a single continuous ring would effectively read the "plurality" and "radially-arranged" limitations out of the claim, in violation of the all-limitations rule.

(2) The circumferential groove is not "corresponding detents formed on the seal member." The '237 Patent specification distinguishes detents—defined as discrete recesses that individually correspond to and receive individual pawls—from continuous grooves. The PE-12000's circumferential groove is a single continuous channel that extends around the entire circumference of the seal insert. It is not a series of discrete "detents" that "correspond" to individual pawls. The specification's description of detents as "discrete recesses" (col. 5, ll. 42–55) precludes construction of "detents" to encompass a continuous groove.

Furthermore, even if the Court were to construe the Claim 7 limitations broadly, non-infringement of Claim 7 also follows from non-infringement of the parent Claim 1, as established in Sections 4.4 and 4.5 above.

7. Claim Chart — Claim 12 (Dependent on Claim 7, Which Depends on Claim 1)

7.1 Claim Language

"The locking seal assembly of claim 7, wherein the release actuator comprises a rotatable collar operatively connected to the plurality of pawls, rotation of the collar causing the pawls to disengage from the detents."

Claim 12 depends from Claim 7 (which itself depends from Claim 1) and is the narrowest of the four asserted claims. It requires all of the limitations of Claims 1 and 7, plus the additional requirement that the release actuator comprises a "rotatable collar" that is "operatively connected to the plurality of pawls" and that "rotation of the collar caus[es] the pawls to disengage from the detents." This claim adds three specific structural and functional requirements: (1) the release actuator must be a "rotatable collar"; (2) the collar must be "operatively connected to the plurality of pawls"; and (3) rotation of the collar must cause the pawls to disengage from the detents—i.e., the release mechanism must operate through a rotational motion.

PE-5000 Analysis. The PE-5000 has no rotatable collar, no pawls, and no detents. Every element added by Claims 7 and 12 is completely absent from the PE-5000. The PE-5000's friction-fit retention mechanism has no rotational, translational, or other release mechanism—the gasket is removed solely by prying with an external tool. This represents the strongest non-infringement position across all asserted claims and both accused products.

PE-12000 Analysis. The PE-12000 has no rotatable collar. The disassembly tab on the PE-12000 housing cap is a depressible feature—it is pressed axially (i.e., pushed inward toward the center of the housing) to deflect the snap-ring. The tab is not a "rotatable collar" in any sense: it is not a collar (it is a localized tab, not a circumferential collar); it is not rotatable (it is depressible, operating through axial displacement rather than rotation); and it does not cause any feature to disengage through rotational motion.

There is no rotation-based release mechanism in any PrecisionEdge™ product, including the PE-5000, PE-12000, and PE-15000. The Solstice engineering team has confirmed that rotational release mechanisms were specifically considered and rejected during the PE-12000 design process in favor of the simpler axial-depression tab design. Design history file documents (DHF-PE12-REV-B, dated January 15, 2020) reflect this decision and may be relevant to demonstrating the absence of any rotation-based mechanism and the independent development of the PE-12000's design.

Non-Infringement Position. Both Products: Literal non-infringement of Claim 12 is clear for both the PE-5000 and the PE-12000. Neither product includes a rotatable collar, and neither product employs any rotational release mechanism. The PE-5000 has no release mechanism at all, and the PE-12000's depression tab operates through axial depression, not rotation.

Doctrine of Equivalents Analysis for Claim 12: The doctrine of equivalents argument is also weak for Apex on this claim for two independent reasons:

(1) All-Limitations Rule / Vitiation. The "rotatable collar" is a specific structural limitation that defines both the structure (a collar) and its mode of operation (rotation). Expanding this limitation under the doctrine of equivalents to encompass any release feature—including a non-rotatable, non-collar depression tab—would effectively vitiate the "rotatable" limitation and the "collar" limitation, eliminating their meaning from the claim. The Federal Circuit has consistently held that the doctrine of equivalents cannot be applied in a manner that vitiates a claim limitation. See Sage Prods., Inc. v. Devon Indus., Inc., 126 F.3d 1420, 1424 (Fed. Cir. 1997); Asyst Techs., Inc. v. Emtrak, Inc., 544 F.3d 1310, 1316 (Fed. Cir. 2008).

(2) Prosecution History Estoppel. During prosecution of the '237 Patent, the applicant added the "rotatable collar" limitation in a narrowing amendment to distinguish prior art push-button release mechanisms. Specifically, the examiner rejected the original claims over the Hargreaves reference (U.S. Patent No. 8,123,456), which disclosed a trocar seal assembly with a push-button release. In response, the applicant amended the claims to require a "rotatable collar" and argued that the rotatable collar was structurally and functionally distinct from the prior art's push-button release. By narrowing the claim to distinguish a push-button release, the applicant surrendered coverage of push-button and other non-rotational release mechanisms. The PE-12000's axial-depression tab falls squarely within the surrendered territory—it is a depressible feature that operates through axial motion, which is directly analogous to the push-button release that the applicant distinguished during prosecution. Prosecution history estoppel therefore bars Apex from arguing that the PE-12000's depression tab is equivalent to the claimed "rotatable collar." See Festo Corp. v. Fenmore & Co., 535 U.S. 722, 740 (2002) (narrowing amendment creates a presumption that the patentee surrendered the territory between the original claim and the amended claim).

The relevant prosecution history file wrapper documents supporting these estoppel arguments are being confirmed and will be more fully developed upon receipt of Apex's document production. However, our preliminary review of the publicly available prosecution history, supplemented by the analysis provided by Kendrick & Lau LLP, supports the estoppel arguments outlined above.

8. Summary of Non-Infringement Positions by Product

The following sections provide a consolidated summary of the non-infringement positions for each accused product across all four asserted claims.

8.1 PrecisionEdge™ PE-5000 Series

Overall Assessment: Strong non-infringement position across all four asserted claims.

The PE-5000 presents multiple independent bases for non-infringement on each asserted claim. The product's friction-fit retention mechanism and integral overmolded gasket design are fundamentally different from the locking seal assembly claimed in the '237 Patent. The non-infringement positions are summarized as follows:

Claim 1 (Independent):

• The PE-5000 lacks a "locking mechanism" as recited in Element 1(c). The friction-fit retention ring is not a "locking mechanism" under any reasonable construction; the prosecution history confirms that friction-fit retention was distinguished from the claimed "locking mechanism" during prosecution.

• The PE-5000 lacks a "release actuator" as recited in Element 1(d). There is no actuator of any kind—no collar, button, lever, tab, or other user-manipulable release feature. The gasket is removed only by prying with an external tool during disassembly.

• Two independent missing elements provide a strong basis for non-infringement.

Claim 3 (Dependent on Claim 1):

• Non-infringement follows from non-infringement of Claim 1.

• Additionally, the PE-5000's slit extends only approximately 60% across the interior passage, which may not satisfy the "extending across the interior passage" limitation, providing an independent basis for non-infringement on the added limitation.

Claim 7 (Dependent on Claim 1):

• Complete absence of "radially-arranged pawls" and "corresponding detents." The friction-fit retention ring has no pawls, and the integral gasket has no detents.

• Non-infringement on the added limitation is clear and provides an independent basis for non-infringement in addition to the Claim 1 non-infringement positions.

Claim 12 (Dependent on Claim 7):

• Complete absence of a "rotatable collar," pawls, and detents. Every element added by Claims 7 and 12 is entirely missing from the PE-5000.

• This represents the strongest non-infringement position across all claims and products.

Summary Judgment Candidate: Based on the strength of the non-infringement positions for the PE-5000, this product line is the strongest candidate for a motion for summary judgment of non-infringement with respect to the '237 Patent. We note that, as of the date of this memorandum, it is anticipated that a motion for summary judgment will ultimately be filed on April 1, 2025, seeking summary judgment of non-infringement of the '237 and '884 Patents as to the PE-5000 Series. The viability of this motion will be reassessed following the Markman hearing and the issuance of the Claim Construction Order.

8.2 PrecisionEdge™ PE-12000 Series

Overall Assessment: Moderate non-infringement position; some elements present colorable disputes that will be influenced by claim construction outcomes.

The PE-12000 presents viable non-infringement arguments on multiple claim elements, but the positions are not as strong as those for the PE-5000. The PE-12000's snap-ring retainer and depression tab introduce structures that Apex will argue are analogous to the claimed locking mechanism and release actuator, requiring more nuanced claim construction arguments to sustain the non-infringement positions. The non-infringement positions are summarized as follows:

Claim 1 (Independent):

• Element 1(c) — Locking mechanism: The primary non-infringement argument is that the PE-12000's snap-ring engages the housing groove, not the seal member, so the claim requirement that the locking mechanism "engage the seal member" is not met. This argument depends on the construction of "engage the seal member" and is supported by the prosecution history amendment adding this language.

• Element 1(d) — Release actuator: The PE-12000's depression tab is an integral portion of the housing cap, not a separate "release actuator operatively connected to" the snap-ring. The tab does not "transition" the snap-ring between "locked" and "unlocked" positions; it merely deflects the snap-ring during disassembly.

• These arguments are viable but present closer factual and legal questions than the PE-5000 positions.

Claim 3 (Dependent on Claim 1):

• Non-infringement follows from non-infringement of Claim 1. The additional limitation of Claim 3 itself may be met by the PE-12000's dual-layer silicone seal insert with self-sealing slit.

Claim 7 (Dependent on Claim 1):

• The snap-ring is not "a plurality of radially-arranged pawls" because it is a single continuous element.

• The circumferential groove on the seal insert is not "corresponding detents" because it is a continuous groove, not discrete recesses.

• These positions are supported by the specification's description of detents as discrete recesses and by the all-limitations rule (construing "plurality" and "radially-arranged" to cover a continuous ring would vitiate those limitations).

Claim 12 (Dependent on Claim 7):

• No rotatable collar exists in the PE-12000. The depression tab operates through axial depression, not rotation.

• This provides the strongest independent basis for non-infringement of Claim 12 with respect to the PE-12000.

• Prosecution history estoppel and the all-limitations rule / vitiation doctrine further preclude infringement under the doctrine of equivalents.

Claim Construction Dependency: The viability of the PE-12000 non-infringement positions depends critically on the claim construction outcomes. The constructions of "locking mechanism," "engage the seal member," and "release actuator" will likely determine whether the PE-12000 non-infringement positions hold. These are among the nine disputed terms that we expect to be briefed in the Joint Claim Construction Brief. Favorable constructions on any one of these terms could be dispositive; conversely, broad constructions adopted by the Court could significantly weaken the PE-12000 non-infringement positions and may necessitate reliance on the Claim 7 and Claim 12 specific limitations (pawls, detents, rotatable collar) as the primary non-infringement arguments.

9. Claim Construction Considerations and Key Disputed Terms

The following claim terms have been identified as requiring construction and are expected to be among the disputed terms briefed in the Joint Claim Construction Brief. For each term, we set forth Solstice's preliminary proposed construction and the construction that Apex is likely to advance. These preliminary positions are informed by the intrinsic record (claim language, specification, and prosecution history), Federal Circuit precedent, and the initial prosecution history analysis provided by Kendrick & Lau LLP.

"Locking mechanism".

Solstice's Proposed Construction: A mechanism that positively locks by mechanical interengagement of mating structural features, excluding friction-fit or press-fit retention.

Apex's Likely Construction: Any mechanism that holds the seal in place and prevents displacement, regardless of how the holding force is generated.

Analysis: Solstice's narrower construction is supported by (a) the specification, which describes the locking mechanism in terms of positive mechanical interengagement (pawl-detent engagement) and expressly distinguishes friction-fit retention as a deficiency of the prior art (col. 3, ll. 15–28); (b) the prosecution history, in which the applicant distinguished friction-fit prior art by arguing that friction-fit retention is not a "locking mechanism" as claimed; and (c) the claim structure, in which the dependent Claims 7 and 12 describe the locking mechanism in terms of specific mechanical interengagement features (pawls, detents, collar), indicating that the independent claim's "locking mechanism" encompasses mechanisms of this type, not friction-fit retention. This is one of the most important terms for the PE-5000 non-infringement position.

"Engage the seal member"

Solstice's Proposed Construction: Direct mechanical contact between the locking mechanism and the seal member, such that the locking mechanism physically contacts and exerts a restraining force on the seal member.

Apex's Likely Construction: Any arrangement that holds the seal member in place, whether through direct or indirect contact, including retention through engagement with the housing or other intermediate structures.

Analysis: Solstice's construction is supported by (a) the plain claim language, which uses the active verb "engage" followed by the direct object "the seal member," grammatically requiring direct engagement; (b) the specification, which describes the locking mechanism engaging the seal member through direct pawl-detent contact (col. 5, ll. 42–55); and (c) the prosecution history, which reflects a narrowing amendment adding "engage the seal member" to distinguish prior art that taught indirect retention. This term is critical for the PE-12000 non-infringement position, as it determines whether the PE-12000's snap-ring (which engages the housing groove, not the seal member) satisfies this limitation.

"Release actuator".

Solstice's Proposed Construction: A separately formed component that is distinct from the housing and the locking mechanism and that is manipulated by the user to release the locking mechanism from the locked position.

Apex's Likely Construction: Any feature—whether integral or separate—that, when manipulated by the user, allows the seal to be removed.

Analysis: Solstice's construction is supported by (a) the claim language, which recites "a release actuator" as a separate element of the combination (Element 1(d)), distinct from "a housing" (Element 1(a)) and "a locking mechanism" (Element 1(c)), indicating that the release actuator must be a separate component; (b) the specification, which describes the release actuator as a distinct component (the rotatable collar) that is separate from both the housing and the locking mechanism; and (c) the prosecution history, in which the applicant described the release actuator as a "dedicated release component" to distinguish prior art. This term is critical for both the PE-5000 (which has no release mechanism at all) and the PE-12000 (whose depression tab is an integral part of the housing cap).

"Rotatable collar".

Solstice's Proposed Construction: A collar—i.e., a ring-shaped component encircling the housing or a portion thereof—that is rotated by the user about the longitudinal axis of the device to effect disengagement of the locking mechanism.

Apex's Likely Construction: A collar or ring-like component that can be manipulated in any manner, including depression or translation, to effect disengagement.

Analysis: Solstice's construction is strongly supported by the plain meaning of "rotatable," which unambiguously requires rotation as the mode of operation. The specification describes the collar as being rotated by the user (col. 6, ll. 10–22: "The user rotates the collar 150 in the direction indicated by arrow A, causing the cam surfaces 155 on the collar to displace the p

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PRELIMINARY CLAIM CHART — NON-INFRINGEMENT ANALYSIS
U.S. Patent No. 9,814,237
"Locking Seal Assembly for Minimally Invasive Surgical Access Device"
Date: July 20, 2024
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1. Introduction and Purpose
This memorandum presents a preliminary element-by-element claim chart mapping the asserted claims of U.S. Patent No. 9,814,237 (hereinafter, "the '237 Patent") against Solstice Biomedical's PrecisionEdge™ PE-5000 Series (5 mm trocar assembly) and PrecisionEdge™ PE-12000 Series (12 mm trocar assembly). The purpose of this analysis is threefold: (1) to identify and document non-infringement positions for each asserted claim element on a limitation-by-limitation basis; (2) to guide further technical investigation, expert engagement, and claim construction strategy in advance of the Markman hearing currently scheduled for November 18, 2024; and (3) to provide a working foundation for the litigation team as it prepares for the discovery phase and formulates the overall defense strategy.
This is a preliminary internal work product prepared approximately five weeks after the filing of Solstice Biomedical's Answer, Affirmative Defenses, and Counterclaims on June 14, 2024. It is intended to be a living document that will be revised and updated as additional information becomes available throughout the course of the litigation. The analysis set forth herein reflects the best assessment of the undersigned attorneys as of the date of this memorandum, based on the information then available.
The analysis is based on information currently available from Solstice's internal engineering documentation—including design specifications, bill-of-materials records, manufacturing process instructions, and quality control test reports for the PE-5000 and PE-12000 product lines—as well as the allegations and exhibits contained in Apex Surgical Innovations' Complaint filed on May 9, 2024. This preliminary analysis will be supplemented as discovery proceeds and following several key upcoming milestones, including (a) Apex's document production, which is currently expected on or about October 7, 2024; (b) the exchange of Proposed Claim Constructions scheduled for October 22, 2024; (c) the filing of the Joint Claim Construction Brief due November 4, 2024; and (d) the claim construction proceedings and Markman hearing before Chief Judge Andrews, currently scheduled for November 18, 2024. The Court's Claim Construction Order, which we anticipate will issue in late November or December 2024, will be critical to evaluating the viability of several of the non-infringement positions set forth in this memorandum, particularly those relating to the PE-12000 Series.
This memorandum should be read in conjunction with the companion claim charts prepared for the other two asserted patents in this matter. The claim chart addressing U.S. Patent No. 10,291,884 (the "'884 Patent") is dated July 22, 2024, and the claim chart addressing U.S. Patent No. 11,045,105 (the "'105 Patent") is dated July 25, 2024. Together, these three memoranda provide a comprehensive preliminary mapping of Solstice's non-infringement positions across all patents at issue in this litigation.
2. Background on the '237 Patent
2.1 Patent Identification
The following table summarizes the key identifying information for the '237 Patent:
Dr. Raymond Szabo, the named inventor, is identified in publicly available corporate filings and industry publications as the Vice President of Engineering at Apex Surgical Innovations, Inc. Dr. Szabo holds a Ph.D. in Mechanical Engineering from MIT and has been named as an inventor on more than thirty U.S. patents in the field of minimally invasive surgical devices.
The '237 Patent is part of the broader Apex Trocar Patent Family, which comprises fourteen issued U.S. patents and six pending continuation applications. The family traces its priority to Provisional Application No. 62/183,914, filed on June 24, 2014. The '237 Patent is related to the other two asserted patents in this litigation (the '884 Patent and the '105 Patent) through a chain of continuation and continuation-in-part applications, although the specific priority relationships and their implications for prior art dates will be addressed in detail in the forthcoming Invalidity Contentions — Prior Art Analysis Memorandum, currently scheduled for preparation by September 18, 2024.
The '237 Patent specification describes a surgical access device—commonly referred to as a trocar—that includes a locking seal assembly. The specification identifies problems with prior art trocar seals, including the tendency for seals to become dislodged during surgery, leading to loss of pneumoperitoneum (insufflation gas pressure in the abdominal cavity). The '237 Patent purports to solve this problem through a seal assembly that incorporates a positive locking mechanism to prevent axial displacement of the seal, combined with a release actuator that allows the seal to be removed or replaced during the procedure when desired. The specification describes several embodiments, including a preferred embodiment utilizing radially-arranged pawls, detents, and a rotatable collar for locking and release functions.
2.2 Asserted Claims
Apex has asserted Claims 1, 3, 7, and 12 of the '237 Patent in its Complaint filed on May 9, 2024 (D.I. 1). Of these, Claim 1 is the sole independent claim at issue; Claims 3, 7, and 12 are dependent claims that incorporate the limitations of Claim 1 and add further structural limitations. The claim dependency structure is as follows:
•  Claim 1 — Independent claim
•  Claim 3 — Depends from Claim 1
•  Claim 7 — Depends from Claim 1
•  Claim 12 — Depends from Claim 7 (which depends from Claim 1)
Claim 1 is directed to a locking seal assembly for a minimally invasive surgical access device and recites a multi-element combination comprising: (a) a housing defining an interior passage configured to receive a surgical instrument; (b) a seal member disposed within the housing and configured to form a gas-tight seal around the surgical instrument; (c) a locking mechanism configured to engage the seal member in a locked position to prevent axial displacement of the seal member relative to the housing; and (d) a release actuator operatively connected to the locking mechanism, the release actuator being configured to transition the locking mechanism from the locked position to an unlocked position to permit removal or replacement of the seal member. The full text of Claim 1, as well as Claims 3, 7, and 12, is reproduced verbatim in Appendix A to this memorandum.
Claim 3 depends from Claim 1 and adds a limitation specifying that the seal member comprises an elastomeric valve having a self-sealing slit extending across the interior passage. This limitation narrows the broad "seal member" recitation of Claim 1 to a specific type of seal structure commonly used in laparoscopic trocars.
Claim 7 depends from Claim 1 and adds a limitation specifying that the locking mechanism comprises a plurality of radially-arranged pawls configured to engage corresponding detents formed on the seal member. This limitation narrows the broad "locking mechanism" recitation of Claim 1 to a specific mechanical configuration involving discrete pawls and detents.
Claim 12 depends from Claim 7 (and thereby incorporates the limitations of both Claim 7 and Claim 1) and further requires that the release actuator comprises a rotatable collar operatively connected to the plurality of pawls, wherein rotation of the collar causes the pawls to disengage from the detents. This represents the narrowest asserted claim, requiring the specific combination of a rotatable collar, pawls, and detents.
2.3 Accused Products
Apex's Complaint identifies two Solstice Biomedical product lines as allegedly infringing the '237 Patent:
PrecisionEdge™ PE-5000 Series (5 mm Laparoscopic Trocar Assembly). The PE-5000 is a single-use, 5 mm diameter laparoscopic trocar assembly designed for use in minimally invasive surgical procedures. It is accused of infringing Claims 1, 3, 7, and 12 of the '237 Patent, as alleged in paragraphs 34–47 of Apex's Complaint. The PE-5000 was first commercially introduced in the United States in March 2021 and has been sold continuously since that date. The PE-5000 is manufactured at Solstice's facility in San Jose, California, and is distributed through both direct hospital sales and third-party group purchasing organizations.
PrecisionEdge™ PE-12000 Series (12 mm Laparoscopic Trocar Assembly). The PE-12000 is a single-use, 12 mm diameter laparoscopic trocar assembly designed for procedures requiring larger instrument access, including stapler insertion. It is accused of infringing Claims 1, 3, 7, and 12 of the '237 Patent, as alleged in paragraphs 48–61 of Apex's Complaint. The PE-12000 was commercially introduced in the United States in August 2021 and has been sold continuously since that date. In addition to the '237 Patent, the PE-12000 is also accused of infringing the '884 and '105 Patents; those allegations are addressed in the separate companion claim charts referenced in Section 1 above.
The PrecisionEdge™ PE-15000 Series (15 mm) is not accused of infringing the '237 Patent, although it is accused under the '105 Patent and is addressed in the '105 Patent claim chart dated July 25, 2024.
For context, the combined U.S. sales of all accused PrecisionEdge™ products (i.e., those product lines accused across all three asserted patents) for the period from calendar year 2021 through the third quarter of 2024 total approximately $74.6 million. A year-by-year breakdown is as follows:
The weighted average gross margin on the accused products across this period is approximately 61.3%. However, the breakdown of these revenue figures by individual product line (PE-5000, PE-12000, and PE-15000) and the apportionment of damages on a patent-specific basis will be addressed separately in the damages analysis to be prepared by the damages expert, whose retention is currently anticipated for late 2024. These revenue and margin figures are provided here solely for context and to underscore the magnitude of the potential exposure at issue in this litigation.
3. Methodology
The methodology employed in preparing this preliminary claim chart is as follows:
Element-by-Element Decomposition. Each asserted claim has been broken into its constituent elements and limitations. For the independent Claim 1, this decomposition identifies the preamble and four substantive structural limitations. For each dependent claim, the additional limitation added by the dependent claim is analyzed separately, with the understanding that infringement of a dependent claim requires that all limitations of the parent independent claim also be met.
Three-Column Analysis. For each claim element, the chart identifies: (a) the relevant claim language as it appears in the issued patent; (b) a description of the corresponding structure (if any) in each of the two accused products—the PE-5000 and the PE-12000—based on Solstice's internal engineering documentation and physical inspection of production samples; and (c) the preliminary non-infringement position, explaining why the accused product does not literally meet the claim element or, where applicable, why the doctrine of equivalents should not extend infringement liability to encompass the differences between the accused product structure and the claimed element.
Preliminary Claim Constructions. Where the non-infringement analysis turns on the construction of a particular claim term, the chart identifies the disputed term and sets forth Solstice's preliminary proposed construction, as well as the construction that Apex is likely to advance. These preliminary constructions are informed by (a) the intrinsic record, including the claim language, the specification, and the prosecution history; (b) applicable Federal Circuit precedent; and (c) initial input from prosecution counsel, as described below. Formal claim construction positions will be developed and finalized for the Proposed Claim Constructions exchange currently scheduled for October 22, 2024, and the Joint Claim Construction Brief due November 4, 2024.
Prosecution History Analysis. This analysis incorporates initial input from Kendrick & Lau LLP, our co-counsel responsible for patent prosecution analysis in this matter. Dr. Jonathan Kendrick, Lead Partner at Kendrick & Lau, has provided a preliminary prosecution history analysis of the '237 Patent, as well as prior art search results relevant to potential prosecution history estoppel arguments. Dr. Kendrick's analysis has been particularly valuable in identifying at least three narrowing amendments made during prosecution that may support Solstice's narrower claim constructions and limit the scope of the doctrine of equivalents. The prosecution history analysis is ongoing and will be refined as additional documents are obtained through discovery.
Expert Consultation. Dr. Miriam Ostrowski, Professor of Biomedical Engineering at Halford University, has been identified as the technical expert to be retained in this matter. Dr. Ostrowski has extensive experience in the design and development of minimally invasive surgical devices and has previously served as a testifying expert in patent litigation in this technology space. The retention agreement with Dr. Ostrowski is expected to be executed on or about August 20, 2024, at which point she will be consulted to review and refine the non-infringement positions set forth in this memorandum. Dr. Ostrowski's hourly rate is $750. Until Dr. Ostrowski's retention is formalized, the technical analysis set forth herein reflects the understanding of the undersigned attorneys based on their review of Solstice's engineering documentation and discussions with Solstice's internal engineering team.
Scope and Limitations. This analysis addresses literal infringement and, where relevant, the doctrine of equivalents. It does not address indirect infringement theories (induced infringement under 35 U.S.C. § 271(b) or contributory infringement under 35 U.S.C. § 271(c)), which will be analyzed separately if Apex advances such theories. The analysis also does not address invalidity defenses, which are the subject of the forthcoming Invalidity Contentions — Prior Art Analysis Memorandum. Finally, this analysis is preliminary and is based on the information currently available; it will be updated as the record develops through discovery and claim construction proceedings.
4. Claim Chart — Claim 1 (Independent Claim)
Claim 1 is the sole independent claim among the four asserted claims. Because Claims 3, 7, and 12 all depend directly or indirectly from Claim 1, a finding of non-infringement on any element of Claim 1 is dispositive of all four asserted claims. The analysis below addresses each element of Claim 1 in sequence.
4.1 Preamble: "A locking seal assembly for a minimally invasive surgical access device, comprising:"
PE-5000 Analysis.  The PE-5000 Series includes a seal assembly that is integrated into the trocar housing and is designed for use with minimally invasive laparoscopic surgical procedures. In a general sense, the PE-5000 is a "surgical access device" that incorporates a "seal assembly." However, the preamble specifically recites a "locking seal assembly," and as discussed in detail in connection with Element 1(c) below, the PE-5000 does not employ a locking mechanism in any conventional sense—it utilizes a friction-retention mechanism rather than a positive lock engagement.
PE-12000 Analysis.  Similarly, the PE-12000 Series includes a seal assembly integrated into its trocar housing and is used in minimally invasive surgical procedures. The PE-12000 likewise includes a seal assembly, but the same issue arises as to whether the PE-12000's retention mechanism constitutes a "locking" mechanism within the meaning of the preamble and the claim body.
Non-Infringement Position.  Whether the preamble of Claim 1 is limiting is a threshold claim construction issue. Our preliminary position is that the preamble should be treated as limiting because it provides antecedent basis for subsequent limitations in the claim body—specifically, the term "locking" in the preamble is necessary to give life and meaning to the "locking mechanism" recited in Element 1(c) and the "locked position" and "unlocked position" recited in Element 1(d). Moreover, the prosecution history supports treating the preamble as limiting: during prosecution, the applicant relied on the "locking" feature of the claimed seal assembly to distinguish the claimed invention from prior art seal assemblies that used friction-fit or press-fit retention. The applicant specifically argued in the October 23, 2016 Response to Office Action that the prior art failed to disclose a "locking seal assembly" as claimed, thereby importing the "locking" limitation from the preamble into the scope of the claim.
If the preamble is treated as limiting—as we believe it should be—the PE-5000 and PE-12000 seal assemblies use a friction-retention mechanism rather than a "locking" mechanism, and there is no positive lock engagement in either product. This distinction is fundamental and flows through the analysis of the remaining claim elements, particularly Elements 1(c) and 1(d).
If, however, the Court determines that the preamble is not limiting—a risk that must be acknowledged—the non-infringement analysis would rest entirely on the claim body elements analyzed below.
4.2 Element 1(a): "a housing defining an interior passage configured to receive a surgical instrument"
PE-5000 Analysis.  The PE-5000 includes a cylindrical polycarbonate housing that defines a 5 mm interior passage. The interior passage is configured to receive standard 5 mm laparoscopic instruments, including graspers, scissors, dissectors, and electrosurgical devices. The housing is a two-piece construction consisting of a main body and a housing cap that are snap-fitted together during assembly. The interior passage extends through the full length of the housing from the proximal (surgeon-facing) end to the distal (patient-facing) end. This element appears to be met by the PE-5000.
PE-12000 Analysis.  The PE-12000 includes a cylindrical polycarbonate housing that defines a 12 mm interior passage. The interior passage is configured to receive larger laparoscopic instruments, including endoscopic staplers and clip appliers. Like the PE-5000, the PE-12000 housing is a two-piece construction. This element appears to be met by the PE-12000.
Non-Infringement Position.  We do not advance a non-infringement argument on this element standing alone. The housing structure recited in Element 1(a) is conventional and is present in substantially all laparoscopic trocar assemblies on the market, including the PE-5000 and PE-12000. The recitation of "a housing defining an interior passage configured to receive a surgical instrument" is met by both accused products. Our non-infringement positions are focused on the more specific structural limitations of Elements 1(c) and 1(d), as discussed below.
4.3 Element 1(b): "a seal member disposed within the housing and configured to form a gas-tight seal around the surgical instrument"
PE-5000 Analysis.  The PE-5000 includes an elastomeric seal component positioned within the housing that provides gas-tight sealing during insufflation (i.e., when the abdominal cavity is inflated with CO₂ gas to create a working space for the surgeon). The seal is manufactured from medical-grade silicone and is designed to conform around instruments of varying diameters (within the 5 mm range) to maintain pneumoperitoneum.
However, our preliminary position is that the PE-5000's seal is a compression-fit gasket that is integrally molded as part of the housing cap, rather than a discrete "seal member disposed within the housing." Specifically, during the PE-5000 manufacturing process, the silicone seal material is overmolded directly onto the inner surface of the polycarbonate housing cap using a two-shot injection molding process. The resulting structure is a unitary housing cap with an integral seal, not a separate seal member that is independently "disposed within" the housing. This distinction is supported by the PE-5000 bill of materials (BOM), which lists the housing cap assembly as a single part number (SBD-PE5-HC-001) rather than listing the housing cap and seal as separate components.
PE-12000 Analysis.  The PE-12000 uses a different seal design. It employs a dual-layer silicone seal insert that is separately manufactured as a discrete component (part number SBD-PE12-SI-003) and is subsequently inserted into the housing during assembly. The PE-12000 seal insert is a freestanding component that can be removed from the housing and is held in place by the snap-ring retainer discussed in connection with Element 1(c) below. The PE-12000 seal insert forms a gas-tight seal around 12 mm instruments during insufflation.
Given the PE-12000's use of a separately manufactured and inserted seal component, this element may be more difficult to distinguish for the PE-12000 than for the PE-5000. The PE-12000 seal insert appears to be a "seal member disposed within the housing" within the plain meaning of that claim language.
Non-Infringement Position.  PE-5000: The PE-5000's integral compression-fit gasket is not a separate "seal member disposed within the housing" because it is integrally formed with the housing cap through overmolding. The claim language "disposed within" implies a discrete component that is placed or positioned within the housing as a separate element, not one that is integrally molded as part of the housing itself. This interpretation is supported by the '237 Patent specification, which at column 3, lines 15–28, expressly distinguishes "integral seals" from the "discrete seal members" that are the subject of the invention. The specification states: "Prior art devices have employed integral seals molded directly into the housing structure. While such integral seals provide adequate sealing, they cannot be readily removed or replaced during a surgical procedure. The present invention addresses this limitation by providing a discrete seal member that is disposed within the housing and that can be locked in place and released as needed." (Col. 3, ll. 15–28) (emphasis added). This passage makes clear that the "seal member disposed within the housing" limitation excludes integral seals, which is precisely what the PE-5000 employs.
PE-12000: The non-infringement position on this element is weaker for the PE-12000 because its dual-layer silicone seal insert is a separately manufactured component that is inserted into the housing. This structure is more consistent with a "seal member disposed within the housing" as that term is used in the claim and described in the specification. Accordingly, for the PE-12000, our non-infringement arguments are focused on other elements—particularly Elements 1(c) and 1(d)—rather than on this element.
4.4 Element 1(c): "a locking mechanism configured to engage the seal member in a locked position to prevent axial displacement of the seal member relative to the housing"
This element is the centerpiece of our non-infringement analysis for both accused products. The construction of the terms "locking mechanism" and "engage the seal member" will be outcome-determinative for much of this litigation.
PE-5000 Analysis.  The PE-5000 uses a friction-fit retention ring to hold the integral gasket in place within the housing cap. The retention ring is a thin polycarbonate ring that is press-fitted into the housing cap during assembly. The retention ring holds the gasket in position through compressive friction—that is, the interference fit between the ring and the housing cap creates sufficient frictional force to prevent the gasket from moving axially during normal use. There is no discrete locking engagement; no positive mechanical interengagement between mating features (such as pawls and detents, latches and catches, or bayonet-style locking features) occurs. The gasket is simply held in place by the compressive force of the press-fit ring.
The friction-fit mechanism in the PE-5000 is fundamentally different from the "locking mechanism" described in the '237 Patent specification. The specification describes locking mechanisms that involve positive mechanical engagement—specifically, pawls that engage detents, creating a locked state that can only be overcome by affirmative actuation of a release mechanism. By contrast, the PE-5000's friction-fit retention ring can be overcome simply by applying sufficient pulling force—there is no "locked position" from which the seal must be affirmatively released.
PE-12000 Analysis.  The PE-12000 uses a snap-ring retainer (part number SBD-PE12-SR-002) that clicks into a circumferential groove formed on the interior surface of the housing. The snap-ring is a C-shaped spring steel ring that is compressed during insertion and expands into the housing groove to hold the seal insert in place. Apex will likely argue that the snap-ring constitutes a "locking mechanism" because it prevents the seal insert from being displaced axially under normal conditions.
However, Solstice's position is that the snap-ring is a passive retention device, not a "locking mechanism" that is "configured to engage the seal member" as required by the claim. Critically, the snap-ring engages the housing (by expanding into the circumferential groove on the housing's interior surface), not the seal member itself. The claim requires the locking mechanism to "engage the seal member"—that is, to make direct mechanical contact with and exert a locking force upon the seal member. The PE-12000 snap-ring does not directly engage the seal insert; rather, the snap-ring engages the housing groove, and the seal insert is retained between the snap-ring and a shoulder in the housing. The seal insert is held in place indirectly—by the physical barrier created by the snap-ring and the housing shoulder—not by a locking mechanism that "engages" the seal member.
Non-Infringement Position.  PE-5000: This element presents a strong non-infringement argument for the PE-5000. A friction-fit retention mechanism is not a "locking mechanism" under any reasonable construction of that term. The prosecution history of the '237 Patent confirms this: during prosecution, the applicant specifically distinguished prior art friction-fit seals to secure allowance of the claims. In the Response to Office Action dated October 23, 2016, the applicant argued that the claimed "locking mechanism" was patentably distinct from the prior art's friction-fit seal retention because "[t]he prior art's friction-fit arrangement does not constitute a 'locking mechanism' as claimed because it does not positively lock the seal in a locked position—it merely holds the seal through frictional interference, which can be overcome without actuation of any release mechanism." The applicant's own characterization of the distinction between friction-fit retention and a "locking mechanism" directly supports Solstice's non-infringement position with respect to the PE-5000.
PE-12000: The non-infringement argument for the PE-12000 on this element is based on the claim language requiring the locking mechanism to "engage the seal member." The PE-12000 snap-ring engages the housing groove, not the seal member. The claim requires direct mechanical engagement between the locking mechanism and the seal member, not indirect retention of the seal member through engagement with the housing. This construction is supported by (a) the plain language of the claim, which uses the active verb "engage" followed by the direct object "the seal member," indicating direct interaction between the two components; (b) the specification, which describes the locking mechanism as engaging the seal member through pawl-detent interengagement, with the pawls making direct contact with detent features on the seal member itself (col. 5, ll. 42–55); and (c) the prosecution history, which reflects a narrowing amendment made during prosecution to add the "engage the seal member" language specifically to overcome prior art that taught retention mechanisms engaging the housing rather than the seal. This amendment-based estoppel argument is particularly powerful: by amending the claim to require engagement of "the seal member" (rather than the housing or some other structure), the applicant surrendered coverage of mechanisms that engage the housing to indirectly retain the seal—which is precisely what the PE-12000 snap-ring does.
4.5 Element 1(d): "a release actuator operatively connected to the locking mechanism, the release actuator being configured to transition the locking mechanism from the locked position to an unlocked position to permit removal or replacement of the seal member"
PE-5000 Analysis.  The PE-5000 has no release actuator of any kind. The friction-fit gasket in the PE-5000 is removed by prying during disassembly using a standard flat-blade tool or similar instrument. The removal process involves physically deforming the retention ring to break the interference fit—there is no actuator, button, lever, collar, tab, or any other user-manipulable feature that functions to release the seal. The PE-5000 is, in practice, not designed for intra-operative seal replacement; the friction-fit gasket is intended to remain in place for the life of the single-use device.
PE-12000 Analysis.  The PE-12000 includes a depression tab on the housing cap that, when depressed by the user, deflects the snap-ring outward from the housing groove, thereby allowing the snap-ring (and consequently the seal insert) to be removed. Apex may argue that this depression tab functions as a "release actuator" within the meaning of the claim because it is a user-manipulable feature that, when actuated, allows the seal to be removed.
Solstice's position is that the depression tab does not constitute a "release actuator operatively connected to the locking mechanism" for several reasons. First, the depression tab is a unitary, integral portion of the molded polycarbonate housing cap—it is not a "separately formed component" or a distinct structural element. It is simply a thinned region of the housing cap wall that can be flexed inward by finger pressure. The claim recites "a release actuator operatively connected to the locking mechanism," which implies two distinct components—an actuator and a locking mechanism—that are connected to each other. In the PE-12000, there is no such structural distinction; the tab is part of the housing, and the snap-ring is a separate retention element, but there is no "operative connection" between them in the sense required by the claim. When the tab is depressed, it physically pushes the snap-ring out of the groove through direct contact—there is no linkage, cam, lever, or other operative connection between the tab and the snap-ring.
Second, the depression tab does not "transition the locking mechanism from the locked position to an unlocked position." The concept of transitioning between a "locked position" and an "unlocked position" implies two defined states of the locking mechanism—a locked state in which the seal is secured, and an unlocked state in which the seal is free to be removed. The PE-12000 tab simply deflects the snap-ring outward during intentional disassembly; there is no defined "unlocked position" to which the snap-ring transitions. Once the tab is released, the snap-ring does not remain in an "unlocked position"—it simply springs back to its neutral state. The tab functions as a disassembly aid, not as a release actuator that transitions a locking mechanism between defined positions.
Non-Infringement Position.  PE-5000: The absence of any release actuator in the PE-5000 provides a strong literal non-infringement position on this element. The claim requires "a release actuator operatively connected to the locking mechanism," and the PE-5000 simply does not include any such structure. There is no actuator—whether a collar, button, lever, tab, or any other user-operable feature—that functions to release the seal. This is a complete absence of a claimed element, which is dispositive of literal non-infringement. See Becton, Dickinson & Co. v. C.R. Bard, Inc., 922 F.2d 792, 798 (Fed. Cir. 1990) ("To establish literal infringement, every limitation set forth in a claim must be found in an accused product.").
PE-12000: The non-infringement position for the PE-12000 on this element rests on several grounds: (1) the depression tab is an integral, unitary portion of the molded housing cap, not a separate "release actuator" component; (2) the tab is not "operatively connected to" the snap-ring in the manner contemplated by the claim—there is no linkage or connection mechanism between the tab and the snap-ring, only incidental physical contact during disassembly; (3) the tab does not "transition" the snap-ring between a "locked position" and an "unlocked position"—it merely deflects the snap-ring during intentional disassembly, which is a fundamentally different function from the claimed transitioning between two defined positions; and (4) the PE-12000's disassembly process is not analogous to the release mechanism described in the '237 Patent specification, which contemplates a user actuating a dedicated release feature (the rotatable collar) to switch the locking mechanism between two stable states.
5. Claim Chart — Claim 3 (Dependent on Claim 1)
5.1 Claim Language
"The locking seal assembly of claim 1, wherein the seal member comprises an elastomeric valve having a self-sealing slit extending across the interior passage."
Claim 3 depends from Claim 1 and adds a single additional limitation specifying the nature of the seal member: it must be an "elastomeric valve having a self-sealing slit extending across the interior passage." This type of seal—commonly known as a "duckbill" or "flap" valve in the industry—is widely used in laparoscopic trocars to maintain pneumoperitoneum while allowing instruments to be inserted and withdrawn.
PE-5000 Analysis.  The PE-5000's integral silicone gasket includes a slit that self-seals around instruments when they are inserted through the trocar. The slit is formed by a laser-cut incision through the silicone material during manufacturing. However, the PE-5000's slit does not extend fully across the interior passage; rather, it extends approximately 60% of the diameter of the passage (approximately 3 mm of the 5 mm diameter). The remaining 40% of the seal surface consists of an uncut annular perimeter that provides structural support for the gasket.
Notwithstanding the question of whether the PE-5000's partial slit satisfies the "extending across the interior passage" limitation, the more fundamental issue is that Claim 3 is a dependent claim that incorporates all limitations of Claim 1. Because the PE-5000 does not meet the "locking mechanism" (Element 1(c)) or "release actuator" (Element 1(d)) limitations of Claim 1, as discussed in detail in Sections 4.4 and 4.5 above, Claim 3 is necessarily not infringed by the PE-5000 regardless of whether the additional limitation of Claim 3 itself is met.
PE-12000 Analysis.  The PE-12000's dual-layer silicone seal insert includes a self-sealing slit in the inner layer that extends fully across the 12 mm interior passage. The slit is formed by a precision die-cutting process during manufacturing and extends from edge to edge of the seal insert. The PE-12000's seal structure appears to meet the additional limitation of Claim 3 on its face—the inner layer of the dual-layer seal is an "elastomeric valve having a self-sealing slit extending across the interior passage."
Non-infringement of Claim 3 as to the PE-12000 rests primarily on the non-infringement positions established for the independent Claim 1 elements, particularly Elements 1(c) (locking mechanism) and 1(d) (release actuator). If the Claim 1 limitations are not met—as we contend—then Claim 3, which depends from Claim 1, is likewise not infringed.
Non-Infringement Position.  Non-infringement of Claim 3 follows from non-infringement of Claim 1 for both the PE-5000 and the PE-12000. Because a dependent claim cannot be infringed unless the independent claim from which it depends is also infringed, Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1552 n.9 (Fed. Cir. 1989), the non-infringement positions established for Claim 1 in Sections 4.2 through 4.5 above are fully dispositive of Claim 3.
Additionally, with respect to the PE-5000, there exists an independent basis for non-infringement on the additional limitation of Claim 3 itself. The PE-5000's slit extends only approximately 60% of the way across the interior passage (approximately 3 mm of the 5 mm diameter). The claim language "extending across the interior passage" may reasonably be construed to require a slit that extends fully across—i.e., from one side to the other of—the interior passage. The specification supports this reading: the disclosed embodiments show slits that extend fully across the passage diameter (see Figs. 4A–4C), and the specification describes the slit as "extending across the full diameter of the interior passage to permit passage of the surgical instrument" (col. 4, ll. 30–33). While this argument may face resistance if Apex contends that "extending across" does not require full-diameter extension, it provides an additional layer of protection for the PE-5000 non-infringement position on Claim 3.
6. Claim Chart — Claim 7 (Dependent on Claim 1)
6.1 Claim Language
"The locking seal assembly of claim 1, wherein the locking mechanism comprises a plurality of radially-arranged pawls configured to engage corresponding detents formed on the seal member."
Claim 7 depends from Claim 1 and narrows the "locking mechanism" limitation by specifying that the mechanism comprises "a plurality of radially-arranged pawls configured to engage corresponding detents formed on the seal member." This limitation requires three specific structural features: (1) a plurality of pawls (i.e., more than one); (2) the pawls must be "radially-arranged" (i.e., arranged in a radial pattern around the circumference of the assembly); and (3) the pawls must be "configured to engage corresponding detents formed on the seal member" (i.e., the seal member must have discrete detent features that correspond to and mate with the pawls).
PE-5000 Analysis.  The PE-5000's friction-fit retention ring has no pawls of any kind—radially arranged or otherwise. The retention ring is a smooth, continuous annular ring with no projecting features, tabs, teeth, or pawl-like elements. Similarly, the PE-5000's integral gasket has no detents—there are no recesses, notches, or other features on the gasket that are designed to receive or interengage with any mating structure on the retention ring. The PE-5000 retention mechanism is purely friction-based, with no mechanical interengagement between discrete features.
This element is entirely absent from the PE-5000. The non-infringement position on this element is exceptionally strong.
PE-12000 Analysis.  The PE-12000's snap-ring retainer is a continuous C-shaped spring steel ring. It is not "a plurality of radially-arranged pawls." The snap-ring is a single, unitary element—not a plurality of discrete elements arranged radially. While the snap-ring does have a circumferential profile, it does not comprise multiple discrete pawls that can independently engage corresponding features on the seal member.
Furthermore, the PE-12000 seal insert has a circumferential groove on its outer surface that accommodates the snap-ring, but it does not have discrete "detents." The '237 Patent specification describes detents as discrete recesses—specifically, individual pocket-like formations that are spaced around the circumference of the seal member and that correspond to and receive individual pawls (col. 5, ll. 42–55: "The seal member 120 includes a plurality of detents 125 formed on its outer circumferential surface. Each detent 125 is a discrete recess sized and positioned to receive a corresponding pawl 135."). A continuous circumferential groove is structurally and functionally distinguishable from a plurality of "discrete recesses" (i.e., detents). The PE-12000's circumferential groove is a single continuous channel, not a series of discrete recesses corresponding to individual pawls.
Non-Infringement Position.  PE-5000: The complete absence of pawls and detents in the PE-5000 makes literal non-infringement clear and indisputable on this element. There is no structure in the PE-5000 that could reasonably be characterized as a "plurality of radially-arranged pawls" or as "corresponding detents formed on the seal member." This provides an independent basis for non-infringement of Claim 7, in addition to the non-infringement positions on the Claim 1 elements that are incorporated by dependency.
PE-12000: The non-infringement position for the PE-12000 on this element rests on two independent grounds:
(1) The snap-ring is not "a plurality of radially-arranged pawls." The snap-ring is a single continuous element, not a plurality of discrete elements. The claim language "a plurality of radially-arranged pawls" requires at least two (and in the context of the specification, typically three or more) individual pawl elements arranged in a radial pattern. A single continuous snap-ring does not satisfy this limitation. Construing "a plurality of radially-arranged pawls" to encompass a single continuous ring would effectively read the "plurality" and "radially-arranged" limitations out of the claim, in violation of the all-limitations rule.
(2) The circumferential groove is not "corresponding detents formed on the seal member." The '237 Patent specification distinguishes detents—defined as discrete recesses that individually correspond to and receive individual pawls—from continuous grooves. The PE-12000's circumferential groove is a single continuous channel that extends around the entire circumference of the seal insert. It is not a series of discrete "detents" that "correspond" to individual pawls. The specification's description of detents as "discrete recesses" (col. 5, ll. 42–55) precludes construction of "detents" to encompass a continuous groove.
Furthermore, even if the Court were to construe the Claim 7 limitations broadly, non-infringement of Claim 7 also follows from non-infringement of the parent Claim 1, as established in Sections 4.4 and 4.5 above.
7. Claim Chart — Claim 12 (Dependent on Claim 7, Which Depends on Claim 1)
7.1 Claim Language
"The locking seal assembly of claim 7, wherein the release actuator comprises a rotatable collar operatively connected to the plurality of pawls, rotation of the collar causing the pawls to disengage from the detents."
Claim 12 depends from Claim 7 (which itself depends from Claim 1) and is the narrowest of the four asserted claims. It requires all of the limitations of Claims 1 and 7, plus the additional requirement that the release actuator comprises a "rotatable collar" that is "operatively connected to the plurality of pawls" and that "rotation of the collar caus[es] the pawls to disengage from the detents." This claim adds three specific structural and functional requirements: (1) the release actuator must be a "rotatable collar"; (2) the collar must be "operatively connected to the plurality of pawls"; and (3) rotation of the collar must cause the pawls to disengage from the detents—i.e., the release mechanism must operate through a rotational motion.
PE-5000 Analysis.  The PE-5000 has no rotatable collar, no pawls, and no detents. Every element added by Claims 7 and 12 is completely absent from the PE-5000. The PE-5000's friction-fit retention mechanism has no rotational, translational, or other release mechanism—the gasket is removed solely by prying with an external tool. This represents the strongest non-infringement position across all asserted claims and both accused products.
PE-12000 Analysis.  The PE-12000 has no rotatable collar. The disassembly tab on the PE-12000 housing cap is a depressible feature—it is pressed axially (i.e., pushed inward toward the center of the housing) to deflect the snap-ring. The tab is not a "rotatable collar" in any sense: it is not a collar (it is a localized tab, not a circumferential collar); it is not rotatable (it is depressible, operating through axial displacement rather than rotation); and it does not cause any feature to disengage through rotational motion.
There is no rotation-based release mechanism in any PrecisionEdge™ product, including the PE-5000, PE-12000, and PE-15000. The Solstice engineering team has confirmed that rotational release mechanisms were specifically considered and rejected during the PE-12000 design process in favor of the simpler axial-depression tab design. Design history file documents (DHF-PE12-REV-B, dated January 15, 2020) reflect this decision and may be relevant to demonstrating the absence of any rotation-based mechanism and the independent development of the PE-12000's design.
Non-Infringement Position.  Both Products: Literal non-infringement of Claim 12 is clear for both the PE-5000 and the PE-12000. Neither product includes a rotatable collar, and neither product employs any rotational release mechanism. The PE-5000 has no release mechanism at all, and the PE-12000's depression tab operates through axial depression, not rotation.
Doctrine of Equivalents Analysis for Claim 12: The doctrine of equivalents argument is also weak for Apex on this claim for two independent reasons:
(1) All-Limitations Rule / Vitiation. The "rotatable collar" is a specific structural limitation that defines both the structure (a collar) and its mode of operation (rotation). Expanding this limitation under the doctrine of equivalents to encompass any release feature—including a non-rotatable, non-collar depression tab—would effectively vitiate the "rotatable" limitation and the "collar" limitation, eliminating their meaning from the claim. The Federal Circuit has consistently held that the doctrine of equivalents cannot be applied in a manner that vitiates a claim limitation. See Sage Prods., Inc. v. Devon Indus., Inc., 126 F.3d 1420, 1424 (Fed. Cir. 1997); Asyst Techs., Inc. v. Emtrak, Inc., 544 F.3d 1310, 1316 (Fed. Cir. 2008).
(2) Prosecution History Estoppel. During prosecution of the '237 Patent, the applicant added the "rotatable collar" limitation in a narrowing amendment to distinguish prior art push-button release mechanisms. Specifically, the examiner rejected the original claims over the Hargreaves reference (U.S. Patent No. 8,123,456), which disclosed a trocar seal assembly with a push-button release. In response, the applicant amended the claims to require a "rotatable collar" and argued that the rotatable collar was structurally and functionally distinct from the prior art's push-button release. By narrowing the claim to distinguish a push-button release, the applicant surrendered coverage of push-button and other non-rotational release mechanisms. The PE-12000's axial-depression tab falls squarely within the surrendered territory—it is a depressible feature that operates through axial motion, which is directly analogous to the push-button release that the applicant distinguished during prosecution. Prosecution history estoppel therefore bars Apex from arguing that the PE-12000's depression tab is equivalent to the claimed "rotatable collar." See Festo Corp. v. Fenmore & Co., 535 U.S. 722, 740 (2002) (narrowing amendment creates a presumption that the patentee surrendered the territory between the original claim and the amended claim).
The relevant prosecution history file wrapper documents supporting these estoppel arguments are being confirmed and will be more fully developed upon receipt of Apex's document production. However, our preliminary review of the publicly available prosecution history, supplemented by the analysis provided by Kendrick & Lau LLP, supports the estoppel arguments outlined above.
8. Summary of Non-Infringement Positions by Product
The following sections provide a consolidated summary of the non-infringement positions for each accused product across all four asserted claims.
8.1 PrecisionEdge™ PE-5000 Series
Overall Assessment: Strong non-infringement position across all four asserted claims.
The PE-5000 presents multiple independent bases for non-infringement on each asserted claim. The product's friction-fit retention mechanism and integral overmolded gasket design are fundamentally different from the locking seal assembly claimed in the '237 Patent. The non-infringement positions are summarized as follows:
Claim 1 (Independent):
•  The PE-5000 lacks a "locking mechanism" as recited in Element 1(c). The friction-fit retention ring is not a "locking mechanism" under any reasonable construction; the prosecution history confirms that friction-fit retention was distinguished from the claimed "locking mechanism" during prosecution.
•  The PE-5000 lacks a "release actuator" as recited in Element 1(d). There is no actuator of any kind—no collar, button, lever, tab, or other user-manipulable release feature. The gasket is removed only by prying with an external tool during disassembly.
•  Two independent missing elements provide a strong basis for non-infringement.
Claim 3 (Dependent on Claim 1):
•  Non-infringement follows from non-infringement of Claim 1.
•  Additionally, the PE-5000's slit extends only approximately 60% across the interior passage, which may not satisfy the "extending across the interior passage" limitation, providing an independent basis for non-infringement on the added limitation.
Claim 7 (Dependent on Claim 1):
•  Complete absence of "radially-arranged pawls" and "corresponding detents." The friction-fit retention ring has no pawls, and the integral gasket has no detents.
•  Non-infringement on the added limitation is clear and provides an independent basis for non-infringement in addition to the Claim 1 non-infringement positions.
Claim 12 (Dependent on Claim 7):
•  Complete absence of a "rotatable collar," pawls, and detents. Every element added by Claims 7 and 12 is entirely missing from the PE-5000.
•  This represents the strongest non-infringement position across all claims and products.
Summary Judgment Candidate: Based on the strength of the non-infringement positions for the PE-5000, this product line is the strongest candidate for a motion for summary judgment of non-infringement with respect to the '237 Patent. We note that, as of the date of this memorandum, it is anticipated that a motion for summary judgment will ultimately be filed on April 1, 2025, seeking summary judgment of non-infringement of the '237 and '884 Patents as to the PE-5000 Series. The viability of this motion will be reassessed following the Markman hearing and the issuance of the Claim Construction Order.
8.2 PrecisionEdge™ PE-12000 Series
Overall Assessment: Moderate non-infringement position; some elements present colorable disputes that will be influenced by claim construction outcomes.
The PE-12000 presents viable non-infringement arguments on multiple claim elements, but the positions are not as strong as those for the PE-5000. The PE-12000's snap-ring retainer and depression tab introduce structures that Apex will argue are analogous to the claimed locking mechanism and release actuator, requiring more nuanced claim construction arguments to sustain the non-infringement positions. The non-infringement positions are summarized as follows:
Claim 1 (Independent):
•  Element 1(c) — Locking mechanism: The primary non-infringement argument is that the PE-12000's snap-ring engages the housing groove, not the seal member, so the claim requirement that the locking mechanism "engage the seal member" is not met. This argument depends on the construction of "engage the seal member" and is supported by the prosecution history amendment adding this language.
•  Element 1(d) — Release actuator: The PE-12000's depression tab is an integral portion of the housing cap, not a separate "release actuator operatively connected to" the snap-ring. The tab does not "transition" the snap-ring between "locked" and "unlocked" positions; it merely deflects the snap-ring during disassembly.
•  These arguments are viable but present closer factual and legal questions than the PE-5000 positions.
Claim 3 (Dependent on Claim 1):
•  Non-infringement follows from non-infringement of Claim 1. The additional limitation of Claim 3 itself may be met by the PE-12000's dual-layer silicone seal insert with self-sealing slit.
Claim 7 (Dependent on Claim 1):
•  The snap-ring is not "a plurality of radially-arranged pawls" because it is a single continuous element.
•  The circumferential groove on the seal insert is not "corresponding detents" because it is a continuous groove, not discrete recesses.
•  These positions are supported by the specification's description of detents as discrete recesses and by the all-limitations rule (construing "plurality" and "radially-arranged" to cover a continuous ring would vitiate those limitations).
Claim 12 (Dependent on Claim 7):
•  No rotatable collar exists in the PE-12000. The depression tab operates through axial depression, not rotation.
•  This provides the strongest independent basis for non-infringement of Claim 12 with respect to the PE-12000.
•  Prosecution history estoppel and the all-limitations rule / vitiation doctrine further preclude infringement under the doctrine of equivalents.
Claim Construction Dependency: The viability of the PE-12000 non-infringement positions depends critically on the claim construction outcomes. The constructions of "locking mechanism," "engage the seal member," and "release actuator" will likely determine whether the PE-12000 non-infringement positions hold. These are among the nine disputed terms that we expect to be briefed in the Joint Claim Construction Brief. Favorable constructions on any one of these terms could be dispositive; conversely, broad constructions adopted by the Court could significantly weaken the PE-12000 non-infringement positions and may necessitate reliance on the Claim 7 and Claim 12 specific limitations (pawls, detents, rotatable collar) as the primary non-infringement arguments.
9. Claim Construction Considerations and Key Disputed Terms
The following claim terms have been identified as requiring construction and are expected to be among the disputed terms briefed in the Joint Claim Construction Brief. For each term, we set forth Solstice's preliminary proposed construction and the construction that Apex is likely to advance. These preliminary positions are informed by the intrinsic record (claim language, specification, and prosecution history), Federal Circuit precedent, and the initial prosecution history analysis provided by Kendrick & Lau LLP.
"Locking mechanism".  
Solstice's Proposed Construction: A mechanism that positively locks by mechanical interengagement of mating structural features, excluding friction-fit or press-fit retention.
Apex's Likely Construction: Any mechanism that holds the seal in place and prevents displacement, regardless of how the holding force is generated.
Analysis: Solstice's narrower construction is supported by (a) the specification, which describes the locking mechanism in terms of positive mechanical interengagement (pawl-detent engagement) and expressly distinguishes friction-fit retention as a deficiency of the prior art (col. 3, ll. 15–28); (b) the prosecution history, in which the applicant distinguished friction-fit prior art by arguing that friction-fit retention is not a "locking mechanism" as claimed; and (c) the claim structure, in which the dependent Claims 7 and 12 describe the locking mechanism in terms of specific mechanical interengagement features (pawls, detents, collar), indicating that the independent claim's "locking mechanism" encompasses mechanisms of this type, not friction-fit retention. This is one of the most important terms for the PE-5000 non-infringement position.
"Engage the seal member"
Solstice's Proposed Construction: Direct mechanical contact between the locking mechanism and the seal member, such that the locking mechanism physically contacts and exerts a restraining force on the seal member.
Apex's Likely Construction: Any arrangement that holds the seal member in place, whether through direct or indirect contact, including retention through engagement with the housing or other intermediate structures.
Analysis: Solstice's construction is supported by (a) the plain claim language, which uses the active verb "engage" followed by the direct object "the seal member," grammatically requiring direct engagement; (b) the specification, which describes the locking mechanism engaging the seal member through direct pawl-detent contact (col. 5, ll. 42–55); and (c) the prosecution history, which reflects a narrowing amendment adding "engage the seal member" to distinguish prior art that taught indirect retention. This term is critical for the PE-12000 non-infringement position, as it determines whether the PE-12000's snap-ring (which engages the housing groove, not the seal member) satisfies this limitation.
"Release actuator".  
Solstice's Proposed Construction: A separately formed component that is distinct from the housing and the locking mechanism and that is manipulated by the user to release the locking mechanism from the locked position.
Apex's Likely Construction: Any feature—whether integral or separate—that, when manipulated by the user, allows the seal to be removed.
Analysis: Solstice's construction is supported by (a) the claim language, which recites "a release actuator" as a separate element of the combination (Element 1(d)), distinct from "a housing" (Element 1(a)) and "a locking mechanism" (Element 1(c)), indicating that the release actuator must be a separate component; (b) the specification, which describes the release actuator as a distinct component (the rotatable collar) that is separate from both the housing and the locking mechanism; and (c) the prosecution history, in which the applicant described the release actuator as a "dedicated release component" to distinguish prior art. This term is critical for both the PE-5000 (which has no release mechanism at all) and the PE-12000 (whose depression tab is an integral part of the housing cap).
"Rotatable collar".  
Solstice's Proposed Construction: A collar—i.e., a ring-shaped component encircling the housing or a portion thereof—that is rotated by the user about the longitudinal axis of the device to effect disengagement of the locking mechanism.
Apex's Likely Construction: A collar or ring-like component that can be manipulated in any manner, including depression or translation, to effect disengagement.
Analysis: Solstice's construction is strongly supported by the plain meaning of "rotatable," which unambiguously requires rotation as the mode of operation. The specification describes the collar as being rotated by the user (col. 6, ll. 10–22: "The user rotates the collar 150 in the direction indicated by arrow A, causing the cam surfaces 155 on the collar to displace the p

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