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UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

DEFENDANT SOLSTICE BIOMEDICAL, INC.'S MEMORANDUM OF LAW IN SUPPORT OF ITS MOTION FOR SUMMARY JUDGMENT OF NON-INFRINGEMENT AS TO THE PRECISIONEDGE™ PE-5000 SERIES

Filed: April 1, 2025

CALDERWOOD & HARKNESS LLP Marcus Delgado (Bar No. 5814) Christy Bauer (Bar No. 6279) Peter Vassiliev (Bar No. 6503) 1201 Market Street, Suite 2500 Wilmington, DE 19801 Telephone: (302) 658-7400

Attorneys for Defendant Solstice Biomedical, Inc.

PRELIMINARY STATEMENT

Defendant Solstice Biomedical, Inc. ("Solstice") respectfully submits this Memorandum of Law in support of its Motion for Summary Judgment of Non-Infringement as to the PrecisionEdge™ PE-5000 Series. Solstice is a Delaware corporation and the U.S. operating subsidiary of Solstice Biomedical Devices Ltd., an Irish-domiciled private limited company (CRO No. 648217). Solstice maintains its principal offices at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803.

Plaintiff Apex Surgical Innovations, Inc. ("Apex") is a Delaware corporation with principal offices at 1220 North Market Street, Suite 550, Wilmington, Delaware 19801. On May 9, 2024, Apex filed this patent infringement action alleging that Solstice's PrecisionEdge™ line of laparoscopic trocar assemblies infringes three Apex utility patents: U.S. Patent No. 9,814,237 (the "'237 Patent"), U.S. Patent No. 10,271,884 (the "'884 Patent"), and U.S. Patent No. 10,932,105 (the "'105 Patent"). All three patents name Dr. Raymond Szabo, Apex's Vice President of Engineering, as the sole inventor and are assigned to Apex.

This memorandum addresses non-infringement of the '237 and '884 Patents only as to the PrecisionEdge™ PE-5000 Series, which is Solstice's 5 mm laparoscopic trocar assembly. The PE-5000 is accused of infringing Claims 1, 3, 7, and 12 of the '237 Patent and Claims 1, 2, 5, 9, and 14 of the '884 Patent. The '105 Patent is not asserted against the PE-5000 Series; it is asserted only against the PE-12000 and PE-15000 Series and is therefore not at issue in this motion.

On December 6, 2024, this Court issued its Claim Construction Order (D.I. 87) construing nine disputed claim terms across the three asserted patents. That Order is the product of extensive briefing by the parties and a Markman hearing held on November 18, 2024. The Court's constructions of two key terms — "locking seal assembly" as used in the '237 Patent and "retractable blade deployment mechanism" as used in the '884 Patent — are dispositive of the infringement allegations against the PE-5000 Series.

Of the nine disputed terms construed by this Court, five were resolved favorably to Solstice and four were resolved favorably to Apex. The two constructions most directly relevant to this motion — "locking seal assembly" and "retractable blade deployment mechanism" — were both construed consistently with Solstice's proposed constructions and are fatal to Apex's infringement case against the PE-5000. The Court's construction of "locking seal assembly" requires a multi-component mechanical interlock with a discrete locking detent engaged by rotational actuation — structural features entirely absent from the PE-5000's compressive elastomeric gasket seal. The Court's construction of "retractable blade deployment mechanism" requires a spring-loaded blade carriage that retracts the cutting blade to a fully shielded position upon release of an affirmative manual actuating force — a mechanism fundamentally different from the PE-5000's cam-driven blade retraction system.

Summary judgment is warranted because no reasonable jury, applying the Court's claim constructions to the undisputed facts, could find that the PE-5000 Series meets the limitations of the asserted claims of either the '237 or the '884 Patent. The structural and mechanical differences between the PE-5000 and the patented inventions are not merely incremental or arguable — they are categorical. The PE-5000 lacks the very structural elements that the Court determined are required by the claim language, and that Apex itself distinguished from prior art during patent prosecution to secure allowance of its claims. Apex's own technical expert, Dr. Calvin Ng, does not assert that the PE-5000 literally satisfies the "locking seal assembly" limitation, and his attempt to bridge the gap through the doctrine of equivalents is foreclosed by prosecution history estoppel. Similarly, Dr. Ng's infringement report fails to identify any spring element in the PE-5000 or to explain how the PE-5000's cam-driven blade mechanism satisfies the Court's construction of "retractable blade deployment mechanism."

The undisputed structural and mechanical differences between the PE-5000 and the patented inventions establish non-infringement as a matter of law. Solstice is entitled to summary judgment on all claims alleging infringement by the PE-5000 Series.

STATEMENT OF UNDISPUTED MATERIAL FACTS

A. The Parties and Their Products

1. Solstice Biomedical Devices Ltd. was founded in 2011 in Dublin, Ireland, and designs, manufactures, and distributes minimally invasive surgical instruments worldwide, including laparoscopic trocars (marketed under the PrecisionEdge™ brand), endoscopic graspers, and electrosurgical hand instruments. The company employs approximately 620 people worldwide across its facilities in Dublin, Ireland; Limerick, Ireland; and Wilmington, Delaware. For fiscal year ending December 31, 2023, Solstice Biomedical Devices Ltd. generated consolidated revenue of €187.4 million. (Delgado Decl. ¶ 2, Ex. A (Solstice Corporate Overview).) Solstice Biomedical, Inc. is Solstice's Delaware-incorporated U.S. operating subsidiary (EIN: 84-3291056), responsible for all U.S. sales, marketing, regulatory, and distribution activities. (Id. ¶ 3.)

2. Apex Surgical Innovations, Inc. was founded in 2006 and is a Delaware corporation that manufactures and sells surgical access devices, trocar systems, and insufflation equipment. Apex employs approximately 1,100 people and generated estimated revenue of approximately $312 million for fiscal year 2023. (Delgado Decl. ¶ 4, Ex. B (Apex Annual Report 2023, publicly available).)

3. The PrecisionEdge™ PE-5000 Series is a 5 mm laparoscopic trocar assembly designed, manufactured, and sold by Solstice in the United States for use in minimally invasive surgical procedures. The PE-5000 Series has been commercially available in the United States since January 2021. Combined U.S. sales of all accused PrecisionEdge™ products — including the PE-5000, PE-12000, and PE-15000 Series — for calendar years 2021 through the third quarter of 2024 total approximately $74.6 million. (Delgado Decl. ¶ 5, Ex. C (Solstice U.S. Sales Data, Bates Nos. SBD-003415 through SBD-003422).)

B. The Asserted Patents

4. U.S. Patent No. 9,814,237, titled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," was filed on June 22, 2015, and issued on November 14, 2017. The '237 Patent expires on June 22, 2035. Claims 1, 3, 7, and 12 of the '237 Patent are asserted against the PE-5000 Series in this action. (Delgado Decl. ¶ 6, Ex. D (U.S. Patent No. 9,814,237).)

5. U.S. Patent No. 10,271,884, titled "Retractable Blade Deployment Mechanism for Trocar Systems," was filed on September 15, 2016, and issued on April 30, 2019. The '884 Patent expires on September 15, 2036. Claims 1, 2, 5, 9, and 14 of the '884 Patent are asserted against the PE-5000 Series in this action. (Delgado Decl. ¶ 7, Ex. E (U.S. Patent No. 10,271,884).)

6. Both the '237 Patent and the '884 Patent are part of a patent family comprising fourteen (14) issued U.S. utility patents and six (6) pending continuation applications, all assigned to Apex Surgical Innovations, Inc. and all naming Dr. Raymond Szabo as the sole inventor. (Delgado Decl. ¶ 8, Ex. F (Patent Family Tree).)

C. The Court's Claim Construction Order

7. On November 18, 2024, this Court held a Markman hearing on nine disputed claim terms arising from the three asserted patents. The parties submitted a Joint Claim Construction Brief (D.I. 74), individual Claim Construction Briefs (D.I. 72, D.I. 73), and tutorial presentations from their respective technical experts. (Delgado Decl. ¶ 9.)

8. On December 6, 2024, this Court issued its Claim Construction Order (D.I. 87), construing all nine disputed terms. The Court's Order resolved five of the nine disputed terms consistently with Solstice's proposed constructions, and four consistently with Apex's proposed constructions. The two constructions most directly relevant to this motion are those of "locking seal assembly" (from the '237 Patent) and "retractable blade deployment mechanism" (from the '884 Patent). (Id. ¶ 10, Ex. G (Claim Construction Order, D.I. 87).)

9. The Court construed the term "locking seal assembly" as used in Claim 1 of the '237 Patent to mean:

"A multi-component assembly comprising (i) a seal element, (ii) a mechanical interlock that includes a discrete locking detent, and (iii) a rotational actuation mechanism that engages the locking detent to secure the seal element in a closed, sealing position."

(D.I. 87 at 14.) This construction was consistent with Solstice's proposed construction and with the patent specification's description of the preferred embodiment, which discloses a detent-and-groove rotational lock mechanism. The Court rejected Apex's broader proposed construction, which would have encompassed any seal element "maintained in a sealing configuration by a securing mechanism." (Id. at 12-14.)

10. The Court construed the term "retractable blade deployment mechanism" as used in Claim 1 of the '884 Patent to mean:

"A spring-loaded blade carriage that (i) deploys a cutting blade upon application of an affirmative manual actuating force and (ii) retracts the cutting blade to a fully shielded position upon release of that manual actuating force, such that the blade is biased toward retraction by a spring element."

(D.I. 87 at 21.) This construction was consistent with Solstice's proposed construction and required the mechanism to be spring-biased toward the retracted and fully shielded position — meaning the default state of the mechanism, absent the surgeon's affirmative application of force, is blade-retracted and blade-shielded. The Court rejected Apex's broader proposed construction, which would have encompassed any mechanism capable of both deploying and retracting a cutting blade. (Id. at 18-21.)

D. The PE-5000's Design — Undisputed Technical Facts

11. The PE-5000 Series employs a sealing mechanism that is structurally distinct from the "locking seal assembly" described in the '237 Patent. Specifically, the PE-5000 uses a compressive elastomeric gasket seal — a medical-grade silicone gasket that is compressed between two housing components when the trocar is assembled. The gasket seal is maintained in position by the axial compression forces generated when the upper and lower housing halves are snapped together. The PE-5000 does not employ a multi-component mechanical interlock, does not contain a discrete locking detent, and does not use a rotational actuation mechanism to engage any locking element. (Delgado Decl. ¶ 12, Ex. H (PE-5000 Engineering Drawings and Product Specifications, Bates Nos. SBD-012841 through SBD-012887); Ex. I (Deposition of Thomas Hennessy, Solstice Director of Engineering, at 47:3-52:18).)

12. The PE-5000 Series does not employ a spring-loaded blade carriage as described in the '884 Patent. Instead, the PE-5000's blade is advanced and retracted by a cam-driven mechanism actuated by forward advancement of the obturator housing. In the PE-5000, a cam follower affixed to the blade carrier rides along a cam track integrated into the interior wall of the obturator housing. The surgeon's forward advancement of the obturator causes the cam follower to travel along the cam track, deploying the blade. Continued forward advancement past the tissue plane causes the cam follower to ride along a descending portion of the cam track profile, withdrawing the blade to a shielded position. There is no spring element biasing the blade toward retraction, and there is no separate manual actuating force whose release triggers blade retraction. (Delgado Decl. ¶ 13, Ex. J (PE-5000 Engineering Schematics and CAD Files, Bates Nos. SBD-013104 through SBD-013298); Ex. K (Expert Report of Dr. Miriam Ostrowski, served January 27, 2025, at ¶¶ 47-68).)

13. Apex's own technical expert, Dr. Calvin Ng, Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute, in his infringement expert report served February 10, 2025, acknowledged the structural differences between the PE-5000's elastomeric gasket seal and the claimed "locking seal assembly." Dr. Ng's report states: "The PE-5000 does not employ a detent-and-groove mechanism or a rotational actuation mechanism to secure its seal element in a closed position. Rather, the PE-5000 maintains its seal through compression of an elastomeric gasket." (Delgado Decl. ¶ 14, Ex. L (Expert Report of Dr. Calvin Ng, served February 10, 2025, at ¶ 83).) Dr. Ng did not assert that the PE-5000 literally satisfies the "locking seal assembly" limitation as construed by the Court. Instead, he attempted to bridge the gap between the PE-5000's design and the claim limitation through a doctrine-of-equivalents theory. (Id. at ¶¶ 84-102.)

E. Expert Testimony

14. Solstice retained Dr. Miriam Ostrowski, Professor of Biomedical Engineering at Halford University, as its technical expert on issues of infringement and validity. Dr. Ostrowski holds a Ph.D. in Biomedical Engineering from Stanford University and has over twenty-five years of experience in the design and evaluation of minimally invasive surgical instruments. In her expert report served January 27, 2025, Dr. Ostrowski opined that the PE-5000 Series does not meet the claim limitations of either the '237 Patent or the '884 Patent under the Court's claim constructions. (Delgado Decl. ¶ 15, Ex. K (Expert Report of Dr. Miriam Ostrowski, at ¶¶ 27-112).) In her rebuttal expert report served March 3, 2025, Dr. Ostrowski specifically addressed and refuted Dr. Ng's doctrine-of-equivalents arguments regarding the '237 Patent and his literal infringement arguments regarding the '884 Patent. (Delgado Decl. ¶ 16, Ex. M (Rebuttal Expert Report of Dr. Miriam Ostrowski, served March 3, 2025, at ¶¶ 8-64).)

15. Dr. Ng's February 10, 2025 infringement expert report concedes — or at minimum does not dispute — that the PE-5000's elastomeric gasket seal does not literally satisfy the "locking seal assembly" limitation as construed by the Court. (Delgado Decl. ¶ 14, Ex. L (Expert Report of Dr. Calvin Ng, at ¶¶ 83-84) (acknowledging the absence of a detent-and-groove mechanism and rotational actuation mechanism in the PE-5000 and proceeding directly to a doctrine-of-equivalents analysis).) With respect to the '884 Patent, Dr. Ng's report does not identify any spring element in the PE-5000 and does not explain how the PE-5000's cam-driven blade mechanism satisfies the Court's construction of "retractable blade deployment mechanism." (Id. at ¶¶ 128-145.)

F. Procedural History Relevant to This Motion

16. Apex filed its Complaint (D.I. 1) on May 9, 2024, asserting infringement of the '237, '884, and '105 Patents. Solstice filed its Answer, Affirmative Defenses, and Counterclaims (D.I. 12) on June 14, 2024, denying infringement and asserting counterclaims for declaratory judgment of non-infringement and invalidity.

17. Fact discovery in this action has been extensive. Solstice produced 48,217 documents bearing Bates numbers SBD-000001 through SBD-048217, encompassing engineering drawings, design history files, manufacturing records, sales data, marketing materials, and internal correspondence. Apex produced 31,450 documents bearing Bates numbers APEX-000001 through APEX-031450, encompassing patent prosecution files, inventor notebooks, internal technical memoranda, licensing correspondence, and prior art search records. (Delgado Decl. ¶ 18.)

18. Expert discovery opened on January 13, 2025. Opening expert reports were served by January 27, 2025 (Solstice) and February 10, 2025 (Apex). Rebuttal expert reports were exchanged on March 3, 2025. Expert depositions were completed by March 14, 2025. (Delgado Decl. ¶ 19.) Additionally, the parties participated in a court-ordered mediation on March 17, 2025, before the Honorable Margaret Forsythe (Ret.) at Amberstone ADR Services in Wilmington, Delaware. The mediation did not result in resolution of the dispute. (Id. ¶ 20.)

19. Trial in this action is currently set for September 30, 2025, before Chief Judge Andrews. (D.I. 94, Scheduling Order.)

LEGAL STANDARD

Summary judgment is appropriate under Federal Rule of Civil Procedure 56(a) where "the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a). A dispute of material fact is "genuine" only "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). In evaluating a motion for summary judgment, the Court must view the evidence in the light most favorable to the non-movant, draw all reasonable inferences in the non-movant's favor, and refrain from making credibility determinations. Id. at 255; Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). However, "the mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment; the requirement is that there be no genuine issue of material fact." Anderson, 477 U.S. at 247-48 (emphasis in original).

In patent cases, the determination of infringement involves a well-established two-step analysis. First, the Court must construe the claims of the asserted patent to determine their scope and meaning as a matter of law. Markman v. Westview Instruments, Inc., 517 U.S. 370, 384, 388-90 (1996). Second, the properly construed claims are compared to the accused product or process, which is a question of fact. Id.; Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454 (Fed. Cir. 1998) (en banc). Although the second step is a question of fact, it is well-suited to resolution on summary judgment where no reasonable factfinder could find that the accused product satisfies every limitation of the asserted claims. Chimie v. PPG Indus., Inc., 402 F.3d 1371, 1376 (Fed. Cir. 2005) ("Summary judgment of noninfringement is . . . appropriate where the patent owner's proof is deficient in meeting an essential element of the claim of infringement.").

The patent holder bears the burden of proving infringement by a preponderance of the evidence. Harborview Corporation, Inc. v. Mirowski Family Ventures, LLC, 571 U.S. 191, 199 (2014). To establish literal infringement, the patent holder must prove that the accused product contains every limitation set forth in the properly construed claim. Severin Holdings v. Quillon Corporation, 289 F.3d 801, 812 (Fed. Cir. 2002). If even a single claim limitation is not met, there is no literal infringement. Laitram Corp. v. Rexnord, Inc., 939 F.2d 1533, 1535 (Fed. Cir. 1991).

The accused infringer may obtain summary judgment of non-infringement by demonstrating the absence of a genuine dispute of material fact as to whether any claim limitation is met. See Celotex Corp. v. Catrett, 477 U.S. 317, 325 (1986). Where the court has already construed the relevant claim terms and the structural characteristics of the accused product are undisputed, the comparison of the construed claims to the accused product may be resolved as a matter of law. See Chimie, 402 F.3d at 1376; Netword, LLC v. Centraal Corp., 242 F.3d 1347, 1352-53 (Fed. Cir. 2001).

Summary judgment of non-infringement is particularly appropriate where the accused device clearly does not meet a claim limitation as construed by the court and the patentee's only response is a theory of equivalents that is foreclosed by prosecution history estoppel. See Festo Corp. v. Fenmore & Co., 535 U.S. 722, 733-34 (2002); Biagro W. Sales, Inc. v. Grow More, Inc., 423 F.3d 1296, 1306 (Fed. Cir. 2005).

ARGUMENT

I. THE PE-5000 DOES NOT INFRINGE THE '237 PATENT

A. The Court's Construction of "Locking Seal Assembly". Claims 1, 3, 7, and 12 of the '237 Patent are asserted against the PE-5000 Series. Claim 1 is the sole independent claim among those asserted; Claims 3, 7, and 12 each depend from Claim 1 and therefore incorporate all of its limitations. The relevant claim language is as follows:

Claim 1 of the '237 Patent recites:

"1. A surgical access device for use in minimally invasive surgical procedures, comprising:

a housing defining a longitudinal passage therethrough;

a locking seal assembly disposed within the housing, the locking seal assembly comprising a seal element configured to sealingly engage an instrument inserted through the longitudinal passage, a mechanical interlock, and a rotational actuation mechanism;

wherein the mechanical interlock comprises a discrete locking detent engageable by the rotational actuation mechanism to secure the seal element in a closed, sealing position; and

wherein the locking seal assembly is configured to transition between a locked sealing configuration, in which the locking detent is engaged and the seal element is compressed against the instrument, and an unlocked configuration, in which the locking detent is disengaged and the instrument may be freely inserted or withdrawn."

(Delgado Decl., Ex. D ('237 Patent), col. 14, ll. 22-42.)

Claim 3 depends from Claim 1 and further recites "wherein the seal element comprises a plurality of overlapping petals arranged in a radial configuration." (Id., col. 14, ll. 48-51.) Claim 7 depends from Claim 1 and further recites "wherein the rotational actuation mechanism comprises a cam ring rotatably disposed about the housing." (Id., col. 15, ll. 3-6.) Claim 12 depends from Claim 1 and further recites "wherein the locking seal assembly further comprises a biasing element configured to urge the seal element toward the closed, sealing position." (Id., col. 15, ll. 25-29.)

Each of these dependent claims incorporates the requirement for a "locking seal assembly" as recited in Claim 1. Because each asserted claim requires the presence of a "locking seal assembly," the Court's construction of that term controls the infringement analysis for all four claims.

On December 6, 2024, this Court construed the term "locking seal assembly" as follows:

(D.I. 87 at 14.)

The Court's construction is firmly grounded in the intrinsic evidence. The '237 Patent specification describes a single preferred embodiment of the "locking seal assembly," which employs a detent-and-groove rotational lock mechanism. (See '237 Patent, col. 5, ll. 14-48 (describing the "locking detent 120" as a "raised boss or protrusion extending radially inward from the cam ring 110" that "engages a corresponding groove 122 formed in the seal housing 104" upon rotation of the cam ring); col. 6, ll. 2-19 (describing the rotational actuation mechanism as a "cam ring 110" that is "rotated approximately 45 degrees" to engage the detent with the groove, thereby "locking the seal element 102 in the compressed, sealing configuration").) The specification consistently describes the "locking" function as one accomplished through a discrete mechanical interlock — a detent engaging a groove — actuated by rotation, and nowhere suggests that a friction-fit or compression-maintained seal, without such a mechanical interlock, would constitute a "locking seal assembly."

The prosecution history further supports the Court's narrow construction. During prosecution of the '237 Patent before the United States Patent and Trademark Office, the Examiner rejected original Claim 1 under 35 U.S.C. § 102(a)(1) as anticipated by U.S. Patent No. 7,438,702 to Milliman (the "Milliman reference"), which disclosed a trocar seal maintained in position by axial compression of an elastomeric gasket. (Delgado Decl., Ex. N ('237 Patent Prosecution History, Bates Nos. APEX-009842 through APEX-009903), at APEX-009867 (Office Action dated March 14, 2016).) In response, Apex — through a declaration under 37 C.F.R. § 1.132 signed by Dr. Szabo — distinguished the Milliman reference by arguing that Milliman's compressive gasket seal did "not constitute a 'locking' assembly because it lacks any discrete mechanical interlock or locking detent that affirmatively secures the seal in the closed position." (Delgado Decl., Ex. N, at APEX-009881 (Dr. Szabo Declaration dated May 20, 2016, at ¶ 7).) Apex simultaneously amended Claim 1 to expressly recite the "locking" limitation and the "mechanical interlock comprising a discrete locking detent." (Id. at APEX-009877 (Amendment dated May 20, 2016).) The Examiner subsequently allowed the claims. (Id. at APEX-009897 (Notice of Allowance dated August 3, 2017).)

These narrowing amendments and the inventor's sworn statements distinguishing compressive gasket seals are precisely the type of prosecution history that informs — and limits — the scope of the claims. The Court recognized as much in its Claim Construction Order, stating:

"The prosecution history confirms that the patentee distinguished prior art compression-gasket seals and amended the claims to require a 'mechanical interlock' with a 'discrete locking detent.' The Court's construction reflects these prosecution history disclaimers."

(D.I. 87 at 13-14.)

B. The PE-5000 Lacks a "Locking Seal Assembly" Under the Court's Construction. Under the Court's construction, the "locking seal assembly" limitation of Claim 1 requires three specific structural components: (i) a seal element, (ii) a mechanical interlock that includes a discrete locking detent, and (iii) a rotational actuation mechanism that engages the locking detent to secure the seal element in a closed, sealing position. A detailed element-by-element comparison of the PE-5000 to the Court's construction demonstrates that the PE-5000 is missing two of the three required components.

(i) Seal Element. The PE-5000 does contain a seal element: a medical-grade silicone elastomeric gasket that provides a seal around instruments inserted through the trocar cannula. (Delgado Decl., Ex. H (PE-5000 Engineering Drawings, Bates Nos. SBD-012841 through SBD-012887), at SBD-012856 (gasket specification sheet); Ex. K (Ostrowski Report, ¶ 35).) However, the claim requires far more than just a seal element — it requires a "locking seal assembly" with the additional structural components of a mechanical interlock and a rotational actuation mechanism. The presence of a seal element alone is insufficient to satisfy the claim limitation.

(ii) Mechanical Interlock with Discrete Locking Detent. The PE-5000 does not contain a mechanical interlock of any kind, let alone one that includes a "discrete locking detent." In the PE-5000, the elastomeric gasket is held in position solely by friction fit and axial compression. When the upper and lower halves of the trocar housing are assembled — by pressing them together axially — the gasket is compressed between the housing halves, creating a seal. (Delgado Decl., Ex. H, at SBD-012862 (assembly drawing); Ex. I (Hennessy Dep. at 48:7-49:14) ("Q: Is there any detent, groove, latch, or other discrete mechanical interlocking feature that holds the gasket in the sealed position? A: No. The gasket is held by compression between the upper and lower housing shells. There is no separate locking mechanism.").) There is no detent, no groove, no latch, no boss, no protrusion, and no other discrete interlocking feature anywhere in the PE-5000's seal assembly. (Delgado Decl., Ex. K (Ostrowski Report, ¶¶ 38-42).) The compression of the elastomeric gasket is a fundamentally different mechanism from the detent-and-groove mechanical interlock required by the Court's construction.

Dr. Ostrowski explained the distinction in detail in her expert report:

"The PE-5000's elastomeric gasket seal operates on the principle of material deformation under compression. The gasket is compressed between the housing halves, and the sealing force is generated by the elastic restoring force of the deformed gasket material. There is no discrete mechanical interlock — no detent engaging a groove or any analogous structure — that 'locks' the seal in position. The gasket's position is maintained by the same compression forces that generate the seal. This is the very type of 'compressive gasket seal' that the patentee distinguished during prosecution of the '237 Patent."

(Delgado Decl., Ex. K (Ostrowski Report, ¶ 40).)

(iii) Rotational Actuation Mechanism. The PE-5000 does not contain a rotational actuation mechanism of any kind. The PE-5000's housing components are assembled axially — pushed together in a linear, longitudinal direction — not rotated to engage a lock. (Delgado Decl., Ex. H, at SBD-012862 (assembly drawing showing axial assembly with snap-fit tabs); Ex. I (Hennessy Dep. at 50:2-51:8) ("Q: Is there any component of the PE-5000 that is rotated to engage a locking mechanism for the seal? A: No. The housing halves are pressed together. There is no rotational actuation.").) The snap-fit tabs that hold the housing halves together are engaged by axial force, not rotation, and in any event do not interact with the gasket seal itself — they hold the housing together, and the seal is a secondary consequence of the housing compression. (Delgado Decl., Ex. K (Ostrowski Report, ¶¶ 43-46).)

The following table summarizes the element-by-element comparison:

The undisputed evidence establishes that the PE-5000 lacks two of the three structural components required by the Court's construction of "locking seal assembly." Dr. Ng's infringement report does not dispute these structural facts. As Dr. Ng himself acknowledged, "The PE-5000 does not employ a detent-and-groove mechanism or a rotational actuation mechanism to secure its seal element in a closed position." (Delgado Decl., Ex. L (Ng Report, ¶ 83).)

Because the PE-5000 does not contain a "locking seal assembly" as construed by this Court, it does not satisfy the "locking seal assembly" limitation of Claim 1 of the '237 Patent, and it therefore does not literally infringe Claim 1 or any of the dependent claims that incorporate that limitation.

C. No Reasonable Jury Could Find Literal Infringement of Claims 1, 3, 7, and 12. Summary judgment of non-infringement of Claims 1, 3, 7, and 12 of the '237 Patent is appropriate because no reasonable jury could find that the PE-5000 literally satisfies the "locking seal assembly" limitation of Claim 1.

Claim 1 is the sole independent claim among those asserted against the PE-5000. Claims 3, 7, and 12 each depend from Claim 1 and therefore incorporate every limitation of Claim 1. See Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1552 n.9 (Fed. Cir. 1989) ("One who does not infringe an independent claim cannot infringe a claim dependent on (and thus containing all the limitations of) that claim."). Because each dependent claim necessarily includes the "locking seal assembly" limitation, the failure of the PE-5000 to satisfy that limitation is dispositive of all four asserted claims.

The undisputed evidence — including the PE-5000's engineering drawings, the deposition testimony of Solstice's Director of Engineering, Dr. Ostrowski's expert analysis, and the concession of Apex's own expert Dr. Ng — establishes beyond genuine dispute that the PE-5000 does not contain a "locking seal assembly" as construed by this Court. There is no mechanical interlock. There is no discrete locking detent. There is no rotational actuation mechanism. The PE-5000's elastomeric gasket seal is the very type of compressive seal that Apex distinguished from its claimed invention during prosecution of the '237 Patent.

Dr. Ng's infringement report does not assert that the PE-5000 literally meets the "locking seal assembly" limitation as construed by the Court. Instead, Dr. Ng proceeds directly from his acknowledgment of the structural differences between the PE-5000 and the claimed invention to a doctrine-of-equivalents analysis. (Delgado Decl., Ex. L (Ng Report, ¶¶ 83-84).) This effective concession of the absence of literal infringement is dispositive. See Gart v. Logitech, Inc., 254 F.3d 1334, 1339 (Fed. Cir. 2001) (granting summary judgment of no literal infringement where the accused device admittedly lacked a required claim element).

No reasonable jury could find literal infringement of any asserted claim of the '237 Patent by the PE-5000 Series.

D. The Doctrine of Equivalents Does Not Save Apex's Infringement Theory. Having failed to establish literal infringement, Apex's only remaining theory of infringement of the '237 Patent by the PE-5000 rests on the doctrine of equivalents. In his expert report, Dr. Ng applied the function-way-result test and opined that the PE-5000's compressive elastomeric gasket seal performs "substantially the same function in substantially the same way to achieve substantially the same result" as the claimed "locking seal assembly." (Delgado Decl., Ex. L (Ng Report, ¶¶ 86-102).) Specifically, Dr. Ng argued that: (a) both the claimed locking seal assembly and the PE-5000's gasket seal perform the function of "maintaining a gas-tight seal around an inserted instrument" (id. ¶ 88); (b) both achieve this function in "substantially the same way" because both "apply compressive force to a seal element to create a seal" (id. ¶ 92); and (c) both achieve "substantially the same result" because both "prevent insufflation gas leakage during a laparoscopic procedure" (id. ¶ 96).

This argument fails for two independent reasons: (1) prosecution history estoppel bars Apex from recapturing through equivalents the very subject matter it surrendered to obtain its patent, and (2) even absent estoppel, the differences between the PE-5000's design and the claimed invention are not insubstantial.

1. Prosecution History Estoppel Forecloses Apex's Equivalents Argument.

Under the doctrine of prosecution history estoppel, "a patentee who narrows a claim as a condition for obtaining a patent . . . may not argue that the surrendered territory comprised unforeseen subject matter that should be deemed equivalent to the limitation added by the amendment." Festo Corp. v. Fenmore & Co., 535 U.S. 722, 733-34 (2002). When a patentee amends a claim to add a limitation for a reason related to patentability, a rebuttable presumption arises that the patentee has surrendered all equivalents of that added limitation. Id. at 740. The presumption may be rebutted only if the patentee can demonstrate that (a) the alleged equivalent was unforeseeable at the time of the amendment, (b) the rationale underlying the amendment bears no more than a tangential relation to the equivalent in question, or (c) there is some other reason the patentee could not reasonably have been expected to have described the equivalent. Id. at 740-41.

Here, prosecution history estoppel applies with particular force. During prosecution of the '237 Patent, Apex was confronted with a prior art rejection based on the Milliman reference, which disclosed a trocar seal maintained by axial compression of an elastomeric gasket — the same type of seal used in the PE-5000. In response, Apex made two critical concessions. First, Apex amended Claim 1 to expressly require a "locking" seal assembly with a "mechanical interlock comprising a discrete locking detent" engaged by a "rotational actuation mechanism." (Delgado Decl., Ex. N, at APEX-009877 (Amendment dated May 20, 2016).) Second, Apex submitted a declaration by Dr. Szabo in which the inventor expressly distinguished compressive gasket seals from the claimed invention, stating that Milliman's compressive gasket "does not constitute a 'locking' assembly because it lacks any discrete mechanical interlock or locking detent that affirmatively secures the seal in the closed position." (Id. at APEX-009881 (Dr. Szabo Declaration, ¶ 7).)

These narrowing amendments and inventor declarations were unambiguously made for reasons related to patentability — they were made to overcome a prior art rejection and secure allowance of the claims. Accordingly, the presumption of surrender under Festo attaches, and Apex is presumed to have surrendered equivalents encompassing compressive gasket seals that lack a discrete locking detent and rotational actuation mechanism.

None of the Festo rebuttal criteria are satisfied. First, the alleged equivalent — a compressive elastomeric gasket seal — was not unforeseeable at the time of the amendment. To the contrary, it was the specific subject matter that Apex distinguished and surrendered: the Milliman reference's compressive gasket seal was the very prior art that prompted the narrowing amendment. An equivalent that is not merely foreseeable but was actually before the applicant during prosecution cannot satisfy the unforeseeability exception. See Festo, 535 U.S. at 740; Honeywell Int'l Inc. v. Hamilton Sundstrand Corp., 370 F.3d 1131, 1141 (Fed. Cir. 2004) (en banc).

Second, the rationale underlying the amendment is not tangential to the alleged equivalent. The amendment was made specifically to distinguish compressive gasket seals — the very category of seal technology used in the PE-5000. The nexus between the amendment and the alleged equivalent could not be more direct.

Third, there is no "other reason" why Apex could not reasonably have been expected to describe the PE-5000's compressive gasket seal as an equivalent. Compressive gasket seals were well-known in the art of laparoscopic trocars at the time of Apex's amendment in May 2016, and Apex was specifically aware of them because the Milliman reference was before the Examiner. Apex made a deliberate strategic choice to narrow its claims to exclude compressive gasket seals in exchange for patentability, and it cannot now recapture through equivalents the very territory it ceded.

Apex cannot reclaim through the doctrine of equivalents the compressive-gasket-seal designs it expressly and deliberately surrendered to secure allowance of the '237 Patent. Prosecution history estoppel bars Apex's equivalents theory as a matter of law. See Festo, 535 U.S. at 733-34; Biagro, 423 F.3d at 1306.

2. Even Absent Estoppel, the Differences Are Substantial.

Even if prosecution history estoppel did not apply — and it plainly does — Apex's doctrine-of-equivalents theory would fail on the merits. The differences between the PE-5000's compressive elastomeric gasket seal and the claimed multi-component locking seal assembly with a discrete detent and rotational actuation are not insubstantial; they are fundamental.

Dr. Ng's function-way-result analysis collapses the claim at an impermissibly high level of abstraction. See Sage Prods., Inc. v. Devon Indus., Inc., 126 F.3d 1420, 1425 (Fed. Cir. 1997) (cautioning against applying the doctrine of equivalents at such a high level of generality as to render claim limitations meaningless). Dr. Ng contends that both the claimed locking seal assembly and the PE-5000's gasket seal perform the "function" of "maintaining a gas-tight seal." But at that level of generality, every seal in every trocar in existence performs the same function. The relevant inquiry is more granular: the claimed locking seal assembly performs the function of mechanically locking the seal in position through a discrete detent engaged by rotational actuation, so that the seal is affirmatively secured against displacement. The PE-5000's gasket seal does not perform this locking function at all — it is held in place by material compression, with no mechanical lock.

Similarly, the claimed locking seal assembly and the PE-5000's gasket seal do not operate in "substantially the same way." The claimed invention achieves its sealed state through rotation of an actuation mechanism that drives a detent into a groove, creating a discrete mechanical interlock. The PE-5000 achieves its sealed state through axial compression of an elastomeric material. These are fundamentally different mechanical principles — mechanical interlocking versus material deformation under compression — and no reasonable factfinder could conclude that they operate in "substantially the same way." See Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 609 (1950) (equivalence must be assessed in the context of the specific claim limitation at issue).

Dr. Ostrowski's rebuttal report addressed and refuted each element of Dr. Ng's equivalents analysis, concluding:

"Dr. Ng's equivalents theory would require the Court to effectively read the 'locking' and 'mechanical interlock' and 'rotational actuation' limitations out of the claims. If a simple compressive gasket seal is the 'equivalent' of a multi-component locking assembly with a detent and rotational actuation, then those claim limitations have no meaning. The doctrine of equivalents cannot be applied in a manner that vitiates the express limitations of the claims."

(Delgado Decl., Ex. M (Ostrowski Rebuttal Report, ¶ 28).)

The doctrine of equivalents does not save Apex's infringement theory with respect to the '237 Patent. Summary judgment of non-infringement should be entered on Claims 1, 3, 7, and 12.

II. THE PE-5000 DOES NOT INFRINGE THE '884 PATENT

A. The Court's Construction of "Retractable Blade Deployment Mechanism". Claims 1, 2, 5, 9, and 14 of the '884 Patent are asserted against the PE-5000 Series. Claim 1 is the sole independent claim among those asserted; Claims 2, 5, 9, and 14 each depend from Claim 1 and therefore incorporate all of its limitations. The relevant claim language is as follows:

Claim 1 of the '884 Patent recites:

"1. A trocar assembly for penetrating tissue during a minimally invasive surgical procedure, comprising:

an obturator body defining a distal tip region;

a retractable blade deployment mechanism disposed within the obturator body, the retractable blade deployment mechanism comprising a blade carriage, a cutting blade mounted to the blade carriage, and a spring element;

wherein the blade carriage is movable between a deployed position in which the cutting blade extends beyond the distal tip region and a retracted position in which the cutting blade is fully shielded within the obturator body;

wherein the spring element biases the blade carriage toward the retracted position;

wherein the cutting blade is deployed to the deployed position upon application of an affirmative manual actuating force that overcomes the bias of the spring element; and

wherein the cutting blade retracts to the retracted position upon release of the affirmative manual actuating force."

(Delgado Decl., Ex. E ('884 Patent), col. 16, ll. 8-30.)

Claim 2 depends from Claim 1 and further recites "wherein the spring element comprises a coil compression spring disposed coaxially with the blade carriage." (Id., col. 16, ll. 31-34.) Claim 5 depends from Claim 1 and further recites "wherein the blade carriage is slidably received within a guide channel formed in the obturator body." (Id., col. 16, ll. 44-47.) Claim 9 depends from Claim 1 and further recites "wherein the cutting blade comprises a trocar-point blade having three cutting edges arranged in a triangular configuration." (Id., col. 17, ll. 5-9.) Claim 14 depends from Claim 1 and further recites "further comprising a blade shield fixedly disposed at the distal tip region, the blade shield defining an aperture through which the cutting blade extends when in the deployed position." (Id., col. 17, ll. 28-33.)

Each of these dependent claims incorporates the requirement for a "retractable blade deployment mechanism" as recited in Claim 1. Because each asserted claim requires the presence of a "retractable blade deployment mechanism," the Court's construction of that term controls the infringement analysis for all five claims.

On December 6, 2024, this Court construed the term "retractable blade deployment mechanism" as follows:

(D.I. 87 at 21.)

The Court's construction requires that the mechanism be spring-biased toward the retracted and fully shielded position. This means that the default state of the mechanism — the state in which no external force is being applied — is with the blade retracted and shielded. The surgeon must affirmatively overcome the spring bias by applying manual force to deploy the blade. When that manual force is released, the spring automatically returns the blade to the retracted, shielded position. This is the essence of the safety feature described in the '884 Patent specification: the blade is biased toward retraction so that it cannot remain exposed without the surgeon's continuous, affirmative action.

The Court's construction is grounded in the specification's detailed description of the preferred embodiment, which discloses a coil compression spring that biases the blade carriage toward the retracted position:

"The spring element 210, preferably a coil compression spring, is disposed coaxially with the blade carriage 200 and exerts a biasing force that urges the blade carriage 200 toward the retracted position. In this manner, the cutting blade 220 is automatically retracted to the fully shielded position upon release of the manual actuating force applied by the surgeon, providing a fail-safe mechanism that prevents unintended blade exposure."

('884 Patent, col. 8, ll. 32-42.)

The prosecution history further supports the Court's narrow construction. During prosecution of the '884 Patent, the Examiner rejected original Claim 1 under 35 U.S.C. § 102(a)(1) as anticipated by U.S. Patent No. 6,579,302 to Pontus (the "Pontus reference"), which disclosed a trocar with a cam-actuated blade mechanism. (Delgado Decl., Ex. O ('884 Patent Prosecution History, Bates Nos. APEX-015221 through APEX-015314), at APEX-015247 (Office Action dated July 11, 2017).) In response, Apex — through its prosecuting attorney — filed a response arguing that Pontus's cam-actuated blade was patentably distinct from the claimed "retractable blade deployment mechanism" because Pontus did not employ a spring element biasing the blade toward retraction. Apex argued:

"The Pontus reference discloses a cam-driven blade mechanism in which the blade position is determined by the cam geometry and the linear position of the obturator within the housing. Pontus does not disclose or suggest a spring element that biases the blade toward the retracted, shielded position. In the Pontus device, the blade does not automatically retract upon release of a manual actuating force; rather, blade retraction requires continued forward advancement through the cam profile. This is fundamentally different from Applicant's claimed retractable blade deployment mechanism, in which a spring element provides an automatic safety return to the fully shielded position independent of the surgeon's manual manipulation of the obturator."

(Delgado Decl., Ex. O, at APEX-015268-69 (Response to Office Action dated October 23, 2017).)

The Examiner was persuaded by this distinction and allowed the claims. (Id. at APEX-015291 (Notice of Allowance dated February 9, 2018).)

This prosecution history is significant for two reasons. First, it confirms that the Court's construction — requiring a spring-biased mechanism — accurately reflects the scope of the claims as understood by both the applicant and the Examiner during prosecution. Second, it establishes that Apex specifically distinguished cam-driven blade mechanisms — the exact type of mechanism used in the PE-5000 — as not falling within the scope of the claims. As discussed in Section II.D below, this distinction gives rise to prosecution history estoppel that forecloses any argument of infringement under the doctrine of equivalents.

B. The PE-5000 Lacks a "Retractable Blade Deployment Mechanism" Under the Court's Construction. The PE-5000 uses a cam-driven blade mechanism — the exact type of mechanism that Apex distinguished during prosecution of the '884 Patent. A detailed examination of the PE-5000's blade mechanism reveals that it fails to satisfy the Court's construction of "retractable blade deployment mechanism" in every material respect.

The PE-5000's Cam-Driven Blade Mechanism. In the PE-5000, the cutting blade is mounted on a blade carrier that is slidably disposed within the obturator housing. A cam follower — a small pin or roller — is affixed to the blade carrier and extends radially outward into a cam track that is machined into the interior wall of the obturator housing. The cam track follows a predetermined profile that controls the position of the blade as the obturator is advanced through the trocar cannula and into tissue.

When the surgeon advances the obturator forward, the cam follower rides along the cam track. The ascending portion of the cam track profile causes the blade carrier to translate distally, deploying the cutting blade beyond the distal tip of the obturator. As the obturator continues to advance — past the tissue plane — the cam follower enters the descending portion of the cam track, causing the blade carrier to translate proximally and withdrawing the cutting blade to a shielded position within the obturator body. (Delgado Decl., Ex. J (PE-5000 Engineering Schematics and CAD Files, Bates Nos. SBD-013104 through SBD-013298), at SBD-013142 (cam track profile drawing); SBD-013187 (blade carrier assembly drawing); Ex. K (Ostrowski Report, ¶¶ 47-68).)

Critically, the blade position in the PE-5000 is determined entirely by the cam geometry and the linear position of the obturator within the housing. There is no spring. There is no "release" of a manual force that triggers retraction. Deployment and retraction are both consequences of a single, continuous forward motion of the obturator. The cam track profile dictates when the blade deploys and when it retracts, based on the obturator's position relative to the housing.

Element-by-Element Comparison. A comparison of the PE-5000's blade mechanism to the Court's construction of "retractable blade deployment mechanism" reveals the absence of every critical element:

(i) Spring-Loaded Blade Carriage. The PE-5000's blade carriage is not spring-loaded. There is no spring element — no coil spring, no leaf spring, no torsion spring, no gas spring, no spring of any kind — associated with the blade carriage or the blade carrier assembly. (Delgado Decl., Ex. J, at SBD-013187 (blade carrier assembly drawing — no spring element depicted or listed in the bill of materials); Ex. I (Hennessy Dep. at 62:4-63:11) ("Q: Does the PE-5000 contain a spring that biases the blade toward a retracted position? A: No. There is no spring in the blade mechanism. The blade position is controlled entirely by the cam track."); Ex. K (Ostrowski Report, ¶¶ 52-55).) The blade carriage rides in the cam track, and its position is determined by the cam geometry — not by any spring bias.

(ii) Deployment Upon Application of an Affirmative Manual Actuating Force. The Court's construction requires that the cutting blade be deployed "upon application of an affirmative manual actuating force" that overcomes the bias of a spring element. In the PE-5000, the blade deploys as a consequence of the obturator's forward advancement through the cam track — not through the application of a separate, discrete manual force that overcomes a spring bias. The surgeon pushes the obturator forward, and the cam profile causes the blade to deploy at a specific point in the obturator's travel. (Delgado Decl., Ex. K (Ostrowski Report, ¶¶ 56-59).) There is no distinct manual actuating force that is separate from the force used to advance the obturator, and there is no spring bias to overcome.

(iii) Retraction Upon Release of Manual Actuating Force / Spring Bias Toward Retraction. The Court's construction requires that the cutting blade retract "upon release of that manual actuating force" and that the blade be "biased toward retraction by a spring element." The PE-5000 satisfies neither requirement. In the PE-5000, blade retraction is not accomplished by releasing a force and allowing a spring to return the blade — it is accomplished by continued forward motion of the obturator through the cam profile. The descending portion of the cam track withdraws the blade as the obturator advances past the tissue plane. (Delgado Decl., Ex. J, at SBD-013142 (cam track profile drawing showing ascending deployment portion and descending retraction portion); Ex. K (Ostrowski Report, ¶¶ 60-65).) If the surgeon stops advancing the obturator at the point of maximum blade deployment and releases all force, the blade does not retract — it remains in the deployed position because there is no spring bias to drive it back. The blade retracts only when the surgeon continues the forward stroke, causing the cam follower to enter the retraction portion of the cam track. (Id. ¶ 63.)

This last point bears emphasis. The Court's construction requires a mechanism in which the blade is "biased toward retraction by a spring element," such that the default state — absent manual force — is blade-retracted. In the PE-5000, there is no default state of blade retraction. The blade's position is a function of the obturator's position within the cam track. If the obturator is positioned at the point of maximum blade extension and no force is applied, the blade remains extended. This is the fundamental safety distinction that Apex itself identified during prosecution of the '884 Patent: the claimed invention provides "an automatic safety return to the fully shielded position independent of the surgeon's manual manipulation," whereas cam-driven mechanisms like the Pontus reference (and the PE-5000) do not.

The following table summarizes the element-by-element comparison:

The undisputed evidence — the PE-5000's engineering schematics, CAD files, physical samples produced in discovery, the deposition testimony of Mr. Hennessy, and Dr. Ostrowski's expert analysis — establishes that the PE-5000 lacks every element of the Court's construction of "retractable blade deployment mechanism" other than the general concept of a blade that can be deployed and retracted. The PE-5000 uses a fundamentally different mechanism — cam-driven rather than spring-biased — to control blade deployment and retraction.

C. No Reasonable Jury Could Find Literal Infringement of Claims 1, 2, 5, 9, and 14. Summary judgment of non-infringement of Claims 1, 2, 5, 9, and 14 of the '884 Patent is appropriate because no reasonable jury could find that the PE-5000 literally satisfies the "retractable blade deployment mechanism" limitation of Claim 1.

As with the '237 Patent analysis, Claim 1 is the sole independent claim among those asserted against the PE-5000, and Claims 2, 5, 9, and 14 each depend from Claim 1. Failure to meet any limitation of the independent claim is dispositive of all dependent claims. See Wahpeton Canvas, 870 F.2d at 1552 n.9. Because the PE-5000 does not satisfy the "retractable blade deployment mechanism" limitation of Claim 1, it cannot infringe any of the dependent claims, regardless of whether it might otherwise satisfy the additional limitations recited in those dependent claims.

Indeed, the failure of literal infringement is particularly stark with respect to dependent Claim 2, which further requires "wherein the spring element comprises a coil compression spring disposed coaxially with the blade carriage." The PE-5000 contains no spring element of any kind, let alone a coil compression spring disposed coaxially with the blade carriage.

The undisputed evidence demonstrates that the PE-5000 uses a cam-driven blade mechanism that does not contain a spring element, does not deploy the blade upon application of a manual actuating force that overcomes a spring bias, and does not retract the blade upon release of that manual actuating force. These are not close questions on which reasonable minds could differ — they are categorical structural differences that are evident from the PE-5000's engineering drawings, confirmed by the deposition testimony of Solstice's Director of Engineering, and acknowledged by the absence of any contrary analysis in Dr. Ng's expert report.

Dr. Ng's infringement report, with respect to the '884 Patent, does not identify any spring element in the PE-5000. Nor does it explain how the PE-5000's cam-driven mechanism satisfies the Court's construction of "retractable blade deployment mechanism." Dr. Ng's report discusses the PE-5000's blade mechanism in general terms, noting that the blade "deploys and retracts during use" (Delgado Decl., Ex. L (Ng Report, ¶ 132)), but does not address — let alone rebut — the specific structural requirements of the Court's construction. The ability of the blade to "deploy and retract" is not in dispute; what is in dispute is whether the mechanism by which deployment and retraction are accomplished satisfies the Court's construction, and the undisputed evidence demonstrates that it does not.

No reasonable jury could find literal infringement of any asserted claim of the '884 Patent by the PE-5000 Series. The structural characteristics of the PE-5000's blade mechanism are undisputed, and those characteristics are irreconcilable with the Court's construction of "retractable blade deployment mechanism."

D. Prosecution History Estoppel Bars Equivalents. Even if Apex were to advance a doctrine-of-equivalents theory with respect to the '884 Patent — and Dr. Ng's report does not clearly articulate such a theory as to this patent — prosecution history estoppel would bar it as a matter of law.

During prosecution of the '884 Patent, Apex confronted a prior art rejection based on the Pontus reference, which disclosed a cam-actuated blade mechanism. The Pontus reference described a trocar in which the blade position was controlled by a cam track integrated into the obturator housing — precisely the type of mechanism used in the PE-5000. Apex distinguished the Pontus reference by arguing that its claimed "retractable blade deployment mechanism" was patentably distinct from cam-driven systems because the spring bias provided "an automatic safety return to the fully shielded position independent of the surgeon's manual manipulation." (Delgado Decl., Ex. O, at APEX-015268-69.)

Apex's arguments to the Examiner were not merely passing observations — they were the basis on which the claims were allowed. Apex made clear, affirmative representations that the scope of its claims did not encompass cam-driven blade mechanisms, and the Examiner relied on those representations in allowing the claims. Under Festo and its progeny, Apex's prosecution history arguments constitute clear and unmistakable surrender of cam-driven blade mechanisms from the scope of its claims.

The Federal Circuit has consistently held that prosecution history estoppel bars a patentee from recapturing through equivalents subject matter that was surrendered during prosecution, whether through claim amendments or through arguments made to the Examiner. See Cybor Corp., 138 F.3d at 1460; Omega Eng'g, Inc. v. Raytek Corp., 334 F.3d 1314, 13

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
DEFENDANT SOLSTICE BIOMEDICAL, INC.'S MEMORANDUM OF LAW IN SUPPORT OF ITS MOTION FOR SUMMARY JUDGMENT OF NON-INFRINGEMENT AS TO THE PRECISIONEDGE™ PE-5000 SERIES
Filed: April 1, 2025
CALDERWOOD & HARKNESS LLP Marcus Delgado (Bar No. 5814) Christy Bauer (Bar No. 6279) Peter Vassiliev (Bar No. 6503) 1201 Market Street, Suite 2500 Wilmington, DE 19801 Telephone: (302) 658-7400
Attorneys for Defendant Solstice Biomedical, Inc.
TABLE OF CONTENTS
PRELIMINARY STATEMENT
Defendant Solstice Biomedical, Inc. ("Solstice") respectfully submits this Memorandum of Law in support of its Motion for Summary Judgment of Non-Infringement as to the PrecisionEdge™ PE-5000 Series. Solstice is a Delaware corporation and the U.S. operating subsidiary of Solstice Biomedical Devices Ltd., an Irish-domiciled private limited company (CRO No. 648217). Solstice maintains its principal offices at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803.
Plaintiff Apex Surgical Innovations, Inc. ("Apex") is a Delaware corporation with principal offices at 1220 North Market Street, Suite 550, Wilmington, Delaware 19801. On May 9, 2024, Apex filed this patent infringement action alleging that Solstice's PrecisionEdge™ line of laparoscopic trocar assemblies infringes three Apex utility patents: U.S. Patent No. 9,814,237 (the "'237 Patent"), U.S. Patent No. 10,271,884 (the "'884 Patent"), and U.S. Patent No. 10,932,105 (the "'105 Patent"). All three patents name Dr. Raymond Szabo, Apex's Vice President of Engineering, as the sole inventor and are assigned to Apex.
This memorandum addresses non-infringement of the '237 and '884 Patents only as to the PrecisionEdge™ PE-5000 Series, which is Solstice's 5 mm laparoscopic trocar assembly. The PE-5000 is accused of infringing Claims 1, 3, 7, and 12 of the '237 Patent and Claims 1, 2, 5, 9, and 14 of the '884 Patent. The '105 Patent is not asserted against the PE-5000 Series; it is asserted only against the PE-12000 and PE-15000 Series and is therefore not at issue in this motion.
On December 6, 2024, this Court issued its Claim Construction Order (D.I. 87) construing nine disputed claim terms across the three asserted patents. That Order is the product of extensive briefing by the parties and a Markman hearing held on November 18, 2024. The Court's constructions of two key terms — "locking seal assembly" as used in the '237 Patent and "retractable blade deployment mechanism" as used in the '884 Patent — are dispositive of the infringement allegations against the PE-5000 Series.
Of the nine disputed terms construed by this Court, five were resolved favorably to Solstice and four were resolved favorably to Apex. The two constructions most directly relevant to this motion — "locking seal assembly" and "retractable blade deployment mechanism" — were both construed consistently with Solstice's proposed constructions and are fatal to Apex's infringement case against the PE-5000. The Court's construction of "locking seal assembly" requires a multi-component mechanical interlock with a discrete locking detent engaged by rotational actuation — structural features entirely absent from the PE-5000's compressive elastomeric gasket seal. The Court's construction of "retractable blade deployment mechanism" requires a spring-loaded blade carriage that retracts the cutting blade to a fully shielded position upon release of an affirmative manual actuating force — a mechanism fundamentally different from the PE-5000's cam-driven blade retraction system.
Summary judgment is warranted because no reasonable jury, applying the Court's claim constructions to the undisputed facts, could find that the PE-5000 Series meets the limitations of the asserted claims of either the '237 or the '884 Patent. The structural and mechanical differences between the PE-5000 and the patented inventions are not merely incremental or arguable — they are categorical. The PE-5000 lacks the very structural elements that the Court determined are required by the claim language, and that Apex itself distinguished from prior art during patent prosecution to secure allowance of its claims. Apex's own technical expert, Dr. Calvin Ng, does not assert that the PE-5000 literally satisfies the "locking seal assembly" limitation, and his attempt to bridge the gap through the doctrine of equivalents is foreclosed by prosecution history estoppel. Similarly, Dr. Ng's infringement report fails to identify any spring element in the PE-5000 or to explain how the PE-5000's cam-driven blade mechanism satisfies the Court's construction of "retractable blade deployment mechanism."
The undisputed structural and mechanical differences between the PE-5000 and the patented inventions establish non-infringement as a matter of law. Solstice is entitled to summary judgment on all claims alleging infringement by the PE-5000 Series.
STATEMENT OF UNDISPUTED MATERIAL FACTS
A. The Parties and Their Products
1. Solstice Biomedical Devices Ltd. was founded in 2011 in Dublin, Ireland, and designs, manufactures, and distributes minimally invasive surgical instruments worldwide, including laparoscopic trocars (marketed under the PrecisionEdge™ brand), endoscopic graspers, and electrosurgical hand instruments. The company employs approximately 620 people worldwide across its facilities in Dublin, Ireland; Limerick, Ireland; and Wilmington, Delaware. For fiscal year ending December 31, 2023, Solstice Biomedical Devices Ltd. generated consolidated revenue of €187.4 million. (Delgado Decl. ¶ 2, Ex. A (Solstice Corporate Overview).) Solstice Biomedical, Inc. is Solstice's Delaware-incorporated U.S. operating subsidiary (EIN: 84-3291056), responsible for all U.S. sales, marketing, regulatory, and distribution activities. (Id. ¶ 3.)
2. Apex Surgical Innovations, Inc. was founded in 2006 and is a Delaware corporation that manufactures and sells surgical access devices, trocar systems, and insufflation equipment. Apex employs approximately 1,100 people and generated estimated revenue of approximately $312 million for fiscal year 2023. (Delgado Decl. ¶ 4, Ex. B (Apex Annual Report 2023, publicly available).)
3. The PrecisionEdge™ PE-5000 Series is a 5 mm laparoscopic trocar assembly designed, manufactured, and sold by Solstice in the United States for use in minimally invasive surgical procedures. The PE-5000 Series has been commercially available in the United States since January 2021. Combined U.S. sales of all accused PrecisionEdge™ products — including the PE-5000, PE-12000, and PE-15000 Series — for calendar years 2021 through the third quarter of 2024 total approximately $74.6 million. (Delgado Decl. ¶ 5, Ex. C (Solstice U.S. Sales Data, Bates Nos. SBD-003415 through SBD-003422).)
B. The Asserted Patents
4. U.S. Patent No. 9,814,237, titled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," was filed on June 22, 2015, and issued on November 14, 2017. The '237 Patent expires on June 22, 2035. Claims 1, 3, 7, and 12 of the '237 Patent are asserted against the PE-5000 Series in this action. (Delgado Decl. ¶ 6, Ex. D (U.S. Patent No. 9,814,237).)
5. U.S. Patent No. 10,271,884, titled "Retractable Blade Deployment Mechanism for Trocar Systems," was filed on September 15, 2016, and issued on April 30, 2019. The '884 Patent expires on September 15, 2036. Claims 1, 2, 5, 9, and 14 of the '884 Patent are asserted against the PE-5000 Series in this action. (Delgado Decl. ¶ 7, Ex. E (U.S. Patent No. 10,271,884).)
6. Both the '237 Patent and the '884 Patent are part of a patent family comprising fourteen (14) issued U.S. utility patents and six (6) pending continuation applications, all assigned to Apex Surgical Innovations, Inc. and all naming Dr. Raymond Szabo as the sole inventor. (Delgado Decl. ¶ 8, Ex. F (Patent Family Tree).)
C. The Court's Claim Construction Order
7. On November 18, 2024, this Court held a Markman hearing on nine disputed claim terms arising from the three asserted patents. The parties submitted a Joint Claim Construction Brief (D.I. 74), individual Claim Construction Briefs (D.I. 72, D.I. 73), and tutorial presentations from their respective technical experts. (Delgado Decl. ¶ 9.)
8. On December 6, 2024, this Court issued its Claim Construction Order (D.I. 87), construing all nine disputed terms. The Court's Order resolved five of the nine disputed terms consistently with Solstice's proposed constructions, and four consistently with Apex's proposed constructions. The two constructions most directly relevant to this motion are those of "locking seal assembly" (from the '237 Patent) and "retractable blade deployment mechanism" (from the '884 Patent). (Id. ¶ 10, Ex. G (Claim Construction Order, D.I. 87).)
9. The Court construed the term "locking seal assembly" as used in Claim 1 of the '237 Patent to mean:
"A multi-component assembly comprising (i) a seal element, (ii) a mechanical interlock that includes a discrete locking detent, and (iii) a rotational actuation mechanism that engages the locking detent to secure the seal element in a closed, sealing position."
(D.I. 87 at 14.) This construction was consistent with Solstice's proposed construction and with the patent specification's description of the preferred embodiment, which discloses a detent-and-groove rotational lock mechanism. The Court rejected Apex's broader proposed construction, which would have encompassed any seal element "maintained in a sealing configuration by a securing mechanism." (Id. at 12-14.)
10. The Court construed the term "retractable blade deployment mechanism" as used in Claim 1 of the '884 Patent to mean:
"A spring-loaded blade carriage that (i) deploys a cutting blade upon application of an affirmative manual actuating force and (ii) retracts the cutting blade to a fully shielded position upon release of that manual actuating force, such that the blade is biased toward retraction by a spring element."
(D.I. 87 at 21.) This construction was consistent with Solstice's proposed construction and required the mechanism to be spring-biased toward the retracted and fully shielded position — meaning the default state of the mechanism, absent the surgeon's affirmative application of force, is blade-retracted and blade-shielded. The Court rejected Apex's broader proposed construction, which would have encompassed any mechanism capable of both deploying and retracting a cutting blade. (Id. at 18-21.)
D. The PE-5000's Design — Undisputed Technical Facts
11. The PE-5000 Series employs a sealing mechanism that is structurally distinct from the "locking seal assembly" described in the '237 Patent. Specifically, the PE-5000 uses a compressive elastomeric gasket seal — a medical-grade silicone gasket that is compressed between two housing components when the trocar is assembled. The gasket seal is maintained in position by the axial compression forces generated when the upper and lower housing halves are snapped together. The PE-5000 does not employ a multi-component mechanical interlock, does not contain a discrete locking detent, and does not use a rotational actuation mechanism to engage any locking element. (Delgado Decl. ¶ 12, Ex. H (PE-5000 Engineering Drawings and Product Specifications, Bates Nos. SBD-012841 through SBD-012887); Ex. I (Deposition of Thomas Hennessy, Solstice Director of Engineering, at 47:3-52:18).)
12. The PE-5000 Series does not employ a spring-loaded blade carriage as described in the '884 Patent. Instead, the PE-5000's blade is advanced and retracted by a cam-driven mechanism actuated by forward advancement of the obturator housing. In the PE-5000, a cam follower affixed to the blade carrier rides along a cam track integrated into the interior wall of the obturator housing. The surgeon's forward advancement of the obturator causes the cam follower to travel along the cam track, deploying the blade. Continued forward advancement past the tissue plane causes the cam follower to ride along a descending portion of the cam track profile, withdrawing the blade to a shielded position. There is no spring element biasing the blade toward retraction, and there is no separate manual actuating force whose release triggers blade retraction. (Delgado Decl. ¶ 13, Ex. J (PE-5000 Engineering Schematics and CAD Files, Bates Nos. SBD-013104 through SBD-013298); Ex. K (Expert Report of Dr. Miriam Ostrowski, served January 27, 2025, at ¶¶ 47-68).)
13. Apex's own technical expert, Dr. Calvin Ng, Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute, in his infringement expert report served February 10, 2025, acknowledged the structural differences between the PE-5000's elastomeric gasket seal and the claimed "locking seal assembly." Dr. Ng's report states: "The PE-5000 does not employ a detent-and-groove mechanism or a rotational actuation mechanism to secure its seal element in a closed position. Rather, the PE-5000 maintains its seal through compression of an elastomeric gasket." (Delgado Decl. ¶ 14, Ex. L (Expert Report of Dr. Calvin Ng, served February 10, 2025, at ¶ 83).) Dr. Ng did not assert that the PE-5000 literally satisfies the "locking seal assembly" limitation as construed by the Court. Instead, he attempted to bridge the gap between the PE-5000's design and the claim limitation through a doctrine-of-equivalents theory. (Id. at ¶¶ 84-102.)
E. Expert Testimony
14. Solstice retained Dr. Miriam Ostrowski, Professor of Biomedical Engineering at Halford University, as its technical expert on issues of infringement and validity. Dr. Ostrowski holds a Ph.D. in Biomedical Engineering from Stanford University and has over twenty-five years of experience in the design and evaluation of minimally invasive surgical instruments. In her expert report served January 27, 2025, Dr. Ostrowski opined that the PE-5000 Series does not meet the claim limitations of either the '237 Patent or the '884 Patent under the Court's claim constructions. (Delgado Decl. ¶ 15, Ex. K (Expert Report of Dr. Miriam Ostrowski, at ¶¶ 27-112).) In her rebuttal expert report served March 3, 2025, Dr. Ostrowski specifically addressed and refuted Dr. Ng's doctrine-of-equivalents arguments regarding the '237 Patent and his literal infringement arguments regarding the '884 Patent. (Delgado Decl. ¶ 16, Ex. M (Rebuttal Expert Report of Dr. Miriam Ostrowski, served March 3, 2025, at ¶¶ 8-64).)
15. Dr. Ng's February 10, 2025 infringement expert report concedes — or at minimum does not dispute — that the PE-5000's elastomeric gasket seal does not literally satisfy the "locking seal assembly" limitation as construed by the Court. (Delgado Decl. ¶ 14, Ex. L (Expert Report of Dr. Calvin Ng, at ¶¶ 83-84) (acknowledging the absence of a detent-and-groove mechanism and rotational actuation mechanism in the PE-5000 and proceeding directly to a doctrine-of-equivalents analysis).) With respect to the '884 Patent, Dr. Ng's report does not identify any spring element in the PE-5000 and does not explain how the PE-5000's cam-driven blade mechanism satisfies the Court's construction of "retractable blade deployment mechanism." (Id. at ¶¶ 128-145.)
F. Procedural History Relevant to This Motion
16. Apex filed its Complaint (D.I. 1) on May 9, 2024, asserting infringement of the '237, '884, and '105 Patents. Solstice filed its Answer, Affirmative Defenses, and Counterclaims (D.I. 12) on June 14, 2024, denying infringement and asserting counterclaims for declaratory judgment of non-infringement and invalidity.
17. Fact discovery in this action has been extensive. Solstice produced 48,217 documents bearing Bates numbers SBD-000001 through SBD-048217, encompassing engineering drawings, design history files, manufacturing records, sales data, marketing materials, and internal correspondence. Apex produced 31,450 documents bearing Bates numbers APEX-000001 through APEX-031450, encompassing patent prosecution files, inventor notebooks, internal technical memoranda, licensing correspondence, and prior art search records. (Delgado Decl. ¶ 18.)
18. Expert discovery opened on January 13, 2025. Opening expert reports were served by January 27, 2025 (Solstice) and February 10, 2025 (Apex). Rebuttal expert reports were exchanged on March 3, 2025. Expert depositions were completed by March 14, 2025. (Delgado Decl. ¶ 19.) Additionally, the parties participated in a court-ordered mediation on March 17, 2025, before the Honorable Margaret Forsythe (Ret.) at Amberstone ADR Services in Wilmington, Delaware. The mediation did not result in resolution of the dispute. (Id. ¶ 20.)
19. Trial in this action is currently set for September 30, 2025, before Chief Judge Andrews. (D.I. 94, Scheduling Order.)
LEGAL STANDARD
Summary judgment is appropriate under Federal Rule of Civil Procedure 56(a) where "the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a). A dispute of material fact is "genuine" only "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). In evaluating a motion for summary judgment, the Court must view the evidence in the light most favorable to the non-movant, draw all reasonable inferences in the non-movant's favor, and refrain from making credibility determinations. Id. at 255; Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). However, "the mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment; the requirement is that there be no genuine issue of material fact." Anderson, 477 U.S. at 247-48 (emphasis in original).
In patent cases, the determination of infringement involves a well-established two-step analysis. First, the Court must construe the claims of the asserted patent to determine their scope and meaning as a matter of law. Markman v. Westview Instruments, Inc., 517 U.S. 370, 384, 388-90 (1996). Second, the properly construed claims are compared to the accused product or process, which is a question of fact. Id.; Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454 (Fed. Cir. 1998) (en banc). Although the second step is a question of fact, it is well-suited to resolution on summary judgment where no reasonable factfinder could find that the accused product satisfies every limitation of the asserted claims. Chimie v. PPG Indus., Inc., 402 F.3d 1371, 1376 (Fed. Cir. 2005) ("Summary judgment of noninfringement is . . . appropriate where the patent owner's proof is deficient in meeting an essential element of the claim of infringement.").
The patent holder bears the burden of proving infringement by a preponderance of the evidence. Harborview Corporation, Inc. v. Mirowski Family Ventures, LLC, 571 U.S. 191, 199 (2014). To establish literal infringement, the patent holder must prove that the accused product contains every limitation set forth in the properly construed claim. Severin Holdings v. Quillon Corporation, 289 F.3d 801, 812 (Fed. Cir. 2002). If even a single claim limitation is not met, there is no literal infringement. Laitram Corp. v. Rexnord, Inc., 939 F.2d 1533, 1535 (Fed. Cir. 1991).
The accused infringer may obtain summary judgment of non-infringement by demonstrating the absence of a genuine dispute of material fact as to whether any claim limitation is met. See Celotex Corp. v. Catrett, 477 U.S. 317, 325 (1986). Where the court has already construed the relevant claim terms and the structural characteristics of the accused product are undisputed, the comparison of the construed claims to the accused product may be resolved as a matter of law. See Chimie, 402 F.3d at 1376; Netword, LLC v. Centraal Corp., 242 F.3d 1347, 1352-53 (Fed. Cir. 2001).
Summary judgment of non-infringement is particularly appropriate where the accused device clearly does not meet a claim limitation as construed by the court and the patentee's only response is a theory of equivalents that is foreclosed by prosecution history estoppel. See Festo Corp. v. Fenmore & Co., 535 U.S. 722, 733-34 (2002); Biagro W. Sales, Inc. v. Grow More, Inc., 423 F.3d 1296, 1306 (Fed. Cir. 2005).
ARGUMENT
I. THE PE-5000 DOES NOT INFRINGE THE '237 PATENT
A. The Court's Construction of "Locking Seal Assembly". Claims 1, 3, 7, and 12 of the '237 Patent are asserted against the PE-5000 Series. Claim 1 is the sole independent claim among those asserted; Claims 3, 7, and 12 each depend from Claim 1 and therefore incorporate all of its limitations. The relevant claim language is as follows:
Claim 1 of the '237 Patent recites:
"1. A surgical access device for use in minimally invasive surgical procedures, comprising:
a housing defining a longitudinal passage therethrough;
a locking seal assembly disposed within the housing, the locking seal assembly comprising a seal element configured to sealingly engage an instrument inserted through the longitudinal passage, a mechanical interlock, and a rotational actuation mechanism;
wherein the mechanical interlock comprises a discrete locking detent engageable by the rotational actuation mechanism to secure the seal element in a closed, sealing position; and
wherein the locking seal assembly is configured to transition between a locked sealing configuration, in which the locking detent is engaged and the seal element is compressed against the instrument, and an unlocked configuration, in which the locking detent is disengaged and the instrument may be freely inserted or withdrawn."
(Delgado Decl., Ex. D ('237 Patent), col. 14, ll. 22-42.)
Claim 3 depends from Claim 1 and further recites "wherein the seal element comprises a plurality of overlapping petals arranged in a radial configuration." (Id., col. 14, ll. 48-51.) Claim 7 depends from Claim 1 and further recites "wherein the rotational actuation mechanism comprises a cam ring rotatably disposed about the housing." (Id., col. 15, ll. 3-6.) Claim 12 depends from Claim 1 and further recites "wherein the locking seal assembly further comprises a biasing element configured to urge the seal element toward the closed, sealing position." (Id., col. 15, ll. 25-29.)
Each of these dependent claims incorporates the requirement for a "locking seal assembly" as recited in Claim 1. Because each asserted claim requires the presence of a "locking seal assembly," the Court's construction of that term controls the infringement analysis for all four claims.
On December 6, 2024, this Court construed the term "locking seal assembly" as follows:
"A multi-component assembly comprising (i) a seal element, (ii) a mechanical interlock that includes a discrete locking detent, and (iii) a rotational actuation mechanism that engages the locking detent to secure the seal element in a closed, sealing position."
(D.I. 87 at 14.)
The Court's construction is firmly grounded in the intrinsic evidence. The '237 Patent specification describes a single preferred embodiment of the "locking seal assembly," which employs a detent-and-groove rotational lock mechanism. (See '237 Patent, col. 5, ll. 14-48 (describing the "locking detent 120" as a "raised boss or protrusion extending radially inward from the cam ring 110" that "engages a corresponding groove 122 formed in the seal housing 104" upon rotation of the cam ring); col. 6, ll. 2-19 (describing the rotational actuation mechanism as a "cam ring 110" that is "rotated approximately 45 degrees" to engage the detent with the groove, thereby "locking the seal element 102 in the compressed, sealing configuration").) The specification consistently describes the "locking" function as one accomplished through a discrete mechanical interlock — a detent engaging a groove — actuated by rotation, and nowhere suggests that a friction-fit or compression-maintained seal, without such a mechanical interlock, would constitute a "locking seal assembly."
The prosecution history further supports the Court's narrow construction. During prosecution of the '237 Patent before the United States Patent and Trademark Office, the Examiner rejected original Claim 1 under 35 U.S.C. § 102(a)(1) as anticipated by U.S. Patent No. 7,438,702 to Milliman (the "Milliman reference"), which disclosed a trocar seal maintained in position by axial compression of an elastomeric gasket. (Delgado Decl., Ex. N ('237 Patent Prosecution History, Bates Nos. APEX-009842 through APEX-009903), at APEX-009867 (Office Action dated March 14, 2016).) In response, Apex — through a declaration under 37 C.F.R. § 1.132 signed by Dr. Szabo — distinguished the Milliman reference by arguing that Milliman's compressive gasket seal did "not constitute a 'locking' assembly because it lacks any discrete mechanical interlock or locking detent that affirmatively secures the seal in the closed position." (Delgado Decl., Ex. N, at APEX-009881 (Dr. Szabo Declaration dated May 20, 2016, at ¶ 7).) Apex simultaneously amended Claim 1 to expressly recite the "locking" limitation and the "mechanical interlock comprising a discrete locking detent." (Id. at APEX-009877 (Amendment dated May 20, 2016).) The Examiner subsequently allowed the claims. (Id. at APEX-009897 (Notice of Allowance dated August 3, 2017).)
These narrowing amendments and the inventor's sworn statements distinguishing compressive gasket seals are precisely the type of prosecution history that informs — and limits — the scope of the claims. The Court recognized as much in its Claim Construction Order, stating:
"The prosecution history confirms that the patentee distinguished prior art compression-gasket seals and amended the claims to require a 'mechanical interlock' with a 'discrete locking detent.' The Court's construction reflects these prosecution history disclaimers."
(D.I. 87 at 13-14.)
B. The PE-5000 Lacks a "Locking Seal Assembly" Under the Court's Construction. Under the Court's construction, the "locking seal assembly" limitation of Claim 1 requires three specific structural components: (i) a seal element, (ii) a mechanical interlock that includes a discrete locking detent, and (iii) a rotational actuation mechanism that engages the locking detent to secure the seal element in a closed, sealing position. A detailed element-by-element comparison of the PE-5000 to the Court's construction demonstrates that the PE-5000 is missing two of the three required components.
(i) Seal Element. The PE-5000 does contain a seal element: a medical-grade silicone elastomeric gasket that provides a seal around instruments inserted through the trocar cannula. (Delgado Decl., Ex. H (PE-5000 Engineering Drawings, Bates Nos. SBD-012841 through SBD-012887), at SBD-012856 (gasket specification sheet); Ex. K (Ostrowski Report, ¶ 35).) However, the claim requires far more than just a seal element — it requires a "locking seal assembly" with the additional structural components of a mechanical interlock and a rotational actuation mechanism. The presence of a seal element alone is insufficient to satisfy the claim limitation.
(ii) Mechanical Interlock with Discrete Locking Detent. The PE-5000 does not contain a mechanical interlock of any kind, let alone one that includes a "discrete locking detent." In the PE-5000, the elastomeric gasket is held in position solely by friction fit and axial compression. When the upper and lower halves of the trocar housing are assembled — by pressing them together axially — the gasket is compressed between the housing halves, creating a seal. (Delgado Decl., Ex. H, at SBD-012862 (assembly drawing); Ex. I (Hennessy Dep. at 48:7-49:14) ("Q: Is there any detent, groove, latch, or other discrete mechanical interlocking feature that holds the gasket in the sealed position? A: No. The gasket is held by compression between the upper and lower housing shells. There is no separate locking mechanism.").) There is no detent, no groove, no latch, no boss, no protrusion, and no other discrete interlocking feature anywhere in the PE-5000's seal assembly. (Delgado Decl., Ex. K (Ostrowski Report, ¶¶ 38-42).) The compression of the elastomeric gasket is a fundamentally different mechanism from the detent-and-groove mechanical interlock required by the Court's construction.
Dr. Ostrowski explained the distinction in detail in her expert report:
"The PE-5000's elastomeric gasket seal operates on the principle of material deformation under compression. The gasket is compressed between the housing halves, and the sealing force is generated by the elastic restoring force of the deformed gasket material. There is no discrete mechanical interlock — no detent engaging a groove or any analogous structure — that 'locks' the seal in position. The gasket's position is maintained by the same compression forces that generate the seal. This is the very type of 'compressive gasket seal' that the patentee distinguished during prosecution of the '237 Patent."
(Delgado Decl., Ex. K (Ostrowski Report, ¶ 40).)
(iii) Rotational Actuation Mechanism. The PE-5000 does not contain a rotational actuation mechanism of any kind. The PE-5000's housing components are assembled axially — pushed together in a linear, longitudinal direction — not rotated to engage a lock. (Delgado Decl., Ex. H, at SBD-012862 (assembly drawing showing axial assembly with snap-fit tabs); Ex. I (Hennessy Dep. at 50:2-51:8) ("Q: Is there any component of the PE-5000 that is rotated to engage a locking mechanism for the seal? A: No. The housing halves are pressed together. There is no rotational actuation.").) The snap-fit tabs that hold the housing halves together are engaged by axial force, not rotation, and in any event do not interact with the gasket seal itself — they hold the housing together, and the seal is a secondary consequence of the housing compression. (Delgado Decl., Ex. K (Ostrowski Report, ¶¶ 43-46).)
The following table summarizes the element-by-element comparison:
The undisputed evidence establishes that the PE-5000 lacks two of the three structural components required by the Court's construction of "locking seal assembly." Dr. Ng's infringement report does not dispute these structural facts. As Dr. Ng himself acknowledged, "The PE-5000 does not employ a detent-and-groove mechanism or a rotational actuation mechanism to secure its seal element in a closed position." (Delgado Decl., Ex. L (Ng Report, ¶ 83).)
Because the PE-5000 does not contain a "locking seal assembly" as construed by this Court, it does not satisfy the "locking seal assembly" limitation of Claim 1 of the '237 Patent, and it therefore does not literally infringe Claim 1 or any of the dependent claims that incorporate that limitation.
C. No Reasonable Jury Could Find Literal Infringement of Claims 1, 3, 7, and 12. Summary judgment of non-infringement of Claims 1, 3, 7, and 12 of the '237 Patent is appropriate because no reasonable jury could find that the PE-5000 literally satisfies the "locking seal assembly" limitation of Claim 1.
Claim 1 is the sole independent claim among those asserted against the PE-5000. Claims 3, 7, and 12 each depend from Claim 1 and therefore incorporate every limitation of Claim 1. See Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1552 n.9 (Fed. Cir. 1989) ("One who does not infringe an independent claim cannot infringe a claim dependent on (and thus containing all the limitations of) that claim."). Because each dependent claim necessarily includes the "locking seal assembly" limitation, the failure of the PE-5000 to satisfy that limitation is dispositive of all four asserted claims.
The undisputed evidence — including the PE-5000's engineering drawings, the deposition testimony of Solstice's Director of Engineering, Dr. Ostrowski's expert analysis, and the concession of Apex's own expert Dr. Ng — establishes beyond genuine dispute that the PE-5000 does not contain a "locking seal assembly" as construed by this Court. There is no mechanical interlock. There is no discrete locking detent. There is no rotational actuation mechanism. The PE-5000's elastomeric gasket seal is the very type of compressive seal that Apex distinguished from its claimed invention during prosecution of the '237 Patent.
Dr. Ng's infringement report does not assert that the PE-5000 literally meets the "locking seal assembly" limitation as construed by the Court. Instead, Dr. Ng proceeds directly from his acknowledgment of the structural differences between the PE-5000 and the claimed invention to a doctrine-of-equivalents analysis. (Delgado Decl., Ex. L (Ng Report, ¶¶ 83-84).) This effective concession of the absence of literal infringement is dispositive. See Gart v. Logitech, Inc., 254 F.3d 1334, 1339 (Fed. Cir. 2001) (granting summary judgment of no literal infringement where the accused device admittedly lacked a required claim element).
No reasonable jury could find literal infringement of any asserted claim of the '237 Patent by the PE-5000 Series.
D. The Doctrine of Equivalents Does Not Save Apex's Infringement Theory. Having failed to establish literal infringement, Apex's only remaining theory of infringement of the '237 Patent by the PE-5000 rests on the doctrine of equivalents. In his expert report, Dr. Ng applied the function-way-result test and opined that the PE-5000's compressive elastomeric gasket seal performs "substantially the same function in substantially the same way to achieve substantially the same result" as the claimed "locking seal assembly." (Delgado Decl., Ex. L (Ng Report, ¶¶ 86-102).) Specifically, Dr. Ng argued that: (a) both the claimed locking seal assembly and the PE-5000's gasket seal perform the function of "maintaining a gas-tight seal around an inserted instrument" (id. ¶ 88); (b) both achieve this function in "substantially the same way" because both "apply compressive force to a seal element to create a seal" (id. ¶ 92); and (c) both achieve "substantially the same result" because both "prevent insufflation gas leakage during a laparoscopic procedure" (id. ¶ 96).
This argument fails for two independent reasons: (1) prosecution history estoppel bars Apex from recapturing through equivalents the very subject matter it surrendered to obtain its patent, and (2) even absent estoppel, the differences between the PE-5000's design and the claimed invention are not insubstantial.
1. Prosecution History Estoppel Forecloses Apex's Equivalents Argument.
Under the doctrine of prosecution history estoppel, "a patentee who narrows a claim as a condition for obtaining a patent . . . may not argue that the surrendered territory comprised unforeseen subject matter that should be deemed equivalent to the limitation added by the amendment." Festo Corp. v. Fenmore & Co., 535 U.S. 722, 733-34 (2002). When a patentee amends a claim to add a limitation for a reason related to patentability, a rebuttable presumption arises that the patentee has surrendered all equivalents of that added limitation. Id. at 740. The presumption may be rebutted only if the patentee can demonstrate that (a) the alleged equivalent was unforeseeable at the time of the amendment, (b) the rationale underlying the amendment bears no more than a tangential relation to the equivalent in question, or (c) there is some other reason the patentee could not reasonably have been expected to have described the equivalent. Id. at 740-41.
Here, prosecution history estoppel applies with particular force. During prosecution of the '237 Patent, Apex was confronted with a prior art rejection based on the Milliman reference, which disclosed a trocar seal maintained by axial compression of an elastomeric gasket — the same type of seal used in the PE-5000. In response, Apex made two critical concessions. First, Apex amended Claim 1 to expressly require a "locking" seal assembly with a "mechanical interlock comprising a discrete locking detent" engaged by a "rotational actuation mechanism." (Delgado Decl., Ex. N, at APEX-009877 (Amendment dated May 20, 2016).) Second, Apex submitted a declaration by Dr. Szabo in which the inventor expressly distinguished compressive gasket seals from the claimed invention, stating that Milliman's compressive gasket "does not constitute a 'locking' assembly because it lacks any discrete mechanical interlock or locking detent that affirmatively secures the seal in the closed position." (Id. at APEX-009881 (Dr. Szabo Declaration, ¶ 7).)
These narrowing amendments and inventor declarations were unambiguously made for reasons related to patentability — they were made to overcome a prior art rejection and secure allowance of the claims. Accordingly, the presumption of surrender under Festo attaches, and Apex is presumed to have surrendered equivalents encompassing compressive gasket seals that lack a discrete locking detent and rotational actuation mechanism.
None of the Festo rebuttal criteria are satisfied. First, the alleged equivalent — a compressive elastomeric gasket seal — was not unforeseeable at the time of the amendment. To the contrary, it was the specific subject matter that Apex distinguished and surrendered: the Milliman reference's compressive gasket seal was the very prior art that prompted the narrowing amendment. An equivalent that is not merely foreseeable but was actually before the applicant during prosecution cannot satisfy the unforeseeability exception. See Festo, 535 U.S. at 740; Honeywell Int'l Inc. v. Hamilton Sundstrand Corp., 370 F.3d 1131, 1141 (Fed. Cir. 2004) (en banc).
Second, the rationale underlying the amendment is not tangential to the alleged equivalent. The amendment was made specifically to distinguish compressive gasket seals — the very category of seal technology used in the PE-5000. The nexus between the amendment and the alleged equivalent could not be more direct.
Third, there is no "other reason" why Apex could not reasonably have been expected to describe the PE-5000's compressive gasket seal as an equivalent. Compressive gasket seals were well-known in the art of laparoscopic trocars at the time of Apex's amendment in May 2016, and Apex was specifically aware of them because the Milliman reference was before the Examiner. Apex made a deliberate strategic choice to narrow its claims to exclude compressive gasket seals in exchange for patentability, and it cannot now recapture through equivalents the very territory it ceded.
Apex cannot reclaim through the doctrine of equivalents the compressive-gasket-seal designs it expressly and deliberately surrendered to secure allowance of the '237 Patent. Prosecution history estoppel bars Apex's equivalents theory as a matter of law. See Festo, 535 U.S. at 733-34; Biagro, 423 F.3d at 1306.
2. Even Absent Estoppel, the Differences Are Substantial.
Even if prosecution history estoppel did not apply — and it plainly does — Apex's doctrine-of-equivalents theory would fail on the merits. The differences between the PE-5000's compressive elastomeric gasket seal and the claimed multi-component locking seal assembly with a discrete detent and rotational actuation are not insubstantial; they are fundamental.
Dr. Ng's function-way-result analysis collapses the claim at an impermissibly high level of abstraction. See Sage Prods., Inc. v. Devon Indus., Inc., 126 F.3d 1420, 1425 (Fed. Cir. 1997) (cautioning against applying the doctrine of equivalents at such a high level of generality as to render claim limitations meaningless). Dr. Ng contends that both the claimed locking seal assembly and the PE-5000's gasket seal perform the "function" of "maintaining a gas-tight seal." But at that level of generality, every seal in every trocar in existence performs the same function. The relevant inquiry is more granular: the claimed locking seal assembly performs the function of mechanically locking the seal in position through a discrete detent engaged by rotational actuation, so that the seal is affirmatively secured against displacement. The PE-5000's gasket seal does not perform this locking function at all — it is held in place by material compression, with no mechanical lock.
Similarly, the claimed locking seal assembly and the PE-5000's gasket seal do not operate in "substantially the same way." The claimed invention achieves its sealed state through rotation of an actuation mechanism that drives a detent into a groove, creating a discrete mechanical interlock. The PE-5000 achieves its sealed state through axial compression of an elastomeric material. These are fundamentally different mechanical principles — mechanical interlocking versus material deformation under compression — and no reasonable factfinder could conclude that they operate in "substantially the same way." See Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 609 (1950) (equivalence must be assessed in the context of the specific claim limitation at issue).
Dr. Ostrowski's rebuttal report addressed and refuted each element of Dr. Ng's equivalents analysis, concluding:
"Dr. Ng's equivalents theory would require the Court to effectively read the 'locking' and 'mechanical interlock' and 'rotational actuation' limitations out of the claims. If a simple compressive gasket seal is the 'equivalent' of a multi-component locking assembly with a detent and rotational actuation, then those claim limitations have no meaning. The doctrine of equivalents cannot be applied in a manner that vitiates the express limitations of the claims."
(Delgado Decl., Ex. M (Ostrowski Rebuttal Report, ¶ 28).)
The doctrine of equivalents does not save Apex's infringement theory with respect to the '237 Patent. Summary judgment of non-infringement should be entered on Claims 1, 3, 7, and 12.
II. THE PE-5000 DOES NOT INFRINGE THE '884 PATENT
A. The Court's Construction of "Retractable Blade Deployment Mechanism". Claims 1, 2, 5, 9, and 14 of the '884 Patent are asserted against the PE-5000 Series. Claim 1 is the sole independent claim among those asserted; Claims 2, 5, 9, and 14 each depend from Claim 1 and therefore incorporate all of its limitations. The relevant claim language is as follows:
Claim 1 of the '884 Patent recites:
"1. A trocar assembly for penetrating tissue during a minimally invasive surgical procedure, comprising:
an obturator body defining a distal tip region;
a retractable blade deployment mechanism disposed within the obturator body, the retractable blade deployment mechanism comprising a blade carriage, a cutting blade mounted to the blade carriage, and a spring element;
wherein the blade carriage is movable between a deployed position in which the cutting blade extends beyond the distal tip region and a retracted position in which the cutting blade is fully shielded within the obturator body;
wherein the spring element biases the blade carriage toward the retracted position;
wherein the cutting blade is deployed to the deployed position upon application of an affirmative manual actuating force that overcomes the bias of the spring element; and
wherein the cutting blade retracts to the retracted position upon release of the affirmative manual actuating force."
(Delgado Decl., Ex. E ('884 Patent), col. 16, ll. 8-30.)
Claim 2 depends from Claim 1 and further recites "wherein the spring element comprises a coil compression spring disposed coaxially with the blade carriage." (Id., col. 16, ll. 31-34.) Claim 5 depends from Claim 1 and further recites "wherein the blade carriage is slidably received within a guide channel formed in the obturator body." (Id., col. 16, ll. 44-47.) Claim 9 depends from Claim 1 and further recites "wherein the cutting blade comprises a trocar-point blade having three cutting edges arranged in a triangular configuration." (Id., col. 17, ll. 5-9.) Claim 14 depends from Claim 1 and further recites "further comprising a blade shield fixedly disposed at the distal tip region, the blade shield defining an aperture through which the cutting blade extends when in the deployed position." (Id., col. 17, ll. 28-33.)
Each of these dependent claims incorporates the requirement for a "retractable blade deployment mechanism" as recited in Claim 1. Because each asserted claim requires the presence of a "retractable blade deployment mechanism," the Court's construction of that term controls the infringement analysis for all five claims.
On December 6, 2024, this Court construed the term "retractable blade deployment mechanism" as follows:
"A spring-loaded blade carriage that (i) deploys a cutting blade upon application of an affirmative manual actuating force and (ii) retracts the cutting blade to a fully shielded position upon release of that manual actuating force, such that the blade is biased toward retraction by a spring element."
(D.I. 87 at 21.)
The Court's construction requires that the mechanism be spring-biased toward the retracted and fully shielded position. This means that the default state of the mechanism — the state in which no external force is being applied — is with the blade retracted and shielded. The surgeon must affirmatively overcome the spring bias by applying manual force to deploy the blade. When that manual force is released, the spring automatically returns the blade to the retracted, shielded position. This is the essence of the safety feature described in the '884 Patent specification: the blade is biased toward retraction so that it cannot remain exposed without the surgeon's continuous, affirmative action.
The Court's construction is grounded in the specification's detailed description of the preferred embodiment, which discloses a coil compression spring that biases the blade carriage toward the retracted position:
"The spring element 210, preferably a coil compression spring, is disposed coaxially with the blade carriage 200 and exerts a biasing force that urges the blade carriage 200 toward the retracted position. In this manner, the cutting blade 220 is automatically retracted to the fully shielded position upon release of the manual actuating force applied by the surgeon, providing a fail-safe mechanism that prevents unintended blade exposure."
('884 Patent, col. 8, ll. 32-42.)
The prosecution history further supports the Court's narrow construction. During prosecution of the '884 Patent, the Examiner rejected original Claim 1 under 35 U.S.C. § 102(a)(1) as anticipated by U.S. Patent No. 6,579,302 to Pontus (the "Pontus reference"), which disclosed a trocar with a cam-actuated blade mechanism. (Delgado Decl., Ex. O ('884 Patent Prosecution History, Bates Nos. APEX-015221 through APEX-015314), at APEX-015247 (Office Action dated July 11, 2017).) In response, Apex — through its prosecuting attorney — filed a response arguing that Pontus's cam-actuated blade was patentably distinct from the claimed "retractable blade deployment mechanism" because Pontus did not employ a spring element biasing the blade toward retraction. Apex argued:
"The Pontus reference discloses a cam-driven blade mechanism in which the blade position is determined by the cam geometry and the linear position of the obturator within the housing. Pontus does not disclose or suggest a spring element that biases the blade toward the retracted, shielded position. In the Pontus device, the blade does not automatically retract upon release of a manual actuating force; rather, blade retraction requires continued forward advancement through the cam profile. This is fundamentally different from Applicant's claimed retractable blade deployment mechanism, in which a spring element provides an automatic safety return to the fully shielded position independent of the surgeon's manual manipulation of the obturator."
(Delgado Decl., Ex. O, at APEX-015268-69 (Response to Office Action dated October 23, 2017).)
The Examiner was persuaded by this distinction and allowed the claims. (Id. at APEX-015291 (Notice of Allowance dated February 9, 2018).)
This prosecution history is significant for two reasons. First, it confirms that the Court's construction — requiring a spring-biased mechanism — accurately reflects the scope of the claims as understood by both the applicant and the Examiner during prosecution. Second, it establishes that Apex specifically distinguished cam-driven blade mechanisms — the exact type of mechanism used in the PE-5000 — as not falling within the scope of the claims. As discussed in Section II.D below, this distinction gives rise to prosecution history estoppel that forecloses any argument of infringement under the doctrine of equivalents.
B. The PE-5000 Lacks a "Retractable Blade Deployment Mechanism" Under the Court's Construction. The PE-5000 uses a cam-driven blade mechanism — the exact type of mechanism that Apex distinguished during prosecution of the '884 Patent. A detailed examination of the PE-5000's blade mechanism reveals that it fails to satisfy the Court's construction of "retractable blade deployment mechanism" in every material respect.
The PE-5000's Cam-Driven Blade Mechanism. In the PE-5000, the cutting blade is mounted on a blade carrier that is slidably disposed within the obturator housing. A cam follower — a small pin or roller — is affixed to the blade carrier and extends radially outward into a cam track that is machined into the interior wall of the obturator housing. The cam track follows a predetermined profile that controls the position of the blade as the obturator is advanced through the trocar cannula and into tissue.
When the surgeon advances the obturator forward, the cam follower rides along the cam track. The ascending portion of the cam track profile causes the blade carrier to translate distally, deploying the cutting blade beyond the distal tip of the obturator. As the obturator continues to advance — past the tissue plane — the cam follower enters the descending portion of the cam track, causing the blade carrier to translate proximally and withdrawing the cutting blade to a shielded position within the obturator body. (Delgado Decl., Ex. J (PE-5000 Engineering Schematics and CAD Files, Bates Nos. SBD-013104 through SBD-013298), at SBD-013142 (cam track profile drawing); SBD-013187 (blade carrier assembly drawing); Ex. K (Ostrowski Report, ¶¶ 47-68).)
Critically, the blade position in the PE-5000 is determined entirely by the cam geometry and the linear position of the obturator within the housing. There is no spring. There is no "release" of a manual force that triggers retraction. Deployment and retraction are both consequences of a single, continuous forward motion of the obturator. The cam track profile dictates when the blade deploys and when it retracts, based on the obturator's position relative to the housing.
Element-by-Element Comparison. A comparison of the PE-5000's blade mechanism to the Court's construction of "retractable blade deployment mechanism" reveals the absence of every critical element:
(i) Spring-Loaded Blade Carriage. The PE-5000's blade carriage is not spring-loaded. There is no spring element — no coil spring, no leaf spring, no torsion spring, no gas spring, no spring of any kind — associated with the blade carriage or the blade carrier assembly. (Delgado Decl., Ex. J, at SBD-013187 (blade carrier assembly drawing — no spring element depicted or listed in the bill of materials); Ex. I (Hennessy Dep. at 62:4-63:11) ("Q: Does the PE-5000 contain a spring that biases the blade toward a retracted position? A: No. There is no spring in the blade mechanism. The blade position is controlled entirely by the cam track."); Ex. K (Ostrowski Report, ¶¶ 52-55).) The blade carriage rides in the cam track, and its position is determined by the cam geometry — not by any spring bias.
(ii) Deployment Upon Application of an Affirmative Manual Actuating Force. The Court's construction requires that the cutting blade be deployed "upon application of an affirmative manual actuating force" that overcomes the bias of a spring element. In the PE-5000, the blade deploys as a consequence of the obturator's forward advancement through the cam track — not through the application of a separate, discrete manual force that overcomes a spring bias. The surgeon pushes the obturator forward, and the cam profile causes the blade to deploy at a specific point in the obturator's travel. (Delgado Decl., Ex. K (Ostrowski Report, ¶¶ 56-59).) There is no distinct manual actuating force that is separate from the force used to advance the obturator, and there is no spring bias to overcome.
(iii) Retraction Upon Release of Manual Actuating Force / Spring Bias Toward Retraction. The Court's construction requires that the cutting blade retract "upon release of that manual actuating force" and that the blade be "biased toward retraction by a spring element." The PE-5000 satisfies neither requirement. In the PE-5000, blade retraction is not accomplished by releasing a force and allowing a spring to return the blade — it is accomplished by continued forward motion of the obturator through the cam profile. The descending portion of the cam track withdraws the blade as the obturator advances past the tissue plane. (Delgado Decl., Ex. J, at SBD-013142 (cam track profile drawing showing ascending deployment portion and descending retraction portion); Ex. K (Ostrowski Report, ¶¶ 60-65).) If the surgeon stops advancing the obturator at the point of maximum blade deployment and releases all force, the blade does not retract — it remains in the deployed position because there is no spring bias to drive it back. The blade retracts only when the surgeon continues the forward stroke, causing the cam follower to enter the retraction portion of the cam track. (Id. ¶ 63.)
This last point bears emphasis. The Court's construction requires a mechanism in which the blade is "biased toward retraction by a spring element," such that the default state — absent manual force — is blade-retracted. In the PE-5000, there is no default state of blade retraction. The blade's position is a function of the obturator's position within the cam track. If the obturator is positioned at the point of maximum blade extension and no force is applied, the blade remains extended. This is the fundamental safety distinction that Apex itself identified during prosecution of the '884 Patent: the claimed invention provides "an automatic safety return to the fully shielded position independent of the surgeon's manual manipulation," whereas cam-driven mechanisms like the Pontus reference (and the PE-5000) do not.
The following table summarizes the element-by-element comparison:
The undisputed evidence — the PE-5000's engineering schematics, CAD files, physical samples produced in discovery, the deposition testimony of Mr. Hennessy, and Dr. Ostrowski's expert analysis — establishes that the PE-5000 lacks every element of the Court's construction of "retractable blade deployment mechanism" other than the general concept of a blade that can be deployed and retracted. The PE-5000 uses a fundamentally different mechanism — cam-driven rather than spring-biased — to control blade deployment and retraction.
C. No Reasonable Jury Could Find Literal Infringement of Claims 1, 2, 5, 9, and 14. Summary judgment of non-infringement of Claims 1, 2, 5, 9, and 14 of the '884 Patent is appropriate because no reasonable jury could find that the PE-5000 literally satisfies the "retractable blade deployment mechanism" limitation of Claim 1.
As with the '237 Patent analysis, Claim 1 is the sole independent claim among those asserted against the PE-5000, and Claims 2, 5, 9, and 14 each depend from Claim 1. Failure to meet any limitation of the independent claim is dispositive of all dependent claims. See Wahpeton Canvas, 870 F.2d at 1552 n.9. Because the PE-5000 does not satisfy the "retractable blade deployment mechanism" limitation of Claim 1, it cannot infringe any of the dependent claims, regardless of whether it might otherwise satisfy the additional limitations recited in those dependent claims.
Indeed, the failure of literal infringement is particularly stark with respect to dependent Claim 2, which further requires "wherein the spring element comprises a coil compression spring disposed coaxially with the blade carriage." The PE-5000 contains no spring element of any kind, let alone a coil compression spring disposed coaxially with the blade carriage.
The undisputed evidence demonstrates that the PE-5000 uses a cam-driven blade mechanism that does not contain a spring element, does not deploy the blade upon application of a manual actuating force that overcomes a spring bias, and does not retract the blade upon release of that manual actuating force. These are not close questions on which reasonable minds could differ — they are categorical structural differences that are evident from the PE-5000's engineering drawings, confirmed by the deposition testimony of Solstice's Director of Engineering, and acknowledged by the absence of any contrary analysis in Dr. Ng's expert report.
Dr. Ng's infringement report, with respect to the '884 Patent, does not identify any spring element in the PE-5000. Nor does it explain how the PE-5000's cam-driven mechanism satisfies the Court's construction of "retractable blade deployment mechanism." Dr. Ng's report discusses the PE-5000's blade mechanism in general terms, noting that the blade "deploys and retracts during use" (Delgado Decl., Ex. L (Ng Report, ¶ 132)), but does not address — let alone rebut — the specific structural requirements of the Court's construction. The ability of the blade to "deploy and retract" is not in dispute; what is in dispute is whether the mechanism by which deployment and retraction are accomplished satisfies the Court's construction, and the undisputed evidence demonstrates that it does not.
No reasonable jury could find literal infringement of any asserted claim of the '884 Patent by the PE-5000 Series. The structural characteristics of the PE-5000's blade mechanism are undisputed, and those characteristics are irreconcilable with the Court's construction of "retractable blade deployment mechanism."
D. Prosecution History Estoppel Bars Equivalents. Even if Apex were to advance a doctrine-of-equivalents theory with respect to the '884 Patent — and Dr. Ng's report does not clearly articulate such a theory as to this patent — prosecution history estoppel would bar it as a matter of law.
During prosecution of the '884 Patent, Apex confronted a prior art rejection based on the Pontus reference, which disclosed a cam-actuated blade mechanism. The Pontus reference described a trocar in which the blade position was controlled by a cam track integrated into the obturator housing — precisely the type of mechanism used in the PE-5000. Apex distinguished the Pontus reference by arguing that its claimed "retractable blade deployment mechanism" was patentably distinct from cam-driven systems because the spring bias provided "an automatic safety return to the fully shielded position independent of the surgeon's manual manipulation." (Delgado Decl., Ex. O, at APEX-015268-69.)
Apex's arguments to the Examiner were not merely passing observations — they were the basis on which the claims were allowed. Apex made clear, affirmative representations that the scope of its claims did not encompass cam-driven blade mechanisms, and the Examiner relied on those representations in allowing the claims. Under Festo and its progeny, Apex's prosecution history arguments constitute clear and unmistakable surrender of cam-driven blade mechanisms from the scope of its claims.
The Federal Circuit has consistently held that prosecution history estoppel bars a patentee from recapturing through equivalents subject matter that was surrendered during prosecution, whether through claim amendments or through arguments made to the Examiner. See Cybor Corp., 138 F.3d at 1460; Omega Eng'g, Inc. v. Raytek Corp., 334 F.3d 1314, 13

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

TABLE OF CONTENTS

PRELIMINARY STATEMENT

STATEMENT OF UNDISPUTED MATERIAL FACTS

LEGAL STANDARD

ARGUMENT

I. THE PE-5000 DOES NOT INFRINGE THE '237 PATENT

II. THE PE-5000 DOES NOT INFRINGE THE '884 PATENT

Record

Parties

Dates

Amounts