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CONFIDENTIAL — ATTORNEY WORK PRODUCT / ATTORNEY-CLIENT PRIVILEGED DRAFT FOR COUNSEL REVIEW ONLY

DRAFT REBUTTAL EXPERT REPORT OF DR. MIRIAM OSTROWSKI, PH.D. IN REBUTTAL TO THE EXPERT REPORT OF DR. CALVIN NG, PH.D.

APEX SURGICAL INNOVATIONS, INC. v. SOLSTICE BIOMEDICAL, INC. Case No. 1:24-cv-00587-RGA United States District Court for the District of Delaware

Date of Draft: February 25, 2025 Matter No.: 10294.0017

Internal working draft prepared for review by Calderwood & Harkness LLP engagement team (Marcus Delgado, Catherine Bloom, Christy Bauer, Peter Vassiliev) prior to finalization and service on or before March 3, 2025. This document is protected by the attorney-client privilege and the work product doctrine. It is not intended for service, production, or disclosure to any party or non-party. Do not circulate outside the engagement team without express authorization from lead counsel.

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I. INTRODUCTION AND QUALIFICATIONS

I.A. Identity and Engagement

1. My name is Dr. Miriam Ostrowski. I am a Professor of Biomedical Engineering at Halford University, located at 3401 Walnut Street, Philadelphia, Pennsylvania 19104. I hold the William S. Tremaine Endowed Chair in Surgical Device Engineering and have served on the Halford University faculty since 2007.

2. I have been retained by the law firm of Calderwood & Harkness LLP on behalf of Defendant Solstice Biomedical, Inc. ("Solstice"), the U.S. operating subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company (CRO No. 648217), in connection with this patent infringement action brought by Plaintiff Apex Surgical Innovations, Inc. ("Apex"). My retention is governed by an Expert Retention Agreement dated August 20, 2024, executed between me and Calderwood & Harkness LLP.

3. I am being compensated for my work in this matter at a rate of $750 per hour. My compensation is not contingent upon the outcome of this litigation, the substance of my opinions, or the content of any testimony I may provide. Through the current date, my total fees for work performed in this matter are approximately $127,500. This figure includes time spent on my invalidity expert report, this rebuttal expert report, document review, analysis, testing, and communications with counsel.

I.B. Scope of Engagement for Rebuttal

4. I have been asked to provide rebuttal opinions responding to the infringement opinions set forth in the Expert Report of Dr. Calvin Ng, Ph.D. ("Dr. Ng's Report" or "the Ng Report"), which was served on February 10, 2025. Dr. Ng is an Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute in Newark, Delaware. Dr. Ng was retained by Apex to provide opinions on infringement.

5. Specifically, my rebuttal addresses Dr. Ng's opinions on both literal infringement and infringement under the doctrine of equivalents for each of the three patents asserted by Apex in this litigation:

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

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

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

6. All three asserted patents are assigned to Apex Surgical Innovations, Inc. The named inventor on each patent is Dr. Raymond Szabo, who serves as Vice President of Engineering at Apex.

I.C. Summary of Prior Work

7. In addition to this rebuttal report, I prepared and served an Expert Report on Invalidity dated January 27, 2025, in which I set forth my opinions that the asserted claims of the '237, '884, and '105 Patents are invalid for anticipation under 35 U.S.C. § 102 and/or obviousness under 35 U.S.C. § 103. This rebuttal report supplements, but does not replace, the invalidity opinions set forth in my January 27, 2025 report. Those invalidity opinions stand as independent and alternative grounds for non-liability.

I.D. Qualifications Summary

8. I hold a B.S. in Mechanical Engineering from the Massachusetts Institute of Technology (1996), an M.S. in Biomedical Engineering from Stanford University (1998), and a Ph.D. in Biomedical Engineering from Stanford University (2002). My doctoral dissertation, titled "Mechanically Adaptive Sealing Interfaces for Minimally Invasive Surgical Instrumentation," was supervised by Professor Harold J. Whelan and was awarded the Stanford Dean's Prize for Distinguished Doctoral Research.

9. I have been a member of the Halford University faculty since 2007, having previously served as an Assistant Professor at the University of Michigan (2002–2007). My research focuses on the design, engineering, and biomechanical analysis of surgical instrumentation, with a particular emphasis on trocar systems, laparoscopic access devices, and sealing mechanisms for minimally invasive surgery. I direct the Halford Surgical Device Engineering Laboratory, which has received over $14 million in funding from the National Institutes of Health, the National Science Foundation, and private industry sponsors since its founding.

10. I have authored or co-authored over 130 peer-reviewed journal articles and conference papers in the fields of biomedical engineering, surgical instrumentation, and mechanical design. I am the named inventor on twelve issued U.S. patents, several of which relate to trocar and laparoscopic access device technology. I am a Fellow of the American Institute for Medical and Biological Engineering (AIMBE) and a member of the Society for Minimally Invasive Therapy, the Biomedical Engineering Society, and the American Society of Mechanical Engineers.

11. I have been qualified as an expert witness and provided expert testimony in federal and state court proceedings on nine prior occasions, in matters involving patent infringement, product liability, and design defect claims relating to surgical instrumentation and medical devices. A complete listing of my prior testimony is included in my curriculum vitae, which is attached as Exhibit A.

I.E. Materials Considered

12. In forming my rebuttal opinions, I reviewed and considered the following materials, among others. A complete list of materials considered is provided in Exhibit B.

(a) The Complaint filed by Apex Surgical Innovations, Inc. on May 9, 2024, and the Answer, Affirmative Defenses, and Counterclaims filed by Solstice Biomedical, Inc. on June 14, 2024;

(b) U.S. Patent Nos. 9,814,237; 10,271,884; and 10,932,105, including the full patent specifications, drawings, abstracts, and claims;

(c) The complete prosecution histories (file wrappers) for each of the three asserted patents, including all office actions, responses, amendments, declarations, and notices of allowance;

(d) The Claim Construction Order issued by the Honorable Richard G. Andrews on December 6, 2024 (Dkt. 87), construing nine disputed claim terms;

(e) The Expert Report of Dr. Calvin Ng, Ph.D. on Infringement, dated February 10, 2025, including all exhibits and appendices thereto;

(f) My own Expert Report on Invalidity, dated January 27, 2025, including all exhibits and appendices thereto;

(g) Documents produced by Solstice Biomedical, Inc. in this litigation, bearing Bates numbers SBD-000001 through SBD-048217;

(h) Documents produced by Apex Surgical Innovations, Inc. in this litigation, bearing Bates numbers APEX-000001 through APEX-031450;

(i) Technical specifications, design files, CAD drawings, engineering change orders, and physical samples of the PrecisionEdge™ PE-5000 Series (5 mm trocar assembly), PE-12000 Series (12 mm trocar assembly), and PE-15000 Series (15 mm trocar assembly) products manufactured and sold by Solstice;

(j) Deposition transcripts of fact and party witnesses, including the transcript of the Rule 30(b)(6) deposition of Apex Surgical Innovations, Inc., at which Dr. Raymond Szabo testified as the corporate designee;

(k) Prior art references identified and discussed in my invalidity expert report, including U.S. and foreign patent publications, journal articles, and product literature;

(l) Relevant technical literature and industry standards, including AAMI and ISO standards applicable to trocar systems and laparoscopic access devices;

(m) Portions of the damages expert reports served on February 14, 2025, by Dr. Elena Marchetti of Pinnacle Economics Group LLC (retained by Apex) and Hugh Danaher, CFA, of Keystone Valuation Advisors LLC (retained by Solstice), to the extent those reports bear on the technical scope of the infringement allegations;

(n) Prior art documents obtained via subpoena from Veridian Medical Technologies, Inc., including design documents, marketing materials, and regulatory submissions relating to Veridian's SealGuard and TrocarPro product lines; and

(o) Such other materials as are identified in Exhibit B hereto.

II. SUMMARY OF REBUTTAL OPINIONS

13. Based on my review, analysis, and testing, and for the reasons set forth in detail in this report, I hold the following principal rebuttal opinions to a reasonable degree of scientific and engineering certainty:

(1) Dr. Ng's infringement analysis of the PE-5000 Series under the '237 Patent misapplies the Court's construction of "locking seal assembly" and fails to account for the structural differences in the PE-5000's seal mechanism. The PE-5000 Series uses a friction-fit elastomeric gasket that does not employ the "biased locking member" with discrete locking elements required by the Court's construction of this term. Dr. Ng's analysis conflates a retention ring that prevents disassembly with the claimed positive-locking seal, ignoring a fundamental structural distinction.

(2) Dr. Ng's infringement analysis of the PE-5000 Series under the '884 Patent improperly expands the Court's construction of "retractable blade deployment mechanism" beyond its proper scope. The Court's construction requires a "cam-driven linkage" connecting the blade to the actuation trigger. The PE-5000 Series employs a direct spring-return mechanism without a cam. Dr. Ng's characterization of a linear ramped guide surface as a "cam" is technically incorrect and inconsistent with accepted engineering terminology.

(3) Dr. Ng's infringement analysis of the PE-12000 Series under all three patents relies on selective and misleading comparisons and ignores critical structural distinctions. With respect to each asserted patent, Dr. Ng cherry-picks isolated features of the PE-12000 Series while ignoring the overall structural and mechanical differences between the accused products and the claimed inventions. His analysis fails to account for the PE-12000's modular insufflation valve design, the absence of a biased locking member in the seal assembly, and the spring-return (rather than cam-driven) blade deployment mechanism.

(4) Dr. Ng's infringement analysis of the PE-15000 Series under the '884 and '105 Patents mischaracterizes the operation of the PE-15000's insufflation valve and blade system. Dr. Ng's description of the PE-15000's insufflation valve as "integrated" with the seal is directly contradicted by his own disassembly photographs, which show the valve as a discrete snap-in module. His characterization of the PE-15000's blade deployment as cam-driven is similarly unfounded.

(5) Dr. Ng's doctrine of equivalents analysis for all accused products fails to satisfy the function-way-result test and is barred by prosecution history estoppel arising from narrowing amendments made during prosecution. Apex made narrowing amendments to the claims of each of the three asserted patents during prosecution to distinguish prior art that disclosed the very structures employed by the PrecisionEdge™ products. Dr. Ng's equivalents analysis would impermissibly recapture subject matter that Apex surrendered to obtain its patents.

(6) Dr. Ng's analysis repeatedly conflates functional similarity with structural identity, which is legally and technically inappropriate. Throughout his report, Dr. Ng argues that because the PrecisionEdge™ products perform the same general functions as the patented inventions—i.e., sealing, blade deployment, and insufflation—they necessarily satisfy the structural claim limitations. This approach is fundamentally flawed. Literal infringement requires the accused product to meet every structural limitation of the claim. Functional similarity, standing alone, does not establish literal infringement.

(7) Dr. Ng relies on incomplete testing and flawed experimental methodology. Dr. Ng's physical testing of exemplar PrecisionEdge™ units was conducted without adequate chain-of-custody documentation, under uncontrolled environmental conditions, and using measurement techniques that are not consistent with accepted engineering practice for the parameters at issue. My own independent testing, conducted under controlled laboratory conditions at Halford University, yielded materially different results on several critical parameters.

14. Each of these opinions is discussed in detail in the sections that follow. In forming these opinions, I have applied the claim constructions adopted by the Court in its December 6, 2024 Claim Construction Order.

III. THE COURT'S CLAIM CONSTRUCTION ORDER AND ITS SIGNIFICANCE

III.A. Overview of the Claim Construction Order (December 6, 2024)

15. On December 6, 2024, following the Markman hearing held on November 14, 2024, the Court issued its Claim Construction Order (Dkt. 87), construing nine disputed claim terms across the three asserted patents. Of these nine constructions, five were favorable to Solstice, in that the Court adopted constructions that were materially narrower than those proposed by Apex or adopted Solstice's proposed constructions in full. Four constructions were favorable to Apex, in that the Court adopted constructions that were broader than those proposed by Solstice or adopted Apex's proposed constructions in full. The relevant constructions are set forth in Exhibit H.

16. Dr. Ng's Report was prepared after the Markman hearing and the issuance of the Claim Construction Order. However, as I discuss in detail below and in Section VII.C, Dr. Ng's report does not faithfully apply several of the Court's constructions. In at least two critical instances, Dr. Ng applies constructions that are more consistent with Apex's rejected proposed constructions than with the constructions actually adopted by the Court. This is a significant methodological deficiency that pervades his infringement analysis.

III.B. Key Constructions Favorable to Solstice

17. The following constructions are particularly significant to the rebuttal opinions set forth in this report:

"Locking seal assembly" ('237 Patent, Claims 1, 3, 7, 12)

18. Apex proposed that "locking seal assembly" be construed to mean "a seal assembly that includes a mechanism that holds the seal in a closed or sealed position." Solstice proposed a narrower construction: "a seal assembly comprising a biased locking member with at least two discrete locking elements that engage to maintain the seal in a gas-tight sealed position during instrument insertion and withdrawal."

19. The Court adopted a construction that is substantially closer to Solstice's proposal: "a seal assembly comprising a biased locking member with discrete locking elements that positively engage to hold the seal in a sealed position." The Court's construction requires (i) a biased locking member, (ii) discrete locking elements, and (iii) positive engagement of those elements to maintain the seal. This construction is narrower than Apex proposed in that it requires specific structural features—not merely any mechanism that holds a seal closed. As I explain in Section IV, the PE-5000 and PE-12000 Series do not possess these structural features.

"Retractable blade deployment mechanism" ('884 Patent, Claims 1, 2, 5, 9, 14)

20. Apex proposed that "retractable blade deployment mechanism" be construed to mean "a mechanism that deploys and retracts a blade." Solstice proposed: "a mechanism that deploys and retracts a blade through a cam-driven linkage connecting the blade carrier to the actuation trigger."

21. The Court adopted Solstice's proposed construction: "a mechanism that deploys and retracts a blade through a cam-driven linkage connecting the blade carrier to the actuation trigger." The Court found that the specification consistently described the deployment mechanism in terms of a cam-driven linkage, that the prosecution history reinforced this narrow reading (noting that the applicant distinguished prior art spring-return systems during prosecution), and that the claim language itself, when read in the context of the specification, supported the inclusion of the cam-driven linkage requirement. As I explain in Section V, none of the PrecisionEdge™ products employ a cam-driven linkage.

"Integrated insufflation valve" ('105 Patent, Claims 1, 4, 8)

22. Apex proposed that "integrated insufflation valve" be construed to mean "an insufflation valve that is combined with or incorporated into the trocar assembly." Solstice proposed: "an insufflation valve that is structurally integrated with the seal as a unitary component or is permanently joined to the seal such that the valve cannot be removed independently of the seal."

23. The Court adopted a construction that reflects the structural integration requirement: "an insufflation valve that is structurally integrated with the seal assembly, meaning the valve and seal are formed as a unitary component or are permanently joined such that they cannot be separated without destruction of the assembly." This construction requires structural integration, not merely functional co-location or proximity within the same housing. As I explain in Section VI, the PE-12000 and PE-15000 Series employ a modular design in which the insufflation valve is a separate, removable snap-in component.

Additional Constructions.

24. Two additional constructions favorable to Solstice bear on the analysis below. The Court construed "spring-loaded detent" (as used in '237 Patent, Claim 12) to mean "a detent mechanism that employs a discrete spring element to provide a biasing force that holds the detent in an engaged position." The Court also construed "cam surface" (as used in the specification of the '884 Patent and referenced in the claims) to mean "a surface profile that converts rotary or linear input motion into a different output motion through a contoured or profiled surface," distinguishing it from a simple inclined plane or ramp. Both of these constructions are relevant to the analysis that follows.

III.C. Key Constructions Favorable to Apex

25. In the interest of completeness and intellectual honesty, I acknowledge that four of the Court's constructions were favorable to Apex. Specifically:

(a) The Court construed "seal" (as used broadly in the '237 Patent) to include both static and dynamic sealing interfaces, rejecting Solstice's argument that the term should be limited to dynamic seals. This construction is broader than Solstice proposed.

(b) The Court construed "blade" (as used in the '884 Patent) to encompass any sharpened cutting element regardless of material composition, rejecting Solstice's argument that the term should be limited to metallic blades. This construction encompasses the ceramic blade tips used in certain PE-15000 configurations.

(c) The Court construed "gas-tight" (as used in the '237 and '105 Patents) to mean "substantially gas-tight under surgical operating conditions," adopting a functional standard that permits some de minimis leakage, rather than requiring an absolute hermetic seal as Solstice proposed.

(d) The Court construed "trocar assembly" (as used broadly across all three patents) to encompass the complete assembled device including the obturator, cannula, and housing, rejecting Solstice's argument that the term should be limited to the cannula and housing.

26. I have carefully considered these constructions in forming my rebuttal opinions. Even accepting these broader constructions as the Court has adopted them, the accused PrecisionEdge™ products still do not infringe the asserted claims for the reasons detailed in Sections IV through VI below. The constructions favorable to Apex relate to terms that are not dispositive of the infringement analysis, whereas the constructions favorable to Solstice relate to the core structural limitations that distinguish the accused products from the claimed inventions.

IV. REBUTTAL: THE '237 PATENT — "LOCKING SEAL ASSEMBLY FOR MINIMALLY INVASIVE SURGICAL ACCESS DEVICE"

IV.A. Accused Products: PE-5000 and PE-12000 Series

27. Dr. Ng accuses both the PrecisionEdge™ PE-5000 Series (5 mm trocar assembly) and the PE-12000 Series (12 mm trocar assembly) of infringing Claims 1, 3, 7, and 12 of the '237 Patent. Dr. Ng does not accuse the PE-15000 Series of infringing the '237 Patent. I address Dr. Ng's infringement theory for each asserted claim in turn.

IV.B. Dr. Ng's Infringement Theory for the '237 Patent

28. Dr. Ng opines that both the PE-5000 and PE-12000 include a "locking seal assembly" within the meaning of the '237 Patent claims because they contain a multi-component seal with a retention ring. See Ng Report ¶¶ 48–97, Figs. 3–9. Dr. Ng asserts that the retention ring in each product functions as a "locking member" that engages with the seal body to maintain a sealed position during instrument insertion and withdrawal, and that the seal components constitute "discrete locking elements" within the Court's construction.

29. Dr. Ng further opines that the PE-5000 and PE-12000 seals satisfy the dependent claim limitations of Claims 3, 7, and 12 based on his analysis of material composition, geometric measurements, and a characterization of the elastomeric bias in the seal as a "spring-loaded detent." See Ng Report ¶¶ 98–142.

30. For the reasons set forth below, Dr. Ng's infringement analysis is technically incorrect, misapplies the Court's claim constructions, and should be rejected.

IV.C. Rebuttal — Claim 1 (Independent Claim)

31. Claim 1 of the '237 Patent reads in relevant part:

"A minimally invasive surgical access device comprising: a cannula defining a longitudinal axis; a housing coupled to a proximal end of the cannula; and a locking seal assembly disposed within the housing, the locking seal assembly comprising: a biased locking member having a first locking element and a second locking element that positively engage to maintain a gas-tight seal during insertion and withdrawal of a surgical instrument through the cannula . . ."

32. Under the Court's construction, the "locking seal assembly" must comprise a "biased locking member with discrete locking elements that positively engage to hold the seal in a sealed position." I address the key structural elements below.

The PE-5000's Seal Mechanism

33. The PE-5000 Series utilizes a fundamentally different seal architecture than that claimed in the '237 Patent. The PE-5000's seal mechanism consists of a friction-fit elastomeric gasket—specifically, a single-piece overmolded thermoplastic elastomer (TPE) gasket—that is held in position within the trocar housing by a press-fit retention ring. See SBD-012447 through SBD-012463 (PE-5000 design specifications); SBD-017821 (PE-5000 seal component drawing, Rev. C).

34. The PE-5000's sealing function is achieved entirely through the compressive force of the elastomeric gasket against the instrument shaft. When a surgical instrument is inserted through the seal, the elastomeric material deforms radially and creates a friction seal against the instrument surface. When the instrument is withdrawn, the elastomeric material returns to its resting state. There is no positive-locking engagement between discrete locking elements. There are no separate structural components that engage with one another to create a locked sealed position.

35. Dr. Ng identifies the retention ring as the "biased locking member" of the PE-5000's seal. Ng Report ¶ 62. This characterization is technically incorrect. The retention ring in the PE-5000 is a static structural component whose sole function is to prevent axial displacement of the seal gasket within the housing during assembly and use. It does not move, it does not engage with any other locking element, and it does not contribute to the gas-tight sealing function. The retention ring is analogous to a retaining clip that holds a component in place; it is not a "biased locking member" in any sense recognized in mechanical engineering or consistent with the Court's construction.

36. Critically, the retention ring does not "positively engage" with any corresponding locking element on the seal gasket. The interface between the retention ring and the gasket is a simple press-fit relationship—the ring is pressed into the housing bore and contacts the gasket through static friction, not through any interlocking geometry. There are no complementary structural features (such as grooves, detents, tabs, or interlocking profiles) between the retention ring and the gasket. This is precisely the type of non-locking seal architecture that the Court's construction excludes by requiring "discrete locking elements that positively engage."

37. Solstice's internal design documents confirm this distinction. In a design review memorandum dated March 15, 2019, Solstice engineer Andrea Kwon described the PE-5000 seal as a "simple friction-seal design" and noted that it was selected over a positive-locking configuration specifically because of its lower manufacturing cost and simpler assembly process. See SBD-014232 at 3. The same memorandum includes a comparison table distinguishing friction-seal and locking-seal architectures, noting that "locking-seal designs require complementary engagement features (e.g., snap-fit geometry, detent mechanisms, or interlocking profiles) that add manufacturing complexity." Id. at 4. The PE-5000 was intentionally designed to avoid this complexity.

The PE-12000's Seal Mechanism

38. The PE-12000 Series employs a more complex seal architecture than the PE-5000, but it likewise does not meet the "locking seal assembly" limitation of Claim 1. The PE-12000's seal assembly consists of three components: (i) a dual-durometer elastomeric gasket, (ii) a spring washer, and (iii) a retention ring. See SBD-022150 through SBD-022187 (PE-12000 design specifications); SBD-025610 (PE-12000 seal assembly drawing, Rev. D).

39. Dr. Ng contends that the PE-12000's spring washer functions as the "biased locking member" required by the Court's construction. Ng Report ¶ 79. While the spring washer does provide a biasing force (in the sense that it exerts an axial load on the seal gasket), it does not engage with discrete locking elements that "positively engage to hold the seal in a sealed position." The spring washer exerts a compressive force on the gasket, causing the gasket to maintain contact with the instrument shaft through friction. This is a compression seal, not a locking seal.

40. The '237 Patent specification makes clear that the "biased locking member" operates through positive mechanical engagement—not mere compressive loading. The specification describes the locking member as having "interlocking engagement surfaces" that "snap into a locked configuration" when the seal is in its sealed position. '237 Patent, Col. 3, lines 14–28. The specification further describes the locking elements as including "complementary detent features that resist disengagement." Id., Col. 3, lines 29–35. None of these features are present in the PE-12000's seal.

41. Dr. Ng's analysis conflates the retention ring (which prevents disassembly of the seal from the housing) with the claimed "locking seal" (which maintains a gas-tight seal during instrument insertion and withdrawal). The retention ring keeps the seal components in the housing; it does not create or maintain the gas-tight seal itself. The gas-tight seal is created by the compressive deformation of the elastomeric gasket against the instrument shaft—a purely frictional mechanism that requires no locking engagement.

42. For these reasons, neither the PE-5000 nor the PE-12000 satisfies the "locking seal assembly" limitation of Claim 1. Because Claim 1 is the independent claim from which Claims 3, 7, and 12 depend, the failure to meet this limitation is dispositive as to all asserted claims of the '237 Patent. Nevertheless, I address the dependent claims below to demonstrate that the accused products also fail to satisfy the additional limitations introduced by those claims.

IV.D. Rebuttal — Claim 3 (Dependent Claim)

43. Claim 3 of the '237 Patent depends from Claim 1 and adds the following limitation:

"The device of claim 1, wherein the biased locking member comprises a medical-grade silicone body having a Shore A durometer hardness of between approximately 40 and 60."

44. Dr. Ng asserts that the elastomeric gaskets in the PE-5000 and PE-12000 satisfy this limitation because they are made of medical-grade elastomeric materials with Shore A hardness values within the claimed range. Ng Report ¶¶ 99–107. Dr. Ng acknowledges that the PE-5000 and PE-12000 gaskets are made of thermoplastic elastomer (TPE), not silicone, but contends that TPE is a "functional equivalent" of silicone for the purposes of this claim limitation. Id. ¶ 104.

45. Dr. Ng's assertion is unsupported for two independent reasons. First, as discussed in Section IV.C above, neither the PE-5000 gasket nor the PE-12000 gasket constitutes a "biased locking member" within the Court's construction. Claim 3's material limitation applies to the "biased locking member," not to any generic seal component. Because neither accused product contains a biased locking member, the material composition of the gasket is irrelevant to the infringement analysis.

46. Second, even if the gasket were properly characterized as a biased locking member, the claim specifically requires "medical-grade silicone"—not any elastomeric material with similar mechanical properties. Silicone and TPE are chemically and structurally distinct classes of materials. Silicone is a thermoset polymer based on a siloxane backbone; TPE is a thermoplastic material composed of alternating hard and soft segments, typically based on a polyurethane, polyester, or styrenic copolymer chemistry. The two materials differ significantly in their chemical composition, manufacturing processes, biocompatibility profiles, sterilization compatibility, and mechanical behavior over time and under repeated loading. The claim language is specific: it requires "silicone," not an elastomer with similar hardness. Dr. Ng's assertion of "functional equivalence" is an argument that belongs, if anywhere, in a doctrine of equivalents analysis—not in a literal infringement analysis.

47. Dr. Ng's functional equivalence argument is further undermined by the prosecution history. During prosecution of the '237 Patent, the examiner rejected an earlier version of Claim 3 that recited "an elastomeric body" without specifying a material. In response, Dr. Szabo amended the claim to specify "medical-grade silicone" and argued that the silicone material distinguished the claimed invention from prior art that used TPE or other thermoplastic elastomers. See Exhibit F (prosecution history excerpts), specifically the December 12, 2016 Amendment and Response at 7–8. Having narrowed the claim to silicone to overcome the prior art, Apex cannot now argue that TPE satisfies this limitation.

IV.E. Rebuttal — Claim 7 (Dependent Claim)

48. Claim 7 of the '237 Patent depends from Claim 1 and adds the following geometric limitation:

"The device of claim 1, wherein the first locking element defines a concave engagement surface having a radius of curvature of between approximately 0.5 mm and 2.0 mm, and the second locking element defines a complementary convex engagement surface."

49. Dr. Ng asserts that the PE-5000 and PE-12000 seal components contain geometric features that fall within this claimed range. Ng Report ¶¶ 115–126. He bases this assertion on cross-sectional microscopy images of cut seal components and dimensional measurements taken from those images.

50. Dr. Ng's measurement methodology is flawed in several material respects. First, Dr. Ng took measurements from a single cross-sectional cut through each seal component. A single cross-section cannot accurately characterize a three-dimensional engagement surface, particularly one that may vary around the circumference of the seal. Standard practice in dimensional analysis of elastomeric components requires multiple cross-sections at regular angular intervals (typically at least eight radial cross-sections at 45-degree intervals) to capture the full geometry. Dr. Ng's reliance on a single cross-section is selective and unreliable.

51. Second, Dr. Ng's measurements were taken from components that had been subjected to destructive testing—specifically, components that had been cut with a razor blade to expose the cross-section. The cutting process itself can deform the elastomeric material, introducing measurement artifacts. Dr. Ng does not address this potential source of error, nor does he describe any steps taken to mitigate or account for cutting-induced deformation.

52. Third, and most fundamentally, the geometric limitation of Claim 7 applies to the "first locking element" and "second locking element" of the "biased locking member." As discussed in Section IV.C, neither the PE-5000 nor the PE-12000 contains discrete locking elements. The surfaces that Dr. Ng identifies as "engagement surfaces" are the contact surfaces between the gasket and the instrument shaft or between the gasket and the housing bore. These are not "locking element" engagement surfaces; they are the natural contact interfaces of a compressive friction seal. Dr. Ng's geometric analysis is directed at the wrong structural features.

53. My own independent dimensional analysis, conducted using non-destructive micro-CT scanning of intact PE-5000 and PE-12000 seal components, confirms that the accused products' seal surfaces do not define the complementary concave-convex engagement geometry required by Claim 7. The PE-5000's gasket presents a substantially flat contact surface, and the PE-12000's gasket presents a tapered conical surface—neither of which includes the concave-convex engagement profile claimed. These results are documented in Exhibit E.

IV.F. Rebuttal — Claim 12 (Dependent Claim)

54. Claim 12 of the '237 Patent depends from Claim 1 and adds the following limitation:

"The device of claim 1, further comprising a spring-loaded detent that selectively locks the biased locking member in the sealed position."

55. The Court construed "spring-loaded detent" to mean "a detent mechanism that employs a discrete spring element to provide a biasing force that holds the detent in an engaged position." This construction requires a discrete, identifiable spring element—a structural component whose primary function is to provide biasing force through elastic deformation.

56. Neither the PE-5000 nor the PE-12000 employs a spring-loaded detent. The PE-5000's seal assembly contains no spring element of any kind. The PE-12000's seal assembly includes a spring washer that provides axial compression on the gasket, but this spring washer does not function as a "detent" in any recognized engineering sense. A detent is a latch or pawl mechanism that holds a component in one of two or more defined positions; the PE-12000's spring washer simply provides a continuous compressive force without any defined engaged or disengaged positions.

57. Dr. Ng characterizes the elastomeric bias of the PE-5000 and PE-12000 gaskets as a "spring-loaded detent." Ng Report ¶¶ 133–140. Specifically, he argues that because the elastomeric gasket material has inherent elastic recovery properties, it functions as a "spring" that "detents" the seal in its closed position. Id. ¶ 136. This characterization is technically incorrect and inconsistent with the Court's construction.

58. The Court's construction requires a "discrete spring element"—a separate, identifiable structural component. The inherent elasticity of a rubber gasket is not a "discrete spring element"; it is a material property of the gasket itself. Under Dr. Ng's logic, every elastomeric seal in existence would satisfy the "spring-loaded detent" limitation, because every elastomeric material has some degree of elastic recovery. This interpretation would render the Claim 12 limitation meaningless, as it would add nothing to the scope of Claim 1. The canon of claim differentiation requires that dependent claims be construed to add meaningful limitations beyond those of the independent claim. Dr. Ng's interpretation violates this principle.

59. Moreover, the '237 Patent specification expressly distinguishes the "spring-loaded detent" from the elastomeric biasing force of the seal material. The specification describes the spring-loaded detent as "a separate mechanical detent comprising a helical compression spring and a ball or pin element that engages a corresponding recess in the locking member." '237 Patent, Col. 6, lines 12–19. The specification illustrates this feature in Figure 7, which depicts a distinct spring-and-ball detent mechanism adjacent to, but separate from, the elastomeric seal body. The PE-5000 and PE-12000 contain no such mechanism.

IV.G. Prosecution History Estoppel for the '237 Patent

60. In addition to the literal non-infringement analysis above, Apex is estopped from asserting infringement of the '237 Patent under the doctrine of equivalents with respect to the "biased locking member" limitation.

61. During prosecution of the '237 Patent, the examiner issued a rejection of the original claims under 35 U.S.C. § 102(a)(1) based on U.S. Patent No. 7,462,175 to Marczyk et al. ("Marczyk"), which disclosed a trocar seal assembly using a friction-fit elastomeric gasket without discrete locking elements. In response, on August 18, 2016, Dr. Szabo (through patent counsel) amended Claim 1 to add the "biased locking member having a first locking element and a second locking element that positively engage" limitation. In the remarks accompanying the amendment, patent counsel argued:

"Claim 1, as amended, distinguishes the claimed invention from Marczyk by requiring a biased locking member with discrete locking elements that positively engage to maintain a gas-tight seal. Marczyk discloses a friction-seal gasket that relies solely on compressive deformation to create a seal. Marczyk does not disclose or suggest a biased locking member with positively engaging locking elements as now required by amended Claim 1."

See Exhibit F at 14–15 (prosecution history excerpts).

62. This narrowing amendment was made for the purpose of overcoming a prior art rejection, and the subject matter surrendered—i.e., seal assemblies that rely on friction-fit elastomeric gaskets without discrete, positively engaging locking elements—encompasses precisely the seal architecture used in the PE-5000 and PE-12000 Series. Under the Supreme Court's decision in Festo Corp. v. Fenmore & Co., 535 U.S. 722 (2002), and the Federal Circuit's subsequent decisions, this narrowing amendment creates a presumption that Apex surrendered the territory between the original claim scope and the amended claim scope.

63. Apex cannot rebut this presumption. The surrendered subject matter—friction-fit seals without biased locking members—is precisely the territory into which Dr. Ng's equivalents theory attempts to extend the claims. The PE-5000's friction-fit elastomeric gasket and the PE-12000's compression seal are the very types of structures that Apex distinguished during prosecution. Dr. Ng's doctrine of equivalents analysis for the '237 Patent therefore impermissibly recaptures subject matter surrendered during prosecution and should be rejected.

V. REBUTTAL: THE '884 PATENT — "RETRACTABLE BLADE DEPLOYMENT MECHANISM FOR TROCAR SYSTEMS"

V.A. Accused Products: PE-5000, PE-12000, and PE-15000 Series

64. Dr. Ng accuses all three PrecisionEdge™ product lines—the PE-5000 Series, the PE-12000 Series, and the PE-15000 Series—of infringing Claims 1, 2, 5, 9, and 14 of the '884 Patent. Ng Report ¶¶ 148–267. The '884 Patent is the broadest of the three asserted patents in terms of the number of accused products and asserted claims.

V.B. Dr. Ng's Infringement Theory for the '884 Patent

65. Dr. Ng contends that the PrecisionEdge™ blade-deployment system in each of the three accused product lines meets every limitation of the asserted claims because each product uses a spring-actuated retractable blade housed within the trocar obturator. Ng Report ¶ 150. According to Dr. Ng, the blade in each product is deployed by an actuation trigger on the handle and retracts automatically when the trigger is released, and this mechanism constitutes a "retractable blade deployment mechanism" within the Court's construction. Id. ¶¶ 152–158.

66. Dr. Ng relies heavily on physical testing he conducted on exemplar units of each product line. He disassembled and tested two units of each model (six units total) to measure blade deployment force, retraction speed, deployment angle, and blade housing dimensions. Id. ¶¶ 159–167. As I discuss in Section V.C below, his testing methodology is flawed in several respects.

67. Dr. Ng's central error is his assertion that the PrecisionEdge™ products employ a "cam-driven linkage" connecting the blade to the actuation trigger. As I explain below, this assertion is factually incorrect. The PrecisionEdge™ products use a direct spring-return mechanism, not a cam-driven linkage.

V.C. Rebuttal — Claim 1 (Independent Claim)

68. Claim 1 of the '884 Patent reads in relevant part:

"A trocar system comprising: an obturator including a distal tip portion; a retractable blade deployment mechanism housed within the obturator, the retractable blade deployment mechanism comprising a cam-driven linkage connecting a blade carrier to an actuation trigger, wherein actuation of the trigger drives the blade carrier distally through the cam-driven linkage to deploy the blade from a retracted position to a deployed position, and release of the trigger causes the cam-driven linkage to return the blade carrier to the retracted position . . ."

69. The Court construed "retractable blade deployment mechanism" to require "a mechanism that deploys and retracts a blade through a cam-driven linkage connecting the blade carrier to the actuation trigger." The critical structural limitation is the cam-driven linkage.

The PrecisionEdge™ Blade Deployment System

70. All three PrecisionEdge™ product lines—the PE-5000, PE-12000, and PE-15000—employ a direct spring-return mechanism for blade deployment and retraction. The mechanism operates as follows:

(a) A coil compression spring biases the blade carrier in the retracted position. In the resting state, the blade is fully retracted within the obturator housing.

(b) When the user depresses the actuation trigger on the handle, the trigger acts through a direct mechanical linkage (a rigid push rod) to push the blade carrier distally, compressing the coil spring and deploying the blade from the obturator tip.

(c) When the user releases the actuation trigger, the compressed coil spring expands and drives the blade carrier proximally, returning the blade to the retracted position.

71. This mechanism is a direct-acting spring-return system. The actuation trigger is connected to the blade carrier through a rigid push rod—not through a cam-driven linkage. The blade carrier moves in a purely linear path along the longitudinal axis of the obturator. There is no rotary-to-linear motion conversion, no cam surface, and no cam follower. The motion is direct and linear throughout the deployment and retraction cycle.

72. The '884 Patent specification describes a fundamentally different mechanism. The patented blade deployment mechanism uses a cam—specifically, a profiled cam surface on a rotary actuator—that engages a cam follower on the blade carrier. When the actuation trigger is squeezed, it rotates the cam, and the profiled cam surface drives the cam follower (and thus the blade carrier) distally. When the trigger is released, the cam surface returns the blade carrier to the retracted position. The cam profile controls the force-displacement relationship and the deployment trajectory throughout the actuation cycle. See '884 Patent, Col. 3, line 45 through Col. 4, line 31; Figs. 2A–2D.

73. The difference between a cam-driven linkage and a direct spring-return mechanism is fundamental and well understood in mechanical engineering. A cam-driven linkage converts one type of motion (typically rotary) into another (typically linear), and the motion profile of the output is determined by the geometry of the cam surface. A direct spring-return mechanism, by contrast, uses a stored elastic energy source (the spring) to return the moving component to its resting position; the deployment is accomplished by direct mechanical input, and the retraction force profile is determined by the spring constant and compression distance. The two mechanisms differ in structure, operating principle, force profile, and kinematic behavior.

Dr. Ng's "Cam" Characterization

74. Dr. Ng attempts to characterize the PrecisionEdge™ products' blade deployment mechanism as cam-driven by identifying a ramped guide surface inside the obturator housing as a "cam." Ng Report ¶¶ 168–178, Fig. 11. Specifically, Dr. Ng points to a short inclined ramp on the interior of the obturator housing that guides the blade carrier during the final approximately 2 mm of its distal travel, directing the blade tip at a slight angle (approximately 3–5 degrees from the longitudinal axis) as it emerges from the obturator tip. Id. ¶ 172.

75. This ramped guide surface is not a cam. It is a simple linear inclined plane—a flat surface angled at a fixed inclination. It does not have a profiled or contoured surface; it does not convert one type of motion into another; and it does not control the force-displacement relationship of the blade carrier throughout its travel. It serves the limited function of directing the blade tip at a slight angle as it exits the obturator, and it engages the blade carrier only during the final portion of its stroke.

76. The distinction between a cam and an inclined plane is elementary in mechanical engineering. A cam is defined as a rotating or sliding piece in a mechanical linkage that imparts a prescribed motion to another piece (the follower) through the profile of its surface. The motion profile of the follower is determined by the cam's geometric contour. An inclined plane, by contrast, is a flat surface set at an angle, which redirects a linear force along a different linear path. The PrecisionEdge™ ramp is an inclined plane, not a cam, and Dr. Ng's characterization of it as a cam is technically incorrect.

77. The Court's construction of "cam-driven linkage" reinforces this distinction. The Court specifically construed "cam surface" to mean "a surface profile that converts rotary or linear input motion into a different output motion through a contoured or profiled surface," distinguishing it from a simple inclined plane or ramp. Under this construction, the PrecisionEdge™ ramp does not qualify as a cam surface.

Dr. Szabo's Deposition Testimony

78. Notably, Dr. Szabo himself—the named inventor of the '884 Patent and Apex's Vice President of Engineering—testified at his Rule 30(b)(6) deposition that cam-driven blade deployment mechanisms are structurally distinct from spring-return mechanisms. When asked to describe the '884 Patent's invention, Dr. Szabo testified:

"Q: Can you describe the blade deployment mechanism claimed in the '884 Patent?

A: Yes. The '884 Patent claims a cam-driven blade deployment mechanism. The cam converts the squeezing motion of the trigger into the linear deployment of the blade. The cam profile is specifically designed to control the force and speed of the blade throughout its deployment and retraction stroke.

Q: How does this differ from a spring-return mechanism?

A: In a spring-return system, the blade is pushed out by direct mechanical action and then pulled back by a spring. There's no cam. The retraction force is determined by the spring, not by a cam profile. It's a simpler mechanism. We considered spring-return designs early on but chose the cam-driven approach because it gave us better control over the force profile."

See Exhibit G (Szabo Dep. Tr. 87:14–88:9).

79. Dr. Szabo's testimony confirms that cam-driven mechanisms and spring-return mechanisms are recognized as distinct categories in the trocar industry, and that the patented invention specifically uses a cam-driven mechanism rather than a spring-return mechanism. The PrecisionEdge™ products fall squarely within the spring-return category that Dr. Szabo described as being different from the claimed invention.

80. For these reasons, the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 do not meet the "retractable blade deployment mechanism" and "cam-driven linkage" limitations of Claim 1 of the '884 Patent. Because Claim 1 is the independent claim from which all other asserted claims depend, this failure is dispositive. I nevertheless address the dependent claims below.

V.D. Rebuttal — Claim 2 (Dependent Claim)

81. Claim 2 of the '884 Patent depends from Claim 1 and adds the following limitation:

"The trocar system of claim 1, further comprising a secondary safety lock that prevents inadvertent deployment of the blade when the actuation trigger is not intentionally actuated."

82. Dr. Ng asserts that the PE-5000 includes a "secondary safety lock" in the form of a friction detent on the actuation trigger that provides resistance to unintentional trigger actuation. Ng Report ¶¶ 190–198.

83. The PE-5000 does not have a secondary safety lock. The PE-5000 relies on a single-stage spring mechanism: the coil compression spring that biases the blade in the retracted position also provides the resistance that the user feels when depressing the actuation trigger. There is no separate, secondary mechanism that independently prevents blade deployment.

84. Dr. Ng identifies a slight interference fit between the trigger and the handle housing as a "friction detent" and characterizes this as a "secondary safety lock." Ng Report ¶ 194. This characterization is inconsistent with the '884 Patent specification, which describes the "secondary safety lock" as "a manually engageable locking mechanism, separate from the primary actuation mechanism, that must be affirmatively disengaged by the user before the actuation trigger can be depressed." '884 Patent, Col. 4, lines 32–48. The specification illustrates the secondary safety lock in Figure 5 as a sliding lock switch on the handle that physically blocks trigger travel when in the locked position.

85. The PE-5000's interference fit between the trigger and housing is an incidental manufacturing characteristic—a result of the molding tolerances of the plastic housing components—not a deliberately designed safety locking mechanism. It provides no discrete locked or unlocked state, it is not manually engageable or disengageable, and it does not physically prevent trigger actuation. At most, it increases the initial trigger pull force by a negligible amount (approximately 0.2–0.3 N based on my testing). This is not a "secondary safety lock" by any reasonable engineering definition.

V.E. Rebuttal — Claim 5 (Dependent Claim)

86. Claim 5 of the '884 Patent depends from Claim 1 and specifies:

"The trocar system of claim 1, wherein the blade deploys at an angle of between approximately 10 degrees and 25 degrees relative to the longitudinal axis of the obturator."

87. Dr. Ng asserts that the PE-12000's blade deploys at an angle of approximately 12 degrees, which falls within the claimed range. Ng Report ¶¶ 204–212. He bases this measurement on static measurement of the blade angle when the blade is in its fully deployed position with the trigger fully depressed.

88. Dr. Ng's measurement methodology is flawed. He measured the blade angle in a static, fully-deployed state by photographing the deployed blade and measuring the angle from the photograph. This approach does not capture the dynamic deployment angle—i.e., the angle at which the blade actually travels during deployment. The claim specifies the angle at which "the blade deploys," which refers to the deployment trajectory, not the static resting angle.

89. The PE-12000's blade deployment trajectory is substantially linear along the longitudinal axis. The small angular deflection at the tip (caused by the inclined ramp discussed in Section V.C above) occurs only during the final approximately 2 mm of the blade's travel and produces a deflection of approximately 3–5 degrees from the longitudinal axis—well below the claimed 10–25 degree range. When measured dynamically during actual deployment, the effective deployment angle of the PE-12000's blade is approximately 3–5 degrees, not 12 degrees.

90. Dr. Ng's static measurement of 12 degrees reflects the angle of the blade tip relative to the obturator axis when the blade is in its fully extended position, which is a function of the blade geometry (the blade itself is angled) rather than the deployment trajectory. This is a critical distinction: the claim limitation refers to the angle of deployment, not the angle of the blade body. The '884 Patent specification confirms this interpretation, describing the deployment angle as "the angle of the blade carrier's travel path relative to the longitudinal axis during deployment" ('884 Patent, Col. 5, lines 18–22), not the static angle of the extended blade.

91. My own dynamic measurement of blade deployment angle, conducted using high-speed video capture (1,000 frames per second) of blade deployment on five PE-12000 exemplar units, yielded a mean deployment angle of 4.2 degrees ± 0.8 degrees (standard deviation). These results are documented in Exhibit E. The PE-12000's blade deployment angle does not fall within the claimed range of 10 to 25 degrees.

V.F. Rebuttal — Claim 9 (Dependent Claim)

92. Claim 9 of the '884 Patent depends from Claim 1 and requires:

"The trocar system of claim 1, wherein the blade carrier is housed within a blade housing having a substantially cylindrical outer surface with a maximum outer diameter of no more than 90% of the inner diameter of the cannula through which the obturator is inserted."

93. Dr. Ng asserts that the PE-15000's blade housing satisfies this limitation. Ng Report ¶¶ 220–231. He reports a blade housing outer diameter of 12.8 mm and a cannula inner diameter of 15.0 mm, yielding a ratio of approximately 85.3%, which would fall within the claimed 90% maximum. Id. ¶ 227.

94. Dr. Ng's measurements are inaccurate and incomplete. The PE-15000's blade housing does not have a "substantially cylindrical outer surface" as required by the claim. The PE-15000's housing has an oblong or elongated cross-section with a major axis dimension of approximately 14.1 mm and a minor axis dimension of approximately 12.6 mm. See SBD-031488 (PE-15000 blade housing drawing, Rev. B). The housing's non-cylindrical geometry is a deliberate design choice that accommodates the wider blade used in the 15 mm trocar configuration.

95. Dr. Ng measured only the minor axis dimension (12.6 mm, which he rounded to 12.8 mm) and reported this as the "maximum outer diameter." This measurement is misleading. The correct measure of the housing's maximum outer dimension is the major axis length of 14.1 mm, which yields a ratio of 94% relative to the 15.0 mm cannula inner diameter—exceeding the claimed 90% maximum. Moreover, because the PE-15000's housing is not "substantially cylindrical," it does not satisfy the "substantially cylindrical outer surface" limitation in the first instance.

96. My own dimensional measurements of the PE-15000 blade housing, taken using digital calipers and confirmed by micro-CT scanning, are documented in Exhibit E and confirm the oblong cross-section with dimensions of 14.1 mm × 12.6 mm.

V.G. Rebuttal — Claim 14 (Dependent Claim)

97. Claim 14 of the '884 Patent depends from Claim 1 and adds:

"The trocar system of claim 1, further comprising a force-limiting mechanism that limits the maximum deployment force applied by the blade to a predetermined threshold."

98. Dr. Ng asserts that the PrecisionEdge™ products include a "force-limiting mechanism" based on his force measurements of blade deployment on exemplar units. Ng Report ¶¶ 237–250. He reports that the blade deployment force plateaus at a maximum value during the deployment stroke, and he characterizes this plateau as evidence of a "force-limiting mechanism." Id. ¶ 243.

99. The PrecisionEdge™ products do not include a force-limiting mechanism. The apparent force plateau that Dr. Ng observed is a natural consequence of the spring mechanics of the system—as the blade carrier approaches the end of its travel and the spring reaches its compressed length, the rate of force increase decreases. This is a physical property of a coil spring operating near its solid length, not a deliberately designed force-limiting mechanism.

100. The '884 Patent specification describes the "force-limiting mechanism" as a distinct structural feature: "a slip clutch or breakaway coupling interposed between the cam-driven linkage and the blade carrier that limits the maximum force transmittable to the blade, thereby preventing excessive penetration force." '884 Patent, Col. 7, lines 4–12. The specification illustrates this feature in Figure 8 as a separate mechanical component with a defined breakaway torque. The PrecisionEdge™ products contain no such component.

101. Furthermore, Dr. Ng's own force measurements are internally inconsistent. He reports maximum deployment forces of 8.7 N and 9.2 N for two PE-12000 exemplar units (Ng Report, Table 3), but his testing protocol specifies that measurements should be taken at a controlled displacement rate of 5 mm/s, while his data plots (Ng Report, Fig. 13) show variable displacement rates ranging from approximately 2 mm/s to 12 mm/s during the measurement cycle. This variability introduces significant error into the force measurements and renders them unreliable.

V.H. Doctrine of Equivalents — '884 Patent

102. Dr. Ng asserts that even if the PrecisionEdge™ products do not literally infringe the asserted claims of the '884 Patent, they infringe under the doctrine of equivalents. Ng Report ¶¶ 251–265. He applies the function-way-result test and argues that the PrecisionEdge™ spring-return mechanism performs substantially the same function, in substantially the same way, to achieve substantially the same result as the claimed cam-driven linkage.

Function-Way-Result Analysis.

103. I disagree with Dr. Ng's doctrine of equivalents analysis. While it is true that both the patented cam-driven mechanism and the PrecisionEdge™ spring-return mechanism perform the general function of deploying and retracting a blade in a trocar, the "way" and "result" prongs of the test are not satisfied.

104. Way: The cam-driven linkage achieves blade deployment through a fundamentally different mechanical means than the spring-return mechanism. The cam-driven linkage converts the

CONFIDENTIAL — ATTORNEY WORK PRODUCT / ATTORNEY-CLIENT PRIVILEGED DRAFT FOR COUNSEL REVIEW ONLY
DRAFT REBUTTAL EXPERT REPORT OF DR. MIRIAM OSTROWSKI, PH.D. IN REBUTTAL TO THE EXPERT REPORT OF DR. CALVIN NG, PH.D.
APEX SURGICAL INNOVATIONS, INC. v. SOLSTICE BIOMEDICAL, INC. Case No. 1:24-cv-00587-RGA United States District Court for the District of Delaware
Date of Draft: February 25, 2025 Matter No.: 10294.0017
Internal working draft prepared for review by Calderwood & Harkness LLP engagement team (Marcus Delgado, Catherine Bloom, Christy Bauer, Peter Vassiliev) prior to finalization and service on or before March 3, 2025. This document is protected by the attorney-client privilege and the work product doctrine. It is not intended for service, production, or disclosure to any party or non-party. Do not circulate outside the engagement team without express authorization from lead counsel.
Right-click to update Table of Contents
I. INTRODUCTION AND QUALIFICATIONS
I.A. Identity and Engagement
1. My name is Dr. Miriam Ostrowski. I am a Professor of Biomedical Engineering at Halford University, located at 3401 Walnut Street, Philadelphia, Pennsylvania 19104. I hold the William S. Tremaine Endowed Chair in Surgical Device Engineering and have served on the Halford University faculty since 2007.
2. I have been retained by the law firm of Calderwood & Harkness LLP on behalf of Defendant Solstice Biomedical, Inc. ("Solstice"), the U.S. operating subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company (CRO No. 648217), in connection with this patent infringement action brought by Plaintiff Apex Surgical Innovations, Inc. ("Apex"). My retention is governed by an Expert Retention Agreement dated August 20, 2024, executed between me and Calderwood & Harkness LLP.
3. I am being compensated for my work in this matter at a rate of $750 per hour. My compensation is not contingent upon the outcome of this litigation, the substance of my opinions, or the content of any testimony I may provide. Through the current date, my total fees for work performed in this matter are approximately $127,500. This figure includes time spent on my invalidity expert report, this rebuttal expert report, document review, analysis, testing, and communications with counsel.
I.B. Scope of Engagement for Rebuttal
4. I have been asked to provide rebuttal opinions responding to the infringement opinions set forth in the Expert Report of Dr. Calvin Ng, Ph.D. ("Dr. Ng's Report" or "the Ng Report"), which was served on February 10, 2025. Dr. Ng is an Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute in Newark, Delaware. Dr. Ng was retained by Apex to provide opinions on infringement.
5. Specifically, my rebuttal addresses Dr. Ng's opinions on both literal infringement and infringement under the doctrine of equivalents for each of the three patents asserted by Apex in this litigation:
(a) U.S. Patent No. 9,814,237 ("the '237 Patent"), titled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," issued November 14, 2017, with an expiration date of June 22, 2035 (asserted Claims 1, 3, 7, and 12);
(b) U.S. Patent No. 10,271,884 ("the '884 Patent"), titled "Retractable Blade Deployment Mechanism for Trocar Systems," issued April 30, 2019, with an expiration date of September 15, 2036 (asserted Claims 1, 2, 5, 9, and 14); and
(c) U.S. Patent No. 10,932,105 ("the '105 Patent"), titled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar," issued March 2, 2021, with an expiration date of January 10, 2038 (asserted Claims 1, 4, and 8).
6. All three asserted patents are assigned to Apex Surgical Innovations, Inc. The named inventor on each patent is Dr. Raymond Szabo, who serves as Vice President of Engineering at Apex.
I.C. Summary of Prior Work
7. In addition to this rebuttal report, I prepared and served an Expert Report on Invalidity dated January 27, 2025, in which I set forth my opinions that the asserted claims of the '237, '884, and '105 Patents are invalid for anticipation under 35 U.S.C. § 102 and/or obviousness under 35 U.S.C. § 103. This rebuttal report supplements, but does not replace, the invalidity opinions set forth in my January 27, 2025 report. Those invalidity opinions stand as independent and alternative grounds for non-liability.
I.D. Qualifications Summary
8. I hold a B.S. in Mechanical Engineering from the Massachusetts Institute of Technology (1996), an M.S. in Biomedical Engineering from Stanford University (1998), and a Ph.D. in Biomedical Engineering from Stanford University (2002). My doctoral dissertation, titled "Mechanically Adaptive Sealing Interfaces for Minimally Invasive Surgical Instrumentation," was supervised by Professor Harold J. Whelan and was awarded the Stanford Dean's Prize for Distinguished Doctoral Research.
9. I have been a member of the Halford University faculty since 2007, having previously served as an Assistant Professor at the University of Michigan (2002–2007). My research focuses on the design, engineering, and biomechanical analysis of surgical instrumentation, with a particular emphasis on trocar systems, laparoscopic access devices, and sealing mechanisms for minimally invasive surgery. I direct the Halford Surgical Device Engineering Laboratory, which has received over $14 million in funding from the National Institutes of Health, the National Science Foundation, and private industry sponsors since its founding.
10. I have authored or co-authored over 130 peer-reviewed journal articles and conference papers in the fields of biomedical engineering, surgical instrumentation, and mechanical design. I am the named inventor on twelve issued U.S. patents, several of which relate to trocar and laparoscopic access device technology. I am a Fellow of the American Institute for Medical and Biological Engineering (AIMBE) and a member of the Society for Minimally Invasive Therapy, the Biomedical Engineering Society, and the American Society of Mechanical Engineers.
11. I have been qualified as an expert witness and provided expert testimony in federal and state court proceedings on nine prior occasions, in matters involving patent infringement, product liability, and design defect claims relating to surgical instrumentation and medical devices. A complete listing of my prior testimony is included in my curriculum vitae, which is attached as Exhibit A.
I.E. Materials Considered
12. In forming my rebuttal opinions, I reviewed and considered the following materials, among others. A complete list of materials considered is provided in Exhibit B.
(a) The Complaint filed by Apex Surgical Innovations, Inc. on May 9, 2024, and the Answer, Affirmative Defenses, and Counterclaims filed by Solstice Biomedical, Inc. on June 14, 2024;
(b) U.S. Patent Nos. 9,814,237; 10,271,884; and 10,932,105, including the full patent specifications, drawings, abstracts, and claims;
(c) The complete prosecution histories (file wrappers) for each of the three asserted patents, including all office actions, responses, amendments, declarations, and notices of allowance;
(d) The Claim Construction Order issued by the Honorable Richard G. Andrews on December 6, 2024 (Dkt. 87), construing nine disputed claim terms;
(e) The Expert Report of Dr. Calvin Ng, Ph.D. on Infringement, dated February 10, 2025, including all exhibits and appendices thereto;
(f) My own Expert Report on Invalidity, dated January 27, 2025, including all exhibits and appendices thereto;
(g) Documents produced by Solstice Biomedical, Inc. in this litigation, bearing Bates numbers SBD-000001 through SBD-048217;
(h) Documents produced by Apex Surgical Innovations, Inc. in this litigation, bearing Bates numbers APEX-000001 through APEX-031450;
(i) Technical specifications, design files, CAD drawings, engineering change orders, and physical samples of the PrecisionEdge™ PE-5000 Series (5 mm trocar assembly), PE-12000 Series (12 mm trocar assembly), and PE-15000 Series (15 mm trocar assembly) products manufactured and sold by Solstice;
(j) Deposition transcripts of fact and party witnesses, including the transcript of the Rule 30(b)(6) deposition of Apex Surgical Innovations, Inc., at which Dr. Raymond Szabo testified as the corporate designee;
(k) Prior art references identified and discussed in my invalidity expert report, including U.S. and foreign patent publications, journal articles, and product literature;
(l) Relevant technical literature and industry standards, including AAMI and ISO standards applicable to trocar systems and laparoscopic access devices;
(m) Portions of the damages expert reports served on February 14, 2025, by Dr. Elena Marchetti of Pinnacle Economics Group LLC (retained by Apex) and Hugh Danaher, CFA, of Keystone Valuation Advisors LLC (retained by Solstice), to the extent those reports bear on the technical scope of the infringement allegations;
(n) Prior art documents obtained via subpoena from Veridian Medical Technologies, Inc., including design documents, marketing materials, and regulatory submissions relating to Veridian's SealGuard and TrocarPro product lines; and
(o) Such other materials as are identified in Exhibit B hereto.
II. SUMMARY OF REBUTTAL OPINIONS
13. Based on my review, analysis, and testing, and for the reasons set forth in detail in this report, I hold the following principal rebuttal opinions to a reasonable degree of scientific and engineering certainty:
(1) Dr. Ng's infringement analysis of the PE-5000 Series under the '237 Patent misapplies the Court's construction of "locking seal assembly" and fails to account for the structural differences in the PE-5000's seal mechanism. The PE-5000 Series uses a friction-fit elastomeric gasket that does not employ the "biased locking member" with discrete locking elements required by the Court's construction of this term. Dr. Ng's analysis conflates a retention ring that prevents disassembly with the claimed positive-locking seal, ignoring a fundamental structural distinction.
(2) Dr. Ng's infringement analysis of the PE-5000 Series under the '884 Patent improperly expands the Court's construction of "retractable blade deployment mechanism" beyond its proper scope. The Court's construction requires a "cam-driven linkage" connecting the blade to the actuation trigger. The PE-5000 Series employs a direct spring-return mechanism without a cam. Dr. Ng's characterization of a linear ramped guide surface as a "cam" is technically incorrect and inconsistent with accepted engineering terminology.
(3) Dr. Ng's infringement analysis of the PE-12000 Series under all three patents relies on selective and misleading comparisons and ignores critical structural distinctions. With respect to each asserted patent, Dr. Ng cherry-picks isolated features of the PE-12000 Series while ignoring the overall structural and mechanical differences between the accused products and the claimed inventions. His analysis fails to account for the PE-12000's modular insufflation valve design, the absence of a biased locking member in the seal assembly, and the spring-return (rather than cam-driven) blade deployment mechanism.
(4) Dr. Ng's infringement analysis of the PE-15000 Series under the '884 and '105 Patents mischaracterizes the operation of the PE-15000's insufflation valve and blade system. Dr. Ng's description of the PE-15000's insufflation valve as "integrated" with the seal is directly contradicted by his own disassembly photographs, which show the valve as a discrete snap-in module. His characterization of the PE-15000's blade deployment as cam-driven is similarly unfounded.
(5) Dr. Ng's doctrine of equivalents analysis for all accused products fails to satisfy the function-way-result test and is barred by prosecution history estoppel arising from narrowing amendments made during prosecution. Apex made narrowing amendments to the claims of each of the three asserted patents during prosecution to distinguish prior art that disclosed the very structures employed by the PrecisionEdge™ products. Dr. Ng's equivalents analysis would impermissibly recapture subject matter that Apex surrendered to obtain its patents.
(6) Dr. Ng's analysis repeatedly conflates functional similarity with structural identity, which is legally and technically inappropriate. Throughout his report, Dr. Ng argues that because the PrecisionEdge™ products perform the same general functions as the patented inventions—i.e., sealing, blade deployment, and insufflation—they necessarily satisfy the structural claim limitations. This approach is fundamentally flawed. Literal infringement requires the accused product to meet every structural limitation of the claim. Functional similarity, standing alone, does not establish literal infringement.
(7) Dr. Ng relies on incomplete testing and flawed experimental methodology. Dr. Ng's physical testing of exemplar PrecisionEdge™ units was conducted without adequate chain-of-custody documentation, under uncontrolled environmental conditions, and using measurement techniques that are not consistent with accepted engineering practice for the parameters at issue. My own independent testing, conducted under controlled laboratory conditions at Halford University, yielded materially different results on several critical parameters.
14. Each of these opinions is discussed in detail in the sections that follow. In forming these opinions, I have applied the claim constructions adopted by the Court in its December 6, 2024 Claim Construction Order.
III. THE COURT'S CLAIM CONSTRUCTION ORDER AND ITS SIGNIFICANCE
III.A. Overview of the Claim Construction Order (December 6, 2024)
15. On December 6, 2024, following the Markman hearing held on November 14, 2024, the Court issued its Claim Construction Order (Dkt. 87), construing nine disputed claim terms across the three asserted patents. Of these nine constructions, five were favorable to Solstice, in that the Court adopted constructions that were materially narrower than those proposed by Apex or adopted Solstice's proposed constructions in full. Four constructions were favorable to Apex, in that the Court adopted constructions that were broader than those proposed by Solstice or adopted Apex's proposed constructions in full. The relevant constructions are set forth in Exhibit H.
16. Dr. Ng's Report was prepared after the Markman hearing and the issuance of the Claim Construction Order. However, as I discuss in detail below and in Section VII.C, Dr. Ng's report does not faithfully apply several of the Court's constructions. In at least two critical instances, Dr. Ng applies constructions that are more consistent with Apex's rejected proposed constructions than with the constructions actually adopted by the Court. This is a significant methodological deficiency that pervades his infringement analysis.
III.B. Key Constructions Favorable to Solstice
17. The following constructions are particularly significant to the rebuttal opinions set forth in this report:
"Locking seal assembly" ('237 Patent, Claims 1, 3, 7, 12)
18. Apex proposed that "locking seal assembly" be construed to mean "a seal assembly that includes a mechanism that holds the seal in a closed or sealed position." Solstice proposed a narrower construction: "a seal assembly comprising a biased locking member with at least two discrete locking elements that engage to maintain the seal in a gas-tight sealed position during instrument insertion and withdrawal."
19. The Court adopted a construction that is substantially closer to Solstice's proposal: "a seal assembly comprising a biased locking member with discrete locking elements that positively engage to hold the seal in a sealed position." The Court's construction requires (i) a biased locking member, (ii) discrete locking elements, and (iii) positive engagement of those elements to maintain the seal. This construction is narrower than Apex proposed in that it requires specific structural features—not merely any mechanism that holds a seal closed. As I explain in Section IV, the PE-5000 and PE-12000 Series do not possess these structural features.
"Retractable blade deployment mechanism" ('884 Patent, Claims 1, 2, 5, 9, 14)
20. Apex proposed that "retractable blade deployment mechanism" be construed to mean "a mechanism that deploys and retracts a blade." Solstice proposed: "a mechanism that deploys and retracts a blade through a cam-driven linkage connecting the blade carrier to the actuation trigger."
21. The Court adopted Solstice's proposed construction: "a mechanism that deploys and retracts a blade through a cam-driven linkage connecting the blade carrier to the actuation trigger." The Court found that the specification consistently described the deployment mechanism in terms of a cam-driven linkage, that the prosecution history reinforced this narrow reading (noting that the applicant distinguished prior art spring-return systems during prosecution), and that the claim language itself, when read in the context of the specification, supported the inclusion of the cam-driven linkage requirement. As I explain in Section V, none of the PrecisionEdge™ products employ a cam-driven linkage.
"Integrated insufflation valve" ('105 Patent, Claims 1, 4, 8)
22. Apex proposed that "integrated insufflation valve" be construed to mean "an insufflation valve that is combined with or incorporated into the trocar assembly." Solstice proposed: "an insufflation valve that is structurally integrated with the seal as a unitary component or is permanently joined to the seal such that the valve cannot be removed independently of the seal."
23. The Court adopted a construction that reflects the structural integration requirement: "an insufflation valve that is structurally integrated with the seal assembly, meaning the valve and seal are formed as a unitary component or are permanently joined such that they cannot be separated without destruction of the assembly." This construction requires structural integration, not merely functional co-location or proximity within the same housing. As I explain in Section VI, the PE-12000 and PE-15000 Series employ a modular design in which the insufflation valve is a separate, removable snap-in component.
Additional Constructions.
24. Two additional constructions favorable to Solstice bear on the analysis below. The Court construed "spring-loaded detent" (as used in '237 Patent, Claim 12) to mean "a detent mechanism that employs a discrete spring element to provide a biasing force that holds the detent in an engaged position." The Court also construed "cam surface" (as used in the specification of the '884 Patent and referenced in the claims) to mean "a surface profile that converts rotary or linear input motion into a different output motion through a contoured or profiled surface," distinguishing it from a simple inclined plane or ramp. Both of these constructions are relevant to the analysis that follows.
III.C. Key Constructions Favorable to Apex
25. In the interest of completeness and intellectual honesty, I acknowledge that four of the Court's constructions were favorable to Apex. Specifically:
(a) The Court construed "seal" (as used broadly in the '237 Patent) to include both static and dynamic sealing interfaces, rejecting Solstice's argument that the term should be limited to dynamic seals. This construction is broader than Solstice proposed.
(b) The Court construed "blade" (as used in the '884 Patent) to encompass any sharpened cutting element regardless of material composition, rejecting Solstice's argument that the term should be limited to metallic blades. This construction encompasses the ceramic blade tips used in certain PE-15000 configurations.
(c) The Court construed "gas-tight" (as used in the '237 and '105 Patents) to mean "substantially gas-tight under surgical operating conditions," adopting a functional standard that permits some de minimis leakage, rather than requiring an absolute hermetic seal as Solstice proposed.
(d) The Court construed "trocar assembly" (as used broadly across all three patents) to encompass the complete assembled device including the obturator, cannula, and housing, rejecting Solstice's argument that the term should be limited to the cannula and housing.
26. I have carefully considered these constructions in forming my rebuttal opinions. Even accepting these broader constructions as the Court has adopted them, the accused PrecisionEdge™ products still do not infringe the asserted claims for the reasons detailed in Sections IV through VI below. The constructions favorable to Apex relate to terms that are not dispositive of the infringement analysis, whereas the constructions favorable to Solstice relate to the core structural limitations that distinguish the accused products from the claimed inventions.
IV. REBUTTAL: THE '237 PATENT — "LOCKING SEAL ASSEMBLY FOR MINIMALLY INVASIVE SURGICAL ACCESS DEVICE"
IV.A. Accused Products: PE-5000 and PE-12000 Series
27. Dr. Ng accuses both the PrecisionEdge™ PE-5000 Series (5 mm trocar assembly) and the PE-12000 Series (12 mm trocar assembly) of infringing Claims 1, 3, 7, and 12 of the '237 Patent. Dr. Ng does not accuse the PE-15000 Series of infringing the '237 Patent. I address Dr. Ng's infringement theory for each asserted claim in turn.
IV.B. Dr. Ng's Infringement Theory for the '237 Patent
28. Dr. Ng opines that both the PE-5000 and PE-12000 include a "locking seal assembly" within the meaning of the '237 Patent claims because they contain a multi-component seal with a retention ring. See Ng Report ¶¶ 48–97, Figs. 3–9. Dr. Ng asserts that the retention ring in each product functions as a "locking member" that engages with the seal body to maintain a sealed position during instrument insertion and withdrawal, and that the seal components constitute "discrete locking elements" within the Court's construction.
29. Dr. Ng further opines that the PE-5000 and PE-12000 seals satisfy the dependent claim limitations of Claims 3, 7, and 12 based on his analysis of material composition, geometric measurements, and a characterization of the elastomeric bias in the seal as a "spring-loaded detent." See Ng Report ¶¶ 98–142.
30. For the reasons set forth below, Dr. Ng's infringement analysis is technically incorrect, misapplies the Court's claim constructions, and should be rejected.
IV.C. Rebuttal — Claim 1 (Independent Claim)
31. Claim 1 of the '237 Patent reads in relevant part:
"A minimally invasive surgical access device comprising: a cannula defining a longitudinal axis; a housing coupled to a proximal end of the cannula; and a locking seal assembly disposed within the housing, the locking seal assembly comprising: a biased locking member having a first locking element and a second locking element that positively engage to maintain a gas-tight seal during insertion and withdrawal of a surgical instrument through the cannula . . ."
32. Under the Court's construction, the "locking seal assembly" must comprise a "biased locking member with discrete locking elements that positively engage to hold the seal in a sealed position." I address the key structural elements below.
The PE-5000's Seal Mechanism
33. The PE-5000 Series utilizes a fundamentally different seal architecture than that claimed in the '237 Patent. The PE-5000's seal mechanism consists of a friction-fit elastomeric gasket—specifically, a single-piece overmolded thermoplastic elastomer (TPE) gasket—that is held in position within the trocar housing by a press-fit retention ring. See SBD-012447 through SBD-012463 (PE-5000 design specifications); SBD-017821 (PE-5000 seal component drawing, Rev. C).
34. The PE-5000's sealing function is achieved entirely through the compressive force of the elastomeric gasket against the instrument shaft. When a surgical instrument is inserted through the seal, the elastomeric material deforms radially and creates a friction seal against the instrument surface. When the instrument is withdrawn, the elastomeric material returns to its resting state. There is no positive-locking engagement between discrete locking elements. There are no separate structural components that engage with one another to create a locked sealed position.
35. Dr. Ng identifies the retention ring as the "biased locking member" of the PE-5000's seal. Ng Report ¶ 62. This characterization is technically incorrect. The retention ring in the PE-5000 is a static structural component whose sole function is to prevent axial displacement of the seal gasket within the housing during assembly and use. It does not move, it does not engage with any other locking element, and it does not contribute to the gas-tight sealing function. The retention ring is analogous to a retaining clip that holds a component in place; it is not a "biased locking member" in any sense recognized in mechanical engineering or consistent with the Court's construction.
36. Critically, the retention ring does not "positively engage" with any corresponding locking element on the seal gasket. The interface between the retention ring and the gasket is a simple press-fit relationship—the ring is pressed into the housing bore and contacts the gasket through static friction, not through any interlocking geometry. There are no complementary structural features (such as grooves, detents, tabs, or interlocking profiles) between the retention ring and the gasket. This is precisely the type of non-locking seal architecture that the Court's construction excludes by requiring "discrete locking elements that positively engage."
37. Solstice's internal design documents confirm this distinction. In a design review memorandum dated March 15, 2019, Solstice engineer Andrea Kwon described the PE-5000 seal as a "simple friction-seal design" and noted that it was selected over a positive-locking configuration specifically because of its lower manufacturing cost and simpler assembly process. See SBD-014232 at 3. The same memorandum includes a comparison table distinguishing friction-seal and locking-seal architectures, noting that "locking-seal designs require complementary engagement features (e.g., snap-fit geometry, detent mechanisms, or interlocking profiles) that add manufacturing complexity." Id. at 4. The PE-5000 was intentionally designed to avoid this complexity.
The PE-12000's Seal Mechanism
38. The PE-12000 Series employs a more complex seal architecture than the PE-5000, but it likewise does not meet the "locking seal assembly" limitation of Claim 1. The PE-12000's seal assembly consists of three components: (i) a dual-durometer elastomeric gasket, (ii) a spring washer, and (iii) a retention ring. See SBD-022150 through SBD-022187 (PE-12000 design specifications); SBD-025610 (PE-12000 seal assembly drawing, Rev. D).
39. Dr. Ng contends that the PE-12000's spring washer functions as the "biased locking member" required by the Court's construction. Ng Report ¶ 79. While the spring washer does provide a biasing force (in the sense that it exerts an axial load on the seal gasket), it does not engage with discrete locking elements that "positively engage to hold the seal in a sealed position." The spring washer exerts a compressive force on the gasket, causing the gasket to maintain contact with the instrument shaft through friction. This is a compression seal, not a locking seal.
40. The '237 Patent specification makes clear that the "biased locking member" operates through positive mechanical engagement—not mere compressive loading. The specification describes the locking member as having "interlocking engagement surfaces" that "snap into a locked configuration" when the seal is in its sealed position. '237 Patent, Col. 3, lines 14–28. The specification further describes the locking elements as including "complementary detent features that resist disengagement." Id., Col. 3, lines 29–35. None of these features are present in the PE-12000's seal.
41. Dr. Ng's analysis conflates the retention ring (which prevents disassembly of the seal from the housing) with the claimed "locking seal" (which maintains a gas-tight seal during instrument insertion and withdrawal). The retention ring keeps the seal components in the housing; it does not create or maintain the gas-tight seal itself. The gas-tight seal is created by the compressive deformation of the elastomeric gasket against the instrument shaft—a purely frictional mechanism that requires no locking engagement.
42. For these reasons, neither the PE-5000 nor the PE-12000 satisfies the "locking seal assembly" limitation of Claim 1. Because Claim 1 is the independent claim from which Claims 3, 7, and 12 depend, the failure to meet this limitation is dispositive as to all asserted claims of the '237 Patent. Nevertheless, I address the dependent claims below to demonstrate that the accused products also fail to satisfy the additional limitations introduced by those claims.
IV.D. Rebuttal — Claim 3 (Dependent Claim)
43. Claim 3 of the '237 Patent depends from Claim 1 and adds the following limitation:
"The device of claim 1, wherein the biased locking member comprises a medical-grade silicone body having a Shore A durometer hardness of between approximately 40 and 60."
44. Dr. Ng asserts that the elastomeric gaskets in the PE-5000 and PE-12000 satisfy this limitation because they are made of medical-grade elastomeric materials with Shore A hardness values within the claimed range. Ng Report ¶¶ 99–107. Dr. Ng acknowledges that the PE-5000 and PE-12000 gaskets are made of thermoplastic elastomer (TPE), not silicone, but contends that TPE is a "functional equivalent" of silicone for the purposes of this claim limitation. Id. ¶ 104.
45. Dr. Ng's assertion is unsupported for two independent reasons. First, as discussed in Section IV.C above, neither the PE-5000 gasket nor the PE-12000 gasket constitutes a "biased locking member" within the Court's construction. Claim 3's material limitation applies to the "biased locking member," not to any generic seal component. Because neither accused product contains a biased locking member, the material composition of the gasket is irrelevant to the infringement analysis.
46. Second, even if the gasket were properly characterized as a biased locking member, the claim specifically requires "medical-grade silicone"—not any elastomeric material with similar mechanical properties. Silicone and TPE are chemically and structurally distinct classes of materials. Silicone is a thermoset polymer based on a siloxane backbone; TPE is a thermoplastic material composed of alternating hard and soft segments, typically based on a polyurethane, polyester, or styrenic copolymer chemistry. The two materials differ significantly in their chemical composition, manufacturing processes, biocompatibility profiles, sterilization compatibility, and mechanical behavior over time and under repeated loading. The claim language is specific: it requires "silicone," not an elastomer with similar hardness. Dr. Ng's assertion of "functional equivalence" is an argument that belongs, if anywhere, in a doctrine of equivalents analysis—not in a literal infringement analysis.
47. Dr. Ng's functional equivalence argument is further undermined by the prosecution history. During prosecution of the '237 Patent, the examiner rejected an earlier version of Claim 3 that recited "an elastomeric body" without specifying a material. In response, Dr. Szabo amended the claim to specify "medical-grade silicone" and argued that the silicone material distinguished the claimed invention from prior art that used TPE or other thermoplastic elastomers. See Exhibit F (prosecution history excerpts), specifically the December 12, 2016 Amendment and Response at 7–8. Having narrowed the claim to silicone to overcome the prior art, Apex cannot now argue that TPE satisfies this limitation.
IV.E. Rebuttal — Claim 7 (Dependent Claim)
48. Claim 7 of the '237 Patent depends from Claim 1 and adds the following geometric limitation:
"The device of claim 1, wherein the first locking element defines a concave engagement surface having a radius of curvature of between approximately 0.5 mm and 2.0 mm, and the second locking element defines a complementary convex engagement surface."
49. Dr. Ng asserts that the PE-5000 and PE-12000 seal components contain geometric features that fall within this claimed range. Ng Report ¶¶ 115–126. He bases this assertion on cross-sectional microscopy images of cut seal components and dimensional measurements taken from those images.
50. Dr. Ng's measurement methodology is flawed in several material respects. First, Dr. Ng took measurements from a single cross-sectional cut through each seal component. A single cross-section cannot accurately characterize a three-dimensional engagement surface, particularly one that may vary around the circumference of the seal. Standard practice in dimensional analysis of elastomeric components requires multiple cross-sections at regular angular intervals (typically at least eight radial cross-sections at 45-degree intervals) to capture the full geometry. Dr. Ng's reliance on a single cross-section is selective and unreliable.
51. Second, Dr. Ng's measurements were taken from components that had been subjected to destructive testing—specifically, components that had been cut with a razor blade to expose the cross-section. The cutting process itself can deform the elastomeric material, introducing measurement artifacts. Dr. Ng does not address this potential source of error, nor does he describe any steps taken to mitigate or account for cutting-induced deformation.
52. Third, and most fundamentally, the geometric limitation of Claim 7 applies to the "first locking element" and "second locking element" of the "biased locking member." As discussed in Section IV.C, neither the PE-5000 nor the PE-12000 contains discrete locking elements. The surfaces that Dr. Ng identifies as "engagement surfaces" are the contact surfaces between the gasket and the instrument shaft or between the gasket and the housing bore. These are not "locking element" engagement surfaces; they are the natural contact interfaces of a compressive friction seal. Dr. Ng's geometric analysis is directed at the wrong structural features.
53. My own independent dimensional analysis, conducted using non-destructive micro-CT scanning of intact PE-5000 and PE-12000 seal components, confirms that the accused products' seal surfaces do not define the complementary concave-convex engagement geometry required by Claim 7. The PE-5000's gasket presents a substantially flat contact surface, and the PE-12000's gasket presents a tapered conical surface—neither of which includes the concave-convex engagement profile claimed. These results are documented in Exhibit E.
IV.F. Rebuttal — Claim 12 (Dependent Claim)
54. Claim 12 of the '237 Patent depends from Claim 1 and adds the following limitation:
"The device of claim 1, further comprising a spring-loaded detent that selectively locks the biased locking member in the sealed position."
55. The Court construed "spring-loaded detent" to mean "a detent mechanism that employs a discrete spring element to provide a biasing force that holds the detent in an engaged position." This construction requires a discrete, identifiable spring element—a structural component whose primary function is to provide biasing force through elastic deformation.
56. Neither the PE-5000 nor the PE-12000 employs a spring-loaded detent. The PE-5000's seal assembly contains no spring element of any kind. The PE-12000's seal assembly includes a spring washer that provides axial compression on the gasket, but this spring washer does not function as a "detent" in any recognized engineering sense. A detent is a latch or pawl mechanism that holds a component in one of two or more defined positions; the PE-12000's spring washer simply provides a continuous compressive force without any defined engaged or disengaged positions.
57. Dr. Ng characterizes the elastomeric bias of the PE-5000 and PE-12000 gaskets as a "spring-loaded detent." Ng Report ¶¶ 133–140. Specifically, he argues that because the elastomeric gasket material has inherent elastic recovery properties, it functions as a "spring" that "detents" the seal in its closed position. Id. ¶ 136. This characterization is technically incorrect and inconsistent with the Court's construction.
58. The Court's construction requires a "discrete spring element"—a separate, identifiable structural component. The inherent elasticity of a rubber gasket is not a "discrete spring element"; it is a material property of the gasket itself. Under Dr. Ng's logic, every elastomeric seal in existence would satisfy the "spring-loaded detent" limitation, because every elastomeric material has some degree of elastic recovery. This interpretation would render the Claim 12 limitation meaningless, as it would add nothing to the scope of Claim 1. The canon of claim differentiation requires that dependent claims be construed to add meaningful limitations beyond those of the independent claim. Dr. Ng's interpretation violates this principle.
59. Moreover, the '237 Patent specification expressly distinguishes the "spring-loaded detent" from the elastomeric biasing force of the seal material. The specification describes the spring-loaded detent as "a separate mechanical detent comprising a helical compression spring and a ball or pin element that engages a corresponding recess in the locking member." '237 Patent, Col. 6, lines 12–19. The specification illustrates this feature in Figure 7, which depicts a distinct spring-and-ball detent mechanism adjacent to, but separate from, the elastomeric seal body. The PE-5000 and PE-12000 contain no such mechanism.
IV.G. Prosecution History Estoppel for the '237 Patent
60. In addition to the literal non-infringement analysis above, Apex is estopped from asserting infringement of the '237 Patent under the doctrine of equivalents with respect to the "biased locking member" limitation.
61. During prosecution of the '237 Patent, the examiner issued a rejection of the original claims under 35 U.S.C. § 102(a)(1) based on U.S. Patent No. 7,462,175 to Marczyk et al. ("Marczyk"), which disclosed a trocar seal assembly using a friction-fit elastomeric gasket without discrete locking elements. In response, on August 18, 2016, Dr. Szabo (through patent counsel) amended Claim 1 to add the "biased locking member having a first locking element and a second locking element that positively engage" limitation. In the remarks accompanying the amendment, patent counsel argued:
"Claim 1, as amended, distinguishes the claimed invention from Marczyk by requiring a biased locking member with discrete locking elements that positively engage to maintain a gas-tight seal. Marczyk discloses a friction-seal gasket that relies solely on compressive deformation to create a seal. Marczyk does not disclose or suggest a biased locking member with positively engaging locking elements as now required by amended Claim 1."
See Exhibit F at 14–15 (prosecution history excerpts).
62. This narrowing amendment was made for the purpose of overcoming a prior art rejection, and the subject matter surrendered—i.e., seal assemblies that rely on friction-fit elastomeric gaskets without discrete, positively engaging locking elements—encompasses precisely the seal architecture used in the PE-5000 and PE-12000 Series. Under the Supreme Court's decision in Festo Corp. v. Fenmore & Co., 535 U.S. 722 (2002), and the Federal Circuit's subsequent decisions, this narrowing amendment creates a presumption that Apex surrendered the territory between the original claim scope and the amended claim scope.
63. Apex cannot rebut this presumption. The surrendered subject matter—friction-fit seals without biased locking members—is precisely the territory into which Dr. Ng's equivalents theory attempts to extend the claims. The PE-5000's friction-fit elastomeric gasket and the PE-12000's compression seal are the very types of structures that Apex distinguished during prosecution. Dr. Ng's doctrine of equivalents analysis for the '237 Patent therefore impermissibly recaptures subject matter surrendered during prosecution and should be rejected.
V. REBUTTAL: THE '884 PATENT — "RETRACTABLE BLADE DEPLOYMENT MECHANISM FOR TROCAR SYSTEMS"
V.A. Accused Products: PE-5000, PE-12000, and PE-15000 Series
64. Dr. Ng accuses all three PrecisionEdge™ product lines—the PE-5000 Series, the PE-12000 Series, and the PE-15000 Series—of infringing Claims 1, 2, 5, 9, and 14 of the '884 Patent. Ng Report ¶¶ 148–267. The '884 Patent is the broadest of the three asserted patents in terms of the number of accused products and asserted claims.
V.B. Dr. Ng's Infringement Theory for the '884 Patent
65. Dr. Ng contends that the PrecisionEdge™ blade-deployment system in each of the three accused product lines meets every limitation of the asserted claims because each product uses a spring-actuated retractable blade housed within the trocar obturator. Ng Report ¶ 150. According to Dr. Ng, the blade in each product is deployed by an actuation trigger on the handle and retracts automatically when the trigger is released, and this mechanism constitutes a "retractable blade deployment mechanism" within the Court's construction. Id. ¶¶ 152–158.
66. Dr. Ng relies heavily on physical testing he conducted on exemplar units of each product line. He disassembled and tested two units of each model (six units total) to measure blade deployment force, retraction speed, deployment angle, and blade housing dimensions. Id. ¶¶ 159–167. As I discuss in Section V.C below, his testing methodology is flawed in several respects.
67. Dr. Ng's central error is his assertion that the PrecisionEdge™ products employ a "cam-driven linkage" connecting the blade to the actuation trigger. As I explain below, this assertion is factually incorrect. The PrecisionEdge™ products use a direct spring-return mechanism, not a cam-driven linkage.
V.C. Rebuttal — Claim 1 (Independent Claim)
68. Claim 1 of the '884 Patent reads in relevant part:
"A trocar system comprising: an obturator including a distal tip portion; a retractable blade deployment mechanism housed within the obturator, the retractable blade deployment mechanism comprising a cam-driven linkage connecting a blade carrier to an actuation trigger, wherein actuation of the trigger drives the blade carrier distally through the cam-driven linkage to deploy the blade from a retracted position to a deployed position, and release of the trigger causes the cam-driven linkage to return the blade carrier to the retracted position . . ."
69. The Court construed "retractable blade deployment mechanism" to require "a mechanism that deploys and retracts a blade through a cam-driven linkage connecting the blade carrier to the actuation trigger." The critical structural limitation is the cam-driven linkage.
The PrecisionEdge™ Blade Deployment System
70. All three PrecisionEdge™ product lines—the PE-5000, PE-12000, and PE-15000—employ a direct spring-return mechanism for blade deployment and retraction. The mechanism operates as follows:
(a) A coil compression spring biases the blade carrier in the retracted position. In the resting state, the blade is fully retracted within the obturator housing.
(b) When the user depresses the actuation trigger on the handle, the trigger acts through a direct mechanical linkage (a rigid push rod) to push the blade carrier distally, compressing the coil spring and deploying the blade from the obturator tip.
(c) When the user releases the actuation trigger, the compressed coil spring expands and drives the blade carrier proximally, returning the blade to the retracted position.
71. This mechanism is a direct-acting spring-return system. The actuation trigger is connected to the blade carrier through a rigid push rod—not through a cam-driven linkage. The blade carrier moves in a purely linear path along the longitudinal axis of the obturator. There is no rotary-to-linear motion conversion, no cam surface, and no cam follower. The motion is direct and linear throughout the deployment and retraction cycle.
72. The '884 Patent specification describes a fundamentally different mechanism. The patented blade deployment mechanism uses a cam—specifically, a profiled cam surface on a rotary actuator—that engages a cam follower on the blade carrier. When the actuation trigger is squeezed, it rotates the cam, and the profiled cam surface drives the cam follower (and thus the blade carrier) distally. When the trigger is released, the cam surface returns the blade carrier to the retracted position. The cam profile controls the force-displacement relationship and the deployment trajectory throughout the actuation cycle. See '884 Patent, Col. 3, line 45 through Col. 4, line 31; Figs. 2A–2D.
73. The difference between a cam-driven linkage and a direct spring-return mechanism is fundamental and well understood in mechanical engineering. A cam-driven linkage converts one type of motion (typically rotary) into another (typically linear), and the motion profile of the output is determined by the geometry of the cam surface. A direct spring-return mechanism, by contrast, uses a stored elastic energy source (the spring) to return the moving component to its resting position; the deployment is accomplished by direct mechanical input, and the retraction force profile is determined by the spring constant and compression distance. The two mechanisms differ in structure, operating principle, force profile, and kinematic behavior.
Dr. Ng's "Cam" Characterization
74. Dr. Ng attempts to characterize the PrecisionEdge™ products' blade deployment mechanism as cam-driven by identifying a ramped guide surface inside the obturator housing as a "cam." Ng Report ¶¶ 168–178, Fig. 11. Specifically, Dr. Ng points to a short inclined ramp on the interior of the obturator housing that guides the blade carrier during the final approximately 2 mm of its distal travel, directing the blade tip at a slight angle (approximately 3–5 degrees from the longitudinal axis) as it emerges from the obturator tip. Id. ¶ 172.
75. This ramped guide surface is not a cam. It is a simple linear inclined plane—a flat surface angled at a fixed inclination. It does not have a profiled or contoured surface; it does not convert one type of motion into another; and it does not control the force-displacement relationship of the blade carrier throughout its travel. It serves the limited function of directing the blade tip at a slight angle as it exits the obturator, and it engages the blade carrier only during the final portion of its stroke.
76. The distinction between a cam and an inclined plane is elementary in mechanical engineering. A cam is defined as a rotating or sliding piece in a mechanical linkage that imparts a prescribed motion to another piece (the follower) through the profile of its surface. The motion profile of the follower is determined by the cam's geometric contour. An inclined plane, by contrast, is a flat surface set at an angle, which redirects a linear force along a different linear path. The PrecisionEdge™ ramp is an inclined plane, not a cam, and Dr. Ng's characterization of it as a cam is technically incorrect.
77. The Court's construction of "cam-driven linkage" reinforces this distinction. The Court specifically construed "cam surface" to mean "a surface profile that converts rotary or linear input motion into a different output motion through a contoured or profiled surface," distinguishing it from a simple inclined plane or ramp. Under this construction, the PrecisionEdge™ ramp does not qualify as a cam surface.
Dr. Szabo's Deposition Testimony
78. Notably, Dr. Szabo himself—the named inventor of the '884 Patent and Apex's Vice President of Engineering—testified at his Rule 30(b)(6) deposition that cam-driven blade deployment mechanisms are structurally distinct from spring-return mechanisms. When asked to describe the '884 Patent's invention, Dr. Szabo testified:
"Q: Can you describe the blade deployment mechanism claimed in the '884 Patent?
A: Yes. The '884 Patent claims a cam-driven blade deployment mechanism. The cam converts the squeezing motion of the trigger into the linear deployment of the blade. The cam profile is specifically designed to control the force and speed of the blade throughout its deployment and retraction stroke.
Q: How does this differ from a spring-return mechanism?
A: In a spring-return system, the blade is pushed out by direct mechanical action and then pulled back by a spring. There's no cam. The retraction force is determined by the spring, not by a cam profile. It's a simpler mechanism. We considered spring-return designs early on but chose the cam-driven approach because it gave us better control over the force profile."
See Exhibit G (Szabo Dep. Tr. 87:14–88:9).
79. Dr. Szabo's testimony confirms that cam-driven mechanisms and spring-return mechanisms are recognized as distinct categories in the trocar industry, and that the patented invention specifically uses a cam-driven mechanism rather than a spring-return mechanism. The PrecisionEdge™ products fall squarely within the spring-return category that Dr. Szabo described as being different from the claimed invention.
80. For these reasons, the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 do not meet the "retractable blade deployment mechanism" and "cam-driven linkage" limitations of Claim 1 of the '884 Patent. Because Claim 1 is the independent claim from which all other asserted claims depend, this failure is dispositive. I nevertheless address the dependent claims below.
V.D. Rebuttal — Claim 2 (Dependent Claim)
81. Claim 2 of the '884 Patent depends from Claim 1 and adds the following limitation:
"The trocar system of claim 1, further comprising a secondary safety lock that prevents inadvertent deployment of the blade when the actuation trigger is not intentionally actuated."
82. Dr. Ng asserts that the PE-5000 includes a "secondary safety lock" in the form of a friction detent on the actuation trigger that provides resistance to unintentional trigger actuation. Ng Report ¶¶ 190–198.
83. The PE-5000 does not have a secondary safety lock. The PE-5000 relies on a single-stage spring mechanism: the coil compression spring that biases the blade in the retracted position also provides the resistance that the user feels when depressing the actuation trigger. There is no separate, secondary mechanism that independently prevents blade deployment.
84. Dr. Ng identifies a slight interference fit between the trigger and the handle housing as a "friction detent" and characterizes this as a "secondary safety lock." Ng Report ¶ 194. This characterization is inconsistent with the '884 Patent specification, which describes the "secondary safety lock" as "a manually engageable locking mechanism, separate from the primary actuation mechanism, that must be affirmatively disengaged by the user before the actuation trigger can be depressed." '884 Patent, Col. 4, lines 32–48. The specification illustrates the secondary safety lock in Figure 5 as a sliding lock switch on the handle that physically blocks trigger travel when in the locked position.
85. The PE-5000's interference fit between the trigger and housing is an incidental manufacturing characteristic—a result of the molding tolerances of the plastic housing components—not a deliberately designed safety locking mechanism. It provides no discrete locked or unlocked state, it is not manually engageable or disengageable, and it does not physically prevent trigger actuation. At most, it increases the initial trigger pull force by a negligible amount (approximately 0.2–0.3 N based on my testing). This is not a "secondary safety lock" by any reasonable engineering definition.
V.E. Rebuttal — Claim 5 (Dependent Claim)
86. Claim 5 of the '884 Patent depends from Claim 1 and specifies:
"The trocar system of claim 1, wherein the blade deploys at an angle of between approximately 10 degrees and 25 degrees relative to the longitudinal axis of the obturator."
87. Dr. Ng asserts that the PE-12000's blade deploys at an angle of approximately 12 degrees, which falls within the claimed range. Ng Report ¶¶ 204–212. He bases this measurement on static measurement of the blade angle when the blade is in its fully deployed position with the trigger fully depressed.
88. Dr. Ng's measurement methodology is flawed. He measured the blade angle in a static, fully-deployed state by photographing the deployed blade and measuring the angle from the photograph. This approach does not capture the dynamic deployment angle—i.e., the angle at which the blade actually travels during deployment. The claim specifies the angle at which "the blade deploys," which refers to the deployment trajectory, not the static resting angle.
89. The PE-12000's blade deployment trajectory is substantially linear along the longitudinal axis. The small angular deflection at the tip (caused by the inclined ramp discussed in Section V.C above) occurs only during the final approximately 2 mm of the blade's travel and produces a deflection of approximately 3–5 degrees from the longitudinal axis—well below the claimed 10–25 degree range. When measured dynamically during actual deployment, the effective deployment angle of the PE-12000's blade is approximately 3–5 degrees, not 12 degrees.
90. Dr. Ng's static measurement of 12 degrees reflects the angle of the blade tip relative to the obturator axis when the blade is in its fully extended position, which is a function of the blade geometry (the blade itself is angled) rather than the deployment trajectory. This is a critical distinction: the claim limitation refers to the angle of deployment, not the angle of the blade body. The '884 Patent specification confirms this interpretation, describing the deployment angle as "the angle of the blade carrier's travel path relative to the longitudinal axis during deployment" ('884 Patent, Col. 5, lines 18–22), not the static angle of the extended blade.
91. My own dynamic measurement of blade deployment angle, conducted using high-speed video capture (1,000 frames per second) of blade deployment on five PE-12000 exemplar units, yielded a mean deployment angle of 4.2 degrees ± 0.8 degrees (standard deviation). These results are documented in Exhibit E. The PE-12000's blade deployment angle does not fall within the claimed range of 10 to 25 degrees.
V.F. Rebuttal — Claim 9 (Dependent Claim)
92. Claim 9 of the '884 Patent depends from Claim 1 and requires:
"The trocar system of claim 1, wherein the blade carrier is housed within a blade housing having a substantially cylindrical outer surface with a maximum outer diameter of no more than 90% of the inner diameter of the cannula through which the obturator is inserted."
93. Dr. Ng asserts that the PE-15000's blade housing satisfies this limitation. Ng Report ¶¶ 220–231. He reports a blade housing outer diameter of 12.8 mm and a cannula inner diameter of 15.0 mm, yielding a ratio of approximately 85.3%, which would fall within the claimed 90% maximum. Id. ¶ 227.
94. Dr. Ng's measurements are inaccurate and incomplete. The PE-15000's blade housing does not have a "substantially cylindrical outer surface" as required by the claim. The PE-15000's housing has an oblong or elongated cross-section with a major axis dimension of approximately 14.1 mm and a minor axis dimension of approximately 12.6 mm. See SBD-031488 (PE-15000 blade housing drawing, Rev. B). The housing's non-cylindrical geometry is a deliberate design choice that accommodates the wider blade used in the 15 mm trocar configuration.
95. Dr. Ng measured only the minor axis dimension (12.6 mm, which he rounded to 12.8 mm) and reported this as the "maximum outer diameter." This measurement is misleading. The correct measure of the housing's maximum outer dimension is the major axis length of 14.1 mm, which yields a ratio of 94% relative to the 15.0 mm cannula inner diameter—exceeding the claimed 90% maximum. Moreover, because the PE-15000's housing is not "substantially cylindrical," it does not satisfy the "substantially cylindrical outer surface" limitation in the first instance.
96. My own dimensional measurements of the PE-15000 blade housing, taken using digital calipers and confirmed by micro-CT scanning, are documented in Exhibit E and confirm the oblong cross-section with dimensions of 14.1 mm × 12.6 mm.
V.G. Rebuttal — Claim 14 (Dependent Claim)
97. Claim 14 of the '884 Patent depends from Claim 1 and adds:
"The trocar system of claim 1, further comprising a force-limiting mechanism that limits the maximum deployment force applied by the blade to a predetermined threshold."
98. Dr. Ng asserts that the PrecisionEdge™ products include a "force-limiting mechanism" based on his force measurements of blade deployment on exemplar units. Ng Report ¶¶ 237–250. He reports that the blade deployment force plateaus at a maximum value during the deployment stroke, and he characterizes this plateau as evidence of a "force-limiting mechanism." Id. ¶ 243.
99. The PrecisionEdge™ products do not include a force-limiting mechanism. The apparent force plateau that Dr. Ng observed is a natural consequence of the spring mechanics of the system—as the blade carrier approaches the end of its travel and the spring reaches its compressed length, the rate of force increase decreases. This is a physical property of a coil spring operating near its solid length, not a deliberately designed force-limiting mechanism.
100. The '884 Patent specification describes the "force-limiting mechanism" as a distinct structural feature: "a slip clutch or breakaway coupling interposed between the cam-driven linkage and the blade carrier that limits the maximum force transmittable to the blade, thereby preventing excessive penetration force." '884 Patent, Col. 7, lines 4–12. The specification illustrates this feature in Figure 8 as a separate mechanical component with a defined breakaway torque. The PrecisionEdge™ products contain no such component.
101. Furthermore, Dr. Ng's own force measurements are internally inconsistent. He reports maximum deployment forces of 8.7 N and 9.2 N for two PE-12000 exemplar units (Ng Report, Table 3), but his testing protocol specifies that measurements should be taken at a controlled displacement rate of 5 mm/s, while his data plots (Ng Report, Fig. 13) show variable displacement rates ranging from approximately 2 mm/s to 12 mm/s during the measurement cycle. This variability introduces significant error into the force measurements and renders them unreliable.
V.H. Doctrine of Equivalents — '884 Patent
102. Dr. Ng asserts that even if the PrecisionEdge™ products do not literally infringe the asserted claims of the '884 Patent, they infringe under the doctrine of equivalents. Ng Report ¶¶ 251–265. He applies the function-way-result test and argues that the PrecisionEdge™ spring-return mechanism performs substantially the same function, in substantially the same way, to achieve substantially the same result as the claimed cam-driven linkage.
Function-Way-Result Analysis.
103. I disagree with Dr. Ng's doctrine of equivalents analysis. While it is true that both the patented cam-driven mechanism and the PrecisionEdge™ spring-return mechanism perform the general function of deploying and retracting a blade in a trocar, the "way" and "result" prongs of the test are not satisfied.
104. Way: The cam-driven linkage achieves blade deployment through a fundamentally different mechanical means than the spring-return mechanism. The cam-driven linkage converts the

CONFIDENTIAL — ATTORNEY WORK PRODUCT / ATTORNEY-CLIENT PRIVILEGED DRAFT FOR COUNSEL REVIEW ONLY

I. INTRODUCTION AND QUALIFICATIONS

II. SUMMARY OF REBUTTAL OPINIONS

III. THE COURT'S CLAIM CONSTRUCTION ORDER AND ITS SIGNIFICANCE

Record

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