Contract analysis

I. INTRODUCTION AND QUALIFICATIONS

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 Agreemen

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 repo

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,

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.

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 rep

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 awarde

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 S

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 o

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.

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, includin

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-

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 f

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

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 i

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

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 pr

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)

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 Cou

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 constr

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 withd

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

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-0

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 e

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 do

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, ta

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 compa

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 dra

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 f

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

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 g

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 addit

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 t