Contract analysis

I. INTRODUCTION AND QUALIFICATIONS 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 submit this Expert Report in connection with the above-captioned litigation, Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA, pending before the United States District Court for the District of Delaware.

2. I have been retained by Calderwood & Harkness LLP on behalf of Defendant Solstice Biomedical, Inc. ("Solstice") pursuant to a retention agreement dated August 20, 2024. The purpose of my engagement is to offer expert opinions on the validity of the asserted claims of the following three United States patents (collectively, the "Asserted Patents"), all of which are owned by Plaintiff Apex Surgical Innovations, Inc.

3. Dr. Raymond Szabo, who I understand to be the Vice President of Engineering at Apex, is the sole named inventor on each of the three Asserted Patents. Each patent is assigned to Apex Surgical Innovations, Inc.

4. My compensation for this engagement is at a rate of $750 per hour for all time spent in connection with this matter, including research, analysis, report preparation, deposition, and trial testimony. My compensation is in no way contingent upon the substance of my opinions or the outcome of this case. B. Professional Background and Qualifications

5. I currently hold the position of Professor of Biomedical Engineering at Halford University, a position I have held since 2008. Prior to my appointment at Halford, I served as an Associate Professor at the University of Chesterton from 2002 to 2008, and as an Assistant Professor at the same institution from 1998 to 2002. Before entering academia, I spent four years (1994–1998) as a senior design engineer at Meridia

6. I hold a Ph.D. in Mechanical Engineering with a concentration in biomedical applications from the Massachusetts Institute of Technology, which I received in 1994. My doctoral dissertation, titled "Biomechanical Analysis of Tissue Penetration Forces in Trocar Insertion," involved the study and modeling of trocar blade geometries and their interaction with abdominal wall tissues during laparoscopic access procedures

7. My primary research areas include the design and optimization of minimally invasive surgical instruments, with a particular focus on trocar mechanics, seal technology for laparoscopic access devices, blade deployment and retraction systems, and the integration of functional components within trocar assemblies. I have directed or co-directed over forty funded research projects in these areas, including grants from

8. Over the course of more than twenty-five years of experience in this field, I have published over eighty-five peer-reviewed articles in leading biomedical engineering and surgical device journals, including the Journal of Biomedical Engineering, Minimally Invasive Therapy & Allied Technologies, Surgical Endoscopy, and the Journal of Laparoendoscopic & Advanced Surgical Techniques. My publications have addressed to

9. I am a named inventor on twelve United States patents relating to surgical access devices and instrument design. Several of these patents relate to trocar seal mechanisms and blade deployment features analogous to the subject matter of the Asserted Patents in this litigation.

10. I have been qualified as an expert witness and have provided testimony in federal court on multiple prior occasions in matters involving patent validity and infringement in the medical device field. A complete listing of cases in which I have testified at trial or by deposition within the past four years is provided in my curriculum vitae, which is attached to this Report as Appendix A.

11. My full curriculum vitae, including a complete listing of my publications, patents, prior testimony experience, research grants, professional memberships, and honors, is attached as Appendix A to this Report. C. Summary of Opinions

12. Based on my education, training, research, and professional experience, and based on my review and analysis of the materials identified in Section II below, it is my opinion, stated to a reasonable degree of engineering and scientific certainty, that the asserted claims of the '237 Patent, the '884 Patent, and the '105 Patent are invalid under one or both of 35 U.S.C. §§ 102 and 103.

13. Specifically, it is my opinion that the asserted claims of the three Asserted Patents are anticipated by and/or would have been obvious in light of identified prior art references, either individually or in combination, to a person of ordinary skill in the art at the time of the respective filing dates of the Asserted Patents. The bases for these opinions are set forth in detail in Sections VI, VII, and VIII of t

14. The specific asserted claims at issue in this litigation, as identified in Apex's infringement contentions, and the relevant dates for each Asserted Patent, are as follows: (a) U.S. Patent No. 9,814,237 ('237 Patent): Claims 1, 3, 7, and 12. Title: "Locking Seal Assembly for Minimally Invasive Surgical Access Device." Issued: November 14, 2017. Expiration Date: June 22, 2035. (b) U.S. Patent No. 10,271,884 ('884

15. In total, twelve asserted claims across the three Asserted Patents are the subject of this Report. For each asserted claim, I have identified at least one basis for invalidity under 35 U.S.C. § 102 (anticipation) and/or 35 U.S.C. § 103 (obviousness), as summarized in the invalidity matrix presented in Section X and supported by the detailed claim charts attached as Appendices D, E, and F.

16. In forming my opinions, I have reviewed and considered the materials described in this Section. A complete list of all materials considered is attached as Appendix C to this Report. A. Patent Documents

17. I reviewed the complete file histories (prosecution histories) of U.S. Patent Nos. 9,814,237; 10,271,884; and 10,932,105. These file histories include all office actions issued by the United States Patent and Trademark Office ("USPTO"), all applicant responses, amendments, claim changes, declarations, information disclosure statements, and all other correspondence and filings made during prosecution of each of th

18. I also reviewed all fourteen issued U.S. patents and six pending continuation applications within the Apex Trocar Patent Family, which includes the three Asserted Patents as well as related patents and applications claiming priority to common parent applications. This review allowed me to understand the full scope of Apex's patent portfolio in this technology area and to assess the prosecution history of related

19. In addition, I reviewed an analysis of narrowing amendments made during prosecution of the '237, '884, and '105 Patents. This analysis was prepared collaboratively with Kendrick & Lau LLP, patent prosecution counsel retained in connection with this matter, located at 601 Pennsylvania Avenue NW, Suite 820, Washington, DC 20004 (lead partner: Dr. Jonathan Kendrick). The prosecution history analysis identified speci

20. I reviewed the following court filings and litigation materials in this case: (a) Apex's Complaint, filed May 9, 2024, asserting infringement of the three Asserted Patents by Solstice's PrecisionEdge™ trocar product line; (b) Solstice's Answer, Affirmative Defenses, and Counterclaims, filed June 14, 2024, including Solstice's affirmative defenses of patent invalidity under 35 U.S.C. §§ 102 and 103; (c) The Court'

21. I reviewed relevant documents from the following discovery productions: (a) Apex's Document Production: Bates Nos. APEX-000001 through APEX-031450, consisting of 31,450 documents produced on October 7, 2024. This production included, among other materials, the inventor notebooks of Dr. Raymond Szabo, internal prosecution correspondence between Apex and its patent prosecution counsel, prior licensing agreements in

22. I reviewed all prior art references relied upon in this Report. A full listing of the prior art references is provided in Section V below and in Appendix B to this Report. These references include issued patents, published patent applications, peer-reviewed journal articles, trade publications, product literature, FDA regulatory submissions, and conference proceedings, all of which pre-date the priority dates of

23. I also reviewed prior art search materials generated by Kendrick & Lau LLP, which included search reports, results of patent and non-patent literature searches, and analyses identifying potentially invalidating references. I independently evaluated each reference and exercised my own judgment in determining its relevance and applicability to the asserted claims. E. Other Materials

24. In addition to the foregoing, I reviewed the following materials: (a) Technical specifications, design documents, and CAD files for the Solstice PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series trocar products; (b) Industry standards relevant to laparoscopic trocar design, including applicable ASTM standards for medical device testing and performance requirements; (c) FDA guidance documents relevant to lapar

26. I am not a lawyer, and I do not offer legal opinions. However, I have been informed by counsel of the legal standards applicable to the invalidity analysis I have been asked to perform, and I have applied those standards in forming my opinions. My understanding of those standards is set forth below. A. Anticipation Under 35 U.S.C. § 102

27. I understand that a patent claim is invalid as anticipated under 35 U.S.C. § 102 if a single prior art reference discloses every element of the claim, arranged or combined in the same way as recited in the claim. To anticipate a claim, a prior art reference must disclose, either expressly or inherently, each and every limitation of the claim.

28. I understand that the applicable version of § 102 depends on whether the patent at issue is governed by the pre-AIA (America Invents Act) or post-AIA provisions of 35 U.S.C. § 102. The determination is based on the effective filing date of the claims at issue. For the Asserted Patents in this case, I have analyzed the priority dates and filing dates and have identified the applicable statutory framework for each

29. I further understand that invalidity must be proven by clear and convincing evidence. This is the standard that I have endeavored to meet in the opinions expressed in this Report. B. Obviousness Under 35 U.S.C. § 103

30. I understand that a patent claim is invalid as obvious under 35 U.S.C. § 103 if the claimed invention, as a whole, would have been obvious to a person of ordinary skill in the art at the time of filing (or, for pre-AIA patents, at the time the invention was made) in view of the prior art.

31. I have been advised that the framework for analyzing obviousness is set forth in Graham v. John Deere Co., 383 U.S. 1 (1966), which requires consideration of four factors: (1) The scope and content of the prior art; (2) The differences between the prior art and the claims at issue; (3) The level of ordinary skill in the pertinent art; and (4) Secondary considerations of non-obviousness, also referred to as "objec

32. I further understand that the Supreme Court, in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), clarified that the obviousness inquiry should take into account common sense, the ability of a person of ordinary skill to combine known elements with predictable results, recognized design choices, known problem-solving approaches, and the identification of a finite number of predictable solutions to a kn

33. I also understand that in assessing obviousness, a person of ordinary skill in the art is not an automaton, but rather is presumed to have ordinary creativity and the ability to apply known techniques and principles from the prior art to solve identified design problems. The rationale for combining references need not be found in the references themselves but may be based on the knowledge, creativity, and common

34. For purposes of my analysis, I define a person of ordinary skill in the art ("POSITA") at the time of the inventions claimed in the Asserted Patents as a person who possesses the following qualifications: (a) At least a bachelor's degree in mechanical engineering, biomedical engineering, or a closely related engineering discipline; (b) At least three to five years of professional experience in the design, develop

35. A higher level of education may compensate for less professional experience, and vice versa. For example, a person holding a master's degree or Ph.D. in a relevant discipline with two to three years of relevant work experience would also qualify as a person of ordinary skill.

36. I note that my own qualifications significantly exceed those of a POSITA as defined above. In forming my opinions, I have endeavored to evaluate the prior art and the asserted claims from the perspective of a POSITA, rather than from my own, more advanced perspective. 37. [DRAFT NOTE: Confirm with counsel that this POSITA definition aligns with what was presented at the Markman hearing and in Solstice's invalidit

38. To provide context for my invalidity analysis, I set forth below an overview of the relevant technologies and the state of the art at the time of the Asserted Patents' priority dates. A. Overview of Laparoscopic Surgery and Trocar Systems

39. Laparoscopic surgery, also referred to as minimally invasive surgery, is a widely used surgical technique in which operative procedures are performed through small incisions in the body wall rather than through large, open incisions. In the abdominal context, laparoscopic procedures typically involve the creation of small access ports through the abdominal wall, through which instruments, cameras, and other devic

40. The trocar is a fundamental instrument used in laparoscopic surgery to create and maintain these access ports. A trocar system typically consists of two primary components: an obturator (sometimes called a stylet) and a cannula (sometimes called a sleeve or sheath). The obturator is used to penetrate the abdominal wall, after which it is withdrawn, leaving the cannula in place as a conduit through which other ins

41. Modern trocar systems generally include several additional functional components beyond the basic obturator and cannula. These components include: (a) Seal Assembly: A seal or group of seals positioned at the proximal end of the cannula that maintain a gas-tight seal around instruments inserted through the trocar while allowing instruments to be exchanged during the procedure. Seal assemblies typically include an

42. The functional requirements of a trocar system are well understood in the art. The system must maintain pneumoperitoneum by preventing gas leakage through the trocar port. It must allow the smooth insertion and withdrawal of surgical instruments of various sizes. It must incorporate blade safety mechanisms to minimize the risk of unintended tissue damage during insertion. And it must be reliable, easy to use, and

43. Trocar systems have been the subject of extensive design effort and patent activity since the widespread adoption of laparoscopic surgery in the late 1980s and early 1990s. By the time of the earliest priority date among the Asserted Patents, the fundamental components and design principles of trocar systems were well established in the art. B. Locking Seal Assemblies

44. Seal technology in laparoscopic trocars has undergone significant development over the past three decades. Early trocar seals were simple flapper-valve or trumpet-valve designs that provided only rudimentary sealing capability. As laparoscopic procedures became more complex and the range of instruments used through trocar ports expanded, the demands placed on seal assemblies increased commensurately.

45. Modern trocar seal assemblies typically employ multiple seal elements arranged in series within a seal housing. Common seal types include: (a) Instrument Seals: Conformable seals, often made of silicone elastomer, that stretch to accommodate instruments of varying diameters while maintaining a gas-tight seal around the instrument shaft. These seals may take the form of duckbill seals, flat seals with radial slits

46. A recognized problem in the art prior to the '237 Patent priority date was the inadvertent dislodgement of seal assemblies from the trocar housing during instrument exchange. When a surgeon inserts or withdraws an instrument through the trocar, frictional forces between the instrument and the seal can cause the seal assembly to be pulled out of its housing, breaking the gas-tight seal and disrupting pneumoperiton

47. Various locking mechanisms for retaining seal assemblies had been disclosed in the prior art before the '237 Patent priority date. These mechanisms included snap-fit retaining rings, bayonet-style locking features, threaded retention caps, friction-fit arrangements, and cantilever-latch designs. The general concept of providing a locking mechanism to prevent inadvertent seal dislodgement was thus well established

48. Safety trocars — trocars incorporating mechanisms to protect against inadvertent tissue injury after the obturator penetrates the abdominal wall — have been a major focus of innovation in the trocar field since the early 1990s. The most common approach to blade safety is the use of a retractable blade that is deployed for tissue penetration and automatically retracted or shielded after the blade passes through th

49. Multiple approaches to blade retraction have been developed and disclosed in the prior art: (a) Spring-Loaded Retraction Systems: These systems employ a biasing element, typically a compression spring or torsion spring, that urges the blade toward a retracted position. The blade is extended against the spring force during tissue penetration and automatically retracts when the resistance from tissue penetration ce

50. By the time of the '884 Patent priority date, spring-loaded blade retraction was a well-known and commercially established approach to trocar blade safety. Multiple commercially available trocar systems, including products from Kestrel Partners LLC (a Strathmore Partners LLC), Harborview Corporation (formerly Stonefield Enterprises), and Beaumont Group, employed spring-loaded blade retraction mechanisms. The spec

51. Insufflation valves play a critical role in laparoscopic trocar systems by enabling the introduction and maintenance of pressurized carbon dioxide gas within the abdominal cavity. During a laparoscopic procedure, the insufflation valve allows gas to flow into the peritoneal cavity while preventing backflow and maintaining a consistent intra-abdominal pressure.

52. Traditionally, the insufflation valve and the instrument seal assembly were provided as separate components within the trocar housing. The insufflation valve was typically a stopcock-style valve or a Luer-lock fitting located on the side of the trocar cannula, while the seal assembly was positioned at the proximal end of the cannula.

53. Prior to the '105 Patent priority date, the concept of integrating the insufflation valve and the instrument seal into a single module within the trocar housing was well recognized as a desirable design goal. Integration offered several potential advantages: reduced overall component count, simplified manufacturing and assembly, improved gas-tight performance by reducing the number of potential leak paths, and a

54. The state of the art at the time of the '105 Patent priority date included several commercial trocar products and published references that disclosed or suggested the integration of insufflation and sealing functions within a single module. The design challenges associated with such integration — including material selection for sealing elements, valve actuation mechanisms, and compatibility with instruments of v

55. The following prior art references are relied upon in this Report. Full copies of each reference are included in Appendix B. The references are organized into patent prior art (Section V.A) and non-patent prior art (Section V.B). A summary chart mapping each reference to the specific claims and claim elements it addresses is provided in Section V.C below, and full, element-by-element claim charts are attached as

56. Reference 1 — U.S. Patent No. 6,428,513 to Harmon ("Harmon"): U.S. Patent No. 6,428,513, entitled "Locking Seal Mechanism for Laparoscopic Access Devices," issued to Edward J. Harmon on August 6, 2002. The Harmon patent discloses a seal assembly for a laparoscopic trocar comprising a seal housing, an instrument seal element, a zero-closure seal element, and a locking mechanism that secures the seal assembly withi

57. Reference 2 — U.S. Patent No. 7,195,611 to Petrov ("Petrov"): U.S. Patent No. 7,195,611, entitled "Retractable Blade Trocar with Spring-Loaded Deployment System," issued to Alexei V. Petrov et al. on March 27, 2007. The Petrov patent discloses a trocar obturator having a cutting blade that is deployed by manual actuation against the force of a biasing spring and automatically retracted by the spring when tissue r