UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
APEX SURGICAL INNOVATIONS, INC.,
Plaintiff,
v.
SOLSTICE BIOMEDICAL, INC.,
Defendant.
Case No. 1:24-cv-00587-RGA
EXPERT REPORT OF DR. MIRIAM OSTROWSKI REGARDING INVALIDITY OF U.S. PATENT NOS. 9,814,237; 10,271,884; AND 10,932,105
DRAFT — ATTORNEY WORK PRODUCT / PRIVILEGED
January 20, 2025
Prepared for: Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, DE 19801
NOTICE: This is an internal working draft prepared for review by counsel prior to finalization. The final version is scheduled for service on January 27, 2025. Comments and tracked-change placeholders are included for counsel's feedback. This draft is protected by attorney-client privilege and the work product doctrine. This document should not be produced, disclosed, or served upon any party or third party without the express authorization of Calderwood & Harkness LLP.
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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. ("Apex"):
(a) U.S. Patent No. 9,814,237 (the "'237 Patent"), entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," issued November 14, 2017;
(b) U.S. Patent No. 10,271,884 (the "'884 Patent"), entitled "Retractable Blade Deployment Mechanism for Trocar Systems," issued April 30, 2019; and
(c) U.S. Patent No. 10,932,105 (the "'105 Patent"), entitled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar," issued March 2, 2021.
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 Meridian Surgical Systems, Inc., where I was directly involved in the design, prototyping, and regulatory submission of laparoscopic surgical instruments, including trocar assemblies.
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. I also hold a Bachelor of Science in Biomedical Engineering from Carnegie Mellon University, which I received in 1989.
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 the National Institutes of Health, the National Science Foundation, and industry sponsors.
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 topics directly relevant to the technologies at issue in this case, including seal retention mechanisms, blade safety features, insufflation valve design, and the integration of multiple functional elements in trocar assemblies.
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 this Report.
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 Patent): Claims 1, 2, 5, 9, and 14. Title: "Retractable Blade Deployment Mechanism for Trocar Systems." Issued: April 30, 2019. Expiration Date: September 15, 2036.
(c) U.S. Patent No. 10,932,105 ('105 Patent): Claims 1, 4, and 8. Title: "Integrated Insufflation Valve and Seal for Laparoscopic Trocar." Issued: March 2, 2021. Expiration Date: January 10, 2038.
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.
II. MATERIALS CONSIDERED
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 the three Asserted Patents.
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 family members for statements and amendments that bear on the interpretation and validity of the asserted claims.
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 specific claim amendments and arguments made by Dr. Szabo and Apex's prosecution counsel during examination that narrowed the scope of the asserted claims in response to prior art rejections by the USPTO examiner. These narrowing amendments and arguments are relevant both to claim construction and to the invalidity analysis presented herein.
B. Court Filings and Litigation Materials
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's Claim Construction Order (Markman Order), dated December 6, 2024, in which the Court construed nine disputed claim terms across the three Asserted Patents. Of the nine disputed terms, the Court adopted constructions favorable to Solstice for five terms and constructions favorable to Apex for four terms. The Court's constructions are incorporated into my analysis as set forth in Sections VI, VII, and VIII below;
(d) The Joint Claim Construction Brief, filed November 4, 2024, setting forth the parties' respective proposed constructions and supporting arguments for each disputed term;
(e) Solstice's individual Claim Construction Brief, dated October 28, 2024, which I reviewed for the detailed prosecution history arguments supporting Solstice's proposed constructions.
C. Discovery Productions
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 involving the Asserted Patents, and technical documents relating to the development of the patented trocar technologies.
(b) Solstice's Document Production: Bates Nos. SBD-000001 through SBD-048217, consisting of 48,217 documents produced on September 30, 2024. This production included technical specifications, design histories, and engineering records for Solstice's PrecisionEdge™ product line.
(c) Deposition Transcripts: I reviewed all deposition transcripts available as of the date of this draft. I understand that additional depositions, including expert depositions, may be taken after the date of this Report, and I reserve the right to supplement my opinions based on testimony provided in those depositions.
(d) Third-Party Subpoena Production: Documents obtained via third-party subpoena issued to Veridian Medical Technologies, Inc. on September 12, 2024. The Veridian production included internal technical publications, patent applications, and engineering records relating to trocar seal designs that constitute relevant prior art, as discussed in Section V below.
D. Prior Art References
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 one or more of the Asserted Patents.
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 laparoscopic trocar design, including the FDA's Guidance for Industry and FDA Staff on "Laparoscopic Trocar/Veress Needle (Class II Special Controls Guidance)" and relevant 510(k) clearance summaries;
(d) Such other materials as are identified in the complete list of all materials considered, attached as Appendix C.
25. [DRAFT NOTE TO COUNSEL: Please confirm whether any additional depositions taken after January 13, 2025 (expert discovery opening) should be added to the materials list before finalization. In particular, please advise whether the deposition of Dr. Szabo (tentatively scheduled for January 22, 2025) will be completed before the service date.]
III. LEGAL STANDARDS
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 patent. My analysis of the applicable prior art categories for each patent takes into account the differences between the pre-AIA and post-AIA provisions.
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 "objective indicia," including commercial success, long-felt but unresolved need, failure of others, and copying.
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 known problem ("obvious to try"). I have applied both the Graham framework and the KSR standard in my obviousness analysis.
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 sense of the person of ordinary skill.
C. Person of Ordinary Skill in the Art (POSITA)
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, development, testing, or evaluation of minimally invasive surgical devices, and in particular, laparoscopic access instruments including trocar assemblies; and
(c) Familiarity with the relevant technologies, including seal mechanisms (e.g., instrument seals, zero-closure seals, flapper valves, and silicone duckbill seals), blade deployment and retraction systems (e.g., spring-loaded retraction, shield mechanisms), insufflation valve designs, and the applicable regulatory environment for FDA Class II medical devices, including 510(k) clearance requirements.
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 invalidity contentions served September 18, 2024. If there are any differences, please identify them so that the definition can be harmonized before finalization.]
IV. TECHNOLOGY BACKGROUND
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 devices are inserted to perform surgical tasks within the peritoneal cavity.
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 instruments can be passed.
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 instrument seal (which accommodates instruments of varying diameters) and a zero-closure seal (which maintains the seal when no instrument is present).
(b) Insufflation Valve: A valve mechanism that allows gas (typically carbon dioxide) to be introduced into the abdominal cavity to establish and maintain pneumoperitoneum — the pressurized gas environment necessary for visualization and working space during laparoscopic procedures. The insufflation valve may be integrated into the cannula or the seal housing.
(c) Blade or Cutting Mechanism: Many trocars include a blade or sharp tip on the obturator to facilitate penetration through tissue layers. Safety trocars include mechanisms that retract or shield the blade after the obturator has passed through the abdominal wall, reducing the risk of injury to internal organs (visceral injury).
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 compatible with the ergonomic demands of laparoscopic surgical procedures.
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, or iris-type seals.
(b) Zero-Closure Seals: Seals that maintain a gas-tight closure when no instrument is inserted through the trocar port. These are typically self-closing seals, such as flapper valves or silicone membranes, that open to admit an instrument and close automatically when the instrument is withdrawn.
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 pneumoperitoneum. This problem was well known and had been addressed by numerous prior art designs employing locking mechanisms to retain the seal assembly within the trocar housing.
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 in the state of the art.
C. Retractable Blade Deployment Mechanisms
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 the tissue layers.
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 ceases upon entry into the peritoneal cavity.
(b) Shield Mechanisms: Rather than retracting the blade itself, some designs employ a protective shield or sleeve that advances over the blade tip after penetration, preventing the exposed blade from contacting internal organs.
(c) Optical Trocars: Some trocar designs eliminate the cutting blade entirely, using a clear, blunt-tipped obturator through which the surgeon can visualize tissue layers as the trocar is advanced. While these designs represent a different approach, they illustrate the art's recognition of the importance of blade safety.
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 specific engineering challenges associated with blade deployment and retraction — including control of deployment force, retraction speed, actuation reliability, and blade geometry — had been the subject of extensive prior art disclosure.
D. Integrated Insufflation Valves
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 more compact trocar design. Multiple prior art references disclosed approaches to achieving this integration, as discussed in Section V below.
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 varying sizes — were understood by persons of ordinary skill in the art.
V. PRIOR ART REFERENCES
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 Appendices D, E, and F.
A. Patent Prior Art References
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 within the cannula housing by means of a rotatable locking ring with bayonet-style engagement features. The Harmon patent qualifies as prior art to the '237 Patent under 35 U.S.C. § 102 because it was issued more than twelve years before the earliest priority date of the '237 Patent. The Harmon reference is also relevant to the obviousness analysis of the '884 Patent claims.
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 resistance ceases. The Petrov patent describes a safety interlock mechanism that prevents blade deployment unless the obturator is properly seated within the cannula. The Petrov patent qualifies as prior art to the '884 Patent under 35 U.S.C. § 102 because it was issued more than nine years before the earliest priority date of the '884 Patent.
58. Reference 3 — U.S. Published Patent Application No. 2012/0143197 to Chen ("Chen"): U.S. Published Patent Application No. 2012/0143197, entitled "Combined Insufflation Valve and Seal Module for Laparoscopic Access Systems," was published on June 7, 2012 and lists Wei-Lin Chen as the inventor. The Chen application discloses a trocar housing containing a single integrated module that incorporates both an insufflation valve and an instrument seal. The Chen application describes the module as including a gas inlet port with a one-way valve, a conformable silicone instrument seal, and a retention mechanism for securing the module within the trocar cannula. The Chen application qualifies as prior art to the '105 Patent under 35 U.S.C. § 102 because it was published more than five years before the earliest priority date of the '105 Patent.
59. Reference 4 — European Patent No. EP 1,847,231 to Dalmqvist ("Dalmqvist"): European Patent No. EP 1,847,231, entitled "Trocar Assembly with Combined Seal Locking and Blade Retraction Features," was published on October 24, 2007 and lists Anders K. Dalmqvist as the inventor. The Dalmqvist patent discloses a trocar assembly incorporating both a locking seal mechanism and a blade retraction system within a unified housing. The Dalmqvist reference describes a snap-fit seal retention feature and a spring-biased blade retraction mechanism, and discusses the advantages of integrating multiple safety and functional features within a single trocar assembly. The Dalmqvist patent qualifies as prior art to the '237, '884, and '105 Patents under the applicable provisions of 35 U.S.C. § 102.
60. Reference 5 — U.S. Patent No. 8,323,297 to Nakamura ("Nakamura"): U.S. Patent No. 8,323,297, entitled "Insufflation Valve Design for Minimally Invasive Surgical Instruments," issued to Takeshi Nakamura on December 4, 2012. The Nakamura patent discloses an insufflation valve for use in laparoscopic instruments, including a valve body with a self-sealing elastomeric element, a gas inlet passage with controlled flow characteristics, and a quick-connect fitting for coupling to an insufflation line. The Nakamura patent qualifies as prior art to the '105 Patent under 35 U.S.C. § 102 and is also relevant to the obviousness analysis of certain '884 Patent claims.
61. Reference 6 — Veridian Internal Publication/Patent Application ("Veridian Reference"): This reference was obtained through the production of documents from Veridian Medical Technologies, Inc. pursuant to third-party subpoena. The Veridian Reference consists of an internal technical publication and associated patent application filing relating to a trocar seal design incorporating an improved retention feature and a combined valve-seal arrangement. The Veridian Reference pre-dates the earliest priority date of the Asserted Patents and constitutes prior art under the applicable provisions of 35 U.S.C. § 102. The specific relevance of this reference is discussed in the detailed claim charts attached as appendices.
B. Non-Patent Prior Art References
62. Reference 7 — Hoffman et al., "Elastomeric Seal Materials for Laparoscopic Trocar Applications: A Comparative Study," *Journal of Biomedical Materials Research*, Vol. 48, No. 3, pp. 312–325 (2010) ("Hoffman Article"): This peer-reviewed journal article presents a comparative study of elastomeric seal materials for use in laparoscopic trocar instruments. The article evaluates the performance of various silicone, thermoplastic elastomer, and fluoroelastomer seal materials in terms of gas-tight sealing, instrument compatibility, and durability. The Hoffman Article was published prior to the earliest priority date of the Asserted Patents and qualifies as prior art under 35 U.S.C. § 102.
63. Reference 8 — "Trocar Technology Review: Commercial Systems and Design Trends," *Medical Device & Diagnostic Industry (MD+DI)*, August 2013, pp. 42–58 ("MD+DI Trade Publication"): This trade publication article provides a comprehensive review of commercially available trocar systems as of mid-2013, including detailed descriptions and comparisons of blade deployment mechanisms, seal configurations, insufflation valve designs, and locking features. The article includes photographs, cross-sectional diagrams, and performance data for trocar products from major manufacturers. The MD+DI Trade Publication was published prior to the earliest priority date of the Asserted Patents and qualifies as prior art under 35 U.S.C. § 102.
64. Reference 9 — FDA 510(k) Clearance Summaries ("FDA 510(k) Summaries"): I reviewed a set of FDA 510(k) clearance summaries for laparoscopic trocar products that incorporate design features relevant to the asserted claims. These summaries, which are publicly available through the FDA's 510(k) Premarket Notification database, describe the design, intended use, and substantial equivalence determinations for trocar products that were cleared for marketing prior to the priority dates of the Asserted Patents. Relevant clearance summaries include those for products incorporating locking seal assemblies, retractable blade mechanisms, and integrated valve-seal modules.
65. Reference 10 — Park and Johansson, "Integrated Valve-Seal Designs for Next-Generation Laparoscopic Access Devices," *Proceedings of the 2011 ASME International Mechanical Engineering Congress and Exposition*, Paper No. IMECE2011-63481 ("Park Conference Paper"): This conference proceedings paper, presented at the 2011 ASME IMECE conference, describes an integrated valve-seal design for laparoscopic trocar instruments. The paper presents a prototype integrated module that combines insufflation valve functionality with instrument sealing capability in a single, compact assembly. The Park Conference Paper was published prior to the earliest priority date of the '105 Patent and qualifies as prior art under 35 U.S.C. § 102.
C. Prior Art Chart Summary Table
66. The following table provides a summary mapping of each prior art reference to the specific asserted claims it addresses and the invalidity theory (anticipation or obviousness) for which it is relied upon. Full, element-by-element claim charts are attached as Appendix D (for the '237 Patent), Appendix E (for the '884 Patent), and Appendix F (for the '105 Patent).
VI. INVALIDITY ANALYSIS — U.S. PATENT NO. 9,814,237 (THE '237 PATENT)
A. Overview of the '237 Patent
67. The '237 Patent, titled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," was issued on November 14, 2017, and expires on June 22, 2035. The sole named inventor is Dr. Raymond Szabo, and the patent is assigned to Apex Surgical Innovations, Inc.
68. The '237 Patent generally discloses and claims a seal assembly for use in a trocar or other minimally invasive surgical access device. The disclosed seal assembly includes a seal housing, one or more seal elements configured to provide a gas-tight seal around instruments of varying diameters, and a locking feature that secures the seal assembly within the trocar cannula housing to prevent inadvertent dislodgement during instrument insertion and withdrawal. The patent describes the locking feature as including a rotatable locking ring or collar with engagement tabs that mate with corresponding recesses or grooves in the cannula housing. When the locking ring is rotated to a locked position, the engagement tabs prevent axial displacement of the seal assembly relative to the cannula.
69. Apex has asserted Claims 1, 3, 7, and 12 of the '237 Patent in this litigation. Claim 1 is an independent claim; Claims 3, 7, and 12 are dependent claims that depend directly or indirectly from Claim 1.
B. Claim-by-Claim Construction (Per the Court's December 6, 2024 Order)
70. In the Court's Claim Construction Order dated December 6, 2024, the Court construed several terms that appear in the asserted claims of the '237 Patent. The following sets forth the asserted claims and the relevant claim constructions adopted by the Court.
71. Claim 1 of the '237 Patent recites:
A locking seal assembly for a minimally invasive surgical access device, comprising:
a seal housing configured for insertion into a cannula housing of a trocar;
a seal element disposed within the seal housing and configured to form a gas-tight seal around a surgical instrument extending through the seal housing;
a locking mechanism coupled to the seal housing, the locking mechanism including at least one engagement feature configured to engage a corresponding retention feature on the cannula housing to resist axial displacement of the seal assembly relative to the cannula housing;
wherein the locking mechanism is movable between a locked position in which the at least one engagement feature engages the corresponding retention feature and an unlocked position in which the seal assembly is removable from the cannula housing.
72. The Court construed the term "locking seal assembly" to mean "a seal assembly that includes a mechanism for securing the seal assembly within the cannula housing to prevent inadvertent removal during use." This construction was favorable to Solstice in that it requires a specific mechanism for securing rather than merely a friction-fit or interference-fit retention. The Court construed the term "engagement feature" to mean "a structural element, such as a tab, projection, or detent, that physically contacts and engages a complementary structure." The Court construed "axial displacement" to mean "movement along the longitudinal axis of the cannula." These constructions are consistent with the prior art disclosures in the Harmon and Dalmqvist references.
73. Claim 3 depends from Claim 1 and further requires that "the locking mechanism comprises a rotatable locking ring disposed about the seal housing, the locking ring including the at least one engagement feature."
74. Claim 7 depends from Claim 1 and further requires that "the seal element comprises a first seal configured to seal around instruments of a first diameter range and a second seal configured to seal around instruments of a second, smaller diameter range."
75. Claim 12 depends from Claim 7 and further requires that "the first seal and the second seal are each formed of a medical-grade silicone elastomer and are axially spaced within the seal housing."
76. With respect to the dependent claim terms, the Court did not construe any additional disputed terms in Claims 3, 7, or 12 beyond the constructions applied to Claim 1. The parties agreed that the terms appearing in Claims 3, 7, and 12 carry their plain and ordinary meaning.
77. I note that the Court's construction of "locking seal assembly" was favorable to Solstice's invalidity position. The Court rejected Apex's narrower proposed construction, which would have required the locking mechanism to include a "positive-engagement locking feature that requires deliberate manual actuation to transition between locked and unlocked positions." The Court's broader construction encompasses the types of locking mechanisms disclosed in the Harmon and Dalmqvist prior art references.
C. Anticipation Analysis — Claim 1
78. It is my opinion that Claim 1 of the '237 Patent is anticipated by the Harmon reference (U.S. Patent No. 6,428,513). Each element of Claim 1 is expressly disclosed in the Harmon reference. The following is a summary of the element-by-element mapping; the full detailed claim chart is provided in Appendix D.
79. Preamble — "A locking seal assembly for a minimally invasive surgical access device": The Harmon reference discloses a locking seal mechanism for a laparoscopic access device (i.e., a trocar). Harmon, Abstract; Col. 1, ll. 15–30. Laparoscopic access devices are minimally invasive surgical access devices within the meaning of the claim preamble.
80. Element 1a — "a seal housing configured for insertion into a cannula housing of a trocar": Harmon discloses a seal housing (referred to as "seal cartridge 20" in Harmon) that is configured for insertion into the proximal end of a cannula housing. Harmon, Col. 3, ll. 42–58; Fig. 2. The seal cartridge 20 has an outer profile dimensioned to fit within the interior of the cannula housing and includes alignment features to guide insertion. Harmon, Col. 4, ll. 5–18.
81. Element 1b — "a seal element disposed within the seal housing and configured to form a gas-tight seal around a surgical instrument extending through the seal housing": Harmon discloses that the seal cartridge 20 contains an instrument seal element (referred to as "elastomeric seal 24" in Harmon) that is disposed within the seal cartridge and is configured to form a gas-tight seal around surgical instruments of varying diameters inserted through the trocar port. Harmon, Col. 4, ll. 19–35; Fig. 3. Harmon describes the elastomeric seal as being formed of silicone rubber and having a self-sealing slit configuration that accommodates instruments from 5 mm to 12 mm in diameter. Harmon, Col. 4, ll. 36–48.
82. Element 1c — "a locking mechanism coupled to the seal housing, the locking mechanism including at least one engagement feature configured to engage a corresponding retention feature on the cannula housing to resist axial displacement of the seal assembly relative to the cannula housing": Harmon discloses a locking mechanism in the form of a rotatable locking ring (referred to as "retention collar 30" in Harmon) that is coupled to the seal cartridge 20. Harmon, Col. 5, ll. 1–22; Figs. 4A–4B. The retention collar 30 includes a plurality of engagement tabs (referred to as "bayonet tabs 32" in Harmon) that are configured to engage corresponding retention grooves (referred to as "locking slots 34" in Harmon) formed in the inner wall of the cannula housing. Harmon, Col. 5, ll. 23–45; Fig. 5. When the bayonet tabs 32 are engaged within the locking slots 34, the seal cartridge is prevented from axial displacement (i.e., movement along the longitudinal axis of the cannula) relative to the cannula housing. Harmon, Col. 5, ll. 46–60.
83. Element 1d — "wherein the locking mechanism is movable between a locked position in which the at least one engagement feature engages the corresponding retention feature and an unlocked position in which the seal assembly is removable from the cannula housing": Harmon discloses that the retention collar 30 is rotatable between a locked position, in which the bayonet tabs 32 are engaged within the locking slots 34, and an unlocked position, in which the bayonet tabs 32 are aligned with entry slots in the cannula housing, permitting the seal cartridge 20 to be removed from the cannula housing. Harmon, Col. 6, ll. 1–20; Figs. 6A–6B. This disclosure directly corresponds to the claimed locked and unlocked positions.
84. Accordingly, the Harmon reference expressly discloses each and every element of Claim 1 of the '237 Patent, arranged as recited in the claim. The Harmon reference anticipates Claim 1 under 35 U.S.C. § 102.
D. Anticipation Analysis — Claims 3, 7, 12
85. Claim 3 — Anticipated by Harmon: Claim 3 depends from Claim 1 and further requires that the locking mechanism comprises a rotatable locking ring disposed about the seal housing, the locking ring including the at least one engagement feature. As discussed in paragraph 82 above, Harmon discloses a rotatable locking ring (retention collar 30) disposed about the seal cartridge (seal housing), with the locking ring including the bayonet tabs (engagement features). Harmon, Col. 5, ll. 1–45; Figs. 4A–4B. Accordingly, the Harmon reference anticipates Claim 3 under 35 U.S.C. § 102.
86. Claim 7 — Not Anticipated by a Single Reference: Claim 7 depends from Claim 1 and further requires that the seal element comprises a first seal configured to seal around instruments of a first diameter range and a second seal configured to seal around instruments of a second, smaller diameter range. While the Harmon reference discloses an elastomeric seal that accommodates instruments of varying diameters, Harmon does not expressly disclose two distinct seal elements configured for two different diameter ranges as required by Claim 7. Accordingly, I do not assert that Claim 7 is anticipated under § 102. However, Claim 7 is rendered obvious under § 103, as discussed in Section VI.E below.
87. Claim 12 — Not Anticipated by a Single Reference: Claim 12 depends from Claim 7 and further requires that the first seal and the second seal are each formed of a medical-grade silicone elastomer and are axially spaced within the seal housing. Because Claim 7 is not anticipated, Claim 12 — which depends from Claim 7 — is likewise not anticipated by a single reference. However, Claim 12 is rendered obvious under § 103, as discussed in Section VI.E below.
E. Obviousness Analysis — Claims 1, 3, 7, 12
88. In addition to the anticipation grounds described above, it is my opinion that each of the asserted claims of the '237 Patent would have been obvious to a person of ordinary skill in the art at the time of filing in view of the Harmon and Dalmqvist references, either alone or in combination. For Claims 1 and 3, the obviousness analysis provides an alternative basis for invalidity in addition to anticipation. For Claims 7 and 12, the obviousness analysis provides the primary basis for invalidity.
Claims 1 and 3
89. As an alternative basis for invalidity, Claims 1 and 3 are rendered obvious by the combination of Harmon and Dalmqvist. As discussed above, Harmon discloses every element of Claims 1 and 3. The Dalmqvist reference independently discloses a trocar assembly with a locking seal mechanism that includes a snap-fit seal retention feature. Dalmqvist, Description, pp. 6–9; Figs. 3–5. A POSITA would have recognized that both Harmon and Dalmqvist address the same technical problem — preventing inadvertent dislodgement of the seal assembly from the trocar housing — and would have found it obvious to apply the teachings of either reference to a trocar design. The combination of Harmon and Dalmqvist yields nothing more than the predictable result of providing a locking seal assembly in a trocar, which is exactly what both references independently teach.
Claim 7.
90. Claim 7 requires a seal element comprising a first seal for instruments of a first diameter range and a second seal for instruments of a second, smaller diameter range. While Harmon discloses a single seal that accommodates instruments of varying diameters, the Dalmqvist reference expressly discloses a trocar seal assembly comprising two separate seal elements arranged within the seal housing — a primary instrument seal for larger-diameter instruments and a secondary seal for smaller-diameter instruments. Dalmqvist, Description, pp. 10–12; Figs. 6–7. Dalmqvist explains that the dual-seal configuration provides improved sealing performance across a wider range of instrument sizes and reduces gas leakage during instrument exchange. Dalmqvist, Description, p. 11, ll. 15–28.
91. A POSITA would have been motivated to combine the locking seal assembly of Harmon with the dual-seal configuration of Dalmqvist. Both references are directed to the same field (laparoscopic trocar seal assemblies) and address the same general design objectives (reliable sealing and seal retention). The use of multiple seal elements to accommodate instruments of different diameters was a well-known design technique in the art, as evidenced by numerous commercially available trocar products that employed dual-seal configurations prior to the '237 Patent priority date. The combination represents the application of a known technique (dual-seal configuration) to a known device (Harmon's locking seal assembly) to yield a predictable result (improved sealing across a wider instrument diameter range). Under the KSR standard, this combination would have been obvious.
Claim 12.
92. Claim 12 depends from Claim 7 and further requires that the first seal and the second seal are each formed of a medical-grade silicone elastomer and are axially spaced within the seal housing. The Dalmqvist reference discloses that its dual-seal elements are formed of silicone elastomer and are arranged in an axially spaced configuration within the seal housing. Dalmqvist, Description, p. 12, ll. 1–10. Additionally, the Hoffman Article (Reference 7) discusses the use of medical-grade silicone elastomers as preferred seal materials for laparoscopic trocar applications due to their biocompatibility, durability, and conformability. Hoffman et al., pp. 315–317.
93. The MD+DI Trade Publication (Reference 8) further confirms that by 2013, multiple commercially available trocar products employed medical-grade silicone seals in axially spaced configurations. MD+DI Trade Publication, pp. 46–49. A POSITA would have found it obvious to specify medical-grade silicone elastomer as the seal material and to arrange the two seals in an axially spaced configuration within the seal housing. The selection of medical-grade silicone was the standard, predictable choice for trocar seal materials, and axial spacing of multiple seals was a routine design arrangement well known in the art.
94. Accordingly, the combination of Harmon, Dalmqvist, and Reference 8 renders Claim 12 obvious under 35 U.S.C. § 103.
Prosecution History Considerations
95. During prosecution of the '237 Patent, the applicant made narrowing amendments to the claims in response to prior art rejections by the USPTO examiner. Specifically, in the office action response filed on March 14, 2017, the applicant amended Claim 1 to add the limitation requiring the locking mechanism to be "movable between a locked position ... and an unlocked position." This amendment was made to distinguish the prior art cited by the examiner, which included references disclosing permanent (non-removable) seal retention features.
96. While this amendment narrowed the scope of Claim 1, it does not overcome the invalidity arguments presented herein. The Harmon reference expressly discloses a locking mechanism that is movable between locked and unlocked positions, as discussed in paragraph 83 above. The narrowing amendment thus does not save Claim 1 from anticipation or obviate the obviousness analysis.
97. I also note that the narrowing amendments made during prosecution are relevant to the scope of prosecution history estoppel that may apply in the infringement analysis. While the scope of estoppel is beyond the focus of this invalidity report, the prosecution history confirms that the claims were narrowed to their present scope specifically in response to prior art — prior art that is itself less relevant than the references I have identified and that was not before the examiner during prosecution.
F. Secondary Considerations (Objective Indicia of Non-Obviousness)
98. I have considered whether any secondary considerations of non-obviousness support the validity of the asserted claims of the '237 Patent. Based on my review of the available evidence, I do not find any secondary considerations that, individually or collectively, would overcome the strong evidence of obviousness presented above.
99. Commercial Success: I am aware that Apex's trocar products incorporating the claimed locking seal assembly have achieved significant commercial sales. However, based on my review of the available evidence, any commercial success enjoyed by Apex's products is attributable to factors other than the patented locking seal assembly features. In particular, Apex's established market position in the surgical instrument market, its extensive distribution network, its brand recognition among surgeons and hospital purchasing departments, and its relationships with group purchasing organizations ("GPOs") are all factors that contribute to commercial success independently of the specific claimed features. Moreover, the commercial success of a product does not establish non-obviousness where, as here, the prior art clearly teaches the claimed features and the combination of those features is straightforward.
100. Long-Felt Need and Failure of Others: I have not identified evidence of a long-felt but unresolved need for the specific claimed combination of features. As discussed in Section IV.B above, locking seal assemblies for trocars were well known in the art before the '237 Patent priority date, and multiple prior art designs successfully addressed the problem of inadvertent seal dislodgement.
101. Skepticism and Copying: I have not identified evidence that persons of ordinary skill expressed skepticism about the feasibility of the claimed invention or that competitors copied the specific claimed features of the '237 Patent. To the contrary, the prior art shows that multiple independent actors arrived at similar solutions to the same design problem.
102. [DRAFT NOTE: Await discovery on commercial success evidence from Apex; need to supplement with rebuttal if Apex raises strong secondary considerations. Specifically, review Apex's interrogatory responses regarding commercial success and any related revenue data produced in the APEX document production.]
VII. INVALIDITY ANALYSIS — U.S. PATENT NO. 10,271,884 (THE '884 PATENT)
A. Overview of the '884 Patent
103. The '884 Patent, titled "Retractable Blade Deployment Mechanism for Trocar Systems," was issued on April 30, 2019, and expires on September 15, 2036. The sole named inventor is Dr. Raymond Szabo, and the patent is assigned to Apex Surgical Innovations, Inc.
104. The '884 Patent generally discloses and claims a mechanism for deploying and retracting a cutting blade in a trocar obturator. The disclosed mechanism includes a blade element mounted within the obturator, a biasing element (described as a compression spring) that urges the blade toward a retracted, protected position, and an actuation mechanism by which the user deploys the blade against the biasing force. The patent further describes a safety interlock feature that prevents blade deployment unless certain predefined conditions are met, such as the obturator being properly seated within the cannula. Upon deployment, the blade extends beyond the distal tip of the obturator for tissue penetration. When tissue resistance ceases (i.e., when the obturator tip enters the peritoneal cavity), the biasing element automatically retracts the blade to the protected position.
105. Apex has asserted Claims 1, 2, 5, 9, and 14 of the '884 Patent in this litigation. Claim 1 is an independent claim; Claims 2, 5, 9, and 14 are dependent claims that depend directly or indirectly from Claim 1.
B. Claim-by-Claim Construction (Per the Court's December 6, 2024 Order)
106. Claim 1 of the '884 Patent recites:
A retractable blade deployment mechanism for a trocar system, comprising:
an obturator body configured for insertion into a cannula of a trocar;
a blade element movably disposed within the obturator body between a deployed position in which a cutting edge of the blade element extends beyond a distal end of the obturator body and a retracted position in which the cutting edge is protected within the obturator body;
a biasing element configured to bias the blade element toward the retracted position;
an actuation mechanism configured to move the blade element from the retracted position to the deployed position against the bias of the biasing element;