PRIVILEGED AND CONFIDENTIAL — ATTORNEY WORK PRODUCT This memorandum is protected by the attorney-client privilege and the work product doctrine. It was prepared in anticipation of litigation and reflects the mental impressions, conclusions, opinions, and legal theories of counsel. It is not to be disclosed to any person or entity outside of the privilege without the express written consent of Calderwood & Harkness LLP and Solstice Biomedical Devices Ltd.
INTERNAL MEMORANDUM
September 18, 2024
TO: Marcus Delgado, Responsible Partner, intellectual Property, Calderwood & Harkness LLP
FROM: Christy Bauer, Lead Associate, and Peter Vassiliev, Working Associate, intellectual Property, Calderwood & Harkness LLP
RE: Invalidity Contentions — Prior Art Analysis Supporting Invalidity of Asserted Claims of U.S. Patent Nos. 9,814,237; 10,271,884; and 10,932,105
MATTER: Solstice Biomedical Devices Ltd. — Defense of Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA (D. Del.)
MATTER NUMBER: 10294.0017
COPIES: Catherine Bloom, Billing Partner, Calderwood & Harkness LLP; Eamon Rourke, General Counsel, Solstice Biomedical Devices Ltd. (via separate privilege-protected transmittal)
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I. Executive Summary
This memorandum consolidates and synthesizes all prior art identified to date by Calderwood & Harkness LLP ("C&H") and Kendrick & Lau LLP ("K&L") (Dr. Jonathan Kendrick, Lead Partner, Patent Prosecution, 601 Pennsylvania Avenue NW, Suite 820, Washington, DC 20004) supporting invalidity contentions under 35 U.S.C. §§ 102 (anticipation) and 103 (obviousness) for each asserted claim of the three Apex Surgical Innovations, Inc. ("Apex") utility patents at issue in this litigation. The memorandum is intended to serve as the foundation for (a) the invalidity contentions to be served on Apex pursuant to the Court's Scheduling Order, (b) the preparation of Dr. Miriam Ostrowski's expert invalidity report, and (c) claim construction positions for the upcoming Markman hearing.
Overview of the Three Asserted Patents
Apex asserts three utility patents in this action, each directed to various aspects of minimally invasive surgical access devices—specifically, laparoscopic trocar systems. The asserted patents are as follows:
U.S. Patent No. 9,814,237 (the "'237 Patent") — Entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," the '237 Patent was issued on November 14, 2017, and expires on June 22, 2035. The '237 Patent is generally directed to a locking seal assembly for a trocar cannula that provides improved sealing during minimally invasive surgical procedures. Apex asserts Claims 1, 3, 7, and 12 of the '237 Patent against Solstice's PrecisionEdge™ PE-5000 and PE-12000 Series trocar products.
U.S. Patent No. 10,271,884 (the "'884 Patent") — Entitled "Retractable Blade Deployment Mechanism for Trocar Systems," the '884 Patent was issued on April 30, 2019, and expires on September 15, 2036. The '884 Patent is generally directed to a retractable blade mechanism for a trocar obturator that incorporates a spring-loaded deployment system with a safety interlock. Apex asserts Claims 1, 2, 5, 9, and 14 of the '884 Patent.
U.S. Patent No. 10,932,105 (the "'105 Patent") — Entitled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar," the '105 Patent was issued on March 2, 2021, and expires on January 10, 2038. The '105 Patent is generally directed to a trocar assembly that integrates an insufflation valve with the sealing member, allowing gas insufflation during laparoscopic surgery without the need for a separate insufflation port. Apex asserts Claims 1, 4, and 8 of the '105 Patent.
All three patents name Dr. Raymond Szabo (Vice President, Engineering, Apex Surgical Innovations, Inc.) as the sole named inventor. All three patents are assigned to Apex Surgical Innovations, Inc., a Delaware corporation (EIN: 51-0483762) with its principal office at 1220 North Market Street, Suite 550, Wilmington, Delaware 19801. The three asserted patents are part of a larger patent family that comprises fourteen (14) total issued U.S. patents and six (6) pending continuation applications, all claiming priority to or through a chain of provisional and non-provisional applications filed between 2015 and 2020.
Summary of Conclusions
Based on our comprehensive analysis, strong prior art bases exist for invalidity of all asserted claims of the '237 and '884 Patents under both § 102 and § 103. Multiple prior art references anticipate or render obvious each asserted claim of these two patents, and the prior art record includes both patented references and commercial products that were available well before the effective filing dates of these patents. The '884 Patent is further vulnerable because key prior art references were cited during prosecution and were distinguished by the applicant through narrowing amendments that may themselves be subject to challenge.
The '105 Patent presents a closer question but remains vulnerable under § 103 based on combinations of identified references. No single reference identified to date clearly anticipates all elements of the independent claims of the '105 Patent under a narrow construction of certain claim terms—particularly "self-sealing instrument passage" and "integrated" as used in Claim 1. However, several two-reference obviousness combinations comprehensively address all claim limitations, and additional evidence expected from the Veridian Medical Technologies, Inc. subpoena may strengthen the invalidity case further.
Coordination with Kendrick & Lau LLP
K&L conducted initial prior art searches and a freedom-to-operate analysis under a separate engagement. Fees incurred by K&L to date total $184,500. K&L's prior art searches identified the majority of the U.S. patent references and non-patent literature references discussed in this memorandum. C&H has supplemented K&L's search with additional references identified during review of Apex's prosecution history files and document production. Apex produced documents bearing Bates numbers APEX-000001 through APEX-031450 on October 7, 2024 (noting that as of the date of this memorandum, that production is forthcoming; review will follow promptly upon receipt). In addition, C&H served a third-party subpoena on Veridian Medical Technologies, Inc. on September 12, 2024, seeking product documentation, design records, and sales data for Veridian's SealPro and BladeGuard trocar products, which constitute potentially significant on-sale and public use prior art.
Use of This Memorandum
This memorandum will inform the following work streams:
1. Invalidity Contentions — The invalidity contentions to be served on Apex pursuant to the Court's Scheduling Order.
2. Expert Invalidity Report — The preparation of Dr. Miriam Ostrowski's expert invalidity report. Dr. Ostrowski is a Professor of Biomedical Engineering at Halford University. Her retention is pending, with the expert agreement anticipated to be executed imminently. Her expert report will be due in connection with the expert discovery deadlines set by the Court.
3. Claim Construction — Proposed claim constructions to be exchanged on October 22, 2024, and argued at the Markman hearing currently scheduled for November 18, 2024.
4. Settlement Valuation — Assessment of the strength of Apex's infringement case for purposes of settlement discussions, as the invalidity of the asserted claims directly affects the expected value of Apex's damages claims.
II. Legal Standards
A. Anticipation Under 35 U.S.C. § 102
The Anticipation Standard
Under 35 U.S.C. § 102, a patent claim is invalid as anticipated if a single prior art reference discloses every element of the claim, arranged as in the claim, either expressly or inherently. Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003). Anticipation is a question of fact. In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009). To anticipate, a single prior art reference must describe each and every claim limitation and enable a person of ordinary skill in the art to practice the claimed invention without undue experimentation. In re Paulsen, 30 F.3d 1475, 1478 (Fed. Cir. 1994).
The Federal Circuit has long held that "[t]hat which would literally infringe if later in time anticipates if earlier." Lewmar Marine, Inc. v. Barient, Inc., 827 F.2d 744, 747 (Fed. Cir. 1987). This principle provides a useful framework for element-by-element comparison: if the prior art reference would infringe the patent claim if it had been made after the patent issued, then the reference anticipates the claim.
Burden of Proof
Because issued patents carry a presumption of validity under 35 U.S.C. § 282, the party challenging validity must establish invalidity by clear and convincing evidence. Kestrel Partners LLC v. i4i Ltd. P'ship, 564 U.S. 91, 95 (2011). This burden applies whether the challenge is based on anticipation, obviousness, or any other ground of invalidity. While the clear and convincing evidence standard is demanding, it is not insurmountable, and the Federal Circuit has regularly affirmed findings of invalidity where the challenger presents a thorough prior art record. Notably, where the prior art at issue was not before the Patent Office during prosecution, the burden is nominally unchanged, but the practical significance of the prior art may be enhanced because the examiner did not have the opportunity to consider it. Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA, Inc., 617 F.3d 1296, 1310 (Fed. Cir. 2010).
Relevant Subsections of § 102
Two subsections of § 102 are primarily relevant to our prior art analysis:
§ 102(a)(1) — A claimed invention is not entitled to a patent if it was "patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention." This subsection encompasses prior patents, published patent applications, non-patent literature (journal articles, conference papers), and products that were publicly available or on sale.
§ 102(a)(2) — A claimed invention is not entitled to a patent if it was "described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention." This subsection captures prior-filed but later-published patent applications as prior art.
Effective Filing Dates
The determination of whether a reference qualifies as prior art depends on the effective filing date of the claimed invention. The effective filing dates for each asserted patent, determined based on the earliest provisional application to which each patent claims priority, are as follows:
Any reference that was published, patented, in public use, or on sale before the applicable effective filing date qualifies as prior art under § 102(a)(1), subject to the grace period exceptions of § 102(b) (which are not applicable here, as none of the identified prior art references are attributable to the named inventor Dr. Szabo or to any party having an obligation of assignment to Apex).
Inherent Disclosure. A prior art reference may anticipate a claim even if it does not expressly disclose every element, provided that the missing element is inherently present in the reference's disclosure. Schering Corp., 339 F.3d at 1377. Inherent disclosure requires that the missing limitation is "necessarily present" in the prior art reference—that is, the reference inevitably results in the claimed element as a natural consequence of the disclosed structure, composition, or method. In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). The inherent disclosure must be certain, not merely probable. Brightmoor & Co., Inc. v. Becton, Dickinson & Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010). Inherent anticipation may be particularly relevant in the context of the '237 Patent's locking seal assembly, where certain functional characteristics (e.g., radial engagement) may be inherent in disclosed mechanical structures.
B. Obviousness Under 35 U.S.C. § 103
The Obviousness Standard
Under 35 U.S.C. § 103, a patent claim is invalid as obvious if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious to a person of ordinary skill in the art at the time of the invention's effective filing date. Obviousness is a question of law based on underlying factual determinations. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
The *KSR* Framework
The Supreme Court's decision in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), established a flexible, expansive approach to the obviousness inquiry. Under KSR, the combination of known elements that yields predictable results is likely to be obvious. Id. at 416. The Court rejected the rigid "teaching, suggestion, or motivation" (TSM) test as the sole basis for an obviousness determination, holding instead that common sense and the knowledge of a person of ordinary skill in the art may provide sufficient reason to combine or modify prior art references. Id. at 421. Relevant considerations under the KSR framework include:
• Whether the claimed invention involves the combination of familiar elements according to known methods to yield predictable results;
• Whether one prior art reference teaches away from the combination or modification;
• Whether a person of ordinary skill in the art would have recognized a reason to combine the teachings of multiple references;
• Whether the claimed invention produces unexpected results beyond what a person of ordinary skill would have predicted.
The KSR framework is particularly applicable here, given that the asserted patents relate to mechanical devices (trocar assemblies) involving the combination and integration of known functional components (seals, blades, valves) using well-understood engineering principles.
The *Graham* Factors
The factual underpinnings of the obviousness analysis are governed by the four-factor framework set forth in Graham v. John Deere Co., 383 U.S. at 17:
1. Scope and content of the prior art. This factor requires identifying the relevant prior art and understanding what it discloses. In the context of trocar technology, the relevant prior art encompasses patents, publications, and commercial products relating to minimally invasive surgical access devices, including seal assemblies, blade deployment mechanisms, and insufflation systems.
2. Differences between the prior art and the claims. This factor requires a detailed, element-by-element comparison between what the prior art teaches and what the patent claims require. Claim charts mapping prior art disclosures to individual claim limitations are the standard method for conducting this analysis and are provided in the appendices to this memorandum.
3. Level of ordinary skill in the art. This factor defines the hypothetical person against whom obviousness is measured. As discussed below, we propose that a person of ordinary skill in the art (POSITA) in this field would be a biomedical engineer or mechanical engineer with at least three to five years of experience in the design or development of minimally invasive surgical instruments, particularly laparoscopic access devices such as trocars.
4. Secondary considerations of non-obviousness. Objective indicia of non-obviousness, including commercial success, long-felt need, failure of others, copying, and industry praise, must also be considered. These secondary considerations are relevant only to the extent there is a nexus between the evidence and the merits of the claimed invention. Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988).
Definition of Person of Ordinary Skill in the Art (POSITA)
For purposes of the obviousness analysis across all three asserted patents, we propose the following definition of a person of ordinary skill in the art:
A POSITA in the relevant field would be a biomedical engineer or mechanical engineer with at least three to five years of experience in the design or development of minimally invasive surgical instruments, particularly laparoscopic access devices including trocars, cannulae, obturators, and associated sealing and insufflation components. Such a person would possess a working knowledge of materials science (including elastomeric and polymeric materials used in surgical seals), mechanical engineering principles (including spring mechanisms, locking assemblies, and valve systems), and the functional requirements and regulatory standards applicable to surgical access devices. A POSITA would also be familiar with the relevant patent and non-patent literature and with commercially available surgical access products.
This definition is consistent with the qualifications typically attributed to design engineers in the field and aligns with the level of skill reflected in the prior art references themselves. We anticipate that Dr. Ostrowski's expert report will adopt a similar or identical definition.
C. Key Prosecution History Considerations
The prosecution history of each asserted patent is relevant to the invalidity analysis in several respects. A detailed analysis of the prosecution history is set forth in the separate Prosecution History Analysis Memorandum dated September 5, 2024, prepared by Peter Vassiliev and Christy Bauer. For purposes of this memorandum, we highlight the following key considerations:
Narrowing Amendments. During prosecution of the '237 and '884 Patents, the applicant (Dr. Szabo, through his prosecution counsel) made narrowing amendments to certain independent claims in response to examiner rejections based on prior art. These narrowing amendments may affect the scope of the claims for purposes of both infringement and invalidity analysis. In particular, to the extent that Apex argues that certain prior art references do not disclose a specific claim limitation that was added through amendment, we must assess whether the narrowing amendment was in fact directed to a feature that distinguishes the prior art, or whether the prior art in fact discloses the narrowed limitation. The prosecution history estoppel implications of these amendments are discussed in greater detail in Section VIII of this memorandum.
Applicant Admitted Prior Art (AAPAs). The specifications of each asserted patent include background sections that describe the prior art known to the inventor. Under Federal Circuit precedent, statements in a patent specification describing the state of the prior art constitute applicant admitted prior art and may be used against the patentee in an invalidity analysis. PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1362 (Fed. Cir. 2007). The background sections of the '237, '884, and '105 Patents each describe known trocar seal assemblies, blade mechanisms, and insufflation systems, respectively, and these admissions may be useful in establishing the scope and content of the prior art.
Examiner-Cited References. During prosecution of each patent, the examiner cited various prior art references in office actions. Some of these references were applied in rejections of claims that were ultimately cancelled or amended, while others were cited but not relied upon in any rejection. References cited by the examiner but not applied to the issued claims are particularly valuable because they are already part of the prosecution record and were known to the Patent Office, yet were not found to render the issued claims unpatentable—a fact that Apex will likely emphasize but that does not foreclose our arguments based on combinations of these references with other prior art.
III. Prior Art Reference Inventory
A. Master List of Identified Prior Art References
The table below provides a summary of all prior art references identified to date. A total of approximately twenty-eight (28) prior art references have been identified across all categories. Each reference is listed with its citation, title, publication or issue date, author(s) or inventor(s), the source through which it was identified, and the asserted patent(s) to which it is applicable. A complete version of this table with full citations and strength assessments is provided in Appendix A.
The remaining approximately sixteen (16) references, including additional U.S. patents, foreign patents, non-patent literature, and commercial products, are catalogued in full in Appendix A. The references listed above represent the key references that form the basis of the primary invalidity contentions detailed in Sections IV through VI.
B. Categories of Prior Art
1. U.S. Patents and Published Applications (Approximately 14 References)
Approximately fourteen U.S. patents and published patent applications have been identified as relevant prior art. These references span the period from 2001 to 2016 and disclose various trocar components, including seal assemblies, blade deployment mechanisms, and insufflation valve systems. The key references in this category, which form the backbone of the anticipation and obviousness contentions, are described below.
U.S. Patent No. 6,245,071 to Harmon ("Harmon '071") — Entitled "Seal Assembly for Trocar Cannula," issued June 12, 2001. Harmon '071 discloses a locking seal mechanism for use in a trocar cannula housing. The seal assembly includes an elastomeric valve arrangement with a locking ring that engages a cannula housing through a radial compression mechanism. Figures 3 through 6 of Harmon '071 illustrate the detailed mechanical structure of the locking mechanism, including a detent-based radial engagement feature shown in Figure 4. Harmon '071 was not cited during prosecution of the '237 Patent and was identified by K&L in its prior art search. This reference is of critical importance to the invalidity case for the '237 Patent.
U.S. Patent No. 7,128,394 to Prasad et al. ("Prasad '394") — Entitled "Trocar Assembly with Retractable Obturator Blade," issued October 31, 2006. Prasad '394 discloses a spring-loaded retractable blade deployment mechanism for a trocar obturator, including a safety mechanism that prevents unintended blade deployment. The spring configuration described in Prasad '394 at column 4, lines 10-35, directly maps to the spring-loaded deployment mechanism recited in the '884 Patent claims. Prasad '394 was cited by the examiner during prosecution of the '884 Patent and was distinguished by the applicant through a narrowing amendment to the independent claims. As discussed in Section V.B.1, the basis for distinguishing Prasad '394 during prosecution is narrow and may not withstand scrutiny in litigation.
U.S. Patent No. 7,563,268 to Fletcher ("Fletcher '268") — Entitled "Laparoscopic Access Device with Integrated Gas Valve," issued July 21, 2009. Fletcher '268 discloses a trocar housing that integrates an insufflation gas valve with the main body of the device, allowing insufflation gas to be delivered through the trocar assembly itself rather than through a separate port. Fletcher '268 describes a seal member that accommodates instrument passage while maintaining a gas-tight seal during insufflation. This reference is central to the invalidity analysis for the '105 Patent, though it may not expressly disclose the "self-sealing instrument passage" limitation under certain claim constructions.
U.S. Patent No. 8,012,149 to Van der Berg et al. ("Van der Berg '149") — Entitled "Multi-Seal Trocar with Locking Mechanism," issued September 6, 2011. Van der Berg '149 discloses a trocar with multiple seal elements and a locking mechanism that includes a specific radial engagement geometry. The radial engagement geometry disclosed in Van der Berg '149 directly maps to the dependent limitation of Claim 7 of the '237 Patent. Van der Berg '149 was cited by the examiner during prosecution of the '237 Patent but was applied only to non-asserted claims. The examiner did not apply Van der Berg '149 to Claims 1 or 7 as issued, leaving this reference as potentially powerful prior art that was before the Patent Office but not fully utilized by the examiner.
U.S. Patent No. 8,444,583 to Kim ("Kim '583") — Entitled "Blade Safety Mechanism for Surgical Trocars," issued May 21, 2013. Kim '583 discloses a safety-retraction mechanism for a trocar blade that includes a trigger-actuated blade retraction system. The safety interlock described in Kim '583 maps to the safety interlock elements recited in Claims 1 and 5 of the '884 Patent. Kim '583 was identified by K&L during its prior art search and was not cited during prosecution of the '884 Patent.
U.S. Published Application No. 2014/0107683 to Dominguez ("Dominguez '683") — Entitled "Trocar Seal with Integrated Valve," published April 17, 2014. Dominguez '683 discloses an insufflation-compatible seal arrangement for a trocar that incorporates an integrated valve within the seal body. The publication date of April 17, 2014, predates the January 10, 2018 effective filing date of the '105 Patent by nearly four years. Dominguez '683 is relevant to the '105 Patent invalidity analysis but may have gaps with respect to the one-way gas flow mechanism limitation.
Additional U.S. patent references identified through K&L's searches and C&H's review of the prosecution history files include approximately eight further patents and published applications that disclose various trocar components, seal designs, and blade mechanisms. These are catalogued in Appendix A and are addressed to the extent relevant in the claim-specific invalidity analyses in Sections IV through VI.
2. Foreign Patents and Published Applications (Approximately 4 References)
Approximately four foreign patents and published applications have been identified as relevant prior art. These include European, Japanese, and WIPO publications disclosing trocar seal assemblies and blade mechanisms that predate the effective filing dates of the asserted patents. The key reference in this category is:
EP 1,892,045 to Bergström — Entitled "Surgical Access Port with Self-Sealing Valve," published February 27, 2008. Bergström describes a surgical access port that includes a self-sealing valve mechanism for maintaining pneumoperitoneum during laparoscopic surgery. The self-sealing valve includes an elastomeric seal member that automatically closes around an instrument or upon instrument withdrawal, maintaining gas pressure within the patient's abdominal cavity. This reference is relevant to the '105 Patent invalidity analysis, particularly in combination with Fletcher '268, as it provides an express disclosure of a "self-sealing" feature that may supply any limitation not expressly disclosed by Fletcher alone.
The remaining three foreign references disclose various trocar components and are catalogued in Appendix A. We recommend supplemental searching in Japanese and German patent databases, as discussed in Section IX.B, to identify additional foreign-language prior art that may strengthen the invalidity case for the '105 Patent.
3. Non-Patent Literature (Approximately 6 References)
Approximately six non-patent literature references have been identified, including journal articles from biomedical engineering and surgical technology journals and conference proceedings from professional societies. The key references are:
Okonkwo et al., "Design Principles for Self-Sealing Trocar Ports," *Journal of Minimally Invasive Surgery*, Vol. 18, No. 3, pp. 245-261 (2012). This article provides a comprehensive review of design principles for self-sealing trocar port assemblies, including discussions of radial engagement concepts, elastomeric seal materials, and locking mechanisms. The article surveys the state of the art as of 2012 and identifies several design approaches that correspond to the limitations of the '237 Patent claims. The Okonkwo article is particularly useful as a secondary reference in obviousness combinations because it demonstrates that the techniques claimed in the '237 Patent were well-known design principles in the field before the 2015 effective filing date.
Tanaka & Reeves, "Spring-Loaded Blade Retraction in Laparoscopic Obturators: A Comparative Study," *Biomedical Engineering Advances*, Vol. 7, No. 2, pp. 112-128 (2014). This article provides a comparative study of spring-loaded blade retraction mechanisms in laparoscopic obturators, including quantitative analysis of spring configurations, retraction speeds, and retraction forces. The article expressly evaluates and compares designs of the type disclosed in Prasad '394, providing a POSITA with direct guidance on the specific spring configurations and retraction parameters that map to Claims 2 and 14 of the '884 Patent. The Tanaka & Reeves article was published in 2014, over two years before the September 15, 2016 effective filing date of the '884 Patent.
Whitcomb, "Integrated Insufflation Systems for Next-Generation Trocars," Proceedings of the 2015 SAGES Annual Meeting, pp. 78-85 (2015). This conference paper discusses the design and development of integrated insufflation systems for next-generation trocar devices. The paper was presented at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), a leading professional society whose meetings are widely attended by engineers and clinicians in the minimally invasive surgical device field. Whitcomb's paper describes one-way gas flow mechanisms and self-sealing instrument passages for insufflation-capable trocars, providing design guidance that directly addresses several limitations of the '105 Patent claims. The paper was published in 2015, nearly three years before the January 10, 2018 effective filing date of the '105 Patent.
The remaining three non-patent literature references include additional journal articles and conference proceedings addressing trocar seal designs, blade mechanisms, and gas management systems. These are catalogued in Appendix A.
4. Products in Public Use or On Sale (Approximately 4 References)
Approximately four competitor trocar products have been identified as potentially qualifying as prior art under § 102(a)(1) based on their public use or sale before the effective filing dates of the asserted patents. These products are significant because they demonstrate that the claimed inventions were not merely theoretical concepts in the patent literature but were reduced to practice in commercially available devices. The key products are:
Veridian "SealPro" Trocar System (launched 2010). The Veridian SealPro trocar system was commercially launched in 2010 and features a locking seal assembly with a radial compression mechanism. Preliminary information about the SealPro was identified through K&L's market research and confirmed through the third-party subpoena to Veridian Medical Technologies, Inc. served on September 12, 2024. The SealPro's seal assembly features are relevant to the '237 and '105 Patent invalidity analyses.
Veridian "BladeGuard" Trocar (launched 2013). The Veridian BladeGuard trocar was commercially launched in 2013 and features a spring-loaded retractable blade with a safety interlock mechanism. The BladeGuard was launched over three years before the September 15, 2016 effective filing date of the '884 Patent. Product documentation for the BladeGuard is being obtained through the Veridian subpoena, and preliminary materials reviewed to date indicate that the BladeGuard may anticipate or render obvious multiple claims of the '884 Patent.
Two additional commercial trocar products from other manufacturers have been identified through K&L's market research and investigation. These are catalogued in Appendix A and are discussed where relevant in the patent-specific analyses below.
IV. Invalidity Analysis — U.S. Patent No. 9,814,237 (the '237 Patent)
A. Patent Overview
Title: "Locking Seal Assembly for Minimally Invasive Surgical Access Device"
Issue Date: November 14, 2017
Effective Filing Date: June 22, 2015 (based on the earliest provisional application, U.S. Provisional Application No. 62/183,216, filed June 22, 2015)
Named Inventor: Dr. Raymond Szabo
Asserted Claims: 1, 3, 7, 12
The '237 Patent is generally directed to a locking seal assembly designed for use in a trocar cannula or similar minimally invasive surgical access device. The patent specification describes a seal assembly that provides an improved seal around surgical instruments passing through a trocar port while also incorporating a locking mechanism that secures the seal in position during use. The specification identifies as a problem in the prior art the tendency of existing trocar seals to shift or become dislodged during surgical procedures, particularly when instruments of varying diameters are inserted and withdrawn. The '237 Patent purports to solve this problem through a radial engagement mechanism that locks the elastomeric seal member into the cannula housing.
Asserted Claim Language
Claim 1 (independent):
A locking seal assembly for a minimally invasive surgical access device, comprising:
(a) a cannula housing defining an axial passage therethrough;
(b) an elastomeric seal member disposed within the cannula housing, the seal member configured to form a seal around a surgical instrument inserted through the axial passage;
(c) a locking ring disposed about the elastomeric seal member; and
(d) a radial engagement mechanism operatively connecting the locking ring to the cannula housing, the radial engagement mechanism configured to selectively secure the elastomeric seal member in a locked position within the cannula housing.
Claim 3 (dependent on Claim 1):
The locking seal assembly of claim 1, wherein the locking ring comprises a rigid annular member formed of a biocompatible thermoplastic material and having a plurality of circumferentially-spaced engagement tabs extending radially outward from an outer surface of the annular member.
Claim 7 (dependent on Claim 1):
The locking seal assembly of claim 1, wherein the radial engagement mechanism comprises a plurality of detent recesses formed in an inner wall of the cannula housing, each detent recess configured to receive a corresponding engagement tab of the locking ring upon radial displacement of the locking ring from an unlocked position to the locked position.
Claim 12 (independent):
A method for securing a seal in a trocar cannula assembly, the method comprising:
(a) inserting an elastomeric seal member into a cannula housing of the trocar cannula assembly;
(b) positioning a locking ring about the elastomeric seal member within the cannula housing; and
(c) engaging a radial engagement mechanism to secure the locking ring and the elastomeric seal member in a locked position within the cannula housing.
B. Anticipation Contentions (§ 102)
1. Harmon '071 Anticipates Claims 1, 3, and 12
U.S. Patent No. 6,245,071 to Harmon ("Harmon '071"), issued June 12, 2001, discloses a "Seal Assembly for Trocar Cannula" that anticipates Claims 1, 3, and 12 of the '237 Patent. Harmon '071 was issued over fourteen years before the June 22, 2015 effective filing date of the '237 Patent and constitutes prior art under § 102(a)(1). Critically, Harmon '071 was not cited during prosecution of the '237 Patent and was not before the Patent Office. It was identified by K&L during its comprehensive prior art search.
The element-by-element mapping of Harmon '071 to Claim 1 is as follows:
Claim 1 Preamble — "A locking seal assembly for a minimally invasive surgical access device": Harmon '071 discloses a seal assembly for a trocar cannula (Abstract; col. 1, ll. 15-25). A trocar cannula is a minimally invasive surgical access device. The preamble is met.
Claim 1, Element (a) — "a cannula housing defining an axial passage therethrough": Harmon '071 discloses a cannula body (element 12 in Figure 1) that defines a central axial lumen through which surgical instruments may be passed (col. 2, ll. 30-42). The cannula body of Harmon '071 corresponds to the "cannula housing" of Claim 1, and its central axial lumen corresponds to the "axial passage."
Claim 1, Element (b) — "an elastomeric seal member disposed within the cannula housing, the seal member configured to form a seal around a surgical instrument inserted through the axial passage": Harmon '071 discloses an elastomeric valve member (element 24 in Figure 2) formed of silicone rubber that is disposed within the cannula body and configured to seal around instruments of varying diameters (col. 3, ll. 5-22). This corresponds to the "elastomeric seal member" of Claim 1.
Claim 1, Element (c) — "a locking ring disposed about the elastomeric seal member": Harmon '071 discloses a retaining ring (element 30 in Figure 3) that is disposed about the elastomeric valve member and serves to secure it within the cannula body (col. 4, ll. 8-20). The retaining ring of Harmon '071 corresponds to the "locking ring" of Claim 1.
Claim 1, Element (d) — "a radial engagement mechanism operatively connecting the locking ring to the cannula housing, the radial engagement mechanism configured to selectively secure the elastomeric seal member in a locked position within the cannula housing": Harmon '071 discloses a detent-based engagement mechanism illustrated in Figure 4 (col. 4, ll. 35-55). The retaining ring includes outwardly-projecting tabs (element 32) that engage corresponding recesses (element 34) in the inner wall of the cannula body. When the retaining ring is rotated, the tabs snap into the recesses, locking the ring and the seal member in position. This detent-based engagement operates radially—the tabs are displaced radially outward into the recesses—and is configured to selectively secure the seal in a locked position. This corresponds to the "radial engagement mechanism" of Claim 1.
Based on this element-by-element analysis, Harmon '071 expressly discloses every limitation of Claim 1 of the '237 Patent. A detailed claim chart for this mapping is provided in Appendix B.
Claim 3 adds the dependent limitation that the locking ring comprises "a rigid annular member formed of a biocompatible thermoplastic material and having a plurality of circumferentially-spaced engagement tabs extending radially outward from an outer surface of the annular member." Harmon '071 discloses that the retaining ring (element 30) is formed of a rigid biocompatible polymer (described as polycarbonate at col. 4, ll. 12-15, which is a thermoplastic material) and includes a plurality of tabs (element 32) that are circumferentially spaced and extend radially outward from the outer surface of the ring (Fig. 3; col. 4, ll. 18-30). Polycarbonate is a well-known biocompatible thermoplastic material used in surgical devices. Accordingly, Harmon '071 also anticipates Claim 3.
Claim 12 is a method claim that recites three steps: (a) inserting an elastomeric seal member into a cannula housing; (b) positioning a locking ring about the seal member within the housing; and (c) engaging a radial engagement mechanism to secure the locking ring and seal member in a locked position. Harmon '071 describes the assembly procedure for its seal assembly at column 6, lines 22-48, which includes each of these three steps in sequence. Specifically, Harmon describes inserting the elastomeric valve member into the cannula body (col. 6, ll. 22-30), placing the retaining ring over the valve member (col. 6, ll. 30-38), and rotating the ring to engage the detent mechanism (col. 6, ll. 38-48). This assembly description maps to each step of Claim 12. Accordingly, Harmon '071 also anticipates Claim 12.
Assessment: The anticipation case based on Harmon '071 is strong for Claims 1, 3, and 12. Every element is expressly disclosed in the reference, and the mapping is straightforward. The fact that Harmon '071 was not before the Patent Office during prosecution enhances its practical significance, as the examiner never had the opportunity to consider whether this reference rendered the claims unpatentable.
2. Van der Berg '149 Anticipates Claims 1 and 7
U.S. Patent No. 8,012,149 to Van der Berg et al. ("Van der Berg '149"), issued September 6, 2011, discloses a "Multi-Seal Trocar with Locking Mechanism" that anticipates Claims 1 and 7 of the '237 Patent. Van der Berg '149 was issued nearly four years before the June 22, 2015 effective filing date of the '237 Patent and constitutes prior art under § 102(a)(1).
The element-by-element mapping of Van der Berg '149 to Claim 1 follows a similar structure to the Harmon '071 mapping above. Van der Berg '149 discloses a trocar housing (element 102) with an axial passage (col. 3, ll. 10-18), multiple elastomeric seal members (elements 110, 112) disposed within the housing (col. 3, ll. 25-40), a locking ring (element 120) disposed about the seal members (col. 4, ll. 5-15), and a radial engagement mechanism (described as a radial snap-fit arrangement at col. 4, ll. 20-35) that secures the locking ring and seals in a locked position. Each element of Claim 1 is expressly disclosed.
Critically, Van der Berg '149 also discloses the specific radial engagement geometry recited in the dependent limitation of Claim 7. Claim 7 requires that the radial engagement mechanism comprise "a plurality of detent recesses formed in an inner wall of the cannula housing, each detent recess configured to receive a corresponding engagement tab of the locking ring upon radial displacement of the locking ring from an unlocked position to the locked position." Van der Berg '149 describes exactly this configuration at column 4, lines 25-40, and illustrates it in Figures 5 and 6. The inner wall of Van der Berg's trocar housing includes multiple circumferentially-spaced detent recesses (element 130), and the locking ring includes corresponding tabs (element 122) that snap radially into the recesses when the ring is displaced from an unlocked to a locked position.
Van der Berg '149 was cited by the examiner during prosecution of the '237 Patent. However, the examiner applied it only to non-asserted claims (specifically, Claims 15 through 18, which relate to a multi-seal configuration). The examiner did not apply Van der Berg '149 to Claims 1 or 7 as issued. This is significant because the reference was before the Patent Office yet was not found to be invalidating of the asserted claims—a fact that Apex will likely emphasize. However, the failure of the examiner to apply Van der Berg '149 to Claims 1 and 7 does not preclude our use of this reference in litigation, and the element-by-element mapping supports anticipation.
Assessment: The anticipation case based on Van der Berg '149 is strong for Claims 1 and 7. The reference was before the examiner, which means Apex will argue that the Patent Office considered and rejected its applicability to the asserted claims. However, the examiner's analysis was directed to different claims and did not address the specific mappings we have identified. We believe the clear and convincing evidence standard can be met for these claims.
C. Obviousness Contentions (§ 103)
1. Harmon '071 in Combination with Van der Berg '149 Renders Claims 1, 3, 7, and 12 Obvious
To the extent that any single element of the asserted claims is not expressly disclosed in Harmon '071 standing alone, the combination of Harmon '071 with Van der Berg '149 renders Claims 1, 3, 7, and 12 obvious. In particular, while Harmon '071 provides strong anticipation of Claims 1, 3, and 12, the Claim 7 dependent limitation regarding specific detent recess geometry may be more fully disclosed in Van der Berg '149. The combination of these two references ensures that all limitations of all four asserted claims of the '237 Patent are addressed.
Motivation to Combine: Both Harmon '071 and Van der Berg '149 are squarely in the same field of art: trocar seal assemblies. Both are directed to the same technical problem—securing a seal within a trocar housing to prevent dislodgement during surgical procedures. A person of ordinary skill in the art would naturally look to both references when designing a locking seal assembly for a trocar and would have been motivated to combine the straightforward locking ring mechanism of Harmon '071 with the specific radial engagement geometry of Van der Berg '149 to achieve improved seal reliability and ease of assembly. Under KSR, this combination of known elements according to known methods to yield predictable results is precisely the type of combination that supports an obviousness finding. 550 U.S. at 416.
Reasonable Expectation of Success: Both Harmon '071 and Van der Berg '149 employ well-understood mechanical principles—snap-fit detent mechanisms, elastomeric compression seals, and rigid locking rings. Combining the locking ring approach of Harmon with the specific detent geometry of Van der Berg would not have required any inventive effort; it would have involved the routine application of known mechanical engineering techniques. A POSITA would have had a reasonable expectation of success in combining these approaches.
A detailed claim chart for this obviousness combination is provided in Appendix C.
2. Harmon '071 in Combination with Okonkwo et al. (2012 NPL)
As an alternative and independent basis for obviousness, the combination of Harmon '071 with the Okonkwo et al. article (2012) renders all limitations of Claims 1, 3, 7, and 12 obvious. The Okonkwo article is a review article that surveys design principles for self-sealing trocar ports, including radial engagement concepts and locking mechanisms. The article describes several approaches to trocar seal design, including detent-based radial engagement geometries that correspond to the limitations of Claims 1 and 7.
Motivation to Combine: The Okonkwo article is a review of known design principles published in the Journal of Minimally Invasive Surgery, a peer-reviewed journal in the relevant field. A person of ordinary skill in the art would have been aware of and would have consulted this article as part of any effort to design or improve a trocar seal assembly. The article provides the kind of general design guidance that a POSITA would use to modify or optimize a design such as that disclosed in Harmon '071. The combination is further motivated by the fact that Okonkwo expressly discusses the advantages of radial engagement mechanisms for trocar seals, providing a POSITA with a clear reason to adopt such mechanisms.
Reasonable Expectation of Success: The design principles described in Okonkwo are well-established and have been successfully implemented in multiple commercial products, as the article itself notes. A POSITA would have had a high degree of confidence that combining Harmon's locking ring with the specific radial engagement geometries described in Okonkwo would produce a functioning, reliable trocar seal assembly.
A detailed claim chart for this obviousness combination is provided in Appendix C.
3. Secondary Considerations Analysis
Apex may attempt to rebut the obviousness case for the '237 Patent by invoking secondary considerations of non-obviousness, including commercial success, long-felt need, failure of others, and industry praise.
Commercial Success. Apex may argue that its trocar products incorporating the patented locking seal assembly have achieved significant commercial success. However, any such argument must establish a nexus between the commercial success and the specific patented features—i.e., the locking seal assembly as claimed. We anticipate several counter-arguments:
(a) The commercial success of Apex's trocar products is attributable to factors other than the patented locking seal feature, including Apex's established brand recognition, its longstanding customer relationships with hospitals and surgical centers, its sales force and distribution network, and its practice of bundling trocar products with insufflation equipment at discounted prices. These factors would have driven sales regardless of the specific seal design.
(b) Apex has not established, and likely cannot establish, the requisite nexus between any commercial success and the claimed invention. The products at issue incorporate numerous features beyond the locking seal assembly, and it is the combination of all features—not the locking seal alone—that drives purchasing decisions.
(c) Even if some degree of commercial success is attributable to the locking seal feature, the prior art demonstrates that locking seal assemblies for trocar cannulae were well-known before the '237 Patent's effective filing date. Commercial success of a product incorporating a known feature does not support non-obviousness. Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 (Fed. Cir. 2011).
Long-Felt Need and Failure of Others. Apex may argue that there was a long-felt need for improved trocar seals and that others had failed to develop an effective locking seal assembly. The prior art record refutes this argument: Harmon '071 (2001), Van der Berg '149 (2011), and the Okonkwo article (2012) each describe effective locking seal mechanisms for trocar cannulae, and the Veridian SealPro trocar system (launched 2010) commercially implemented a locking seal assembly with radial compression. There is no evidence of a long-felt, unmet need, and no evidence of failure of others.
V. Invalidity Analysis — U.S. Patent No. 10,271,884 (the '884 Patent)
A. Patent Overview
Title: "Retractable Blade Deployment Mechanism for Trocar Systems"
Issue Date: April 30, 2019
Effective Filing Date: September 15, 2016 (based on the earliest non-provisional application, U.S. Application No. 15/266,914, filed September 15, 2016)
Named Inventor: Dr. Raymond Szabo
Asserted Claims: 1, 2, 5, 9, 14
The '884 Patent is generally directed to a retractable blade deployment mechanism for use in a trocar obturator. The patent specification describes the problem of blade safety in trocar systems: during laparoscopic surgery, the trocar's obturator blade must be sharp enough to penetrate tissue during initial access but must retract into a safe position after penetration to avoid injuring internal organs. The '884 Patent claims a spring-loaded deployment mechanism combined with a safety interlock that prevents the blade from being inadvertently deployed after initial tissue penetration.
Asserted Claim Language
Claim 1 (independent):
A trocar obturator comprising:
(a) a housing configured for insertion into a trocar cannula for laparoscopic access;
(b) a blade member movably disposed within the housing, the blade member having a sharpened distal tip;
(c) a spring-loaded deployment mechanism operatively connected to the blade member, the deployment mechanism configured to bias the blade member toward a retracted position within the housing; and
(d) a safety interlock mechanism configured to prevent deployment of the blade member from the retracted position unless a predetermined actuation force is applied.
Claim 2 (dependent on Claim 1):
The trocar obturator of claim 1, wherein the spring-loaded deployment mechanism comprises a compression spring having a spring constant in the range of approximately 0.5 N/mm to approximately 3.0 N/mm, the compression spring disposed coaxially about a guide shaft within the housing.
Claim 5 (dependent on Claim 1):
The trocar obturator of claim 1, wherein the safety interlock mechanism comprises a trigger member disposed on an exterior surface of the housing, the trigger member movable between a locked position and an unlocked position, wherein the blade member is prevented from deployment when the trigger member is in the locked position.
Claim 9 (independent):
A trocar assembly comprising:
(a) a cannula defining an axial lumen;
(b) a seal member disposed at a proximal end of the cannula; and
(c) an obturator comprising a housing insertable into the axial lumen, a retractable blade member, a spring-loaded deployment mechanism biasing the blade member toward a retracted position, and a safety interlock mechanism preventing blade deployment unless actuated.
Claim 14 (dependent on Claim 9):
The trocar assembly of claim 9, wherein the spring-loaded deployment mechanism is configured to retract the blade member from a deployed position to the retracted position in less than approximately 50 milliseconds upon release of the actuation force.
B. Anticipation Contentions (§ 102)
1. Prasad '394 Anticipates Claims 1, 2, and 5
U.S. Patent No. 7,128,394 to Prasad et al. ("Prasad '394"), issued October 31, 2006, discloses a "Trocar Assembly with Retractable Obturator Blade" that anticipates Claims 1, 2, and 5 of the '884 Patent. Prasad '394 was issued nearly ten years before the September 15, 2016 effective filing date of the '884 Patent and constitutes prior art under § 102(a)(1).
The element-by-element mapping of Prasad '394 to Claim 1 is as follows:
Claim 1, Element (a) — "a housing configured for insertion into a trocar cannula for laparoscopic access": Prasad '394 discloses an obturator housing (element 202 in Figure 2) that is configured for insertion into a trocar cannula for use in laparoscopic surgical procedures (col. 2, ll. 45-55). This corresponds to the housing element of Claim 1.
Claim 1, Element (b) — "a blade member movably disposed within the housing, the blade member having a sharpened distal tip": Prasad '394 discloses a retractable blade (element 210 in Figure 3) that is movably disposed within the obturator housing and includes a sharpened distal tip for tissue penetration (col. 3, ll. 15-28). This corresponds to the blade member element of Claim 1.
Claim 1, Element (c) — "a spring-loaded deployment mechanism operatively connected to the blade member, the deployment mechanism configured to bias the blade member toward a retracted position within the housing": Prasad '394 discloses a spring-loaded mechanism (element 220 in Figure 4) that biases the blade toward a retracted position within the housing. The spring mechanism is described in detail at column 4, lines 10-35, and includes a compression spring that automatically retracts the blade after tissue penetration. This corresponds to the spring-loaded deployment mechanism of Claim 1.
Claim 1, Element (d) — "a safety interlock mechanism configured to prevent deployment of the blade member from the retracted position unless a predetermined actuation force is applied": Prasad '394 discloses a safety mechanism (element 230 in Figure 5) that prevents the blade from being deployed unless a predetermined actuation force is applied by the surgeon (col. 5, ll. 5-25). The safety mechanism includes a latch that must be released before the blade can be advanced to the deployed position. This corresponds to the safety interlock mechanism of Claim 1.
Claim 2 adds the limitation that the spring-loaded deployment mechanism comprises "a compression spring having a spring constant in the range of approximately 0.5 N/mm to approximately 3.0 N/mm, the compression spring disposed coaxially about a guide shaft within the housing." Prasad '394 discloses a compression spring disposed coaxially about a central guide rod (element 222) within the housing (col. 4, ll. 20-30). The specification of Prasad '394 further states that the spring has a spring constant of "approximately 1.5 to 2.5 N/mm" (col. 4, ll. 28-32), which falls squarely within the range recited in Claim 2. Accordingly, Prasad '394 anticipates Claim 2.
Claim 5 adds the limitation that the safety interlock mechanism comprises "a trigger member disposed on an exterior surface of the housing, the trigger member movable between a locked position and an unlocked position, wherein the blade member is prevented from deployment when the trigger member is in the locked position." Prasad '394 discloses a trigger (element 232 in Figure 5) that is disposed on the exterior surface of the obturator housing and is movable between locked and unlocked positions (col. 5, ll. 10-22). When the trigger is in the locked position, the safety latch prevents blade deployment. This corresponds to the trigger member limitation of Claim 5. Accordingly, Prasad '394 anticipates Claim 5.
Prosecution History Note: Prasad '394 was cited by the examiner during prosecution of the '884 Patent and was applied in a rejection of certain claim versions. In response, the applicant amended the independent claims and argued that Prasad '394 did not disclose a particular feature of the safety interlock mechanism. Specifically, the applicant argued that Prasad's trigger operates by a different mechanical principle than the claimed safety interlock—asserting that Prasad's trigger releases a latch, whereas the claimed safety interlock "prevents deployment" of the blade member, suggesting a distinction between a latch-release mechanism and a deployment-prevention mechanism.
We believe this distinction is illusory. Prasad's latch-release trigger inherently "prevents deployment" when in the locked position because the latch physically blocks blade advancement. The applicant's argument during prosecution amounts to a semantic distinction without a structural difference. However, prosecution history estoppel may limit the scope of this argument to some extent. The impact of the narrowing amendment is discussed in Section VIII. Even if the anticipation argument is weakened by the prosecution history distinction, the reference remains fully available for use in obviousness combinations.
2. Kim '583 Anticipates Claims 1 and 5
U.S. Patent No. 8,444,583 to Kim ("Kim '583"), issued May 21, 2013, discloses a "Blade Safety Mechanism for Surgical Trocars" that anticipates Claims 1 and 5 of the '884 Patent. Kim '583 was issued over three years before the September 15, 2016 effective filing date and constitutes prior art under § 102(a)(1). Importantly, Kim '583 was not cited during prosecution of the '884 Patent and was not before the Patent Office. It was identified by K&L during its prior art search.
Kim '583 discloses a trocar obturator with a retractable blade, a spring mechanism that biases the blade toward retraction, and a trigger-actuated safety interlock that prevents blade deployment unless the trigger is actuated by the surgeon. The trigger mechanism of Kim '583 is described as a "trigger-actuated safety mechanism" (col. 3, ll. 40-58) that operates by physically blocking the blade's advancement path when in the locked position. This mechanism directly maps to the safety interlock limitation of Claim 1 and the trigger member limitation of Claim 5.