Contract analysis

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 Ape

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, 1

§ 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

§ 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-pub

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 a

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 (F

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 identifi

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 ba

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 Bergströ

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, p

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 li

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 P

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 du

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 eleme

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 limitat

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 articl

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

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

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

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 Pa

1. Prasad '394 in Combination with Kim '583 Renders Claims 1, 2, 5, 9, and 14 Obvious The combination of Prasad '394 and Kim '583 renders all five asserted claims of the '884 Patent obvious. Prasad '394 provides the primary disclosure of the retractable blade, spring-loaded deployment mechanism, and safety interlock, while Kim '583 provides the specific trigger-actuated safety interlock mechanism that maps to Claim 5