Contract analysis

I. INTRODUCTION AND PURPOSE 1.1 Background of the Engagement Calderwood & Harkness LLP represents Solstice Biomedical, Inc. ("Solstice U.S."), the United States operating subsidiary of Solstice Biomedical Devices Ltd. ("Solstice Ireland"), an Irish private limited company, CRO No. 648217, in the defense of a patent infringement action filed by Apex Surgical Innovations, Inc. ("Apex") on May 9, 2024. The action, capti

1. PrecisionEdge™ PE-12000 Series — a 12 mm laparoscopic trocar assembly; and

2. PrecisionEdge™ PE-15000 Series — a 15 mm laparoscopic trocar assembly. Apex's infringement contentions identify the PE-12000 Series and PE-15000 Series by model numbers (PE-12010, PE-12020, PE-12030, PE-15010, PE-15020, and PE-15030), encompassing all configurations within each product series. Notably, Apex does not accuse the PrecisionEdge™ PE-5000 Series (a 5 mm trocar assembly) of infringing the '105 Patent. Th

II. CLAIM CHART METHODOLOGY 2.1 Approach This preliminary claim chart follows a structured, element-by-element analysis of each asserted claim of the '105 Patent. The approach is as follows: Each asserted claim—Claim 1 (independent), Claim 4 (dependent), and Claim 8 (dependent)—is broken down into its constituent limitations, including the preamble and each individual structural element or feature recited in the clai

1. U.S. Patent No. 10,932,105 — Specification and Drawings. The full patent specification, including the abstract, detailed description, and all figures (Figs. 1–14), was reviewed for purposes of understanding the claimed invention, identifying the scope of the asserted claims, and analyzing the intrinsic record.

2. U.S. Patent No. 10,932,105 — File History (Prosecution History). The complete file history of the '105 Patent was obtained from the United States Patent and Trademark Office and has been subjected to an initial review. A more detailed prosecution history analysis memorandum is in preparation and is expected to be completed by September 5, 2024, in coordination with Kendrick & Lau LLP.

3. Solstice Internal Design Documents and Engineering Specifications. Design documents and engineering specifications for the PrecisionEdge™ PE-12000 and PE-15000 product lines were provided by Niamh Cassidy, Vice President, Regulatory & IP, Solstice Biomedical Devices Ltd. These documents include product design history files, design verification and validation reports, design input and output specifications, and eng

4. Solstice Manufacturing Drawings and Bills of Materials. Detailed manufacturing drawings (including cross-sectional views, exploded assembly diagrams, and dimensional tolerances) and bills of materials for the PE-12000 and PE-15000 assemblies were reviewed to confirm the structural configuration, component count, and assembly architecture of the accused products.

5. Solstice 510(k) Submissions. The 510(k) premarket notification submissions filed by Solstice with the U.S. Food and Drug Administration for the PE-12000 and PE-15000 product lines were reviewed to the extent relevant to device configuration, intended use, and design characteristics. These submissions confirm the modular, non-integrated design architecture of the accused products.

6. Preliminary Prosecution History Analysis Memorandum. A preliminary prosecution history analysis memorandum is in preparation by Kendrick & Lau LLP, with expected completion on September 5, 2024. Initial findings from this review have been incorporated into the present chart to the extent available.

7. Technical Consultation — Dr. Miriam Ostrowski. Dr. Miriam Ostrowski, Professor of Biomedical Engineering at Halford University, Philadelphia, Pennsylvania, has been retained as an expert consultant in this matter with respect to claim construction and invalidity issues. Dr. Ostrowski's retention agreement is dated August 20, 2024 and had not yet been formally executed at the time of this chart's preparation; howev

III. ACCUSED PRODUCTS — TECHNICAL DESCRIPTION 3.1 PrecisionEdge™ PE-12000 Series (12 mm Trocar Assembly) The PrecisionEdge™ PE-12000 Series is a 12 mm diameter laparoscopic trocar assembly designed for minimally invasive surgical access. It is manufactured by Solstice Biomedical Devices Ltd. at its ISO 13485-certified facility in Galway, Ireland, and distributed in the United States by Solstice Biomedical, Inc. The P

IV. CLAIM CHART — CLAIM 1 (INDEPENDENT CLAIM) Claim 1 of the '105 Patent is the sole independent claim asserted against the accused products. All asserted dependent claims (Claims 4 and 8) depend from Claim 1. Accordingly, the Claim 1 analysis is the foundation of the non-infringement defense. 4.1 Preamble: Claim 1 Claim Language (Preamble): "An integrated insufflation valve and seal assembly for a laparoscopic troca

V. CLAIM CHART — CLAIM 4 (DEPENDENT CLAIM) 5.1 Dependency Claim 4 of the '105 Patent is a dependent claim that depends directly from independent Claim 1. As a dependent claim, Claim 4 incorporates all limitations of Claim 1 and adds at least one additional limitation. Under well-established patent law, a dependent claim cannot be infringed unless all limitations of the independent claim from which it depends are also

VI. CLAIM CHART — CLAIM 8 (DEPENDENT CLAIM) 6.1 Dependency Claim 8 of the '105 Patent is a dependent claim. Based on initial review of the patent claims, Claim 8 depends directly from Claim 1 (the exact dependency chain is to be confirmed against the patent text; if Claim 8 depends from an intermediate dependent claim, all intermediate limitations would also need to be met). All limitations of Claim 1 must be satisfi

VII. DOCTRINE OF EQUIVALENTS ANALYSIS 7.1 Overview For each claim element where literal non-infringement is asserted, this section anticipates potential doctrine-of-equivalents arguments by Apex and identifies the defenses available to Solstice. Under the doctrine of equivalents, a product may infringe a patent claim even if it does not literally satisfy every limitation, if the differences between the accused produc