Contract analysis

1. Introduction and Purpose This memorandum sets forth a preliminary element-by-element claim chart mapping the asserted claims of U.S. Patent No. 10,271,884 (the "'884 Patent") against the PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series trocar assemblies manufactured and sold by Solstice Biomedical, Inc. ("Solstice" or "Defendant"). Solstice Biomedical, Inc. is the U.S. operating subsidiary of So

2. Summary of the '884 Patent 2.1 Patent Overview U.S. Patent No. 10,271,884, entitled "Retractable Blade Deployment Mechanism for Trocar Systems," was filed in the United States Patent and Trademark Office and issued on April 30, 2019. The patent is set to expire on September 15, 2036, assuming payment of all required maintenance fees. The named inventor is Dr. Raymond Szabo, who is currently Vice President of Engin

3. Description of Accused Products 3.1 PrecisionEdge™ PE-5000 Series (5 mm Trocar Assembly) The PrecisionEdge™ PE-5000 Series is a 5 mm diameter laparoscopic trocar assembly designed for minimally invasive surgical access. The PE-5000 is the smallest-diameter product in the PrecisionEdge™ line and is typically used for secondary port access during laparoscopic procedures, accommodating 5 mm diameter laparoscopic inst

4. Claim Chart: Claim 1 (Independent) The following claim chart maps each limitation of Claim 1 of the '884 Patent against the features of the accused PrecisionEdge™ products and sets forth Solstice's preliminary non-infringement position for each limitation. The claim language is based on the issued claim text as it appears in the '884 Patent. Each limitation has been parsed into a separate row for clarity of analys

5. Claim Chart: Claim 2 (Dependent on Claim 1) Claim 2 of the '884 Patent depends from Claim 1 and therefore incorporates all of the limitations of Claim 1 by reference. Claim 2 adds a further limitation relating to the specific configuration of the spring-biased retraction system. As a threshold matter, because Claim 2 is dependent on Claim 1, non-infringement of Claim 1 necessarily establishes non-infringement of C

6. Claim Chart: Claim 5 (Dependent on Claim 1) Claim 5 of the '884 Patent depends from Claim 1 and therefore incorporates all of the limitations of Claim 1 by reference. Claim 5 adds a further limitation requiring that the deployment trigger be responsive to a predetermined axial force threshold. As with Claim 2, non-infringement of Claim 1 necessarily establishes non-infringement of Claim 5. The analysis below addre

7. Claim Chart: Claim 9 (Independent — Method Claim) Claim 9 of the '884 Patent is an independent method claim directed to a method of deploying a retractable blade in a trocar system. The method claim presents both structural/operational non-infringement arguments (paralleling the apparatus claim analysis for Claim 1) and a separate, independent divided infringement defense. Each method step is analyzed below. 7.1 P

8. Claim Chart: Claim 14 (Dependent on Claim 9) Claim 14 of the '884 Patent depends from Claim 9 and therefore incorporates all of the method steps of Claim 9 by reference. Claim 14 adds a further limitation requiring that the automatic retraction of the blade occur upon "detection" of penetration. As with the dependent apparatus claims, non-infringement of Claim 9 necessarily establishes non-infringement of Claim 14

9. Cross-Product Summary Matrix 9.1 Non-Infringement Summary Table The following matrix summarizes the strength of Solstice's non-infringement position for each asserted claim of the '884 Patent across each accused product line: Key Takeaways: PE-5000 Series: Presents the strongest non-infringement position across all five asserted claims. The principal distinctions lie in the PE-5000's cam-based deployment mechanism

10. Preliminary Assessment of Doctrine of Equivalents In addition to literal non-infringement, the analysis must address the possibility that Apex will assert infringement under the doctrine of equivalents. Under the doctrine of equivalents, a product that does not literally satisfy a claim limitation may nonetheless infringe if the accused product element performs substantially the same function, in substantially th

11. Discovery and Investigation Needs The following discovery and investigation steps are necessary to develop and support Solstice's non-infringement positions and to advance the defense of this action. 11.1 Documents Needed from Apex The following categories of documents should be sought from Apex through formal written discovery: (a) Internal design documents and engineering specifications for the patented blade d

12. Relationship to Invalidity Contentions Non-infringement and invalidity are complementary defenses that together form the foundation of Solstice's defense strategy. While this memorandum addresses non-infringement, a parallel analysis of invalidity contentions is being developed. Preliminary prior art references identified by Kendrick & Lau LLP that are relevant to the asserted claims of the '884 Patent will be de

13. Next Steps and Action Items The following action items are identified for the continued development of Solstice's non-infringement positions and the broader defense of this action:

1. Prosecution History Review: Complete review and analysis of Apex's prosecution file history for the '884 Patent and related continuations/divisionals upon receipt from Apex. Target completion: September 5, 2024 (Christy Bauer and Peter Vassiliev, with input from Dr. Jonathan Kendrick of Kendrick & Lau LLP).

2. Claim Construction: Refine claim charts following the exchange of Proposed Claim Constructions by the parties, currently expected on or about October 22, 2024, and the submission of the Joint Claim Construction Brief, due November 4, 2024.

3. Markman Hearing: Update the non-infringement analysis following the Markman hearing (date to be scheduled by the Court) and the issuance of the Court's Claim Construction Order. The Court's constructions of disputed claim terms will be critical to the non-infringement analysis, particularly for terms such as "mechanical linkage," "spring," "mechanical detent," and "predetermined axial force threshold."

4. Prosecution History Estoppel: Coordinate with Kendrick & Lau LLP on the development of prosecution history estoppel arguments that may limit Apex's ability to assert infringement under the doctrine of equivalents.

5. Expert Retention: Retain Dr. Miriam Ostrowski (or an alternative technical expert) for detailed claim-by-claim analysis. Prepare and execute retention agreement. Target for initial expert consultation: August 2024.

6. Solstice Document Production: Incorporate findings from Solstice's own document production (48,217 documents, Bates Nos. SBD-000001 through SBD-048217, to be produced by September 30, 2024). Ensure that engineering specifications and design history files for the accused products are reviewed and integrated into the claim chart analysis.

7. Apex Document Production: Review Apex's responsive document production (Bates Nos. APEX-000001 through APEX-031450, expected approximately October 7, 2024) for additional information bearing on claim scope, prosecution history, prior licensing activity, and other matters relevant to the non-infringement and invalidity positions.

8. Invalidity Contentions: Complete the Invalidity Contentions — Prior Art Analysis Memorandum (target: September 18, 2024) and coordinate invalidity and non-infringement strategies.

9. Third-Party discovery: Issue subpoena to Veridian Medical Technologies, Inc. for prior art documents (target: September 2024).

10. Ongoing Refinement: This claim chart is preliminary and will be revised and updated as the litigation progresses through fact discovery, expert discovery, claim construction, and the development of the summary judgment record. All non-infringement positions are subject to revision based on new information, claim construction rulings, and the results of expert analysis.

14. Certification This Preliminary Claim Chart — Non-Infringement Analysis has been prepared, reviewed, and approved by the undersigned counsel in connection with the defense of Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA, U.S. District Court for the District of Delaware. Prepared by: ________________________________________ Peter Vassiliev Associate Calderwood & Harkness