Contract analysis

1. Solstice Biomedical Devices Ltd. was founded in 2011 in Dublin, Ireland, and designs, manufactures, and distributes minimally invasive surgical instruments worldwide, including laparoscopic trocars (marketed under the PrecisionEdge™ brand), endoscopic graspers, and electrosurgical hand instruments. The company employs approximately 620 people worldwide across its facilities in Dublin, Ireland; Limerick, Ireland; a

2. Apex Surgical Innovations, Inc. was founded in 2006 and is a Delaware corporation that manufactures and sells surgical access devices, trocar systems, and insufflation equipment. Apex employs approximately 1,100 people and generated estimated revenue of approximately $312 million for fiscal year 2023. (Delgado Decl. ¶ 4, Ex. B (Apex Annual Report 2023, publicly available).)

3. The PrecisionEdge™ PE-5000 Series is a 5 mm laparoscopic trocar assembly designed, manufactured, and sold by Solstice in the United States for use in minimally invasive surgical procedures. The PE-5000 Series has been commercially available in the United States since January 2021. Combined U.S. sales of all accused PrecisionEdge™ products — including the PE-5000, PE-12000, and PE-15000 Series — for calendar years

4. U.S. Patent No. 9,814,237, titled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," was filed on June 22, 2015, and issued on November 14, 2017. The '237 Patent expires on June 22, 2035. Claims 1, 3, 7, and 12 of the '237 Patent are asserted against the PE-5000 Series in this action. (Delgado Decl. ¶ 6, Ex. D (U.S. Patent No. 9,814,237).)

5. U.S. Patent No. 10,271,884, titled "Retractable Blade Deployment Mechanism for Trocar Systems," was filed on September 15, 2016, and issued on April 30, 2019. The '884 Patent expires on September 15, 2036. Claims 1, 2, 5, 9, and 14 of the '884 Patent are asserted against the PE-5000 Series in this action. (Delgado Decl. ¶ 7, Ex. E (U.S. Patent No. 10,271,884).)

6. Both the '237 Patent and the '884 Patent are part of a patent family comprising fourteen (14) issued U.S. utility patents and six (6) pending continuation applications, all assigned to Apex Surgical Innovations, Inc. and all naming Dr. Raymond Szabo as the sole inventor. (Delgado Decl. ¶ 8, Ex. F (Patent Family Tree).) C. The Court's Claim Construction Order

7. On November 18, 2024, this Court held a Markman hearing on nine disputed claim terms arising from the three asserted patents. The parties submitted a Joint Claim Construction Brief (D.I. 74), individual Claim Construction Briefs (D.I. 72, D.I. 73), and tutorial presentations from their respective technical experts. (Delgado Decl. ¶ 9.)

8. On December 6, 2024, this Court issued its Claim Construction Order (D.I. 87), construing all nine disputed terms. The Court's Order resolved five of the nine disputed terms consistently with Solstice's proposed constructions, and four consistently with Apex's proposed constructions. The two constructions most directly relevant to this motion are those of "locking seal assembly" (from the '237 Patent) and "retract

9. The Court construed the term "locking seal assembly" as used in Claim 1 of the '237 Patent to mean: "A multi-component assembly comprising (i) a seal element, (ii) a mechanical interlock that includes a discrete locking detent, and (iii) a rotational actuation mechanism that engages the locking detent to secure the seal element in a closed, sealing position." (D.I. 87 at 14.) This construction was consistent with

10. The Court construed the term "retractable blade deployment mechanism" as used in Claim 1 of the '884 Patent to mean: "A spring-loaded blade carriage that (i) deploys a cutting blade upon application of an affirmative manual actuating force and (ii) retracts the cutting blade to a fully shielded position upon release of that manual actuating force, such that the blade is biased toward retraction by a spring elemen

11. The PE-5000 Series employs a sealing mechanism that is structurally distinct from the "locking seal assembly" described in the '237 Patent. Specifically, the PE-5000 uses a compressive elastomeric gasket seal — a medical-grade silicone gasket that is compressed between two housing components when the trocar is assembled. The gasket seal is maintained in position by the axial compression forces generated when the

12. The PE-5000 Series does not employ a spring-loaded blade carriage as described in the '884 Patent. Instead, the PE-5000's blade is advanced and retracted by a cam-driven mechanism actuated by forward advancement of the obturator housing. In the PE-5000, a cam follower affixed to the blade carrier rides along a cam track integrated into the interior wall of the obturator housing. The surgeon's forward advancement

13. Apex's own technical expert, Dr. Calvin Ng, Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute, in his infringement expert report served February 10, 2025, acknowledged the structural differences between the PE-5000's elastomeric gasket seal and the claimed "locking seal assembly." Dr. Ng's report states: "The PE-5000 does not employ a detent-and-groove mechanism or a rotational actuati

14. Solstice retained Dr. Miriam Ostrowski, Professor of Biomedical Engineering at Halford University, as its technical expert on issues of infringement and validity. Dr. Ostrowski holds a Ph.D. in Biomedical Engineering from Stanford University and has over twenty-five years of experience in the design and evaluation of minimally invasive surgical instruments. In her expert report served January 27, 2025, Dr. Ostrow

15. Dr. Ng's February 10, 2025 infringement expert report concedes — or at minimum does not dispute — that the PE-5000's elastomeric gasket seal does not literally satisfy the "locking seal assembly" limitation as construed by the Court. (Delgado Decl. ¶ 14, Ex. L (Expert Report of Dr. Calvin Ng, at ¶¶ 83-84) (acknowledging the absence of a detent-and-groove mechanism and rotational actuation mechanism in the PE-5000

16. Apex filed its Complaint (D.I. 1) on May 9, 2024, asserting infringement of the '237, '884, and '105 Patents. Solstice filed its Answer, Affirmative Defenses, and Counterclaims (D.I. 12) on June 14, 2024, denying infringement and asserting counterclaims for declaratory judgment of non-infringement and invalidity.

17. Fact discovery in this action has been extensive. Solstice produced 48,217 documents bearing Bates numbers SBD-000001 through SBD-048217, encompassing engineering drawings, design history files, manufacturing records, sales data, marketing materials, and internal correspondence. Apex produced 31,450 documents bearing Bates numbers APEX-000001 through APEX-031450, encompassing patent prosecution files, inventor no

18. Expert discovery opened on January 13, 2025. Opening expert reports were served by January 27, 2025 (Solstice) and February 10, 2025 (Apex). Rebuttal expert reports were exchanged on March 3, 2025. Expert depositions were completed by March 14, 2025. (Delgado Decl. ¶ 19.) Additionally, the parties participated in a court-ordered mediation on March 17, 2025, before the Honorable Margaret Forsythe (Ret.) at Amberst

19. Trial in this action is currently set for September 30, 2025, before Chief Judge Andrews. (D.I. 94, Scheduling Order.) LEGAL STANDARD Summary judgment is appropriate under Federal Rule of Civil Procedure 56(a) where "the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a). A dispute of material fact is "genuine" on

I. THE PE-5000 DOES NOT INFRINGE THE '237 PATENT A. The Court's Construction of "Locking Seal Assembly". Claims 1, 3, 7, and 12 of the '237 Patent are asserted against the PE-5000 Series. Claim 1 is the sole independent claim among those asserted; Claims 3, 7, and 12 each depend from Claim 1 and therefore incorporate all of its limitations. The relevant claim language is as follows: Claim 1 of the '237 Patent recites

1. Prosecution History Estoppel Forecloses Apex's Equivalents Argument. Under the doctrine of prosecution history estoppel, "a patentee who narrows a claim as a condition for obtaining a patent . . . may not argue that the surrendered territory comprised unforeseen subject matter that should be deemed equivalent to the limitation added by the amendment." Festo Corp. v. Fenmore & Co., 535 U.S. 722, 733-34 (2002). When

2. Even Absent Estoppel, the Differences Are Substantial. Even if prosecution history estoppel did not apply — and it plainly does — Apex's doctrine-of-equivalents theory would fail on the merits. The differences between the PE-5000's compressive elastomeric gasket seal and the claimed multi-component locking seal assembly with a discrete detent and rotational actuation are not insubstantial; they are fundamental. Dr

II. THE PE-5000 DOES NOT INFRINGE THE '884 PATENT A. The Court's Construction of "Retractable Blade Deployment Mechanism". Claims 1, 2, 5, 9, and 14 of the '884 Patent are asserted against the PE-5000 Series. Claim 1 is the sole independent claim among those asserted; Claims 2, 5, 9, and 14 each depend from Claim 1 and therefore incorporate all of its limitations. The relevant claim language is as follows: Claim 1 of