Contract analysis

I. INTRODUCTION Defendant Solstice Biomedical, Inc. ("Solstice") respectfully moves this Court pursuant to Federal Rule of Civil Procedure 56 for summary judgment of non-infringement of U.S. Patent No. 9,814,237 (the "'237 Patent") and U.S. Patent No. 10,271,884 (the "'884 Patent") as to Solstice's PrecisionEdge™ PE-5000 Series 5 mm laparoscopic trocar assembly. The undisputed facts, viewed in the light most favorabl

II. PROCEDURAL HISTORY The procedural history of this action is relevant to understanding the posture of this Motion and the extensive record upon which it is based. Commencement of Action. Apex filed its Complaint (D.I. 1) on May 9, 2024, asserting infringement of three utility patents: the '237 Patent, the '884 Patent, and U.S. Patent No. 10,932,105 (the "'105 Patent," titled "Ergonomic Handle Assembly for Laparosc

III. STATEMENT OF UNDISPUTED MATERIAL FACTS Solstice states the following material facts as to which there is no genuine dispute, supported by citations to the record, the Court's Claim Construction Order (D.I. 187), deposition testimony, expert reports, and documents produced in discovery. Each fact is material to the resolution of this Motion and is established by admissible evidence in the record. Pursuant to Loca

1. The '237 Patent (U.S. Patent No. 9,814,237), titled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," was issued by the United States Patent and Trademark Office on November 14, 2017. It is assigned to Apex Surgical Innovations, Inc. and names Dr. Raymond Szabo as the sole inventor. (Bauer Decl. Ex. A (certified copy of '237 Patent).)

2. The '237 Patent contains twenty-three claims, of which Claims 1, 3, 7, and 12 are asserted against the PE-5000 Series. Claim 1 is an independent claim. Claims 3, 7, and 12 are dependent claims that each depend, directly or indirectly, from Claim 1 and incorporate all of the limitations of Claim 1. (Id. at col. 14, ll. 8–67; col. 15, ll. 1–42.)

3. The '884 Patent (U.S. Patent No. 10,271,884), titled "Retractable Blade Deployment Mechanism for Trocar Systems," was issued by the United States Patent and Trademark Office on April 30, 2019. It is assigned to Apex Surgical Innovations, Inc. and names Dr. Raymond Szabo as the sole inventor. (Bauer Decl. Ex. B (certified copy of '884 Patent).)

4. The '884 Patent contains nineteen claims, of which Claims 1, 2, 5, 9, and 14 are asserted against the PE-5000 Series. Claim 1 is an independent claim. Claims 2, 5, 9, and 14 are dependent claims that each depend, directly or indirectly, from Claim 1 and incorporate all of the limitations of Claim 1. (Id. at col. 12, ll. 15–58; col. 13, ll. 1–34.)

5. Both patents are currently in force. The '237 Patent has a statutory expiration date of June 22, 2035. The '884 Patent has a statutory expiration date of September 15, 2036. Neither patent has been the subject of any inter partes review, post-grant review, or ex parte reexamination. (Bauer Decl. ¶¶ 7–8.) B. The PE-5000 Series Product

6. The PrecisionEdge™ PE-5000 Series is a 5 mm laparoscopic trocar assembly designed and manufactured by Solstice Biomedical Devices Ltd. at its facility in Galway, Ireland, and sold in the United States by Solstice Biomedical, Inc. The PE-5000 Series received 510(k) clearance from the U.S. Food and Drug Administration (510(k) No. K192847) on March 12, 2020, and was first offered for sale in the United States in June

7. The PE-5000 is the smallest-diameter product in the PrecisionEdge™ product line. Apex separately accuses the PE-12000 Series (12 mm trocar assembly) and the PE-15000 Series (15 mm trocar assembly), but those products are not at issue in this Motion and are the subject of a separate motion for partial summary judgment filed concurrently herewith. (Bauer Decl. ¶ 12.)

8. The PE-5000 Series was designed independently from the PE-12000 and PE-15000 Series and employs a distinct internal architecture that was necessitated by the physical constraints of the 5 mm form factor. Specifically, the PE-5000 Series features: (a) a friction-fit elastomeric seal with a single radial compression band, rather than a mechanical interlock; (b) a manual push-rod blade advancement mechanism that is a

9. U.S. sales of the PE-5000 Series form part of the combined U.S. sales of accused PrecisionEdge™ products totaling approximately $74.6 million from calendar years 2021 through the third quarter of 2024. Of this total, the PE-5000 Series accounted for approximately $18.9 million in U.S. revenue during the same period. (Bauer Decl. Ex. K (Solstice Sales Data Summary, Bates Nos. SBD-041003 through SBD-041017); Marchet

10. On December 6, 2024, this Court issued its Claim Construction Order (D.I. 187), construing nine disputed claim terms across the three asserted patents. The Court's Order and accompanying Memorandum Opinion (D.I. 188) are part of the record and are incorporated herein by reference. (Bauer Decl. Ex. C.)

11. With respect to the '237 Patent, the Court construed the term "locking seal assembly" (as recited in Claim 1 and incorporated by dependent Claims 3, 7, and 12) to mean: "a seal assembly comprising a dual-stage mechanical interlock mechanism with positive detent engagement, wherein a first stage provides radial compression of a sealing element against an inserted instrument and a second stage provides axial lockin

12. With respect to the '884 Patent, the Court construed the term "retractable blade deployment mechanism" (as recited in Claim 1 and incorporated by dependent Claims 2, 5, 9, and 14) to mean: "a mechanism for deploying a cutting blade from a retracted position to a deployed position, comprising a spring-loaded retraction system with a discrete trigger actuation step, wherein release of the trigger causes the blade t

13. Additional constructions favorable to Solstice bear on whether the PE-5000's particular 5 mm-scale architecture meets various structural and functional limitations in the dependent claims. In particular, the Court construed "positive detent engagement" (Claim 3 of the '237 Patent) to require "mechanical engagement of a projecting detent element with a corresponding receiving recess, producing an audible and tacti

15. By contrast, the PE-12000 and PE-15000 Series employ a dual-stage mechanical interlock seal assembly with a spring-loaded detent ring that engages corresponding annular recesses machined into the inner wall of the cannula housing. The larger diameters of the PE-12000 (12 mm) and PE-15000 (15 mm) physically accommodate the additional mechanical components necessary for this dual-stage system. The PE-5000's 5 mm in

16. Apex's own technical expert, Dr. Calvin Ng, acknowledged in his February 10, 2025 infringement report that "the PE-5000 Series seal mechanism differs architecturally from the seal mechanisms of the PE-12000 and PE-15000 Series in that it does not incorporate a mechanical detent ring or corresponding cannula recesses." (Ng Report ¶ 94.) Dr. Ng nevertheless opined that the PE-5000's friction-fit seal satisfies the

17. During his deposition on March 7, 2025, Dr. Ng was asked directly whether the PE-5000's seal mechanism includes "a dual-stage mechanical interlock mechanism with positive detent engagement" as those terms were construed by the Court. Dr. Ng testified: "Under the Court's construction, the PE-5000 as I understand it does not have a dual-stage mechanical interlock in the same sense as the PE-12000 or PE-15000. My op

19. By contrast, the PE-12000 and PE-15000 Series each incorporate a coiled stainless-steel retraction spring (18-8 stainless steel, 0.045" wire diameter in the PE-12000; 0.055" wire diameter in the PE-15000) housed within the obturator handle. These larger products feature a trigger lever on the handle that, when squeezed, releases a sear mechanism and allows the retraction spring to drive the blade from the deploye

20. As with the seal mechanism, Apex's expert Dr. Ng acknowledged the structural differences in the PE-5000's blade mechanism. Dr. Ng stated in his report that "the PE-5000 uses a sliding actuator for blade advancement and retraction, whereas the PE-12000 and PE-15000 use a spring-loaded trigger mechanism." (Ng Report ¶ 112.) Dr. Ng opined that the PE-5000's manual push-rod system nonetheless constitutes a "retractab

21. At his deposition, Dr. Ng confirmed that "the PE-5000 does not have a spring. It does not have a trigger. The blade is advanced and retracted manually." (Ng Dep. at 167:19–22 (Bauer Decl. Ex. N).) E. No Doctrine of Equivalents

22. The prosecution histories of both the '237 Patent and the '884 Patent include narrowing amendments made by the applicant (Apex, through its patent prosecution counsel at Kendrick & Lau LLP) to overcome prior art rejections issued by the U.S. Patent and Trademark Office, giving rise to prosecution history estoppel that bars Apex from asserting infringement under the doctrine of equivalents as to the specific limit

23. During prosecution of the '237 Patent, the examiner rejected Claims 1–12 as anticipated by U.S. Patent No. 7,883,492 to Mercer ("the Mercer reference") under 35 U.S.C. § 102(a)(1). In its October 14, 2016 Response to Office Action, Apex amended Claim 1 to add the "dual-stage mechanical interlock mechanism with positive detent engagement" limitation, arguing that Mercer disclosed only a "single-stage elastomeric f

24. During prosecution of the '884 Patent, the examiner rejected Claims 1–10 as obvious over U.S. Patent No. 8,241,307 to Chen ("the Chen reference") in view of U.S. Patent Application Publication No. 2014/0188135 to Mikhailov ("the Mikhailov reference") under 35 U.S.C. § 103. In its March 22, 2018 Response to Office Action, Apex amended Claim 1 to add the "spring-loaded retraction system with a discrete trigger actu

25. These prosecution history amendments and arguments are documented in the certified prosecution history files produced in this action (Bates Nos. APEX-001247 through APEX-001582 ('237 Patent file history); Bates Nos. APEX-002104 through APEX-002489 ('884 Patent file history)) and were the subject of detailed analysis in the claim construction briefing (D.I. 124) and in the expert reports of Dr. Ostrowski (Ostrowsk

IV. LEGAL STANDARD Summary judgment is appropriate under Federal Rule of Civil Procedure 56(a) when "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). The moving party bears the initial burden of identifying those portions of the record that demonstrate the absence of any genuine issue of material fact. Celotex Corp. v. Catrett, 477

V. ARGUMENT A. The PE-5000 Series Does Not Literally Infringe the '237 Patent

1. Claims 1, 3, 7, and 12 Each Require a "Locking Seal Assembly" as Construed by the Court. Each of the four asserted claims of the '237 Patent requires, either expressly or by incorporation through dependency, the presence of a "locking seal assembly." Independent Claim 1 recites, in relevant part: "A surgical access device comprising: a cannula having a proximal end and a distal end; an obturator receivable within

2. The PE-5000's Seal Mechanism Does Not Meet the Construed Limitation. The undisputed evidence establishes that the PE-5000 Series does not include a "locking seal assembly" as the Court construed that term. The PE-5000 employs a single-stage, friction-fit elastomeric seal — a fundamentally different architecture from the dual-stage mechanical interlock mechanism required by the claims. As detailed in the Statement

3. Dependent Claims 3, 7, and 12 Also Fail. Because the PE-5000 does not satisfy the "locking seal assembly" limitation of independent Claim 1, it necessarily does not infringe any of the dependent claims that incorporate Claim 1's limitations. See Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1553 (Fed. Cir. 1989) ("One who does not infringe an independent claim cannot infringe a claim dependent on (and thus

1. Claims 1, 2, 5, 9, and 14 Each Require a "Retractable Blade Deployment Mechanism" as Construed by the Court. Each of the five asserted claims of the '884 Patent requires, either expressly or by incorporation through dependency, the presence of a "retractable blade deployment mechanism." Independent Claim 1 recites, in relevant part: "A trocar system comprising: a cannula assembly; an obturator assembly receivable

2. The PE-5000's Blade Mechanism Does Not Meet the Construed Limitation. The PE-5000 Series employs a fundamentally different blade advancement and retraction mechanism than what is required by the claims as construed. The PE-5000 uses a manual push-rod mechanism — not a spring-loaded retraction system, and not a trigger-actuated system. As detailed in the Statement of Undisputed Material Facts above (¶¶ 18–21), the

3. Dependent Claims 2, 5, 9, and 14 Also Fail. Because the PE-5000 does not satisfy the "retractable blade deployment mechanism" limitation of independent Claim 1, it necessarily does not infringe any of the dependent claims that incorporate Claim 1's limitations. Wahpeton Canvas, 870 F.2d at 1553. The dependent claims recite additional narrowing limitations that the PE-5000 also does not practice. Claim 2 requires t

1. Prosecution History Estoppel Bars Equivalents-Based Infringement. Under the Supreme Court's decision in Festo Corp. v. Fenmore & Co., 535 U.S. 722 (2002), when a patentee narrows a claim during prosecution for a "substantial reason related to patentability," a presumption arises that the patentee has surrendered the territory between the original claim scope and the amended claim scope. Id. at 733–34, 740. The pat

2. The All-Limitations Rule Precludes Equivalents. Even absent prosecution history estoppel, application of the doctrine of equivalents would be barred by the all-limitations rule. The doctrine of equivalents "must be applied to individual elements of the claim, not to the invention as a whole." Warner-Jenkinson, 520 U.S. at 29. Moreover, the doctrine "is limited by the 'all-limitations' rule, which provides that the

VI. CONCLUSION AND PRAYER FOR RELIEF For the foregoing reasons, Defendant Solstice Biomedical, Inc. respectfully requests that this Court grant its Motion for Summary Judgment of Non-Infringement and enter judgment as follows:

1. That the PrecisionEdge™ PE-5000 Series does not infringe, either literally or under the doctrine of equivalents, Claims 1, 3, 7, and 12 of U.S. Patent No. 9,814,237 (the '237 Patent);

2. That the PrecisionEdge™ PE-5000 Series does not infringe, either literally or under the doctrine of equivalents, Claims 1, 2, 5, 9, and 14 of U.S. Patent No. 10,271,884 (the '884 Patent);

3. That judgment be entered as a matter of law in favor of Solstice Biomedical, Inc. and against Apex Surgical Innovations, Inc. with respect to