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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

DEFENDANT SOLSTICE BIOMEDICAL, INC.'S MOTION FOR SUMMARY JUDGMENT OF NON-INFRINGEMENT AS TO THE PRECISIONEDGE™ PE-5000 SERIES

Filed: April 1, 2025

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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 favorable to the non-movant, establish that the PE-5000 Series does not satisfy at least one limitation of every asserted claim of the '237 Patent and the '884 Patent, either literally or under the doctrine of equivalents. Accordingly, Solstice is entitled to judgment as a matter of law.

Solstice is the U.S. operating subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company (Companies Registration Office No. 648217), with its principal offices located at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803 (Employer Identification Number: 84-3291056). Solstice designs, manufactures (through its parent), imports, markets, distributes, and sells laparoscopic surgical access devices throughout the United States, including the PrecisionEdge™ family of trocar assemblies.

Plaintiff Apex Surgical Innovations, Inc. ("Apex") is a Delaware corporation with principal offices at 1220 North Market Street, Suite 550, Wilmington, Delaware 19801 (Employer Identification Number: 51-0483762). Apex filed its Complaint in this action on May 9, 2024, alleging, inter alia, that the PrecisionEdge™ PE-5000 Series infringes Claims 1, 3, 7, and 12 of the '237 Patent and Claims 1, 2, 5, 9, and 14 of the '884 Patent. Apex seeks damages, an injunction, and attorneys' fees.

The '237 Patent, titled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," was duly issued by the United States Patent and Trademark Office on November 14, 2017, based on U.S. Patent Application Serial No. 14/746,883, filed June 22, 2015, and carries a statutory expiration date of June 22, 2035. The '884 Patent, titled "Retractable Blade Deployment Mechanism for Trocar Systems," was duly issued on April 30, 2019, based on U.S. Patent Application Serial No. 15/707,491, filed September 18, 2017, and carries a statutory expiration date of September 15, 2036. The named inventor on both patents is Dr. Raymond Szabo, who serves as Apex's Vice President of Engineering.

This case has proceeded through extensive fact and expert discovery, the exchange of claim construction briefing, and a Markman hearing held on November 18, 2024. On December 6, 2024, this Court issued its Claim Construction Order (D.I. 187) construing nine disputed claim terms across the three patents originally asserted in this litigation. Five of the Court's constructions were favorable to Solstice, including two constructions that are dispositive of the infringement inquiry as to the PE-5000 Series. Specifically, the Court construed "locking seal assembly" (as recited in the '237 Patent) and "retractable blade deployment mechanism" (as recited in the '884 Patent) in accordance with Solstice's proposed constructions, each of which requires structural and functional features that the PE-5000 Series indisputably does not possess. Based on the Court's constructions, there is no genuine dispute of material fact that the PE-5000 Series does not infringe either the '237 Patent or the '884 Patent, and Solstice is entitled to judgment as a matter of law.

This Motion is supported by the accompanying Memorandum of Law in Support of Defendant Solstice Biomedical, Inc.'s Motion for Summary Judgment of Non-Infringement (filed concurrently herewith), the Declaration of Christy Bauer in Support of Motion for Summary Judgment (the "Bauer Declaration"), together with Exhibits A through T attached thereto, and the complete record of this action. A proposed form of order is attached hereto as Exhibit U to the Bauer Declaration.

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 Laparoscopic Trocar"). The '105 Patent is not asserted against the PE-5000 Series and is not at issue in this Motion. The Complaint alleges that Solstice's PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series each infringe one or more claims of the asserted patents.

Service of Process. Solstice was served with the Summons and Complaint on May 23, 2024, through its registered agent, Pemberton Industries, located at 251 Little Falls Drive, Wilmington, Delaware 19808.

Responsive Pleadings. On June 14, 2024, Solstice timely filed its Answer, Affirmative Defenses, and Counterclaims (D.I. 14). Solstice's Answer denied the material allegations of infringement and asserted, inter alia, affirmative defenses of non-infringement, invalidity under 35 U.S.C. §§ 102 and 103, and inequitable conduct during prosecution of the asserted patents. Solstice also counterclaimed for declaratory judgment of non-infringement and invalidity. Apex filed its Answer to Solstice's Counterclaims on July 1, 2024 (D.I. 21).

Initial Scheduling Conference and Scheduling Order. The Court held the Initial Scheduling Conference on July 2, 2024 (D.I. 24). The Scheduling Order (D.I. 27) was entered on the same date, establishing deadlines for fact discovery, claim construction briefing, expert discovery, dispositive motions, and trial.

Joint discovery Plan. The parties filed their Joint discovery Plan (D.I. 33) on July 15, 2024, in accordance with Local Rule 26.1 and Federal Rule of Civil Procedure 26(f). The discovery Plan provided for, among other things, phased production of technical documents and source code, the use of a shared document review platform, and a protocol for asserting and challenging privilege designations.

Fact discovery. Extensive fact discovery was conducted over the course of several months. On August 5, 2024, Apex served its First Set of Interrogatories (eighteen interrogatories) and its First Set of Requests for Production (forty-two requests) on Solstice. Solstice served its First Set of Interrogatories (fifteen interrogatories) and its First Set of Requests for Production (thirty-eight requests) on Apex on August 19, 2024. Additional discovery requests were exchanged through October 2024, including subpoenas to third-party component suppliers, Solstice's Irish parent, and several hospitals that participated in clinical evaluations of the PE-5000 Series.

Solstice produced 48,217 documents, bearing Bates numbers SBD-000001 through SBD-048217, by the close of Solstice's document production on September 30, 2024. These productions included, among other things, engineering drawings, design history files, product specifications, manufacturing records, quality control documentation, sales data, marketing materials, and internal communications concerning the design and development of the PrecisionEdge™ product line. Apex produced 31,450 documents, bearing Bates numbers APEX-000001 through APEX-031450, by October 7, 2024, including patent prosecution files, inventor notebooks, prior art search files, licensing correspondence, and sales records for Apex's own competing trocar products.

The parties conducted a total of fourteen fact depositions between September and November 2024, including the depositions of Dr. Raymond Szabo (inventor), Nicole Driscoll (Apex's Director of Product Development), Kenneth Irvine (Solstice's Senior Vice President of Engineering), Dr. Howard Tanaka (Solstice's lead design engineer for the PrecisionEdge™ line), and representatives of two third-party component suppliers.

Claim Construction. The parties exchanged their Proposed Claim Constructions and Identification of Extrinsic Evidence on October 22, 2024 (D.I. 109). Nine claim terms were disputed across the three asserted patents. The parties filed a Joint Claim Construction Brief on November 4, 2024 (D.I. 124), together with claim construction exhibits, tutorial materials, and excerpts of prosecution history.

The Court held a Markman hearing on November 18, 2024 (D.I. 138). Both parties presented oral argument and responded to questions from the Court. On December 6, 2024, the Court issued its Claim Construction Order (D.I. 187), construing all nine disputed terms. Five of the Court's constructions were favorable to Solstice and four were favorable to Apex. Critically, the Court adopted Solstice's proposed constructions for both "locking seal assembly" (as recited in the '237 Patent) and "retractable blade deployment mechanism" (as recited in the '884 Patent), the two limitations that are dispositive of non-infringement as to the PE-5000 Series.

Expert discovery. Expert discovery opened on January 13, 2025. On January 27, 2025, Solstice served the expert report of Dr. Miriam Ostrowski, Professor of Biomedical Engineering at Halford University, Philadelphia, Pennsylvania, addressing invalidity of the asserted claims under 35 U.S.C. §§ 102 and 103 and non-infringement of the PE-5000 Series. (Bauer Decl. Ex. D.) On February 10, 2025, Apex served the expert report of Dr. Calvin Ng, Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute, Newark, Delaware, addressing alleged infringement of the asserted claims by the PrecisionEdge™ product line. (Bauer Decl. Ex. E.)

On February 14, 2025, the parties exchanged damages expert reports. Solstice's damages expert is Dr. Elena Marchetti, Managing Director of Pinnacle Economics Group LLC, who opined on the appropriate measure of damages and rebutted Apex's damages theory. (Bauer Decl. Ex. F.) Apex's damages expert is Hugh Danaher, CFA, Senior Managing Director of Keystone Valuation Advisors LLC. (Bauer Decl. Ex. G.)

Rebuttal expert reports were exchanged on March 3, 2025. The deposition of Dr. Calvin Ng was conducted on March 7, 2025. The deposition of Dr. Miriam Ostrowski was conducted on March 10, 2025. Remaining expert depositions were completed by March 14, 2025.

Mediation. The parties participated in a court-ordered mediation on March 17, 2025, before the Honorable Margaret Forsythe (Ret.) of Amberstone ADR Services, Wilmington, Delaware. The mediation did not result in a resolution of the dispute.

Current Posture. Trial is currently set for September 30, 2025. This Motion is timely filed in accordance with the dispositive motions deadline of April 1, 2025, as set forth in the Scheduling Order (D.I. 27).

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 Local Rule 56.1, a separate Statement of Undisputed Material Facts is filed concurrently herewith, with pinpoint citations to the evidentiary record.

A. The Asserted Patents and Claims

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 2020. (Bauer Decl. Ex. H (510(k) clearance letter); Bauer Decl. ¶ 11; Deposition of Kenneth Irvine ("Irvine Dep.") at 47:8–48:3.)

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 actuated by linear thumb pressure on a sliding actuator, rather than a spring-loaded retraction system; and (c) a unitary cannula-obturator interface that does not include a detent mechanism. (Bauer Decl. Ex. I (PE-5000 Engineering Specification, Document No. SBD-PE5-ES-003, Rev. C); Deposition of Dr. Howard Tanaka ("Tanaka Dep.") at 72:14–74:22; Bauer Decl. Ex. J (PE-5000 Exploded Assembly Drawing, Bates No. SBD-017832).)

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); Marchetti Report ¶¶ 34–38.)

C. The Court's Claim Construction Order (December 6, 2024)

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 locking through engagement of at least one detent feature with a corresponding recess on the cannula housing."

(D.I. 188 at 18–23.) The Court rejected Apex's broader proposed construction, which would have defined "locking seal assembly" simply as "any seal assembly that resists unintentional displacement of a surgical instrument during use." (Id. at 20.) The Court found that the intrinsic evidence — including the specification's repeated descriptions of the dual-stage mechanism (see '237 Patent, col. 4, ll. 22–58; col. 5, ll. 3–31; col. 7, ll. 14–45; Figs. 3A–3C) and the prosecution history (including the applicant's October 14, 2016 Response to Office Action in which the applicant distinguished over the Mercer prior art reference by emphasizing the dual-stage mechanical interlock with positive detent engagement) — compelled the narrower construction. (Id. at 19–22.)

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 to retract from the deployed position to the retracted position under spring force."

(D.I. 188 at 28–34.) The Court rejected Apex's broader proposed construction, which would have defined "retractable blade deployment mechanism" as "any mechanism that advances and retracts a cutting blade in a trocar system." (Id. at 30.) The Court found that the specification consistently described the blade deployment mechanism in terms of a spring-loaded retraction system activated by a discrete trigger (see '884 Patent, col. 3, ll. 40–67; col. 6, ll. 5–42; Figs. 5A–5D) and that the prosecution history confirmed this narrower scope, as the applicant distinguished over the Chen and Mikhailov prior art references by emphasizing the spring-loaded retraction and discrete trigger actuation features during prosecution. (Id. at 31–33.)

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 tactile confirmation of locking" (D.I. 188 at 24–25), and construed "discrete trigger actuation step" (Claims 2 and 5 of the '884 Patent) to require "a separate, user-initiated mechanical input that is distinct from the act of advancing the blade" (D.I. 188 at 35–36). Both of these constructions further confirm that the PE-5000 Series does not meet the asserted claim limitations, as discussed below.

D. Comparison of the PE-5000 to the Construed Claim Limitations

14. '237 Patent — "Locking Seal Assembly" Limitation. The PE-5000 Series employs a single-stage, friction-fit elastomeric seal. This seal consists of a medical-grade silicone gasket (Part No. PE5-SEAL-440, 40 Shore A durometer) seated within a cylindrical retaining collar. When a 5 mm surgical instrument is inserted through the trocar cannula, the elastomeric gasket compresses radially under the instrument's diameter, creating a fluid-tight seal through friction alone. The PE-5000's seal does not include any mechanical interlock. It does not include any detent feature. It does not include any recess on the cannula housing configured to receive a detent feature. It does not provide axial locking through any mechanism other than radial friction. There is no first stage and second stage; there is a single continuous compression event. (Bauer Decl. Ex. I at 14–17 (PE-5000 Engineering Specification, Seal Assembly Section); Bauer Decl. Ex. J (Exploded Assembly Drawing, Bates No. SBD-017832); Bauer Decl. Ex. L (Enlarged Cross-Sectional View, Bates No. SBD-017849); Tanaka Dep. at 88:6–91:14; Ostrowski Report ¶¶ 67–82.)

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 internal diameter does not permit the inclusion of a detent ring, annular recesses, or any other mechanical interlock components; the design history file confirms that the engineering team evaluated and rejected a mechanical interlock design for the 5 mm platform due to dimensional constraints. (Bauer Decl. Ex. M (Design History File Excerpt, Bates Nos. SBD-022145 through SBD-022168, documenting design review meeting of April 3, 2019); Tanaka Dep. at 94:2–97:18; Irvine Dep. at 112:7–113:22.)

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 "locking seal assembly" limitation because, in his view, the elastomeric compression constitutes a form of "locking." (Id. ¶¶ 95–98.) However, Dr. Ng's opinion relies on Apex's rejected claim construction — that is, his analysis is premised on the broader definition of "any seal assembly that resists unintentional displacement," which the Court expressly declined to adopt. (D.I. 188 at 20.) Under the Court's adopted construction, Dr. Ng's own factual admission that the PE-5000 lacks a mechanical detent ring and corresponding cannula recesses is dispositive.

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 opinion is that the Court's construction is narrower than what the patent requires, but I understand that is the construction the Court adopted." (Ng Dep. at 143:11–144:2 (Bauer Decl. Ex. N).)

18. '884 Patent — "Retractable Blade Deployment Mechanism" Limitation. The PE-5000 Series employs a manual push-rod blade advancement mechanism. The PE-5000's obturator assembly includes a sharpened pyramidal trocar tip mounted on a linear push-rod. The surgeon advances the blade from the retracted position to the deployed position by applying forward thumb pressure on a sliding actuator located on the proximal end of the handle. To retract the blade, the surgeon pulls the sliding actuator rearward, manually drawing the push-rod and blade back to the retracted position. The entire actuation sequence is manual and linear; there is no spring. There is no stored mechanical energy that drives retraction. There is no trigger. (Bauer Decl. Ex. I at 22–28 (PE-5000 Engineering Specification, Obturator Mechanism Section); Bauer Decl. Ex. O (PE-5000 Obturator Cross-Section Drawing, Bates No. SBD-018102); Tanaka Dep. at 103:8–108:14; Ostrowski Report ¶¶ 89–114.)

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 deployed position to the retracted position automatically and under spring force. The discrete trigger actuation step is a separate mechanical input from the initial blade advancement. The PE-5000 does not include any of these components. (Bauer Decl. Ex. P (Comparative Design Table, Bates No. SBD-023417); Tanaka Dep. at 109:3–112:22.)

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 "retractable blade deployment mechanism" because it "deploys and retracts a blade." (Id. ¶ 114.) Once again, however, this opinion rests entirely on Apex's broader proposed construction — "any mechanism that advances and retracts a cutting blade" — which the Court rejected. Under the Court's adopted construction, the absence of a spring-loaded retraction system and a discrete trigger actuation step in the PE-5000 is dispositive.

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 limitations at issue.

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 friction seal" that did not include "any mechanical interlock, detent feature, or multi-stage locking sequence." (Bauer Decl. Ex. Q (October 14, 2016 Response at 7–9).) The examiner subsequently allowed the claims. Apex's amendment and argument were directed specifically to distinguishing friction-fit elastomeric seals — precisely the type of seal mechanism used in the PE-5000.

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 actuation step" limitation, arguing that neither Chen nor Mikhailov, alone or in combination, disclosed a "spring-loaded retraction system" or a "discrete trigger actuation step" that was "separate from and independent of the blade advancement input." (Bauer Decl. Ex. R (March 22, 2018 Response at 10–13).) Apex specifically argued that Chen's manual push-rod system lacked these features. (Id. at 11.) The PE-5000, like the Chen reference, uses a manual push-rod system.

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 (Ostrowski Report ¶¶ 118–137) and Calderwood & Harkness LLP's prosecution history analysis submitted at the Markman hearing (D.I. 138, Ex. 7).

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 U.S. 317, 323 (1986). Once that burden is met, the non-moving party must set forth specific facts, supported by the record, showing that there is a genuine issue for trial. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A dispute is "genuine" only if "the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Id. The Court must view the facts in the light most favorable to the non-moving party, but "the mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment; the requirement is that there be no genuine issue of material fact." Id. at 247–48 (emphasis in original).

In patent cases, "summary judgment of non-infringement is appropriate where the patent owner's proof is deficient in meeting an essential element of the infringement charge." Celsis In Vitro, Inc. v. CellzDirect, Inc., 664 F.3d 922, 930 (Fed. Cir. 2012). A determination of patent infringement requires a two-step analysis: first, the court must construe the asserted claims to determine their scope and meaning as a matter of law; and second, the properly construed claims must be compared to the accused device to determine whether every limitation of the claim is met. Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996); Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454 (Fed. Cir. 1998) (en banc).

The first step — claim construction — is a question of law for the Court. Markman, 52 F.3d at 979. That step has been completed in this action through the Court's December 6, 2024 Claim Construction Order (D.I. 187). The second step — comparing the construed claims to the accused product — is a question of fact, but summary judgment is appropriate where there is no genuine dispute regarding the structure or operation of the accused product and the comparison can be performed as a matter of law. PC Connector Solutions LLC v. SmartDisk Corp., 406 F.3d 1359, 1364 (Fed. Cir. 2005); Gart v. Logitech, Inc., 254 F.3d 1334, 1339 (Fed. Cir. 2001) ("When no reasonable jury could find that every limitation recited in a properly construed claim either literally or under the doctrine of equivalents is found in an accused device, the patentee has failed to meet its burden and the accused infringer is entitled to judgment as a matter of law.").

The patentee bears the burden of proving infringement by a preponderance of the evidence. SmithKline Diagnostics, Inc. v. Helena Labs. Corp., 859 F.2d 878, 889 (Fed. Cir. 1988). Where the undisputed facts show that at least one limitation of each asserted claim is absent from the accused product, summary judgment of non-infringement is warranted. Lemelson v. U.S., 752 F.2d 1538, 1551 (Fed. Cir. 1985); TechSearch, L.L.C. v. Bramwell Partners LLC, 286 F.3d 1360, 1369 (Fed. Cir. 2002) ("To establish literal infringement, every limitation set forth in a claim must be found in an accused product.") (quoting Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1575 (Fed. Cir. 1995)).

With respect to the doctrine of equivalents, infringement may be found where an element of the accused product "performs substantially the same function in substantially the same way to achieve substantially the same result" as a claim limitation. Warner-Jenkinson Co. v. Harborline Enterprises Davis Chem. Co., 520 U.S. 17, 40 (1997). However, the doctrine of equivalents is subject to several important limitations, including prosecution history estoppel and the all-limitations rule. Under the doctrine of prosecution history estoppel, a patentee who narrows a claim during prosecution to obtain the patent may not later assert equivalents that would recapture the surrendered subject matter. Festo Corp. v. Fenmore & Co., 535 U.S. 722, 733–34 (2002). When a claim amendment is made for a "substantial reason related to patentability," a presumption arises that the patentee surrendered the territory between the original claim and the amended claim, and the patentee bears the burden of rebutting that presumption by demonstrating that: (1) the alleged equivalent was unforeseeable at the time of the amendment; (2) the rationale underlying the amendment bore no more than a tangential relation to the equivalent in question; or (3) there is some other reason suggesting that the patentee could not reasonably have been expected to have described the alleged equivalent. Id. at 740–41. Under the all-limitations rule, the doctrine of equivalents cannot be applied in a manner that effectively eliminates a claim limitation. Freedman Seating Co. v. Am. Seating Co., 420 F.3d 1350, 1358 (Fed. Cir. 2005).

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 the cannula; and a locking seal assembly disposed at the proximal end of the cannula, the locking seal assembly configured to form a fluid-tight seal around an instrument inserted through the cannula . . . ."

('237 Patent, col. 14, ll. 8–22 (emphasis added).)

Dependent Claims 3, 7, and 12 each depend from Claim 1 — Claims 3 and 7 directly, and Claim 12 through intervening Claim 9, which itself depends from Claim 1. Each dependent claim therefore necessarily incorporates the "locking seal assembly" limitation of Claim 1, in addition to reciting further narrowing limitations. (See '237 Patent, col. 14, ll. 28–32 (Claim 3: "The surgical access device of claim 1, wherein the locking seal assembly further comprises a positive detent engagement member . . ."); col. 14, ll. 45–51 (Claim 7: "The surgical access device of claim 1, wherein the dual-stage mechanical interlock mechanism includes an audible confirmation feature . . ."); col. 15, ll. 8–16 (Claim 12: "The surgical access device of claim 9, wherein the locking seal assembly is configured for single-handed operation . . .").)

This Court construed "locking seal assembly" 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 locking through engagement of at least one detent feature with a corresponding recess on the cannula housing." (D.I. 188 at 22–23.) The Court's construction is the law of this case and governs the infringement analysis.

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 of Undisputed Material Facts above (¶¶ 14–17), the PE-5000's seal consists of a single medical-grade silicone gasket (Part No. PE5-SEAL-440, 40 Shore A durometer) seated within a cylindrical retaining collar. When a surgical instrument is inserted through the trocar cannula, the gasket compresses radially around the instrument shaft, creating a fluid-tight seal through frictional engagement alone. There is no second-stage axial locking. There is no detent feature. There is no corresponding recess machined into the cannula housing. There is no mechanical interlock of any kind. The seal operates through a single, continuous radial compression event — not through a dual-stage mechanism involving both radial compression and axial detent engagement. (Bauer Decl. Exs. I, J, L; Tanaka Dep. at 88:6–91:14; Ostrowski Report ¶¶ 67–82.)

The physical differences between the PE-5000's seal and the claimed "locking seal assembly" are not merely quantitative — they are qualitative and structural. The Court's construction requires three essential components that are entirely absent from the PE-5000: (i) a mechanical interlock mechanism (as opposed to an elastomeric friction fit); (ii) positive detent engagement (as opposed to continuous compression); and (iii) a dual-stage operation involving both radial compression and axial locking through detent-recess engagement (as opposed to a single-stage radial compression event). None of these components or functions is present in the PE-5000.

The design history of the PE-5000 confirms that these differences are fundamental and deliberate. Solstice's engineering team evaluated and rejected a mechanical interlock design for the 5 mm platform during the product's development phase in 2019, concluding that the 5 mm internal diameter of the cannula was physically too small to accommodate a detent ring, annular recesses, and the associated manufacturing tolerances required for reliable detent engagement. (Bauer Decl. Ex. M (Design History File Excerpt, Bates Nos. SBD-022145 through SBD-022168); Tanaka Dep. at 94:2–97:18.) The PE-5000's friction-fit elastomeric seal was purpose-designed as an alternative sealing architecture for the 5 mm form factor.

Critically, Apex's own expert, Dr. Calvin Ng, does not dispute the physical structure of the PE-5000's seal mechanism. Dr. Ng acknowledged in his expert 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.) At his deposition, Dr. Ng confirmed that "[u]nder 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." (Ng Dep. at 143:11–144:2.)

Dr. Ng's infringement opinion with respect to the PE-5000 is based entirely on Apex's rejected claim construction — that "locking seal assembly" means simply "any seal assembly that resists unintentional displacement of a surgical instrument during use." (Ng Report ¶¶ 95–98.) The Court rejected this construction as inconsistent with the intrinsic evidence. (D.I. 188 at 20.) An expert opinion premised on a claim construction that the Court has rejected cannot create a genuine dispute of material fact. See Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1321 (Fed. Cir. 2009) ("An expert's conclusory assertion based on a rejected claim construction is insufficient to create a genuine issue of material fact for purposes of summary judgment."); Glenrock Enterprises v. Adriatic Partners LLC, 242 F.3d 1337, 1344 (Fed. Cir. 2001).

No reasonable jury, applying the Court's construction of "locking seal assembly," could find that the PE-5000 Series satisfies this limitation. Accordingly, the PE-5000 does not literally infringe Claim 1 of the '237 Patent.

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 containing all the limitations of) that claim.").

Moreover, even setting aside the independent claim limitation, the dependent claims recite additional limitations that the PE-5000 does not practice. Claim 3 requires "a positive detent engagement member configured to produce an audible click upon full engagement." ('237 Patent, col. 14, ll. 28–32.) The PE-5000 has no detent engagement member and produces no audible click upon instrument insertion. (Ostrowski Report ¶ 83; Tanaka Dep. at 92:4–93:8.) Claim 7 requires that "the dual-stage mechanical interlock mechanism includes an audible confirmation feature integrated with a visual alignment indicator." ('237 Patent, col. 14, ll. 45–51.) The PE-5000 has no dual-stage mechanical interlock mechanism, no audible confirmation feature, and no visual alignment indicator associated with seal engagement. (Ostrowski Report ¶ 84; Tanaka Dep. at 93:9–93:22.) Claim 12 requires that "the locking seal assembly is configured for single-handed operation with a maximum actuation force of 5 N." ('237 Patent, col. 15, ll. 8–16.) Because the PE-5000 has no "locking seal assembly" as construed, this limitation is not met, and in any event, the PE-5000's friction-fit seal does not involve any deliberate "actuation" — it is a passive compression that occurs automatically upon instrument insertion. (Ostrowski Report ¶ 86.)

For all of these reasons, Solstice is entitled to summary judgment of non-infringement as to Claims 1, 3, 7, and 12 of the '237 Patent.

B. The PE-5000 Series Does Not Literally Infringe the '884 Patent

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 within the cannula assembly, the obturator assembly comprising a cutting blade and a retractable blade deployment mechanism configured to deploy the cutting blade from a retracted position to a deployed position and to retract the cutting blade from the deployed position to the retracted position . . . ."

('884 Patent, col. 12, ll. 15–28 (emphasis added).)

Dependent Claims 2, 5, 9, and 14 each depend from Claim 1 — Claims 2 and 5 directly, Claim 9 through intervening Claim 6, and Claim 14 through intervening Claim 11. Each dependent claim therefore incorporates all of the limitations of Claim 1, including the "retractable blade deployment mechanism" limitation.

This Court construed "retractable blade deployment mechanism" 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 to retract from the deployed position to the retracted position under spring force." (D.I. 188 at 33–34.)

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 PE-5000's obturator assembly includes a sharpened pyramidal trocar tip mounted on a linear push-rod. To deploy the blade, the surgeon applies forward thumb pressure on a sliding actuator located on the proximal end of the obturator handle. The push-rod translates linearly within the handle housing, advancing the blade from the retracted position to the deployed position. To retract the blade, the surgeon reverses the motion, pulling the sliding actuator rearward along the same linear track, thereby manually drawing the push-rod and blade back to the retracted position. The entire actuation sequence is manual, linear, and bidirectional. (Bauer Decl. Exs. I, O; Tanaka Dep. at 103:8–108:14; Ostrowski Report ¶¶ 89–114.)

The PE-5000 does not contain a spring of any kind within the obturator assembly. There is no stored mechanical energy. There is no mechanism by which the blade retracts automatically or under spring force. The blade remains in whatever position the surgeon places it until the surgeon manually moves it. (Tanaka Dep. at 105:22–106:8; Ostrowski Report ¶¶ 92–95.)

The PE-5000 does not contain a trigger. There is no lever, button, switch, or other discrete input device that, when actuated, releases stored energy to drive blade retraction. The sliding actuator on the PE-5000 is not a "trigger" within any reasonable understanding of that term — it is a simple linear slide that the surgeon pushes forward to advance the blade and pulls backward to retract it. There is no "discrete trigger actuation step" — i.e., no "separate, user-initiated mechanical input that is distinct from the act of advancing the blade" (as the Court construed this term in dependent Claims 2 and 5). The same input (linear thumb pressure on the sliding actuator) is used for both advancement and retraction. (Bauer Decl. Ex. I at 25–26; Tanaka Dep. at 107:3–108:14; Ostrowski Report ¶¶ 96–102.)

Once again, Apex's own expert, Dr. Ng, does not dispute the physical structure of the PE-5000's blade mechanism. Dr. Ng acknowledged 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.) At his deposition, Dr. Ng confirmed unequivocally: "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.)

Dr. Ng's infringement opinion as to the PE-5000 is based on Apex's broader proposed construction — "any mechanism that advances and retracts a cutting blade in a trocar system" — which the Court rejected. (Ng Report ¶ 114; D.I. 188 at 30.) Under the Court's adopted construction, which requires a "spring-loaded retraction system with a discrete trigger actuation step," the undisputed absence of any spring and any trigger in the PE-5000 is dispositive.

No reasonable jury, applying the Court's construction of "retractable blade deployment mechanism," could find that the PE-5000 Series satisfies this limitation. Accordingly, the PE-5000 does not literally infringe Claim 1 of the '884 Patent.

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 that "the retractable blade deployment mechanism includes a discrete trigger actuation step that is independent of a blade advancement input." ('884 Patent, col. 12, ll. 30–33.) As noted, the PE-5000's sliding actuator performs both advancement and retraction functions — there is no separate trigger input. (Ostrowski Report ¶ 103.) Claim 5 further requires that "the discrete trigger actuation step comprises depressing a trigger lever disposed on the obturator handle." ('884 Patent, col. 12, ll. 42–45.) The PE-5000 has no trigger lever. (Ostrowski Report ¶ 105; Tanaka Dep. at 108:15–109:2.) Claim 9 requires that "the spring-loaded retraction system comprises a coiled retraction spring having a spring constant between 0.8 N/mm and 3.5 N/mm." ('884 Patent, col. 13, ll. 5–9.) The PE-5000 has no retraction spring. (Ostrowski Report ¶ 108.) Claim 14 requires that "upon release of the trigger, the blade retracts to the retracted position in less than 200 milliseconds." ('884 Patent, col. 13, ll. 25–29.) The PE-5000 has no trigger and no automatic retraction; the blade retracts only as fast as the surgeon manually pulls the sliding actuator. (Ostrowski Report ¶ 111.)

For all of these reasons, Solstice is entitled to summary judgment of non-infringement as to Claims 1, 2, 5, 9, and 14 of the '884 Patent.

C. The Doctrine of Equivalents Does Not Save Apex's Infringement Claims

Even if Apex could not establish literal infringement — which it cannot — Apex's infringement claims also fail under the doctrine of equivalents. Both prosecution history estoppel and the all-limitations rule bar any attempt by Apex to extend its claims to cover the PE-5000's fundamentally different architecture.

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 patentee may rebut this presumption only by showing that: (1) the alleged equivalent was unforeseeable at the time of the amendment; (2) the rationale underlying the amendment bore no more than a tangential relation to the equivalent in question; or (3) there is some other reason suggesting that the patentee could not reasonably have been expected to have described the alleged equivalent. Id. at 740–41.

The '237 Patent. During prosecution of the '237 Patent, Apex narrowed Claim 1 by amendment to add the "dual-stage mechanical interlock mechanism with positive detent engagement" limitation. This amendment was made in Apex's October 14, 2016 Response to Office Action for the express purpose of overcoming an anticipation rejection based on the Mercer prior art reference (U.S. Patent No. 7,883,492). (Bauer Decl. Ex. Q.) In that Response, Apex's patent counsel argued that the Mercer reference disclosed only a "single-stage elastomeric friction seal" and that the amended claims were patentable because they required a "dual-stage mechanical interlock" that Mercer did not teach. (Id. at 7–9.) The amendment was unquestionably made for a "substantial reason related to patentability" — it was the basis upon which the examiner allowed the claims.

The PE-5000's friction-fit elastomeric seal is precisely the type of seal that Apex distinguished and surrendered during prosecution. Apex argued that a "single-stage elastomeric friction seal" — which is exactly what the PE-5000 uses — was insufficient to constitute a "locking seal assembly" and that the dual-stage mechanical interlock was the distinguishing feature. Apex cannot now recapture through the doctrine of equivalents the very subject matter it surrendered to obtain the patent. See Honeywell Int'l, Inc. v. Hamilton Sundstrand Corp., 370 F.3d 1131, 1143 (Fed. Cir. 2004) (en banc) ("The question [under Festo] is whether the surrendered subject matter can be shown to be not more than tangential to the amendment.").

None of the Festo exceptions apply. First, friction-fit elastomeric seals were not unforeseeable at the time of the amendment — they were the very technology that Apex was distinguishing over. The Mercer reference itself disclosed such a seal, and Apex's prosecution arguments were directed at explaining why the claimed invention was different from that seal. Second, the rationale for the amendment was not tangential to the alleged equivalent — it was directed squarely at the distinction between friction-fit seals and mechanical interlock mechanisms. Third, there is no other reason to believe Apex could not have described a friction-fit elastomeric seal as an equivalent at the time of the amendment; to the contrary, Apex deliberately excluded such seals from the claim scope.

The '884 Patent. The same analysis applies to the '884 Patent. During prosecution, Apex narrowed Claim 1 by amendment to add the "spring-loaded retraction system with a discrete trigger actuation step" limitation in its March 22, 2018 Response to Office Action. (Bauer Decl. Ex. R.) This amendment was made to overcome an obviousness rejection based on the Chen and Mikhailov prior art references. In arguing for patentability, Apex specifically distinguished the Chen reference's manual push-rod system, asserting that Chen "fails to disclose a spring-loaded retraction system or a discrete trigger actuation step" and that Chen's "manual advancement and retraction of the blade via a sliding push-rod" was fundamentally different from the claimed invention. (Id. at 11.)

The PE-5000 uses a manual push-rod system that is structurally analogous to — and in key respects identical to — the Chen reference that Apex distinguished during prosecution. Apex surrendered the territory occupied by manual push-rod blade advancement mechanisms when it amended its claims to require spring-loaded trigger retraction. Prosecution history estoppel bars Apex from reasserting equivalents-based infringement over the PE-5000's manual push-rod mechanism.

Again, none of the Festo exceptions apply. Manual push-rod mechanisms were not unforeseeable — they were the subject of the prior art rejection. The rationale for the amendment was directed at the very distinction between manual push-rod systems and spring-loaded trigger systems. And Apex was plainly aware of manual push-rod systems at the time of the amendment, having expressly discussed and distinguished them in its prosecution arguments.

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 doctrine may not be used to effectively eliminate a claim limitation." Freedman Seating, 420 F.3d at 1358.

Here, applying the doctrine of equivalents to find that the PE-5000's friction-fit elastomeric seal is "equivalent" to the claimed "locking seal assembly" (i.e., a dual-stage mechanical interlock with positive detent engagement) would effectively eliminate the "dual-stage mechanical interlock mechanism with positive detent engagement" limitation from the claim. The entire purpose of this limitation, as the Court found in its Claim Construction Order and as the prosecution history confirms, is to distinguish mechanical interlock seals from friction-fit seals. Finding equivalence between the two would render the limitation meaningless. See Moore U.S.A., Inc. v. Standard Register Co., 229 F.3d 1091, 1106 (Fed. Cir. 2000) ("If a theory of equivalence would entirely vitiate a particular claim element, partial or complete judgment should be rendered by the court, as there would be nothing further for the jury to decide.").

Similarly, finding that the PE-5000's manual push-rod mechanism is "equivalent" to the claimed "retractable blade deployment mechanism" (i.e., a spring-loaded retraction system with a discrete trigger actuation step) would effectively eliminate the "spring-loaded retraction system" and "discrete trigger actuation step" limitations from the claim. The Court's construction specifically requires stored mechanical energy (a spring) and a separate user input (a trigger) that are wholly absent from the PE-5000. Finding equivalence would vitiate these limitations entirely.

Furthermore, there is no equivalent function, way, or result between the PE-5000's mechanisms and the claimed mechanisms as construed. With respect to the seal, the PE-5000's friction-fit seal functions through elastic radial compression alone, whereas the claimed dual-stage mechanical interlock functions through both radial compression and axial detent engagement — a fundamentally different "way" of achieving sealing and locking. With respect to the blade mechanism, the PE-5000's manual push-rod functions through direct manual force in both directions, whereas the claimed spring-loaded trigger mechanism functions through stored mechanical energy released by a discrete trigger — again, a fundamentally different "way" of achieving blade retraction.

For all of these reasons, the doctrine of equivalents does not save Apex's infringement claims with respect to the PE-5000 Series.

D. No Genuine Dispute of Material Fact Precludes Summary Judgment

This case presents the paradigmatic scenario for summary judgment of non-infringement. The Court has construed the disputed claim terms. The physical structure and operation of the PE-5000 Series are not in dispute. The parties' experts agree on what the PE-5000 does — it employs a friction-fit elastomeric seal and a manual push-rod blade mechanism. The experts differ only on whether these features satisfy the asserted claim limitations, and that disagreement is rooted entirely in the parties' differing claim construction positions, which the Court has now resolved.

Dr. Ng's infringement opinions with respect to the PE-5000 are premised on Apex's proposed claim constructions, which the Court rejected. Under the Court's adopted constructions, Dr. Ng's own factual admissions — that the PE-5000 lacks a mechanical detent ring, corresponding cannula recesses, a spring, and a trigger — establish that the PE-5000 does not satisfy the asserted claim limitations. An expert opinion that relies on a rejected legal standard cannot create a genuine dispute of material fact sufficient to defeat summary judgment. See Exergen, 575 F.3d at 1321; Ashbury Industries, Inc. v. Teva Pharms., USA, Inc., 429 F.3d 1364, 1373–74 (Fed. Cir. 2005) (affirming summary judgment of non-infringement where expert's infringement opinion was predicated on claim construction the court rejected).

Apex cannot create a genuine dispute by reasserting claim constructions the Court has already rejected or by pointing to alleged similarities between the PE-5000 and the patented invention at a level of generality that ignores the specific claim limitations the Court has construed. The sole question before the Court is the application of the Court's constructions to undisputed product features — a comparison that can and should be resolved on summary judgment. See PC Connector Solutions, 406 F.3d at 1364; Chimie v. PPG Indus., Inc., 402 F.3d 1371, 1376 (Fed. Cir. 2005) ("Where the parties do not dispute any relevant facts regarding the accused product . . . but disagree over claim construction and the meaning of the claims, the question of infringement collapses to one of claim construction and is amenable to summary judgment.").

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

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
DEFENDANT SOLSTICE BIOMEDICAL, INC.'S MOTION FOR SUMMARY JUDGMENT OF NON-INFRINGEMENT AS TO THE PRECISIONEDGE™ PE-5000 SERIES
Filed: April 1, 2025
TABLE OF CONTENTS
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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 favorable to the non-movant, establish that the PE-5000 Series does not satisfy at least one limitation of every asserted claim of the '237 Patent and the '884 Patent, either literally or under the doctrine of equivalents. Accordingly, Solstice is entitled to judgment as a matter of law.
Solstice is the U.S. operating subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company (Companies Registration Office No. 648217), with its principal offices located at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803 (Employer Identification Number: 84-3291056). Solstice designs, manufactures (through its parent), imports, markets, distributes, and sells laparoscopic surgical access devices throughout the United States, including the PrecisionEdge™ family of trocar assemblies.
Plaintiff Apex Surgical Innovations, Inc. ("Apex") is a Delaware corporation with principal offices at 1220 North Market Street, Suite 550, Wilmington, Delaware 19801 (Employer Identification Number: 51-0483762). Apex filed its Complaint in this action on May 9, 2024, alleging, inter alia, that the PrecisionEdge™ PE-5000 Series infringes Claims 1, 3, 7, and 12 of the '237 Patent and Claims 1, 2, 5, 9, and 14 of the '884 Patent. Apex seeks damages, an injunction, and attorneys' fees.
The '237 Patent, titled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," was duly issued by the United States Patent and Trademark Office on November 14, 2017, based on U.S. Patent Application Serial No. 14/746,883, filed June 22, 2015, and carries a statutory expiration date of June 22, 2035. The '884 Patent, titled "Retractable Blade Deployment Mechanism for Trocar Systems," was duly issued on April 30, 2019, based on U.S. Patent Application Serial No. 15/707,491, filed September 18, 2017, and carries a statutory expiration date of September 15, 2036. The named inventor on both patents is Dr. Raymond Szabo, who serves as Apex's Vice President of Engineering.
This case has proceeded through extensive fact and expert discovery, the exchange of claim construction briefing, and a Markman hearing held on November 18, 2024. On December 6, 2024, this Court issued its Claim Construction Order (D.I. 187) construing nine disputed claim terms across the three patents originally asserted in this litigation. Five of the Court's constructions were favorable to Solstice, including two constructions that are dispositive of the infringement inquiry as to the PE-5000 Series. Specifically, the Court construed "locking seal assembly" (as recited in the '237 Patent) and "retractable blade deployment mechanism" (as recited in the '884 Patent) in accordance with Solstice's proposed constructions, each of which requires structural and functional features that the PE-5000 Series indisputably does not possess. Based on the Court's constructions, there is no genuine dispute of material fact that the PE-5000 Series does not infringe either the '237 Patent or the '884 Patent, and Solstice is entitled to judgment as a matter of law.
This Motion is supported by the accompanying Memorandum of Law in Support of Defendant Solstice Biomedical, Inc.'s Motion for Summary Judgment of Non-Infringement (filed concurrently herewith), the Declaration of Christy Bauer in Support of Motion for Summary Judgment (the "Bauer Declaration"), together with Exhibits A through T attached thereto, and the complete record of this action. A proposed form of order is attached hereto as Exhibit U to the Bauer Declaration.
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 Laparoscopic Trocar"). The '105 Patent is not asserted against the PE-5000 Series and is not at issue in this Motion. The Complaint alleges that Solstice's PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series each infringe one or more claims of the asserted patents.
Service of Process. Solstice was served with the Summons and Complaint on May 23, 2024, through its registered agent, Pemberton Industries, located at 251 Little Falls Drive, Wilmington, Delaware 19808.
Responsive Pleadings. On June 14, 2024, Solstice timely filed its Answer, Affirmative Defenses, and Counterclaims (D.I. 14). Solstice's Answer denied the material allegations of infringement and asserted, inter alia, affirmative defenses of non-infringement, invalidity under 35 U.S.C. §§ 102 and 103, and inequitable conduct during prosecution of the asserted patents. Solstice also counterclaimed for declaratory judgment of non-infringement and invalidity. Apex filed its Answer to Solstice's Counterclaims on July 1, 2024 (D.I. 21).
Initial Scheduling Conference and Scheduling Order. The Court held the Initial Scheduling Conference on July 2, 2024 (D.I. 24). The Scheduling Order (D.I. 27) was entered on the same date, establishing deadlines for fact discovery, claim construction briefing, expert discovery, dispositive motions, and trial.
Joint discovery Plan. The parties filed their Joint discovery Plan (D.I. 33) on July 15, 2024, in accordance with Local Rule 26.1 and Federal Rule of Civil Procedure 26(f). The discovery Plan provided for, among other things, phased production of technical documents and source code, the use of a shared document review platform, and a protocol for asserting and challenging privilege designations.
Fact discovery. Extensive fact discovery was conducted over the course of several months. On August 5, 2024, Apex served its First Set of Interrogatories (eighteen interrogatories) and its First Set of Requests for Production (forty-two requests) on Solstice. Solstice served its First Set of Interrogatories (fifteen interrogatories) and its First Set of Requests for Production (thirty-eight requests) on Apex on August 19, 2024. Additional discovery requests were exchanged through October 2024, including subpoenas to third-party component suppliers, Solstice's Irish parent, and several hospitals that participated in clinical evaluations of the PE-5000 Series.
Solstice produced 48,217 documents, bearing Bates numbers SBD-000001 through SBD-048217, by the close of Solstice's document production on September 30, 2024. These productions included, among other things, engineering drawings, design history files, product specifications, manufacturing records, quality control documentation, sales data, marketing materials, and internal communications concerning the design and development of the PrecisionEdge™ product line. Apex produced 31,450 documents, bearing Bates numbers APEX-000001 through APEX-031450, by October 7, 2024, including patent prosecution files, inventor notebooks, prior art search files, licensing correspondence, and sales records for Apex's own competing trocar products.
The parties conducted a total of fourteen fact depositions between September and November 2024, including the depositions of Dr. Raymond Szabo (inventor), Nicole Driscoll (Apex's Director of Product Development), Kenneth Irvine (Solstice's Senior Vice President of Engineering), Dr. Howard Tanaka (Solstice's lead design engineer for the PrecisionEdge™ line), and representatives of two third-party component suppliers.
Claim Construction. The parties exchanged their Proposed Claim Constructions and Identification of Extrinsic Evidence on October 22, 2024 (D.I. 109). Nine claim terms were disputed across the three asserted patents. The parties filed a Joint Claim Construction Brief on November 4, 2024 (D.I. 124), together with claim construction exhibits, tutorial materials, and excerpts of prosecution history.
The Court held a Markman hearing on November 18, 2024 (D.I. 138). Both parties presented oral argument and responded to questions from the Court. On December 6, 2024, the Court issued its Claim Construction Order (D.I. 187), construing all nine disputed terms. Five of the Court's constructions were favorable to Solstice and four were favorable to Apex. Critically, the Court adopted Solstice's proposed constructions for both "locking seal assembly" (as recited in the '237 Patent) and "retractable blade deployment mechanism" (as recited in the '884 Patent), the two limitations that are dispositive of non-infringement as to the PE-5000 Series.
Expert discovery. Expert discovery opened on January 13, 2025. On January 27, 2025, Solstice served the expert report of Dr. Miriam Ostrowski, Professor of Biomedical Engineering at Halford University, Philadelphia, Pennsylvania, addressing invalidity of the asserted claims under 35 U.S.C. §§ 102 and 103 and non-infringement of the PE-5000 Series. (Bauer Decl. Ex. D.) On February 10, 2025, Apex served the expert report of Dr. Calvin Ng, Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute, Newark, Delaware, addressing alleged infringement of the asserted claims by the PrecisionEdge™ product line. (Bauer Decl. Ex. E.)
On February 14, 2025, the parties exchanged damages expert reports. Solstice's damages expert is Dr. Elena Marchetti, Managing Director of Pinnacle Economics Group LLC, who opined on the appropriate measure of damages and rebutted Apex's damages theory. (Bauer Decl. Ex. F.) Apex's damages expert is Hugh Danaher, CFA, Senior Managing Director of Keystone Valuation Advisors LLC. (Bauer Decl. Ex. G.)
Rebuttal expert reports were exchanged on March 3, 2025. The deposition of Dr. Calvin Ng was conducted on March 7, 2025. The deposition of Dr. Miriam Ostrowski was conducted on March 10, 2025. Remaining expert depositions were completed by March 14, 2025.
Mediation. The parties participated in a court-ordered mediation on March 17, 2025, before the Honorable Margaret Forsythe (Ret.) of Amberstone ADR Services, Wilmington, Delaware. The mediation did not result in a resolution of the dispute.
Current Posture. Trial is currently set for September 30, 2025. This Motion is timely filed in accordance with the dispositive motions deadline of April 1, 2025, as set forth in the Scheduling Order (D.I. 27).
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 Local Rule 56.1, a separate Statement of Undisputed Material Facts is filed concurrently herewith, with pinpoint citations to the evidentiary record.
A. The Asserted Patents and Claims
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 2020. (Bauer Decl. Ex. H (510(k) clearance letter); Bauer Decl. ¶ 11; Deposition of Kenneth Irvine ("Irvine Dep.") at 47:8–48:3.)
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 actuated by linear thumb pressure on a sliding actuator, rather than a spring-loaded retraction system; and (c) a unitary cannula-obturator interface that does not include a detent mechanism. (Bauer Decl. Ex. I (PE-5000 Engineering Specification, Document No. SBD-PE5-ES-003, Rev. C); Deposition of Dr. Howard Tanaka ("Tanaka Dep.") at 72:14–74:22; Bauer Decl. Ex. J (PE-5000 Exploded Assembly Drawing, Bates No. SBD-017832).)
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); Marchetti Report ¶¶ 34–38.)
C. The Court's Claim Construction Order (December 6, 2024)
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 locking through engagement of at least one detent feature with a corresponding recess on the cannula housing."
(D.I. 188 at 18–23.) The Court rejected Apex's broader proposed construction, which would have defined "locking seal assembly" simply as "any seal assembly that resists unintentional displacement of a surgical instrument during use." (Id. at 20.) The Court found that the intrinsic evidence — including the specification's repeated descriptions of the dual-stage mechanism (see '237 Patent, col. 4, ll. 22–58; col. 5, ll. 3–31; col. 7, ll. 14–45; Figs. 3A–3C) and the prosecution history (including the applicant's October 14, 2016 Response to Office Action in which the applicant distinguished over the Mercer prior art reference by emphasizing the dual-stage mechanical interlock with positive detent engagement) — compelled the narrower construction. (Id. at 19–22.)
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 to retract from the deployed position to the retracted position under spring force."
(D.I. 188 at 28–34.) The Court rejected Apex's broader proposed construction, which would have defined "retractable blade deployment mechanism" as "any mechanism that advances and retracts a cutting blade in a trocar system." (Id. at 30.) The Court found that the specification consistently described the blade deployment mechanism in terms of a spring-loaded retraction system activated by a discrete trigger (see '884 Patent, col. 3, ll. 40–67; col. 6, ll. 5–42; Figs. 5A–5D) and that the prosecution history confirmed this narrower scope, as the applicant distinguished over the Chen and Mikhailov prior art references by emphasizing the spring-loaded retraction and discrete trigger actuation features during prosecution. (Id. at 31–33.)
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 tactile confirmation of locking" (D.I. 188 at 24–25), and construed "discrete trigger actuation step" (Claims 2 and 5 of the '884 Patent) to require "a separate, user-initiated mechanical input that is distinct from the act of advancing the blade" (D.I. 188 at 35–36). Both of these constructions further confirm that the PE-5000 Series does not meet the asserted claim limitations, as discussed below.
D. Comparison of the PE-5000 to the Construed Claim Limitations
14. '237 Patent — "Locking Seal Assembly" Limitation. The PE-5000 Series employs a single-stage, friction-fit elastomeric seal. This seal consists of a medical-grade silicone gasket (Part No. PE5-SEAL-440, 40 Shore A durometer) seated within a cylindrical retaining collar. When a 5 mm surgical instrument is inserted through the trocar cannula, the elastomeric gasket compresses radially under the instrument's diameter, creating a fluid-tight seal through friction alone. The PE-5000's seal does not include any mechanical interlock. It does not include any detent feature. It does not include any recess on the cannula housing configured to receive a detent feature. It does not provide axial locking through any mechanism other than radial friction. There is no first stage and second stage; there is a single continuous compression event. (Bauer Decl. Ex. I at 14–17 (PE-5000 Engineering Specification, Seal Assembly Section); Bauer Decl. Ex. J (Exploded Assembly Drawing, Bates No. SBD-017832); Bauer Decl. Ex. L (Enlarged Cross-Sectional View, Bates No. SBD-017849); Tanaka Dep. at 88:6–91:14; Ostrowski Report ¶¶ 67–82.)
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 internal diameter does not permit the inclusion of a detent ring, annular recesses, or any other mechanical interlock components; the design history file confirms that the engineering team evaluated and rejected a mechanical interlock design for the 5 mm platform due to dimensional constraints. (Bauer Decl. Ex. M (Design History File Excerpt, Bates Nos. SBD-022145 through SBD-022168, documenting design review meeting of April 3, 2019); Tanaka Dep. at 94:2–97:18; Irvine Dep. at 112:7–113:22.)
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 "locking seal assembly" limitation because, in his view, the elastomeric compression constitutes a form of "locking." (Id. ¶¶ 95–98.) However, Dr. Ng's opinion relies on Apex's rejected claim construction — that is, his analysis is premised on the broader definition of "any seal assembly that resists unintentional displacement," which the Court expressly declined to adopt. (D.I. 188 at 20.) Under the Court's adopted construction, Dr. Ng's own factual admission that the PE-5000 lacks a mechanical detent ring and corresponding cannula recesses is dispositive.
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 opinion is that the Court's construction is narrower than what the patent requires, but I understand that is the construction the Court adopted." (Ng Dep. at 143:11–144:2 (Bauer Decl. Ex. N).)
18. '884 Patent — "Retractable Blade Deployment Mechanism" Limitation. The PE-5000 Series employs a manual push-rod blade advancement mechanism. The PE-5000's obturator assembly includes a sharpened pyramidal trocar tip mounted on a linear push-rod. The surgeon advances the blade from the retracted position to the deployed position by applying forward thumb pressure on a sliding actuator located on the proximal end of the handle. To retract the blade, the surgeon pulls the sliding actuator rearward, manually drawing the push-rod and blade back to the retracted position. The entire actuation sequence is manual and linear; there is no spring. There is no stored mechanical energy that drives retraction. There is no trigger. (Bauer Decl. Ex. I at 22–28 (PE-5000 Engineering Specification, Obturator Mechanism Section); Bauer Decl. Ex. O (PE-5000 Obturator Cross-Section Drawing, Bates No. SBD-018102); Tanaka Dep. at 103:8–108:14; Ostrowski Report ¶¶ 89–114.)
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 deployed position to the retracted position automatically and under spring force. The discrete trigger actuation step is a separate mechanical input from the initial blade advancement. The PE-5000 does not include any of these components. (Bauer Decl. Ex. P (Comparative Design Table, Bates No. SBD-023417); Tanaka Dep. at 109:3–112:22.)
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 "retractable blade deployment mechanism" because it "deploys and retracts a blade." (Id. ¶ 114.) Once again, however, this opinion rests entirely on Apex's broader proposed construction — "any mechanism that advances and retracts a cutting blade" — which the Court rejected. Under the Court's adopted construction, the absence of a spring-loaded retraction system and a discrete trigger actuation step in the PE-5000 is dispositive.
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 limitations at issue.
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 friction seal" that did not include "any mechanical interlock, detent feature, or multi-stage locking sequence." (Bauer Decl. Ex. Q (October 14, 2016 Response at 7–9).) The examiner subsequently allowed the claims. Apex's amendment and argument were directed specifically to distinguishing friction-fit elastomeric seals — precisely the type of seal mechanism used in the PE-5000.
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 actuation step" limitation, arguing that neither Chen nor Mikhailov, alone or in combination, disclosed a "spring-loaded retraction system" or a "discrete trigger actuation step" that was "separate from and independent of the blade advancement input." (Bauer Decl. Ex. R (March 22, 2018 Response at 10–13).) Apex specifically argued that Chen's manual push-rod system lacked these features. (Id. at 11.) The PE-5000, like the Chen reference, uses a manual push-rod system.
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 (Ostrowski Report ¶¶ 118–137) and Calderwood & Harkness LLP's prosecution history analysis submitted at the Markman hearing (D.I. 138, Ex. 7).
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 U.S. 317, 323 (1986). Once that burden is met, the non-moving party must set forth specific facts, supported by the record, showing that there is a genuine issue for trial. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A dispute is "genuine" only if "the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Id. The Court must view the facts in the light most favorable to the non-moving party, but "the mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment; the requirement is that there be no genuine issue of material fact." Id. at 247–48 (emphasis in original).
In patent cases, "summary judgment of non-infringement is appropriate where the patent owner's proof is deficient in meeting an essential element of the infringement charge." Celsis In Vitro, Inc. v. CellzDirect, Inc., 664 F.3d 922, 930 (Fed. Cir. 2012). A determination of patent infringement requires a two-step analysis: first, the court must construe the asserted claims to determine their scope and meaning as a matter of law; and second, the properly construed claims must be compared to the accused device to determine whether every limitation of the claim is met. Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996); Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454 (Fed. Cir. 1998) (en banc).
The first step — claim construction — is a question of law for the Court. Markman, 52 F.3d at 979. That step has been completed in this action through the Court's December 6, 2024 Claim Construction Order (D.I. 187). The second step — comparing the construed claims to the accused product — is a question of fact, but summary judgment is appropriate where there is no genuine dispute regarding the structure or operation of the accused product and the comparison can be performed as a matter of law. PC Connector Solutions LLC v. SmartDisk Corp., 406 F.3d 1359, 1364 (Fed. Cir. 2005); Gart v. Logitech, Inc., 254 F.3d 1334, 1339 (Fed. Cir. 2001) ("When no reasonable jury could find that every limitation recited in a properly construed claim either literally or under the doctrine of equivalents is found in an accused device, the patentee has failed to meet its burden and the accused infringer is entitled to judgment as a matter of law.").
The patentee bears the burden of proving infringement by a preponderance of the evidence. SmithKline Diagnostics, Inc. v. Helena Labs. Corp., 859 F.2d 878, 889 (Fed. Cir. 1988). Where the undisputed facts show that at least one limitation of each asserted claim is absent from the accused product, summary judgment of non-infringement is warranted. Lemelson v. U.S., 752 F.2d 1538, 1551 (Fed. Cir. 1985); TechSearch, L.L.C. v. Bramwell Partners LLC, 286 F.3d 1360, 1369 (Fed. Cir. 2002) ("To establish literal infringement, every limitation set forth in a claim must be found in an accused product.") (quoting Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1575 (Fed. Cir. 1995)).
With respect to the doctrine of equivalents, infringement may be found where an element of the accused product "performs substantially the same function in substantially the same way to achieve substantially the same result" as a claim limitation. Warner-Jenkinson Co. v. Harborline Enterprises Davis Chem. Co., 520 U.S. 17, 40 (1997). However, the doctrine of equivalents is subject to several important limitations, including prosecution history estoppel and the all-limitations rule. Under the doctrine of prosecution history estoppel, a patentee who narrows a claim during prosecution to obtain the patent may not later assert equivalents that would recapture the surrendered subject matter. Festo Corp. v. Fenmore & Co., 535 U.S. 722, 733–34 (2002). When a claim amendment is made for a "substantial reason related to patentability," a presumption arises that the patentee surrendered the territory between the original claim and the amended claim, and the patentee bears the burden of rebutting that presumption by demonstrating that: (1) the alleged equivalent was unforeseeable at the time of the amendment; (2) the rationale underlying the amendment bore no more than a tangential relation to the equivalent in question; or (3) there is some other reason suggesting that the patentee could not reasonably have been expected to have described the alleged equivalent. Id. at 740–41. Under the all-limitations rule, the doctrine of equivalents cannot be applied in a manner that effectively eliminates a claim limitation. Freedman Seating Co. v. Am. Seating Co., 420 F.3d 1350, 1358 (Fed. Cir. 2005).
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 the cannula; and a locking seal assembly disposed at the proximal end of the cannula, the locking seal assembly configured to form a fluid-tight seal around an instrument inserted through the cannula . . . ."
('237 Patent, col. 14, ll. 8–22 (emphasis added).)
Dependent Claims 3, 7, and 12 each depend from Claim 1 — Claims 3 and 7 directly, and Claim 12 through intervening Claim 9, which itself depends from Claim 1. Each dependent claim therefore necessarily incorporates the "locking seal assembly" limitation of Claim 1, in addition to reciting further narrowing limitations. (See '237 Patent, col. 14, ll. 28–32 (Claim 3: "The surgical access device of claim 1, wherein the locking seal assembly further comprises a positive detent engagement member . . ."); col. 14, ll. 45–51 (Claim 7: "The surgical access device of claim 1, wherein the dual-stage mechanical interlock mechanism includes an audible confirmation feature . . ."); col. 15, ll. 8–16 (Claim 12: "The surgical access device of claim 9, wherein the locking seal assembly is configured for single-handed operation . . .").)
This Court construed "locking seal assembly" 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 locking through engagement of at least one detent feature with a corresponding recess on the cannula housing." (D.I. 188 at 22–23.) The Court's construction is the law of this case and governs the infringement analysis.
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 of Undisputed Material Facts above (¶¶ 14–17), the PE-5000's seal consists of a single medical-grade silicone gasket (Part No. PE5-SEAL-440, 40 Shore A durometer) seated within a cylindrical retaining collar. When a surgical instrument is inserted through the trocar cannula, the gasket compresses radially around the instrument shaft, creating a fluid-tight seal through frictional engagement alone. There is no second-stage axial locking. There is no detent feature. There is no corresponding recess machined into the cannula housing. There is no mechanical interlock of any kind. The seal operates through a single, continuous radial compression event — not through a dual-stage mechanism involving both radial compression and axial detent engagement. (Bauer Decl. Exs. I, J, L; Tanaka Dep. at 88:6–91:14; Ostrowski Report ¶¶ 67–82.)
The physical differences between the PE-5000's seal and the claimed "locking seal assembly" are not merely quantitative — they are qualitative and structural. The Court's construction requires three essential components that are entirely absent from the PE-5000: (i) a mechanical interlock mechanism (as opposed to an elastomeric friction fit); (ii) positive detent engagement (as opposed to continuous compression); and (iii) a dual-stage operation involving both radial compression and axial locking through detent-recess engagement (as opposed to a single-stage radial compression event). None of these components or functions is present in the PE-5000.
The design history of the PE-5000 confirms that these differences are fundamental and deliberate. Solstice's engineering team evaluated and rejected a mechanical interlock design for the 5 mm platform during the product's development phase in 2019, concluding that the 5 mm internal diameter of the cannula was physically too small to accommodate a detent ring, annular recesses, and the associated manufacturing tolerances required for reliable detent engagement. (Bauer Decl. Ex. M (Design History File Excerpt, Bates Nos. SBD-022145 through SBD-022168); Tanaka Dep. at 94:2–97:18.) The PE-5000's friction-fit elastomeric seal was purpose-designed as an alternative sealing architecture for the 5 mm form factor.
Critically, Apex's own expert, Dr. Calvin Ng, does not dispute the physical structure of the PE-5000's seal mechanism. Dr. Ng acknowledged in his expert 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.) At his deposition, Dr. Ng confirmed that "[u]nder 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." (Ng Dep. at 143:11–144:2.)
Dr. Ng's infringement opinion with respect to the PE-5000 is based entirely on Apex's rejected claim construction — that "locking seal assembly" means simply "any seal assembly that resists unintentional displacement of a surgical instrument during use." (Ng Report ¶¶ 95–98.) The Court rejected this construction as inconsistent with the intrinsic evidence. (D.I. 188 at 20.) An expert opinion premised on a claim construction that the Court has rejected cannot create a genuine dispute of material fact. See Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1321 (Fed. Cir. 2009) ("An expert's conclusory assertion based on a rejected claim construction is insufficient to create a genuine issue of material fact for purposes of summary judgment."); Glenrock Enterprises v. Adriatic Partners LLC, 242 F.3d 1337, 1344 (Fed. Cir. 2001).
No reasonable jury, applying the Court's construction of "locking seal assembly," could find that the PE-5000 Series satisfies this limitation. Accordingly, the PE-5000 does not literally infringe Claim 1 of the '237 Patent.
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 containing all the limitations of) that claim.").
Moreover, even setting aside the independent claim limitation, the dependent claims recite additional limitations that the PE-5000 does not practice. Claim 3 requires "a positive detent engagement member configured to produce an audible click upon full engagement." ('237 Patent, col. 14, ll. 28–32.) The PE-5000 has no detent engagement member and produces no audible click upon instrument insertion. (Ostrowski Report ¶ 83; Tanaka Dep. at 92:4–93:8.) Claim 7 requires that "the dual-stage mechanical interlock mechanism includes an audible confirmation feature integrated with a visual alignment indicator." ('237 Patent, col. 14, ll. 45–51.) The PE-5000 has no dual-stage mechanical interlock mechanism, no audible confirmation feature, and no visual alignment indicator associated with seal engagement. (Ostrowski Report ¶ 84; Tanaka Dep. at 93:9–93:22.) Claim 12 requires that "the locking seal assembly is configured for single-handed operation with a maximum actuation force of 5 N." ('237 Patent, col. 15, ll. 8–16.) Because the PE-5000 has no "locking seal assembly" as construed, this limitation is not met, and in any event, the PE-5000's friction-fit seal does not involve any deliberate "actuation" — it is a passive compression that occurs automatically upon instrument insertion. (Ostrowski Report ¶ 86.)
For all of these reasons, Solstice is entitled to summary judgment of non-infringement as to Claims 1, 3, 7, and 12 of the '237 Patent.
B. The PE-5000 Series Does Not Literally Infringe the '884 Patent
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 within the cannula assembly, the obturator assembly comprising a cutting blade and a retractable blade deployment mechanism configured to deploy the cutting blade from a retracted position to a deployed position and to retract the cutting blade from the deployed position to the retracted position . . . ."
('884 Patent, col. 12, ll. 15–28 (emphasis added).)
Dependent Claims 2, 5, 9, and 14 each depend from Claim 1 — Claims 2 and 5 directly, Claim 9 through intervening Claim 6, and Claim 14 through intervening Claim 11. Each dependent claim therefore incorporates all of the limitations of Claim 1, including the "retractable blade deployment mechanism" limitation.
This Court construed "retractable blade deployment mechanism" 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 to retract from the deployed position to the retracted position under spring force." (D.I. 188 at 33–34.)
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 PE-5000's obturator assembly includes a sharpened pyramidal trocar tip mounted on a linear push-rod. To deploy the blade, the surgeon applies forward thumb pressure on a sliding actuator located on the proximal end of the obturator handle. The push-rod translates linearly within the handle housing, advancing the blade from the retracted position to the deployed position. To retract the blade, the surgeon reverses the motion, pulling the sliding actuator rearward along the same linear track, thereby manually drawing the push-rod and blade back to the retracted position. The entire actuation sequence is manual, linear, and bidirectional. (Bauer Decl. Exs. I, O; Tanaka Dep. at 103:8–108:14; Ostrowski Report ¶¶ 89–114.)
The PE-5000 does not contain a spring of any kind within the obturator assembly. There is no stored mechanical energy. There is no mechanism by which the blade retracts automatically or under spring force. The blade remains in whatever position the surgeon places it until the surgeon manually moves it. (Tanaka Dep. at 105:22–106:8; Ostrowski Report ¶¶ 92–95.)
The PE-5000 does not contain a trigger. There is no lever, button, switch, or other discrete input device that, when actuated, releases stored energy to drive blade retraction. The sliding actuator on the PE-5000 is not a "trigger" within any reasonable understanding of that term — it is a simple linear slide that the surgeon pushes forward to advance the blade and pulls backward to retract it. There is no "discrete trigger actuation step" — i.e., no "separate, user-initiated mechanical input that is distinct from the act of advancing the blade" (as the Court construed this term in dependent Claims 2 and 5). The same input (linear thumb pressure on the sliding actuator) is used for both advancement and retraction. (Bauer Decl. Ex. I at 25–26; Tanaka Dep. at 107:3–108:14; Ostrowski Report ¶¶ 96–102.)
Once again, Apex's own expert, Dr. Ng, does not dispute the physical structure of the PE-5000's blade mechanism. Dr. Ng acknowledged 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.) At his deposition, Dr. Ng confirmed unequivocally: "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.)
Dr. Ng's infringement opinion as to the PE-5000 is based on Apex's broader proposed construction — "any mechanism that advances and retracts a cutting blade in a trocar system" — which the Court rejected. (Ng Report ¶ 114; D.I. 188 at 30.) Under the Court's adopted construction, which requires a "spring-loaded retraction system with a discrete trigger actuation step," the undisputed absence of any spring and any trigger in the PE-5000 is dispositive.
No reasonable jury, applying the Court's construction of "retractable blade deployment mechanism," could find that the PE-5000 Series satisfies this limitation. Accordingly, the PE-5000 does not literally infringe Claim 1 of the '884 Patent.
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 that "the retractable blade deployment mechanism includes a discrete trigger actuation step that is independent of a blade advancement input." ('884 Patent, col. 12, ll. 30–33.) As noted, the PE-5000's sliding actuator performs both advancement and retraction functions — there is no separate trigger input. (Ostrowski Report ¶ 103.) Claim 5 further requires that "the discrete trigger actuation step comprises depressing a trigger lever disposed on the obturator handle." ('884 Patent, col. 12, ll. 42–45.) The PE-5000 has no trigger lever. (Ostrowski Report ¶ 105; Tanaka Dep. at 108:15–109:2.) Claim 9 requires that "the spring-loaded retraction system comprises a coiled retraction spring having a spring constant between 0.8 N/mm and 3.5 N/mm." ('884 Patent, col. 13, ll. 5–9.) The PE-5000 has no retraction spring. (Ostrowski Report ¶ 108.) Claim 14 requires that "upon release of the trigger, the blade retracts to the retracted position in less than 200 milliseconds." ('884 Patent, col. 13, ll. 25–29.) The PE-5000 has no trigger and no automatic retraction; the blade retracts only as fast as the surgeon manually pulls the sliding actuator. (Ostrowski Report ¶ 111.)
For all of these reasons, Solstice is entitled to summary judgment of non-infringement as to Claims 1, 2, 5, 9, and 14 of the '884 Patent.
C. The Doctrine of Equivalents Does Not Save Apex's Infringement Claims
Even if Apex could not establish literal infringement — which it cannot — Apex's infringement claims also fail under the doctrine of equivalents. Both prosecution history estoppel and the all-limitations rule bar any attempt by Apex to extend its claims to cover the PE-5000's fundamentally different architecture.
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 patentee may rebut this presumption only by showing that: (1) the alleged equivalent was unforeseeable at the time of the amendment; (2) the rationale underlying the amendment bore no more than a tangential relation to the equivalent in question; or (3) there is some other reason suggesting that the patentee could not reasonably have been expected to have described the alleged equivalent. Id. at 740–41.
The '237 Patent. During prosecution of the '237 Patent, Apex narrowed Claim 1 by amendment to add the "dual-stage mechanical interlock mechanism with positive detent engagement" limitation. This amendment was made in Apex's October 14, 2016 Response to Office Action for the express purpose of overcoming an anticipation rejection based on the Mercer prior art reference (U.S. Patent No. 7,883,492). (Bauer Decl. Ex. Q.) In that Response, Apex's patent counsel argued that the Mercer reference disclosed only a "single-stage elastomeric friction seal" and that the amended claims were patentable because they required a "dual-stage mechanical interlock" that Mercer did not teach. (Id. at 7–9.) The amendment was unquestionably made for a "substantial reason related to patentability" — it was the basis upon which the examiner allowed the claims.
The PE-5000's friction-fit elastomeric seal is precisely the type of seal that Apex distinguished and surrendered during prosecution. Apex argued that a "single-stage elastomeric friction seal" — which is exactly what the PE-5000 uses — was insufficient to constitute a "locking seal assembly" and that the dual-stage mechanical interlock was the distinguishing feature. Apex cannot now recapture through the doctrine of equivalents the very subject matter it surrendered to obtain the patent. See Honeywell Int'l, Inc. v. Hamilton Sundstrand Corp., 370 F.3d 1131, 1143 (Fed. Cir. 2004) (en banc) ("The question [under Festo] is whether the surrendered subject matter can be shown to be not more than tangential to the amendment.").
None of the Festo exceptions apply. First, friction-fit elastomeric seals were not unforeseeable at the time of the amendment — they were the very technology that Apex was distinguishing over. The Mercer reference itself disclosed such a seal, and Apex's prosecution arguments were directed at explaining why the claimed invention was different from that seal. Second, the rationale for the amendment was not tangential to the alleged equivalent — it was directed squarely at the distinction between friction-fit seals and mechanical interlock mechanisms. Third, there is no other reason to believe Apex could not have described a friction-fit elastomeric seal as an equivalent at the time of the amendment; to the contrary, Apex deliberately excluded such seals from the claim scope.
The '884 Patent. The same analysis applies to the '884 Patent. During prosecution, Apex narrowed Claim 1 by amendment to add the "spring-loaded retraction system with a discrete trigger actuation step" limitation in its March 22, 2018 Response to Office Action. (Bauer Decl. Ex. R.) This amendment was made to overcome an obviousness rejection based on the Chen and Mikhailov prior art references. In arguing for patentability, Apex specifically distinguished the Chen reference's manual push-rod system, asserting that Chen "fails to disclose a spring-loaded retraction system or a discrete trigger actuation step" and that Chen's "manual advancement and retraction of the blade via a sliding push-rod" was fundamentally different from the claimed invention. (Id. at 11.)
The PE-5000 uses a manual push-rod system that is structurally analogous to — and in key respects identical to — the Chen reference that Apex distinguished during prosecution. Apex surrendered the territory occupied by manual push-rod blade advancement mechanisms when it amended its claims to require spring-loaded trigger retraction. Prosecution history estoppel bars Apex from reasserting equivalents-based infringement over the PE-5000's manual push-rod mechanism.
Again, none of the Festo exceptions apply. Manual push-rod mechanisms were not unforeseeable — they were the subject of the prior art rejection. The rationale for the amendment was directed at the very distinction between manual push-rod systems and spring-loaded trigger systems. And Apex was plainly aware of manual push-rod systems at the time of the amendment, having expressly discussed and distinguished them in its prosecution arguments.
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 doctrine may not be used to effectively eliminate a claim limitation." Freedman Seating, 420 F.3d at 1358.
Here, applying the doctrine of equivalents to find that the PE-5000's friction-fit elastomeric seal is "equivalent" to the claimed "locking seal assembly" (i.e., a dual-stage mechanical interlock with positive detent engagement) would effectively eliminate the "dual-stage mechanical interlock mechanism with positive detent engagement" limitation from the claim. The entire purpose of this limitation, as the Court found in its Claim Construction Order and as the prosecution history confirms, is to distinguish mechanical interlock seals from friction-fit seals. Finding equivalence between the two would render the limitation meaningless. See Moore U.S.A., Inc. v. Standard Register Co., 229 F.3d 1091, 1106 (Fed. Cir. 2000) ("If a theory of equivalence would entirely vitiate a particular claim element, partial or complete judgment should be rendered by the court, as there would be nothing further for the jury to decide.").
Similarly, finding that the PE-5000's manual push-rod mechanism is "equivalent" to the claimed "retractable blade deployment mechanism" (i.e., a spring-loaded retraction system with a discrete trigger actuation step) would effectively eliminate the "spring-loaded retraction system" and "discrete trigger actuation step" limitations from the claim. The Court's construction specifically requires stored mechanical energy (a spring) and a separate user input (a trigger) that are wholly absent from the PE-5000. Finding equivalence would vitiate these limitations entirely.
Furthermore, there is no equivalent function, way, or result between the PE-5000's mechanisms and the claimed mechanisms as construed. With respect to the seal, the PE-5000's friction-fit seal functions through elastic radial compression alone, whereas the claimed dual-stage mechanical interlock functions through both radial compression and axial detent engagement — a fundamentally different "way" of achieving sealing and locking. With respect to the blade mechanism, the PE-5000's manual push-rod functions through direct manual force in both directions, whereas the claimed spring-loaded trigger mechanism functions through stored mechanical energy released by a discrete trigger — again, a fundamentally different "way" of achieving blade retraction.
For all of these reasons, the doctrine of equivalents does not save Apex's infringement claims with respect to the PE-5000 Series.
D. No Genuine Dispute of Material Fact Precludes Summary Judgment
This case presents the paradigmatic scenario for summary judgment of non-infringement. The Court has construed the disputed claim terms. The physical structure and operation of the PE-5000 Series are not in dispute. The parties' experts agree on what the PE-5000 does — it employs a friction-fit elastomeric seal and a manual push-rod blade mechanism. The experts differ only on whether these features satisfy the asserted claim limitations, and that disagreement is rooted entirely in the parties' differing claim construction positions, which the Court has now resolved.
Dr. Ng's infringement opinions with respect to the PE-5000 are premised on Apex's proposed claim constructions, which the Court rejected. Under the Court's adopted constructions, Dr. Ng's own factual admissions — that the PE-5000 lacks a mechanical detent ring, corresponding cannula recesses, a spring, and a trigger — establish that the PE-5000 does not satisfy the asserted claim limitations. An expert opinion that relies on a rejected legal standard cannot create a genuine dispute of material fact sufficient to defeat summary judgment. See Exergen, 575 F.3d at 1321; Ashbury Industries, Inc. v. Teva Pharms., USA, Inc., 429 F.3d 1364, 1373–74 (Fed. Cir. 2005) (affirming summary judgment of non-infringement where expert's infringement opinion was predicated on claim construction the court rejected).
Apex cannot create a genuine dispute by reasserting claim constructions the Court has already rejected or by pointing to alleged similarities between the PE-5000 and the patented invention at a level of generality that ignores the specific claim limitations the Court has construed. The sole question before the Court is the application of the Court's constructions to undisputed product features — a comparison that can and should be resolved on summary judgment. See PC Connector Solutions, 406 F.3d at 1364; Chimie v. PPG Indus., Inc., 402 F.3d 1371, 1376 (Fed. Cir. 2005) ("Where the parties do not dispute any relevant facts regarding the accused product . . . but disagree over claim construction and the meaning of the claims, the question of infringement collapses to one of claim construction and is amenable to summary judgment.").
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

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

TABLE OF CONTENTS

I. INTRODUCTION

II. PROCEDURAL HISTORY

III. STATEMENT OF UNDISPUTED MATERIAL FACTS

IV. LEGAL STANDARD

V. ARGUMENT

VI. CONCLUSION AND PRAYER FOR RELIEF

Record

Parties

Dates

Amounts