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PRIVILEGED AND CONFIDENTIAL — ATTORNEY WORK PRODUCT

INTERNAL STRATEGY MEMORANDUM

CALDERWOOD & HARKNESS LLP intellectual Property Litigation Group

FROM: Christy Bauer, Lead Associate, intellectual Property, Calderwood & Harkness LLP

TO: Marcus Delgado, Responsible Partner, intellectual Property, Calderwood & Harkness LLP

CC: Catherine Bloom, Billing Partner; Peter Vassiliev, Working Associate

DATE: March 15, 2025

RE: Summary Judgment Strategy — Non-Infringement of U.S. Patent Nos. 9,814,237 and 10,271,884 as to PrecisionEdge™ PE-5000 Series

MATTER: Solstice Biomedical Devices Ltd. — Patent Infringement Defense; Matter No. 10294.0017

CASE: Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA (D. Del.)

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I. Executive Summary

This memorandum analyzes whether Solstice Biomedical, Inc. ("Solstice") should file a motion for summary judgment of non-infringement limited to the PrecisionEdge™ PE-5000 Series, the 5 mm trocar assembly that is one of the three product lines accused in this litigation. For the reasons set forth in detail below, I recommend that we proceed with filing the motion for summary judgment targeting the PE-5000 Series only, on the basis that the Court's Claim Construction Order — issued December 6, 2024 by Judge Richard G. Andrews — construed key disputed claim terms in a manner that places the PE-5000 outside the literal scope of the asserted claims of both the '237 Patent and the '884 Patent.

As a threshold matter, it is important to note that the PE-5000 is not accused of infringing the third asserted patent in this case, U.S. Patent No. 10,932,105 (the "'105 Patent"). Apex asserts only the '237 Patent and the '884 Patent against the PE-5000. Accordingly, a successful motion for summary judgment on these two patents would eliminate the PE-5000 from the case entirely.

The proposed filing date is April 1, 2025, which is consistent with the Scheduling Order's deadline for dispositive motions. This timeline affords sufficient opportunity to finalize the motion papers and supporting declarations while meeting the Court's deadline.

My assessment of the likelihood of success is as follows: the motion presents a moderate-to-strong basis for summary judgment on the '237 Patent claims, and a moderate basis for summary judgment on the '884 Patent claims. The combined assessment supports filing. On the '237 Patent, the Court's construction of "locking seal assembly" — requiring a "distinct locking element" that "mechanically engages" the seal body — is effectively dispositive, as the PE-5000's friction-fit seal design undisputedly lacks any such discrete mechanical locking element. On the '884 Patent, the analysis is closer, turning on whether the PE-5000's cam-driven blade retraction upon manual trigger release constitutes "automatic" retraction within the meaning of the Court's construction. While this issue is genuinely contested, the weight of the intrinsic evidence and the undisputed physical characteristics of the PE-5000 support our position.

Even if the motion is ultimately denied in whole or in part, the filing serves important strategic purposes. The briefing will sharpen the issues for trial, which is currently set for September 30, 2025, and will provide the jury and the Court with a clear framework for evaluating the non-infringement defense. Additionally, the motion provides additional settlement leverage, particularly given that the prior mediation session on March 17, 2025, before the Honorable Margaret Forsythe (Ret.) at Amberstone ADR Services, did not resolve the case. A well-supported motion for summary judgment signals Solstice's confidence in its defense and may motivate Apex to reassess its damages expectations.

I request your approval to proceed with drafting, with an estimated completion date of March 25, 2025 for a draft of the motion papers for partner review.

II. Background

A. The Parties

Solstice Biomedical Devices Ltd. is an Irish-domiciled private company (Companies Registration Office No. 648217), founded in 2011, that designs and manufactures minimally invasive surgical instruments for the global market. The company reported fiscal year 2023 revenue of €187.4 million and employs approximately 620 people worldwide, with manufacturing facilities in Galway, Ireland, and distribution operations throughout Europe, North America, and Asia-Pacific.

The named defendant in this action is Solstice Biomedical, Inc., the U.S. operating subsidiary of Solstice Biomedical Devices Ltd. Solstice Biomedical, Inc. is a Delaware corporation (EIN: 84-3291056), with its principal offices located at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803. The U.S. subsidiary manages all sales, marketing, and distribution activities for PrecisionEdge™ products within the United States.

Apex Surgical Innovations, Inc. ("Apex") is a Delaware corporation (EIN: 51-0483762), founded in 2006, that manufactures surgical access devices and trocar systems. Apex is a larger competitor in the surgical access device space, with estimated fiscal year 2023 revenue of approximately $312 million and approximately 1,100 employees. Apex is the named plaintiff in this action and is the assignee of all three asserted patents. Apex is represented in this matter by Hargrove, Tate & Bennington LLP, with Victoria Stanton serving as lead partner and Derek Loomis as the primary associate on the case.

B. Procedural History

Apex filed its Complaint for Patent Infringement on May 9, 2024, asserting infringement of U.S. Patent Nos. 9,814,237, 10,271,884, and 10,932,105. Solstice was served with the Complaint on May 23, 2024.

Solstice filed its Answer, Affirmative Defenses, and Counterclaims on June 14, 2024. The counterclaims asserted non-infringement, invalidity, and inequitable conduct with respect to all three asserted patents. The inequitable conduct counterclaim is based on the failure of Dr. Raymond Szabo, the named inventor on all three patents, to disclose certain prior art references to the Patent Office during prosecution, as detailed in our separate memorandum dated August 12, 2024.

The Court entered its Scheduling Order on July 2, 2024, establishing the following key deadlines: close of fact discovery on December 20, 2024; close of expert discovery on March 7, 2025; dispositive motion deadline of April 1, 2025; pretrial conference on August 15, 2025; and trial commencing September 30, 2025.

Discovery in this case has been extensive. Solstice produced 48,217 documents (Bates Nos. SBD-000001 through SBD-048217), encompassing product design files, engineering notebooks, regulatory submissions, manufacturing specifications, sales data, internal communications regarding the PrecisionEdge™ product line, and prior art materials. Apex produced 31,450 documents (Bates Nos. APEX-000001 through APEX-031450), including patent prosecution files, prior art references, internal design documents, and licensing materials. The parties also exchanged interrogatory responses and conducted a total of fourteen fact depositions, including depositions of key engineers, sales personnel, and corporate designees from both sides.

Claim construction briefing proceeded on the following schedule: the parties exchanged proposed claim constructions on October 22, 2024; the Joint Claim Construction Brief was filed on November 4, 2024; and the Markman hearing was held on November 18, 2024 before Judge Andrews. The Court issued its Claim Construction Order on December 6, 2024, construing nine disputed claim terms. Of these nine terms, five were construed favorably to Solstice and four were construed favorably to Apex. The two constructions most critical to this proposed motion are discussed in detail in Section III below.

Expert discovery opened on January 13, 2025. The following reports have been served to date: Dr. Karl Ostrowski (Solstice's technical expert) served his invalidity and claim construction report on January 27, 2025; Dr. Jennifer Ng (Apex's technical expert) served her infringement report on February 10, 2025; both parties' damages experts served their respective reports on February 14, 2025 (Hugh Danaher for Apex and Dr. Elena Marchetti for Solstice); and rebuttal expert reports were exchanged on March 3, 2025. Expert depositions are currently being scheduled and are expected to be completed by the close of expert discovery.

C. The Asserted Patents and Accused Products

The Asserted Patents

All three asserted patents list Dr. Raymond Szabo, Apex's Vice President of Engineering, as the sole named inventor, and all three are assigned to Apex Surgical Innovations, Inc.

U.S. Patent No. 9,814,237 (the "'237 Patent") is titled "Locking Seal Assembly for Minimally Invasive Surgical Access Device." It was issued on November 14, 2017, and expires on June 22, 2035. The '237 Patent is directed to a seal assembly for use in trocar devices that incorporates a locking mechanism to maintain the seal in a closed position during surgical procedures. Apex asserts Claims 1, 3, 7, and 12 of the '237 Patent against the PE-5000 Series.

U.S. Patent No. 10,271,884 (the "'884 Patent") is titled "Retractable Blade Deployment Mechanism for Trocar Systems." It was issued on April 30, 2019, and expires on September 15, 2036. The '884 Patent is directed to a mechanism for deploying and retracting a cutting blade within a trocar assembly, with particular emphasis on safety features relating to automatic retraction of the blade following penetration of the abdominal wall. Apex asserts Claims 1, 2, 5, 9, and 14 of the '884 Patent against the PE-5000 Series.

U.S. Patent No. 10,932,105 (the "'105 Patent") is titled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar." It was issued on March 2, 2021, and expires on January 10, 2038. Apex asserts Claims 1, 4, and 8 of the '105 Patent, but not against the PE-5000 Series. The '105 Patent is asserted only against the PE-12000 and PE-15000 product lines.

The Accused Products

Apex accuses three product lines within the Solstice PrecisionEdge™ family of infringing the asserted patents:

• PE-5000 Series (5 mm trocar assembly): Accused of infringing the '237 Patent (Claims 1, 3, 7, 12) and the '884 Patent (Claims 1, 2, 5, 9, 14). The PE-5000 is the smallest and simplest trocar in the PrecisionEdge™ line, designed for 5 mm laparoscopic port access. This is the only product line at issue in the proposed motion for summary judgment.

• PE-12000 Series (12 mm trocar assembly): Accused of infringing all three asserted patents. The PE-12000 is a more complex design that incorporates additional sealing and blade features not present in the PE-5000.

• PE-15000 Series (15 mm trocar assembly): Accused of infringing the '884 Patent and the '105 Patent. The PE-15000 is the largest trocar in the line and includes features specific to larger-diameter surgical access.

The PE-12000 and PE-15000 product lines are not the subject of this proposed motion. The strategic rationale for limiting the motion to the PE-5000 is discussed in Section VI below.

Combined U.S. sales of all accused PrecisionEdge™ products for the period of calendar year 2021 through the third quarter of 2024 (through September 30, 2024) total $74.6 million. Based on the sales data produced in discovery (Bates Nos. SBD-041200 through SBD-041387), the PE-5000 Series accounts for approximately $18.9 million of that total, representing approximately 25.3% of the combined accused product revenue during the relevant period. This sales breakdown is relevant to the damages exposure analysis discussed in Section VI.B below.

III. The Claim Construction Order — Key Constructions Favorable to Solstice

A. Overview

The Claim Construction Order issued by Judge Andrews on December 6, 2024 construed nine disputed claim terms across the three asserted patents. Of the nine terms, five were construed in a manner favorable to Solstice's non-infringement and invalidity positions, and four were construed in a manner favorable to Apex. While the full scope of the Claim Construction Order has implications across the entire case, the two constructions most critical to the PE-5000 non-infringement motion are (1) the construction of "locking seal assembly" as used in the '237 Patent, and (2) the construction of "retractable blade deployment mechanism" as used in the '884 Patent. These constructions are analyzed in detail below.

B. Construction of "Locking Seal Assembly" ('237 Patent)

The term "locking seal assembly" appears in independent Claim 1 of the '237 Patent and is incorporated by reference into each of the asserted dependent claims (Claims 3, 7, and 12). The parties' proposed constructions differed substantially, and the Court's adopted construction aligns closely with Solstice's proposal.

Apex's Proposed Construction: Apex proposed that "locking seal assembly" should be construed broadly to mean "any seal in a trocar housing that can be secured in a closed position." Under this construction, virtually any seal mechanism — including friction-fit seals, compression seals, and interference-fit designs — could satisfy the limitation, so long as the seal could be maintained in a closed position by some means.

Solstice's Proposed Construction: Solstice proposed a narrower construction, arguing that "locking seal assembly" should be construed to mean "a seal assembly comprising a distinct locking element that mechanically engages the seal body to fix the seal in a closed position independent of external pressure." This construction was based on the intrinsic evidence from the '237 Patent specification, which repeatedly and consistently describes the locking function as being performed by a discrete locking pawl that mechanically engages a corresponding feature on the seal body.

The Court's Construction: The Court adopted Solstice's proposed construction in its entirety, requiring a "distinct locking element" that "mechanically engages" the seal body. In its Claim Construction Order, the Court relied on several pillars of intrinsic evidence:

First, the Court noted that the '237 Patent specification contains no fewer than fourteen references to a "locking pawl" or "discrete locking element" as the mechanism by which the seal is secured in the closed position. The specification consistently distinguishes this mechanism from friction-based or pressure-dependent sealing methods, expressly stating that "[t]he locking seal assembly of the present invention provides a positive mechanical engagement that secures the seal body in the closed position independent of any external pressure applied by the operator or by the insufflation gases." ('237 Patent, col. 4, ll. 22–27.)

Second, the Court examined the prosecution history of the '237 Patent and found that the applicant made narrowing amendments during prosecution to distinguish the claimed invention from the prior art. Specifically, during prosecution, the Examiner rejected the original claims in view of U.S. Patent No. 7,192,430 to Veridian Medical Technologies, which disclosed a friction-fit seal in a trocar housing. In response, Dr. Szabo amended the claims to add the "locking" limitation and argued that the amended claims were patentable over the Veridian reference because the claimed "locking seal assembly" required a "distinct mechanical locking element" that was not disclosed by Veridian's friction-based seal. (See Response to Office Action, filed August 14, 2015, at pp. 8–10.) The Court concluded that these prosecution history statements confirmed that "locking seal assembly" requires a discrete mechanical locking element and cannot encompass friction-fit designs.

Third, the Court rejected Apex's reliance on the doctrine of claim differentiation, finding that although certain dependent claims add specific structural details about the locking element (e.g., Claim 7's "radial compression ring"), the independent claim nonetheless requires the presence of some distinct locking element as a baseline.

Impact on PE-5000: This construction is highly favorable to Solstice's non-infringement defense as to the PE-5000 Series. The PE-5000 employs a friction-fit seal design that does not incorporate any discrete mechanical locking element. In the PE-5000's seal assembly, the seal body is held in the closed position by the inherent friction between the elastomeric seal material and the inner wall of the trocar housing. There is no pawl, no engagement feature, no separate locking component of any kind. The seal is maintained in position solely by the interference fit between the seal's outer surface and the housing bore.

This fact is documented in the PE-5000 design specifications and engineering drawings produced in discovery (Bates Nos. SBD-003412 through SBD-003498) and was confirmed by the testimony of Solstice's Director of Engineering, Colin Farraday, during his deposition on October 8, 2024. Under the Court's construction, the PE-5000 does not practice the "locking seal assembly" limitation.

This construction is dispositive for all four asserted claims of the '237 Patent (Claims 1, 3, 7, and 12), as each claim depends on the "locking seal assembly" element either directly — Claim 1 is the independent claim that expressly recites this limitation — or through dependency, as Claims 3, 7, and 12 each depend from Claim 1 and thus incorporate all of Claim 1's limitations.

C. Construction of "Retractable Blade Deployment Mechanism" ('884 Patent)

The term "retractable blade deployment mechanism" appears in independent Claim 1 of the '884 Patent and is incorporated into each of the asserted dependent claims (Claims 2, 5, 9, and 14). The parties' proposed constructions again differed substantially, and the Court's construction fell between the two proposals — narrower than Apex's but broader than Solstice's.

Apex's Proposed Construction: Apex proposed an expansive construction: "any mechanism that deploys and retracts a cutting blade within a trocar." Under this construction, any blade mechanism capable of movement between extended and retracted positions, by any means, would satisfy the limitation.

Solstice's Proposed Construction: Solstice proposed a much narrower construction: "a spring-loaded mechanism that automatically retracts the blade into a shielded position upon penetration of the abdominal wall, with the blade being deployed by application of axial force to a manually operable actuator." This construction was drawn from the specification's preferred embodiment and prosecution history, which consistently describe the mechanism as spring-loaded.

The Court's Construction: The Court adopted a construction that is narrower than Apex's proposal but broader than Solstice's: "a mechanism that deploys a blade to a cutting position and automatically retracts the blade to a shielded position after penetration." Significantly, the Court did not adopt Solstice's proposed requirement that the mechanism be "spring-loaded," reasoning that while the specification's preferred embodiment uses a spring, the claim language does not expressly require a spring and the specification contains language suggesting that other biasing means could be employed. However, the Court did require that the retraction be "automatic" — meaning the blade must retract without the need for a separate, independent operator action beyond the initial deployment and penetration sequence.

The Court's discussion of the "automatically retracts" aspect of the construction warrants close attention. In the Claim Construction Order, Judge Andrews stated:

"The term 'automatically retracts' as used in the context of the '884 Patent requires that the blade retract to a shielded position without the need for a discrete, affirmative operator action to initiate retraction. The specification distinguishes the claimed mechanism from 'manually actuated retraction systems' (col. 3, ll. 15–18) and describes automatic retraction as the blade returning to a shielded position 'without any operator input following initial penetration' (col. 5, ll. 41–43). The Court finds that this language requires the retraction to occur passively — that is, as an inherent consequence of the penetration event or the mechanical design of the mechanism — rather than as a response to an operator's deliberate act of releasing a control element."

Impact on PE-5000: The PE-5000 employs a cam-driven blade that retracts upon the operator's release of a manual trigger. In operation, the surgeon depresses a manual trigger to deploy the blade to the cutting position. The surgeon then advances the trocar through the abdominal wall. Upon completion of penetration, the surgeon releases the manual trigger, which causes the cam mechanism to rotate and retract the blade to its shielded position. Critically, the blade does not retract until the operator affirmatively releases the trigger. If the operator maintains pressure on the trigger, the blade remains in the deployed, cutting position indefinitely.

The question presented is whether the PE-5000's cam-driven retraction upon manual trigger release qualifies as "automatic" retraction under the Court's construction. This is the central contested issue for the '884 Patent portion of the motion. As discussed further in Section V below, we believe that the PE-5000's design does not meet the "automatic" retraction requirement because retraction requires the operator to perform a discrete, affirmative act (releasing the trigger) to initiate the retraction sequence. However, Apex and its expert, Dr. Ng, will argue that trigger release is a passive act (the mere cessation of applied force) and therefore qualifies as automatic retraction.

This analysis is closer than the '237 Patent analysis and is discussed in detail in Section V.

D. Other Favorable Constructions (Secondary Relevance)

Of the five constructions that favored Solstice, the remaining three relate to terms used in the '105 Patent or in claims not asserted against the PE-5000. Most notable is the Court's construction of "integrated insufflation valve" in the '105 Patent, which requires a "single-piece valve body incorporating both the insufflation and sealing functions." This construction is significant for the broader case — it may support non-infringement of the '105 Patent as to the PE-12000 and PE-15000 — but it is not relevant to the PE-5000 motion because the '105 Patent is not asserted against the PE-5000.

With respect to the four constructions that favored Apex, none directly impacts the core non-infringement analysis for the PE-5000. The most significant of the Apex-favorable constructions relates to the term "trocar housing" in both the '237 and '884 Patents, which the Court construed more broadly than Solstice had proposed. However, there is no dispute that the PE-5000 includes a "trocar housing" under any reasonable construction, so this term does not affect the analysis. The remaining three Apex-favorable constructions pertain to limitation elements that are undisputedly present in the PE-5000 and are therefore not contested.

IV. Non-Infringement Analysis — '237 Patent (Claims 1, 3, 7, 12)

A. Independent Claim 1

Claim 1 of the '237 Patent is an independent claim that recites a trocar assembly comprising multiple elements, including the critical "locking seal assembly" limitation. A complete element-by-element walkthrough of Claim 1 against the PE-5000 technical design is set forth below.

Claim 1 of the '237 Patent reads as follows:

1. A surgical access device comprising:

a trocar housing having a proximal end and a distal end and defining a central lumen extending therethrough;

an obturator slidably received within the central lumen;

a locking seal assembly disposed within the trocar housing at the proximal end, the locking seal assembly comprising a seal body and a distinct locking element that mechanically engages the seal body to fix the seal in a closed position independent of external pressure; and

a cannula extending distally from the trocar housing and configured for insertion through an incision in a patient's body wall.

Element (a) — "a trocar housing having a proximal end and a distal end and defining a central lumen extending therethrough": The PE-5000 includes a cylindrical trocar housing with defined proximal and distal ends and a central lumen. This element is met. There is no dispute between the parties on this point.

Element (b) — "an obturator slidably received within the central lumen": The PE-5000 includes an obturator that is slidably received within the central lumen of the trocar housing. This element is met. There is no dispute between the parties on this point.

Element (c) — "a locking seal assembly disposed within the trocar housing at the proximal end, the locking seal assembly comprising a seal body and a distinct locking element that mechanically engages the seal body to fix the seal in a closed position independent of external pressure": This is the critical missing limitation. The PE-5000 does not include a "locking seal assembly" as construed by the Court. The PE-5000 employs a friction-fit seal design that consists of an elastomeric seal body press-fit into the proximal end of the trocar housing. The seal body is held in the closed position by the frictional engagement between the elastomeric material and the inner wall of the housing. There is no "distinct locking element" — no pawl, no detent, no engagement feature, no separate locking component of any kind — that mechanically engages the seal body. The seal is maintained entirely by material compression and friction. This element is not met.

Element (d) — "a cannula extending distally from the trocar housing and configured for insertion through an incision in a patient's body wall": The PE-5000 includes a 5 mm cannula extending distally from the trocar housing. This element is met. There is no dispute between the parties on this point.

The only disputed element is Element (c), and the basis for non-infringement is clear and well-supported. Our preliminary claim chart, prepared on July 20, 2024, identified this gap early in the case, well before claim construction. The favorable claim construction has confirmed and strengthened our position.

The conclusion that the PE-5000 lacks a "distinct locking element" is supported by the following evidence:

• PE-5000 Design Specifications and Engineering Drawings (Bates Nos. SBD-003412 through SBD-003498): These documents, produced in discovery, include the complete design specifications and annotated engineering drawings for the PE-5000 seal assembly. The drawings unambiguously depict a friction-fit seal with no discrete locking component. Dimensional specifications confirm that the seal body is designed to be press-fit into the housing bore with an interference fit of approximately 0.15 mm, and no additional locking feature is specified or shown.

• Dr. Karl Ostrowski's Expert Report (served January 27, 2025): Dr. Ostrowski, Solstice's technical expert and a professor of biomedical engineering at the University of Pennsylvania, examined the PE-5000 design specifications, disassembled physical samples of the PE-5000, and performed detailed measurements and imaging of the seal assembly. He concluded that the PE-5000 seal assembly "does not include any distinct locking element that mechanically engages the seal body" and that "the seal is held in position exclusively by the inherent friction between the elastomeric material and the housing wall." (Ostrowski Report, ¶¶ 87–94.)

• Deposition Testimony of Colin Farraday (Solstice Director of Engineering, October 8, 2024): Mr. Farraday testified that the PE-5000 seal was intentionally designed as a friction-fit assembly to achieve simplicity and cost efficiency in the 5 mm form factor, and that no mechanical locking feature was ever considered for or incorporated into the PE-5000 seal design. (Farraday Dep. Tr. at 112:8–114:3.)

• Physical Samples: Physical samples of the PE-5000 were produced for inspection and are available for submission to the Court. Disassembly of the seal assembly confirms the absence of any locking element.

There is no genuine dispute of material fact on this issue. Apex has not identified any feature in the PE-5000 that it contends constitutes a "distinct locking element" other than the friction-fit seal itself. Dr. Ng's infringement report (February 10, 2025) does not identify a specific locking element in the PE-5000 but instead argues that the friction-fit seal "functions as a lock" because it holds the seal in the closed position. However, this argument is foreclosed by the Court's construction, which requires a distinct locking element separate from the seal body itself. The friction between the seal material and the housing wall is an inherent material property, not a distinct mechanical locking element.

B. Dependent Claims 3, 7, and 12

Each of the dependent claims asserted by Apex against the PE-5000 depends from independent Claim 1 and therefore incorporates all of Claim 1's limitations, including the "locking seal assembly" limitation. As a matter of patent law, it is axiomatic that "[o]ne who does not infringe an independent claim cannot infringe a claim dependent on (and thus containing all the limitations of) that claim." Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1552 n.9 (Fed. Cir. 1989). If the PE-5000 does not practice the "locking seal assembly" limitation of Claim 1, it necessarily does not infringe Claims 3, 7, or 12.

For completeness, Claim 7 provides an additional, independent basis for non-infringement. Claim 7 depends from Claim 1 and further requires "a radial compression ring disposed circumferentially about the seal body and configured to apply inward radial pressure to maintain the seal body in the closed position." The PE-5000 does not include a radial compression ring; the PE-5000's seal body is a monolithic elastomeric component with no separate compression ring or circumferential pressure element. This absence provides a further, independent basis for non-infringement of Claim 7, even if a dispute were to arise regarding the "locking seal assembly" limitation.

C. Doctrine of Equivalents

We anticipate that Apex will argue, in opposition to the motion, that even if the PE-5000 does not literally infringe the "locking seal assembly" limitation, the PE-5000's friction-fit seal is equivalent to a "locking seal assembly" under the doctrine of equivalents. We are well-positioned to defeat this argument on two independent grounds.

First, prosecution history estoppel bars Apex from recapturing through the doctrine of equivalents the scope of coverage that it surrendered during prosecution. As discussed in Section III.B above, during prosecution of the '237 Patent, the Examiner rejected the original claims in view of the Veridian Medical Technologies prior art patent (U.S. Patent No. 7,192,430), which disclosed a friction-fit seal in a trocar housing. In response, Apex (through Dr. Szabo as inventor and applicant) amended the claims to add the "locking" limitation specifically to distinguish the claimed invention from the Veridian friction-fit seal. Apex argued to the Patent Office that its "locking seal assembly" was patentable over Veridian because it required a "distinct mechanical locking element" not present in Veridian's friction-based seal design.

Under Festo Corp. v. Fenmore & Co., 535 U.S. 722 (2002), a narrowing amendment made during prosecution to avoid prior art creates a presumption that the patent holder surrendered the territory between the original claim scope and the amended claim scope. Here, the original claims were broad enough to encompass friction-fit seals; the amendment narrowed the claims to require a distinct mechanical locking element, thereby excluding friction-fit seals. Apex cannot now recapture the excluded territory — friction-fit seals — through the doctrine of equivalents. This is precisely the type of prosecution history estoppel that the Festo presumption is designed to address.

Our prosecution history analysis memorandum, dated September 5, 2024, identifies the specific narrowing amendments and corresponding applicant arguments that give rise to estoppel. The relevant prosecution history excerpts will be attached as exhibits to the motion.

Second, even absent prosecution history estoppel, the function-way-result test weighs heavily against equivalence. Under Warner-Jenkinson Co. v. Harborline Enterprises Davis Chemical Co., 520 U.S. 17 (1997), the doctrine of equivalents requires that the accused element perform substantially the same function, in substantially the same way, to achieve substantially the same result as the claimed element. Here:

• Function: The "locking seal assembly" functions by providing a positive mechanical lock that secures the seal body independent of external pressure. The PE-5000's friction-fit seal functions by relying on material compression and friction to hold the seal in position. These functions are different: one provides a discrete, positive lock; the other relies on a continuous frictional resistance that can be overcome by sufficient force.

• Way: The "locking seal assembly" achieves its sealing function through the mechanical engagement of a distinct locking element (e.g., a pawl) with the seal body. The PE-5000 achieves its sealing function through the inherent frictional properties of the elastomeric material pressed against the housing bore. These are fundamentally different mechanical approaches — the former involves a discrete structural engagement, while the latter involves distributed material contact.

• Result: While both approaches result in a seal being held in position, the nature of the hold is different: a mechanical lock provides a positive, binary hold (locked or unlocked), whereas a friction fit provides a graduated, force-dependent hold that can be overcome if sufficient force is applied.

Given the weakness of any equivalents argument, we are confident in our ability to defeat this anticipated counterargument.

D. Assessment of Strength

The basis for summary judgment on the '237 Patent claims as to the PE-5000 is strong. The Court's own construction requires a "distinct locking element" that is demonstrably and undisputedly absent from the PE-5000. The evidence supporting the absence of a distinct locking element is comprehensive and uncontroverted: design specifications, engineering drawings, expert testimony, deposition testimony, and physical samples all confirm that the PE-5000 uses a friction-fit seal without any discrete mechanical locking component.

The prosecution history estoppel argument provides a robust defense against any attempt to invoke the doctrine of equivalents, and the function-way-result analysis independently weighs against equivalence. The likelihood of success on the '237 Patent portion of the motion is high, and I assess the probability of the Court granting summary judgment of non-infringement on Claims 1, 3, 7, and 12 of the '237 Patent as to the PE-5000 at approximately 75–85%.

V. Non-Infringement Analysis — '884 Patent (Claims 1, 2, 5, 9, 14)

A. Independent Claim 1

Claim 1 of the '884 Patent is an independent claim directed to a trocar system with a retractable blade deployment mechanism. A complete element-by-element walkthrough of Claim 1 against the PE-5000 technical design is set forth below.

Claim 1 of the '884 Patent reads as follows:

1. A trocar system comprising:

a cannula having a proximal end and a distal end;

an obturator assembly received within the cannula, the obturator assembly comprising:

a retractable blade deployment mechanism configured to deploy a blade to a cutting position for penetration of a body wall and to automatically retract the blade to a shielded position after penetration;

a blade housing surrounding the blade in the shielded position; and

an actuator operably connected to the retractable blade deployment mechanism for deploying the blade.

Element (a) — "a cannula having a proximal end and a distal end": The PE-5000 includes a 5 mm cannula with defined proximal and distal ends. This element is met and undisputed.

Element (b) — "an obturator assembly received within the cannula": The PE-5000 includes an obturator assembly received within the cannula. This element is met and undisputed.

Element (c) — "a retractable blade deployment mechanism configured to deploy a blade to a cutting position for penetration of a body wall and to automatically retract the blade to a shielded position after penetration": This is the key disputed limitation. The PE-5000 includes a blade deployment mechanism — specifically, a cam-driven mechanism that moves the blade between an extended (cutting) position and a retracted (shielded) position. The critical question is whether the PE-5000's retraction mechanism satisfies the "automatically retract" requirement as construed by the Court.

In the PE-5000, the blade deployment and retraction sequence operates as follows: The operator depresses a manual trigger on the proximal end of the obturator assembly. This trigger actuation, via a mechanical linkage, rotates a cam that deploys the blade from its shielded position to the cutting position. The operator then advances the trocar assembly through the abdominal wall. Upon completion of the penetration, the operator releases the manual trigger. The release of the trigger allows a return cam profile to rotate, which drives the blade back to its shielded position. Critically, the blade remains in the deployed cutting position for as long as the operator maintains pressure on the trigger; retraction occurs only when the operator affirmatively releases the trigger.

Under the Court's construction, the "retractable blade deployment mechanism" must "automatically retract the blade to a shielded position after penetration." The Court further explained that "automatically retracts" requires the blade to retract "without the need for a discrete, affirmative operator action to initiate retraction" and that retraction must occur "as an inherent consequence of the penetration event or the mechanical design of the mechanism — rather than as a response to an operator's deliberate act of releasing a control element."

We submit that the PE-5000's cam-driven retraction upon manual trigger release does not constitute "automatic" retraction under this construction. Releasing the trigger is a "discrete, affirmative operator action" — the operator must make a conscious decision to release the trigger, and must physically open the hand or relax the fingers to allow the trigger to move from the depressed to the released position. This is a volitional act, not an involuntary or passive occurrence. The blade does not retract as an "inherent consequence of the penetration event"; it retracts as a consequence of the operator's deliberate decision to release the trigger after penetration is complete.

This analysis is supported by our preliminary claim chart dated July 22, 2024, which identified the cam-driven retraction mechanism as the primary non-infringement basis for the PE-5000 with respect to the '884 Patent.

Dr. Ostrowski's rebuttal report (exchanged March 3, 2025) addresses this distinction at length. Dr. Ostrowski explains the mechanical difference between cam-driven manual-release retraction and the automatic retraction described in the '884 Patent specification. He states:

"The PE-5000's cam-driven blade mechanism requires an affirmative operator action — the release of the manual trigger — to initiate blade retraction. This is fundamentally different from the automatic retraction mechanism described in the '884 Patent, in which the blade retracts as a consequence of the penetration event itself, without any further operator input. In the PE-5000, the operator retains full control over when the blade retracts; the blade will remain deployed indefinitely as long as the operator continues to depress the trigger. This is the hallmark of a manually controlled system, not an automatic one." (Ostrowski Rebuttal Report, ¶¶ 42–48.)

Element (d) — "a blade housing surrounding the blade in the shielded position": The PE-5000 includes a blade housing that surrounds the blade when it is in the retracted (shielded) position. This element is met and undisputed.

Element (e) — "an actuator operably connected to the retractable blade deployment mechanism for deploying the blade": The PE-5000 includes a manual trigger actuator that is operably connected to the cam-driven blade mechanism. This element is met and undisputed.

As with the '237 Patent analysis, the only disputed element is the critical "locking seal assembly" — here, its analog is the "automatically retracts" aspect of the "retractable blade deployment mechanism." The remaining elements of Claim 1 are undisputedly present in the PE-5000.

B. Dependent Claims 2, 5, 9, and 14

Each of the asserted dependent claims ultimately depends from independent Claim 1 and therefore incorporates all of Claim 1's limitations, including the "retractable blade deployment mechanism" that "automatically retracts" the blade. If Claim 1 is not infringed, the dependent claims necessarily are not infringed.

However, two of the dependent claims provide additional, independent bases for non-infringement that are worth identifying because they strengthen our overall position and provide fallback arguments in the event the Court finds the "automatic retraction" issue to be genuinely disputed.

Claim 5 depends from Claim 1 and further requires "a spring bias urging the blade to the retracted position." The PE-5000 does not include any spring in its blade deployment mechanism. The PE-5000's cam-driven mechanism uses a cam profile and a manually operated trigger to control blade position. There is no spring, torsion element, or other biasing component that urges the blade toward the retracted position. The retraction force is generated entirely by the cam profile upon trigger release. The absence of a spring provides a clear, independent basis for non-infringement of Claim 5, which is not dependent on the "automatic retraction" issue and is supported by undisputed design evidence.

Claim 14 depends from Claim 9 (which itself depends from Claim 1) and further requires "an audible indication of blade retraction." The PE-5000 does not produce any audible click, tone, or other sound when the blade retracts. The cam-driven retraction in the PE-5000 is a quiet, smooth mechanical movement that does not generate an intentional audible indication. Apex has not identified any audible indication feature in the PE-5000, and Dr. Ng's infringement report does not address Claim 14's audible indication limitation. This absence provides a separate, independent basis for non-infringement of Claim 14.

Claims 2 and 9 add further narrowing limitations to independent Claim 1 but do not introduce limitations that are independently absent from the PE-5000 (beyond the Claim 1 limitations already discussed). Non-infringement of these claims therefore rests on the same bases as non-infringement of Claim 1.

C. Apex's Counterarguments — Dr. Ng's Report

We must anticipate the arguments that Apex will advance in opposition to the motion, particularly with respect to the '884 Patent. The primary counterargument will be drawn from Dr. Jennifer Ng's infringement report, served on February 10, 2025.

Dr. Ng opines in her report that the PE-5000's cam-driven retraction qualifies as "automatic" retraction under the Court's construction. Her reasoning can be summarized as follows:

Dr. Ng contends that trigger release is a "passive" act rather than a "discrete, affirmative operator action." She argues that when the operator releases the trigger, the operator is merely removing applied force — ceasing to do something — rather than performing an affirmative action. In her analysis, the distinction between "action" (applying force) and "inaction" (ceasing to apply force) is critical: she contends that only the application of a new, separate force should qualify as an "operator action" that would preclude a finding of automatic retraction. Under her theory, the PE-5000's retraction occurs "automatically" because it happens as a natural consequence of the operator stopping the application of force. (Ng Report, ¶¶ 63–71.)

Dr. Ng further argues that the PE-5000's cam-driven retraction is functionally indistinguishable from the spring-loaded retraction described in the '884 Patent specification because, in both cases, the blade moves to the retracted position when the deploying force is removed. She contends that the source of the retraction force (spring vs. cam profile) is irrelevant and that the key characteristic — retraction upon removal of the deploying force — is the same. (Ng Report, ¶¶ 72–78.)

Weaknesses in Dr. Ng's Analysis: While Dr. Ng's argument is not frivolous and presents a theory that Apex will vigorously pursue, there are significant weaknesses in her analysis that we will exploit in our motion and reply briefing.

First, the '884 Patent specification repeatedly distinguishes the claimed mechanism from "manually actuated retraction systems." Column 3, lines 15–18, of the '884 Patent state: "Unlike manually actuated retraction systems, in which the operator must perform a separate action to retract the blade after penetration, the present invention provides for automatic retraction upon penetration of the body wall." This language directly undermines Dr. Ng's position. In the PE-5000, the operator must perform a "separate action" — releasing the trigger — to retract the blade. The fact that this action involves the removal of force rather than the application of force does not change the fact that it is a deliberate, conscious, volitional act by the operator.

Second, the specification further describes automatic retraction as occurring "without any operator input following initial penetration." ('884 Patent, col. 5, ll. 41–43.) In the PE-5000, the operator must provide input — specifically, must release the trigger — following penetration. Until the operator provides that input, the blade remains deployed. This is inconsistent with the specification's description of automatic retraction.

Third, Dr. Ng's characterization of trigger release as "passive" is inconsistent with the common understanding of operator actions in the surgical device field. Releasing a trigger is a deliberate manual action that surgeons are trained to perform at a specific point during the surgical procedure. Surgeons exercise judgment about when to release the trigger, and the timing of release affects the safety and efficacy of the penetration. This is not a passive, involuntary event; it is an active surgical decision.

Fourth, the specification's preferred embodiment uses a spring-loaded mechanism in which the blade retracts as soon as it encounters reduced tissue resistance upon completing penetration. In the preferred embodiment, the retraction is truly automatic — it occurs as a consequence of the penetration event itself, without any separate operator action (or inaction) required. The PE-5000's design is fundamentally different: the blade remains deployed regardless of whether penetration is complete, until the operator affirmatively releases the trigger.

We note that Dr. Ostrowski's rebuttal report (March 3, 2025) addresses each of these points and provides a thorough technical explanation of why the PE-5000's cam-driven retraction is not "automatic" under the Court's construction.

D. Doctrine of Equivalents

The doctrine of equivalents analysis for the '884 Patent is somewhat less favorable to Solstice than the corresponding analysis for the '237 Patent, because the prosecution history of the '884 Patent does not include the same type of narrowing amendments that give rise to strong prosecution history estoppel.

Prosecution History Estoppel: Unlike the '237 Patent, the '884 Patent's prosecution history does not contain narrowing amendments specifically directed to the "retractable blade deployment mechanism" limitation. The claims of the '884 Patent were allowed without the type of amendment that would create a presumption of surrender under Festo. Accordingly, the prosecution history estoppel argument is weaker here, and we should not rely on it as a primary defense against equivalents for the '884 Patent.

Function-Way-Result Analysis: However, the function-way-result analysis still favors Solstice. The PE-5000's cam-driven retraction upon manual trigger release performs a different function (operator-controlled retraction), in a different way (cam rotation driven by trigger release), to achieve a result that, while similar in its endpoint (blade in shielded position), is fundamentally different in its operational characteristics (retraction timing controlled by operator rather than occurring automatically).

• Function: The claimed mechanism functions to automatically retract the blade without operator input. The PE-5000's mechanism functions to retract the blade upon the operator's affirmative release of the trigger, giving the operator control over retraction timing.

• Way: The claimed mechanism achieves retraction through a self-actuating mechanism (whether spring-loaded or otherwise) that responds to the penetration event. The PE-5000 achieves retraction through cam rotation that is initiated only by the operator's release of a held trigger.

• Result: While both ultimately result in blade retraction, the claimed mechanism results in automatic retraction that occurs without operator decision-making during the critical penetration phase, enhancing safety by ensuring immediate shielding of the blade. The PE-5000's mechanism results in retraction only when the operator decides to release the trigger, leaving the blade deployed during any delay in the operator's response.

Vitiation: Additionally, finding equivalents on this limitation would effectively eliminate the "automatically retracts" requirement from the claims. The Federal Circuit has consistently held that the doctrine of equivalents cannot be applied in a manner that vitiates a claim limitation. See, e.g., Asyst Techs., Inc. v. Emtrak, Inc., 402 F.3d 1188, 1195 (Fed. Cir. 2005). If a mechanism that requires affirmative operator action to retract the blade is deemed equivalent to a mechanism that "automatically retracts" the blade, the word "automatically" would be rendered meaningless. This vitiation argument provides an additional basis for defeating any equivalents claim.

E. Assessment of Strength

The basis for summary judgment on the '884 Patent claims as to the PE-5000 is moderate. The "automatic retraction" dispute is genuinely close, and Apex will argue vigorously that Dr. Ng's report creates a triable issue of fact. However, we believe the motion should be filed for several reasons.

First, the question presented is fundamentally a legal question of claim construction application, not a battle of experts on underlying facts. The physical design of the PE-5000 is undisputed — both sides agree on how the cam-driven mechanism works, how the trigger operates, and the sequence of operator actions required to retract the blade. The only question is whether that undisputed design meets the construed claim language. This is a question of law appropriate for summary judgment. See Ericsson, Inc. v. D-Link Sys., Inc., 773 F.3d 1201, 1216 (Fed. Cir. 2014) ("[I]nfringement, whether literal or under the doctrine of equivalents, is a question of fact, but where the relevant facts are undisputed, the question of infringement is a question of law.").

Second, even if the Court finds the "automatic retraction" issue to be genuinely disputed, the Court may still grant partial summary judgment on the claims that have additional, independent non-infringement bases. Specifically, Claim 5 (requiring a spring bias not present in PE-5000) and Claim 14 (requiring an audible indication not present in PE-5000) can be resolved in our favor regardless of how the Court resolves the "automatic retraction" issue.

Third, the independent non-infringement bases for Claims 5 and 14 are strong and essentially undisputed. These claims should be susceptible to summary judgment even if the broader "automatic retraction" argument is rejected.

Risk factor: The most significant risk is that the Court may conclude that a genuine dispute exists regarding whether trigger release constitutes a "discrete, affirmative operator action" sufficient to preclude "automatic" retraction under the Court's construction. If so, the '884 Patent portion of the motion could be denied (at least as to Claims 1, 2, and 9) while the '237 Patent portion may still succeed. We should be prepared for this outcome and should structure the motion to allow the Court to grant partial relief — i.e., granting summary judgment on the '237 Patent and on '884 Patent Claims 5 and 14, even if it denies summary judgment on the remaining '884 Patent claims.

VI. Strategic Considerations

A. Why Limit the Motion to PE-5000 Only

The decision to limit the motion for summary judgment to the PE-5000 Series, rather than filing a broader motion encompassing all accused products, is a deliberate strategic choice driven by several considerations.

Strongest non-infringement case. The PE-5000 presents the strongest non-infringement case of the three accused product lines because it is the simplest design in the PrecisionEdge™ line and lacks the more complex seal and blade features present in the PE-12000 and PE-15000. The PE-5000's friction-fit seal and cam-driven blade mechanism are the most stripped-down versions of these features across the product line. The PE-12000, by contrast, incorporates a multi-element seal assembly with a retention clip that is closer to the "distinct locking element" contemplated by the Court's construction of "locking seal assembly," making the non-infringement argument substantially more difficult. The PE-15000 includes a partially spring-assisted blade mechanism that undermines the "no spring" argument available for the PE-5000.

Avoiding overreach. The PE-12000 is accused of infringing all three asserted patents, and the design includes elements that are closer to the claimed features on multiple limitations. We anticipate that Apex's cross-motion for partial summary judgment of infringement on the PE-12000 has been filed or will be filed in the near term. Filing a broad motion that includes weaker arguments as to the PE-12000 and PE-15000 risks undermining our credibility with the Court and could taint the Court's perception of the stronger PE-5000 arguments. A narrow, well-supported motion limited to the product with the strongest non-infringement case increases credibility and avoids the risk of overreach.

Judicial economy. Even a partial victory — eliminating the PE-5000 from the case — reduces the complexity of the trial. The jury would no longer need to evaluate infringement of the PE-5000 across two patents and nine claims, reducing the number of claim charts, expert opinions, and damages calculations that must be presented at trial. This benefits the Court and the jury, and positions Solstice favorably in the Court's eyes as a party seeking to streamline the proceedings.

B. Impact on Damages Exposure

The damages implications of eliminating the PE-5000 from the case are significant.

Hugh Danaher, Apex's damages expert, claims $31,800,000 in reasonable royalty damages across all accused products for the relevant damages period (calendar year 2021 through the third quarter of 2024 and continuing). This figure is based on a royalty rate applied to the combined U.S. sales of all accused PrecisionEdge™ products, which total $74.6 million for the relevant period, with a weighted average gross margin of 61.3%.

Removing the PE-5000 from the case would reduce the royalty base by the PE-5000's share of total accused product sales. Based on the sales data produced in discovery, the PE-5000 accounts for approximately $18.9 million of the $74.6 million total, or approximately 25.3% of the royalty base. Eliminating the PE-5000 would therefore reduce Danaher's claimed damages by a corresponding amount — potentially reducing the damages figure by approximately $8 million, depending on how the royalty rate and apportionment analysis are applied.

Additionally, eliminating the PE-5000 from the case strengthens the apportionment analysis presented by Dr. Elena Marchetti, Solstice's damages expert, in her report served on February 14, 2025. Dr. Marchetti's report argues that Danaher's royalty calculation improperly fails to apportion damages to the specific patented features and instead applies the royalty to the entire value of the accused products. If the PE-5000 is removed from the case, Dr. Marchetti's apportionment analysis becomes more compelling because it further demonstrates that the accused products vary in their relationship to the patented features and should not be lumped together for damages purposes.

C. Settlement Leverage

Filing the motion for summary judgment creates additional pressure for settlement negotiations, which remain ongoing. The mediation held on March 17, 2025, before the Honorable Margaret Forsythe (Ret.) of Amberstone ADR Services, did not result in a resolution of the case. While both parties engaged in good-faith discussions, the gap between Apex's demand and Solstice's offer remained substantial, and no further mediation sessions have been scheduled at this time.

A strong motion for summary judgment, even if not decided before potential further settlement discussions, serves as a powerful signal to Apex that Solstice is confident in its non-infringement position and is prepared to litigate aggressively. If the motion is successful, it directly reduces Apex's potential recovery and may motivate Apex to reconsider its damages expectations and compromise. Even if the motion is merely pending, the filing itself demonstrates Solstice's willingness to invest in an aggressive defense and shifts the dynamic in settlement discussions.

It is important to note that even if the Court ultimately denies the motion, the denial would be "without prejudice" to Solstice's right to raise the same non-infringement arguments at trial. A denial of summary judgment does not constitute an adjudication on the merits, and the issues addressed in the motion would remain fully available for trial. Accordingly, the downside risk of filing the motion is limited to the expenditure of attorney time and resources required to prepare and brief it.

D. Timing and Resource Considerations

Filing deadline. The Scheduling Order entered on July 2, 2024 establishes April 1, 2025 as the deadline for filing dispositive motions. We intend to file the motion on that date. This allows approximately two and a half weeks from today (March 15, 2025) to finalize the motion papers, which is sufficient given the preparatory work already completed.

Estimated attorney hours. I estimate that preparing the complete motion package — including the Motion for Summary Judgment, the Memorandum of Law in Support, the Statement of Undisputed Material Facts, the Declaration of Christy Bauer, any supplemental declarations, and the exhibit binder — will require approximately 120 to 160 attorney hours. The bulk of this work will be performed by me (Christy Bauer) and Peter Vassiliev, with partner review by Marcus Delgado. The preliminary claim charts, prosecution history analysis, and expert report analysis have already been completed, which substantially reduces the drafting burden.

Supporting declarations. A Declaration of Christy Bauer will be prepared to authenticate the exhibits attached to the motion and to provide the Court with context regarding document provenance. Additionally, we should consider whether a supplemental de

PRIVILEGED AND CONFIDENTIAL — ATTORNEY WORK PRODUCT
INTERNAL STRATEGY MEMORANDUM
CALDERWOOD & HARKNESS LLP intellectual Property Litigation Group
FROM: Christy Bauer, Lead Associate, intellectual Property, Calderwood & Harkness LLP
TO: Marcus Delgado, Responsible Partner, intellectual Property, Calderwood & Harkness LLP
CC: Catherine Bloom, Billing Partner; Peter Vassiliev, Working Associate
DATE: March 15, 2025
RE: Summary Judgment Strategy — Non-Infringement of U.S. Patent Nos. 9,814,237 and 10,271,884 as to PrecisionEdge™ PE-5000 Series
MATTER: Solstice Biomedical Devices Ltd. — Patent Infringement Defense; Matter No. 10294.0017
CASE: Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA (D. Del.)
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I. Executive Summary
This memorandum analyzes whether Solstice Biomedical, Inc. ("Solstice") should file a motion for summary judgment of non-infringement limited to the PrecisionEdge™ PE-5000 Series, the 5 mm trocar assembly that is one of the three product lines accused in this litigation. For the reasons set forth in detail below, I recommend that we proceed with filing the motion for summary judgment targeting the PE-5000 Series only, on the basis that the Court's Claim Construction Order — issued December 6, 2024 by Judge Richard G. Andrews — construed key disputed claim terms in a manner that places the PE-5000 outside the literal scope of the asserted claims of both the '237 Patent and the '884 Patent.
As a threshold matter, it is important to note that the PE-5000 is not accused of infringing the third asserted patent in this case, U.S. Patent No. 10,932,105 (the "'105 Patent"). Apex asserts only the '237 Patent and the '884 Patent against the PE-5000. Accordingly, a successful motion for summary judgment on these two patents would eliminate the PE-5000 from the case entirely.
The proposed filing date is April 1, 2025, which is consistent with the Scheduling Order's deadline for dispositive motions. This timeline affords sufficient opportunity to finalize the motion papers and supporting declarations while meeting the Court's deadline.
My assessment of the likelihood of success is as follows: the motion presents a moderate-to-strong basis for summary judgment on the '237 Patent claims, and a moderate basis for summary judgment on the '884 Patent claims. The combined assessment supports filing. On the '237 Patent, the Court's construction of "locking seal assembly" — requiring a "distinct locking element" that "mechanically engages" the seal body — is effectively dispositive, as the PE-5000's friction-fit seal design undisputedly lacks any such discrete mechanical locking element. On the '884 Patent, the analysis is closer, turning on whether the PE-5000's cam-driven blade retraction upon manual trigger release constitutes "automatic" retraction within the meaning of the Court's construction. While this issue is genuinely contested, the weight of the intrinsic evidence and the undisputed physical characteristics of the PE-5000 support our position.
Even if the motion is ultimately denied in whole or in part, the filing serves important strategic purposes. The briefing will sharpen the issues for trial, which is currently set for September 30, 2025, and will provide the jury and the Court with a clear framework for evaluating the non-infringement defense. Additionally, the motion provides additional settlement leverage, particularly given that the prior mediation session on March 17, 2025, before the Honorable Margaret Forsythe (Ret.) at Amberstone ADR Services, did not resolve the case. A well-supported motion for summary judgment signals Solstice's confidence in its defense and may motivate Apex to reassess its damages expectations.
I request your approval to proceed with drafting, with an estimated completion date of March 25, 2025 for a draft of the motion papers for partner review.
II. Background
A. The Parties
Solstice Biomedical Devices Ltd. is an Irish-domiciled private company (Companies Registration Office No. 648217), founded in 2011, that designs and manufactures minimally invasive surgical instruments for the global market. The company reported fiscal year 2023 revenue of €187.4 million and employs approximately 620 people worldwide, with manufacturing facilities in Galway, Ireland, and distribution operations throughout Europe, North America, and Asia-Pacific.
The named defendant in this action is Solstice Biomedical, Inc., the U.S. operating subsidiary of Solstice Biomedical Devices Ltd. Solstice Biomedical, Inc. is a Delaware corporation (EIN: 84-3291056), with its principal offices located at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803. The U.S. subsidiary manages all sales, marketing, and distribution activities for PrecisionEdge™ products within the United States.
Apex Surgical Innovations, Inc. ("Apex") is a Delaware corporation (EIN: 51-0483762), founded in 2006, that manufactures surgical access devices and trocar systems. Apex is a larger competitor in the surgical access device space, with estimated fiscal year 2023 revenue of approximately $312 million and approximately 1,100 employees. Apex is the named plaintiff in this action and is the assignee of all three asserted patents. Apex is represented in this matter by Hargrove, Tate & Bennington LLP, with Victoria Stanton serving as lead partner and Derek Loomis as the primary associate on the case.
B. Procedural History
Apex filed its Complaint for Patent Infringement on May 9, 2024, asserting infringement of U.S. Patent Nos. 9,814,237, 10,271,884, and 10,932,105. Solstice was served with the Complaint on May 23, 2024.
Solstice filed its Answer, Affirmative Defenses, and Counterclaims on June 14, 2024. The counterclaims asserted non-infringement, invalidity, and inequitable conduct with respect to all three asserted patents. The inequitable conduct counterclaim is based on the failure of Dr. Raymond Szabo, the named inventor on all three patents, to disclose certain prior art references to the Patent Office during prosecution, as detailed in our separate memorandum dated August 12, 2024.
The Court entered its Scheduling Order on July 2, 2024, establishing the following key deadlines: close of fact discovery on December 20, 2024; close of expert discovery on March 7, 2025; dispositive motion deadline of April 1, 2025; pretrial conference on August 15, 2025; and trial commencing September 30, 2025.
Discovery in this case has been extensive. Solstice produced 48,217 documents (Bates Nos. SBD-000001 through SBD-048217), encompassing product design files, engineering notebooks, regulatory submissions, manufacturing specifications, sales data, internal communications regarding the PrecisionEdge™ product line, and prior art materials. Apex produced 31,450 documents (Bates Nos. APEX-000001 through APEX-031450), including patent prosecution files, prior art references, internal design documents, and licensing materials. The parties also exchanged interrogatory responses and conducted a total of fourteen fact depositions, including depositions of key engineers, sales personnel, and corporate designees from both sides.
Claim construction briefing proceeded on the following schedule: the parties exchanged proposed claim constructions on October 22, 2024; the Joint Claim Construction Brief was filed on November 4, 2024; and the Markman hearing was held on November 18, 2024 before Judge Andrews. The Court issued its Claim Construction Order on December 6, 2024, construing nine disputed claim terms. Of these nine terms, five were construed favorably to Solstice and four were construed favorably to Apex. The two constructions most critical to this proposed motion are discussed in detail in Section III below.
Expert discovery opened on January 13, 2025. The following reports have been served to date: Dr. Karl Ostrowski (Solstice's technical expert) served his invalidity and claim construction report on January 27, 2025; Dr. Jennifer Ng (Apex's technical expert) served her infringement report on February 10, 2025; both parties' damages experts served their respective reports on February 14, 2025 (Hugh Danaher for Apex and Dr. Elena Marchetti for Solstice); and rebuttal expert reports were exchanged on March 3, 2025. Expert depositions are currently being scheduled and are expected to be completed by the close of expert discovery.
C. The Asserted Patents and Accused Products
The Asserted Patents
All three asserted patents list Dr. Raymond Szabo, Apex's Vice President of Engineering, as the sole named inventor, and all three are assigned to Apex Surgical Innovations, Inc.
U.S. Patent No. 9,814,237 (the "'237 Patent") is titled "Locking Seal Assembly for Minimally Invasive Surgical Access Device." It was issued on November 14, 2017, and expires on June 22, 2035. The '237 Patent is directed to a seal assembly for use in trocar devices that incorporates a locking mechanism to maintain the seal in a closed position during surgical procedures. Apex asserts Claims 1, 3, 7, and 12 of the '237 Patent against the PE-5000 Series.
U.S. Patent No. 10,271,884 (the "'884 Patent") is titled "Retractable Blade Deployment Mechanism for Trocar Systems." It was issued on April 30, 2019, and expires on September 15, 2036. The '884 Patent is directed to a mechanism for deploying and retracting a cutting blade within a trocar assembly, with particular emphasis on safety features relating to automatic retraction of the blade following penetration of the abdominal wall. Apex asserts Claims 1, 2, 5, 9, and 14 of the '884 Patent against the PE-5000 Series.
U.S. Patent No. 10,932,105 (the "'105 Patent") is titled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar." It was issued on March 2, 2021, and expires on January 10, 2038. Apex asserts Claims 1, 4, and 8 of the '105 Patent, but not against the PE-5000 Series. The '105 Patent is asserted only against the PE-12000 and PE-15000 product lines.
The Accused Products
Apex accuses three product lines within the Solstice PrecisionEdge™ family of infringing the asserted patents:
• PE-5000 Series (5 mm trocar assembly): Accused of infringing the '237 Patent (Claims 1, 3, 7, 12) and the '884 Patent (Claims 1, 2, 5, 9, 14). The PE-5000 is the smallest and simplest trocar in the PrecisionEdge™ line, designed for 5 mm laparoscopic port access. This is the only product line at issue in the proposed motion for summary judgment.
• PE-12000 Series (12 mm trocar assembly): Accused of infringing all three asserted patents. The PE-12000 is a more complex design that incorporates additional sealing and blade features not present in the PE-5000.
• PE-15000 Series (15 mm trocar assembly): Accused of infringing the '884 Patent and the '105 Patent. The PE-15000 is the largest trocar in the line and includes features specific to larger-diameter surgical access.
The PE-12000 and PE-15000 product lines are not the subject of this proposed motion. The strategic rationale for limiting the motion to the PE-5000 is discussed in Section VI below.
Combined U.S. sales of all accused PrecisionEdge™ products for the period of calendar year 2021 through the third quarter of 2024 (through September 30, 2024) total $74.6 million. Based on the sales data produced in discovery (Bates Nos. SBD-041200 through SBD-041387), the PE-5000 Series accounts for approximately $18.9 million of that total, representing approximately 25.3% of the combined accused product revenue during the relevant period. This sales breakdown is relevant to the damages exposure analysis discussed in Section VI.B below.
III. The Claim Construction Order — Key Constructions Favorable to Solstice
A. Overview
The Claim Construction Order issued by Judge Andrews on December 6, 2024 construed nine disputed claim terms across the three asserted patents. Of the nine terms, five were construed in a manner favorable to Solstice's non-infringement and invalidity positions, and four were construed in a manner favorable to Apex. While the full scope of the Claim Construction Order has implications across the entire case, the two constructions most critical to the PE-5000 non-infringement motion are (1) the construction of "locking seal assembly" as used in the '237 Patent, and (2) the construction of "retractable blade deployment mechanism" as used in the '884 Patent. These constructions are analyzed in detail below.
B. Construction of "Locking Seal Assembly" ('237 Patent)
The term "locking seal assembly" appears in independent Claim 1 of the '237 Patent and is incorporated by reference into each of the asserted dependent claims (Claims 3, 7, and 12). The parties' proposed constructions differed substantially, and the Court's adopted construction aligns closely with Solstice's proposal.
Apex's Proposed Construction: Apex proposed that "locking seal assembly" should be construed broadly to mean "any seal in a trocar housing that can be secured in a closed position." Under this construction, virtually any seal mechanism — including friction-fit seals, compression seals, and interference-fit designs — could satisfy the limitation, so long as the seal could be maintained in a closed position by some means.
Solstice's Proposed Construction: Solstice proposed a narrower construction, arguing that "locking seal assembly" should be construed to mean "a seal assembly comprising a distinct locking element that mechanically engages the seal body to fix the seal in a closed position independent of external pressure." This construction was based on the intrinsic evidence from the '237 Patent specification, which repeatedly and consistently describes the locking function as being performed by a discrete locking pawl that mechanically engages a corresponding feature on the seal body.
The Court's Construction: The Court adopted Solstice's proposed construction in its entirety, requiring a "distinct locking element" that "mechanically engages" the seal body. In its Claim Construction Order, the Court relied on several pillars of intrinsic evidence:
First, the Court noted that the '237 Patent specification contains no fewer than fourteen references to a "locking pawl" or "discrete locking element" as the mechanism by which the seal is secured in the closed position. The specification consistently distinguishes this mechanism from friction-based or pressure-dependent sealing methods, expressly stating that "[t]he locking seal assembly of the present invention provides a positive mechanical engagement that secures the seal body in the closed position independent of any external pressure applied by the operator or by the insufflation gases." ('237 Patent, col. 4, ll. 22–27.)
Second, the Court examined the prosecution history of the '237 Patent and found that the applicant made narrowing amendments during prosecution to distinguish the claimed invention from the prior art. Specifically, during prosecution, the Examiner rejected the original claims in view of U.S. Patent No. 7,192,430 to Veridian Medical Technologies, which disclosed a friction-fit seal in a trocar housing. In response, Dr. Szabo amended the claims to add the "locking" limitation and argued that the amended claims were patentable over the Veridian reference because the claimed "locking seal assembly" required a "distinct mechanical locking element" that was not disclosed by Veridian's friction-based seal. (See Response to Office Action, filed August 14, 2015, at pp. 8–10.) The Court concluded that these prosecution history statements confirmed that "locking seal assembly" requires a discrete mechanical locking element and cannot encompass friction-fit designs.
Third, the Court rejected Apex's reliance on the doctrine of claim differentiation, finding that although certain dependent claims add specific structural details about the locking element (e.g., Claim 7's "radial compression ring"), the independent claim nonetheless requires the presence of some distinct locking element as a baseline.
Impact on PE-5000: This construction is highly favorable to Solstice's non-infringement defense as to the PE-5000 Series. The PE-5000 employs a friction-fit seal design that does not incorporate any discrete mechanical locking element. In the PE-5000's seal assembly, the seal body is held in the closed position by the inherent friction between the elastomeric seal material and the inner wall of the trocar housing. There is no pawl, no engagement feature, no separate locking component of any kind. The seal is maintained in position solely by the interference fit between the seal's outer surface and the housing bore.
This fact is documented in the PE-5000 design specifications and engineering drawings produced in discovery (Bates Nos. SBD-003412 through SBD-003498) and was confirmed by the testimony of Solstice's Director of Engineering, Colin Farraday, during his deposition on October 8, 2024. Under the Court's construction, the PE-5000 does not practice the "locking seal assembly" limitation.
This construction is dispositive for all four asserted claims of the '237 Patent (Claims 1, 3, 7, and 12), as each claim depends on the "locking seal assembly" element either directly — Claim 1 is the independent claim that expressly recites this limitation — or through dependency, as Claims 3, 7, and 12 each depend from Claim 1 and thus incorporate all of Claim 1's limitations.
C. Construction of "Retractable Blade Deployment Mechanism" ('884 Patent)
The term "retractable blade deployment mechanism" appears in independent Claim 1 of the '884 Patent and is incorporated into each of the asserted dependent claims (Claims 2, 5, 9, and 14). The parties' proposed constructions again differed substantially, and the Court's construction fell between the two proposals — narrower than Apex's but broader than Solstice's.
Apex's Proposed Construction: Apex proposed an expansive construction: "any mechanism that deploys and retracts a cutting blade within a trocar." Under this construction, any blade mechanism capable of movement between extended and retracted positions, by any means, would satisfy the limitation.
Solstice's Proposed Construction: Solstice proposed a much narrower construction: "a spring-loaded mechanism that automatically retracts the blade into a shielded position upon penetration of the abdominal wall, with the blade being deployed by application of axial force to a manually operable actuator." This construction was drawn from the specification's preferred embodiment and prosecution history, which consistently describe the mechanism as spring-loaded.
The Court's Construction: The Court adopted a construction that is narrower than Apex's proposal but broader than Solstice's: "a mechanism that deploys a blade to a cutting position and automatically retracts the blade to a shielded position after penetration." Significantly, the Court did not adopt Solstice's proposed requirement that the mechanism be "spring-loaded," reasoning that while the specification's preferred embodiment uses a spring, the claim language does not expressly require a spring and the specification contains language suggesting that other biasing means could be employed. However, the Court did require that the retraction be "automatic" — meaning the blade must retract without the need for a separate, independent operator action beyond the initial deployment and penetration sequence.
The Court's discussion of the "automatically retracts" aspect of the construction warrants close attention. In the Claim Construction Order, Judge Andrews stated:
"The term 'automatically retracts' as used in the context of the '884 Patent requires that the blade retract to a shielded position without the need for a discrete, affirmative operator action to initiate retraction. The specification distinguishes the claimed mechanism from 'manually actuated retraction systems' (col. 3, ll. 15–18) and describes automatic retraction as the blade returning to a shielded position 'without any operator input following initial penetration' (col. 5, ll. 41–43). The Court finds that this language requires the retraction to occur passively — that is, as an inherent consequence of the penetration event or the mechanical design of the mechanism — rather than as a response to an operator's deliberate act of releasing a control element."
Impact on PE-5000: The PE-5000 employs a cam-driven blade that retracts upon the operator's release of a manual trigger. In operation, the surgeon depresses a manual trigger to deploy the blade to the cutting position. The surgeon then advances the trocar through the abdominal wall. Upon completion of penetration, the surgeon releases the manual trigger, which causes the cam mechanism to rotate and retract the blade to its shielded position. Critically, the blade does not retract until the operator affirmatively releases the trigger. If the operator maintains pressure on the trigger, the blade remains in the deployed, cutting position indefinitely.
The question presented is whether the PE-5000's cam-driven retraction upon manual trigger release qualifies as "automatic" retraction under the Court's construction. This is the central contested issue for the '884 Patent portion of the motion. As discussed further in Section V below, we believe that the PE-5000's design does not meet the "automatic" retraction requirement because retraction requires the operator to perform a discrete, affirmative act (releasing the trigger) to initiate the retraction sequence. However, Apex and its expert, Dr. Ng, will argue that trigger release is a passive act (the mere cessation of applied force) and therefore qualifies as automatic retraction.
This analysis is closer than the '237 Patent analysis and is discussed in detail in Section V.
D. Other Favorable Constructions (Secondary Relevance)
Of the five constructions that favored Solstice, the remaining three relate to terms used in the '105 Patent or in claims not asserted against the PE-5000. Most notable is the Court's construction of "integrated insufflation valve" in the '105 Patent, which requires a "single-piece valve body incorporating both the insufflation and sealing functions." This construction is significant for the broader case — it may support non-infringement of the '105 Patent as to the PE-12000 and PE-15000 — but it is not relevant to the PE-5000 motion because the '105 Patent is not asserted against the PE-5000.
With respect to the four constructions that favored Apex, none directly impacts the core non-infringement analysis for the PE-5000. The most significant of the Apex-favorable constructions relates to the term "trocar housing" in both the '237 and '884 Patents, which the Court construed more broadly than Solstice had proposed. However, there is no dispute that the PE-5000 includes a "trocar housing" under any reasonable construction, so this term does not affect the analysis. The remaining three Apex-favorable constructions pertain to limitation elements that are undisputedly present in the PE-5000 and are therefore not contested.
IV. Non-Infringement Analysis — '237 Patent (Claims 1, 3, 7, 12)
A. Independent Claim 1
Claim 1 of the '237 Patent is an independent claim that recites a trocar assembly comprising multiple elements, including the critical "locking seal assembly" limitation. A complete element-by-element walkthrough of Claim 1 against the PE-5000 technical design is set forth below.
Claim 1 of the '237 Patent reads as follows:
1. A surgical access device comprising:
a trocar housing having a proximal end and a distal end and defining a central lumen extending therethrough;
an obturator slidably received within the central lumen;
a locking seal assembly disposed within the trocar housing at the proximal end, the locking seal assembly comprising a seal body and a distinct locking element that mechanically engages the seal body to fix the seal in a closed position independent of external pressure; and
a cannula extending distally from the trocar housing and configured for insertion through an incision in a patient's body wall.
Element (a) — "a trocar housing having a proximal end and a distal end and defining a central lumen extending therethrough": The PE-5000 includes a cylindrical trocar housing with defined proximal and distal ends and a central lumen. This element is met. There is no dispute between the parties on this point.
Element (b) — "an obturator slidably received within the central lumen": The PE-5000 includes an obturator that is slidably received within the central lumen of the trocar housing. This element is met. There is no dispute between the parties on this point.
Element (c) — "a locking seal assembly disposed within the trocar housing at the proximal end, the locking seal assembly comprising a seal body and a distinct locking element that mechanically engages the seal body to fix the seal in a closed position independent of external pressure": This is the critical missing limitation. The PE-5000 does not include a "locking seal assembly" as construed by the Court. The PE-5000 employs a friction-fit seal design that consists of an elastomeric seal body press-fit into the proximal end of the trocar housing. The seal body is held in the closed position by the frictional engagement between the elastomeric material and the inner wall of the housing. There is no "distinct locking element" — no pawl, no detent, no engagement feature, no separate locking component of any kind — that mechanically engages the seal body. The seal is maintained entirely by material compression and friction. This element is not met.
Element (d) — "a cannula extending distally from the trocar housing and configured for insertion through an incision in a patient's body wall": The PE-5000 includes a 5 mm cannula extending distally from the trocar housing. This element is met. There is no dispute between the parties on this point.
The only disputed element is Element (c), and the basis for non-infringement is clear and well-supported. Our preliminary claim chart, prepared on July 20, 2024, identified this gap early in the case, well before claim construction. The favorable claim construction has confirmed and strengthened our position.
The conclusion that the PE-5000 lacks a "distinct locking element" is supported by the following evidence:
• PE-5000 Design Specifications and Engineering Drawings (Bates Nos. SBD-003412 through SBD-003498): These documents, produced in discovery, include the complete design specifications and annotated engineering drawings for the PE-5000 seal assembly. The drawings unambiguously depict a friction-fit seal with no discrete locking component. Dimensional specifications confirm that the seal body is designed to be press-fit into the housing bore with an interference fit of approximately 0.15 mm, and no additional locking feature is specified or shown.
• Dr. Karl Ostrowski's Expert Report (served January 27, 2025): Dr. Ostrowski, Solstice's technical expert and a professor of biomedical engineering at the University of Pennsylvania, examined the PE-5000 design specifications, disassembled physical samples of the PE-5000, and performed detailed measurements and imaging of the seal assembly. He concluded that the PE-5000 seal assembly "does not include any distinct locking element that mechanically engages the seal body" and that "the seal is held in position exclusively by the inherent friction between the elastomeric material and the housing wall." (Ostrowski Report, ¶¶ 87–94.)
• Deposition Testimony of Colin Farraday (Solstice Director of Engineering, October 8, 2024): Mr. Farraday testified that the PE-5000 seal was intentionally designed as a friction-fit assembly to achieve simplicity and cost efficiency in the 5 mm form factor, and that no mechanical locking feature was ever considered for or incorporated into the PE-5000 seal design. (Farraday Dep. Tr. at 112:8–114:3.)
• Physical Samples: Physical samples of the PE-5000 were produced for inspection and are available for submission to the Court. Disassembly of the seal assembly confirms the absence of any locking element.
There is no genuine dispute of material fact on this issue. Apex has not identified any feature in the PE-5000 that it contends constitutes a "distinct locking element" other than the friction-fit seal itself. Dr. Ng's infringement report (February 10, 2025) does not identify a specific locking element in the PE-5000 but instead argues that the friction-fit seal "functions as a lock" because it holds the seal in the closed position. However, this argument is foreclosed by the Court's construction, which requires a distinct locking element separate from the seal body itself. The friction between the seal material and the housing wall is an inherent material property, not a distinct mechanical locking element.
B. Dependent Claims 3, 7, and 12
Each of the dependent claims asserted by Apex against the PE-5000 depends from independent Claim 1 and therefore incorporates all of Claim 1's limitations, including the "locking seal assembly" limitation. As a matter of patent law, it is axiomatic that "[o]ne who does not infringe an independent claim cannot infringe a claim dependent on (and thus containing all the limitations of) that claim." Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1552 n.9 (Fed. Cir. 1989). If the PE-5000 does not practice the "locking seal assembly" limitation of Claim 1, it necessarily does not infringe Claims 3, 7, or 12.
For completeness, Claim 7 provides an additional, independent basis for non-infringement. Claim 7 depends from Claim 1 and further requires "a radial compression ring disposed circumferentially about the seal body and configured to apply inward radial pressure to maintain the seal body in the closed position." The PE-5000 does not include a radial compression ring; the PE-5000's seal body is a monolithic elastomeric component with no separate compression ring or circumferential pressure element. This absence provides a further, independent basis for non-infringement of Claim 7, even if a dispute were to arise regarding the "locking seal assembly" limitation.
C. Doctrine of Equivalents
We anticipate that Apex will argue, in opposition to the motion, that even if the PE-5000 does not literally infringe the "locking seal assembly" limitation, the PE-5000's friction-fit seal is equivalent to a "locking seal assembly" under the doctrine of equivalents. We are well-positioned to defeat this argument on two independent grounds.
First, prosecution history estoppel bars Apex from recapturing through the doctrine of equivalents the scope of coverage that it surrendered during prosecution. As discussed in Section III.B above, during prosecution of the '237 Patent, the Examiner rejected the original claims in view of the Veridian Medical Technologies prior art patent (U.S. Patent No. 7,192,430), which disclosed a friction-fit seal in a trocar housing. In response, Apex (through Dr. Szabo as inventor and applicant) amended the claims to add the "locking" limitation specifically to distinguish the claimed invention from the Veridian friction-fit seal. Apex argued to the Patent Office that its "locking seal assembly" was patentable over Veridian because it required a "distinct mechanical locking element" not present in Veridian's friction-based seal design.
Under Festo Corp. v. Fenmore & Co., 535 U.S. 722 (2002), a narrowing amendment made during prosecution to avoid prior art creates a presumption that the patent holder surrendered the territory between the original claim scope and the amended claim scope. Here, the original claims were broad enough to encompass friction-fit seals; the amendment narrowed the claims to require a distinct mechanical locking element, thereby excluding friction-fit seals. Apex cannot now recapture the excluded territory — friction-fit seals — through the doctrine of equivalents. This is precisely the type of prosecution history estoppel that the Festo presumption is designed to address.
Our prosecution history analysis memorandum, dated September 5, 2024, identifies the specific narrowing amendments and corresponding applicant arguments that give rise to estoppel. The relevant prosecution history excerpts will be attached as exhibits to the motion.
Second, even absent prosecution history estoppel, the function-way-result test weighs heavily against equivalence. Under Warner-Jenkinson Co. v. Harborline Enterprises Davis Chemical Co., 520 U.S. 17 (1997), the doctrine of equivalents requires that the accused element perform substantially the same function, in substantially the same way, to achieve substantially the same result as the claimed element. Here:
• Function: The "locking seal assembly" functions by providing a positive mechanical lock that secures the seal body independent of external pressure. The PE-5000's friction-fit seal functions by relying on material compression and friction to hold the seal in position. These functions are different: one provides a discrete, positive lock; the other relies on a continuous frictional resistance that can be overcome by sufficient force.
• Way: The "locking seal assembly" achieves its sealing function through the mechanical engagement of a distinct locking element (e.g., a pawl) with the seal body. The PE-5000 achieves its sealing function through the inherent frictional properties of the elastomeric material pressed against the housing bore. These are fundamentally different mechanical approaches — the former involves a discrete structural engagement, while the latter involves distributed material contact.
• Result: While both approaches result in a seal being held in position, the nature of the hold is different: a mechanical lock provides a positive, binary hold (locked or unlocked), whereas a friction fit provides a graduated, force-dependent hold that can be overcome if sufficient force is applied.
Given the weakness of any equivalents argument, we are confident in our ability to defeat this anticipated counterargument.
D. Assessment of Strength
The basis for summary judgment on the '237 Patent claims as to the PE-5000 is strong. The Court's own construction requires a "distinct locking element" that is demonstrably and undisputedly absent from the PE-5000. The evidence supporting the absence of a distinct locking element is comprehensive and uncontroverted: design specifications, engineering drawings, expert testimony, deposition testimony, and physical samples all confirm that the PE-5000 uses a friction-fit seal without any discrete mechanical locking component.
The prosecution history estoppel argument provides a robust defense against any attempt to invoke the doctrine of equivalents, and the function-way-result analysis independently weighs against equivalence. The likelihood of success on the '237 Patent portion of the motion is high, and I assess the probability of the Court granting summary judgment of non-infringement on Claims 1, 3, 7, and 12 of the '237 Patent as to the PE-5000 at approximately 75–85%.
V. Non-Infringement Analysis — '884 Patent (Claims 1, 2, 5, 9, 14)
A. Independent Claim 1
Claim 1 of the '884 Patent is an independent claim directed to a trocar system with a retractable blade deployment mechanism. A complete element-by-element walkthrough of Claim 1 against the PE-5000 technical design is set forth below.
Claim 1 of the '884 Patent reads as follows:
1. A trocar system comprising:
a cannula having a proximal end and a distal end;
an obturator assembly received within the cannula, the obturator assembly comprising:
a retractable blade deployment mechanism configured to deploy a blade to a cutting position for penetration of a body wall and to automatically retract the blade to a shielded position after penetration;
a blade housing surrounding the blade in the shielded position; and
an actuator operably connected to the retractable blade deployment mechanism for deploying the blade.
Element (a) — "a cannula having a proximal end and a distal end": The PE-5000 includes a 5 mm cannula with defined proximal and distal ends. This element is met and undisputed.
Element (b) — "an obturator assembly received within the cannula": The PE-5000 includes an obturator assembly received within the cannula. This element is met and undisputed.
Element (c) — "a retractable blade deployment mechanism configured to deploy a blade to a cutting position for penetration of a body wall and to automatically retract the blade to a shielded position after penetration": This is the key disputed limitation. The PE-5000 includes a blade deployment mechanism — specifically, a cam-driven mechanism that moves the blade between an extended (cutting) position and a retracted (shielded) position. The critical question is whether the PE-5000's retraction mechanism satisfies the "automatically retract" requirement as construed by the Court.
In the PE-5000, the blade deployment and retraction sequence operates as follows: The operator depresses a manual trigger on the proximal end of the obturator assembly. This trigger actuation, via a mechanical linkage, rotates a cam that deploys the blade from its shielded position to the cutting position. The operator then advances the trocar assembly through the abdominal wall. Upon completion of the penetration, the operator releases the manual trigger. The release of the trigger allows a return cam profile to rotate, which drives the blade back to its shielded position. Critically, the blade remains in the deployed cutting position for as long as the operator maintains pressure on the trigger; retraction occurs only when the operator affirmatively releases the trigger.
Under the Court's construction, the "retractable blade deployment mechanism" must "automatically retract the blade to a shielded position after penetration." The Court further explained that "automatically retracts" requires the blade to retract "without the need for a discrete, affirmative operator action to initiate retraction" and that retraction must occur "as an inherent consequence of the penetration event or the mechanical design of the mechanism — rather than as a response to an operator's deliberate act of releasing a control element."
We submit that the PE-5000's cam-driven retraction upon manual trigger release does not constitute "automatic" retraction under this construction. Releasing the trigger is a "discrete, affirmative operator action" — the operator must make a conscious decision to release the trigger, and must physically open the hand or relax the fingers to allow the trigger to move from the depressed to the released position. This is a volitional act, not an involuntary or passive occurrence. The blade does not retract as an "inherent consequence of the penetration event"; it retracts as a consequence of the operator's deliberate decision to release the trigger after penetration is complete.
This analysis is supported by our preliminary claim chart dated July 22, 2024, which identified the cam-driven retraction mechanism as the primary non-infringement basis for the PE-5000 with respect to the '884 Patent.
Dr. Ostrowski's rebuttal report (exchanged March 3, 2025) addresses this distinction at length. Dr. Ostrowski explains the mechanical difference between cam-driven manual-release retraction and the automatic retraction described in the '884 Patent specification. He states:
"The PE-5000's cam-driven blade mechanism requires an affirmative operator action — the release of the manual trigger — to initiate blade retraction. This is fundamentally different from the automatic retraction mechanism described in the '884 Patent, in which the blade retracts as a consequence of the penetration event itself, without any further operator input. In the PE-5000, the operator retains full control over when the blade retracts; the blade will remain deployed indefinitely as long as the operator continues to depress the trigger. This is the hallmark of a manually controlled system, not an automatic one." (Ostrowski Rebuttal Report, ¶¶ 42–48.)
Element (d) — "a blade housing surrounding the blade in the shielded position": The PE-5000 includes a blade housing that surrounds the blade when it is in the retracted (shielded) position. This element is met and undisputed.
Element (e) — "an actuator operably connected to the retractable blade deployment mechanism for deploying the blade": The PE-5000 includes a manual trigger actuator that is operably connected to the cam-driven blade mechanism. This element is met and undisputed.
As with the '237 Patent analysis, the only disputed element is the critical "locking seal assembly" — here, its analog is the "automatically retracts" aspect of the "retractable blade deployment mechanism." The remaining elements of Claim 1 are undisputedly present in the PE-5000.
B. Dependent Claims 2, 5, 9, and 14
Each of the asserted dependent claims ultimately depends from independent Claim 1 and therefore incorporates all of Claim 1's limitations, including the "retractable blade deployment mechanism" that "automatically retracts" the blade. If Claim 1 is not infringed, the dependent claims necessarily are not infringed.
However, two of the dependent claims provide additional, independent bases for non-infringement that are worth identifying because they strengthen our overall position and provide fallback arguments in the event the Court finds the "automatic retraction" issue to be genuinely disputed.
Claim 5 depends from Claim 1 and further requires "a spring bias urging the blade to the retracted position." The PE-5000 does not include any spring in its blade deployment mechanism. The PE-5000's cam-driven mechanism uses a cam profile and a manually operated trigger to control blade position. There is no spring, torsion element, or other biasing component that urges the blade toward the retracted position. The retraction force is generated entirely by the cam profile upon trigger release. The absence of a spring provides a clear, independent basis for non-infringement of Claim 5, which is not dependent on the "automatic retraction" issue and is supported by undisputed design evidence.
Claim 14 depends from Claim 9 (which itself depends from Claim 1) and further requires "an audible indication of blade retraction." The PE-5000 does not produce any audible click, tone, or other sound when the blade retracts. The cam-driven retraction in the PE-5000 is a quiet, smooth mechanical movement that does not generate an intentional audible indication. Apex has not identified any audible indication feature in the PE-5000, and Dr. Ng's infringement report does not address Claim 14's audible indication limitation. This absence provides a separate, independent basis for non-infringement of Claim 14.
Claims 2 and 9 add further narrowing limitations to independent Claim 1 but do not introduce limitations that are independently absent from the PE-5000 (beyond the Claim 1 limitations already discussed). Non-infringement of these claims therefore rests on the same bases as non-infringement of Claim 1.
C. Apex's Counterarguments — Dr. Ng's Report
We must anticipate the arguments that Apex will advance in opposition to the motion, particularly with respect to the '884 Patent. The primary counterargument will be drawn from Dr. Jennifer Ng's infringement report, served on February 10, 2025.
Dr. Ng opines in her report that the PE-5000's cam-driven retraction qualifies as "automatic" retraction under the Court's construction. Her reasoning can be summarized as follows:
Dr. Ng contends that trigger release is a "passive" act rather than a "discrete, affirmative operator action." She argues that when the operator releases the trigger, the operator is merely removing applied force — ceasing to do something — rather than performing an affirmative action. In her analysis, the distinction between "action" (applying force) and "inaction" (ceasing to apply force) is critical: she contends that only the application of a new, separate force should qualify as an "operator action" that would preclude a finding of automatic retraction. Under her theory, the PE-5000's retraction occurs "automatically" because it happens as a natural consequence of the operator stopping the application of force. (Ng Report, ¶¶ 63–71.)
Dr. Ng further argues that the PE-5000's cam-driven retraction is functionally indistinguishable from the spring-loaded retraction described in the '884 Patent specification because, in both cases, the blade moves to the retracted position when the deploying force is removed. She contends that the source of the retraction force (spring vs. cam profile) is irrelevant and that the key characteristic — retraction upon removal of the deploying force — is the same. (Ng Report, ¶¶ 72–78.)
Weaknesses in Dr. Ng's Analysis: While Dr. Ng's argument is not frivolous and presents a theory that Apex will vigorously pursue, there are significant weaknesses in her analysis that we will exploit in our motion and reply briefing.
First, the '884 Patent specification repeatedly distinguishes the claimed mechanism from "manually actuated retraction systems." Column 3, lines 15–18, of the '884 Patent state: "Unlike manually actuated retraction systems, in which the operator must perform a separate action to retract the blade after penetration, the present invention provides for automatic retraction upon penetration of the body wall." This language directly undermines Dr. Ng's position. In the PE-5000, the operator must perform a "separate action" — releasing the trigger — to retract the blade. The fact that this action involves the removal of force rather than the application of force does not change the fact that it is a deliberate, conscious, volitional act by the operator.
Second, the specification further describes automatic retraction as occurring "without any operator input following initial penetration." ('884 Patent, col. 5, ll. 41–43.) In the PE-5000, the operator must provide input — specifically, must release the trigger — following penetration. Until the operator provides that input, the blade remains deployed. This is inconsistent with the specification's description of automatic retraction.
Third, Dr. Ng's characterization of trigger release as "passive" is inconsistent with the common understanding of operator actions in the surgical device field. Releasing a trigger is a deliberate manual action that surgeons are trained to perform at a specific point during the surgical procedure. Surgeons exercise judgment about when to release the trigger, and the timing of release affects the safety and efficacy of the penetration. This is not a passive, involuntary event; it is an active surgical decision.
Fourth, the specification's preferred embodiment uses a spring-loaded mechanism in which the blade retracts as soon as it encounters reduced tissue resistance upon completing penetration. In the preferred embodiment, the retraction is truly automatic — it occurs as a consequence of the penetration event itself, without any separate operator action (or inaction) required. The PE-5000's design is fundamentally different: the blade remains deployed regardless of whether penetration is complete, until the operator affirmatively releases the trigger.
We note that Dr. Ostrowski's rebuttal report (March 3, 2025) addresses each of these points and provides a thorough technical explanation of why the PE-5000's cam-driven retraction is not "automatic" under the Court's construction.
D. Doctrine of Equivalents
The doctrine of equivalents analysis for the '884 Patent is somewhat less favorable to Solstice than the corresponding analysis for the '237 Patent, because the prosecution history of the '884 Patent does not include the same type of narrowing amendments that give rise to strong prosecution history estoppel.
Prosecution History Estoppel: Unlike the '237 Patent, the '884 Patent's prosecution history does not contain narrowing amendments specifically directed to the "retractable blade deployment mechanism" limitation. The claims of the '884 Patent were allowed without the type of amendment that would create a presumption of surrender under Festo. Accordingly, the prosecution history estoppel argument is weaker here, and we should not rely on it as a primary defense against equivalents for the '884 Patent.
Function-Way-Result Analysis: However, the function-way-result analysis still favors Solstice. The PE-5000's cam-driven retraction upon manual trigger release performs a different function (operator-controlled retraction), in a different way (cam rotation driven by trigger release), to achieve a result that, while similar in its endpoint (blade in shielded position), is fundamentally different in its operational characteristics (retraction timing controlled by operator rather than occurring automatically).
• Function: The claimed mechanism functions to automatically retract the blade without operator input. The PE-5000's mechanism functions to retract the blade upon the operator's affirmative release of the trigger, giving the operator control over retraction timing.
• Way: The claimed mechanism achieves retraction through a self-actuating mechanism (whether spring-loaded or otherwise) that responds to the penetration event. The PE-5000 achieves retraction through cam rotation that is initiated only by the operator's release of a held trigger.
• Result: While both ultimately result in blade retraction, the claimed mechanism results in automatic retraction that occurs without operator decision-making during the critical penetration phase, enhancing safety by ensuring immediate shielding of the blade. The PE-5000's mechanism results in retraction only when the operator decides to release the trigger, leaving the blade deployed during any delay in the operator's response.
Vitiation: Additionally, finding equivalents on this limitation would effectively eliminate the "automatically retracts" requirement from the claims. The Federal Circuit has consistently held that the doctrine of equivalents cannot be applied in a manner that vitiates a claim limitation. See, e.g., Asyst Techs., Inc. v. Emtrak, Inc., 402 F.3d 1188, 1195 (Fed. Cir. 2005). If a mechanism that requires affirmative operator action to retract the blade is deemed equivalent to a mechanism that "automatically retracts" the blade, the word "automatically" would be rendered meaningless. This vitiation argument provides an additional basis for defeating any equivalents claim.
E. Assessment of Strength
The basis for summary judgment on the '884 Patent claims as to the PE-5000 is moderate. The "automatic retraction" dispute is genuinely close, and Apex will argue vigorously that Dr. Ng's report creates a triable issue of fact. However, we believe the motion should be filed for several reasons.
First, the question presented is fundamentally a legal question of claim construction application, not a battle of experts on underlying facts. The physical design of the PE-5000 is undisputed — both sides agree on how the cam-driven mechanism works, how the trigger operates, and the sequence of operator actions required to retract the blade. The only question is whether that undisputed design meets the construed claim language. This is a question of law appropriate for summary judgment. See Ericsson, Inc. v. D-Link Sys., Inc., 773 F.3d 1201, 1216 (Fed. Cir. 2014) ("[I]nfringement, whether literal or under the doctrine of equivalents, is a question of fact, but where the relevant facts are undisputed, the question of infringement is a question of law.").
Second, even if the Court finds the "automatic retraction" issue to be genuinely disputed, the Court may still grant partial summary judgment on the claims that have additional, independent non-infringement bases. Specifically, Claim 5 (requiring a spring bias not present in PE-5000) and Claim 14 (requiring an audible indication not present in PE-5000) can be resolved in our favor regardless of how the Court resolves the "automatic retraction" issue.
Third, the independent non-infringement bases for Claims 5 and 14 are strong and essentially undisputed. These claims should be susceptible to summary judgment even if the broader "automatic retraction" argument is rejected.
Risk factor: The most significant risk is that the Court may conclude that a genuine dispute exists regarding whether trigger release constitutes a "discrete, affirmative operator action" sufficient to preclude "automatic" retraction under the Court's construction. If so, the '884 Patent portion of the motion could be denied (at least as to Claims 1, 2, and 9) while the '237 Patent portion may still succeed. We should be prepared for this outcome and should structure the motion to allow the Court to grant partial relief — i.e., granting summary judgment on the '237 Patent and on '884 Patent Claims 5 and 14, even if it denies summary judgment on the remaining '884 Patent claims.
VI. Strategic Considerations
A. Why Limit the Motion to PE-5000 Only
The decision to limit the motion for summary judgment to the PE-5000 Series, rather than filing a broader motion encompassing all accused products, is a deliberate strategic choice driven by several considerations.
Strongest non-infringement case. The PE-5000 presents the strongest non-infringement case of the three accused product lines because it is the simplest design in the PrecisionEdge™ line and lacks the more complex seal and blade features present in the PE-12000 and PE-15000. The PE-5000's friction-fit seal and cam-driven blade mechanism are the most stripped-down versions of these features across the product line. The PE-12000, by contrast, incorporates a multi-element seal assembly with a retention clip that is closer to the "distinct locking element" contemplated by the Court's construction of "locking seal assembly," making the non-infringement argument substantially more difficult. The PE-15000 includes a partially spring-assisted blade mechanism that undermines the "no spring" argument available for the PE-5000.
Avoiding overreach. The PE-12000 is accused of infringing all three asserted patents, and the design includes elements that are closer to the claimed features on multiple limitations. We anticipate that Apex's cross-motion for partial summary judgment of infringement on the PE-12000 has been filed or will be filed in the near term. Filing a broad motion that includes weaker arguments as to the PE-12000 and PE-15000 risks undermining our credibility with the Court and could taint the Court's perception of the stronger PE-5000 arguments. A narrow, well-supported motion limited to the product with the strongest non-infringement case increases credibility and avoids the risk of overreach.
Judicial economy. Even a partial victory — eliminating the PE-5000 from the case — reduces the complexity of the trial. The jury would no longer need to evaluate infringement of the PE-5000 across two patents and nine claims, reducing the number of claim charts, expert opinions, and damages calculations that must be presented at trial. This benefits the Court and the jury, and positions Solstice favorably in the Court's eyes as a party seeking to streamline the proceedings.
B. Impact on Damages Exposure
The damages implications of eliminating the PE-5000 from the case are significant.
Hugh Danaher, Apex's damages expert, claims $31,800,000 in reasonable royalty damages across all accused products for the relevant damages period (calendar year 2021 through the third quarter of 2024 and continuing). This figure is based on a royalty rate applied to the combined U.S. sales of all accused PrecisionEdge™ products, which total $74.6 million for the relevant period, with a weighted average gross margin of 61.3%.
Removing the PE-5000 from the case would reduce the royalty base by the PE-5000's share of total accused product sales. Based on the sales data produced in discovery, the PE-5000 accounts for approximately $18.9 million of the $74.6 million total, or approximately 25.3% of the royalty base. Eliminating the PE-5000 would therefore reduce Danaher's claimed damages by a corresponding amount — potentially reducing the damages figure by approximately $8 million, depending on how the royalty rate and apportionment analysis are applied.
Additionally, eliminating the PE-5000 from the case strengthens the apportionment analysis presented by Dr. Elena Marchetti, Solstice's damages expert, in her report served on February 14, 2025. Dr. Marchetti's report argues that Danaher's royalty calculation improperly fails to apportion damages to the specific patented features and instead applies the royalty to the entire value of the accused products. If the PE-5000 is removed from the case, Dr. Marchetti's apportionment analysis becomes more compelling because it further demonstrates that the accused products vary in their relationship to the patented features and should not be lumped together for damages purposes.
C. Settlement Leverage
Filing the motion for summary judgment creates additional pressure for settlement negotiations, which remain ongoing. The mediation held on March 17, 2025, before the Honorable Margaret Forsythe (Ret.) of Amberstone ADR Services, did not result in a resolution of the case. While both parties engaged in good-faith discussions, the gap between Apex's demand and Solstice's offer remained substantial, and no further mediation sessions have been scheduled at this time.
A strong motion for summary judgment, even if not decided before potential further settlement discussions, serves as a powerful signal to Apex that Solstice is confident in its non-infringement position and is prepared to litigate aggressively. If the motion is successful, it directly reduces Apex's potential recovery and may motivate Apex to reconsider its damages expectations and compromise. Even if the motion is merely pending, the filing itself demonstrates Solstice's willingness to invest in an aggressive defense and shifts the dynamic in settlement discussions.
It is important to note that even if the Court ultimately denies the motion, the denial would be "without prejudice" to Solstice's right to raise the same non-infringement arguments at trial. A denial of summary judgment does not constitute an adjudication on the merits, and the issues addressed in the motion would remain fully available for trial. Accordingly, the downside risk of filing the motion is limited to the expenditure of attorney time and resources required to prepare and brief it.
D. Timing and Resource Considerations
Filing deadline. The Scheduling Order entered on July 2, 2024 establishes April 1, 2025 as the deadline for filing dispositive motions. We intend to file the motion on that date. This allows approximately two and a half weeks from today (March 15, 2025) to finalize the motion papers, which is sufficient given the preparatory work already completed.
Estimated attorney hours. I estimate that preparing the complete motion package — including the Motion for Summary Judgment, the Memorandum of Law in Support, the Statement of Undisputed Material Facts, the Declaration of Christy Bauer, any supplemental declarations, and the exhibit binder — will require approximately 120 to 160 attorney hours. The bulk of this work will be performed by me (Christy Bauer) and Peter Vassiliev, with partner review by Marcus Delgado. The preliminary claim charts, prosecution history analysis, and expert report analysis have already been completed, which substantially reduces the drafting burden.
Supporting declarations. A Declaration of Christy Bauer will be prepared to authenticate the exhibits attached to the motion and to provide the Court with context regarding document provenance. Additionally, we should consider whether a supplemental de

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