1037-00004 · Solstice Biomedical Devices Ltd · Motions Practice

sur-reply-opposition-apex-cross-msj.docx DOCUMENT Litigation

41 / 75 ← → ✕

DRAFT — FOR INTERNAL REVIEW ONLY — NOT FOR FILING Prepared by: C. Bauer / P. Vassiliev

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

DEFENDANT SOLSTICE BIOMEDICAL, INC.'S SUR-REPLY IN OPPOSITION TO PLAINTIFF'S CROSS-MOTION FOR PARTIAL SUMMARY JUDGMENT OF INFRINGEMENT (PE-12000 SERIES)

Right-click to update Table of Contents

I. PRELIMINARY STATEMENT

Defendant Solstice Biomedical, Inc. ("Solstice") respectfully submits this sur-reply brief to address new arguments and evidence improperly raised for the first time in Plaintiff Apex Surgical Innovations, Inc.'s ("Apex") reply brief in support of its Cross-Motion for Partial Summary Judgment of Infringement directed at the PrecisionEdge™ PE-12000 Series 12 mm trocar assembly (the "PE-12000"). Apex's cross-motion, filed on April 14, 2025, sought a finding of infringement as a matter of law on a subset of the claims asserted in this action. However, Apex's reply brief — filed in late April 2025 — introduced arguments and expert testimony that were entirely absent from its opening papers, thereby depriving Solstice of any meaningful opportunity to respond in the ordinary course of briefing. This sur-reply is necessary to protect Solstice's right to address these new materials and to apprise the Court of their deficiencies.

The three patents that Apex asserts against the PE-12000 Series are: United States Patent No. 9,814,237 (the "'237 Patent"), United States Patent No. 10,271,884 (the "'884 Patent"), and United States Patent No. 10,932,105 (the "'105 Patent"). The specific claims at issue are Claims 1, 3, 7, and 12 of the '237 Patent; Claims 1, 2, 5, 9, and 14 of the '884 Patent; and Claims 1, 4, and 8 of the '105 Patent. Together, these claims span a range of structural and functional limitations relating to trocar seal assemblies, blade deployment mechanisms, and insufflation valves — limitations that are the subject of substantial, unresolved factual dispute between the parties' respective experts.

The core deficiency of Apex's reply is threefold. First, Apex advances a new claim construction theory for the term "integrated insufflation valve" under the '105 Patent that directly contradicts the Court's Claim Construction Order entered on December 6, 2024 (D.I. 97) (the "Claim Construction Order"), following the Markman hearing held on November 18, 2024. Second, Apex attaches and relies upon a supplemental declaration from its infringement expert, Dr. Calvin Ng — an Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute in Newark, Delaware — containing new infringement analysis and testing data that were not disclosed in Dr. Ng's original expert report served on February 10, 2025, and that were never made available to Solstice for deposition or rebuttal during expert discovery. Third, Apex attempts to resurrect prosecution history arguments concerning the scope of the "locking seal assembly" limitation in the '237 Patent that were expressly considered and rejected by this Court in the Claim Construction Order.

Even if the Court were to consider these improperly raised arguments and materials on their merits, genuine disputes of material fact remain that preclude the entry of summary judgment of infringement as to the PE-12000 Series. The competing testimony of Dr. Ng and Solstice's expert, Dr. Miriam Ostrowski — a Professor of Biomedical Engineering at Halford University in Philadelphia, Pennsylvania — demonstrates that reasonable minds could differ on whether the PE-12000's specific structural features satisfy the asserted claim limitations as properly construed. This is a classic case in which the application of claim language to accused product features requires credibility determinations and factual resolutions that are the province of the jury, not the Court on a paper record. Apex's cross-motion should be denied.

II. PROCEDURAL BACKGROUND

A. The Pending Motions

The summary judgment motions pending before this Court arose from the parties' competing views of whether genuine disputes of material fact exist with respect to infringement of the asserted patents by Solstice's PrecisionEdge™ product line. On April 1, 2025, Solstice filed its Motion for Summary Judgment of Non-Infringement (D.I. 148), directed at the PrecisionEdge™ PE-5000 Series 5 mm trocar assembly (the "PE-5000") with respect to the '237 Patent and the '884 Patent. In its motion, Solstice demonstrated that the PE-5000's design does not satisfy several key claim limitations as construed by this Court, and that no genuine dispute of material fact exists as to non-infringement of the PE-5000 Series.

In response, rather than simply opposing Solstice's motion, Apex filed its own Cross-Motion for Partial Summary Judgment of Infringement on April 14, 2025 (D.I. 155), directed at a different product — the PE-12000 Series — and asserting all three patents: the '237 Patent, the '884 Patent, and the '105 Patent. The filing of this cross-motion broadened the summary judgment record to encompass a product line that Solstice had not targeted in its own motion and introduced the '105 Patent, which was not at issue in Solstice's PE-5000 motion.

Solstice timely filed its Opposition to Apex's Cross-Motion on April 28, 2025 (D.I. 162), identifying multiple genuine disputes of material fact that preclude summary judgment of infringement as to the PE-12000 Series. Solstice's Opposition was supported by the record evidence developed during fact and expert discovery, including the rebuttal expert report of Dr. Miriam Ostrowski served on March 3, 2025, deposition testimony of Apex's named inventor and Vice President of Engineering, Dr. Raymond Szabo, and the documentary record of the PE-12000's design and engineering specifications.

Apex filed its reply brief in support of its cross-motion on or about April 25–28, 2025 (D.I. 165). It is this reply that prompts the present sur-reply. As detailed below, Apex's reply raises arguments and introduces evidence that were not present in its opening papers, necessitating this response.

B. The Claim Construction Order

On December 6, 2024, this Court issued its Claim Construction Order (D.I. 97) following full briefing and oral argument. The parties submitted a Joint Claim Construction Brief on November 4, 2024 (D.I. 85), addressing nine disputed claim terms. The Markman hearing was held on November 18, 2024, at which the Court received argument from both sides on each of the nine terms.

Of the nine disputed terms construed in the December 6, 2024 Order, five were construed in a manner favorable to Solstice and four in a manner favorable to Apex. The Claim Construction Order is the law of the case and governs the infringement analysis at summary judgment and trial. Neither party sought reconsideration of the Claim Construction Order, and the time for doing so has long since expired.

Three of the construed terms are of particular relevance to the PE-12000 dispute now before the Court:

(a) "locking seal assembly" ('237 Patent) — construed by the Court to require "a seal assembly comprising at least two components that engage one another through a positive-lock mechanism to maintain a gas-tight seal during trocar insertion and removal." This construction was one of the five terms construed favorably to Solstice. Notably, the Court's construction excluded friction-fit and interference-fit arrangements from the scope of the limitation.

(b) "retractable blade deployment mechanism" ('884 Patent) — construed by the Court to require "a mechanism that deploys a cutting blade from a retracted position to an extended position and that automatically retracts the blade upon removal of the trocar tip from tissue." The parties' principal dispute as to this term concerned whether automatic retraction was required; the Court held that it was.

(c) "integrated insufflation valve" ('105 Patent) — construed by the Court to require "a valve that is structurally unified with the trocar housing as a single integral component, rather than a separately attached or modular valve." This construction was one of the five terms construed favorably to Solstice and is the subject of Apex's impermissible new argument in its reply.

C. The Expert Record

The expert discovery schedule in this action was set by the Court's Revised Scheduling Order entered October 14, 2024 (D.I. 78). Expert discovery opened on January 13, 2025. Dr. Calvin Ng, Apex's technical expert on infringement, served his expert report on February 10, 2025, as required by the Scheduling Order. Dr. Ng is an Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute in Newark, Delaware, and has been engaged by Apex to provide opinions on whether Solstice's PrecisionEdge™ products infringe the asserted claims.

Dr. Miriam Ostrowski, Solstice's technical expert on non-infringement, served her rebuttal expert report on March 3, 2025, as required by the Scheduling Order. Dr. Ostrowski is a Professor of Biomedical Engineering at Halford University in Philadelphia, Pennsylvania, and has extensive experience in minimally invasive surgical device design and trocar assembly technology. Dr. Ostrowski's rebuttal report addressed and rebutted each of Dr. Ng's infringement opinions on a claim-by-claim, element-by-element basis.

Expert depositions were completed prior to the close of expert discovery. Both Dr. Ng and Dr. Ostrowski were deposed. The expert discovery period has closed. No provision of the Scheduling Order or the Federal Rules of Civil Procedure authorizes the submission of a supplemental expert declaration at the summary judgment stage containing new opinions that were not disclosed during expert discovery. Yet that is precisely what Apex has done in its reply brief, attaching a supplemental declaration from Dr. Ng that contains new infringement analysis of the PE-12000's seal housing sub-assembly and blade-deployment spring mechanism — opinions that were neither contained in Dr. Ng's February 10, 2025 report nor disclosed at any point during the expert discovery period.

III. LEGAL STANDARD FOR SUR-REPLY

It is well established in this District that a sur-reply may be filed where the moving party's reply brief raises new arguments, new evidence, or new legal theories that were not fairly presented in its opening brief, such that the non-moving party has been deprived of an opportunity to respond. See, e.g., Idenix Pharms. LLC v. Gilead Scis., Inc., No. 13-1987-LPS, 2016 WL 1274553, at 4 (D. Del. Mar. 31, 2016) (permitting sur-reply where reply raised new arguments); Pemberton Partners LLC v. Greaves Industries, Inc., No. 18-924-CFC, 2020 WL 3447607, at 1 n.1 (D. Del. June 24, 2020) (same). The purpose of allowing a sur-reply in such circumstances is to ensure fundamental fairness and to prevent the reply brief from being used as a vehicle for sandbagging the opposing party with arguments to which no response is possible within the ordinary briefing framework.

Here, Apex's reply brief raises at least three categories of new material that were not presented in its opening papers and that warrant a response from Solstice:

(1) A new claim construction theory for "integrated insufflation valve" under the '105 Patent. Apex's opening brief applied the Court's construction of this term without qualification. In its reply, however, Apex advances an expanded interpretation of "structurally unified" that was never briefed at claim construction and that contradicts the Court's December 6, 2024 Order.

(2) A supplemental declaration from Dr. Calvin Ng containing a new infringement analysis of the PE-12000's seal housing sub-assembly and blade-deployment spring mechanism. This declaration includes testing data and analytical conclusions that were not part of Dr. Ng's February 10, 2025 expert report, were not disclosed during expert discovery, and were not subject to deposition or rebuttal by Dr. Ostrowski.

(3) New reliance on prosecution history arguments regarding the scope of the "locking seal assembly" limitation of the '237 Patent. These arguments were presented to the Court at the Markman hearing, were considered in the Claim Construction Order, and were rejected. Apex may not relitigate them in a summary judgment reply brief.

Solstice respectfully submits that these new materials more than satisfy the standard for a sur-reply. In addition, Solstice reserves all arguments raised in its April 28, 2025 Opposition brief (D.I. 162) and incorporates them herein by reference in their entirety.

IV. ARGUMENT

A. Apex's New Claim Construction Theory for "Integrated Insufflation Valve" Is Foreclosed by the Court's December 6, 2024 Order

1. The Court's Construction Is the Law of the Case. This Court construed the term "integrated insufflation valve" as it appears in Claims 1, 4, and 8 of the '105 Patent to mean "a valve that is structurally unified with the trocar housing as a single integral component, rather than a separately attached or modular valve." Claim Construction Order at 27 (D.I. 97). In reaching this construction, the Court considered the full range of intrinsic evidence — the claim language itself, the written description and figures of the '105 Patent specification, and the prosecution history — as well as the extrinsic evidence submitted by the parties, including competing expert declarations. See id. at 24–27.

This term was among the nine disputed terms briefed in the Joint Claim Construction Brief filed November 4, 2024 (D.I. 85), and was the subject of extensive oral argument at the Markman hearing on November 18, 2024. Both parties had a full and fair opportunity to present their positions. Apex advocated for a broader construction — one that would have encompassed any valve "associated with" or "connected to" the trocar housing, regardless of whether the valve was a separate, modular component. See Apex's Claim Construction Br. at 31–35 (D.I. 83). The Court rejected Apex's proposed construction in favor of Solstice's narrower reading, which requires structural unity as a single integral component. Claim Construction Order at 26–27.

The Claim Construction Order is the law of the case. Under the law-of-the-case doctrine, a court's prior construction of a patent claim term should not be reconsidered absent extraordinary circumstances, such as an intervening change in controlling law, newly discovered evidence, or clear error. See Christianson v. Colt Indus. Operating Corp., 486 U.S. 800, 816 (1988); Gould, Inc. v. United States, 67 F.3d 925, 930 (Fed. Cir. 1995). None of those circumstances is present here, and Apex has not moved for reconsideration of the Claim Construction Order.

2. Apex's Reply Impermissibly Seeks to Expand the Court's Construction. Despite the clarity of the Court's construction, Apex's reply brief recharacterizes the "integrated insufflation valve" limitation of Claims 1, 4, and 8 of the '105 Patent in a manner that is flatly inconsistent with the Claim Construction Order. Specifically, Apex now argues that "structurally unified" should be understood to encompass a multi-component valve assembly so long as the individual components are "permanently affixed" or "non-removable" in the finished device — a construction that the Court never adopted and that is materially different from the requirement of "a single integral component." See Apex Reply at 14–16 (D.I. 165).

This is not a permissible application of the Court's construction to the facts; it is an attempt to obtain de facto reconsideration of the Markman ruling through the procedural vehicle of a summary judgment reply brief. The distinction matters. A "single integral component" is, by definition, a unitary structure — not a multi-part assembly held together by adhesive, welding, or mechanical fasteners. Apex's recharacterization would collapse the distinction between a structurally unified valve and a modular valve that has been permanently joined, and it would render the Court's express exclusion of "separately attached or modular" valves a nullity.

It is black-letter law in this Circuit that a party may not relitigate claim construction at the summary judgment stage by repackaging a rejected construction as a "reasonable reading" or "alternative interpretation" of the Court's order. See Pemberton Partners LLC v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1365 (Fed. Cir. 2009) ("It is not for the litigants to redefine the court's claim constructions on summary judgment."); see also Ashbury Industries, Inc. v. Teva Pharms. USA, Inc., 429 F.3d 1364, 1374 (Fed. Cir. 2005) (holding that the trial court's claim construction cannot be expanded or altered through expert testimony or argument at summary judgment). That is precisely what Apex seeks to do here, and the Court should decline the invitation.

Applied to the PE-12000 Series, the consequence of the Court's construction is straightforward. It is undisputed that the PE-12000's insufflation valve is housed in a two-piece valve housing that is assembled from separately manufactured components and connected to the trocar body via a snap-fit connection. See Ostrowski Rebuttal Report at ¶¶ 87–94 (Ex. 8 to D.I. 162); PE-12000 Engineering Drawings, SOL-00024891–98 (Ex. 12 to D.I. 162). The PE-12000's valve housing is not a single integral component; it is a modular, detachable assembly. Under the Court's construction, the PE-12000's valve configuration does not meet the "integrated" limitation of the '105 Patent.

3. Even Under Apex's Expanded Construction, a Factual Dispute Exists. Even if the Court were to entertain Apex's new, expanded construction of "integrated insufflation valve" — which Solstice submits would be error — genuine disputes of material fact would still preclude summary judgment. The competing expert testimony on this point is stark.

Dr. Ng opines that the PE-12000's valve housing qualifies as "integrated" because, once assembled, the two halves of the housing are joined by a snap-fit connection that is designed not to be separated during normal clinical use. See Ng Expert Report at ¶¶ 142–148. Dr. Ostrowski's rebuttal report, however, identifies specific structural differences between the PE-12000's valve assembly and the structurally unified valve described in the '105 Patent specification. Dr. Ostrowski explains that the PE-12000's two-piece valve housing comprises an upper housing component and a lower housing component that are manufactured as separate injection-molded parts, assembled with a separate gasket seal interposed between them, and joined by a snap-fit connection that permits disassembly for cleaning and inspection. See Ostrowski Rebuttal Report at ¶¶ 87–94.

Dr. Ostrowski further testified that the PE-12000's separate gasket seal — which sits between the two housing halves and provides the gas-tight seal for insufflation — is a distinct component that is not structurally unified with either housing half. Id. at ¶ 91. This three-component arrangement (upper housing, gasket seal, lower housing) is materially different from the single-piece, integrally molded valve depicted in Figures 4A and 4B of the '105 Patent specification. Id. at ¶ 93.

Where, as here, the factual dispute turns on the application of a claim limitation to specific product features and the parties' experts disagree on whether those features satisfy the limitation, summary judgment is inappropriate. See Shire LLC v. Amneal Pharms., LLC, 802 F.3d 1301, 1307 (Fed. Cir. 2015) ("Where the parties' experts provide conflicting testimony on whether the accused product meets a claim limitation, the issue is one for the factfinder."). The Court should deny Apex's motion as to the '105 Patent.

B. Dr. Ng's Supplemental Declaration Should Be Disregarded as Untimely and Prejudicial

1. The Expert discovery Schedule Has Closed. The Revised Scheduling Order entered by this Court on October 14, 2024 (D.I. 78) established a clear and orderly schedule for expert discovery. Expert discovery opened on January 13, 2025. Dr. Ng's infringement expert report was due and served on February 10, 2025. Rebuttal expert reports — including Dr. Ostrowski's rebuttal to Dr. Ng's opinions — were due and exchanged on March 3, 2025. Expert depositions were thereafter completed, and expert discovery has closed.

The Scheduling Order did not provide for supplemental expert reports or declarations. Nor did Apex seek leave of Court to supplement Dr. Ng's expert disclosures at any point prior to filing its cross-motion or its reply. The supplemental declaration attached to Apex's reply (the "Ng Supplemental Declaration") was not served during the expert discovery period, was not subject to deposition by Solstice, and was not made available to Dr. Ostrowski for rebuttal. It appeared for the first time as Exhibit A to Apex's reply brief — a filing to which Solstice has no automatic right of response.

Federal Rule of Civil Procedure 26(a)(2)(E) requires that expert disclosures be made at the times and in the sequence directed by the Court. Rule 37(c)(1) provides that if a party fails to provide information or identify a witness as required by Rule 26, the party is not allowed to use that information or witness on a motion unless the failure was substantially justified or is harmless. Apex has offered no justification — substantial or otherwise — for the late submission of the Ng Supplemental Declaration, and its inclusion is far from harmless, as discussed below.

2. The Supplemental Declaration Contains New Opinions Not Disclosed in Dr. Ng's Original Report. The Ng Supplemental Declaration is not a mere clarification or summary of opinions previously disclosed. It contains substantively new expert analysis directed at a critical claim limitation that was insufficiently addressed in Dr. Ng's original report. Specifically, the Ng Supplemental Declaration sets forth a new and detailed analysis of the PE-12000's blade-deployment spring mechanism as allegedly meeting the "retractable blade deployment mechanism" limitation of Claims 1, 2, 5, 9, and 14 of the '884 Patent. See Ng Supplemental Decl. at ¶¶ 8–22.

This new analysis is based on testing or analytical work — including force-displacement measurements of the PE-12000's blade retraction spring — that was not referenced, described, or cited anywhere in Dr. Ng's February 10, 2025 expert report. Compare Ng Expert Report at ¶¶ 98–112 (addressing the '884 Patent "retractable blade deployment mechanism" limitation at a general level, without spring force data or testing results), with Ng Supplemental Decl. at ¶¶ 12–18 (presenting new force-displacement data and a detailed mechanical analysis of the spring retraction mechanism).

This constitutes a new expert opinion. Solstice has had no opportunity to depose Dr. Ng on these new opinions. Dr. Ostrowski has had no opportunity to review the underlying data, evaluate Dr. Ng's methodology, or submit a rebuttal. The prejudice to Solstice is manifest: Apex seeks to use an untimely, undisclosed expert opinion to carry its burden on summary judgment, while Solstice is deprived of the basic procedural protections that the discovery rules are designed to provide.

The prejudice is compounded by the practical and economic burden that would be imposed on Solstice if it were required to respond to these new opinions at this stage of the litigation. Dr. Ostrowski's expert fees to date total $127,500, reflecting 170 hours of work at her standard rate of $750 per hour. Requiring Dr. Ostrowski to perform additional rebuttal analysis, review new test data, and prepare a responsive declaration — all outside the scheduled expert discovery period — would impose significant additional costs on Solstice and further delay the resolution of this case.

3. Relief Requested. For the foregoing reasons, Solstice respectfully requests that the Court strike or, at a minimum, disregard the Ng Supplemental Declaration in evaluating Apex's Cross-Motion for Partial Summary Judgment of Infringement. The declaration is untimely, prejudicial, and unsupported by any justification for its late submission. Apex chose to rest on Dr. Ng's February 10, 2025 report during expert discovery and cannot now supplement that record through a reply-brief declaration.

In the alternative, if the Court determines that it will consider the Ng Supplemental Declaration, Solstice respectfully requests the opportunity to submit a responsive declaration from Dr. Ostrowski addressing the new opinions set forth therein. Fairness and due process require no less.

C. Apex's Prosecution History Arguments Were Rejected at Claim Construction and Cannot Be Revived

1. The "Locking Seal Assembly" Limitation ('237 Patent). Apex's reply brief revisits prosecution history arguments regarding the scope of the "locking seal assembly" limitation as it appears in Claims 1, 3, 7, and 12 of the '237 Patent. The '237 Patent, United States Patent No. 9,814,237, was issued on November 14, 2017, and does not expire until June 22, 2035. It is the oldest of the three asserted patents and has the most extensive prosecution history.

The prosecution history of the '237 Patent was the subject of thorough analysis by Solstice's counsel, both at Calderwood & Harkness LLP and in coordination with patent prosecution counsel at Kendrick & Lau LLP. Dr. Jonathan Kendrick of Kendrick & Lau LLP, 601 Pennsylvania Avenue NW, Suite 820, Washington, DC 20004, assisted in the analysis of narrowing amendments made during prosecution by the named inventor, Dr. Raymond Szabo, who serves as Apex's Vice President of Engineering. During prosecution, Dr. Szabo and Apex's patent counsel amended the claims to distinguish over the prior art by narrowing the scope of the "locking seal assembly" limitation. Specifically, the applicants amended the claims to require a "positive-lock engagement" between the seal components, expressly distinguishing their invention from prior art trocar seals that relied on friction-fit or interference-fit retention. See '237 Patent Prosecution History, Amendment dated September 12, 2016, at 4–6 (Ex. 6 to D.I. 162).

These prosecution history estoppel arguments were presented in full in Solstice's Claim Construction Brief filed October 28, 2024 (D.I. 81), and addressed in the Joint Claim Construction Brief filed November 4, 2024 (D.I. 85). The Court considered them at the Markman hearing on November 18, 2024, and expressly adopted a construction of "locking seal assembly" that requires a "positive-lock mechanism" — consistent with the narrowing amendments made during prosecution. Claim Construction Order at 14–17.

Apex's reply now attempts to argue that the prosecution history supports a broader reading of the "locking seal assembly" limitation than the Court's construction permits — specifically, that the narrowing amendments were directed only at a particular prior art reference (U.S. Patent No. 7,422,581 to Henderson) and should not be read to exclude friction-fit mechanisms more broadly. See Apex Reply at 8–11 (D.I. 165). But this is the very argument that Apex made at claim construction and that the Court rejected. The Court's construction requires a "positive-lock mechanism," not merely a mechanism that can be distinguished from a single prior art reference. Apex cannot relitigate this issue through its summary judgment reply brief.

2. Application to the PE-12000 Series. Under the Court's construction of "locking seal assembly," the PE-12000's seal mechanism presents a genuine factual dispute as to whether it meets the limitation — a dispute that favors denial of Apex's motion, not its grant. The PE-12000 utilizes a friction-fit retention system in which the upper and lower seal components are held in place by the compressive force of an elastomeric O-ring, rather than by a positive-lock engagement such as a bayonet mount, detent mechanism, or threaded connection. See Ostrowski Rebuttal Report at ¶¶ 42–56; PE-12000 Design Verification Report, SOL-00031204 at 7–8 (Ex. 14 to D.I. 162).

Dr. Ostrowski's rebuttal report provides a detailed analysis of the PE-12000's seal retention mechanism, concluding that it does not satisfy the "positive-lock mechanism" requirement of the Court's construction because the seal components are held together solely by friction and compressive force, and can be separated by applying a modest axial pull force without releasing any locking element. See Ostrowski Rebuttal Report at ¶¶ 48–52. Dr. Ostrowski contrasts the PE-12000 design with the '237 Patent's specification, which describes and depicts a bayonet-style positive-lock engagement between the seal housing and the trocar body. Id. at ¶¶ 53–56.

Dr. Ng's original expert report acknowledges that the PE-12000's seal components are not joined by a bayonet mount or threaded connection, but reaches the contrary conclusion that the friction-fit retention system nonetheless constitutes a "positive-lock mechanism" because the O-ring creates a "sufficiently secure" engagement that resists inadvertent separation. See Ng Expert Report at ¶¶ 74–82. This is a classic battle of the experts. The two experts have examined the same product, applied the same claim construction, and reached opposite conclusions based on their respective assessments of the PE-12000's structural features. This factual disagreement cannot be resolved on summary judgment and must be submitted to the finder of fact at trial. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986) ("Credibility determinations, the weighing of the evidence, and the drawing of legitimate inferences from the facts are jury functions, not those of a judge . . . on a motion for summary judgment.").

D. Genuine Disputes of Material Fact Preclude Summary Judgment on the PE-12000 Series for All Three Patents

The foregoing discussion demonstrates that genuine disputes of material fact pervade Apex's infringement case as to the PE-12000 Series across all three asserted patents. The following summarizes the specific disputes as to each patent.

1. The '237 Patent (Claims 1, 3, 7, 12). As discussed in Section IV.C above, the central factual dispute with respect to the '237 Patent is whether the PE-12000's seal mechanism meets the "locking seal assembly" limitation as construed by this Court. The parties' experts — Dr. Ng and Dr. Ostrowski — have reached diametrically opposed conclusions on this question. Dr. Ng contends that the PE-12000's friction-fit O-ring retention system constitutes a "positive-lock mechanism"; Dr. Ostrowski disagrees, explaining that friction-fit retention is fundamentally different from positive-lock engagement and was the very type of mechanism distinguished during prosecution of the '237 Patent.

This dispute is not peripheral. The "locking seal assembly" limitation appears in each of the four asserted claims of the '237 Patent (Claims 1, 3, 7, and 12). If the PE-12000's seal mechanism does not satisfy this limitation, none of the asserted claims of the '237 Patent is infringed. Conversely, if it does, additional element-by-element disputes remain. Either way, the issue cannot be resolved without weighing expert credibility and making factual findings that are inappropriate at the summary judgment stage.

The significance of this dispute is underscored by the magnitude of the commercial stakes. The PE-12000 is one of three accused product lines in the PrecisionEdge™ family. Combined United States sales of accused PrecisionEdge™ products — the PE-5000, PE-12000, and PE-15000 — total approximately $74.6 million from 2021 through the third quarter of 2024. See Solstice's Responses and Objections to Apex's First Set of Interrogatories, Interrogatory No. 7, at 12–14 (D.I. 162, Ex. 18). The determination of infringement vel non as to the PE-12000 will have substantial consequences for the damages calculation in this case, and the parties are entitled to a full trial on the merits.

2. The '884 Patent (Claims 1, 2, 5, 9, 14). The primary factual dispute with respect to the '884 Patent concerns whether the PE-12000's blade mechanism meets the "retractable blade deployment mechanism" limitation as construed by this Court. The Court's construction requires "a mechanism that deploys a cutting blade from a retracted position to an extended position and that automatically retracts the blade upon removal of the trocar tip from tissue." Claim Construction Order at 20.

Five claims of the '884 Patent are asserted against the PE-12000 — Claims 1, 2, 5, 9, and 14. In its original expert report, Dr. Ng addressed this limitation at a general level, opining that the PE-12000's spring-loaded blade mechanism satisfies the "retractable blade deployment mechanism" requirement. Ng Expert Report at ¶¶ 98–112. Dr. Ostrowski's rebuttal report identified specific deficiencies in Dr. Ng's analysis, including the absence of any force-displacement data or testing results to support his opinion that the PE-12000's blade retraction is "automatic" within the meaning of the Court's construction. Ostrowski Rebuttal Report at ¶¶ 63–78.

It is telling that Dr. Ng's supplemental declaration — which Solstice submits should be stricken — specifically targets this very limitation. The fact that Apex found it necessary to submit additional expert testimony on this point in its reply brief underscores that Apex itself recognized a gap in its original evidentiary showing as to the '884 Patent. This is an admission by conduct that genuine disputes of material fact exist.

In addition, the claim chart analysis supporting Solstice's non-infringement position is extensive. A preliminary claim chart for the '884 Patent was prepared by Solstice's counsel on July 22, 2024 (prior to the filing of Solstice's Answer and Counterclaims), identifying element-by-element non-infringement positions for each of the five asserted claims. That claim chart was subsequently refined and incorporated into Dr. Ostrowski's rebuttal report. See Ostrowski Rebuttal Report, Appendix C (Element-by-Element Claim Chart for '884 Patent). The claim chart identifies multiple claim elements — beyond the "retractable blade deployment mechanism" — as to which the PE-12000 does not satisfy the claim limitations. Summary judgment is precluded on this patent.

3. The '105 Patent (Claims 1, 4, 8). As discussed in detail in Section IV.A above, the central factual dispute with respect to the '105 Patent is whether the PE-12000's valve configuration meets the "integrated insufflation valve" limitation as construed by this Court. Apex's reply advances a new construction of this term that is inconsistent with the Claim Construction Order. Even under that impermissible construction, Dr. Ostrowski's testimony creates a genuine dispute of material fact that precludes summary judgment.

The '105 Patent is the newest of the three asserted patents. United States Patent No. 10,932,105 was issued on March 2, 2021, and does not expire until January 10, 2038. Its claims are the narrowest of the three patents, reflecting the extensive prosecution history in which the applicants made multiple narrowing amendments to distinguish over the prior art. See '105 Patent Prosecution History (Ex. 9 to D.I. 162). Indeed, the claims of the '105 Patent were allowed only after Apex's patent counsel expressly disclaimed coverage of modular or detachable valve assemblies. See id., Remarks dated August 4, 2020, at 8–9.

The PE-12000's two-piece valve housing, separate gasket seal, and snap-fit connection present the very type of modular valve assembly that was disclaimed during prosecution. Dr. Ostrowski's rebuttal report details these structural features and explains why they fall outside the scope of the "integrated insufflation valve" limitation. Ostrowski Rebuttal Report at ¶¶ 87–94. Dr. Ng disagrees, but his disagreement creates a factual dispute — it does not resolve one.

E. Apex's Damages Theory Does Not Support Summary Judgment on Liability

Even setting aside the merits of Apex's infringement case, practical considerations counsel against granting partial summary judgment on the PE-12000 Series. Apex's damages expert, Hugh Danaher, CFA — a Senior Managing Director at Keystone Valuation Advisors LLC in Philadelphia, Pennsylvania — has opined that Apex is entitled to $31,800,000 in reasonable royalty damages across all three accused product lines (the PE-5000, PE-12000, and PE-15000). See Danaher Expert Report at ¶ 147, served February 12, 2025 (Ex. 19 to D.I. 162). This figure represents approximately 42.6% of total United States sales of accused PrecisionEdge™ products ($74.6 million) over the relevant damages period — a royalty rate and base that are themselves the subject of substantial dispute.

The enormity of the damages claim underscores the importance of a full trial on the merits rather than piecemeal resolution through summary judgment on a single product line. Granting partial summary judgment of infringement as to the PE-12000 would not eliminate the need for trial on the remaining accused products, nor would it resolve the damages disputes. It would, however, create a risk of prejudice at trial by signaling to the jury that one product line has already been found to infringe — a finding that could color the jury's assessment of the closely related PE-5000 and PE-15000 designs.

Solstice's damages expert, Dr. Elena Marchetti — a Managing Director at Pinnacle Economics Group LLC in New York, New York — served her expert report on February 14, 2025. Dr. Marchetti's report demonstrates significant flaws in Mr. Danaher's royalty base and rate calculations, including his failure to apportion the royalty base to the patented features (as distinct from unpatented features of the PrecisionEdge™ product line), his reliance on comparable licenses that are not technically comparable, and his application of an inflated royalty rate that does not account for the availability of non-infringing alternatives. See Marchetti Expert Report at ¶¶ 34–89. These damages disputes are intertwined with the liability issues and further demonstrate that this case should proceed to a full trial rather than be resolved in a piecemeal fashion through cross-motions for summary judgment.

Even if liability were to be established as to one product line — which Solstice submits it cannot be on this record — the remaining factual disputes regarding apportionment, the proper royalty base, and the applicable royalty rate weigh heavily against granting partial summary judgment. The Court and the parties would still be required to try the damages case in full, and the efficiency gains from a partial liability determination would be minimal, if not illusory.

V. CONCLUSION

For the foregoing reasons, Defendant Solstice Biomedical, Inc. respectfully requests that the Court deny Plaintiff Apex Surgical Innovations, Inc.'s Cross-Motion for Partial Summary Judgment of Infringement as to the PrecisionEdge™ PE-12000 Series in its entirety as to each of the three asserted patents — United States Patent Nos. 9,814,237; 10,271,884; and 10,932,105 — and each of the asserted claims thereof.

In the alternative, Solstice respectfully requests that the Court:

(a) Strike or disregard the Supplemental Declaration of Dr. Calvin Ng (Exhibit A to D.I. 165) as untimely, prejudicial, and in violation of the expert discovery schedule; or

(b) At a minimum, permit Solstice to submit a responsive declaration from Dr. Miriam Ostrowski addressing the new opinions set forth in the Ng Supplemental Declaration, with a reasonable period to prepare such a response.

Solstice further respectfully requests oral argument on the pending motions, should the Court deem it appropriate.

This matter should proceed to trial, currently scheduled for September 30, 2025, where the genuine disputes of material fact identified herein can be resolved by the finder of fact. Summary judgment is a drastic remedy, and it is not warranted where, as here, the parties' experts have reached fundamentally different conclusions on the application of the asserted claim limitations to the accused product. The Court's time and the parties' resources are best served by a full trial on the merits.

VI. SIGNATURE BLOCK

Respectfully submitted,

CALDERWOOD & HARKNESS LLP

By: ________

Marcus Delgado (Del. Bar No. 5738) Christy Bauer (Del. Bar No. 6412) Peter Vassiliev (Del. Bar No. 6819) 1201 Market Street, Suite 2500 Wilmington, DE 19801 Telephone: (302) 555-7100 Facsimile: (302) 555-7101 mdelgado@calderwoodharkness.com cbauer@calderwoodharkness.com pvassiliev@calderwoodharkness.com

Counsel for Defendant Solstice Biomedical, Inc.

Dated: May 1, 2025

CERTIFICATE OF SERVICE

I, Christy Bauer, hereby certify that on May 1, 2025, a true and correct copy of the foregoing Defendant Solstice Biomedical, Inc.'s Sur-Reply in Opposition to Plaintiff's Cross-Motion for Partial Summary Judgment of Infringement (PE-12000 Series) was served via the Court's CM/ECF electronic filing system upon the following counsel of record:

Victoria Stanton, Esq. Derek Loomis, Esq. Hargrove, Tate & Bennington LLP 900 North King Street, Suite 1200 Wilmington, DE 19801 vstanton@htblaw.com dloomis@htblaw.com

Counsel for Plaintiff Apex Surgical Innovations, Inc.

________________________________________

Christy Bauer (Del. Bar No. 6412)

INTERNAL NOTATION — NOT FOR FILING

This draft sur-reply was prepared by Christy Bauer and Peter Vassiliev for review by Marcus Delgado.

Matter No.: 10294.0017 Client: Solstice Biomedical, Inc. Status: DRAFT — Never filed.

Subsequent History: On May 5, 2025, the Court denied both Solstice's Motion for Summary Judgment of Non-Infringement (D.I. 148) and Apex's Cross-Motion for Partial Summary Judgment of Infringement (D.I. 155) without prejudice and ordered the parties to attend a second settlement conference before Magistrate Judge Colleen Pratt on May 12, 2025. The parties subsequently engaged in intensive settlement negotiations from May 19 through June 4, 2025, culminating in the execution of a Term Sheet on June 10, 2025. As a result, this sur-reply was never filed with the Court.

APEX SURGICAL INNOVATIONS, INC.,

Plaintiff,

SOLSTICE BIOMEDICAL, INC.,

Defendant.

DRAFT — FOR INTERNAL REVIEW ONLY — NOT FOR FILING Prepared by: C. Bauer / P. Vassiliev | For Review by: M. Delgado Matter No. 10294.0017
IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
DEFENDANT SOLSTICE BIOMEDICAL, INC.'S SUR-REPLY IN OPPOSITION TO PLAINTIFF'S CROSS-MOTION FOR PARTIAL SUMMARY JUDGMENT OF INFRINGEMENT (PE-12000 SERIES)
Right-click to update Table of Contents
I. PRELIMINARY STATEMENT
Defendant Solstice Biomedical, Inc. ("Solstice") respectfully submits this sur-reply brief to address new arguments and evidence improperly raised for the first time in Plaintiff Apex Surgical Innovations, Inc.'s ("Apex") reply brief in support of its Cross-Motion for Partial Summary Judgment of Infringement directed at the PrecisionEdge™ PE-12000 Series 12 mm trocar assembly (the "PE-12000"). Apex's cross-motion, filed on April 14, 2025, sought a finding of infringement as a matter of law on a subset of the claims asserted in this action. However, Apex's reply brief — filed in late April 2025 — introduced arguments and expert testimony that were entirely absent from its opening papers, thereby depriving Solstice of any meaningful opportunity to respond in the ordinary course of briefing. This sur-reply is necessary to protect Solstice's right to address these new materials and to apprise the Court of their deficiencies.
The three patents that Apex asserts against the PE-12000 Series are: United States Patent No. 9,814,237 (the "'237 Patent"), United States Patent No. 10,271,884 (the "'884 Patent"), and United States Patent No. 10,932,105 (the "'105 Patent"). The specific claims at issue are Claims 1, 3, 7, and 12 of the '237 Patent; Claims 1, 2, 5, 9, and 14 of the '884 Patent; and Claims 1, 4, and 8 of the '105 Patent. Together, these claims span a range of structural and functional limitations relating to trocar seal assemblies, blade deployment mechanisms, and insufflation valves — limitations that are the subject of substantial, unresolved factual dispute between the parties' respective experts.
The core deficiency of Apex's reply is threefold. First, Apex advances a new claim construction theory for the term "integrated insufflation valve" under the '105 Patent that directly contradicts the Court's Claim Construction Order entered on December 6, 2024 (D.I. 97) (the "Claim Construction Order"), following the Markman hearing held on November 18, 2024. Second, Apex attaches and relies upon a supplemental declaration from its infringement expert, Dr. Calvin Ng — an Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute in Newark, Delaware — containing new infringement analysis and testing data that were not disclosed in Dr. Ng's original expert report served on February 10, 2025, and that were never made available to Solstice for deposition or rebuttal during expert discovery. Third, Apex attempts to resurrect prosecution history arguments concerning the scope of the "locking seal assembly" limitation in the '237 Patent that were expressly considered and rejected by this Court in the Claim Construction Order.
Even if the Court were to consider these improperly raised arguments and materials on their merits, genuine disputes of material fact remain that preclude the entry of summary judgment of infringement as to the PE-12000 Series. The competing testimony of Dr. Ng and Solstice's expert, Dr. Miriam Ostrowski — a Professor of Biomedical Engineering at Halford University in Philadelphia, Pennsylvania — demonstrates that reasonable minds could differ on whether the PE-12000's specific structural features satisfy the asserted claim limitations as properly construed. This is a classic case in which the application of claim language to accused product features requires credibility determinations and factual resolutions that are the province of the jury, not the Court on a paper record. Apex's cross-motion should be denied.
II. PROCEDURAL BACKGROUND
A. The Pending Motions
The summary judgment motions pending before this Court arose from the parties' competing views of whether genuine disputes of material fact exist with respect to infringement of the asserted patents by Solstice's PrecisionEdge™ product line. On April 1, 2025, Solstice filed its Motion for Summary Judgment of Non-Infringement (D.I. 148), directed at the PrecisionEdge™ PE-5000 Series 5 mm trocar assembly (the "PE-5000") with respect to the '237 Patent and the '884 Patent. In its motion, Solstice demonstrated that the PE-5000's design does not satisfy several key claim limitations as construed by this Court, and that no genuine dispute of material fact exists as to non-infringement of the PE-5000 Series.
In response, rather than simply opposing Solstice's motion, Apex filed its own Cross-Motion for Partial Summary Judgment of Infringement on April 14, 2025 (D.I. 155), directed at a different product — the PE-12000 Series — and asserting all three patents: the '237 Patent, the '884 Patent, and the '105 Patent. The filing of this cross-motion broadened the summary judgment record to encompass a product line that Solstice had not targeted in its own motion and introduced the '105 Patent, which was not at issue in Solstice's PE-5000 motion.
Solstice timely filed its Opposition to Apex's Cross-Motion on April 28, 2025 (D.I. 162), identifying multiple genuine disputes of material fact that preclude summary judgment of infringement as to the PE-12000 Series. Solstice's Opposition was supported by the record evidence developed during fact and expert discovery, including the rebuttal expert report of Dr. Miriam Ostrowski served on March 3, 2025, deposition testimony of Apex's named inventor and Vice President of Engineering, Dr. Raymond Szabo, and the documentary record of the PE-12000's design and engineering specifications.
Apex filed its reply brief in support of its cross-motion on or about April 25–28, 2025 (D.I. 165). It is this reply that prompts the present sur-reply. As detailed below, Apex's reply raises arguments and introduces evidence that were not present in its opening papers, necessitating this response.
B. The Claim Construction Order
On December 6, 2024, this Court issued its Claim Construction Order (D.I. 97) following full briefing and oral argument. The parties submitted a Joint Claim Construction Brief on November 4, 2024 (D.I. 85), addressing nine disputed claim terms. The Markman hearing was held on November 18, 2024, at which the Court received argument from both sides on each of the nine terms.
Of the nine disputed terms construed in the December 6, 2024 Order, five were construed in a manner favorable to Solstice and four in a manner favorable to Apex. The Claim Construction Order is the law of the case and governs the infringement analysis at summary judgment and trial. Neither party sought reconsideration of the Claim Construction Order, and the time for doing so has long since expired.
Three of the construed terms are of particular relevance to the PE-12000 dispute now before the Court:
(a) "locking seal assembly" ('237 Patent) — construed by the Court to require "a seal assembly comprising at least two components that engage one another through a positive-lock mechanism to maintain a gas-tight seal during trocar insertion and removal." This construction was one of the five terms construed favorably to Solstice. Notably, the Court's construction excluded friction-fit and interference-fit arrangements from the scope of the limitation.
(b) "retractable blade deployment mechanism" ('884 Patent) — construed by the Court to require "a mechanism that deploys a cutting blade from a retracted position to an extended position and that automatically retracts the blade upon removal of the trocar tip from tissue." The parties' principal dispute as to this term concerned whether automatic retraction was required; the Court held that it was.
(c) "integrated insufflation valve" ('105 Patent) — construed by the Court to require "a valve that is structurally unified with the trocar housing as a single integral component, rather than a separately attached or modular valve." This construction was one of the five terms construed favorably to Solstice and is the subject of Apex's impermissible new argument in its reply.
C. The Expert Record
The expert discovery schedule in this action was set by the Court's Revised Scheduling Order entered October 14, 2024 (D.I. 78). Expert discovery opened on January 13, 2025. Dr. Calvin Ng, Apex's technical expert on infringement, served his expert report on February 10, 2025, as required by the Scheduling Order. Dr. Ng is an Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute in Newark, Delaware, and has been engaged by Apex to provide opinions on whether Solstice's PrecisionEdge™ products infringe the asserted claims.
Dr. Miriam Ostrowski, Solstice's technical expert on non-infringement, served her rebuttal expert report on March 3, 2025, as required by the Scheduling Order. Dr. Ostrowski is a Professor of Biomedical Engineering at Halford University in Philadelphia, Pennsylvania, and has extensive experience in minimally invasive surgical device design and trocar assembly technology. Dr. Ostrowski's rebuttal report addressed and rebutted each of Dr. Ng's infringement opinions on a claim-by-claim, element-by-element basis.
Expert depositions were completed prior to the close of expert discovery. Both Dr. Ng and Dr. Ostrowski were deposed. The expert discovery period has closed. No provision of the Scheduling Order or the Federal Rules of Civil Procedure authorizes the submission of a supplemental expert declaration at the summary judgment stage containing new opinions that were not disclosed during expert discovery. Yet that is precisely what Apex has done in its reply brief, attaching a supplemental declaration from Dr. Ng that contains new infringement analysis of the PE-12000's seal housing sub-assembly and blade-deployment spring mechanism — opinions that were neither contained in Dr. Ng's February 10, 2025 report nor disclosed at any point during the expert discovery period.
III. LEGAL STANDARD FOR SUR-REPLY
It is well established in this District that a sur-reply may be filed where the moving party's reply brief raises new arguments, new evidence, or new legal theories that were not fairly presented in its opening brief, such that the non-moving party has been deprived of an opportunity to respond. See, e.g., Idenix Pharms. LLC v. Gilead Scis., Inc., No. 13-1987-LPS, 2016 WL 1274553, at 4 (D. Del. Mar. 31, 2016) (permitting sur-reply where reply raised new arguments); Pemberton Partners LLC v. Greaves Industries, Inc., No. 18-924-CFC, 2020 WL 3447607, at 1 n.1 (D. Del. June 24, 2020) (same). The purpose of allowing a sur-reply in such circumstances is to ensure fundamental fairness and to prevent the reply brief from being used as a vehicle for sandbagging the opposing party with arguments to which no response is possible within the ordinary briefing framework.
Here, Apex's reply brief raises at least three categories of new material that were not presented in its opening papers and that warrant a response from Solstice:
(1) A new claim construction theory for "integrated insufflation valve" under the '105 Patent. Apex's opening brief applied the Court's construction of this term without qualification. In its reply, however, Apex advances an expanded interpretation of "structurally unified" that was never briefed at claim construction and that contradicts the Court's December 6, 2024 Order.
(2) A supplemental declaration from Dr. Calvin Ng containing a new infringement analysis of the PE-12000's seal housing sub-assembly and blade-deployment spring mechanism. This declaration includes testing data and analytical conclusions that were not part of Dr. Ng's February 10, 2025 expert report, were not disclosed during expert discovery, and were not subject to deposition or rebuttal by Dr. Ostrowski.
(3) New reliance on prosecution history arguments regarding the scope of the "locking seal assembly" limitation of the '237 Patent. These arguments were presented to the Court at the Markman hearing, were considered in the Claim Construction Order, and were rejected. Apex may not relitigate them in a summary judgment reply brief.
Solstice respectfully submits that these new materials more than satisfy the standard for a sur-reply. In addition, Solstice reserves all arguments raised in its April 28, 2025 Opposition brief (D.I. 162) and incorporates them herein by reference in their entirety.
IV. ARGUMENT
A. Apex's New Claim Construction Theory for "Integrated Insufflation Valve" Is Foreclosed by the Court's December 6, 2024 Order
1. The Court's Construction Is the Law of the Case. This Court construed the term "integrated insufflation valve" as it appears in Claims 1, 4, and 8 of the '105 Patent to mean "a valve that is structurally unified with the trocar housing as a single integral component, rather than a separately attached or modular valve." Claim Construction Order at 27 (D.I. 97). In reaching this construction, the Court considered the full range of intrinsic evidence — the claim language itself, the written description and figures of the '105 Patent specification, and the prosecution history — as well as the extrinsic evidence submitted by the parties, including competing expert declarations. See id. at 24–27.
This term was among the nine disputed terms briefed in the Joint Claim Construction Brief filed November 4, 2024 (D.I. 85), and was the subject of extensive oral argument at the Markman hearing on November 18, 2024. Both parties had a full and fair opportunity to present their positions. Apex advocated for a broader construction — one that would have encompassed any valve "associated with" or "connected to" the trocar housing, regardless of whether the valve was a separate, modular component. See Apex's Claim Construction Br. at 31–35 (D.I. 83). The Court rejected Apex's proposed construction in favor of Solstice's narrower reading, which requires structural unity as a single integral component. Claim Construction Order at 26–27.
The Claim Construction Order is the law of the case. Under the law-of-the-case doctrine, a court's prior construction of a patent claim term should not be reconsidered absent extraordinary circumstances, such as an intervening change in controlling law, newly discovered evidence, or clear error. See Christianson v. Colt Indus. Operating Corp., 486 U.S. 800, 816 (1988); Gould, Inc. v. United States, 67 F.3d 925, 930 (Fed. Cir. 1995). None of those circumstances is present here, and Apex has not moved for reconsideration of the Claim Construction Order.
2. Apex's Reply Impermissibly Seeks to Expand the Court's Construction. Despite the clarity of the Court's construction, Apex's reply brief recharacterizes the "integrated insufflation valve" limitation of Claims 1, 4, and 8 of the '105 Patent in a manner that is flatly inconsistent with the Claim Construction Order. Specifically, Apex now argues that "structurally unified" should be understood to encompass a multi-component valve assembly so long as the individual components are "permanently affixed" or "non-removable" in the finished device — a construction that the Court never adopted and that is materially different from the requirement of "a single integral component." See Apex Reply at 14–16 (D.I. 165).
This is not a permissible application of the Court's construction to the facts; it is an attempt to obtain de facto reconsideration of the Markman ruling through the procedural vehicle of a summary judgment reply brief. The distinction matters. A "single integral component" is, by definition, a unitary structure — not a multi-part assembly held together by adhesive, welding, or mechanical fasteners. Apex's recharacterization would collapse the distinction between a structurally unified valve and a modular valve that has been permanently joined, and it would render the Court's express exclusion of "separately attached or modular" valves a nullity.
It is black-letter law in this Circuit that a party may not relitigate claim construction at the summary judgment stage by repackaging a rejected construction as a "reasonable reading" or "alternative interpretation" of the Court's order. See Pemberton Partners LLC v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1365 (Fed. Cir. 2009) ("It is not for the litigants to redefine the court's claim constructions on summary judgment."); see also Ashbury Industries, Inc. v. Teva Pharms. USA, Inc., 429 F.3d 1364, 1374 (Fed. Cir. 2005) (holding that the trial court's claim construction cannot be expanded or altered through expert testimony or argument at summary judgment). That is precisely what Apex seeks to do here, and the Court should decline the invitation.
Applied to the PE-12000 Series, the consequence of the Court's construction is straightforward. It is undisputed that the PE-12000's insufflation valve is housed in a two-piece valve housing that is assembled from separately manufactured components and connected to the trocar body via a snap-fit connection. See Ostrowski Rebuttal Report at ¶¶ 87–94 (Ex. 8 to D.I. 162); PE-12000 Engineering Drawings, SOL-00024891–98 (Ex. 12 to D.I. 162). The PE-12000's valve housing is not a single integral component; it is a modular, detachable assembly. Under the Court's construction, the PE-12000's valve configuration does not meet the "integrated" limitation of the '105 Patent.
3. Even Under Apex's Expanded Construction, a Factual Dispute Exists. Even if the Court were to entertain Apex's new, expanded construction of "integrated insufflation valve" — which Solstice submits would be error — genuine disputes of material fact would still preclude summary judgment. The competing expert testimony on this point is stark.
Dr. Ng opines that the PE-12000's valve housing qualifies as "integrated" because, once assembled, the two halves of the housing are joined by a snap-fit connection that is designed not to be separated during normal clinical use. See Ng Expert Report at ¶¶ 142–148. Dr. Ostrowski's rebuttal report, however, identifies specific structural differences between the PE-12000's valve assembly and the structurally unified valve described in the '105 Patent specification. Dr. Ostrowski explains that the PE-12000's two-piece valve housing comprises an upper housing component and a lower housing component that are manufactured as separate injection-molded parts, assembled with a separate gasket seal interposed between them, and joined by a snap-fit connection that permits disassembly for cleaning and inspection. See Ostrowski Rebuttal Report at ¶¶ 87–94.
Dr. Ostrowski further testified that the PE-12000's separate gasket seal — which sits between the two housing halves and provides the gas-tight seal for insufflation — is a distinct component that is not structurally unified with either housing half. Id. at ¶ 91. This three-component arrangement (upper housing, gasket seal, lower housing) is materially different from the single-piece, integrally molded valve depicted in Figures 4A and 4B of the '105 Patent specification. Id. at ¶ 93.
Where, as here, the factual dispute turns on the application of a claim limitation to specific product features and the parties' experts disagree on whether those features satisfy the limitation, summary judgment is inappropriate. See Shire LLC v. Amneal Pharms., LLC, 802 F.3d 1301, 1307 (Fed. Cir. 2015) ("Where the parties' experts provide conflicting testimony on whether the accused product meets a claim limitation, the issue is one for the factfinder."). The Court should deny Apex's motion as to the '105 Patent.
B. Dr. Ng's Supplemental Declaration Should Be Disregarded as Untimely and Prejudicial
1. The Expert discovery Schedule Has Closed. The Revised Scheduling Order entered by this Court on October 14, 2024 (D.I. 78) established a clear and orderly schedule for expert discovery. Expert discovery opened on January 13, 2025. Dr. Ng's infringement expert report was due and served on February 10, 2025. Rebuttal expert reports — including Dr. Ostrowski's rebuttal to Dr. Ng's opinions — were due and exchanged on March 3, 2025. Expert depositions were thereafter completed, and expert discovery has closed.
The Scheduling Order did not provide for supplemental expert reports or declarations. Nor did Apex seek leave of Court to supplement Dr. Ng's expert disclosures at any point prior to filing its cross-motion or its reply. The supplemental declaration attached to Apex's reply (the "Ng Supplemental Declaration") was not served during the expert discovery period, was not subject to deposition by Solstice, and was not made available to Dr. Ostrowski for rebuttal. It appeared for the first time as Exhibit A to Apex's reply brief — a filing to which Solstice has no automatic right of response.
Federal Rule of Civil Procedure 26(a)(2)(E) requires that expert disclosures be made at the times and in the sequence directed by the Court. Rule 37(c)(1) provides that if a party fails to provide information or identify a witness as required by Rule 26, the party is not allowed to use that information or witness on a motion unless the failure was substantially justified or is harmless. Apex has offered no justification — substantial or otherwise — for the late submission of the Ng Supplemental Declaration, and its inclusion is far from harmless, as discussed below.
2. The Supplemental Declaration Contains New Opinions Not Disclosed in Dr. Ng's Original Report. The Ng Supplemental Declaration is not a mere clarification or summary of opinions previously disclosed. It contains substantively new expert analysis directed at a critical claim limitation that was insufficiently addressed in Dr. Ng's original report. Specifically, the Ng Supplemental Declaration sets forth a new and detailed analysis of the PE-12000's blade-deployment spring mechanism as allegedly meeting the "retractable blade deployment mechanism" limitation of Claims 1, 2, 5, 9, and 14 of the '884 Patent. See Ng Supplemental Decl. at ¶¶ 8–22.
This new analysis is based on testing or analytical work — including force-displacement measurements of the PE-12000's blade retraction spring — that was not referenced, described, or cited anywhere in Dr. Ng's February 10, 2025 expert report. Compare Ng Expert Report at ¶¶ 98–112 (addressing the '884 Patent "retractable blade deployment mechanism" limitation at a general level, without spring force data or testing results), with Ng Supplemental Decl. at ¶¶ 12–18 (presenting new force-displacement data and a detailed mechanical analysis of the spring retraction mechanism).
This constitutes a new expert opinion. Solstice has had no opportunity to depose Dr. Ng on these new opinions. Dr. Ostrowski has had no opportunity to review the underlying data, evaluate Dr. Ng's methodology, or submit a rebuttal. The prejudice to Solstice is manifest: Apex seeks to use an untimely, undisclosed expert opinion to carry its burden on summary judgment, while Solstice is deprived of the basic procedural protections that the discovery rules are designed to provide.
The prejudice is compounded by the practical and economic burden that would be imposed on Solstice if it were required to respond to these new opinions at this stage of the litigation. Dr. Ostrowski's expert fees to date total $127,500, reflecting 170 hours of work at her standard rate of $750 per hour. Requiring Dr. Ostrowski to perform additional rebuttal analysis, review new test data, and prepare a responsive declaration — all outside the scheduled expert discovery period — would impose significant additional costs on Solstice and further delay the resolution of this case.
3. Relief Requested. For the foregoing reasons, Solstice respectfully requests that the Court strike or, at a minimum, disregard the Ng Supplemental Declaration in evaluating Apex's Cross-Motion for Partial Summary Judgment of Infringement. The declaration is untimely, prejudicial, and unsupported by any justification for its late submission. Apex chose to rest on Dr. Ng's February 10, 2025 report during expert discovery and cannot now supplement that record through a reply-brief declaration.
In the alternative, if the Court determines that it will consider the Ng Supplemental Declaration, Solstice respectfully requests the opportunity to submit a responsive declaration from Dr. Ostrowski addressing the new opinions set forth therein. Fairness and due process require no less.
C. Apex's Prosecution History Arguments Were Rejected at Claim Construction and Cannot Be Revived
1. The "Locking Seal Assembly" Limitation ('237 Patent). Apex's reply brief revisits prosecution history arguments regarding the scope of the "locking seal assembly" limitation as it appears in Claims 1, 3, 7, and 12 of the '237 Patent. The '237 Patent, United States Patent No. 9,814,237, was issued on November 14, 2017, and does not expire until June 22, 2035. It is the oldest of the three asserted patents and has the most extensive prosecution history.
The prosecution history of the '237 Patent was the subject of thorough analysis by Solstice's counsel, both at Calderwood & Harkness LLP and in coordination with patent prosecution counsel at Kendrick & Lau LLP. Dr. Jonathan Kendrick of Kendrick & Lau LLP, 601 Pennsylvania Avenue NW, Suite 820, Washington, DC 20004, assisted in the analysis of narrowing amendments made during prosecution by the named inventor, Dr. Raymond Szabo, who serves as Apex's Vice President of Engineering. During prosecution, Dr. Szabo and Apex's patent counsel amended the claims to distinguish over the prior art by narrowing the scope of the "locking seal assembly" limitation. Specifically, the applicants amended the claims to require a "positive-lock engagement" between the seal components, expressly distinguishing their invention from prior art trocar seals that relied on friction-fit or interference-fit retention. See '237 Patent Prosecution History, Amendment dated September 12, 2016, at 4–6 (Ex. 6 to D.I. 162).
These prosecution history estoppel arguments were presented in full in Solstice's Claim Construction Brief filed October 28, 2024 (D.I. 81), and addressed in the Joint Claim Construction Brief filed November 4, 2024 (D.I. 85). The Court considered them at the Markman hearing on November 18, 2024, and expressly adopted a construction of "locking seal assembly" that requires a "positive-lock mechanism" — consistent with the narrowing amendments made during prosecution. Claim Construction Order at 14–17.
Apex's reply now attempts to argue that the prosecution history supports a broader reading of the "locking seal assembly" limitation than the Court's construction permits — specifically, that the narrowing amendments were directed only at a particular prior art reference (U.S. Patent No. 7,422,581 to Henderson) and should not be read to exclude friction-fit mechanisms more broadly. See Apex Reply at 8–11 (D.I. 165). But this is the very argument that Apex made at claim construction and that the Court rejected. The Court's construction requires a "positive-lock mechanism," not merely a mechanism that can be distinguished from a single prior art reference. Apex cannot relitigate this issue through its summary judgment reply brief.
2. Application to the PE-12000 Series. Under the Court's construction of "locking seal assembly," the PE-12000's seal mechanism presents a genuine factual dispute as to whether it meets the limitation — a dispute that favors denial of Apex's motion, not its grant. The PE-12000 utilizes a friction-fit retention system in which the upper and lower seal components are held in place by the compressive force of an elastomeric O-ring, rather than by a positive-lock engagement such as a bayonet mount, detent mechanism, or threaded connection. See Ostrowski Rebuttal Report at ¶¶ 42–56; PE-12000 Design Verification Report, SOL-00031204 at 7–8 (Ex. 14 to D.I. 162).
Dr. Ostrowski's rebuttal report provides a detailed analysis of the PE-12000's seal retention mechanism, concluding that it does not satisfy the "positive-lock mechanism" requirement of the Court's construction because the seal components are held together solely by friction and compressive force, and can be separated by applying a modest axial pull force without releasing any locking element. See Ostrowski Rebuttal Report at ¶¶ 48–52. Dr. Ostrowski contrasts the PE-12000 design with the '237 Patent's specification, which describes and depicts a bayonet-style positive-lock engagement between the seal housing and the trocar body. Id. at ¶¶ 53–56.
Dr. Ng's original expert report acknowledges that the PE-12000's seal components are not joined by a bayonet mount or threaded connection, but reaches the contrary conclusion that the friction-fit retention system nonetheless constitutes a "positive-lock mechanism" because the O-ring creates a "sufficiently secure" engagement that resists inadvertent separation. See Ng Expert Report at ¶¶ 74–82. This is a classic battle of the experts. The two experts have examined the same product, applied the same claim construction, and reached opposite conclusions based on their respective assessments of the PE-12000's structural features. This factual disagreement cannot be resolved on summary judgment and must be submitted to the finder of fact at trial. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986) ("Credibility determinations, the weighing of the evidence, and the drawing of legitimate inferences from the facts are jury functions, not those of a judge . . . on a motion for summary judgment.").
D. Genuine Disputes of Material Fact Preclude Summary Judgment on the PE-12000 Series for All Three Patents
The foregoing discussion demonstrates that genuine disputes of material fact pervade Apex's infringement case as to the PE-12000 Series across all three asserted patents. The following summarizes the specific disputes as to each patent.
1. The '237 Patent (Claims 1, 3, 7, 12). As discussed in Section IV.C above, the central factual dispute with respect to the '237 Patent is whether the PE-12000's seal mechanism meets the "locking seal assembly" limitation as construed by this Court. The parties' experts — Dr. Ng and Dr. Ostrowski — have reached diametrically opposed conclusions on this question. Dr. Ng contends that the PE-12000's friction-fit O-ring retention system constitutes a "positive-lock mechanism"; Dr. Ostrowski disagrees, explaining that friction-fit retention is fundamentally different from positive-lock engagement and was the very type of mechanism distinguished during prosecution of the '237 Patent.
This dispute is not peripheral. The "locking seal assembly" limitation appears in each of the four asserted claims of the '237 Patent (Claims 1, 3, 7, and 12). If the PE-12000's seal mechanism does not satisfy this limitation, none of the asserted claims of the '237 Patent is infringed. Conversely, if it does, additional element-by-element disputes remain. Either way, the issue cannot be resolved without weighing expert credibility and making factual findings that are inappropriate at the summary judgment stage.
The significance of this dispute is underscored by the magnitude of the commercial stakes. The PE-12000 is one of three accused product lines in the PrecisionEdge™ family. Combined United States sales of accused PrecisionEdge™ products — the PE-5000, PE-12000, and PE-15000 — total approximately $74.6 million from 2021 through the third quarter of 2024. See Solstice's Responses and Objections to Apex's First Set of Interrogatories, Interrogatory No. 7, at 12–14 (D.I. 162, Ex. 18). The determination of infringement vel non as to the PE-12000 will have substantial consequences for the damages calculation in this case, and the parties are entitled to a full trial on the merits.
2. The '884 Patent (Claims 1, 2, 5, 9, 14). The primary factual dispute with respect to the '884 Patent concerns whether the PE-12000's blade mechanism meets the "retractable blade deployment mechanism" limitation as construed by this Court. The Court's construction requires "a mechanism that deploys a cutting blade from a retracted position to an extended position and that automatically retracts the blade upon removal of the trocar tip from tissue." Claim Construction Order at 20.
Five claims of the '884 Patent are asserted against the PE-12000 — Claims 1, 2, 5, 9, and 14. In its original expert report, Dr. Ng addressed this limitation at a general level, opining that the PE-12000's spring-loaded blade mechanism satisfies the "retractable blade deployment mechanism" requirement. Ng Expert Report at ¶¶ 98–112. Dr. Ostrowski's rebuttal report identified specific deficiencies in Dr. Ng's analysis, including the absence of any force-displacement data or testing results to support his opinion that the PE-12000's blade retraction is "automatic" within the meaning of the Court's construction. Ostrowski Rebuttal Report at ¶¶ 63–78.
It is telling that Dr. Ng's supplemental declaration — which Solstice submits should be stricken — specifically targets this very limitation. The fact that Apex found it necessary to submit additional expert testimony on this point in its reply brief underscores that Apex itself recognized a gap in its original evidentiary showing as to the '884 Patent. This is an admission by conduct that genuine disputes of material fact exist.
In addition, the claim chart analysis supporting Solstice's non-infringement position is extensive. A preliminary claim chart for the '884 Patent was prepared by Solstice's counsel on July 22, 2024 (prior to the filing of Solstice's Answer and Counterclaims), identifying element-by-element non-infringement positions for each of the five asserted claims. That claim chart was subsequently refined and incorporated into Dr. Ostrowski's rebuttal report. See Ostrowski Rebuttal Report, Appendix C (Element-by-Element Claim Chart for '884 Patent). The claim chart identifies multiple claim elements — beyond the "retractable blade deployment mechanism" — as to which the PE-12000 does not satisfy the claim limitations. Summary judgment is precluded on this patent.
3. The '105 Patent (Claims 1, 4, 8). As discussed in detail in Section IV.A above, the central factual dispute with respect to the '105 Patent is whether the PE-12000's valve configuration meets the "integrated insufflation valve" limitation as construed by this Court. Apex's reply advances a new construction of this term that is inconsistent with the Claim Construction Order. Even under that impermissible construction, Dr. Ostrowski's testimony creates a genuine dispute of material fact that precludes summary judgment.
The '105 Patent is the newest of the three asserted patents. United States Patent No. 10,932,105 was issued on March 2, 2021, and does not expire until January 10, 2038. Its claims are the narrowest of the three patents, reflecting the extensive prosecution history in which the applicants made multiple narrowing amendments to distinguish over the prior art. See '105 Patent Prosecution History (Ex. 9 to D.I. 162). Indeed, the claims of the '105 Patent were allowed only after Apex's patent counsel expressly disclaimed coverage of modular or detachable valve assemblies. See id., Remarks dated August 4, 2020, at 8–9.
The PE-12000's two-piece valve housing, separate gasket seal, and snap-fit connection present the very type of modular valve assembly that was disclaimed during prosecution. Dr. Ostrowski's rebuttal report details these structural features and explains why they fall outside the scope of the "integrated insufflation valve" limitation. Ostrowski Rebuttal Report at ¶¶ 87–94. Dr. Ng disagrees, but his disagreement creates a factual dispute — it does not resolve one.
E. Apex's Damages Theory Does Not Support Summary Judgment on Liability
Even setting aside the merits of Apex's infringement case, practical considerations counsel against granting partial summary judgment on the PE-12000 Series. Apex's damages expert, Hugh Danaher, CFA — a Senior Managing Director at Keystone Valuation Advisors LLC in Philadelphia, Pennsylvania — has opined that Apex is entitled to $31,800,000 in reasonable royalty damages across all three accused product lines (the PE-5000, PE-12000, and PE-15000). See Danaher Expert Report at ¶ 147, served February 12, 2025 (Ex. 19 to D.I. 162). This figure represents approximately 42.6% of total United States sales of accused PrecisionEdge™ products ($74.6 million) over the relevant damages period — a royalty rate and base that are themselves the subject of substantial dispute.
The enormity of the damages claim underscores the importance of a full trial on the merits rather than piecemeal resolution through summary judgment on a single product line. Granting partial summary judgment of infringement as to the PE-12000 would not eliminate the need for trial on the remaining accused products, nor would it resolve the damages disputes. It would, however, create a risk of prejudice at trial by signaling to the jury that one product line has already been found to infringe — a finding that could color the jury's assessment of the closely related PE-5000 and PE-15000 designs.
Solstice's damages expert, Dr. Elena Marchetti — a Managing Director at Pinnacle Economics Group LLC in New York, New York — served her expert report on February 14, 2025. Dr. Marchetti's report demonstrates significant flaws in Mr. Danaher's royalty base and rate calculations, including his failure to apportion the royalty base to the patented features (as distinct from unpatented features of the PrecisionEdge™ product line), his reliance on comparable licenses that are not technically comparable, and his application of an inflated royalty rate that does not account for the availability of non-infringing alternatives. See Marchetti Expert Report at ¶¶ 34–89. These damages disputes are intertwined with the liability issues and further demonstrate that this case should proceed to a full trial rather than be resolved in a piecemeal fashion through cross-motions for summary judgment.
Even if liability were to be established as to one product line — which Solstice submits it cannot be on this record — the remaining factual disputes regarding apportionment, the proper royalty base, and the applicable royalty rate weigh heavily against granting partial summary judgment. The Court and the parties would still be required to try the damages case in full, and the efficiency gains from a partial liability determination would be minimal, if not illusory.
V. CONCLUSION
For the foregoing reasons, Defendant Solstice Biomedical, Inc. respectfully requests that the Court deny Plaintiff Apex Surgical Innovations, Inc.'s Cross-Motion for Partial Summary Judgment of Infringement as to the PrecisionEdge™ PE-12000 Series in its entirety as to each of the three asserted patents — United States Patent Nos. 9,814,237; 10,271,884; and 10,932,105 — and each of the asserted claims thereof.
In the alternative, Solstice respectfully requests that the Court:
(a) Strike or disregard the Supplemental Declaration of Dr. Calvin Ng (Exhibit A to D.I. 165) as untimely, prejudicial, and in violation of the expert discovery schedule; or
(b) At a minimum, permit Solstice to submit a responsive declaration from Dr. Miriam Ostrowski addressing the new opinions set forth in the Ng Supplemental Declaration, with a reasonable period to prepare such a response.
Solstice further respectfully requests oral argument on the pending motions, should the Court deem it appropriate.
This matter should proceed to trial, currently scheduled for September 30, 2025, where the genuine disputes of material fact identified herein can be resolved by the finder of fact. Summary judgment is a drastic remedy, and it is not warranted where, as here, the parties' experts have reached fundamentally different conclusions on the application of the asserted claim limitations to the accused product. The Court's time and the parties' resources are best served by a full trial on the merits.
VI. SIGNATURE BLOCK
Respectfully submitted,
CALDERWOOD & HARKNESS LLP
By: ________
Marcus Delgado (Del. Bar No. 5738) Christy Bauer (Del. Bar No. 6412) Peter Vassiliev (Del. Bar No. 6819) 1201 Market Street, Suite 2500 Wilmington, DE 19801 Telephone: (302) 555-7100 Facsimile: (302) 555-7101 mdelgado@calderwoodharkness.com cbauer@calderwoodharkness.com pvassiliev@calderwoodharkness.com
Counsel for Defendant Solstice Biomedical, Inc.
Dated: May 1, 2025
CERTIFICATE OF SERVICE
I, Christy Bauer, hereby certify that on May 1, 2025, a true and correct copy of the foregoing Defendant Solstice Biomedical, Inc.'s Sur-Reply in Opposition to Plaintiff's Cross-Motion for Partial Summary Judgment of Infringement (PE-12000 Series) was served via the Court's CM/ECF electronic filing system upon the following counsel of record:
Victoria Stanton, Esq. Derek Loomis, Esq. Hargrove, Tate & Bennington LLP 900 North King Street, Suite 1200 Wilmington, DE 19801 vstanton@htblaw.com dloomis@htblaw.com
Counsel for Plaintiff Apex Surgical Innovations, Inc.
________________________________________
Christy Bauer (Del. Bar No. 6412)
INTERNAL NOTATION — NOT FOR FILING
This draft sur-reply was prepared by Christy Bauer and Peter Vassiliev for review by Marcus Delgado.
Matter No.: 10294.0017 Client: Solstice Biomedical, Inc. Status: DRAFT — Never filed.
Subsequent History: On May 5, 2025, the Court denied both Solstice's Motion for Summary Judgment of Non-Infringement (D.I. 148) and Apex's Cross-Motion for Partial Summary Judgment of Infringement (D.I. 155) without prejudice and ordered the parties to attend a second settlement conference before Magistrate Judge Colleen Pratt on May 12, 2025. The parties subsequently engaged in intensive settlement negotiations from May 19 through June 4, 2025, culminating in the execution of a Term Sheet on June 10, 2025. As a result, this sur-reply was never filed with the Court.
APEX SURGICAL INNOVATIONS, INC.,
Plaintiff,
v. | Case No. 1:24-cv-00587-RGA
SOLSTICE BIOMEDICAL, INC.,
Defendant.