Contract analysis

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")

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™ P

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

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 th

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-c

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" b

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

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 de

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 disco

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 t

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 elastom

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-rin

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 remov

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 constructi

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 t

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 B