Contract analysis

I. PRELIMINARY STATEMENT Apex Surgical Innovations, Inc. ("Apex") filed its Cross-Motion for Partial Summary Judgment on April 14, 2025, asking this Court to find, as a matter of law, that Solstice Biomedical, Inc.'s ("Solstice") PrecisionEdge™ PE-12000 Series (12 mm trocar assembly) infringes all three asserted patents in this action: U.S. Patent No. 9,814,237 ("the '237 Patent"), U.S. Patent No. 10,271,884 ("the '8

II. STATEMENT OF FACTS A. The Parties Defendant Solstice Biomedical, Inc. is a Delaware corporation with its principal offices located at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803 (EIN: 84-3291056). Solstice Biomedical, Inc. is the wholly owned U.S. operating subsidiary of Solstice Biomedical Devices Ltd., an Irish-domiciled private limited company registered with the Companies Registration Office (CRO

III. LEGAL STANDARD A. Summary Judgment Under Federal Rule of Civil Procedure 56 Summary judgment is appropriate "if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a). A genuine dispute of material fact exists when "the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Ander

IV. ARGUMENT The record before this Court demonstrates that genuine disputes of material fact pervade every aspect of Apex's infringement theory as to the PE-12000 Series. As set forth in detail below, each of the three asserted patents presents multiple disputed claim limitations that cannot be resolved without weighing competing expert testimony and evaluating conflicting physical evidence. Summary judgment of infr

1. The Court's Construction of "Locking Seal Assembly" Creates a Disputed Factual Issue. The central claim limitation in independent Claim 1 of the '237 Patent — and the limitation from which Claims 3, 7, and 12 each depend — is the "locking seal assembly." This term was among the nine disputed claim terms addressed at the Markman hearing, and the Court's December 6, 2024 Claim Construction Order construed it in a ma

2. Claim 7 Requires a "Radially Compressible Seal Element" — Disputed Evidence. Claim 7 of the '237 Patent depends from Claim 1 and adds the requirement of a "radially compressible seal element" that "deforms radially to accommodate insertion of surgical instruments of varying diameters." '237 Patent, col. 14, ll. 28-33. This limitation requires that the seal element compress in the radial direction — that is, perpen

3. Claim 12's "Housing Detent" Limitation Is Not Met. Claim 12 of the '237 Patent depends from Claim 1 and further requires a "housing detent" that "positively engages the seal in the locked position." '237 Patent, col. 15, ll. 4-8. The term "housing detent" was not among the nine terms construed in the Court's Claim Construction Order, and the parties have applied its plain and ordinary meaning. A "detent" is unders

1. The "Retractable Blade Deployment Mechanism" — Structural Differences. The independent claim of the '884 Patent — Claim 1 — recites a "retractable blade deployment mechanism" as a key element. This term was construed by the Court in its December 6, 2024 Claim Construction Order, which defined it to require "a spring-loaded blade that automatically retracts upon penetration of the body wall." D.I. 87 at 18. The Cou

2. Claim 5 — "Blade Guard" Limitation. Even assuming arguendo that the PE-12000 satisfies Claim 1's "retractable blade deployment mechanism" limitation, independent factual disputes preclude summary judgment on several dependent claims. Claim 5 of the '884 Patent depends from Claim 1 and adds the requirement of a "blade guard" that "shields the blade during retraction to prevent tissue contact." '884 Patent, col. 18,

3. Claim 9 — "Sequential Deployment" Feature Disputed. Claim 9 of the '884 Patent depends from Claim 1 and adds the requirement of "sequential deployment" of the blade and the trocar cannula. Specifically, Claim 9 requires that the blade be deployed first, followed by advancement of the cannula over the obturator, in a defined temporal sequence. '884 Patent, col. 19, ll. 7-15. The PE-12000 deploys the blade and the c

4. Claim 14 — Dependent Claim Adding "Biased Return Spring". Claim 14 of the '884 Patent depends from Claim 1 and adds the limitation of a "biased return spring" with specified mechanical characteristics — specifically, a "compression return spring having a spring constant of between 2.0 and 4.0 N/mm." '884 Patent, col. 20, ll. 2-8. Solstice's engineering records demonstrate that the PE-12000 uses a torsion spring ra

2. Claim 4 — "Self-Sealing Membrane" Element Absent. Claim 4 of the '105 Patent depends from Claim 1 and adds the limitation of a "self-sealing membrane" that "closes automatically when no instrument is inserted through the trocar, thereby preventing escape of insufflation gas." '105 Patent, col. 16, ll. 22-27. Solstice has presented evidence that the PE-12000 does not use a "self-sealing membrane." Instead, the PE-1

3. Claim 8 — "Gas-Tight Seal at Pressures Exceeding 20 mmHg" — Testing Discrepancy. Claim 8 of the '105 Patent depends from Claim 1 and adds the limitation that the seal must "maintain a gas-tight seal at insufflation pressures exceeding 20 mmHg." '105 Patent, col. 17, ll. 8-12. The parties have presented directly conflicting bench testing data on whether the PE-12000's seal satisfies this limitation. Solstice's benc

1. Prosecution History Estoppel Bars Equivalents Arguments. During prosecution of all three asserted patents, the named inventor, Dr. Raymond Szabo, and Apex's prosecution counsel made narrowing amendments to the claims in response to prior art rejections issued by the United States Patent and Trademark Office. These narrowing amendments surrender claim scope under the doctrine of prosecution history estoppel, barrin

2. The "All-Limitations" Rule Precludes Equivalents. Even if prosecution history estoppel did not apply — which it does — Apex's equivalents theory would still fail under the all-limitations rule. Under this rule, the doctrine of equivalents cannot be applied in a manner that effectively eliminates a claim limitation, thereby reading the limitation out of the claim. Pennwalt, 833 F.2d at 935; Warner-Jenkinson, 520 U.