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UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

DEFENDANT SOLSTICE BIOMEDICAL, INC.'S MEMORANDUM OF LAW IN OPPOSITION TO PLAINTIFF'S CROSS-MOTION FOR PARTIAL SUMMARY JUDGMENT OF INFRINGEMENT AS TO THE PRECISIONEDGE™ PE-12000 SERIES

Marcus Delgado (Bar No. 4817) Christy Bauer (Bar No. 6293) Peter Vassiliev (Bar No. 6740) CALDERWOOD & HARKNESS LLP 1201 Market Street, Suite 2500 Wilmington, DE 19801 Telephone: (302) 654-7800 Facsimile: (302) 654-7801

Counsel for Defendant Solstice Biomedical, Inc.

Dated: April 28, 2025

TABLE OF AUTHORITIES

Cases

Statutes and Rules

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 '884 Patent"), and U.S. Patent No. 10,932,105 ("the '105 Patent"). The PE-12000 Series is the only accused product line for which Apex seeks summary adjudication of infringement in its cross-motion. It is distinct from the PE-5000 Series (5 mm trocar) and the PE-15000 Series (15 mm trocar), which are the subjects of separate motions and separate infringement contentions in this litigation.

The Court should deny Apex's cross-motion in its entirety. The record before this Court is replete with genuine disputes of material fact as to whether the PE-12000 Series meets every limitation of each of the asserted claims under the claim constructions adopted by this Court in its December 6, 2024 Claim Construction Order (D.I. 87). Apex's cross-motion rests on a deeply flawed premise: that the infringement analysis for the PE-12000 is straightforward and uncontested. It is neither.

Throughout its moving brief, Apex improperly ignores or glosses over critical factual disputes that have been squarely identified by both parties' technical experts. Apex's infringement expert, Dr. Calvin Ng, an Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute, offered opinions concerning the structure and operation of the PE-12000 that are directly contradicted by the detailed analysis of Solstice's non-infringement and invalidity expert, Dr. Miriam Ostrowski, a tenured Professor of Biomedical Engineering at Halford University. These expert disputes span the most critical claim limitations at issue in this case, including: (i) whether the PE-12000's seal mechanism constitutes a "locking seal assembly" under the '237 Patent; (ii) whether the PE-12000's blade-deployment system is a "retractable blade deployment mechanism" under the '884 Patent; and (iii) whether the PE-12000's insufflation valve constitutes an "integrated insufflation valve and seal" under the '105 Patent.

Where, as here, two qualified experts have offered diametrically opposed opinions on factual questions that are dispositive of infringement, summary judgment is inappropriate. It is black-letter law that summary judgment is a "drastic remedy" that should not be granted when there are genuine issues of material fact in dispute. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249-50 (1986). In the patent infringement context, the comparison of the accused product to the asserted claims is a question of fact. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). The existence of dueling expert opinions on that comparison, supported by documentary evidence, physical teardown analyses, and bench testing data, creates material factual disputes that a jury must resolve.

Apex cannot carry its burden by simply pointing to its own expert's report and asking this Court to accept Dr. Ng's opinions over Dr. Ostrowski's. That is precisely what a trial is for. The cross-motion should be denied, and these disputes should be resolved by the finder of fact at trial, currently set for September 30, 2025.

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 No. 648217) and headquartered in Galway, Ireland. Solstice designs, manufactures, and distributes minimally invasive surgical instruments, including laparoscopic access devices, trocar systems, and related accessories for use in abdominal, thoracic, and pelvic surgical procedures. Founded in 2011, Solstice employs approximately 620 employees worldwide, with manufacturing operations in Galway, Ireland and distribution facilities in the United States. In fiscal year 2023, Solstice reported consolidated revenue of approximately €187.4 million.

Plaintiff Apex Surgical Innovations, Inc. is a Delaware corporation with its principal offices located at 1220 North Market Street, Suite 550, Wilmington, Delaware 19801 (EIN: 51-0483762). Founded in 2006, Apex manufactures surgical access devices, trocar systems, and insufflation equipment marketed to hospitals and ambulatory surgical centers in the United States and internationally. Apex reported estimated fiscal year 2023 revenue of approximately $312 million and employs approximately 1,100 employees.

Apex commenced this action on May 9, 2024, by filing its Complaint (D.I. 1) alleging that Solstice's PrecisionEdge™ product line infringes the three patents-in-suit. On June 14, 2024, Solstice filed its Answer, Affirmative Defenses, and Counterclaims (D.I. 12), in which it denied infringement of each asserted patent, asserted affirmative defenses of non-infringement and invalidity under 35 U.S.C. §§ 102 and 103, and asserted a counterclaim for declaratory judgment of unenforceability based on inequitable conduct during prosecution of the asserted patents.

B. The Asserted Patents

Apex asserts three United States patents in this litigation, all of which are listed as part of a patent family comprising fourteen total issued U.S. patents and six pending continuation applications. Each of the three asserted patents lists Dr. Raymond Szabo, Apex's Vice President of Engineering, as the sole named inventor. All three patents are assigned to Apex.

U.S. Patent No. 9,814,237 (the '237 Patent). The '237 Patent, entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," was issued on November 14, 2017 and bears an expiration date of June 22, 2035. The '237 Patent generally discloses and claims a locking seal assembly for use in a trocar or similar minimally invasive surgical access device, in which a seal body mechanically interlocks with a housing upon insertion of a surgical instrument to maintain a gas-tight seal during a laparoscopic procedure. Apex asserts Claims 1, 3, 7, and 12 of the '237 Patent against the PE-12000 Series. Claim 1 is an independent claim directed to the locking seal assembly, while Claims 3, 7, and 12 are dependent claims reciting additional structural and functional limitations, including a "radially compressible seal element" (Claim 7) and a "housing detent" (Claim 12).

U.S. Patent No. 10,271,884 (the '884 Patent). The '884 Patent, entitled "Retractable Blade Deployment Mechanism for Trocar Systems," was issued on April 30, 2019 and bears an expiration date of September 15, 2036. The '884 Patent generally discloses and claims a retractable blade mechanism for use in trocar systems, in which a spring-loaded blade is deployed for tissue penetration and automatically retracts upon penetration of the body wall to reduce the risk of inadvertent injury to internal organs. Apex asserts Claims 1, 2, 5, 9, and 14 of the '884 Patent against the PE-12000 Series. Claim 1 is an independent claim reciting the retractable blade deployment mechanism. Claims 2, 5, 9, and 14 add further structural limitations, including a "blade guard" (Claim 5), "sequential deployment" of the blade and trocar cannula (Claim 9), and a "biased return spring" of specified characteristics (Claim 14).

U.S. Patent No. 10,932,105 (the '105 Patent). The '105 Patent, entitled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar," was issued on March 2, 2021 and bears an expiration date of January 10, 2038. The '105 Patent generally discloses and claims an integrated insufflation valve and seal for use in a laparoscopic trocar, in which the valve and seal functions are combined in a unitary structure to maintain pneumoperitoneum during insufflation. Apex asserts Claims 1, 4, and 8 of the '105 Patent against the PE-12000 Series. Claim 1 is an independent claim directed to the integrated insufflation valve and seal assembly. Claim 4 adds a "self-sealing membrane" limitation, and Claim 8 requires the seal to maintain gas-tightness at pressures exceeding 20 mmHg.

All three patents share a common specification disclosure and relate to components of a trocar system used in minimally invasive laparoscopic surgery. During prosecution, each patent was the subject of narrowing amendments that are material to the infringement analysis, as discussed in Section IV.D below.

C. The Accused PE-12000 Series

The PrecisionEdge™ PE-12000 Series is a 12 mm laparoscopic trocar assembly designed and manufactured by Solstice for use in minimally invasive abdominal surgical procedures. The PE-12000 is one of three product lines accused of infringement in this litigation. Apex contends that the PE-12000 is the only accused product that infringes all three asserted patents, making it the centerpiece of Apex's case and the focal point of its damages theory.

The two other accused product lines — the PE-5000 Series (5 mm) and the PE-15000 Series (15 mm) — are accused of infringing subsets of the asserted patents. Specifically, the PE-5000 Series is accused of infringing the '237 and '884 Patents (but not the '105 Patent), and the PE-15000 Series is accused of infringing the '884 and '105 Patents (but not the '237 Patent). The present cross-motion addresses only the PE-12000 Series.

Combined U.S. sales of all accused PrecisionEdge™ products from calendar year 2021 through September 30, 2024 totaled approximately $74.6 million, distributed as follows: FY 2021, $12.1 million; FY 2022, $17.8 million; FY 2023, $22.4 million; and the first three quarters of FY 2024 (through September 30, 2024), $22.3 million. The weighted average gross margin across all accused PrecisionEdge™ products during that period was approximately 61.3%. The PE-12000 accounts for the single largest share of accused-product revenue and, accordingly, is the primary driver of Apex's claimed damages.

D. Procedural History Relevant to This Motion

The parties have engaged in extensive fact and expert discovery. Solstice produced 48,217 documents (Bates Nos. SBD-000001 through SBD-048217), including design drawings, engineering specifications, manufacturing records, and internal communications relating to the accused PrecisionEdge™ product line. Apex produced 31,450 documents (Bates Nos. APEX-000001 through APEX-031450), including the prosecution histories of the asserted patents, internal design documentation, and communications with the United States Patent and Trademark Office.

On November 18, 2024, the Court held a Markman hearing to address nine disputed claim terms across the three asserted patents. On December 6, 2024, the Court issued its Claim Construction Order (D.I. 87), resolving all nine disputed terms. Of the nine constructions, five were adopted in a manner favorable to Solstice and four in a manner favorable to Apex. The Court's constructions are central to the infringement analysis and are discussed in detail in Section IV below.

Expert discovery opened on January 13, 2025, pursuant to the Scheduling Order (D.I. 42). Dr. Miriam Ostrowski, Professor of Biomedical Engineering at Halford University, served Solstice's expert report on invalidity and non-infringement on January 27, 2025. Dr. Calvin Ng, Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute, served Apex's infringement expert report on February 10, 2025. Rebuttal expert reports were exchanged by both parties on March 3, 2025. Expert depositions were conducted in March and early April 2025.

On March 17, 2025, the parties participated in a full-day mediation before the Honorable Margaret Forsythe (Ret.) at Amberstone ADR Services in Wilmington, Delaware. The mediation did not result in resolution of the dispute.

On April 1, 2025, Solstice filed its Motion for Summary Judgment of Non-Infringement as to the PE-5000 Series (D.I. 112). On April 14, 2025, Apex filed the present Cross-Motion for Partial Summary Judgment of Infringement as to the PE-12000 Series (D.I. 118), which is the subject of this Opposition. Trial is currently scheduled to commence on September 30, 2025.

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." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A fact is "material" if it "might affect the outcome of the suit under the governing law." Id.

The party moving for summary judgment bears the initial burden of demonstrating the absence of any genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). Once the movant has carried this initial burden, the burden shifts to the non-moving party to "set forth specific facts showing that there is a genuine issue for trial." Anderson, 477 U.S. at 250. However, the non-moving party need not produce evidence in a form that would be admissible at trial, so long as the evidence could be presented in an admissible form. See Celotex, 477 U.S. at 324.

In evaluating a motion for summary judgment, the Court must view all facts in the light most favorable to the non-moving party and draw all reasonable inferences in its favor. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986); Anderson, 477 U.S. at 255. The Court's role is not to weigh the evidence or determine the truth of the matter, but rather to determine whether there is a genuine issue for trial. Anderson, 477 U.S. at 249. Where the non-moving party has presented evidence creating a genuine factual dispute, summary judgment must be denied.

B. Summary Judgment in Patent Infringement Cases

The analysis of patent infringement is a two-step process. The first step is claim construction — the interpretation of the meaning and scope of the patent claims. Claim construction is a question of law for the Court. Markman v. Westview Instruments, Inc., 517 U.S. 370, 372 (1996); Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc). In this case, the Court has already resolved claim construction in its December 6, 2024 Claim Construction Order. The second step is the comparison of the properly construed claims to the accused device. This comparison is a question of fact. Markman, 52 F.3d at 976; see also Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454 (Fed. Cir. 1998) (en banc).

Because the second step of the infringement analysis — comparing the claims to the accused product — is a factual inquiry, summary judgment of infringement is appropriate only where "no reasonable jury could find" that the accused device does not infringe the asserted claims. SRI Int'l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1116 (Fed. Cir. 1985). Conversely, where the parties' technical experts offer conflicting testimony on whether the accused device meets a claim limitation, summary judgment must be denied because a genuine dispute of material fact exists. See Conroy v. Reebok Int'l, Ltd., 14 F.3d 1570, 1575 (Fed. Cir. 1994) (reversing summary judgment of non-infringement where competing expert testimony created genuine factual dispute).

The patentee bears the burden of proving infringement by a preponderance of the evidence. Cross Med. Prods., Inc. v. Harborview Corporation Sofamor Danek, Inc., 424 F.3d 1293, 1310 (Fed. Cir. 2005). On a motion for summary judgment of infringement, the patentee must demonstrate that no reasonable jury could find in favor of the accused infringer on the question of infringement. Where, as here, the accused infringer has produced evidence raising genuine factual disputes, the patentee has failed to carry its burden.

C. Literal Infringement and the Doctrine of Equivalents

Patent infringement may be established under two theories: literal infringement and infringement under the doctrine of equivalents.

Literal infringement requires that every limitation of the asserted claim be met by the accused device. Tarrant Corporation v. Ben Venue Labs., Inc., 271 F.3d 1043, 1049 (Fed. Cir. 2001). If even a single limitation of the claim is absent from the accused device, literal infringement cannot be found. Stumbo v. Eastman Outdoors, Inc., 508 F.3d 1358, 1362 (Fed. Cir. 2007). The patentee bears the burden of proving that every limitation is present.

Under the doctrine of equivalents, infringement may be found even where the accused device does not literally satisfy every claim limitation, if the accused device contains an element that performs substantially the same function, in substantially the same way, to achieve substantially the same result as the claimed element. Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 608 (1950); Warner-Jenkinson Co. v. Harborline Enterprises Davis Chem. Co., 520 U.S. 17, 39-40 (1997). The doctrine of equivalents is applied on an element-by-element basis, not to the claim as a whole. Warner-Jenkinson, 520 U.S. at 29.

However, the doctrine of equivalents is subject to important limitations. First, prosecution history estoppel prevents a patentee from using the doctrine of equivalents to recapture subject matter that was surrendered during prosecution of the patent. Festo Corp. v. Fenmore & Co., 535 U.S. 722, 733-34 (2002). Where a patentee makes a narrowing amendment to overcome a prior art rejection, a presumption arises that the patentee surrendered the territory between the original claim scope and the amended claim scope. Id. at 740. This presumption may be rebutted only under narrow circumstances. Id. at 740-41.

Second, the all-limitations rule prevents the doctrine of equivalents from being applied in a manner that would effectively eliminate a claim limitation and thereby render the limitation meaningless. Pennwalt Corp. v. Durand-Wayland, Inc., 833 F.2d 931, 935 (Fed. Cir. 1987) (en banc); see also Warner-Jenkinson, 520 U.S. at 29. The patentee bears the burden of establishing infringement under the doctrine of equivalents. Bai v. L & L Wings, Inc., 160 F.3d 1350, 1353 (Fed. Cir. 1998).

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 infringement is therefore inappropriate as to any asserted claim of any asserted patent.

A. Genuine Disputes of Material Fact Preclude Summary Judgment as to the '237 Patent (Claims 1, 3, 7, and 12)

Apex asserts Claims 1, 3, 7, and 12 of the '237 Patent against the PE-12000 Series. Each of these claims includes limitations that are the subject of genuine factual disputes, supported by competing expert testimony, physical teardown evidence, and design documentation produced in discovery. For the reasons set forth below, the Court should deny summary judgment as to all asserted claims of the '237 Patent.

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 manner favorable to Solstice. Specifically, the Court construed "locking seal assembly" to require "a specific mechanical interlock between the seal body and the housing that engages upon insertion of a surgical instrument." D.I. 87 at 12. The Court rejected Apex's proposed broader construction, which would have encompassed any mechanism — including friction-based retention — that holds the seal in place relative to the housing. Id. at 13-14.

The Court's construction is dispositive of the factual dispute at the heart of this motion. Dr. Miriam Ostrowski testified in her January 27, 2025 expert report, and reaffirmed in her March 3, 2025 rebuttal report, that the PE-12000's seal mechanism operates through a fundamentally different principle than the "locking seal assembly" claimed in the '237 Patent. Specifically, Dr. Ostrowski explained that the PE-12000 employs a friction-based retention system in which an elastomeric seal is held in position within the trocar housing through frictional engagement between the seal body and the inner wall of the housing. Ostrowski Report ¶¶ 47-62; Ostrowski Rebuttal ¶¶ 18-31. Unlike the claimed "locking seal assembly," the PE-12000's friction-based system does not involve any mechanical interlock — there is no physical engagement of mating structural features (such as a tab, groove, detent, or snap-fit) that locks the seal to the housing. Id.

Dr. Ostrowski's analysis is supported by extensive physical evidence. She performed a detailed physical teardown of five PE-12000 units, examining the seal housing under magnification and documenting her findings with annotated photographs. Ostrowski Report ¶¶ 53-57, Exs. 8-14. She further referenced Solstice's original design drawings (Bates Nos. SBD-014322 through SBD-014389), which specify dimensional tolerances for the friction-fit interface between the seal body and the housing. Id. ¶ 58, Ex. 15. Those drawings confirm that the PE-12000's seal is retained through an interference fit — that is, the seal body is manufactured with an outer diameter slightly larger than the inner diameter of the housing, so that the seal is held in place through compressive friction when press-fitted into the housing. Id. ¶ 59. Dr. Ostrowski explained that this friction-based approach is structurally and functionally distinct from the mechanical interlock required by the Court's construction: the PE-12000 does not "lock" in the sense of engaging complementary mechanical features, and the seal can be dislodged from the housing by applying sufficient axial force — a characteristic inconsistent with a true mechanical interlock. Id. ¶¶ 60-62.

Apex's expert, Dr. Calvin Ng, offered a contrary opinion in his February 10, 2025 infringement report. Dr. Ng opined that the PE-12000's friction-retention feature is "functionally equivalent to a mechanical interlock" because it serves the same purpose of holding the seal in place within the housing during use. Ng Report ¶¶ 72-89. Dr. Ng acknowledged the structural differences identified by Dr. Ostrowski but argued that the friction fit achieves the same result as a mechanical interlock and therefore satisfies the "locking seal assembly" limitation. Id. ¶¶ 85-89.

This is a classic battle of the experts. Two qualified technical experts have examined the same accused product and arrived at diametrically opposed conclusions regarding whether the PE-12000's seal mechanism constitutes a "locking seal assembly" under the Court's construction. Dr. Ostrowski says the PE-12000's friction-based system is not a "mechanical interlock" and therefore does not meet the Court's construction. Dr. Ng says it is functionally equivalent and satisfies the limitation. The Court cannot resolve this factual dispute on summary judgment. The credibility and persuasiveness of these competing expert opinions is for the jury to assess at trial. See Anderson, 477 U.S. at 255 ("Credibility determinations, the weighing of the evidence, and the drawing of legitimate inferences from the facts are jury functions, not those of a judge . . . .").

Apex's attempt to sidestep this dispute by characterizing the infringement analysis as "straightforward" is unavailing. The very claim term at the heart of the dispute was contested during claim construction, and the Court's construction adopted language that is in tension with the PE-12000's actual design. Whether the PE-12000's design falls within or outside the Court's construction is precisely the type of factual question that must be resolved by the jury. Summary judgment on the "locking seal assembly" limitation should be denied.

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, perpendicular to the axis of the trocar — to create a seal around instruments of different sizes.

Apex's expert, Dr. Ng, asserts that the PE-12000's elastomeric seal insert satisfies this limitation because the seal insert is made of a compressible elastomeric material that deforms to accommodate instruments of different diameters when they are inserted through the trocar. Ng Report ¶¶ 94-102. Dr. Ng points to the fact that the PE-12000's seal insert is designed to seal around both 5 mm and 12 mm instruments, and opines that this ability to accommodate different diameters constitutes "radial compression." Id. ¶ 99.

Solstice's expert, Dr. Ostrowski, disputes this characterization. In her rebuttal report, Dr. Ostrowski explained that the PE-12000's elastomeric seal insert achieves sealing through a fundamentally different mechanism: axial compression, not radial compression. Ostrowski Rebuttal ¶¶ 34-48. Specifically, Dr. Ostrowski described the PE-12000's seal as a stack of elastomeric discs that are compressed along the longitudinal axis of the trocar (the axial direction) by a retaining cap. Id. ¶ 37. As the discs are compressed axially, they bulge inward, creating a seal around the instrument. Id. ¶ 38. Dr. Ostrowski explained that this is fundamentally different from the "radially compressible seal element" claimed in the '237 Patent, which contemplates a seal element that compresses in the radial direction through direct radial contact with the instrument. Id. ¶¶ 39-42.

Critically, Dr. Ostrowski's opinion is supported by physical testing data produced in discovery. Solstice produced bench testing data (Bates Nos. SBD-031005 through SBD-031042) from testing conducted during the PE-12000's design phase. This data documents the compression behavior of the PE-12000's seal insert under controlled conditions, using strain gauges and high-speed imaging to measure the direction and magnitude of compression. Id. ¶ 43, Ex. 22. The testing data demonstrates that the predominant compression vector in the PE-12000 seal is axial, not radial — the axial compression component accounted for approximately 78% of the total deformation, while the radial component accounted for only approximately 22%. Id. ¶ 44. Dr. Ostrowski explained that this testing data confirms that the PE-12000 achieves sealing primarily through axial compression, with any radial deformation being an incidental byproduct of the axial compression, rather than the primary sealing mechanism. Id. ¶¶ 45-47.

Dr. Ng did not address this testing data in his infringement report, nor did he conduct independent compression testing of the PE-12000's seal insert. In his rebuttal, Dr. Ng acknowledged the existence of the axial compression component but maintained that any radial deformation, regardless of its relative magnitude, satisfies the "radially compressible" limitation. Ng Rebuttal ¶¶ 31-38. However, this characterization is itself a factual matter on which reasonable minds can differ. A reasonable jury could credit Dr. Ostrowski's opinion that the PE-12000's seal is predominantly axially compressible and does not satisfy Claim 7's requirement of a "radially compressible seal element."

This factual dispute — grounded in competing expert opinions and conflicting interpretations of physical testing data — precludes summary judgment on Claim 7 of the '237 Patent.

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 understood by those of skill in the art to be a discrete mechanical feature — typically a protrusion, catch, or recess — that engages a corresponding feature to hold a component in a fixed position. See Ostrowski Report ¶ 65; Ng Report ¶ 107 (both experts agreeing on the general definition of "detent").

Despite this agreement on the definition, the experts disagree sharply on whether the PE-12000 possesses such a feature. Solstice has presented substantial evidence that the PE-12000 lacks any detent feature entirely. Dr. Ostrowski's report includes a detailed examination of the PE-12000's housing and seal body, using cross-sectional photographs, CAD models, and dimensional measurements to demonstrate that the PE-12000's seal housing does not contain any protrusion, catch, or recess that positively engages the seal in a fixed position. Ostrowski Report ¶¶ 63-74, Exs. 16-19. Instead, the PE-12000 relies on the same continuous frictional engagement described above — the interference fit between the seal body and the housing wall. Id. ¶ 68.

Dr. Ostrowski's rebuttal report further addresses this point with annotated cross-sectional photographs comparing the PE-12000's housing interior to the patent's disclosed embodiment (Figure 4A of the '237 Patent). Ostrowski Rebuttal ¶¶ 49-58, Exs. 25-28. The comparison is striking: the '237 Patent's Figure 4A clearly shows a discrete detent feature — a raised ridge on the inner surface of the housing that snaps into a corresponding groove on the seal body. Id. ¶ 50, Ex. 25. By contrast, the PE-12000's housing interior is smooth and uniform, with no analogous ridge, catch, or groove. Id. ¶ 52, Ex. 26. Dr. Ostrowski concluded that the PE-12000 "entirely lacks a housing detent as that term is understood by those of skill in the art." Id. ¶ 58.

Apex's expert, Dr. Ng, attempted to characterize the PE-12000's friction-fit interface as a "functional detent," reasoning that the interference fit between the seal body and the housing creates a "positive engagement" that holds the seal in position. Ng Report ¶¶ 107-114. However, Dr. Ng did not identify any discrete mechanical feature in the PE-12000 that functions as a detent. His opinion effectively asks the Court to expand the meaning of "detent" to encompass any frictional engagement, which would render the "housing detent" limitation superfluous — a result inconsistent with established principles of claim construction that disfavor interpretations rendering claim terms redundant.

At minimum, a reasonable jury could find that the PE-12000 does not possess a "housing detent" as required by Claim 12. The competing expert testimony and physical evidence in the record create a genuine dispute of material fact that precludes summary judgment on this claim.

B. Genuine Disputes of Material Fact Preclude Summary Judgment as to the '884 Patent (Claims 1, 2, 5, 9, and 14)

Apex asserts Claims 1, 2, 5, 9, and 14 of the '884 Patent against the PE-12000 Series. Each of these claims includes limitations that are the subject of genuine factual disputes. As set forth below, the structural and functional differences between the PE-12000's blade deployment system and the claimed "retractable blade deployment mechanism" are substantial, well-documented, and contested by the parties' experts.

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 Court's construction was adopted over Apex's proposed broader construction, which would not have required automatic retraction and would have encompassed manually actuated retraction systems. Id. at 19-20. The Court's construction was one of the five terms construed favorably to Solstice.

The undisputed evidence in the record demonstrates that the PE-12000 employs a manually actuated blade deployment system, not a spring-loaded automatic retraction system. In the PE-12000, the blade is deployed when the surgeon presses a trigger on the trocar handle, extending the blade beyond the obturator tip. Critically, retraction of the blade occurs only when the surgeon releases the trigger — the blade does not retract automatically upon penetration of the body wall. Rather, retraction requires the affirmative physical act of the surgeon releasing the trigger. Ostrowski Report ¶¶ 78-95; see also SBD-018742 (PE-12000 Product Instruction Manual, describing blade deployment and retraction as a manual process).

Dr. Ostrowski opined in her expert report that the PE-12000's manually actuated blade deployment system does not satisfy the "retractable blade deployment mechanism" limitation as construed by the Court. Ostrowski Report ¶¶ 78-95. She explained that the Court's construction requires automatic retraction — meaning that the blade retracts without requiring any volitional act by the surgeon beyond the initial penetration. Id. ¶ 82. The PE-12000's system, by contrast, requires the surgeon to perform a separate, deliberate act (releasing the trigger) to initiate blade retraction. Id. ¶ 83. Dr. Ostrowski described this as a "fundamental structural and functional difference" between the PE-12000 and the claimed mechanism. Id. ¶ 84.

Dr. Ng offered the contrary opinion that the PE-12000's trigger mechanism is "effectively automatic" because, in his view, the trigger is designed to be released reflexively by the surgeon upon feeling the reduced resistance that occurs when the blade has penetrated the body wall. Ng Report ¶¶ 120-138. According to Dr. Ng, the surgeon's release of the trigger is a natural and involuntary response to the tactile feedback of penetration, rendering the retraction "automatic" for practical purposes. Id. ¶ 132.

Dr. Ng's characterization is both factually disputed and scientifically questionable. Dr. Ostrowski explained in her rebuttal report that whether a surgeon releases the trigger "reflexively" or deliberately is a question of human biomechanics and individual surgical technique that varies from surgeon to surgeon. Ostrowski Rebuttal ¶¶ 62-71. She cited peer-reviewed literature on trocar insertion techniques demonstrating that surgeons employ a range gripping and insertion strategies, and that trigger release is not an involuntary or automatic response in all cases. Id. ¶¶ 65-68 (citing three published studies). More fundamentally, Dr. Ostrowski explained that the question of whether the PE-12000's retraction is "automatic" turns on the user's physical interaction with the device — a factual inquiry that is entirely inappropriate for resolution on summary judgment. Id. ¶ 71.

The dispute over the "retractable blade deployment mechanism" limitation goes to the heart of Claim 1 — the independent claim from which Claims 2, 5, 9, and 14 all depend. If the PE-12000 does not satisfy Claim 1's independent requirement of a "retractable blade deployment mechanism," it cannot infringe any of the dependent claims. The factual dispute on this limitation alone is sufficient to preclude summary judgment as to all asserted claims of the '884 Patent.

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, ll. 12-16.

Solstice's technical evidence demonstrates that the PE-12000 does not contain a "blade guard" as claimed. The PE-12000's obturator tip, which Apex identifies as the alleged "blade guard," functions differently from the blade guard disclosed in the '884 Patent specification. Dr. Ostrowski identified specific dimensional and functional differences between the PE-12000's obturator tip and the claimed blade guard. Ostrowski Report ¶¶ 96-112. She explained that the '884 Patent discloses a blade guard as a separate, independently moving component that extends to cover the blade during retraction. Id. ¶ 98. By contrast, the PE-12000's obturator tip is not independently moving — it is fixed relative to the obturator shaft, and the blade retracts behind it. Id. ¶ 100. In other words, the PE-12000's obturator tip does not "shield" the blade in the manner contemplated by Claim 5; rather, the blade is simply pulled back into the obturator body by the spring mechanism when the trigger is released. Id. ¶ 102.

Apex's expert, Dr. Ng, opined that the PE-12000's obturator tip is "equivalent" to the claimed blade guard under the doctrine of equivalents, arguing that the obturator tip performs substantially the same function (shielding tissue from the blade) in substantially the same way (by being positioned between the blade and the tissue) to achieve substantially the same result (preventing inadvertent tissue contact during retraction). Ng Report ¶¶ 145-158.

However, Apex's reliance on the doctrine of equivalents to satisfy the "blade guard" limitation of Claim 5 is barred by prosecution history estoppel. During prosecution of the '884 Patent, the applicant (Dr. Szabo, through Apex's prosecution counsel) narrowed the "blade guard" limitation in response to an Office Action rejection based on U.S. Patent No. 7,442,193 to Veridian Medical Technologies, Inc. In a response filed during prosecution, Apex's counsel amended the claim language to distinguish the prior art by specifying that the "blade guard" is a separate component that "shields the blade during retraction." This narrowing amendment surrendered claim scope that encompasses the PE-12000's design, in which the obturator tip is not a separate, independently moving component. The prosecution history (included in the record at APEX-008341 through APEX-008372) documents this narrowing amendment and the applicant's corresponding arguments to the examiner distinguishing the prior art on the basis of the blade guard's separate, independent movement.

Under Festo, this narrowing amendment creates a presumption that Apex surrendered the territory between the original, broader claim scope and the narrower amended scope. 535 U.S. at 740. Apex has not identified any basis for overcoming this presumption. Accordingly, prosecution history estoppel bars Apex from asserting that the PE-12000's obturator tip infringes Claim 5 under the doctrine of equivalents.

Because Apex cannot establish literal infringement of the "blade guard" limitation (given the undisputed structural differences between the PE-12000's obturator tip and the claimed blade guard) and cannot rely on the doctrine of equivalents (due to prosecution history estoppel), summary judgment of infringement on Claim 5 must be denied. At minimum, genuine factual disputes exist regarding whether the PE-12000's obturator tip satisfies the "blade guard" limitation, precluding summary judgment.

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 cannula essentially simultaneously, rather than sequentially. Dr. Ostrowski's testing protocols, documented in her January 27, 2025 expert report, involved high-speed video analysis of the PE-12000's deployment sequence in both bench-top and simulated-use conditions. Ostrowski Report ¶¶ 113-128, Exs. 30-33. The high-speed video footage (captured at 1,000 frames per second) demonstrated that the temporal offset between blade deployment and cannula advancement in the PE-12000 is on the order of 5 to 12 milliseconds — a time interval that is imperceptible to the human eye and, in Dr. Ostrowski's opinion, does not constitute "sequential deployment" within the meaning of the '884 Patent. Id. ¶¶ 120-123.

Dr. Ostrowski explained that the '884 Patent's specification describes "sequential deployment" as a deliberate, staged process in which the blade fully extends and achieves penetration before the cannula begins to advance. Id. ¶ 115 (citing '884 Patent, col. 7, ll. 18-34). The patent specification further states that the sequential design "ensures that the blade has fully penetrated the body wall before the cannula is advanced, thereby reducing the risk of incomplete penetration." Id. (quoting '884 Patent, col. 7, ll. 30-34). The PE-12000's near-simultaneous deployment does not achieve this staged process. Id. ¶ 124.

Dr. Ng characterized the 5-to-12-millisecond temporal offset as "sequential," reasoning that the blade does, in a strictly temporal sense, begin to deploy before the cannula begins to advance. Ng Report ¶¶ 160-172. In Dr. Ng's view, any temporal offset — no matter how small — constitutes "sequential" deployment. Id. ¶ 168.

This difference in characterization is a factual dispute for the jury. The question of whether a 5-to-12-millisecond temporal offset constitutes "sequential deployment" within the meaning of the '884 Patent — particularly in light of the specification's description of sequential deployment as a deliberate, staged process — is a question on which reasonable minds could differ. It cannot be resolved on summary judgment.

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 rather than a compression "return spring" for blade retraction. SBD-019887 through SBD-019912 (PE-12000 Spring Specification Documents). A torsion spring operates through rotational force applied around an axis, whereas a compression spring operates through axial force applied along its length. These are structurally and functionally distinct spring types. Ostrowski Report ¶¶ 129-140.

Moreover, the mechanical properties of the PE-12000's torsion spring differ from the claimed specifications. Dr. Ostrowski calculated the effective spring constant of the PE-12000's torsion spring (converted to an equivalent linear force metric for comparison purposes) and determined that it falls outside the 2.0-4.0 N/mm range specified in Claim 14. Ostrowski Report ¶ 136, Ex. 35. The PE-12000's torsion spring has an effective spring constant of approximately 1.4 N/mm, below the claimed range. Id.

Dr. Ng did not directly address the spring-type discrepancy in his infringement report, instead asserting generally that the PE-12000's spring mechanism "functions as a biased return spring" and achieves the same result of returning the blade to the retracted position. Ng Report ¶¶ 175-182. He did not provide any calculation or measurement of the PE-12000's spring constant.

This is an additional factual dispute that precludes summary judgment on Claim 14. A reasonable jury could find that the PE-12000's torsion spring does not constitute a "compression return spring" and does not possess the specified spring constant, and therefore does not satisfy Claim 14's limitations.

C. Genuine Disputes of Material Fact Preclude Summary Judgment as to the '105 Patent (Claims 1, 4, and 8)

Apex asserts Claims 1, 4, and 8 of the '105 Patent against the PE-12000 Series. As with the '237 and '884 Patents, each asserted claim of the '105 Patent presents genuine factual disputes that preclude summary judgment.

1. "Integrated Insufflation Valve and Seal" — Single vs. Dual Component Dispute. Claim 1 of the '105 Patent — the independent claim — recites an "integrated insufflation valve and seal." This term was construed by the Court in its Claim Construction Order to mean "a unitary structure combining valve and seal functions." D.I. 87 at 24. This construction was one of the four terms construed favorably to Apex, in that the Court rejected Solstice's proposed construction requiring the valve and seal to be "formed as a single, monolithic piece." Id. at 25.

However, the Court's construction of "integrated" as requiring a "unitary structure" still presents a contested factual question when applied to the PE-12000. The PE-12000 uses a two-component assembly consisting of: (1) a separate stopcock valve that controls the flow of insufflation gas, and (2) a distinct elastomeric seal that prevents gas leakage around the inserted instrument. These two components are separately manufactured, separately assembled into the trocar housing, and separately replaceable. Ostrowski Report ¶¶ 142-160, Exs. 36-40.

Dr. Ostrowski's report includes exploded-view diagrams of the PE-12000's insufflation valve assembly, clearly showing the two distinct components. Ostrowski Report ¶ 146, Ex. 37. She further explained that the stopcock valve and the elastomeric seal are made of different materials (the stopcock is molded polycarbonate; the seal is silicone elastomer), are manufactured in separate production processes, and are assembled into the trocar housing as independent components during the manufacturing process. Id. ¶¶ 148-152. Critically, each component can be removed and replaced independently without disturbing the other, confirming that they are not a "unitary structure." Id. ¶ 153.

Dr. Ng opined in his infringement report that the PE-12000's two-component assembly is nonetheless "integrated" within the meaning of the '105 Patent because the stopcock valve and the seal function together within the trocar housing to maintain pneumoperitoneum during insufflation. Ng Report ¶¶ 190-208. In Dr. Ng's view, the fact that the two components operate in concert to achieve a unified result — gas-tight insufflation — means they constitute an "integrated" assembly, even if they are separately manufactured and replaceable. Id. ¶ 201.

This factual characterization is disputed and depends on how the Court's construction of "unitary structure" is applied to the physical design of the PE-12000. A "unitary structure" can reasonably be understood to require a single, combined component — not two separate, independently replaceable parts that happen to be housed within the same device. Dr. Ostrowski's opinion that the PE-12000's two-component design is not a "unitary structure" is well-supported by the physical evidence. A reasonable jury could agree. Accordingly, summary judgment on the "integrated insufflation valve and seal" limitation is inappropriate.

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-12000 uses a duckbill valve — a well-known valve design in which two opposing flaps of flexible material are biased into a closed position and open when an instrument is passed between them. Ostrowski Report ¶¶ 161-178, Ex. 41. Dr. Ostrowski explained that a duckbill valve is structurally and functionally distinct from a "membrane." A membrane, in the context of the '105 Patent, is a continuous sheet of material that deforms or stretches to permit instrument passage and returns to its original configuration when the instrument is removed. Id. ¶ 165. A duckbill valve, by contrast, consists of two discrete flaps that open along a slit line and close through material memory and bias force. Id. ¶ 166. The sealing mechanism is different: a membrane seals through continuous contact between the deformed material and the instrument along the entire circumference of the opening, while a duckbill valve seals through contact between the two flap edges along a single line. Id. ¶¶ 167-169.

Dr. Ng asserted in his infringement report that a duckbill valve is "a species of 'self-sealing membrane'" because it achieves self-sealing functionality — that is, it closes automatically when no instrument is inserted. Ng Report ¶¶ 212-224. In Dr. Ng's view, the claim term "self-sealing membrane" encompasses any self-sealing structure, including a duckbill valve. Id. ¶ 218.

This is a factual dispute on which reasonable minds could differ. The question of whether a duckbill valve is properly characterized as a "self-sealing membrane" turns on the scope and meaning of the term "membrane" — a factual question when applied to the specific physical structure of the PE-12000. Dr. Ostrowski's opinion that a duckbill valve is not a membrane is well-supported and cannot be rejected on summary judgment. A reasonable jury could find in Solstice's favor on this limitation.

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 bench testing data (Bates Nos. SBD-038710 through SBD-038742), which was generated during the PE-12000's product development and quality assurance testing, shows measurable gas leakage at insufflation pressures above 18 mmHg. Ostrowski Report ¶¶ 179-195, Ex. 42. Specifically, Solstice's testing documented leakage rates of between 0.3 and 0.8 liters per minute at pressures of 18-22 mmHg across a sample of 15 PE-12000 units. Id. ¶ 184. Dr. Ostrowski opined that these leakage rates indicate that the PE-12000's seal does not maintain "gas-tight" performance at pressures exceeding 20 mmHg. Id. ¶ 190.

Apex's own testing data (Bates Nos. APEX-022150 through APEX-022188), conducted by Apex's in-house testing laboratory, purportedly shows gas-tightness at pressures up to 25 mmHg. Ng Report ¶¶ 228-240, Ex. 18. However, the Apex testing was conducted under materially different testing conditions than the Solstice testing. Dr. Ostrowski identified several discrepancies between the two testing protocols: (1) Apex's testing used a sealed chamber with no instrument inserted through the trocar, whereas Solstice's testing was conducted with a 10 mm instrument inserted (simulating actual surgical conditions); (2) Apex's testing used a lower flow rate of insufflation gas; and (3) Apex's testing was conducted at room temperature, whereas Solstice's testing included elevated-temperature conditions simulating body-temperature exposure. Ostrowski Rebuttal ¶¶ 80-91.

These testing-methodology differences are material. Dr. Ostrowski explained that the presence of an inserted instrument is a critical variable because gas leakage most commonly occurs at the seal-instrument interface, not at the valve itself. Ostrowski Rebuttal ¶ 85. Accordingly, Apex's testing — which did not include an inserted instrument — would be expected to show lower leakage rates than real-world use conditions. Id. ¶ 86. The elevated-temperature testing conducted by Solstice is also more representative of actual surgical conditions, as the elastomeric seal material may soften and lose sealing force at body temperature. Id. ¶ 88.

The conflicting test results and the disputed testing methodologies constitute a genuine factual dispute that precludes summary judgment on Claim 8. Whether the PE-12000 maintains a "gas-tight seal at pressures exceeding 20 mmHg" depends on which testing protocol the jury finds more representative of actual conditions and which testing results the jury credits. This is quintessentially a factual determination for trial.

D. Apex Fails to Establish Infringement Under the Doctrine of Equivalents for Any Asserted Claim

In its cross-motion, Apex asserts infringement of the PE-12000 under both literal infringement and the doctrine of equivalents for several claim limitations. As shown above, genuine disputes of material fact preclude summary judgment on literal infringement. The doctrine of equivalents provides Apex no additional support, because prosecution history estoppel bars Apex's equivalents theories, and the all-limitations rule independently precludes them.

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, barring Apex from recapturing that scope through the doctrine of equivalents. Festo, 535 U.S. at 733-34.

The prosecution histories of each of the three patents document specific, material narrowing amendments:

The '237 Patent. During prosecution, the original claims recited a generic "seal assembly." In response to a rejection based on prior art identified as the Veridian Medical Technologies, Inc. references (the same prior art that is the subject of a third-party subpoena in this case), Apex's prosecution counsel amended the claims to narrow "seal assembly" to "locking seal assembly," adding the "locking" limitation to distinguish the prior art. APEX-004218 through APEX-004237 (Amendment and Response dated March 14, 2016). The accompanying remarks argued that the prior art's seal assembly did not include a "locking" mechanism. Id. at APEX-004231. This narrowing amendment forecloses Apex from using the doctrine of equivalents to capture seal assemblies that do not "lock" — including the PE-12000's friction-based retention system.

The '884 Patent. During prosecution, the original claims recited a generic "blade mechanism." In response to a rejection, Apex narrowed the claims to require a "retractable blade deployment mechanism" with automatic retraction upon body-wall penetration. APEX-008341 through APEX-008372 (Amendment and Response dated August 7, 2018). The applicant's remarks specifically argued that the prior art's blade mechanism was not "retractable" in the claimed sense because it required manual actuation. Id. at APEX-008358. This amendment directly forecloses Apex from arguing under equivalents that a manually actuated blade system (such as the PE-12000's system) is equivalent to the claimed automatic retraction mechanism — the very subject matter Apex distinguished during prosecution.

The '105 Patent. During prosecution, the original claims recited an "insufflation valve and seal." Apex narrowed the claims by adding the word "integrated," amending the limitation to "integrated insufflation valve and seal." APEX-011894 through APEX-011922 (Amendment and Response dated June 12, 2020). The applicant argued that the prior art disclosed separate, non-integrated valve and seal components, and that the "integrated" limitation distinguished the claimed invention. Id. at APEX-011910. This amendment forecloses Apex from using the doctrine of equivalents to encompass two-component, non-integrated designs — such as the PE-12000's separate stopcock valve and elastomeric seal.

In each instance, the narrowing amendment was made for a substantial reason relating to patentability — specifically, to distinguish prior art. Under Festo, a presumption arises that Apex surrendered the territory between the original and amended claim scope. 535 U.S. at 740. Apex has not attempted to rebut this presumption in its cross-motion and has not argued that any of the recognized exceptions to the Festo presumption apply. See Honeywell Int'l, Inc. v. Hamilton Sundstrand Corp., 370 F.3d 1131, 1141-42 (Fed. Cir. 2004) (describing the narrow circumstances under which the Festo presumption may be rebutted). Accordingly, prosecution history estoppel bars Apex's equivalents theories for the "locking seal assembly" limitation of the '237 Patent, the "retractable blade deployment mechanism" limitation of the '884 Patent, and the "integrated insufflation valve and seal" limitation of the '105 Patent.

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.S. at 29.

Apex's equivalents theory would render the very limitations that distinguish the asserted claims from the prior art meaningless. Specifically:

• "Locking" limitation ('237 Patent): If the PE-12000's friction-based retention system is deemed "equivalent" to a "locking" mechanism, then the word "locking" in the claim is rendered meaningless. Any seal assembly that holds a seal in place through any means would infringe, eliminating the limiting effect of the "locking" requirement that the applicant added during prosecution.

• "Retractable" limitation ('884 Patent): If the PE-12000's manually actuated blade system is deemed "equivalent" to an "automatically retracting" system, then the automatic-retraction requirement is effectively eliminated from the claim. The distinction between manual and automatic retraction — which the applicant expressly relied upon to distinguish the prior art — would be obliterated.

• "Integrated" limitation ('105 Patent): If the PE-12000's two-component valve-and-seal assembly is deemed "equivalent" to an "integrated" unitary structure, then the word "integrated" is rendered meaningless. Any combination of a valve and a seal, regardless of whether they are combined in a unitary structure, would infringe — precisely the scope that was surrendered during prosecution.

In each case, applying the doctrine of equivalents as Apex proposes would not merely expand the scope of the claim limitation;

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
DEFENDANT SOLSTICE BIOMEDICAL, INC.'S MEMORANDUM OF LAW IN OPPOSITION TO PLAINTIFF'S CROSS-MOTION FOR PARTIAL SUMMARY JUDGMENT OF INFRINGEMENT AS TO THE PRECISIONEDGE™ PE-12000 SERIES
Marcus Delgado (Bar No. 4817) Christy Bauer (Bar No. 6293) Peter Vassiliev (Bar No. 6740) CALDERWOOD & HARKNESS LLP 1201 Market Street, Suite 2500 Wilmington, DE 19801 Telephone: (302) 654-7800 Facsimile: (302) 654-7801
Counsel for Defendant Solstice Biomedical, Inc.
Dated: April 28, 2025
TABLE OF CONTENTS
TABLE OF AUTHORITIES
Cases
Statutes and Rules
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 '884 Patent"), and U.S. Patent No. 10,932,105 ("the '105 Patent"). The PE-12000 Series is the only accused product line for which Apex seeks summary adjudication of infringement in its cross-motion. It is distinct from the PE-5000 Series (5 mm trocar) and the PE-15000 Series (15 mm trocar), which are the subjects of separate motions and separate infringement contentions in this litigation.
The Court should deny Apex's cross-motion in its entirety. The record before this Court is replete with genuine disputes of material fact as to whether the PE-12000 Series meets every limitation of each of the asserted claims under the claim constructions adopted by this Court in its December 6, 2024 Claim Construction Order (D.I. 87). Apex's cross-motion rests on a deeply flawed premise: that the infringement analysis for the PE-12000 is straightforward and uncontested. It is neither.
Throughout its moving brief, Apex improperly ignores or glosses over critical factual disputes that have been squarely identified by both parties' technical experts. Apex's infringement expert, Dr. Calvin Ng, an Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute, offered opinions concerning the structure and operation of the PE-12000 that are directly contradicted by the detailed analysis of Solstice's non-infringement and invalidity expert, Dr. Miriam Ostrowski, a tenured Professor of Biomedical Engineering at Halford University. These expert disputes span the most critical claim limitations at issue in this case, including: (i) whether the PE-12000's seal mechanism constitutes a "locking seal assembly" under the '237 Patent; (ii) whether the PE-12000's blade-deployment system is a "retractable blade deployment mechanism" under the '884 Patent; and (iii) whether the PE-12000's insufflation valve constitutes an "integrated insufflation valve and seal" under the '105 Patent.
Where, as here, two qualified experts have offered diametrically opposed opinions on factual questions that are dispositive of infringement, summary judgment is inappropriate. It is black-letter law that summary judgment is a "drastic remedy" that should not be granted when there are genuine issues of material fact in dispute. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249-50 (1986). In the patent infringement context, the comparison of the accused product to the asserted claims is a question of fact. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). The existence of dueling expert opinions on that comparison, supported by documentary evidence, physical teardown analyses, and bench testing data, creates material factual disputes that a jury must resolve.
Apex cannot carry its burden by simply pointing to its own expert's report and asking this Court to accept Dr. Ng's opinions over Dr. Ostrowski's. That is precisely what a trial is for. The cross-motion should be denied, and these disputes should be resolved by the finder of fact at trial, currently set for September 30, 2025.
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 No. 648217) and headquartered in Galway, Ireland. Solstice designs, manufactures, and distributes minimally invasive surgical instruments, including laparoscopic access devices, trocar systems, and related accessories for use in abdominal, thoracic, and pelvic surgical procedures. Founded in 2011, Solstice employs approximately 620 employees worldwide, with manufacturing operations in Galway, Ireland and distribution facilities in the United States. In fiscal year 2023, Solstice reported consolidated revenue of approximately €187.4 million.
Plaintiff Apex Surgical Innovations, Inc. is a Delaware corporation with its principal offices located at 1220 North Market Street, Suite 550, Wilmington, Delaware 19801 (EIN: 51-0483762). Founded in 2006, Apex manufactures surgical access devices, trocar systems, and insufflation equipment marketed to hospitals and ambulatory surgical centers in the United States and internationally. Apex reported estimated fiscal year 2023 revenue of approximately $312 million and employs approximately 1,100 employees.
Apex commenced this action on May 9, 2024, by filing its Complaint (D.I. 1) alleging that Solstice's PrecisionEdge™ product line infringes the three patents-in-suit. On June 14, 2024, Solstice filed its Answer, Affirmative Defenses, and Counterclaims (D.I. 12), in which it denied infringement of each asserted patent, asserted affirmative defenses of non-infringement and invalidity under 35 U.S.C. §§ 102 and 103, and asserted a counterclaim for declaratory judgment of unenforceability based on inequitable conduct during prosecution of the asserted patents.
B. The Asserted Patents
Apex asserts three United States patents in this litigation, all of which are listed as part of a patent family comprising fourteen total issued U.S. patents and six pending continuation applications. Each of the three asserted patents lists Dr. Raymond Szabo, Apex's Vice President of Engineering, as the sole named inventor. All three patents are assigned to Apex.
U.S. Patent No. 9,814,237 (the '237 Patent). The '237 Patent, entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," was issued on November 14, 2017 and bears an expiration date of June 22, 2035. The '237 Patent generally discloses and claims a locking seal assembly for use in a trocar or similar minimally invasive surgical access device, in which a seal body mechanically interlocks with a housing upon insertion of a surgical instrument to maintain a gas-tight seal during a laparoscopic procedure. Apex asserts Claims 1, 3, 7, and 12 of the '237 Patent against the PE-12000 Series. Claim 1 is an independent claim directed to the locking seal assembly, while Claims 3, 7, and 12 are dependent claims reciting additional structural and functional limitations, including a "radially compressible seal element" (Claim 7) and a "housing detent" (Claim 12).
U.S. Patent No. 10,271,884 (the '884 Patent). The '884 Patent, entitled "Retractable Blade Deployment Mechanism for Trocar Systems," was issued on April 30, 2019 and bears an expiration date of September 15, 2036. The '884 Patent generally discloses and claims a retractable blade mechanism for use in trocar systems, in which a spring-loaded blade is deployed for tissue penetration and automatically retracts upon penetration of the body wall to reduce the risk of inadvertent injury to internal organs. Apex asserts Claims 1, 2, 5, 9, and 14 of the '884 Patent against the PE-12000 Series. Claim 1 is an independent claim reciting the retractable blade deployment mechanism. Claims 2, 5, 9, and 14 add further structural limitations, including a "blade guard" (Claim 5), "sequential deployment" of the blade and trocar cannula (Claim 9), and a "biased return spring" of specified characteristics (Claim 14).
U.S. Patent No. 10,932,105 (the '105 Patent). The '105 Patent, entitled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar," was issued on March 2, 2021 and bears an expiration date of January 10, 2038. The '105 Patent generally discloses and claims an integrated insufflation valve and seal for use in a laparoscopic trocar, in which the valve and seal functions are combined in a unitary structure to maintain pneumoperitoneum during insufflation. Apex asserts Claims 1, 4, and 8 of the '105 Patent against the PE-12000 Series. Claim 1 is an independent claim directed to the integrated insufflation valve and seal assembly. Claim 4 adds a "self-sealing membrane" limitation, and Claim 8 requires the seal to maintain gas-tightness at pressures exceeding 20 mmHg.
All three patents share a common specification disclosure and relate to components of a trocar system used in minimally invasive laparoscopic surgery. During prosecution, each patent was the subject of narrowing amendments that are material to the infringement analysis, as discussed in Section IV.D below.
C. The Accused PE-12000 Series
The PrecisionEdge™ PE-12000 Series is a 12 mm laparoscopic trocar assembly designed and manufactured by Solstice for use in minimally invasive abdominal surgical procedures. The PE-12000 is one of three product lines accused of infringement in this litigation. Apex contends that the PE-12000 is the only accused product that infringes all three asserted patents, making it the centerpiece of Apex's case and the focal point of its damages theory.
The two other accused product lines — the PE-5000 Series (5 mm) and the PE-15000 Series (15 mm) — are accused of infringing subsets of the asserted patents. Specifically, the PE-5000 Series is accused of infringing the '237 and '884 Patents (but not the '105 Patent), and the PE-15000 Series is accused of infringing the '884 and '105 Patents (but not the '237 Patent). The present cross-motion addresses only the PE-12000 Series.
Combined U.S. sales of all accused PrecisionEdge™ products from calendar year 2021 through September 30, 2024 totaled approximately $74.6 million, distributed as follows: FY 2021, $12.1 million; FY 2022, $17.8 million; FY 2023, $22.4 million; and the first three quarters of FY 2024 (through September 30, 2024), $22.3 million. The weighted average gross margin across all accused PrecisionEdge™ products during that period was approximately 61.3%. The PE-12000 accounts for the single largest share of accused-product revenue and, accordingly, is the primary driver of Apex's claimed damages.
D. Procedural History Relevant to This Motion
The parties have engaged in extensive fact and expert discovery. Solstice produced 48,217 documents (Bates Nos. SBD-000001 through SBD-048217), including design drawings, engineering specifications, manufacturing records, and internal communications relating to the accused PrecisionEdge™ product line. Apex produced 31,450 documents (Bates Nos. APEX-000001 through APEX-031450), including the prosecution histories of the asserted patents, internal design documentation, and communications with the United States Patent and Trademark Office.
On November 18, 2024, the Court held a Markman hearing to address nine disputed claim terms across the three asserted patents. On December 6, 2024, the Court issued its Claim Construction Order (D.I. 87), resolving all nine disputed terms. Of the nine constructions, five were adopted in a manner favorable to Solstice and four in a manner favorable to Apex. The Court's constructions are central to the infringement analysis and are discussed in detail in Section IV below.
Expert discovery opened on January 13, 2025, pursuant to the Scheduling Order (D.I. 42). Dr. Miriam Ostrowski, Professor of Biomedical Engineering at Halford University, served Solstice's expert report on invalidity and non-infringement on January 27, 2025. Dr. Calvin Ng, Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute, served Apex's infringement expert report on February 10, 2025. Rebuttal expert reports were exchanged by both parties on March 3, 2025. Expert depositions were conducted in March and early April 2025.
On March 17, 2025, the parties participated in a full-day mediation before the Honorable Margaret Forsythe (Ret.) at Amberstone ADR Services in Wilmington, Delaware. The mediation did not result in resolution of the dispute.
On April 1, 2025, Solstice filed its Motion for Summary Judgment of Non-Infringement as to the PE-5000 Series (D.I. 112). On April 14, 2025, Apex filed the present Cross-Motion for Partial Summary Judgment of Infringement as to the PE-12000 Series (D.I. 118), which is the subject of this Opposition. Trial is currently scheduled to commence on September 30, 2025.
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." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A fact is "material" if it "might affect the outcome of the suit under the governing law." Id.
The party moving for summary judgment bears the initial burden of demonstrating the absence of any genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). Once the movant has carried this initial burden, the burden shifts to the non-moving party to "set forth specific facts showing that there is a genuine issue for trial." Anderson, 477 U.S. at 250. However, the non-moving party need not produce evidence in a form that would be admissible at trial, so long as the evidence could be presented in an admissible form. See Celotex, 477 U.S. at 324.
In evaluating a motion for summary judgment, the Court must view all facts in the light most favorable to the non-moving party and draw all reasonable inferences in its favor. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986); Anderson, 477 U.S. at 255. The Court's role is not to weigh the evidence or determine the truth of the matter, but rather to determine whether there is a genuine issue for trial. Anderson, 477 U.S. at 249. Where the non-moving party has presented evidence creating a genuine factual dispute, summary judgment must be denied.
B. Summary Judgment in Patent Infringement Cases
The analysis of patent infringement is a two-step process. The first step is claim construction — the interpretation of the meaning and scope of the patent claims. Claim construction is a question of law for the Court. Markman v. Westview Instruments, Inc., 517 U.S. 370, 372 (1996); Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc). In this case, the Court has already resolved claim construction in its December 6, 2024 Claim Construction Order. The second step is the comparison of the properly construed claims to the accused device. This comparison is a question of fact. Markman, 52 F.3d at 976; see also Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454 (Fed. Cir. 1998) (en banc).
Because the second step of the infringement analysis — comparing the claims to the accused product — is a factual inquiry, summary judgment of infringement is appropriate only where "no reasonable jury could find" that the accused device does not infringe the asserted claims. SRI Int'l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1116 (Fed. Cir. 1985). Conversely, where the parties' technical experts offer conflicting testimony on whether the accused device meets a claim limitation, summary judgment must be denied because a genuine dispute of material fact exists. See Conroy v. Reebok Int'l, Ltd., 14 F.3d 1570, 1575 (Fed. Cir. 1994) (reversing summary judgment of non-infringement where competing expert testimony created genuine factual dispute).
The patentee bears the burden of proving infringement by a preponderance of the evidence. Cross Med. Prods., Inc. v. Harborview Corporation Sofamor Danek, Inc., 424 F.3d 1293, 1310 (Fed. Cir. 2005). On a motion for summary judgment of infringement, the patentee must demonstrate that no reasonable jury could find in favor of the accused infringer on the question of infringement. Where, as here, the accused infringer has produced evidence raising genuine factual disputes, the patentee has failed to carry its burden.
C. Literal Infringement and the Doctrine of Equivalents
Patent infringement may be established under two theories: literal infringement and infringement under the doctrine of equivalents.
Literal infringement requires that every limitation of the asserted claim be met by the accused device. Tarrant Corporation v. Ben Venue Labs., Inc., 271 F.3d 1043, 1049 (Fed. Cir. 2001). If even a single limitation of the claim is absent from the accused device, literal infringement cannot be found. Stumbo v. Eastman Outdoors, Inc., 508 F.3d 1358, 1362 (Fed. Cir. 2007). The patentee bears the burden of proving that every limitation is present.
Under the doctrine of equivalents, infringement may be found even where the accused device does not literally satisfy every claim limitation, if the accused device contains an element that performs substantially the same function, in substantially the same way, to achieve substantially the same result as the claimed element. Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 608 (1950); Warner-Jenkinson Co. v. Harborline Enterprises Davis Chem. Co., 520 U.S. 17, 39-40 (1997). The doctrine of equivalents is applied on an element-by-element basis, not to the claim as a whole. Warner-Jenkinson, 520 U.S. at 29.
However, the doctrine of equivalents is subject to important limitations. First, prosecution history estoppel prevents a patentee from using the doctrine of equivalents to recapture subject matter that was surrendered during prosecution of the patent. Festo Corp. v. Fenmore & Co., 535 U.S. 722, 733-34 (2002). Where a patentee makes a narrowing amendment to overcome a prior art rejection, a presumption arises that the patentee surrendered the territory between the original claim scope and the amended claim scope. Id. at 740. This presumption may be rebutted only under narrow circumstances. Id. at 740-41.
Second, the all-limitations rule prevents the doctrine of equivalents from being applied in a manner that would effectively eliminate a claim limitation and thereby render the limitation meaningless. Pennwalt Corp. v. Durand-Wayland, Inc., 833 F.2d 931, 935 (Fed. Cir. 1987) (en banc); see also Warner-Jenkinson, 520 U.S. at 29. The patentee bears the burden of establishing infringement under the doctrine of equivalents. Bai v. L & L Wings, Inc., 160 F.3d 1350, 1353 (Fed. Cir. 1998).
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 infringement is therefore inappropriate as to any asserted claim of any asserted patent.
A. Genuine Disputes of Material Fact Preclude Summary Judgment as to the '237 Patent (Claims 1, 3, 7, and 12)
Apex asserts Claims 1, 3, 7, and 12 of the '237 Patent against the PE-12000 Series. Each of these claims includes limitations that are the subject of genuine factual disputes, supported by competing expert testimony, physical teardown evidence, and design documentation produced in discovery. For the reasons set forth below, the Court should deny summary judgment as to all asserted claims of the '237 Patent.
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 manner favorable to Solstice. Specifically, the Court construed "locking seal assembly" to require "a specific mechanical interlock between the seal body and the housing that engages upon insertion of a surgical instrument." D.I. 87 at 12. The Court rejected Apex's proposed broader construction, which would have encompassed any mechanism — including friction-based retention — that holds the seal in place relative to the housing. Id. at 13-14.
The Court's construction is dispositive of the factual dispute at the heart of this motion. Dr. Miriam Ostrowski testified in her January 27, 2025 expert report, and reaffirmed in her March 3, 2025 rebuttal report, that the PE-12000's seal mechanism operates through a fundamentally different principle than the "locking seal assembly" claimed in the '237 Patent. Specifically, Dr. Ostrowski explained that the PE-12000 employs a friction-based retention system in which an elastomeric seal is held in position within the trocar housing through frictional engagement between the seal body and the inner wall of the housing. Ostrowski Report ¶¶ 47-62; Ostrowski Rebuttal ¶¶ 18-31. Unlike the claimed "locking seal assembly," the PE-12000's friction-based system does not involve any mechanical interlock — there is no physical engagement of mating structural features (such as a tab, groove, detent, or snap-fit) that locks the seal to the housing. Id.
Dr. Ostrowski's analysis is supported by extensive physical evidence. She performed a detailed physical teardown of five PE-12000 units, examining the seal housing under magnification and documenting her findings with annotated photographs. Ostrowski Report ¶¶ 53-57, Exs. 8-14. She further referenced Solstice's original design drawings (Bates Nos. SBD-014322 through SBD-014389), which specify dimensional tolerances for the friction-fit interface between the seal body and the housing. Id. ¶ 58, Ex. 15. Those drawings confirm that the PE-12000's seal is retained through an interference fit — that is, the seal body is manufactured with an outer diameter slightly larger than the inner diameter of the housing, so that the seal is held in place through compressive friction when press-fitted into the housing. Id. ¶ 59. Dr. Ostrowski explained that this friction-based approach is structurally and functionally distinct from the mechanical interlock required by the Court's construction: the PE-12000 does not "lock" in the sense of engaging complementary mechanical features, and the seal can be dislodged from the housing by applying sufficient axial force — a characteristic inconsistent with a true mechanical interlock. Id. ¶¶ 60-62.
Apex's expert, Dr. Calvin Ng, offered a contrary opinion in his February 10, 2025 infringement report. Dr. Ng opined that the PE-12000's friction-retention feature is "functionally equivalent to a mechanical interlock" because it serves the same purpose of holding the seal in place within the housing during use. Ng Report ¶¶ 72-89. Dr. Ng acknowledged the structural differences identified by Dr. Ostrowski but argued that the friction fit achieves the same result as a mechanical interlock and therefore satisfies the "locking seal assembly" limitation. Id. ¶¶ 85-89.
This is a classic battle of the experts. Two qualified technical experts have examined the same accused product and arrived at diametrically opposed conclusions regarding whether the PE-12000's seal mechanism constitutes a "locking seal assembly" under the Court's construction. Dr. Ostrowski says the PE-12000's friction-based system is not a "mechanical interlock" and therefore does not meet the Court's construction. Dr. Ng says it is functionally equivalent and satisfies the limitation. The Court cannot resolve this factual dispute on summary judgment. The credibility and persuasiveness of these competing expert opinions is for the jury to assess at trial. See Anderson, 477 U.S. at 255 ("Credibility determinations, the weighing of the evidence, and the drawing of legitimate inferences from the facts are jury functions, not those of a judge . . . .").
Apex's attempt to sidestep this dispute by characterizing the infringement analysis as "straightforward" is unavailing. The very claim term at the heart of the dispute was contested during claim construction, and the Court's construction adopted language that is in tension with the PE-12000's actual design. Whether the PE-12000's design falls within or outside the Court's construction is precisely the type of factual question that must be resolved by the jury. Summary judgment on the "locking seal assembly" limitation should be denied.
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, perpendicular to the axis of the trocar — to create a seal around instruments of different sizes.
Apex's expert, Dr. Ng, asserts that the PE-12000's elastomeric seal insert satisfies this limitation because the seal insert is made of a compressible elastomeric material that deforms to accommodate instruments of different diameters when they are inserted through the trocar. Ng Report ¶¶ 94-102. Dr. Ng points to the fact that the PE-12000's seal insert is designed to seal around both 5 mm and 12 mm instruments, and opines that this ability to accommodate different diameters constitutes "radial compression." Id. ¶ 99.
Solstice's expert, Dr. Ostrowski, disputes this characterization. In her rebuttal report, Dr. Ostrowski explained that the PE-12000's elastomeric seal insert achieves sealing through a fundamentally different mechanism: axial compression, not radial compression. Ostrowski Rebuttal ¶¶ 34-48. Specifically, Dr. Ostrowski described the PE-12000's seal as a stack of elastomeric discs that are compressed along the longitudinal axis of the trocar (the axial direction) by a retaining cap. Id. ¶ 37. As the discs are compressed axially, they bulge inward, creating a seal around the instrument. Id. ¶ 38. Dr. Ostrowski explained that this is fundamentally different from the "radially compressible seal element" claimed in the '237 Patent, which contemplates a seal element that compresses in the radial direction through direct radial contact with the instrument. Id. ¶¶ 39-42.
Critically, Dr. Ostrowski's opinion is supported by physical testing data produced in discovery. Solstice produced bench testing data (Bates Nos. SBD-031005 through SBD-031042) from testing conducted during the PE-12000's design phase. This data documents the compression behavior of the PE-12000's seal insert under controlled conditions, using strain gauges and high-speed imaging to measure the direction and magnitude of compression. Id. ¶ 43, Ex. 22. The testing data demonstrates that the predominant compression vector in the PE-12000 seal is axial, not radial — the axial compression component accounted for approximately 78% of the total deformation, while the radial component accounted for only approximately 22%. Id. ¶ 44. Dr. Ostrowski explained that this testing data confirms that the PE-12000 achieves sealing primarily through axial compression, with any radial deformation being an incidental byproduct of the axial compression, rather than the primary sealing mechanism. Id. ¶¶ 45-47.
Dr. Ng did not address this testing data in his infringement report, nor did he conduct independent compression testing of the PE-12000's seal insert. In his rebuttal, Dr. Ng acknowledged the existence of the axial compression component but maintained that any radial deformation, regardless of its relative magnitude, satisfies the "radially compressible" limitation. Ng Rebuttal ¶¶ 31-38. However, this characterization is itself a factual matter on which reasonable minds can differ. A reasonable jury could credit Dr. Ostrowski's opinion that the PE-12000's seal is predominantly axially compressible and does not satisfy Claim 7's requirement of a "radially compressible seal element."
This factual dispute — grounded in competing expert opinions and conflicting interpretations of physical testing data — precludes summary judgment on Claim 7 of the '237 Patent.
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 understood by those of skill in the art to be a discrete mechanical feature — typically a protrusion, catch, or recess — that engages a corresponding feature to hold a component in a fixed position. See Ostrowski Report ¶ 65; Ng Report ¶ 107 (both experts agreeing on the general definition of "detent").
Despite this agreement on the definition, the experts disagree sharply on whether the PE-12000 possesses such a feature. Solstice has presented substantial evidence that the PE-12000 lacks any detent feature entirely. Dr. Ostrowski's report includes a detailed examination of the PE-12000's housing and seal body, using cross-sectional photographs, CAD models, and dimensional measurements to demonstrate that the PE-12000's seal housing does not contain any protrusion, catch, or recess that positively engages the seal in a fixed position. Ostrowski Report ¶¶ 63-74, Exs. 16-19. Instead, the PE-12000 relies on the same continuous frictional engagement described above — the interference fit between the seal body and the housing wall. Id. ¶ 68.
Dr. Ostrowski's rebuttal report further addresses this point with annotated cross-sectional photographs comparing the PE-12000's housing interior to the patent's disclosed embodiment (Figure 4A of the '237 Patent). Ostrowski Rebuttal ¶¶ 49-58, Exs. 25-28. The comparison is striking: the '237 Patent's Figure 4A clearly shows a discrete detent feature — a raised ridge on the inner surface of the housing that snaps into a corresponding groove on the seal body. Id. ¶ 50, Ex. 25. By contrast, the PE-12000's housing interior is smooth and uniform, with no analogous ridge, catch, or groove. Id. ¶ 52, Ex. 26. Dr. Ostrowski concluded that the PE-12000 "entirely lacks a housing detent as that term is understood by those of skill in the art." Id. ¶ 58.
Apex's expert, Dr. Ng, attempted to characterize the PE-12000's friction-fit interface as a "functional detent," reasoning that the interference fit between the seal body and the housing creates a "positive engagement" that holds the seal in position. Ng Report ¶¶ 107-114. However, Dr. Ng did not identify any discrete mechanical feature in the PE-12000 that functions as a detent. His opinion effectively asks the Court to expand the meaning of "detent" to encompass any frictional engagement, which would render the "housing detent" limitation superfluous — a result inconsistent with established principles of claim construction that disfavor interpretations rendering claim terms redundant.
At minimum, a reasonable jury could find that the PE-12000 does not possess a "housing detent" as required by Claim 12. The competing expert testimony and physical evidence in the record create a genuine dispute of material fact that precludes summary judgment on this claim.
B. Genuine Disputes of Material Fact Preclude Summary Judgment as to the '884 Patent (Claims 1, 2, 5, 9, and 14)
Apex asserts Claims 1, 2, 5, 9, and 14 of the '884 Patent against the PE-12000 Series. Each of these claims includes limitations that are the subject of genuine factual disputes. As set forth below, the structural and functional differences between the PE-12000's blade deployment system and the claimed "retractable blade deployment mechanism" are substantial, well-documented, and contested by the parties' experts.
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 Court's construction was adopted over Apex's proposed broader construction, which would not have required automatic retraction and would have encompassed manually actuated retraction systems. Id. at 19-20. The Court's construction was one of the five terms construed favorably to Solstice.
The undisputed evidence in the record demonstrates that the PE-12000 employs a manually actuated blade deployment system, not a spring-loaded automatic retraction system. In the PE-12000, the blade is deployed when the surgeon presses a trigger on the trocar handle, extending the blade beyond the obturator tip. Critically, retraction of the blade occurs only when the surgeon releases the trigger — the blade does not retract automatically upon penetration of the body wall. Rather, retraction requires the affirmative physical act of the surgeon releasing the trigger. Ostrowski Report ¶¶ 78-95; see also SBD-018742 (PE-12000 Product Instruction Manual, describing blade deployment and retraction as a manual process).
Dr. Ostrowski opined in her expert report that the PE-12000's manually actuated blade deployment system does not satisfy the "retractable blade deployment mechanism" limitation as construed by the Court. Ostrowski Report ¶¶ 78-95. She explained that the Court's construction requires automatic retraction — meaning that the blade retracts without requiring any volitional act by the surgeon beyond the initial penetration. Id. ¶ 82. The PE-12000's system, by contrast, requires the surgeon to perform a separate, deliberate act (releasing the trigger) to initiate blade retraction. Id. ¶ 83. Dr. Ostrowski described this as a "fundamental structural and functional difference" between the PE-12000 and the claimed mechanism. Id. ¶ 84.
Dr. Ng offered the contrary opinion that the PE-12000's trigger mechanism is "effectively automatic" because, in his view, the trigger is designed to be released reflexively by the surgeon upon feeling the reduced resistance that occurs when the blade has penetrated the body wall. Ng Report ¶¶ 120-138. According to Dr. Ng, the surgeon's release of the trigger is a natural and involuntary response to the tactile feedback of penetration, rendering the retraction "automatic" for practical purposes. Id. ¶ 132.
Dr. Ng's characterization is both factually disputed and scientifically questionable. Dr. Ostrowski explained in her rebuttal report that whether a surgeon releases the trigger "reflexively" or deliberately is a question of human biomechanics and individual surgical technique that varies from surgeon to surgeon. Ostrowski Rebuttal ¶¶ 62-71. She cited peer-reviewed literature on trocar insertion techniques demonstrating that surgeons employ a range gripping and insertion strategies, and that trigger release is not an involuntary or automatic response in all cases. Id. ¶¶ 65-68 (citing three published studies). More fundamentally, Dr. Ostrowski explained that the question of whether the PE-12000's retraction is "automatic" turns on the user's physical interaction with the device — a factual inquiry that is entirely inappropriate for resolution on summary judgment. Id. ¶ 71.
The dispute over the "retractable blade deployment mechanism" limitation goes to the heart of Claim 1 — the independent claim from which Claims 2, 5, 9, and 14 all depend. If the PE-12000 does not satisfy Claim 1's independent requirement of a "retractable blade deployment mechanism," it cannot infringe any of the dependent claims. The factual dispute on this limitation alone is sufficient to preclude summary judgment as to all asserted claims of the '884 Patent.
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, ll. 12-16.
Solstice's technical evidence demonstrates that the PE-12000 does not contain a "blade guard" as claimed. The PE-12000's obturator tip, which Apex identifies as the alleged "blade guard," functions differently from the blade guard disclosed in the '884 Patent specification. Dr. Ostrowski identified specific dimensional and functional differences between the PE-12000's obturator tip and the claimed blade guard. Ostrowski Report ¶¶ 96-112. She explained that the '884 Patent discloses a blade guard as a separate, independently moving component that extends to cover the blade during retraction. Id. ¶ 98. By contrast, the PE-12000's obturator tip is not independently moving — it is fixed relative to the obturator shaft, and the blade retracts behind it. Id. ¶ 100. In other words, the PE-12000's obturator tip does not "shield" the blade in the manner contemplated by Claim 5; rather, the blade is simply pulled back into the obturator body by the spring mechanism when the trigger is released. Id. ¶ 102.
Apex's expert, Dr. Ng, opined that the PE-12000's obturator tip is "equivalent" to the claimed blade guard under the doctrine of equivalents, arguing that the obturator tip performs substantially the same function (shielding tissue from the blade) in substantially the same way (by being positioned between the blade and the tissue) to achieve substantially the same result (preventing inadvertent tissue contact during retraction). Ng Report ¶¶ 145-158.
However, Apex's reliance on the doctrine of equivalents to satisfy the "blade guard" limitation of Claim 5 is barred by prosecution history estoppel. During prosecution of the '884 Patent, the applicant (Dr. Szabo, through Apex's prosecution counsel) narrowed the "blade guard" limitation in response to an Office Action rejection based on U.S. Patent No. 7,442,193 to Veridian Medical Technologies, Inc. In a response filed during prosecution, Apex's counsel amended the claim language to distinguish the prior art by specifying that the "blade guard" is a separate component that "shields the blade during retraction." This narrowing amendment surrendered claim scope that encompasses the PE-12000's design, in which the obturator tip is not a separate, independently moving component. The prosecution history (included in the record at APEX-008341 through APEX-008372) documents this narrowing amendment and the applicant's corresponding arguments to the examiner distinguishing the prior art on the basis of the blade guard's separate, independent movement.
Under Festo, this narrowing amendment creates a presumption that Apex surrendered the territory between the original, broader claim scope and the narrower amended scope. 535 U.S. at 740. Apex has not identified any basis for overcoming this presumption. Accordingly, prosecution history estoppel bars Apex from asserting that the PE-12000's obturator tip infringes Claim 5 under the doctrine of equivalents.
Because Apex cannot establish literal infringement of the "blade guard" limitation (given the undisputed structural differences between the PE-12000's obturator tip and the claimed blade guard) and cannot rely on the doctrine of equivalents (due to prosecution history estoppel), summary judgment of infringement on Claim 5 must be denied. At minimum, genuine factual disputes exist regarding whether the PE-12000's obturator tip satisfies the "blade guard" limitation, precluding summary judgment.
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 cannula essentially simultaneously, rather than sequentially. Dr. Ostrowski's testing protocols, documented in her January 27, 2025 expert report, involved high-speed video analysis of the PE-12000's deployment sequence in both bench-top and simulated-use conditions. Ostrowski Report ¶¶ 113-128, Exs. 30-33. The high-speed video footage (captured at 1,000 frames per second) demonstrated that the temporal offset between blade deployment and cannula advancement in the PE-12000 is on the order of 5 to 12 milliseconds — a time interval that is imperceptible to the human eye and, in Dr. Ostrowski's opinion, does not constitute "sequential deployment" within the meaning of the '884 Patent. Id. ¶¶ 120-123.
Dr. Ostrowski explained that the '884 Patent's specification describes "sequential deployment" as a deliberate, staged process in which the blade fully extends and achieves penetration before the cannula begins to advance. Id. ¶ 115 (citing '884 Patent, col. 7, ll. 18-34). The patent specification further states that the sequential design "ensures that the blade has fully penetrated the body wall before the cannula is advanced, thereby reducing the risk of incomplete penetration." Id. (quoting '884 Patent, col. 7, ll. 30-34). The PE-12000's near-simultaneous deployment does not achieve this staged process. Id. ¶ 124.
Dr. Ng characterized the 5-to-12-millisecond temporal offset as "sequential," reasoning that the blade does, in a strictly temporal sense, begin to deploy before the cannula begins to advance. Ng Report ¶¶ 160-172. In Dr. Ng's view, any temporal offset — no matter how small — constitutes "sequential" deployment. Id. ¶ 168.
This difference in characterization is a factual dispute for the jury. The question of whether a 5-to-12-millisecond temporal offset constitutes "sequential deployment" within the meaning of the '884 Patent — particularly in light of the specification's description of sequential deployment as a deliberate, staged process — is a question on which reasonable minds could differ. It cannot be resolved on summary judgment.
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 rather than a compression "return spring" for blade retraction. SBD-019887 through SBD-019912 (PE-12000 Spring Specification Documents). A torsion spring operates through rotational force applied around an axis, whereas a compression spring operates through axial force applied along its length. These are structurally and functionally distinct spring types. Ostrowski Report ¶¶ 129-140.
Moreover, the mechanical properties of the PE-12000's torsion spring differ from the claimed specifications. Dr. Ostrowski calculated the effective spring constant of the PE-12000's torsion spring (converted to an equivalent linear force metric for comparison purposes) and determined that it falls outside the 2.0-4.0 N/mm range specified in Claim 14. Ostrowski Report ¶ 136, Ex. 35. The PE-12000's torsion spring has an effective spring constant of approximately 1.4 N/mm, below the claimed range. Id.
Dr. Ng did not directly address the spring-type discrepancy in his infringement report, instead asserting generally that the PE-12000's spring mechanism "functions as a biased return spring" and achieves the same result of returning the blade to the retracted position. Ng Report ¶¶ 175-182. He did not provide any calculation or measurement of the PE-12000's spring constant.
This is an additional factual dispute that precludes summary judgment on Claim 14. A reasonable jury could find that the PE-12000's torsion spring does not constitute a "compression return spring" and does not possess the specified spring constant, and therefore does not satisfy Claim 14's limitations.
C. Genuine Disputes of Material Fact Preclude Summary Judgment as to the '105 Patent (Claims 1, 4, and 8)
Apex asserts Claims 1, 4, and 8 of the '105 Patent against the PE-12000 Series. As with the '237 and '884 Patents, each asserted claim of the '105 Patent presents genuine factual disputes that preclude summary judgment.
1. "Integrated Insufflation Valve and Seal" — Single vs. Dual Component Dispute. Claim 1 of the '105 Patent — the independent claim — recites an "integrated insufflation valve and seal." This term was construed by the Court in its Claim Construction Order to mean "a unitary structure combining valve and seal functions." D.I. 87 at 24. This construction was one of the four terms construed favorably to Apex, in that the Court rejected Solstice's proposed construction requiring the valve and seal to be "formed as a single, monolithic piece." Id. at 25.
However, the Court's construction of "integrated" as requiring a "unitary structure" still presents a contested factual question when applied to the PE-12000. The PE-12000 uses a two-component assembly consisting of: (1) a separate stopcock valve that controls the flow of insufflation gas, and (2) a distinct elastomeric seal that prevents gas leakage around the inserted instrument. These two components are separately manufactured, separately assembled into the trocar housing, and separately replaceable. Ostrowski Report ¶¶ 142-160, Exs. 36-40.
Dr. Ostrowski's report includes exploded-view diagrams of the PE-12000's insufflation valve assembly, clearly showing the two distinct components. Ostrowski Report ¶ 146, Ex. 37. She further explained that the stopcock valve and the elastomeric seal are made of different materials (the stopcock is molded polycarbonate; the seal is silicone elastomer), are manufactured in separate production processes, and are assembled into the trocar housing as independent components during the manufacturing process. Id. ¶¶ 148-152. Critically, each component can be removed and replaced independently without disturbing the other, confirming that they are not a "unitary structure." Id. ¶ 153.
Dr. Ng opined in his infringement report that the PE-12000's two-component assembly is nonetheless "integrated" within the meaning of the '105 Patent because the stopcock valve and the seal function together within the trocar housing to maintain pneumoperitoneum during insufflation. Ng Report ¶¶ 190-208. In Dr. Ng's view, the fact that the two components operate in concert to achieve a unified result — gas-tight insufflation — means they constitute an "integrated" assembly, even if they are separately manufactured and replaceable. Id. ¶ 201.
This factual characterization is disputed and depends on how the Court's construction of "unitary structure" is applied to the physical design of the PE-12000. A "unitary structure" can reasonably be understood to require a single, combined component — not two separate, independently replaceable parts that happen to be housed within the same device. Dr. Ostrowski's opinion that the PE-12000's two-component design is not a "unitary structure" is well-supported by the physical evidence. A reasonable jury could agree. Accordingly, summary judgment on the "integrated insufflation valve and seal" limitation is inappropriate.
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-12000 uses a duckbill valve — a well-known valve design in which two opposing flaps of flexible material are biased into a closed position and open when an instrument is passed between them. Ostrowski Report ¶¶ 161-178, Ex. 41. Dr. Ostrowski explained that a duckbill valve is structurally and functionally distinct from a "membrane." A membrane, in the context of the '105 Patent, is a continuous sheet of material that deforms or stretches to permit instrument passage and returns to its original configuration when the instrument is removed. Id. ¶ 165. A duckbill valve, by contrast, consists of two discrete flaps that open along a slit line and close through material memory and bias force. Id. ¶ 166. The sealing mechanism is different: a membrane seals through continuous contact between the deformed material and the instrument along the entire circumference of the opening, while a duckbill valve seals through contact between the two flap edges along a single line. Id. ¶¶ 167-169.
Dr. Ng asserted in his infringement report that a duckbill valve is "a species of 'self-sealing membrane'" because it achieves self-sealing functionality — that is, it closes automatically when no instrument is inserted. Ng Report ¶¶ 212-224. In Dr. Ng's view, the claim term "self-sealing membrane" encompasses any self-sealing structure, including a duckbill valve. Id. ¶ 218.
This is a factual dispute on which reasonable minds could differ. The question of whether a duckbill valve is properly characterized as a "self-sealing membrane" turns on the scope and meaning of the term "membrane" — a factual question when applied to the specific physical structure of the PE-12000. Dr. Ostrowski's opinion that a duckbill valve is not a membrane is well-supported and cannot be rejected on summary judgment. A reasonable jury could find in Solstice's favor on this limitation.
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 bench testing data (Bates Nos. SBD-038710 through SBD-038742), which was generated during the PE-12000's product development and quality assurance testing, shows measurable gas leakage at insufflation pressures above 18 mmHg. Ostrowski Report ¶¶ 179-195, Ex. 42. Specifically, Solstice's testing documented leakage rates of between 0.3 and 0.8 liters per minute at pressures of 18-22 mmHg across a sample of 15 PE-12000 units. Id. ¶ 184. Dr. Ostrowski opined that these leakage rates indicate that the PE-12000's seal does not maintain "gas-tight" performance at pressures exceeding 20 mmHg. Id. ¶ 190.
Apex's own testing data (Bates Nos. APEX-022150 through APEX-022188), conducted by Apex's in-house testing laboratory, purportedly shows gas-tightness at pressures up to 25 mmHg. Ng Report ¶¶ 228-240, Ex. 18. However, the Apex testing was conducted under materially different testing conditions than the Solstice testing. Dr. Ostrowski identified several discrepancies between the two testing protocols: (1) Apex's testing used a sealed chamber with no instrument inserted through the trocar, whereas Solstice's testing was conducted with a 10 mm instrument inserted (simulating actual surgical conditions); (2) Apex's testing used a lower flow rate of insufflation gas; and (3) Apex's testing was conducted at room temperature, whereas Solstice's testing included elevated-temperature conditions simulating body-temperature exposure. Ostrowski Rebuttal ¶¶ 80-91.
These testing-methodology differences are material. Dr. Ostrowski explained that the presence of an inserted instrument is a critical variable because gas leakage most commonly occurs at the seal-instrument interface, not at the valve itself. Ostrowski Rebuttal ¶ 85. Accordingly, Apex's testing — which did not include an inserted instrument — would be expected to show lower leakage rates than real-world use conditions. Id. ¶ 86. The elevated-temperature testing conducted by Solstice is also more representative of actual surgical conditions, as the elastomeric seal material may soften and lose sealing force at body temperature. Id. ¶ 88.
The conflicting test results and the disputed testing methodologies constitute a genuine factual dispute that precludes summary judgment on Claim 8. Whether the PE-12000 maintains a "gas-tight seal at pressures exceeding 20 mmHg" depends on which testing protocol the jury finds more representative of actual conditions and which testing results the jury credits. This is quintessentially a factual determination for trial.
D. Apex Fails to Establish Infringement Under the Doctrine of Equivalents for Any Asserted Claim
In its cross-motion, Apex asserts infringement of the PE-12000 under both literal infringement and the doctrine of equivalents for several claim limitations. As shown above, genuine disputes of material fact preclude summary judgment on literal infringement. The doctrine of equivalents provides Apex no additional support, because prosecution history estoppel bars Apex's equivalents theories, and the all-limitations rule independently precludes them.
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, barring Apex from recapturing that scope through the doctrine of equivalents. Festo, 535 U.S. at 733-34.
The prosecution histories of each of the three patents document specific, material narrowing amendments:
The '237 Patent. During prosecution, the original claims recited a generic "seal assembly." In response to a rejection based on prior art identified as the Veridian Medical Technologies, Inc. references (the same prior art that is the subject of a third-party subpoena in this case), Apex's prosecution counsel amended the claims to narrow "seal assembly" to "locking seal assembly," adding the "locking" limitation to distinguish the prior art. APEX-004218 through APEX-004237 (Amendment and Response dated March 14, 2016). The accompanying remarks argued that the prior art's seal assembly did not include a "locking" mechanism. Id. at APEX-004231. This narrowing amendment forecloses Apex from using the doctrine of equivalents to capture seal assemblies that do not "lock" — including the PE-12000's friction-based retention system.
The '884 Patent. During prosecution, the original claims recited a generic "blade mechanism." In response to a rejection, Apex narrowed the claims to require a "retractable blade deployment mechanism" with automatic retraction upon body-wall penetration. APEX-008341 through APEX-008372 (Amendment and Response dated August 7, 2018). The applicant's remarks specifically argued that the prior art's blade mechanism was not "retractable" in the claimed sense because it required manual actuation. Id. at APEX-008358. This amendment directly forecloses Apex from arguing under equivalents that a manually actuated blade system (such as the PE-12000's system) is equivalent to the claimed automatic retraction mechanism — the very subject matter Apex distinguished during prosecution.
The '105 Patent. During prosecution, the original claims recited an "insufflation valve and seal." Apex narrowed the claims by adding the word "integrated," amending the limitation to "integrated insufflation valve and seal." APEX-011894 through APEX-011922 (Amendment and Response dated June 12, 2020). The applicant argued that the prior art disclosed separate, non-integrated valve and seal components, and that the "integrated" limitation distinguished the claimed invention. Id. at APEX-011910. This amendment forecloses Apex from using the doctrine of equivalents to encompass two-component, non-integrated designs — such as the PE-12000's separate stopcock valve and elastomeric seal.
In each instance, the narrowing amendment was made for a substantial reason relating to patentability — specifically, to distinguish prior art. Under Festo, a presumption arises that Apex surrendered the territory between the original and amended claim scope. 535 U.S. at 740. Apex has not attempted to rebut this presumption in its cross-motion and has not argued that any of the recognized exceptions to the Festo presumption apply. See Honeywell Int'l, Inc. v. Hamilton Sundstrand Corp., 370 F.3d 1131, 1141-42 (Fed. Cir. 2004) (describing the narrow circumstances under which the Festo presumption may be rebutted). Accordingly, prosecution history estoppel bars Apex's equivalents theories for the "locking seal assembly" limitation of the '237 Patent, the "retractable blade deployment mechanism" limitation of the '884 Patent, and the "integrated insufflation valve and seal" limitation of the '105 Patent.
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.S. at 29.
Apex's equivalents theory would render the very limitations that distinguish the asserted claims from the prior art meaningless. Specifically:
• "Locking" limitation ('237 Patent): If the PE-12000's friction-based retention system is deemed "equivalent" to a "locking" mechanism, then the word "locking" in the claim is rendered meaningless. Any seal assembly that holds a seal in place through any means would infringe, eliminating the limiting effect of the "locking" requirement that the applicant added during prosecution.
• "Retractable" limitation ('884 Patent): If the PE-12000's manually actuated blade system is deemed "equivalent" to an "automatically retracting" system, then the automatic-retraction requirement is effectively eliminated from the claim. The distinction between manual and automatic retraction — which the applicant expressly relied upon to distinguish the prior art — would be obliterated.
• "Integrated" limitation ('105 Patent): If the PE-12000's two-component valve-and-seal assembly is deemed "equivalent" to an "integrated" unitary structure, then the word "integrated" is rendered meaningless. Any combination of a valve and a seal, regardless of whether they are combined in a unitary structure, would infringe — precisely the scope that was surrendered during prosecution.
In each case, applying the doctrine of equivalents as Apex proposes would not merely expand the scope of the claim limitation;

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

TABLE OF CONTENTS

TABLE OF AUTHORITIES

I. PRELIMINARY STATEMENT

II. STATEMENT OF FACTS

III. LEGAL STANDARD

IV. ARGUMENT

Record

Parties

Dates

Amounts