post-markman-strategy-memo.docx

1037-00004 · Solstice Biomedical Devices Ltd · Claim Construction & Invalidity

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MEMORANDUM

TO: Marcus Delgado, Responsible Partner, intellectual Property

FROM: Christy Bauer, Lead Associate, intellectual Property Peter Vassiliev, Working Associate, intellectual Property

DATE: December 10, 2024

RE: Post-Markman Strategy Assessment — Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA (D. Del.)

MATTER NO.: 10294.0017

CLIENT: Solstice Biomedical Devices Ltd. / Solstice Biomedical, Inc.

CC: Catherine Bloom, Billing Partner

I. Executive Summary

The purpose of this memorandum is to analyze the Claim Construction Order issued on December 6, 2024 by Chief Judge Richard G. Andrews of the United States District Court for the District of Delaware and to assess its impact on the defense strategy for all three accused PrecisionEdge™ product lines. This analysis draws on the proceedings to date—including Solstice's individual Claim Construction Brief (filed October 28, 2024), the Joint Claim Construction Brief (filed November 4, 2024), and the Markman Hearing (held November 18, 2024)—and is intended to inform strategic decision-making for the remainder of this litigation.

In its Claim Construction Order, the Court construed nine disputed claim terms spanning three asserted patents: 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"). Of these nine constructions, five were favorable to Solstice and four were favorable to Apex. Although the numerical split is nearly even, the practical consequences are asymmetric across the three accused product lines.

Our net assessment is as follows:

• PE-5000 Series: The Markman ruling materially strengthens the non-infringement position. Two of the most favorable constructions—"locking seal assembly" and "retractable blade deployment mechanism"—are likely dispositive of infringement as to this product line. We recommend pursuing summary judgment of non-infringement.

• PE-12000 Series: The Markman ruling creates a mixed picture. While certain favorable constructions provide non-infringement arguments, the fact-intensive nature of the PE-12000's design features—particularly its rotational cam locking mechanism and spring-actuated blade with manual safety override—will likely preclude summary judgment. Several unfavorable constructions (Terms 6, 7, 8, and 9) weaken particular defense arguments. The invalidity defense and damages-mitigation strategy should be bolstered for this product line.

• PE-15000 Series: The Markman ruling modestly weakens the overall defense posture. While the favorable construction of "insufflation port in fluid communication with the seal assembly" (Term 4) provides a meaningful defense on the '105 Patent, the broadened constructions on blade deployment angle, integrated insufflation valve, and substantially cylindrical obturator tip erode non-infringement positions on other claims.

Based on this analysis, we recommend the following actions: (1) pursue summary judgment of non-infringement on the PE-5000 Series as to both the '237 and '884 Patents, with a target filing date of early April 2025; (2) refine and strengthen the invalidity strategy for the '884 and '105 Patents, capitalizing on the broader constructions that expand the universe of invalidating prior art; (3) prepare robust trial presentations for the PE-12000 and PE-15000 Series, emphasizing non-infringement distinctions and invalidity as a secondary defense; and (4) recalibrate the settlement posture in light of the improved litigation position, with a recommendation to defer substantive settlement discussions until after the PE-5000 summary judgment motion is decided to maximize leverage heading into the March 17, 2025 mediation.

Each of these recommendations is discussed in detail below.

II. Background

A. The Asserted Patents

Apex Surgical Innovations, Inc. ("Apex") asserts three patents in this action, all of which relate to surgical trocar technology used in minimally invasive laparoscopic procedures. The named inventor on all three patents is Dr. Raymond Szabo, Vice President of Engineering at Apex. All three patents are assigned to Apex. The patent family to which these three patents belong includes fourteen total issued U.S. patents and six pending continuation applications.

U.S. Patent No. 9,814,237 ("the '237 Patent") is entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device." It was issued on November 14, 2017, and expires on June 22, 2035. The '237 Patent generally discloses and claims a multi-component seal assembly for a surgical trocar that incorporates a locking mechanism to maintain the seal in a fixed position during a surgical procedure, thereby preventing inadvertent displacement and gas leakage. Apex asserts Claims 1, 3, 7, and 12 of the '237 Patent against Solstice's products.

U.S. Patent No. 10,271,884 ("the '884 Patent") is entitled "Retractable Blade Deployment Mechanism for Trocar Systems." It was issued on April 30, 2019, and expires on September 15, 2036. The '884 Patent generally discloses and claims a mechanism for deploying and retracting an obturator blade within a trocar assembly, with specific focus on a spring-actuated system that controls blade movement for tissue penetration. The '884 Patent is the most broadly asserted of the three patents, with Apex asserting Claims 1, 2, 5, 9, and 14 against various Solstice product lines.

U.S. Patent No. 10,932,105 ("the '105 Patent") is entitled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar." It was issued on March 2, 2021, and expires on January 10, 2038. The '105 Patent generally discloses and claims a trocar design that integrates an insufflation valve with the seal assembly, allowing for continuous gas flow management during laparoscopic surgery. Apex asserts Claims 1, 4, and 8 of the '105 Patent.

B. The Accused Products

Apex accuses three product lines within Solstice's PrecisionEdge™ family of trocar assemblies:

PrecisionEdge™ PE-5000 Series is a 5 mm trocar assembly designed for smaller-diameter laparoscopic access. The PE-5000 is accused of infringing the '237 Patent (Claims 1, 3, 7, 12) and the '884 Patent (Claims 1, 2, 5, 9, 14). This product line is the smallest-diameter device in the PrecisionEdge™ family and uses a friction-fit single-component seal and a dual-actuator blade deployment system that are architecturally distinct from the mechanisms described in the asserted patents.

PrecisionEdge™ PE-12000 Series is a 12 mm trocar assembly designed for standard laparoscopic access and is the most widely sold product in the PrecisionEdge™ family. The PE-12000 is accused of infringing all three patents: the '237 Patent (Claims 1, 3, 7, 12), the '884 Patent (Claims 1, 2, 5, 9, 14), and the '105 Patent (Claims 1, 4, 8). The PE-12000 uses a two-component seal with a rotational cam locking mechanism, a single spring-actuated blade with a manual safety override, and a co-located but separately manufactured insufflation valve.

PrecisionEdge™ PE-15000 Series is a 15 mm trocar assembly designed for larger-diameter access used in procedures requiring extraction of tissue specimens. The PE-15000 is accused of infringing the '884 Patent (Claims 1, 2, 5, 9, 14) and the '105 Patent (Claims 1, 4, 8). The PE-15000 features a conical-tapered obturator tip, a single spring-actuated blade with manual safety override, and a gas pathway that includes a dedicated intermediary pressure-regulation chamber.

Combined U.S. sales of the three accused product lines for calendar years 2021 through the third quarter of 2024 total approximately $74.6 million, broken down as follows:

The weighted average gross margin across the three product lines is 61.3%.

C. Procedural Posture

The current procedural posture of the case is as follows:

• May 9, 2024: Apex filed its Complaint alleging patent infringement of the '237, '884, and '105 Patents.

• June 14, 2024: Solstice filed its Answer, Affirmative Defenses, and Counterclaims, asserting defenses of non-infringement, invalidity under 35 U.S.C. §§ 102 and 103, and inequitable conduct.

• October 22, 2024: The parties exchanged Proposed Claim Constructions and identified nine disputed terms for resolution.

• October 28, 2024: Solstice filed its individual Claim Construction Brief.

• November 4, 2024: The Joint Claim Construction Brief was filed.

• November 18, 2024: The Markman Hearing was held before Chief Judge Andrews.

• December 6, 2024: The Court issued its Claim Construction Order, construing all nine disputed terms.

• January 13, 2025: Expert discovery opens.

• January 27, 2025: Defendant's opening expert reports due (invalidity/claim construction).

• February 10, 2025 (estimated): Plaintiff's infringement expert report expected.

• February 14, 2025: Damages expert reports due for both sides.

• March 3, 2025: Rebuttal expert reports due.

• September 30, 2025: Trial.

Plaintiff's counsel is Victoria Stanton of Hargrove, Tate & Bennington LLP. Apex's retained experts include Dr. Calvin Ng of the Veltrano Polytechnic Institute (infringement and claim construction) and Hugh Danaher, CFA, of Keystone Valuation Advisors LLC (damages).

Defendant's experts include Dr. Miriam Ostrowski of Halford University (invalidity and claim construction) and Dr. Elena Marchetti of Pinnacle Economics Group LLC (damages). Patent prosecution counsel Kendrick & Lau LLP, led by Dr. Jonathan Kendrick, has previously provided prosecution history analysis and prior art searches supporting the defense. Their work product is referenced throughout this memorandum.

III. Summary of the Claim Construction Order

A. Overview of the Nine Disputed Terms

The Court's December 6, 2024 Order addressed all nine claim terms that the parties identified as disputed. The following table summarizes each disputed term, the patent and claims in which it appears, each party's proposed construction, the Court's adopted construction, and our assessment of which party the construction favors.

As the table reflects, the Court adopted constructions substantially tracking Solstice's proposals on five terms (Terms 1 through 5) and constructions substantially tracking Apex's proposals on four terms (Terms 6 through 9). The practical significance of these constructions varies considerably by accused product, as discussed in detail in Sections IV and V below.

B. Terms Construed Favorably to Solstice (5 Terms)

Term 1: "Locking Seal Assembly" ('237 Patent, Claims 1, 3, 7, 12)

This term appeared in every asserted claim of the '237 Patent and was the most heavily briefed term in the Joint Claim Construction Brief. Solstice proposed a narrow construction requiring a "mechanically actuated multi-component seal with a discrete locking detent"—a construction grounded in the patent specification's repeated and exclusive description of a detent-based locking mechanism. Apex, by contrast, proposed a broad construction encompassing "any seal mechanism that prevents fluid leakage and maintains position," which would have swept in virtually every trocar seal on the market.

The Court adopted a construction closely tracking Solstice's proposal, defining the term as "a mechanically actuated seal comprising at least two cooperating components with a positive locking detent mechanism." In reaching this construction, the Court relied heavily on the specification's repeated description of the detent mechanism as the "essence of the invention" and on the prosecution history, in which Apex's patent counsel distinguished prior art by emphasizing the presence of the detent. The Court specifically rejected Apex's argument that "locking" could refer to any friction-based retention, noting that such a reading would render the "locking" limitation superfluous.

Significance: This construction has substantial implications for the PE-5000 Series defense. The PE-5000 uses a friction-fit single-component seal without any discrete detent. Under the Court's construction, the PE-5000's seal clearly lacks both the "at least two cooperating components" and the "positive locking detent mechanism" required by the claim. For the PE-12000, the analysis is more nuanced: the PE-12000 uses a two-component seal, satisfying the first prong, but its locking mechanism is a rotational cam rather than a "positive locking detent." Whether a rotational cam constitutes or is equivalent to a "positive locking detent" will be a fact-intensive inquiry—one that may not be resolvable at summary judgment but provides a meaningful defense at trial.

Term 2: "Retractable Blade Deployment Mechanism" ('884 Patent, Claims 1, 2, 5, 9, 14)

This term was the second most heavily contested term and is critical to the infringement analysis across all three product lines. Solstice proposed a construction requiring "a spring-loaded blade that both deploys and retracts via the same spring actuation," emphasizing the specification's detailed description of a single bidirectional spring that serves both the deployment and retraction functions. Apex proposed a construction covering "any mechanism that moves a blade between deployed and retracted positions," which would encompass virtually any retractable blade system regardless of the actuation method.

The Court adopted Solstice's construction, defining the term as "a single spring-actuated mechanism that both deploys and retracts the blade." The Court found that the specification described the single-spring design as the disclosed embodiment and that the claims, read in light of the specification, required this structural feature. The Court noted that the prosecution history was consistent with this reading, as the applicant had distinguished prior art dual-actuator systems during prosecution.

Significance: This construction is potentially dispositive for the PE-5000 Series. The PE-5000 employs a dual-actuator system with a separate deployment spring and retraction cam—two distinct mechanisms performing two distinct functions. This system does not meet the "single spring-actuated mechanism that both deploys and retracts the blade" construction. For the PE-12000 and PE-15000, the analysis is closer: both products use a single spring mechanism, but each also incorporates a manual safety override. The question whether the presence of a manual safety override means the mechanism is not solely "spring-actuated" will require expert testimony and fact development.

Term 3: "Cannula Housing" ('237 Patent, Claim 7; '884 Patent, Claim 9)

The Court adopted Solstice's construction limiting "cannula housing" to "a unitary molded structure forming the outer housing of the cannula assembly." Apex had urged a broader construction that would encompass any outer structural component, whether unitary or assembled from multiple parts. The Court found that the specification consistently described the cannula housing as a unitary molded structure and that the use of "housing" (singular) in the claims supported a unitary reading. The Court also noted that Claim 7 of the '237 Patent distinguishes between the "cannula housing" and other structural components, suggesting that the housing is a single piece.

Significance: This construction helps the PE-5000 defense, as the PE-5000 uses a multi-part assembled housing rather than a unitary molded structure, thereby falling outside this limitation in Claim 7 of the '237 Patent and Claim 9 of the '884 Patent. The PE-12000, however, uses a unitary molded housing, so this construction does not assist the defense as to that product.

Term 4: "Insufflation Port in Fluid Communication with the Seal Assembly" ('105 Patent, Claims 1, 4, 8)

The Court adopted a construction requiring "a direct, dedicated fluid pathway between the insufflation port and the seal assembly, excluding configurations where gas flows through an intermediary valve chamber." This construction closely tracked Solstice's proposal. Apex had argued for a broader reading encompassing any fluid pathway—direct or indirect—connecting the insufflation port and the seal. The Court's analysis relied on the claim language's use of "in fluid communication with the seal assembly," which the Court found, in light of the specification, to require a direct connection rather than a pathway mediated through additional chambers or valves.

Significance: This construction is important for the PE-15000 defense. The PE-15000's gas pathway includes an intermediary pressure-regulation chamber situated between the insufflation port and the seal assembly. Under the Court's construction, this intermediary chamber may place the PE-15000 outside the scope of literal infringement of the '105 Patent Claims 1, 4, and 8. The PE-12000 presents a closer question: its gas pathway runs through a shared manifold but includes a direct bypass channel to the seal, which Apex will likely argue constitutes the required "direct, dedicated fluid pathway."

Term 5: "Proximal Blade Guard" ('884 Patent, Claim 14)

The Court adopted Solstice's narrower construction, defining "proximal blade guard" as "a rigid shield structure fixedly positioned proximal to the blade cutting edge that extends circumferentially around at least 270° of the blade perimeter." Apex had proposed a much broader construction encompassing "any structure proximal to the blade that provides a guarding function."

Significance: This construction provides a non-infringement argument for both the PE-5000 and PE-15000 as to Claim 14 of the '884 Patent. The PE-5000's guard structure does not extend circumferentially around 270° of the blade perimeter, and the PE-15000 incorporates a guard structure that may also fall short of this dimensional requirement, though further measurement and expert analysis will be needed to confirm. For the PE-12000, the guard structure's circumferential extent will need to be precisely assessed.

C. Terms Construed Favorably to Apex (4 Terms)

Term 6: "Resilient Sealing Member" ('237 Patent, Claims 1, 12)

Apex proposed a broad construction, and the Court adopted a broader reading, defining the term as "an elastomeric or deformable component that provides a sealing function, regardless of specific material composition." Solstice had argued for a narrower construction limited to the specific class of thermoplastic elastomers described in the specification, but the Court found that the specification's reference to thermoplastic elastomers was exemplary rather than limiting.

Significance: This construction weakens Solstice's argument that the PE-12000's silicone-based seal element is materially distinguishable from the patent's described "resilient sealing member." Under the broad construction, the PE-12000's silicone seal—and indeed any elastomeric or deformable sealing component—would satisfy this limitation. This does not independently establish infringement, as the other claim limitations must still be met, but it eliminates one line of defense that Solstice had advanced.

Term 7: "Blade Deployment Angle" ('884 Patent, Claims 1, 2)

The Court rejected Solstice's proposal to limit "blade deployment angle" to the 15°–45° angular range described in the specification. Instead, the Court adopted Apex's construction, defining the term as "the angle at which the blade achieves a cutting configuration relative to the longitudinal axis of the obturator." The Court found that the specification's recitation of a specific angular range was illustrative and that the claims did not incorporate numerical range limitations.

Significance: This construction broadens the infringement read on the PE-12000 and PE-15000 blade geometries. Both products deploy their blades at angles outside the 15°–45° range described in the specification but within the Court's broader construction (which encompasses any angle at which the blade achieves a cutting configuration). This eliminates what would have been a strong non-infringement argument for both product lines on Claims 1 and 2 of the '884 Patent.

Term 8: "Integrated Insufflation Valve" ('105 Patent, Claims 1, 4)

The Court adopted Apex's construction, holding that "integrated" requires only "co-location within the trocar housing" and does not require monolithic manufacture. Solstice had argued that "integrated" should be construed to require that the insufflation valve be monolithically manufactured as a single piece with the trocar housing, which would have excluded the PE-12000 and PE-15000 (both of which use separately manufactured but co-located valve components).

Significance: This construction substantially weakens Solstice's design-around argument for the PE-12000 and PE-15000. Both products use insufflation valves that are separately manufactured but assembled into and co-located within the trocar housing. Under the Court's construction, this co-location satisfies the "integrated" limitation, meaning both products likely meet this claim element.

Term 9: "Substantially Cylindrical Obturator Tip" ('884 Patent, Claim 5)

The Court adopted Apex's broader construction, holding that "substantially cylindrical" includes "tapered geometries with a generally cylindrical cross-section." Solstice had argued for a uniform cylindrical cross-section without taper, but the Court found that the modifier "substantially" accommodated minor deviations from a perfect cylinder, including tapers.

Significance: This construction adversely impacts the PE-12000 and PE-15000, both of which use tapered obturator tips. Under the Court's construction, these tapered tips likely fall within the scope of Claim 5 of the '884 Patent, eliminating what would have been a geometric non-infringement argument.

IV. Impact Analysis by Accused Product Line

A. PrecisionEdge™ PE-5000 Series (5 mm Trocar)

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

The Claim Construction Order materially strengthens the non-infringement position for the PE-5000 Series as to the '237 Patent. The Court's favorable construction of "locking seal assembly" (Term 1) is the cornerstone of this position. As construed, the term requires "a mechanically actuated seal comprising at least two cooperating components with a positive locking detent mechanism." The PE-5000 uses a single-component friction-fit seal without any discrete detent mechanism. The PE-5000's seal assembly therefore fails to meet two independent requirements of the construction: (a) it does not comprise "at least two cooperating components," and (b) it does not include a "positive locking detent mechanism."

The favorable construction of "cannula housing" (Term 3) further supports non-infringement of Claim 7 of the '237 Patent. The PE-5000 uses a multi-part assembled housing, not the unitary molded structure required by the Court's construction. This independently defeats infringement of Claim 7.

Although the Court's unfavorable construction of "resilient sealing member" (Term 6) broadened this limitation to encompass any elastomeric or deformable component regardless of material composition, this broader reading does not overcome the dispositive gap created by the "locking seal assembly" construction. Even if the PE-5000's sealing component satisfies the "resilient sealing member" limitation, the PE-5000 still lacks the multi-component structure and the positive locking detent required by the independent claims. The unfavorable construction of Term 6 is therefore immaterial to the PE-5000 analysis.

Overall Assessment: The non-infringement position for the PE-5000 as to the '237 Patent is strong and is likely suitable for resolution on summary judgment.

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

The non-infringement position for the PE-5000 as to the '884 Patent is even stronger. The Court's favorable construction of "retractable blade deployment mechanism" (Term 2) is dispositive for most, if not all, asserted claims. The PE-5000 employs a dual-actuator system in which a separate deployment spring advances the blade to a cutting position and a separate retraction cam withdraws the blade after tissue penetration. This is fundamentally different from the "single spring-actuated mechanism that both deploys and retracts the blade" required by the Court's construction. The two separate mechanical components in the PE-5000 perform two separate functions; there is no single spring that serves both deployment and retraction. This distinction is clear from the product's engineering drawings, bill of materials, and functional testing data, all of which are already in the record.

The favorable construction of "proximal blade guard" (Term 5) further supports non-infringement of Claim 14 specifically. The PE-5000's guard structure is a partial shield that does not extend circumferentially around 270° of the blade perimeter. Under the Court's construction requiring such circumferential extent, the PE-5000 does not practice this limitation.

The unfavorable constructions of "blade deployment angle" (Term 7) and "substantially cylindrical obturator tip" (Term 9) are less material to the PE-5000 analysis because the favorable constructions on Terms 2 and 5 are likely dispositive. Even if the PE-5000's blade angle and obturator tip geometry fall within the broader constructions adopted by the Court, the PE-5000 still does not meet the "retractable blade deployment mechanism" limitation of the independent claims. Since the independent claims must be satisfied before any dependent claim can be infringed, the favorable Term 2 construction effectively resolves the '884 Patent infringement question for the PE-5000.

Overall Assessment: The non-infringement position for the PE-5000 as to the '884 Patent is very strong and is well-suited for summary judgment.

3. Recommendation. We recommend that Solstice move for summary judgment of non-infringement on the PE-5000 Series as to both the '237 Patent and the '884 Patent. The target filing date should be early April 2025, after the close of expert reports and rebuttal reports, which will allow us to incorporate and rely on Dr. Ostrowski's expert opinions and to address any arguments raised by Dr. Ng in his infringement report.

If granted, a summary judgment ruling excluding the PE-5000 Series would remove from the damages base the PE-5000's $12.1 million in 2021 sales plus allocated portions of 2022–2024 sales. Based on our product mix analysis, the PE-5000 accounts for approximately 30–35% of total accused product sales. Eliminating this product from the case would substantially reduce Solstice's damages exposure and simplify the trial.

We should coordinate with Dr. Ostrowski promptly to obtain a supporting declaration for the summary judgment motion. Dr. Ostrowski's declaration should opine on the structural and functional differences between the PE-5000's single-component friction-fit seal and dual-actuator blade system, on the one hand, and the '237 Patent's "locking seal assembly" and the '884 Patent's "retractable blade deployment mechanism" as construed by the Court, on the other. Engineering drawings, component specifications, and testing data for the PE-5000 should be compiled and attached as exhibits.

B. PrecisionEdge™ PE-12000 Series (12 mm Trocar)

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

The PE-12000's non-infringement position as to the '237 Patent is mixed. The Court's favorable construction of "locking seal assembly" (Term 1) provides a basis for argument, but the outcome is less clear-cut than for the PE-5000. The PE-12000 uses a two-component seal, which satisfies the "at least two cooperating components" requirement. However, the PE-12000's locking mechanism is a rotational cam rather than a "positive locking detent." The rotational cam engages and locks the two seal components in position by rotating a collar that compresses the seal against the cannula wall. This is mechanically distinct from a detent mechanism, which typically involves a spring-loaded ball, pin, or projection that snaps into a corresponding recess to hold a component in a fixed position.

The question whether a rotational cam constitutes or is equivalent to a "positive locking detent mechanism" is fact-intensive and may depend on expert testimony regarding the structural and functional differences between cam-based and detent-based locking mechanisms. While we believe the better reading distinguishes the PE-12000's rotational cam from the claimed detent, Apex will argue that the cam performs the same locking function and that the distinction is one of semantics rather than substance. This argument is not frivolous, and a reasonable fact-finder could potentially credit it.

The unfavorable construction of "resilient sealing member" (Term 6) further weakens the PE-12000 defense on the '237 Patent. The PE-12000 uses a silicone-based seal element that clearly falls within the Court's broad construction of "an elastomeric or deformable component that provides a sealing function, regardless of specific material composition." Solstice's argument that the PE-12000's silicone seal is materially distinguishable from the patent's described resilient sealing member is no longer viable under this construction.

The favorable construction of "cannula housing" (Term 3) does not assist the PE-12000 defense on Claim 7, because the PE-12000 actually uses a unitary molded housing. The PE-12000's housing is injection-molded as a single piece, which falls squarely within the Court's construction. This limitation is met.

Overall Assessment: The non-infringement position for the PE-12000 on the '237 Patent is arguable but fact-intensive. The rotational cam versus detent distinction is the critical defense argument, but it is unlikely to be resolved at summary judgment. Trial presentation must effectively demonstrate to the jury the mechanical differences between a rotational cam and a positive locking detent, using physical models, animations, and expert testimony.

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

The PE-12000's non-infringement position on the '884 Patent is weaker than the PE-5000's but still presents legitimate arguments. The favorable construction of "retractable blade deployment mechanism" (Term 2) requires "a single spring-actuated mechanism that both deploys and retracts the blade." The PE-12000 does use a single spring mechanism for blade deployment and retraction. However, the PE-12000 also incorporates a manual safety override—a thumb-actuated switch that can prevent blade deployment or hold the blade in a retracted position regardless of the spring's state. The question is whether the presence of this manual safety override means the mechanism is not solely "spring-actuated" as required by the construction.

Solstice's argument is that the manual safety override constitutes an additional actuation mechanism, making the PE-12000's system a multi-actuator system rather than a single spring-actuated mechanism. Apex will counter that the safety override is merely a secondary control that does not alter the fundamental spring-actuated nature of the deployment and retraction mechanism. This is a closer call than the PE-5000 analysis and will likely require expert testimony to resolve.

The unfavorable construction of "blade deployment angle" (Term 7) is problematic for the PE-12000. Under the Court's broad construction—"the angle at which the blade achieves a cutting configuration relative to the longitudinal axis of the obturator"—the PE-12000's blade geometry likely meets this limitation. The PE-12000 deploys its blade at approximately 52° from the obturator axis, which falls outside the 15°–45° range described in the specification but is within the scope of the Court's construction, which is not limited to any specific angular range.

Similarly, the unfavorable construction of "substantially cylindrical obturator tip" (Term 9) includes tapered geometries with a generally cylindrical cross-section. The PE-12000 uses a tapered obturator tip that maintains a generally cylindrical cross-section, which falls within this broadened construction.

Overall Assessment: The non-infringement position for the PE-12000 on the '884 Patent is weaker than the PE-5000's position. Genuine factual disputes exist regarding the safety override issue, and the unfavorable constructions on Terms 7 and 9 eliminate arguments that would otherwise have been available. Summary judgment is unlikely to succeed.

3. Non-Infringement Position — '105 Patent (Claims 1, 4, 8)

The PE-12000's non-infringement position on the '105 Patent is mixed and will depend on technical evidence regarding the PE-12000's gas pathway architecture. The favorable construction of "insufflation port in fluid communication with the seal assembly" (Term 4) requires a "direct, dedicated fluid pathway" and excludes configurations where gas flows through an intermediary valve chamber. The PE-12000's gas pathway runs through a shared manifold but includes a direct bypass channel to the seal. Apex will argue that this bypass channel constitutes the required "direct, dedicated fluid pathway." Solstice can counter that the shared manifold constitutes an intermediary structure that the gas must traverse before reaching the bypass channel, but this argument is nuanced and will require detailed expert testimony regarding the gas flow dynamics within the PE-12000's housing.

The unfavorable construction of "integrated insufflation valve" (Term 8) is problematic. The PE-12000 uses co-located but separately manufactured valve components assembled within the trocar housing. Under the Court's construction—which requires only co-location within the trocar housing, not monolithic manufacture—the PE-12000's valve arrangement likely satisfies this limitation.

Overall Assessment: The non-infringement position for the PE-12000 on the '105 Patent presents some arguments, but they are fact-intensive and uncertain. Expert testimony will be critical to establishing the gas flow pathway and whether the bypass channel constitutes a "direct, dedicated fluid pathway" within the meaning of the Court's construction.

4. Invalidity Strategy for PE-12000–Related Claims

Given the weaker non-infringement position for the PE-12000, it is critical to strengthen the invalidity defense for the claims most likely to be asserted against this product. The prior art identified by Kendrick & Lau LLP and detailed in the Invalidity Contentions memorandum dated September 18, 2024 remains robust, particularly for Claims 1 and 2 of the '884 Patent under 35 U.S.C. § 102 (anticipation) and Claims 5 and 9 under 35 U.S.C. § 103 (obviousness).

Dr. Ostrowski's invalidity report, due January 27, 2025, should emphasize prior art combinations against the '884 Patent claims in light of the Court's constructions. The narrowed construction of "retractable blade deployment mechanism" (Term 2) focuses the anticipation analysis on prior art references that disclose a single spring-actuated mechanism that both deploys and retracts the blade. As discussed in Section V below, the prior art from Veridian Medical Technologies discloses precisely this mechanism.

For the '105 Patent, the Court's unfavorable construction of "integrated insufflation valve" (Term 8) actually enhances the invalidity defense. By broadening the claim to encompass co-located valve components regardless of manufacturing method, the Court has expanded the scope of the claim and, correspondingly, expanded the universe of prior art that could anticipate or render obvious the claimed invention. Multiple earlier trocar designs incorporated co-located insufflation valves within the trocar housing, and these designs now fall squarely within the claim scope under the Court's construction.

5. Recommendation. We do not recommend seeking summary judgment on the PE-12000 Series. The factual disputes regarding the rotational cam versus detent distinction, the safety override issue, and the gas flow pathway analysis make summary judgment impractical and risky. A denied motion could signal weakness to the Court and consume valuable resources.

Instead, we recommend the following approach for the PE-12000:

• Focus expert preparation on distinguishing the PE-12000's rotational cam from a "positive locking detent mechanism" and on characterizing the spring-actuation-plus-safety-override system as a multi-actuator system falling outside the claim construction.

• Develop compelling demonstrative exhibits contrasting the PE-12000's locking mechanism with the detent-based mechanism disclosed in the '237 Patent and contrasting the PE-12000's blade deployment system (with safety override) with the single spring-actuated mechanism of the '884 Patent.

• Bolster the invalidity case for the '884 and '105 Patent claims that are most relevant to the PE-12000. The invalidity defense should serve as a robust secondary defense in the event the jury finds infringement.

• Prepare strong damages-mitigation arguments to limit any damages award even if infringement is found.

C. PrecisionEdge™ PE-15000 Series (15 mm Trocar)

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

The PE-15000's non-infringement position on the '884 Patent is similar to the PE-12000's and faces many of the same challenges. Like the PE-12000, the PE-15000 uses a single spring mechanism for blade deployment and retraction but incorporates a manual safety override. The favorable construction of "retractable blade deployment mechanism" (Term 2) provides the same argument regarding the safety override, but this argument is a closer call than the PE-5000's dual-actuator defense and will require expert testimony.

The unfavorable construction of "blade deployment angle" (Term 7) is problematic for the PE-15000. The PE-15000's blade angle configuration falls within the Court's broadened construction, which encompasses any angle at which the blade achieves a cutting configuration. This eliminates a defense that would have been available under Solstice's narrower proposed construction.

Similarly, the unfavorable construction of "substantially cylindrical obturator tip" (Term 9) encompasses the PE-15000's conical-tapered tip. The PE-15000 uses a more pronounced taper than the PE-12000, but because the Court's construction includes "tapered geometries with a generally cylindrical cross-section," the PE-15000's tip likely falls within the claim scope. This is a setback for the defense.

The favorable construction of "proximal blade guard" (Term 5) provides a potential non-infringement argument specifically on Claim 14 of the '884 Patent. The PE-15000 incorporates a guard structure, but its circumferential extent must be precisely measured to determine whether it meets the 270° threshold required by the Court's construction. Preliminary engineering review suggests the PE-15000's guard extends approximately 240°–260° around the blade perimeter, which would fall short of the 270° requirement, but this must be confirmed through precise metrology and documented in expert testimony.

Overall Assessment: The PE-15000 has moderate non-infringement arguments on certain claims of the '884 Patent but is weakened by the unfavorable constructions on Terms 7 and 9. The safety override argument (Term 2) and the proximal blade guard argument (Term 5, Claim 14) are the strongest remaining defenses, but neither is likely to be dispositive at summary judgment.

2. Non-Infringement Position — '105 Patent (Claims 1, 4, 8)

The PE-15000's non-infringement position on the '105 Patent presents the strongest defense available for this product line. The favorable construction of "insufflation port in fluid communication with the seal assembly" (Term 4) is the centerpiece of this defense. The PE-15000's gas pathway includes a dedicated intermediary pressure-regulation chamber situated between the insufflation port and the seal assembly. Gas entering the insufflation port must first pass through this pressure-regulation chamber—where it is conditioned and metered before flowing to the seal—rather than traveling along a "direct, dedicated fluid pathway" from the port to the seal.

The Court's construction specifically excludes "configurations where gas flows through an intermediary valve chamber." The PE-15000's pressure-regulation chamber functions as an intermediary processing station, not a direct pathway. This places the PE-15000 potentially outside the scope of literal infringement for Claims 1, 4, and 8 of the '105 Patent. Apex may attempt to characterize the pressure-regulation chamber as something other than an "intermediary valve chamber," but the chamber's design and function—including its metering and conditioning of gas flow—are consistent with the excluded category.

However, the unfavorable construction of "integrated insufflation valve" (Term 8) partially counterbalances this defense. Like the PE-12000, the PE-15000 uses a co-located but separately manufactured insufflation valve. Under the Court's construction, this arrangement satisfies the "integrated" limitation. Accordingly, the PE-15000 meets at least this claim limitation.

Overall Assessment: The favorable Term 4 construction provides a meaningful and potentially strong defense for the PE-15000 on the '105 Patent. This argument may be sufficiently clear-cut to warrant a targeted partial summary judgment motion, though the risk of denial must be assessed. The unfavorable Term 8 construction is a counterweight but does not negate the Term 4 defense, as both limitations must be met for infringement.

3. Invalidity Strategy for PE-15000–Related Claims

The invalidity strategy for the PE-15000 largely parallels the approach for the PE-12000 on the '884 Patent claims. The same prior art references and the same analytical framework apply, as the PE-15000 is accused of infringing the same '884 Patent claims as the PE-12000.

For the '105 Patent, the broadened "integrated insufflation valve" construction (Term 8) is a significant development for the invalidity defense. By expanding the scope of "integrated" to include any co-located valve, the Court has effectively broadened the claims of the '105 Patent. This broader scope increases the universe of prior art that may anticipate or render obvious the claimed invention. In particular, earlier trocar designs—including those from Veridian Medical Technologies and others—that incorporated co-located insufflation valves but manufactured those valves separately from the housing now fall within the claim scope and may serve as anticipating or obviating references.

The subpoenaed documents from Veridian Medical Technologies, Inc. (subpoena issued September 12, 2024) include technical specifications and engineering drawings for Veridian's VeriPort™ 15 mm trocar system, which was commercially available as early as 2013. These documents are relevant to the '105 Patent invalidity analysis and should be foregrounded in Dr. Ostrowski's invalidity report and any trial presentation. The VeriPort™ system used a co-located insufflation valve with a direct fluid pathway to the seal, potentially anticipating multiple claims of the '105 Patent under the Court's constructions.

4. Recommendation. We do not recommend seeking summary judgment on the PE-15000 Series generally. The factual disputes on the '884 Patent claims are too significant for summary judgment, and a broad motion would likely be denied.

However, we should carefully evaluate whether a narrower partial summary judgment motion limited to the '105 Patent claims could succeed based on the favorable Term 4 construction and the PE-15000's intermediary pressure-regulation chamber. The advantage of such a motion is that it would, if granted, narrow the case at trial and eliminate the '105 Patent from the PE-15000 analysis. The risk is that a denial could undermine the defense's credibility on this issue at trial, and the factual characterization of the pressure-regulation chamber will be contested. We recommend deferring this decision until after expert reports are exchanged and we can assess the strength of Apex's counter-arguments.

For the trial, the PE-15000 strategy should prioritize the following:

• Lead with the "insufflation port" non-infringement argument under the favorable Term 4 construction for the '105 Patent. This is the strongest non-infringement argument available for the PE-15000 and should be presented prominently.

• Present invalidity as a secondary defense for both the '884 and '105 Patent claims, leveraging the broadened constructions to expand the prior art base.

• Pursue damages apportionment to minimize any damages award attributable to the PE-15000, emphasizing that the patented features—even if found to be infringed—represent only a small fraction of the overall value of the PE-15000 trocar system.

V. Impact on Invalidity Defenses

A. General Observations

The Markman ruling's impact on the invalidity defenses is somewhat paradoxical. Favorable claim constructions that narrow the claims are beneficial for non-infringement but can reduce the universe of invalidating prior art by requiring that the prior art disclose the narrower claim limitations. Conversely, unfavorable broader constructions that expand claim scope and hurt the non-infringement defense can actually enhance the invalidity defense by broadening the prior art that falls within the expanded claim scope.

In this case, the Court's broader constructions on Terms 6 (resilient sealing member), 7 (blade deployment angle), 8 (integrated insufflation valve), and 9 (substantially cylindrical obturator tip) may actually enhance our invalidity arguments under 35 U.S.C. §§ 102 and 103. Each of these broader constructions enlarges the scope of the corresponding claims, thereby increasing the number of prior art references that may anticipate or render obvious the claimed inventions. This effect is most pronounced for the '105 Patent, where the broadened "integrated insufflation valve" construction significantly expands the prior art landscape.

B. '237 Patent — Invalidity

The narrow "locking seal assembly" construction adopted by the Court (favorable Term 1) limits Claims 1, 3, 7, and 12 to a "mechanically actuated seal comprising at least two cooperating components with a positive locking detent mechanism." To anticipate or render obvious these claims, prior art must disclose this specific structural configuration—particularly the "positive locking detent mechanism."

The prior art references identified in the prosecution history analysis (memorandum prepared by Kendrick & Lau LLP, dated September 5, 2024) include three references that are relevant to this narrower construction:

(a) U.S. Patent No. 8,241,307 (Forester), which discloses a trocar seal assembly with a detent-based locking mechanism comprising two cooperating seal components;

(b) U.S. Published Application No. 2012/0046692 (Marchetti), which discloses a multi-component access device seal with a spring-loaded ball detent for positional locking; and

(c) U.S. Published Application No. 2014/0094821 (Yamada), which discloses a laparoscopic seal assembly with a detent ring that engages a corresponding groove to lock the seal in position.

Dr. Ostrowski should assess whether these references, individually or in combination, disclose all elements of Claims 1, 3, 7, and 12 as construed by the Court. Our preliminary assessment is that the Forester patent likely anticipates Claims 1 and 3 under the narrower construction, as it discloses the multi-component seal with a positive locking detent. However, the case is tighter under the narrower construction than it would have been under a broader construction, and Apex will argue that the references fail to disclose one or more elements. Dr. Ostrowski's report should address these arguments in detail.

C. '884 Patent — Invalidity

The invalidity case for the '884 Patent remains robust after the Markman ruling, and the mix of favorable and unfavorable constructions creates a balanced landscape for the invalidity defense.

The favorable construction of "retractable blade deployment mechanism" (Term 2) narrows the claims to a "single spring-actuated mechanism that both deploys and retracts the blade." This narrowing requires that the anticipating prior art disclose a single spring performing both functions. The prior art from Veridian Medical Technologies is critical here: Veridian's U.S. Published Application No. 2014/0171973 (filed June 2014, published December 2014) discloses a trocar obturator with a single bidirectional spring that both deploys and retracts the cutting blade. This reference predates the '884 Patent's priority date and discloses the precise mechanism required by the Court's construction.

The unfavorable construction of "blade deployment angle" (Term 7) broadens the claim scope to encompass any angle at which the blade achieves a cutting configuration. This broader scope means that prior art references disclosing blade deployment at any functional angle—not just within the 15°–45° range of the specification—can satisfy this limitation. This makes it easier to identify anticipating prior art, as there is a wider range of prior art blade geometries that meet this element.

Similarly, the unfavorable construction of "substantially cylindrical obturator tip" (Term 9) includes tapered geometries with a generally cylindrical cross-section. This broadening means that prior art references with tapered obturator tips—which are common in the trocar art—can satisfy this claim limitation. This further expands the prior art base available for anticipation and obviousness arguments.

Overall Assessment: The invalidity case for the '884 Patent remains strong. The narrowed "retractable blade deployment mechanism" construction is met by the Veridian prior art, and the broadened constructions on Terms 7 and 9 expand the universe of available prior art. Dr. Ostrowski's invalidity report should present a comprehensive anticipation analysis for Claims 1 and 2 (under § 102) and an obviousness analysis for Claims 5 and 9 (under § 103), incorporating the Court's constructions.

D. '105 Patent — Invalidity

The invalidity position for the '105 Patent may have actually improved as a result of the Markman ruling. The favorable construction of "insufflation port in fluid communication with the seal assembly" (Term 4) narrows the claims to require a "direct, dedicated fluid pathway" and excludes intermediary valve chamber configurations. This narrowing does not significantly undermine the invalidity defense, because the prior art references identified by Kendrick & Lau LLP include several designs that use direct fluid pathways from the insufflation port to the seal without intermediary chambers. These references satisfy the narrower construction.

More significantly, the unfavorable construction of "integrated insufflation valve" (Term 8) substantially broadens the claim scope by requiring only co-location within the trocar housing rather than monolithic manufacture. This broadening is a major development for the invalidity defense. Multiple prior art trocar designs incorporated co-located insufflation valves that were separately manufactured but assembled within the trocar housing. Under the Court's construction, these designs now fall within the scope of the '105 Patent claims and may anticipate or render obvious the claimed invention. The prior art landscape for the '105 Patent has effectively been enlarged by this construction.

Overall Assessment: The invalidity position for the '105 Patent is likely stronger after the Markman ruling. The broadened "integrated insufflation valve" construction substantially expands the prior art base, potentially making it easier to establish anticipation or obviousness. Dr. Ostrowski's report should capitalize on this broadening.

E. Inequitable Conduct Counterclaim

The Claim Construction Order also has implications for Solstice's inequitable conduct counterclaim. During prosecution of the '237 Patent, Dr. Szabo and Apex's prosecution counsel made narrowing amendments and arguments to distinguish prior art, emphasizing the detent-based locking mechanism as a novel feature. These narrowing amendments were identified and documented in the prosecution history analysis memorandum prepared by Kendrick & Lau LLP. The Court's adoption of a narrow "locking seal assembly" construction (Term 1) is consistent with these narrowing amendments and may provide additional support for prosecution history estoppel arguments.

However, the inequitable conduct theory rests on more specific allegations—namely, that Apex's prosecution counsel failed to disclose material prior art references during prosecution. The materiality of the undisclosed references must be reassessed in light of the claim constructions. If the claims are now construed narrowly, the undisclosed prior art must be material under the narrower constructions. Our preliminary assessment is that the undisclosed references remain material even under the narrower constructions, but this analysis should be updated in coordination with Dr. Kendrick at Kendrick & Lau LLP.

We recommend continuing to develop the inequitable conduct theory as a defense and as potential leverage in settlement discussions, while assessing whether the Markman constructions strengthen or weaken the materiality element.

VI. Impact on Damages Exposure

A. Revised Damages Framework

Apex's damages expert, Hugh Danaher of Keystone Valuation Advisors LLC, has previewed a reasonable royalty damages claim of $31.8 million in his damages contentions, with his full expert report expected to be served on or about February 14, 2025. This figure is based on the full accused product sales base of $74.6 million (2021 through Q3 2024, with projections through trial) and an asserted royalty rate that has not yet been finalized but is expected to be in the range of 15–20% of net sales.

The Markman ruling has significant implications for the damages framework. If the PE-5000 Series is excluded from the case via summary judgment, the damages base is reduced. Based on our product mix analysis, the PE-5000 accounts for approximately 30–35% of total accused product sales. Depending on the precise product mix in each year, this translates to an estimated reduction of $22–26 million from the accused sales base.

The remaining accused sales attributable to the PE-12000 and PE-15000 Series are estimated at $48–52 million for the 2021–2024 period. Applying the weighted average gross margin of 61.3% to this reduced base, the maximum lost profits exposure (if Apex were to pursue a lost profits theory, which it has not indicated) would be approximately $29–32 million. Under a reasonable royalty theory, the reduced base would support a maximum royalty exposure in the range of $7–10 million at the asserted 15–20% royalty rate, though this figure may be further reduced through apportionment and other damages-limiting arguments.

Dr. Elena Marchetti of Pinnacle Economics Group LLC should recalibrate her Georgia-Pacific analysis in light of the Markman ruling. The claim constructions affect several Georgia-Pacific factors, including Factor 13 (the portion of the realizable profit attributable to the patent) and Factor 6 (the effect of the patented invention in promoting sales of other products). The narrowing of the claims to specific subcomponents (the locking detent mechanism, the single-spring blade deployment system) supports the argument that the patented features contribute only a fraction of the overall product value.

B. Apportionment

The favorable claim constructions narrowing the patented features to specific, discrete subcomponents provide strong support for apportionment arguments. The "locking seal assembly" construction (Term 1) limits the patented feature to a specific positive locking detent mechanism—one subcomponent within a complex multi-component trocar system. Similarly, the "retractable blade deployment mechanism" construction (Term 2) limits the patented feature to a single spring-actuated deployment/retraction mechanism. These are specific mechanical subcomponents, not the entire trocar or even the entire seal or blade assembly.

Under VirnetX, Inc. v. Sterling Reach Holdings, 767 F.3d 1308 (Fed. Cir. 2014), and Uniloc USA, Inc. v. Kestrel Partners LLC, 632 F.3d 1292 (Fed. Cir. 2011), the royalty base must be apportioned to the smallest salable patent-practicing unit unless the entire product embodies the patented technology. Here, the patented features—as construed by the Court—are clearly subcomponents of a larger, multi-component device. The entire trocar assembly is not the smallest salable patent-practicing unit.

Dr. Marchetti's damages report, due February 14, 2025, should emphasize that the licensed technology, as defined by the Court's constructions, constitutes a small fraction of the overall product value. The PrecisionEdge™ trocar assemblies contain dozens of individually designed and manufactured components, including the cannula tube, housing, obturator, handle assembly, insufflation system, seal system, blade mechanism, safety features, and ergonomic grip—only a few of which are implicated by the narrowly construed patent claims. A reasonable royalty must be apportioned to reflect this reality.

C. Revised Settlement Valuation Implications

The Markman ruling's impact on patent strength and damages exposure should be reflected in any updated patent valuation and settlement analysis. We previously retained Dr. Arthur Gaines of Ridgeline IP Analytics LLC to perform a confidential patent portfolio valuation for Solstice. That valuation, completed prior to the Markman ruling, assessed the strength and enforceability of the three asserted patents and the risk-adjusted damages exposure. In light of the Claim Construction Order, Dr. Gaines's valuation should be updated to reflect the narrowed claim scope, the reduced accused product base (assuming PE-5000 exclusion), and the strengthened invalidity arguments.

The revised risk-adjusted damages exposure, once calculated, should be used to inform any future settlement discussions. As discussed in Section IX below, we recommend deferring substantive settlement discussions until after the PE-5000 summary judgment motion is decided, but the preliminary valuation update should be completed in advance of the March 17, 2025 mediation.

VII. Expert discovery Preparation

A. Dr. Miriam Ostrowski — Invalidity / Claim Construction Expert

Dr. Ostrowski's opening expert report is due January 27, 2025—forty-seven days from the date of this memorandum. Her report must incorporate the Court's claim constructions into the invalidity analysis. Key areas for her attention include:

(a) '237 Patent Anticipation Analysis: Adapt the anticipation analysis to account for the narrower "locking seal assembly" construction. Confirm that the identified prior art references (Forester, Marchetti, Yamada) disclose all elements of Claims 1, 3, 7, and 12 under the Court's constructions, including the "positive locking detent mechanism" requirement.

(b) '884 Patent Anticipation/Obviousness Analysis: Confirm that the Veridian prior art discloses the "single spring-actuated mechanism that both deploys and retracts the blade" required by the Term 2 construction. Capitalize on the broadened Term 7 ("blade deployment angle") and Term 9 ("substantially cylindrical obturator tip") constructions to identify additional anticipating or obviating references.

PRIVILEGED AND CONFIDENTIAL — ATTORNEY WORK PRODUCT This memorandum is protected by the attorney-client privilege and the work product doctrine. It contains confidential legal analysis prepared in anticipation of litigation. Do not copy, distribute, or disclose to any person outside the firm without express partner authorization.
MEMORANDUM
TO: Marcus Delgado, Responsible Partner, intellectual Property
FROM: Christy Bauer, Lead Associate, intellectual Property Peter Vassiliev, Working Associate, intellectual Property
DATE: December 10, 2024
RE: Post-Markman Strategy Assessment — Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA (D. Del.)
MATTER NO.: 10294.0017
CLIENT: Solstice Biomedical Devices Ltd. / Solstice Biomedical, Inc.
CC: Catherine Bloom, Billing Partner
I. Executive Summary
The purpose of this memorandum is to analyze the Claim Construction Order issued on December 6, 2024 by Chief Judge Richard G. Andrews of the United States District Court for the District of Delaware and to assess its impact on the defense strategy for all three accused PrecisionEdge™ product lines. This analysis draws on the proceedings to date—including Solstice's individual Claim Construction Brief (filed October 28, 2024), the Joint Claim Construction Brief (filed November 4, 2024), and the Markman Hearing (held November 18, 2024)—and is intended to inform strategic decision-making for the remainder of this litigation.
In its Claim Construction Order, the Court construed nine disputed claim terms spanning three asserted patents: 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"). Of these nine constructions, five were favorable to Solstice and four were favorable to Apex. Although the numerical split is nearly even, the practical consequences are asymmetric across the three accused product lines.
Our net assessment is as follows:
• PE-5000 Series: The Markman ruling materially strengthens the non-infringement position. Two of the most favorable constructions—"locking seal assembly" and "retractable blade deployment mechanism"—are likely dispositive of infringement as to this product line. We recommend pursuing summary judgment of non-infringement.
• PE-12000 Series: The Markman ruling creates a mixed picture. While certain favorable constructions provide non-infringement arguments, the fact-intensive nature of the PE-12000's design features—particularly its rotational cam locking mechanism and spring-actuated blade with manual safety override—will likely preclude summary judgment. Several unfavorable constructions (Terms 6, 7, 8, and 9) weaken particular defense arguments. The invalidity defense and damages-mitigation strategy should be bolstered for this product line.
• PE-15000 Series: The Markman ruling modestly weakens the overall defense posture. While the favorable construction of "insufflation port in fluid communication with the seal assembly" (Term 4) provides a meaningful defense on the '105 Patent, the broadened constructions on blade deployment angle, integrated insufflation valve, and substantially cylindrical obturator tip erode non-infringement positions on other claims.
Based on this analysis, we recommend the following actions: (1) pursue summary judgment of non-infringement on the PE-5000 Series as to both the '237 and '884 Patents, with a target filing date of early April 2025; (2) refine and strengthen the invalidity strategy for the '884 and '105 Patents, capitalizing on the broader constructions that expand the universe of invalidating prior art; (3) prepare robust trial presentations for the PE-12000 and PE-15000 Series, emphasizing non-infringement distinctions and invalidity as a secondary defense; and (4) recalibrate the settlement posture in light of the improved litigation position, with a recommendation to defer substantive settlement discussions until after the PE-5000 summary judgment motion is decided to maximize leverage heading into the March 17, 2025 mediation.
Each of these recommendations is discussed in detail below.
II. Background
A. The Asserted Patents
Apex Surgical Innovations, Inc. ("Apex") asserts three patents in this action, all of which relate to surgical trocar technology used in minimally invasive laparoscopic procedures. The named inventor on all three patents is Dr. Raymond Szabo, Vice President of Engineering at Apex. All three patents are assigned to Apex. The patent family to which these three patents belong includes fourteen total issued U.S. patents and six pending continuation applications.
U.S. Patent No. 9,814,237 ("the '237 Patent") is entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device." It was issued on November 14, 2017, and expires on June 22, 2035. The '237 Patent generally discloses and claims a multi-component seal assembly for a surgical trocar that incorporates a locking mechanism to maintain the seal in a fixed position during a surgical procedure, thereby preventing inadvertent displacement and gas leakage. Apex asserts Claims 1, 3, 7, and 12 of the '237 Patent against Solstice's products.
U.S. Patent No. 10,271,884 ("the '884 Patent") is entitled "Retractable Blade Deployment Mechanism for Trocar Systems." It was issued on April 30, 2019, and expires on September 15, 2036. The '884 Patent generally discloses and claims a mechanism for deploying and retracting an obturator blade within a trocar assembly, with specific focus on a spring-actuated system that controls blade movement for tissue penetration. The '884 Patent is the most broadly asserted of the three patents, with Apex asserting Claims 1, 2, 5, 9, and 14 against various Solstice product lines.
U.S. Patent No. 10,932,105 ("the '105 Patent") is entitled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar." It was issued on March 2, 2021, and expires on January 10, 2038. The '105 Patent generally discloses and claims a trocar design that integrates an insufflation valve with the seal assembly, allowing for continuous gas flow management during laparoscopic surgery. Apex asserts Claims 1, 4, and 8 of the '105 Patent.
B. The Accused Products
Apex accuses three product lines within Solstice's PrecisionEdge™ family of trocar assemblies:
PrecisionEdge™ PE-5000 Series is a 5 mm trocar assembly designed for smaller-diameter laparoscopic access. The PE-5000 is accused of infringing the '237 Patent (Claims 1, 3, 7, 12) and the '884 Patent (Claims 1, 2, 5, 9, 14). This product line is the smallest-diameter device in the PrecisionEdge™ family and uses a friction-fit single-component seal and a dual-actuator blade deployment system that are architecturally distinct from the mechanisms described in the asserted patents.
PrecisionEdge™ PE-12000 Series is a 12 mm trocar assembly designed for standard laparoscopic access and is the most widely sold product in the PrecisionEdge™ family. The PE-12000 is accused of infringing all three patents: the '237 Patent (Claims 1, 3, 7, 12), the '884 Patent (Claims 1, 2, 5, 9, 14), and the '105 Patent (Claims 1, 4, 8). The PE-12000 uses a two-component seal with a rotational cam locking mechanism, a single spring-actuated blade with a manual safety override, and a co-located but separately manufactured insufflation valve.
PrecisionEdge™ PE-15000 Series is a 15 mm trocar assembly designed for larger-diameter access used in procedures requiring extraction of tissue specimens. The PE-15000 is accused of infringing the '884 Patent (Claims 1, 2, 5, 9, 14) and the '105 Patent (Claims 1, 4, 8). The PE-15000 features a conical-tapered obturator tip, a single spring-actuated blade with manual safety override, and a gas pathway that includes a dedicated intermediary pressure-regulation chamber.
Combined U.S. sales of the three accused product lines for calendar years 2021 through the third quarter of 2024 total approximately $74.6 million, broken down as follows:
The weighted average gross margin across the three product lines is 61.3%.
C. Procedural Posture
The current procedural posture of the case is as follows:
• May 9, 2024: Apex filed its Complaint alleging patent infringement of the '237, '884, and '105 Patents.
• June 14, 2024: Solstice filed its Answer, Affirmative Defenses, and Counterclaims, asserting defenses of non-infringement, invalidity under 35 U.S.C. §§ 102 and 103, and inequitable conduct.
• October 22, 2024: The parties exchanged Proposed Claim Constructions and identified nine disputed terms for resolution.
• October 28, 2024: Solstice filed its individual Claim Construction Brief.
• November 4, 2024: The Joint Claim Construction Brief was filed.
• November 18, 2024: The Markman Hearing was held before Chief Judge Andrews.
• December 6, 2024: The Court issued its Claim Construction Order, construing all nine disputed terms.
• January 13, 2025: Expert discovery opens.
• January 27, 2025: Defendant's opening expert reports due (invalidity/claim construction).
• February 10, 2025 (estimated): Plaintiff's infringement expert report expected.
• February 14, 2025: Damages expert reports due for both sides.
• March 3, 2025: Rebuttal expert reports due.
• September 30, 2025: Trial.
Plaintiff's counsel is Victoria Stanton of Hargrove, Tate & Bennington LLP. Apex's retained experts include Dr. Calvin Ng of the Veltrano Polytechnic Institute (infringement and claim construction) and Hugh Danaher, CFA, of Keystone Valuation Advisors LLC (damages).
Defendant's experts include Dr. Miriam Ostrowski of Halford University (invalidity and claim construction) and Dr. Elena Marchetti of Pinnacle Economics Group LLC (damages). Patent prosecution counsel Kendrick & Lau LLP, led by Dr. Jonathan Kendrick, has previously provided prosecution history analysis and prior art searches supporting the defense. Their work product is referenced throughout this memorandum.
III. Summary of the Claim Construction Order
A. Overview of the Nine Disputed Terms
The Court's December 6, 2024 Order addressed all nine claim terms that the parties identified as disputed. The following table summarizes each disputed term, the patent and claims in which it appears, each party's proposed construction, the Court's adopted construction, and our assessment of which party the construction favors.
As the table reflects, the Court adopted constructions substantially tracking Solstice's proposals on five terms (Terms 1 through 5) and constructions substantially tracking Apex's proposals on four terms (Terms 6 through 9). The practical significance of these constructions varies considerably by accused product, as discussed in detail in Sections IV and V below.
B. Terms Construed Favorably to Solstice (5 Terms)
Term 1: "Locking Seal Assembly" ('237 Patent, Claims 1, 3, 7, 12)
This term appeared in every asserted claim of the '237 Patent and was the most heavily briefed term in the Joint Claim Construction Brief. Solstice proposed a narrow construction requiring a "mechanically actuated multi-component seal with a discrete locking detent"—a construction grounded in the patent specification's repeated and exclusive description of a detent-based locking mechanism. Apex, by contrast, proposed a broad construction encompassing "any seal mechanism that prevents fluid leakage and maintains position," which would have swept in virtually every trocar seal on the market.
The Court adopted a construction closely tracking Solstice's proposal, defining the term as "a mechanically actuated seal comprising at least two cooperating components with a positive locking detent mechanism." In reaching this construction, the Court relied heavily on the specification's repeated description of the detent mechanism as the "essence of the invention" and on the prosecution history, in which Apex's patent counsel distinguished prior art by emphasizing the presence of the detent. The Court specifically rejected Apex's argument that "locking" could refer to any friction-based retention, noting that such a reading would render the "locking" limitation superfluous.
Significance: This construction has substantial implications for the PE-5000 Series defense. The PE-5000 uses a friction-fit single-component seal without any discrete detent. Under the Court's construction, the PE-5000's seal clearly lacks both the "at least two cooperating components" and the "positive locking detent mechanism" required by the claim. For the PE-12000, the analysis is more nuanced: the PE-12000 uses a two-component seal, satisfying the first prong, but its locking mechanism is a rotational cam rather than a "positive locking detent." Whether a rotational cam constitutes or is equivalent to a "positive locking detent" will be a fact-intensive inquiry—one that may not be resolvable at summary judgment but provides a meaningful defense at trial.
Term 2: "Retractable Blade Deployment Mechanism" ('884 Patent, Claims 1, 2, 5, 9, 14)
This term was the second most heavily contested term and is critical to the infringement analysis across all three product lines. Solstice proposed a construction requiring "a spring-loaded blade that both deploys and retracts via the same spring actuation," emphasizing the specification's detailed description of a single bidirectional spring that serves both the deployment and retraction functions. Apex proposed a construction covering "any mechanism that moves a blade between deployed and retracted positions," which would encompass virtually any retractable blade system regardless of the actuation method.
The Court adopted Solstice's construction, defining the term as "a single spring-actuated mechanism that both deploys and retracts the blade." The Court found that the specification described the single-spring design as the disclosed embodiment and that the claims, read in light of the specification, required this structural feature. The Court noted that the prosecution history was consistent with this reading, as the applicant had distinguished prior art dual-actuator systems during prosecution.
Significance: This construction is potentially dispositive for the PE-5000 Series. The PE-5000 employs a dual-actuator system with a separate deployment spring and retraction cam—two distinct mechanisms performing two distinct functions. This system does not meet the "single spring-actuated mechanism that both deploys and retracts the blade" construction. For the PE-12000 and PE-15000, the analysis is closer: both products use a single spring mechanism, but each also incorporates a manual safety override. The question whether the presence of a manual safety override means the mechanism is not solely "spring-actuated" will require expert testimony and fact development.
Term 3: "Cannula Housing" ('237 Patent, Claim 7; '884 Patent, Claim 9)
The Court adopted Solstice's construction limiting "cannula housing" to "a unitary molded structure forming the outer housing of the cannula assembly." Apex had urged a broader construction that would encompass any outer structural component, whether unitary or assembled from multiple parts. The Court found that the specification consistently described the cannula housing as a unitary molded structure and that the use of "housing" (singular) in the claims supported a unitary reading. The Court also noted that Claim 7 of the '237 Patent distinguishes between the "cannula housing" and other structural components, suggesting that the housing is a single piece.
Significance: This construction helps the PE-5000 defense, as the PE-5000 uses a multi-part assembled housing rather than a unitary molded structure, thereby falling outside this limitation in Claim 7 of the '237 Patent and Claim 9 of the '884 Patent. The PE-12000, however, uses a unitary molded housing, so this construction does not assist the defense as to that product.
Term 4: "Insufflation Port in Fluid Communication with the Seal Assembly" ('105 Patent, Claims 1, 4, 8)
The Court adopted a construction requiring "a direct, dedicated fluid pathway between the insufflation port and the seal assembly, excluding configurations where gas flows through an intermediary valve chamber." This construction closely tracked Solstice's proposal. Apex had argued for a broader reading encompassing any fluid pathway—direct or indirect—connecting the insufflation port and the seal. The Court's analysis relied on the claim language's use of "in fluid communication with the seal assembly," which the Court found, in light of the specification, to require a direct connection rather than a pathway mediated through additional chambers or valves.
Significance: This construction is important for the PE-15000 defense. The PE-15000's gas pathway includes an intermediary pressure-regulation chamber situated between the insufflation port and the seal assembly. Under the Court's construction, this intermediary chamber may place the PE-15000 outside the scope of literal infringement of the '105 Patent Claims 1, 4, and 8. The PE-12000 presents a closer question: its gas pathway runs through a shared manifold but includes a direct bypass channel to the seal, which Apex will likely argue constitutes the required "direct, dedicated fluid pathway."
Term 5: "Proximal Blade Guard" ('884 Patent, Claim 14)
The Court adopted Solstice's narrower construction, defining "proximal blade guard" as "a rigid shield structure fixedly positioned proximal to the blade cutting edge that extends circumferentially around at least 270° of the blade perimeter." Apex had proposed a much broader construction encompassing "any structure proximal to the blade that provides a guarding function."
Significance: This construction provides a non-infringement argument for both the PE-5000 and PE-15000 as to Claim 14 of the '884 Patent. The PE-5000's guard structure does not extend circumferentially around 270° of the blade perimeter, and the PE-15000 incorporates a guard structure that may also fall short of this dimensional requirement, though further measurement and expert analysis will be needed to confirm. For the PE-12000, the guard structure's circumferential extent will need to be precisely assessed.
C. Terms Construed Favorably to Apex (4 Terms)
Term 6: "Resilient Sealing Member" ('237 Patent, Claims 1, 12)
Apex proposed a broad construction, and the Court adopted a broader reading, defining the term as "an elastomeric or deformable component that provides a sealing function, regardless of specific material composition." Solstice had argued for a narrower construction limited to the specific class of thermoplastic elastomers described in the specification, but the Court found that the specification's reference to thermoplastic elastomers was exemplary rather than limiting.
Significance: This construction weakens Solstice's argument that the PE-12000's silicone-based seal element is materially distinguishable from the patent's described "resilient sealing member." Under the broad construction, the PE-12000's silicone seal—and indeed any elastomeric or deformable sealing component—would satisfy this limitation. This does not independently establish infringement, as the other claim limitations must still be met, but it eliminates one line of defense that Solstice had advanced.
Term 7: "Blade Deployment Angle" ('884 Patent, Claims 1, 2)
The Court rejected Solstice's proposal to limit "blade deployment angle" to the 15°–45° angular range described in the specification. Instead, the Court adopted Apex's construction, defining the term as "the angle at which the blade achieves a cutting configuration relative to the longitudinal axis of the obturator." The Court found that the specification's recitation of a specific angular range was illustrative and that the claims did not incorporate numerical range limitations.
Significance: This construction broadens the infringement read on the PE-12000 and PE-15000 blade geometries. Both products deploy their blades at angles outside the 15°–45° range described in the specification but within the Court's broader construction (which encompasses any angle at which the blade achieves a cutting configuration). This eliminates what would have been a strong non-infringement argument for both product lines on Claims 1 and 2 of the '884 Patent.
Term 8: "Integrated Insufflation Valve" ('105 Patent, Claims 1, 4)
The Court adopted Apex's construction, holding that "integrated" requires only "co-location within the trocar housing" and does not require monolithic manufacture. Solstice had argued that "integrated" should be construed to require that the insufflation valve be monolithically manufactured as a single piece with the trocar housing, which would have excluded the PE-12000 and PE-15000 (both of which use separately manufactured but co-located valve components).
Significance: This construction substantially weakens Solstice's design-around argument for the PE-12000 and PE-15000. Both products use insufflation valves that are separately manufactured but assembled into and co-located within the trocar housing. Under the Court's construction, this co-location satisfies the "integrated" limitation, meaning both products likely meet this claim element.
Term 9: "Substantially Cylindrical Obturator Tip" ('884 Patent, Claim 5)
The Court adopted Apex's broader construction, holding that "substantially cylindrical" includes "tapered geometries with a generally cylindrical cross-section." Solstice had argued for a uniform cylindrical cross-section without taper, but the Court found that the modifier "substantially" accommodated minor deviations from a perfect cylinder, including tapers.
Significance: This construction adversely impacts the PE-12000 and PE-15000, both of which use tapered obturator tips. Under the Court's construction, these tapered tips likely fall within the scope of Claim 5 of the '884 Patent, eliminating what would have been a geometric non-infringement argument.
IV. Impact Analysis by Accused Product Line
A. PrecisionEdge™ PE-5000 Series (5 mm Trocar)
1. Non-Infringement Position — '237 Patent (Claims 1, 3, 7, 12)
The Claim Construction Order materially strengthens the non-infringement position for the PE-5000 Series as to the '237 Patent. The Court's favorable construction of "locking seal assembly" (Term 1) is the cornerstone of this position. As construed, the term requires "a mechanically actuated seal comprising at least two cooperating components with a positive locking detent mechanism." The PE-5000 uses a single-component friction-fit seal without any discrete detent mechanism. The PE-5000's seal assembly therefore fails to meet two independent requirements of the construction: (a) it does not comprise "at least two cooperating components," and (b) it does not include a "positive locking detent mechanism."
The favorable construction of "cannula housing" (Term 3) further supports non-infringement of Claim 7 of the '237 Patent. The PE-5000 uses a multi-part assembled housing, not the unitary molded structure required by the Court's construction. This independently defeats infringement of Claim 7.
Although the Court's unfavorable construction of "resilient sealing member" (Term 6) broadened this limitation to encompass any elastomeric or deformable component regardless of material composition, this broader reading does not overcome the dispositive gap created by the "locking seal assembly" construction. Even if the PE-5000's sealing component satisfies the "resilient sealing member" limitation, the PE-5000 still lacks the multi-component structure and the positive locking detent required by the independent claims. The unfavorable construction of Term 6 is therefore immaterial to the PE-5000 analysis.
Overall Assessment: The non-infringement position for the PE-5000 as to the '237 Patent is strong and is likely suitable for resolution on summary judgment.
2. Non-Infringement Position — '884 Patent (Claims 1, 2, 5, 9, 14)
The non-infringement position for the PE-5000 as to the '884 Patent is even stronger. The Court's favorable construction of "retractable blade deployment mechanism" (Term 2) is dispositive for most, if not all, asserted claims. The PE-5000 employs a dual-actuator system in which a separate deployment spring advances the blade to a cutting position and a separate retraction cam withdraws the blade after tissue penetration. This is fundamentally different from the "single spring-actuated mechanism that both deploys and retracts the blade" required by the Court's construction. The two separate mechanical components in the PE-5000 perform two separate functions; there is no single spring that serves both deployment and retraction. This distinction is clear from the product's engineering drawings, bill of materials, and functional testing data, all of which are already in the record.
The favorable construction of "proximal blade guard" (Term 5) further supports non-infringement of Claim 14 specifically. The PE-5000's guard structure is a partial shield that does not extend circumferentially around 270° of the blade perimeter. Under the Court's construction requiring such circumferential extent, the PE-5000 does not practice this limitation.
The unfavorable constructions of "blade deployment angle" (Term 7) and "substantially cylindrical obturator tip" (Term 9) are less material to the PE-5000 analysis because the favorable constructions on Terms 2 and 5 are likely dispositive. Even if the PE-5000's blade angle and obturator tip geometry fall within the broader constructions adopted by the Court, the PE-5000 still does not meet the "retractable blade deployment mechanism" limitation of the independent claims. Since the independent claims must be satisfied before any dependent claim can be infringed, the favorable Term 2 construction effectively resolves the '884 Patent infringement question for the PE-5000.
Overall Assessment: The non-infringement position for the PE-5000 as to the '884 Patent is very strong and is well-suited for summary judgment.
3. Recommendation. We recommend that Solstice move for summary judgment of non-infringement on the PE-5000 Series as to both the '237 Patent and the '884 Patent. The target filing date should be early April 2025, after the close of expert reports and rebuttal reports, which will allow us to incorporate and rely on Dr. Ostrowski's expert opinions and to address any arguments raised by Dr. Ng in his infringement report.
If granted, a summary judgment ruling excluding the PE-5000 Series would remove from the damages base the PE-5000's $12.1 million in 2021 sales plus allocated portions of 2022–2024 sales. Based on our product mix analysis, the PE-5000 accounts for approximately 30–35% of total accused product sales. Eliminating this product from the case would substantially reduce Solstice's damages exposure and simplify the trial.
We should coordinate with Dr. Ostrowski promptly to obtain a supporting declaration for the summary judgment motion. Dr. Ostrowski's declaration should opine on the structural and functional differences between the PE-5000's single-component friction-fit seal and dual-actuator blade system, on the one hand, and the '237 Patent's "locking seal assembly" and the '884 Patent's "retractable blade deployment mechanism" as construed by the Court, on the other. Engineering drawings, component specifications, and testing data for the PE-5000 should be compiled and attached as exhibits.
B. PrecisionEdge™ PE-12000 Series (12 mm Trocar)
1. Non-Infringement Position — '237 Patent (Claims 1, 3, 7, 12)
The PE-12000's non-infringement position as to the '237 Patent is mixed. The Court's favorable construction of "locking seal assembly" (Term 1) provides a basis for argument, but the outcome is less clear-cut than for the PE-5000. The PE-12000 uses a two-component seal, which satisfies the "at least two cooperating components" requirement. However, the PE-12000's locking mechanism is a rotational cam rather than a "positive locking detent." The rotational cam engages and locks the two seal components in position by rotating a collar that compresses the seal against the cannula wall. This is mechanically distinct from a detent mechanism, which typically involves a spring-loaded ball, pin, or projection that snaps into a corresponding recess to hold a component in a fixed position.
The question whether a rotational cam constitutes or is equivalent to a "positive locking detent mechanism" is fact-intensive and may depend on expert testimony regarding the structural and functional differences between cam-based and detent-based locking mechanisms. While we believe the better reading distinguishes the PE-12000's rotational cam from the claimed detent, Apex will argue that the cam performs the same locking function and that the distinction is one of semantics rather than substance. This argument is not frivolous, and a reasonable fact-finder could potentially credit it.
The unfavorable construction of "resilient sealing member" (Term 6) further weakens the PE-12000 defense on the '237 Patent. The PE-12000 uses a silicone-based seal element that clearly falls within the Court's broad construction of "an elastomeric or deformable component that provides a sealing function, regardless of specific material composition." Solstice's argument that the PE-12000's silicone seal is materially distinguishable from the patent's described resilient sealing member is no longer viable under this construction.
The favorable construction of "cannula housing" (Term 3) does not assist the PE-12000 defense on Claim 7, because the PE-12000 actually uses a unitary molded housing. The PE-12000's housing is injection-molded as a single piece, which falls squarely within the Court's construction. This limitation is met.
Overall Assessment: The non-infringement position for the PE-12000 on the '237 Patent is arguable but fact-intensive. The rotational cam versus detent distinction is the critical defense argument, but it is unlikely to be resolved at summary judgment. Trial presentation must effectively demonstrate to the jury the mechanical differences between a rotational cam and a positive locking detent, using physical models, animations, and expert testimony.
2. Non-Infringement Position — '884 Patent (Claims 1, 2, 5, 9, 14)
The PE-12000's non-infringement position on the '884 Patent is weaker than the PE-5000's but still presents legitimate arguments. The favorable construction of "retractable blade deployment mechanism" (Term 2) requires "a single spring-actuated mechanism that both deploys and retracts the blade." The PE-12000 does use a single spring mechanism for blade deployment and retraction. However, the PE-12000 also incorporates a manual safety override—a thumb-actuated switch that can prevent blade deployment or hold the blade in a retracted position regardless of the spring's state. The question is whether the presence of this manual safety override means the mechanism is not solely "spring-actuated" as required by the construction.
Solstice's argument is that the manual safety override constitutes an additional actuation mechanism, making the PE-12000's system a multi-actuator system rather than a single spring-actuated mechanism. Apex will counter that the safety override is merely a secondary control that does not alter the fundamental spring-actuated nature of the deployment and retraction mechanism. This is a closer call than the PE-5000 analysis and will likely require expert testimony to resolve.
The unfavorable construction of "blade deployment angle" (Term 7) is problematic for the PE-12000. Under the Court's broad construction—"the angle at which the blade achieves a cutting configuration relative to the longitudinal axis of the obturator"—the PE-12000's blade geometry likely meets this limitation. The PE-12000 deploys its blade at approximately 52° from the obturator axis, which falls outside the 15°–45° range described in the specification but is within the scope of the Court's construction, which is not limited to any specific angular range.
Similarly, the unfavorable construction of "substantially cylindrical obturator tip" (Term 9) includes tapered geometries with a generally cylindrical cross-section. The PE-12000 uses a tapered obturator tip that maintains a generally cylindrical cross-section, which falls within this broadened construction.
Overall Assessment: The non-infringement position for the PE-12000 on the '884 Patent is weaker than the PE-5000's position. Genuine factual disputes exist regarding the safety override issue, and the unfavorable constructions on Terms 7 and 9 eliminate arguments that would otherwise have been available. Summary judgment is unlikely to succeed.
3. Non-Infringement Position — '105 Patent (Claims 1, 4, 8)
The PE-12000's non-infringement position on the '105 Patent is mixed and will depend on technical evidence regarding the PE-12000's gas pathway architecture. The favorable construction of "insufflation port in fluid communication with the seal assembly" (Term 4) requires a "direct, dedicated fluid pathway" and excludes configurations where gas flows through an intermediary valve chamber. The PE-12000's gas pathway runs through a shared manifold but includes a direct bypass channel to the seal. Apex will argue that this bypass channel constitutes the required "direct, dedicated fluid pathway." Solstice can counter that the shared manifold constitutes an intermediary structure that the gas must traverse before reaching the bypass channel, but this argument is nuanced and will require detailed expert testimony regarding the gas flow dynamics within the PE-12000's housing.
The unfavorable construction of "integrated insufflation valve" (Term 8) is problematic. The PE-12000 uses co-located but separately manufactured valve components assembled within the trocar housing. Under the Court's construction—which requires only co-location within the trocar housing, not monolithic manufacture—the PE-12000's valve arrangement likely satisfies this limitation.
Overall Assessment: The non-infringement position for the PE-12000 on the '105 Patent presents some arguments, but they are fact-intensive and uncertain. Expert testimony will be critical to establishing the gas flow pathway and whether the bypass channel constitutes a "direct, dedicated fluid pathway" within the meaning of the Court's construction.
4. Invalidity Strategy for PE-12000–Related Claims
Given the weaker non-infringement position for the PE-12000, it is critical to strengthen the invalidity defense for the claims most likely to be asserted against this product. The prior art identified by Kendrick & Lau LLP and detailed in the Invalidity Contentions memorandum dated September 18, 2024 remains robust, particularly for Claims 1 and 2 of the '884 Patent under 35 U.S.C. § 102 (anticipation) and Claims 5 and 9 under 35 U.S.C. § 103 (obviousness).
Dr. Ostrowski's invalidity report, due January 27, 2025, should emphasize prior art combinations against the '884 Patent claims in light of the Court's constructions. The narrowed construction of "retractable blade deployment mechanism" (Term 2) focuses the anticipation analysis on prior art references that disclose a single spring-actuated mechanism that both deploys and retracts the blade. As discussed in Section V below, the prior art from Veridian Medical Technologies discloses precisely this mechanism.
For the '105 Patent, the Court's unfavorable construction of "integrated insufflation valve" (Term 8) actually enhances the invalidity defense. By broadening the claim to encompass co-located valve components regardless of manufacturing method, the Court has expanded the scope of the claim and, correspondingly, expanded the universe of prior art that could anticipate or render obvious the claimed invention. Multiple earlier trocar designs incorporated co-located insufflation valves within the trocar housing, and these designs now fall squarely within the claim scope under the Court's construction.
5. Recommendation. We do not recommend seeking summary judgment on the PE-12000 Series. The factual disputes regarding the rotational cam versus detent distinction, the safety override issue, and the gas flow pathway analysis make summary judgment impractical and risky. A denied motion could signal weakness to the Court and consume valuable resources.
Instead, we recommend the following approach for the PE-12000:
• Focus expert preparation on distinguishing the PE-12000's rotational cam from a "positive locking detent mechanism" and on characterizing the spring-actuation-plus-safety-override system as a multi-actuator system falling outside the claim construction.
• Develop compelling demonstrative exhibits contrasting the PE-12000's locking mechanism with the detent-based mechanism disclosed in the '237 Patent and contrasting the PE-12000's blade deployment system (with safety override) with the single spring-actuated mechanism of the '884 Patent.
• Bolster the invalidity case for the '884 and '105 Patent claims that are most relevant to the PE-12000. The invalidity defense should serve as a robust secondary defense in the event the jury finds infringement.
• Prepare strong damages-mitigation arguments to limit any damages award even if infringement is found.
C. PrecisionEdge™ PE-15000 Series (15 mm Trocar)
1. Non-Infringement Position — '884 Patent (Claims 1, 2, 5, 9, 14)
The PE-15000's non-infringement position on the '884 Patent is similar to the PE-12000's and faces many of the same challenges. Like the PE-12000, the PE-15000 uses a single spring mechanism for blade deployment and retraction but incorporates a manual safety override. The favorable construction of "retractable blade deployment mechanism" (Term 2) provides the same argument regarding the safety override, but this argument is a closer call than the PE-5000's dual-actuator defense and will require expert testimony.
The unfavorable construction of "blade deployment angle" (Term 7) is problematic for the PE-15000. The PE-15000's blade angle configuration falls within the Court's broadened construction, which encompasses any angle at which the blade achieves a cutting configuration. This eliminates a defense that would have been available under Solstice's narrower proposed construction.
Similarly, the unfavorable construction of "substantially cylindrical obturator tip" (Term 9) encompasses the PE-15000's conical-tapered tip. The PE-15000 uses a more pronounced taper than the PE-12000, but because the Court's construction includes "tapered geometries with a generally cylindrical cross-section," the PE-15000's tip likely falls within the claim scope. This is a setback for the defense.
The favorable construction of "proximal blade guard" (Term 5) provides a potential non-infringement argument specifically on Claim 14 of the '884 Patent. The PE-15000 incorporates a guard structure, but its circumferential extent must be precisely measured to determine whether it meets the 270° threshold required by the Court's construction. Preliminary engineering review suggests the PE-15000's guard extends approximately 240°–260° around the blade perimeter, which would fall short of the 270° requirement, but this must be confirmed through precise metrology and documented in expert testimony.
Overall Assessment: The PE-15000 has moderate non-infringement arguments on certain claims of the '884 Patent but is weakened by the unfavorable constructions on Terms 7 and 9. The safety override argument (Term 2) and the proximal blade guard argument (Term 5, Claim 14) are the strongest remaining defenses, but neither is likely to be dispositive at summary judgment.
2. Non-Infringement Position — '105 Patent (Claims 1, 4, 8)
The PE-15000's non-infringement position on the '105 Patent presents the strongest defense available for this product line. The favorable construction of "insufflation port in fluid communication with the seal assembly" (Term 4) is the centerpiece of this defense. The PE-15000's gas pathway includes a dedicated intermediary pressure-regulation chamber situated between the insufflation port and the seal assembly. Gas entering the insufflation port must first pass through this pressure-regulation chamber—where it is conditioned and metered before flowing to the seal—rather than traveling along a "direct, dedicated fluid pathway" from the port to the seal.
The Court's construction specifically excludes "configurations where gas flows through an intermediary valve chamber." The PE-15000's pressure-regulation chamber functions as an intermediary processing station, not a direct pathway. This places the PE-15000 potentially outside the scope of literal infringement for Claims 1, 4, and 8 of the '105 Patent. Apex may attempt to characterize the pressure-regulation chamber as something other than an "intermediary valve chamber," but the chamber's design and function—including its metering and conditioning of gas flow—are consistent with the excluded category.
However, the unfavorable construction of "integrated insufflation valve" (Term 8) partially counterbalances this defense. Like the PE-12000, the PE-15000 uses a co-located but separately manufactured insufflation valve. Under the Court's construction, this arrangement satisfies the "integrated" limitation. Accordingly, the PE-15000 meets at least this claim limitation.
Overall Assessment: The favorable Term 4 construction provides a meaningful and potentially strong defense for the PE-15000 on the '105 Patent. This argument may be sufficiently clear-cut to warrant a targeted partial summary judgment motion, though the risk of denial must be assessed. The unfavorable Term 8 construction is a counterweight but does not negate the Term 4 defense, as both limitations must be met for infringement.
3. Invalidity Strategy for PE-15000–Related Claims
The invalidity strategy for the PE-15000 largely parallels the approach for the PE-12000 on the '884 Patent claims. The same prior art references and the same analytical framework apply, as the PE-15000 is accused of infringing the same '884 Patent claims as the PE-12000.
For the '105 Patent, the broadened "integrated insufflation valve" construction (Term 8) is a significant development for the invalidity defense. By expanding the scope of "integrated" to include any co-located valve, the Court has effectively broadened the claims of the '105 Patent. This broader scope increases the universe of prior art that may anticipate or render obvious the claimed invention. In particular, earlier trocar designs—including those from Veridian Medical Technologies and others—that incorporated co-located insufflation valves but manufactured those valves separately from the housing now fall within the claim scope and may serve as anticipating or obviating references.
The subpoenaed documents from Veridian Medical Technologies, Inc. (subpoena issued September 12, 2024) include technical specifications and engineering drawings for Veridian's VeriPort™ 15 mm trocar system, which was commercially available as early as 2013. These documents are relevant to the '105 Patent invalidity analysis and should be foregrounded in Dr. Ostrowski's invalidity report and any trial presentation. The VeriPort™ system used a co-located insufflation valve with a direct fluid pathway to the seal, potentially anticipating multiple claims of the '105 Patent under the Court's constructions.
4. Recommendation. We do not recommend seeking summary judgment on the PE-15000 Series generally. The factual disputes on the '884 Patent claims are too significant for summary judgment, and a broad motion would likely be denied.
However, we should carefully evaluate whether a narrower partial summary judgment motion limited to the '105 Patent claims could succeed based on the favorable Term 4 construction and the PE-15000's intermediary pressure-regulation chamber. The advantage of such a motion is that it would, if granted, narrow the case at trial and eliminate the '105 Patent from the PE-15000 analysis. The risk is that a denial could undermine the defense's credibility on this issue at trial, and the factual characterization of the pressure-regulation chamber will be contested. We recommend deferring this decision until after expert reports are exchanged and we can assess the strength of Apex's counter-arguments.
For the trial, the PE-15000 strategy should prioritize the following:
• Lead with the "insufflation port" non-infringement argument under the favorable Term 4 construction for the '105 Patent. This is the strongest non-infringement argument available for the PE-15000 and should be presented prominently.
• Present invalidity as a secondary defense for both the '884 and '105 Patent claims, leveraging the broadened constructions to expand the prior art base.
• Pursue damages apportionment to minimize any damages award attributable to the PE-15000, emphasizing that the patented features—even if found to be infringed—represent only a small fraction of the overall value of the PE-15000 trocar system.
V. Impact on Invalidity Defenses
A. General Observations
The Markman ruling's impact on the invalidity defenses is somewhat paradoxical. Favorable claim constructions that narrow the claims are beneficial for non-infringement but can reduce the universe of invalidating prior art by requiring that the prior art disclose the narrower claim limitations. Conversely, unfavorable broader constructions that expand claim scope and hurt the non-infringement defense can actually enhance the invalidity defense by broadening the prior art that falls within the expanded claim scope.
In this case, the Court's broader constructions on Terms 6 (resilient sealing member), 7 (blade deployment angle), 8 (integrated insufflation valve), and 9 (substantially cylindrical obturator tip) may actually enhance our invalidity arguments under 35 U.S.C. §§ 102 and 103. Each of these broader constructions enlarges the scope of the corresponding claims, thereby increasing the number of prior art references that may anticipate or render obvious the claimed inventions. This effect is most pronounced for the '105 Patent, where the broadened "integrated insufflation valve" construction significantly expands the prior art landscape.
B. '237 Patent — Invalidity
The narrow "locking seal assembly" construction adopted by the Court (favorable Term 1) limits Claims 1, 3, 7, and 12 to a "mechanically actuated seal comprising at least two cooperating components with a positive locking detent mechanism." To anticipate or render obvious these claims, prior art must disclose this specific structural configuration—particularly the "positive locking detent mechanism."
The prior art references identified in the prosecution history analysis (memorandum prepared by Kendrick & Lau LLP, dated September 5, 2024) include three references that are relevant to this narrower construction:
(a) U.S. Patent No. 8,241,307 (Forester), which discloses a trocar seal assembly with a detent-based locking mechanism comprising two cooperating seal components;
(b) U.S. Published Application No. 2012/0046692 (Marchetti), which discloses a multi-component access device seal with a spring-loaded ball detent for positional locking; and
(c) U.S. Published Application No. 2014/0094821 (Yamada), which discloses a laparoscopic seal assembly with a detent ring that engages a corresponding groove to lock the seal in position.
Dr. Ostrowski should assess whether these references, individually or in combination, disclose all elements of Claims 1, 3, 7, and 12 as construed by the Court. Our preliminary assessment is that the Forester patent likely anticipates Claims 1 and 3 under the narrower construction, as it discloses the multi-component seal with a positive locking detent. However, the case is tighter under the narrower construction than it would have been under a broader construction, and Apex will argue that the references fail to disclose one or more elements. Dr. Ostrowski's report should address these arguments in detail.
C. '884 Patent — Invalidity
The invalidity case for the '884 Patent remains robust after the Markman ruling, and the mix of favorable and unfavorable constructions creates a balanced landscape for the invalidity defense.
The favorable construction of "retractable blade deployment mechanism" (Term 2) narrows the claims to a "single spring-actuated mechanism that both deploys and retracts the blade." This narrowing requires that the anticipating prior art disclose a single spring performing both functions. The prior art from Veridian Medical Technologies is critical here: Veridian's U.S. Published Application No. 2014/0171973 (filed June 2014, published December 2014) discloses a trocar obturator with a single bidirectional spring that both deploys and retracts the cutting blade. This reference predates the '884 Patent's priority date and discloses the precise mechanism required by the Court's construction.
The unfavorable construction of "blade deployment angle" (Term 7) broadens the claim scope to encompass any angle at which the blade achieves a cutting configuration. This broader scope means that prior art references disclosing blade deployment at any functional angle—not just within the 15°–45° range of the specification—can satisfy this limitation. This makes it easier to identify anticipating prior art, as there is a wider range of prior art blade geometries that meet this element.
Similarly, the unfavorable construction of "substantially cylindrical obturator tip" (Term 9) includes tapered geometries with a generally cylindrical cross-section. This broadening means that prior art references with tapered obturator tips—which are common in the trocar art—can satisfy this claim limitation. This further expands the prior art base available for anticipation and obviousness arguments.
Overall Assessment: The invalidity case for the '884 Patent remains strong. The narrowed "retractable blade deployment mechanism" construction is met by the Veridian prior art, and the broadened constructions on Terms 7 and 9 expand the universe of available prior art. Dr. Ostrowski's invalidity report should present a comprehensive anticipation analysis for Claims 1 and 2 (under § 102) and an obviousness analysis for Claims 5 and 9 (under § 103), incorporating the Court's constructions.
D. '105 Patent — Invalidity
The invalidity position for the '105 Patent may have actually improved as a result of the Markman ruling. The favorable construction of "insufflation port in fluid communication with the seal assembly" (Term 4) narrows the claims to require a "direct, dedicated fluid pathway" and excludes intermediary valve chamber configurations. This narrowing does not significantly undermine the invalidity defense, because the prior art references identified by Kendrick & Lau LLP include several designs that use direct fluid pathways from the insufflation port to the seal without intermediary chambers. These references satisfy the narrower construction.
More significantly, the unfavorable construction of "integrated insufflation valve" (Term 8) substantially broadens the claim scope by requiring only co-location within the trocar housing rather than monolithic manufacture. This broadening is a major development for the invalidity defense. Multiple prior art trocar designs incorporated co-located insufflation valves that were separately manufactured but assembled within the trocar housing. Under the Court's construction, these designs now fall within the scope of the '105 Patent claims and may anticipate or render obvious the claimed invention. The prior art landscape for the '105 Patent has effectively been enlarged by this construction.
Overall Assessment: The invalidity position for the '105 Patent is likely stronger after the Markman ruling. The broadened "integrated insufflation valve" construction substantially expands the prior art base, potentially making it easier to establish anticipation or obviousness. Dr. Ostrowski's report should capitalize on this broadening.
E. Inequitable Conduct Counterclaim
The Claim Construction Order also has implications for Solstice's inequitable conduct counterclaim. During prosecution of the '237 Patent, Dr. Szabo and Apex's prosecution counsel made narrowing amendments and arguments to distinguish prior art, emphasizing the detent-based locking mechanism as a novel feature. These narrowing amendments were identified and documented in the prosecution history analysis memorandum prepared by Kendrick & Lau LLP. The Court's adoption of a narrow "locking seal assembly" construction (Term 1) is consistent with these narrowing amendments and may provide additional support for prosecution history estoppel arguments.
However, the inequitable conduct theory rests on more specific allegations—namely, that Apex's prosecution counsel failed to disclose material prior art references during prosecution. The materiality of the undisclosed references must be reassessed in light of the claim constructions. If the claims are now construed narrowly, the undisclosed prior art must be material under the narrower constructions. Our preliminary assessment is that the undisclosed references remain material even under the narrower constructions, but this analysis should be updated in coordination with Dr. Kendrick at Kendrick & Lau LLP.
We recommend continuing to develop the inequitable conduct theory as a defense and as potential leverage in settlement discussions, while assessing whether the Markman constructions strengthen or weaken the materiality element.
VI. Impact on Damages Exposure
A. Revised Damages Framework
Apex's damages expert, Hugh Danaher of Keystone Valuation Advisors LLC, has previewed a reasonable royalty damages claim of $31.8 million in his damages contentions, with his full expert report expected to be served on or about February 14, 2025. This figure is based on the full accused product sales base of $74.6 million (2021 through Q3 2024, with projections through trial) and an asserted royalty rate that has not yet been finalized but is expected to be in the range of 15–20% of net sales.
The Markman ruling has significant implications for the damages framework. If the PE-5000 Series is excluded from the case via summary judgment, the damages base is reduced. Based on our product mix analysis, the PE-5000 accounts for approximately 30–35% of total accused product sales. Depending on the precise product mix in each year, this translates to an estimated reduction of $22–26 million from the accused sales base.
The remaining accused sales attributable to the PE-12000 and PE-15000 Series are estimated at $48–52 million for the 2021–2024 period. Applying the weighted average gross margin of 61.3% to this reduced base, the maximum lost profits exposure (if Apex were to pursue a lost profits theory, which it has not indicated) would be approximately $29–32 million. Under a reasonable royalty theory, the reduced base would support a maximum royalty exposure in the range of $7–10 million at the asserted 15–20% royalty rate, though this figure may be further reduced through apportionment and other damages-limiting arguments.
Dr. Elena Marchetti of Pinnacle Economics Group LLC should recalibrate her Georgia-Pacific analysis in light of the Markman ruling. The claim constructions affect several Georgia-Pacific factors, including Factor 13 (the portion of the realizable profit attributable to the patent) and Factor 6 (the effect of the patented invention in promoting sales of other products). The narrowing of the claims to specific subcomponents (the locking detent mechanism, the single-spring blade deployment system) supports the argument that the patented features contribute only a fraction of the overall product value.
B. Apportionment
The favorable claim constructions narrowing the patented features to specific, discrete subcomponents provide strong support for apportionment arguments. The "locking seal assembly" construction (Term 1) limits the patented feature to a specific positive locking detent mechanism—one subcomponent within a complex multi-component trocar system. Similarly, the "retractable blade deployment mechanism" construction (Term 2) limits the patented feature to a single spring-actuated deployment/retraction mechanism. These are specific mechanical subcomponents, not the entire trocar or even the entire seal or blade assembly.
Under VirnetX, Inc. v. Sterling Reach Holdings, 767 F.3d 1308 (Fed. Cir. 2014), and Uniloc USA, Inc. v. Kestrel Partners LLC, 632 F.3d 1292 (Fed. Cir. 2011), the royalty base must be apportioned to the smallest salable patent-practicing unit unless the entire product embodies the patented technology. Here, the patented features—as construed by the Court—are clearly subcomponents of a larger, multi-component device. The entire trocar assembly is not the smallest salable patent-practicing unit.
Dr. Marchetti's damages report, due February 14, 2025, should emphasize that the licensed technology, as defined by the Court's constructions, constitutes a small fraction of the overall product value. The PrecisionEdge™ trocar assemblies contain dozens of individually designed and manufactured components, including the cannula tube, housing, obturator, handle assembly, insufflation system, seal system, blade mechanism, safety features, and ergonomic grip—only a few of which are implicated by the narrowly construed patent claims. A reasonable royalty must be apportioned to reflect this reality.
C. Revised Settlement Valuation Implications
The Markman ruling's impact on patent strength and damages exposure should be reflected in any updated patent valuation and settlement analysis. We previously retained Dr. Arthur Gaines of Ridgeline IP Analytics LLC to perform a confidential patent portfolio valuation for Solstice. That valuation, completed prior to the Markman ruling, assessed the strength and enforceability of the three asserted patents and the risk-adjusted damages exposure. In light of the Claim Construction Order, Dr. Gaines's valuation should be updated to reflect the narrowed claim scope, the reduced accused product base (assuming PE-5000 exclusion), and the strengthened invalidity arguments.
The revised risk-adjusted damages exposure, once calculated, should be used to inform any future settlement discussions. As discussed in Section IX below, we recommend deferring substantive settlement discussions until after the PE-5000 summary judgment motion is decided, but the preliminary valuation update should be completed in advance of the March 17, 2025 mediation.
VII. Expert discovery Preparation
A. Dr. Miriam Ostrowski — Invalidity / Claim Construction Expert
Dr. Ostrowski's opening expert report is due January 27, 2025—forty-seven days from the date of this memorandum. Her report must incorporate the Court's claim constructions into the invalidity analysis. Key areas for her attention include:
(a) '237 Patent Anticipation Analysis: Adapt the anticipation analysis to account for the narrower "locking seal assembly" construction. Confirm that the identified prior art references (Forester, Marchetti, Yamada) disclose all elements of Claims 1, 3, 7, and 12 under the Court's constructions, including the "positive locking detent mechanism" requirement.
(b) '884 Patent Anticipation/Obviousness Analysis: Confirm that the Veridian prior art discloses the "single spring-actuated mechanism that both deploys and retracts the blade" required by the Term 2 construction. Capitalize on the broadened Term 7 ("blade deployment angle") and Term 9 ("substantially cylindrical obturator tip") constructions to identify additional anticipating or obviating references.
(c) '105 Patent Invalidity Analysis: Capitalize on the broadened "integrated insufflation valve" con

MEMORANDUM

MATTER NO.: 10294.0017

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