PRIVILEGED & CONFIDENTIAL — ATTORNEY WORK PRODUCT
MEMORANDUM
CALDERWOOD & HARKNESS LLP intellectual Property Group 1201 Market Street, Suite 2500 Wilmington, DE 19801
Date: February 12, 2025
To: Marcus Delgado, Responsible Partner
From: Christy Bauer, Lead Associate; Peter Vassiliev, Working Associate
Re: Review and Analysis of Expert Report of Dr. Calvin Ng Regarding Infringement — Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA (D. Del.)
Matter No.: 10294.0017
CONFIDENTIALITY NOTICE: This memorandum is protected by the attorney-client privilege and the work product doctrine. It is prepared in anticipation of litigation and for the purpose of rendering legal advice. This document contains mental impressions, conclusions, opinions, and legal theories of attorneys. Do not distribute outside of the Calderwood & Harkness engagement team and authorized client representatives without prior approval. Any unauthorized disclosure may constitute a waiver of applicable privileges.
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I. Executive Summary
This memorandum provides a comprehensive review and critical analysis of the opening expert report of Dr. Calvin Ng, Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute, Newark, Delaware, submitted on behalf of plaintiff Apex Surgical Innovations, Inc. ("Apex"). Dr. Ng's report was served on February 10, 2025, in accordance with the Court's expert discovery schedule, and addresses infringement of the three Apex utility patents asserted in this action.
Dr. Ng's report opines on both literal infringement and, in the alternative, infringement under the doctrine of equivalents for each of the following asserted patents and claims:
• U.S. Patent No. 9,814,237 ("the '237 Patent") — Claims 1, 3, 7, and 12
• U.S. Patent No. 10,271,884 ("the '884 Patent") — Claims 1, 2, 5, 9, and 14
• U.S. Patent No. 10,932,105 ("the '105 Patent") — Claims 1, 4, and 8
Dr. Ng's infringement opinions are directed at three accused product lines manufactured and sold by Solstice Biomedical, Inc. ("Solstice"): the PrecisionEdge™ PE-5000 Series (5 mm trocar), the PE-12000 Series (12 mm trocar), and the PE-15000 Series (15 mm trocar).
The purposes of this memorandum are fourfold: (a) to summarize Dr. Ng's principal infringement opinions across the three asserted patents and twelve asserted claims; (b) to evaluate each opinion against the Court's Claim Construction Order entered December 6, 2024 (Dkt. No. 87); (c) to identify weaknesses, analytical gaps, and factual errors in Dr. Ng's methodology and conclusions; and (d) to formulate a rebuttal strategy keyed to Dr. Miriam Ostrowski's expertise and timed to the March 3, 2025 rebuttal report deadline.
Overall Assessment. Our review reveals that Dr. Ng's report contains several significant vulnerabilities that we are well-positioned to exploit in rebuttal and at trial. The vulnerabilities are most pronounced with respect to the five claim terms that this Court construed in a manner favorable to Solstice. Dr. Ng appears, in at least four separate instances, to have applied Apex's rejected proposed constructions rather than the Court's adopted constructions — a fundamental analytical flaw that pervades multiple sections of his report. His doctrine-of-equivalents analysis is thin on the PE-5000 Series, relying on conclusory assertions of function-way-result equivalence rather than detailed engineering analysis, and his treatment of prosecution history estoppel is essentially non-existent despite clearly applicable narrowing amendments in all three patent prosecution histories. The PE-12000 Series analysis is his strongest overall but still contains exploitable gaps, particularly regarding the "integrated" and "resilient sealing member" claim limitations. The PE-15000 analysis under the '105 Patent conflates functional equivalence with structural identity in a manner that does not withstand scrutiny under the Court's construction of "integrated." His measurement methodology for the angular displacement limitation of Claim 9 of the '884 Patent — based on a single static photograph rather than dynamic testing — is unreliable and constitutes a potential basis for a Daubert challenge.
We believe these weaknesses, taken together, provide a strong foundation for Dr. Ostrowski's rebuttal report, create multiple avenues for effective cross-examination of Dr. Ng, and may support renewed dispositive motion practice on at least the PE-5000 Series.
II. Background and Procedural Posture
A. The Asserted Patents and Claims
Apex asserts three related utility patents in this action, all naming Dr. Raymond Szabo (Vice President of Engineering at Apex Surgical Innovations, Inc.) as the sole named inventor. All three patents are assigned to Apex Surgical Innovations, Inc. and form part of a broader patent family comprising fourteen total issued United States patents and six pending continuation applications directed to various aspects of trocar and minimally invasive surgical access device technology. The three asserted patents and their respective asserted claims are as follows:
U.S. Patent No. 9,814,237 ("the '237 Patent"). Entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," the '237 Patent was issued on November 14, 2017, based on Application No. 14/712,305 filed May 14, 2015. The patent expires on June 22, 2035, accounting for any applicable patent term adjustments. The '237 Patent is generally directed to a seal assembly for use in trocar devices employed in laparoscopic surgical procedures, with particular focus on a mechanical locking interface that secures the seal in place during instrument passage. Apex asserts Claims 1, 3, 7, and 12 of the '237 Patent. Claim 1 is an independent apparatus claim. Claims 3 and 7 are dependent apparatus claims depending from Claim 1. Claim 12 is an independent method claim directed to a method of deploying and locking the seal assembly during surgical use.
U.S. Patent No. 10,271,884 ("the '884 Patent"). Entitled "Retractable Blade Deployment Mechanism for Trocar Systems," the '884 Patent was issued on April 30, 2019, based on Application No. 15/489,721 filed April 17, 2017. The patent expires on September 15, 2036. The '884 Patent is generally directed to a mechanism for deploying and retracting a cutting blade in a trocar device, including safety features that prevent inadvertent blade deployment. Apex asserts Claims 1, 2, 5, 9, and 14 of the '884 Patent. Claim 1 is an independent apparatus claim. Claims 2, 5, and 9 are dependent apparatus claims depending from Claim 1, directed respectively to a biasing element, a safety interlock mechanism, and a specified angular displacement range for blade retraction. Claim 14 is an independent method claim directed to the method of deploying and retracting the blade.
U.S. Patent No. 10,932,105 ("the '105 Patent"). Entitled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar," the '105 Patent was issued on March 2, 2021, based on Application No. 16/234,892 filed December 28, 2018. The patent expires on January 10, 2038. The '105 Patent is generally directed to a combined insufflation valve and sealing structure for a laparoscopic trocar, emphasizing an integrated design that reduces gas leakage during insufflation. Apex asserts Claims 1, 4, and 8 of the '105 Patent. Claim 1 is an independent apparatus claim. Claim 4 is a dependent apparatus claim directed to a "zero-leak" performance specification at a defined pressure threshold. Claim 8 is a dependent apparatus claim directed to the material composition of the elastomeric seal component.
The three asserted patents share a common specification framework and cross-reference one another as part of a continuation family. This interconnection is relevant to the prosecution history estoppel analysis discussed in Section IV.C.1 below, as narrowing amendments in one application may bear on the scope of claims in related applications.
B. The Accused Products
Apex accuses three product lines within Solstice's PrecisionEdge™ portfolio of infringing the asserted patents. These product lines span the range of trocar sizes commonly used in laparoscopic surgical procedures:
PE-5000 Series (5 mm trocar assembly). The PE-5000 Series is Solstice's 5 mm diameter trocar assembly, designed for use with smaller-gauge laparoscopic instruments. It is accused of infringing the '237 Patent (Claims 1, 3, 7, and 12) and the '884 Patent (Claims 1, 2, 5, 9, and 14). The PE-5000 is not accused of infringing the '105 Patent. As discussed in detail below, the PE-5000 Series underwent a significant design revision in Q3 2022, a fact that Dr. Ng's report fails to address.
PE-12000 Series (12 mm trocar assembly). The PE-12000 Series is Solstice's 12 mm diameter trocar assembly, representing the most commonly used size for general laparoscopic procedures. It is accused of infringing all three asserted patents — the '237 Patent (Claims 1, 3, 7, and 12), the '884 Patent (Claims 1, 2, 5, 9, and 14), and the '105 Patent (Claims 1, 4, and 8). The PE-12000 is thus the product line with the broadest infringement exposure under Dr. Ng's analysis.
PE-15000 Series (15 mm trocar assembly). The PE-15000 Series is Solstice's 15 mm diameter trocar assembly, designed for use with larger instruments and specimen retrieval bags. It is accused of infringing the '884 Patent (Claims 1, 2, 5, 9, and 14) and the '105 Patent (Claims 1, 4, and 8). The PE-15000 is not accused of infringing the '237 Patent.
The combined United States sales of the accused PrecisionEdge™ products from calendar year 2021 through September 30, 2024 total approximately $74.6 million, broken down as follows:
These sales figures form the royalty base for Apex's damages claim, which is addressed separately in the damages expert report of Hugh Danaher, CFA. The breakdown of sales by individual product line is relevant to the damages rebuttal strategy discussed in Section VI.D below, as successful non-infringement arguments on the PE-5000 Series alone would substantially reduce the damages exposure.
C. Claim Construction Order (December 6, 2024)
Following a Markman hearing conducted on November 18, 2024, the Honorable Richard G. Andrews entered a Claim Construction Order on December 6, 2024 (Dkt. No. 87), construing nine disputed claim terms. The parties had briefed their respective proposed constructions in individual claim construction briefs filed October 28, 2024 (Dkt. Nos. 72, 73) and a joint claim construction chart and responsive briefs filed November 4, 2024 (Dkt. Nos. 76, 77, 78).
The outcome of the Markman ruling was mixed, but on balance favorable to Solstice: five of the nine disputed terms were construed in a manner favorable to Solstice, while four were construed in a manner favorable to Apex. Our Post-Markman Strategy Memorandum dated December 10, 2024 (prepared by Bauer and Vassiliev with input from Delgado) analyzed the impact of each construction on Solstice's infringement defense and invalidity counterclaims.
The five Solstice-favorable constructions are of particular importance to this memorandum, as they define the claim scope that Dr. Ng was required to apply in his infringement analysis. As discussed in detail in Section IV below, Dr. Ng's report was required to apply the Court's adopted constructions but in several instances appears to deviate from or selectively apply them, reverting instead to Apex's rejected proposed constructions. This deviation constitutes a foundational analytical error that pervades his report and creates significant opportunities for both rebuttal and cross-examination.
D. Dr. Ng's Qualifications and Engagement
Dr. Calvin Ng holds a Ph.D. in Mechanical Engineering from the Massachusetts Institute of Technology and currently serves as an Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute in Newark, Delaware. His curriculum vitae, attached as Exhibit A to his report, reflects experience in mechanical design, materials science, and medical device engineering, though the bulk of his academic publications are in the field of general mechanical design rather than surgical instrumentation specifically. He has been retained as an expert witness in approximately twelve prior patent cases, primarily in the District of Delaware and the Eastern District of Texas.
Dr. Ng was retained by Apex through its counsel at Hargrove, Tate & Bennington LLP. The engagement is led by Victoria Stanton, lead partner, with support from Derek Loomis, associate. Dr. Ng's report was served on February 10, 2025, in compliance with the Court's Scheduling Order, which set the opening of expert discovery on January 13, 2025 and required opening expert reports to be served by that date. Under the same schedule, rebuttal expert reports are due on March 3, 2025, giving the Solstice team approximately three weeks from the date of this memorandum to finalize Dr. Ostrowski's rebuttal report.
III. Summary of Dr. Ng's Infringement Opinions
A. Overview of Report Structure
Dr. Ng's opening infringement expert report spans approximately 187 pages, exclusive of exhibits. The report is accompanied by 24 exhibits, including tear-down photographs, annotated patent claim charts, copies of referenced Solstice and Apex production documents, and Dr. Ng's curriculum vitae and list of prior expert engagements.
The report is organized hierarchically: first by asserted patent, then within each patent section by accused product line, and within each product section by individual claim element. This organizational approach allows for a methodical element-by-element mapping but also has the effect of obscuring certain cross-cutting weaknesses, such as the consistent application of Apex's rejected claim constructions, which appear across multiple patent sections.
Dr. Ng's analysis includes a physical tear-down analysis of production samples of each of the three accused PrecisionEdge™ product lines. He reports that he obtained and disassembled one sample unit of each product line, documented the disassembly through photographs, and examined the internal components and their functional relationships. The tear-down analysis is central to his structural mapping of the accused products to the asserted claims.
In support of his opinions, Dr. Ng relies on Apex production documents bearing Bates numbers APEX-000001 through APEX-031450 and Solstice production documents bearing Bates numbers SBD-000001 through SBD-048217. He also references the Court's December 6, 2024 Claim Construction Order (Dkt. No. 87), the asserted patents and their prosecution histories, and published literature relating to trocar design and laparoscopic surgical instrumentation.
Notably, while Dr. Ng cites the Court's Claim Construction Order, he also references Apex's rejected proposed constructions in several passages of the report, applying them as though they were the operative claim scope. This issue is analyzed in detail in Section IV.A.1 below.
B. '237 Patent — "Locking Seal Assembly"
Claims at issue: 1, 3, 7, and 12.
Accused products: PE-5000 Series and PE-12000 Series.
Dr. Ng opines that both the PE-5000 and PE-12000 Series literally satisfy each element of independent Claim 1 of the '237 Patent, including the "locking seal assembly" and "resilient sealing member" limitations. His analysis proceeds element by element, mapping the structural features of each accused product to the corresponding claim language. For the PE-5000, he identifies the press-fit interference between the seal component and the trocar housing as satisfying the "locking seal assembly" limitation. For the PE-12000, he identifies a bayonet-style retention feature that engages corresponding grooves in the housing.
With respect to dependent Claims 3 and 7, Dr. Ng argues structural correspondence based on tear-down photographs and Solstice internal design specifications produced in discovery (SBD-012440 through SBD-012488). Claim 3 adds a limitation regarding the geometry of the sealing surface, and Claim 7 adds a limitation regarding the material durometer of the resilient sealing member. Dr. Ng's analysis on both dependent claims relies primarily on visual comparison of the tear-down photographs to the patent figures and on dimensional measurements taken from the Solstice design specifications.
For Claim 12, which is a method claim directed to the method of deploying and locking the seal during clinical use, Dr. Ng opines that the method is performed during normal clinical use of the PE-12000 Series and that Solstice induces such performance through its Instructions for Use ("IFU") documentation and surgical training materials. Dr. Ng's induced infringement analysis for Claim 12 is limited, consisting primarily of citations to the IFU document without detailed analysis of the knowledge and specific intent elements required for induced infringement.
In the alternative, Dr. Ng presents a doctrine-of-equivalents theory for the PE-5000 Series with respect to the "locking seal assembly" limitation. He argues that the PE-5000's press-fit interference design performs substantially the same function, in substantially the same way, to achieve substantially the same result as the claimed mechanical locking interface. This analysis is contained in a single paragraph and is discussed in Section IV.B.1.d below.
C. '884 Patent — "Retractable Blade Deployment Mechanism"
Claims at issue: 1, 2, 5, 9, and 14.
Accused products: All three product lines — PE-5000, PE-12000, and PE-15000 Series.
Dr. Ng's core infringement opinion on the '884 Patent is that the spring-loaded blade mechanism present in each of the three PrecisionEdge™ product lines meets the "retractable blade deployment mechanism" limitation as construed by the Court. The Court's construction of this term — one of the four constructions favorable to Apex — defined the term broadly as "a mechanism that deploys a cutting blade from a retracted position to a deployed position and subsequently retracts the blade." Dr. Ng's analysis on this term benefits from the breadth of the Court's construction.
For independent Claim 1, Dr. Ng asserts literal infringement by all three accused product lines, focusing on the cam-actuated retraction feature common to the PrecisionEdge™ platform. His element-by-element analysis identifies the spring-loaded blade cartridge, the cam-and-follower retraction assembly, and the blade housing as corresponding to the claimed elements of the retractable blade deployment mechanism. This analysis is supported by tear-down photographs showing the internal blade mechanism of each product line.
For dependent Claims 2 and 5, Dr. Ng addresses the "biasing element" and "safety interlock" sub-limitations, respectively. He identifies the coil spring in the blade cartridge as the "biasing element" of Claim 2, and he identifies the single-button release on the PE-5000 and the two-step activation mechanisms on the PE-12000 and PE-15000 as the "safety interlock" of Claim 5. His mapping of the PE-5000's single-button release to the "safety interlock" limitation is discussed in Section IV.B.2.b below as a significant weakness in his analysis.
For dependent Claim 9, Dr. Ng addresses the specific angular displacement range limitation, which requires the blade retraction arc to fall within a range of 15° to 45°. He asserts that the blade retraction in all three accused product lines falls within this range, based on measurements taken from a static photograph of the blade in its retracted position. The limitations of this measurement methodology are discussed in Section IV.B.2.c below.
For method Claim 14, Dr. Ng opines that the method of blade deployment and retraction recited in the claim is "inherently practiced" during normal use of each PrecisionEdge™ product. He also offers an alternative theory of induced infringement based on Solstice's IFU documentation. As with Claim 12 of the '237 Patent, his induced infringement analysis lacks the specificity required to establish knowledge and specific intent.
Dr. Ng raises a doctrine-of-equivalents argument for the PE-5000 Series with respect to the "safety interlock" element of Claim 5, arguing that the PE-5000's single-button release is the equivalent of the multi-step interlock recited in the claim.
D. '105 Patent — "Integrated Insufflation Valve and Seal"
Claims at issue: 1, 4, and 8.
Accused products: PE-12000 and PE-15000 Series.
Dr. Ng opines that the valve-and-seal integration in both the PE-12000 and PE-15000 Series literally satisfies the elements of independent Claim 1 of the '105 Patent. His analysis centers on the physical arrangement of the insufflation valve and the sealing structure within the trocar housing, which he characterizes as forming an "integrated" unit within the meaning of the claim. For the PE-12000, he notes that the valve and seal components are housed within a common subassembly that is inserted into the trocar body as a single unit. For the PE-15000, he notes a similar arrangement with minor dimensional differences.
For dependent Claim 4, Dr. Ng addresses the "zero-leak" threshold specification, which requires "substantially zero leakage at pressures up to 25 mmHg." He relies on Solstice's own quality control testing data produced in discovery (SBD-031200 through SBD-031284) to show that the accused products achieve a leak rate of less than 0.1 cc/min, which he characterizes as meeting the "substantially zero leakage" requirement. The critical issue with this reliance — that the Solstice QC data were measured at 15 mmHg rather than the 25 mmHg specified in the claim — is discussed in Section IV.B.3.b below.
For dependent Claim 8, Dr. Ng addresses the material composition limitation, which requires a "biocompatible elastomeric seal" with specified material properties. He identifies the material used in the PrecisionEdge™ seal components as medical-grade silicone based on Solstice's published product specifications and marketing literature, and he opines that this material satisfies the claimed limitation. He does not report any independent material testing to confirm the durometer, elongation-at-break, or other specific material properties recited in the claim specification.
Dr. Ng invokes the doctrine of equivalents for the PE-15000 Series with respect to the "integrated" limitation of Claim 1, arguing that even if the PE-15000's valve-and-seal configuration does not literally meet the Court's construction of "integrated" as requiring a "single unitary structure or permanently joined" configuration, the PE-15000's design is the functional equivalent. This DOE analysis is discussed in Section IV.B.3.d below, where we identify prosecution history estoppel as a likely bar.
IV. Detailed Analysis and Identified Weaknesses
A. Overarching Methodological Concerns
Before addressing the patent-by-patent weaknesses in Dr. Ng's report, we identify three overarching methodological concerns that affect the reliability and persuasiveness of his opinions across all three asserted patents.
1. Selective Application of Court's Claim Constructions. The most pervasive and fundamental flaw in Dr. Ng's report is his inconsistent application of the Court's Claim Construction Order. While the report purports to apply the Court's constructions and cites the December 6, 2024 Order in its introductory methodology section, our review has identified at least four specific instances in which Dr. Ng applies Apex's proposed constructions — which were expressly rejected by the Court — rather than the Court's adopted constructions. These instances are catalogued below:
(i) At pages 42–44 of the report (addressing the "locking seal assembly" limitation of Claim 1 of the '237 Patent), Dr. Ng applies the construction "an assembly that secures a seal in position during use," which is Apex's rejected proposed construction. The Court's adopted construction is "a mechanical locking interface that positively retains the seal in a fixed position during use." The omission of "mechanical locking interface" and "positively retains" is significant, as these terms impose structural and functional requirements that Apex's broader construction did not.
(ii) At pages 78–80 of the report (addressing the "safety interlock" limitation of Claim 5 of the '884 Patent as applied to the PE-5000), Dr. Ng states that the claim requires "a mechanism that prevents unintended blade deployment," which corresponds to Apex's rejected proposed construction. The Court's adopted construction is "a mechanism that prevents blade deployment unless a predetermined sequence of user actions is completed." The inclusion of "predetermined sequence" is critical to the analysis of whether the PE-5000's single-button release satisfies the limitation.
(iii) At pages 112–115 of the report (addressing the "integrated" limitation of Claim 1 of the '105 Patent), Dr. Ng applies the construction "combined into a single functional unit," which tracks Apex's rejected proposal. The Court's adopted construction is "formed as a single unitary structure or permanently joined so as to function as a single unit." The Court's construction adds the requirements of either unitary formation or permanent joining, neither of which is reflected in Dr. Ng's analysis.
(iv) At pages 134–136 of the report (addressing the "substantially zero leakage" limitation of Claim 4 of the '105 Patent), Dr. Ng references a leak rate threshold that corresponds to Apex's proposed numerical boundary rather than the qualitative standard adopted by the Court.
This pattern of applying rejected constructions constitutes a fundamental analytical flaw. Under well-established Federal Circuit precedent, an expert's infringement analysis must be "tied to the claim construction adopted by the court." AquaTex Indus., Inc. v. Techniche, Inc., 479 F.3d 1320, 1328 (Fed. Cir. 2007). An expert who applies a different construction than the one adopted by the court renders opinions that are legally unreliable and potentially excludable. Each of these instances should be highlighted in Dr. Ostrowski's rebuttal report, raised on cross-examination of Dr. Ng, and, if the pattern persists through trial, raised in a motion in limine.
2. Inadequate Tear-Down Methodology. Dr. Ng reports that he performed physical tear-downs of production samples of each of the three accused PrecisionEdge™ product lines. The tear-down analysis is central to his infringement opinions, as it provides the factual basis for his element-by-element mapping of the accused product structures to the asserted claim limitations. However, his description of the tear-down methodology contains several notable deficiencies.
First, Dr. Ng does not specify the lot numbers, manufacturing dates, or serial numbers of the samples he analyzed. His report states only that he obtained "production units" of each product line, without identifying when or where the units were manufactured, from which production lot they were drawn, or how they were procured. This omission raises questions about the representativeness of the samples, particularly in light of the PE-5000 design revision discussed below.
Second, Dr. Ng provides no chain-of-custody documentation for the samples. There is no attestation regarding who procured the samples, how they were stored prior to analysis, or whether they were maintained in their original factory-sealed packaging prior to tear-down. The absence of chain-of-custody documentation is a departure from standard expert practice in patent cases involving physical product analysis.
Third, Dr. Ng does not independently verify that the samples he analyzed are representative of the accused products as manufactured and sold during the relevant damages period (CY 2021 through CY 2024). Given that the PE-5000 Series underwent a design revision in Q3 2022, it is critical to know whether Dr. Ng's PE-5000 sample reflects the pre-revision or post-revision design configuration. His report is silent on this point.
By contrast, Dr. Ostrowski's tear-down methodology — developed in coordination with our team — documents the chain of custody for each sample, identifies the lot number and manufacturing date, confirms the sample's consistency with the accused products through comparison to Solstice's manufacturing records, and addresses both pre- and post-revision PE-5000 configurations. This methodological rigor provides a strong basis for challenging Dr. Ng's comparatively cursory approach.
3. Failure to Address Design Changes. Solstice's production documents (SBD-023100 through SBD-023415) establish that the PE-5000 Series blade deployment mechanism underwent a significant design revision in Q3 2022. The revision, documented in Solstice Engineering Change Order No. ECO-2022-0147 (SBD-023108), modified the cam-actuated blade retraction system to a direct-linkage retraction system, altered the geometry of the blade housing, and changed the angular displacement characteristics of the blade retraction arc. The revision was implemented across all PE-5000 production beginning with Lot No. 5K-2022-0731 (manufactured July 31, 2022) and was fully transitioned by September 2022.
Dr. Ng's report treats all PE-5000 Series units as having a single, uniform design configuration. He does not acknowledge the Q3 2022 design revision, does not distinguish between pre- and post-revision PE-5000 units, and does not analyze whether the post-revision design meets the asserted claim limitations. This oversight is particularly significant for the '884 Patent claims, which are directed to the blade deployment mechanism — the very subsystem that was redesigned.
The failure to address design changes is a critical gap that undermines the reliability of Dr. Ng's PE-5000 infringement opinions for the '884 Patent. If the post-revision PE-5000 operates via a direct-linkage system rather than a cam-actuated system, the element-by-element mapping that Dr. Ng presents may not apply to PE-5000 units manufactured after Q3 2022. Given that the damages period extends from CY 2021 through CY 2024, a substantial portion of the accused PE-5000 units would be post-revision products. Dr. Ostrowski's rebuttal report should address this design revision in detail, presenting the engineering differences between the pre- and post-revision configurations and analyzing whether the post-revision configuration meets each asserted claim limitation.
B. Patent-by-Patent Weakness Analysis
1. '237 Patent Weaknesses. ##### a. "Locking Seal Assembly" — Claim 1
The "locking seal assembly" limitation of independent Claim 1 of the '237 Patent is the single most important disputed limitation for the PE-5000 Series infringement analysis. The Court construed this term as requiring "a mechanical locking interface that positively retains the seal in a fixed position during use." This construction was one of the five constructions favorable to Solstice, and it was the subject of extensive briefing and argument at the Markman hearing.
The Court's construction requires two distinct elements: (1) a mechanical locking interface — i.e., a structural mechanism that locks via mechanical engagement rather than mere friction, adhesion, or interference — and (2) positive retention of the seal in a fixed position during use. Both elements impose meaningful structural and functional requirements that distinguish a true locking mechanism from a press-fit or friction-fit arrangement.
Dr. Ng's analysis of this limitation as applied to the PE-5000 conflates frictional retention with positive mechanical locking. The PE-5000 Series employs a press-fit interference design in which the seal component is pressed into the trocar housing with an interference fit that relies on friction between the seal's outer diameter and the housing's inner bore to retain the seal in position. There is no distinct mechanical locking interface — no detent, no bayonet engagement, no snap-fit latch, no threading, and no other structural feature that mechanically locks the seal independent of frictional forces.
Dr. Ng characterizes the press-fit interference as a "mechanical retention mechanism" and asserts that it "positively retains the seal during use." However, this characterization misapplies the Court's construction. A press-fit interference relies on frictional forces generated by the dimensional mismatch between the seal's outer diameter and the housing's inner bore; it does not involve a mechanical locking interface as that term is understood in the art and as the Court construed it. The Court's construction was specifically crafted to distinguish mechanical locking from frictional retention, and Dr. Ng's analysis effectively reads the "mechanical locking interface" requirement out of the claim.
This is our strongest non-infringement argument for the PE-5000 Series under the '237 Patent. It formed the basis for Solstice's Motion for Summary Judgment of Non-Infringement filed on April 1, 2025 (Dkt. No. 112). Although the Court denied the motion on May 5, 2025 (Dkt. No. 134), the denial was expressly without prejudice, and the Court noted that the factual record would benefit from trial presentation. The Court's denial order did not address the merits of the argument and does not preclude Solstice from pressing this non-infringement position at trial.
The PE-12000, by contrast, uses a bayonet-style retention feature — a quarter-turn engagement between protruding tabs on the seal assembly and corresponding slots in the housing — that more closely maps to the "mechanical locking interface" requirement. Dr. Ng's analysis of the PE-12000 on this limitation is correspondingly stronger, though questions remain about whether the bayonet engagement constitutes "positive retention" given evidence in Solstice's own design specifications (SBD-012465) noting that the bayonet feature provides "secondary retention" supplementing the primary press-fit interference.
##### b. "Resilient Sealing Member" — Claims 3 and 7
Dependent Claims 3 and 7 of the '237 Patent add limitations directed to the "resilient sealing member" component of the seal assembly. Dr. Ng asserts that the elastomeric gasket used in the PE-12000 satisfies this limitation.
However, the Court's construction of "resilient sealing member" requires the resilient member to be "a discrete component separate from the housing." This construction addresses the structural relationship between the sealing member and the trocar housing, requiring that they be distinct, separable components rather than an integral or monolithic structure.
The PE-12000's elastomeric gasket is manufactured through an overmolding process in which the elastomeric material is injected directly onto and around portions of the housing subassembly. The result is a gasket that is physically bonded to the housing at its interface surfaces and cannot be removed or separated without destroying either the gasket or the housing. Dr. Ng acknowledges the overmolding manufacturing process in a footnote at page 58 of his report but dismisses its significance in a single sentence, stating that "the overmolded gasket remains a functionally discrete sealing component notwithstanding its manufacturing integration with the housing."
This dismissal is inadequate. The Court's construction requires structural separateness ("a discrete component separate from the housing"), not merely functional discreteness. An overmolded gasket that is permanently bonded to the housing is, by definition, not "separate from the housing" in a structural sense. Dr. Ng's conflation of functional discreteness with structural separateness does not satisfy the Court's construction and is vulnerable to challenge in rebuttal and on cross-examination.
We note, however, that this argument is strongest with respect to the PE-12000 and may not apply with equal force to other product configurations. The PE-5000 uses a separately manufactured gasket that is inserted into the housing during assembly, which may satisfy the "discrete component separate from the housing" requirement. The rebuttal should focus the overmolding argument specifically on the PE-12000's Claims 3 and 7 analysis.
##### c. Claim 12 (Method Claim) — Induced Infringement
Dr. Ng opines that Solstice induces infringement of method Claim 12 of the '237 Patent by selling the PE-12000 Series together with IFU documentation that instructs surgeons and surgical technicians to deploy and lock the seal assembly in a manner that practices the claimed method steps. His induced infringement analysis occupies approximately two pages of the report (pages 64–66) and is limited to the following: (i) identification of the IFU document (SBD-008912 through SBD-008934); (ii) a general assertion that the IFU "instructs users to practice each step of the claimed method"; and (iii) a conclusory statement that "Solstice knew or should have known that its products would be used in an infringing manner."
This analysis is deficient in several critical respects. Under the Federal Circuit's decisions in Limelight Networks, Inc. v. Akamai Technologies, Inc., 572 U.S. 915 (2014), and Akamai Technologies, Inc. v. Limelight Networks, Inc., 797 F.3d 1020 (Fed. Cir. 2015) (en banc on remand), induced infringement under 35 U.S.C. § 271(b) requires proof that the accused inducer (i) had knowledge of the asserted patent, (ii) knew or was willfully blind to the fact that the induced acts constituted patent infringement, and (iii) took affirmative steps to induce the infringing conduct with specific intent to cause infringement.
Dr. Ng provides no evidence that Solstice had knowledge of the '237 Patent prior to the filing of this lawsuit. He cites no pre-suit notice letters, no evidence of patent marking by Apex, no Solstice internal documents reflecting awareness of the '237 Patent, and no other indicia of actual knowledge. His assertion that Solstice "knew or should have known" is a legal conclusion rather than a factual opinion supported by evidence, and it conflates the knowledge standard (which requires actual knowledge or willful blindness) with a negligence standard (which is insufficient for induced infringement).
Furthermore, Dr. Ng's reliance on the IFU document, standing alone, does not establish specific intent to induce infringement. An IFU document provides instructions for safe and effective use of a medical device as required by FDA regulations; it does not, without more, demonstrate that the manufacturer specifically intended that users would practice a patented method. Dr. Ng does not analyze the IFU instructions in sufficient detail to establish a step-by-step correspondence between the IFU instructions and the claimed method steps, nor does he address whether the instructions could be followed in a non-infringing manner.
This gap in the induced infringement analysis is significant because Claim 12 is a method claim, and direct infringement of a method claim requires performance of all claimed steps by a single entity or under the direction and control of a single entity. Surgeons and surgical technicians who use the PE-12000 are not agents of Solstice, and Solstice does not direct or control their surgical procedures. Accordingly, if induced infringement cannot be established, method Claim 12 may not be infringed at all.
##### d. DOE Analysis for PE-5000
As noted above, Dr. Ng presents an alternative doctrine-of-equivalents theory for the PE-5000 Series with respect to the "locking seal assembly" limitation of Claim 1. His function-way-result analysis is contained in a single paragraph at page 48 of his report and states, in its entirety:
"Even if the PE-5000's press-fit design does not literally meet the 'locking seal assembly' limitation as construed by the Court, it performs substantially the same function (retaining the seal in position during use), in substantially the same way (through a tight-fitting interface between the seal and the housing), to achieve substantially the same result (preventing seal dislodgement during instrument insertion and removal). Accordingly, the PE-5000 infringes Claim 1 under the doctrine of equivalents."
This analysis is conclusory in the extreme. It contains no engineering detail, no quantitative comparison of the forces involved in press-fit retention versus mechanical locking, no analysis of whether the "way" (friction-based retention versus mechanical engagement) is truly "substantially the same," and no consideration of the structural and functional differences between the two retention approaches. Courts routinely reject doctrine-of-equivalents arguments that are presented in conclusory terms without supporting technical analysis. See, e.g., Ashgrove & Co. v. Cypress Semiconductor Corp., 90 F.3d 1558, 1567 (Fed. Cir. 1996) (requiring a "particularized" analysis for doctrine of equivalents).
More fundamentally, prosecution history estoppel likely bars the application of the doctrine of equivalents to the "locking seal assembly" limitation. During prosecution of the '237 Patent, Apex amended the claims to add the "locking" language to distinguish prior art. Specifically, in a Response to Office Action dated March 14, 2016, Apex narrowed the original claim language from "seal assembly" to "locking seal assembly" and argued to the examiner that the prior art reference (U.S. Patent No. 8,157,832 to Whitfield et al.) disclosed only a friction-fit seal retention without a mechanical locking interface. This narrowing amendment was identified and analyzed in the prosecution history analysis memorandum prepared by Vassiliev and Bauer on September 5, 2024, with input from Dr. Jonathan Kendrick at Kendrick & Lau LLP.
Under Festo Corp. v. Fenmore & Co., 535 U.S. 722 (2002), and its progeny, a narrowing amendment made during prosecution to avoid prior art creates a presumption that the patentee surrendered all equivalents between the original claim scope and the amended claim scope. The patentee can rebut this presumption only by showing that (i) the equivalent was unforeseeable at the time of the amendment, (ii) the rationale for the amendment bore no more than a tangential relation to the equivalent in question, or (iii) there is some other reason why the patentee could not reasonably have been expected to have described the equivalent. None of these exceptions appears available here: a press-fit interference design was not only foreseeable but was the very type of prior art that Apex distinguished through the narrowing amendment. Dr. Ng's report does not address prosecution history estoppel at all — a pervasive omission discussed further in Section IV.C.1 below.
2. '884 Patent Weaknesses. ##### a. "Retractable Blade Deployment Mechanism" — Claim 1
The Court's construction of "retractable blade deployment mechanism" — one of the four constructions favorable to Apex — defined the term broadly as "a mechanism that deploys a cutting blade from a retracted position to a deployed position and subsequently retracts the blade." This construction gives Apex a broad claim scope that encompasses range mechanical configurations for blade deployment and retraction.
Dr. Ng's analysis on this term is relatively strong for the PE-12000 and PE-15000 Series, both of which employ a cam-actuated blade retraction system that clearly falls within the Court's broad construction. The cam-and-follower mechanism in these products deploys the blade through spring-loaded actuation and retracts it through a cam surface that rotates the blade back into the housing. Dr. Ng's element-by-element mapping on these products is well-supported by the tear-down evidence and the Solstice design specifications.
However, Dr. Ng's analysis is significantly less persuasive for the PE-5000 Series. As discussed in Section IV.A.3, the PE-5000 underwent a design revision in Q3 2022 that replaced the cam-actuated retraction system with a direct-linkage retraction system. The post-revision PE-5000 uses a sliding linkage mechanism rather than a cam-and-follower arrangement to retract the blade. While the post-revision mechanism may still fall within the Court's broad construction of "retractable blade deployment mechanism" (since it does deploy and retract a blade), Dr. Ng's element-by-element analysis is premised entirely on the cam-actuated system and does not address the direct-linkage system at all. His structural mapping, tear-down photographs, and engineering analysis all describe a cam-actuated mechanism; if his tear-down sample was a post-revision PE-5000, his description of the mechanism is inaccurate, and if it was a pre-revision sample, his analysis does not apply to post-revision units.
The rebuttal should emphasize the PE-5000 design revision, present the engineering differences between the pre- and post-revision configurations, and challenge Dr. Ng's failure to distinguish between them. Even if both configurations fall within the broad construction of "retractable blade deployment mechanism," the dependent claim limitations (particularly the angular displacement range of Claim 9) may not be met by the post-revision design.
##### b. "Safety Interlock" — Claim 5
The Court construed "safety interlock" as requiring "a mechanism that prevents blade deployment unless a predetermined sequence of user actions is completed." This construction was one of the five constructions favorable to Solstice and imposes a specific requirement: the safety mechanism must require a sequence — i.e., multiple steps performed in a defined order — to enable blade deployment.
Dr. Ng maps the PE-5000's single-button release to this limitation, asserting that the button press constitutes a "predetermined sequence" because the user must first grasp the trocar handle, then depress the button. This characterization is unpersuasive. Grasping the handle is not a deliberate safety-related user action; it is a necessary prerequisite to holding the device and is performed as part of all trocar operations, whether or not the blade is deployed. A single-button press does not constitute a "predetermined sequence of user actions" under any reasonable reading of the Court's construction.
The PE-12000 and PE-15000 Series, by contrast, employ a two-step activation mechanism: the user must first rotate a safety collar to an unlocked position and then depress the blade deployment button. This two-step process — rotate, then press — constitutes a "predetermined sequence of user actions" that more plausibly satisfies the Court's construction. Dr. Ng's analysis for the PE-12000 and PE-15000 on this limitation is correspondingly stronger.
The PE-5000 analysis on Claim 5 is therefore a significant non-infringement argument. If the PE-5000's single-button release does not meet the "safety interlock" limitation, Claim 5 is not infringed by the PE-5000 as a matter of law, regardless of whether the broader independent Claim 1 is met. This argument should be presented prominently in Dr. Ostrowski's rebuttal report.
##### c. "Angular Displacement Range" — Claim 9
Dependent Claim 9 of the '884 Patent requires that the blade retraction arc fall within a specified angular displacement range of 15° to 45°. This is a narrow numerical limitation that defines the geometry of the blade retraction motion.
Dr. Ng asserts that the blade retraction in all three accused product lines falls within the claimed 15° to 45° angular displacement range. His opinion is based on measurements taken from a single static photograph of each product's blade in its fully retracted position, from which he calculates the angular displacement by measuring the angle between the blade's deployed position (shown in a separate photograph) and its retracted position. He reports the PE-5000 blade retraction arc as "approximately 38°," the PE-12000 as "approximately 32°," and the PE-15000 as "approximately 29°."
This measurement methodology is problematic for several reasons. First, measuring angular displacement from static photographs does not capture the dynamic behavior of the blade during retraction. The blade retraction arc is a dynamic motion that occurs over a short time interval; a static photograph captures only the endpoint of that motion, not the path. If the blade oscillates, bounces, or overshoots its final resting position during retraction (as is common in spring-loaded mechanisms), the effective angular displacement during the retraction motion may differ from the angle measured between the deployed and final retracted positions.
Second, the accuracy of angular measurements taken from photographs depends critically on the camera angle, lens distortion, parallax, and the precision of the angle-measuring method. Dr. Ng does not describe any calibration or correction for these factors, nor does he provide uncertainty estimates for his measurements.
Third, and most importantly, Dr. Ostrowski's independent testing using a high-speed camera operating at 10,000 frames per second has shown that the PE-5000 blade retraction arc is approximately 48° to 52°, which is outside the claimed 15° to 45° range. This testing captures the full dynamic retraction motion, including the initial overshoot of the blade past its final resting position. The discrepancy between Dr. Ng's static measurement (approximately 38°) and Dr. Ostrowski's dynamic measurement (48°–52°) is likely attributable to the blade's overshoot behavior, which is visible in the high-speed footage but invisible in a static photograph.
This discrepancy is a strong non-infringement argument for the PE-5000 on Claim 9. If the PE-5000's blade retraction arc is 48°–52°, it falls outside the claimed 15°–45° range, and Claim 9 is not infringed by the PE-5000. Furthermore, Dr. Ng's reliance on static photographs rather than dynamic testing is a potential basis for a Daubert challenge to the reliability of his measurement methodology.
We note that the PE-12000 and PE-15000 measurements may also be vulnerable to challenge on the same methodological grounds, though Dr. Ostrowski's high-speed testing for those products has not shown the same degree of discrepancy. Her measurements for the PE-12000 (approximately 34°–37°) and PE-15000 (approximately 27°–31°) fall within the claimed range even under dynamic testing. The angular displacement argument is therefore strongest as applied to the PE-5000.
##### d. Claim 14 (Method Claim)
Dr. Ng's analysis of method Claim 14 of the '884 Patent suffers from the same induced infringement deficiency identified above with respect to Claim 12 of the '237 Patent. He provides no evidence of Solstice's knowledge of the '884 Patent prior to the lawsuit, no evidence of specific intent to induce infringement, and relies solely on the IFU documentation without adequate analysis of the correspondence between the IFU instructions and the claimed method steps. The analysis under Limelight and Akamai set forth in Section IV.B.1.c above applies with equal force here and need not be repeated.
Additionally, Dr. Ng's opinion that the method of Claim 14 is "inherently practiced" during normal use of the accused products conflates direct infringement with induced infringement. Inherency is a doctrine applicable to anticipation in the invalidity context and, in limited circumstances, to direct infringement when all method steps are necessarily performed by the user during normal product operation. But Dr. Ng's report frames the "inherently practiced" opinion as an alternative to his induced infringement theory, suggesting that Solstice is liable as an indirect infringer because the method is inherently practiced by users. This conflation of legal theories muddies his analysis and is subject to challenge.
To the extent Dr. Ng means to argue that direct infringement occurs because end users inherently practice all method steps during normal use, this theory requires proof that (i) each step of the claimed method is necessarily performed during normal use (not merely that it can be performed), and (ii) there is no non-infringing use of the product that avoids practicing all steps. Dr. Ng does not address either requirement in his report.
3. '105 Patent Weaknesses. ##### a. "Integrated Insufflation Valve and Seal" — Claim 1
The Court construed "integrated" in the context of the '105 Patent's Claim 1 to mean "formed as a single unitary structure or permanently joined so as to function as a single unit." This construction was favorable to Solstice because it requires either unitary formation (i.e., the valve and seal must be manufactured as a single monolithic component) or permanent joining (i.e., the valve and seal must be joined by a method that creates a permanent bond, such as welding, adhesive bonding, or overmolding).
The PE-12000 Series uses a snap-fit connection between the insufflation valve component and the seal component. The snap-fit design allows the valve and seal to be assembled into a unified subassembly by pressing the valve into the seal housing until snap-fit tabs engage corresponding recesses. Critically, this snap-fit connection is designed to be disassembled for cleaning and sterilization — a feature documented in Solstice's own product maintenance manual (SBD-009240 through SBD-009268), which instructs users to separate the valve and seal components between uses for autoclaving. A connection that is designed for disassembly is, by definition, not "permanently joined."
The PE-15000 Series has a somewhat different configuration that is closer to the claimed integration but still uses a releasable connection. The PE-15000 employs a threaded engagement between the valve and seal subassembly components, allowing separation by unscrewing. While the threaded connection provides a more secure attachment than the PE-12000's snap-fit, it remains a releasable, non-permanent connection.
Dr. Ng's analysis of the "integrated" limitation glosses over the disassembly feature with a single sentence, stating that "the snap-fit connection in the PE-12000 (and the threaded connection in the PE-15000) creates a functionally permanent joining that satisfies the 'integrated' limitation because, once assembled, the valve and seal operate as a single functional unit during surgical use." This assertion conflates functional integration with structural integration as required by the Court's construction. The Court's construction requires either unitary formation or permanent joining — both of which are structural characteristics. That two components function together during use does not make them "permanently joined" if they can be (and are intended to be) separated.
Dr. Ng provides no engineering analysis to support his characterization of the snap-fit or threaded connections as "functionally permanent." He does not address the product maintenance manual's disassembly instructions, does not discuss the mechanical properties of the snap-fit or threaded connections (e.g., the force required for disassembly, the number of assembly-disassembly cycles the connection is designed to withstand), and does not engage with the distinction between releasable and permanent connections.
This is a strong non-infringement argument for both the PE-12000 and PE-15000 on Claim 1 of the '105 Patent, and it should be a focal point of Dr. Ostrowski's rebuttal report. Dr. Ostrowski should present mechanical testing data demonstrating the releasability of the snap-fit and threaded connections, photographs of the disassembly process, and reference to the product maintenance manual's disassembly instructions.
##### b. "Zero-Leak" Threshold — Claim 4
Dependent Claim 4 of the '105 Patent requires "substantially zero leakage at pressures up to 25 mmHg." This limitation defines a performance specification: the accused product must achieve substantially zero leakage at insufflation pressures up to and including 25 mmHg, which is a standard insufflation pressure used in laparoscopic surgery.
Dr. Ng relies on Solstice's own QC testing data produced in discovery (SBD-031200 through SBD-031284) to demonstrate that the PE-12000 and PE-15000 achieve a leak rate of less than 0.1 cc/min, which he characterizes as "substantially zero leakage" within the meaning of the claim. On its face, a leak rate of less than 0.1 cc/min would appear to satisfy the "substantially zero" requirement.
However, the Solstice QC data on which Dr. Ng relies were measured at 15 mmHg, not at 25 mmHg as required by the claim. The QC test protocol (SBD-031204) specifies a test pressure of 15 mmHg, which is a standard QC pressure used by Solstice for routine production testing. The claim, however, requires substantially zero leakage "at pressures up to 25 mmHg" — meaning the performance must be demonstrated at pressures up to and including 25 mmHg, which is 67% higher than the pressure at which the QC data were collected.
Leak rate in pneumatic sealing systems is generally a function of pressure differential; higher pressures tend to increase leak rates by forcing more gas through any imperfections or gaps in the seal. There is no basis in the record — and Dr. Ng provides none — to assume that a leak rate measured at 15 mmHg would be the same or comparable at 25 mmHg. To the contrary, basic fluid dynamics principles suggest that leak rate would increase with pressure, potentially to a level that no longer qualifies as "substantially zero."
Dr. Ng does not address or even acknowledge this discrepancy between the test pressure in the QC data and the pressure specified in the claim. This is a significant factual vulnerability that may support a non-infringement finding on Claim 4. Dr. Ostrowski should address this issue in her rebuttal report, noting the pressure discrepancy and, if possible, presenting leak rate test data collected at 25 mmHg to demonstrate that the accused products do not achieve "substantially zero leakage" at the claim-specified pressure.
##### c. "Biocompatible Elastomeric Seal" — Claim 8
Dependent Claim 8 of the '105 Patent adds a material composition limitation requiring a "biocompatible elastomeric seal" with specific material properties. The claim specification, in describing the preferred embodiment, references a silicone elastomer with a durometer in the range of 30 to 50 Shore A and an elongation at break of at least 400%. While the claim language itself uses the broader term "biocompatible elastomeric seal," the specification's disclosure of these specific material properties may be relevant to construing the scope of the limitation.
Dr. Ng's opinion on Claim 8 identifies the seal material in the PE-12000 and PE-15000 as "medical-grade silicone" based on Solstice's published product specifications and marketing literature. He opines that medical-grade silicone is a biocompatible elastomer and therefore satisfies the material composition limitation.
However, Dr. Ng's analysis has a notable shortcoming: he did not conduct any independent material testing to confirm the material properties of the seal component. He did not measure the durometer, the elongation at break, the tensile strength, or any other material property. His identification of the material as "medical-grade silicone" is based solely on Solstice's published specifications, which describe the material in general terms but do not provide the specific durometer or elongation-at-break values that may be relevant to claim scope.
While the claim language does not expressly require a specific durometer or elongation range, the absence of independent material testing is a methodological weakness that can be exploited. If the claim is construed to require the specific material properties described in the specification (a construction that Solstice may advance at trial), Dr. Ng's analysis provides no factual basis to determine whether the accused products' seal ma