PRIVILEGED AND CONFIDENTIAL — ATTORNEY WORK PRODUCT
PRELIMINARY CLAIM CHART — NON-INFRINGEMENT ANALYSIS
U.S. PATENT NO. 10,932,105 ("THE '105 PATENT")
Matter No.: 10294.0017 Date: July 25, 2024
Prepared for: Solstice Biomedical Devices Ltd. / Solstice Biomedical, Inc.
Matter: Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA, United States District Court for the District of Delaware
Prepared by: Peter Vassiliev, Associate, Calderwood & Harkness LLP
Reviewed by: Christy Bauer, Lead Associate, Calderwood & Harkness LLP Marcus Delgado, Responsible Partner, Calderwood & Harkness LLP
Firm: Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, Delaware 19801
NOTICE: This document constitutes attorney work product prepared in anticipation of litigation and is protected by the work product doctrine and the attorney-client privilege. This document is prepared solely for the use of Solstice Biomedical Devices Ltd. and Solstice Biomedical, Inc. and their authorized representatives in connection with the above-captioned matter. This document shall not be disclosed, disseminated, distributed, or copied to any person or entity outside the authorized litigation team without the prior written approval of Marcus Delgado, Responsible Partner.
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I. INTRODUCTION AND PURPOSE
1.1 Background of the Engagement
Calderwood & Harkness LLP represents Solstice Biomedical, Inc. ("Solstice U.S."), the United States operating subsidiary of Solstice Biomedical Devices Ltd. ("Solstice Ireland"), an Irish private limited company, CRO No. 648217, in the defense of a patent infringement action filed by Apex Surgical Innovations, Inc. ("Apex") on May 9, 2024. The action, captioned Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA, is pending before Chief Judge Richard G. Andrews in the United States District Court for the District of Delaware.
Apex's Complaint alleges that certain laparoscopic trocar assembly products manufactured, marketed, sold, and/or offered for sale by Solstice U.S. in the United States infringe three patents owned by Apex: U.S. Patent No. 10,932,105 (the "'105 Patent"), U.S. Patent No. 11,247,237 (the "'237 Patent"), and U.S. Patent No. 11,589,884 (the "'884 Patent"). The Complaint asserts claims for direct infringement under 35 U.S.C. § 271(a) and induced infringement under 35 U.S.C. § 271(b) with respect to each asserted patent.
On June 14, 2024, Solstice U.S. timely filed its Answer, Affirmative Defenses, and Counterclaims. The Counterclaims assert claims for declaratory judgments of non-infringement, invalidity under 35 U.S.C. §§ 102, 103, and 112, and unenforceability based on inequitable conduct during prosecution of the asserted patents.
The present claim chart constitutes one of three preliminary non-infringement claim charts prepared in connection with the defense of the asserted patents. Companion preliminary non-infringement claim charts have been prepared for the '237 Patent (dated July 20, 2024) and the '884 Patent (dated July 22, 2024). Each chart addresses the specific claims asserted against the specific Solstice product lines identified in Apex's Complaint and subsequent infringement contentions.
1.2 The '105 Patent
The patent at issue in this claim chart is U.S. Patent No. 10,932,105, entitled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar" (the "'105 Patent"). The relevant bibliographic and ownership data for the '105 Patent are as follows:
• U.S. Patent No.: 10,932,105
• Title: "Integrated Insufflation Valve and Seal for Laparoscopic Trocar"
• Issue Date: March 2, 2021
• Filing Date: January 10, 2018
• Expiration Date: January 10, 2038 (absent any patent term adjustment or terminal disclaimer)
• Named Inventor: Dr. Raymond Szabo (identified as Vice President, Engineering, Apex Surgical Innovations, Inc.)
• Assignee: Apex Surgical Innovations, Inc., 1220 North Market Street, Suite 550, Wilmington, Delaware 19801 (EIN: 51-0483762)
• Number of Claims: 22 (3 independent claims; 19 dependent claims)
The '105 Patent is part of a broader patent family held by Apex that includes fourteen (14) total issued U.S. patents and six (6) pending continuation applications. The '105 Patent generally relates to a laparoscopic trocar design in which the insufflation valve and the instrument seal are structurally integrated into a single unified component within the trocar housing, as opposed to conventional modular designs in which the valve and seal are separate, independently replaceable parts. The specification of the '105 Patent repeatedly emphasizes the purported advantages of the "integrated" design, including reduction in leak points, simplified assembly, and enhanced pneumoperitoneum maintenance during laparoscopic procedures.
1.3 Asserted Claims
In its Complaint and preliminary infringement contentions served on June 28, 2024, Apex asserts Claims 1, 4, and 8 of the '105 Patent against two Solstice product lines:
1. PrecisionEdge™ PE-12000 Series — a 12 mm laparoscopic trocar assembly; and
2. PrecisionEdge™ PE-15000 Series — a 15 mm laparoscopic trocar assembly.
Apex's infringement contentions identify the PE-12000 Series and PE-15000 Series by model numbers (PE-12010, PE-12020, PE-12030, PE-15010, PE-15020, and PE-15030), encompassing all configurations within each product series. Notably, Apex does not accuse the PrecisionEdge™ PE-5000 Series (a 5 mm trocar assembly) of infringing the '105 Patent. The PE-5000 Series is, however, accused of infringing the '237 Patent and '884 Patent, and is addressed in the companion claim charts for those patents.
Claim 1 of the '105 Patent is an independent claim. Claims 4 and 8 are dependent claims, each depending directly from Claim 1 and adding further limitations to the claimed structure.
1.4 Purpose of This Chart
This preliminary claim chart provides an element-by-element non-infringement analysis mapping each limitation of Claims 1, 4, and 8 of the '105 Patent against the accused PrecisionEdge™ PE-12000 and PE-15000 products. The chart is intended to:
• Organize and document the factual and legal bases for Solstice's non-infringement positions at an early stage of the litigation;
• Identify the claim limitations that present the strongest non-infringement arguments and those that are most sensitive to claim construction outcomes;
• Anticipate and address potential doctrine-of-equivalents arguments by Apex;
• Guide the development of claim construction positions and expert discovery strategy; and
• Facilitate coordination among counsel of record and technical experts.
This chart is prepared in advance of claim construction proceedings. As of the date of this chart, the Markman hearing has not yet been scheduled. The parties' proposed claim constructions are to be exchanged on October 22, 2024, and a Joint Claim Construction Brief is due on November 4, 2024. Based on currently available scheduling information, the Markman hearing is anticipated to be held on November 18, 2024, before Chief Judge Andrews.
The analysis set forth herein is based on currently available information, including Solstice's own design documentation, product specifications, and an initial review of the '105 Patent's prosecution history as obtained from the United States Patent and Trademark Office. This chart is expressly subject to revision upon receipt and review of Apex's document production (expected on or about October 7, 2024), following the Court's Claim Construction Order, and as additional factual and technical information becomes available during the course of discovery.
The prosecution history analysis underlying certain aspects of this chart is being further developed in coordination with Kendrick & Lau LLP. Dr. Jonathan Kendrick, Lead Partner, Patent Prosecution, at Kendrick & Lau LLP (601 Pennsylvania Avenue NW, Suite 820, Washington, DC 20004), is assisting Calderwood & Harkness LLP with detailed prosecution history reviews and freedom-to-operate opinions for the asserted patents, including the '105 Patent. The prosecution history analysis memorandum is expected to be completed by September 5, 2024.
1.5 Privilege Designation
This document, in its entirety, constitutes attorney work product prepared in anticipation of litigation and is protected from disclosure by the work product doctrine under Federal Rule of Civil Procedure 26(b)(3) and the attorney-client privilege. The opinions, analyses, legal theories, and mental impressions contained herein reflect the legal assessments of counsel and are entitled to the heightened protection afforded to opinion work product.
This document is prepared solely for the use of Solstice Biomedical Devices Ltd. and Solstice Biomedical, Inc., together with their authorized officers, directors, employees, and outside counsel who have a need to know for purposes of the above-captioned litigation. This document shall not be disclosed, disseminated, distributed, or copied to any person or entity outside the authorized litigation team—including but not limited to business partners, vendors, insurers, or governmental authorities—without the prior written approval of Marcus Delgado, Responsible Partner, Calderwood & Harkness LLP. Any inadvertent disclosure of this document does not constitute a waiver of any applicable privilege or protection, and immediate return of the document and all copies is hereby requested in the event of inadvertent disclosure.
II. CLAIM CHART METHODOLOGY
2.1 Approach
This preliminary claim chart follows a structured, element-by-element analysis of each asserted claim of the '105 Patent. The approach is as follows:
Each asserted claim—Claim 1 (independent), Claim 4 (dependent), and Claim 8 (dependent)—is broken down into its constituent limitations, including the preamble and each individual structural element or feature recited in the claim body. For each limitation, the chart provides three categories of analysis:
(a) Patent Claim Language. The relevant claim language for the limitation is identified. Because the full verbatim text of the asserted claims is appended as Appendix 1, the claim language referenced in the body of this chart is presented in summarized or paraphrased form, with the understanding that the precise claim language governs. To the extent exact claim language was not available to the drafting team at the time of preparation (e.g., where language is anticipated based on the patent specification and initial claim review), bracketed notations are used to indicate that the precise language is to be confirmed against the patent itself.
(b) Accused Product Analysis. For each limitation, the chart describes the corresponding structure, feature, or design element (or the absence thereof) in the accused PrecisionEdge™ PE-12000 and PE-15000 products. This description is based on Solstice's internal design documentation, engineering specifications, manufacturing drawings, and bills of materials, as described in Section 2.2 below.
(c) Preliminary Non-Infringement Position. For each limitation, the chart sets forth Solstice's preliminary non-infringement position, explaining why the accused product does not meet the limitation under a proper claim construction. Where the non-infringement position is dependent on a particular claim construction, the chart identifies the relevant claim term and the construction upon which the position is based.
In addition to the literal non-infringement analysis, where literal non-infringement is argued for a given element, the chart also notes whether a doctrine-of-equivalents argument by Apex may be anticipated with respect to that element, and identifies any prosecution history estoppel, vitiation of claim limitations, or prior art ensnarement defenses that may foreclose such arguments. The doctrine-of-equivalents analysis is addressed in detail in Section VII of this chart.
The chart addresses each accused product line—PE-12000 and PE-15000—separately for each claim limitation, recognizing that the two products employ somewhat different seal designs (duck-bill vs. iris diaphragm) that may present distinct non-infringement arguments for certain limitations, even though the central non-infringement thesis (modular, non-integrated design) applies equally to both.
2.2 Sources Reviewed
In preparing this preliminary claim chart, the following sources were reviewed and relied upon:
1. U.S. Patent No. 10,932,105 — Specification and Drawings. The full patent specification, including the abstract, detailed description, and all figures (Figs. 1–14), was reviewed for purposes of understanding the claimed invention, identifying the scope of the asserted claims, and analyzing the intrinsic record.
2. U.S. Patent No. 10,932,105 — File History (Prosecution History). The complete file history of the '105 Patent was obtained from the United States Patent and Trademark Office and has been subjected to an initial review. A more detailed prosecution history analysis memorandum is in preparation and is expected to be completed by September 5, 2024, in coordination with Kendrick & Lau LLP.
3. Solstice Internal Design Documents and Engineering Specifications. Design documents and engineering specifications for the PrecisionEdge™ PE-12000 and PE-15000 product lines were provided by Niamh Cassidy, Vice President, Regulatory & IP, Solstice Biomedical Devices Ltd. These documents include product design history files, design verification and validation reports, design input and output specifications, and engineering change orders.
4. Solstice Manufacturing Drawings and Bills of Materials. Detailed manufacturing drawings (including cross-sectional views, exploded assembly diagrams, and dimensional tolerances) and bills of materials for the PE-12000 and PE-15000 assemblies were reviewed to confirm the structural configuration, component count, and assembly architecture of the accused products.
5. Solstice 510(k) Submissions. The 510(k) premarket notification submissions filed by Solstice with the U.S. Food and Drug Administration for the PE-12000 and PE-15000 product lines were reviewed to the extent relevant to device configuration, intended use, and design characteristics. These submissions confirm the modular, non-integrated design architecture of the accused products.
6. Preliminary Prosecution History Analysis Memorandum. A preliminary prosecution history analysis memorandum is in preparation by Kendrick & Lau LLP, with expected completion on September 5, 2024. Initial findings from this review have been incorporated into the present chart to the extent available.
7. Technical Consultation — Dr. Miriam Ostrowski. Dr. Miriam Ostrowski, Professor of Biomedical Engineering at Halford University, Philadelphia, Pennsylvania, has been retained as an expert consultant in this matter with respect to claim construction and invalidity issues. Dr. Ostrowski's retention agreement is dated August 20, 2024 and had not yet been formally executed at the time of this chart's preparation; however, engagement has been confirmed. Dr. Ostrowski's technical expertise in laparoscopic instrumentation and medical device design has informed the preliminary technical assessments set forth herein, and her formal input will be incorporated into revised versions of this chart.
2.3 Claim Construction Assumptions
Because the Markman hearing has not yet occurred and the Court has not yet issued a Claim Construction Order, this chart necessarily applies preliminary claim construction assumptions. For each disputed claim term, the chart applies both (a) Solstice's proposed plain-and-ordinary-meaning construction (where applicable) and (b) anticipated narrowing constructions based on the prosecution history and intrinsic record.
The key terms in the '105 Patent that are expected to be the subject of claim construction dispute include, but are not limited to, the following:
This chart flags each of these terms at the relevant limitation and notes where Solstice's non-infringement position is dependent upon the adoption of a particular construction. Where the non-infringement position would be weakened under Apex's anticipated broader construction, the chart identifies the degree of risk and alternative non-infringement arguments that may be available.
III. ACCUSED PRODUCTS — TECHNICAL DESCRIPTION
3.1 PrecisionEdge™ PE-12000 Series (12 mm Trocar Assembly)
The PrecisionEdge™ PE-12000 Series is a 12 mm diameter laparoscopic trocar assembly designed for minimally invasive surgical access. It is manufactured by Solstice Biomedical Devices Ltd. at its ISO 13485-certified facility in Galway, Ireland, and distributed in the United States by Solstice Biomedical, Inc. The PE-12000 Series is available in three primary configurations—the PE-12010 (standard length), PE-12020 (extended length), and PE-12030 (bariatric length)—each sharing the same fundamental trocar architecture and differing only in cannula length.
Key Components. The PE-12000 assembly comprises the following principal components, each of which is a separate, independently manufactured, and independently replaceable part:
(i) Outer Cannula Housing. A rigid polymer (polycarbonate) proximal housing body with an integral obturator channel and longitudinal bore extending distally to the cannula shaft. The housing serves as the primary structural frame of the trocar assembly.
(ii) Insufflation Stopcock. A standard medical-grade rotary stopcock valve (polycarbonate body with silicone O-ring seals) that connects to the trocar housing via a standard ISO 594 luer-lock port. The stopcock is a discrete, detachable component that is not physically incorporated into or structurally integrated with the instrument seal. It is connected to the housing at a port located on the lateral aspect of the proximal housing, external to the instrument bore.
(iii) Instrument Seal (Duck-Bill Style Silicone Seal). A self-closing, slit-type silicone elastomer seal configured in a "duck-bill" geometry. The seal is mounted in a removable seal cap that snaps onto the proximal end of the trocar housing. The seal provides instrument sealing by elastic deformation of the silicone slit around the instrument shaft. The seal does not incorporate any valve function; its sole function is to maintain pneumoperitoneum during instrument insertion and exchange.
(iv) Stability Anchor Sleeve. A threaded external sleeve on the cannula shaft that provides tissue anchoring and prevents inadvertent trocar migration during surgery.
Insufflation Mechanism. In the PE-12000 Series, insufflation gas (typically CO₂) enters the trocar assembly through the external stopcock valve, passes through the luer-lock port into the housing bore, and flows distally past the instrument seal into the patient's abdominal cavity. Critically, the gas pathway runs from an external, detachable stopcock component through a mechanical luer-lock fitting into the housing bore. The valve and seal are not in the same structural component; they occupy separate, distinct locations within the assembly architecture, and the gas pathway between them traverses a mechanical connection point (the luer-lock fitting) rather than an internal passage within a unified component.
Seal Design. The duck-bill silicone seal in the PE-12000 is a multi-layer elastomeric structure in which two opposing tapered silicone membranes form a self-closing slit. When no instrument is present, the slit is closed by the natural elasticity of the silicone, providing a gas-tight seal. When an instrument is inserted, the slit opens to accommodate the instrument shaft, and the silicone deforms elastically around the instrument to maintain a seal. The seal is housed in a removable seal cap that is mechanically separate from the trocar housing and can be removed, cleaned, and replaced independently. The seal does not incorporate any valve functionality, and its design, manufacturing, and assembly are entirely independent of the insufflation stopcock.
U.S. Sales Data. The PE-12000 Series is the highest-volume accused product. Cumulative U.S. sales for the period 2021 through Q3 2024, across all accused PrecisionEdge™ products (PE-12000 and PE-15000 combined), total approximately $74.6 million. The PE-12000 Series is accused of infringing all three asserted patents: the '237 Patent, the '884 Patent, and the '105 Patent.
3.2 PrecisionEdge™ PE-15000 Series (15 mm Trocar Assembly)
The PrecisionEdge™ PE-15000 Series is a 15 mm diameter laparoscopic trocar assembly designed for larger instrument access, including passage of endoscopic staplers, specimen retrieval bags, and other wide-bore laparoscopic instruments. Like the PE-12000 Series, the PE-15000 is manufactured in Galway, Ireland, and distributed in the United States by Solstice Biomedical, Inc. It is available in configurations PE-15010 (standard length), PE-15020 (extended length), and PE-15030 (bariatric length).
Key Components. The PE-15000 assembly comprises the following principal components:
(i) Outer Cannula Housing. A rigid polymer proximal housing body substantially similar in general design to the PE-12000, but with a larger bore diameter (15 mm) to accommodate larger instrumentation.
(ii) Insufflation Stopcock. A standard medical-grade rotary stopcock valve connected to the trocar housing via a standard ISO 594 luer-lock port. As with the PE-12000, the stopcock is a discrete, detachable component that is not physically incorporated into or integrated with the instrument seal. It is connected externally at a luer-lock port on the lateral aspect of the proximal housing.
(iii) Instrument Seal (Iris-Style Diaphragm Seal). Unlike the PE-12000's duck-bill seal, the PE-15000 employs an iris-style diaphragm seal composed of multiple overlapping polymer leaves arranged in a radial pattern. The iris mechanism allows the seal aperture to accommodate instruments of varying diameters while maintaining a gas-tight seal around the instrument shaft. The iris seal is housed in an independent seal module that is mechanically separate from the trocar housing and from the insufflation stopcock. The seal module does not incorporate any valve functionality.
(iv) Reducer Cap. A snap-fit adapter cap that can be placed over the seal module to reduce the effective bore diameter for accommodating smaller-diameter instruments, providing versatility in a single trocar assembly.
Insufflation Mechanism. The insufflation mechanism in the PE-15000 is architecturally similar to that of the PE-12000. The external stopcock valve connects to the trocar housing via a luer-lock fitting. Insufflation gas enters through the stopcock, passes through the luer-lock port into the housing bore, and flows distally past the iris seal into the abdominal cavity. The stopcock valve is mechanically separate from the iris seal, and the gas pathway between them traverses the luer-lock connection point.
Seal Design. The iris-style diaphragm seal in the PE-15000 operates on a fundamentally different mechanical principle than the duck-bill seal in the PE-12000 and, critically, on a fundamentally different principle than the "zero-clearance sealing interface" described in the '105 Patent. The iris mechanism uses multiple overlapping rigid-yet-flexible polymer leaves that slide radially to open and close the seal aperture. The sealing action is achieved by the overlapping arrangement of the leaves, not by compressive elastomeric contact around the circumference of the instrument. The iris seal module is a self-contained component that is removable from the trocar housing and contains no valve elements.
Accused Patent Claims. The PE-15000 Series is accused of infringing the '884 Patent and the '105 Patent. It is not accused of infringing the '237 Patent.
3.3 Critical Design Distinction (Both Products)
The central non-infringement theme for the '105 Patent, applicable to both the PE-12000 and PE-15000 product lines, is as follows:
In both the PE-12000 and PE-15000, the insufflation valve and the instrument seal are separate, discrete, independently manufactured, and independently removable components that are connected by a standard ISO 594 luer-lock fitting. The insufflation stopcock is an externally-mounted, detachable component that attaches to the trocar housing at a luer-lock port. The instrument seal (whether duck-bill in the PE-12000 or iris diaphragm in the PE-15000) is housed in a separate seal cap or seal module that is independently removable from the trocar housing. There is no structural integration between the valve and the seal; they are manufactured as separate parts, assembled into separate subassemblies, and can be removed and replaced independently without affecting the other component.
By contrast, the '105 Patent claims an "integrated insufflation valve and seal" — a single, unified structural component in which the valve and seal functions are combined into one integral assembly disposed within the trocar housing. The '105 Patent specification describes and illustrates this integrated design in detail, emphasizing that the integration eliminates the need for external connections and reduces the number of potential leak points. The specification expressly distinguishes the claimed integrated design from prior art modular designs in which the valve and seal are separate components.
This fundamental architectural difference — modular and non-integrated (Solstice) versus structurally integrated (the '105 Patent) — is the cornerstone of the non-infringement defense and permeates the claim-by-claim analysis that follows.
IV. CLAIM CHART — CLAIM 1 (INDEPENDENT CLAIM)
Claim 1 of the '105 Patent is the sole independent claim asserted against the accused products. All asserted dependent claims (Claims 4 and 8) depend from Claim 1. Accordingly, the Claim 1 analysis is the foundation of the non-infringement defense.
4.1 Preamble: Claim 1
Claim Language (Preamble):
"An integrated insufflation valve and seal assembly for a laparoscopic trocar, comprising:"
PE-12000 Analysis:
The PrecisionEdge™ PE-12000 trocar assembly includes a trocar with an insufflation stopcock and a separate instrument seal (duck-bill style). These are distinct, independently manufactured and independently assembled components. The insufflation stopcock is attached externally to the housing via a luer-lock port. The instrument seal is mounted in a removable seal cap. At no point in the design, manufacture, or assembly of the PE-12000 are the valve and seal combined into a single "integrated" component. The PE-12000 does not embody an "integrated insufflation valve and seal assembly" as recited in the preamble.
PE-15000 Analysis:
The PrecisionEdge™ PE-15000 likewise uses a separate stopcock valve (externally attached via luer-lock) and a separate iris diaphragm seal (housed in an independent seal module). As with the PE-12000, the valve and seal in the PE-15000 are discrete, modular components, not an "integrated" assembly. The PE-15000 does not embody an "integrated insufflation valve and seal assembly" as recited in the preamble.
Preliminary Non-Infringement Position:
The preamble of Claim 1 recites "[a]n integrated insufflation valve and seal assembly for a laparoscopic trocar." Solstice's position is that this preamble is limiting — i.e., it gives life, meaning, and vitality to the claim and narrows the scope of the claim to require that the assembly be "integrated" within the meaning of the specification. The specification of the '105 Patent defines the invention in express contradistinction to prior art modular designs, stating that "[t]he present invention provides a single, unified valve-and-seal assembly in which the insufflation valve and the instrument seal are structurally integrated, thereby eliminating the need for separate valve and seal components and reducing the number of potential gas leak pathways." (See '105 Patent, col. 2, ll. 14–21.) This language demonstrates that the term "integrated" in the preamble is not merely a general descriptive label but serves as a fundamental limitation on the claimed structure.
Because the accused PE-12000 and PE-15000 products use modular, non-integrated architectures in which the valve and seal are separate components, neither product satisfies the preamble limitation. If the preamble is found to be limiting (as Solstice will argue), this alone defeats infringement of Claim 1 and, by extension, all dependent claims.
Even if the Court were to find the preamble non-limiting, the individual element limitations analyzed below independently establish non-infringement.
4.2 Element 1a — Trocar Housing Defining a Longitudinal Bore
Claim Language (Element 1a):
"a trocar housing defining a longitudinal bore extending from a proximal end to a distal end of the housing;"
PE-12000 Analysis:
The PE-12000 includes an outer cannula housing made of rigid polycarbonate that defines a longitudinal bore extending from the proximal end (where the seal cap and instrument entry are located) through the cannula shaft to the distal end. This element appears to be literally met by the PE-12000. The PE-12000's outer cannula housing defines a longitudinal bore through which surgical instruments are inserted and through which insufflation gas flows into the abdominal cavity.
PE-15000 Analysis:
Similarly, the PE-15000 includes an outer cannula housing with a longitudinal bore extending from the proximal to distal ends of the device. The bore diameter is 15 mm, but the structural configuration is analogous to the PE-12000. This element also appears to be literally met by the PE-15000.
Preliminary Non-Infringement Position:
Solstice does not contest this element in isolation. Both the PE-12000 and PE-15000 include a trocar housing defining a longitudinal bore, and this element is likely met under any reasonable claim construction. The non-infringement defense for Claim 1 does not rest on this element.
However, it should be noted that the term "trocar housing" may require construction depending on whether it encompasses the entire trocar assembly (including the cannula shaft, seal cap, and stopcock port) or refers only to the proximal housing body in which the claimed integrated valve-and-seal assembly is disposed. Solstice's proposed construction of "trocar housing" as the proximal housing body is consistent with the specification's use of the term and may have implications for other claim limitations (particularly element 1b, discussed below).
4.3 Element 1b — Insufflation Valve Disposed Within the Trocar Housing
Claim Language (Element 1b):
"an insufflation valve disposed within said trocar housing and integrated with a seal body within said trocar housing, the insufflation valve being configured to regulate the flow of insufflation gas into the longitudinal bore;"
PE-12000 Analysis:
The insufflation stopcock on the PE-12000 is a separate, externally-mounted component that connects to the trocar housing via a standard ISO 594 luer-lock port located on the lateral aspect of the proximal housing. The stopcock body is positioned outside the housing — it protrudes laterally from the housing surface and is not disposed within the housing interior. The stopcock is detachable: it can be connected to or disconnected from the luer-lock port by hand without tools and without disturbing the instrument seal or any other component of the trocar assembly. The stopcock is not "integrated with a seal body" — it is a mechanically and structurally separate component from the duck-bill instrument seal, which is housed in a removable seal cap at the proximal end of the housing.
PE-15000 Analysis:
The PE-15000 employs the same insufflation architecture as the PE-12000. The insufflation stopcock is an externally-mounted, detachable component connected to the housing via a luer-lock port. It is not disposed within the trocar housing, and it is not integrated with the iris diaphragm seal module. The stopcock and the seal module are manufactured separately, housed separately, and are independently removable.
Preliminary Non-Infringement Position:
This element represents one of the strongest grounds for non-infringement. The claim requires an insufflation valve that is (i) "disposed within" the trocar housing and (ii) "integrated with a seal body within said trocar housing." Neither condition is met by the accused products:
(i) "Disposed within." The insufflation stopcock on both the PE-12000 and PE-15000 is not disposed within the trocar housing. It is an externally-mounted component that attaches to the outside surface of the housing via a luer-lock port. The stopcock body is external to the housing bore and external to the housing structure. The plain meaning of "disposed within" requires that the valve be located inside the housing, not attached to its exterior surface.
(ii) "Integrated with a seal body." The insufflation stopcock is not "integrated with" the instrument seal in any structural sense. The stopcock and the seal are separate parts, manufactured independently, assembled independently, and connected only through the housing bore (with the luer-lock fitting serving as the connection between the stopcock and the housing). The stopcock and the seal do not share any structural elements, are not co-assembled, and are not part of a single component.
Prosecution History Estoppel Note: The prosecution history of the '105 Patent should be reviewed for any amendments or arguments made during prosecution that narrowed the scope of "disposed within" or "integrated with" to exclude externally-coupled valve configurations. Preliminary review suggests that during prosecution, the examiner rejected original claims as anticipated by prior art references disclosing modular trocar designs with external stopcock valves, and the applicant responded by amending the claims to require the valve to be "disposed within said trocar housing and integrated with a seal body within said trocar housing." If confirmed, this amendment would create prosecution history estoppel precluding Apex from arguing that an external, detachable stopcock valve is equivalent to a valve "disposed within" and "integrated with" the housing. Cross-reference: Prosecution History Analysis Memorandum (target completion September 5, 2024).
4.4 Element 1c — Zero-Clearance Sealing Interface
Claim Language (Element 1c):
"a seal member positioned within the trocar housing, the seal member providing a zero-clearance sealing interface around a surgical instrument inserted through the longitudinal bore;"
PE-12000 Analysis:
The PE-12000 uses a duck-bill silicone seal that provides instrument sealing through a self-closing elastomeric slit design. When an instrument is inserted through the seal, the two opposing tapered silicone membranes deform elastically around the instrument shaft. The seal does not provide a "zero-clearance sealing interface" as that term is properly construed. The duck-bill seal design inherently involves a slit that opens upon instrument insertion, creating a dynamic sealing contact that depends on the elasticity of the silicone rather than a compressive gasket-style contact around the entire circumference. The duck-bill slit does not provide uniform circumferential compressive contact; rather, it provides line-contact sealing along the slit edges.
Solstice will argue that "zero-clearance sealing interface" requires a specific mechanical seal configuration as disclosed in the '105 Patent specification — namely, a gasket-style seal with continuous compressive contact around the entire circumference of the instrument, maintaining zero gap between the seal surface and the instrument at all contact points. The duck-bill slit seal does not satisfy this construction.
PE-15000 Analysis:
The PE-15000 uses an iris-style diaphragm seal composed of multiple overlapping polymer leaves arranged in a radial pattern. The iris mechanism allows variable aperture sealing by the overlapping of the leaves around the instrument shaft. The iris seal operates on a fundamentally different mechanical principle than the "zero-clearance sealing interface" described in the '105 Patent. The overlapping leaves create a seal through mechanical overlap and slight compression, but the seal is not a continuous, circumferentially-uniform compressive gasket. There are inherent micro-gaps between adjacent leaves that are managed by the overlap geometry, not by continuous compressive contact. Solstice will argue that the iris diaphragm seal is structurally and functionally distinct from the "zero-clearance sealing interface" described and claimed in the '105 Patent.
Preliminary Non-Infringement Position:
Neither the duck-bill seal (PE-12000) nor the iris diaphragm seal (PE-15000) meets the "zero-clearance sealing interface" limitation under Solstice's proposed construction. The '105 Patent specification describes the "zero-clearance sealing interface" in the context of a compressive gasket-type seal that maintains continuous, uniform circumferential contact with the instrument shaft, stating that "the seal member provides a zero-clearance sealing interface in which the seal surface maintains continuous compressive contact around the full circumference of the instrument, ensuring that no clearance or gap exists between the seal and the instrument at any point." (See '105 Patent, col. 5, ll. 32–39.)
Furthermore, the prosecution history includes amendments and arguments by the applicant that distinguished prior art references disclosing slit-style (duck-bill) and iris-style diaphragm seals. Preliminary review indicates that during prosecution, the examiner cited U.S. Patent No. 6,142,933 (Wigness), which discloses a duck-bill slit seal in a trocar, and the applicant distinguished Wigness by arguing that the duck-bill slit seal does not provide a "zero-clearance sealing interface" as claimed. If confirmed, this prosecution history argument would estop Apex from reading "zero-clearance sealing interface" broadly enough to encompass duck-bill or iris seal designs.
Claim Construction Sensitivity: This non-infringement position is moderately sensitive to the claim construction outcome. If the Court adopts Apex's anticipated broader construction of "zero-clearance sealing interface" as "any seal that provides a tight fit around an instrument," the non-infringement position on this element would be weakened, particularly for the PE-12000 (whose duck-bill seal does provide a functional, though not gasket-style, seal around instruments). However, even under a broader construction, the other non-infringement grounds (elements 1b, 1d, 1e, and the preamble) remain strong and independently defeat infringement.
4.5 Element 1d — Fluidic Coupling Between Valve and Seal
Claim Language (Element 1d):
"the insufflation valve being fluidically coupled to the seal member such that insufflation gas passes through the insufflation valve and past the seal member into an abdominal cavity of a patient;"
PE-12000 Analysis:
In the PE-12000, the insufflation gas pathway runs from the external stopcock valve through the luer-lock port, enters the housing bore, and flows distally past the instrument seal into the patient's abdominal cavity. In a general, functional sense, the stopcock and the seal are in the same gas flow pathway — gas does pass "through" the stopcock and "past" the seal en route to the abdominal cavity. However, the stopcock and the seal are not "fluidically coupled" in the sense contemplated by the '105 Patent. The claim recites the insufflation valve being "fluidically coupled to the seal member" in the context of an integrated assembly in which both the valve and the seal are internal components of a single unified structure. In the PE-12000, the valve and seal are in separate housings connected by a mechanical fitting (the luer-lock). The gas pathway between them is not an internal fluid passage within a unified component; it traverses an external mechanical connection.
PE-15000 Analysis:
The PE-15000 has the same insufflation architecture. The external stopcock connects via luer-lock to the housing bore, and gas flows past the iris seal. The stopcock and seal are not fluidically coupled within an integrated component; they are in separate housings connected by a mechanical fitting.
Preliminary Non-Infringement Position:
Solstice's position is that "fluidically coupled," in the context of the '105 Patent, means an internal fluid pathway within an integrated valve-and-seal component — that is, the valve and seal are connected by an internal gas passage within a single unified structural assembly, without the need for external connections or mechanical fittings. This construction is supported by the specification, which describes the fluid coupling as an internal feature of the integrated assembly: "the insufflation valve is fluidically coupled to the seal member by means of an internal gas channel formed within the integrated valve-and-seal body." (See '105 Patent, col. 6, ll. 8–12.)
The accused products' architecture — in which the stopcock is an external component connected to the housing by a luer-lock fitting, and the gas pathway between the stopcock and the seal traverses this external connection — does not satisfy the "fluidically coupled" limitation. The specification teaches away from externally-coupled, modular designs, describing the prior art as having "multiple external connections that are susceptible to gas leaks and require careful assembly to ensure a seal." (See '105 Patent, col. 1, ll. 45–49.) The claimed "fluidic coupling" is an internal, inherent feature of the integrated design that is absent from the modular Solstice products.
Claim Construction Sensitivity: This non-infringement position is sensitive to claim construction. If "fluidically coupled" is construed broadly to mean any fluid connection between a valve and a seal, regardless of whether the connection is internal or external, integrated or modular, the non-infringement argument on this element alone would be weakened. However, even under a broad construction, the non-infringement positions on elements 1b (valve not disposed within the housing), 1e (valve actuator not part of integrated assembly), and the preamble remain independently strong.
4.6 Element 1e — Valve Actuator Mechanism
Claim Language (Element 1e):
"a valve actuator mechanism operably connected to the insufflation valve for controlling the flow of insufflation gas, the valve actuator mechanism being accessible from an exterior of the trocar housing;"
PE-12000 Analysis:
The PE-12000 uses a standard rotary stopcock for insufflation control. The stopcock includes a rotary handle (the actuator) that the user turns to open or close the gas flow pathway. This rotary handle is a conventional component of the detachable external stopcock and is not integrated into the trocar housing or the seal body. The actuator is located on the external stopcock component, physically separate from the housing and the seal. While the actuator is "accessible from an exterior" of the device in a colloquial sense (it can be turned by hand), it is not "accessible from an exterior of the trocar housing" in the claimed sense, because it is not part of the trocar housing at all — it is part of a separate, detachable stopcock component.
PE-15000 Analysis:
The PE-15000 employs the same standard rotary stopcock with the same externally-located rotary actuator. The actuator is on the detachable stopcock, not on the trocar housing.
Preliminary Non-Infringement Position:
The "valve actuator mechanism" as claimed in the '105 Patent is a component of the integrated valve-and-seal assembly within the trocar housing. The claim recites that the valve actuator mechanism is "operably connected to the insufflation valve" and "accessible from an exterior of the trocar housing." This language presupposes that the valve (and its actuator) are part of the trocar housing assembly — the actuator is "accessible from an exterior of the trocar housing" because it is built into the housing and extends to the housing exterior for user access, while the valve itself is internal.
In the accused products, the stopcock actuator is not part of the trocar housing. It is part of a separate, detachable stopcock component that is merely attached to the housing via a luer-lock fitting. The actuator does not extend through or from the trocar housing; it is on a separate component. Even if the actuator function is nominally similar (both control gas flow by rotating a valve element), the structural integration required by the claim — an actuator that is part of the trocar housing and "accessible from an exterior" thereof — is absent from the accused products.
4.7 Summary — Claim 1 Non-Infringement Position
The preliminary analysis identifies multiple independent grounds for non-infringement of Claim 1 with respect to both the PE-12000 and PE-15000 product lines:
(1) Preamble — No "Integrated" Assembly. The accused products use modular, non-integrated architectures in which the insufflation valve and instrument seal are separate, discrete components. The preamble's recitation of "integrated" is limiting and is not met.
(2) Element 1b — Valve Not "Disposed Within" the Trocar Housing. The insufflation stopcock is externally mounted and attached via luer-lock, not disposed within the trocar housing. The stopcock is not "integrated with a seal body within" the housing.
(3) Element 1c — No "Zero-Clearance Sealing Interface." Neither the duck-bill seal (PE-12000) nor the iris diaphragm seal (PE-15000) constitutes a "zero-clearance sealing interface" as properly construed based on the specification and prosecution history.
(4) Element 1d — No "Fluidic Coupling" Within an Integrated Component. The gas pathway between the external stopcock and the instrument seal traverses a luer-lock fitting between separate components, not an internal fluid channel within an integrated valve-and-seal body.
(5) Element 1e — No "Valve Actuator Mechanism" as Part of an Integrated Assembly. The stopcock actuator is on the external, detachable stopcock component and is not part of the trocar housing assembly.
Strongest Positions. Elements 1b and 1c present the strongest non-infringement arguments for both accused products. Element 1b (valve not disposed within the housing) is a clear structural distinction that should be straightforward to demonstrate with physical product exhibits and engineering drawings. Element 1c (no zero-clearance sealing interface) is further supported by prosecution history arguments distinguishing slit-seal and iris-seal designs.
Doctrine of Equivalents. Apex may argue that Solstice's external stopcock connected via luer-lock is equivalent to an integrated valve under the doctrine of equivalents. This argument should be foreclosed by (a) prosecution history estoppel, if the applicant amended claims or made arguments during prosecution to distinguish modular designs, (b) vitiation of the "integrated" limitation (discussed in Section VII), and (c) prior art ensnarement (discussed in Section VII).
V. CLAIM CHART — CLAIM 4 (DEPENDENT CLAIM)
5.1 Dependency
Claim 4 of the '105 Patent is a dependent claim that depends directly from independent Claim 1. As a dependent claim, Claim 4 incorporates all limitations of Claim 1 and adds at least one additional limitation. Under well-established patent law, a dependent claim cannot be infringed unless all limitations of the independent claim from which it depends are also met. See 35 U.S.C. § 112(d); Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1553 (Fed. Cir. 1989).
Because Solstice's preliminary analysis demonstrates that the accused PE-12000 and PE-15000 products do not infringe independent Claim 1 on multiple independent grounds, Claim 4 is likewise not infringed as a threshold matter. Nevertheless, this section addresses the additional limitation of Claim 4 for completeness, to establish an independent non-infringement ground for this dependent claim and to ensure a fully developed record for claim construction and expert discovery.
5.2 Additional Limitation of Claim 4
Claim Language (Additional Limitation of Claim 4):
"The integrated insufflation valve and seal assembly of claim 1, wherein the seal member comprises a self-sealing elastomeric membrane concentrically disposed within the trocar housing and forming a gas-tight seal around an instrument of varying diameter inserted through the longitudinal bore."
PE-12000 Analysis:
The PE-12000's duck-bill seal is fabricated from silicone elastomer and is, in a general material sense, an "elastomeric membrane." However, it is not "concentrically disposed within the trocar housing" as claimed. The duck-bill seal is mounted in a removable seal cap that snaps onto the proximal end of the trocar housing. The seal is not disposed concentrically within the housing bore itself; rather, it is housed in an independent cap component that sits atop the housing. The term "concentrically disposed within the trocar housing" requires that the seal membrane be positioned inside the housing bore in a concentric arrangement — i.e., with the seal's central axis aligned concentrically with the longitudinal bore of the housing, and with the seal physically located within the housing interior. The PE-12000's duck-bill seal is not positioned within the housing interior; it is in a removable cap component that is attached to the exterior of the housing's proximal end.
Furthermore, the duck-bill seal's slit geometry does not form a "concentric" seal. The slit creates a linear opening that deforms around the instrument, but the sealing contact is along the slit edges rather than around the full circumference in a concentric pattern. This is structurally distinct from the concentric elastomeric membrane described in the '105 Patent specification, which illustrates a continuous annular membrane disposed within the housing bore.
PE-15000 Analysis:
The PE-15000's iris diaphragm seal is not an "elastomeric membrane" at all. The iris mechanism is a multi-leaf mechanical diaphragm composed of overlapping rigid-yet-flexible polymer leaves. These leaves are not elastomeric in the material science sense — they do not rely on elastic deformation to seal, but rather on mechanical overlap and radial sliding motion. The iris seal is also housed in an independent seal module, not concentrically disposed within the trocar housing.
The iris diaphragm is structurally and functionally different from a "self-sealing elastomeric membrane." The iris seal requires mechanical actuation (the leaves slide radially) rather than self-sealing elastomeric recovery. This is a categorical distinction that independently defeats infringement of Claim 4 for the PE-15000.
Preliminary Non-Infringement Position:
Even assuming arguendo that all limitations of Claim 1 were met (which they are not), Claim 4's additional limitation is independently not met for both accused products:
(a) PE-12000. The duck-bill seal is not "concentrically disposed within the trocar housing" as claimed. It is mounted in a removable seal cap, not within the housing bore. The slit geometry does not provide concentric sealing.
(b) PE-15000. The iris diaphragm seal is not a "self-sealing elastomeric membrane." It is a multi-leaf mechanical diaphragm composed of polymer leaves, not an elastomeric membrane. This is a categorical structural difference that is not subject to reasonable dispute.
Each of these grounds provides an independent basis for non-infringement of Claim 4, supplementing the multiple independent grounds established for Claim 1.
VI. CLAIM CHART — CLAIM 8 (DEPENDENT CLAIM)
6.1 Dependency
Claim 8 of the '105 Patent is a dependent claim. Based on initial review of the patent claims, Claim 8 depends directly from Claim 1 (the exact dependency chain is to be confirmed against the patent text; if Claim 8 depends from an intermediate dependent claim, all intermediate limitations would also need to be met). All limitations of Claim 1 must be satisfied as a prerequisite to infringement of Claim 8.
As with Claim 4, the threshold non-infringement argument applies: because Solstice's preliminary analysis demonstrates that the accused products do not infringe independent Claim 1 on multiple independent grounds, Claim 8 is likewise not infringed. This section addresses the additional limitation of Claim 8 for completeness and to establish independent non-infringement grounds.
6.2 Additional Limitation of Claim 8
Claim Language (Additional Limitation of Claim 8):
"The integrated insufflation valve and seal assembly of claim 1, wherein the valve actuator mechanism comprises a rotatable cam element that transitions between an open position permitting insufflation gas flow and a closed position blocking gas flow, the cam element being co-molded with the seal member."
PE-12000 Analysis:
The PE-12000's insufflation stopcock uses a rotary valve element — a standard rotary stopcock handle that the user turns to open or close the gas flow pathway. In a general functional sense, this rotary handle operates in a manner analogous to a "rotatable cam element" that transitions between open and closed positions. However, this functional similarity is irrelevant to the non-infringement analysis because the claim further requires that the cam element be "co-molded with the seal member."
In the PE-12000, the stopcock is an entirely separate component from the duck-bill seal. The stopcock is manufactured independently (injection-molded polycarbonate body with silicone O-ring seals), and the duck-bill seal is manufactured independently (silicone elastomer). They are never co-molded; they are produced in separate manufacturing processes, in separate molds, and are assembled as discrete components connected by a luer-lock fitting. There is no manufacturing step in which the valve element and the seal member are formed together as a single co-molded piece.