claim-chart-884-patent.docx

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

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PRELIMINARY CLAIM CHART — NON-INFRINGEMENT ANALYSIS

U.S. Patent No. 10,271,884 ("the '884 Patent")

"Retractable Blade Deployment Mechanism for Trocar Systems"

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1. Introduction and Purpose

This memorandum sets forth a preliminary element-by-element claim chart mapping the asserted claims of U.S. Patent No. 10,271,884 (the "'884 Patent") against the PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series trocar assemblies manufactured and sold by Solstice Biomedical, Inc. ("Solstice" or "Defendant"). Solstice Biomedical, Inc. is the U.S. operating subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company (CRO No. 648217), with its principal U.S. offices located at 9400 Innovation Drive, Suite 300, San Diego, California 92121.

This claim chart has been prepared in connection with the defense of the patent infringement action captioned Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA, filed on May 9, 2024 in the United States District Court for the District of Delaware by Apex Surgical Innovations, Inc. ("Apex" or "Plaintiff"), a Delaware corporation (EIN: 51-0483762), with its principal place of business at 1220 North Market Street, Suite 550, Wilmington, Delaware 19801.

This document constitutes a preliminary non-infringement analysis and is intended to serve several critical purposes in connection with the defense of this action:

(a) To identify, on a limitation-by-limitation basis, the specific claim elements of the asserted claims of the '884 Patent that are not met by each accused PrecisionEdge™ product line;

(b) To inform the overall defensive strategy for Solstice in connection with the '884 Patent, including the identification of the strongest non-infringement arguments available for each accused product;

(c) To guide the scope and direction of discovery, including written discovery directed to Apex and the identification of internal Solstice documents and third-party materials that will be critical to the development and support of Solstice's non-infringement positions; and

(d) To provide a framework for coordination with invalidity contentions being developed in parallel, such that the litigation team can present a comprehensive and coherent defense.

The '884 Patent is one of three patents asserted by Apex in this action. The remaining two asserted patents are as follows:

• U.S. Patent No. 9,814,237 (the "'237 Patent"), which is the subject of a separate preliminary claim chart and non-infringement analysis dated July 20, 2024; and

• U.S. Patent No. 10,932,105 (the "'105 Patent"), which is the subject of a separate preliminary claim chart and non-infringement analysis currently in preparation, with a target completion date of July 25, 2024.

It is important to note that claim construction has not yet occurred in this litigation. As of the date of this memorandum, the Markman hearing has not yet been scheduled by the Court. Accordingly, this analysis is based on the plain and ordinary meaning of the claim terms as they would be understood by a person of ordinary skill in the art at the time of the invention, informed by the intrinsic record (the claims, specification, and prosecution history). This analysis will be updated and refined following the exchange of proposed claim constructions by the parties, currently expected on or about October 22, 2024, and following the issuance of the Court's Claim Construction Order after the Markman hearing.

The prior art search and prosecution history review underlying portions of this analysis were conducted with the assistance of Kendrick & Lau LLP (Dr. Jonathan Kendrick, Lead Partner, Patent Prosecution, 601 Pennsylvania Avenue NW, Suite 820, Washington, DC 20004). Kendrick & Lau's search results and prosecution history analysis have been incorporated into this memorandum where relevant, and a comprehensive report from Kendrick & Lau is forthcoming.

Finally, it should be noted that the '884 Patent is part of a larger patent family comprising fourteen (14) issued U.S. patents and six (6) pending continuation applications, all assigned to Apex. The claim charts and non-infringement analyses prepared in connection with this litigation address only those claims of those patents that have been specifically asserted by Apex against the accused PrecisionEdge™ products. However, the broader patent family is being monitored for potential additional assertions and for the purpose of understanding the full scope of Apex's prosecution history across related applications, which may have bearing on claim construction and prosecution history estoppel arguments.

2. Summary of the '884 Patent

2.1 Patent Overview

U.S. Patent No. 10,271,884, entitled "Retractable Blade Deployment Mechanism for Trocar Systems," was filed in the United States Patent and Trademark Office and issued on April 30, 2019. The patent is set to expire on September 15, 2036, assuming payment of all required maintenance fees.

The named inventor is Dr. Raymond Szabo, who is currently Vice President of Engineering at Apex Surgical Innovations, Inc. Dr. Szabo is identified as the sole inventor on the face of the patent. The patent is assigned to Apex Surgical Innovations, Inc., 1220 North Market Street, Suite 550, Wilmington, Delaware 19801. The assignment was recorded with the USPTO and is reflected in the patent's assignment records.

The '884 Patent contains twenty-two (22) claims in total, of which Claims 1 and 9 are independent claims. Apex has asserted Claims 1, 2, 5, 9, and 14 against the accused PrecisionEdge™ products. Claims 2 and 5 are dependent on independent Claim 1. Claim 14 is dependent on independent Claim 9.

2.2 Technology Overview

The '884 Patent generally relates to a retractable blade deployment mechanism for trocar systems used in minimally invasive laparoscopic surgery. Trocars are surgical instruments used to create access ports through the abdominal wall or other body tissue, through which laparoscopic instruments are subsequently inserted to perform surgical procedures. The trocar typically consists of two principal components: a hollow cannula (which remains in place during the procedure to maintain the access port) and an obturator (which is inserted through the cannula and includes a sharp tip or blade to puncture the tissue).

The '884 Patent describes a mechanism whereby a cutting blade within a trocar obturator is deployed from a retracted (shielded) position to an extended (cutting) position upon the application of axial force against tissue. The patent further describes an automatic retraction feature, whereby the blade automatically retracts to the shielded position upon penetration of the body wall, thereby reducing the risk of inadvertent injury to underlying organs and tissues. This automatic retraction is a safety feature intended to address one of the longstanding concerns in laparoscopic trocar design — the risk of uncontrolled trocar entry causing damage to intra-abdominal structures.

The key inventive concepts claimed in the '884 Patent include:

(i) A specific mechanical linkage governing the deployment and retraction of the blade, described in the specification as comprising a series of interconnected lever arms, pivot points, and guide channels within the obturator housing;

(ii) A spring-biased retraction system that continuously urges the blade toward the retracted (shielded) position, such that the blade deploys only when the axial force applied to the trocar tip exceeds the biasing force of the spring;

(iii) A trigger mechanism responsive to axial loading, whereby the application of force against the trocar tip by contact with tissue activates the deployment linkage and causes the blade to transition from the retracted to the deployed position; and

(iv) A safety lock mechanism that prevents inadvertent blade deployment in the absence of a predetermined condition, such as the application of a threshold axial force or the engagement of a manual release.

The specification of the '884 Patent describes several embodiments of the retractable blade deployment mechanism, including variations in the number and configuration of lever arms, the type and arrangement of biasing springs, and the design of the safety lock. The claims at issue, however, are directed to particular configurations of these elements, as set forth in the claim chart analysis below.

2.3 Prosecution History Highlights

A detailed prosecution history analysis for the '884 Patent is being prepared in a separate memorandum (working title: Analysis of Apex Prosecution History — U.S. Patent No. 10,271,884), with a target completion date of September 5, 2024. That memorandum is being prepared by Christy Bauer and Peter Vassiliev with input from Dr. Jonathan Kendrick of Kendrick & Lau LLP.

On a preliminary basis, the following observations regarding the prosecution history are noted:

• During prosecution, the claims of the '884 Patent were narrowed in response to prior art rejections issued by the USPTO examiner. The original claims were broader in scope and did not include certain limitations that now appear in the issued claims, including specific structural requirements for the mechanical linkage and the spring-biased retraction system.

• Amendments were made to distinguish prior art references relating to blade deployment mechanisms in surgical access devices, including trocar and endoscopic access device designs disclosed in earlier patents. The specific references cited and the arguments made by the applicant during prosecution are being catalogued and analyzed.

• Based on preliminary review, prosecution history estoppel arguments may be available to limit the scope of certain claim elements, particularly where Apex narrowed claim language to overcome prior art rejections. These arguments will be developed in detail in the prosecution history analysis memorandum and will inform the doctrine of equivalents analysis set forth in Section 10 of this memorandum.

2.4 Claims Asserted

Apex has asserted Claims 1, 2, 5, 9, and 14 of the '884 Patent against the accused PrecisionEdge™ products. The structure of the asserted claims is as follows:

Claim 1 is an independent claim directed to a trocar assembly comprising a retractable blade deployment mechanism. Claim 1 sets forth the core structural limitations of the apparatus, including the housing/cannula structure, the retractable blade element, the mechanical linkage/deployment mechanism, the spring-biased retraction system, and the safety lock feature. Each of these limitations is analyzed in detail in Section 4 below.

Claim 2 is dependent on Claim 1 and incorporates all of the limitations of Claim 1 by reference. Claim 2 adds a further limitation regarding the specific configuration of the spring-biased retraction system, including requirements relating to the type of spring, its orientation within the obturator, and/or the force characteristics of the biasing member.

Claim 5 is also dependent on Claim 1 and incorporates all of the limitations of Claim 1 by reference. Claim 5 adds a limitation requiring that the trigger mechanism be responsive to a predetermined axial force threshold applied to the trocar tip — that is, the blade deploys only when the axial force against tissue reaches a specific, predetermined level.

Claim 9 is an independent method claim directed to a method of deploying a retractable blade in a trocar system. Claim 9 recites a series of method steps that parallel the structural elements of Claim 1, including steps for positioning the trocar assembly, applying axial force, deploying the blade through a mechanical linkage, and retracting the blade after penetration.

Claim 14 is dependent on Claim 9 and incorporates all of the method steps of Claim 9 by reference. Claim 14 adds a limitation requiring that the automatic retraction of the blade occur upon "detection" of penetration of the body wall, suggesting the use of a specific sensing or mechanical feedback mechanism to determine when penetration has occurred.

3. Description of Accused Products

3.1 PrecisionEdge™ PE-5000 Series (5 mm Trocar Assembly)

The PrecisionEdge™ PE-5000 Series is a 5 mm diameter laparoscopic trocar assembly designed for minimally invasive surgical access. The PE-5000 is the smallest-diameter product in the PrecisionEdge™ line and is typically used for secondary port access during laparoscopic procedures, accommodating 5 mm diameter laparoscopic instruments such as graspers, dissectors, and scissors.

The PE-5000 Series incorporates a blade deployment mechanism within the obturator component. The key structural features of the PE-5000's blade mechanism that are relevant to this non-infringement analysis include:

• Blade Architecture: The PE-5000 utilizes a dual-edge triangular blade housed within the obturator tip. The blade is mounted on a sliding carriage that moves along a linear guide track within the obturator body. Unlike the lever-arm-based mechanical linkage described in the '884 Patent specification, the PE-5000's blade carriage translates linearly along a single axis without the use of interconnected pivot-mounted lever arms.

• Deployment Mechanism: The PE-5000 employs a cam-based actuation system in which a cam follower on the blade carriage engages with a helical cam groove machined into the interior wall of the obturator housing. Axial displacement of the trocar tip causes the cam follower to travel along the cam groove, which imparts both axial and rotational motion to the blade carriage, resulting in blade extension. This cam-based system is structurally distinct from the lever-and-pivot mechanical linkage claimed in the '884 Patent.

• Retraction Mechanism: The PE-5000 uses an elastomeric retraction band — a medical-grade silicone elastomer loop — rather than a coiled compression spring, to bias the blade toward the retracted position. The elastomeric band provides a restoring force that returns the blade carriage to the shielded position when axial force against the trocar tip is released.

• Safety Features: The PE-5000 incorporates a rotary safety collar on the proximal end of the obturator that must be manually rotated to a "ready" position before the blade can deploy. This rotary collar mechanism differs from the mechanical detent-based safety lock described in the '884 Patent specification.

The PE-5000 Series has been commercially available in the United States since approximately the third quarter of 2020. U.S. sales data for the accused PrecisionEdge™ products, in the aggregate across all three product lines, total approximately $74.6 million for the period from calendar year 2021 through the third quarter of 2024. The PE-5000 contributes a portion of the combined yearly totals of $12.1 million (CY 2021), $17.8 million (CY 2022), $22.4 million (CY 2023), and $22.3 million (CY 2024 through September 30, 2024). Disaggregated sales figures for each individual product line are being compiled and will be supplemented in subsequent analyses.

The PE-5000 is accused of infringing the '884 Patent and also the '237 Patent. The '237 Patent infringement allegations are addressed separately in the claim chart dated July 20, 2024.

3.2 PrecisionEdge™ PE-12000 Series (12 mm Trocar Assembly)

The PrecisionEdge™ PE-12000 Series is a 12 mm diameter laparoscopic trocar assembly and is the most versatile product in the PrecisionEdge™ line. The 12 mm diameter accommodates a wide range of laparoscopic instruments, including staplers, clip appliers, and specimen retrieval devices, making it the most commonly used port size in laparoscopic general surgery, bariatric surgery, and gynecologic procedures.

The key structural features of the PE-12000's blade deployment mechanism relevant to this analysis include:

• Blade Architecture: The PE-12000 utilizes a pyramidal (three-sided) blade geometry with a broader cutting profile than the PE-5000. The blade is mounted on a deployment carriage that translates within the obturator body along a guided track.

• Deployment Mechanism: The PE-12000 employs a hybrid cam-and-lever actuation system. The primary deployment motion is initiated by a cam mechanism similar to that of the PE-5000, but the PE-12000 incorporates a secondary lever arm that amplifies the blade extension stroke. While this hybrid system includes a lever element, the overall architecture, pivot geometry, and operational sequence differ from the multi-arm mechanical linkage described and claimed in the '884 Patent. The PE-12000's lever arm acts as a stroke amplifier rather than as a direct deployment linkage connecting the trigger to the blade. The extent of the structural distinction between the PE-12000's hybrid system and the claimed "mechanical linkage" is a key issue requiring further factual development during discovery.

• Retraction Mechanism: The PE-12000 uses a dual-spring retraction assembly comprising two nested stainless steel coil springs that bias the blade carriage toward the retracted position. While the PE-12000 does use coil springs, the arrangement (nested, dual-spring, with a progressive force curve) differs from the single-spring or constant-force spring arrangements described in the '884 Patent specification. The significance of this distinction under the claim language will depend on claim construction.

• Safety Features: The PE-12000 incorporates an electronic proximity sensor-based safety interlock that detects the position of the cannula seal relative to the obturator and prevents blade deployment unless the obturator is fully seated within the cannula. This electronic safety system is architecturally distinct from the purely mechanical safety lock described in the '884 Patent.

The PE-12000 is accused of infringing all three asserted patents — the '237, '884, and '105 Patents. It is the highest-volume product in the PrecisionEdge™ line and accounts for the largest share of the combined accused product sales figures.

3.3 PrecisionEdge™ PE-15000 Series (15 mm Trocar Assembly)

The PrecisionEdge™ PE-15000 Series is a 15 mm diameter laparoscopic trocar assembly designed for larger-port procedures requiring the passage of larger instruments or the extraction of surgical specimens. The 15 mm port size is commonly used in procedures involving endoscopic staplers, large-diameter specimen retrieval bags, and other instruments that require a wider access channel.

The key structural features of the PE-15000's blade deployment mechanism relevant to this analysis include:

• Blade Architecture: The PE-15000 uses a broad, flat-profile blade with a beveled cutting edge. The blade is mounted on a deployment sled that translates within a channel machined into the obturator body. The blade geometry and mounting configuration differ from those described in the '884 Patent, which illustrates and describes a more compact, tapered blade profile in the preferred embodiments.

• Deployment Mechanism: The PE-15000 employs a pneumatically-assisted cam actuation system. The initial deployment is cam-actuated (similar to the PE-5000), but the PE-15000 incorporates a pneumatic assist cylinder that augments the deployment force at larger trocar diameters where tissue resistance is greater. The pneumatic assist component has no analog in the purely mechanical system described in the '884 Patent.

• Retraction Mechanism: The PE-15000 uses a gas-spring retraction mechanism — a sealed cylinder containing pressurized nitrogen gas that provides a constant biasing force to return the blade to the retracted position. This gas-spring system is functionally and structurally distinct from the coiled mechanical spring described in the '884 Patent.

• Safety Features: The PE-15000 incorporates a dual-redundant safety system comprising (i) a mechanical detent pin that must be manually released before the blade can deploy, and (ii) an electronic sensor that detects whether the obturator is correctly seated in the cannula. The mechanical detent component of this dual system bears some superficial resemblance to the safety lock described in the '884 Patent, but the dual-redundant architecture and the incorporation of an electronic sensor distinguish it from the purely mechanical lock claimed in the patent.

The PE-15000 is accused of infringing the '884 Patent and the '105 Patent. It is the lowest-volume product of the three accused product lines, reflecting the more specialized clinical applications for which a 15 mm port is required.

4. Claim Chart: Claim 1 (Independent)

The following claim chart maps each limitation of Claim 1 of the '884 Patent against the features of the accused PrecisionEdge™ products and sets forth Solstice's preliminary non-infringement position for each limitation. The claim language is based on the issued claim text as it appears in the '884 Patent. Each limitation has been parsed into a separate row for clarity of analysis.

4.1 Preamble

4.2 Limitation 1(a) — Housing / Cannula Structure

4.3 Limitation 1(b) — Retractable Blade Element

4.4 Limitation 1(c) — Mechanical Linkage / Deployment Mechanism

4.5 Limitation 1(d) — Spring-Biased Retraction System

4.6 Limitation 1(e) — Safety Lock Feature

4.7 Summary — Claim 1 Non-Infringement Position by Product

Based on the preliminary analysis set forth above, the non-infringement position for each accused product with respect to Claim 1 is summarized as follows:

PE-5000 Series: The PE-5000 does not meet at least limitations 1(c) and 1(d), and likely does not meet limitation 1(e). The PE-5000's cam-based actuation system, elastomeric retraction band, and rotary safety collar are each structurally and functionally distinct from the corresponding claimed elements. The PE-5000 presents the strongest non-infringement position of the three accused product lines with respect to Claim 1.

PE-12000 Series: The PE-12000 potentially does not meet limitation 1(c) (mechanical linkage), as its hybrid cam-and-lever system does not include a "plurality of interconnected lever arms mounted on respective pivot points." The PE-12000 also does not meet limitation 1(e) (safety lock), as it uses an electronic sensor-based interlock rather than a mechanical detent. However, the PE-12000's use of coil springs in its retraction system may satisfy limitation 1(d), and the PE-12000's hybrid system includes a lever element that, while not meeting the literal claim language, is closer to the claimed structure than the purely cam-based systems of the PE-5000 and PE-15000. The PE-12000 position requires further factual development through discovery, particularly regarding the internal architecture of the PE-12000's deployment mechanism.

PE-15000 Series: The PE-15000 potentially does not meet limitations 1(c) and 1(e), and may not meet limitation 1(d). The PE-15000's pneumatically-assisted cam system lacks lever arms; its gas-spring retraction mechanism differs from a conventional mechanical spring; and its dual-redundant safety system, while incorporating a mechanical detent pin, operates on a manual-release principle rather than a force-responsive principle as claimed. The PE-15000 presents a moderate to strong non-infringement position. The analysis is ongoing and will be refined as additional technical details of the PE-15000 mechanism are developed.

5. Claim Chart: Claim 2 (Dependent on Claim 1)

Claim 2 of the '884 Patent depends from Claim 1 and therefore incorporates all of the limitations of Claim 1 by reference. Claim 2 adds a further limitation relating to the specific configuration of the spring-biased retraction system. As a threshold matter, because Claim 2 is dependent on Claim 1, non-infringement of Claim 1 necessarily establishes non-infringement of Claim 2. The analysis below addresses the additional limitation of Claim 2 for completeness.

5.1 Additional Limitation — Specific Spring-Biased Configuration

6. Claim Chart: Claim 5 (Dependent on Claim 1)

Claim 5 of the '884 Patent depends from Claim 1 and therefore incorporates all of the limitations of Claim 1 by reference. Claim 5 adds a further limitation requiring that the deployment trigger be responsive to a predetermined axial force threshold. As with Claim 2, non-infringement of Claim 1 necessarily establishes non-infringement of Claim 5. The analysis below addresses the additional limitation of Claim 5 for completeness.

6.1 Additional Limitation — Trigger Responsive to Predetermined Axial Force Threshold

7. Claim Chart: Claim 9 (Independent — Method Claim)

Claim 9 of the '884 Patent is an independent method claim directed to a method of deploying a retractable blade in a trocar system. The method claim presents both structural/operational non-infringement arguments (paralleling the apparatus claim analysis for Claim 1) and a separate, independent divided infringement defense. Each method step is analyzed below.

7.1 Preamble

7.2 Step 9(a) — Positioning the Trocar Assembly

7.3 Step 9(b) — Applying Axial Force

7.4 Step 9(c) — Blade Deployment via Mechanical Linkage

7.5 Step 9(d) — Blade Retraction After Penetration

7.6 Summary — Claim 9 Non-Infringement Position

The non-infringement position for Claim 9 is supported by two independent theories, either of which is independently sufficient to defeat infringement:

Theory 1 — Structural/Operational Differences: The method steps of Claim 9 require the use of a "mechanical linkage" (Steps 9(a) and 9(c)) and a "biasing member" effecting automatic retraction (Step 9(d)). As established in the Claim 1 analysis, the PrecisionEdge™ products' deployment mechanisms and retraction systems differ structurally from the claimed elements. If the accused products do not contain the claimed structures, the claimed method steps cannot be practiced using the accused products, and the method claim is not infringed. The structural non-infringement arguments developed for Claim 1 apply with equal force to the corresponding method steps of Claim 9.

Theory 2 — Divided Infringement: Even assuming, arguendo, that the structural elements of the accused products satisfy the apparatus limitations recited in the method steps, Solstice does not itself perform all method steps of Claim 9. The claimed method is practiced, if at all, by surgeons using the PrecisionEdge™ products in the operating room. Solstice manufactures and sells the devices but does not position the trocar, apply axial force, or deploy the blade. There is no agency, contractual, or joint-enterprise relationship between Solstice and the end-user surgeons that would create vicarious liability. Under Akamai Technologies, Inc. v. Limelight Networks, Inc., 797 F.3d 1020 (Fed. Cir. 2015) (en banc), a defendant cannot be liable for direct infringement of a method claim unless it performs all steps of the claimed method, either directly or through agents acting under its direction or control. Solstice does not direct or control the surgical use of the PrecisionEdge™ products by independent physician users.

Both theories apply across all three accused product lines — the PE-5000, PE-12000, and PE-15000 — though the structural arguments are strongest for the PE-5000 and PE-15000, and the divided infringement defense applies uniformly to all three.

8. Claim Chart: Claim 14 (Dependent on Claim 9)

Claim 14 of the '884 Patent depends from Claim 9 and therefore incorporates all of the method steps of Claim 9 by reference. Claim 14 adds a further limitation requiring that the automatic retraction of the blade occur upon "detection" of penetration. As with the dependent apparatus claims, non-infringement of Claim 9 necessarily establishes non-infringement of Claim 14. The analysis below addresses the additional limitation of Claim 14 for completeness.

8.1 Additional Limitation — Automatic Retraction Upon Penetration Detection

9. Cross-Product Summary Matrix

9.1 Non-Infringement Summary Table

The following matrix summarizes the strength of Solstice's non-infringement position for each asserted claim of the '884 Patent across each accused product line:

Key Takeaways:

PE-5000 Series: Presents the strongest non-infringement position across all five asserted claims. The principal distinctions lie in the PE-5000's cam-based deployment mechanism architecture (limitation 1(c)), its elastomeric retraction band (limitation 1(d)), and its rotary safety collar (limitation 1(e)). Each of these features is fundamentally different in structure and operation from the corresponding claimed elements. The displacement-based (rather than force-threshold) deployment trigger further strengthens the position with respect to Claim 5. The divided infringement defense provides an additional, independent basis for non-infringement of the method claims (Claims 9 and 14).

PE-12000 Series: Presents a moderate non-infringement position that requires further factual development during discovery. The primary non-infringement argument is the absence of a "plurality of interconnected lever arms mounted on respective pivot points" (limitation 1(c)), as the PE-12000's hybrid cam-and-lever system includes only a single lever arm acting as a stroke amplifier. The PE-12000's electronic safety interlock (limitation 1(e)) also differs from the claimed mechanical detent. However, some claim limitations — particularly the spring-biased retraction system (limitation 1(d)) — are more closely aligned with the PE-12000's design (which uses coil springs), potentially reducing the strength of the non-infringement position on those specific limitations. Additional technical investigation of the PE-12000's internal mechanism architecture during discovery is critical to strengthening this position.

PE-15000 Series: Presents a moderate to strong non-infringement position. The principal distinctions lie in the PE-15000's pneumatically-assisted cam deployment mechanism (lacking lever arms — limitation 1(c)) and its gas-spring retraction mechanism (differing from a conventional mechanical spring — limitation 1(d)). The safety lock analysis (limitation 1(e)) presents a more nuanced argument given the presence of a mechanical detent pin, though the manually-released nature of the pin distinguishes it from the force-responsive detent of the '884 Patent. The method claims (Claims 9 and 14) are additionally subject to the divided infringement defense, which applies uniformly. The absence of a penetration detection mechanism provides a strong basis for non-infringement of Claim 14 independent of the Claim 9 analysis.

10. Preliminary Assessment of Doctrine of Equivalents

In addition to literal non-infringement, the analysis must address the possibility that Apex will assert infringement under the doctrine of equivalents. Under the doctrine of equivalents, a product that does not literally satisfy a claim limitation may nonetheless infringe if the accused product element performs substantially the same function, in substantially the same way, to achieve substantially the same result as the claimed limitation. Warner-Jenkinson Co. v. Harborline Enterprises Davis Chem. Co., 520 U.S. 17 (1997). The doctrine of equivalents is applied on a limitation-by-limitation basis and is subject to important limiting doctrines, including prosecution history estoppel, the all-limitations rule, and the disclosure-dedication doctrine.

For each key limitation where literal non-infringement is strongest, the following preliminary assessment of potential doctrine of equivalents arguments is provided:

Limitation 1(c) — Mechanical Linkage: Apex could argue that the PrecisionEdge™ cam-based, hybrid cam-and-lever, and pneumatically-assisted deployment mechanisms perform substantially the same function (translating axial force into blade deployment), in substantially the same way (converting linear motion to blade extension), to achieve substantially the same result (deploying the blade from a retracted position to a deployed position). However, this argument faces significant obstacles. First, the function-way-result analysis is not as straightforward as Apex might contend: a cam-follower mechanism and a lever-arm linkage operate on fundamentally different mechanical principles. A cam system converts motion through a groove-and-follower interface; a lever-arm linkage converts motion through interconnected rigid bodies pivoting on fixed points. These are different "ways" of achieving the result. Second, prosecution history estoppel may bar Apex from expanding the claim scope under the doctrine of equivalents if the specific lever-arm linkage language was added or narrowed during prosecution to overcome prior art. If Apex amended the claims to require "a plurality of interconnected lever arms mounted on respective pivot points" to distinguish prior art references disclosing alternative deployment mechanisms (such as cam-based systems), Apex surrendered claim scope and cannot recapture that scope through the doctrine of equivalents. Festo Corp. v. Fenmore & Co., 535 U.S. 722 (2002). This argument will be fully developed following completion of the prosecution history analysis.

Limitation 1(d) — Spring-Biased Retraction System: Apex could argue that elastomeric retraction bands (PE-5000) and gas springs (PE-15000) perform substantially the same function as a mechanical spring (biasing the blade toward the retracted position). While there is some functional overlap, the "way" in which each element operates differs: an elastomeric band stores energy through molecular deformation of a polymer; a gas spring stores energy through compression of a gas; and a mechanical coil spring stores energy through elastic deformation of a metal coil. These are different physical mechanisms. Additionally, prosecution history estoppel may apply if the term "spring" was specifically chosen during prosecution to distinguish prior art using non-spring biasing elements. The all-limitations rule further constrains this analysis: if "spring" is given a specific meaning through claim construction that excludes elastomeric and pneumatic biasing elements, the doctrine of equivalents cannot be used to effectively read out the "spring" limitation.

Limitation 1(e) — Safety Lock Feature: Apex could argue that the PrecisionEdge™ products' rotary collar (PE-5000), electronic sensor (PE-12000), and dual-redundant system (PE-15000) are equivalents of the claimed mechanical detent. However, the claim specifically requires "a mechanical detent engageable with the cutting blade or the mechanical linkage," which is a structurally specific limitation. An electronic sensor performs the safety function in a fundamentally different way than a mechanical detent (electronic sensing vs. physical engagement). The rotary collar also differs in kind. Prosecution history estoppel arguments and the all-limitations rule apply here as well.

Preliminary View: Prosecution history estoppel and the all-limitations rule provide meaningful defenses against doctrine of equivalents arguments, particularly for the mechanical linkage and spring-biased retraction limitations (limitations 1(c) and 1(d)). The prosecution history analysis being prepared by Christy Bauer and Peter Vassiliev (target completion: September 5, 2024) will be critical to fully developing these estoppel arguments. Based on preliminary review, it appears that the applicant narrowed the claims during prosecution in ways that will limit Apex's ability to expand claim scope under the doctrine of equivalents. This analysis will be updated and refined as the prosecution history review is completed.

11. Discovery and Investigation Needs

The following discovery and investigation steps are necessary to develop and support Solstice's non-infringement positions and to advance the defense of this action.

11.1 Documents Needed from Apex

The following categories of documents should be sought from Apex through formal written discovery:

(a) Internal design documents and engineering specifications for the patented blade deployment mechanism, including engineering drawings, CAD files, design specifications, test data, and prototype records relating to the retractable blade deployment mechanism described in the '884 Patent. These documents are critical to understanding the scope of the claimed invention and the specific structural embodiments that Apex contends fall within the claims.

(b) Complete prosecution file history for the '884 Patent (Application No. to be confirmed), including all communications between Apex (or its patent counsel) and the USPTO, all office actions, responses, amendments, declarations, and information disclosure statements. The complete file wrappers for related family members (the fourteen issued U.S. patents and six pending continuation applications) should also be obtained to the extent they contain prosecution arguments or amendments that may give rise to prosecution history estoppel or that bear on the construction of the asserted claims.

(c) Prior licensing agreements involving the '884 Patent, including any licenses, settlement agreements, or covenant-not-to-sue agreements that Apex has entered into with third parties relating to the '884 Patent or related patents in the same family. These agreements are relevant to understanding the claim scope that Apex has previously asserted (or conceded) in licensing negotiations and may bear on damages issues as well.

(d) Inventor notebooks, laboratory records, and communications of Dr. Raymond Szabo relating to the development, design, testing, and refinement of the claimed retractable blade deployment mechanism. These documents are relevant to claim construction (understanding what the inventor considered to be within the scope of the invention) and may also be relevant to invalidity contentions.

(e) Apex's marketing materials, product literature, and technical presentations relating to products embodying the '884 Patent, which may be relevant to understanding how Apex itself characterizes the scope and novelty of the patented technology.

Solstice's First Set of Interrogatories (fifteen (15) interrogatories) and First Set of Requests for Production (thirty-eight (38) requests) directed to Apex are currently being prepared and are scheduled for service on August 19, 2024. The above categories of documents will be addressed in the requests for production.

11.2 Internal Solstice Documents Needed

The following categories of internal Solstice documents must be collected, reviewed, and produced (to the extent required by discovery obligations):

(a) Complete engineering specifications, CAD drawings, and design history files for the PE-5000, PE-12000, and PE-15000 blade deployment subsystems, including detailed mechanical drawings, assembly drawings, bill of materials, tolerance specifications, and functional descriptions of the deployment mechanism, retraction mechanism, and safety features of each product.

(b) Manufacturing process documentation, including manufacturing instructions, quality control specifications, and inspection records for the blade deployment subsystems of the accused products. These documents are relevant to establishing the precise structure and operation of the accused products' mechanisms.

(c) Design-around analyses or freedom-to-operate opinions previously obtained by Solstice in connection with the development of the PrecisionEdge™ products. If Solstice obtained FTO opinions relating to the '884 Patent or related Apex patents prior to product launch, these opinions may be relevant (subject to privilege considerations) to demonstrating that Solstice designed the PrecisionEdge™ products to avoid the '884 Patent claims.

(d) Prior art search results and FTO analysis prepared by Kendrick & Lau LLP (Dr. Jonathan Kendrick) in connection with this litigation. These materials are being compiled and will inform both the non-infringement and invalidity analyses.

Solstice's document production is in progress. A total of 48,217 documents (Bates Nos. SBD-000001 through SBD-048217) are scheduled for production by September 30, 2024.

11.3 Expert Consultation

Retention of a technical expert in biomedical engineering is recommended to support claim construction, non-infringement analysis, and invalidity contentions. Expert input will be critical for refining the non-infringement positions on the mechanical linkage (limitation 1(c)) and deployment mechanism limitations, as these positions require detailed technical analysis of the structural and operational differences between the PrecisionEdge™ products and the patented mechanism.

Preliminary candidate for expert retention:

Dr. Miriam Ostrowski Professor of Biomedical Engineering Halford University Department of Biomedical Engineering 3401 Walnut Street, Philadelphia, PA 19104 Rate: $750/hour

Dr. Ostrowski has extensive experience in surgical instrument design and has served as an expert witness in prior patent litigation involving laparoscopic devices. Her curriculum vitae and list of prior testimony are on file. A retention agreement is being prepared for review and execution.

Expert input will be sought on the following specific topics:

(i) Whether the PrecisionEdge™ products' deployment mechanisms constitute a "mechanical linkage comprising a plurality of interconnected lever arms mounted on respective pivot points" within the plain and ordinary meaning of that term as understood by a person of ordinary skill in the art;

(ii) Whether the PE-5000's elastomeric retraction band and the PE-15000's gas-spring retraction mechanism constitute a "spring" within the meaning of the '884 Patent claims;

(iii) The functional and structural distinctions between the accused products' deployment and retraction mechanisms and the mechanisms described in the '884 Patent specification; and

(iv) Identification and analysis of prior art references relevant to invalidity contentions.

11.4 Third-Party discovery

A third-party subpoena to Veridian Medical Technologies, Inc. is anticipated for documents relevant to invalidity defenses against the '884 Patent. Veridian is believed to have developed and marketed trocar products incorporating blade deployment mechanisms that may constitute prior art to the '884 Patent. The subpoena is anticipated for issuance in September 2024 and will seek design documents, engineering specifications, product literature, and sales records for relevant Veridian trocar products predating the effective filing date of the '884 Patent.

Additional third-party discovery targets may be identified as the prior art search and prosecution history review continue.

12. Relationship to Invalidity Contentions

Non-infringement and invalidity are complementary defenses that together form the foundation of Solstice's defense strategy. While this memorandum addresses non-infringement, a parallel analysis of invalidity contentions is being developed.

Preliminary prior art references identified by Kendrick & Lau LLP that are relevant to the asserted claims of the '884 Patent will be detailed in a separate Invalidity Contentions — Prior Art Analysis Memorandum, with a target completion date of September 18, 2024. That memorandum will address:

(a) Anticipation references under 35 U.S.C. § 102 — prior art references that disclose each and every element of the asserted claims and that predate the effective filing date of the '884 Patent;

(b) Obviousness combinations under 35 U.S.C. § 103 — combinations of prior art references that, together, render the asserted claims obvious to a person of ordinary skill in the art at the time of the invention; and

(c) Other invalidity defenses, including potential challenges under 35 U.S.C. § 112 (written description, enablement, and indefiniteness) to the extent applicable.

The relative strength of the invalidity contentions may influence the emphasis placed on non-infringement versus invalidity at summary judgment and at trial. Where non-infringement arguments are strongest (e.g., the PE-5000 Series), invalidity may serve as an alternative or supplementary defense. Where non-infringement arguments require further factual development (e.g., certain aspects of the PE-12000 analysis), invalidity contentions may take on greater strategic importance. The litigation team will coordinate the development and presentation of both defenses to ensure a consistent and comprehensive approach.

13. Next Steps and Action Items

The following action items are identified for the continued development of Solstice's non-infringement positions and the broader defense of this action:

1. Prosecution History Review: Complete review and analysis of Apex's prosecution file history for the '884 Patent and related continuations/divisionals upon receipt from Apex. Target completion: September 5, 2024 (Christy Bauer and Peter Vassiliev, with input from Dr. Jonathan Kendrick of Kendrick & Lau LLP).

2. Claim Construction: Refine claim charts following the exchange of Proposed Claim Constructions by the parties, currently expected on or about October 22, 2024, and the submission of the Joint Claim Construction Brief, due November 4, 2024.

3. Markman Hearing: Update the non-infringement analysis following the Markman hearing (date to be scheduled by the Court) and the issuance of the Court's Claim Construction Order. The Court's constructions of disputed claim terms will be critical to the non-infringement analysis, particularly for terms such as "mechanical linkage," "spring," "mechanical detent," and "predetermined axial force threshold."

4. Prosecution History Estoppel: Coordinate with Kendrick & Lau LLP on the development of prosecution history estoppel arguments that may limit Apex's ability to assert infringement under the doctrine of equivalents.

5. Expert Retention: Retain Dr. Miriam Ostrowski (or an alternative technical expert) for detailed claim-by-claim analysis. Prepare and execute retention agreement. Target for initial expert consultation: August 2024.

6. Solstice Document Production: Incorporate findings from Solstice's own document production (48,217 documents, Bates Nos. SBD-000001 through SBD-048217, to be produced by September 30, 2024). Ensure that engineering specifications and design history files for the accused products are reviewed and integrated into the claim chart analysis.

7. Apex Document Production: Review Apex's responsive document production (Bates Nos. APEX-000001 through APEX-031450, expected approximately October 7, 2024) for additional information bearing on claim scope, prosecution history, prior licensing activity, and other matters relevant to the non-infringement and invalidity positions.

8. Invalidity Contentions: Complete the Invalidity Contentions — Prior Art Analysis Memorandum (target: September 18, 2024) and coordinate invalidity and non-infringement strategies.

9. Third-Party discovery: Issue subpoena to Veridian Medical Technologies, Inc. for prior art documents (target: September 2024).

10. Ongoing Refinement: This claim chart is preliminary and will be revised and updated as the litigation progresses through fact discovery, expert discovery, claim construction, and the development of the summary judgment record. All non-infringement positions are subject to revision based on new information, claim construction rulings, and the results of expert analysis.

14. Certification

This Preliminary Claim Chart — Non-Infringement Analysis has been prepared, reviewed, and approved by the undersigned counsel in connection with the defense of Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA, U.S. District Court for the District of Delaware.

Prepared by:

________________________________________

Peter Vassiliev Associate Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, DE 19801 Tel: (302) 555-7100 pvassiliev@calderwoodharkness.com

Date: July 22, 2024

Reviewed by:

________________________________________

Christy Bauer Lead Associate Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, DE 19801 Tel: (302) 555-7104 cbauer@calderwoodharkness.com

Date: July 22, 2024

Approved by:

________________________________________

Marcus Delgado Partner, intellectual Property Practice Group Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, DE 19801 Tel: (302) 555-7108 mdelgado@calderwoodharkness.com

Date: July 22, 2024

Matter No.: 10294.0017

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

CONFIDENTIALITY NOTICE: This document is protected by the attorney-client privilege and the work product doctrine. It was prepared in anticipation of litigation and for the purpose of providing legal advice to the client. This document contains the mental impressions, conclusions, opinions, and legal theories of attorneys and is entitled to the highest level of work product protection. This document is not to be disclosed to any person or entity without the prior written authorization of Calderwood & Harkness LLP. Inadvertent disclosure of this document does not constitute a waiver of any applicable privilege or protection.

Patent at Issue:	U.S. Patent No. 10,271,884 (the "'884 Patent")
Title of Patent:	Retractable Blade Deployment Mechanism for Trocar Systems
Patent Issue Date:	April 30, 2019
Patent Expiration Date:	September 15, 2036
Named Inventor:	Dr. Raymond Szabo
Assignee:	Apex Surgical Innovations, Inc.
Asserted Claims:	1, 2, 5, 9, and 14
Case:	Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA, U.S. District Court for the District of Delaware
Accused Products:	PrecisionEdge™ PE-5000 Series (5 mm trocar assembly); PrecisionEdge™ PE-12000 Series (12 mm trocar assembly); PrecisionEdge™ PE-15000 Series (15 mm trocar assembly)
Date:	July 22, 2024
Prepared by:	Peter Vassiliev, Associate, Calderwood & Harkness LLP
Reviewed by:	Christy Bauer, Lead Associate, Calderwood & Harkness LLP
Supervising Attorney:	Marcus Delgado, Partner, Calderwood & Harkness LLP
Matter No.:	10294.0017
Claim Language / Element	Accused Product Feature(s)	Non-Infringement Position
"A trocar assembly comprising a retractable blade deployment mechanism, comprising:"	The PE-5000, PE-12000, and PE-15000 are each trocar assemblies that include a blade that can be deployed and retracted within the obturator. Each product line incorporates a mechanism for effecting blade deployment and retraction, though the specific architectures of these mechanisms differ across the product lines and differ from the mechanism described in the '884 Patent.	To the extent the preamble is limiting — i.e., to the extent it recites structural limitations that are necessary to give "life, meaning, and vitality" to the claims — the accused products may be distinguishable based on the nature and architecture of their respective deployment mechanisms. As detailed below, the PrecisionEdge™ products employ cam-based, hybrid cam-and-lever, and pneumatically-assisted actuation systems, respectively, rather than the lever-arm-based mechanical linkage described and claimed in the '884 Patent. If the preamble is not treated as limiting (as is often the case where the preamble merely states the purpose or intended use of the claimed apparatus), the analysis proceeds to the body of the claim, and non-infringement is established based on the failure to meet one or more of the body limitations set forth below.
Claim Language / Element	Accused Product Feature(s)	Non-Infringement Position
"a hollow elongated cannula defining a longitudinal axis and having a proximal end and a distal end, and an obturator slidably received within the cannula, the obturator having an obturator housing extending along the longitudinal axis;"	PE-5000: The PE-5000 includes a hollow 5 mm diameter cannula with proximal and distal ends. An obturator is slidably received within the cannula. The obturator includes a housing that extends along the longitudinal axis of the cannula. PE-12000: The PE-12000 includes a hollow 12 mm diameter cannula with a similar configuration. The obturator is slidably received within the cannula and includes an obturator housing extending along the longitudinal axis. PE-15000: The PE-15000 includes a hollow 15 mm diameter cannula with an obturator slidably received therein. The obturator housing extends along the longitudinal axis.	This limitation is likely met by all three accused product lines. The general structural arrangement of a hollow cannula with a slidably received obturator is common to essentially all modern trocar designs, including the PrecisionEdge™ products. Solstice does not, at this preliminary stage, identify a strong basis for contesting this limitation, though detailed dimensional and structural analysis during discovery may reveal distinctions in the housing configuration (e.g., cross-sectional geometry, sealing arrangements, or structural features of the obturator housing) that could support a non-infringement argument. This limitation is not the primary focus of Solstice's non-infringement position.
Claim Language / Element	Accused Product Feature(s)	Non-Infringement Position
"a cutting blade disposed within the obturator housing, the cutting blade being movable between a retracted position in which the cutting blade is shielded within the obturator housing and a deployed position in which the cutting blade extends distally beyond the obturator housing;"	PE-5000: The PE-5000 includes a dual-edge triangular blade mounted on a sliding carriage within the obturator. The blade moves between a retracted (shielded) position and a deployed (extended) position. In the retracted position, the blade is contained within the obturator housing and is not exposed. In the deployed position, the blade extends beyond the distal tip of the obturator. PE-12000: The PE-12000 includes a pyramidal three-sided blade mounted on a deployment carriage. The blade similarly moves between retracted and deployed positions. PE-15000: The PE-15000 includes a broad, flat-profile blade with a beveled cutting edge, mounted on a deployment sled. The blade moves between retracted and deployed positions.	The PrecisionEdge™ products each include a blade that moves between a retracted and a deployed position, which is facially consistent with this limitation. However, there are potential distinctions in the blade geometry, the mounting configuration, and the movement pathway that may support a non-infringement argument under a narrower construction of the claim language. Specifically: (i) the '884 Patent specification describes the blade as a "lancet-type" blade with a specific tapered profile, and the claim term "cutting blade" may be construed in light of the specification to require a particular geometry — the PE-5000's triangular dual-edge blade, the PE-12000's pyramidal blade, and the PE-15000's flat-profile blade each differ from the described lancet-type geometry; (ii) the PE-5000's blade follows a helical (combined linear and rotational) movement pathway rather than a purely linear deployment path; and (iii) the PE-15000's blade is mounted on a sled rather than directly within the obturator housing, with the sled itself being a separate structural component not described in the '884 Patent. The strength of this argument depends on claim construction. If "cutting blade" is construed broadly to encompass any blade that cuts tissue, this limitation is likely met. If construed more narrowly in light of the specification, distinctions may exist. This limitation is not the primary basis for Solstice's non-infringement position but may provide supplementary support.
Claim Language / Element	Accused Product Feature(s)	Non-Infringement Position
"a mechanical linkage disposed within the obturator housing and operatively connecting the cutting blade to a deployment trigger, the mechanical linkage comprising a plurality of interconnected lever arms mounted on respective pivot points within the obturator housing, the lever arms being configured to translate axial force applied to a distal tip of the obturator into lateral displacement of the cutting blade from the retracted position to the deployed position;"	PE-5000: The PE-5000 does not use a plurality of interconnected lever arms mounted on pivot points. Instead, the PE-5000 employs a cam-based actuation system in which a cam follower on the blade carriage engages with a helical cam groove in the obturator housing wall. Axial force applied to the trocar tip causes the cam follower to travel along the cam groove, producing blade extension. There are no lever arms, no pivot points, and no interconnected linkage elements as described in this limitation. PE-12000: The PE-12000 employs a hybrid cam-and-lever system. While the PE-12000 does incorporate a single secondary lever arm, this lever arm acts as a stroke amplifier and is not part of a "plurality of interconnected lever arms mounted on respective pivot points" as required by this limitation. The primary deployment motion is cam-initiated, and the lever arm is ancillary to the cam mechanism. The PE-12000's system lacks the specific interconnected, multi-pivot-point lever architecture described in the '884 Patent. PE-15000: The PE-15000 employs a pneumatically-assisted cam actuation system. The deployment mechanism is cam-based with pneumatic augmentation. There are no lever arms or pivot-mounted linkage elements in the PE-15000's deployment mechanism.	This is the strongest non-infringement argument across all three accused product lines. The claim requires a "mechanical linkage" comprising "a plurality of interconnected lever arms mounted on respective pivot points." None of the accused products use a plurality of interconnected lever arms mounted on pivot points to translate axial force into blade deployment. PE-5000: The PE-5000's cam-based actuation system is structurally and operationally distinct from the claimed mechanical linkage. A cam-and-cam-follower system operates on fundamentally different mechanical principles than an interconnected lever-arm linkage. There are no lever arms, no pivot points, and no interconnected linkage elements. The PE-5000 does not meet this limitation. PE-12000: Although the PE-12000 includes a single lever arm, it does not include "a plurality of interconnected lever arms." A single lever acting as a stroke amplifier within a predominantly cam-based system is not a "mechanical linkage comprising a plurality of interconnected lever arms mounted on respective pivot points." The lever arm in the PE-12000 is not interconnected with other lever arms and does not form part of a multi-element linkage as claimed. The PE-12000 likely does not meet this limitation, though further factual development regarding the PE-12000's internal mechanism is needed during discovery. PE-15000: The PE-15000's pneumatically-assisted cam system does not include any lever arms or pivot-mounted linkage elements. The PE-15000 does not meet this limitation. Additionally, prosecution history estoppel may further support the argument that this limitation should be construed narrowly, as the applicant may have amended the claims during prosecution to specifically require the multi-lever-arm linkage to distinguish prior art. This will be addressed in the prosecution history analysis memorandum.
Claim Language / Element	Accused Product Feature(s)	Non-Infringement Position
"a biasing member comprising a spring disposed within the obturator housing and operatively connected to the cutting blade, the spring urging the cutting blade toward the retracted position such that the cutting blade returns to the retracted position when the axial force applied to the distal tip is removed;"	PE-5000: The PE-5000

ATTORNEY-CLIENT PRIVILEGED AND CONFIDENTIAL ATTORNEY WORK PRODUCT — PREPARED IN ANTICIPATION OF LITIGATION DO NOT DISTRIBUTE WITHOUT AUTHORIZATION FROM CALDERWOOD & HARKNESS LLP
PRELIMINARY CLAIM CHART — NON-INFRINGEMENT ANALYSIS
U.S. Patent No. 10,271,884 ("the '884 Patent")
"Retractable Blade Deployment Mechanism for Trocar Systems"
Right-click to update Table of Contents
1. Introduction and Purpose
This memorandum sets forth a preliminary element-by-element claim chart mapping the asserted claims of U.S. Patent No. 10,271,884 (the "'884 Patent") against the PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series trocar assemblies manufactured and sold by Solstice Biomedical, Inc. ("Solstice" or "Defendant"). Solstice Biomedical, Inc. is the U.S. operating subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company (CRO No. 648217), with its principal U.S. offices located at 9400 Innovation Drive, Suite 300, San Diego, California 92121.
This claim chart has been prepared in connection with the defense of the patent infringement action captioned Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA, filed on May 9, 2024 in the United States District Court for the District of Delaware by Apex Surgical Innovations, Inc. ("Apex" or "Plaintiff"), a Delaware corporation (EIN: 51-0483762), with its principal place of business at 1220 North Market Street, Suite 550, Wilmington, Delaware 19801.
This document constitutes a preliminary non-infringement analysis and is intended to serve several critical purposes in connection with the defense of this action:
(a) To identify, on a limitation-by-limitation basis, the specific claim elements of the asserted claims of the '884 Patent that are not met by each accused PrecisionEdge™ product line;
(b) To inform the overall defensive strategy for Solstice in connection with the '884 Patent, including the identification of the strongest non-infringement arguments available for each accused product;
(c) To guide the scope and direction of discovery, including written discovery directed to Apex and the identification of internal Solstice documents and third-party materials that will be critical to the development and support of Solstice's non-infringement positions; and
(d) To provide a framework for coordination with invalidity contentions being developed in parallel, such that the litigation team can present a comprehensive and coherent defense.
The '884 Patent is one of three patents asserted by Apex in this action. The remaining two asserted patents are as follows:
•  U.S. Patent No. 9,814,237 (the "'237 Patent"), which is the subject of a separate preliminary claim chart and non-infringement analysis dated July 20, 2024; and
•  U.S. Patent No. 10,932,105 (the "'105 Patent"), which is the subject of a separate preliminary claim chart and non-infringement analysis currently in preparation, with a target completion date of July 25, 2024.
It is important to note that claim construction has not yet occurred in this litigation. As of the date of this memorandum, the Markman hearing has not yet been scheduled by the Court. Accordingly, this analysis is based on the plain and ordinary meaning of the claim terms as they would be understood by a person of ordinary skill in the art at the time of the invention, informed by the intrinsic record (the claims, specification, and prosecution history). This analysis will be updated and refined following the exchange of proposed claim constructions by the parties, currently expected on or about October 22, 2024, and following the issuance of the Court's Claim Construction Order after the Markman hearing.
The prior art search and prosecution history review underlying portions of this analysis were conducted with the assistance of Kendrick & Lau LLP (Dr. Jonathan Kendrick, Lead Partner, Patent Prosecution, 601 Pennsylvania Avenue NW, Suite 820, Washington, DC 20004). Kendrick & Lau's search results and prosecution history analysis have been incorporated into this memorandum where relevant, and a comprehensive report from Kendrick & Lau is forthcoming.
Finally, it should be noted that the '884 Patent is part of a larger patent family comprising fourteen (14) issued U.S. patents and six (6) pending continuation applications, all assigned to Apex. The claim charts and non-infringement analyses prepared in connection with this litigation address only those claims of those patents that have been specifically asserted by Apex against the accused PrecisionEdge™ products. However, the broader patent family is being monitored for potential additional assertions and for the purpose of understanding the full scope of Apex's prosecution history across related applications, which may have bearing on claim construction and prosecution history estoppel arguments.
2. Summary of the '884 Patent
2.1 Patent Overview
U.S. Patent No. 10,271,884, entitled "Retractable Blade Deployment Mechanism for Trocar Systems," was filed in the United States Patent and Trademark Office and issued on April 30, 2019. The patent is set to expire on September 15, 2036, assuming payment of all required maintenance fees.
The named inventor is Dr. Raymond Szabo, who is currently Vice President of Engineering at Apex Surgical Innovations, Inc. Dr. Szabo is identified as the sole inventor on the face of the patent. The patent is assigned to Apex Surgical Innovations, Inc., 1220 North Market Street, Suite 550, Wilmington, Delaware 19801. The assignment was recorded with the USPTO and is reflected in the patent's assignment records.
The '884 Patent contains twenty-two (22) claims in total, of which Claims 1 and 9 are independent claims. Apex has asserted Claims 1, 2, 5, 9, and 14 against the accused PrecisionEdge™ products. Claims 2 and 5 are dependent on independent Claim 1. Claim 14 is dependent on independent Claim 9.
2.2 Technology Overview
The '884 Patent generally relates to a retractable blade deployment mechanism for trocar systems used in minimally invasive laparoscopic surgery. Trocars are surgical instruments used to create access ports through the abdominal wall or other body tissue, through which laparoscopic instruments are subsequently inserted to perform surgical procedures. The trocar typically consists of two principal components: a hollow cannula (which remains in place during the procedure to maintain the access port) and an obturator (which is inserted through the cannula and includes a sharp tip or blade to puncture the tissue).
The '884 Patent describes a mechanism whereby a cutting blade within a trocar obturator is deployed from a retracted (shielded) position to an extended (cutting) position upon the application of axial force against tissue. The patent further describes an automatic retraction feature, whereby the blade automatically retracts to the shielded position upon penetration of the body wall, thereby reducing the risk of inadvertent injury to underlying organs and tissues. This automatic retraction is a safety feature intended to address one of the longstanding concerns in laparoscopic trocar design — the risk of uncontrolled trocar entry causing damage to intra-abdominal structures.
The key inventive concepts claimed in the '884 Patent include:
(i) A specific mechanical linkage governing the deployment and retraction of the blade, described in the specification as comprising a series of interconnected lever arms, pivot points, and guide channels within the obturator housing;
(ii) A spring-biased retraction system that continuously urges the blade toward the retracted (shielded) position, such that the blade deploys only when the axial force applied to the trocar tip exceeds the biasing force of the spring;
(iii) A trigger mechanism responsive to axial loading, whereby the application of force against the trocar tip by contact with tissue activates the deployment linkage and causes the blade to transition from the retracted to the deployed position; and
(iv) A safety lock mechanism that prevents inadvertent blade deployment in the absence of a predetermined condition, such as the application of a threshold axial force or the engagement of a manual release.
The specification of the '884 Patent describes several embodiments of the retractable blade deployment mechanism, including variations in the number and configuration of lever arms, the type and arrangement of biasing springs, and the design of the safety lock. The claims at issue, however, are directed to particular configurations of these elements, as set forth in the claim chart analysis below.
2.3 Prosecution History Highlights
A detailed prosecution history analysis for the '884 Patent is being prepared in a separate memorandum (working title: Analysis of Apex Prosecution History — U.S. Patent No. 10,271,884), with a target completion date of September 5, 2024. That memorandum is being prepared by Christy Bauer and Peter Vassiliev with input from Dr. Jonathan Kendrick of Kendrick & Lau LLP.
On a preliminary basis, the following observations regarding the prosecution history are noted:
•  During prosecution, the claims of the '884 Patent were narrowed in response to prior art rejections issued by the USPTO examiner. The original claims were broader in scope and did not include certain limitations that now appear in the issued claims, including specific structural requirements for the mechanical linkage and the spring-biased retraction system.
•  Amendments were made to distinguish prior art references relating to blade deployment mechanisms in surgical access devices, including trocar and endoscopic access device designs disclosed in earlier patents. The specific references cited and the arguments made by the applicant during prosecution are being catalogued and analyzed.
•  Based on preliminary review, prosecution history estoppel arguments may be available to limit the scope of certain claim elements, particularly where Apex narrowed claim language to overcome prior art rejections. These arguments will be developed in detail in the prosecution history analysis memorandum and will inform the doctrine of equivalents analysis set forth in Section 10 of this memorandum.
2.4 Claims Asserted
Apex has asserted Claims 1, 2, 5, 9, and 14 of the '884 Patent against the accused PrecisionEdge™ products. The structure of the asserted claims is as follows:
Claim 1 is an independent claim directed to a trocar assembly comprising a retractable blade deployment mechanism. Claim 1 sets forth the core structural limitations of the apparatus, including the housing/cannula structure, the retractable blade element, the mechanical linkage/deployment mechanism, the spring-biased retraction system, and the safety lock feature. Each of these limitations is analyzed in detail in Section 4 below.
Claim 2 is dependent on Claim 1 and incorporates all of the limitations of Claim 1 by reference. Claim 2 adds a further limitation regarding the specific configuration of the spring-biased retraction system, including requirements relating to the type of spring, its orientation within the obturator, and/or the force characteristics of the biasing member.
Claim 5 is also dependent on Claim 1 and incorporates all of the limitations of Claim 1 by reference. Claim 5 adds a limitation requiring that the trigger mechanism be responsive to a predetermined axial force threshold applied to the trocar tip — that is, the blade deploys only when the axial force against tissue reaches a specific, predetermined level.
Claim 9 is an independent method claim directed to a method of deploying a retractable blade in a trocar system. Claim 9 recites a series of method steps that parallel the structural elements of Claim 1, including steps for positioning the trocar assembly, applying axial force, deploying the blade through a mechanical linkage, and retracting the blade after penetration.
Claim 14 is dependent on Claim 9 and incorporates all of the method steps of Claim 9 by reference. Claim 14 adds a limitation requiring that the automatic retraction of the blade occur upon "detection" of penetration of the body wall, suggesting the use of a specific sensing or mechanical feedback mechanism to determine when penetration has occurred.
3. Description of Accused Products
3.1 PrecisionEdge™ PE-5000 Series (5 mm Trocar Assembly)
The PrecisionEdge™ PE-5000 Series is a 5 mm diameter laparoscopic trocar assembly designed for minimally invasive surgical access. The PE-5000 is the smallest-diameter product in the PrecisionEdge™ line and is typically used for secondary port access during laparoscopic procedures, accommodating 5 mm diameter laparoscopic instruments such as graspers, dissectors, and scissors.
The PE-5000 Series incorporates a blade deployment mechanism within the obturator component. The key structural features of the PE-5000's blade mechanism that are relevant to this non-infringement analysis include:
•  Blade Architecture: The PE-5000 utilizes a dual-edge triangular blade housed within the obturator tip. The blade is mounted on a sliding carriage that moves along a linear guide track within the obturator body. Unlike the lever-arm-based mechanical linkage described in the '884 Patent specification, the PE-5000's blade carriage translates linearly along a single axis without the use of interconnected pivot-mounted lever arms.
•  Deployment Mechanism: The PE-5000 employs a cam-based actuation system in which a cam follower on the blade carriage engages with a helical cam groove machined into the interior wall of the obturator housing. Axial displacement of the trocar tip causes the cam follower to travel along the cam groove, which imparts both axial and rotational motion to the blade carriage, resulting in blade extension. This cam-based system is structurally distinct from the lever-and-pivot mechanical linkage claimed in the '884 Patent.
•  Retraction Mechanism: The PE-5000 uses an elastomeric retraction band — a medical-grade silicone elastomer loop — rather than a coiled compression spring, to bias the blade toward the retracted position. The elastomeric band provides a restoring force that returns the blade carriage to the shielded position when axial force against the trocar tip is released.
•  Safety Features: The PE-5000 incorporates a rotary safety collar on the proximal end of the obturator that must be manually rotated to a "ready" position before the blade can deploy. This rotary collar mechanism differs from the mechanical detent-based safety lock described in the '884 Patent specification.
The PE-5000 Series has been commercially available in the United States since approximately the third quarter of 2020. U.S. sales data for the accused PrecisionEdge™ products, in the aggregate across all three product lines, total approximately $74.6 million for the period from calendar year 2021 through the third quarter of 2024. The PE-5000 contributes a portion of the combined yearly totals of $12.1 million (CY 2021), $17.8 million (CY 2022), $22.4 million (CY 2023), and $22.3 million (CY 2024 through September 30, 2024). Disaggregated sales figures for each individual product line are being compiled and will be supplemented in subsequent analyses.
The PE-5000 is accused of infringing the '884 Patent and also the '237 Patent. The '237 Patent infringement allegations are addressed separately in the claim chart dated July 20, 2024.
3.2 PrecisionEdge™ PE-12000 Series (12 mm Trocar Assembly)
The PrecisionEdge™ PE-12000 Series is a 12 mm diameter laparoscopic trocar assembly and is the most versatile product in the PrecisionEdge™ line. The 12 mm diameter accommodates a wide range of laparoscopic instruments, including staplers, clip appliers, and specimen retrieval devices, making it the most commonly used port size in laparoscopic general surgery, bariatric surgery, and gynecologic procedures.
The key structural features of the PE-12000's blade deployment mechanism relevant to this analysis include:
•  Blade Architecture: The PE-12000 utilizes a pyramidal (three-sided) blade geometry with a broader cutting profile than the PE-5000. The blade is mounted on a deployment carriage that translates within the obturator body along a guided track.
•  Deployment Mechanism: The PE-12000 employs a hybrid cam-and-lever actuation system. The primary deployment motion is initiated by a cam mechanism similar to that of the PE-5000, but the PE-12000 incorporates a secondary lever arm that amplifies the blade extension stroke. While this hybrid system includes a lever element, the overall architecture, pivot geometry, and operational sequence differ from the multi-arm mechanical linkage described and claimed in the '884 Patent. The PE-12000's lever arm acts as a stroke amplifier rather than as a direct deployment linkage connecting the trigger to the blade. The extent of the structural distinction between the PE-12000's hybrid system and the claimed "mechanical linkage" is a key issue requiring further factual development during discovery.
•  Retraction Mechanism: The PE-12000 uses a dual-spring retraction assembly comprising two nested stainless steel coil springs that bias the blade carriage toward the retracted position. While the PE-12000 does use coil springs, the arrangement (nested, dual-spring, with a progressive force curve) differs from the single-spring or constant-force spring arrangements described in the '884 Patent specification. The significance of this distinction under the claim language will depend on claim construction.
•  Safety Features: The PE-12000 incorporates an electronic proximity sensor-based safety interlock that detects the position of the cannula seal relative to the obturator and prevents blade deployment unless the obturator is fully seated within the cannula. This electronic safety system is architecturally distinct from the purely mechanical safety lock described in the '884 Patent.
The PE-12000 is accused of infringing all three asserted patents — the '237, '884, and '105 Patents. It is the highest-volume product in the PrecisionEdge™ line and accounts for the largest share of the combined accused product sales figures.
3.3 PrecisionEdge™ PE-15000 Series (15 mm Trocar Assembly)
The PrecisionEdge™ PE-15000 Series is a 15 mm diameter laparoscopic trocar assembly designed for larger-port procedures requiring the passage of larger instruments or the extraction of surgical specimens. The 15 mm port size is commonly used in procedures involving endoscopic staplers, large-diameter specimen retrieval bags, and other instruments that require a wider access channel.
The key structural features of the PE-15000's blade deployment mechanism relevant to this analysis include:
•  Blade Architecture: The PE-15000 uses a broad, flat-profile blade with a beveled cutting edge. The blade is mounted on a deployment sled that translates within a channel machined into the obturator body. The blade geometry and mounting configuration differ from those described in the '884 Patent, which illustrates and describes a more compact, tapered blade profile in the preferred embodiments.
•  Deployment Mechanism: The PE-15000 employs a pneumatically-assisted cam actuation system. The initial deployment is cam-actuated (similar to the PE-5000), but the PE-15000 incorporates a pneumatic assist cylinder that augments the deployment force at larger trocar diameters where tissue resistance is greater. The pneumatic assist component has no analog in the purely mechanical system described in the '884 Patent.
•  Retraction Mechanism: The PE-15000 uses a gas-spring retraction mechanism — a sealed cylinder containing pressurized nitrogen gas that provides a constant biasing force to return the blade to the retracted position. This gas-spring system is functionally and structurally distinct from the coiled mechanical spring described in the '884 Patent.
•  Safety Features: The PE-15000 incorporates a dual-redundant safety system comprising (i) a mechanical detent pin that must be manually released before the blade can deploy, and (ii) an electronic sensor that detects whether the obturator is correctly seated in the cannula. The mechanical detent component of this dual system bears some superficial resemblance to the safety lock described in the '884 Patent, but the dual-redundant architecture and the incorporation of an electronic sensor distinguish it from the purely mechanical lock claimed in the patent.
The PE-15000 is accused of infringing the '884 Patent and the '105 Patent. It is the lowest-volume product of the three accused product lines, reflecting the more specialized clinical applications for which a 15 mm port is required.
4. Claim Chart: Claim 1 (Independent)
The following claim chart maps each limitation of Claim 1 of the '884 Patent against the features of the accused PrecisionEdge™ products and sets forth Solstice's preliminary non-infringement position for each limitation. The claim language is based on the issued claim text as it appears in the '884 Patent. Each limitation has been parsed into a separate row for clarity of analysis.
4.1 Preamble
4.2 Limitation 1(a) — Housing / Cannula Structure
4.3 Limitation 1(b) — Retractable Blade Element
4.4 Limitation 1(c) — Mechanical Linkage / Deployment Mechanism
4.5 Limitation 1(d) — Spring-Biased Retraction System
4.6 Limitation 1(e) — Safety Lock Feature
4.7 Summary — Claim 1 Non-Infringement Position by Product
Based on the preliminary analysis set forth above, the non-infringement position for each accused product with respect to Claim 1 is summarized as follows:
PE-5000 Series: The PE-5000 does not meet at least limitations 1(c) and 1(d), and likely does not meet limitation 1(e). The PE-5000's cam-based actuation system, elastomeric retraction band, and rotary safety collar are each structurally and functionally distinct from the corresponding claimed elements. The PE-5000 presents the strongest non-infringement position of the three accused product lines with respect to Claim 1.
PE-12000 Series: The PE-12000 potentially does not meet limitation 1(c) (mechanical linkage), as its hybrid cam-and-lever system does not include a "plurality of interconnected lever arms mounted on respective pivot points." The PE-12000 also does not meet limitation 1(e) (safety lock), as it uses an electronic sensor-based interlock rather than a mechanical detent. However, the PE-12000's use of coil springs in its retraction system may satisfy limitation 1(d), and the PE-12000's hybrid system includes a lever element that, while not meeting the literal claim language, is closer to the claimed structure than the purely cam-based systems of the PE-5000 and PE-15000. The PE-12000 position requires further factual development through discovery, particularly regarding the internal architecture of the PE-12000's deployment mechanism.
PE-15000 Series: The PE-15000 potentially does not meet limitations 1(c) and 1(e), and may not meet limitation 1(d). The PE-15000's pneumatically-assisted cam system lacks lever arms; its gas-spring retraction mechanism differs from a conventional mechanical spring; and its dual-redundant safety system, while incorporating a mechanical detent pin, operates on a manual-release principle rather than a force-responsive principle as claimed. The PE-15000 presents a moderate to strong non-infringement position. The analysis is ongoing and will be refined as additional technical details of the PE-15000 mechanism are developed.
5. Claim Chart: Claim 2 (Dependent on Claim 1)
Claim 2 of the '884 Patent depends from Claim 1 and therefore incorporates all of the limitations of Claim 1 by reference. Claim 2 adds a further limitation relating to the specific configuration of the spring-biased retraction system. As a threshold matter, because Claim 2 is dependent on Claim 1, non-infringement of Claim 1 necessarily establishes non-infringement of Claim 2. The analysis below addresses the additional limitation of Claim 2 for completeness.
5.1 Additional Limitation — Specific Spring-Biased Configuration
6. Claim Chart: Claim 5 (Dependent on Claim 1)
Claim 5 of the '884 Patent depends from Claim 1 and therefore incorporates all of the limitations of Claim 1 by reference. Claim 5 adds a further limitation requiring that the deployment trigger be responsive to a predetermined axial force threshold. As with Claim 2, non-infringement of Claim 1 necessarily establishes non-infringement of Claim 5. The analysis below addresses the additional limitation of Claim 5 for completeness.
6.1 Additional Limitation — Trigger Responsive to Predetermined Axial Force Threshold
7. Claim Chart: Claim 9 (Independent — Method Claim)
Claim 9 of the '884 Patent is an independent method claim directed to a method of deploying a retractable blade in a trocar system. The method claim presents both structural/operational non-infringement arguments (paralleling the apparatus claim analysis for Claim 1) and a separate, independent divided infringement defense. Each method step is analyzed below.
7.1 Preamble
7.2 Step 9(a) — Positioning the Trocar Assembly
7.3 Step 9(b) — Applying Axial Force
7.4 Step 9(c) — Blade Deployment via Mechanical Linkage
7.5 Step 9(d) — Blade Retraction After Penetration
7.6 Summary — Claim 9 Non-Infringement Position
The non-infringement position for Claim 9 is supported by two independent theories, either of which is independently sufficient to defeat infringement:
Theory 1 — Structural/Operational Differences: The method steps of Claim 9 require the use of a "mechanical linkage" (Steps 9(a) and 9(c)) and a "biasing member" effecting automatic retraction (Step 9(d)). As established in the Claim 1 analysis, the PrecisionEdge™ products' deployment mechanisms and retraction systems differ structurally from the claimed elements. If the accused products do not contain the claimed structures, the claimed method steps cannot be practiced using the accused products, and the method claim is not infringed. The structural non-infringement arguments developed for Claim 1 apply with equal force to the corresponding method steps of Claim 9.
Theory 2 — Divided Infringement: Even assuming, arguendo, that the structural elements of the accused products satisfy the apparatus limitations recited in the method steps, Solstice does not itself perform all method steps of Claim 9. The claimed method is practiced, if at all, by surgeons using the PrecisionEdge™ products in the operating room. Solstice manufactures and sells the devices but does not position the trocar, apply axial force, or deploy the blade. There is no agency, contractual, or joint-enterprise relationship between Solstice and the end-user surgeons that would create vicarious liability. Under Akamai Technologies, Inc. v. Limelight Networks, Inc., 797 F.3d 1020 (Fed. Cir. 2015) (en banc), a defendant cannot be liable for direct infringement of a method claim unless it performs all steps of the claimed method, either directly or through agents acting under its direction or control. Solstice does not direct or control the surgical use of the PrecisionEdge™ products by independent physician users.
Both theories apply across all three accused product lines — the PE-5000, PE-12000, and PE-15000 — though the structural arguments are strongest for the PE-5000 and PE-15000, and the divided infringement defense applies uniformly to all three.
8. Claim Chart: Claim 14 (Dependent on Claim 9)
Claim 14 of the '884 Patent depends from Claim 9 and therefore incorporates all of the method steps of Claim 9 by reference. Claim 14 adds a further limitation requiring that the automatic retraction of the blade occur upon "detection" of penetration. As with the dependent apparatus claims, non-infringement of Claim 9 necessarily establishes non-infringement of Claim 14. The analysis below addresses the additional limitation of Claim 14 for completeness.
8.1 Additional Limitation — Automatic Retraction Upon Penetration Detection
9. Cross-Product Summary Matrix
9.1 Non-Infringement Summary Table
The following matrix summarizes the strength of Solstice's non-infringement position for each asserted claim of the '884 Patent across each accused product line:
Key Takeaways:
PE-5000 Series: Presents the strongest non-infringement position across all five asserted claims. The principal distinctions lie in the PE-5000's cam-based deployment mechanism architecture (limitation 1(c)), its elastomeric retraction band (limitation 1(d)), and its rotary safety collar (limitation 1(e)). Each of these features is fundamentally different in structure and operation from the corresponding claimed elements. The displacement-based (rather than force-threshold) deployment trigger further strengthens the position with respect to Claim 5. The divided infringement defense provides an additional, independent basis for non-infringement of the method claims (Claims 9 and 14).
PE-12000 Series: Presents a moderate non-infringement position that requires further factual development during discovery. The primary non-infringement argument is the absence of a "plurality of interconnected lever arms mounted on respective pivot points" (limitation 1(c)), as the PE-12000's hybrid cam-and-lever system includes only a single lever arm acting as a stroke amplifier. The PE-12000's electronic safety interlock (limitation 1(e)) also differs from the claimed mechanical detent. However, some claim limitations — particularly the spring-biased retraction system (limitation 1(d)) — are more closely aligned with the PE-12000's design (which uses coil springs), potentially reducing the strength of the non-infringement position on those specific limitations. Additional technical investigation of the PE-12000's internal mechanism architecture during discovery is critical to strengthening this position.
PE-15000 Series: Presents a moderate to strong non-infringement position. The principal distinctions lie in the PE-15000's pneumatically-assisted cam deployment mechanism (lacking lever arms — limitation 1(c)) and its gas-spring retraction mechanism (differing from a conventional mechanical spring — limitation 1(d)). The safety lock analysis (limitation 1(e)) presents a more nuanced argument given the presence of a mechanical detent pin, though the manually-released nature of the pin distinguishes it from the force-responsive detent of the '884 Patent. The method claims (Claims 9 and 14) are additionally subject to the divided infringement defense, which applies uniformly. The absence of a penetration detection mechanism provides a strong basis for non-infringement of Claim 14 independent of the Claim 9 analysis.
10. Preliminary Assessment of Doctrine of Equivalents
In addition to literal non-infringement, the analysis must address the possibility that Apex will assert infringement under the doctrine of equivalents. Under the doctrine of equivalents, a product that does not literally satisfy a claim limitation may nonetheless infringe if the accused product element performs substantially the same function, in substantially the same way, to achieve substantially the same result as the claimed limitation. Warner-Jenkinson Co. v. Harborline Enterprises Davis Chem. Co., 520 U.S. 17 (1997). The doctrine of equivalents is applied on a limitation-by-limitation basis and is subject to important limiting doctrines, including prosecution history estoppel, the all-limitations rule, and the disclosure-dedication doctrine.
For each key limitation where literal non-infringement is strongest, the following preliminary assessment of potential doctrine of equivalents arguments is provided:
Limitation 1(c) — Mechanical Linkage: Apex could argue that the PrecisionEdge™ cam-based, hybrid cam-and-lever, and pneumatically-assisted deployment mechanisms perform substantially the same function (translating axial force into blade deployment), in substantially the same way (converting linear motion to blade extension), to achieve substantially the same result (deploying the blade from a retracted position to a deployed position). However, this argument faces significant obstacles. First, the function-way-result analysis is not as straightforward as Apex might contend: a cam-follower mechanism and a lever-arm linkage operate on fundamentally different mechanical principles. A cam system converts motion through a groove-and-follower interface; a lever-arm linkage converts motion through interconnected rigid bodies pivoting on fixed points. These are different "ways" of achieving the result. Second, prosecution history estoppel may bar Apex from expanding the claim scope under the doctrine of equivalents if the specific lever-arm linkage language was added or narrowed during prosecution to overcome prior art. If Apex amended the claims to require "a plurality of interconnected lever arms mounted on respective pivot points" to distinguish prior art references disclosing alternative deployment mechanisms (such as cam-based systems), Apex surrendered claim scope and cannot recapture that scope through the doctrine of equivalents. Festo Corp. v. Fenmore & Co., 535 U.S. 722 (2002). This argument will be fully developed following completion of the prosecution history analysis.
Limitation 1(d) — Spring-Biased Retraction System: Apex could argue that elastomeric retraction bands (PE-5000) and gas springs (PE-15000) perform substantially the same function as a mechanical spring (biasing the blade toward the retracted position). While there is some functional overlap, the "way" in which each element operates differs: an elastomeric band stores energy through molecular deformation of a polymer; a gas spring stores energy through compression of a gas; and a mechanical coil spring stores energy through elastic deformation of a metal coil. These are different physical mechanisms. Additionally, prosecution history estoppel may apply if the term "spring" was specifically chosen during prosecution to distinguish prior art using non-spring biasing elements. The all-limitations rule further constrains this analysis: if "spring" is given a specific meaning through claim construction that excludes elastomeric and pneumatic biasing elements, the doctrine of equivalents cannot be used to effectively read out the "spring" limitation.
Limitation 1(e) — Safety Lock Feature: Apex could argue that the PrecisionEdge™ products' rotary collar (PE-5000), electronic sensor (PE-12000), and dual-redundant system (PE-15000) are equivalents of the claimed mechanical detent. However, the claim specifically requires "a mechanical detent engageable with the cutting blade or the mechanical linkage," which is a structurally specific limitation. An electronic sensor performs the safety function in a fundamentally different way than a mechanical detent (electronic sensing vs. physical engagement). The rotary collar also differs in kind. Prosecution history estoppel arguments and the all-limitations rule apply here as well.
Preliminary View: Prosecution history estoppel and the all-limitations rule provide meaningful defenses against doctrine of equivalents arguments, particularly for the mechanical linkage and spring-biased retraction limitations (limitations 1(c) and 1(d)). The prosecution history analysis being prepared by Christy Bauer and Peter Vassiliev (target completion: September 5, 2024) will be critical to fully developing these estoppel arguments. Based on preliminary review, it appears that the applicant narrowed the claims during prosecution in ways that will limit Apex's ability to expand claim scope under the doctrine of equivalents. This analysis will be updated and refined as the prosecution history review is completed.
11. Discovery and Investigation Needs
The following discovery and investigation steps are necessary to develop and support Solstice's non-infringement positions and to advance the defense of this action.
11.1 Documents Needed from Apex
The following categories of documents should be sought from Apex through formal written discovery:
(a) Internal design documents and engineering specifications for the patented blade deployment mechanism, including engineering drawings, CAD files, design specifications, test data, and prototype records relating to the retractable blade deployment mechanism described in the '884 Patent. These documents are critical to understanding the scope of the claimed invention and the specific structural embodiments that Apex contends fall within the claims.
(b) Complete prosecution file history for the '884 Patent (Application No. to be confirmed), including all communications between Apex (or its patent counsel) and the USPTO, all office actions, responses, amendments, declarations, and information disclosure statements. The complete file wrappers for related family members (the fourteen issued U.S. patents and six pending continuation applications) should also be obtained to the extent they contain prosecution arguments or amendments that may give rise to prosecution history estoppel or that bear on the construction of the asserted claims.
(c) Prior licensing agreements involving the '884 Patent, including any licenses, settlement agreements, or covenant-not-to-sue agreements that Apex has entered into with third parties relating to the '884 Patent or related patents in the same family. These agreements are relevant to understanding the claim scope that Apex has previously asserted (or conceded) in licensing negotiations and may bear on damages issues as well.
(d) Inventor notebooks, laboratory records, and communications of Dr. Raymond Szabo relating to the development, design, testing, and refinement of the claimed retractable blade deployment mechanism. These documents are relevant to claim construction (understanding what the inventor considered to be within the scope of the invention) and may also be relevant to invalidity contentions.
(e) Apex's marketing materials, product literature, and technical presentations relating to products embodying the '884 Patent, which may be relevant to understanding how Apex itself characterizes the scope and novelty of the patented technology.
Solstice's First Set of Interrogatories (fifteen (15) interrogatories) and First Set of Requests for Production (thirty-eight (38) requests) directed to Apex are currently being prepared and are scheduled for service on August 19, 2024. The above categories of documents will be addressed in the requests for production.
11.2 Internal Solstice Documents Needed
The following categories of internal Solstice documents must be collected, reviewed, and produced (to the extent required by discovery obligations):
(a) Complete engineering specifications, CAD drawings, and design history files for the PE-5000, PE-12000, and PE-15000 blade deployment subsystems, including detailed mechanical drawings, assembly drawings, bill of materials, tolerance specifications, and functional descriptions of the deployment mechanism, retraction mechanism, and safety features of each product.
(b) Manufacturing process documentation, including manufacturing instructions, quality control specifications, and inspection records for the blade deployment subsystems of the accused products. These documents are relevant to establishing the precise structure and operation of the accused products' mechanisms.
(c) Design-around analyses or freedom-to-operate opinions previously obtained by Solstice in connection with the development of the PrecisionEdge™ products. If Solstice obtained FTO opinions relating to the '884 Patent or related Apex patents prior to product launch, these opinions may be relevant (subject to privilege considerations) to demonstrating that Solstice designed the PrecisionEdge™ products to avoid the '884 Patent claims.
(d) Prior art search results and FTO analysis prepared by Kendrick & Lau LLP (Dr. Jonathan Kendrick) in connection with this litigation. These materials are being compiled and will inform both the non-infringement and invalidity analyses.
Solstice's document production is in progress. A total of 48,217 documents (Bates Nos. SBD-000001 through SBD-048217) are scheduled for production by September 30, 2024.
11.3 Expert Consultation
Retention of a technical expert in biomedical engineering is recommended to support claim construction, non-infringement analysis, and invalidity contentions. Expert input will be critical for refining the non-infringement positions on the mechanical linkage (limitation 1(c)) and deployment mechanism limitations, as these positions require detailed technical analysis of the structural and operational differences between the PrecisionEdge™ products and the patented mechanism.
Preliminary candidate for expert retention:
Dr. Miriam Ostrowski Professor of Biomedical Engineering Halford University Department of Biomedical Engineering 3401 Walnut Street, Philadelphia, PA 19104 Rate: $750/hour
Dr. Ostrowski has extensive experience in surgical instrument design and has served as an expert witness in prior patent litigation involving laparoscopic devices. Her curriculum vitae and list of prior testimony are on file. A retention agreement is being prepared for review and execution.
Expert input will be sought on the following specific topics:
(i) Whether the PrecisionEdge™ products' deployment mechanisms constitute a "mechanical linkage comprising a plurality of interconnected lever arms mounted on respective pivot points" within the plain and ordinary meaning of that term as understood by a person of ordinary skill in the art;
(ii) Whether the PE-5000's elastomeric retraction band and the PE-15000's gas-spring retraction mechanism constitute a "spring" within the meaning of the '884 Patent claims;
(iii) The functional and structural distinctions between the accused products' deployment and retraction mechanisms and the mechanisms described in the '884 Patent specification; and
(iv) Identification and analysis of prior art references relevant to invalidity contentions.
11.4 Third-Party discovery
A third-party subpoena to Veridian Medical Technologies, Inc. is anticipated for documents relevant to invalidity defenses against the '884 Patent. Veridian is believed to have developed and marketed trocar products incorporating blade deployment mechanisms that may constitute prior art to the '884 Patent. The subpoena is anticipated for issuance in September 2024 and will seek design documents, engineering specifications, product literature, and sales records for relevant Veridian trocar products predating the effective filing date of the '884 Patent.
Additional third-party discovery targets may be identified as the prior art search and prosecution history review continue.
12. Relationship to Invalidity Contentions
Non-infringement and invalidity are complementary defenses that together form the foundation of Solstice's defense strategy. While this memorandum addresses non-infringement, a parallel analysis of invalidity contentions is being developed.
Preliminary prior art references identified by Kendrick & Lau LLP that are relevant to the asserted claims of the '884 Patent will be detailed in a separate Invalidity Contentions — Prior Art Analysis Memorandum, with a target completion date of September 18, 2024. That memorandum will address:
(a) Anticipation references under 35 U.S.C. § 102 — prior art references that disclose each and every element of the asserted claims and that predate the effective filing date of the '884 Patent;
(b) Obviousness combinations under 35 U.S.C. § 103 — combinations of prior art references that, together, render the asserted claims obvious to a person of ordinary skill in the art at the time of the invention; and
(c) Other invalidity defenses, including potential challenges under 35 U.S.C. § 112 (written description, enablement, and indefiniteness) to the extent applicable.
The relative strength of the invalidity contentions may influence the emphasis placed on non-infringement versus invalidity at summary judgment and at trial. Where non-infringement arguments are strongest (e.g., the PE-5000 Series), invalidity may serve as an alternative or supplementary defense. Where non-infringement arguments require further factual development (e.g., certain aspects of the PE-12000 analysis), invalidity contentions may take on greater strategic importance. The litigation team will coordinate the development and presentation of both defenses to ensure a consistent and comprehensive approach.
13. Next Steps and Action Items
The following action items are identified for the continued development of Solstice's non-infringement positions and the broader defense of this action:
1.  Prosecution History Review: Complete review and analysis of Apex's prosecution file history for the '884 Patent and related continuations/divisionals upon receipt from Apex. Target completion: September 5, 2024 (Christy Bauer and Peter Vassiliev, with input from Dr. Jonathan Kendrick of Kendrick & Lau LLP).
2.  Claim Construction: Refine claim charts following the exchange of Proposed Claim Constructions by the parties, currently expected on or about October 22, 2024, and the submission of the Joint Claim Construction Brief, due November 4, 2024.
3.  Markman Hearing: Update the non-infringement analysis following the Markman hearing (date to be scheduled by the Court) and the issuance of the Court's Claim Construction Order. The Court's constructions of disputed claim terms will be critical to the non-infringement analysis, particularly for terms such as "mechanical linkage," "spring," "mechanical detent," and "predetermined axial force threshold."
4.  Prosecution History Estoppel: Coordinate with Kendrick & Lau LLP on the development of prosecution history estoppel arguments that may limit Apex's ability to assert infringement under the doctrine of equivalents.
5.  Expert Retention: Retain Dr. Miriam Ostrowski (or an alternative technical expert) for detailed claim-by-claim analysis. Prepare and execute retention agreement. Target for initial expert consultation: August 2024.
6.  Solstice Document Production: Incorporate findings from Solstice's own document production (48,217 documents, Bates Nos. SBD-000001 through SBD-048217, to be produced by September 30, 2024). Ensure that engineering specifications and design history files for the accused products are reviewed and integrated into the claim chart analysis.
7.  Apex Document Production: Review Apex's responsive document production (Bates Nos. APEX-000001 through APEX-031450, expected approximately October 7, 2024) for additional information bearing on claim scope, prosecution history, prior licensing activity, and other matters relevant to the non-infringement and invalidity positions.
8.  Invalidity Contentions: Complete the Invalidity Contentions — Prior Art Analysis Memorandum (target: September 18, 2024) and coordinate invalidity and non-infringement strategies.
9.  Third-Party discovery: Issue subpoena to Veridian Medical Technologies, Inc. for prior art documents (target: September 2024).
10.  Ongoing Refinement: This claim chart is preliminary and will be revised and updated as the litigation progresses through fact discovery, expert discovery, claim construction, and the development of the summary judgment record. All non-infringement positions are subject to revision based on new information, claim construction rulings, and the results of expert analysis.
14. Certification
This Preliminary Claim Chart — Non-Infringement Analysis has been prepared, reviewed, and approved by the undersigned counsel in connection with the defense of Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA, U.S. District Court for the District of Delaware.
Prepared by:
________________________________________
Peter Vassiliev Associate Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, DE 19801 Tel: (302) 555-7100 pvassiliev@calderwoodharkness.com
Date: July 22, 2024
Reviewed by:
________________________________________
Christy Bauer Lead Associate Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, DE 19801 Tel: (302) 555-7104 cbauer@calderwoodharkness.com
Date: July 22, 2024
Approved by:
________________________________________
Marcus Delgado Partner, intellectual Property Practice Group Calderwood & Harkness LLP 1201 Market Street, Suite 2500 Wilmington, DE 19801 Tel: (302) 555-7108 mdelgado@calderwoodharkness.com
Date: July 22, 2024
Matter No.: 10294.0017
Client: Solstice Biomedical Devices Ltd. / Solstice Biomedical, Inc.
CONFIDENTIALITY NOTICE: This document is protected by the attorney-client privilege and the work product doctrine. It was prepared in anticipation of litigation and for the purpose of providing legal advice to the client. This document contains the mental impressions, conclusions, opinions, and legal theories of attorneys and is entitled to the highest level of work product protection. This document is not to be disclosed to any person or entity without the prior written authorization of Calderwood & Harkness LLP. Inadvertent disclosure of this document does not constitute a waiver of any applicable privilege or protection.
Patent at Issue: | U.S. Patent No. 10,271,884 (the "'884 Patent")
Title of Patent: | Retractable Blade Deployment Mechanism for Trocar Systems
Patent Issue Date: | April 30, 2019
Patent Expiration Date: | September 15, 2036
Named Inventor: | Dr. Raymond Szabo
Assignee: | Apex Surgical Innovations, Inc.
Asserted Claims: | 1, 2, 5, 9, and 14
Case: | Apex Surgical Innovations, Inc. v. Solstice Biomedical, Inc., Case No. 1:24-cv-00587-RGA, U.S. District Court for the District of Delaware
Accused Products: | PrecisionEdge™ PE-5000 Series (5 mm trocar assembly); PrecisionEdge™ PE-12000 Series (12 mm trocar assembly); PrecisionEdge™ PE-15000 Series (15 mm trocar assembly)
Date: | July 22, 2024
Prepared by: | Peter Vassiliev, Associate, Calderwood & Harkness LLP
Reviewed by: | Christy Bauer, Lead Associate, Calderwood & Harkness LLP
Supervising Attorney: | Marcus Delgado, Partner, Calderwood & Harkness LLP
Matter No.: | 10294.0017
Claim Language / Element | Accused Product Feature(s) | Non-Infringement Position
"A trocar assembly comprising a retractable blade deployment mechanism, comprising:" | The PE-5000, PE-12000, and PE-15000 are each trocar assemblies that include a blade that can be deployed and retracted within the obturator. Each product line incorporates a mechanism for effecting blade deployment and retraction, though the specific architectures of these mechanisms differ across the product lines and differ from the mechanism described in the '884 Patent. | To the extent the preamble is limiting — i.e., to the extent it recites structural limitations that are necessary to give "life, meaning, and vitality" to the claims — the accused products may be distinguishable based on the nature and architecture of their respective deployment mechanisms. As detailed below, the PrecisionEdge™ products employ cam-based, hybrid cam-and-lever, and pneumatically-assisted actuation systems, respectively, rather than the lever-arm-based mechanical linkage described and claimed in the '884 Patent. If the preamble is not treated as limiting (as is often the case where the preamble merely states the purpose or intended use of the claimed apparatus), the analysis proceeds to the body of the claim, and non-infringement is established based on the failure to meet one or more of the body limitations set forth below.
Claim Language / Element | Accused Product Feature(s) | Non-Infringement Position
"a hollow elongated cannula defining a longitudinal axis and having a proximal end and a distal end, and an obturator slidably received within the cannula, the obturator having an obturator housing extending along the longitudinal axis;" | PE-5000: The PE-5000 includes a hollow 5 mm diameter cannula with proximal and distal ends. An obturator is slidably received within the cannula. The obturator includes a housing that extends along the longitudinal axis of the cannula. PE-12000: The PE-12000 includes a hollow 12 mm diameter cannula with a similar configuration. The obturator is slidably received within the cannula and includes an obturator housing extending along the longitudinal axis. PE-15000: The PE-15000 includes a hollow 15 mm diameter cannula with an obturator slidably received therein. The obturator housing extends along the longitudinal axis. | This limitation is likely met by all three accused product lines. The general structural arrangement of a hollow cannula with a slidably received obturator is common to essentially all modern trocar designs, including the PrecisionEdge™ products. Solstice does not, at this preliminary stage, identify a strong basis for contesting this limitation, though detailed dimensional and structural analysis during discovery may reveal distinctions in the housing configuration (e.g., cross-sectional geometry, sealing arrangements, or structural features of the obturator housing) that could support a non-infringement argument. This limitation is not the primary focus of Solstice's non-infringement position.
Claim Language / Element | Accused Product Feature(s) | Non-Infringement Position
"a cutting blade disposed within the obturator housing, the cutting blade being movable between a retracted position in which the cutting blade is shielded within the obturator housing and a deployed position in which the cutting blade extends distally beyond the obturator housing;" | PE-5000: The PE-5000 includes a dual-edge triangular blade mounted on a sliding carriage within the obturator. The blade moves between a retracted (shielded) position and a deployed (extended) position. In the retracted position, the blade is contained within the obturator housing and is not exposed. In the deployed position, the blade extends beyond the distal tip of the obturator. PE-12000: The PE-12000 includes a pyramidal three-sided blade mounted on a deployment carriage. The blade similarly moves between retracted and deployed positions. PE-15000: The PE-15000 includes a broad, flat-profile blade with a beveled cutting edge, mounted on a deployment sled. The blade moves between retracted and deployed positions. | The PrecisionEdge™ products each include a blade that moves between a retracted and a deployed position, which is facially consistent with this limitation. However, there are potential distinctions in the blade geometry, the mounting configuration, and the movement pathway that may support a non-infringement argument under a narrower construction of the claim language. Specifically: (i) the '884 Patent specification describes the blade as a "lancet-type" blade with a specific tapered profile, and the claim term "cutting blade" may be construed in light of the specification to require a particular geometry — the PE-5000's triangular dual-edge blade, the PE-12000's pyramidal blade, and the PE-15000's flat-profile blade each differ from the described lancet-type geometry; (ii) the PE-5000's blade follows a helical (combined linear and rotational) movement pathway rather than a purely linear deployment path; and (iii) the PE-15000's blade is mounted on a sled rather than directly within the obturator housing, with the sled itself being a separate structural component not described in the '884 Patent. The strength of this argument depends on claim construction. If "cutting blade" is construed broadly to encompass any blade that cuts tissue, this limitation is likely met. If construed more narrowly in light of the specification, distinctions may exist. This limitation is not the primary basis for Solstice's non-infringement position but may provide supplementary support.
Claim Language / Element | Accused Product Feature(s) | Non-Infringement Position
"a mechanical linkage disposed within the obturator housing and operatively connecting the cutting blade to a deployment trigger, the mechanical linkage comprising a plurality of interconnected lever arms mounted on respective pivot points within the obturator housing, the lever arms being configured to translate axial force applied to a distal tip of the obturator into lateral displacement of the cutting blade from the retracted position to the deployed position;" | PE-5000: The PE-5000 does not use a plurality of interconnected lever arms mounted on pivot points. Instead, the PE-5000 employs a cam-based actuation system in which a cam follower on the blade carriage engages with a helical cam groove in the obturator housing wall. Axial force applied to the trocar tip causes the cam follower to travel along the cam groove, producing blade extension. There are no lever arms, no pivot points, and no interconnected linkage elements as described in this limitation. PE-12000: The PE-12000 employs a hybrid cam-and-lever system. While the PE-12000 does incorporate a single secondary lever arm, this lever arm acts as a stroke amplifier and is not part of a "plurality of interconnected lever arms mounted on respective pivot points" as required by this limitation. The primary deployment motion is cam-initiated, and the lever arm is ancillary to the cam mechanism. The PE-12000's system lacks the specific interconnected, multi-pivot-point lever architecture described in the '884 Patent. PE-15000: The PE-15000 employs a pneumatically-assisted cam actuation system. The deployment mechanism is cam-based with pneumatic augmentation. There are no lever arms or pivot-mounted linkage elements in the PE-15000's deployment mechanism. | This is the strongest non-infringement argument across all three accused product lines. The claim requires a "mechanical linkage" comprising "a plurality of interconnected lever arms mounted on respective pivot points." None of the accused products use a plurality of interconnected lever arms mounted on pivot points to translate axial force into blade deployment. PE-5000: The PE-5000's cam-based actuation system is structurally and operationally distinct from the claimed mechanical linkage. A cam-and-cam-follower system operates on fundamentally different mechanical principles than an interconnected lever-arm linkage. There are no lever arms, no pivot points, and no interconnected linkage elements. The PE-5000 does not meet this limitation. PE-12000: Although the PE-12000 includes a single lever arm, it does not include "a plurality of interconnected lever arms." A single lever acting as a stroke amplifier within a predominantly cam-based system is not a "mechanical linkage comprising a plurality of interconnected lever arms mounted on respective pivot points." The lever arm in the PE-12000 is not interconnected with other lever arms and does not form part of a multi-element linkage as claimed. The PE-12000 likely does not meet this limitation, though further factual development regarding the PE-12000's internal mechanism is needed during discovery. PE-15000: The PE-15000's pneumatically-assisted cam system does not include any lever arms or pivot-mounted linkage elements. The PE-15000 does not meet this limitation. Additionally, prosecution history estoppel may further support the argument that this limitation should be construed narrowly, as the applicant may have amended the claims during prosecution to specifically require the multi-lever-arm linkage to distinguish prior art. This will be addressed in the prosecution history analysis memorandum.
Claim Language / Element | Accused Product Feature(s) | Non-Infringement Position
"a biasing member comprising a spring disposed within the obturator housing and operatively connected to the cutting blade, the spring urging the cutting blade toward the retracted position such that the cutting blade returns to the retracted position when the axial force applied to the distal tip is removed;" | PE-5000: The PE-5000

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