IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
DEFENDANT SOLSTICE BIOMEDICAL, INC.'S RESPONSES AND OBJECTIONS TO PLAINTIFF APEX SURGICAL INNOVATIONS, INC.'S FIRST SET OF INTERROGATORIES (NOS. 1–18)
Date Served: September 16, 2024
I. INTRODUCTORY STATEMENT
Defendant Solstice Biomedical, Inc. ("Solstice" or "Defendant"), by and through its undersigned counsel, Calderwood & Harkness LLP, hereby serves its Responses and Objections to Plaintiff Apex Surgical Innovations, Inc.'s ("Apex" or "Plaintiff") First Set of Interrogatories (Nos. 1–18) (the "Interrogatories"), served on Defendant on August 5, 2024, pursuant to Rules 26 and 33 of the Federal Rules of Civil Procedure and the Local Rules of the United States District Court for the District of Delaware.
These Responses and Objections are made by Solstice Biomedical, Inc., a Delaware corporation (EIN 84-3291056), the United States operating subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company (CRO No. 648217), which is the named Defendant in this action. Solstice Biomedical, Inc. maintains its principal offices at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803. No other entity is a party to this action, and these responses are submitted solely on behalf of the named Defendant.
II. PRELIMINARY STATEMENT AND GENERAL OBJECTIONS
Solstice makes the following General Objections, which are incorporated by reference into each specific response set forth below as if fully restated therein. The assertion of a specific objection in response to any particular interrogatory does not waive any General Objection as to that interrogatory, and the failure to assert a specific objection in response to any particular interrogatory does not waive any General Objection or any specific objection that may be applicable to that interrogatory.
A. Reservation of Rights and Ongoing Investigation
Solstice's investigation and discovery in this matter are ongoing and have not been completed. These Responses and Objections are based upon information and documents reasonably available to Solstice as of the date of service of these responses, September 16, 2024. Solstice has not yet completed its review and analysis of all potentially responsive documents, including documents produced by Plaintiff, third-party documents, and documents in the custody and control of Solstice's parent company. Accordingly, Solstice expressly reserves the right to supplement, amend, or correct any and all of the responses contained herein as additional information becomes available through the course of investigation and discovery in this matter, in accordance with the obligations imposed by Federal Rule of Civil Procedure 26(e) and the Scheduling Order entered by this Court on July 2, 2024.
Nothing contained in these Responses and Objections is intended to, or shall be deemed to, constitute an admission or waiver of any claim, defense, right, or objection available to Solstice in this action, including but not limited to any affirmative defense or counterclaim raised in Solstice's Answer, Affirmative Defenses, and Counterclaims filed on June 14, 2024. Solstice's provision of any response to an interrogatory that it has objected to shall not be construed as a waiver of such objection.
B. Objection to Definitions and Instructions
To the extent that Apex's Interrogatories contain definitions or instructions that purport to impose obligations on Solstice beyond those required by the Federal Rules of Civil Procedure, the Local Rules of the United States District Court for the District of Delaware, or the Scheduling Order entered by the Honorable Richard G. Andrews on July 2, 2024 (Dkt. No. 24), Solstice objects to such definitions and instructions and will respond to the Interrogatories only as required by such rules and orders.
Solstice specifically objects to Apex's definition of "Solstice" and "You" to the extent such definitions purport to encompass entities that are not parties to this action, including but not limited to Solstice Biomedical Devices Ltd. (Ireland), its subsidiaries, affiliates, agents, representatives, predecessors, and successors. The named Defendant in this action is Solstice Biomedical, Inc., a Delaware corporation, and Solstice will respond to the Interrogatories on behalf of the named Defendant only. To the extent any interrogatory seeks information within the custody, possession, or control of non-party entities, Solstice objects that such requests are beyond the scope of permissible interrogatory practice and are more properly directed to those entities through third-party discovery mechanisms.
C. Privilege Objection
Solstice objects to each and every interrogatory to the extent it calls for the disclosure of information or the identification of documents that are protected by the attorney-client privilege, the work product doctrine (including opinion work product), the common interest privilege, the joint defense privilege, or any other applicable privilege, immunity, or protection from disclosure. Solstice does not intend to waive, and does not waive, any such privilege, immunity, or protection by virtue of the responses provided herein. Any inadvertent disclosure of information or documents that are subject to any privilege, immunity, or protection from disclosure shall not constitute, and shall not be deemed to constitute, a waiver of any such privilege, immunity, or protection, whether as to the specific information or documents inadvertently disclosed or as to any other information or documents. The parties' protocol regarding the assertion and logging of privilege claims was established in accordance with the Joint discovery Plan filed on July 15, 2024 (Dkt. No. 28) and is governed by Federal Rule of Evidence 502(d).
D. Proportionality Objection
Solstice objects to each and every interrogatory to the extent it is overbroad, unduly burdensome, or disproportionate to the needs of the case, taking into account the importance of the issues at stake in the action, the amount in controversy, the parties' relative access to relevant information, the parties' resources, the importance of the discovery in resolving the issues, and whether the burden or expense of the proposed discovery outweighs its likely benefit, within the meaning of Federal Rule of Civil Procedure 26(b)(1). Solstice further objects to each interrogatory to the extent it is not relevant to any party's claim or defense or is not reasonably calculated to lead to the discovery of admissible evidence.
E. Confidentiality. Certain information provided in these Responses and Objections, including but not limited to financial data, sales figures, profit margin information, and trade secret or proprietary technical information, may be designated as "CONFIDENTIAL" or "ATTORNEYS' EYES ONLY" pursuant to the Stipulated Protective Order entered in this action on July 22, 2024 (Dkt. No. 32). All parties, their counsel, and any persons who receive copies of these responses are bound by the terms of the Stipulated Protective Order with respect to any information so designated. To the extent not previously designated, Solstice reserves the right to designate specific information contained herein under the terms of the Stipulated Protective Order.
F. Contention Interrogatory Timing
To the extent that any interrogatory constitutes, in whole or in part, a contention interrogatory within the meaning of Federal Rule of Civil Procedure 33(a)(2), Solstice objects that such interrogatories are premature and that complete responses cannot reasonably be provided prior to the completion of fact discovery, claim construction proceedings, and expert discovery. Expert discovery opens on January 13, 2025, and the Markman hearing on claim construction is currently scheduled for November 18, 2024, before the Honorable Richard G. Andrews. Solstice responds to contention interrogatories to the extent practicable based on its current knowledge and the current state of the proceedings, and expressly reserves the right to supplement, amend, or modify its responses to contention interrogatories as claim construction proceeds, as expert analyses are completed, and as additional fact discovery is obtained.
G. Subparts Objection
To the extent any single interrogatory contains discrete subparts that are not logically or factually subsumed within a single interrogatory topic, Solstice objects that such subparts constitute separate interrogatories and should be counted as such under the numerical limit of twenty-five (25) interrogatories established by Federal Rule of Civil Procedure 33(a)(1). Solstice reserves the right to count such subparts as separate interrogatories and to decline to respond to any interrogatories that exceed the numerical limit.
III. SPECIFIC INTERROGATORY RESPONSES AND OBJECTIONS
Subject to and without waiver of the foregoing General Objections, which are incorporated by reference into each specific response below, Solstice responds to each of Apex's Interrogatories as follows:
INTERROGATORY NO. 1
Identify Defendant Solstice Biomedical, Inc., including its state of incorporation, principal place of business, federal employer identification number, and describe the corporate relationship between Solstice Biomedical, Inc. and Solstice Biomedical Devices Ltd., including the nature and extent of the parent-subsidiary relationship, the date of incorporation of each entity, and the principal officers and directors of each entity.
OBJECTIONS:
Solstice incorporates the General Objections set forth in Section II above as if fully restated herein. Solstice further objects to this Interrogatory to the extent it seeks detailed information about entities that are not parties to this action, including Solstice Biomedical Devices Ltd., an Irish private limited company, to the extent such information is not relevant to any claim or defense asserted in this action or is disproportionate to the needs of the case. Solstice further objects to the extent this Interrogatory seeks information about "the nature and extent of the parent-subsidiary relationship" beyond what is reasonably relevant to the claims and defenses at issue, as no alter ego or veil-piercing theory has been pleaded by Apex.
RESPONSE:
Subject to and without waiver of the foregoing objections, Solstice responds as follows:
Solstice Biomedical, Inc. is a corporation organized and existing under the laws of the State of Delaware. Its federal employer identification number is 84-3291056. Solstice Biomedical, Inc. maintains its principal offices at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803. Solstice Biomedical, Inc. was incorporated on March 15, 2016, and serves as the United States operating subsidiary responsible for the marketing, distribution, sale, and servicing of Solstice Biomedical products in the United States.
Solstice Biomedical, Inc. is a wholly-owned subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company, Companies Registration Office Number 648217, with its registered office at Unit 14, Clonskeagh Business Park, Clonskeagh Road, Dublin 14, D14 YF28, Ireland. Solstice Biomedical Devices Ltd. was founded in 2011 and is engaged in the design, development, and manufacture of minimally invasive surgical instruments and related medical devices. As of the date of this response, Solstice Biomedical Devices Ltd. and its subsidiaries employ approximately 620 persons worldwide. For the fiscal year ending December 31, 2023, the Solstice Biomedical Devices Ltd. group reported consolidated revenue of approximately €187.4 million (unaudited).
The principal officers of Solstice Biomedical Devices Ltd. (the parent company) known to Solstice are as follows:
• Chief Executive Officer: Dr. Fiona Tierney
• General Counsel: Eamon Rourke
• Vice President, Regulatory & intellectual Property: Niamh Cassidy
• Chief Financial Officer: Brendan Molloy
The independent auditors of Solstice Biomedical Devices Ltd. are Glenmore & Byrne LLP, 25 St. Stephen's Green, Dublin 2, D02 XF99, Ireland.
Solstice reserves the right to supplement this response as additional information becomes available.
INTERROGATORY NO. 2
Identify all persons with knowledge of the design, development, manufacture, testing, marketing, sale, or distribution of each of the accused PrecisionEdge™ products, including each person's name, title, employer, last known address, telephone number, and a description of the subjects about which each person has knowledge.
OBJECTIONS:
Solstice incorporates the General Objections set forth in Section II above as if fully restated herein. Solstice further objects to this Interrogatory as overbroad and unduly burdensome to the extent it seeks identification of "all persons" with any knowledge of any aspect of the design, development, manufacture, testing, marketing, sale, or distribution of the accused products. A complete identification of every individual who may possess some knowledge on any of these topics would be impracticable and disproportionate to the needs of the case. Solstice further objects to the extent this Interrogatory seeks contact information such as home addresses and personal telephone numbers, the disclosure of which would implicate privacy concerns.
Subject to and without waiver of the foregoing objections, Solstice will identify persons with material knowledge of the subjects identified in this Interrogatory who are known to Solstice at this time, and Solstice reserves the right to supplement this response in accordance with Federal Rule of Civil Procedure 26(e) as its investigation continues and as additional custodian interviews are conducted.
RESPONSE:
Subject to and without waiver of the foregoing objections, Solstice responds as follows:
The following persons are known to Solstice to have material knowledge relevant to the design, development, manufacture, testing, marketing, sale, or distribution of the accused PrecisionEdge™ products:
1. Niamh Cassidy, Vice President, Regulatory & intellectual Property, Solstice Biomedical Devices Ltd. Ms. Cassidy has knowledge of the design history files, regulatory submissions (including FDA 510(k) clearances), and intellectual property clearance processes for the PrecisionEdge™ product line, including the PE-5000, PE-12000, and PE-15000 Series.
2. Engineering personnel involved in the design and development of the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series. Specific names and contact information for these individuals will be identified in a supplemental response following the completion of custodian interviews currently in progress. Solstice notes that a litigation hold notice was issued on May 11, 2024, which identified the relevant custodians; interviews of those custodians are ongoing.
3. Sales and marketing personnel responsible for the United States distribution and commercialization of the PrecisionEdge™ product line. Specific names and contact information for these individuals will be identified in a supplemental response.
4. Brendan Molloy, Chief Financial Officer, Solstice Biomedical Devices Ltd. Mr. Molloy has knowledge of financial data pertaining to the accused products, including sales figures, revenues, costs of goods sold, and profit margins.
5. Eamon Rourke, General Counsel, Solstice Biomedical Devices Ltd. Mr. Rourke has knowledge of the intellectual property clearance process and freedom-to-operate analyses conducted with respect to the PrecisionEdge™ product line, subject to and without waiver of the attorney-client privilege and work product protection.
Solstice reserves the right to supplement this response as its investigation continues and as additional persons with material knowledge are identified.
INTERROGATORY NO. 3
Describe each accused PrecisionEdge™ product in detail, including its model number or designation, the nature and purpose of the product, a detailed technical description of its design and components, a description of how the product operates, and the date each product was first offered for sale or sold in the United States.
OBJECTIONS:
Solstice incorporates the General Objections set forth in Section II above as if fully restated herein. Solstice further objects to this Interrogatory as overbroad and unduly burdensome to the extent it seeks a "detailed technical description" of the design and components and operation of each accused product, as such information encompasses proprietary and trade secret technical information that goes far beyond what is relevant to the patent infringement claims at issue in this action. Solstice further objects to this Interrogatory to the extent it seeks information that is more completely and accurately set forth in the design history files, engineering specifications, and technical documentation being produced in Solstice's document production, and Solstice refers Apex to those documents pursuant to Federal Rule of Civil Procedure 33(d) to the extent applicable.
Subject to and without waiver of the foregoing objections, Solstice responds to the extent pertinent to the asserted patent claims.
RESPONSE:
Subject to and without waiver of the foregoing objections, Solstice responds as follows:
The accused PrecisionEdge™ products at issue in this litigation are as follows:
PrecisionEdge™ PE-5000 Series. The PE-5000 Series is a 5 mm trocar assembly designed for use in laparoscopic surgical access procedures. The PE-5000 Series is intended to provide surgeons with a minimally invasive access port for the introduction of surgical instruments during laparoscopic surgery. The PE-5000 Series has been accused by Apex of infringing the '237 Patent (U.S. Patent No. 9,814,237), specifically Claims 1, 3, 7, and 12, and the '884 Patent (U.S. Patent No. 10,271,884), specifically Claims 1, 2, 5, 9, and 14.
PrecisionEdge™ PE-12000 Series. The PE-12000 Series is a 12 mm trocar assembly designed for use in laparoscopic surgical access procedures. The PE-12000 Series has been accused by Apex of infringing all three asserted patents in this action: the '237 Patent (U.S. Patent No. 9,814,237), Claims 1, 3, 7, and 12; the '884 Patent (U.S. Patent No. 10,271,884), Claims 1, 2, 5, 9, and 14; and the '105 Patent (U.S. Patent No. 10,932,105), Claims 1, 4, and 8.
PrecisionEdge™ PE-15000 Series. The PE-15000 Series is a 15 mm trocar assembly designed for use in laparoscopic surgical access procedures. The PE-15000 Series has been accused by Apex of infringing the '884 Patent (U.S. Patent No. 10,271,884), Claims 1, 2, 5, 9, and 14, and the '105 Patent (U.S. Patent No. 10,932,105), Claims 1, 4, and 8.
Detailed technical descriptions, design schematics, engineering drawings, bills of materials, and other technical documentation for each of the foregoing product lines are being produced in the ordinary course of Solstice's document production in this action and are identified at Bates Numbers SBD-000001 through SBD-048217, produced on September 30, 2024. Solstice refers Apex to those documents for comprehensive technical specifications and detailed descriptions of the design, components, and operation of each accused product.
Each of the PrecisionEdge™ products is designed, manufactured, and sold for use by surgeons performing minimally invasive laparoscopic surgical procedures. Further details regarding the structural and functional differences between the PrecisionEdge™ products and the claim elements of the asserted patents will be set forth in Solstice's non-infringement contentions and in the expert reports to be served during expert discovery. Solstice's position is that none of the accused products infringes any asserted claim of any asserted patent.
Solstice reserves the right to supplement this response.
INTERROGATORY NO. 4
State the total United States sales revenue, total number of units sold, and total number of units manufactured for each accused PrecisionEdge™ product, broken down by year, from the date each product was first offered for sale or sold in the United States to the present.
OBJECTIONS:
Solstice incorporates the General Objections set forth in Section II above as if fully restated herein. Solstice further objects to this Interrogatory as overly broad with respect to the time period requested and the level of granularity demanded. Solstice further objects to the extent this Interrogatory seeks information regarding units manufactured, as opposed to units sold, in the United States, as manufacturing volume data is not directly relevant to any damages theory in this patent infringement action and the burden of compiling such data outweighs its likely benefit. Solstice further objects to the extent this Interrogatory seeks confidential and commercially sensitive financial information. The financial information provided in this response is designated CONFIDENTIAL pursuant to the Stipulated Protective Order entered in this action on July 22, 2024 (Dkt. No. 32), and all recipients are bound by the terms of that Order.
Subject to and without waiver of the foregoing objections, Solstice responds as follows.
RESPONSE:
Subject to and without waiver of the foregoing objections, Solstice responds as follows:
DESIGNATED CONFIDENTIAL PURSUANT TO THE STIPULATED PROTECTIVE ORDER
Combined United States sales of the accused PrecisionEdge™ products (PE-5000, PE-12000, and PE-15000 Series), for calendar years 2021 through September 30, 2024, totaled approximately $74,600,000, broken down as follows:
The weighted average gross margin on the accused PrecisionEdge™ products for the periods stated above is approximately 61.3%.
Product-by-product breakdowns of revenue, units sold, and related financial data for each of the PE-5000, PE-12000, and PE-15000 Series are currently being prepared and compiled by Solstice's finance department in coordination with counsel. Such product-by-product breakdowns will be provided in a supplemental response to this Interrogatory. Financial records supporting the aggregate figures stated above, including invoices, sales reports, and revenue summaries, are included in Solstice's document production at Bates Numbers SBD-000001 through SBD-048217, produced on September 30, 2024.
Solstice reserves the right to supplement this response.
INTERROGATORY NO. 5
Identify all prior art known to Solstice that Solstice contends renders any asserted claim of U.S. Patent No. 9,814,237 (the "'237 Patent"), U.S. Patent No. 10,271,884 (the "'884 Patent"), or U.S. Patent No. 10,932,105 (the "'105 Patent") invalid, including for each item of prior art the title, author(s), publication date, patent number or publication number (if applicable), and a general description of the prior art's relevance to the asserted claims.
OBJECTIONS:
Solstice incorporates the General Objections set forth in Section II above as if fully restated herein. Solstice further objects to this Interrogatory as a contention interrogatory that is premature to the extent it seeks Solstice's final or complete invalidity contentions prior to the completion of claim construction proceedings and prior to the completion of Solstice's ongoing investigation into prior art. Solstice notes that the Markman hearing on claim construction is scheduled for November 18, 2024, and that nine disputed claim terms remain at issue. The proper construction of the asserted claims will directly affect the scope and relevance of the prior art identified, and Solstice cannot reasonably be expected to provide final invalidity contentions before the Court rules on claim construction.
Solstice further notes that its investigation into prior art is ongoing and includes work being conducted by its patent prosecution counsel, Kendrick & Lau LLP, 601 Pennsylvania Avenue NW, Suite 820, Washington, DC 20004 (Dr. Jonathan Kendrick, Lead Partner), as well as its retained technical expert, Dr. Miriam Ostrowski. This investigation includes searches of patent databases, technical literature, and commercial products, as well as a review of documents being obtained from third parties, including documents subpoenaed from Veridian Medical Technologies, Inc.
Subject to and without waiver of the foregoing objections, Solstice responds with the prior art identified to date and expressly reserves the right to supplement this response as its investigation continues and as claim construction and expert discovery proceed.
RESPONSE:
Subject to and without waiver of the foregoing objections, Solstice responds as follows:
Solstice contends that the asserted claims of the '237 Patent, the '884 Patent, and the '105 Patent are invalid under one or more of the provisions of 35 U.S.C. §§ 102 and 103, as well as potentially under 35 U.S.C. § 112 for failure to satisfy the written description, enablement, and/or definiteness requirements.
The prior art references identified to date by Solstice include, but are not limited to, the following categories:
1. Published patent applications and issued patents identified through searches conducted by Kendrick & Lau LLP and Calderwood & Harkness LLP. Specific references, including patent numbers, publication numbers, titles, inventors, and issue or publication dates, will be set forth in Solstice's Invalidity Contentions, which are currently under preparation. A detailed analysis memorandum cataloging and charting the identified prior art references is in progress as of September 2024 and is expected to be substantially complete following the Court's Claim Construction Order.
2. Prior art publications, articles, and technical literature from third-party sources, including conference proceedings, journal articles, and technical manuals relating to laparoscopic trocar assemblies, seal assemblies, blade deployment mechanisms, and insufflation valve configurations. Solstice's technical expert, Dr. Miriam Ostrowski, is reviewing these materials as part of her analysis.
3. Prior art products and commercial systems available before the priority dates of the asserted patents, including products manufactured, sold, or offered for sale by third parties. Documents pertaining to such prior art products have been subpoenaed from Veridian Medical Technologies, Inc. (subpoena duces tecum issued September 12, 2024), and the production of documents responsive to that subpoena is pending.
4. Prior art references cited during prosecution of the '237, '884, and '105 Patents before the United States Patent and Trademark Office, as reflected in the prosecution histories of those patents. Solstice is analyzing the prosecution histories to identify references cited by the Examiner and by the applicant, as well as to evaluate whether all material prior art was disclosed during prosecution.
Solstice's formal Invalidity Contentions will be served in accordance with the Scheduling Order entered by this Court on July 2, 2024. Solstice further reserves the right to supplement this response following the completion of expert analysis. Dr. Miriam Ostrowski, Professor of Biomedical Engineering at Halford University, 3401 Walnut Street, Philadelphia, Pennsylvania 19104, has been retained as Solstice's technical expert on claim construction and invalidity pursuant to a retention agreement dated August 20, 2024. Dr. Ostrowski's expert report will set forth detailed prior art charting and invalidity analyses for each asserted claim.
Solstice reserves the right to supplement this response.
INTERROGATORY NO. 6
For each item of prior art identified in response to Interrogatory No. 5, state whether Solstice contends the prior art anticipates or renders obvious the asserted claims of the '237 Patent, the '884 Patent, and/or the '105 Patent, and for each such contention, identify the specific claim elements of each asserted claim that are met by each prior art reference, including whether the reference is relied upon alone or in combination with other references.
OBJECTIONS:
Solstice incorporates the General Objections set forth in Section II above as if fully restated herein. Solstice further objects to this Interrogatory as a contention interrogatory that is premature and unduly burdensome. A complete element-by-element analysis mapping each prior art reference to each element of each asserted claim cannot reasonably be provided at this stage of the litigation, prior to the completion of claim construction proceedings (the Markman hearing is scheduled for November 18, 2024) and prior to the opening of expert discovery (January 13, 2025). The Court's construction of the nine disputed claim terms—including "locking seal assembly," "retractable blade deployment mechanism," and "integrated insufflation valve"—will directly affect the scope of the claims and the relevance of the prior art identified by Solstice. Accordingly, Solstice objects that a complete response to this Interrogatory is premature.
Subject to and without waiver of the foregoing objections, Solstice responds in general terms based on its preliminary analysis and expressly reserves the right to supplement this response.
RESPONSE:
Subject to and without waiver of the foregoing objections, Solstice responds as follows:
Solstice's preliminary invalidity contentions include both anticipation theories under 35 U.S.C. § 102 and obviousness theories under 35 U.S.C. § 103 for each of the three asserted patents. Detailed claim-by-claim, element-by-element charting mapping identified prior art references to each element of each asserted claim is currently underway and will be set forth in Solstice's formal Invalidity Contentions and addressed in detail in the expert report of Dr. Miriam Ostrowski, to be served during expert discovery.
In general terms, and subject to further development following the Court's Claim Construction Order:
As to the '237 Patent (Claims 1, 3, 7, and 12): Solstice has identified prior art references that disclose locking seal assemblies for minimally invasive surgical access devices. Solstice contends that one or more of these references anticipate the asserted claims or render them obvious, either alone or in combination with other references. The specific claim elements met by each reference will be detailed in Solstice's Invalidity Contentions and expert report.
As to the '884 Patent (Claims 1, 2, 5, 9, and 14): Solstice has identified prior art references that disclose retractable blade deployment mechanisms for trocar systems. Solstice contends that one or more of these references anticipate the asserted claims or render them obvious, either alone or in combination with other references. The specific claim elements met by each reference will be detailed in Solstice's Invalidity Contentions and expert report.
As to the '105 Patent (Claims 1, 4, and 8): Solstice has identified prior art references that disclose integrated insufflation valves and seal configurations for laparoscopic trocars. Solstice contends that one or more of these references anticipate the asserted claims or render them obvious, either alone or in combination with other references. The specific claim elements met by each reference will be detailed in Solstice's Invalidity Contentions and expert report.
Solstice reserves the right to supplement this response as its investigation continues and as claim construction and expert discovery proceed.
INTERROGATORY NO. 7
For each asserted claim of each asserted patent, identify the basis on which Solstice contends the accused PrecisionEdge™ products do not infringe, including whether Solstice's non-infringement contention is based on literal non-infringement, the absence of infringement under the doctrine of equivalents, or both, and identify the specific claim element(s) that Solstice contends are not met by each accused product.
OBJECTIONS:
Solstice incorporates the General Objections set forth in Section II above as if fully restated herein. Solstice further objects to this Interrogatory as a contention interrogatory that is premature prior to the completion of claim construction proceedings. The Markman hearing is scheduled for November 18, 2024, and nine disputed claim terms are at issue. Solstice's non-infringement positions are necessarily dependent upon the construction the Court gives to the disputed claim terms. A complete and final response to this Interrogatory cannot reasonably be provided until after the Court issues its Claim Construction Order.
Subject to and without waiver of the foregoing objections, Solstice responds based on its preliminary analysis and expressly reserves the right to supplement or amend this response following the Court's Claim Construction Order and the completion of expert analysis.
RESPONSE:
Subject to and without waiver of the foregoing objections, Solstice responds as follows:
Solstice contends that none of the accused PrecisionEdge™ products—the PE-5000 Series, the PE-12000 Series, or the PE-15000 Series—infringes any asserted claim of any of the three asserted patents, either literally or under the doctrine of equivalents. Solstice's non-infringement positions are set forth in preliminary claim charts that have been prepared by counsel in consultation with Solstice's technical personnel and are summarized as follows:
• '237 Patent claim chart, dated July 20, 2024, mapping each element of Claims 1, 3, 7, and 12 of the '237 Patent against the PE-5000 Series and the PE-12000 Series.
• '884 Patent claim chart, dated July 22, 2024, mapping each element of Claims 1, 2, 5, 9, and 14 of the '884 Patent against the PE-5000 Series, the PE-12000 Series, and the PE-15000 Series.
• '105 Patent claim chart, dated July 25, 2024, mapping each element of Claims 1, 4, and 8 of the '105 Patent against the PE-12000 Series and the PE-15000 Series.
These preliminary claim charts identify specific structural and functional differences between the accused PrecisionEdge™ products and the claim elements of the asserted patents. Solstice's non-infringement positions will be refined and finalized following the Court's Claim Construction Order. As noted, the Markman hearing is scheduled for November 18, 2024, and nine disputed claim terms remain at issue, including but not limited to "locking seal assembly," "retractable blade deployment mechanism," and "integrated insufflation valve." Proposed claim constructions were exchanged between the parties on October 22, 2024, and the Joint Claim Construction Brief is scheduled to be filed on November 4, 2024.
Solstice's non-infringement positions will be further detailed in the expert report of Dr. Miriam Ostrowski, to be served during expert discovery.
Solstice reserves the right to supplement this response.
INTERROGATORY NO. 8
Identify all documents that support Solstice's non-infringement and invalidity contentions as set forth in its responses to Interrogatories Nos. 5, 6, and 7, including the Bates number, title, author, date, and a description of the relevance of each document.
OBJECTIONS:
Solstice incorporates the General Objections set forth in Section II above as if fully restated herein. Solstice further objects to this Interrogatory as overbroad and unduly burdensome to the extent it calls for a document-by-document listing of every document that supports Solstice's non-infringement and invalidity contentions, together with a description of the relevance of each such document. The burden and expense of compiling such a catalogue is disproportionate to the needs of the case. Responsive documents have been and are being produced in the parties' respective document productions, and Solstice's non-infringement and invalidity contentions will be supported by specific documentary evidence identified in Solstice's Invalidity Contentions, non-infringement contentions, and expert reports.
Subject to and without waiver of the foregoing objections, Solstice responds as follows.
RESPONSE:
Subject to and without waiver of the foregoing objections, Solstice responds as follows:
Documents supporting Solstice's non-infringement and invalidity contentions are included in Solstice's document production in this action, bearing Bates Numbers SBD-000001 through SBD-048217, produced on September 30, 2024. These documents include, among other things, design history files, engineering specifications, technical drawings, bills of materials, patent prosecution correspondence, freedom-to-operate analysis materials (to the extent not privileged), and prior art references.
Additional documents that may support Solstice's non-infringement and invalidity contentions may be identified within Apex's document production, bearing Bates Numbers APEX-000001 through APEX-031450, produced on October 7, 2024. Solstice's review of Apex's production is ongoing.
Additional documents may also be identified through third-party discovery, including the document production expected from Veridian Medical Technologies, Inc. pursuant to the subpoena duces tecum issued on September 12, 2024.
Solstice will identify specific documents relied upon in its formal Invalidity Contentions, non-infringement contentions, and expert reports, as those materials are prepared and served.
Solstice reserves the right to supplement this response.
INTERROGATORY NO. 9
Describe in detail Solstice's contentions regarding inequitable conduct, as raised in Solstice's counterclaims filed on June 14, 2024, including the identity of the person(s) alleged to have committed inequitable conduct, the specific acts or omissions alleged to constitute inequitable conduct, the specific prior art or other information allegedly withheld or misrepresented, and the materiality and intent elements underlying each contention.
OBJECTIONS:
Solstice incorporates the General Objections set forth in Section II above as if fully restated herein. Solstice further objects to this Interrogatory as a contention interrogatory that is premature to the extent it seeks Solstice's final or complete inequitable conduct contentions prior to the completion of fact discovery, including the review of Apex's document production and the depositions of Apex personnel. Solstice's inequitable conduct counterclaim, as set forth in its Answer, Affirmative Defenses, and Counterclaims filed on June 14, 2024 (Dkt. No. 18), is based on information obtained to date and is subject to ongoing investigation through discovery. Solstice further objects to the extent this Interrogatory seeks disclosure of information protected by the attorney-client privilege or work product doctrine.
Subject to and without waiver of the foregoing objections, Solstice responds based on its current knowledge and investigation and expressly reserves the right to supplement this response as discovery proceeds.
RESPONSE:
Subject to and without waiver of the foregoing objections, Solstice responds as follows:
In its Answer, Affirmative Defenses, and Counterclaims filed on June 14, 2024 (Dkt. No. 18), Solstice asserted affirmative defenses and counterclaims of inequitable conduct with respect to the prosecution of the '237 Patent, the '884 Patent, and the '105 Patent before the United States Patent and Trademark Office.
Solstice's investigation into the prosecution histories of the asserted patents is ongoing. A prosecution history analysis memorandum was prepared by Calderwood & Harkness LLP, dated September 5, 2024, identifying certain narrowing amendments made during prosecution and potential omissions of material prior art references that were not disclosed to the USPTO by the applicant during prosecution. The memorandum is protected by the work product doctrine and is not being produced.
Based on Solstice's investigation to date, Solstice contends that the named inventor on all three asserted patents, Dr. Raymond Szabo, who is the Vice President of Engineering at Apex Surgical Innovations, Inc., is believed to have had knowledge of prior art references and/or prior commercial products that were material to the patentability of the asserted claims and that may not have been disclosed to the USPTO during the prosecution of one or more of the asserted patents. Solstice further contends that the omission of such material prior art, if established, was made with the specific intent to deceive the USPTO.
Solstice's inequitable conduct contentions will be further developed through the course of discovery in this action, including review and analysis of Apex's document production (Bates Numbers APEX-000001 through APEX-031450, produced October 7, 2024), deposition testimony of Dr. Szabo and other Apex personnel, and third-party discovery. Solstice reserves the right to amend its counterclaims and to supplement this response as the factual basis for its inequitable conduct contentions is further developed.
Solstice reserves the right to supplement this response.
INTERROGATORY NO. 10
Identify all licenses Solstice has obtained or sought relating to the asserted patents or any technology similar to the technology claimed in the asserted patents, including the identity of the licensor, the date of the license, the scope of the license, and any royalty rates or other financial terms.
OBJECTIONS:
Solstice incorporates the General Objections set forth in Section II above as if fully restated herein. Solstice further objects to this Interrogatory as overbroad to the extent it seeks information about licenses relating to "any technology similar to the technology claimed in the asserted patents," which is vague, undefined, and potentially encompasses an unlimited universe of technology licensing arrangements that have no relevance to this action. Solstice further objects to the extent this Interrogatory seeks confidential and commercially sensitive business information, the disclosure of which would be prejudicial and is not justified by the needs of this case. Any information provided in response to this Interrogatory is subject to the Stipulated Protective Order entered in this action on July 22, 2024 (Dkt. No. 32).
Subject to and without waiver of the foregoing objections, Solstice responds as follows.
RESPONSE:
Subject to and without waiver of the foregoing objections, Solstice responds as follows:
Solstice has not previously obtained, and has not previously sought, any license from Apex Surgical Innovations, Inc. for U.S. Patent No. 9,814,237 (the '237 Patent), U.S. Patent No. 10,271,884 (the '884 Patent), or U.S. Patent No. 10,932,105 (the '105 Patent), nor has any license been offered to Solstice by Apex for those patents.
Solstice has obtained freedom-to-operate opinions from its patent prosecution counsel, Kendrick & Lau LLP, regarding the PrecisionEdge™ product line. Such opinions and related communications are protected by the attorney-client privilege and the work product doctrine, and Solstice does not waive any privilege with respect to such opinions by virtue of this response or otherwise.
Solstice reserves the right to supplement this response.
INTERROGATORY NO. 11
Describe in detail all opinions of counsel Solstice has obtained concerning the asserted patents, including non-infringement opinions, invalidity opinions, and freedom-to-operate opinions, including the identity of the attorney or firm providing each opinion, the date of each opinion, and the conclusions reached in each opinion.
OBJECTIONS:
Solstice incorporates the General Objections set forth in Section II above as if fully restated herein. Solstice specifically objects to this Interrogatory in its entirety on the grounds that it seeks information protected by the attorney-client privilege and the work product doctrine. Solstice has not asserted, and does not intend to assert, an advice-of-counsel defense in this action, and Solstice does not waive, and has not waived, any privilege with respect to any opinions of counsel obtained in connection with the asserted patents or any other matter. Any inadvertent disclosure of information responsive to this Interrogatory shall not constitute, and shall not be deemed to constitute, a waiver of any applicable privilege.
Solstice declines to provide a substantive response to this Interrogatory on the basis of the foregoing objection.
RESPONSE:
See objection. No substantive response is provided.
INTERROGATORY NO. 12
State the date on which Solstice first became aware of each of the asserted patents—U.S. Patent No. 9,814,237 (the '237 Patent), U.S. Patent No. 10,271,884 (the '884 Patent), and U.S. Patent No. 10,932,105 (the '105 Patent)—and describe the circumstances under which Solstice first became aware of each patent.
OBJECTIONS:
Solstice incorporates the General Objections set forth in Section II above as if fully restated herein. No additional specific objections are asserted with respect to this Interrogatory.
RESPONSE:
Subject to and without waiver of the foregoing General Objections, Solstice responds as follows:
Solstice became aware of the '237 Patent (U.S. Patent No. 9,814,237), the '884 Patent (U.S. Patent No. 10,271,884), and the '105 Patent (U.S. Patent No. 10,932,105) upon receipt of the Complaint filed by Apex Surgical Innovations, Inc. on May 9, 2024, in Case No. 1:24-cv-00587-RGA in the United States District Court for the District of Delaware. Solstice was served with the Summons and Complaint on May 23, 2024, through its registered agent, Pemberton Industries, located in Wilmington, Delaware.
Solstice's investigation into whether any individual employee or officer of Solstice Biomedical, Inc. or Solstice Biomedical Devices Ltd. had awareness of any of the asserted patents prior to the filing and service of the Complaint is ongoing. Solstice reserves the right to supplement this response as its investigation continues.
INTERROGATORY NO. 13
Identify all persons who participated in the design and development of each accused PrecisionEdge™ product, including each person's name, title, employer, role in the design and development process, and the time period during which each person participated.
OBJECTIONS:
Solstice incorporates the General Objections set forth in Section II above as if fully restated herein. Solstice further objects to this Interrogatory as overbroad and unduly burdensome to the extent it seeks identification of "all persons" who participated in any aspect of the design and development of each accused product. A comprehensive identification of every individual who contributed to any aspect of the design and development process for each product line would encompass a large number of engineers, technicians, quality assurance personnel, regulatory personnel, and other individuals across multiple departments and potentially multiple facilities, and the compilation of such a comprehensive list would impose an undue burden on Solstice.
Subject to and without waiver of the foregoing objections, Solstice identifies the following persons known at this time to have had material participation in the design and development of the accused PrecisionEdge™ products.
RESPONSE:
Subject to and without waiver of the foregoing objections, Solstice responds as follows:
1. Niamh Cassidy, Vice President, Regulatory & intellectual Property, Solstice Biomedical Devices Ltd. Ms. Cassidy provided oversight of the design and regulatory process for the PrecisionEdge™ product line, including the design history file review, regulatory submissions, and intellectual property clearance activities.
2. Engineering team members who were directly involved in the mechanical, electrical, and manufacturing engineering design and development of the PE-5000, PE-12000, and PE-15000 Series products. The specific names, titles, roles, and time periods of participation of these individuals are being compiled through custodian interviews that are currently in progress and will be provided in a supplemental response to this Interrogatory.
Solstice reserves the right to supplement this response as its investigation continues and as additional persons with relevant knowledge are identified.
INTERROGATORY NO. 14
State whether Solstice contends that any accused PrecisionEdge™ product has been redesigned, modified, or altered in any way in order to avoid infringement of the asserted patents, and if so, describe in detail each such redesign, modification, or alteration, including the date of the redesign, the nature of the changes made, and the persons responsible for implementing the changes.
OBJECTIONS:
Solstice incorporates the General Objections set forth in Section II above as if fully restated herein. No additional specific objections are asserted with respect to this Interrogatory.
RESPONSE:
Subject to and without waiver of the foregoing General Objections, Solstice responds as follows:
It is Solstice's position that the accused PrecisionEdge™ products (PE-5000, PE-12000, and PE-15000 Series) do not infringe any asserted claim of any of the asserted patents, and accordingly, no redesign or modification to avoid infringement was necessary or undertaken. The PrecisionEdge™ product line was designed and developed independently by Solstice's engineering team and without reference to the '237 Patent, the '884 Patent, or the '105 Patent.
To the extent Solstice may pursue product modifications, design improvements, or new product development in the future in the ordinary course of its business, any such modifications or developments will be addressed at the appropriate time and in the appropriate manner. Nothing in this response should be construed as a commitment by Solstice not to modify its products in the future.
Solstice reserves the right to supplement this response.
INTERROGATORY NO. 15
Identify all expert witnesses Solstice expects to call at trial or in connection with any motion or hearing in this action, including each expert's name, qualifications, employer or affiliation, the subject matter on which each expert is expected to testify, and a summary of the opinions each expert is expected to offer.
OBJECTIONS:
Solstice incorporates the General Objections set forth in Section II above as if fully restated herein. Solstice further objects to this Interrogatory as premature. Expert discovery in this action does not open until January 13, 2025, pursuant to the Scheduling Order entered on July 2, 2024 (Dkt. No. 24). Solstice's expert retention and preparation is ongoing, and Solstice has not yet finalized its expert witness list. Detailed expert disclosures, including written expert reports containing a complete statement of all opinions the expert will express and the basis and reasons for them, will be provided in accordance with Federal Rule of Civil Procedure 26(a)(2) and the deadlines set forth in the Scheduling Order.
Subject to and without waiver of the foregoing objections, Solstice identifies the following experts retained as of the date of this response.
RESPONSE:
Subject to and without waiver of the foregoing objections, Solstice responds as follows:
1. Dr. Miriam Ostrowski, Professor of Biomedical Engineering, Halford University, 3401 Walnut Street, Philadelphia, Pennsylvania 19104. Dr. Ostrowski was retained by Solstice pursuant to a retention agreement dated August 20, 2024. Dr. Ostrowski is expected to offer expert testimony on the following subject matters: claim construction of the disputed terms of the asserted claims; invalidity of the asserted claims of the '237 Patent, the '884 Patent, and the '105 Patent under 35 U.S.C. §§ 102, 103, and/or 112; and non-infringement of the asserted claims by the accused PrecisionEdge™ products. Dr. Ostrowski's consulting rate is $750 per hour.
2. Dr. Elena Marchetti, Managing Director, Pinnacle Economics Group LLC, 590 Madison Avenue, 22nd Floor, New York, New York 10022. As of the date of this response, September 16, 2024, Solstice has identified Dr. Marchetti as a prospective damages expert and has engaged in preliminary discussions regarding her retention; however, a formal retention agreement has not yet been executed (anticipated retention agreement date: on or about November 15, 2024). Dr. Marchetti is expected to offer expert testimony on the following subject matters: damages analysis, including the appropriate royalty base and rate; reasonable royalty calculation under the Georgia-Pacific framework; and rebuttal of Apex's damages theories. The specific opinions Dr. Marchetti will offer will be set forth in her expert report to be served during expert discovery.