1037-00004 · Solstice Biomedical Devices Ltd · Discovery/Outbound

solstice-responses-apex-rfps.docx DOCUMENT Litigation

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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 REQUESTS FOR PRODUCTION OF DOCUMENTS (NOS. 1–42)

Date Served: September 16, 2024

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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 Requests for Production of Documents (Nos. 1–42) (the "Requests"), which were served on Solstice on August 5, 2024. These Responses and Objections are made pursuant to Rules 26 and 34 of the Federal Rules of Civil Procedure and the Local Rules of the United States District Court for the District of Delaware.

Solstice responds to each Request subject to and without waiving the General Objections set forth in Section II below, each of which is incorporated by reference into each specific response as though set forth fully therein. To the extent any specific response does not restate a General Objection, the failure to do so shall not be deemed a waiver of that General Objection.

These Responses and Objections are based upon information reasonably available to Solstice as of the date of service hereof. Counsel for Solstice has undertaken a diligent and reasonable search for responsive documents, consistent with its obligations under the Federal Rules of Civil Procedure and the parties' Joint discovery Plan filed on July 15, 2024. Discovery and investigation in this matter are ongoing. Solstice expressly reserves the right to amend, supplement, or modify its responses and objections as additional information becomes available through continued discovery, investigation, analysis, expert consultation, or otherwise, as permitted by Rule 26(e) of the Federal Rules of Civil Procedure.

No response or objection contained herein shall be construed as an admission of the relevance, materiality, or admissibility of any document or category of information described in the Requests, nor as an admission of any fact, legal conclusion, or legal theory. Solstice does not, by responding to any Request, concede that any particular Request is proper, reasonable, or proportional to the needs of this case.

Production of responsive, non-privileged documents will be made on or about September 30, 2024, and shall be identified by Bates numbers SBD-000001 through SBD-048217, consisting of 48,217 documents. The production will be made in the form and manner set forth in the Document Production Statement in Section V below, consistent with the ESI protocol agreed upon in the Joint discovery Plan and the Scheduling Order entered by this Court on July 2, 2024.

II. GENERAL OBJECTIONS

Solstice makes the following General Objections, each of which is incorporated by reference into every specific response set forth in Section IV below. These General Objections are not intended to be exhaustive and are without prejudice to any additional or more specific objections asserted in the individual responses.

General Objection No. 1 — Overbreadth and Undue Burden

Solstice objects to any Request that is overbroad, unduly burdensome, or disproportionate to the needs of this case as defined by Rule 26(b)(1) of the Federal Rules of Civil Procedure. In evaluating the proportionality of each Request, Solstice has considered: (a) the importance of the issues at stake in this action, including the validity and infringement of the Asserted Patents; (b) the amount in controversy; (c) the parties' relative access to relevant information; (d) the parties' resources; (e) the importance of the discovery in resolving the issues; and (f) whether the burden or expense of the proposed discovery outweighs its likely benefit. To the extent any Request, by its terms, seeks the production of documents that are cumulative, duplicative, or obtainable from a less burdensome or less expensive source, Solstice objects under Rule 26(b)(2)(C).

General Objection No. 2 — Attorney-Client Privilege and Work Product Doctrine

Solstice objects to any Request to the extent it calls for the production of documents or communications protected by the attorney-client privilege, the work product doctrine established in Hickman v. Taylor, 329 U.S. 495 (1947), and its progeny, the joint defense privilege, the common interest privilege, or any other applicable privilege, immunity, or protection from disclosure recognized under federal or state law. Without limitation, Solstice will not produce communications between Solstice and its counsel, including Calderwood & Harkness LLP (litigation counsel), Kendrick & Lau LLP (patent prosecution counsel), and in-house legal counsel, or any documents reflecting the mental impressions, conclusions, opinions, or legal theories of counsel prepared in anticipation of litigation or for trial.

No inadvertent production of any privileged or protected material shall be deemed a waiver of any privilege, protection, or immunity, whether as to the specific document produced or as to any other document or communication involving the same or related subject matter, consistent with Rule 502(b) of the Federal Rules of Evidence and the clawback provisions of the ESI protocol set forth in the parties' Joint discovery Plan filed July 15, 2024. Solstice will provide a privilege log in accordance with the Court's Scheduling Order entered July 2, 2024, and the parties' Joint discovery Plan, identifying all documents withheld on the basis of privilege.

General Objection No. 3 — Vague and Ambiguous Terms

Solstice objects to any Request that uses vague, ambiguous, or undefined terms to the extent those terms render the Request incapable of reasonably precise response or otherwise fail to apprise Solstice of the specific documents sought. Where practicable, and without waiving any objection, Solstice will construe such terms in their ordinary and reasonable meaning for purposes of responding.

General Objection No. 4 — "All" and "Each" Qualifiers

Solstice objects to any Request that employs the terms "all," "any," "each," or "every" without reasonable limitation as to time, scope, or subject matter, insofar as such requests are facially overbroad, unduly burdensome, and seek documents beyond those proportional to the needs of this case. Solstice will interpret such terms as requesting all responsive, non-privileged documents identified through a reasonable and diligent search of sources reasonably likely to contain responsive materials.

General Objection No. 5 — Temporal Scope

Solstice objects to any Request that is not reasonably limited in temporal scope. Unless otherwise stated in a specific response, Solstice will interpret Requests as limited to the period from January 1, 2019 through the date of service of the Requests (August 5, 2024), which period Solstice considers reasonably relevant to the claims and defenses in this action involving U.S. Patent Nos. 9,814,237; 10,271,884; and 10,932,105. To the extent any Request seeks documents outside of this period without adequate justification, Solstice objects on grounds of overbreadth and disproportionality.

General Objection No. 6 — Third-Party and Publicly Available Information

Solstice objects to any Request seeking documents that are equally available to Apex from public sources, including without limitation the United States Patent and Trademark Office ("USPTO"), the Securities and Exchange Commission ("SEC"), published scientific and technical literature, the Food and Drug Administration ("FDA") databases, and patent prosecution file histories available through the USPTO's Public Patent Application Information Retrieval ("Public PAIR") or Patent Center systems. Solstice should not be required to bear the burden and expense of collecting, reviewing, and producing documents that are readily accessible to Apex through its own independent efforts.

General Objection No. 7 — Requests Seeking Information Beyond the Scope of the Claims and Defenses

Solstice objects to any Request that seeks information or documents beyond the scope of the claims, counterclaims, affirmative defenses, and defenses in this action as set forth in Apex's Complaint (filed May 9, 2024), Solstice's Answer, Affirmative Defenses, and Counterclaims (filed June 14, 2024), and any amendments thereto. Discovery in this matter is properly limited to matters relevant to the parties' claims and defenses, as required by Rule 26(b)(1) of the Federal Rules of Civil Procedure.

General Objection No. 8 — Confidentiality

Solstice objects to any Request to the extent that compliance would require the disclosure of trade secrets, confidential business information, proprietary technical information, or competitively sensitive data without adequate protection. Solstice will produce responsive documents containing such information subject to the terms and conditions of the Stipulated Protective Order entered in this action (Dkt. No. 34), with appropriate designations of "CONFIDENTIAL" or "ATTORNEYS' EYES ONLY" as warranted by the nature of the information disclosed. To the extent any Request seeks information the disclosure of which would cause competitive or commercial harm beyond the scope contemplated by the Protective Order, Solstice reserves the right to seek additional protections from the Court.

General Objection No. 9 — Form of Production

Solstice will produce documents in the form in which they are kept in the ordinary course of business, or in a reasonably usable form, consistent with the requirements of Rule 34(b)(2)(E) of the Federal Rules of Civil Procedure. Production shall be made in accordance with the ESI protocol agreed upon in the Joint discovery Plan filed July 15, 2024, including production in single-page TIFF format with load files containing extracted text, metadata fields, and Bates numbering, and consistent with the technology-assisted review ("TAR") protocol established with DataVault Litigation Solutions, LLC for the identification and review of electronically stored information.

General Objection No. 10 — Reservation of Rights

Solstice reserves all rights, objections, and defenses not expressly waived herein, including but not limited to the right to object to the admissibility or use at trial, deposition, hearing, or otherwise of any document produced in response to the Requests, and the right to supplement, amend, or modify these Responses and Objections as permitted by the Federal Rules of Civil Procedure and the Court's orders. The production of any document shall not be deemed an admission that such document is relevant, material, or admissible for any purpose.

III. DEFINITIONS AND INSTRUCTIONS

Solstice acknowledges and, where consistent with the Federal Rules of Civil Procedure, the Local Rules of the United States District Court for the District of Delaware, and the Court's orders, adopts Apex's definitions and instructions as set forth in Apex's First Set of Requests for Production of Documents. To the extent any of Apex's definitions or instructions purport to impose obligations beyond those required by the Federal Rules of Civil Procedure, the Local Rules, or the Court's orders, Solstice objects to and does not adopt such definitions or instructions.

For purposes of these Responses and Objections, the following clarifications apply:

"Solstice" refers to Solstice Biomedical, Inc., the named Defendant in this action, a Delaware corporation (EIN: 84-3291056), with its principal offices at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803. Where context requires, "Solstice" also refers to its parent company, Solstice Biomedical Devices Ltd., an Irish private limited company (Companies Registration Office No. 648217), registered at Unit 14, Clonskeagh Business Park, Clonskeagh Road, Dublin 14, D14 YF28, Ireland. References to "Solstice" in these responses should be construed accordingly based on the context of each particular Request and Response.

"Accused Products" refers to the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series trocar assemblies designed, manufactured, marketed, sold, offered for sale, imported, and/or used by Solstice, which are the products accused of infringement in this action.

"Asserted Patents" refers to U.S. Patent No. 9,814,237 (the "'237 Patent"), issued November 14, 2017; U.S. Patent No. 10,271,884 (the "'884 Patent"), issued April 30, 2019; and U.S. Patent No. 10,932,105 (the "'105 Patent"), issued February 23, 2021. These are the three patents asserted by Apex in its Complaint.

All other terms used herein shall have the meanings ascribed to them in Apex's Requests, except as modified by the General Objections and specific Responses and Objections set forth below.

IV. SPECIFIC RESPONSES AND OBJECTIONS TO REQUESTS FOR PRODUCTION NOS. 1–42

REQUEST FOR PRODUCTION NO. 1

Request: Produce all documents relating to the design, development, engineering, and testing of the PrecisionEdge™ PE-5000 Series trocar assembly, including but not limited to design specifications, engineering drawings, CAD files, prototypes, and testing reports.

Objections: Solstice objects to this Request on the following grounds. First, the Request is overbroad in its use of "all documents relating to" the design, development, engineering, and testing of the PE-5000 Series, which encompasses an expansive and undefined category of materials that extends well beyond those relevant to the patent claims at issue in this litigation. The PE-5000 Series is a complex medical device with numerous components, features, and subsystems, many of which bear no relationship whatsoever to the locking-seal assembly, blade-deployment mechanism, and insufflation valve features implicated by the claim limitations of the Asserted Patents. Solstice incorporates by reference General Objections Nos. 1, 2, 4, 5, and 8. To the extent the Request seeks documents protected by the attorney-client privilege or work product doctrine—including any communications with counsel regarding the design or development of the PE-5000 Series in light of third-party patent rights—Solstice will withhold such documents and identify them on its privilege log. Solstice further objects that production of all design and engineering documents, without limitation to the accused features, would impose an undue burden and would require the disclosure of trade secret manufacturing and design information unrelated to the claims at issue, which is disproportionate to the needs of this case.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged documents in its possession, custody, or control that are reasonably related to the design and development of the locking-seal assembly, blade-deployment mechanism, and insufflation valve features of the PrecisionEdge™ PE-5000 Series trocar assembly. This production will include, to the extent they exist and are responsive: design specifications, engineering drawings, CAD files, prototype documentation, and testing reports pertaining to those accused features. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024. Documents containing confidential or proprietary information will be designated pursuant to the Protective Order as appropriate.

REQUEST FOR PRODUCTION NO. 2

Request: Produce all documents relating to the design, development, engineering, and testing of the PrecisionEdge™ PE-12000 Series trocar assembly, including but not limited to design specifications, engineering drawings, CAD files, prototypes, and testing reports.

Objections: Solstice objects to this Request on the same grounds as stated in response to Request No. 1. The Request is overbroad in its use of "all documents relating to" the design, development, engineering, and testing of the PE-12000 Series without limitation to the features accused of infringement. Solstice incorporates by reference General Objections Nos. 1, 2, 4, 5, and 8. The PE-12000 Series shares certain platform architecture with the PE-5000 Series but incorporates additional features and subsystems that are not at issue in this litigation, and documents relating to those non-accused features are neither relevant nor proportional to the needs of this case.

REQUEST FOR PRODUCTION NO. 3

Request: Produce all documents relating to the design, development, engineering, and testing of the PrecisionEdge™ PE-15000 Series trocar assembly, including but not limited to design specifications, engineering drawings, CAD files, prototypes, and testing reports.

Objections: Solstice objects to this Request on the same grounds as stated in response to Request Nos. 1 and 2. The Request is overbroad in its use of "all documents relating to" the design, development, engineering, and testing of the PE-15000 Series without limitation to the features accused of infringement. Solstice incorporates by reference General Objections Nos. 1, 2, 4, 5, and 8. The PE-15000 Series is the most recently introduced product line in the PrecisionEdge™ family and includes proprietary design innovations that are entirely unrelated to the Asserted Patents' claim limitations.

REQUEST FOR PRODUCTION NO. 4

Request: Produce all documents relating to the manufacture, assembly, and quality control of the Accused Products, including but not limited to bills of materials, manufacturing instructions, manufacturing work orders, assembly drawings, quality control procedures, inspection records, and process validation documentation.

Objections: Solstice objects to this Request as overbroad and unduly burdensome to the extent it seeks all manufacturing documents for the Accused Products without limitation to those aspects of the manufacturing process relevant to the claim limitations of the Asserted Patents. Solstice incorporates by reference General Objections Nos. 1, 2, 4, and 8. The Accused Products are manufactured through complex, multi-stage processes involving hundreds of individual components and numerous proprietary manufacturing techniques. Production of the entirety of Solstice's manufacturing documentation would entail the disclosure of highly sensitive trade secret information concerning manufacturing processes, vendor relationships, and quality control methodologies that have no bearing on the patent infringement claims at issue. To the extent responsive manufacturing documents contain trade secret information, production will be made subject to the protections afforded by the Protective Order entered in this action.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged manufacturing documents in its possession, custody, or control that are reasonably related to the manufacture and assembly of the locking-seal assembly, blade-deployment mechanism, and insufflation valve features of the Accused Products. This includes relevant bills of materials, assembly drawings, and quality control records for those accused features. Documents will be designated as "CONFIDENTIAL" or "ATTORNEYS' EYES ONLY" pursuant to the Protective Order where appropriate. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 5

Request: Produce all technical drawings, schematics, exploded views, and engineering documentation specifically depicting the locking-seal mechanism used in each Accused Product.

Objections: Solstice objects to the use of "all" as overbroad to the extent it is not limited to non-duplicative, non-cumulative documents. Solstice incorporates by reference General Objections Nos. 1, 2, and 8. Solstice acknowledges the general relevance of the subject matter of this Request, as the locking-seal mechanism is one of the features at the center of Apex's infringement allegations. To the extent any technical drawings or engineering documentation were prepared in connection with or at the direction of counsel in anticipation of this litigation, such documents are protected by the work product doctrine and will be withheld and identified on the privilege log.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce responsive non-privileged technical drawings, schematics, exploded views, and engineering documentation depicting the locking-seal mechanism of the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series trocar assemblies. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024. Documents will be designated pursuant to the Protective Order as appropriate.

REQUEST FOR PRODUCTION NO. 6

Request: Produce all technical drawings, schematics, exploded views, and engineering documentation specifically depicting the blade-deployment mechanism used in each Accused Product.

Objections: Solstice objects to this Request on the same grounds as stated in response to Request No. 5. Solstice incorporates by reference General Objections Nos. 1, 2, and 8. Solstice acknowledges the general relevance of the blade-deployment mechanism to the claims and defenses in this action.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce responsive non-privileged technical drawings, schematics, exploded views, and engineering documentation depicting the blade-deployment mechanism of the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series trocar assemblies. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 7

Request: Produce all technical drawings, schematics, exploded views, and engineering documentation specifically depicting the integrated insufflation valve and seal used in each Accused Product.

Objections: Solstice objects to this Request on the same grounds as stated in response to Request Nos. 5 and 6. Solstice incorporates by reference General Objections Nos. 1, 2, and 8. Solstice acknowledges the general relevance of the insufflation valve and seal features to the claims and defenses in this action.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce responsive non-privileged technical drawings, schematics, exploded views, and engineering documentation depicting the integrated insufflation valve and seal of the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series trocar assemblies. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 8

Request: Produce all documents relating to any prior art search, freedom-to-operate analysis, patentability search, or clearance study conducted by or on behalf of Solstice relating to the Asserted Patents or the technology embodied in the Accused Products, including but not limited to search reports, opinion letters, memoranda, and communications with patent counsel.

Objections: Solstice objects to this Request in its entirety on the grounds that it seeks documents and communications protected by the attorney-client privilege and the work product doctrine. Solstice incorporates by reference General Objections Nos. 1, 2, and 7. Prior art searches, freedom-to-operate analyses, patentability searches, and clearance studies of the type described in this Request were prepared by or at the direction of counsel, including Kendrick & Lau LLP (patent prosecution counsel, 601 Pennsylvania Avenue NW, Suite 820, Washington, DC 20004) and Calderwood & Harkness LLP (litigation counsel), and reflect the mental impressions, opinions, conclusions, and legal theories of counsel. Communications between Solstice and its counsel regarding such analyses are protected by the attorney-client privilege. To the extent any such documents constitute opinion work product, they are entitled to heightened protection under In re Cendant Corp. Securities Litigation, 343 F.3d 658, 663 (3d Cir. 2003). Solstice has not waived, and does not intend to waive, any applicable privilege or protection with respect to such documents.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, and specifically without waiving the attorney-client privilege or work product doctrine, Solstice will produce non-privileged documents responsive to this Request, to the extent they exist and are not protected. Solstice's privilege log, to be served in accordance with the Scheduling Order, will identify all documents withheld on the basis of privilege in response to this Request, including the author, recipient, date, and general subject matter of each withheld document or communication.

REQUEST FOR PRODUCTION NO. 9

Request: Produce all documents evidencing or relating to Solstice's awareness or knowledge of the Asserted Patents (U.S. Patent Nos. 9,814,237; 10,271,884; and 10,932,105) prior to the filing of the Complaint on May 9, 2024.

Objections: Solstice objects to this Request to the extent it is designed to elicit the production of documents and communications protected by the attorney-client privilege and work product doctrine. Solstice incorporates by reference General Objections Nos. 1 and 2. Communications between Solstice and its counsel at Kendrick & Lau LLP and Calderwood & Harkness LLP, including Eamon Rourke (General Counsel of Solstice Biomedical Devices Ltd.), regarding the Asserted Patents and Apex's patent portfolio are privileged. Solstice further objects that this Request is overly broad to the extent it seeks any document that tangentially "relates to" awareness of the Asserted Patents, including, for example, industry publications or public databases that may reference the Asserted Patents.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged documents in its possession, custody, or control that evidence or reflect Solstice's awareness of the Asserted Patents prior to the filing of the Complaint, to the extent such documents exist and are not protected by privilege. Responsive privileged documents will be identified on the privilege log to be served in accordance with the Scheduling Order.

REQUEST FOR PRODUCTION NO. 10

Request: Produce all communications between Solstice and any third party concerning the Asserted Patents or any patent in Apex's patent portfolio.

Objections: Solstice objects to this Request as overbroad and disproportionate to the needs of this case. Solstice incorporates by reference General Objections Nos. 1, 2, 3, and 4. The Request is facially overbroad in its demand for communications concerning "any patent in Apex's patent portfolio." Publicly available records indicate that the Apex Trocar Patent Family encompasses at least 14 issued United States patents and 6 pending patent applications, only three of which are asserted in this action. Solstice objects that documents relating to the 11 non-asserted patents and 6 pending applications are not relevant to the claims and defenses in this litigation and that requiring Solstice to search for and produce such documents would impose an undue burden disproportionate to any conceivable benefit. Solstice further objects that the term "any third party" is undefined and unlimited, and that a reasonable search for communications with all possible third parties worldwide would be extraordinarily burdensome.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged communications between Solstice and third parties that specifically concern the three Asserted Patents (U.S. Patent Nos. 9,814,237; 10,271,884; and 10,932,105). Solstice declines to search for and produce documents relating to non-asserted patents in Apex's portfolio, as such production would be disproportionate to the needs of this case. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 11

Request: Produce all documents reflecting or relating to United States sales, revenues, and units sold for each Accused Product on a quarterly and annual basis from the date of first sale through the present.

Objections: Solstice objects to this Request to the extent it seeks sales data predating the issuance of the earliest Asserted Patent. The '237 Patent issued on November 14, 2017, and no claim for damages can properly extend to sales made prior to that date or, for products accused of infringing the later-issued '884 and '105 Patents, prior to the respective issuance dates of those patents. Solstice incorporates by reference General Objections Nos. 1, 5, and 8. Production of sales data constitutes the disclosure of highly sensitive confidential business information, and Solstice will designate such documents pursuant to the Protective Order.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce documents in its possession, custody, or control reflecting U.S. sales data—including revenues and units sold—for the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series trocar assemblies for the period from calendar year 2021 through September 30, 2024. During this period, combined U.S. sales of the Accused Products totaled approximately $74.6 million, broken down as follows: approximately $12.1 million in calendar year 2021; approximately $17.8 million in calendar year 2022; approximately $22.4 million in calendar year 2023; and approximately $22.3 million through September 30, 2024. Documents will be produced subject to the "CONFIDENTIAL" designation under the Protective Order. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 12

Request: Produce all documents reflecting the cost of goods sold, gross margin, and profitability of each Accused Product.

Objections: Solstice objects to this Request to the extent it seeks granular cost-of-goods data at a level of detail beyond that necessary for damages calculations in this action. Solstice incorporates by reference General Objections Nos. 1, 5, and 8. The cost-of-goods and profitability information sought by this Request constitutes among the most competitively sensitive information in Solstice's possession. Disclosure of detailed, line-item cost data to a direct competitor (Apex being a participant in the same laparoscopic trocar market) would cause significant and irreparable competitive harm. Accordingly, production of responsive documents will be limited to summary-level financial data and will be made exclusively under the "ATTORNEYS' EYES ONLY" designation of the Protective Order.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce summary financial data reflecting the weighted average gross margin on the Accused Products for the relevant period. Solstice's weighted average gross margin on the Accused Products during the relevant period was approximately 61.3%. Solstice will produce supporting documentation sufficient to allow Apex's damages expert to evaluate the basis for this figure, including aggregate cost-of-goods-sold summaries. All such documents will be designated "ATTORNEYS' EYES ONLY" pursuant to the Protective Order. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 13

Request: Produce all price lists, pricing proposals, discount schedules, and pricing communications relating to the Accused Products.

Objections: Solstice objects to this Request as overbroad and unduly burdensome. Solstice incorporates by reference General Objections Nos. 1, 4, 5, and 8. The Accused Products are sold through multiple distribution channels to hundreds of customers across the United States, and production of every individual pricing communication, discount approval, and negotiation would be enormously burdensome and largely cumulative. Solstice will produce representative pricing documents sufficient to provide a fair picture of the pricing of the Accused Products during the relevant period.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce representative pricing documents for the Accused Products, including standard price lists, representative pricing proposals, and discount schedules. Such documents will be designated "CONFIDENTIAL" or "ATTORNEYS' EYES ONLY" pursuant to the Protective Order as appropriate. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 14

Request: Produce all documents identifying customers, distributors, and sales channels for the Accused Products in the United States.

Objections: Solstice objects to this Request as overbroad and unduly burdensome to the extent it seeks the production of a complete list of every customer of the Accused Products in the United States. Solstice incorporates by reference General Objections Nos. 1, 4, and 8. Production of complete customer lists would impose significant competitive harm, as it would provide Apex—a direct competitor—with a comprehensive picture of Solstice's customer relationships. Solstice will limit its production to documents reflecting the identity of major customers and distribution relationships that are relevant to the damages analysis in this action, including documents necessary to assess market share, lost profits, and reasonable royalty calculations.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce responsive documents reflecting its major customers and distribution relationships for the Accused Products in the United States. All such documents will be produced under the "ATTORNEYS' EYES ONLY" designation of the Protective Order. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 15

Request: Produce all marketing materials, brochures, advertisements, presentations, trade show materials, and promotional documents relating to the Accused Products.

Objections: Solstice objects to this Request to the extent the term "all" is overbroad and seeks the production of every iteration or draft of marketing materials, including duplicative or preliminary versions. Solstice incorporates by reference General Objections Nos. 1, 4, and 5.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged marketing and promotional materials for the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series, including product brochures, sales presentations, trade show materials, and advertisements. Solstice will produce final or published versions of such materials, as well as representative drafts to the extent they differ materially from final versions. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 16

Request: Produce all 510(k) submissions, FDA clearance letters, and regulatory correspondence relating to the Accused Products.

Objections: Solstice objects to this Request to the extent it seeks the entirety of its 510(k) submissions, which contain substantial volumes of confidential information—including proprietary testing protocols, biocompatibility data, and sterilization validation data—that bear no relationship to the patent claim limitations at issue in this action. Solstice incorporates by reference General Objections Nos. 1, 2, and 8.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce 510(k) submissions and FDA clearance documents for the Accused Products to the extent those documents describe the technical features relevant to the claim limitations of the Asserted Patents, including the locking-seal assembly, blade-deployment mechanism, and insufflation valve. Documents will be designated "CONFIDENTIAL" pursuant to the Protective Order. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 17

Request: Produce all documents relating to any effort by Solstice to design around, modify, or redesign the Accused Products to avoid infringement of the Asserted Patents.

Objections: Solstice objects to this Request on the grounds that it seeks documents and communications protected by the attorney-client privilege and work product doctrine. Solstice incorporates by reference General Objections Nos. 1 and 2. To the extent Solstice has undertaken any evaluation of potential design modifications to the Accused Products in light of the Asserted Patents, such activities were conducted at the direction of and in consultation with counsel, including Calderwood & Harkness LLP and in-house counsel, and the resulting documents reflect the mental impressions, conclusions, opinions, and legal theories of counsel regarding the scope and validity of the Asserted Patents' claims. Such documents are core attorney work product and are not subject to disclosure.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, and specifically without waiving any privilege or work product protection, Solstice will produce non-privileged responsive documents, if any exist. To the extent responsive documents are withheld on the basis of privilege, they will be identified on the privilege log to be served in accordance with the Scheduling Order.

REQUEST FOR PRODUCTION NO. 18

Request: Produce all documents relating to or analyzing Apex's products, including Apex's trocar systems and surgical access devices, and any analysis of the Asserted Patents by Solstice personnel.

Objections: Solstice objects to this Request as overbroad in its scope. The phrase "all documents relating to or analyzing Apex's products" is extraordinarily broad and would encompass every document in Solstice's files that mentions Apex or any Apex product, regardless of whether the document has any relevance to the claims and defenses in this action. Solstice incorporates by reference General Objections Nos. 1, 2, 3, and 4. Solstice further objects to the extent the Request seeks privileged analyses of the Asserted Patents prepared by or at the direction of counsel.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged documents reflecting competitive intelligence analyses, marketing comparisons, or product evaluations comparing Apex's trocar products with the Accused Products. Privileged documents will be identified on the privilege log. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 19

Request: Produce all documents relating to Solstice's own patent applications and issued patents covering the technology used in the Accused Products.

Objections: Solstice objects to this Request on multiple grounds. Solstice incorporates by reference General Objections Nos. 1, 2, 6, and 7. Solstice's own patent portfolio is not relevant to Apex's infringement claims or to the damages analysis in this case. To the extent Solstice's patents may be relevant to Solstice's invalidity counterclaims or defenses, the prosecution file histories and specifications of Solstice's issued patents and published applications are publicly available from the USPTO through Patent Center and can be accessed by Apex at no cost. Solstice's internal prosecution files—including communications between Solstice and its patent prosecution counsel at Kendrick & Lau LLP—are protected by the attorney-client privilege and will not be produced. Requiring Solstice to produce publicly available documents that Apex can obtain independently would serve no purpose and would impose unnecessary burden and expense.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice directs Apex to the publicly available records of the USPTO for the prosecution file histories and specifications of Solstice's issued patents and published patent applications. Solstice will not produce its internal prosecution files or communications with patent prosecution counsel, which are privileged.

REQUEST FOR PRODUCTION NO. 20

Request: Produce all license agreements, term sheets, or proposals relating to the Asserted Patents or any technology relating to laparoscopic trocar locking-seal assemblies, blade-deployment mechanisms, or insufflation valves, to which Solstice is a party.

Objections: Solstice objects to this Request as overbroad to the extent it seeks license agreements relating to "any technology relating to" the described mechanisms, which would encompass a vast universe of agreements potentially covering any component technology used in laparoscopic trocar devices, regardless of whether such agreements bear any relationship to the Asserted Patents or the accused features. Solstice incorporates by reference General Objections Nos. 1, 2, 3, and 8. Solstice further objects to the extent that any license agreement negotiations or term sheet discussions involved privileged communications with counsel.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged license agreements, if any, to which Solstice is a party that specifically relate to the Asserted Patents. Solstice states that, after a reasonable search, it is not aware of any existing license agreement between Solstice and Apex covering any of the Asserted Patents. To the extent Solstice has entered into third-party license agreements relevant to the Georgia-Pacific reasonable royalty damages analysis, Solstice will produce such agreements subject to "CONFIDENTIAL" or "ATTORNEYS' EYES ONLY" designation under the Protective Order. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 21

Request: Produce all communications between Solstice (or its agents) and Apex (or its agents) relating to the Asserted Patents, the Accused Products, or any potential licensing arrangement.

Objections: Solstice objects to this Request to the extent it seeks communications protected by the attorney-client privilege, including any communications between Solstice's counsel and Apex's counsel. Solstice incorporates by reference General Objections Nos. 1, 2, and 5.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged communications between Solstice and Apex relating to the Asserted Patents, the Accused Products, or potential licensing arrangements. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 22

Request: Produce all documents provided to, reviewed by, or generated by Solstice's board of directors, Chief Executive Officer, or executive management team concerning this litigation, the Asserted Patents, or the Accused Products.

Objections: Solstice objects to this Request on the grounds of attorney-client privilege and work product doctrine. Solstice incorporates by reference General Objections Nos. 1, 2, and 8. Board-level and executive-level documents concerning this litigation were prepared by or at the direction of counsel, including Calderwood & Harkness LLP (litigation counsel) and Eamon Rourke, General Counsel of Solstice Biomedical Devices Ltd. Such documents reflect privileged attorney-client communications and attorney work product, including counsel's assessment of the merits of the claims and defenses, litigation strategy, and settlement posture. Solstice further objects that the Request is overbroad to the extent it seeks "all documents" reviewed by executive management concerning the Accused Products, which would include ordinary-course business documents unrelated to the patent claims at issue.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, and specifically reserving the attorney-client privilege and work product protection, Solstice will produce non-privileged board and executive-level documents to the extent they are responsive and not protected by privilege. Documents withheld on the basis of privilege will be identified on the privilege log. Responsive non-privileged documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 23

Request: Produce all documents supporting or relating to Solstice's invalidity contentions and affirmative defenses as to the Asserted Patents, including prior art references, prior art search reports, and analysis thereof.

Objections: Solstice objects to this Request to the extent it seeks internal analyses of prior art prepared by or at the direction of counsel, which constitute protected attorney work product. Solstice incorporates by reference General Objections Nos. 1 and 2. Prior art search reports and invalidity analyses prepared by Calderwood & Harkness LLP and Kendrick & Lau LLP reflect the mental impressions, legal opinions, and litigation strategies of counsel and are core work product entitled to the highest level of protection. The prior art references themselves—published patents, printed publications, and other public documents—are typically publicly available and can be obtained by Apex independently.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce copies of prior art references identified in its invalidity contentions served in accordance with the Court's Scheduling Order. Internal analyses, memoranda, and attorney work product relating to the invalidity contentions will be withheld and identified on the privilege log. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 24

Request: Produce all documents supporting Solstice's non-infringement defenses, including claim charts, technical analyses, and comparison documents.

Objections: Solstice objects to this Request on the grounds of work product doctrine and attorney-client privilege. Solstice incorporates by reference General Objections Nos. 1 and 2. Non-infringement analyses, claim charts, and related comparison documents were prepared by or at the direction of counsel at Calderwood & Harkness LLP in anticipation of and for use in this litigation. Such documents constitute core attorney work product reflecting counsel's mental impressions, conclusions, opinions, and legal theories regarding the construction of the claims of the Asserted Patents and the application of those claims to the Accused Products, and are not subject to discovery.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged documents that form the factual basis for its non-infringement contentions, including technical product documentation for the Accused Products that describes the structure and operation of the accused features. Attorney work product, including claim charts and legal analyses, will be withheld and identified on the privilege log. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 25

Request: Produce all documents supporting Solstice's counterclaim of inequitable conduct, including documents relating to alleged misrepresentations or material omissions during prosecution of the Asserted Patents before the USPTO.

Objections: Solstice objects to this Request to the extent it seeks Solstice's internal analysis of the prosecution history of the Asserted Patents, which constitutes protected attorney work product. Solstice incorporates by reference General Objections Nos. 1, 2, and 6. The prosecution file histories of the '237, '884, and '105 Patents are publicly available through the USPTO's Patent Center system and can be accessed by Apex—the patent holder—without any production from Solstice. Indeed, Apex is in the best position to possess and access all documents relating to the prosecution of its own patents.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged documents supporting the factual basis for its inequitable conduct counterclaim, including relevant prosecution history documents and prior art references that Solstice contends were material to the patentability of the Asserted Patents and were not disclosed to the USPTO during prosecution. Solstice directs Apex to the publicly available prosecution files for U.S. Patent Nos. 9,814,237; 10,271,884; and 10,932,105. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 26

Request: Produce all documents relating to the retention of any expert, consultant, or technical advisor by Solstice in connection with this action, including retention agreements, communications, and draft or final expert reports.

Objections: Solstice objects to this Request in its entirety on the grounds of the work product doctrine and attorney-client privilege. Solstice incorporates by reference General Objections Nos. 1 and 2. The retention of experts and consultants in this matter was undertaken by and at the direction of counsel at Calderwood & Harkness LLP. Retention agreements, communications between counsel and experts, and draft expert reports are protected from disclosure under the work product doctrine and, to the extent they reflect communications with counsel, the attorney-client privilege. Discovery concerning testifying experts is governed by Rule 26(a)(2) and Rule 26(b)(4) of the Federal Rules of Civil Procedure, and Solstice will make the required disclosures regarding testifying experts at the time set in the Court's Scheduling Order (expert discovery opens January 13, 2025). Discovery concerning consulting (non-testifying) experts is governed by Rule 26(b)(4)(D), which provides that facts known or opinions held by such experts are not discoverable absent exceptional circumstances.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will make all disclosures required by Rule 26(a)(2) of the Federal Rules of Civil Procedure at the time prescribed by the Scheduling Order. No documents responsive to this Request that are not privileged or protected by the work product doctrine are produced at this time.

REQUEST FOR PRODUCTION NO. 27

Request: Produce all documents provided to or received from any testifying or consulting expert retained by Solstice in connection with this action.

Objections: Solstice objects to this Request on the same grounds as stated in response to Request No. 26. Solstice incorporates by reference General Objections Nos. 1 and 2. Documents provided to or received from consulting (non-testifying) experts are protected by Rule 26(b)(4)(D) of the Federal Rules of Civil Procedure. Documents provided to testifying experts are subject to disclosure under Rule 26(a)(2)(B) and Rule 26(b)(4)(A)–(C), and will be disclosed at the appropriate time as set forth in the Scheduling Order.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will comply with its disclosure obligations under Rule 26(a)(2) of the Federal Rules of Civil Procedure at the time prescribed by the Scheduling Order. No documents responsive to this Request that are not privileged or protected are produced at this time.

REQUEST FOR PRODUCTION NO. 28

Request: Produce all documents relating to any insurance policy, indemnification agreement, or other arrangement pursuant to which Solstice may be reimbursed for defense costs or damages arising from this action.

Objections: Solstice objects to this Request to the extent it seeks the full text of insurance policies and all correspondence between Solstice and its insurer, which may contain communications protected by the attorney-client privilege or work product doctrine. Solstice incorporates by reference General Objections Nos. 1 and 8. Solstice acknowledges its obligation under Rule 26(a)(1)(A)(iv) of the Federal Rules of Civil Procedure to produce, for inspection and copying, any insurance agreement under which an insurance business may be liable to satisfy all or part of a possible judgment in the action or to indemnify or reimburse for payments made to satisfy the judgment.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce the declarations page and relevant policy provisions of its intellectual property litigation insurance policy issued by Halcyon Specialty Insurance Co. (Policy No. HSI-IP-2023-04891). The policy provides coverage for patent infringement defense with a $5,000,000 per-occurrence limit, a $10,000,000 aggregate limit, and a $250,000 self-insured retention. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 29

Request: Produce all organizational documents, corporate structure charts, and documents reflecting the relationship between Solstice Biomedical, Inc. (Delaware) and Solstice Biomedical Devices Ltd. (Ireland), including documents reflecting ownership, management, and operational control.

Objections: Solstice objects to this Request as overbroad to the extent it seeks "all organizational documents" of Solstice's Irish parent company, Solstice Biomedical Devices Ltd., which is not a party to this action. Solstice incorporates by reference General Objections Nos. 1, 4, and 8. Production of the entirety of the parent company's organizational documents—including articles of association, board resolutions, shareholder agreements, and similar corporate governance materials—would be burdensome and disproportionate to the needs of this case.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce organizational charts, corporate structure documents, and summary documentation reflecting the corporate relationship between Solstice Biomedical, Inc. (Delaware corporation, EIN: 84-3291056, principal offices at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803) and its parent company, Solstice Biomedical Devices Ltd. (Irish private limited company, CRO No. 648217, registered at Unit 14, Clonskeagh Business Park, Clonskeagh Road, Dublin 14, D14 YF28, Ireland), including ownership structure, reporting relationships, and operational control. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 30

Request: Produce all financial statements, annual reports, and audited or unaudited financial records for Solstice (including the parent company and U.S. subsidiary) for fiscal years 2019 through 2024.

Objections: Solstice objects to this Request as overbroad in both temporal scope and substantive scope. Solstice incorporates by reference General Objections Nos. 1, 5, and 8. Solstice objects to the production of entity-wide financial statements for the period prior to calendar year 2021, which predates the relevant period for damages analysis, and to the production of group-level financials that encompass product lines and business units entirely unrelated to the Accused Products. Solstice Biomedical Devices Ltd. is a private company, and its group-level financial statements are highly confidential and not publicly available. Disclosure of entity-wide financial data to a direct competitor raises serious concerns regarding competitive harm.

Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce financial data relevant to the damages analysis in this action, including product-line revenue and profitability data for the Accused Products for fiscal years 2021 through 2024. For context, Solstice notes that Solstice Biomedical Devices Ltd.'s FY 2023 group-level revenue was approximately €187.4 million (unaudited). To the extent group-level audited financial statements, prepared by Glenmore & Byrne LLP (Dublin, Ireland), are relevant to the damages inquiry, Solstice will produce such statements subject to "ATTORNEYS' EYES ONLY" designation under the Protective Order. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.

REQUEST FOR PRODUCTION NO. 31

Request: Produce all business plans, revenue forecasts, budgets, and strategic plans relating to the Accused Products.

Objections: Solstice objects to this Reques

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 REQUESTS FOR PRODUCTION OF DOCUMENTS (NOS. 1–42)
Date Served: September 16, 2024
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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 Requests for Production of Documents (Nos. 1–42) (the "Requests"), which were served on Solstice on August 5, 2024. These Responses and Objections are made pursuant to Rules 26 and 34 of the Federal Rules of Civil Procedure and the Local Rules of the United States District Court for the District of Delaware.
Solstice responds to each Request subject to and without waiving the General Objections set forth in Section II below, each of which is incorporated by reference into each specific response as though set forth fully therein. To the extent any specific response does not restate a General Objection, the failure to do so shall not be deemed a waiver of that General Objection.
These Responses and Objections are based upon information reasonably available to Solstice as of the date of service hereof. Counsel for Solstice has undertaken a diligent and reasonable search for responsive documents, consistent with its obligations under the Federal Rules of Civil Procedure and the parties' Joint discovery Plan filed on July 15, 2024. Discovery and investigation in this matter are ongoing. Solstice expressly reserves the right to amend, supplement, or modify its responses and objections as additional information becomes available through continued discovery, investigation, analysis, expert consultation, or otherwise, as permitted by Rule 26(e) of the Federal Rules of Civil Procedure.
No response or objection contained herein shall be construed as an admission of the relevance, materiality, or admissibility of any document or category of information described in the Requests, nor as an admission of any fact, legal conclusion, or legal theory. Solstice does not, by responding to any Request, concede that any particular Request is proper, reasonable, or proportional to the needs of this case.
Production of responsive, non-privileged documents will be made on or about September 30, 2024, and shall be identified by Bates numbers SBD-000001 through SBD-048217, consisting of 48,217 documents. The production will be made in the form and manner set forth in the Document Production Statement in Section V below, consistent with the ESI protocol agreed upon in the Joint discovery Plan and the Scheduling Order entered by this Court on July 2, 2024.
II. GENERAL OBJECTIONS
Solstice makes the following General Objections, each of which is incorporated by reference into every specific response set forth in Section IV below. These General Objections are not intended to be exhaustive and are without prejudice to any additional or more specific objections asserted in the individual responses.
General Objection No. 1 — Overbreadth and Undue Burden
Solstice objects to any Request that is overbroad, unduly burdensome, or disproportionate to the needs of this case as defined by Rule 26(b)(1) of the Federal Rules of Civil Procedure. In evaluating the proportionality of each Request, Solstice has considered: (a) the importance of the issues at stake in this action, including the validity and infringement of the Asserted Patents; (b) the amount in controversy; (c) the parties' relative access to relevant information; (d) the parties' resources; (e) the importance of the discovery in resolving the issues; and (f) whether the burden or expense of the proposed discovery outweighs its likely benefit. To the extent any Request, by its terms, seeks the production of documents that are cumulative, duplicative, or obtainable from a less burdensome or less expensive source, Solstice objects under Rule 26(b)(2)(C).
General Objection No. 2 — Attorney-Client Privilege and Work Product Doctrine
Solstice objects to any Request to the extent it calls for the production of documents or communications protected by the attorney-client privilege, the work product doctrine established in Hickman v. Taylor, 329 U.S. 495 (1947), and its progeny, the joint defense privilege, the common interest privilege, or any other applicable privilege, immunity, or protection from disclosure recognized under federal or state law. Without limitation, Solstice will not produce communications between Solstice and its counsel, including Calderwood & Harkness LLP (litigation counsel), Kendrick & Lau LLP (patent prosecution counsel), and in-house legal counsel, or any documents reflecting the mental impressions, conclusions, opinions, or legal theories of counsel prepared in anticipation of litigation or for trial.
No inadvertent production of any privileged or protected material shall be deemed a waiver of any privilege, protection, or immunity, whether as to the specific document produced or as to any other document or communication involving the same or related subject matter, consistent with Rule 502(b) of the Federal Rules of Evidence and the clawback provisions of the ESI protocol set forth in the parties' Joint discovery Plan filed July 15, 2024. Solstice will provide a privilege log in accordance with the Court's Scheduling Order entered July 2, 2024, and the parties' Joint discovery Plan, identifying all documents withheld on the basis of privilege.
General Objection No. 3 — Vague and Ambiguous Terms
Solstice objects to any Request that uses vague, ambiguous, or undefined terms to the extent those terms render the Request incapable of reasonably precise response or otherwise fail to apprise Solstice of the specific documents sought. Where practicable, and without waiving any objection, Solstice will construe such terms in their ordinary and reasonable meaning for purposes of responding.
General Objection No. 4 — "All" and "Each" Qualifiers
Solstice objects to any Request that employs the terms "all," "any," "each," or "every" without reasonable limitation as to time, scope, or subject matter, insofar as such requests are facially overbroad, unduly burdensome, and seek documents beyond those proportional to the needs of this case. Solstice will interpret such terms as requesting all responsive, non-privileged documents identified through a reasonable and diligent search of sources reasonably likely to contain responsive materials.
General Objection No. 5 — Temporal Scope
Solstice objects to any Request that is not reasonably limited in temporal scope. Unless otherwise stated in a specific response, Solstice will interpret Requests as limited to the period from January 1, 2019 through the date of service of the Requests (August 5, 2024), which period Solstice considers reasonably relevant to the claims and defenses in this action involving U.S. Patent Nos. 9,814,237; 10,271,884; and 10,932,105. To the extent any Request seeks documents outside of this period without adequate justification, Solstice objects on grounds of overbreadth and disproportionality.
General Objection No. 6 — Third-Party and Publicly Available Information
Solstice objects to any Request seeking documents that are equally available to Apex from public sources, including without limitation the United States Patent and Trademark Office ("USPTO"), the Securities and Exchange Commission ("SEC"), published scientific and technical literature, the Food and Drug Administration ("FDA") databases, and patent prosecution file histories available through the USPTO's Public Patent Application Information Retrieval ("Public PAIR") or Patent Center systems. Solstice should not be required to bear the burden and expense of collecting, reviewing, and producing documents that are readily accessible to Apex through its own independent efforts.
General Objection No. 7 — Requests Seeking Information Beyond the Scope of the Claims and Defenses
Solstice objects to any Request that seeks information or documents beyond the scope of the claims, counterclaims, affirmative defenses, and defenses in this action as set forth in Apex's Complaint (filed May 9, 2024), Solstice's Answer, Affirmative Defenses, and Counterclaims (filed June 14, 2024), and any amendments thereto. Discovery in this matter is properly limited to matters relevant to the parties' claims and defenses, as required by Rule 26(b)(1) of the Federal Rules of Civil Procedure.
General Objection No. 8 — Confidentiality
Solstice objects to any Request to the extent that compliance would require the disclosure of trade secrets, confidential business information, proprietary technical information, or competitively sensitive data without adequate protection. Solstice will produce responsive documents containing such information subject to the terms and conditions of the Stipulated Protective Order entered in this action (Dkt. No. 34), with appropriate designations of "CONFIDENTIAL" or "ATTORNEYS' EYES ONLY" as warranted by the nature of the information disclosed. To the extent any Request seeks information the disclosure of which would cause competitive or commercial harm beyond the scope contemplated by the Protective Order, Solstice reserves the right to seek additional protections from the Court.
General Objection No. 9 — Form of Production
Solstice will produce documents in the form in which they are kept in the ordinary course of business, or in a reasonably usable form, consistent with the requirements of Rule 34(b)(2)(E) of the Federal Rules of Civil Procedure. Production shall be made in accordance with the ESI protocol agreed upon in the Joint discovery Plan filed July 15, 2024, including production in single-page TIFF format with load files containing extracted text, metadata fields, and Bates numbering, and consistent with the technology-assisted review ("TAR") protocol established with DataVault Litigation Solutions, LLC for the identification and review of electronically stored information.
General Objection No. 10 — Reservation of Rights
Solstice reserves all rights, objections, and defenses not expressly waived herein, including but not limited to the right to object to the admissibility or use at trial, deposition, hearing, or otherwise of any document produced in response to the Requests, and the right to supplement, amend, or modify these Responses and Objections as permitted by the Federal Rules of Civil Procedure and the Court's orders. The production of any document shall not be deemed an admission that such document is relevant, material, or admissible for any purpose.
III. DEFINITIONS AND INSTRUCTIONS
Solstice acknowledges and, where consistent with the Federal Rules of Civil Procedure, the Local Rules of the United States District Court for the District of Delaware, and the Court's orders, adopts Apex's definitions and instructions as set forth in Apex's First Set of Requests for Production of Documents. To the extent any of Apex's definitions or instructions purport to impose obligations beyond those required by the Federal Rules of Civil Procedure, the Local Rules, or the Court's orders, Solstice objects to and does not adopt such definitions or instructions.
For purposes of these Responses and Objections, the following clarifications apply:
"Solstice" refers to Solstice Biomedical, Inc., the named Defendant in this action, a Delaware corporation (EIN: 84-3291056), with its principal offices at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803. Where context requires, "Solstice" also refers to its parent company, Solstice Biomedical Devices Ltd., an Irish private limited company (Companies Registration Office No. 648217), registered at Unit 14, Clonskeagh Business Park, Clonskeagh Road, Dublin 14, D14 YF28, Ireland. References to "Solstice" in these responses should be construed accordingly based on the context of each particular Request and Response.
"Accused Products" refers to the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series trocar assemblies designed, manufactured, marketed, sold, offered for sale, imported, and/or used by Solstice, which are the products accused of infringement in this action.
"Asserted Patents" refers to U.S. Patent No. 9,814,237 (the "'237 Patent"), issued November 14, 2017; U.S. Patent No. 10,271,884 (the "'884 Patent"), issued April 30, 2019; and U.S. Patent No. 10,932,105 (the "'105 Patent"), issued February 23, 2021. These are the three patents asserted by Apex in its Complaint.
All other terms used herein shall have the meanings ascribed to them in Apex's Requests, except as modified by the General Objections and specific Responses and Objections set forth below.
IV. SPECIFIC RESPONSES AND OBJECTIONS TO REQUESTS FOR PRODUCTION NOS. 1–42
REQUEST FOR PRODUCTION NO. 1
Request: Produce all documents relating to the design, development, engineering, and testing of the PrecisionEdge™ PE-5000 Series trocar assembly, including but not limited to design specifications, engineering drawings, CAD files, prototypes, and testing reports.
Objections: Solstice objects to this Request on the following grounds. First, the Request is overbroad in its use of "all documents relating to" the design, development, engineering, and testing of the PE-5000 Series, which encompasses an expansive and undefined category of materials that extends well beyond those relevant to the patent claims at issue in this litigation. The PE-5000 Series is a complex medical device with numerous components, features, and subsystems, many of which bear no relationship whatsoever to the locking-seal assembly, blade-deployment mechanism, and insufflation valve features implicated by the claim limitations of the Asserted Patents. Solstice incorporates by reference General Objections Nos. 1, 2, 4, 5, and 8. To the extent the Request seeks documents protected by the attorney-client privilege or work product doctrine—including any communications with counsel regarding the design or development of the PE-5000 Series in light of third-party patent rights—Solstice will withhold such documents and identify them on its privilege log. Solstice further objects that production of all design and engineering documents, without limitation to the accused features, would impose an undue burden and would require the disclosure of trade secret manufacturing and design information unrelated to the claims at issue, which is disproportionate to the needs of this case.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged documents in its possession, custody, or control that are reasonably related to the design and development of the locking-seal assembly, blade-deployment mechanism, and insufflation valve features of the PrecisionEdge™ PE-5000 Series trocar assembly. This production will include, to the extent they exist and are responsive: design specifications, engineering drawings, CAD files, prototype documentation, and testing reports pertaining to those accused features. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024. Documents containing confidential or proprietary information will be designated pursuant to the Protective Order as appropriate.
REQUEST FOR PRODUCTION NO. 2
Request: Produce all documents relating to the design, development, engineering, and testing of the PrecisionEdge™ PE-12000 Series trocar assembly, including but not limited to design specifications, engineering drawings, CAD files, prototypes, and testing reports.
Objections: Solstice objects to this Request on the same grounds as stated in response to Request No. 1. The Request is overbroad in its use of "all documents relating to" the design, development, engineering, and testing of the PE-12000 Series without limitation to the features accused of infringement. Solstice incorporates by reference General Objections Nos. 1, 2, 4, 5, and 8. The PE-12000 Series shares certain platform architecture with the PE-5000 Series but incorporates additional features and subsystems that are not at issue in this litigation, and documents relating to those non-accused features are neither relevant nor proportional to the needs of this case.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged documents in its possession, custody, or control that are reasonably related to the design and development of the locking-seal assembly, blade-deployment mechanism, and insufflation valve features of the PrecisionEdge™ PE-12000 Series trocar assembly. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 3
Request: Produce all documents relating to the design, development, engineering, and testing of the PrecisionEdge™ PE-15000 Series trocar assembly, including but not limited to design specifications, engineering drawings, CAD files, prototypes, and testing reports.
Objections: Solstice objects to this Request on the same grounds as stated in response to Request Nos. 1 and 2. The Request is overbroad in its use of "all documents relating to" the design, development, engineering, and testing of the PE-15000 Series without limitation to the features accused of infringement. Solstice incorporates by reference General Objections Nos. 1, 2, 4, 5, and 8. The PE-15000 Series is the most recently introduced product line in the PrecisionEdge™ family and includes proprietary design innovations that are entirely unrelated to the Asserted Patents' claim limitations.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged documents in its possession, custody, or control that are reasonably related to the design and development of the locking-seal assembly, blade-deployment mechanism, and insufflation valve features of the PrecisionEdge™ PE-15000 Series trocar assembly. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 4
Request: Produce all documents relating to the manufacture, assembly, and quality control of the Accused Products, including but not limited to bills of materials, manufacturing instructions, manufacturing work orders, assembly drawings, quality control procedures, inspection records, and process validation documentation.
Objections: Solstice objects to this Request as overbroad and unduly burdensome to the extent it seeks all manufacturing documents for the Accused Products without limitation to those aspects of the manufacturing process relevant to the claim limitations of the Asserted Patents. Solstice incorporates by reference General Objections Nos. 1, 2, 4, and 8. The Accused Products are manufactured through complex, multi-stage processes involving hundreds of individual components and numerous proprietary manufacturing techniques. Production of the entirety of Solstice's manufacturing documentation would entail the disclosure of highly sensitive trade secret information concerning manufacturing processes, vendor relationships, and quality control methodologies that have no bearing on the patent infringement claims at issue. To the extent responsive manufacturing documents contain trade secret information, production will be made subject to the protections afforded by the Protective Order entered in this action.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged manufacturing documents in its possession, custody, or control that are reasonably related to the manufacture and assembly of the locking-seal assembly, blade-deployment mechanism, and insufflation valve features of the Accused Products. This includes relevant bills of materials, assembly drawings, and quality control records for those accused features. Documents will be designated as "CONFIDENTIAL" or "ATTORNEYS' EYES ONLY" pursuant to the Protective Order where appropriate. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 5
Request: Produce all technical drawings, schematics, exploded views, and engineering documentation specifically depicting the locking-seal mechanism used in each Accused Product.
Objections: Solstice objects to the use of "all" as overbroad to the extent it is not limited to non-duplicative, non-cumulative documents. Solstice incorporates by reference General Objections Nos. 1, 2, and 8. Solstice acknowledges the general relevance of the subject matter of this Request, as the locking-seal mechanism is one of the features at the center of Apex's infringement allegations. To the extent any technical drawings or engineering documentation were prepared in connection with or at the direction of counsel in anticipation of this litigation, such documents are protected by the work product doctrine and will be withheld and identified on the privilege log.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce responsive non-privileged technical drawings, schematics, exploded views, and engineering documentation depicting the locking-seal mechanism of the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series trocar assemblies. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024. Documents will be designated pursuant to the Protective Order as appropriate.
REQUEST FOR PRODUCTION NO. 6
Request: Produce all technical drawings, schematics, exploded views, and engineering documentation specifically depicting the blade-deployment mechanism used in each Accused Product.
Objections: Solstice objects to this Request on the same grounds as stated in response to Request No. 5. Solstice incorporates by reference General Objections Nos. 1, 2, and 8. Solstice acknowledges the general relevance of the blade-deployment mechanism to the claims and defenses in this action.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce responsive non-privileged technical drawings, schematics, exploded views, and engineering documentation depicting the blade-deployment mechanism of the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series trocar assemblies. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 7
Request: Produce all technical drawings, schematics, exploded views, and engineering documentation specifically depicting the integrated insufflation valve and seal used in each Accused Product.
Objections: Solstice objects to this Request on the same grounds as stated in response to Request Nos. 5 and 6. Solstice incorporates by reference General Objections Nos. 1, 2, and 8. Solstice acknowledges the general relevance of the insufflation valve and seal features to the claims and defenses in this action.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce responsive non-privileged technical drawings, schematics, exploded views, and engineering documentation depicting the integrated insufflation valve and seal of the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series trocar assemblies. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 8
Request: Produce all documents relating to any prior art search, freedom-to-operate analysis, patentability search, or clearance study conducted by or on behalf of Solstice relating to the Asserted Patents or the technology embodied in the Accused Products, including but not limited to search reports, opinion letters, memoranda, and communications with patent counsel.
Objections: Solstice objects to this Request in its entirety on the grounds that it seeks documents and communications protected by the attorney-client privilege and the work product doctrine. Solstice incorporates by reference General Objections Nos. 1, 2, and 7. Prior art searches, freedom-to-operate analyses, patentability searches, and clearance studies of the type described in this Request were prepared by or at the direction of counsel, including Kendrick & Lau LLP (patent prosecution counsel, 601 Pennsylvania Avenue NW, Suite 820, Washington, DC 20004) and Calderwood & Harkness LLP (litigation counsel), and reflect the mental impressions, opinions, conclusions, and legal theories of counsel. Communications between Solstice and its counsel regarding such analyses are protected by the attorney-client privilege. To the extent any such documents constitute opinion work product, they are entitled to heightened protection under In re Cendant Corp. Securities Litigation, 343 F.3d 658, 663 (3d Cir. 2003). Solstice has not waived, and does not intend to waive, any applicable privilege or protection with respect to such documents.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, and specifically without waiving the attorney-client privilege or work product doctrine, Solstice will produce non-privileged documents responsive to this Request, to the extent they exist and are not protected. Solstice's privilege log, to be served in accordance with the Scheduling Order, will identify all documents withheld on the basis of privilege in response to this Request, including the author, recipient, date, and general subject matter of each withheld document or communication.
REQUEST FOR PRODUCTION NO. 9
Request: Produce all documents evidencing or relating to Solstice's awareness or knowledge of the Asserted Patents (U.S. Patent Nos. 9,814,237; 10,271,884; and 10,932,105) prior to the filing of the Complaint on May 9, 2024.
Objections: Solstice objects to this Request to the extent it is designed to elicit the production of documents and communications protected by the attorney-client privilege and work product doctrine. Solstice incorporates by reference General Objections Nos. 1 and 2. Communications between Solstice and its counsel at Kendrick & Lau LLP and Calderwood & Harkness LLP, including Eamon Rourke (General Counsel of Solstice Biomedical Devices Ltd.), regarding the Asserted Patents and Apex's patent portfolio are privileged. Solstice further objects that this Request is overly broad to the extent it seeks any document that tangentially "relates to" awareness of the Asserted Patents, including, for example, industry publications or public databases that may reference the Asserted Patents.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged documents in its possession, custody, or control that evidence or reflect Solstice's awareness of the Asserted Patents prior to the filing of the Complaint, to the extent such documents exist and are not protected by privilege. Responsive privileged documents will be identified on the privilege log to be served in accordance with the Scheduling Order.
REQUEST FOR PRODUCTION NO. 10
Request: Produce all communications between Solstice and any third party concerning the Asserted Patents or any patent in Apex's patent portfolio.
Objections: Solstice objects to this Request as overbroad and disproportionate to the needs of this case. Solstice incorporates by reference General Objections Nos. 1, 2, 3, and 4. The Request is facially overbroad in its demand for communications concerning "any patent in Apex's patent portfolio." Publicly available records indicate that the Apex Trocar Patent Family encompasses at least 14 issued United States patents and 6 pending patent applications, only three of which are asserted in this action. Solstice objects that documents relating to the 11 non-asserted patents and 6 pending applications are not relevant to the claims and defenses in this litigation and that requiring Solstice to search for and produce such documents would impose an undue burden disproportionate to any conceivable benefit. Solstice further objects that the term "any third party" is undefined and unlimited, and that a reasonable search for communications with all possible third parties worldwide would be extraordinarily burdensome.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged communications between Solstice and third parties that specifically concern the three Asserted Patents (U.S. Patent Nos. 9,814,237; 10,271,884; and 10,932,105). Solstice declines to search for and produce documents relating to non-asserted patents in Apex's portfolio, as such production would be disproportionate to the needs of this case. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 11
Request: Produce all documents reflecting or relating to United States sales, revenues, and units sold for each Accused Product on a quarterly and annual basis from the date of first sale through the present.
Objections: Solstice objects to this Request to the extent it seeks sales data predating the issuance of the earliest Asserted Patent. The '237 Patent issued on November 14, 2017, and no claim for damages can properly extend to sales made prior to that date or, for products accused of infringing the later-issued '884 and '105 Patents, prior to the respective issuance dates of those patents. Solstice incorporates by reference General Objections Nos. 1, 5, and 8. Production of sales data constitutes the disclosure of highly sensitive confidential business information, and Solstice will designate such documents pursuant to the Protective Order.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce documents in its possession, custody, or control reflecting U.S. sales data—including revenues and units sold—for the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series trocar assemblies for the period from calendar year 2021 through September 30, 2024. During this period, combined U.S. sales of the Accused Products totaled approximately $74.6 million, broken down as follows: approximately $12.1 million in calendar year 2021; approximately $17.8 million in calendar year 2022; approximately $22.4 million in calendar year 2023; and approximately $22.3 million through September 30, 2024. Documents will be produced subject to the "CONFIDENTIAL" designation under the Protective Order. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 12
Request: Produce all documents reflecting the cost of goods sold, gross margin, and profitability of each Accused Product.
Objections: Solstice objects to this Request to the extent it seeks granular cost-of-goods data at a level of detail beyond that necessary for damages calculations in this action. Solstice incorporates by reference General Objections Nos. 1, 5, and 8. The cost-of-goods and profitability information sought by this Request constitutes among the most competitively sensitive information in Solstice's possession. Disclosure of detailed, line-item cost data to a direct competitor (Apex being a participant in the same laparoscopic trocar market) would cause significant and irreparable competitive harm. Accordingly, production of responsive documents will be limited to summary-level financial data and will be made exclusively under the "ATTORNEYS' EYES ONLY" designation of the Protective Order.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce summary financial data reflecting the weighted average gross margin on the Accused Products for the relevant period. Solstice's weighted average gross margin on the Accused Products during the relevant period was approximately 61.3%. Solstice will produce supporting documentation sufficient to allow Apex's damages expert to evaluate the basis for this figure, including aggregate cost-of-goods-sold summaries. All such documents will be designated "ATTORNEYS' EYES ONLY" pursuant to the Protective Order. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 13
Request: Produce all price lists, pricing proposals, discount schedules, and pricing communications relating to the Accused Products.
Objections: Solstice objects to this Request as overbroad and unduly burdensome. Solstice incorporates by reference General Objections Nos. 1, 4, 5, and 8. The Accused Products are sold through multiple distribution channels to hundreds of customers across the United States, and production of every individual pricing communication, discount approval, and negotiation would be enormously burdensome and largely cumulative. Solstice will produce representative pricing documents sufficient to provide a fair picture of the pricing of the Accused Products during the relevant period.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce representative pricing documents for the Accused Products, including standard price lists, representative pricing proposals, and discount schedules. Such documents will be designated "CONFIDENTIAL" or "ATTORNEYS' EYES ONLY" pursuant to the Protective Order as appropriate. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 14
Request: Produce all documents identifying customers, distributors, and sales channels for the Accused Products in the United States.
Objections: Solstice objects to this Request as overbroad and unduly burdensome to the extent it seeks the production of a complete list of every customer of the Accused Products in the United States. Solstice incorporates by reference General Objections Nos. 1, 4, and 8. Production of complete customer lists would impose significant competitive harm, as it would provide Apex—a direct competitor—with a comprehensive picture of Solstice's customer relationships. Solstice will limit its production to documents reflecting the identity of major customers and distribution relationships that are relevant to the damages analysis in this action, including documents necessary to assess market share, lost profits, and reasonable royalty calculations.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce responsive documents reflecting its major customers and distribution relationships for the Accused Products in the United States. All such documents will be produced under the "ATTORNEYS' EYES ONLY" designation of the Protective Order. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 15
Request: Produce all marketing materials, brochures, advertisements, presentations, trade show materials, and promotional documents relating to the Accused Products.
Objections: Solstice objects to this Request to the extent the term "all" is overbroad and seeks the production of every iteration or draft of marketing materials, including duplicative or preliminary versions. Solstice incorporates by reference General Objections Nos. 1, 4, and 5.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged marketing and promotional materials for the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series, including product brochures, sales presentations, trade show materials, and advertisements. Solstice will produce final or published versions of such materials, as well as representative drafts to the extent they differ materially from final versions. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 16
Request: Produce all 510(k) submissions, FDA clearance letters, and regulatory correspondence relating to the Accused Products.
Objections: Solstice objects to this Request to the extent it seeks the entirety of its 510(k) submissions, which contain substantial volumes of confidential information—including proprietary testing protocols, biocompatibility data, and sterilization validation data—that bear no relationship to the patent claim limitations at issue in this action. Solstice incorporates by reference General Objections Nos. 1, 2, and 8.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce 510(k) submissions and FDA clearance documents for the Accused Products to the extent those documents describe the technical features relevant to the claim limitations of the Asserted Patents, including the locking-seal assembly, blade-deployment mechanism, and insufflation valve. Documents will be designated "CONFIDENTIAL" pursuant to the Protective Order. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 17
Request: Produce all documents relating to any effort by Solstice to design around, modify, or redesign the Accused Products to avoid infringement of the Asserted Patents.
Objections: Solstice objects to this Request on the grounds that it seeks documents and communications protected by the attorney-client privilege and work product doctrine. Solstice incorporates by reference General Objections Nos. 1 and 2. To the extent Solstice has undertaken any evaluation of potential design modifications to the Accused Products in light of the Asserted Patents, such activities were conducted at the direction of and in consultation with counsel, including Calderwood & Harkness LLP and in-house counsel, and the resulting documents reflect the mental impressions, conclusions, opinions, and legal theories of counsel regarding the scope and validity of the Asserted Patents' claims. Such documents are core attorney work product and are not subject to disclosure.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, and specifically without waiving any privilege or work product protection, Solstice will produce non-privileged responsive documents, if any exist. To the extent responsive documents are withheld on the basis of privilege, they will be identified on the privilege log to be served in accordance with the Scheduling Order.
REQUEST FOR PRODUCTION NO. 18
Request: Produce all documents relating to or analyzing Apex's products, including Apex's trocar systems and surgical access devices, and any analysis of the Asserted Patents by Solstice personnel.
Objections: Solstice objects to this Request as overbroad in its scope. The phrase "all documents relating to or analyzing Apex's products" is extraordinarily broad and would encompass every document in Solstice's files that mentions Apex or any Apex product, regardless of whether the document has any relevance to the claims and defenses in this action. Solstice incorporates by reference General Objections Nos. 1, 2, 3, and 4. Solstice further objects to the extent the Request seeks privileged analyses of the Asserted Patents prepared by or at the direction of counsel.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged documents reflecting competitive intelligence analyses, marketing comparisons, or product evaluations comparing Apex's trocar products with the Accused Products. Privileged documents will be identified on the privilege log. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 19
Request: Produce all documents relating to Solstice's own patent applications and issued patents covering the technology used in the Accused Products.
Objections: Solstice objects to this Request on multiple grounds. Solstice incorporates by reference General Objections Nos. 1, 2, 6, and 7. Solstice's own patent portfolio is not relevant to Apex's infringement claims or to the damages analysis in this case. To the extent Solstice's patents may be relevant to Solstice's invalidity counterclaims or defenses, the prosecution file histories and specifications of Solstice's issued patents and published applications are publicly available from the USPTO through Patent Center and can be accessed by Apex at no cost. Solstice's internal prosecution files—including communications between Solstice and its patent prosecution counsel at Kendrick & Lau LLP—are protected by the attorney-client privilege and will not be produced. Requiring Solstice to produce publicly available documents that Apex can obtain independently would serve no purpose and would impose unnecessary burden and expense.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice directs Apex to the publicly available records of the USPTO for the prosecution file histories and specifications of Solstice's issued patents and published patent applications. Solstice will not produce its internal prosecution files or communications with patent prosecution counsel, which are privileged.
REQUEST FOR PRODUCTION NO. 20
Request: Produce all license agreements, term sheets, or proposals relating to the Asserted Patents or any technology relating to laparoscopic trocar locking-seal assemblies, blade-deployment mechanisms, or insufflation valves, to which Solstice is a party.
Objections: Solstice objects to this Request as overbroad to the extent it seeks license agreements relating to "any technology relating to" the described mechanisms, which would encompass a vast universe of agreements potentially covering any component technology used in laparoscopic trocar devices, regardless of whether such agreements bear any relationship to the Asserted Patents or the accused features. Solstice incorporates by reference General Objections Nos. 1, 2, 3, and 8. Solstice further objects to the extent that any license agreement negotiations or term sheet discussions involved privileged communications with counsel.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged license agreements, if any, to which Solstice is a party that specifically relate to the Asserted Patents. Solstice states that, after a reasonable search, it is not aware of any existing license agreement between Solstice and Apex covering any of the Asserted Patents. To the extent Solstice has entered into third-party license agreements relevant to the Georgia-Pacific reasonable royalty damages analysis, Solstice will produce such agreements subject to "CONFIDENTIAL" or "ATTORNEYS' EYES ONLY" designation under the Protective Order. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 21
Request: Produce all communications between Solstice (or its agents) and Apex (or its agents) relating to the Asserted Patents, the Accused Products, or any potential licensing arrangement.
Objections: Solstice objects to this Request to the extent it seeks communications protected by the attorney-client privilege, including any communications between Solstice's counsel and Apex's counsel. Solstice incorporates by reference General Objections Nos. 1, 2, and 5.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged communications between Solstice and Apex relating to the Asserted Patents, the Accused Products, or potential licensing arrangements. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 22
Request: Produce all documents provided to, reviewed by, or generated by Solstice's board of directors, Chief Executive Officer, or executive management team concerning this litigation, the Asserted Patents, or the Accused Products.
Objections: Solstice objects to this Request on the grounds of attorney-client privilege and work product doctrine. Solstice incorporates by reference General Objections Nos. 1, 2, and 8. Board-level and executive-level documents concerning this litigation were prepared by or at the direction of counsel, including Calderwood & Harkness LLP (litigation counsel) and Eamon Rourke, General Counsel of Solstice Biomedical Devices Ltd. Such documents reflect privileged attorney-client communications and attorney work product, including counsel's assessment of the merits of the claims and defenses, litigation strategy, and settlement posture. Solstice further objects that the Request is overbroad to the extent it seeks "all documents" reviewed by executive management concerning the Accused Products, which would include ordinary-course business documents unrelated to the patent claims at issue.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, and specifically reserving the attorney-client privilege and work product protection, Solstice will produce non-privileged board and executive-level documents to the extent they are responsive and not protected by privilege. Documents withheld on the basis of privilege will be identified on the privilege log. Responsive non-privileged documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 23
Request: Produce all documents supporting or relating to Solstice's invalidity contentions and affirmative defenses as to the Asserted Patents, including prior art references, prior art search reports, and analysis thereof.
Objections: Solstice objects to this Request to the extent it seeks internal analyses of prior art prepared by or at the direction of counsel, which constitute protected attorney work product. Solstice incorporates by reference General Objections Nos. 1 and 2. Prior art search reports and invalidity analyses prepared by Calderwood & Harkness LLP and Kendrick & Lau LLP reflect the mental impressions, legal opinions, and litigation strategies of counsel and are core work product entitled to the highest level of protection. The prior art references themselves—published patents, printed publications, and other public documents—are typically publicly available and can be obtained by Apex independently.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce copies of prior art references identified in its invalidity contentions served in accordance with the Court's Scheduling Order. Internal analyses, memoranda, and attorney work product relating to the invalidity contentions will be withheld and identified on the privilege log. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 24
Request: Produce all documents supporting Solstice's non-infringement defenses, including claim charts, technical analyses, and comparison documents.
Objections: Solstice objects to this Request on the grounds of work product doctrine and attorney-client privilege. Solstice incorporates by reference General Objections Nos. 1 and 2. Non-infringement analyses, claim charts, and related comparison documents were prepared by or at the direction of counsel at Calderwood & Harkness LLP in anticipation of and for use in this litigation. Such documents constitute core attorney work product reflecting counsel's mental impressions, conclusions, opinions, and legal theories regarding the construction of the claims of the Asserted Patents and the application of those claims to the Accused Products, and are not subject to discovery.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged documents that form the factual basis for its non-infringement contentions, including technical product documentation for the Accused Products that describes the structure and operation of the accused features. Attorney work product, including claim charts and legal analyses, will be withheld and identified on the privilege log. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 25
Request: Produce all documents supporting Solstice's counterclaim of inequitable conduct, including documents relating to alleged misrepresentations or material omissions during prosecution of the Asserted Patents before the USPTO.
Objections: Solstice objects to this Request to the extent it seeks Solstice's internal analysis of the prosecution history of the Asserted Patents, which constitutes protected attorney work product. Solstice incorporates by reference General Objections Nos. 1, 2, and 6. The prosecution file histories of the '237, '884, and '105 Patents are publicly available through the USPTO's Patent Center system and can be accessed by Apex—the patent holder—without any production from Solstice. Indeed, Apex is in the best position to possess and access all documents relating to the prosecution of its own patents.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce non-privileged documents supporting the factual basis for its inequitable conduct counterclaim, including relevant prosecution history documents and prior art references that Solstice contends were material to the patentability of the Asserted Patents and were not disclosed to the USPTO during prosecution. Solstice directs Apex to the publicly available prosecution files for U.S. Patent Nos. 9,814,237; 10,271,884; and 10,932,105. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 26
Request: Produce all documents relating to the retention of any expert, consultant, or technical advisor by Solstice in connection with this action, including retention agreements, communications, and draft or final expert reports.
Objections: Solstice objects to this Request in its entirety on the grounds of the work product doctrine and attorney-client privilege. Solstice incorporates by reference General Objections Nos. 1 and 2. The retention of experts and consultants in this matter was undertaken by and at the direction of counsel at Calderwood & Harkness LLP. Retention agreements, communications between counsel and experts, and draft expert reports are protected from disclosure under the work product doctrine and, to the extent they reflect communications with counsel, the attorney-client privilege. Discovery concerning testifying experts is governed by Rule 26(a)(2) and Rule 26(b)(4) of the Federal Rules of Civil Procedure, and Solstice will make the required disclosures regarding testifying experts at the time set in the Court's Scheduling Order (expert discovery opens January 13, 2025). Discovery concerning consulting (non-testifying) experts is governed by Rule 26(b)(4)(D), which provides that facts known or opinions held by such experts are not discoverable absent exceptional circumstances.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will make all disclosures required by Rule 26(a)(2) of the Federal Rules of Civil Procedure at the time prescribed by the Scheduling Order. No documents responsive to this Request that are not privileged or protected by the work product doctrine are produced at this time.
REQUEST FOR PRODUCTION NO. 27
Request: Produce all documents provided to or received from any testifying or consulting expert retained by Solstice in connection with this action.
Objections: Solstice objects to this Request on the same grounds as stated in response to Request No. 26. Solstice incorporates by reference General Objections Nos. 1 and 2. Documents provided to or received from consulting (non-testifying) experts are protected by Rule 26(b)(4)(D) of the Federal Rules of Civil Procedure. Documents provided to testifying experts are subject to disclosure under Rule 26(a)(2)(B) and Rule 26(b)(4)(A)–(C), and will be disclosed at the appropriate time as set forth in the Scheduling Order.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will comply with its disclosure obligations under Rule 26(a)(2) of the Federal Rules of Civil Procedure at the time prescribed by the Scheduling Order. No documents responsive to this Request that are not privileged or protected are produced at this time.
REQUEST FOR PRODUCTION NO. 28
Request: Produce all documents relating to any insurance policy, indemnification agreement, or other arrangement pursuant to which Solstice may be reimbursed for defense costs or damages arising from this action.
Objections: Solstice objects to this Request to the extent it seeks the full text of insurance policies and all correspondence between Solstice and its insurer, which may contain communications protected by the attorney-client privilege or work product doctrine. Solstice incorporates by reference General Objections Nos. 1 and 8. Solstice acknowledges its obligation under Rule 26(a)(1)(A)(iv) of the Federal Rules of Civil Procedure to produce, for inspection and copying, any insurance agreement under which an insurance business may be liable to satisfy all or part of a possible judgment in the action or to indemnify or reimburse for payments made to satisfy the judgment.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce the declarations page and relevant policy provisions of its intellectual property litigation insurance policy issued by Halcyon Specialty Insurance Co. (Policy No. HSI-IP-2023-04891). The policy provides coverage for patent infringement defense with a $5,000,000 per-occurrence limit, a $10,000,000 aggregate limit, and a $250,000 self-insured retention. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 29
Request: Produce all organizational documents, corporate structure charts, and documents reflecting the relationship between Solstice Biomedical, Inc. (Delaware) and Solstice Biomedical Devices Ltd. (Ireland), including documents reflecting ownership, management, and operational control.
Objections: Solstice objects to this Request as overbroad to the extent it seeks "all organizational documents" of Solstice's Irish parent company, Solstice Biomedical Devices Ltd., which is not a party to this action. Solstice incorporates by reference General Objections Nos. 1, 4, and 8. Production of the entirety of the parent company's organizational documents—including articles of association, board resolutions, shareholder agreements, and similar corporate governance materials—would be burdensome and disproportionate to the needs of this case.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce organizational charts, corporate structure documents, and summary documentation reflecting the corporate relationship between Solstice Biomedical, Inc. (Delaware corporation, EIN: 84-3291056, principal offices at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803) and its parent company, Solstice Biomedical Devices Ltd. (Irish private limited company, CRO No. 648217, registered at Unit 14, Clonskeagh Business Park, Clonskeagh Road, Dublin 14, D14 YF28, Ireland), including ownership structure, reporting relationships, and operational control. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 30
Request: Produce all financial statements, annual reports, and audited or unaudited financial records for Solstice (including the parent company and U.S. subsidiary) for fiscal years 2019 through 2024.
Objections: Solstice objects to this Request as overbroad in both temporal scope and substantive scope. Solstice incorporates by reference General Objections Nos. 1, 5, and 8. Solstice objects to the production of entity-wide financial statements for the period prior to calendar year 2021, which predates the relevant period for damages analysis, and to the production of group-level financials that encompass product lines and business units entirely unrelated to the Accused Products. Solstice Biomedical Devices Ltd. is a private company, and its group-level financial statements are highly confidential and not publicly available. Disclosure of entity-wide financial data to a direct competitor raises serious concerns regarding competitive harm.
Response: Subject to and without waiving the foregoing objections and the General Objections incorporated herein, Solstice will produce financial data relevant to the damages analysis in this action, including product-line revenue and profitability data for the Accused Products for fiscal years 2021 through 2024. For context, Solstice notes that Solstice Biomedical Devices Ltd.'s FY 2023 group-level revenue was approximately €187.4 million (unaudited). To the extent group-level audited financial statements, prepared by Glenmore & Byrne LLP (Dublin, Ireland), are relevant to the damages inquiry, Solstice will produce such statements subject to "ATTORNEYS' EYES ONLY" designation under the Protective Order. Responsive documents are included in the production bearing Bates Nos. SBD-000001 through SBD-048217, to be produced on or about September 30, 2024.
REQUEST FOR PRODUCTION NO. 31
Request: Produce all business plans, revenue forecasts, budgets, and strategic plans relating to the Accused Products.
Objections: Solstice objects to this Reques