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

solstice-first-rfps.docx DOCUMENT Litigation

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UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

DEFENDANT SOLSTICE BIOMEDICAL, INC.'S FIRST SET OF REQUESTS FOR PRODUCTION OF DOCUMENTS TO PLAINTIFF APEX SURGICAL INNOVATIONS, INC.

Served Pursuant to Federal Rules of Civil Procedure 26 and 34

Date Served: August 19, 2024

Defendant Solstice Biomedical, Inc. ("Solstice" or "Defendant"), by and through its undersigned counsel, Calderwood & Harkness LLP, hereby requests that Plaintiff Apex Surgical Innovations, Inc. ("Apex" or "Plaintiff") produce the documents and things described below within thirty (30) days of service hereof, or at such other time as may be agreed upon by the parties or ordered by the Court, pursuant to Federal Rules of Civil Procedure 26(b) and 34. These Requests are propounded in connection with all claims and defenses at issue in the above-captioned action, including but not limited to Apex's claims of patent infringement and Solstice's affirmative defenses of invalidity, unenforceability, and non-infringement.

Documents responsive to these Requests shall be produced at the offices of Calderwood & Harkness LLP, 1201 Market Street, Suite 2500, Wilmington, Delaware 19801, or, alternatively, produced electronically in accordance with the parties' agreed-upon protocol for the production of electronically stored information ("ESI") as set forth in the Joint discovery Plan filed with the Court on July 15, 2024 (Dkt. No. 28).

I. DEFINITIONS

As used in these Requests for Production, the following terms shall have the meanings set forth below. These definitions are intended to supplement, and not to limit, the meanings otherwise ascribed to such terms under the Federal Rules of Civil Procedure or applicable law.

1. "Apex" means Apex Surgical Innovations, Inc., together with its predecessors, successors, parent entities, subsidiaries, affiliates, divisions, officers, directors, employees, agents, representatives, and any other persons or entities acting or purporting to act on its behalf.

2. "Asserted Patents" means U.S. Patent No. 9,814,237 (hereinafter "the '237 Patent"), U.S. Patent No. 10,271,884 (hereinafter "the '884 Patent"), and U.S. Patent No. 10,932,105 (hereinafter "the '105 Patent"), each of which is asserted in Apex's Complaint filed on May 9, 2024 (Dkt. No. 1).

3. "Asserted Claims" means Claims 1, 3, 7, and 12 of the '237 Patent; Claims 1, 2, 5, 9, and 14 of the '884 Patent; and Claims 1, 4, and 8 of the '105 Patent, as identified in Apex's Preliminary Infringement Contentions served on July 29, 2024.

4. "Accused Products" means the PrecisionEdge™ PE-5000 Series, PrecisionEdge™ PE-12000 Series, and PrecisionEdge™ PE-15000 Series laparoscopic trocar assemblies, as identified and accused of infringement in Apex's Complaint and Preliminary Infringement Contentions.

5. "Patent Family" means all U.S. and foreign patents and patent applications that are related to any of the Asserted Patents by way of continuation, continuation-in-part, divisional, reissue, reexamination, or claim of priority to a common application, including but not limited to the fourteen (14) issued U.S. patents and six (6) pending continuation applications identified in Apex's Initial Disclosures served on July 15, 2024.

6. "Communication" means any exchange or transmission of information between two or more persons, whether oral, written, or electronic in form, including but not limited to letters, emails, electronic mail attachments, memoranda, facsimiles, text messages, instant messages, messages transmitted via any messaging platform or application (including but not limited to Meridian Solutions, Northgate Data Systems, and similar platforms), voicemails, telephone calls, videoconference calls, and any record or memorialization of any such exchange.

7. "Document" shall have the broadest meaning afforded under Federal Rule of Civil Procedure 34(a) and includes, without limitation, all writings, drawings, graphs, charts, photographs, sound recordings, images, electronically stored information ("ESI"), and other data or data compilations stored in any medium from which information can be obtained, either directly or, if necessary, after translation by the responding party into a reasonably usable form. The term "Document" includes originals, all non-identical copies (whether different from the original because of handwritten notes, markings, highlighting, redactions, or otherwise), drafts, and metadata associated with any ESI.

8. "Relating to" or "concerning" means referring to, describing, evidencing, constituting, reflecting, mentioning, supporting, contradicting, pertaining to, connected with, commenting upon, or having any logical connection with the subject matter in question, in whole or in part, directly or indirectly.

9. "You" or "Your" means Apex as defined above in Definition No. 1.

10. "Person" means any natural person, corporation, partnership, joint venture, limited liability company, association, trust, governmental entity, or any other legal or business entity, and includes all officers, directors, employees, agents, and representatives of such entity.

11. "Identify" when used with respect to a Document means to state, to the extent known: (a) the date of the Document; (b) the author(s) or originator(s); (c) the recipient(s) and any persons copied; (d) the type or nature of the Document (e.g., letter, memorandum, email, report); (e) the general subject matter of the Document; and (f) the Bates number or range of Bates numbers, if the Document has been previously produced in this or any related proceeding. When used with respect to a Person, "Identify" means to state the Person's full name, title, employer, business address, and telephone number, to the extent known.

12. "Dr. Raymond Szabo" means Dr. Raymond Szabo, who holds the title of Vice President of Engineering at Apex and who is identified as the named inventor or a co-inventor on each of the Asserted Patents.

13. "Relevant Period" means the period from January 1, 2004 to the present, unless a different time period is expressly specified in a particular Request.

14. "Net Sales" means gross sales revenue less returns, rebates, allowances, chargebacks, freight charges, shipping and handling costs, and applicable sales and excise taxes.

15. "Licensed" or "License" means any agreement, arrangement, or understanding, whether formal or informal, written or oral, granting rights under one or more of the Asserted Patents or any patents in the Patent Family, including but not limited to exclusive licenses, non-exclusive licenses, cross-licenses, sublicenses, covenants not to sue, releases, and settlements that include a grant of patent rights.

II. INSTRUCTIONS

The following instructions apply to each of the Requests for Production set forth below and shall be read and interpreted in conjunction with the Definitions set forth in Section I above.

1. Continuing Obligation. These Requests are continuing in nature pursuant to Federal Rule of Civil Procedure 26(e). Apex is required to supplement its responses as additional responsive documents become available, are identified, or are located at any time during the pendency of this action. Supplemental responses shall be served promptly upon the identification or discovery of additional responsive documents.

2. Organization of Production. Documents shall be produced as they are kept in the ordinary course of business, or shall be organized and labeled to correspond with the categories in each specific Request for Production, in accordance with Federal Rule of Civil Procedure 34(b)(2)(E). In either case, the producing party shall identify, for each document produced, the Request or Requests to which the document is responsive.

3. Privilege Log. If any document responsive to any Request herein is withheld, in whole or in part, on the basis of any claim of attorney-client privilege, work product protection, or any other applicable privilege or immunity, Apex shall provide a privilege log in compliance with Federal Rule of Civil Procedure 26(b)(5)(A) and the Court's Scheduling Order entered on July 2, 2024 (Dkt. No. 22). The privilege log shall identify: (a) the nature of the privilege or protection asserted; (b) the date of the document; (c) the author(s) and recipient(s); (d) a description of the subject matter of the document sufficient to assess the applicability of the claimed privilege; and (e) any other information necessary to enable Solstice and the Court to evaluate the validity of the privilege claim.

4. Independent Construction. Each Request shall be construed independently and shall not be limited by reference to any other Request. Documents responsive to more than one Request need be produced only once, provided that Apex includes a notation or index identifying all Requests to which each such document is responsive.

5. Lost or Destroyed Documents. If any document responsive to any Request has been lost, destroyed, discarded, overwritten, or is otherwise unavailable, Apex shall identify such document to the fullest extent possible and shall state in detail the circumstances surrounding the loss, destruction, or unavailability of such document, including the date of loss or destruction (if known), the identity of any person(s) responsible for or involved in the loss or destruction, and the reason for the loss or destruction.

6. Format of ESI Production. Electronically stored information ("ESI") shall be produced in native format or as single-page TIFF images (300 dpi minimum resolution) with associated load files (including Ashgrove Technologies/Relativity-compatible DAT and OPT files), extracted or OCR text, and all reasonably accessible metadata fields, consistent with the ESI production protocol agreed to by the parties in the Joint discovery Plan filed on July 15, 2024 (Dkt. No. 28). Spreadsheets, presentations, and databases shall be produced in their native format.

7. No Request for Privileged Material. These Requests are propounded by Defendant Solstice Biomedical, Inc. and are not intended to call for the production of documents or information protected by the attorney-client privilege or the work product doctrine, except to the extent any such privilege or protection has been expressly or impliedly waived by Apex. To the extent that Apex contends that any responsive document is partially privileged, Apex shall produce the non-privileged portions of such document with appropriate redactions and shall identify the redacted portions on its privilege log.

8. Possession, Custody, or Control. Where a Request calls for "all documents," it includes every document within Apex's possession, custody, or control, including but not limited to documents held by Apex's agents, representatives, attorneys (to the extent not privileged), consultants, experts, accountants, auditors, licensees, and any other persons or entities acting or purporting to act on Apex's behalf or subject to Apex's direction or control.

III. REQUESTS FOR PRODUCTION

A. Patent Prosecution Files and Related Documents

REQUEST FOR PRODUCTION NO. 1:

All documents constituting or relating to the complete prosecution history of U.S. Patent No. 9,814,237 ("the '237 Patent"), including but not limited to: the patent application as originally filed; all preliminary amendments; all office actions issued by the U.S. Patent and Trademark Office ("USPTO"); all responses to office actions; all amendments to the claims and/or specification; all information disclosure statements ("IDS") and associated references; all declarations, affidavits, or other sworn statements submitted during prosecution; all petitions and requests filed with the USPTO; all notices of allowance; all issue fee transmittals; all terminal disclaimers; and all correspondence between Apex (or its patent counsel) and the USPTO relating to the '237 Patent.

REQUEST FOR PRODUCTION NO. 2:

All documents constituting or relating to the complete prosecution history of U.S. Patent No. 10,271,884 ("the '884 Patent"), including but not limited to: the patent application as originally filed; all preliminary amendments; all office actions issued by the USPTO; all responses to office actions; all amendments to the claims and/or specification; all information disclosure statements and associated references; all declarations, affidavits, or other sworn statements submitted during prosecution; all petitions and requests filed with the USPTO; all notices of allowance; all issue fee transmittals; all terminal disclaimers; and all correspondence between Apex (or its patent counsel) and the USPTO relating to the '884 Patent.

REQUEST FOR PRODUCTION NO. 3:

All documents constituting or relating to the complete prosecution history of U.S. Patent No. 10,932,105 ("the '105 Patent"), including but not limited to: the patent application as originally filed; all preliminary amendments; all office actions issued by the USPTO; all responses to office actions; all amendments to the claims and/or specification; all information disclosure statements and associated references; all declarations, affidavits, or other sworn statements submitted during prosecution; all petitions and requests filed with the USPTO; all notices of allowance; all issue fee transmittals; all terminal disclaimers; and all correspondence between Apex (or its patent counsel) and the USPTO relating to the '105 Patent.

REQUEST FOR PRODUCTION NO. 4:

All documents constituting or relating to the prosecution history of any other patent or patent application in the Patent Family, including but not limited to any continuation, continuation-in-part, divisional, reissue, or reexamination application or proceeding relating to the Asserted Patents, and including all documents of the types described in Requests Nos. 1 through 3 above for each such patent or patent application.

REQUEST FOR PRODUCTION NO. 5:

All documents relating to any inter partes review ("IPR"), post-grant review ("PGR"), covered business method review ("CBM"), ex parte reexamination, or any other post-issuance proceeding before the USPTO, the Patent Trial and Appeal Board ("PTAB"), or any foreign patent office, involving any of the Asserted Patents or any patent or patent application in the Patent Family. This Request includes, without limitation, all petitions, patent owner preliminary responses, institution decisions, patent owner responses, reply briefs, motions, declarations, exhibits, oral hearing transcripts, final written decisions, and any related correspondence or communications.

REQUEST FOR PRODUCTION NO. 6:

All assignment documents relating to the Asserted Patents and any patent or patent application in the Patent Family, including but not limited to: all assignments from Dr. Raymond Szabo or any other named inventor to Apex or any predecessor entity; all assignments between corporate entities; any chain-of-title documents; any employment agreements, invention assignment agreements, or consultant agreements that effectuate an assignment of rights in the Asserted Patents or the Patent Family; and any documents recorded with the USPTO Assignment Recordation Branch.

REQUEST FOR PRODUCTION NO. 7:

All documents relating to any foreign counterpart applications or patents corresponding to the Asserted Patents or any patent or application in the Patent Family, including but not limited to: prosecution histories of any foreign patent applications claiming priority to, or sharing a common priority date with, the Asserted Patents; any search reports issued by foreign patent offices (including but not limited to the European Patent Office, the Japan Patent Office, the Korean intellectual Property Office, and the World intellectual Property Organization); any substantive examination reports or office actions from foreign patent offices; and any foreign patents granted based on such applications.

B. Invention, Conception, and Development Documents

REQUEST FOR PRODUCTION NO. 8:

All documents relating to the conception, reduction to practice, and development of the inventions claimed in the Asserted Patents, including but not limited to: inventor notebooks and laboratory notebooks; laboratory records, experimental records, and testing logs; design documents, engineering drawings, and schematics; computer-aided design ("CAD") files; prototype specifications and photographs; records of prototype testing, bench testing, and validation testing; internal memoranda and correspondence relating to the design and development of the claimed inventions; meeting notes, minutes, and agendas relating to the conception or development of the claimed inventions; and any internal communications involving Dr. Raymond Szabo or any other named inventor relating to the subject matter of the Asserted Patents.

REQUEST FOR PRODUCTION NO. 9:

All documents relating to any prior art references known to Apex, its employees, officers, directors, agents, inventors, or patent counsel at any time during the prosecution of the Asserted Patents or any patent or application in the Patent Family, including but not limited to: prior art search results; prior art search requests and reports, whether prepared internally or by any outside search firm; databases or files of prior art maintained by Apex; opinions of counsel regarding patentability over prior art; and any communications among any persons at Apex discussing, evaluating, analyzing, or assessing prior art references relevant to the Asserted Patents.

REQUEST FOR PRODUCTION NO. 10:

All documents relating to any duty of candor obligations under 37 C.F.R. § 1.56 in connection with the prosecution of the Asserted Patents or any patent or application in the Patent Family, including but not limited to: any communications among inventors, patent counsel, or Apex personnel regarding the identification, evaluation, and disclosure (or non-disclosure) of material prior art to the USPTO; any policies, procedures, or guidelines maintained by Apex regarding compliance with the duty of candor; and any documents reflecting decisions regarding whether to submit particular prior art references in an information disclosure statement to the USPTO.

REQUEST FOR PRODUCTION NO. 11:

All documents relating to any analysis of the patentability, validity, enforceability, or scope of the Asserted Claims conducted by or on behalf of Apex at any time, including but not limited to: freedom-to-operate analyses; invalidity or validity studies; claim scope analyses or claim interpretation studies; opinions of counsel regarding validity or enforceability; and any internal memoranda, presentations, or reports evaluating the strength or scope of the Asserted Patents. This Request seeks only documents that are not protected by the attorney-client privilege or the work product doctrine, or documents as to which any such protection has been waived, whether expressly or impliedly.

C. Infringement Allegations and Claim Charts

REQUEST FOR PRODUCTION NO. 12:

All documents relating to Apex's contention that any of the Accused Products infringe any of the Asserted Claims, including but not limited to: claim charts mapping the elements of the Asserted Claims to features of the Accused Products; infringement analyses prepared by Apex or any expert, consultant, or technical advisor retained by or on behalf of Apex; technical comparisons between the Asserted Claims and the Accused Products; any reports, memoranda, or presentations analyzing alleged infringement; any testing, evaluation, or reverse-engineering of the Accused Products conducted in connection with the preparation of infringement contentions; and all communications relating to the foregoing, whether internal to Apex or between Apex and any outside consultant or expert.

REQUEST FOR PRODUCTION NO. 13:

All documents relating to any analysis, study, evaluation, testing, inspection, teardown, reverse engineering, or technical examination of any PrecisionEdge™ PE-5000, PE-12000, or PE-15000 Series product conducted by or on behalf of Apex, including but not limited to: photographs, videos, or diagrams of the Accused Products or their components; reports or notes prepared by any person who performed such analysis, study, or testing; all documents provided to, received from, or exchanged with Dr. Calvin Ng of Veltrano Polytechnic Institute or any other expert or consultant retained by Apex in connection with such work; and any purchase records, chain-of-custody documentation, or other documents relating to the acquisition of any sample or exemplar of the Accused Products for purposes of such analysis or testing.

REQUEST FOR PRODUCTION NO. 14:

All documents relating to the identification of the Accused Products as allegedly infringing products, including but not limited to: any pre-suit investigation or analysis conducted by or on behalf of Apex prior to the filing of the Complaint on May 9, 2024; any market surveillance, product monitoring, or competitive intelligence activities directed at the Accused Products; any product evaluation, feature analysis, or comparison studies involving the Accused Products; and any internal communications or decision-making documents relating to the determination to accuse the PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series of infringing the Asserted Patents.

D. Prior Art References and Publications

REQUEST FOR PRODUCTION NO. 15:

All documents constituting, referencing, or relating to any prior art — including but not limited to U.S. and foreign patents, published patent applications, scientific journal articles, technical publications, conference papers, conference proceedings, symposium presentations, doctoral dissertations, master's theses, product manuals, user guides, product catalogs, brochures, marketing materials, trade publications, and any other publications or publicly available materials — that relate to one or more of the following technical subject areas: (a) locking seal assemblies for minimally invasive surgical access devices or trocar systems; (b) retractable blade deployment mechanisms for minimally invasive surgical access devices or trocar systems; or (c) integrated insufflation valves for minimally invasive surgical access devices or trocar systems, where such documents were published, disclosed, or made publicly available before the earliest effective priority date of each of the Asserted Patents.

REQUEST FOR PRODUCTION NO. 16:

All documents relating to any commercial products, devices, or systems — whether manufactured, sold, or distributed by Apex, Solstice, or any third party — that embody, implement, or incorporate locking seal assemblies, retractable blade deployment mechanisms, or integrated insufflation valves for trocar systems or other minimally invasive surgical access devices, and that were known, used, offered for sale, sold, imported into the United States, or publicly disclosed prior to the earliest effective priority date of each of the Asserted Patents. This Request includes, without limitation, product specifications, design documents, product brochures, sales records, and marketing materials relating to any such products.

REQUEST FOR PRODUCTION NO. 17:

All information disclosure statements ("IDS") filed during prosecution of the Asserted Patents and any patent or patent application in the Patent Family, and all prior art references cited or listed therein, including any references cited by the USPTO examiner or submitted by any third party, and including any documents responsive to this Request that have not already been produced in response to Request Nos. 1 through 4.

E. License Agreements and Royalty Information

REQUEST FOR PRODUCTION NO. 18:

All license agreements, option agreements, covenant-not-to-sue agreements, settlement agreements containing a license or grant of rights, cross-license agreements, joint development agreements, and any other agreements or arrangements, whether formal or informal, written or oral, granting rights under any of the Asserted Patents or any patent or patent application in the Patent Family, to any person or entity, including any amendments, addenda, side letters, or modifications to any such agreement.

REQUEST FOR PRODUCTION NO. 19:

All documents relating to the negotiation of any license agreement, covenant not to sue, or other grant of rights under the Asserted Patents or any patent or patent application in the Patent Family, including but not limited to: proposals and counterproposals; term sheets; letters of intent; correspondence between the parties to such negotiations; internal analyses, memoranda, or presentations prepared by Apex in connection with such negotiations; and any other communications, whether internal or external, regarding the terms, scope, consideration, or structure of any such agreement or proposed agreement.

REQUEST FOR PRODUCTION NO. 20:

All documents relating to royalty rates, running royalties, paid-up royalties, lump-sum payments, milestone payments, minimum royalty obligations, or any other form of consideration paid to or received by Apex in connection with any license, settlement, or other grant of rights involving the Asserted Patents or any patent or patent application in the Patent Family. This Request includes, without limitation, royalty reports, payment records, invoices, and accounting records reflecting the calculation and payment of any such consideration.

REQUEST FOR PRODUCTION NO. 21:

All documents relating to any offers to license, demands for license, invitations to take a license, or licensing discussions involving the Asserted Patents or any patent or patent application in the Patent Family that did not result in a completed or executed license agreement, including but not limited to: demand letters; offer letters; licensing presentations; correspondence between the parties; and any internal documents relating to Apex's assessment of such offers, demands, or discussions.

REQUEST FOR PRODUCTION NO. 22:

All documents relating to any most-favored-licensee provision, most-favored-nation clause, or any other provision in any license agreement involving the Asserted Patents or any patent or patent application in the Patent Family that guarantees, requires, or provides for adjustment of royalty rates or other terms based on the terms of any other license agreement. This Request includes any documents reflecting the operation or application of any such provision.

F. Sales, Revenue, and Financial Data

REQUEST FOR PRODUCTION NO. 23:

All documents sufficient to show Apex's annual revenue, unit sales, and average selling prices for all products that practice, embody, are covered by, or are marketed as practicing the Asserted Claims, for each calendar year from 2017 through the present, including but not limited to sales reports, revenue summaries, pricing schedules, and any reports or summaries generated by Apex's financial, accounting, or sales tracking systems.

REQUEST FOR PRODUCTION NO. 24:

All documents sufficient to show Apex's gross profit margins, cost of goods sold (including direct materials, direct labor, and manufacturing overhead), and net profit margins for all products that practice, embody, are covered by, or are marketed as practicing the Asserted Claims, for each calendar year from 2017 through the present, including but not limited to income statements, cost accounting records, and any reports or analyses prepared by Apex's finance or accounting department.

REQUEST FOR PRODUCTION NO. 25:

All documents relating to the market for laparoscopic trocar systems, surgical access devices, and related products in the United States, including but not limited to: market studies and market sizing analyses; market share analyses; competitive intelligence reports; industry reports or surveys prepared by third parties (e.g., Crowne Albany Group, Granite Harbor Partners LLC, Marlowe Enterprises, or similar research firms); strategic planning documents; and any other documents relating to market conditions, market trends, or the competitive landscape for such products that are in Apex's possession, custody, or control.

REQUEST FOR PRODUCTION NO. 26:

All documents sufficient to show or estimate the total size of the U.S. market for surgical access devices, trocar systems, and insufflation equipment for each calendar year from 2017 through the present, including any market reports, market analyses, industry data, or summaries prepared by or for Apex, and any documents relied upon by Apex in forming its assessment of the size or scope of the relevant market.

REQUEST FOR PRODUCTION NO. 27:

All documents relating to Apex's knowledge of, competitive analyses of, or comparisons to Solstice's PrecisionEdge™ product line or any other Solstice products, including but not limited to: marketing analyses; competitive positioning documents; win/loss analyses; sales force communications (including emails, bulletins, or training materials); competitive intelligence reports; and any other documents in which Apex's products or market position are compared, directly or indirectly, to the Accused Products or other Solstice products.

G. Damages and Lost Profits

REQUEST FOR PRODUCTION NO. 28:

All documents relating to Apex's claimed damages in this action, including but not limited to: any analysis, calculation, model, or methodology used to determine or estimate the amount of damages sought; all assumptions, data inputs, and supporting documentation underlying any damages calculation; and all documents provided to, received from, relied upon by, or prepared by Hugh Danaher, CFA, of Keystone Valuation Advisors LLC, or any other damages expert, financial expert, or economic consultant retained or consulted by Apex in connection with this action.

REQUEST FOR PRODUCTION NO. 29:

All documents relating to any Georgia-Pacific factor analysis or reasonable royalty determination performed by or on behalf of Apex in this matter or in any other patent licensing, enforcement, or litigation matter involving the Asserted Patents or any patent in the Patent Family, including but not limited to: analyses addressing any of the fifteen Georgia-Pacific factors; any hypothetical negotiation analyses; any comparable license analyses; and any documents reflecting the inputs, assumptions, or conclusions of such analyses.

REQUEST FOR PRODUCTION NO. 30:

All documents relating to any lost profits claim or analysis by Apex, including but not limited to: any analysis of the Panduit factors or any comparable framework for establishing entitlement to lost profits; any analysis of price erosion, price suppression, or pricing pressure attributable to the Accused Products; any analysis of lost sales, diverted sales, or market diversion attributable to the Accused Products; any analysis of Apex's manufacturing capacity or ability to meet demand; and any analysis of the availability of acceptable non-infringing alternatives to the Accused Products.

REQUEST FOR PRODUCTION NO. 31:

All financial statements, annual reports, 10-K filings, 10-Q filings, 8-K filings, proxy statements, and audited or unaudited financial reports of Apex for fiscal years 2017 through 2024, including but not limited to: consolidated and unconsolidated financial statements; balance sheets, income statements, statements of cash flows, and statements of stockholders' equity; management discussion and analysis sections; notes to financial statements; and any financial reports, audit reports, management letters, or other financial analyses prepared by Creston Perry LLP or any other independent auditor, accounting firm, or financial advisor retained by Apex.

H. Communications Relating to the Asserted Patents and Accused Products

REQUEST FOR PRODUCTION NO. 32:

All communications between or among Apex employees, officers, directors, or agents relating to the Asserted Patents, the Asserted Claims, the enforcement or licensing of the Asserted Patents, or the decision to initiate the above-captioned action, including but not limited to any communications involving Gerald K. Whitford (Chief Executive Officer), Dr. Priya Chandrasekaran (Chief Technology Officer), Martin Hale (General Counsel), Dr. Raymond Szabo (Vice President of Engineering), or any other officer, director, or senior employee of Apex.

REQUEST FOR PRODUCTION NO. 33:

All communications between Apex and any third party (other than litigation counsel retained in connection with this action) relating to the Accused Products, Solstice's PrecisionEdge™ product line, or Solstice's alleged infringement of the Asserted Patents, including but not limited to: communications with customers, distributors, suppliers, industry contacts, potential licensees, or any other third parties; and communications relating to the technical features, commercial performance, or market reception of the Accused Products.

REQUEST FOR PRODUCTION NO. 34:

All communications between Apex and any expert, consultant, technical advisor, or other non-attorney professional (other than litigation counsel retained in connection with this action) relating to the Asserted Patents, the Accused Products, or the alleged infringement thereof, including but not limited to: all communications with Dr. Calvin Ng of Veltrano Polytechnic Institute; any communications with other technical experts or consultants engaged by Apex to evaluate the Asserted Patents, the prior art, or the Accused Products; and any engagement letters, retainer agreements, or statements of work reflecting the scope of any such engagement.

REQUEST FOR PRODUCTION NO. 35:

All communications between Apex and any third party regarding the potential or actual licensing, sale, transfer, assignment, pledge, encumbrance, or other disposition of any of the Asserted Patents or any patent or patent application in the Patent Family, including but not limited to: communications with potential purchasers, licensees, investors, or financial institutions; and any term sheets, letters of intent, or other preliminary agreements relating to such transactions.

I. Related Litigation and Proceedings

REQUEST FOR PRODUCTION NO. 36:

All documents relating to any other litigation, dispute, arbitration, mediation, or proceeding in which Apex has asserted, enforced, defended, or otherwise been involved with respect to any of the Asserted Patents or any patent or patent application in the Patent Family, whether as plaintiff, defendant, petitioner, patent owner, or in any other capacity, including but not limited to: complaints, counterclaims, and answers; infringement and invalidity contentions; claim construction briefs, Markman hearing transcripts, and claim construction orders; expert reports, rebuttal expert reports, and related exhibits; deposition transcripts and exhibits; summary judgment briefs and orders; trial transcripts and exhibits; jury instructions and verdict forms; court orders and opinions; and settlement agreements, consent judgments, and stipulated dismissals.

REQUEST FOR PRODUCTION NO. 37:

All documents relating to any cease-and-desist letter, demand letter, notice of infringement, invitation to license, or similar communication sent by or on behalf of Apex to any person or entity (other than Solstice) alleging infringement of any of the Asserted Patents or any patent or patent application in the Patent Family, including any responses received and any follow-up correspondence or communications relating thereto.

J. Corporate and Organizational Documents

REQUEST FOR PRODUCTION NO. 38:

All organizational charts, corporate structure charts, divisional structure documents, and any other documents identifying the business units, divisions, departments, or functional groups within Apex that are responsible for, or involved in, the development, prosecution, maintenance, licensing, monetization, and enforcement of the Asserted Patents and the Patent Family, including but not limited to: any documents identifying the individuals responsible for patent portfolio management, patent prosecution oversight, and licensing strategy within Apex; any documents reflecting reporting relationships or lines of authority with respect to intellectual property matters; and any documents identifying the composition, membership, or responsibilities of any patent review committee, intellectual property committee, or similar body within Apex.

IV. RESERVATION OF RIGHTS

Solstice Biomedical, Inc. expressly reserves the right to serve additional Requests for Production of Documents, Interrogatories, and Requests for Admission as permitted by the Court's Scheduling Order entered on July 2, 2024 (Dkt. No. 22), the Joint discovery Plan filed on July 15, 2024 (Dkt. No. 28), the Federal Rules of Civil Procedure, and the Local Rules of the United States District Court for the District of Delaware.

Solstice further reserves the right to supplement, amend, or modify these Requests for Production upon discovery of additional facts, the receipt of discovery responses from Apex, the production of documents by third parties, or any change in circumstances that may warrant additional or revised discovery requests.

Nothing in these Requests for Production shall be construed as an admission by Solstice of the relevance, materiality, admissibility, or authenticity of any document produced or identified in response hereto. The fact that Solstice has requested certain categories of documents does not constitute a concession that any particular fact, issue, or contention is relevant to this action or admissible at trial. Solstice reserves all objections to the relevance, materiality, authenticity, and admissibility of any documents produced in response to these Requests.

Respectfully submitted,

CALDERWOOD & HARKNESS LLP

By: ________

Marcus Delgado (DE Bar No. 5738) mdelgado@calderwoodharkness.com

Christy Bauer (DE Bar No. 6412) cbauer@calderwoodharkness.com

Peter Vassiliev (DE Bar No. 6891) pvassiliev@calderwoodharkness.com

CALDERWOOD & HARKNESS LLP 1201 Market Street, Suite 2500 Wilmington, Delaware 19801 Telephone: (302) 555-4200 Facsimile: (302) 555-4201

Counsel for Defendant Solstice Biomedical, Inc.

Dated: August 19, 2024

CERTIFICATE OF SERVICE

I, Marcus Delgado, hereby certify that on August 19, 2024, a true and correct copy of the foregoing Defendant Solstice Biomedical, Inc.'s First Set of Requests for Production of Documents to Plaintiff Apex Surgical Innovations, Inc. was served upon all counsel of record via the Court's CM/ECF electronic filing system, which will send notification of such filing to all registered participants, and by electronic mail upon:

Victoria Stanton, Esq. Derek Loomis, Esq. Hargrove, Tate & Bennington LLP 900 North King Street, Suite 1200 Wilmington, Delaware 19801 vstanton@htblaw.com dloomis@htblaw.com

Counsel for Plaintiff Apex Surgical Innovations, Inc.

________________________________________

Marcus Delgado

APEX SURGICAL INNOVATIONS, INC.,

Plaintiff,

SOLSTICE BIOMEDICAL, INC.,

Defendant.

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
DEFENDANT SOLSTICE BIOMEDICAL, INC.'S FIRST SET OF REQUESTS FOR PRODUCTION OF DOCUMENTS TO PLAINTIFF APEX SURGICAL INNOVATIONS, INC.
Served Pursuant to Federal Rules of Civil Procedure 26 and 34
Date Served: August 19, 2024
Defendant Solstice Biomedical, Inc. ("Solstice" or "Defendant"), by and through its undersigned counsel, Calderwood & Harkness LLP, hereby requests that Plaintiff Apex Surgical Innovations, Inc. ("Apex" or "Plaintiff") produce the documents and things described below within thirty (30) days of service hereof, or at such other time as may be agreed upon by the parties or ordered by the Court, pursuant to Federal Rules of Civil Procedure 26(b) and 34. These Requests are propounded in connection with all claims and defenses at issue in the above-captioned action, including but not limited to Apex's claims of patent infringement and Solstice's affirmative defenses of invalidity, unenforceability, and non-infringement.
Documents responsive to these Requests shall be produced at the offices of Calderwood & Harkness LLP, 1201 Market Street, Suite 2500, Wilmington, Delaware 19801, or, alternatively, produced electronically in accordance with the parties' agreed-upon protocol for the production of electronically stored information ("ESI") as set forth in the Joint discovery Plan filed with the Court on July 15, 2024 (Dkt. No. 28).
I. DEFINITIONS
As used in these Requests for Production, the following terms shall have the meanings set forth below. These definitions are intended to supplement, and not to limit, the meanings otherwise ascribed to such terms under the Federal Rules of Civil Procedure or applicable law.
1. "Apex" means Apex Surgical Innovations, Inc., together with its predecessors, successors, parent entities, subsidiaries, affiliates, divisions, officers, directors, employees, agents, representatives, and any other persons or entities acting or purporting to act on its behalf.
2. "Asserted Patents" means U.S. Patent No. 9,814,237 (hereinafter "the '237 Patent"), U.S. Patent No. 10,271,884 (hereinafter "the '884 Patent"), and U.S. Patent No. 10,932,105 (hereinafter "the '105 Patent"), each of which is asserted in Apex's Complaint filed on May 9, 2024 (Dkt. No. 1).
3. "Asserted Claims" means Claims 1, 3, 7, and 12 of the '237 Patent; Claims 1, 2, 5, 9, and 14 of the '884 Patent; and Claims 1, 4, and 8 of the '105 Patent, as identified in Apex's Preliminary Infringement Contentions served on July 29, 2024.
4. "Accused Products" means the PrecisionEdge™ PE-5000 Series, PrecisionEdge™ PE-12000 Series, and PrecisionEdge™ PE-15000 Series laparoscopic trocar assemblies, as identified and accused of infringement in Apex's Complaint and Preliminary Infringement Contentions.
5. "Patent Family" means all U.S. and foreign patents and patent applications that are related to any of the Asserted Patents by way of continuation, continuation-in-part, divisional, reissue, reexamination, or claim of priority to a common application, including but not limited to the fourteen (14) issued U.S. patents and six (6) pending continuation applications identified in Apex's Initial Disclosures served on July 15, 2024.
6. "Communication" means any exchange or transmission of information between two or more persons, whether oral, written, or electronic in form, including but not limited to letters, emails, electronic mail attachments, memoranda, facsimiles, text messages, instant messages, messages transmitted via any messaging platform or application (including but not limited to Meridian Solutions, Northgate Data Systems, and similar platforms), voicemails, telephone calls, videoconference calls, and any record or memorialization of any such exchange.
7. "Document" shall have the broadest meaning afforded under Federal Rule of Civil Procedure 34(a) and includes, without limitation, all writings, drawings, graphs, charts, photographs, sound recordings, images, electronically stored information ("ESI"), and other data or data compilations stored in any medium from which information can be obtained, either directly or, if necessary, after translation by the responding party into a reasonably usable form. The term "Document" includes originals, all non-identical copies (whether different from the original because of handwritten notes, markings, highlighting, redactions, or otherwise), drafts, and metadata associated with any ESI.
8. "Relating to" or "concerning" means referring to, describing, evidencing, constituting, reflecting, mentioning, supporting, contradicting, pertaining to, connected with, commenting upon, or having any logical connection with the subject matter in question, in whole or in part, directly or indirectly.
9. "You" or "Your" means Apex as defined above in Definition No. 1.
10. "Person" means any natural person, corporation, partnership, joint venture, limited liability company, association, trust, governmental entity, or any other legal or business entity, and includes all officers, directors, employees, agents, and representatives of such entity.
11. "Identify" when used with respect to a Document means to state, to the extent known: (a) the date of the Document; (b) the author(s) or originator(s); (c) the recipient(s) and any persons copied; (d) the type or nature of the Document (e.g., letter, memorandum, email, report); (e) the general subject matter of the Document; and (f) the Bates number or range of Bates numbers, if the Document has been previously produced in this or any related proceeding. When used with respect to a Person, "Identify" means to state the Person's full name, title, employer, business address, and telephone number, to the extent known.
12. "Dr. Raymond Szabo" means Dr. Raymond Szabo, who holds the title of Vice President of Engineering at Apex and who is identified as the named inventor or a co-inventor on each of the Asserted Patents.
13. "Relevant Period" means the period from January 1, 2004 to the present, unless a different time period is expressly specified in a particular Request.
14. "Net Sales" means gross sales revenue less returns, rebates, allowances, chargebacks, freight charges, shipping and handling costs, and applicable sales and excise taxes.
15. "Licensed" or "License" means any agreement, arrangement, or understanding, whether formal or informal, written or oral, granting rights under one or more of the Asserted Patents or any patents in the Patent Family, including but not limited to exclusive licenses, non-exclusive licenses, cross-licenses, sublicenses, covenants not to sue, releases, and settlements that include a grant of patent rights.
II. INSTRUCTIONS
The following instructions apply to each of the Requests for Production set forth below and shall be read and interpreted in conjunction with the Definitions set forth in Section I above.
1. Continuing Obligation. These Requests are continuing in nature pursuant to Federal Rule of Civil Procedure 26(e). Apex is required to supplement its responses as additional responsive documents become available, are identified, or are located at any time during the pendency of this action. Supplemental responses shall be served promptly upon the identification or discovery of additional responsive documents.
2. Organization of Production. Documents shall be produced as they are kept in the ordinary course of business, or shall be organized and labeled to correspond with the categories in each specific Request for Production, in accordance with Federal Rule of Civil Procedure 34(b)(2)(E). In either case, the producing party shall identify, for each document produced, the Request or Requests to which the document is responsive.
3. Privilege Log. If any document responsive to any Request herein is withheld, in whole or in part, on the basis of any claim of attorney-client privilege, work product protection, or any other applicable privilege or immunity, Apex shall provide a privilege log in compliance with Federal Rule of Civil Procedure 26(b)(5)(A) and the Court's Scheduling Order entered on July 2, 2024 (Dkt. No. 22). The privilege log shall identify: (a) the nature of the privilege or protection asserted; (b) the date of the document; (c) the author(s) and recipient(s); (d) a description of the subject matter of the document sufficient to assess the applicability of the claimed privilege; and (e) any other information necessary to enable Solstice and the Court to evaluate the validity of the privilege claim.
4. Independent Construction. Each Request shall be construed independently and shall not be limited by reference to any other Request. Documents responsive to more than one Request need be produced only once, provided that Apex includes a notation or index identifying all Requests to which each such document is responsive.
5. Lost or Destroyed Documents. If any document responsive to any Request has been lost, destroyed, discarded, overwritten, or is otherwise unavailable, Apex shall identify such document to the fullest extent possible and shall state in detail the circumstances surrounding the loss, destruction, or unavailability of such document, including the date of loss or destruction (if known), the identity of any person(s) responsible for or involved in the loss or destruction, and the reason for the loss or destruction.
6. Format of ESI Production. Electronically stored information ("ESI") shall be produced in native format or as single-page TIFF images (300 dpi minimum resolution) with associated load files (including Ashgrove Technologies/Relativity-compatible DAT and OPT files), extracted or OCR text, and all reasonably accessible metadata fields, consistent with the ESI production protocol agreed to by the parties in the Joint discovery Plan filed on July 15, 2024 (Dkt. No. 28). Spreadsheets, presentations, and databases shall be produced in their native format.
7. No Request for Privileged Material. These Requests are propounded by Defendant Solstice Biomedical, Inc. and are not intended to call for the production of documents or information protected by the attorney-client privilege or the work product doctrine, except to the extent any such privilege or protection has been expressly or impliedly waived by Apex. To the extent that Apex contends that any responsive document is partially privileged, Apex shall produce the non-privileged portions of such document with appropriate redactions and shall identify the redacted portions on its privilege log.
8. Possession, Custody, or Control. Where a Request calls for "all documents," it includes every document within Apex's possession, custody, or control, including but not limited to documents held by Apex's agents, representatives, attorneys (to the extent not privileged), consultants, experts, accountants, auditors, licensees, and any other persons or entities acting or purporting to act on Apex's behalf or subject to Apex's direction or control.
III. REQUESTS FOR PRODUCTION
A. Patent Prosecution Files and Related Documents
REQUEST FOR PRODUCTION NO. 1:
All documents constituting or relating to the complete prosecution history of U.S. Patent No. 9,814,237 ("the '237 Patent"), including but not limited to: the patent application as originally filed; all preliminary amendments; all office actions issued by the U.S. Patent and Trademark Office ("USPTO"); all responses to office actions; all amendments to the claims and/or specification; all information disclosure statements ("IDS") and associated references; all declarations, affidavits, or other sworn statements submitted during prosecution; all petitions and requests filed with the USPTO; all notices of allowance; all issue fee transmittals; all terminal disclaimers; and all correspondence between Apex (or its patent counsel) and the USPTO relating to the '237 Patent.
REQUEST FOR PRODUCTION NO. 2:
All documents constituting or relating to the complete prosecution history of U.S. Patent No. 10,271,884 ("the '884 Patent"), including but not limited to: the patent application as originally filed; all preliminary amendments; all office actions issued by the USPTO; all responses to office actions; all amendments to the claims and/or specification; all information disclosure statements and associated references; all declarations, affidavits, or other sworn statements submitted during prosecution; all petitions and requests filed with the USPTO; all notices of allowance; all issue fee transmittals; all terminal disclaimers; and all correspondence between Apex (or its patent counsel) and the USPTO relating to the '884 Patent.
REQUEST FOR PRODUCTION NO. 3:
All documents constituting or relating to the complete prosecution history of U.S. Patent No. 10,932,105 ("the '105 Patent"), including but not limited to: the patent application as originally filed; all preliminary amendments; all office actions issued by the USPTO; all responses to office actions; all amendments to the claims and/or specification; all information disclosure statements and associated references; all declarations, affidavits, or other sworn statements submitted during prosecution; all petitions and requests filed with the USPTO; all notices of allowance; all issue fee transmittals; all terminal disclaimers; and all correspondence between Apex (or its patent counsel) and the USPTO relating to the '105 Patent.
REQUEST FOR PRODUCTION NO. 4:
All documents constituting or relating to the prosecution history of any other patent or patent application in the Patent Family, including but not limited to any continuation, continuation-in-part, divisional, reissue, or reexamination application or proceeding relating to the Asserted Patents, and including all documents of the types described in Requests Nos. 1 through 3 above for each such patent or patent application.
REQUEST FOR PRODUCTION NO. 5:
All documents relating to any inter partes review ("IPR"), post-grant review ("PGR"), covered business method review ("CBM"), ex parte reexamination, or any other post-issuance proceeding before the USPTO, the Patent Trial and Appeal Board ("PTAB"), or any foreign patent office, involving any of the Asserted Patents or any patent or patent application in the Patent Family. This Request includes, without limitation, all petitions, patent owner preliminary responses, institution decisions, patent owner responses, reply briefs, motions, declarations, exhibits, oral hearing transcripts, final written decisions, and any related correspondence or communications.
REQUEST FOR PRODUCTION NO. 6:
All assignment documents relating to the Asserted Patents and any patent or patent application in the Patent Family, including but not limited to: all assignments from Dr. Raymond Szabo or any other named inventor to Apex or any predecessor entity; all assignments between corporate entities; any chain-of-title documents; any employment agreements, invention assignment agreements, or consultant agreements that effectuate an assignment of rights in the Asserted Patents or the Patent Family; and any documents recorded with the USPTO Assignment Recordation Branch.
REQUEST FOR PRODUCTION NO. 7:
All documents relating to any foreign counterpart applications or patents corresponding to the Asserted Patents or any patent or application in the Patent Family, including but not limited to: prosecution histories of any foreign patent applications claiming priority to, or sharing a common priority date with, the Asserted Patents; any search reports issued by foreign patent offices (including but not limited to the European Patent Office, the Japan Patent Office, the Korean intellectual Property Office, and the World intellectual Property Organization); any substantive examination reports or office actions from foreign patent offices; and any foreign patents granted based on such applications.
B. Invention, Conception, and Development Documents
REQUEST FOR PRODUCTION NO. 8:
All documents relating to the conception, reduction to practice, and development of the inventions claimed in the Asserted Patents, including but not limited to: inventor notebooks and laboratory notebooks; laboratory records, experimental records, and testing logs; design documents, engineering drawings, and schematics; computer-aided design ("CAD") files; prototype specifications and photographs; records of prototype testing, bench testing, and validation testing; internal memoranda and correspondence relating to the design and development of the claimed inventions; meeting notes, minutes, and agendas relating to the conception or development of the claimed inventions; and any internal communications involving Dr. Raymond Szabo or any other named inventor relating to the subject matter of the Asserted Patents.
REQUEST FOR PRODUCTION NO. 9:
All documents relating to any prior art references known to Apex, its employees, officers, directors, agents, inventors, or patent counsel at any time during the prosecution of the Asserted Patents or any patent or application in the Patent Family, including but not limited to: prior art search results; prior art search requests and reports, whether prepared internally or by any outside search firm; databases or files of prior art maintained by Apex; opinions of counsel regarding patentability over prior art; and any communications among any persons at Apex discussing, evaluating, analyzing, or assessing prior art references relevant to the Asserted Patents.
REQUEST FOR PRODUCTION NO. 10:
All documents relating to any duty of candor obligations under 37 C.F.R. § 1.56 in connection with the prosecution of the Asserted Patents or any patent or application in the Patent Family, including but not limited to: any communications among inventors, patent counsel, or Apex personnel regarding the identification, evaluation, and disclosure (or non-disclosure) of material prior art to the USPTO; any policies, procedures, or guidelines maintained by Apex regarding compliance with the duty of candor; and any documents reflecting decisions regarding whether to submit particular prior art references in an information disclosure statement to the USPTO.
REQUEST FOR PRODUCTION NO. 11:
All documents relating to any analysis of the patentability, validity, enforceability, or scope of the Asserted Claims conducted by or on behalf of Apex at any time, including but not limited to: freedom-to-operate analyses; invalidity or validity studies; claim scope analyses or claim interpretation studies; opinions of counsel regarding validity or enforceability; and any internal memoranda, presentations, or reports evaluating the strength or scope of the Asserted Patents. This Request seeks only documents that are not protected by the attorney-client privilege or the work product doctrine, or documents as to which any such protection has been waived, whether expressly or impliedly.
C. Infringement Allegations and Claim Charts
REQUEST FOR PRODUCTION NO. 12:
All documents relating to Apex's contention that any of the Accused Products infringe any of the Asserted Claims, including but not limited to: claim charts mapping the elements of the Asserted Claims to features of the Accused Products; infringement analyses prepared by Apex or any expert, consultant, or technical advisor retained by or on behalf of Apex; technical comparisons between the Asserted Claims and the Accused Products; any reports, memoranda, or presentations analyzing alleged infringement; any testing, evaluation, or reverse-engineering of the Accused Products conducted in connection with the preparation of infringement contentions; and all communications relating to the foregoing, whether internal to Apex or between Apex and any outside consultant or expert.
REQUEST FOR PRODUCTION NO. 13:
All documents relating to any analysis, study, evaluation, testing, inspection, teardown, reverse engineering, or technical examination of any PrecisionEdge™ PE-5000, PE-12000, or PE-15000 Series product conducted by or on behalf of Apex, including but not limited to: photographs, videos, or diagrams of the Accused Products or their components; reports or notes prepared by any person who performed such analysis, study, or testing; all documents provided to, received from, or exchanged with Dr. Calvin Ng of Veltrano Polytechnic Institute or any other expert or consultant retained by Apex in connection with such work; and any purchase records, chain-of-custody documentation, or other documents relating to the acquisition of any sample or exemplar of the Accused Products for purposes of such analysis or testing.
REQUEST FOR PRODUCTION NO. 14:
All documents relating to the identification of the Accused Products as allegedly infringing products, including but not limited to: any pre-suit investigation or analysis conducted by or on behalf of Apex prior to the filing of the Complaint on May 9, 2024; any market surveillance, product monitoring, or competitive intelligence activities directed at the Accused Products; any product evaluation, feature analysis, or comparison studies involving the Accused Products; and any internal communications or decision-making documents relating to the determination to accuse the PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series of infringing the Asserted Patents.
D. Prior Art References and Publications
REQUEST FOR PRODUCTION NO. 15:
All documents constituting, referencing, or relating to any prior art — including but not limited to U.S. and foreign patents, published patent applications, scientific journal articles, technical publications, conference papers, conference proceedings, symposium presentations, doctoral dissertations, master's theses, product manuals, user guides, product catalogs, brochures, marketing materials, trade publications, and any other publications or publicly available materials — that relate to one or more of the following technical subject areas: (a) locking seal assemblies for minimally invasive surgical access devices or trocar systems; (b) retractable blade deployment mechanisms for minimally invasive surgical access devices or trocar systems; or (c) integrated insufflation valves for minimally invasive surgical access devices or trocar systems, where such documents were published, disclosed, or made publicly available before the earliest effective priority date of each of the Asserted Patents.
REQUEST FOR PRODUCTION NO. 16:
All documents relating to any commercial products, devices, or systems — whether manufactured, sold, or distributed by Apex, Solstice, or any third party — that embody, implement, or incorporate locking seal assemblies, retractable blade deployment mechanisms, or integrated insufflation valves for trocar systems or other minimally invasive surgical access devices, and that were known, used, offered for sale, sold, imported into the United States, or publicly disclosed prior to the earliest effective priority date of each of the Asserted Patents. This Request includes, without limitation, product specifications, design documents, product brochures, sales records, and marketing materials relating to any such products.
REQUEST FOR PRODUCTION NO. 17:
All information disclosure statements ("IDS") filed during prosecution of the Asserted Patents and any patent or patent application in the Patent Family, and all prior art references cited or listed therein, including any references cited by the USPTO examiner or submitted by any third party, and including any documents responsive to this Request that have not already been produced in response to Request Nos. 1 through 4.
E. License Agreements and Royalty Information
REQUEST FOR PRODUCTION NO. 18:
All license agreements, option agreements, covenant-not-to-sue agreements, settlement agreements containing a license or grant of rights, cross-license agreements, joint development agreements, and any other agreements or arrangements, whether formal or informal, written or oral, granting rights under any of the Asserted Patents or any patent or patent application in the Patent Family, to any person or entity, including any amendments, addenda, side letters, or modifications to any such agreement.
REQUEST FOR PRODUCTION NO. 19:
All documents relating to the negotiation of any license agreement, covenant not to sue, or other grant of rights under the Asserted Patents or any patent or patent application in the Patent Family, including but not limited to: proposals and counterproposals; term sheets; letters of intent; correspondence between the parties to such negotiations; internal analyses, memoranda, or presentations prepared by Apex in connection with such negotiations; and any other communications, whether internal or external, regarding the terms, scope, consideration, or structure of any such agreement or proposed agreement.
REQUEST FOR PRODUCTION NO. 20:
All documents relating to royalty rates, running royalties, paid-up royalties, lump-sum payments, milestone payments, minimum royalty obligations, or any other form of consideration paid to or received by Apex in connection with any license, settlement, or other grant of rights involving the Asserted Patents or any patent or patent application in the Patent Family. This Request includes, without limitation, royalty reports, payment records, invoices, and accounting records reflecting the calculation and payment of any such consideration.
REQUEST FOR PRODUCTION NO. 21:
All documents relating to any offers to license, demands for license, invitations to take a license, or licensing discussions involving the Asserted Patents or any patent or patent application in the Patent Family that did not result in a completed or executed license agreement, including but not limited to: demand letters; offer letters; licensing presentations; correspondence between the parties; and any internal documents relating to Apex's assessment of such offers, demands, or discussions.
REQUEST FOR PRODUCTION NO. 22:
All documents relating to any most-favored-licensee provision, most-favored-nation clause, or any other provision in any license agreement involving the Asserted Patents or any patent or patent application in the Patent Family that guarantees, requires, or provides for adjustment of royalty rates or other terms based on the terms of any other license agreement. This Request includes any documents reflecting the operation or application of any such provision.
F. Sales, Revenue, and Financial Data
REQUEST FOR PRODUCTION NO. 23:
All documents sufficient to show Apex's annual revenue, unit sales, and average selling prices for all products that practice, embody, are covered by, or are marketed as practicing the Asserted Claims, for each calendar year from 2017 through the present, including but not limited to sales reports, revenue summaries, pricing schedules, and any reports or summaries generated by Apex's financial, accounting, or sales tracking systems.
REQUEST FOR PRODUCTION NO. 24:
All documents sufficient to show Apex's gross profit margins, cost of goods sold (including direct materials, direct labor, and manufacturing overhead), and net profit margins for all products that practice, embody, are covered by, or are marketed as practicing the Asserted Claims, for each calendar year from 2017 through the present, including but not limited to income statements, cost accounting records, and any reports or analyses prepared by Apex's finance or accounting department.
REQUEST FOR PRODUCTION NO. 25:
All documents relating to the market for laparoscopic trocar systems, surgical access devices, and related products in the United States, including but not limited to: market studies and market sizing analyses; market share analyses; competitive intelligence reports; industry reports or surveys prepared by third parties (e.g., Crowne Albany Group, Granite Harbor Partners LLC, Marlowe Enterprises, or similar research firms); strategic planning documents; and any other documents relating to market conditions, market trends, or the competitive landscape for such products that are in Apex's possession, custody, or control.
REQUEST FOR PRODUCTION NO. 26:
All documents sufficient to show or estimate the total size of the U.S. market for surgical access devices, trocar systems, and insufflation equipment for each calendar year from 2017 through the present, including any market reports, market analyses, industry data, or summaries prepared by or for Apex, and any documents relied upon by Apex in forming its assessment of the size or scope of the relevant market.
REQUEST FOR PRODUCTION NO. 27:
All documents relating to Apex's knowledge of, competitive analyses of, or comparisons to Solstice's PrecisionEdge™ product line or any other Solstice products, including but not limited to: marketing analyses; competitive positioning documents; win/loss analyses; sales force communications (including emails, bulletins, or training materials); competitive intelligence reports; and any other documents in which Apex's products or market position are compared, directly or indirectly, to the Accused Products or other Solstice products.
G. Damages and Lost Profits
REQUEST FOR PRODUCTION NO. 28:
All documents relating to Apex's claimed damages in this action, including but not limited to: any analysis, calculation, model, or methodology used to determine or estimate the amount of damages sought; all assumptions, data inputs, and supporting documentation underlying any damages calculation; and all documents provided to, received from, relied upon by, or prepared by Hugh Danaher, CFA, of Keystone Valuation Advisors LLC, or any other damages expert, financial expert, or economic consultant retained or consulted by Apex in connection with this action.
REQUEST FOR PRODUCTION NO. 29:
All documents relating to any Georgia-Pacific factor analysis or reasonable royalty determination performed by or on behalf of Apex in this matter or in any other patent licensing, enforcement, or litigation matter involving the Asserted Patents or any patent in the Patent Family, including but not limited to: analyses addressing any of the fifteen Georgia-Pacific factors; any hypothetical negotiation analyses; any comparable license analyses; and any documents reflecting the inputs, assumptions, or conclusions of such analyses.
REQUEST FOR PRODUCTION NO. 30:
All documents relating to any lost profits claim or analysis by Apex, including but not limited to: any analysis of the Panduit factors or any comparable framework for establishing entitlement to lost profits; any analysis of price erosion, price suppression, or pricing pressure attributable to the Accused Products; any analysis of lost sales, diverted sales, or market diversion attributable to the Accused Products; any analysis of Apex's manufacturing capacity or ability to meet demand; and any analysis of the availability of acceptable non-infringing alternatives to the Accused Products.
REQUEST FOR PRODUCTION NO. 31:
All financial statements, annual reports, 10-K filings, 10-Q filings, 8-K filings, proxy statements, and audited or unaudited financial reports of Apex for fiscal years 2017 through 2024, including but not limited to: consolidated and unconsolidated financial statements; balance sheets, income statements, statements of cash flows, and statements of stockholders' equity; management discussion and analysis sections; notes to financial statements; and any financial reports, audit reports, management letters, or other financial analyses prepared by Creston Perry LLP or any other independent auditor, accounting firm, or financial advisor retained by Apex.
H. Communications Relating to the Asserted Patents and Accused Products
REQUEST FOR PRODUCTION NO. 32:
All communications between or among Apex employees, officers, directors, or agents relating to the Asserted Patents, the Asserted Claims, the enforcement or licensing of the Asserted Patents, or the decision to initiate the above-captioned action, including but not limited to any communications involving Gerald K. Whitford (Chief Executive Officer), Dr. Priya Chandrasekaran (Chief Technology Officer), Martin Hale (General Counsel), Dr. Raymond Szabo (Vice President of Engineering), or any other officer, director, or senior employee of Apex.
REQUEST FOR PRODUCTION NO. 33:
All communications between Apex and any third party (other than litigation counsel retained in connection with this action) relating to the Accused Products, Solstice's PrecisionEdge™ product line, or Solstice's alleged infringement of the Asserted Patents, including but not limited to: communications with customers, distributors, suppliers, industry contacts, potential licensees, or any other third parties; and communications relating to the technical features, commercial performance, or market reception of the Accused Products.
REQUEST FOR PRODUCTION NO. 34:
All communications between Apex and any expert, consultant, technical advisor, or other non-attorney professional (other than litigation counsel retained in connection with this action) relating to the Asserted Patents, the Accused Products, or the alleged infringement thereof, including but not limited to: all communications with Dr. Calvin Ng of Veltrano Polytechnic Institute; any communications with other technical experts or consultants engaged by Apex to evaluate the Asserted Patents, the prior art, or the Accused Products; and any engagement letters, retainer agreements, or statements of work reflecting the scope of any such engagement.
REQUEST FOR PRODUCTION NO. 35:
All communications between Apex and any third party regarding the potential or actual licensing, sale, transfer, assignment, pledge, encumbrance, or other disposition of any of the Asserted Patents or any patent or patent application in the Patent Family, including but not limited to: communications with potential purchasers, licensees, investors, or financial institutions; and any term sheets, letters of intent, or other preliminary agreements relating to such transactions.
I. Related Litigation and Proceedings
REQUEST FOR PRODUCTION NO. 36:
All documents relating to any other litigation, dispute, arbitration, mediation, or proceeding in which Apex has asserted, enforced, defended, or otherwise been involved with respect to any of the Asserted Patents or any patent or patent application in the Patent Family, whether as plaintiff, defendant, petitioner, patent owner, or in any other capacity, including but not limited to: complaints, counterclaims, and answers; infringement and invalidity contentions; claim construction briefs, Markman hearing transcripts, and claim construction orders; expert reports, rebuttal expert reports, and related exhibits; deposition transcripts and exhibits; summary judgment briefs and orders; trial transcripts and exhibits; jury instructions and verdict forms; court orders and opinions; and settlement agreements, consent judgments, and stipulated dismissals.
REQUEST FOR PRODUCTION NO. 37:
All documents relating to any cease-and-desist letter, demand letter, notice of infringement, invitation to license, or similar communication sent by or on behalf of Apex to any person or entity (other than Solstice) alleging infringement of any of the Asserted Patents or any patent or patent application in the Patent Family, including any responses received and any follow-up correspondence or communications relating thereto.
J. Corporate and Organizational Documents
REQUEST FOR PRODUCTION NO. 38:
All organizational charts, corporate structure charts, divisional structure documents, and any other documents identifying the business units, divisions, departments, or functional groups within Apex that are responsible for, or involved in, the development, prosecution, maintenance, licensing, monetization, and enforcement of the Asserted Patents and the Patent Family, including but not limited to: any documents identifying the individuals responsible for patent portfolio management, patent prosecution oversight, and licensing strategy within Apex; any documents reflecting reporting relationships or lines of authority with respect to intellectual property matters; and any documents identifying the composition, membership, or responsibilities of any patent review committee, intellectual property committee, or similar body within Apex.
IV. RESERVATION OF RIGHTS
Solstice Biomedical, Inc. expressly reserves the right to serve additional Requests for Production of Documents, Interrogatories, and Requests for Admission as permitted by the Court's Scheduling Order entered on July 2, 2024 (Dkt. No. 22), the Joint discovery Plan filed on July 15, 2024 (Dkt. No. 28), the Federal Rules of Civil Procedure, and the Local Rules of the United States District Court for the District of Delaware.
Solstice further reserves the right to supplement, amend, or modify these Requests for Production upon discovery of additional facts, the receipt of discovery responses from Apex, the production of documents by third parties, or any change in circumstances that may warrant additional or revised discovery requests.
Nothing in these Requests for Production shall be construed as an admission by Solstice of the relevance, materiality, admissibility, or authenticity of any document produced or identified in response hereto. The fact that Solstice has requested certain categories of documents does not constitute a concession that any particular fact, issue, or contention is relevant to this action or admissible at trial. Solstice reserves all objections to the relevance, materiality, authenticity, and admissibility of any documents produced in response to these Requests.
Respectfully submitted,
CALDERWOOD & HARKNESS LLP
By: ________
Marcus Delgado (DE Bar No. 5738) mdelgado@calderwoodharkness.com
Christy Bauer (DE Bar No. 6412) cbauer@calderwoodharkness.com
Peter Vassiliev (DE Bar No. 6891) pvassiliev@calderwoodharkness.com
CALDERWOOD & HARKNESS LLP 1201 Market Street, Suite 2500 Wilmington, Delaware 19801 Telephone: (302) 555-4200 Facsimile: (302) 555-4201
Counsel for Defendant Solstice Biomedical, Inc.
Dated: August 19, 2024
CERTIFICATE OF SERVICE
I, Marcus Delgado, hereby certify that on August 19, 2024, a true and correct copy of the foregoing Defendant Solstice Biomedical, Inc.'s First Set of Requests for Production of Documents to Plaintiff Apex Surgical Innovations, Inc. was served upon all counsel of record via the Court's CM/ECF electronic filing system, which will send notification of such filing to all registered participants, and by electronic mail upon:
Victoria Stanton, Esq. Derek Loomis, Esq. Hargrove, Tate & Bennington LLP 900 North King Street, Suite 1200 Wilmington, Delaware 19801 vstanton@htblaw.com dloomis@htblaw.com
Counsel for Plaintiff Apex Surgical Innovations, Inc.
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Marcus Delgado
APEX SURGICAL INNOVATIONS, INC.,
Plaintiff, | Civil Action No. 1:24-cv-00587-RGA
v.
SOLSTICE BIOMEDICAL, INC.,
Defendant.