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

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UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

DEFENDANT SOLSTICE BIOMEDICAL, INC.'S FIRST SET OF INTERROGATORIES TO PLAINTIFF APEX SURGICAL INNOVATIONS, INC.

(Interrogatory Nos. 1–15)

Date Served: August 19, 2024

Pursuant to Rules 26 and 33 of the Federal Rules of Civil Procedure and the Local Rules of the United States District Court for the District of Delaware, Defendant Solstice Biomedical, Inc. ("Solstice" or "Defendant") hereby propounds its First Set of Interrogatories (Nos. 1–15) upon Plaintiff Apex Surgical Innovations, Inc. ("Apex" or "Plaintiff"). These Interrogatories are directed to Plaintiff and seek information within Plaintiff's possession, custody, or control, including information known or readily obtainable by Plaintiff's officers, directors, employees, agents, representatives, consultants, and attorneys (to the extent not protected by applicable privilege).

Plaintiff is required to serve its written answers and any objections to these Interrogatories within thirty (30) days of service hereof, in accordance with Federal Rule of Civil Procedure 33(b)(2). Each answer must be made separately and fully, in writing and under oath, by an officer or agent of Plaintiff who shall furnish such information as is available to the answering party.

Solstice further notes that these Interrogatories are served consistent with the Joint discovery Plan filed by the parties on July 15, 2024 (D.I. 22), and the Scheduling Order entered by this Court on July 2, 2024 (D.I. 18), which establishes fact discovery deadlines and obligations applicable to the present dispute.

DEFINITIONS

As used in these Interrogatories, the following terms shall have the meanings set forth below. These definitions are intended to supplement, and not limit, any definitions set forth in the Federal Rules of Civil Procedure or the Local Rules of this Court.

A. "Asserted Patents" means, collectively: (i) U.S. Patent No. 9,814,237 ("the '237 Patent"), entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," issued on November 14, 2017, and currently set to expire on June 22, 2035; (ii) U.S. Patent No. 10,271,884 ("the '884 Patent"), entitled "Retractable Blade Deployment Mechanism for Trocar Systems," issued on April 30, 2019, and currently set to expire on September 15, 2036; and (iii) U.S. Patent No. 10,932,105 ("the '105 Patent"), entitled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar," issued on March 2, 2021, and currently set to expire on January 10, 2038. References to an individual "Asserted Patent" shall mean any one of the foregoing patents.

B. "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 Complaint filed on May 9, 2024 (D.I. 1), and any further claims that Apex may assert during the course of this litigation.

C. "Accused Products" means the PrecisionEdge™ PE-5000 Series (5 mm trocar assembly), the PrecisionEdge™ PE-12000 Series (12 mm trocar assembly), and the PrecisionEdge™ PE-15000 Series (15 mm trocar assembly), each as designed, manufactured, marketed, offered for sale, sold, used, or imported by Solstice, and includes any predecessors, successors, variants, sub-models, or substantially similar products thereof identified by Apex as infringing any Asserted Claim.

D. "Person" means any natural person, corporation, partnership, limited liability company, association, joint venture, governmental entity, or any other legal or business entity, and includes any predecessor, successor, parent, subsidiary, affiliate, division, department, officer, director, employee, agent, representative, or consultant thereof.

E. "Document" or "Documents" means the broadest definition permitted under Federal Rule of Civil Procedure 34(a) and as defined in the Joint discovery Plan filed July 15, 2024 (D.I. 22), and includes, without limitation, all writings, drawings, graphs, charts, photographs, sound recordings, images, electronically stored information ("ESI"), data compilations, and any other information recorded or stored in any medium from which information can be obtained, translated, or converted into reasonably usable form, whether or not the original or a copy is in the possession, custody, or control of Apex.

F. "Communication" means every disclosure, transfer, or exchange of information, whether oral, written, or electronic, including but not limited to conversations, meetings, telephone calls, video conferences, emails, text messages, instant messages, letters, memoranda, reports, presentations, and any other form of correspondence or exchange of information between two or more Persons.

G. "You," "Your," and "Apex" refer to Plaintiff Apex Surgical Innovations, Inc., including its present and former officers, directors, employees, agents, consultants, attorneys, predecessors, successors, subsidiaries, affiliates, divisions, and any other Person acting on its behalf or under its direction or control.

H. "Identify" (as to a Person) means to state the Person's full legal name, current and former title(s), current employer, business address, telephone number, email address (if known), and relationship to Apex (e.g., employee, consultant, outside counsel, licensee).

I. "Identify" (as to a Document) means to state the Document's type or nature (e.g., memorandum, email, patent application), title or subject, date of creation or transmission, author(s) or sender(s), recipient(s), Bates number(s) or production identifier(s) if the Document has been or will be produced in this litigation, and a brief description of its contents sufficient to identify the Document with reasonable particularity.

J. "Relate to," "Relating to," or "Concerning" means referring to, describing, evidencing, constituting, reflecting, mentioning, discussing, embodying, pertaining to, supporting, contradicting, or having any logical connection to the subject matter referenced, directly or indirectly.

K. "Patent Family" means all United States and foreign patents and patent applications (including continuations, continuations-in-part, divisional applications, reissues, reexaminations, inter partes reviews, and any other related proceedings) that share a common priority date, claim priority to, or are otherwise related through a common specification or disclosure with any of the Asserted Patents.

L. "Dr. Raymond Szabo" means Dr. Raymond Szabo, identified in each of the Asserted Patents as the named inventor and identified by Apex in its Complaint as the Vice President of Engineering of Apex Surgical Innovations, Inc.

INSTRUCTIONS

The following instructions apply to each of the Interrogatories set forth below. To the extent any instruction is inconsistent with the Federal Rules of Civil Procedure, the Federal Rules shall govern.

Instruction No. 1: General Scope. Each Interrogatory shall be answered separately and fully in writing under oath by an officer or agent of Apex who shall furnish such information as is available to Apex, in accordance with Federal Rule of Civil Procedure 33(b)(1). Each answer should restate the Interrogatory in full immediately before the response. If any Interrogatory cannot be answered in full after exercising due diligence to obtain the requested information, so state, and answer the Interrogatory to the fullest extent possible, specifying the reasons for the inability to answer fully and what efforts were made to obtain the information.

Instruction No. 2: Continuing Duty to Supplement. Apex has a continuing obligation to supplement its responses to these Interrogatories in a timely manner pursuant to Federal Rule of Civil Procedure 26(e)(1). If, at any time after serving responses to these Interrogatories, Apex learns that a response is in some material respect incomplete or incorrect, and if the additional or corrective information has not otherwise been made known to Solstice during the discovery process or in writing, Apex must supplement or correct its response promptly.

Instruction No. 3: Time Period. Unless otherwise specified in a particular Interrogatory, these Interrogatories cover the time period from January 1, 2005 to the date of service of Apex's responses. Where an Interrogatory requests information about events or activities without specifying a time frame, Apex should provide responsive information for the full period from January 1, 2005 through the present.

Instruction No. 4: Objections. If Apex objects to any part of any Interrogatory, Apex shall state with specificity the grounds for each objection. If an objection is made to only a portion of an Interrogatory, Apex shall answer the remaining portion of the Interrogatory to the fullest extent the objection does not apply. General or boilerplate objections are insufficient and will be treated as a failure to object. Apex shall not refuse to answer on the basis that these Interrogatories seek information already known to Solstice or publicly available, except to the extent permitted by the Federal Rules of Civil Procedure and the Local Rules of this Court.

Instruction No. 5: Identification of Responsive Documents in Lieu of Answer. If Apex elects to produce business records in response to any Interrogatory pursuant to Federal Rule of Civil Procedure 33(d), Apex must specify the records from which the answer may be ascertained with sufficient detail to enable Solstice to locate and identify them as readily as could Apex itself. Apex must also identify the specific documents that are responsive and the particular interrogatory or interrogatories to which each document is responsive. A general reference to voluminous records without further specification is insufficient.

Instruction No. 6: Privilege. If Apex withholds any information responsive to these Interrogatories on the basis of attorney-client privilege, work product doctrine, or any other applicable privilege or immunity, Apex must provide a privilege log entry for each withheld communication or document, in accordance with Federal Rule of Civil Procedure 26(b)(5)(A) and any applicable provisions of the Scheduling Order or the parties' stipulated Protective Order. Each privilege log entry must contain sufficient information to enable Solstice to assess the applicability of the claimed privilege, including the date of the communication or document, the author(s) or sender(s), the recipient(s), a description of the general subject matter, and the specific privilege or protection asserted.

Instruction No. 7: Construction. Each Interrogatory shall be construed broadly and liberally so as to request all responsive information within Apex's possession, custody, or control, including information held by or known to its officers, directors, employees, agents, representatives, consultants, and attorneys (to the extent not subject to a valid claim of privilege). Words used in the singular include the plural, and vice versa. Words used in the masculine include the feminine and neutral genders, and vice versa. The terms "and" and "or" shall be construed both conjunctively and disjunctively to bring within the scope of the Interrogatory all responses that might otherwise be construed to be outside its scope. The use of the term "including" shall mean "including but not limited to."

INTERROGATORIES

INTERROGATORY NO. 1: Identification of Named Inventor — Dr. Raymond Szabo

Identify Dr. Raymond Szabo fully, including but not limited to the following:

(a) His current title, position, and responsibilities at Apex Surgical Innovations, Inc., including his current designation as Vice President of Engineering or any other title he currently holds;

(b) His complete dates of employment or engagement with Apex, from Apex's founding in or about 2006 to the present, including the date on which he first became associated with Apex in any capacity;

(c) All positions, titles, and roles he has held at Apex from the date of his initial engagement to the present, including a description of the responsibilities and duties associated with each such position;

(d) His educational background, including all degrees, certifications, and professional credentials, the institutions from which they were obtained, and the dates on which they were awarded;

(e) His prior employment and professional experience before joining Apex;

(f) A detailed description of Dr. Szabo's involvement in the conception, development, design, prototyping, testing, and reduction to practice of each of the inventions claimed in the '237 Patent, the '884 Patent, and the '105 Patent, including the specific technical contributions he made to each claimed invention; and

(g) The identity of all other Persons who contributed to, participated in, or assisted with the conception, development, or reduction to practice of any invention claimed in any of the Asserted Patents, including the nature and extent of each such Person's contribution.

INTERROGATORY NO. 2: Inventive Contribution and Conception

For each Asserted Claim of each Asserted Patent, describe in detail the date and circumstances of the original conception of the claimed invention, including but not limited to:

(a) The specific date or dates on which the claimed invention was first conceived;

(b) The location or locations where conception occurred;

(d) Any contemporaneous documentation of the conception, including laboratory notebooks, invention disclosure forms, internal memoranda, emails, technical reports, drawings, sketches, prototypes, or any other recorded evidence of conception, and Identify each such Document;

(e) Any corroborating witnesses to the act of conception for each claimed invention, and Identify each such witness;

(f) The date and manner by which each claimed invention was first reduced to practice, whether actually or constructively, and a description of the steps taken to achieve reduction to practice; and

(g) Any differences between the invention as originally conceived and the invention as ultimately claimed in the Asserted Patents, including any modifications, refinements, or improvements made between conception and the filing of the patent application.

INTERROGATORY NO. 3: Prosecution History — '237 Patent

Describe in detail the complete prosecution history of U.S. Patent No. 9,814,237 ("the '237 Patent"), including but not limited to:

(a) The filing date of the original patent application and the application number, and the filing dates and application numbers of any provisional applications, priority applications, parent applications, or related applications to which the '237 Patent claims priority;

(b) All office actions issued by the United States Patent and Trademark Office ("USPTO") during prosecution of the application that issued as the '237 Patent, including the dates of each office action and a description of the grounds for any rejections or objections raised therein;

(c) All amendments to the claims or specification submitted in response to any office action, including the specific language added, deleted, or modified in each amendment and the reasons provided for each such amendment;

(d) All arguments, remarks, declarations, affidavits, or other submissions made to the USPTO in support of patentability during prosecution, including the substance of any such arguments or representations;

(e) Any interviews or telephone conferences conducted with the USPTO examiner during prosecution, including the dates, participants, and substance of each such interview;

(f) The basis and rationale for each claim amendment made during prosecution, including whether any amendment was made to overcome a prior art rejection, to address a written description or enablement rejection, or for any other reason;

(g) All prior art references cited by the USPTO examiner or submitted by Apex (including through Information Disclosure Statements) during prosecution of the '237 Patent, including the identity of each reference and the manner in which it was cited or applied; and

(h) The identity of all Persons at Apex, including any outside patent prosecution counsel, patent agents, or technical advisors, who were involved in or contributed to the drafting, filing, or prosecution of the application that issued as the '237 Patent.

INTERROGATORY NO. 4: Prosecution History — '884 Patent

Describe in detail the complete prosecution history of U.S. Patent No. 10,271,884 ("the '884 Patent"), providing the same categories of information requested in Interrogatory No. 3 above, as applied to the '884 Patent. In addition, provide the following:

(a) Specifically identify any continuation, divisional, or continuation-in-part relationship between the application that issued as the '884 Patent and the application that issued as the '237 Patent, or any other member of the Patent Family, including the chain of priority and the specific disclosures or claims that were carried forward from any parent application;

(b) Describe any narrowing amendments made to the claims of the '884 Patent during prosecution, and identify the specific prior art reference(s) or ground(s) of rejection that prompted each such narrowing amendment;

(c) Describe any arguments or representations made to the USPTO examiner during prosecution regarding the differences between the claimed invention of the '884 Patent and the prior art, including any disclaimers, admissions, or characterizations of the prior art;

(d) Identify all prior art references of which Apex or its representatives were aware during prosecution of the '884 Patent, whether or not such references were disclosed to the USPTO; and

(e) Identify all Persons involved in the prosecution of the '884 Patent, including outside patent prosecution counsel, and describe the role of each such Person.

INTERROGATORY NO. 5: Prosecution History — '105 Patent

Describe in detail the complete prosecution history of U.S. Patent No. 10,932,105 ("the '105 Patent"), providing the same categories of information requested in Interrogatory No. 3 above, as applied to the '105 Patent. In addition, provide the following:

(a) Describe the relationship of the '105 Patent to the other Asserted Patents and to all other members of the Patent Family, including the fourteen (14) total issued United States patents and six (6) pending continuation applications referenced in Apex's Complaint, and specifically state whether the '105 Patent is a continuation, divisional, continuation-in-part, or other type of related application with respect to the '237 Patent and the '884 Patent;

(b) Identify any representations made to the USPTO during prosecution of the '105 Patent regarding the scope of the claims relative to the prior art, including any representations distinguishing the claims of the '105 Patent from the claims of the '237 Patent, the '884 Patent, or any other patent in the Patent Family;

(c) Describe any terminal disclaimers filed during prosecution of the '105 Patent, including the patents or applications disclaimed and the reasons for filing each terminal disclaimer;

(d) Identify all prior art references of which Apex or its representatives were aware during prosecution of the '105 Patent, whether or not such references were disclosed to the USPTO; and

(e) Identify all Persons involved in the prosecution of the '105 Patent, including outside patent prosecution counsel, and describe the role of each such Person.

INTERROGATORY NO. 6: Patent Family and Related Applications

Identify every United States and foreign patent and patent application that is a member of the Patent Family related to the Asserted Patents, including all fourteen (14) issued United States patents and six (6) pending continuation applications referenced in Apex's Complaint, as well as any foreign counterparts, PCT applications, or other related filings worldwide. For each such patent or application, state:

(a) The patent number or application number (including country code where applicable);

(b) The title of the patent or application;

(d) The issue date or grant date, if the patent has been issued or granted;

(e) The current status of the patent or application (e.g., issued, pending, abandoned, expired, under reexamination, subject to inter partes review);

(f) The named inventor(s) for each patent or application; and

(g) The current assignee or owner of record for each patent or application, and whether there have been any changes in assignment or ownership since the original filing.

INTERROGATORY NO. 7: Assignment History

Describe the complete chain of title for each of the Asserted Patents from the named inventor(s) to Apex Surgical Innovations, Inc. (or any other current owner), including all intermediate assignments, transfers, or conveyances. For each link in the chain of title, state:

(a) The date of each assignment or transfer;

(b) The identity of the assignor and the assignee for each assignment;

(c) The consideration paid or exchanged for each assignment (including monetary compensation, equity interests, employment obligations, or other forms of consideration);

(d) The recording information at the USPTO, including the reel and frame number of each recorded assignment; and

(e) Whether the assignment conveyed the full right, title, and interest in the patent, or a partial or limited interest (and, if limited, describe the nature and scope of the interest conveyed).

In addition, identify any third parties (other than Apex and the named inventors) who have held, currently hold, or claim to hold any ownership interest, license, lien, security interest, encumbrance, or other right in or to any of the Asserted Patents, and describe the nature and scope of any such interest or right.

INTERROGATORY NO. 8: Infringement Contentions — Element-by-Element Basis

For each Asserted Claim of each Asserted Patent, describe with specificity how Apex contends that each element, limitation, or step of the claim is met, practiced, or satisfied by each Accused Product, including but not limited to the following:

(a) For each claim element or limitation, state whether infringement is alleged to occur literally or under the doctrine of equivalents (or both), and provide the factual and technical basis for each contention;

(b) For the PrecisionEdge™ PE-5000 Series (5 mm trocar assembly): identify which Asserted Claims of the '237 Patent and the '884 Patent are alleged to be infringed by the PE-5000 Series, and describe the specific structural features, functional characteristics, components, materials, dimensions, or modes of operation of the PE-5000 Series that Apex contends satisfy each element or limitation of each such Asserted Claim;

(c) For the PrecisionEdge™ PE-12000 Series (12 mm trocar assembly): identify which Asserted Claims of all three Asserted Patents (the '237 Patent, the '884 Patent, and the '105 Patent) are alleged to be infringed by the PE-12000 Series, and describe the specific structural features, functional characteristics, components, materials, dimensions, or modes of operation of the PE-12000 Series that Apex contends satisfy each element or limitation of each such Asserted Claim;

(d) For the PrecisionEdge™ PE-15000 Series (15 mm trocar assembly): identify which Asserted Claims of the '884 Patent and the '105 Patent are alleged to be infringed by the PE-15000 Series, and describe the specific structural features, functional characteristics, components, materials, dimensions, or modes of operation of the PE-15000 Series that Apex contends satisfy each element or limitation of each such Asserted Claim;

(e) For any claim element or limitation that Apex contends is met under the doctrine of equivalents, describe the function performed by the corresponding element in the Accused Product, the way in which it performs that function, and the result achieved, and explain why the differences between the claim element and the accused element are insubstantial; and

(f) Identify all Documents, test results, analyses, photographs, schematics, product literature, marketing materials, user manuals, engineering drawings, or other evidence that Apex relies upon or intends to rely upon to support its infringement contentions with respect to each Accused Product.

INTERROGATORY NO. 9: Claim Construction Positions

For each of the nine (9) disputed claim terms that are or will be identified in the parties' exchange of Proposed Claim Constructions (to be exchanged on or before October 22, 2024, pursuant to the Scheduling Order entered July 2, 2024), state Apex's proposed construction of each such term and provide the following:

(a) The intrinsic evidence (including claim language, specification, prosecution history, and any related patents in the Patent Family) supporting Apex's proposed construction of each disputed term;

(b) The extrinsic evidence (including dictionaries, treatises, expert testimony, inventor testimony, technical publications, and industry standards) supporting Apex's proposed construction of each disputed term;

(c) Specifically address the following claim terms and provide Apex's proposed construction and supporting evidence for each:

(i) "locking seal assembly" as used in the Asserted Claims of the '237 Patent;

(ii) "retractable blade deployment mechanism" as used in the Asserted Claims of the '884 Patent; and

(iii) "integrated insufflation valve" as used in the Asserted Claims of the '105 Patent;

(d) For each disputed claim term, identify any prosecution history disclaimer, claim differentiation argument, or means-plus-function analysis that Apex contends is relevant to the proper construction of the term; and

(e) Identify all Persons (including experts or consultants) who have participated in or contributed to the development of Apex's claim construction positions.

INTERROGATORY NO. 10: Prior Licenses and Royalty History

Identify every license, covenant not to sue, settlement agreement, consent decree, or other agreement granting rights under any or all of the Asserted Patents or any other patent in the Patent Family that Apex (or any predecessor, subsidiary, or affiliate) has entered into with any third party from January 1, 2005 to the present. For each such agreement, state:

(a) The identity of the licensee or grantee (including the full legal name of the entity and, where applicable, the identity of any parent, subsidiary, or affiliate covered by the agreement);

(b) The date of the agreement and the effective date of the license or grant of rights (if different);

(d) The licensed field of use, including any restrictions on the type of products, technology, or applications covered;

(e) Whether the license is exclusive, non-exclusive, or sole, and whether any sublicensing rights were granted;

(f) The financial terms of the agreement, including any lump-sum payments, running royalty rates (expressed as a percentage of sales or a per-unit amount), minimum annual royalties, milestone payments, cross-license offsets, equity exchanges, or other forms of consideration;

(g) Whether the agreement was entered into in connection with the resolution or settlement of litigation, a threatened claim, or a licensing negotiation, and if so, identify the related dispute;

(h) The geographic scope of the license; and

(i) The current status of the agreement (e.g., active, expired, terminated) and the term of the agreement.

INTERROGATORY NO. 11: Damages Contentions — Royalty Base

Describe in detail Apex's damages contentions in this action, including but not limited to:

(a) The theory or theories of damages that Apex intends to pursue (e.g., reasonable royalty under 35 U.S.C. § 284, lost profits under 35 U.S.C. § 284, enhanced damages under 35 U.S.C. § 284, or any combination thereof), and the factual and legal basis for each theory;

(b) The royalty base used in Apex's damages calculation, including the specific revenue figures, unit sales, and pricing data attributed to each Accused Product (PE-5000 Series, PE-12000 Series, and PE-15000 Series), broken down by product line and by calendar year from the date of first alleged infringement to the present;

(c) The royalty rate sought by Apex, including the basis for the selection of such rate and any comparable licenses, industry benchmarks, or prior agreements relied upon;

(d) All facts, data, financial analyses, economic models, and assumptions supporting each element of Apex's damages calculation, including any apportionment analysis or smallest salable patent-practicing unit analysis applied;

(e) The combined United States sales figures for the Accused Products that Apex contends form the royalty base, including any distinction between direct sales, distributor sales, or sales through other channels; and

(f) Any pre-suit damages, ongoing royalties, or post-judgment royalties sought by Apex, and the factual and legal basis for each such claim.

INTERROGATORY NO. 12: Damages Contentions — Georgia-Pacific Factors

For each of the fifteen (15) Georgia-Pacific factors set forth in Georgia-Pacific Corp. v. United States Plywood Corp., 318 F. Supp. 1116 (S.D.N.Y. 1970), describe in detail how Apex contends each factor applies to the hypothetical negotiation for a reasonable royalty license under the Asserted Patents. For each factor, provide:

(a) All facts, data, comparable licenses, financial information, market data, and economic analyses that Apex relies upon or intends to rely upon in support of its position on each Georgia-Pacific factor;

(b) The identity of all Documents that support Apex's position on each factor;

(c) Any expert analyses, reports, or opinions (whether preliminary or final) that address any of the Georgia-Pacific factors, and a summary of the conclusions reached therein;

(d) The identity of all Persons (including expert witnesses, consultants, economists, or financial advisors) who have contributed to or will contribute to Apex's damages analysis, including specifically:

(i) Hugh Danaher, CFA, Senior Managing Director of Keystone Valuation Advisors LLC, located at Philadelphia, Pennsylvania, and any other expert or consultant retained by Apex to provide opinions or analysis regarding damages; and

(ii) A description of the scope of each such Person's engagement, the subject matter of their anticipated testimony or analysis, and the data and materials they have reviewed or relied upon in forming their opinions;

(e) The date of the hypothetical negotiation that Apex contends is applicable and the factual basis for the selection of that date; and

(f) Any analysis of the relationship between the patented features and the overall value of the Accused Products, including any demand-side or supply-side analysis of the contribution of the patented technology.

INTERROGATORY NO. 13: Apex's Knowledge of Accused Products and Pre-Suit Investigation

Describe in detail the facts and circumstances under which Apex first became aware of each of the Accused Products (the PrecisionEdge™ PE-5000 Series, the PrecisionEdge™ PE-12000 Series, and the PrecisionEdge™ PE-15000 Series), including:

(a) The date on which Apex first became aware of each Accused Product, and the source or means by which Apex learned of each product;

(b) The identity of all Persons at Apex who were involved in or aware of the initial identification of the Accused Products as potentially infringing;

(c) Any trade shows, conferences, publications, advertisements, surgeon feedback, competitive intelligence reports, or other events or sources that led to Apex's awareness of the Accused Products;

In addition, describe in detail the investigation Apex undertook prior to filing the Complaint on May 9, 2024, including:

(d) Any analysis of the Accused Products conducted by Apex or on Apex's behalf, including any teardowns, reverse engineering, laboratory testing, imaging, physical examination, dimensional analysis, or functional testing of any Accused Product, and the results thereof;

(e) Any infringement opinions, freedom-to-operate opinions, or other legal or technical analyses obtained by Apex regarding the Accused Products (to the extent any privilege has been waived or is not asserted);

(f) The identity of all Persons who participated in or contributed to the pre-suit investigation, including employees, outside counsel, technical consultants, and expert witnesses;

(g) The date(s) on which the pre-suit investigation was conducted and the date on which Apex concluded that the Accused Products infringed the Asserted Patents; and

(h) Any Communications between Apex and Solstice (or any representative of Solstice) prior to the filing of the Complaint, including any cease-and-desist letters, licensing proposals, or other pre-litigation correspondence.

INTERROGATORY NO. 14: Inequitable Conduct — Response to Counterclaim

With respect to Solstice's counterclaim for inequitable conduct, filed on June 14, 2024 (D.I. 9), describe in detail all facts and circumstances Relating to the prosecution of each Asserted Patent that Apex contends demonstrate the absence of any inequitable conduct before the USPTO, including but not limited to:

(a) The identity of all individuals involved in the preparation, filing, and prosecution of each Asserted Patent application, including named inventors, patent attorneys, patent agents, and any other Person who participated in the prosecution process;

(b) All prior art references, publications, products, systems, or other information known to any of the individuals identified in subpart (a) above at the time of prosecution of each Asserted Patent, whether or not such prior art was disclosed to the USPTO;

(c) All prior art references that were disclosed to the USPTO during prosecution of each Asserted Patent, including through Information Disclosure Statements, and the dates of each such disclosure;

(d) Any prior art references or other material information that was known to any individual involved in the prosecution but was not disclosed to the USPTO, and a detailed explanation of the reasons for each instance of non-disclosure, including whether and why each such reference was determined to be not material to patentability;

(e) Any statements, representations, arguments, or declarations made to the USPTO during prosecution of each Asserted Patent regarding the scope, novelty, non-obviousness, utility, written description, or enablement of the claimed inventions, and the factual basis for each such statement or representation;

(f) Any internal communications, memoranda, or analyses at Apex (or by outside prosecution counsel) regarding the materiality of any prior art reference or the duty of candor owed to the USPTO during prosecution of any Asserted Patent; and

(g) Any policies, procedures, or practices maintained by Apex (or its outside prosecution counsel) to ensure compliance with the duty of candor and good faith before the USPTO under 37 C.F.R. § 1.56.

INTERROGATORY NO. 15: Witnesses and Trial Support

Identify each Person whom Apex expects to call as a witness at trial in this matter, whether as a fact witness or an expert witness, including the following information for each such witness:

(a) The witness's full name, title, employer or affiliation, and business address;

(b) A description of the subject matter of the witness's expected testimony, including the specific issues, claims, defenses, or counterclaims to which the testimony relates;

(d) Whether the witness is expected to testify as a fact witness, an expert witness, or both; and

(e) If the witness is an expert witness, a summary of the opinions the witness is expected to offer and the basis for each opinion, to the extent known at this time.

Without limiting the generality of the foregoing, Apex is specifically requested to provide the following:

(f) Identify Dr. Calvin Ng, Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute, Newark, Delaware, and describe in detail the scope of his anticipated expert testimony on infringement, including: (i) the Asserted Claims and Accused Products on which he is expected to opine; (ii) the testing, analysis, or examination of the Accused Products he has performed or intends to perform; (iii) the methodologies he intends to employ in his analysis; and (iv) the materials, documents, and data he has reviewed or relied upon in forming his opinions;

(g) Identify Hugh Danaher, CFA, Senior Managing Director of Keystone Valuation Advisors LLC, located in Philadelphia, Pennsylvania, and describe in detail the scope of his anticipated expert testimony on damages, including: (i) the damages theories on which he is expected to opine; (ii) the specific financial data, comparable license agreements, industry data, and other materials he has reviewed or relied upon; (iii) the methodologies and economic models he intends to employ; (iv) the reasonable royalty figure of $31,800,000 referenced in the Complaint, or any updated or revised calculation, and the factual and analytical basis for such figure; and (v) any alternative damages calculations or ranges he has prepared or intends to prepare.

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Respectfully submitted,

CALDERWOOD & HARKNESS LLP

By: ________

Marcus Delgado Partner, intellectual Property Litigation Group

CALDERWOOD & HARKNESS LLP 1201 Market Street, Suite 2500 Wilmington, Delaware 19801 Telephone: (302) 555-7400 Facsimile: (302) 555-7401

Email: m.delgado@calderwoodharkness.com

Christy Bauer, Lead Associate

Email: c.bauer@calderwoodharkness.com

Peter Vassiliev, Working Associate

Email: p.vassiliev@calderwoodharkness.com

Attorneys for Defendant Solstice Biomedical, Inc.

Dated: August 19, 2024

CERTIFICATE OF SERVICE

I, Christy Bauer, hereby certify that on this 19th day of August, 2024, a true and correct copy of the foregoing Defendant Solstice Biomedical, Inc.'s First Set of Interrogatories to Plaintiff Apex Surgical Innovations, Inc. (Interrogatory Nos. 1–15) was served via the Court's CM/ECF electronic filing system and by electronic mail upon the following counsel of record for Plaintiff:

Victoria Stanton, Esq. Derek Loomis, Esq. HARGROVE, TATE & BENNINGTON LLP 900 North King Street, Suite 1200 Wilmington, Delaware 19801 Telephone: (302) 555-3200

Email: v.stanton@htblaw.com

Email: d.loomis@htblaw.com

Counsel for Plaintiff Apex Surgical Innovations, Inc.

________________________________________

Christy Bauer CALDERWOOD & HARKNESS LLP 1201 Market Street, Suite 2500 Wilmington, Delaware 19801

APEX SURGICAL INNOVATIONS, INC.,

<!-- indent:2 -->Plaintiff,<!-- /indent -->	Civil Action No. 1:24-cv-00587-RGA
v.	Chief Judge Richard G. Andrews
SOLSTICE BIOMEDICAL, INC.,	JURY TRIAL DEMANDED

Defendant.

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
DEFENDANT SOLSTICE BIOMEDICAL, INC.'S FIRST SET OF INTERROGATORIES TO PLAINTIFF APEX SURGICAL INNOVATIONS, INC.
(Interrogatory Nos. 1–15)
Date Served: August 19, 2024
Pursuant to Rules 26 and 33 of the Federal Rules of Civil Procedure and the Local Rules of the United States District Court for the District of Delaware, Defendant Solstice Biomedical, Inc. ("Solstice" or "Defendant") hereby propounds its First Set of Interrogatories (Nos. 1–15) upon Plaintiff Apex Surgical Innovations, Inc. ("Apex" or "Plaintiff"). These Interrogatories are directed to Plaintiff and seek information within Plaintiff's possession, custody, or control, including information known or readily obtainable by Plaintiff's officers, directors, employees, agents, representatives, consultants, and attorneys (to the extent not protected by applicable privilege).
Plaintiff is required to serve its written answers and any objections to these Interrogatories within thirty (30) days of service hereof, in accordance with Federal Rule of Civil Procedure 33(b)(2). Each answer must be made separately and fully, in writing and under oath, by an officer or agent of Plaintiff who shall furnish such information as is available to the answering party.
Solstice further notes that these Interrogatories are served consistent with the Joint discovery Plan filed by the parties on July 15, 2024 (D.I. 22), and the Scheduling Order entered by this Court on July 2, 2024 (D.I. 18), which establishes fact discovery deadlines and obligations applicable to the present dispute.
DEFINITIONS
As used in these Interrogatories, the following terms shall have the meanings set forth below. These definitions are intended to supplement, and not limit, any definitions set forth in the Federal Rules of Civil Procedure or the Local Rules of this Court.
A. "Asserted Patents" means, collectively: (i) U.S. Patent No. 9,814,237 ("the '237 Patent"), entitled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," issued on November 14, 2017, and currently set to expire on June 22, 2035; (ii) U.S. Patent No. 10,271,884 ("the '884 Patent"), entitled "Retractable Blade Deployment Mechanism for Trocar Systems," issued on April 30, 2019, and currently set to expire on September 15, 2036; and (iii) U.S. Patent No. 10,932,105 ("the '105 Patent"), entitled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar," issued on March 2, 2021, and currently set to expire on January 10, 2038. References to an individual "Asserted Patent" shall mean any one of the foregoing patents.
B. "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 Complaint filed on May 9, 2024 (D.I. 1), and any further claims that Apex may assert during the course of this litigation.
C. "Accused Products" means the PrecisionEdge™ PE-5000 Series (5 mm trocar assembly), the PrecisionEdge™ PE-12000 Series (12 mm trocar assembly), and the PrecisionEdge™ PE-15000 Series (15 mm trocar assembly), each as designed, manufactured, marketed, offered for sale, sold, used, or imported by Solstice, and includes any predecessors, successors, variants, sub-models, or substantially similar products thereof identified by Apex as infringing any Asserted Claim.
D. "Person" means any natural person, corporation, partnership, limited liability company, association, joint venture, governmental entity, or any other legal or business entity, and includes any predecessor, successor, parent, subsidiary, affiliate, division, department, officer, director, employee, agent, representative, or consultant thereof.
E. "Document" or "Documents" means the broadest definition permitted under Federal Rule of Civil Procedure 34(a) and as defined in the Joint discovery Plan filed July 15, 2024 (D.I. 22), and includes, without limitation, all writings, drawings, graphs, charts, photographs, sound recordings, images, electronically stored information ("ESI"), data compilations, and any other information recorded or stored in any medium from which information can be obtained, translated, or converted into reasonably usable form, whether or not the original or a copy is in the possession, custody, or control of Apex.
F. "Communication" means every disclosure, transfer, or exchange of information, whether oral, written, or electronic, including but not limited to conversations, meetings, telephone calls, video conferences, emails, text messages, instant messages, letters, memoranda, reports, presentations, and any other form of correspondence or exchange of information between two or more Persons.
G. "You," "Your," and "Apex" refer to Plaintiff Apex Surgical Innovations, Inc., including its present and former officers, directors, employees, agents, consultants, attorneys, predecessors, successors, subsidiaries, affiliates, divisions, and any other Person acting on its behalf or under its direction or control.
H. "Identify" (as to a Person) means to state the Person's full legal name, current and former title(s), current employer, business address, telephone number, email address (if known), and relationship to Apex (e.g., employee, consultant, outside counsel, licensee).
I. "Identify" (as to a Document) means to state the Document's type or nature (e.g., memorandum, email, patent application), title or subject, date of creation or transmission, author(s) or sender(s), recipient(s), Bates number(s) or production identifier(s) if the Document has been or will be produced in this litigation, and a brief description of its contents sufficient to identify the Document with reasonable particularity.
J. "Relate to," "Relating to," or "Concerning" means referring to, describing, evidencing, constituting, reflecting, mentioning, discussing, embodying, pertaining to, supporting, contradicting, or having any logical connection to the subject matter referenced, directly or indirectly.
K. "Patent Family" means all United States and foreign patents and patent applications (including continuations, continuations-in-part, divisional applications, reissues, reexaminations, inter partes reviews, and any other related proceedings) that share a common priority date, claim priority to, or are otherwise related through a common specification or disclosure with any of the Asserted Patents.
L. "Dr. Raymond Szabo" means Dr. Raymond Szabo, identified in each of the Asserted Patents as the named inventor and identified by Apex in its Complaint as the Vice President of Engineering of Apex Surgical Innovations, Inc.
INSTRUCTIONS
The following instructions apply to each of the Interrogatories set forth below. To the extent any instruction is inconsistent with the Federal Rules of Civil Procedure, the Federal Rules shall govern.
Instruction No. 1: General Scope. Each Interrogatory shall be answered separately and fully in writing under oath by an officer or agent of Apex who shall furnish such information as is available to Apex, in accordance with Federal Rule of Civil Procedure 33(b)(1). Each answer should restate the Interrogatory in full immediately before the response. If any Interrogatory cannot be answered in full after exercising due diligence to obtain the requested information, so state, and answer the Interrogatory to the fullest extent possible, specifying the reasons for the inability to answer fully and what efforts were made to obtain the information.
Instruction No. 2: Continuing Duty to Supplement. Apex has a continuing obligation to supplement its responses to these Interrogatories in a timely manner pursuant to Federal Rule of Civil Procedure 26(e)(1). If, at any time after serving responses to these Interrogatories, Apex learns that a response is in some material respect incomplete or incorrect, and if the additional or corrective information has not otherwise been made known to Solstice during the discovery process or in writing, Apex must supplement or correct its response promptly.
Instruction No. 3: Time Period. Unless otherwise specified in a particular Interrogatory, these Interrogatories cover the time period from January 1, 2005 to the date of service of Apex's responses. Where an Interrogatory requests information about events or activities without specifying a time frame, Apex should provide responsive information for the full period from January 1, 2005 through the present.
Instruction No. 4: Objections. If Apex objects to any part of any Interrogatory, Apex shall state with specificity the grounds for each objection. If an objection is made to only a portion of an Interrogatory, Apex shall answer the remaining portion of the Interrogatory to the fullest extent the objection does not apply. General or boilerplate objections are insufficient and will be treated as a failure to object. Apex shall not refuse to answer on the basis that these Interrogatories seek information already known to Solstice or publicly available, except to the extent permitted by the Federal Rules of Civil Procedure and the Local Rules of this Court.
Instruction No. 5: Identification of Responsive Documents in Lieu of Answer. If Apex elects to produce business records in response to any Interrogatory pursuant to Federal Rule of Civil Procedure 33(d), Apex must specify the records from which the answer may be ascertained with sufficient detail to enable Solstice to locate and identify them as readily as could Apex itself. Apex must also identify the specific documents that are responsive and the particular interrogatory or interrogatories to which each document is responsive. A general reference to voluminous records without further specification is insufficient.
Instruction No. 6: Privilege. If Apex withholds any information responsive to these Interrogatories on the basis of attorney-client privilege, work product doctrine, or any other applicable privilege or immunity, Apex must provide a privilege log entry for each withheld communication or document, in accordance with Federal Rule of Civil Procedure 26(b)(5)(A) and any applicable provisions of the Scheduling Order or the parties' stipulated Protective Order. Each privilege log entry must contain sufficient information to enable Solstice to assess the applicability of the claimed privilege, including the date of the communication or document, the author(s) or sender(s), the recipient(s), a description of the general subject matter, and the specific privilege or protection asserted.
Instruction No. 7: Construction. Each Interrogatory shall be construed broadly and liberally so as to request all responsive information within Apex's possession, custody, or control, including information held by or known to its officers, directors, employees, agents, representatives, consultants, and attorneys (to the extent not subject to a valid claim of privilege). Words used in the singular include the plural, and vice versa. Words used in the masculine include the feminine and neutral genders, and vice versa. The terms "and" and "or" shall be construed both conjunctively and disjunctively to bring within the scope of the Interrogatory all responses that might otherwise be construed to be outside its scope. The use of the term "including" shall mean "including but not limited to."
INTERROGATORIES
INTERROGATORY NO. 1: Identification of Named Inventor — Dr. Raymond Szabo
Identify Dr. Raymond Szabo fully, including but not limited to the following:
(a) His current title, position, and responsibilities at Apex Surgical Innovations, Inc., including his current designation as Vice President of Engineering or any other title he currently holds;
(b) His complete dates of employment or engagement with Apex, from Apex's founding in or about 2006 to the present, including the date on which he first became associated with Apex in any capacity;
(c) All positions, titles, and roles he has held at Apex from the date of his initial engagement to the present, including a description of the responsibilities and duties associated with each such position;
(d) His educational background, including all degrees, certifications, and professional credentials, the institutions from which they were obtained, and the dates on which they were awarded;
(e) His prior employment and professional experience before joining Apex;
(f) A detailed description of Dr. Szabo's involvement in the conception, development, design, prototyping, testing, and reduction to practice of each of the inventions claimed in the '237 Patent, the '884 Patent, and the '105 Patent, including the specific technical contributions he made to each claimed invention; and
(g) The identity of all other Persons who contributed to, participated in, or assisted with the conception, development, or reduction to practice of any invention claimed in any of the Asserted Patents, including the nature and extent of each such Person's contribution.
INTERROGATORY NO. 2: Inventive Contribution and Conception
For each Asserted Claim of each Asserted Patent, describe in detail the date and circumstances of the original conception of the claimed invention, including but not limited to:
(a) The specific date or dates on which the claimed invention was first conceived;
(b) The location or locations where conception occurred;
(c) All Persons present at or involved in the conception, including a description of each Person's role;
(d) Any contemporaneous documentation of the conception, including laboratory notebooks, invention disclosure forms, internal memoranda, emails, technical reports, drawings, sketches, prototypes, or any other recorded evidence of conception, and Identify each such Document;
(e) Any corroborating witnesses to the act of conception for each claimed invention, and Identify each such witness;
(f) The date and manner by which each claimed invention was first reduced to practice, whether actually or constructively, and a description of the steps taken to achieve reduction to practice; and
(g) Any differences between the invention as originally conceived and the invention as ultimately claimed in the Asserted Patents, including any modifications, refinements, or improvements made between conception and the filing of the patent application.
INTERROGATORY NO. 3: Prosecution History — '237 Patent
Describe in detail the complete prosecution history of U.S. Patent No. 9,814,237 ("the '237 Patent"), including but not limited to:
(a) The filing date of the original patent application and the application number, and the filing dates and application numbers of any provisional applications, priority applications, parent applications, or related applications to which the '237 Patent claims priority;
(b) All office actions issued by the United States Patent and Trademark Office ("USPTO") during prosecution of the application that issued as the '237 Patent, including the dates of each office action and a description of the grounds for any rejections or objections raised therein;
(c) All amendments to the claims or specification submitted in response to any office action, including the specific language added, deleted, or modified in each amendment and the reasons provided for each such amendment;
(d) All arguments, remarks, declarations, affidavits, or other submissions made to the USPTO in support of patentability during prosecution, including the substance of any such arguments or representations;
(e) Any interviews or telephone conferences conducted with the USPTO examiner during prosecution, including the dates, participants, and substance of each such interview;
(f) The basis and rationale for each claim amendment made during prosecution, including whether any amendment was made to overcome a prior art rejection, to address a written description or enablement rejection, or for any other reason;
(g) All prior art references cited by the USPTO examiner or submitted by Apex (including through Information Disclosure Statements) during prosecution of the '237 Patent, including the identity of each reference and the manner in which it was cited or applied; and
(h) The identity of all Persons at Apex, including any outside patent prosecution counsel, patent agents, or technical advisors, who were involved in or contributed to the drafting, filing, or prosecution of the application that issued as the '237 Patent.
INTERROGATORY NO. 4: Prosecution History — '884 Patent
Describe in detail the complete prosecution history of U.S. Patent No. 10,271,884 ("the '884 Patent"), providing the same categories of information requested in Interrogatory No. 3 above, as applied to the '884 Patent. In addition, provide the following:
(a) Specifically identify any continuation, divisional, or continuation-in-part relationship between the application that issued as the '884 Patent and the application that issued as the '237 Patent, or any other member of the Patent Family, including the chain of priority and the specific disclosures or claims that were carried forward from any parent application;
(b) Describe any narrowing amendments made to the claims of the '884 Patent during prosecution, and identify the specific prior art reference(s) or ground(s) of rejection that prompted each such narrowing amendment;
(c) Describe any arguments or representations made to the USPTO examiner during prosecution regarding the differences between the claimed invention of the '884 Patent and the prior art, including any disclaimers, admissions, or characterizations of the prior art;
(d) Identify all prior art references of which Apex or its representatives were aware during prosecution of the '884 Patent, whether or not such references were disclosed to the USPTO; and
(e) Identify all Persons involved in the prosecution of the '884 Patent, including outside patent prosecution counsel, and describe the role of each such Person.
INTERROGATORY NO. 5: Prosecution History — '105 Patent
Describe in detail the complete prosecution history of U.S. Patent No. 10,932,105 ("the '105 Patent"), providing the same categories of information requested in Interrogatory No. 3 above, as applied to the '105 Patent. In addition, provide the following:
(a) Describe the relationship of the '105 Patent to the other Asserted Patents and to all other members of the Patent Family, including the fourteen (14) total issued United States patents and six (6) pending continuation applications referenced in Apex's Complaint, and specifically state whether the '105 Patent is a continuation, divisional, continuation-in-part, or other type of related application with respect to the '237 Patent and the '884 Patent;
(b) Identify any representations made to the USPTO during prosecution of the '105 Patent regarding the scope of the claims relative to the prior art, including any representations distinguishing the claims of the '105 Patent from the claims of the '237 Patent, the '884 Patent, or any other patent in the Patent Family;
(c) Describe any terminal disclaimers filed during prosecution of the '105 Patent, including the patents or applications disclaimed and the reasons for filing each terminal disclaimer;
(d) Identify all prior art references of which Apex or its representatives were aware during prosecution of the '105 Patent, whether or not such references were disclosed to the USPTO; and
(e) Identify all Persons involved in the prosecution of the '105 Patent, including outside patent prosecution counsel, and describe the role of each such Person.
INTERROGATORY NO. 6: Patent Family and Related Applications
Identify every United States and foreign patent and patent application that is a member of the Patent Family related to the Asserted Patents, including all fourteen (14) issued United States patents and six (6) pending continuation applications referenced in Apex's Complaint, as well as any foreign counterparts, PCT applications, or other related filings worldwide. For each such patent or application, state:
(a) The patent number or application number (including country code where applicable);
(b) The title of the patent or application;
(c) The filing date (and any claimed priority date, if different from the filing date);
(d) The issue date or grant date, if the patent has been issued or granted;
(e) The current status of the patent or application (e.g., issued, pending, abandoned, expired, under reexamination, subject to inter partes review);
(f) The named inventor(s) for each patent or application; and
(g) The current assignee or owner of record for each patent or application, and whether there have been any changes in assignment or ownership since the original filing.
INTERROGATORY NO. 7: Assignment History
Describe the complete chain of title for each of the Asserted Patents from the named inventor(s) to Apex Surgical Innovations, Inc. (or any other current owner), including all intermediate assignments, transfers, or conveyances. For each link in the chain of title, state:
(a) The date of each assignment or transfer;
(b) The identity of the assignor and the assignee for each assignment;
(c) The consideration paid or exchanged for each assignment (including monetary compensation, equity interests, employment obligations, or other forms of consideration);
(d) The recording information at the USPTO, including the reel and frame number of each recorded assignment; and
(e) Whether the assignment conveyed the full right, title, and interest in the patent, or a partial or limited interest (and, if limited, describe the nature and scope of the interest conveyed).
In addition, identify any third parties (other than Apex and the named inventors) who have held, currently hold, or claim to hold any ownership interest, license, lien, security interest, encumbrance, or other right in or to any of the Asserted Patents, and describe the nature and scope of any such interest or right.
INTERROGATORY NO. 8: Infringement Contentions — Element-by-Element Basis
For each Asserted Claim of each Asserted Patent, describe with specificity how Apex contends that each element, limitation, or step of the claim is met, practiced, or satisfied by each Accused Product, including but not limited to the following:
(a) For each claim element or limitation, state whether infringement is alleged to occur literally or under the doctrine of equivalents (or both), and provide the factual and technical basis for each contention;
(b) For the PrecisionEdge™ PE-5000 Series (5 mm trocar assembly): identify which Asserted Claims of the '237 Patent and the '884 Patent are alleged to be infringed by the PE-5000 Series, and describe the specific structural features, functional characteristics, components, materials, dimensions, or modes of operation of the PE-5000 Series that Apex contends satisfy each element or limitation of each such Asserted Claim;
(c) For the PrecisionEdge™ PE-12000 Series (12 mm trocar assembly): identify which Asserted Claims of all three Asserted Patents (the '237 Patent, the '884 Patent, and the '105 Patent) are alleged to be infringed by the PE-12000 Series, and describe the specific structural features, functional characteristics, components, materials, dimensions, or modes of operation of the PE-12000 Series that Apex contends satisfy each element or limitation of each such Asserted Claim;
(d) For the PrecisionEdge™ PE-15000 Series (15 mm trocar assembly): identify which Asserted Claims of the '884 Patent and the '105 Patent are alleged to be infringed by the PE-15000 Series, and describe the specific structural features, functional characteristics, components, materials, dimensions, or modes of operation of the PE-15000 Series that Apex contends satisfy each element or limitation of each such Asserted Claim;
(e) For any claim element or limitation that Apex contends is met under the doctrine of equivalents, describe the function performed by the corresponding element in the Accused Product, the way in which it performs that function, and the result achieved, and explain why the differences between the claim element and the accused element are insubstantial; and
(f) Identify all Documents, test results, analyses, photographs, schematics, product literature, marketing materials, user manuals, engineering drawings, or other evidence that Apex relies upon or intends to rely upon to support its infringement contentions with respect to each Accused Product.
INTERROGATORY NO. 9: Claim Construction Positions
For each of the nine (9) disputed claim terms that are or will be identified in the parties' exchange of Proposed Claim Constructions (to be exchanged on or before October 22, 2024, pursuant to the Scheduling Order entered July 2, 2024), state Apex's proposed construction of each such term and provide the following:
(a) The intrinsic evidence (including claim language, specification, prosecution history, and any related patents in the Patent Family) supporting Apex's proposed construction of each disputed term;
(b) The extrinsic evidence (including dictionaries, treatises, expert testimony, inventor testimony, technical publications, and industry standards) supporting Apex's proposed construction of each disputed term;
(c) Specifically address the following claim terms and provide Apex's proposed construction and supporting evidence for each:
(i) "locking seal assembly" as used in the Asserted Claims of the '237 Patent;
(ii) "retractable blade deployment mechanism" as used in the Asserted Claims of the '884 Patent; and
(iii) "integrated insufflation valve" as used in the Asserted Claims of the '105 Patent;
(d) For each disputed claim term, identify any prosecution history disclaimer, claim differentiation argument, or means-plus-function analysis that Apex contends is relevant to the proper construction of the term; and
(e) Identify all Persons (including experts or consultants) who have participated in or contributed to the development of Apex's claim construction positions.
INTERROGATORY NO. 10: Prior Licenses and Royalty History
Identify every license, covenant not to sue, settlement agreement, consent decree, or other agreement granting rights under any or all of the Asserted Patents or any other patent in the Patent Family that Apex (or any predecessor, subsidiary, or affiliate) has entered into with any third party from January 1, 2005 to the present. For each such agreement, state:
(a) The identity of the licensee or grantee (including the full legal name of the entity and, where applicable, the identity of any parent, subsidiary, or affiliate covered by the agreement);
(b) The date of the agreement and the effective date of the license or grant of rights (if different);
(c) The specific patents or patent applications licensed or covered by the agreement;
(d) The licensed field of use, including any restrictions on the type of products, technology, or applications covered;
(e) Whether the license is exclusive, non-exclusive, or sole, and whether any sublicensing rights were granted;
(f) The financial terms of the agreement, including any lump-sum payments, running royalty rates (expressed as a percentage of sales or a per-unit amount), minimum annual royalties, milestone payments, cross-license offsets, equity exchanges, or other forms of consideration;
(g) Whether the agreement was entered into in connection with the resolution or settlement of litigation, a threatened claim, or a licensing negotiation, and if so, identify the related dispute;
(h) The geographic scope of the license; and
(i) The current status of the agreement (e.g., active, expired, terminated) and the term of the agreement.
INTERROGATORY NO. 11: Damages Contentions — Royalty Base
Describe in detail Apex's damages contentions in this action, including but not limited to:
(a) The theory or theories of damages that Apex intends to pursue (e.g., reasonable royalty under 35 U.S.C. § 284, lost profits under 35 U.S.C. § 284, enhanced damages under 35 U.S.C. § 284, or any combination thereof), and the factual and legal basis for each theory;
(b) The royalty base used in Apex's damages calculation, including the specific revenue figures, unit sales, and pricing data attributed to each Accused Product (PE-5000 Series, PE-12000 Series, and PE-15000 Series), broken down by product line and by calendar year from the date of first alleged infringement to the present;
(c) The royalty rate sought by Apex, including the basis for the selection of such rate and any comparable licenses, industry benchmarks, or prior agreements relied upon;
(d) All facts, data, financial analyses, economic models, and assumptions supporting each element of Apex's damages calculation, including any apportionment analysis or smallest salable patent-practicing unit analysis applied;
(e) The combined United States sales figures for the Accused Products that Apex contends form the royalty base, including any distinction between direct sales, distributor sales, or sales through other channels; and
(f) Any pre-suit damages, ongoing royalties, or post-judgment royalties sought by Apex, and the factual and legal basis for each such claim.
INTERROGATORY NO. 12: Damages Contentions — Georgia-Pacific Factors
For each of the fifteen (15) Georgia-Pacific factors set forth in Georgia-Pacific Corp. v. United States Plywood Corp., 318 F. Supp. 1116 (S.D.N.Y. 1970), describe in detail how Apex contends each factor applies to the hypothetical negotiation for a reasonable royalty license under the Asserted Patents. For each factor, provide:
(a) All facts, data, comparable licenses, financial information, market data, and economic analyses that Apex relies upon or intends to rely upon in support of its position on each Georgia-Pacific factor;
(b) The identity of all Documents that support Apex's position on each factor;
(c) Any expert analyses, reports, or opinions (whether preliminary or final) that address any of the Georgia-Pacific factors, and a summary of the conclusions reached therein;
(d) The identity of all Persons (including expert witnesses, consultants, economists, or financial advisors) who have contributed to or will contribute to Apex's damages analysis, including specifically:
(i) Hugh Danaher, CFA, Senior Managing Director of Keystone Valuation Advisors LLC, located at Philadelphia, Pennsylvania, and any other expert or consultant retained by Apex to provide opinions or analysis regarding damages; and
(ii) A description of the scope of each such Person's engagement, the subject matter of their anticipated testimony or analysis, and the data and materials they have reviewed or relied upon in forming their opinions;
(e) The date of the hypothetical negotiation that Apex contends is applicable and the factual basis for the selection of that date; and
(f) Any analysis of the relationship between the patented features and the overall value of the Accused Products, including any demand-side or supply-side analysis of the contribution of the patented technology.
INTERROGATORY NO. 13: Apex's Knowledge of Accused Products and Pre-Suit Investigation
Describe in detail the facts and circumstances under which Apex first became aware of each of the Accused Products (the PrecisionEdge™ PE-5000 Series, the PrecisionEdge™ PE-12000 Series, and the PrecisionEdge™ PE-15000 Series), including:
(a) The date on which Apex first became aware of each Accused Product, and the source or means by which Apex learned of each product;
(b) The identity of all Persons at Apex who were involved in or aware of the initial identification of the Accused Products as potentially infringing;
(c) Any trade shows, conferences, publications, advertisements, surgeon feedback, competitive intelligence reports, or other events or sources that led to Apex's awareness of the Accused Products;
In addition, describe in detail the investigation Apex undertook prior to filing the Complaint on May 9, 2024, including:
(d) Any analysis of the Accused Products conducted by Apex or on Apex's behalf, including any teardowns, reverse engineering, laboratory testing, imaging, physical examination, dimensional analysis, or functional testing of any Accused Product, and the results thereof;
(e) Any infringement opinions, freedom-to-operate opinions, or other legal or technical analyses obtained by Apex regarding the Accused Products (to the extent any privilege has been waived or is not asserted);
(f) The identity of all Persons who participated in or contributed to the pre-suit investigation, including employees, outside counsel, technical consultants, and expert witnesses;
(g) The date(s) on which the pre-suit investigation was conducted and the date on which Apex concluded that the Accused Products infringed the Asserted Patents; and
(h) Any Communications between Apex and Solstice (or any representative of Solstice) prior to the filing of the Complaint, including any cease-and-desist letters, licensing proposals, or other pre-litigation correspondence.
INTERROGATORY NO. 14: Inequitable Conduct — Response to Counterclaim
With respect to Solstice's counterclaim for inequitable conduct, filed on June 14, 2024 (D.I. 9), describe in detail all facts and circumstances Relating to the prosecution of each Asserted Patent that Apex contends demonstrate the absence of any inequitable conduct before the USPTO, including but not limited to:
(a) The identity of all individuals involved in the preparation, filing, and prosecution of each Asserted Patent application, including named inventors, patent attorneys, patent agents, and any other Person who participated in the prosecution process;
(b) All prior art references, publications, products, systems, or other information known to any of the individuals identified in subpart (a) above at the time of prosecution of each Asserted Patent, whether or not such prior art was disclosed to the USPTO;
(c) All prior art references that were disclosed to the USPTO during prosecution of each Asserted Patent, including through Information Disclosure Statements, and the dates of each such disclosure;
(d) Any prior art references or other material information that was known to any individual involved in the prosecution but was not disclosed to the USPTO, and a detailed explanation of the reasons for each instance of non-disclosure, including whether and why each such reference was determined to be not material to patentability;
(e) Any statements, representations, arguments, or declarations made to the USPTO during prosecution of each Asserted Patent regarding the scope, novelty, non-obviousness, utility, written description, or enablement of the claimed inventions, and the factual basis for each such statement or representation;
(f) Any internal communications, memoranda, or analyses at Apex (or by outside prosecution counsel) regarding the materiality of any prior art reference or the duty of candor owed to the USPTO during prosecution of any Asserted Patent; and
(g) Any policies, procedures, or practices maintained by Apex (or its outside prosecution counsel) to ensure compliance with the duty of candor and good faith before the USPTO under 37 C.F.R. § 1.56.
INTERROGATORY NO. 15: Witnesses and Trial Support
Identify each Person whom Apex expects to call as a witness at trial in this matter, whether as a fact witness or an expert witness, including the following information for each such witness:
(a) The witness's full name, title, employer or affiliation, and business address;
(b) A description of the subject matter of the witness's expected testimony, including the specific issues, claims, defenses, or counterclaims to which the testimony relates;
(c) The Asserted Claims and/or Accused Products to which the testimony relates;
(d) Whether the witness is expected to testify as a fact witness, an expert witness, or both; and
(e) If the witness is an expert witness, a summary of the opinions the witness is expected to offer and the basis for each opinion, to the extent known at this time.
Without limiting the generality of the foregoing, Apex is specifically requested to provide the following:
(f) Identify Dr. Calvin Ng, Adjunct Professor of Mechanical Engineering at Veltrano Polytechnic Institute, Newark, Delaware, and describe in detail the scope of his anticipated expert testimony on infringement, including: (i) the Asserted Claims and Accused Products on which he is expected to opine; (ii) the testing, analysis, or examination of the Accused Products he has performed or intends to perform; (iii) the methodologies he intends to employ in his analysis; and (iv) the materials, documents, and data he has reviewed or relied upon in forming his opinions;
(g) Identify Hugh Danaher, CFA, Senior Managing Director of Keystone Valuation Advisors LLC, located in Philadelphia, Pennsylvania, and describe in detail the scope of his anticipated expert testimony on damages, including: (i) the damages theories on which he is expected to opine; (ii) the specific financial data, comparable license agreements, industry data, and other materials he has reviewed or relied upon; (iii) the methodologies and economic models he intends to employ; (iv) the reasonable royalty figure of $31,800,000 referenced in the Complaint, or any updated or revised calculation, and the factual and analytical basis for such figure; and (v) any alternative damages calculations or ranges he has prepared or intends to prepare.
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Respectfully submitted,
CALDERWOOD & HARKNESS LLP
By: ________
Marcus Delgado Partner, intellectual Property Litigation Group
CALDERWOOD & HARKNESS LLP 1201 Market Street, Suite 2500 Wilmington, Delaware 19801 Telephone: (302) 555-7400 Facsimile: (302) 555-7401
Email: m.delgado@calderwoodharkness.com
Christy Bauer, Lead Associate
Email: c.bauer@calderwoodharkness.com
Peter Vassiliev, Working Associate
Email: p.vassiliev@calderwoodharkness.com
Attorneys for Defendant Solstice Biomedical, Inc.
Dated: August 19, 2024
CERTIFICATE OF SERVICE
I, Christy Bauer, hereby certify that on this 19th day of August, 2024, a true and correct copy of the foregoing Defendant Solstice Biomedical, Inc.'s First Set of Interrogatories to Plaintiff Apex Surgical Innovations, Inc. (Interrogatory Nos. 1–15) was served via the Court's CM/ECF electronic filing system and by electronic mail upon the following counsel of record for Plaintiff:
Victoria Stanton, Esq. Derek Loomis, Esq. HARGROVE, TATE & BENNINGTON LLP 900 North King Street, Suite 1200 Wilmington, Delaware 19801 Telephone: (302) 555-3200
Email: v.stanton@htblaw.com
Email: d.loomis@htblaw.com
Counsel for Plaintiff Apex Surgical Innovations, Inc.
________________________________________
Christy Bauer CALDERWOOD & HARKNESS LLP 1201 Market Street, Suite 2500 Wilmington, Delaware 19801
APEX SURGICAL INNOVATIONS, INC.,
<!-- indent:2 -->Plaintiff,<!-- /indent --> | Civil Action No. 1:24-cv-00587-RGA
v. | Chief Judge Richard G. Andrews
SOLSTICE BIOMEDICAL, INC., | JURY TRIAL DEMANDED
<!-- indent:2 -->Defendant.<!-- /indent -->

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

DEFINITIONS

INSTRUCTIONS

INTERROGATORIES

CALDERWOOD & HARKNESS LLP

CERTIFICATE OF SERVICE

APEX SURGICAL INNOVATIONS, INC.,

Record

Parties

Dates

Amounts