1037-00004 · Solstice Biomedical Devices Ltd · Pleadings & Court Filings

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

DEFENDANT SOLSTICE BIOMEDICAL, INC.'S ANSWER, AFFIRMATIVE DEFENSES, AND COUNTERCLAIMS

Defendant Solstice Biomedical, Inc. ("Solstice" or "Defendant"), by and through its undersigned counsel, Calderwood & Harkness LLP, hereby respectfully answers the Complaint filed by Plaintiff Apex Surgical Innovations, Inc. ("Apex" or "Plaintiff") on May 9, 2024 (Dkt. No. 1) (the "Complaint"), and asserts affirmative defenses and counterclaims as set forth below. Solstice Biomedical, Inc. is a Delaware corporation (EIN: 84-3291056) with principal offices at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803, and is the U.S. operating subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company (CRO No. 648217) with registered office at Unit 14, Clonskeagh Business Park, Clonskeagh Road, Dublin 14, D14 YF28, Ireland.

Solstice denies that it has infringed any valid and enforceable claim of U.S. Patent Nos. 9,814,237 ("the '237 Patent"), 10,271,884 ("the '884 Patent"), or 10,932,105 ("the '105 Patent") (collectively, the "Asserted Patents"). Solstice further avers that the Asserted Patents are invalid and, at least in part, unenforceable for the reasons set forth herein.

To the extent any allegation of the Complaint is not specifically admitted below, it is denied. Solstice reserves the right to amend its Answer and to assert additional defenses or counterclaims as warranted by further investigation, discovery, and the development of the record in this action.

PART I

ANSWER TO COMPLAINT

Solstice responds to the numbered paragraphs of the Complaint as follows. The headings and paragraph numbers used herein correspond to the headings and paragraph numbers used in the Complaint, and are included for ease of reference only. To the extent that a heading or paragraph number does not correspond directly to a paragraph of the Complaint, no admission is made by the inclusion or omission of such heading or paragraph number.

A. Answer to Jurisdictional and Venue Allegations

1. Solstice admits that this action arises under the patent laws of the United States, 35 U.S.C. § 1 et seq., and that the Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1338(a).

2. Solstice admits that Solstice Biomedical, Inc. is a corporation organized and existing under the laws of the State of Delaware and does not contest personal jurisdiction in this District for purposes of this action.

3. Solstice admits that venue is proper in this District under 28 U.S.C. §§ 1391 and 1400(b).

B. Answer to Allegations Regarding the Parties

4. Solstice admits that Apex Surgical Innovations, Inc. is a corporation organized and existing under the laws of the State of Delaware with its principal office at 1220 North Market Street, Suite 550, Wilmington, Delaware 19801. Solstice further admits that Apex is in the business of developing and manufacturing surgical access devices. Solstice lacks knowledge or information sufficient to form a belief as to the truth of Apex's characterization of its annual revenue, its approximate employee count of approximately 1,100 employees, or other self-serving characterizations set forth in the Complaint, and therefore denies the same.

5. Solstice admits that Solstice Biomedical, Inc. is a corporation organized and existing under the laws of the State of Delaware with principal offices at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803. Solstice further admits that it designs, develops, manufactures, markets, and sells minimally invasive surgical instruments, including laparoscopic trocars, endoscopic graspers, and electrosurgical hand instruments. Solstice denies any allegation in the Complaint that characterizes Solstice's products, product designs, or product features as infringing any valid and enforceable claim of any of the Asserted Patents. To the extent the Complaint contains additional characterizations regarding Solstice or its business activities not specifically admitted herein, such allegations are denied.

C. Answer to Allegations Regarding the Asserted Patents

6. With respect to the allegations of the Complaint concerning U.S. Patent No. 9,814,237 (the '237 Patent), Solstice admits that U.S. Patent No. 9,814,237, titled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," was duly issued by the United States Patent and Trademark Office ("USPTO") on November 14, 2017. Solstice admits that the '237 Patent names Dr. Raymond Szabo as an inventor. Solstice admits, on information and belief, that the '237 Patent has been assigned to Apex. Solstice denies that the '237 Patent is valid and enforceable in all respects. Solstice specifically denies that any claim of the '237 Patent, including without limitation Claims 1, 3, 7, and 12, is infringed by any Solstice product, including any product in the PrecisionEdge™ line. To the extent the Complaint contains additional characterizations or legal conclusions concerning the '237 Patent not specifically admitted herein, Solstice denies the same.

7. With respect to the allegations of the Complaint concerning U.S. Patent No. 10,271,884 (the '884 Patent), Solstice admits that U.S. Patent No. 10,271,884, titled "Retractable Blade Deployment Mechanism for Trocar Systems," was duly issued by the USPTO on April 30, 2019. Solstice admits that the '884 Patent names Dr. Raymond Szabo as an inventor. Solstice admits, on information and belief, that the '884 Patent has been assigned to Apex. Solstice denies that the '884 Patent is valid and enforceable in all respects. Solstice specifically denies that any claim of the '884 Patent, including without limitation Claims 1, 2, 5, 9, and 14, is infringed by any Solstice product. To the extent the Complaint contains additional characterizations or legal conclusions concerning the '884 Patent not specifically admitted herein, Solstice denies the same.

8. With respect to the allegations of the Complaint concerning U.S. Patent No. 10,932,105 (the '105 Patent), Solstice admits that U.S. Patent No. 10,932,105, titled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar," was duly issued by the USPTO on March 2, 2021. Solstice admits that the '105 Patent names Dr. Raymond Szabo as an inventor. Solstice admits, on information and belief, that the '105 Patent has been assigned to Apex. Solstice denies that the '105 Patent is valid and enforceable in all respects. Solstice specifically denies that any claim of the '105 Patent, including without limitation Claims 1, 4, and 8, is infringed by any Solstice product. To the extent the Complaint contains additional characterizations or legal conclusions concerning the '105 Patent not specifically admitted herein, Solstice denies the same.

D. Answer to Allegations Regarding the Accused Products

9. Solstice admits that it manufactures, markets, distributes, and sells the PrecisionEdge™ line of laparoscopic trocar assemblies, which includes the PE-5000 Series (5 mm diameter), the PE-12000 Series (12 mm diameter), and the PE-15000 Series (15 mm diameter). Solstice denies that the PrecisionEdge™ PE-5000 Series infringes the '237 Patent or the '884 Patent. Solstice denies that the PrecisionEdge™ PE-12000 Series infringes the '237 Patent, the '884 Patent, or the '105 Patent. Solstice denies that the PrecisionEdge™ PE-15000 Series infringes the '884 Patent or the '105 Patent.

10. Solstice specifically denies each and every allegation that any PrecisionEdge™ product meets any limitation of any asserted claim of any of the Asserted Patents, whether literally or under the doctrine of equivalents. To the extent the Complaint alleges or implies that the PrecisionEdge™ products incorporate, practice, or embody any feature, element, component, or method step claimed in the Asserted Patents, Solstice denies such allegations. The PrecisionEdge™ products were independently designed and developed by Solstice's engineering team and employ designs that are fundamentally different from the claimed inventions of the Asserted Patents.

E. Answer to Allegations Regarding Infringement (Count I — The '237 Patent)

11. In response to the allegations set forth in Count I of the Complaint, which asserts infringement of the '237 Patent, Solstice denies that the PrecisionEdge™ PE-5000 Series or the PE-12000 Series literally infringes Claims 1, 3, 7, or 12 of U.S. Patent No. 9,814,237, or any other claim thereof.

12. Solstice denies that the PrecisionEdge™ PE-5000 Series or the PE-12000 Series infringes any claim of the '237 Patent under the doctrine of equivalents. No element of the accused products performs substantially the same function, in substantially the same way, to achieve substantially the same result as the corresponding limitations of the asserted claims.

13. Solstice denies that it has willfully infringed any claim of the '237 Patent. At all relevant times, Solstice maintained a good-faith belief that the PrecisionEdge™ products did not infringe the '237 Patent and that the asserted claims of the '237 Patent were invalid. Solstice's conduct has not been egregious or otherwise warranting enhanced damages under 35 U.S.C. § 284 or the standard set forth in Halo Electronics, Inc. v. Pulse Electronics, Inc., 579 U.S. 93 (2016).

14. Solstice denies that Apex is entitled to enhanced damages, attorneys' fees, injunctive relief, or any other relief in connection with Count I. To the extent any additional allegations are contained in Count I that are not specifically addressed above, Solstice denies such allegations.

F. Answer to Allegations Regarding Infringement (Count II — The '884 Patent)

15. In response to the allegations set forth in Count II of the Complaint, which asserts infringement of the '884 Patent, Solstice denies that the PrecisionEdge™ PE-5000 Series, PE-12000 Series, or PE-15000 Series literally infringes Claims 1, 2, 5, 9, or 14 of U.S. Patent No. 10,271,884, or any other claim thereof.

16. Solstice denies that any of the PrecisionEdge™ products infringes any claim of the '884 Patent under the doctrine of equivalents. The blade deployment mechanisms employed in the PrecisionEdge™ products are structurally and functionally distinct from the "retractable blade deployment mechanism" recited in the claims of the '884 Patent, and no equivalent relationship exists between the elements of the accused products and the claimed limitations.

17. Solstice denies that it has willfully infringed any claim of the '884 Patent. Solstice's design and commercialization of the PrecisionEdge™ products was undertaken in good faith and without any intent to infringe.

18. Solstice denies that Apex is entitled to enhanced damages, attorneys' fees, or any other relief in connection with Count II. To the extent any additional allegations are contained in Count II that are not specifically addressed above, Solstice denies such allegations.

G. Answer to Allegations Regarding Infringement (Count III — The '105 Patent)

19. In response to the allegations set forth in Count III of the Complaint, which asserts infringement of the '105 Patent, Solstice denies that the PrecisionEdge™ PE-12000 Series or PE-15000 Series literally infringes Claims 1, 4, or 8 of U.S. Patent No. 10,932,105, or any other claim thereof.

20. Solstice denies that any of the PrecisionEdge™ products infringes any claim of the '105 Patent under the doctrine of equivalents. The insufflation and sealing features employed in the PrecisionEdge™ products differ materially from the "integrated insufflation valve and seal" recited in the claims of the '105 Patent. The accused products do not employ an integrated insufflation valve and seal as that term is properly construed in the context of the '105 Patent and its prosecution history.

21. Solstice denies that it has willfully infringed any claim of the '105 Patent. At all relevant times, Solstice held a good-faith belief that the PrecisionEdge™ products did not infringe the '105 Patent.

22. Solstice denies that Apex is entitled to any damages, enhanced damages, attorneys' fees, injunctive relief, or any other relief in connection with Count III. To the extent any additional allegations are contained in Count III that are not specifically addressed above, Solstice denies such allegations.

H. Answer to Allegations Regarding Damages

23. Solstice denies that Apex is entitled to any damages whatsoever, including but not limited to lost profits, reasonable royalty damages, or any other measure of damages.

24. Solstice denies that Apex has suffered any cognizable injury or harm as a result of Solstice's conduct. Apex's allegations of damages are speculative, unsupported, and do not satisfy the requirements of proof imposed by 35 U.S.C. § 284 and applicable precedent.

25. Solstice states that, in the event the Court were to find infringement of any claim of the Asserted Patents (which finding Solstice expressly denies is warranted), any damages awarded must be limited to those proven with reasonable certainty and apportioned to the patented feature in accordance with 35 U.S.C. § 284 and the principles set forth in Rite-Hite Corp. v. Kelley Co., 56 F.3d 1538 (Fed. Cir. 1995), and their progeny. Any reasonable royalty must be based on the incremental value of the claimed invention over the prior art, consistent with Uniloc USA, Inc. v. Kestrel Partners LLC, 632 F.3d 1292 (Fed. Cir. 2011), and applicable law.

26. Solstice denies that this case is "exceptional" within the meaning of 35 U.S.C. § 285 or that Apex is entitled to an award of attorneys' fees.

I. General Denial

27. Solstice denies each and every allegation of the Complaint that is not specifically and expressly admitted in this Answer. To the extent any allegation requires a response that is not set forth above, Solstice denies such allegation.

28. Solstice reserves the right to amend this Answer, including to add, modify, or withdraw admissions or denials, upon the completion of further investigation and discovery in this action.

PART II

AFFIRMATIVE DEFENSES

Without assuming any burden of proof or persuasion that it would not otherwise bear, and without waiving any defense or argument available at law or in equity, Solstice asserts the following affirmative defenses to the claims asserted in Apex's Complaint:

FIRST AFFIRMATIVE DEFENSE: Non-Infringement

29. The PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series do not infringe, either literally or under the doctrine of equivalents, any valid and enforceable claim of the '237 Patent, the '884 Patent, or the '105 Patent. The accused products do not practice one or more limitations of each asserted claim of the Asserted Patents, including without limitation: (a) the "locking seal assembly" limitations of the '237 Patent, including the claimed structural arrangement and functional interrelationship of the seal components; (b) the "retractable blade deployment mechanism" limitations of the '884 Patent, including the claimed spring-loaded retraction and trigger-actuated deployment features; and (c) the "integrated insufflation valve and seal" limitations of the '105 Patent, including the claimed unitary construction and dual-function operation of the valve and seal elements.

30. The PrecisionEdge™ products were independently designed by Solstice's engineering team and employ distinct structural and functional approaches to achieving sealing, blade deployment, and insufflation that are materially different from the inventions claimed in the Asserted Patents. Solstice will demonstrate through claim construction, technical analysis, and expert testimony that the accused products do not meet the claim limitations of the Asserted Patents under any proper construction.

SECOND AFFIRMATIVE DEFENSE: Invalidity — Anticipation (35 U.S.C. § 102)

31. One or more of the asserted claims of the '237 Patent, the '884 Patent, and the '105 Patent are invalid as anticipated under 35 U.S.C. § 102 by one or more prior art references, including but not limited to prior patents, printed publications, and prior public uses or offers for sale that predate the effective filing dates of the Asserted Patents. Each element of the asserted claims, arranged as claimed, is disclosed in one or more prior art references that were either not considered or not adequately considered by the USPTO during prosecution of the Asserted Patents.

32. Solstice reserves the right to identify with specificity the prior art references and the claim-by-claim basis for this defense in its invalidity contentions served in accordance with the Court's scheduling order, and further reserves the right to supplement this defense as additional prior art is identified through discovery and investigation.

THIRD AFFIRMATIVE DEFENSE: Invalidity — Obviousness (35 U.S.C. § 103)

33. One or more of the asserted claims of the '237 Patent, the '884 Patent, and the '105 Patent are invalid as obvious under 35 U.S.C. § 103 in view of the prior art, whether considered individually or in combination. The claimed inventions represent no more than the predictable combination of known elements in the field of laparoscopic and minimally invasive surgical access devices, yielding predictable results to a person of ordinary skill in the art at the time of the alleged inventions.

34. The asserted claims amount to routine design choices that would have been obvious to a person of ordinary skill in the art of surgical device engineering, in view of the well-developed state of the prior art in the areas of trocar seal assemblies, blade deployment mechanisms, and insufflation valves. A person of ordinary skill in the art would have been motivated to combine the teachings of the relevant prior art references, and would have had a reasonable expectation of success in doing so, given the established body of knowledge in this technological field. No objective indicia of nonobviousness, including commercial success, long-felt need, failure of others, or unexpected results, overcome the strong prima facie case of obviousness.

35. Solstice reserves the right to identify with specificity the prior art references and combinations forming the basis for this defense in its invalidity contentions.

FOURTH AFFIRMATIVE DEFENSE: Invalidity — Lack of Written Description (35 U.S.C. § 112(a))

36. One or more of the asserted claims of the '237 Patent, the '884 Patent, and the '105 Patent are invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112(a). The specifications of one or more of the Asserted Patents do not adequately describe the full scope of the claimed inventions in sufficient detail to demonstrate that the named inventor or inventors had possession of the claimed subject matter at the time of filing the relevant patent applications. The claims of the Asserted Patents, as construed in light of the prosecution history and in view of the art, encompass subject matter that extends beyond what the specifications disclose as within the possession of the inventors.

FIFTH AFFIRMATIVE DEFENSE: Invalidity — Lack of Enablement (35 U.S.C. § 112(a))

37. One or more of the asserted claims of the '237 Patent, the '884 Patent, and the '105 Patent are invalid for failure to satisfy the enablement requirement of 35 U.S.C. § 112(a). The specifications of one or more of the Asserted Patents do not enable a person of ordinary skill in the art to make and use the full scope of the claimed inventions without undue experimentation. The breadth of the claims, as properly construed, exceeds the scope of the enabling disclosure in the specifications, and the amount of experimentation required to practice the full scope of the claims would be unreasonable in light of the factors set forth in In re Wands, 858 F.2d 731 (Fed. Cir. 1988).

SIXTH AFFIRMATIVE DEFENSE: Invalidity — Indefiniteness (35 U.S.C. § 112(b))

38. One or more of the asserted claims of the '237 Patent, the '884 Patent, and the '105 Patent are invalid as indefinite under 35 U.S.C. § 112(b). The asserted claims fail to particularly point out and distinctly claim the subject matter regarded as the invention with reasonable certainty, as required by Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014). Certain claim terms used in the Asserted Patents are ambiguous, lack clear antecedent basis, or are susceptible to multiple reasonable constructions such that a person of ordinary skill in the art, reading the claims in light of the specification and prosecution history, would not be reasonably certain of the scope of the claimed invention.

SEVENTH AFFIRMATIVE DEFENSE: Inequitable Conduct

39. One or more of the Asserted Patents are unenforceable, in whole or in part, due to inequitable conduct committed before the USPTO during the prosecution of the applications that matured into the Asserted Patents.

40. On information and belief, the named inventor, Dr. Raymond Szabo, who serves as Vice President of Engineering at Apex, and/or Apex's patent prosecution counsel, had a duty of candor and good faith before the USPTO pursuant to 37 C.F.R. § 1.56 and failed to disclose material prior art references known to them during the prosecution of one or more of the Asserted Patents. On information and belief, such persons withheld material information from the USPTO with the specific intent to deceive the Patent Office and to obtain claims to which they were not entitled.

41. The material information withheld from the USPTO would have been highly relevant to the patentability of the asserted claims and, but for the withholding of such information, one or more of the asserted claims would not have been allowed. The materiality of the withheld information and the intent to deceive satisfy the clear and convincing evidence standard established in Brightmoor & Co., Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc).

42. Solstice reserves the right to supplement and amend this defense as further facts are developed during discovery, including through the review of Apex's prosecution files, inventor notebooks, communications with patent prosecution counsel, and other documents and testimony bearing on the conduct of the applicants and their representatives before the USPTO.

EIGHTH AFFIRMATIVE DEFENSE: Prosecution History Estoppel

43. The scope of the asserted claims of the '237 Patent, the '884 Patent, and the '105 Patent is limited by narrowing amendments, arguments, and representations made by the applicants and their representatives during prosecution of the Asserted Patents before the USPTO. To the extent Apex seeks to assert claim constructions or infringement theories under the doctrine of equivalents that encompass subject matter surrendered or disclaimed during prosecution, Apex is estopped from doing so under the doctrine of prosecution history estoppel. See Festo Corp. v. Fenmore & Co., 535 U.S. 722 (2002).

44. Apex may not, through claim construction arguments or equivalents theories, seek to recapture claim scope that was narrowed, limited, or surrendered during prosecution to overcome prior art rejections, to satisfy the requirements of 35 U.S.C. § 112, or for any other reason related to patentability.

NINTH AFFIRMATIVE DEFENSE: Laches

45. To the extent applicable and not preempted by SCA Hygiene Products Aktiebolag v. First Quality Baby Products, LLC, 580 U.S. 328 (2017), Apex's claims for damages are barred or limited, in whole or in part, by the equitable doctrine of laches. On information and belief, Apex became aware of the PrecisionEdge™ products and their allegedly infringing features well before the filing of this action on May 9, 2024, yet unreasonably and inexcusably delayed in bringing this lawsuit. Solstice has been prejudiced by Apex's delay, including through the continued investment in and expansion of the PrecisionEdge™ product line in reliance on Apex's failure to assert its purported patent rights.

TENTH AFFIRMATIVE DEFENSE: Estoppel

46. Apex is estopped, in whole or in part, from asserting infringement of the Asserted Patents based on its knowledge of and acquiescence to Solstice's design, manufacture, marketing, and sale of the PrecisionEdge™ products prior to the filing of the Complaint. On information and belief, Apex was aware of Solstice's activities in the marketplace, including through industry trade shows, published product catalogs, FDA 510(k) clearances, and other public disclosures, and either expressly or impliedly acquiesced in those activities over a substantial period of time. Solstice reasonably relied on Apex's acquiescence and would be materially prejudiced if Apex were now permitted to assert its purported patent rights.

ELEVENTH AFFIRMATIVE DEFENSE: Failure to Mark (35 U.S.C. § 287)

47. Apex's damages, if any, are limited pursuant to 35 U.S.C. § 287(a) because Apex has failed to comply with the patent marking requirements of that statute with respect to products covered by one or more of the Asserted Patents. On information and belief, Apex manufactures, sells, offers for sale, and distributes products that practice one or more claims of the '237 Patent, the '884 Patent, and/or the '105 Patent, and has failed to mark such products—or their packaging—with the relevant patent numbers, or to provide constructive notice through virtual marking as permitted under 35 U.S.C. § 287(a).

48. In the absence of proper marking or actual notice, Apex is not entitled to recover damages for any period prior to the date it provided actual notice of infringement to Solstice. Solstice avers that it did not receive actual notice of the alleged infringement until no earlier than the date of service of the Complaint on May 23, 2024, or at the earliest, the date the Complaint was filed on May 9, 2024. Accordingly, any recovery of damages, if otherwise warranted, must be limited to the period commencing on or after such date.

TWELFTH AFFIRMATIVE DEFENSE: No Willful Infringement

49. Solstice did not willfully infringe any claim of the '237 Patent, the '884 Patent, or the '105 Patent. At all relevant times, Solstice held a good-faith belief that the PrecisionEdge™ products did not infringe the Asserted Patents and that the Asserted Patents were invalid. Solstice's conduct does not rise to the level of egregious, deliberate, or wanton infringement that would warrant enhanced damages under 35 U.S.C. § 284 or the framework established in Halo Electronics, Inc. v. Pulse Electronics, Inc., 579 U.S. 93 (2016). Apex is not entitled to enhanced damages, treble damages, or any punitive award.

THIRTEENTH AFFIRMATIVE DEFENSE: This Is Not an Exceptional Case

50. This case is not "exceptional" within the meaning of 35 U.S.C. § 285. Apex's claims do not present the type of case that "stands out from others with respect to the substantive strength of a party's litigating position" or "the unreasonable manner in which the case was litigated," as required under Octane Fitness, LLC v. ICON Health & Fitness, Inc., 572 U.S. 545 (2014). Apex is not entitled to an award of its attorneys' fees, and no basis exists for such an award.

Reservation of Defenses

51. Solstice reserves the right to assert additional affirmative defenses as may become appropriate based on information obtained during the course of this litigation, including through fact discovery, expert discovery, claim construction proceedings, and the development of the evidentiary record. The assertion of affirmative defenses herein is not intended to constitute a waiver of any defense or argument that may be available to Solstice at law or in equity, whether currently known or hereafter discovered.

PART III

COUNTERCLAIMS

Solstice Biomedical, Inc., as Counterclaim Plaintiff, hereby asserts the following Counterclaims against Apex Surgical Innovations, Inc., as Counterclaim Defendant:

COUNTERCLAIM PARTIES.

52. Counterclaim Plaintiff Solstice Biomedical, Inc. is a corporation organized and existing under the laws of the State of Delaware, with principal offices at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803. Solstice is the U.S. operating subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company. Solstice designs, develops, manufactures, markets, distributes, and sells minimally invasive surgical instruments, including the PrecisionEdge™ line of laparoscopic trocar assemblies.

53. Counterclaim Defendant Apex Surgical Innovations, Inc. is a corporation organized and existing under the laws of the State of Delaware, with its principal office at 1220 North Market Street, Suite 550, Wilmington, Delaware 19801. Apex is the plaintiff in the above-captioned action and the owner of the Asserted Patents.

JURISDICTION AND VENUE

54. This Court has subject matter jurisdiction over these Counterclaims pursuant to 28 U.S.C. §§ 1331, 1338(a), and 2201. These Counterclaims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201–2202, and the patent laws of the United States, 35 U.S.C. § 1 et seq.

55. There exists an actual, justiciable case or controversy between Solstice and Apex regarding whether the PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series infringe the Asserted Patents, and whether the asserted claims of the Asserted Patents are valid. Apex has asserted that Solstice's products infringe the Asserted Patents, and Solstice denies such infringement and contends that the Asserted Patents are invalid. This controversy is real, immediate, and substantial, and a judicial determination of the parties' respective rights is necessary and appropriate to resolve the dispute.

56. Venue is proper in this District for the Counterclaims under 28 U.S.C. §§ 1391 and 1400(b) for the same reasons that venue is proper for the claims asserted in Apex's Complaint.

FACTUAL BACKGROUND.

57. Solstice Biomedical, Inc. was founded in 2011 and has since established itself as a designer and manufacturer of high-quality minimally invasive surgical instruments. Solstice's product portfolio includes the PrecisionEdge™ line of laparoscopic trocar assemblies, which are used by surgeons in operating rooms throughout the United States and internationally.

58. Solstice independently designed, developed, and commercialized the PrecisionEdge™ PE-5000 Series (5 mm), PE-12000 Series (12 mm), and PE-15000 Series (15 mm) laparoscopic trocar assemblies. The design and engineering of the PrecisionEdge™ products were the result of Solstice's own internal research and development efforts, conducted by Solstice's engineering team without reference to or reliance upon the Asserted Patents or Apex's products.

59. On May 9, 2024, Apex filed the Complaint in this action, alleging that the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series infringe the '237 Patent, the '884 Patent, and the '105 Patent. Solstice was served with the Complaint on May 23, 2024, through its registered agent, Pemberton Industries, located in Wilmington, Delaware.

60. A justiciable controversy exists between the parties as to whether the PrecisionEdge™ products infringe any valid and enforceable claim of the Asserted Patents and as to whether the asserted claims of the Asserted Patents are valid.

COUNTERCLAIM I: Declaratory Judgment of Non-Infringement of the '237 Patent

61. Solstice incorporates by reference and re-alleges Paragraphs 52 through 60 above as though fully set forth herein.

62. Solstice seeks a declaratory judgment under 28 U.S.C. §§ 2201–2202 that the PrecisionEdge™ PE-5000 Series and PE-12000 Series do not infringe, either literally or under the doctrine of equivalents, any asserted claim of U.S. Patent No. 9,814,237, including without limitation Claims 1, 3, 7, and 12.

63. The '237 Patent is titled "Locking Seal Assembly for Minimally Invasive Surgical Access Device" and was issued by the USPTO on November 14, 2017. On information and belief, the '237 Patent has an expiration date of June 22, 2035, subject to any applicable terminal disclaimers, patent term adjustments, or patent term extensions.

64. The PrecisionEdge™ PE-5000 Series and PE-12000 Series employ a fundamentally different design for their seal mechanisms than that claimed in the '237 Patent. Specifically, the PrecisionEdge™ products do not incorporate a "locking seal assembly" as that term is defined by the claims of the '237 Patent when construed in light of the specification and prosecution history. The seal mechanisms in the PrecisionEdge™ products operate through a structurally and functionally distinct approach that does not satisfy one or more limitations of the asserted claims.

65. Solstice is entitled to a declaratory judgment that the PrecisionEdge™ PE-5000 Series and PE-12000 Series do not infringe any asserted claim of the '237 Patent.

COUNTERCLAIM II: Declaratory Judgment of Non-Infringement of the '884 Patent

66. Solstice incorporates by reference and re-alleges Paragraphs 52 through 60 above as though fully set forth herein.

67. Solstice seeks a declaratory judgment under 28 U.S.C. §§ 2201–2202 that the PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series do not infringe, either literally or under the doctrine of equivalents, any asserted claim of U.S. Patent No. 10,271,884, including without limitation Claims 1, 2, 5, 9, and 14.

68. The '884 Patent is titled "Retractable Blade Deployment Mechanism for Trocar Systems" and was issued by the USPTO on April 30, 2019. On information and belief, the '884 Patent has an expiration date of September 15, 2036, subject to any applicable terminal disclaimers, patent term adjustments, or patent term extensions.

69. The blade deployment mechanisms in the PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series operate differently from the "retractable blade deployment mechanism" claimed in the '884 Patent. The PrecisionEdge™ products employ a distinct blade actuation architecture that does not incorporate the structural features, functional relationships, or operational sequences recited in the asserted claims of the '884 Patent. No element of the PrecisionEdge™ blade deployment system corresponds to or is equivalent to the claimed "retractable blade deployment mechanism."

70. Solstice is entitled to a declaratory judgment that the PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series do not infringe any asserted claim of the '884 Patent.

COUNTERCLAIM III: Declaratory Judgment of Non-Infringement of the '105 Patent

71. Solstice incorporates by reference and re-alleges Paragraphs 52 through 60 above as though fully set forth herein.

72. Solstice seeks a declaratory judgment under 28 U.S.C. §§ 2201–2202 that the PrecisionEdge™ PE-12000 Series and PE-15000 Series do not infringe, either literally or under the doctrine of equivalents, any asserted claim of U.S. Patent No. 10,932,105, including without limitation Claims 1, 4, and 8.

73. The '105 Patent is titled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar" and was issued by the USPTO on March 2, 2021. On information and belief, the '105 Patent has an expiration date of January 10, 2038, subject to any applicable terminal disclaimers, patent term adjustments, or patent term extensions.

74. The PrecisionEdge™ PE-12000 Series and PE-15000 Series do not employ an "integrated insufflation valve and seal" as defined by the claims of the '105 Patent. The insufflation and sealing features of the PrecisionEdge™ products utilize a separate-component design architecture that is structurally and functionally distinct from the integrated, unitary construction claimed in the '105 Patent. The accused products do not satisfy one or more limitations of the asserted claims of the '105 Patent under any proper construction.

75. Solstice is entitled to a declaratory judgment that the PrecisionEdge™ PE-12000 Series and PE-15000 Series do not infringe any asserted claim of the '105 Patent.

COUNTERCLAIM IV: Declaratory Judgment of Invalidity of the '237 Patent

76. Solstice incorporates by reference and re-alleges Paragraphs 52 through 60 above as though fully set forth herein.

77. Solstice seeks a declaratory judgment under 28 U.S.C. §§ 2201–2202 that Claims 1, 3, 7, and 12 of U.S. Patent No. 9,814,237 are invalid under one or more of 35 U.S.C. §§ 102, 103, and/or 112.

78. On information and belief, the asserted claims of the '237 Patent are anticipated under 35 U.S.C. § 102 by one or more prior art references, including prior patents, printed publications, and public uses or sales activity, that disclose every element of the asserted claims as arranged therein and that predate the effective filing date of the '237 Patent.

79. On information and belief, the asserted claims of the '237 Patent are rendered obvious under 35 U.S.C. § 103 in view of the prior art, whether considered individually or in combination. The subject matter claimed in Claims 1, 3, 7, and 12 would have been obvious to a person of ordinary skill in the art of surgical access devices at the time the alleged invention was made.

80. On information and belief, one or more of the asserted claims of the '237 Patent fail to satisfy the written description requirement of 35 U.S.C. § 112(a), the enablement requirement of 35 U.S.C. § 112(a), and/or the definiteness requirement of 35 U.S.C. § 112(b).

81. Solstice reserves the right to identify with specificity the prior art references and the claim-by-claim basis for invalidity in its invalidity contentions to be served in accordance with the Court's scheduling order.

COUNTERCLAIM V: Declaratory Judgment of Invalidity of the '884 Patent

82. Solstice incorporates by reference and re-alleges Paragraphs 52 through 60 above as though fully set forth herein.

83. Solstice seeks a declaratory judgment under 28 U.S.C. §§ 2201–2202 that Claims 1, 2, 5, 9, and 14 of U.S. Patent No. 10,271,884 are invalid under one or more of 35 U.S.C. §§ 102, 103, and/or 112.

84. On information and belief, the asserted claims of the '884 Patent are anticipated under 35 U.S.C. § 102 by one or more prior art references, including prior patents, printed publications, and public uses or sales activity, that disclose every element of the asserted claims as arranged therein and that predate the effective filing date of the '884 Patent.

85. On information and belief, the asserted claims of the '884 Patent are rendered obvious under 35 U.S.C. § 103 in view of the prior art, whether considered individually or in combination. The subject matter claimed in Claims 1, 2, 5, 9, and 14 would have been obvious to a person of ordinary skill in the art of trocar and surgical instrument design at the time the alleged invention was made.

86. On information and belief, one or more of the asserted claims of the '884 Patent fail to satisfy the written description requirement of 35 U.S.C. § 112(a), the enablement requirement of 35 U.S.C. § 112(a), and/or the definiteness requirement of 35 U.S.C. § 112(b).

87. Solstice reserves the right to identify with specificity the prior art references and the claim-by-claim basis for invalidity in its invalidity contentions to be served in accordance with the Court's scheduling order.

COUNTERCLAIM VI: Declaratory Judgment of Invalidity of the '105 Patent

88. Solstice incorporates by reference and re-alleges Paragraphs 52 through 60 above as though fully set forth herein.

89. Solstice seeks a declaratory judgment under 28 U.S.C. §§ 2201–2202 that Claims 1, 4, and 8 of U.S. Patent No. 10,932,105 are invalid under one or more of 35 U.S.C. §§ 102, 103, and/or 112.

90. On information and belief, the asserted claims of the '105 Patent are anticipated under 35 U.S.C. § 102 by one or more prior art references, including prior patents, printed publications, and public uses or sales activity, that disclose every element of the asserted claims as arranged therein and that predate the effective filing date of the '105 Patent.

91. On information and belief, the asserted claims of the '105 Patent are rendered obvious under 35 U.S.C. § 103 in view of the prior art, whether considered individually or in combination. The subject matter claimed in Claims 1, 4, and 8 would have been obvious to a person of ordinary skill in the art of laparoscopic trocar and insufflation system design at the time the alleged invention was made.

92. On information and belief, one or more of the asserted claims of the '105 Patent fail to satisfy the written description requirement of 35 U.S.C. § 112(a), the enablement requirement of 35 U.S.C. § 112(a), and/or the definiteness requirement of 35 U.S.C. § 112(b).

93. Solstice reserves the right to identify with specificity the prior art references and the claim-by-claim basis for invalidity in its invalidity contentions to be served in accordance with the Court's scheduling order.

PRAYER FOR RELIEF

WHEREFORE, Defendant and Counterclaim Plaintiff Solstice Biomedical, Inc. respectfully requests that this Court enter judgment in its favor and against Plaintiff and Counterclaim Defendant Apex Surgical Innovations, Inc. as follows:

1. That the Complaint of Apex Surgical Innovations, Inc. be dismissed in its entirety and with prejudice, and that judgment be entered in favor of Solstice Biomedical, Inc. on all claims asserted by Apex in the Complaint;

2. That the Court enter a declaratory judgment that Solstice Biomedical, Inc. has not infringed, and does not infringe, any valid and enforceable claim of U.S. Patent Nos. 9,814,237, 10,271,884, or 10,932,105, either literally or under the doctrine of equivalents;

3. That the Court enter a declaratory judgment that Claims 1, 3, 7, and 12 of U.S. Patent No. 9,814,237 are invalid;

4. That the Court enter a declaratory judgment that Claims 1, 2, 5, 9, and 14 of U.S. Patent No. 10,271,884 are invalid;

5. That the Court enter a declaratory judgment that Claims 1, 4, and 8 of U.S. Patent No. 10,932,105 are invalid;

6. That the Court declare the Asserted Patents unenforceable, in whole or in part, due to inequitable conduct before the USPTO;

7. That Apex Surgical Innovations, Inc. be denied any and all relief sought in the Complaint, including but not limited to compensatory damages, enhanced damages, treble damages, injunctive relief (whether preliminary or permanent), attorneys' fees, costs, and pre-judgment and post-judgment interest;

8. That the Court find this case to be exceptional under 35 U.S.C. § 285 and award Solstice Biomedical, Inc. its reasonable attorneys' fees and costs incurred in this action;

9. That the Court award Solstice Biomedical, Inc. its costs of suit; and

10. That the Court award Solstice Biomedical, Inc. such other and further relief as the Court deems just and proper.

DEMAND FOR JURY TRIAL

Pursuant to Rule 38 of the Federal Rules of Civil Procedure, Defendant and Counterclaim Plaintiff Solstice Biomedical, Inc. hereby demands a trial by jury on all issues so triable in this action, including all claims asserted in the Complaint, all Counterclaims asserted herein, and all affirmative defenses, to the fullest extent permitted by law.

Dated: June 14, 2024

Respectfully submitted,

CALDERWOOD & HARKNESS LLP

/s/ Marcus Delgado

Marcus Delgado (Del. Bar No. 5738) Responsible Partner, intellectual Property Litigation

Christy Bauer (Del. Bar No. 6214) Lead Associate, intellectual Property Litigation

Peter Vassiliev (Del. Bar No. 6592) Working Associate, intellectual Property Litigation

1201 Market Street, Suite 2500 Wilmington, Delaware 19801 Telephone: (302) 658-4700 Facsimile: (302) 658-4701

Email: mdelgado@calderwoodharkness.com

Email: cbauer@calderwoodharkness.com

Email: pvassiliev@calderwoodharkness.com

Counsel for Defendant and Counterclaim Plaintiff Solstice Biomedical, Inc.

CERTIFICATE OF SERVICE

I, Marcus Delgado, hereby certify that on June 14, 2024, I caused the foregoing Defendant Solstice Biomedical, Inc.'s Answer, Affirmative Defenses, and Counterclaims to be electronically filed with the Clerk of Court via the Court's CM/ECF electronic filing system, which will automatically serve a true and correct copy of the foregoing document on all counsel of record who have registered to receive electronic notices in this case, including:

Victoria Stanton, Esq. Derek Loomis, Esq. HARGROVE, TATE & BENNINGTON LLP 900 North King Street, Suite 1200 Wilmington, Delaware 19801 Telephone: (302) 571-6300 Facsimile: (302) 571-6301

Email: vstanton@htblaw.com

Email: dloomis@htblaw.com

Counsel for Plaintiff and Counterclaim Defendant Apex Surgical Innovations, Inc.

/s/ Marcus Delgado

Marcus Delgado (Del. Bar No. 5738) CALDERWOOD & HARKNESS LLP

APEX SURGICAL INNOVATIONS, INC.,

Plaintiff,

v.	Case No. 1:24-cv-00587-RGA
SOLSTICE BIOMEDICAL, INC.,	Chief Judge Richard G. Andrews

Defendant.

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
DEFENDANT SOLSTICE BIOMEDICAL, INC.'S ANSWER, AFFIRMATIVE DEFENSES, AND COUNTERCLAIMS
Defendant Solstice Biomedical, Inc. ("Solstice" or "Defendant"), by and through its undersigned counsel, Calderwood & Harkness LLP, hereby respectfully answers the Complaint filed by Plaintiff Apex Surgical Innovations, Inc. ("Apex" or "Plaintiff") on May 9, 2024 (Dkt. No. 1) (the "Complaint"), and asserts affirmative defenses and counterclaims as set forth below. Solstice Biomedical, Inc. is a Delaware corporation (EIN: 84-3291056) with principal offices at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803, and is the U.S. operating subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company (CRO No. 648217) with registered office at Unit 14, Clonskeagh Business Park, Clonskeagh Road, Dublin 14, D14 YF28, Ireland.
Solstice denies that it has infringed any valid and enforceable claim of U.S. Patent Nos. 9,814,237 ("the '237 Patent"), 10,271,884 ("the '884 Patent"), or 10,932,105 ("the '105 Patent") (collectively, the "Asserted Patents"). Solstice further avers that the Asserted Patents are invalid and, at least in part, unenforceable for the reasons set forth herein.
To the extent any allegation of the Complaint is not specifically admitted below, it is denied. Solstice reserves the right to amend its Answer and to assert additional defenses or counterclaims as warranted by further investigation, discovery, and the development of the record in this action.
PART I
ANSWER TO COMPLAINT
Solstice responds to the numbered paragraphs of the Complaint as follows. The headings and paragraph numbers used herein correspond to the headings and paragraph numbers used in the Complaint, and are included for ease of reference only. To the extent that a heading or paragraph number does not correspond directly to a paragraph of the Complaint, no admission is made by the inclusion or omission of such heading or paragraph number.
A. Answer to Jurisdictional and Venue Allegations
1. Solstice admits that this action arises under the patent laws of the United States, 35 U.S.C. § 1 et seq., and that the Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1338(a).
2. Solstice admits that Solstice Biomedical, Inc. is a corporation organized and existing under the laws of the State of Delaware and does not contest personal jurisdiction in this District for purposes of this action.
3. Solstice admits that venue is proper in this District under 28 U.S.C. §§ 1391 and 1400(b).
B. Answer to Allegations Regarding the Parties
4. Solstice admits that Apex Surgical Innovations, Inc. is a corporation organized and existing under the laws of the State of Delaware with its principal office at 1220 North Market Street, Suite 550, Wilmington, Delaware 19801. Solstice further admits that Apex is in the business of developing and manufacturing surgical access devices. Solstice lacks knowledge or information sufficient to form a belief as to the truth of Apex's characterization of its annual revenue, its approximate employee count of approximately 1,100 employees, or other self-serving characterizations set forth in the Complaint, and therefore denies the same.
5. Solstice admits that Solstice Biomedical, Inc. is a corporation organized and existing under the laws of the State of Delaware with principal offices at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803. Solstice further admits that it designs, develops, manufactures, markets, and sells minimally invasive surgical instruments, including laparoscopic trocars, endoscopic graspers, and electrosurgical hand instruments. Solstice denies any allegation in the Complaint that characterizes Solstice's products, product designs, or product features as infringing any valid and enforceable claim of any of the Asserted Patents. To the extent the Complaint contains additional characterizations regarding Solstice or its business activities not specifically admitted herein, such allegations are denied.
C. Answer to Allegations Regarding the Asserted Patents
6. With respect to the allegations of the Complaint concerning U.S. Patent No. 9,814,237 (the '237 Patent), Solstice admits that U.S. Patent No. 9,814,237, titled "Locking Seal Assembly for Minimally Invasive Surgical Access Device," was duly issued by the United States Patent and Trademark Office ("USPTO") on November 14, 2017. Solstice admits that the '237 Patent names Dr. Raymond Szabo as an inventor. Solstice admits, on information and belief, that the '237 Patent has been assigned to Apex. Solstice denies that the '237 Patent is valid and enforceable in all respects. Solstice specifically denies that any claim of the '237 Patent, including without limitation Claims 1, 3, 7, and 12, is infringed by any Solstice product, including any product in the PrecisionEdge™ line. To the extent the Complaint contains additional characterizations or legal conclusions concerning the '237 Patent not specifically admitted herein, Solstice denies the same.
7. With respect to the allegations of the Complaint concerning U.S. Patent No. 10,271,884 (the '884 Patent), Solstice admits that U.S. Patent No. 10,271,884, titled "Retractable Blade Deployment Mechanism for Trocar Systems," was duly issued by the USPTO on April 30, 2019. Solstice admits that the '884 Patent names Dr. Raymond Szabo as an inventor. Solstice admits, on information and belief, that the '884 Patent has been assigned to Apex. Solstice denies that the '884 Patent is valid and enforceable in all respects. Solstice specifically denies that any claim of the '884 Patent, including without limitation Claims 1, 2, 5, 9, and 14, is infringed by any Solstice product. To the extent the Complaint contains additional characterizations or legal conclusions concerning the '884 Patent not specifically admitted herein, Solstice denies the same.
8. With respect to the allegations of the Complaint concerning U.S. Patent No. 10,932,105 (the '105 Patent), Solstice admits that U.S. Patent No. 10,932,105, titled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar," was duly issued by the USPTO on March 2, 2021. Solstice admits that the '105 Patent names Dr. Raymond Szabo as an inventor. Solstice admits, on information and belief, that the '105 Patent has been assigned to Apex. Solstice denies that the '105 Patent is valid and enforceable in all respects. Solstice specifically denies that any claim of the '105 Patent, including without limitation Claims 1, 4, and 8, is infringed by any Solstice product. To the extent the Complaint contains additional characterizations or legal conclusions concerning the '105 Patent not specifically admitted herein, Solstice denies the same.
D. Answer to Allegations Regarding the Accused Products
9. Solstice admits that it manufactures, markets, distributes, and sells the PrecisionEdge™ line of laparoscopic trocar assemblies, which includes the PE-5000 Series (5 mm diameter), the PE-12000 Series (12 mm diameter), and the PE-15000 Series (15 mm diameter). Solstice denies that the PrecisionEdge™ PE-5000 Series infringes the '237 Patent or the '884 Patent. Solstice denies that the PrecisionEdge™ PE-12000 Series infringes the '237 Patent, the '884 Patent, or the '105 Patent. Solstice denies that the PrecisionEdge™ PE-15000 Series infringes the '884 Patent or the '105 Patent.
10. Solstice specifically denies each and every allegation that any PrecisionEdge™ product meets any limitation of any asserted claim of any of the Asserted Patents, whether literally or under the doctrine of equivalents. To the extent the Complaint alleges or implies that the PrecisionEdge™ products incorporate, practice, or embody any feature, element, component, or method step claimed in the Asserted Patents, Solstice denies such allegations. The PrecisionEdge™ products were independently designed and developed by Solstice's engineering team and employ designs that are fundamentally different from the claimed inventions of the Asserted Patents.
E. Answer to Allegations Regarding Infringement (Count I — The '237 Patent)
11. In response to the allegations set forth in Count I of the Complaint, which asserts infringement of the '237 Patent, Solstice denies that the PrecisionEdge™ PE-5000 Series or the PE-12000 Series literally infringes Claims 1, 3, 7, or 12 of U.S. Patent No. 9,814,237, or any other claim thereof.
12. Solstice denies that the PrecisionEdge™ PE-5000 Series or the PE-12000 Series infringes any claim of the '237 Patent under the doctrine of equivalents. No element of the accused products performs substantially the same function, in substantially the same way, to achieve substantially the same result as the corresponding limitations of the asserted claims.
13. Solstice denies that it has willfully infringed any claim of the '237 Patent. At all relevant times, Solstice maintained a good-faith belief that the PrecisionEdge™ products did not infringe the '237 Patent and that the asserted claims of the '237 Patent were invalid. Solstice's conduct has not been egregious or otherwise warranting enhanced damages under 35 U.S.C. § 284 or the standard set forth in Halo Electronics, Inc. v. Pulse Electronics, Inc., 579 U.S. 93 (2016).
14. Solstice denies that Apex is entitled to enhanced damages, attorneys' fees, injunctive relief, or any other relief in connection with Count I. To the extent any additional allegations are contained in Count I that are not specifically addressed above, Solstice denies such allegations.
F. Answer to Allegations Regarding Infringement (Count II — The '884 Patent)
15. In response to the allegations set forth in Count II of the Complaint, which asserts infringement of the '884 Patent, Solstice denies that the PrecisionEdge™ PE-5000 Series, PE-12000 Series, or PE-15000 Series literally infringes Claims 1, 2, 5, 9, or 14 of U.S. Patent No. 10,271,884, or any other claim thereof.
16. Solstice denies that any of the PrecisionEdge™ products infringes any claim of the '884 Patent under the doctrine of equivalents. The blade deployment mechanisms employed in the PrecisionEdge™ products are structurally and functionally distinct from the "retractable blade deployment mechanism" recited in the claims of the '884 Patent, and no equivalent relationship exists between the elements of the accused products and the claimed limitations.
17. Solstice denies that it has willfully infringed any claim of the '884 Patent. Solstice's design and commercialization of the PrecisionEdge™ products was undertaken in good faith and without any intent to infringe.
18. Solstice denies that Apex is entitled to enhanced damages, attorneys' fees, or any other relief in connection with Count II. To the extent any additional allegations are contained in Count II that are not specifically addressed above, Solstice denies such allegations.
G. Answer to Allegations Regarding Infringement (Count III — The '105 Patent)
19. In response to the allegations set forth in Count III of the Complaint, which asserts infringement of the '105 Patent, Solstice denies that the PrecisionEdge™ PE-12000 Series or PE-15000 Series literally infringes Claims 1, 4, or 8 of U.S. Patent No. 10,932,105, or any other claim thereof.
20. Solstice denies that any of the PrecisionEdge™ products infringes any claim of the '105 Patent under the doctrine of equivalents. The insufflation and sealing features employed in the PrecisionEdge™ products differ materially from the "integrated insufflation valve and seal" recited in the claims of the '105 Patent. The accused products do not employ an integrated insufflation valve and seal as that term is properly construed in the context of the '105 Patent and its prosecution history.
21. Solstice denies that it has willfully infringed any claim of the '105 Patent. At all relevant times, Solstice held a good-faith belief that the PrecisionEdge™ products did not infringe the '105 Patent.
22. Solstice denies that Apex is entitled to any damages, enhanced damages, attorneys' fees, injunctive relief, or any other relief in connection with Count III. To the extent any additional allegations are contained in Count III that are not specifically addressed above, Solstice denies such allegations.
H. Answer to Allegations Regarding Damages
23. Solstice denies that Apex is entitled to any damages whatsoever, including but not limited to lost profits, reasonable royalty damages, or any other measure of damages.
24. Solstice denies that Apex has suffered any cognizable injury or harm as a result of Solstice's conduct. Apex's allegations of damages are speculative, unsupported, and do not satisfy the requirements of proof imposed by 35 U.S.C. § 284 and applicable precedent.
25. Solstice states that, in the event the Court were to find infringement of any claim of the Asserted Patents (which finding Solstice expressly denies is warranted), any damages awarded must be limited to those proven with reasonable certainty and apportioned to the patented feature in accordance with 35 U.S.C. § 284 and the principles set forth in Rite-Hite Corp. v. Kelley Co., 56 F.3d 1538 (Fed. Cir. 1995), and their progeny. Any reasonable royalty must be based on the incremental value of the claimed invention over the prior art, consistent with Uniloc USA, Inc. v. Kestrel Partners LLC, 632 F.3d 1292 (Fed. Cir. 2011), and applicable law.
26. Solstice denies that this case is "exceptional" within the meaning of 35 U.S.C. § 285 or that Apex is entitled to an award of attorneys' fees.
I. General Denial
27. Solstice denies each and every allegation of the Complaint that is not specifically and expressly admitted in this Answer. To the extent any allegation requires a response that is not set forth above, Solstice denies such allegation.
28. Solstice reserves the right to amend this Answer, including to add, modify, or withdraw admissions or denials, upon the completion of further investigation and discovery in this action.
PART II
AFFIRMATIVE DEFENSES
Without assuming any burden of proof or persuasion that it would not otherwise bear, and without waiving any defense or argument available at law or in equity, Solstice asserts the following affirmative defenses to the claims asserted in Apex's Complaint:
FIRST AFFIRMATIVE DEFENSE: Non-Infringement
29. The PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series do not infringe, either literally or under the doctrine of equivalents, any valid and enforceable claim of the '237 Patent, the '884 Patent, or the '105 Patent. The accused products do not practice one or more limitations of each asserted claim of the Asserted Patents, including without limitation: (a) the "locking seal assembly" limitations of the '237 Patent, including the claimed structural arrangement and functional interrelationship of the seal components; (b) the "retractable blade deployment mechanism" limitations of the '884 Patent, including the claimed spring-loaded retraction and trigger-actuated deployment features; and (c) the "integrated insufflation valve and seal" limitations of the '105 Patent, including the claimed unitary construction and dual-function operation of the valve and seal elements.
30. The PrecisionEdge™ products were independently designed by Solstice's engineering team and employ distinct structural and functional approaches to achieving sealing, blade deployment, and insufflation that are materially different from the inventions claimed in the Asserted Patents. Solstice will demonstrate through claim construction, technical analysis, and expert testimony that the accused products do not meet the claim limitations of the Asserted Patents under any proper construction.
SECOND AFFIRMATIVE DEFENSE: Invalidity — Anticipation (35 U.S.C. § 102)
31. One or more of the asserted claims of the '237 Patent, the '884 Patent, and the '105 Patent are invalid as anticipated under 35 U.S.C. § 102 by one or more prior art references, including but not limited to prior patents, printed publications, and prior public uses or offers for sale that predate the effective filing dates of the Asserted Patents. Each element of the asserted claims, arranged as claimed, is disclosed in one or more prior art references that were either not considered or not adequately considered by the USPTO during prosecution of the Asserted Patents.
32. Solstice reserves the right to identify with specificity the prior art references and the claim-by-claim basis for this defense in its invalidity contentions served in accordance with the Court's scheduling order, and further reserves the right to supplement this defense as additional prior art is identified through discovery and investigation.
THIRD AFFIRMATIVE DEFENSE: Invalidity — Obviousness (35 U.S.C. § 103)
33. One or more of the asserted claims of the '237 Patent, the '884 Patent, and the '105 Patent are invalid as obvious under 35 U.S.C. § 103 in view of the prior art, whether considered individually or in combination. The claimed inventions represent no more than the predictable combination of known elements in the field of laparoscopic and minimally invasive surgical access devices, yielding predictable results to a person of ordinary skill in the art at the time of the alleged inventions.
34. The asserted claims amount to routine design choices that would have been obvious to a person of ordinary skill in the art of surgical device engineering, in view of the well-developed state of the prior art in the areas of trocar seal assemblies, blade deployment mechanisms, and insufflation valves. A person of ordinary skill in the art would have been motivated to combine the teachings of the relevant prior art references, and would have had a reasonable expectation of success in doing so, given the established body of knowledge in this technological field. No objective indicia of nonobviousness, including commercial success, long-felt need, failure of others, or unexpected results, overcome the strong prima facie case of obviousness.
35. Solstice reserves the right to identify with specificity the prior art references and combinations forming the basis for this defense in its invalidity contentions.
FOURTH AFFIRMATIVE DEFENSE: Invalidity — Lack of Written Description (35 U.S.C. § 112(a))
36. One or more of the asserted claims of the '237 Patent, the '884 Patent, and the '105 Patent are invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112(a). The specifications of one or more of the Asserted Patents do not adequately describe the full scope of the claimed inventions in sufficient detail to demonstrate that the named inventor or inventors had possession of the claimed subject matter at the time of filing the relevant patent applications. The claims of the Asserted Patents, as construed in light of the prosecution history and in view of the art, encompass subject matter that extends beyond what the specifications disclose as within the possession of the inventors.
FIFTH AFFIRMATIVE DEFENSE: Invalidity — Lack of Enablement (35 U.S.C. § 112(a))
37. One or more of the asserted claims of the '237 Patent, the '884 Patent, and the '105 Patent are invalid for failure to satisfy the enablement requirement of 35 U.S.C. § 112(a). The specifications of one or more of the Asserted Patents do not enable a person of ordinary skill in the art to make and use the full scope of the claimed inventions without undue experimentation. The breadth of the claims, as properly construed, exceeds the scope of the enabling disclosure in the specifications, and the amount of experimentation required to practice the full scope of the claims would be unreasonable in light of the factors set forth in In re Wands, 858 F.2d 731 (Fed. Cir. 1988).
SIXTH AFFIRMATIVE DEFENSE: Invalidity — Indefiniteness (35 U.S.C. § 112(b))
38. One or more of the asserted claims of the '237 Patent, the '884 Patent, and the '105 Patent are invalid as indefinite under 35 U.S.C. § 112(b). The asserted claims fail to particularly point out and distinctly claim the subject matter regarded as the invention with reasonable certainty, as required by Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014). Certain claim terms used in the Asserted Patents are ambiguous, lack clear antecedent basis, or are susceptible to multiple reasonable constructions such that a person of ordinary skill in the art, reading the claims in light of the specification and prosecution history, would not be reasonably certain of the scope of the claimed invention.
SEVENTH AFFIRMATIVE DEFENSE: Inequitable Conduct
39. One or more of the Asserted Patents are unenforceable, in whole or in part, due to inequitable conduct committed before the USPTO during the prosecution of the applications that matured into the Asserted Patents.
40. On information and belief, the named inventor, Dr. Raymond Szabo, who serves as Vice President of Engineering at Apex, and/or Apex's patent prosecution counsel, had a duty of candor and good faith before the USPTO pursuant to 37 C.F.R. § 1.56 and failed to disclose material prior art references known to them during the prosecution of one or more of the Asserted Patents. On information and belief, such persons withheld material information from the USPTO with the specific intent to deceive the Patent Office and to obtain claims to which they were not entitled.
41. The material information withheld from the USPTO would have been highly relevant to the patentability of the asserted claims and, but for the withholding of such information, one or more of the asserted claims would not have been allowed. The materiality of the withheld information and the intent to deceive satisfy the clear and convincing evidence standard established in Brightmoor & Co., Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc).
42. Solstice reserves the right to supplement and amend this defense as further facts are developed during discovery, including through the review of Apex's prosecution files, inventor notebooks, communications with patent prosecution counsel, and other documents and testimony bearing on the conduct of the applicants and their representatives before the USPTO.
EIGHTH AFFIRMATIVE DEFENSE: Prosecution History Estoppel
43. The scope of the asserted claims of the '237 Patent, the '884 Patent, and the '105 Patent is limited by narrowing amendments, arguments, and representations made by the applicants and their representatives during prosecution of the Asserted Patents before the USPTO. To the extent Apex seeks to assert claim constructions or infringement theories under the doctrine of equivalents that encompass subject matter surrendered or disclaimed during prosecution, Apex is estopped from doing so under the doctrine of prosecution history estoppel. See Festo Corp. v. Fenmore & Co., 535 U.S. 722 (2002).
44. Apex may not, through claim construction arguments or equivalents theories, seek to recapture claim scope that was narrowed, limited, or surrendered during prosecution to overcome prior art rejections, to satisfy the requirements of 35 U.S.C. § 112, or for any other reason related to patentability.
NINTH AFFIRMATIVE DEFENSE: Laches
45. To the extent applicable and not preempted by SCA Hygiene Products Aktiebolag v. First Quality Baby Products, LLC, 580 U.S. 328 (2017), Apex's claims for damages are barred or limited, in whole or in part, by the equitable doctrine of laches. On information and belief, Apex became aware of the PrecisionEdge™ products and their allegedly infringing features well before the filing of this action on May 9, 2024, yet unreasonably and inexcusably delayed in bringing this lawsuit. Solstice has been prejudiced by Apex's delay, including through the continued investment in and expansion of the PrecisionEdge™ product line in reliance on Apex's failure to assert its purported patent rights.
TENTH AFFIRMATIVE DEFENSE: Estoppel
46. Apex is estopped, in whole or in part, from asserting infringement of the Asserted Patents based on its knowledge of and acquiescence to Solstice's design, manufacture, marketing, and sale of the PrecisionEdge™ products prior to the filing of the Complaint. On information and belief, Apex was aware of Solstice's activities in the marketplace, including through industry trade shows, published product catalogs, FDA 510(k) clearances, and other public disclosures, and either expressly or impliedly acquiesced in those activities over a substantial period of time. Solstice reasonably relied on Apex's acquiescence and would be materially prejudiced if Apex were now permitted to assert its purported patent rights.
ELEVENTH AFFIRMATIVE DEFENSE: Failure to Mark (35 U.S.C. § 287)
47. Apex's damages, if any, are limited pursuant to 35 U.S.C. § 287(a) because Apex has failed to comply with the patent marking requirements of that statute with respect to products covered by one or more of the Asserted Patents. On information and belief, Apex manufactures, sells, offers for sale, and distributes products that practice one or more claims of the '237 Patent, the '884 Patent, and/or the '105 Patent, and has failed to mark such products—or their packaging—with the relevant patent numbers, or to provide constructive notice through virtual marking as permitted under 35 U.S.C. § 287(a).
48. In the absence of proper marking or actual notice, Apex is not entitled to recover damages for any period prior to the date it provided actual notice of infringement to Solstice. Solstice avers that it did not receive actual notice of the alleged infringement until no earlier than the date of service of the Complaint on May 23, 2024, or at the earliest, the date the Complaint was filed on May 9, 2024. Accordingly, any recovery of damages, if otherwise warranted, must be limited to the period commencing on or after such date.
TWELFTH AFFIRMATIVE DEFENSE: No Willful Infringement
49. Solstice did not willfully infringe any claim of the '237 Patent, the '884 Patent, or the '105 Patent. At all relevant times, Solstice held a good-faith belief that the PrecisionEdge™ products did not infringe the Asserted Patents and that the Asserted Patents were invalid. Solstice's conduct does not rise to the level of egregious, deliberate, or wanton infringement that would warrant enhanced damages under 35 U.S.C. § 284 or the framework established in Halo Electronics, Inc. v. Pulse Electronics, Inc., 579 U.S. 93 (2016). Apex is not entitled to enhanced damages, treble damages, or any punitive award.
THIRTEENTH AFFIRMATIVE DEFENSE: This Is Not an Exceptional Case
50. This case is not "exceptional" within the meaning of 35 U.S.C. § 285. Apex's claims do not present the type of case that "stands out from others with respect to the substantive strength of a party's litigating position" or "the unreasonable manner in which the case was litigated," as required under Octane Fitness, LLC v. ICON Health & Fitness, Inc., 572 U.S. 545 (2014). Apex is not entitled to an award of its attorneys' fees, and no basis exists for such an award.
Reservation of Defenses
51. Solstice reserves the right to assert additional affirmative defenses as may become appropriate based on information obtained during the course of this litigation, including through fact discovery, expert discovery, claim construction proceedings, and the development of the evidentiary record. The assertion of affirmative defenses herein is not intended to constitute a waiver of any defense or argument that may be available to Solstice at law or in equity, whether currently known or hereafter discovered.
PART III
COUNTERCLAIMS
Solstice Biomedical, Inc., as Counterclaim Plaintiff, hereby asserts the following Counterclaims against Apex Surgical Innovations, Inc., as Counterclaim Defendant:
COUNTERCLAIM PARTIES.
52. Counterclaim Plaintiff Solstice Biomedical, Inc. is a corporation organized and existing under the laws of the State of Delaware, with principal offices at 3800 Concord Pike, Suite 410, Wilmington, Delaware 19803. Solstice is the U.S. operating subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company. Solstice designs, develops, manufactures, markets, distributes, and sells minimally invasive surgical instruments, including the PrecisionEdge™ line of laparoscopic trocar assemblies.
53. Counterclaim Defendant Apex Surgical Innovations, Inc. is a corporation organized and existing under the laws of the State of Delaware, with its principal office at 1220 North Market Street, Suite 550, Wilmington, Delaware 19801. Apex is the plaintiff in the above-captioned action and the owner of the Asserted Patents.
JURISDICTION AND VENUE
54. This Court has subject matter jurisdiction over these Counterclaims pursuant to 28 U.S.C. §§ 1331, 1338(a), and 2201. These Counterclaims arise under the Declaratory Judgment Act, 28 U.S.C. §§ 2201–2202, and the patent laws of the United States, 35 U.S.C. § 1 et seq.
55. There exists an actual, justiciable case or controversy between Solstice and Apex regarding whether the PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series infringe the Asserted Patents, and whether the asserted claims of the Asserted Patents are valid. Apex has asserted that Solstice's products infringe the Asserted Patents, and Solstice denies such infringement and contends that the Asserted Patents are invalid. This controversy is real, immediate, and substantial, and a judicial determination of the parties' respective rights is necessary and appropriate to resolve the dispute.
56. Venue is proper in this District for the Counterclaims under 28 U.S.C. §§ 1391 and 1400(b) for the same reasons that venue is proper for the claims asserted in Apex's Complaint.
FACTUAL BACKGROUND.
57. Solstice Biomedical, Inc. was founded in 2011 and has since established itself as a designer and manufacturer of high-quality minimally invasive surgical instruments. Solstice's product portfolio includes the PrecisionEdge™ line of laparoscopic trocar assemblies, which are used by surgeons in operating rooms throughout the United States and internationally.
58. Solstice independently designed, developed, and commercialized the PrecisionEdge™ PE-5000 Series (5 mm), PE-12000 Series (12 mm), and PE-15000 Series (15 mm) laparoscopic trocar assemblies. The design and engineering of the PrecisionEdge™ products were the result of Solstice's own internal research and development efforts, conducted by Solstice's engineering team without reference to or reliance upon the Asserted Patents or Apex's products.
59. On May 9, 2024, Apex filed the Complaint in this action, alleging that the PrecisionEdge™ PE-5000, PE-12000, and PE-15000 Series infringe the '237 Patent, the '884 Patent, and the '105 Patent. Solstice was served with the Complaint on May 23, 2024, through its registered agent, Pemberton Industries, located in Wilmington, Delaware.
60. A justiciable controversy exists between the parties as to whether the PrecisionEdge™ products infringe any valid and enforceable claim of the Asserted Patents and as to whether the asserted claims of the Asserted Patents are valid.
COUNTERCLAIM I: Declaratory Judgment of Non-Infringement of the '237 Patent
61. Solstice incorporates by reference and re-alleges Paragraphs 52 through 60 above as though fully set forth herein.
62. Solstice seeks a declaratory judgment under 28 U.S.C. §§ 2201–2202 that the PrecisionEdge™ PE-5000 Series and PE-12000 Series do not infringe, either literally or under the doctrine of equivalents, any asserted claim of U.S. Patent No. 9,814,237, including without limitation Claims 1, 3, 7, and 12.
63. The '237 Patent is titled "Locking Seal Assembly for Minimally Invasive Surgical Access Device" and was issued by the USPTO on November 14, 2017. On information and belief, the '237 Patent has an expiration date of June 22, 2035, subject to any applicable terminal disclaimers, patent term adjustments, or patent term extensions.
64. The PrecisionEdge™ PE-5000 Series and PE-12000 Series employ a fundamentally different design for their seal mechanisms than that claimed in the '237 Patent. Specifically, the PrecisionEdge™ products do not incorporate a "locking seal assembly" as that term is defined by the claims of the '237 Patent when construed in light of the specification and prosecution history. The seal mechanisms in the PrecisionEdge™ products operate through a structurally and functionally distinct approach that does not satisfy one or more limitations of the asserted claims.
65. Solstice is entitled to a declaratory judgment that the PrecisionEdge™ PE-5000 Series and PE-12000 Series do not infringe any asserted claim of the '237 Patent.
COUNTERCLAIM II: Declaratory Judgment of Non-Infringement of the '884 Patent
66. Solstice incorporates by reference and re-alleges Paragraphs 52 through 60 above as though fully set forth herein.
67. Solstice seeks a declaratory judgment under 28 U.S.C. §§ 2201–2202 that the PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series do not infringe, either literally or under the doctrine of equivalents, any asserted claim of U.S. Patent No. 10,271,884, including without limitation Claims 1, 2, 5, 9, and 14.
68. The '884 Patent is titled "Retractable Blade Deployment Mechanism for Trocar Systems" and was issued by the USPTO on April 30, 2019. On information and belief, the '884 Patent has an expiration date of September 15, 2036, subject to any applicable terminal disclaimers, patent term adjustments, or patent term extensions.
69. The blade deployment mechanisms in the PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series operate differently from the "retractable blade deployment mechanism" claimed in the '884 Patent. The PrecisionEdge™ products employ a distinct blade actuation architecture that does not incorporate the structural features, functional relationships, or operational sequences recited in the asserted claims of the '884 Patent. No element of the PrecisionEdge™ blade deployment system corresponds to or is equivalent to the claimed "retractable blade deployment mechanism."
70. Solstice is entitled to a declaratory judgment that the PrecisionEdge™ PE-5000 Series, PE-12000 Series, and PE-15000 Series do not infringe any asserted claim of the '884 Patent.
COUNTERCLAIM III: Declaratory Judgment of Non-Infringement of the '105 Patent
71. Solstice incorporates by reference and re-alleges Paragraphs 52 through 60 above as though fully set forth herein.
72. Solstice seeks a declaratory judgment under 28 U.S.C. §§ 2201–2202 that the PrecisionEdge™ PE-12000 Series and PE-15000 Series do not infringe, either literally or under the doctrine of equivalents, any asserted claim of U.S. Patent No. 10,932,105, including without limitation Claims 1, 4, and 8.
73. The '105 Patent is titled "Integrated Insufflation Valve and Seal for Laparoscopic Trocar" and was issued by the USPTO on March 2, 2021. On information and belief, the '105 Patent has an expiration date of January 10, 2038, subject to any applicable terminal disclaimers, patent term adjustments, or patent term extensions.
74. The PrecisionEdge™ PE-12000 Series and PE-15000 Series do not employ an "integrated insufflation valve and seal" as defined by the claims of the '105 Patent. The insufflation and sealing features of the PrecisionEdge™ products utilize a separate-component design architecture that is structurally and functionally distinct from the integrated, unitary construction claimed in the '105 Patent. The accused products do not satisfy one or more limitations of the asserted claims of the '105 Patent under any proper construction.
75. Solstice is entitled to a declaratory judgment that the PrecisionEdge™ PE-12000 Series and PE-15000 Series do not infringe any asserted claim of the '105 Patent.
COUNTERCLAIM IV: Declaratory Judgment of Invalidity of the '237 Patent
76. Solstice incorporates by reference and re-alleges Paragraphs 52 through 60 above as though fully set forth herein.
77. Solstice seeks a declaratory judgment under 28 U.S.C. §§ 2201–2202 that Claims 1, 3, 7, and 12 of U.S. Patent No. 9,814,237 are invalid under one or more of 35 U.S.C. §§ 102, 103, and/or 112.
78. On information and belief, the asserted claims of the '237 Patent are anticipated under 35 U.S.C. § 102 by one or more prior art references, including prior patents, printed publications, and public uses or sales activity, that disclose every element of the asserted claims as arranged therein and that predate the effective filing date of the '237 Patent.
79. On information and belief, the asserted claims of the '237 Patent are rendered obvious under 35 U.S.C. § 103 in view of the prior art, whether considered individually or in combination. The subject matter claimed in Claims 1, 3, 7, and 12 would have been obvious to a person of ordinary skill in the art of surgical access devices at the time the alleged invention was made.
80. On information and belief, one or more of the asserted claims of the '237 Patent fail to satisfy the written description requirement of 35 U.S.C. § 112(a), the enablement requirement of 35 U.S.C. § 112(a), and/or the definiteness requirement of 35 U.S.C. § 112(b).
81. Solstice reserves the right to identify with specificity the prior art references and the claim-by-claim basis for invalidity in its invalidity contentions to be served in accordance with the Court's scheduling order.
COUNTERCLAIM V: Declaratory Judgment of Invalidity of the '884 Patent
82. Solstice incorporates by reference and re-alleges Paragraphs 52 through 60 above as though fully set forth herein.
83. Solstice seeks a declaratory judgment under 28 U.S.C. §§ 2201–2202 that Claims 1, 2, 5, 9, and 14 of U.S. Patent No. 10,271,884 are invalid under one or more of 35 U.S.C. §§ 102, 103, and/or 112.
84. On information and belief, the asserted claims of the '884 Patent are anticipated under 35 U.S.C. § 102 by one or more prior art references, including prior patents, printed publications, and public uses or sales activity, that disclose every element of the asserted claims as arranged therein and that predate the effective filing date of the '884 Patent.
85. On information and belief, the asserted claims of the '884 Patent are rendered obvious under 35 U.S.C. § 103 in view of the prior art, whether considered individually or in combination. The subject matter claimed in Claims 1, 2, 5, 9, and 14 would have been obvious to a person of ordinary skill in the art of trocar and surgical instrument design at the time the alleged invention was made.
86. On information and belief, one or more of the asserted claims of the '884 Patent fail to satisfy the written description requirement of 35 U.S.C. § 112(a), the enablement requirement of 35 U.S.C. § 112(a), and/or the definiteness requirement of 35 U.S.C. § 112(b).
87. Solstice reserves the right to identify with specificity the prior art references and the claim-by-claim basis for invalidity in its invalidity contentions to be served in accordance with the Court's scheduling order.
COUNTERCLAIM VI: Declaratory Judgment of Invalidity of the '105 Patent
88. Solstice incorporates by reference and re-alleges Paragraphs 52 through 60 above as though fully set forth herein.
89. Solstice seeks a declaratory judgment under 28 U.S.C. §§ 2201–2202 that Claims 1, 4, and 8 of U.S. Patent No. 10,932,105 are invalid under one or more of 35 U.S.C. §§ 102, 103, and/or 112.
90. On information and belief, the asserted claims of the '105 Patent are anticipated under 35 U.S.C. § 102 by one or more prior art references, including prior patents, printed publications, and public uses or sales activity, that disclose every element of the asserted claims as arranged therein and that predate the effective filing date of the '105 Patent.
91. On information and belief, the asserted claims of the '105 Patent are rendered obvious under 35 U.S.C. § 103 in view of the prior art, whether considered individually or in combination. The subject matter claimed in Claims 1, 4, and 8 would have been obvious to a person of ordinary skill in the art of laparoscopic trocar and insufflation system design at the time the alleged invention was made.
92. On information and belief, one or more of the asserted claims of the '105 Patent fail to satisfy the written description requirement of 35 U.S.C. § 112(a), the enablement requirement of 35 U.S.C. § 112(a), and/or the definiteness requirement of 35 U.S.C. § 112(b).
93. Solstice reserves the right to identify with specificity the prior art references and the claim-by-claim basis for invalidity in its invalidity contentions to be served in accordance with the Court's scheduling order.
PRAYER FOR RELIEF
WHEREFORE, Defendant and Counterclaim Plaintiff Solstice Biomedical, Inc. respectfully requests that this Court enter judgment in its favor and against Plaintiff and Counterclaim Defendant Apex Surgical Innovations, Inc. as follows:
1. That the Complaint of Apex Surgical Innovations, Inc. be dismissed in its entirety and with prejudice, and that judgment be entered in favor of Solstice Biomedical, Inc. on all claims asserted by Apex in the Complaint;
2. That the Court enter a declaratory judgment that Solstice Biomedical, Inc. has not infringed, and does not infringe, any valid and enforceable claim of U.S. Patent Nos. 9,814,237, 10,271,884, or 10,932,105, either literally or under the doctrine of equivalents;
3. That the Court enter a declaratory judgment that Claims 1, 3, 7, and 12 of U.S. Patent No. 9,814,237 are invalid;
4. That the Court enter a declaratory judgment that Claims 1, 2, 5, 9, and 14 of U.S. Patent No. 10,271,884 are invalid;
5. That the Court enter a declaratory judgment that Claims 1, 4, and 8 of U.S. Patent No. 10,932,105 are invalid;
6. That the Court declare the Asserted Patents unenforceable, in whole or in part, due to inequitable conduct before the USPTO;
7. That Apex Surgical Innovations, Inc. be denied any and all relief sought in the Complaint, including but not limited to compensatory damages, enhanced damages, treble damages, injunctive relief (whether preliminary or permanent), attorneys' fees, costs, and pre-judgment and post-judgment interest;
8. That the Court find this case to be exceptional under 35 U.S.C. § 285 and award Solstice Biomedical, Inc. its reasonable attorneys' fees and costs incurred in this action;
9. That the Court award Solstice Biomedical, Inc. its costs of suit; and
10. That the Court award Solstice Biomedical, Inc. such other and further relief as the Court deems just and proper.
DEMAND FOR JURY TRIAL
Pursuant to Rule 38 of the Federal Rules of Civil Procedure, Defendant and Counterclaim Plaintiff Solstice Biomedical, Inc. hereby demands a trial by jury on all issues so triable in this action, including all claims asserted in the Complaint, all Counterclaims asserted herein, and all affirmative defenses, to the fullest extent permitted by law.
Dated: June 14, 2024
Respectfully submitted,
CALDERWOOD & HARKNESS LLP
/s/ Marcus Delgado
Marcus Delgado (Del. Bar No. 5738) Responsible Partner, intellectual Property Litigation
Christy Bauer (Del. Bar No. 6214) Lead Associate, intellectual Property Litigation
Peter Vassiliev (Del. Bar No. 6592) Working Associate, intellectual Property Litigation
1201 Market Street, Suite 2500 Wilmington, Delaware 19801 Telephone: (302) 658-4700 Facsimile: (302) 658-4701
Email: mdelgado@calderwoodharkness.com
Email: cbauer@calderwoodharkness.com
Email: pvassiliev@calderwoodharkness.com
Counsel for Defendant and Counterclaim Plaintiff Solstice Biomedical, Inc.
CERTIFICATE OF SERVICE
I, Marcus Delgado, hereby certify that on June 14, 2024, I caused the foregoing Defendant Solstice Biomedical, Inc.'s Answer, Affirmative Defenses, and Counterclaims to be electronically filed with the Clerk of Court via the Court's CM/ECF electronic filing system, which will automatically serve a true and correct copy of the foregoing document on all counsel of record who have registered to receive electronic notices in this case, including:
Victoria Stanton, Esq. Derek Loomis, Esq. HARGROVE, TATE & BENNINGTON LLP 900 North King Street, Suite 1200 Wilmington, Delaware 19801 Telephone: (302) 571-6300 Facsimile: (302) 571-6301
Email: vstanton@htblaw.com
Email: dloomis@htblaw.com
Counsel for Plaintiff and Counterclaim Defendant Apex Surgical Innovations, Inc.
/s/ Marcus Delgado
Marcus Delgado (Del. Bar No. 5738) CALDERWOOD & HARKNESS LLP
APEX SURGICAL INNOVATIONS, INC.,
Plaintiff,
v. | Case No. 1:24-cv-00587-RGA
SOLSTICE BIOMEDICAL, INC., | Chief Judge Richard G. Andrews
Defendant.