Contract analysis

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 tr

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 ins

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 adm

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

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

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

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, Sols

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 Electron

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 produ

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 prope

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 t

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.

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 affirmativ

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

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

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 discl

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

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

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 s

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 co

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

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 wit

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, Dickins

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 surre

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

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

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,

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

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

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 att

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 b

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 invas

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 Pat

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

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.