Contract analysis

I. Introduction and Identity of Declarant

1. My name is Dr. Aisling Connolly. I am a citizen of Ireland. I am currently employed as Vice President of Research & Development at Solstice Biomedical Devices Ltd. ("Solstice" or "SBD"), with offices located at Unit 4, Liffey Innovation Campus, Parkgate Street, Dublin 8, D08 XR29, Ireland. I am over eighteen (18) years of age and am competent to make this declaration. The facts set forth herein are based on my per

2. I make this declaration under 37 C.F.R. § 1.132 in support of the patentability of the claims currently pending in U.S. Patent Application No. 17/851,216, entitled "Cryoablation Catheter with Integrated Impedance Mapping Electrodes" (hereinafter, the "'216 Application" or "CON-2"). This declaration is submitted in connection with the Applicant's response to the Non-Final Office Action mailed by the United States P

3. I am a named co-inventor on all four applications in the CryoNova patent family, which consists of the following related applications and patents: (a) U.S. Patent Application No. 16/914,337, filed June 28, 2021, now issued as U.S. Patent No. 11,284,561 (the "parent application" or the "'561 Patent"); (b) U.S. Patent Application No. 17/702,489 ("CON-1"), a continuation of the parent application; (c) U.S. Patent App

4. The co-inventors on the CryoNova patent family are as follows: (a) Dr. Tomás Brennan, Chief Medical Officer and Co-Founder of Solstice Biomedical Devices Ltd., is a named co-inventor on all four applications in the CryoNova patent family (i.e., the parent application, CON-1, CON-2, and CON-3). (b) Dr. Henrik Paulsen, formerly a Senior Engineer at Solstice Biomedical Devices Ltd. and currently employed at Arclight

5. The assignee of the '216 Application and all other applications in the CryoNova patent family is Solstice Biomedical Devices Ltd., an Irish private limited company registered with the Companies Registration Office of Ireland under CRO No. 647832.

II. Qualifications and Technical Background of Declarant

6. I hold a Ph.D. in Biomedical Engineering from Trinity College Dublin, which I received in 2009. My doctoral research focused on the thermal modeling of cryogenic tissue ablation and the design of cryoprobe tip geometries for cardiac applications. A copy of my full curriculum vitae is attached hereto as Exhibit A.

7. I have over fifteen (15) years of experience in medical device research and development, with a particular specialization in cardiac cryoablation catheter design and electrophysiology mapping technologies. Throughout my career, I have been involved in the design, prototyping, pre-clinical testing, and clinical evaluation of catheter-based systems for the treatment of cardiac arrhythmias, including atrial fibrillat

8. In my current role as Vice President of Research & Development at Solstice Biomedical Devices Ltd., I lead the engineering team responsible for the design, development, and testing of the CryoNova cryoablation catheter system. This team currently comprises twenty-three (23) engineers and scientists across the disciplines of mechanical engineering, electrical engineering, software engineering, and biomedical engine

9. I personally led the development of the variable-zone cooling architecture and the integrated impedance mapping electrode array that are the subject of the claims pending in the '216 Application. In this capacity, I was responsible for the initial concept definition, the iterative engineering design process, the bench testing and verification protocols, and the coordination with external regulatory and clinical af

10. I am familiar with the current state of the art in cryoablation catheter technology as it pertains to pulmonary vein isolation for the treatment of atrial fibrillation. This familiarity extends to competing commercial products and patent portfolios, including those of Vantage Cryosurgical Systems, Inc. ("Vantage"), Cascade Holdings, Greaves Corporation, and others. I have reviewed published clinical literature, i

11. In addition to my design and development responsibilities, I served as the engineering and technical lead during the European first-in-human clinical study of the CryoNova system. That study enrolled fifteen (15) patients at two investigational sites in Ireland and the Netherlands and was conducted under European regulatory authorization. I subsequently served as the technical lead during the United States pivota

12. In preparation for this declaration, I have reviewed the following documents: (a) The Non-Final Office Action mailed September 15, 2024, in connection with U.S. Patent Application No. 17/851,216; (b) The pending claims (Claims 1–20) of U.S. Patent Application No. 17/851,216, as filed; (c) U.S. Patent No. 10,537,418, assigned to Vantage Cryosurgical Systems, Inc. (hereinafter, the "Vantage '418 patent" or "'418 pa

13. The purpose of this declaration is to provide the Examiner with factual evidence and technical context regarding the following matters: (A) The distinctions between the claimed CryoNova cryoablation catheter system with integrated impedance mapping electrodes and the prior-art references cited in the Non-Final Office Action mailed September 15, 2024; and (B) The full written-description support in the parent spec

14. Specifically, this declaration addresses the following rejections and objections set forth in the Non-Final Office Action: (i) Claims 1–8 — rejected under 35 U.S.C. § 103 as allegedly obvious over U.S. Patent No. 10,537,418 ("Vantage '418") in view of U.S. Patent No. 9,861,432 ("Vantage '432") and U.S. Publication No. 2019/0183567 ("Helios '567"); (ii) Claims 9–14 — rejected under 35 U.S.C. § 112(a) for alleged l

15. I respectfully submit this declaration to assist the Examiner in evaluating the technical merits of the pending claims and to provide the perspective of a named co-inventor who personally conceived and developed the technology at issue.

IV. Overview of the CryoNova Technology

16. The CryoNova cryoablation catheter system is a second-generation cryoablation catheter designed for pulmonary vein isolation ("PVI") in the treatment of atrial fibrillation. Atrial fibrillation is the most common sustained cardiac arrhythmia, affecting millions of patients worldwide, and catheter-based ablation of the pulmonary veins has become an established treatment strategy for drug-refractory cases. The Cryo

17. The first key differentiating feature of the CryoNova system is its variable-zone cooling architecture. Unlike conventional single-zone balloon catheters — which apply a uniform circumferential cryoablation energy across the entire contact surface — the CryoNova catheter incorporates multiple discrete cooling zones that can be independently activated, deactivated, or modulated. This variable-zone architecture ena

18. The second key differentiating feature of the CryoNova system is its integrated impedance mapping electrodes. These electrodes are embedded directly within the catheter body, positioned adjacent to and co-located with the discrete cooling zones. The integrated electrodes allow real-time tissue impedance measurements to be taken during the cryoablation procedure itself, enabling the physician to monitor lesion for

19. The third key differentiating feature of the CryoNova system is its impedance mapping calibration algorithm. This algorithm processes the impedance data collected by the integrated electrodes and distinguishes between viable myocardial tissue and tissue that has been successfully ablated. The algorithm accounts for the temperature-dependent changes in tissue impedance that occur during cryoablation — a factor tha

20. These three features — variable-zone cooling architecture, integrated impedance mapping electrodes, and the impedance mapping calibration algorithm — are the subject of the claims in the CryoNova patent family. The '216 Application (CON-2) is specifically directed to the catheter structure incorporating the integrated impedance mapping electrodes and their arrangement relative to the variable-zone cooling archite

V. Discussion of the Cited Prior Art

21. In this section, I provide my technical analysis of each of the three prior-art references cited in the Non-Final Office Action, based on my review of those references and my familiarity with the field.

V.A. U.S. Patent No. 10,537,418 (Vantage Cryosurgical Systems, Inc.)

22. U.S. Patent No. 10,537,418 (the "Vantage '418 patent") is assigned to Vantage Cryosurgical Systems, Inc., which I understand to be located at 1420 Gateway Boulevard, South San Francisco, California 94080. The Vantage '418 patent describes a cryoablation balloon catheter designed for pulmonary vein isolation.

23. The cryoablation catheter disclosed in the Vantage '418 patent is a single-zone cryoablation balloon catheter. The balloon described in the '418 patent is a compliant balloon that is designed to conform to the anatomical contour of the pulmonary vein ostium upon inflation and to deliver a uniform circumferential cryoablation energy to the tissue in contact with the balloon surface. The entire balloon acts as a si

24. Critically, the Vantage '418 patent does not teach or suggest any form of integrated impedance mapping electrodes within the catheter body. The '418 patent does not describe the use of impedance-based measurements for tissue characterization, lesion assessment, or contact quality monitoring. To the extent that the '418 patent describes any form of tissue or procedural monitoring, such monitoring is limited to tem

25. In my professional opinion, a person of ordinary skill in the art reading the Vantage '418 patent would understand it to be directed to a fundamentally different design approach from the CryoNova system. The '418 patent embodies the conventional single-zone balloon cryoablation paradigm — uniform circumferential cooling applied to the entire pulmonary vein ostium — without any motivation or suggestion to deviate

V.B. U.S. Patent No. 9,861,432 (Vantage Cryosurgical Systems, Inc.)

26. U.S. Patent No. 9,861,432 (the "Vantage '432 patent") is also assigned to Vantage Cryosurgical Systems, Inc. The '432 patent describes improvements to cryoablation balloon catheter construction, including innovations in balloon wall materials, refrigerant delivery mechanisms, and methods for enhancing the thermal performance of the balloon during cryoablation.

27. The '432 patent is directed to enhancing the uniformity and efficiency of the single-zone cooling approach described in related Vantage patents, including the '418 patent. The improvements disclosed in the '432 patent — such as multi-layer balloon wall constructions for improved thermal conductivity and modified refrigerant injection patterns for more uniform cooling — are all directed to optimizing the performan

28. Like the '418 patent, the Vantage '432 patent does not disclose or suggest impedance mapping electrodes integrated into the catheter body. The '432 patent does not address tissue characterization through impedance measurement, does not describe any electrode configuration for that purpose, and does not discuss the challenges associated with impedance measurement in a cryogenic environment.

29. In my professional opinion, combining the teachings of the Vantage '432 patent with those of the Vantage '418 patent would yield, at most, an improved single-zone cryoablation balloon — i.e., a balloon with better materials and more uniform cooling, but still fundamentally a single-zone design without impedance mapping capability. There is no teaching, suggestion, or motivation in either the '418 patent or the '4

V.C. U.S. Publication No. 2019/0183567 (Helios Surgical Technologies, Inc.)

30. U.S. Patent Application Publication No. 2019/0183567 (the "Helios '567 publication") is assigned to Helios Surgical Technologies, Inc., which I understand to be located at 750 Bering Drive, Suite 400, Houston, Texas 77057. The Helios '567 publication describes a standalone diagnostic impedance mapping catheter for use in cardiac electrophysiology procedures.

31. The Helios '567 publication teaches the concept of using impedance-based measurements to characterize cardiac tissue. Specifically, the Helios catheter is described as a multi-electrode catheter that is introduced into the cardiac chambers to generate impedance maps of the endocardial surface. These impedance maps can be used by the physician to identify areas of viable tissue, scar tissue, and transitional tissu

32. However, the Helios '567 publication describes this impedance mapping functionality exclusively in the context of a separate, standalone diagnostic mapping catheter — not in the context of a cryoablation catheter or any other therapeutic ablation device. The Helios catheter is designed to be used as a diagnostic tool, either before or after an ablation procedure, to assess the cardiac substrate. It is not designe

33. Importantly, the Helios '567 publication does not teach or suggest integrating impedance mapping electrodes into a cryoablation catheter. Nor does the Helios publication describe or address the specific technical challenges that arise when impedance measurements are performed during active cryoablation. These challenges include, but are not limited to: (a) Electrode signal degradation at cryogenic temperatures: T

34. In my professional opinion, a person of ordinary skill in the art would not have been motivated to combine the impedance mapping concept of the Helios '567 publication with the single-zone cryoablation balloon concepts of the Vantage '418 and '432 patents. The reasons for this conclusion are threefold: (i) The physical integration of impedance electrodes into a cryoablation balloon presents distinct engineering c

VI. Distinctions Between the Claimed Invention and the Prior Art — Claims 1–8 (§ 103 Rejection)

35. Claims 1–8 of the '216 Application recite a cryoablation catheter with integrated impedance mapping electrodes arranged in a specific configuration that enables simultaneous cryoablation delivery and real-time impedance-based tissue characterization. Independent Claim 1, in particular, recites a cryoablation catheter comprising a catheter body, an expandable cryoablation element having a plurality of discrete coo

36. Based on my review of the cited references and my understanding of the claimed invention, I respectfully submit that the combination of the Vantage '418 patent, the Vantage '432 patent, and the Helios '567 publication does not render Claims 1–8 obvious. My technical basis for this opinion is as follows: (1) No reference, alone or in combination, discloses or suggests the structural integration of impedance mappin

37. In addition to the foregoing technical distinctions, I wish to provide the Examiner with further evidence of the non-obvious character of the claimed invention. The CryoNova system's integration of impedance mapping electrodes into a variable-zone cryoablation catheter was not achieved through routine engineering or straightforward combination of known elements. Rather, the development required extensive engineer

VII. Written-Description Support for the Impedance Mapping Calibration Algorithm — Claims 9–14 (§ 112(a) Rejection)

38. The Examiner rejected Claims 9–14 under 35 U.S.C. § 112(a) for alleged lack of written description regarding the impedance mapping calibration algorithm recited in those claims. I respectfully submit that the parent specification — i.e., the specification of U.S. Patent No. 11,284,561, from which the '216 Application claims priority as a continuation — provides full and complete written-description support for th

39. Claims 9–14 depend from Claim 1 and further define the impedance mapping calibration algorithm used by the CryoNova system to process impedance data from the integrated electrodes. The algorithm, as claimed, includes the steps of acquiring raw impedance measurements from the integrated electrodes, normalizing those measurements against a baseline, applying a temperature-dependent impedance correction, and classif

40. I have reviewed the specification of U.S. Patent No. 11,284,561 in detail, and I can identify specific portions of that specification that describe each element of the calibration algorithm recited in Claims 9–14, as follows: (a) Inputs to the calibration algorithm. The parent specification describes the calibration algorithm as receiving three categories of input data: (i) raw impedance measurements from each of

41. I note that annotated excerpts from U.S. Patent No. 11,284,561 identifying the specific column and line references for each of the foregoing disclosures are being prepared by counsel and will be submitted as Exhibit B to this declaration. I have reviewed drafts of these annotated excerpts and confirm that they accurately identify the relevant passages of the parent specification.

42. As the inventor who conceived and developed the impedance mapping calibration algorithm, I can confirm that the algorithm as claimed in Claims 9–14 of the '216 Application was fully described in the parent specification as filed on June 28, 2021. The parent specification describes the algorithm's inputs, processing steps, and outputs with sufficient specificity that a person of ordinary skill in the art reading t

43. The parent specification includes sufficient detail for a skilled artisan to implement the calibration algorithm, including the mathematical relationships for temperature-dependent impedance correction (expressed as correction functions based on empirically derived temperature-impedance coefficients) and the decision logic for tissue-state classification (expressed as threshold-based comparisons with predefined i

44. Accordingly, I respectfully submit that Claims 9–14 satisfy the written-description requirement of 35 U.S.C. § 112(a), and I ask that the Examiner reconsider the rejection of these claims in light of the specific written-description support identified herein and in Exhibit B.

VIII. Claims 15–20 — Allowable Subject Matter

45. I note that the Examiner's Non-Final Office Action indicates that Claims 15–20 contain allowable subject matter but are objected to only as depending from a rejected base claim (i.e., Claim 1). I appreciate the Examiner's recognition of the patentable merit of these dependent claims.

46. Claims 15–20 further define the integrated impedance mapping and variable-zone cooling features of the CryoNova system in ways that are consistent with and fully supported by the parent specification (U.S. Patent No. 11,284,561). The additional limitations recited in Claims 15–20 — which relate to specific structural and functional aspects of the electrode arrangement and the cooling zone configuration — are desc

47. I understand that the Applicant intends to request that Claims 15–20 be rewritten in independent form if the base claims are amended to overcome the rejections of Claims 1–14. I support this approach and confirm that the subject matter of Claims 15–20 is independently supported by the disclosure of the parent specification.

IX. Factual Statements Regarding the CryoNova Development Program

48. I provide the following factual statements regarding the history and development of the CryoNova cryoablation catheter system to assist the Examiner in understanding the context of the claimed invention.