Contract analysis

I. Executive Summary The purpose of this memorandum is to provide a comprehensive analysis of the Non-Final Office Action mailed on September 15, 2024, by Primary Examiner James R. Dougherty (Art Unit 3794, Supervisory Patent Examiner Linda M. Kowalski) in the second continuation application (CON-2), U.S. Application No. 17/851,216, filed on behalf of Solstice Biomedical Devices Ltd. ("SBD" or the "Client"). This mem

1. Claims 1–8 — Rejected under 35 U.S.C. § 103 as being unpatentable over a combination of three prior-art references: U.S. Patent No. 10,537,418 ("Vantage '418"), U.S. Patent No. 9,861,432 ("Vantage '432"), and U.S. Published Application No. 2019/0183567 ("Helios '567").

2. Claims 9–14 — Rejected under 35 U.S.C. § 112(a) for alleged lack of written description support for the impedance mapping calibration algorithm and related method steps.

3. Claims 15–20 — Objected to as dependent on a rejected base claim (Claim 1) but identified by the Examiner as containing allowable subject matter. Response Deadline. The three-month statutory response period expires on January 15, 2025. Under 37 C.F.R. § 1.136(a), the deadline may be extended by up to three additional months through successive one-month extension requests, pushing the maximum extended deadline to A

II. Procedural Background A. Patent Family Overview The CON-2 application at issue forms part of a family of four related U.S. patent applications filed by Solstice Biomedical Devices Ltd., together with corresponding foreign filings. The family tree is summarized below for reference, with additional detail provided in Appendix E. Parent Application (SBD-001). U.S. Application No. 16/914,337 was filed on June 28, 202

III. Summary of Pending Claims CON-2 contains twenty (20) pending claims, organized into three groups: apparatus claims directed to the cryoablation catheter (Claims 1–8), method claims directed to calibrating the impedance mapping electrodes (Claims 9–14), and system claims directed to a cryoablation system with a feedback algorithm (Claims 15–20). The full text of all twenty claims is reproduced in Appendix B. Belo

IV. Analysis of § 103 Obviousness Rejection — Claims 1–8 A. Cited Prior-Art References The Examiner has rejected Claims 1–8 under 35 U.S.C. § 103 as being unpatentable over a combination of three prior-art references. We analyze each reference below, identifying both the teachings relied upon by the Examiner and the critical limitations that each reference fails to teach or suggest.

1. U.S. Patent No. 10,537,418 (Primary Reference — "Vantage '418") U.S. Patent No. 10,537,418 ("Vantage '418") is assigned to Vantage Cryosurgical Systems, Inc., located at 1420 Gateway Boulevard, South San Francisco, California 94080. The Vantage '418 patent is directed to a cryoablation catheter employing a single-zone balloon design for pulmonary-vein isolation in the treatment of atrial fibrillation. The Examiner

2. U.S. Patent No. 9,861,432 (Secondary Reference — "Vantage '432") U.S. Patent No. 9,861,432 ("Vantage '432") is also assigned to Vantage Cryosurgical Systems, Inc. The Vantage '432 patent is directed to a multi-electrode mapping catheter used as a standalone diagnostic tool for cardiac tissue assessment. The Examiner relies on Vantage '432 as a secondary reference for the impedance mapping electrode teachings, mapp

3. U.S. Published Application No. 2019/0183567 (Tertiary Reference — "Helios '567") U.S. Published Application No. 2019/0183567 ("Helios '567") is assigned to Helios Surgical Technologies, Inc., located at 750 Bering Drive, Suite 400, Houston, Texas 77057. The Helios '567 publication is directed to the general concept of combining ablation and tissue-property sensing functionalities in a single catheter device. The E

1. Variable-Zone Cooling — Not Taught or Suggested The most fundamental deficiency in the Examiner's rejection is the failure to account for the variable-zone cooling limitation of Claim 1. Claim 1 expressly requires "a variable-zone cooling element disposed at the distal end, the variable-zone cooling element including at least two independently controllable cryogenic zones configured to deliver cryogenic cooling to

2. Integration of Impedance Mapping Electrodes on a Cryoablation Catheter Body Even setting aside the variable-zone cooling limitation (which alone should be dispositive), the Examiner's proposed combination improperly conflates two fundamentally different types of catheter devices and two fundamentally different technical environments. Vantage '432 teaches impedance mapping electrodes on a standalone diagnostic cath

3. Real-Time Impedance Measurement During Cryoablation SBD's claims require that the impedance mapping electrodes be configured to "measure tissue impedance in real time during ablation" — that is, while the cryogenic cooling is actively being delivered to the target tissue. This simultaneous-measurement limitation is a critical distinguishing feature and is not taught or suggested by any of the cited references. In

4. Teaching Away / Lack of Motivation to Combine Beyond the absence of the claimed features in the cited art, there is affirmative evidence that the art teaches away from the proposed combination. Vantage '418 specifically teaches that its single-zone balloon design achieves circumferential ablation without the need for mapping during ablation. The Vantage '418 specification describes a clinical workflow in which the

1. Amend Independent Claim 1. We recommend amending Claim 1 to more explicitly recite the distinguishing structural and functional limitations of SBD's invention. Specifically, we recommend amending Claim 1 to recite: (a) at least two independently controllable cryogenic zones, each zone having a separate cryogen supply lumen within the catheter body; (b) the plurality of impedance mapping electrodes being disposed o

2. Consider Conforming Amendments to Claims 2–8. Depending on the final form of the Claim 1 amendment, conforming amendments to dependent Claims 2–8 may be advisable to ensure consistency and to further recite the specific electrode-zone spatial relationship and temperature-compensated impedance measurement features. We will assess the need for dependent-claim amendments after finalizing the Claim 1 language.

3. Present Detailed Arguments Distinguishing All Three References. The response should include a comprehensive argument section that: (a) demonstrates the absence of variable-zone cooling in any of the cited references; (b) explains the unaddressed engineering challenges of impedance electrode integration in the cryogenic environment; (c) rebuts the Examiner's generic motivation to combine by showing the absence of a

4. Support with a Rule 132 Declaration from Dr. Aisling Connolly. We recommend supporting the response with a Declaration under 37 C.F.R. § 1.132 from co-inventor Dr. Aisling Connolly (Ph.D. Biomedical Engineering, Trinity College Dublin; VP R&D at SBD). The declaration should: (a) define the level of ordinary skill in the art relevant to the invention; (b) explain the specific technical challenges of integrating imp

5. Consider Engaging Caravel Prior Art Services LLC. We recommend reviewing the records of Caravel Prior Art Services LLC (Daniel Yoon, primary contact) for any prior landscape analysis that may have been performed in connection with the parent application or the broader SBD patent portfolio. If existing search records do not adequately support our arguments, we may recommend commissioning an updated prior-art landsc

V. Analysis of § 112(a) Written-Description Rejection — Claims 9–14 A. Examiner's Position Examiner Dougherty rejects Claims 9–14 under 35 U.S.C. § 112(a) for alleged failure to satisfy the written-description requirement. The Examiner asserts that the impedance mapping calibration algorithm recited in independent Claim 9 and its dependent Claims 10–14 is not sufficiently described in the specification to demonstrate

1. Parent Specification (U.S. Patent No. 11,284,561) Because CON-2 claims the benefit of U.S. Application No. 16/914,337 (the parent application), the parent specification as filed is the relevant document for assessing written-description support. We have conducted a thorough review of the parent specification and have identified the following sections as providing relevant disclosure for each of the challenged clai

2. Assessment of Written-Description Support Based on our review, the parent specification does provide adequate written-description support for the calibration algorithm as claimed in Claims 9–14. The disclosure is detailed, specific, and encompasses each of the claim limitations identified by the Examiner as lacking support. We believe the Examiner's rejection stems from a failure to locate and synthesize the relev

1. Do NOT amend the claims. The claims as currently drafted accurately reflect the disclosed invention, and the calibration algorithm limitations are fully supported by the specification. Amending the claims to narrow the calibration-algorithm language would unnecessarily surrender claim scope without addressing the actual issue, which is the Examiner's apparent failure to identify the relevant specification disclosu

2. Provide detailed specification citations in the response. The response should include a comprehensive mapping of each challenged claim limitation to specific paragraphs and figures in the parent specification. We recommend the following cross-reference structure:

3. Support with a Declaration under 37 C.F.R. § 1.132 from Dr. Aisling Connolly. Dr. Connolly holds a Ph.D. in Biomedical Engineering from Trinity College Dublin and serves as Vice President of Research and Development at Solstice Biomedical Devices Ltd. She is a co-inventor on all four applications in the SBD patent family and was the principal architect of the calibration algorithm. A declaration from Dr. Connolly

4. Consider an Examiner interview. If we assess that the written response and declaration may not be sufficient to overcome the rejection — for example, if the Examiner has a particular concern that is not evident from the Office Action itself — we recommend conducting an interview with Examiner Dougherty, or if appropriate, Supervisory Patent Examiner Kowalski, to walk through the specification support in person. An

VI. Analysis of Objection to Claims 15–20 A. Examiner's Position Claims 15–20 are not rejected on the merits. Rather, the Examiner has objected to Claims 15–20 as being dependent on a rejected base claim (specifically, Claim 15 depends from Claim 1, which has been rejected under § 103), but has indicated that Claims 15–20 contain allowable subject matter. Specifically, the Examiner has found that the system claims in

1. Rewrite Claim 15 in independent form. We recommend rewriting Claim 15 to remove its current dependency on Claim 1 and to incorporate all necessary limitations from Claim 1 directly into the body of Claim 15. The rewritten Claim 15 should include: (a) the cryoablation catheter limitations (catheter body, variable-zone cooling element with at least two independently controllable cryogenic zones, integrated impedance

2. Maintain parallel track. If our amendment strategy for Claim 1 succeeds and Claims 1–8 are allowed as amended, then Claims 15–20 will also be al