1037-00005 · Solstice Biomedical Devices Ltd · Prosecution Documents/CON-2

draft-office-action-response-con2.docx DOCUMENT Litigation

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RESPONSE TO NON-FINAL OFFICE ACTION

Filed via USPTO Patent Center

Priority Claim: This application claims the benefit under 35 U.S.C. § 120 of U.S. Application No. 16/914,337, filed June 28, 2021, now U.S. Patent No. 11,284,561, issued March 22, 2022.

Entity Status: Small Entity under 37 C.F.R. § 1.27.

Date: DRAFT — For Client Review; Not Yet Filed.

Prepared by: Peter Vassiliev and Wendy Schultz

IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

RESPONSE TO NON-FINAL OFFICE ACTION

Mail Stop Amendment Commissioner for Patents P.O. Box 1450 Alexandria, VA 22313-1450

Dear Examiner Dougherty:

I. Preliminary Statement

Applicant, Solstice Biomedical Devices Ltd. ("Applicant"), by and through its undersigned attorney of record, Peter Vassiliev (Reg. No. 72,340), of Calderwood & Harkness LLP, hereby submits this Response to the Non-Final Office Action mailed by the United States Patent and Trademark Office ("USPTO") on September 15, 2024 (the "Office Action"), in connection with the above-identified application. This Response is directed to all outstanding rejections and objections set forth in the Office Action and respectfully requests reconsideration and complete withdrawal thereof.

This Response is timely filed within the period set by a concurrently filed Extension of Time Request under 37 C.F.R. § 1.136(a). The original three-month shortened statutory period for response expired on December 15, 2024. Applicant concurrently files herewith a request for a three-month extension of time, extending the deadline from January 15, 2025 to April 15, 2025, together with the associated small-entity fees in the total amount of $1,380 ($230 for the first month, $460 for the second month, and $690 for the third month), calculated in accordance with the fee schedule applicable to small entities under 37 C.F.R. § 1.17(a)(1)-(3). Applicant respectfully submits that this Response, together with the concurrently filed Extension of Time Request, renders this filing timely and proper.

Applicant respectfully requests reconsideration and withdrawal of all outstanding rejections set forth in the Office Action, including the rejection of Claims 1-8 under 35 U.S.C. § 103, the rejection of Claims 9-14 under 35 U.S.C. § 112(a), and the objection to Claims 15-20 as depending from a rejected base claim. The named inventors in this application are Dr. Aisling Connolly and Dr. Tomás Brennan.

In further support of this Response, Applicant concurrently submits a Declaration of Dr. Aisling Connolly under 37 C.F.R. § 1.132 (the "Connolly Declaration"), which provides factual evidence and expert testimony relevant to the distinctions between the claimed invention and the prior art of record. The Connolly Declaration is incorporated by reference herein where specifically cited.

II. Status of Claims

The following table summarizes the current status of all pending claims in this application:

By this Response, Applicant amends Claims 1, 2, 4, 5, 7, 9, 10, 12, 13, 15, and 17. No claims are canceled. No new claims are added. Claims 1-20 are pending.

III. Amendments to the Claims

Pursuant to 37 C.F.R. § 1.121, the listing of claims below replaces all prior versions of the claims. The text of amended claims is shown with additions underlined and deletions in strikethrough, in accordance with 37 C.F.R. § 1.121(c)(2).

Claim 1 (Currently Amended):

A cryoablation catheter system for performing tissue ablation with integrated impedance mapping, the system comprising:

an elongate catheter body having a proximal end and a distal end;

a distal catheter segment disposed at the distal end of the elongate catheter body, ~~the distal catheter segment comprising a cryoablation zone and at least one impedance mapping electrode~~ the distal catheter segment comprising a plurality of independently controllable cryoablation zones disposed along the distal catheter segment, each independently controllable cryoablation zone comprising a dedicated refrigerant delivery lumen and a dedicated return lumen;

wherein at least two impedance mapping electrodes are integrated within each independently controllable cryoablation zone, each impedance mapping electrode being configured to measure local tissue impedance simultaneously with cryoablation delivery in the respective zone;

a refrigerant supply conduit extending from the proximal end to the distal catheter segment and configured to deliver a cryogenic refrigerant to ~~the cryoablation zone~~ each of the plurality of independently controllable cryoablation zones;

a control unit operatively coupled to the elongate catheter body and configured to regulate ~~cryoablation delivery~~ cryoablation delivery to each of the plurality of independently controllable cryoablation zones and to receive impedance data from the ~~at least one impedance mapping electrode~~ at least two impedance mapping electrodes integrated within each independently controllable cryoablation zone; and

wherein the plurality of independently controllable cryoablation zones are configured to deliver variable cooling profiles simultaneously to distinct circumferential regions of a target tissue site.

Claim 2 (Currently Amended):

The cryoablation catheter system of Claim 1, wherein ~~the at least one impedance mapping electrode is configured to measure tissue impedance~~ each of the at least two impedance mapping electrodes integrated within each independently controllable cryoablation zone is configured to measure local tissue impedance at a frequency range of between about 1 kHz and about 500 kHz, at a sampling rate of at least 50 samples per second, thereby providing real-time impedance feedback during variable-zone cryoablation delivery.

Claim 3 (Original):

The cryoablation catheter system of Claim 1, wherein the elongate catheter body comprises a braided polyether block amide (PEBA) shaft with an outer diameter of between about 9 French and about 13 French.

Claim 4 (Currently Amended):

The cryoablation catheter system of Claim 1, wherein ~~the refrigerant supply conduit comprises at least one lumen extending from the proximal end to the cryoablation zone~~ each dedicated refrigerant delivery lumen and each dedicated return lumen of each independently controllable cryoablation zone are structurally isolated from the dedicated refrigerant delivery lumens and dedicated return lumens of each other independently controllable cryoablation zone, such that refrigerant flow to and from each independently controllable cryoablation zone is independently regulated by the control unit.

Claim 5 (Currently Amended):

The cryoablation catheter system of Claim 1, further comprising ~~a temperature sensor disposed in the distal catheter segment~~ an independent temperature sensor disposed within each independently controllable cryoablation zone, each independent temperature sensor being configured to measure local tissue-interface temperature and to transmit temperature data to the control unit, wherein the control unit is configured to correlate the temperature data from each independent temperature sensor with the impedance data from the at least two impedance mapping electrodes integrated within the corresponding independently controllable cryoablation zone.

Claim 6 (Original):

The cryoablation catheter system of Claim 1, wherein the distal catheter segment has a length of between about 20 mm and about 40 mm and a maximum expanded outer diameter of between about 23 mm and about 31 mm.

Claim 7 (Currently Amended):

The cryoablation catheter system of Claim 1, wherein the control unit further comprises ~~a processor configured to process impedance data~~ a processor configured to execute a feedback control loop, the feedback control loop receiving impedance data from the at least two impedance mapping electrodes integrated within each independently controllable cryoablation zone and temperature data from a temperature sensor associated with each independently controllable cryoablation zone, and the feedback control loop being configured to independently modulate the variable cooling profile delivered to each independently controllable cryoablation zone based on the received impedance data and temperature data.

Claim 8 (Original):

The cryoablation catheter system of Claim 1, further comprising a proximal connector interface disposed at the proximal end of the elongate catheter body, the proximal connector interface being configured to releasably couple the elongate catheter body to the control unit and to a refrigerant source.

Claim 9 (Currently Amended):

A method of calibrating an impedance mapping system integrated with a cryoablation catheter ~~comprising impedance mapping electrodes and at least one cryoablation zone~~ comprising a plurality of impedance mapping electrodes integrated within a plurality of independently controllable cryoablation zones, the method comprising:

~~measuring impedance values using the impedance mapping electrodes~~ acquiring a baseline impedance measurement from each of the plurality of impedance mapping electrodes prior to initiation of cryoablation, the baseline impedance measurement being obtained while the cryoablation catheter is positioned at a target tissue site and prior to delivery of cryogenic refrigerant to any of the plurality of independently controllable cryoablation zones;

~~applying a calibration function to the measured impedance values~~ computing a temperature-corrected impedance value for each impedance mapping electrode by applying a stored calibration function correlating impedance change to tissue temperature, the stored calibration function being derived from empirical calibration data as described in the parent specification at column 14, lines 22-58 and column 15, lines 1-35 of U.S. Patent No. 11,284,561; and

~~updating the calibration function during cryoablation~~ iteratively updating the calibration function during cryoablation delivery based on real-time impedance data from each of the plurality of impedance mapping electrodes and real-time temperature sensor data from each independently controllable cryoablation zone, such that the calibration function is progressively refined to account for changes in tissue characteristics during cryoablation.

Claim 10 (Currently Amended):

The method of Claim 9, wherein ~~the calibration function is updated at periodic intervals~~ iteratively updating the calibration function comprises acquiring updated impedance measurements and updated temperature sensor data at a data sampling interval of between about 10 milliseconds and about 200 milliseconds, and wherein the feedback loop timing for each calibration update cycle is no greater than about 500 milliseconds from data acquisition to output of an updated calibration function.

Claim 11 (Original):

The method of Claim 9, further comprising generating an impedance map of the target tissue site and displaying the impedance map on a display device operatively coupled to the control unit, the impedance map being updated in real time during cryoablation delivery.

Claim 12 (Currently Amended):

The method of Claim 9, wherein ~~the calibration function is stored in a memory of the control unit~~ the stored calibration function is implemented as a look-up table stored in non-volatile memory of the control unit, the look-up table comprising a plurality of entries, each entry correlating a measured impedance value at a given electrode temperature to a predicted tissue temperature, and wherein computing the temperature-corrected impedance value for each impedance mapping electrode comprises indexing the look-up table using the measured impedance value and the measured electrode temperature as input parameters.

Claim 13 (Currently Amended):

The method of Claim 9, further comprising ~~an error-correction step when impedance values deviate from expected values~~ executing an error-correction protocol when a measured impedance value from any of the plurality of impedance mapping electrodes deviates from an expected impedance value predicted by the calibration function by more than a predetermined threshold value, the error-correction protocol comprising: (i) flagging the deviating electrode measurement; (ii) re-acquiring an impedance measurement from the flagged electrode; and (iii) if the re-acquired impedance measurement continues to deviate from the expected impedance value by more than the predetermined threshold value, generating an alert signal to the control unit and optionally suspending cryoablation delivery to the independently controllable cryoablation zone associated with the flagged electrode.

Claim 14 (Original):

The method of Claim 9, further comprising wirelessly transmitting impedance data and calibration data from the cryoablation catheter to an external console via a short-range wireless communication protocol.

Claim 15 (Currently Amended — Rewritten in Independent Form):

A cryoablation catheter system for performing tissue ablation with integrated impedance-guided ablation control, the system comprising:

an elongate catheter body having a proximal end and a distal end;

a distal catheter segment disposed at the distal end of the elongate catheter body, the distal catheter segment comprising a plurality of independently controllable cryoablation zones disposed along the distal catheter segment, each independently controllable cryoablation zone comprising a dedicated refrigerant delivery lumen and a dedicated return lumen;

wherein at least two impedance mapping electrodes are integrated within each independently controllable cryoablation zone, each impedance mapping electrode being configured to measure local tissue impedance simultaneously with cryoablation delivery in the respective zone;

a refrigerant supply conduit extending from the proximal end to the distal catheter segment and configured to deliver a cryogenic refrigerant to each of the plurality of independently controllable cryoablation zones;

a control unit operatively coupled to the elongate catheter body and configured to regulate cryoablation delivery to each of the plurality of independently controllable cryoablation zones and to receive impedance data from the at least two impedance mapping electrodes integrated within each independently controllable cryoablation zone;

wherein the plurality of independently controllable cryoablation zones are configured to deliver variable cooling profiles simultaneously to distinct circumferential regions of a target tissue site; and

wherein the control unit is further configured to execute a real-time impedance-guided ablation termination protocol comprising: (a) continuously monitoring impedance data from the at least two impedance mapping electrodes integrated within each independently controllable cryoablation zone during cryoablation delivery; (b) computing, for each independently controllable cryoablation zone, an impedance-based tissue status indicator derived from the monitored impedance data; (c) comparing the impedance-based tissue status indicator for each independently controllable cryoablation zone to a predetermined ablation completion threshold; and (d) independently terminating cryoablation delivery to each independently controllable cryoablation zone upon the impedance-based tissue status indicator for that zone reaching the predetermined ablation completion threshold, such that cryoablation delivery to different independently controllable cryoablation zones may be terminated at different times based on the impedance data from the respective zones.

Claim 16 (Original, now depending from rewritten Claim 15):

The cryoablation catheter system of Claim 15, wherein the predetermined ablation completion threshold comprises a percentage change in measured impedance relative to a baseline impedance measurement, the percentage change being between about 15% and about 45%.

Claim 17 (Currently Amended):

The cryoablation catheter system of Claim 15, wherein the real-time impedance-guided ablation termination protocol further comprises ~~providing feedback to a user regarding ablation status~~ generating a zone-specific ablation status display output on a graphical user interface operatively coupled to the control unit, the zone-specific ablation status display output comprising, for each independently controllable cryoablation zone: (i) a real-time impedance trace; (ii) a computed impedance-based tissue status indicator; (iii) a visual indication of proximity to the predetermined ablation completion threshold; and (iv) an indication of whether cryoablation delivery to the respective zone has been terminated.

Claim 18 (Original):

The cryoablation catheter system of Claim 15, wherein the control unit is configured to deliver cryoablation energy for a maximum duration of between about 60 seconds and about 300 seconds per independently controllable cryoablation zone, and to terminate cryoablation delivery to any zone upon expiration of the maximum duration regardless of the impedance-based tissue status indicator.

Claim 19 (Original):

The cryoablation catheter system of Claim 15, further comprising a deflection mechanism operatively coupled to the distal catheter segment and configured to deflect the distal catheter segment through a range of at least about 90 degrees in at least two planes relative to the longitudinal axis of the elongate catheter body.

Claim 20 (Original):

A kit comprising:

the cryoablation catheter system of Claim 15; and

a control unit console comprising a processor, a display device, and a refrigerant source interface, the control unit console being configured to operatively couple to the elongate catheter body via the proximal connector interface and to execute the real-time impedance-guided ablation termination protocol.

IV. Remarks

A. Introduction and Overview

Applicant respectfully submits the following Remarks in support of the amendments set forth above and in traversal of the rejections and objections set forth in the Office Action mailed September 15, 2024. Applicant believes that the amendments and arguments presented herein place all pending Claims 1-20 in condition for allowance, and respectfully requests the Examiner's favorable reconsideration.

The amendments presented in Section III above are fully supported by the original disclosure of the parent specification, namely U.S. Patent No. 11,284,561 (issued March 22, 2022 from U.S. Application No. 16/914,337), the benefit of which is claimed by the present continuation application under 35 U.S.C. § 120. No new matter has been introduced by any of the amendments. Each amended limitation can be traced directly to corresponding disclosure in the parent specification, as detailed below.

The Remarks that follow are organized into three principal sections:

(1) Section B — Traversal of the rejection of Claims 1-8 under 35 U.S.C. § 103 as allegedly obvious over U.S. Patent No. 10,537,418 ("the Vantage '418 patent") in view of U.S. Patent No. 9,861,432 ("the Vantage '432 patent") and further in view of U.S. Patent Application Publication No. 2019/0183567 ("the Helios '567 publication");

(2) Section C — Traversal of the rejection of Claims 9-14 under 35 U.S.C. § 112(a) for alleged lack of written description; and

(3) Section D — Request to allow Claims 15-20, which have been rewritten in independent form incorporating the allowable subject matter identified by the Examiner.

Additionally, Section E sets forth a request for an Examiner interview should any concerns remain after review of this Response.

B. Traversal of the § 103 Rejection of Claims 1-8

B.1. Summary of the Examiner's Rejection. In the Office Action, the Examiner rejected Claims 1-8 under 35 U.S.C. § 103 as allegedly being unpatentable over the combination of:

(i) U.S. Patent No. 10,537,418 to Chen et al. ("the '418 patent"), assigned to Vantage Cryosurgical Systems, Inc., as the primary reference;

(ii) U.S. Patent No. 9,861,432 to Ramachandran et al. ("the '432 patent"), assigned to Vantage Cryosurgical Systems, Inc., as a first secondary reference; and

(iii) U.S. Patent Application Publication No. 2019/0183567 to Park et al. ("the '567 publication"), assigned to Helios Surgical Technologies, Inc., as a second secondary reference.

The Examiner's position, as Applicant understands it, is that the '418 patent discloses a cryoablation catheter with a balloon-based ablation zone; the '432 patent discloses improvements to balloon inflation control relevant to cryoablation catheters; and the '567 publication discloses impedance mapping electrodes for use in cardiac electrophysiology catheters. The Examiner concluded that it would have been obvious to a person of ordinary skill in the art at the time of the invention to combine these references to arrive at the subject matter of Claims 1-8.

Applicant respectfully acknowledges the Examiner's position but traverses the rejection in its entirety for the reasons set forth below. As detailed herein, the combination of references relied upon by the Examiner fails to teach, suggest, or render obvious the claimed invention as now recited in amended Claims 1-8. Moreover, the proposed combination relies on impermissible hindsight reasoning and disregards critical structural and functional distinctions between the claimed invention and the prior art.

B.2. Discussion of the Primary Reference — Vantage '418 Patent. The '418 patent to Chen et al. is directed to a cryoablation balloon catheter designed for pulmonary vein isolation procedures. As disclosed in the '418 patent, the catheter comprises an inflatable balloon disposed at the distal end of a catheter shaft. The balloon is configured to receive a cryogenic refrigerant (e.g., nitrous oxide or liquid nitrogen) through a single delivery lumen, which delivers the refrigerant into the interior of the balloon chamber. The refrigerant expands and cools within the balloon, transferring thermal energy from the surrounding tissue through the balloon wall. The spent refrigerant is then returned through a single return lumen. See, e.g., '418 patent, col. 4, ll. 15-42; col. 6, ll. 1-28; Figs. 1-3.

Critically, the cryoablation balloon disclosed in the '418 patent is a single-zone, circumferentially uniform cooling structure. The '418 patent describes a single balloon chamber into which refrigerant is delivered and from which it is exhausted. There is no teaching or suggestion in the '418 patent of dividing the balloon or distal catheter segment into a plurality of independently controllable cryoablation zones, much less providing each such zone with its own dedicated refrigerant delivery lumen and dedicated return lumen. The '418 patent operates on the fundamental principle that the entire circumference of the balloon contacts the target tissue (e.g., the pulmonary vein ostium) and cools uniformly. See '418 patent, col. 3, ll. 55-67 (describing "uniform circumferential tissue contact and cooling").

Furthermore, the '418 patent does not disclose impedance mapping electrodes integrated within the cryoablation zone. The '418 patent makes a passing reference to impedance monitoring in the context of confirming pulmonary vein isolation after the ablation procedure, but this monitoring is performed by a separate diagnostic catheter that is introduced through a different access site and positioned independently of the cryoablation balloon catheter. See '418 patent, col. 9, ll. 33-51. There is no teaching or suggestion in the '418 patent of integrating impedance mapping electrodes within the cryoablation structure itself, and certainly no suggestion of integrating such electrodes within each of a plurality of independently controllable cryoablation zones.

Accordingly, the '418 patent fails to disclose or suggest the following limitations now recited in amended Claim 1:

(a) "a plurality of independently controllable cryoablation zones disposed along a distal catheter segment, each zone comprising a dedicated refrigerant delivery lumen and a dedicated return lumen";

(b) "at least two impedance mapping electrodes integrated within each independently controllable cryoablation zone, each electrode being configured to measure local tissue impedance simultaneously with cryoablation delivery in the respective zone"; and

(c) "the plurality of independently controllable cryoablation zones are configured to deliver variable cooling profiles simultaneously to distinct circumferential regions of a target tissue site."

B.3. Discussion of the First Secondary Reference — Vantage '432 Patent. The '432 patent to Ramachandran et al. is directed to improvements in cryoablation balloon inflation control and pressure monitoring. Specifically, the '432 patent describes pressure sensors and feedback mechanisms for maintaining consistent balloon inflation pressure during cryoablation procedures. The '432 patent also describes techniques for achieving pressure equalization across the balloon chamber to ensure uniform thermal contact between the balloon wall and the target tissue. See '432 patent, col. 5, ll. 10-45; col. 7, ll. 20-55.

Like the '418 patent, the '432 patent is fundamentally directed to single-zone balloon technology. The entire thrust of the '432 patent's disclosure is directed toward optimizing the performance of a single, circumferentially uniform cryoablation balloon. The pressure equalization techniques described in the '432 patent are specifically designed to ensure that a single balloon chamber maintains uniform pressure and uniform tissue contact around its entire circumference. See '432 patent, col. 3, ll. 22-38 (describing "uniform pressure distribution across the balloon chamber for consistent ablation depth").

The '432 patent does not teach or suggest:

• Dividing a cryoablation structure into multiple independently controllable zones;

• Providing dedicated refrigerant delivery and return lumens for each zone;

• Integrating impedance mapping electrodes within cryoablation zones; or

• Delivering variable cooling profiles simultaneously to distinct circumferential regions of a target tissue site.

Moreover, there is no teaching, suggestion, or motivation in the '432 patent that would lead a person of ordinary skill in the art to combine the '432 patent with the '418 patent in a manner that would arrive at the claimed invention. The '432 patent's disclosure of pressure equalization across a single balloon chamber is conceptually antithetical to the claimed invention's approach of independently controlling multiple zones with variable cooling profiles. A person of ordinary skill in the art, reading the '432 patent, would be led away from the concept of independent zone control, not toward it.

B.4. Discussion of the Second Secondary Reference — Helios '567 Publication. The '567 publication to Park et al. is directed to an impedance mapping catheter for use in cardiac electrophysiology procedures. The '567 publication describes a multi-electrode catheter configured to generate impedance maps of cardiac tissue for diagnostic purposes, such as identifying regions of scar tissue, fibrosis, or abnormal conduction pathways. See '567 publication, paragraphs [0015]-[0023]; Figs. 1-4.

Importantly, the '567 publication describes impedance mapping as a standalone diagnostic function performed by a dedicated mapping catheter. The catheter described in the '567 publication is not a cryoablation catheter — it does not deliver any form of ablation energy, cryogenic or otherwise. The impedance mapping electrodes described in the '567 publication are disposed on a catheter that is designed solely for diagnostic mapping purposes. See '567 publication, paragraph [0012] ("The present disclosure is directed to a diagnostic mapping catheter..."); paragraph [0025] ("The mapping catheter is not configured to deliver therapeutic energy.").

Even assuming arguendo that a person of ordinary skill in the art might consider combining the impedance mapping functionality of the '567 publication with a cryoablation catheter (which Applicant does not concede), such a combination would still fail to arrive at the claimed invention. The '567 publication provides no teaching or suggestion of integrating impedance mapping electrodes within individually controllable cryoablation zones. This is because neither the '418 patent nor the '432 patent — the only cryoablation references in the combination — teaches or suggests the existence of multiple independently controllable cryoablation zones. A person of ordinary skill in the art cannot integrate impedance electrodes within independently controllable zones that do not exist in the prior art. The concept of placing impedance mapping electrodes within each of multiple independent cryoablation zones to enable simultaneous impedance measurement and cryoablation delivery within each zone is a novel structural and functional configuration that is entirely absent from the cited references, whether taken alone or in any combination.

Furthermore, the proposed combination of all three references requires impermissible hindsight reconstruction. As the Federal Circuit has consistently held, "[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant's disclosure, such a reconstruction is proper." In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Here, the Examiner's proposed combination draws upon the Applicant's own disclosure as the template for combining the references — there is no suggestion in any of the three references to integrate impedance mapping electrodes within each of a plurality of independently controllable cryoablation zones. The very concept of independently controllable cryoablation zones is absent from all three references. The combination proposed by the Examiner is, therefore, the product of impermissible hindsight reasoning, using Applicant's claims as a roadmap to reconstruct the invention from disparate and unrelated prior art teachings.

B.5. Arguments Based on Amended Claim Limitations. The amendments to Claims 1-8, as set forth in Section III above, further sharpen the distinctions between the claimed invention and the cited prior art. Amended Claim 1 now explicitly requires:

(a) A plurality of independently controllable cryoablation zones, each comprising a dedicated refrigerant delivery lumen and a dedicated return lumen — a structural configuration that is entirely absent from the '418 patent (single-zone balloon), the '432 patent (single-zone pressure optimization), and the '567 publication (no cryoablation capability whatsoever);

(b) At least two impedance mapping electrodes integrated within each independently controllable cryoablation zone, configured to measure local tissue impedance simultaneously with cryoablation delivery in the respective zone — a functional integration that is not taught or suggested by any of the cited references; and

(c) The plurality of independently controllable cryoablation zones configured to deliver variable cooling profiles simultaneously to distinct circumferential regions of a target tissue site — a therapeutic delivery paradigm that is fundamentally different from the uniform, single-zone cooling disclosed in the Vantage patents.

None of the three references, alone or in combination, disclose or suggest this particular combination of structural and functional features.

In addition, Applicant respectfully directs the Examiner's attention to the significant technical challenges associated with integrating impedance mapping electrodes into cryoablation zones — challenges that further support the non-obviousness of the claimed invention. The extreme temperature gradients encountered during cryoablation (tissue temperatures reaching -40°C to -80°C at the ablation site) create substantial interference with impedance measurements. Electrode-tissue interface impedance is highly temperature-dependent, and the thermal gradients within a cryoablation zone introduce measurement artifacts that must be specifically addressed through calibration techniques. As discussed in the parent specification at column 13, lines 40-67, and as confirmed in the concurrently filed Connolly Declaration at paragraphs 12-18, the integration of impedance mapping electrodes within active cryoablation zones presented unpredictable technical challenges that required extensive experimentation and novel calibration approaches to resolve. This unpredictability further supports the conclusion that the claimed invention would not have been obvious to a person of ordinary skill in the art at the time of the invention.

The Connolly Declaration provides additional factual evidence on this point. Specifically, Dr. Connolly, one of the named inventors and a recognized expert in cryoablation catheter design with over 15 years of experience in the field, testifies that:

• The single-zone cryoablation balloon designs described in the Vantage '418 and '432 patents represent the prevailing approach in the industry at the time of the invention, and there was no recognized motivation to divide a cryoablation structure into independently controllable zones (Connolly Declaration, ¶¶ 8-11);

• The integration of impedance mapping electrodes within active cryoablation zones was not a straightforward engineering exercise, as the cryogenic environment caused significant degradation of impedance measurement accuracy that required development of the novel calibration techniques described in the parent specification (Connolly Declaration, ¶¶ 12-18);

• The claimed combination of multi-zone cryoablation with integrated impedance mapping within each zone represents a paradigm shift from the sequential "ablate-then-map" workflow that characterized prior cryoablation procedures to a simultaneous "ablate-and-map" approach that was not suggested by the prior art (Connolly Declaration, ¶¶ 19-25); and

• The Applicant's CryoNova variable-zone cooling system with integrated impedance mapping has demonstrated clinically significant improvements in procedure time and lesion quality compared to single-zone balloon designs, which further supports the non-obvious nature of the claimed invention (Connolly Declaration, ¶¶ 26-30).

B.6. Conclusion on § 103 Rejection. For the foregoing reasons, Applicant respectfully submits that amended Claims 1-8 are patentable over the combination of the '418 patent, the '432 patent, and the '567 publication. None of the cited references, whether taken individually or in any combination, teaches, suggests, or renders obvious the claimed invention as now recited in amended Claims 1-8. The Examiner's proposed combination of references requires impermissible hindsight reasoning, and the technical unpredictability of integrating impedance mapping electrodes within active cryoablation zones further supports non-obviousness.

Applicant respectfully requests that the Examiner withdraw the rejection of Claims 1-8 under 35 U.S.C. § 103. Dependent Claims 2-8 are patentable at least for the same reasons as independent Claim 1 and, additionally, for the further limitations recited therein, including the specific impedance measurement frequency range and sampling rate (Claim 2), the structurally isolated lumen architecture (Claim 4), the independent temperature sensing correlated with impedance data (Claim 5), and the feedback control loop integrating impedance and temperature data for zone-specific cooling modulation (Claim 7).

C. Traversal of the § 112(a) Rejection of Claims 9-14

C.1. Summary of the Examiner's Rejection. In the Office Action, the Examiner rejected Claims 9-14 under 35 U.S.C. § 112(a) for alleged lack of written description. Specifically, the Examiner took the position that the specification does not provide sufficient written description to support the impedance mapping calibration algorithm steps recited in Claims 9-14. The Examiner stated that "the specification fails to describe with sufficient particularity the calibration algorithm, including the specific computational steps, the calibration function parameters, and the iterative updating methodology, such that a person of ordinary skill in the art would recognize that the inventors were in possession of the claimed subject matter." Office Action at p. 9.

Applicant respectfully traverses this rejection. As demonstrated below, the parent specification — U.S. Patent No. 11,284,561, which serves as the written description for this continuation application — provides extensive and detailed written description support for the calibration algorithm as claimed.

C.2. Written-Description Support in the Parent Specification. The present application is a continuation of U.S. Application No. 16/914,337, which issued as U.S. Patent No. 11,284,561 on March 22, 2022. As a continuation application, the present application claims the benefit of the earlier filing date under 35 U.S.C. § 120 and is entitled to rely upon the written description of the parent specification to satisfy the requirements of 35 U.S.C. § 112(a). The parent specification provides full and detailed written description support for each element of the calibration algorithm as recited in Claims 9-14, as follows:

Column 14, lines 22-58 of U.S. Patent No. 11,284,561 describes in detail the baseline impedance acquisition step that is the first step of the claimed calibration algorithm. Specifically, the parent specification discloses:

"Prior to initiation of cryoablation delivery, the control unit acquires a baseline impedance measurement from each of the plurality of impedance mapping electrodes disposed within the cryoablation zones. The baseline measurement is obtained with the catheter positioned at the target tissue site, with the balloon or ablation structure in contact with the tissue, but prior to delivery of any cryogenic refrigerant. Each electrode is individually addressed by the control unit, and a baseline impedance value is recorded at a predetermined excitation frequency... The baseline impedance values serve as the reference against which subsequent impedance changes during cryoablation are calculated." (col. 14, ll. 22-42).

This disclosure directly supports the limitation in amended Claim 9 of "acquiring a baseline impedance measurement from each of the plurality of impedance mapping electrodes prior to initiation of cryoablation."

Column 15, lines 1-35 of U.S. Patent No. 11,284,561 describes the temperature-corrected impedance calculation step, including the stored calibration function and its parameters:

"The control unit computes a temperature-corrected impedance value for each electrode by applying a stored calibration function that correlates measured impedance change to estimated tissue temperature. The calibration function is derived from empirical calibration data obtained during bench testing and pre-clinical studies, in which known tissue samples were subjected to controlled cooling and the impedance-temperature relationship was characterized across a range of tissue types and temperature values... The calibration function may be implemented as a polynomial fit, a piecewise linear approximation, or a look-up table indexed by measured impedance and electrode temperature." (col. 15, ll. 1-25).

This disclosure directly supports the limitation in amended Claim 9 of "computing a temperature-corrected impedance value for each electrode by applying a stored calibration function correlating impedance change to tissue temperature."

Column 15, lines 36-67 of U.S. Patent No. 11,284,561 describes the iterative updating process during cryoablation delivery:

"During cryoablation delivery, the calibration function is iteratively updated based on real-time impedance and temperature sensor data from each independently controllable cryoablation zone. As the tissue temperature decreases during ablation, the impedance-temperature relationship may shift due to changes in tissue characteristics (e.g., ice crystal formation, cellular disruption). The control unit monitors these changes in real time and adjusts the calibration function parameters accordingly, such that the impedance-to-temperature correlation remains accurate throughout the ablation procedure." (col. 15, ll. 36-55).

This disclosure directly supports the limitation in amended Claim 9 of "iteratively updating the calibration function during cryoablation delivery based on real-time impedance and temperature sensor data from each independently controllable cryoablation zone."

Column 16, lines 1-29 of U.S. Patent No. 11,284,561 further describes the look-up table implementation and the error-correction protocols:

"In a preferred embodiment, the calibration function is implemented as a look-up table stored in non-volatile memory of the control unit. The look-up table comprises a plurality of entries, each entry correlating a measured impedance value at a given electrode temperature to a predicted tissue temperature... When a measured impedance value deviates from the expected value predicted by the calibration function by more than a predetermined threshold (e.g., greater than 10% deviation), the control unit executes an error-correction protocol comprising re-acquisition of the impedance measurement and, if the deviation persists, generation of an alert signal." (col. 16, ll. 1-22).

This disclosure directly supports the limitations in amended Claims 12 and 13 regarding the look-up table implementation and error-correction protocols, respectively.

Figures 8A-8C of U.S. Patent No. 11,284,561 provide flowchart diagrams that illustrate the complete calibration algorithm sequence, including the baseline acquisition step (Fig. 8A), the temperature-corrected impedance computation step (Fig. 8B), and the iterative updating and error-correction steps (Fig. 8C). These figures, together with the accompanying description at column 14, line 22 through column 16, line 29, provide a comprehensive written description of the calibration algorithm sufficient to convey to a person of ordinary skill in the art that the inventors were in possession of the claimed subject matter at the time of filing.

Applicant submits that the foregoing citations to the parent specification demonstrate compliance with the written description requirement of 35 U.S.C. § 112(a) as interpreted by the Federal Circuit and as set forth in MPEP § 2163. The written description requirement is satisfied when "the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad Pharms., Inc. v. Crowne Albany Industries, 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The parent specification's detailed disclosure of each step of the calibration algorithm, including the specific computational methodology, the calibration function parameters, and the iterative updating and error-correction protocols, amply satisfies this standard.

Furthermore, MPEP § 2163.02 provides that "[a]n original claim may lack written description support when... the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved." Here, the parent specification does not merely describe the calibration algorithm in functional terms — it describes the specific steps, the specific data inputs, the specific computational methodology, and the specific implementation structures (e.g., look-up table, error-correction protocol) in sufficient detail to satisfy the written description requirement.

C.3. Amendments to Claims 9-14 Addressing the Rejection. To further address the Examiner's concerns, Applicant has amended Claims 9, 10, 12, and 13 to more explicitly tie each algorithmic step to the corresponding disclosure in the parent specification. Amended Claim 9 now recites the three core steps of the calibration algorithm with specificity that directly tracks the parent specification's disclosure:

(1) Acquiring a baseline impedance measurement from each of the plurality of impedance mapping electrodes prior to initiation of cryoablation (corresponding to col. 14, ll. 22-42 of U.S. Patent No. 11,284,561);

(2) Computing a temperature-corrected impedance value for each electrode by applying a stored calibration function correlating impedance change to tissue temperature (corresponding to col. 15, ll. 1-35 of U.S. Patent No. 11,284,561); and

(3) Iteratively updating the calibration function during cryoablation delivery based on real-time impedance and temperature sensor data from each independently controllable cryoablation zone (corresponding to col. 15, ll. 36-67 of U.S. Patent No. 11,284,561).

Amended Claim 10 adds specificity regarding the data sampling interval and feedback loop timing for calibration updates, which is supported by the parent specification's disclosure of sampling rates and update cycle timing. Amended Claim 12 adds the look-up table implementation limitation, which is directly supported by column 16, lines 1-15 of the parent patent. Amended Claim 13 adds the error-correction protocol limitation with specificity regarding the threshold-based detection and re-acquisition steps, which is directly supported by column 16, lines 15-29 of the parent patent.

Importantly, the amendments to Claims 9-14 do not add new matter. Each amended limitation is drawn directly from the disclosure of the parent specification as identified above. The amendments merely clarify and more precisely claim subject matter that was already fully described in the parent specification.

C.4. Conclusion on § 112(a) Rejection. For the foregoing reasons, Applicant respectfully submits that Claims 9-14, as amended, satisfy the written description requirement of 35 U.S.C. § 112(a). The parent specification, U.S. Patent No. 11,284,561, provides detailed written description support for each element of the calibration algorithm as now recited in Claims 9-14, including the baseline impedance acquisition step, the temperature-corrected impedance computation step, the iterative updating step, the look-up table implementation, and the error-correction protocol.

Applicant respectfully requests that the Examiner withdraw the rejection of Claims 9-14 under 35 U.S.C. § 112(a). Dependent Claims 10-14 are separately patentable for the additional limitations recited therein, including the specific data sampling interval and feedback loop timing (Claim 10), the look-up table implementation (Claim 12), the error-correction protocol with threshold-based detection (Claim 13), and the wireless data transmission capability (Claim 14).

D. Request to Allow Claims 15-20

D.1. Examiner's Indication of Allowable Subject Matter. Applicant acknowledges with appreciation the Examiner's indication in the Office Action that Claims 15-20 contain allowable subject matter. The Examiner objected to Claims 15-20 as being dependent upon rejected base Claim 1, but indicated that the subject matter of Claims 15-20 would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. See Office Action at p. 12. Applicant expresses its appreciation for the Examiner's careful analysis and favorable indication regarding these claims.

D.2. Claims 15-20 Rewritten in Independent Form. In accordance with the Examiner's indication, Claim 15 has been rewritten in independent form. As presented in Section III above, rewritten Claim 15 now incorporates all of the limitations of original Claim 1 (as now amended) together with the additional limitations that the Examiner identified as containing allowable subject matter. Specifically, rewritten Claim 15 now recites the full cryoablation catheter structure with integrated impedance mapping electrodes (incorporating the amended limitations of Claim 1, including the plurality of independently controllable cryoablation zones, the integrated impedance mapping electrodes, and the variable cooling profiles), as well as the specific real-time impedance-guided ablation termination protocol, including the continuous impedance monitoring, computation of an impedance-based tissue status indicator, comparison to a predetermined ablation completion threshold, and independent termination of cryoablation delivery to each zone upon reaching the threshold.

All limitations of the original dependent Claim 15 have been incorporated verbatim into the rewritten independent claim. Claims 16-20 remain dependent on Claim 15 and are not affected by the rewriting other than that they now depend from an independent claim rather than from a dependent claim.

All rewritten and amended claims within this group are fully supported by the parent specification, U.S. Patent No. 11,284,561, and no new matter has been introduced.

D.3. Request for Allowance. Applicant respectfully requests that the Examiner confirm the allowability of Claims 15-20 as rewritten in independent form. Applicant submits that Claims 15-20, as now presented, are in condition for allowance and respectfully requests that the Examiner issue a Notice of Allowance with respect to these claims.

E. Statement Regarding Interview Request

Should the Examiner have any remaining concerns after review of this Response, the amendments, and the supporting Connolly Declaration, Applicant's counsel respectfully requests the opportunity for a telephonic or in-person interview with Examiner Dougherty and/or Supervisory Patent Examiner Linda M. Kowalski to discuss any outstanding issues. Applicant believes that an interview may be productive in advancing prosecution and resolving any remaining concerns efficiently.

Applicant's counsel may be reached at the contact information set forth below:

Peter Vassiliev, Reg. No. 72,340 Calderwood & Harkness LLP 600 Lexington Avenue, 22nd Floor New York, NY 10022 Telephone: (212) 555-0147 Facsimile: (212) 555-0148

Email: pvassiliev@calderwoodharkness.com

Applicant's counsel is available for an interview at the Examiner's convenience and would be pleased to accommodate the Examiner's schedule.

V. Conclusion

In view of the foregoing amendments and Remarks, Applicant respectfully requests reconsideration and complete withdrawal of all rejections and objections set forth in the Office Action mailed September 15, 2024, including:

(1) The rejection of Claims 1-8 under 35 U.S.C. § 103;

(2) The rejection of Claims 9-14 under 35 U.S.C. § 112(a); and

(3) The objection to Claims 15-20 as dependent on a rejected base claim.

Applicant respectfully requests that Claims 1-20, as amended herein, be allowed and that a Notice of Allowance be issued at the Examiner's earliest convenience.

Should there be any additional fees required for entry of this Response beyond those submitted herewith, the Commissioner is authorized to charge any deficiency to, or credit any overpayment to, Deposit Account No. [To Be Inserted] of Calderwood & Harkness LLP, in accordance with 37 C.F.R. § 1.25.

This Response is being filed concurrently with the following documents:

(a) Extension of Time Request under 37 C.F.R. § 1.136(a) with associated small-entity fees in the total amount of $1,380; and

(b) Declaration of Dr. Aisling Connolly under 37 C.F.R. § 1.132.

VI. Signature block

Respectfully submitted,

CALDERWOOD & HARKNESS LLP

By: /Peter Vassiliev/

________________________________________

Peter Vassiliev Registration No. 72,340

Date: ________

Calderwood & Harkness LLP 600 Lexington Avenue, 22nd Floor New York, NY 10022 Telephone: (212) 555-0147 Facsimile: (212) 555-0148

VII. Certificate of Service / Filing

CERTIFICATE OF ELECTRONIC FILING

I hereby certify that this Response to Non-Final Office Action, together with all concurrently filed documents identified in Appendix A hereto, is being filed electronically via the USPTO Patent Center on this date.

/Peter Vassiliev/

________________________________________

Peter Vassiliev Registration No. 72,340

Date: ________

Appendix A — Listing of Concurrently Filed Documents

The following documents are filed concurrently with this Response to Non-Final Office Action in U.S. Application No. 17/851,216:

DRAFT — PRIVILEGED & CONFIDENTIAL — FOR CLIENT REVIEW ONLY — NOT YET FILED

Matter No.: SBD-IP-2021-003	Prepared by: Peter Vassiliev and Wendy Schultz	Technical Review: Dr. Claire Nakamura	Partner Review: Alan Ngo	Client: Solstice Biomedical Devices Ltd.	Application: U.S. 17/851,216 (SBD-001-CON2)
Application No.:	17/851,216
Filing Date:	June 27, 2022
Title:	Cryoablation Catheter with Integrated Impedance Mapping Electrodes
Art Unit:	3794
Examiner:	James R. Dougherty
Confirmation No.:	[To Be Inserted]
Docket No.:	SBD-001-CON2
Applicant:	Solstice Biomedical Devices Ltd.
Address:	Unit 4, Liffey Innovation Campus, Parkgate Street, Dublin 8, D08 XR29, Ireland
Attorney of Record:	Peter Vassiliev, Reg. No. 72,340
Firm:	Calderwood & Harkness LLP
Address:	600 Lexington Avenue, 22nd Floor, New York, NY 10022
Telephone:	(212) 555-0147
Facsimile:	(212) 555-0148
In re Application of:	Dr. Aisling Connolly and Dr. Tomás Brennan
Application No.:	17/851,216
Filed:	June 27, 2022
For:	Cryoablation Catheter with Integrated Impedance Mapping Electrodes
Art Unit:	3794
Examiner:	James R. Dougherty
Docket No.:	SBD-001-CON2
Claim(s)	Previous Status (Office Action)	Action Taken in This Response	Current Status
1-8	Rejected under 35 U.S.C. § 103	Claims 1, 2, 4, 5, and 7 amended; Claims 3, 6, and 8 remain as previously presented	Pending (amended)
9-14	Rejected under 35 U.S.C. § 112(a)	Claims 9, 10, 12, and 13 amended; Claims 11 and 14 remain as previously presented	Pending (amended)

15-20	Objected to as dependent on rejected base claim; indicated as containing allowable subject matter	Claim 15 rewritten in independent form; Claim 17 amended; Claims 16, 18, 19, and 20 remain as previously presented (now depending from rewritten Claim 15)	Pending (rewritten/amended)
Application No.:	17/851,216
Title:	Cryoablation Catheter with Integrated Impedance Mapping Electrodes
Art Unit:	3794
Examiner:	James R. Dougherty
Docket No.:	SBD-001-CON2
No.	Document	Description
1	Extension of Time Request under 37 C.F.R. § 1.136(a)	Three-month extension of time with associated small-entity fees totaling $1,380 (first month: $230; second month: $460; third month: $690), calculated in accordance with the fee schedule for small entities under 37 C.F.R. § 1.17(a)(1)-(3).
2	Declaration of Dr. Aisling Connolly under 37 C.F.R. § 1.132	Declaration of named inventor Dr. Aisling Connolly providing factual evidence and expert testimony in support of the patentability of Claims 1-20, including testimony regarding the technical distinctions between the claimed invention and the prior art of record, the unpredictability of integrating impedance mapping electrodes within active cryoablation zones, and the clinical significance of the claimed invention.
3	Claim Amendment Comparison Chart (CON-2, U.S. 17/851,216)	Courtesy exhibit for the Examiner providing a side-by-side comparison of the previously presented claims and the amended claims, with annotations identifying the written-description support in the parent specification (U.S. Patent No. 11,284,561) for each amended limitation.

RESPONSE TO NON-FINAL OFFICE ACTION
Filed via USPTO Patent Center
Priority Claim: This application claims the benefit under 35 U.S.C. § 120 of U.S. Application No. 16/914,337, filed June 28, 2021, now U.S. Patent No. 11,284,561, issued March 22, 2022.
Entity Status: Small Entity under 37 C.F.R. § 1.27.
Date: DRAFT — For Client Review; Not Yet Filed.
Prepared by: Peter Vassiliev and Wendy Schultz | Technical Review: Dr. Claire Nakamura | Partner Review: Alan Ngo | Client: Solstice Biomedical Devices Ltd. | Application: U.S. 17/851,216 (SBD-001-CON2) | Matter No.: SBD-IP-2021-003
IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
RESPONSE TO NON-FINAL OFFICE ACTION
Mail Stop Amendment Commissioner for Patents P.O. Box 1450 Alexandria, VA 22313-1450
Dear Examiner Dougherty:
I. Preliminary Statement
Applicant, Solstice Biomedical Devices Ltd. ("Applicant"), by and through its undersigned attorney of record, Peter Vassiliev (Reg. No. 72,340), of Calderwood & Harkness LLP, hereby submits this Response to the Non-Final Office Action mailed by the United States Patent and Trademark Office ("USPTO") on September 15, 2024 (the "Office Action"), in connection with the above-identified application. This Response is directed to all outstanding rejections and objections set forth in the Office Action and respectfully requests reconsideration and complete withdrawal thereof.
This Response is timely filed within the period set by a concurrently filed Extension of Time Request under 37 C.F.R. § 1.136(a). The original three-month shortened statutory period for response expired on December 15, 2024. Applicant concurrently files herewith a request for a three-month extension of time, extending the deadline from January 15, 2025 to April 15, 2025, together with the associated small-entity fees in the total amount of $1,380 ($230 for the first month, $460 for the second month, and $690 for the third month), calculated in accordance with the fee schedule applicable to small entities under 37 C.F.R. § 1.17(a)(1)-(3). Applicant respectfully submits that this Response, together with the concurrently filed Extension of Time Request, renders this filing timely and proper.
Applicant respectfully requests reconsideration and withdrawal of all outstanding rejections set forth in the Office Action, including the rejection of Claims 1-8 under 35 U.S.C. § 103, the rejection of Claims 9-14 under 35 U.S.C. § 112(a), and the objection to Claims 15-20 as depending from a rejected base claim. The named inventors in this application are Dr. Aisling Connolly and Dr. Tomás Brennan.
In further support of this Response, Applicant concurrently submits a Declaration of Dr. Aisling Connolly under 37 C.F.R. § 1.132 (the "Connolly Declaration"), which provides factual evidence and expert testimony relevant to the distinctions between the claimed invention and the prior art of record. The Connolly Declaration is incorporated by reference herein where specifically cited.
II. Status of Claims
The following table summarizes the current status of all pending claims in this application:
By this Response, Applicant amends Claims 1, 2, 4, 5, 7, 9, 10, 12, 13, 15, and 17. No claims are canceled. No new claims are added. Claims 1-20 are pending.
III. Amendments to the Claims
Pursuant to 37 C.F.R. § 1.121, the listing of claims below replaces all prior versions of the claims. The text of amended claims is shown with additions underlined and deletions in strikethrough, in accordance with 37 C.F.R. § 1.121(c)(2).
Claim 1 (Currently Amended):
A cryoablation catheter system for performing tissue ablation with integrated impedance mapping, the system comprising:
an elongate catheter body having a proximal end and a distal end;
a distal catheter segment disposed at the distal end of the elongate catheter body, ~~the distal catheter segment comprising a cryoablation zone and at least one impedance mapping electrode~~ <u>the distal catheter segment comprising a plurality of independently controllable cryoablation zones disposed along the distal catheter segment, each independently controllable cryoablation zone comprising a dedicated refrigerant delivery lumen and a dedicated return lumen</u>;
<u>wherein at least two impedance mapping electrodes are integrated within each independently controllable cryoablation zone, each impedance mapping electrode being configured to measure local tissue impedance simultaneously with cryoablation delivery in the respective zone</u>;
a refrigerant supply conduit extending from the proximal end to the distal catheter segment and configured to deliver a cryogenic refrigerant to ~~the cryoablation zone~~ <u>each of the plurality of independently controllable cryoablation zones</u>;
a control unit operatively coupled to the elongate catheter body and configured to regulate ~~cryoablation delivery~~ <u>cryoablation delivery to each of the plurality of independently controllable cryoablation zones</u> and to receive impedance data from the ~~at least one impedance mapping electrode~~ <u>at least two impedance mapping electrodes integrated within each independently controllable cryoablation zone</u>; and
<u>wherein the plurality of independently controllable cryoablation zones are configured to deliver variable cooling profiles simultaneously to distinct circumferential regions of a target tissue site</u>.
Claim 2 (Currently Amended):
The cryoablation catheter system of Claim 1, wherein ~~the at least one impedance mapping electrode is configured to measure tissue impedance~~ <u>each of the at least two impedance mapping electrodes integrated within each independently controllable cryoablation zone is configured to measure local tissue impedance at a frequency range of between about 1 kHz and about 500 kHz, at a sampling rate of at least 50 samples per second, thereby providing real-time impedance feedback during variable-zone cryoablation delivery</u>.
Claim 3 (Original):
The cryoablation catheter system of Claim 1, wherein the elongate catheter body comprises a braided polyether block amide (PEBA) shaft with an outer diameter of between about 9 French and about 13 French.
Claim 4 (Currently Amended):
The cryoablation catheter system of Claim 1, wherein ~~the refrigerant supply conduit comprises at least one lumen extending from the proximal end to the cryoablation zone~~ <u>each dedicated refrigerant delivery lumen and each dedicated return lumen of each independently controllable cryoablation zone are structurally isolated from the dedicated refrigerant delivery lumens and dedicated return lumens of each other independently controllable cryoablation zone, such that refrigerant flow to and from each independently controllable cryoablation zone is independently regulated by the control unit</u>.
Claim 5 (Currently Amended):
The cryoablation catheter system of Claim 1, further comprising ~~a temperature sensor disposed in the distal catheter segment~~ <u>an independent temperature sensor disposed within each independently controllable cryoablation zone, each independent temperature sensor being configured to measure local tissue-interface temperature and to transmit temperature data to the control unit, wherein the control unit is configured to correlate the temperature data from each independent temperature sensor with the impedance data from the at least two impedance mapping electrodes integrated within the corresponding independently controllable cryoablation zone</u>.
Claim 6 (Original):
The cryoablation catheter system of Claim 1, wherein the distal catheter segment has a length of between about 20 mm and about 40 mm and a maximum expanded outer diameter of between about 23 mm and about 31 mm.
Claim 7 (Currently Amended):
The cryoablation catheter system of Claim 1, wherein the control unit further comprises ~~a processor configured to process impedance data~~ <u>a processor configured to execute a feedback control loop, the feedback control loop receiving impedance data from the at least two impedance mapping electrodes integrated within each independently controllable cryoablation zone and temperature data from a temperature sensor associated with each independently controllable cryoablation zone, and the feedback control loop being configured to independently modulate the variable cooling profile delivered to each independently controllable cryoablation zone based on the received impedance data and temperature data</u>.
Claim 8 (Original):
The cryoablation catheter system of Claim 1, further comprising a proximal connector interface disposed at the proximal end of the elongate catheter body, the proximal connector interface being configured to releasably couple the elongate catheter body to the control unit and to a refrigerant source.
Claim 9 (Currently Amended):
A method of calibrating an impedance mapping system integrated with a cryoablation catheter ~~comprising impedance mapping electrodes and at least one cryoablation zone~~ <u>comprising a plurality of impedance mapping electrodes integrated within a plurality of independently controllable cryoablation zones</u>, the method comprising:
~~measuring impedance values using the impedance mapping electrodes~~ <u>acquiring a baseline impedance measurement from each of the plurality of impedance mapping electrodes prior to initiation of cryoablation, the baseline impedance measurement being obtained while the cryoablation catheter is positioned at a target tissue site and prior to delivery of cryogenic refrigerant to any of the plurality of independently controllable cryoablation zones</u>;
~~applying a calibration function to the measured impedance values~~ <u>computing a temperature-corrected impedance value for each impedance mapping electrode by applying a stored calibration function correlating impedance change to tissue temperature, the stored calibration function being derived from empirical calibration data as described in the parent specification at column 14, lines 22-58 and column 15, lines 1-35 of U.S. Patent No. 11,284,561</u>; and
~~updating the calibration function during cryoablation~~ <u>iteratively updating the calibration function during cryoablation delivery based on real-time impedance data from each of the plurality of impedance mapping electrodes and real-time temperature sensor data from each independently controllable cryoablation zone, such that the calibration function is progressively refined to account for changes in tissue characteristics during cryoablation</u>.
Claim 10 (Currently Amended):
The method of Claim 9, wherein ~~the calibration function is updated at periodic intervals~~ <u>iteratively updating the calibration function comprises acquiring updated impedance measurements and updated temperature sensor data at a data sampling interval of between about 10 milliseconds and about 200 milliseconds, and wherein the feedback loop timing for each calibration update cycle is no greater than about 500 milliseconds from data acquisition to output of an updated calibration function</u>.
Claim 11 (Original):
The method of Claim 9, further comprising generating an impedance map of the target tissue site and displaying the impedance map on a display device operatively coupled to the control unit, the impedance map being updated in real time during cryoablation delivery.
Claim 12 (Currently Amended):
The method of Claim 9, wherein ~~the calibration function is stored in a memory of the control unit~~ <u>the stored calibration function is implemented as a look-up table stored in non-volatile memory of the control unit, the look-up table comprising a plurality of entries, each entry correlating a measured impedance value at a given electrode temperature to a predicted tissue temperature, and wherein computing the temperature-corrected impedance value for each impedance mapping electrode comprises indexing the look-up table using the measured impedance value and the measured electrode temperature as input parameters</u>.
Claim 13 (Currently Amended):
The method of Claim 9, further comprising ~~an error-correction step when impedance values deviate from expected values~~ <u>executing an error-correction protocol when a measured impedance value from any of the plurality of impedance mapping electrodes deviates from an expected impedance value predicted by the calibration function by more than a predetermined threshold value, the error-correction protocol comprising: (i) flagging the deviating electrode measurement; (ii) re-acquiring an impedance measurement from the flagged electrode; and (iii) if the re-acquired impedance measurement continues to deviate from the expected impedance value by more than the predetermined threshold value, generating an alert signal to the control unit and optionally suspending cryoablation delivery to the independently controllable cryoablation zone associated with the flagged electrode</u>.
Claim 14 (Original):
The method of Claim 9, further comprising wirelessly transmitting impedance data and calibration data from the cryoablation catheter to an external console via a short-range wireless communication protocol.
Claim 15 (Currently Amended — Rewritten in Independent Form):
A cryoablation catheter system for performing tissue ablation with integrated impedance-guided ablation control, the system comprising:
an elongate catheter body having a proximal end and a distal end;
a distal catheter segment disposed at the distal end of the elongate catheter body, the distal catheter segment comprising a plurality of independently controllable cryoablation zones disposed along the distal catheter segment, each independently controllable cryoablation zone comprising a dedicated refrigerant delivery lumen and a dedicated return lumen;
wherein at least two impedance mapping electrodes are integrated within each independently controllable cryoablation zone, each impedance mapping electrode being configured to measure local tissue impedance simultaneously with cryoablation delivery in the respective zone;
a refrigerant supply conduit extending from the proximal end to the distal catheter segment and configured to deliver a cryogenic refrigerant to each of the plurality of independently controllable cryoablation zones;
a control unit operatively coupled to the elongate catheter body and configured to regulate cryoablation delivery to each of the plurality of independently controllable cryoablation zones and to receive impedance data from the at least two impedance mapping electrodes integrated within each independently controllable cryoablation zone;
wherein the plurality of independently controllable cryoablation zones are configured to deliver variable cooling profiles simultaneously to distinct circumferential regions of a target tissue site; and
wherein the control unit is further configured to execute a real-time impedance-guided ablation termination protocol comprising: (a) continuously monitoring impedance data from the at least two impedance mapping electrodes integrated within each independently controllable cryoablation zone during cryoablation delivery; (b) computing, for each independently controllable cryoablation zone, an impedance-based tissue status indicator derived from the monitored impedance data; (c) comparing the impedance-based tissue status indicator for each independently controllable cryoablation zone to a predetermined ablation completion threshold; and (d) independently terminating cryoablation delivery to each independently controllable cryoablation zone upon the impedance-based tissue status indicator for that zone reaching the predetermined ablation completion threshold, such that cryoablation delivery to different independently controllable cryoablation zones may be terminated at different times based on the impedance data from the respective zones.
Claim 16 (Original, now depending from rewritten Claim 15):
The cryoablation catheter system of Claim 15, wherein the predetermined ablation completion threshold comprises a percentage change in measured impedance relative to a baseline impedance measurement, the percentage change being between about 15% and about 45%.
Claim 17 (Currently Amended):
The cryoablation catheter system of Claim 15, wherein the real-time impedance-guided ablation termination protocol further comprises ~~providing feedback to a user regarding ablation status~~ <u>generating a zone-specific ablation status display output on a graphical user interface operatively coupled to the control unit, the zone-specific ablation status display output comprising, for each independently controllable cryoablation zone: (i) a real-time impedance trace; (ii) a computed impedance-based tissue status indicator; (iii) a visual indication of proximity to the predetermined ablation completion threshold; and (iv) an indication of whether cryoablation delivery to the respective zone has been terminated</u>.
Claim 18 (Original):
The cryoablation catheter system of Claim 15, wherein the control unit is configured to deliver cryoablation energy for a maximum duration of between about 60 seconds and about 300 seconds per independently controllable cryoablation zone, and to terminate cryoablation delivery to any zone upon expiration of the maximum duration regardless of the impedance-based tissue status indicator.
Claim 19 (Original):
The cryoablation catheter system of Claim 15, further comprising a deflection mechanism operatively coupled to the distal catheter segment and configured to deflect the distal catheter segment through a range of at least about 90 degrees in at least two planes relative to the longitudinal axis of the elongate catheter body.
Claim 20 (Original):
A kit comprising:
the cryoablation catheter system of Claim 15; and
a control unit console comprising a processor, a display device, and a refrigerant source interface, the control unit console being configured to operatively couple to the elongate catheter body via the proximal connector interface and to execute the real-time impedance-guided ablation termination protocol.
IV. Remarks
A. Introduction and Overview
Applicant respectfully submits the following Remarks in support of the amendments set forth above and in traversal of the rejections and objections set forth in the Office Action mailed September 15, 2024. Applicant believes that the amendments and arguments presented herein place all pending Claims 1-20 in condition for allowance, and respectfully requests the Examiner's favorable reconsideration.
The amendments presented in Section III above are fully supported by the original disclosure of the parent specification, namely U.S. Patent No. 11,284,561 (issued March 22, 2022 from U.S. Application No. 16/914,337), the benefit of which is claimed by the present continuation application under 35 U.S.C. § 120. No new matter has been introduced by any of the amendments. Each amended limitation can be traced directly to corresponding disclosure in the parent specification, as detailed below.
The Remarks that follow are organized into three principal sections:
(1) Section B — Traversal of the rejection of Claims 1-8 under 35 U.S.C. § 103 as allegedly obvious over U.S. Patent No. 10,537,418 ("the Vantage '418 patent") in view of U.S. Patent No. 9,861,432 ("the Vantage '432 patent") and further in view of U.S. Patent Application Publication No. 2019/0183567 ("the Helios '567 publication");
(2) Section C — Traversal of the rejection of Claims 9-14 under 35 U.S.C. § 112(a) for alleged lack of written description; and
(3) Section D — Request to allow Claims 15-20, which have been rewritten in independent form incorporating the allowable subject matter identified by the Examiner.
Additionally, Section E sets forth a request for an Examiner interview should any concerns remain after review of this Response.
B. Traversal of the § 103 Rejection of Claims 1-8
B.1. Summary of the Examiner's Rejection.  In the Office Action, the Examiner rejected Claims 1-8 under 35 U.S.C. § 103 as allegedly being unpatentable over the combination of:
(i) U.S. Patent No. 10,537,418 to Chen et al. ("the '418 patent"), assigned to Vantage Cryosurgical Systems, Inc., as the primary reference;
(ii) U.S. Patent No. 9,861,432 to Ramachandran et al. ("the '432 patent"), assigned to Vantage Cryosurgical Systems, Inc., as a first secondary reference; and
(iii) U.S. Patent Application Publication No. 2019/0183567 to Park et al. ("the '567 publication"), assigned to Helios Surgical Technologies, Inc., as a second secondary reference.
The Examiner's position, as Applicant understands it, is that the '418 patent discloses a cryoablation catheter with a balloon-based ablation zone; the '432 patent discloses improvements to balloon inflation control relevant to cryoablation catheters; and the '567 publication discloses impedance mapping electrodes for use in cardiac electrophysiology catheters. The Examiner concluded that it would have been obvious to a person of ordinary skill in the art at the time of the invention to combine these references to arrive at the subject matter of Claims 1-8.
Applicant respectfully acknowledges the Examiner's position but traverses the rejection in its entirety for the reasons set forth below. As detailed herein, the combination of references relied upon by the Examiner fails to teach, suggest, or render obvious the claimed invention as now recited in amended Claims 1-8. Moreover, the proposed combination relies on impermissible hindsight reasoning and disregards critical structural and functional distinctions between the claimed invention and the prior art.
B.2. Discussion of the Primary Reference — Vantage '418 Patent.  The '418 patent to Chen et al. is directed to a cryoablation balloon catheter designed for pulmonary vein isolation procedures. As disclosed in the '418 patent, the catheter comprises an inflatable balloon disposed at the distal end of a catheter shaft. The balloon is configured to receive a cryogenic refrigerant (e.g., nitrous oxide or liquid nitrogen) through a single delivery lumen, which delivers the refrigerant into the interior of the balloon chamber. The refrigerant expands and cools within the balloon, transferring thermal energy from the surrounding tissue through the balloon wall. The spent refrigerant is then returned through a single return lumen. See, e.g., '418 patent, col. 4, ll. 15-42; col. 6, ll. 1-28; Figs. 1-3.
Critically, the cryoablation balloon disclosed in the '418 patent is a single-zone, circumferentially uniform cooling structure. The '418 patent describes a single balloon chamber into which refrigerant is delivered and from which it is exhausted. There is no teaching or suggestion in the '418 patent of dividing the balloon or distal catheter segment into a plurality of independently controllable cryoablation zones, much less providing each such zone with its own dedicated refrigerant delivery lumen and dedicated return lumen. The '418 patent operates on the fundamental principle that the entire circumference of the balloon contacts the target tissue (e.g., the pulmonary vein ostium) and cools uniformly. See '418 patent, col. 3, ll. 55-67 (describing "uniform circumferential tissue contact and cooling").
Furthermore, the '418 patent does not disclose impedance mapping electrodes integrated within the cryoablation zone. The '418 patent makes a passing reference to impedance monitoring in the context of confirming pulmonary vein isolation after the ablation procedure, but this monitoring is performed by a separate diagnostic catheter that is introduced through a different access site and positioned independently of the cryoablation balloon catheter. See '418 patent, col. 9, ll. 33-51. There is no teaching or suggestion in the '418 patent of integrating impedance mapping electrodes within the cryoablation structure itself, and certainly no suggestion of integrating such electrodes within each of a plurality of independently controllable cryoablation zones.
Accordingly, the '418 patent fails to disclose or suggest the following limitations now recited in amended Claim 1:
(a) "a plurality of independently controllable cryoablation zones disposed along a distal catheter segment, each zone comprising a dedicated refrigerant delivery lumen and a dedicated return lumen";
(b) "at least two impedance mapping electrodes integrated within each independently controllable cryoablation zone, each electrode being configured to measure local tissue impedance simultaneously with cryoablation delivery in the respective zone"; and
(c) "the plurality of independently controllable cryoablation zones are configured to deliver variable cooling profiles simultaneously to distinct circumferential regions of a target tissue site."
B.3. Discussion of the First Secondary Reference — Vantage '432 Patent.  The '432 patent to Ramachandran et al. is directed to improvements in cryoablation balloon inflation control and pressure monitoring. Specifically, the '432 patent describes pressure sensors and feedback mechanisms for maintaining consistent balloon inflation pressure during cryoablation procedures. The '432 patent also describes techniques for achieving pressure equalization across the balloon chamber to ensure uniform thermal contact between the balloon wall and the target tissue. See '432 patent, col. 5, ll. 10-45; col. 7, ll. 20-55.
Like the '418 patent, the '432 patent is fundamentally directed to single-zone balloon technology. The entire thrust of the '432 patent's disclosure is directed toward optimizing the performance of a single, circumferentially uniform cryoablation balloon. The pressure equalization techniques described in the '432 patent are specifically designed to ensure that a single balloon chamber maintains uniform pressure and uniform tissue contact around its entire circumference. See '432 patent, col. 3, ll. 22-38 (describing "uniform pressure distribution across the balloon chamber for consistent ablation depth").
The '432 patent does not teach or suggest:
•  Dividing a cryoablation structure into multiple independently controllable zones;
•  Providing dedicated refrigerant delivery and return lumens for each zone;
•  Integrating impedance mapping electrodes within cryoablation zones; or
•  Delivering variable cooling profiles simultaneously to distinct circumferential regions of a target tissue site.
Moreover, there is no teaching, suggestion, or motivation in the '432 patent that would lead a person of ordinary skill in the art to combine the '432 patent with the '418 patent in a manner that would arrive at the claimed invention. The '432 patent's disclosure of pressure equalization across a single balloon chamber is conceptually antithetical to the claimed invention's approach of independently controlling multiple zones with variable cooling profiles. A person of ordinary skill in the art, reading the '432 patent, would be led away from the concept of independent zone control, not toward it.
B.4. Discussion of the Second Secondary Reference — Helios '567 Publication.  The '567 publication to Park et al. is directed to an impedance mapping catheter for use in cardiac electrophysiology procedures. The '567 publication describes a multi-electrode catheter configured to generate impedance maps of cardiac tissue for diagnostic purposes, such as identifying regions of scar tissue, fibrosis, or abnormal conduction pathways. See '567 publication, paragraphs [0015]-[0023]; Figs. 1-4.
Importantly, the '567 publication describes impedance mapping as a standalone diagnostic function performed by a dedicated mapping catheter. The catheter described in the '567 publication is not a cryoablation catheter — it does not deliver any form of ablation energy, cryogenic or otherwise. The impedance mapping electrodes described in the '567 publication are disposed on a catheter that is designed solely for diagnostic mapping purposes. See '567 publication, paragraph [0012] ("The present disclosure is directed to a diagnostic mapping catheter..."); paragraph [0025] ("The mapping catheter is not configured to deliver therapeutic energy.").
Even assuming arguendo that a person of ordinary skill in the art might consider combining the impedance mapping functionality of the '567 publication with a cryoablation catheter (which Applicant does not concede), such a combination would still fail to arrive at the claimed invention. The '567 publication provides no teaching or suggestion of integrating impedance mapping electrodes within individually controllable cryoablation zones. This is because neither the '418 patent nor the '432 patent — the only cryoablation references in the combination — teaches or suggests the existence of multiple independently controllable cryoablation zones. A person of ordinary skill in the art cannot integrate impedance electrodes within independently controllable zones that do not exist in the prior art. The concept of placing impedance mapping electrodes within each of multiple independent cryoablation zones to enable simultaneous impedance measurement and cryoablation delivery within each zone is a novel structural and functional configuration that is entirely absent from the cited references, whether taken alone or in any combination.
Furthermore, the proposed combination of all three references requires impermissible hindsight reconstruction. As the Federal Circuit has consistently held, "[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant's disclosure, such a reconstruction is proper." In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Here, the Examiner's proposed combination draws upon the Applicant's own disclosure as the template for combining the references — there is no suggestion in any of the three references to integrate impedance mapping electrodes within each of a plurality of independently controllable cryoablation zones. The very concept of independently controllable cryoablation zones is absent from all three references. The combination proposed by the Examiner is, therefore, the product of impermissible hindsight reasoning, using Applicant's claims as a roadmap to reconstruct the invention from disparate and unrelated prior art teachings.
B.5. Arguments Based on Amended Claim Limitations.  The amendments to Claims 1-8, as set forth in Section III above, further sharpen the distinctions between the claimed invention and the cited prior art. Amended Claim 1 now explicitly requires:
(a) A plurality of independently controllable cryoablation zones, each comprising a dedicated refrigerant delivery lumen and a dedicated return lumen — a structural configuration that is entirely absent from the '418 patent (single-zone balloon), the '432 patent (single-zone pressure optimization), and the '567 publication (no cryoablation capability whatsoever);
(b) At least two impedance mapping electrodes integrated within each independently controllable cryoablation zone, configured to measure local tissue impedance simultaneously with cryoablation delivery in the respective zone — a functional integration that is not taught or suggested by any of the cited references; and
(c) The plurality of independently controllable cryoablation zones configured to deliver variable cooling profiles simultaneously to distinct circumferential regions of a target tissue site — a therapeutic delivery paradigm that is fundamentally different from the uniform, single-zone cooling disclosed in the Vantage patents.
None of the three references, alone or in combination, disclose or suggest this particular combination of structural and functional features.
In addition, Applicant respectfully directs the Examiner's attention to the significant technical challenges associated with integrating impedance mapping electrodes into cryoablation zones — challenges that further support the non-obviousness of the claimed invention. The extreme temperature gradients encountered during cryoablation (tissue temperatures reaching -40°C to -80°C at the ablation site) create substantial interference with impedance measurements. Electrode-tissue interface impedance is highly temperature-dependent, and the thermal gradients within a cryoablation zone introduce measurement artifacts that must be specifically addressed through calibration techniques. As discussed in the parent specification at column 13, lines 40-67, and as confirmed in the concurrently filed Connolly Declaration at paragraphs 12-18, the integration of impedance mapping electrodes within active cryoablation zones presented unpredictable technical challenges that required extensive experimentation and novel calibration approaches to resolve. This unpredictability further supports the conclusion that the claimed invention would not have been obvious to a person of ordinary skill in the art at the time of the invention.
The Connolly Declaration provides additional factual evidence on this point. Specifically, Dr. Connolly, one of the named inventors and a recognized expert in cryoablation catheter design with over 15 years of experience in the field, testifies that:
•  The single-zone cryoablation balloon designs described in the Vantage '418 and '432 patents represent the prevailing approach in the industry at the time of the invention, and there was no recognized motivation to divide a cryoablation structure into independently controllable zones (Connolly Declaration, ¶¶ 8-11);
•  The integration of impedance mapping electrodes within active cryoablation zones was not a straightforward engineering exercise, as the cryogenic environment caused significant degradation of impedance measurement accuracy that required development of the novel calibration techniques described in the parent specification (Connolly Declaration, ¶¶ 12-18);
•  The claimed combination of multi-zone cryoablation with integrated impedance mapping within each zone represents a paradigm shift from the sequential "ablate-then-map" workflow that characterized prior cryoablation procedures to a simultaneous "ablate-and-map" approach that was not suggested by the prior art (Connolly Declaration, ¶¶ 19-25); and
•  The Applicant's CryoNova variable-zone cooling system with integrated impedance mapping has demonstrated clinically significant improvements in procedure time and lesion quality compared to single-zone balloon designs, which further supports the non-obvious nature of the claimed invention (Connolly Declaration, ¶¶ 26-30).
B.6. Conclusion on § 103 Rejection.  For the foregoing reasons, Applicant respectfully submits that amended Claims 1-8 are patentable over the combination of the '418 patent, the '432 patent, and the '567 publication. None of the cited references, whether taken individually or in any combination, teaches, suggests, or renders obvious the claimed invention as now recited in amended Claims 1-8. The Examiner's proposed combination of references requires impermissible hindsight reasoning, and the technical unpredictability of integrating impedance mapping electrodes within active cryoablation zones further supports non-obviousness.
Applicant respectfully requests that the Examiner withdraw the rejection of Claims 1-8 under 35 U.S.C. § 103. Dependent Claims 2-8 are patentable at least for the same reasons as independent Claim 1 and, additionally, for the further limitations recited therein, including the specific impedance measurement frequency range and sampling rate (Claim 2), the structurally isolated lumen architecture (Claim 4), the independent temperature sensing correlated with impedance data (Claim 5), and the feedback control loop integrating impedance and temperature data for zone-specific cooling modulation (Claim 7).
C. Traversal of the § 112(a) Rejection of Claims 9-14
C.1. Summary of the Examiner's Rejection.  In the Office Action, the Examiner rejected Claims 9-14 under 35 U.S.C. § 112(a) for alleged lack of written description. Specifically, the Examiner took the position that the specification does not provide sufficient written description to support the impedance mapping calibration algorithm steps recited in Claims 9-14. The Examiner stated that "the specification fails to describe with sufficient particularity the calibration algorithm, including the specific computational steps, the calibration function parameters, and the iterative updating methodology, such that a person of ordinary skill in the art would recognize that the inventors were in possession of the claimed subject matter." Office Action at p. 9.
Applicant respectfully traverses this rejection. As demonstrated below, the parent specification — U.S. Patent No. 11,284,561, which serves as the written description for this continuation application — provides extensive and detailed written description support for the calibration algorithm as claimed.
C.2. Written-Description Support in the Parent Specification.  The present application is a continuation of U.S. Application No. 16/914,337, which issued as U.S. Patent No. 11,284,561 on March 22, 2022. As a continuation application, the present application claims the benefit of the earlier filing date under 35 U.S.C. § 120 and is entitled to rely upon the written description of the parent specification to satisfy the requirements of 35 U.S.C. § 112(a). The parent specification provides full and detailed written description support for each element of the calibration algorithm as recited in Claims 9-14, as follows:
Column 14, lines 22-58 of U.S. Patent No. 11,284,561 describes in detail the baseline impedance acquisition step that is the first step of the claimed calibration algorithm. Specifically, the parent specification discloses:
"Prior to initiation of cryoablation delivery, the control unit acquires a baseline impedance measurement from each of the plurality of impedance mapping electrodes disposed within the cryoablation zones. The baseline measurement is obtained with the catheter positioned at the target tissue site, with the balloon or ablation structure in contact with the tissue, but prior to delivery of any cryogenic refrigerant. Each electrode is individually addressed by the control unit, and a baseline impedance value is recorded at a predetermined excitation frequency... The baseline impedance values serve as the reference against which subsequent impedance changes during cryoablation are calculated." (col. 14, ll. 22-42).
This disclosure directly supports the limitation in amended Claim 9 of "acquiring a baseline impedance measurement from each of the plurality of impedance mapping electrodes prior to initiation of cryoablation."
Column 15, lines 1-35 of U.S. Patent No. 11,284,561 describes the temperature-corrected impedance calculation step, including the stored calibration function and its parameters:
"The control unit computes a temperature-corrected impedance value for each electrode by applying a stored calibration function that correlates measured impedance change to estimated tissue temperature. The calibration function is derived from empirical calibration data obtained during bench testing and pre-clinical studies, in which known tissue samples were subjected to controlled cooling and the impedance-temperature relationship was characterized across a range of tissue types and temperature values... The calibration function may be implemented as a polynomial fit, a piecewise linear approximation, or a look-up table indexed by measured impedance and electrode temperature." (col. 15, ll. 1-25).
This disclosure directly supports the limitation in amended Claim 9 of "computing a temperature-corrected impedance value for each electrode by applying a stored calibration function correlating impedance change to tissue temperature."
Column 15, lines 36-67 of U.S. Patent No. 11,284,561 describes the iterative updating process during cryoablation delivery:
"During cryoablation delivery, the calibration function is iteratively updated based on real-time impedance and temperature sensor data from each independently controllable cryoablation zone. As the tissue temperature decreases during ablation, the impedance-temperature relationship may shift due to changes in tissue characteristics (e.g., ice crystal formation, cellular disruption). The control unit monitors these changes in real time and adjusts the calibration function parameters accordingly, such that the impedance-to-temperature correlation remains accurate throughout the ablation procedure." (col. 15, ll. 36-55).
This disclosure directly supports the limitation in amended Claim 9 of "iteratively updating the calibration function during cryoablation delivery based on real-time impedance and temperature sensor data from each independently controllable cryoablation zone."
Column 16, lines 1-29 of U.S. Patent No. 11,284,561 further describes the look-up table implementation and the error-correction protocols:
"In a preferred embodiment, the calibration function is implemented as a look-up table stored in non-volatile memory of the control unit. The look-up table comprises a plurality of entries, each entry correlating a measured impedance value at a given electrode temperature to a predicted tissue temperature... When a measured impedance value deviates from the expected value predicted by the calibration function by more than a predetermined threshold (e.g., greater than 10% deviation), the control unit executes an error-correction protocol comprising re-acquisition of the impedance measurement and, if the deviation persists, generation of an alert signal." (col. 16, ll. 1-22).
This disclosure directly supports the limitations in amended Claims 12 and 13 regarding the look-up table implementation and error-correction protocols, respectively.
Figures 8A-8C of U.S. Patent No. 11,284,561 provide flowchart diagrams that illustrate the complete calibration algorithm sequence, including the baseline acquisition step (Fig. 8A), the temperature-corrected impedance computation step (Fig. 8B), and the iterative updating and error-correction steps (Fig. 8C). These figures, together with the accompanying description at column 14, line 22 through column 16, line 29, provide a comprehensive written description of the calibration algorithm sufficient to convey to a person of ordinary skill in the art that the inventors were in possession of the claimed subject matter at the time of filing.
Applicant submits that the foregoing citations to the parent specification demonstrate compliance with the written description requirement of 35 U.S.C. § 112(a) as interpreted by the Federal Circuit and as set forth in MPEP § 2163. The written description requirement is satisfied when "the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad Pharms., Inc. v. Crowne Albany Industries, 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The parent specification's detailed disclosure of each step of the calibration algorithm, including the specific computational methodology, the calibration function parameters, and the iterative updating and error-correction protocols, amply satisfies this standard.
Furthermore, MPEP § 2163.02 provides that "[a]n original claim may lack written description support when... the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved." Here, the parent specification does not merely describe the calibration algorithm in functional terms — it describes the specific steps, the specific data inputs, the specific computational methodology, and the specific implementation structures (e.g., look-up table, error-correction protocol) in sufficient detail to satisfy the written description requirement.
C.3. Amendments to Claims 9-14 Addressing the Rejection.  To further address the Examiner's concerns, Applicant has amended Claims 9, 10, 12, and 13 to more explicitly tie each algorithmic step to the corresponding disclosure in the parent specification. Amended Claim 9 now recites the three core steps of the calibration algorithm with specificity that directly tracks the parent specification's disclosure:
(1) Acquiring a baseline impedance measurement from each of the plurality of impedance mapping electrodes prior to initiation of cryoablation (corresponding to col. 14, ll. 22-42 of U.S. Patent No. 11,284,561);
(2) Computing a temperature-corrected impedance value for each electrode by applying a stored calibration function correlating impedance change to tissue temperature (corresponding to col. 15, ll. 1-35 of U.S. Patent No. 11,284,561); and
(3) Iteratively updating the calibration function during cryoablation delivery based on real-time impedance and temperature sensor data from each independently controllable cryoablation zone (corresponding to col. 15, ll. 36-67 of U.S. Patent No. 11,284,561).
Amended Claim 10 adds specificity regarding the data sampling interval and feedback loop timing for calibration updates, which is supported by the parent specification's disclosure of sampling rates and update cycle timing. Amended Claim 12 adds the look-up table implementation limitation, which is directly supported by column 16, lines 1-15 of the parent patent. Amended Claim 13 adds the error-correction protocol limitation with specificity regarding the threshold-based detection and re-acquisition steps, which is directly supported by column 16, lines 15-29 of the parent patent.
Importantly, the amendments to Claims 9-14 do not add new matter. Each amended limitation is drawn directly from the disclosure of the parent specification as identified above. The amendments merely clarify and more precisely claim subject matter that was already fully described in the parent specification.
C.4. Conclusion on § 112(a) Rejection.  For the foregoing reasons, Applicant respectfully submits that Claims 9-14, as amended, satisfy the written description requirement of 35 U.S.C. § 112(a). The parent specification, U.S. Patent No. 11,284,561, provides detailed written description support for each element of the calibration algorithm as now recited in Claims 9-14, including the baseline impedance acquisition step, the temperature-corrected impedance computation step, the iterative updating step, the look-up table implementation, and the error-correction protocol.
Applicant respectfully requests that the Examiner withdraw the rejection of Claims 9-14 under 35 U.S.C. § 112(a). Dependent Claims 10-14 are separately patentable for the additional limitations recited therein, including the specific data sampling interval and feedback loop timing (Claim 10), the look-up table implementation (Claim 12), the error-correction protocol with threshold-based detection (Claim 13), and the wireless data transmission capability (Claim 14).
D. Request to Allow Claims 15-20
D.1. Examiner's Indication of Allowable Subject Matter.  Applicant acknowledges with appreciation the Examiner's indication in the Office Action that Claims 15-20 contain allowable subject matter. The Examiner objected to Claims 15-20 as being dependent upon rejected base Claim 1, but indicated that the subject matter of Claims 15-20 would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. See Office Action at p. 12. Applicant expresses its appreciation for the Examiner's careful analysis and favorable indication regarding these claims.
D.2. Claims 15-20 Rewritten in Independent Form.  In accordance with the Examiner's indication, Claim 15 has been rewritten in independent form. As presented in Section III above, rewritten Claim 15 now incorporates all of the limitations of original Claim 1 (as now amended) together with the additional limitations that the Examiner identified as containing allowable subject matter. Specifically, rewritten Claim 15 now recites the full cryoablation catheter structure with integrated impedance mapping electrodes (incorporating the amended limitations of Claim 1, including the plurality of independently controllable cryoablation zones, the integrated impedance mapping electrodes, and the variable cooling profiles), as well as the specific real-time impedance-guided ablation termination protocol, including the continuous impedance monitoring, computation of an impedance-based tissue status indicator, comparison to a predetermined ablation completion threshold, and independent termination of cryoablation delivery to each zone upon reaching the threshold.
All limitations of the original dependent Claim 15 have been incorporated verbatim into the rewritten independent claim. Claims 16-20 remain dependent on Claim 15 and are not affected by the rewriting other than that they now depend from an independent claim rather than from a dependent claim.
All rewritten and amended claims within this group are fully supported by the parent specification, U.S. Patent No. 11,284,561, and no new matter has been introduced.
D.3. Request for Allowance.  Applicant respectfully requests that the Examiner confirm the allowability of Claims 15-20 as rewritten in independent form. Applicant submits that Claims 15-20, as now presented, are in condition for allowance and respectfully requests that the Examiner issue a Notice of Allowance with respect to these claims.
E. Statement Regarding Interview Request
Should the Examiner have any remaining concerns after review of this Response, the amendments, and the supporting Connolly Declaration, Applicant's counsel respectfully requests the opportunity for a telephonic or in-person interview with Examiner Dougherty and/or Supervisory Patent Examiner Linda M. Kowalski to discuss any outstanding issues. Applicant believes that an interview may be productive in advancing prosecution and resolving any remaining concerns efficiently.
Applicant's counsel may be reached at the contact information set forth below:
Peter Vassiliev, Reg. No. 72,340 Calderwood & Harkness LLP 600 Lexington Avenue, 22nd Floor New York, NY 10022 Telephone: (212) 555-0147 Facsimile: (212) 555-0148
Email: pvassiliev@calderwoodharkness.com
Applicant's counsel is available for an interview at the Examiner's convenience and would be pleased to accommodate the Examiner's schedule.
V. Conclusion
In view of the foregoing amendments and Remarks, Applicant respectfully requests reconsideration and complete withdrawal of all rejections and objections set forth in the Office Action mailed September 15, 2024, including:
(1) The rejection of Claims 1-8 under 35 U.S.C. § 103;
(2) The rejection of Claims 9-14 under 35 U.S.C. § 112(a); and
(3) The objection to Claims 15-20 as dependent on a rejected base claim.
Applicant respectfully requests that Claims 1-20, as amended herein, be allowed and that a Notice of Allowance be issued at the Examiner's earliest convenience.
Should there be any additional fees required for entry of this Response beyond those submitted herewith, the Commissioner is authorized to charge any deficiency to, or credit any overpayment to, Deposit Account No. [To Be Inserted] of Calderwood & Harkness LLP, in accordance with 37 C.F.R. § 1.25.
This Response is being filed concurrently with the following documents:
(a) Extension of Time Request under 37 C.F.R. § 1.136(a) with associated small-entity fees in the total amount of $1,380; and
(b) Declaration of Dr. Aisling Connolly under 37 C.F.R. § 1.132.
VI. Signature block
Respectfully submitted,
CALDERWOOD & HARKNESS LLP
By: /Peter Vassiliev/
________________________________________
Peter Vassiliev Registration No. 72,340
Date: ________
Calderwood & Harkness LLP 600 Lexington Avenue, 22nd Floor New York, NY 10022 Telephone: (212) 555-0147 Facsimile: (212) 555-0148
VII. Certificate of Service / Filing
CERTIFICATE OF ELECTRONIC FILING
I hereby certify that this Response to Non-Final Office Action, together with all concurrently filed documents identified in Appendix A hereto, is being filed electronically via the USPTO Patent Center on this date.
/Peter Vassiliev/
________________________________________
Peter Vassiliev Registration No. 72,340
Date: ________
Appendix A — Listing of Concurrently Filed Documents
The following documents are filed concurrently with this Response to Non-Final Office Action in U.S. Application No. 17/851,216:
DRAFT — PRIVILEGED & CONFIDENTIAL — FOR CLIENT REVIEW ONLY — NOT YET FILED
Matter No.: SBD-IP-2021-003 | Prepared by: Peter Vassiliev and Wendy Schultz | Technical Review: Dr. Claire Nakamura | Partner Review: Alan Ngo | Client: Solstice Biomedical Devices Ltd. | Application: U.S. 17/851,216 (SBD-001-CON2)
Application No.: | 17/851,216
Filing Date: | June 27, 2022
Title: | Cryoablation Catheter with Integrated Impedance Mapping Electrodes
Art Unit: | 3794
Examiner: | James R. Dougherty
Confirmation No.: | [To Be Inserted]
Docket No.: | SBD-001-CON2
Applicant: | Solstice Biomedical Devices Ltd.
Address: | Unit 4, Liffey Innovation Campus, Parkgate Street, Dublin 8, D08 XR29, Ireland
Attorney of Record: | Peter Vassiliev, Reg. No. 72,340
Firm: | Calderwood & Harkness LLP
Address: | 600 Lexington Avenue, 22nd Floor, New York, NY 10022
Telephone: | (212) 555-0147
Facsimile: | (212) 555-0148
In re Application of: | Dr. Aisling Connolly and Dr. Tomás Brennan
Application No.: | 17/851,216
Filed: | June 27, 2022
For: | Cryoablation Catheter with Integrated Impedance Mapping Electrodes
Art Unit: | 3794
Examiner: | James R. Dougherty
Docket No.: | SBD-001-CON2
Claim(s) | Previous Status (Office Action) | Action Taken in This Response | Current Status
1-8 | Rejected under 35 U.S.C. § 103 | Claims 1, 2, 4, 5, and 7 amended; Claims 3, 6, and 8 remain as previously presented | Pending (amended)
9-14 | Rejected under 35 U.S.C. § 112(a) | Claims 9, 10, 12, and 13 amended; Claims 11 and 14 remain as previously presented | Pending (amended)
15-20 | Objected to as dependent on rejected base claim; indicated as containing allowable subject matter | Claim 15 rewritten in independent form; Claim 17 amended; Claims 16, 18, 19, and 20 remain as previously presented (now depending from rewritten Claim 15) | Pending (rewritten/amended)
Application No.: | 17/851,216
Title: | Cryoablation Catheter with Integrated Impedance Mapping Electrodes
Art Unit: | 3794
Examiner: | James R. Dougherty
Docket No.: | SBD-001-CON2
No. | Document | Description
1 | Extension of Time Request under 37 C.F.R. § 1.136(a) | Three-month extension of time with associated small-entity fees totaling $1,380 (first month: $230; second month: $460; third month: $690), calculated in accordance with the fee schedule for small entities under 37 C.F.R. § 1.17(a)(1)-(3).
2 | Declaration of Dr. Aisling Connolly under 37 C.F.R. § 1.132 | Declaration of named inventor Dr. Aisling Connolly providing factual evidence and expert testimony in support of the patentability of Claims 1-20, including testimony regarding the technical distinctions between the claimed invention and the prior art of record, the unpredictability of integrating impedance mapping electrodes within active cryoablation zones, and the clinical significance of the claimed invention.
3 | Claim Amendment Comparison Chart (CON-2, U.S. 17/851,216) | Courtesy exhibit for the Examiner providing a side-by-side comparison of the previously presented claims and the amended claims, with annotations identifying the written-description support in the parent specification (U.S. Patent No. 11,284,561) for each amended limitation.

RESPONSE TO NON-FINAL OFFICE ACTION

IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

RESPONSE TO NON-FINAL OFFICE ACTION

CALDERWOOD & HARKNESS LLP

CERTIFICATE OF ELECTRONIC FILING

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