1037-00005 · Solstice Biomedical Devices Ltd · Prosecution Documents/CON-1

draft-petition-to-revive-con1.docx DOCUMENT Litigation

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DRAFT — FOR CLIENT REVIEW AND AUTHORIZATION — NOT YET FILED WITH THE USPTO

PETITION TO REVIVE AN APPLICATION PURSUANT TO 37 C.F.R. § 1.137(a)

Attorney Docket No.: SBD-001-CON1 Firm Matter No.: SBD-IP-2021-003

Commissioner for Patents United States Patent and Trademark Office P.O. Box 1450 Alexandria, VA 22313-1450

Application Number: U.S. 17/702,489 Filing Date: March 23, 2022 Title of Invention: Methods of Cryoablation Using Variable-Zone Cooling Catheter Named Inventors: Dr. Aisling Connolly, Dr. Tomás Brennan, Dr. Henrik Paulsen Applicant / Assignee: Solstice Biomedical Devices Ltd., Unit 4, Liffey Innovation Campus, Parkgate Street, Dublin 8, D08 XR29, Ireland Examiner: James R. Dougherty Art Unit: 3794 Confirmation Number: To be confirmed from file records Attorney Docket No.: SBD-001-CON1 Firm Matter No.: SBD-IP-2021-003

I. INTRODUCTION AND BASIS FOR PETITION

Solstice Biomedical Devices Ltd. ("Applicant"), by and through undersigned counsel Peter Vassiliev (USPTO Reg. No. 72,340) of Calderwood & Harkness LLP, 600 Lexington Avenue, 22nd Floor, New York, NY 10022, respectfully petitions the Commissioner for Patents to revive the above-identified application pursuant to 37 C.F.R. § 1.137(a).

The above-referenced application became abandoned due to the non-payment of the issue fee within the period set forth in the Notice of Allowance mailed by the United States Patent and Trademark Office ("USPTO" or the "Office") on April 10, 2023. Specifically, the issue fee payment was due on or before July 10, 2023, and no such payment was made within the prescribed period, resulting in abandonment of the application as of July 11, 2023.

Applicant hereby states, in accordance with the requirements of 37 C.F.R. § 1.137(a), that the entire delay in filing the required reply from the due date of July 10, 2023, to the date of filing of this petition was unintentional. This petition is filed together with: (1) the required petition fee of $1,050.00 at the small-entity rate under 37 C.F.R. § 1.17(m); (2) the outstanding issue fee of $540.00 at the small-entity rate under 37 C.F.R. § 1.18(a); and (3) the required statement that the entire delay was unintentional, as set forth more fully herein.

Applicant respectfully submits that all requirements for revival of this application under 37 C.F.R. § 1.137(a) are satisfied by this petition and the accompanying submissions, and requests that the Commissioner grant this petition and proceed with issuance of the patent in due course.

II. BACKGROUND OF THE APPLICATION

U.S. Application No. 17/702,489 (the "Application" or the "'489 Application") was filed on March 23, 2022, as a continuation of U.S. Patent Application No. 16/914,337, which was filed on June 28, 2021. The parent application, U.S. 16/914,337, was examined and subsequently issued as U.S. Patent No. 11,284,561 on March 22, 2022. The present Application claims priority to and the benefit of the filing date of the parent application under 35 U.S.C. § 120, and the chain of priority is properly established in the Application Data Sheet and the specification of the Application as filed.

The Application is directed to methods of cryoablation using a variable-zone cooling catheter, and more particularly to methods of performing pulmonary vein isolation for the treatment of atrial fibrillation utilizing a catheter capable of selectively activating discrete cryogenic cooling zones along its distal tip structure. The claimed methods are part of the CryoNova cryoablation catheter system developed by Solstice Biomedical Devices Ltd., a Dublin-headquartered medical device company specializing in cardiac cryoablation technology and electrophysiology mapping instrumentation.

The named inventors of the Application are:

(a) Dr. Aisling Connolly, Vice President of Research & Development at Solstice Biomedical Devices Ltd., who contributed to the conception and reduction to practice of the variable-zone cooling methodology and catheter architecture;

(b) Dr. Tomás Brennan, Chief Medical Officer and Co-Founder of Solstice Biomedical Devices Ltd., who contributed to the clinical methodology aspects of the invention, including the procedural techniques for pulmonary vein isolation using the variable-zone catheter; and

(c) Dr. Henrik Paulsen, formerly Senior Engineer at Solstice Biomedical Devices Ltd. and currently employed by Arclight Therapeutics GmbH, who contributed to the engineering design and thermal management aspects of the variable-zone cooling system.

Solstice Biomedical Devices Ltd. is the assignee of the entire right, title, and interest in the Application. Assignments from each of the named inventors to Applicant have been recorded at the USPTO. The Application is currently assigned to Art Unit 3794 under the examination of Primary Examiner James R. Dougherty.

III. PROSECUTION HISTORY LEADING TO ABANDONMENT

The Application was examined in the ordinary course of prosecution by Primary Examiner James R. Dougherty, under the supervision of Supervisory Patent Examiner Linda M. Kowalski, in Art Unit 3794 of the Technology Center 3700, which handles applications relating to surgery and medical instruments.

On April 10, 2023, the USPTO mailed an Examiner's Amendment and Notice of Allowance for the Application. The Examiner's Amendment authorized certain amendments to the claims to place the Application in condition for allowance, and the Notice of Allowance confirmed that all pending claims (Claims 1–24 as amended) were found to be allowable over the prior art of record. The reasons for allowance stated by the Examiner identified the distinguishing features of the claimed variable-zone cooling methodology as not being anticipated by, or rendered obvious by, the cited references, including the closest prior art identified during prosecution.

Pursuant to the Notice of Allowance and in accordance with 37 C.F.R. § 1.311, the issue fee was required to be paid within three (3) months of the mailing date of the Notice of Allowance, i.e., on or before July 10, 2023. The issue fee amount due was $540.00, calculated at the small-entity rate under 37 C.F.R. § 1.27, which rate was properly established in the Application.

The issue fee was not paid by the July 10, 2023 deadline. No request for extension of time was filed, and no other response to the Notice of Allowance was submitted within the prescribed period. As a consequence, as of July 11, 2023, the Application was deemed abandoned by the Office for failure to pay the required issue fee within the time period set forth in the Notice of Allowance.

Applicant acknowledges that the Application is currently in an abandoned status as reflected in the USPTO's records and the Patent Application Information Retrieval (PAIR) system. This petition seeks to revive the Application from that abandoned status pursuant to 37 C.F.R. § 1.137(a).

IV. STATEMENT OF FACTS EXPLAINING THE DELAY

While 37 C.F.R. § 1.137(a) does not require a showing of the specific facts or circumstances underlying the unintentional delay, Applicant provides the following factual background in support of this petition and to provide context for the Office's consideration.

A. The FROST-AF Pivotal Clinical Trial Failure

Solstice Biomedical Devices Ltd. is an Irish-headquartered private limited company registered with the Companies Registration Office of Ireland under CRO No. 647832. The company specializes in the design, development, and commercialization of cardiac cryoablation systems and electrophysiology mapping medical devices for the treatment of cardiac arrhythmias, with a particular focus on atrial fibrillation.

The CryoNova cryoablation catheter system was Applicant's second-generation cryoablation catheter platform, designed specifically for pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation. The CryoNova system incorporated the variable-zone cooling technology that is the subject of the claims of the Application, representing a significant advancement over Applicant's first-generation cryoablation catheter. The CryoNova system was the centerpiece of Applicant's product development pipeline and commercial strategy during the relevant time period.

In pursuit of regulatory clearance for the CryoNova system in the United States, Applicant was conducting a U.S. pivotal clinical trial under an approved Investigational Device Exemption ("IDE"), IDE No. G210047, issued by the U.S. Food and Drug Administration ("FDA"). The pivotal trial, designated the "FROST-AF" study (Full-Range Optimized Segmental Treatment of Atrial Fibrillation), was a prospective, multicenter, single-arm study enrolling two hundred and twenty patients (n=220) across twelve clinical sites in the United States, designed to evaluate the safety and efficacy of the CryoNova system for pulmonary vein isolation.

On May 17, 2023, the results of the FROST-AF pivotal trial were announced following the completion of the twelve-month follow-up period for the final enrolled patient cohort. The trial results disclosed that the primary efficacy endpoint — freedom from documented atrial arrhythmia recurrence at twelve months post-procedure, off antiarrhythmic drug therapy — was not met. Specifically, the observed efficacy rate was 58.2%, which fell below the prespecified performance goal of 65% (p = 0.14). The difference was not statistically significant, and the primary efficacy endpoint was therefore not achieved.

The failure of the FROST-AF pivotal trial had an immediate and profound impact on Applicant's internal operations, strategic direction, and resource allocation related to the CryoNova program. As the pivotal trial was the critical regulatory milestone necessary to support a premarket approval ("PMA") submission to the FDA, the failure of the primary endpoint effectively precluded a near-term path to U.S. market authorization for the CryoNova system.

B. Board Decision to Shelve CryoNova Program

In response to the FROST-AF trial results, Applicant's management team conducted an urgent internal review of the CryoNova program during the weeks following the May 17, 2023 trial results announcement. Following this review and upon the recommendation of management, on June 8, 2023, the Board of Directors of Solstice Biomedical Devices Ltd. formally decided to shelve the CryoNova product development program indefinitely. The Board determined that additional investment in the CryoNova system could not be justified absent a clear path to regulatory approval, and directed that the company's resources be redirected to other product lines within the Solstice portfolio, including the company's electrophysiology mapping platform and its next-generation cryoballoon catheter program.

As a direct and immediate consequence of the Board's shelving decision, the CryoNova research and development team was reassigned to other product lines and programs within the company. This reassignment encompassed personnel across multiple functional areas, including engineering, clinical affairs, regulatory affairs, and intellectual property administration. Critically, the personnel within Applicant's organization who had been responsible for coordinating patent prosecution deadlines with outside counsel — specifically, the IP Coordinator within the CryoNova program office and the paralegal within Applicant's in-house legal department who managed the CryoNova IP docket — were among those reassigned to other programs as part of the restructuring.

The reassignment of these key personnel resulted in an internal docketing lapse at Applicant whereby the July 10, 2023 issue fee deadline for U.S. Application No. 17/702,489 was not tracked, monitored, or communicated to outside patent counsel at Calderwood & Harkness LLP. Specifically, the internal handoff of docketing responsibilities that should have occurred upon the reassignment of the CryoNova IP Coordinator was not completed, and the pending deadline fell through the gap in responsibility that resulted from the organizational restructuring.

C. Unintentional Nature of the Delay

Applicant states unequivocally that the failure to pay the issue fee by the July 10, 2023 deadline was not a deliberate decision to abandon the Application. At no time did any authorized representative of Applicant make a conscious, affirmative determination to allow the Application to lapse or to forego the issuance of a patent on the allowed claims. Rather, the failure to pay the issue fee was the inadvertent and unintentional result of the internal organizational disruption caused by the shelving of the CryoNova program and the attendant reassignment of key personnel responsible for IP docket management.

Neither Applicant's General Counsel, Ronan Gallagher, nor the responsible outside patent counsel at Calderwood & Harkness LLP, was aware of the missed deadline at the time it occurred. Mr. Gallagher has confirmed through counsel that no deliberate determination was made to allow the Application to go abandoned, and that the non-payment of the issue fee was entirely unintentional. Outside counsel at Calderwood & Harkness LLP received the Notice of Allowance and docketed the issue fee deadline on its internal system; however, the standard operating procedure for this application required Applicant's in-house IP team to confirm authorization and arrange for payment of the issue fee, and no such confirmation or instruction was received by outside counsel prior to the deadline, nor was any communication received from Applicant indicating an intent to abandon.

Additional evidence of the unintentional nature of the abandonment is provided by the fact that the last prosecution activity on any application in the CryoNova patent family occurred on July 3, 2023, when counsel filed an extension of time in a related continuation application, U.S. Application No. 17/851,216 (SBD-002-CON2). This filing, made just seven days before the issue fee deadline for the present Application, demonstrates that prosecution of the CryoNova patent family was still being managed by counsel in early July 2023, and further evidences that the prosecution docket went dormant at approximately this time due to the program shelving and personnel reassignment, rather than as a result of any deliberate intent to abandon.

On October 28, 2024, Applicant's General Counsel, Ronan Gallagher, contacted outside counsel at Calderwood & Harkness LLP to request a comprehensive portfolio review and reactivation of the CryoNova patent prosecution docket. This request was prompted by renewed strategic interest in the CryoNova technology platform following positive interim results from a European clinical study and the initiation of discussions with potential licensing partners. Upon conducting the portfolio review, counsel identified the abandoned status of U.S. Application No. 17/702,489 and promptly commenced preparation of this petition.

The entire delay in filing this petition to revive from July 11, 2023 (the date of abandonment) to the date of filing of this petition was unintentional, and Applicant respectfully submits that the facts set forth herein fully support this statement.

V. REQUIRED STATEMENT UNDER 37 C.F.R. § 1.137(a)

Applicant hereby states, as required by 37 C.F.R. § 1.137(a), that the entire delay in filing the required reply from the date such reply was due to the filing of a grantable petition pursuant to this section was unintentional. Specifically, the entire delay in payment of the issue fee from the due date of July 10, 2023, to the filing of this petition was unintentional.

This statement is made in compliance with and satisfies the requirement of 37 C.F.R. § 1.137(a), which provides that a petition to revive an abandoned application may be granted where the delay in filing the required reply was unintentional, upon the filing of: (1) the required reply; (2) the petition fee set forth in 37 C.F.R. § 1.17(m); and (3) a statement that the entire delay in filing the required reply from the due date for the reply to the filing of a grantable petition was unintentional.

VI. REPLY — PAYMENT OF ISSUE FEE

Concurrently with this petition, Applicant submits the required issue fee in the amount of $540.00, calculated at the small-entity rate pursuant to 37 C.F.R. § 1.18(a) and 37 C.F.R. § 1.27. This payment constitutes the "required reply" that was outstanding at the time the Application became abandoned, and its submission herewith satisfies the requirement of 37 C.F.R. § 1.137(a) that the required reply accompany the petition.

Applicant continues to qualify as a small entity within the meaning of 37 C.F.R. § 1.27. Solstice Biomedical Devices Ltd. is a privately held company that, as of its most recent fiscal year-end (December 31, 2023), employed three hundred and twelve (312) persons globally. This employee count is fewer than five hundred (500) employees, which is the threshold for qualification as a small entity under the applicable regulations. Furthermore, the Application has not been licensed or otherwise obligated to any entity that would not itself qualify as a small entity under 37 C.F.R. § 1.27, and no change in circumstances has occurred since the original assertion of small-entity status that would disqualify Applicant from continued small-entity treatment.

The issue fee is submitted herewith to complete the reply that was outstanding at the time the Application became abandoned, and to satisfy the requirements for revival under 37 C.F.R. § 1.137(a).

VII. PETITION FEE

In accordance with 37 C.F.R. § 1.17(m), the required petition fee for revival of an application abandoned unintentionally under 37 C.F.R. § 1.137(a) is $1,050.00 at the small-entity rate. This fee is submitted concurrently with this petition.

Applicant respectfully submits that the payment of this petition fee, together with the issue fee and the statement of unintentional delay set forth herein, satisfies all of the requirements for revival of the Application under 37 C.F.R. § 1.137(a).

VIII. FEE TRANSMITTAL SUMMARY

The following government fees are submitted concurrently with this petition:

Method of Payment: To be determined upon client authorization — payment will be made via USPTO Deposit Account, credit card authorization (Form PTO-2038), or electronic funds transfer (EFT) via USPTO Patent Center.

Authorization to Charge Additional Fees: The Commissioner is hereby authorized to charge any additional fees that may be required in connection with this petition or the issuance of the patent, or to credit any overpayment, to Deposit Account No. ____ of Calderwood & Harkness LLP. Without limitation, any fees due under 37 C.F.R. § 1.16 or § 1.17 that may be required in connection with this petition, the processing of the petition, or the issuance of the patent on the Application, are authorized to be charged to the same deposit account. If any additional fees are necessary to render this petition grantable, Applicant authorizes the Office to charge such fees to the designated deposit account without further authorization from Applicant or counsel.

IX. ENTITY SIZE CONFIRMATION

Applicant hereby reaffirms its status as a small entity under 37 C.F.R. § 1.27 for purposes of the fees submitted in connection with this petition and the issuance of the patent.

Solstice Biomedical Devices Ltd. is a private limited company incorporated under the laws of Ireland and registered with the Companies Registration Office of Ireland under CRO No. 647832. As of December 31, 2023, the company employed three hundred and twelve (312) persons on a global basis, including employees at its headquarters in Dublin, Ireland; its U.S. subsidiary offices; and its European operations. This employee count is below the five hundred (500) employee threshold established for small-entity qualification under 37 C.F.R. § 1.27(a)(2).

Applicant does not qualify as a micro entity under 35 U.S.C. § 123 and 37 C.F.R. § 1.29, as the gross income of Solstice Biomedical Devices Ltd. exceeds the applicable threshold for micro-entity qualification under the statute and regulations. Accordingly, all fees submitted herewith are calculated at the small-entity rate, and Applicant does not claim micro-entity status.

Applicant has not conveyed, and is not under any obligation to convey, a license or other rights in the Application to any entity that would not itself qualify as a small entity under 37 C.F.R. § 1.27. Applicant is not aware of any change in circumstances since the original assertion of small-entity status in this Application that would affect its eligibility for small-entity treatment.

All fees submitted in connection with this petition are calculated at the small-entity rate, and the small-entity status previously established in this Application remains in effect.

X. POWER OF ATTORNEY AND CORRESPONDENCE INFORMATION

This petition is filed by Peter Vassiliev (Reg. No. 72,340), an attorney registered to practice before the United States Patent and Trademark Office, of Calderwood & Harkness LLP. The existing power of attorney on file for this Application, naming Calderwood & Harkness LLP and its registered practitioners as attorneys of record, remains in full force and effect and has not been revoked or superseded. No new power of attorney is submitted with this petition, as the existing power of attorney is sufficient.

All correspondence relating to this petition and to the Application should be directed to the following address:

Calderwood & Harkness LLP 600 Lexington Avenue, 22nd Floor New York, NY 10022 Telephone: (212) 555-3400 Facsimile: (212) 555-3401

Email: peter.vassiliev@calderwoodharkness.com

Applicant's U.S. subsidiary for service and domestic correspondence purposes is:

Solstice Biomedical Inc. 200 Chestnut Ridge Road, Suite 310 Woodcliff Lake, NJ 07677 (Delaware corporation, Secretary of State File No. 7291456)

XI. REQUEST FOR RELIEF

Applicant respectfully requests that the Commissioner for Patents grant the following relief:

1. Grant this Petition to Revive under 37 C.F.R. § 1.137(a), thereby reviving U.S. Application No. 17/702,489 from its abandoned status and restoring the Application to active status before the Office;

2. Accept the issue fee of $540.00 (small-entity rate) submitted herewith as the required reply, completing the outstanding obligation under the Notice of Allowance mailed April 10, 2023;

3. Proceed with issuance of the patent on U.S. Application No. 17/702,489 in due course, in accordance with the Notice of Allowance and 35 U.S.C. § 151; and

4. Charge the petition fee of $1,050.00 (small-entity rate) and any additional required fees to the designated deposit account of Calderwood & Harkness LLP, as authorized herein.

XII. CONCLUSION

For the foregoing reasons, Applicant respectfully submits that all requirements for revival of this Application under 37 C.F.R. § 1.137(a) have been satisfied, including:

(a) The required reply — i.e., payment of the issue fee in the amount of $540.00 (small entity) — is submitted concurrently herewith;

(b) The petition fee in the amount of $1,050.00 (small entity) is submitted concurrently herewith; and

(c) A statement that the entire delay in filing the required reply from the due date (July 10, 2023) to the filing of this petition was unintentional has been provided, as set forth in Section V above.

Applicant respectfully requests favorable action on this petition at the earliest opportunity, and that the Office proceed with issuance of the patent on U.S. Application No. 17/702,489 upon the granting of this petition.

Respectfully submitted,

CALDERWOOD & HARKNESS LLP

By: ________

Peter Vassiliev Registered Patent Attorney Registration No. 72,340 600 Lexington Avenue, 22nd Floor New York, NY 10022 Telephone: (212) 555-3400

Email: peter.vassiliev@calderwoodharkness.com

Date: ________

NOTICE TO CLIENT — FOR INTERNAL REVIEW ONLY

This draft petition has been prepared for review and authorization by Solstice Biomedical Devices Ltd. This document is a draft and has not been filed with the United States Patent and Trademark Office. Filing will proceed only upon written instructions from Ronan Gallagher, General Counsel, Solstice Biomedical Devices Ltd., or his authorized designee.

Professional Fees: Professional fees for preparation and filing of this petition are estimated at $4,500–$6,000, in addition to the $1,590.00 in government fees described above. Actual fees will depend on any additional correspondence with the Office and any supplementary filings that may be required.

Engagement Team:

• Responsible Partner: Alan Ngo (Reg. No. 58,412)

• Billing Partner: Marcus Delgado (Reg. No. 51,987)

• Technical Review: Dr. Claire Nakamura, Patent Agent (Reg. No. 66,203)

• Drafted by: Wendy Schultz (Reg. No. 78,115)

• Filing Attorney: Peter Vassiliev (Reg. No. 72,340)

Client Authorization Required Before Filing.

CERTIFICATE OF ELECTRONIC FILING (PLACEHOLDER — TO BE COMPLETED UPON FILING)

I hereby certify that the foregoing Petition to Revive an Application Pursuant to 37 C.F.R. § 1.137(a), together with all accompanying documents and fee transmittals, was filed electronically via the USPTO Patent Center system on ___, 20__, addressed to:

Commissioner for Patents United States Patent and Trademark Office P.O. Box 1450 Alexandria, VA 22313-1450

The following documents were included with the electronic filing:

1. Petition to Revive an Application Pursuant to 37 C.F.R. § 1.137(a)

2. Issue Fee Payment (PTOL-85B or equivalent electronic submission) — $540.00 (small entity)

3. Petition Fee Payment — $1,050.00 (small entity)

4. Fee Authorization and Deposit Account Charge Authorization

________________________________________

Peter Vassiliev Registered Patent Attorney Registration No. 72,340 Calderwood & Harkness LLP

Date: ________

RELATED PENDING APPLICATIONS — CRYONOVA PATENT FAMILY (For Internal Reference Only)

The following applications and patents are related to U.S. Application No. 17/702,489 and are part of the CryoNova patent family. Counsel notes the following status and upcoming deadlines for client awareness:

Applicant's General Counsel, Ronan Gallagher, has been advised of all pending deadlines in the CryoNova patent family as part of the portfolio review initiated on October 28, 2024. Separate correspondence regarding the Office Action response due in U.S. App. No. 17/851,216 and the maintenance fee due for U.S. Patent No. 11,284,561 has been provided under separate cover.

Fee Description	Amount	Authority
Petition Fee — Unintentional Delay (small entity)	$1,050.00	37 C.F.R. § 1.17(m)
Issue Fee (small entity)	$540.00	37 C.F.R. § 1.18(a)
Total Government Fees	$1,590.00
Application / Patent	Docket No.	Status	Key Deadline
U.S. Patent No. 11,284,561 (Parent)	SBD-001	Issued March 22, 2022	3.5-year maintenance fee of $1,000.00 (small entity) due September 22, 2025
U.S. App. No. 17/702,489 (CON-1)	SBD-001-CON1	Abandoned — Revival Pending (this petition)	Issue fee and petition fee due upon filing
U.S. App. No. 17/851,216 (CON-2)	SBD-002-CON2	Pending — Office Action outstanding	Office Action response due January 15, 2025 (extendable to April 15, 2025)
U.S. App. No. 18/109,744 (CON-3)	SBD-003-CON3	Pending — Awaiting first Office Action	No current deadline

DRAFT — FOR CLIENT REVIEW AND AUTHORIZATION — NOT YET FILED WITH THE USPTO
PETITION TO REVIVE AN APPLICATION PURSUANT TO 37 C.F.R. § 1.137(a)
Attorney Docket No.: SBD-001-CON1 Firm Matter No.: SBD-IP-2021-003
Commissioner for Patents United States Patent and Trademark Office P.O. Box 1450 Alexandria, VA 22313-1450
Application Number: U.S. 17/702,489 Filing Date: March 23, 2022 Title of Invention: Methods of Cryoablation Using Variable-Zone Cooling Catheter Named Inventors: Dr. Aisling Connolly, Dr. Tomás Brennan, Dr. Henrik Paulsen Applicant / Assignee: Solstice Biomedical Devices Ltd., Unit 4, Liffey Innovation Campus, Parkgate Street, Dublin 8, D08 XR29, Ireland Examiner: James R. Dougherty Art Unit: 3794 Confirmation Number: To be confirmed from file records Attorney Docket No.: SBD-001-CON1 Firm Matter No.: SBD-IP-2021-003
I. INTRODUCTION AND BASIS FOR PETITION
Solstice Biomedical Devices Ltd. ("Applicant"), by and through undersigned counsel Peter Vassiliev (USPTO Reg. No. 72,340) of Calderwood & Harkness LLP, 600 Lexington Avenue, 22nd Floor, New York, NY 10022, respectfully petitions the Commissioner for Patents to revive the above-identified application pursuant to 37 C.F.R. § 1.137(a).
The above-referenced application became abandoned due to the non-payment of the issue fee within the period set forth in the Notice of Allowance mailed by the United States Patent and Trademark Office ("USPTO" or the "Office") on April 10, 2023. Specifically, the issue fee payment was due on or before July 10, 2023, and no such payment was made within the prescribed period, resulting in abandonment of the application as of July 11, 2023.
Applicant hereby states, in accordance with the requirements of 37 C.F.R. § 1.137(a), that the entire delay in filing the required reply from the due date of July 10, 2023, to the date of filing of this petition was unintentional. This petition is filed together with: (1) the required petition fee of $1,050.00 at the small-entity rate under 37 C.F.R. § 1.17(m); (2) the outstanding issue fee of $540.00 at the small-entity rate under 37 C.F.R. § 1.18(a); and (3) the required statement that the entire delay was unintentional, as set forth more fully herein.
Applicant respectfully submits that all requirements for revival of this application under 37 C.F.R. § 1.137(a) are satisfied by this petition and the accompanying submissions, and requests that the Commissioner grant this petition and proceed with issuance of the patent in due course.
II. BACKGROUND OF THE APPLICATION
U.S. Application No. 17/702,489 (the "Application" or the "'489 Application") was filed on March 23, 2022, as a continuation of U.S. Patent Application No. 16/914,337, which was filed on June 28, 2021. The parent application, U.S. 16/914,337, was examined and subsequently issued as U.S. Patent No. 11,284,561 on March 22, 2022. The present Application claims priority to and the benefit of the filing date of the parent application under 35 U.S.C. § 120, and the chain of priority is properly established in the Application Data Sheet and the specification of the Application as filed.
The Application is directed to methods of cryoablation using a variable-zone cooling catheter, and more particularly to methods of performing pulmonary vein isolation for the treatment of atrial fibrillation utilizing a catheter capable of selectively activating discrete cryogenic cooling zones along its distal tip structure. The claimed methods are part of the CryoNova cryoablation catheter system developed by Solstice Biomedical Devices Ltd., a Dublin-headquartered medical device company specializing in cardiac cryoablation technology and electrophysiology mapping instrumentation.
The named inventors of the Application are:
(a) Dr. Aisling Connolly, Vice President of Research & Development at Solstice Biomedical Devices Ltd., who contributed to the conception and reduction to practice of the variable-zone cooling methodology and catheter architecture;
(b) Dr. Tomás Brennan, Chief Medical Officer and Co-Founder of Solstice Biomedical Devices Ltd., who contributed to the clinical methodology aspects of the invention, including the procedural techniques for pulmonary vein isolation using the variable-zone catheter; and
(c) Dr. Henrik Paulsen, formerly Senior Engineer at Solstice Biomedical Devices Ltd. and currently employed by Arclight Therapeutics GmbH, who contributed to the engineering design and thermal management aspects of the variable-zone cooling system.
Solstice Biomedical Devices Ltd. is the assignee of the entire right, title, and interest in the Application. Assignments from each of the named inventors to Applicant have been recorded at the USPTO. The Application is currently assigned to Art Unit 3794 under the examination of Primary Examiner James R. Dougherty.
III. PROSECUTION HISTORY LEADING TO ABANDONMENT
The Application was examined in the ordinary course of prosecution by Primary Examiner James R. Dougherty, under the supervision of Supervisory Patent Examiner Linda M. Kowalski, in Art Unit 3794 of the Technology Center 3700, which handles applications relating to surgery and medical instruments.
On April 10, 2023, the USPTO mailed an Examiner's Amendment and Notice of Allowance for the Application. The Examiner's Amendment authorized certain amendments to the claims to place the Application in condition for allowance, and the Notice of Allowance confirmed that all pending claims (Claims 1–24 as amended) were found to be allowable over the prior art of record. The reasons for allowance stated by the Examiner identified the distinguishing features of the claimed variable-zone cooling methodology as not being anticipated by, or rendered obvious by, the cited references, including the closest prior art identified during prosecution.
Pursuant to the Notice of Allowance and in accordance with 37 C.F.R. § 1.311, the issue fee was required to be paid within three (3) months of the mailing date of the Notice of Allowance, i.e., on or before July 10, 2023. The issue fee amount due was $540.00, calculated at the small-entity rate under 37 C.F.R. § 1.27, which rate was properly established in the Application.
The issue fee was not paid by the July 10, 2023 deadline. No request for extension of time was filed, and no other response to the Notice of Allowance was submitted within the prescribed period. As a consequence, as of July 11, 2023, the Application was deemed abandoned by the Office for failure to pay the required issue fee within the time period set forth in the Notice of Allowance.
Applicant acknowledges that the Application is currently in an abandoned status as reflected in the USPTO's records and the Patent Application Information Retrieval (PAIR) system. This petition seeks to revive the Application from that abandoned status pursuant to 37 C.F.R. § 1.137(a).
IV. STATEMENT OF FACTS EXPLAINING THE DELAY
While 37 C.F.R. § 1.137(a) does not require a showing of the specific facts or circumstances underlying the unintentional delay, Applicant provides the following factual background in support of this petition and to provide context for the Office's consideration.
A. The FROST-AF Pivotal Clinical Trial Failure
Solstice Biomedical Devices Ltd. is an Irish-headquartered private limited company registered with the Companies Registration Office of Ireland under CRO No. 647832. The company specializes in the design, development, and commercialization of cardiac cryoablation systems and electrophysiology mapping medical devices for the treatment of cardiac arrhythmias, with a particular focus on atrial fibrillation.
The CryoNova cryoablation catheter system was Applicant's second-generation cryoablation catheter platform, designed specifically for pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation. The CryoNova system incorporated the variable-zone cooling technology that is the subject of the claims of the Application, representing a significant advancement over Applicant's first-generation cryoablation catheter. The CryoNova system was the centerpiece of Applicant's product development pipeline and commercial strategy during the relevant time period.
In pursuit of regulatory clearance for the CryoNova system in the United States, Applicant was conducting a U.S. pivotal clinical trial under an approved Investigational Device Exemption ("IDE"), IDE No. G210047, issued by the U.S. Food and Drug Administration ("FDA"). The pivotal trial, designated the "FROST-AF" study (Full-Range Optimized Segmental Treatment of Atrial Fibrillation), was a prospective, multicenter, single-arm study enrolling two hundred and twenty patients (n=220) across twelve clinical sites in the United States, designed to evaluate the safety and efficacy of the CryoNova system for pulmonary vein isolation.
On May 17, 2023, the results of the FROST-AF pivotal trial were announced following the completion of the twelve-month follow-up period for the final enrolled patient cohort. The trial results disclosed that the primary efficacy endpoint — freedom from documented atrial arrhythmia recurrence at twelve months post-procedure, off antiarrhythmic drug therapy — was not met. Specifically, the observed efficacy rate was 58.2%, which fell below the prespecified performance goal of 65% (p = 0.14). The difference was not statistically significant, and the primary efficacy endpoint was therefore not achieved.
The failure of the FROST-AF pivotal trial had an immediate and profound impact on Applicant's internal operations, strategic direction, and resource allocation related to the CryoNova program. As the pivotal trial was the critical regulatory milestone necessary to support a premarket approval ("PMA") submission to the FDA, the failure of the primary endpoint effectively precluded a near-term path to U.S. market authorization for the CryoNova system.
B. Board Decision to Shelve CryoNova Program
In response to the FROST-AF trial results, Applicant's management team conducted an urgent internal review of the CryoNova program during the weeks following the May 17, 2023 trial results announcement. Following this review and upon the recommendation of management, on June 8, 2023, the Board of Directors of Solstice Biomedical Devices Ltd. formally decided to shelve the CryoNova product development program indefinitely. The Board determined that additional investment in the CryoNova system could not be justified absent a clear path to regulatory approval, and directed that the company's resources be redirected to other product lines within the Solstice portfolio, including the company's electrophysiology mapping platform and its next-generation cryoballoon catheter program.
As a direct and immediate consequence of the Board's shelving decision, the CryoNova research and development team was reassigned to other product lines and programs within the company. This reassignment encompassed personnel across multiple functional areas, including engineering, clinical affairs, regulatory affairs, and intellectual property administration. Critically, the personnel within Applicant's organization who had been responsible for coordinating patent prosecution deadlines with outside counsel — specifically, the IP Coordinator within the CryoNova program office and the paralegal within Applicant's in-house legal department who managed the CryoNova IP docket — were among those reassigned to other programs as part of the restructuring.
The reassignment of these key personnel resulted in an internal docketing lapse at Applicant whereby the July 10, 2023 issue fee deadline for U.S. Application No. 17/702,489 was not tracked, monitored, or communicated to outside patent counsel at Calderwood & Harkness LLP. Specifically, the internal handoff of docketing responsibilities that should have occurred upon the reassignment of the CryoNova IP Coordinator was not completed, and the pending deadline fell through the gap in responsibility that resulted from the organizational restructuring.
C. Unintentional Nature of the Delay
Applicant states unequivocally that the failure to pay the issue fee by the July 10, 2023 deadline was not a deliberate decision to abandon the Application. At no time did any authorized representative of Applicant make a conscious, affirmative determination to allow the Application to lapse or to forego the issuance of a patent on the allowed claims. Rather, the failure to pay the issue fee was the inadvertent and unintentional result of the internal organizational disruption caused by the shelving of the CryoNova program and the attendant reassignment of key personnel responsible for IP docket management.
Neither Applicant's General Counsel, Ronan Gallagher, nor the responsible outside patent counsel at Calderwood & Harkness LLP, was aware of the missed deadline at the time it occurred. Mr. Gallagher has confirmed through counsel that no deliberate determination was made to allow the Application to go abandoned, and that the non-payment of the issue fee was entirely unintentional. Outside counsel at Calderwood & Harkness LLP received the Notice of Allowance and docketed the issue fee deadline on its internal system; however, the standard operating procedure for this application required Applicant's in-house IP team to confirm authorization and arrange for payment of the issue fee, and no such confirmation or instruction was received by outside counsel prior to the deadline, nor was any communication received from Applicant indicating an intent to abandon.
Additional evidence of the unintentional nature of the abandonment is provided by the fact that the last prosecution activity on any application in the CryoNova patent family occurred on July 3, 2023, when counsel filed an extension of time in a related continuation application, U.S. Application No. 17/851,216 (SBD-002-CON2). This filing, made just seven days before the issue fee deadline for the present Application, demonstrates that prosecution of the CryoNova patent family was still being managed by counsel in early July 2023, and further evidences that the prosecution docket went dormant at approximately this time due to the program shelving and personnel reassignment, rather than as a result of any deliberate intent to abandon.
On October 28, 2024, Applicant's General Counsel, Ronan Gallagher, contacted outside counsel at Calderwood & Harkness LLP to request a comprehensive portfolio review and reactivation of the CryoNova patent prosecution docket. This request was prompted by renewed strategic interest in the CryoNova technology platform following positive interim results from a European clinical study and the initiation of discussions with potential licensing partners. Upon conducting the portfolio review, counsel identified the abandoned status of U.S. Application No. 17/702,489 and promptly commenced preparation of this petition.
The entire delay in filing this petition to revive from July 11, 2023 (the date of abandonment) to the date of filing of this petition was unintentional, and Applicant respectfully submits that the facts set forth herein fully support this statement.
V. REQUIRED STATEMENT UNDER 37 C.F.R. § 1.137(a)
Applicant hereby states, as required by 37 C.F.R. § 1.137(a), that the entire delay in filing the required reply from the date such reply was due to the filing of a grantable petition pursuant to this section was unintentional. Specifically, the entire delay in payment of the issue fee from the due date of July 10, 2023, to the filing of this petition was unintentional.
This statement is made in compliance with and satisfies the requirement of 37 C.F.R. § 1.137(a), which provides that a petition to revive an abandoned application may be granted where the delay in filing the required reply was unintentional, upon the filing of: (1) the required reply; (2) the petition fee set forth in 37 C.F.R. § 1.17(m); and (3) a statement that the entire delay in filing the required reply from the due date for the reply to the filing of a grantable petition was unintentional.
VI. REPLY — PAYMENT OF ISSUE FEE
Concurrently with this petition, Applicant submits the required issue fee in the amount of $540.00, calculated at the small-entity rate pursuant to 37 C.F.R. § 1.18(a) and 37 C.F.R. § 1.27. This payment constitutes the "required reply" that was outstanding at the time the Application became abandoned, and its submission herewith satisfies the requirement of 37 C.F.R. § 1.137(a) that the required reply accompany the petition.
Applicant continues to qualify as a small entity within the meaning of 37 C.F.R. § 1.27. Solstice Biomedical Devices Ltd. is a privately held company that, as of its most recent fiscal year-end (December 31, 2023), employed three hundred and twelve (312) persons globally. This employee count is fewer than five hundred (500) employees, which is the threshold for qualification as a small entity under the applicable regulations. Furthermore, the Application has not been licensed or otherwise obligated to any entity that would not itself qualify as a small entity under 37 C.F.R. § 1.27, and no change in circumstances has occurred since the original assertion of small-entity status that would disqualify Applicant from continued small-entity treatment.
The issue fee is submitted herewith to complete the reply that was outstanding at the time the Application became abandoned, and to satisfy the requirements for revival under 37 C.F.R. § 1.137(a).
VII. PETITION FEE
In accordance with 37 C.F.R. § 1.17(m), the required petition fee for revival of an application abandoned unintentionally under 37 C.F.R. § 1.137(a) is $1,050.00 at the small-entity rate. This fee is submitted concurrently with this petition.
Applicant respectfully submits that the payment of this petition fee, together with the issue fee and the statement of unintentional delay set forth herein, satisfies all of the requirements for revival of the Application under 37 C.F.R. § 1.137(a).
VIII. FEE TRANSMITTAL SUMMARY
The following government fees are submitted concurrently with this petition:
Method of Payment: To be determined upon client authorization — payment will be made via USPTO Deposit Account, credit card authorization (Form PTO-2038), or electronic funds transfer (EFT) via USPTO Patent Center.
Authorization to Charge Additional Fees: The Commissioner is hereby authorized to charge any additional fees that may be required in connection with this petition or the issuance of the patent, or to credit any overpayment, to Deposit Account No. ____ of Calderwood & Harkness LLP. Without limitation, any fees due under 37 C.F.R. § 1.16 or § 1.17 that may be required in connection with this petition, the processing of the petition, or the issuance of the patent on the Application, are authorized to be charged to the same deposit account. If any additional fees are necessary to render this petition grantable, Applicant authorizes the Office to charge such fees to the designated deposit account without further authorization from Applicant or counsel.
IX. ENTITY SIZE CONFIRMATION
Applicant hereby reaffirms its status as a small entity under 37 C.F.R. § 1.27 for purposes of the fees submitted in connection with this petition and the issuance of the patent.
Solstice Biomedical Devices Ltd. is a private limited company incorporated under the laws of Ireland and registered with the Companies Registration Office of Ireland under CRO No. 647832. As of December 31, 2023, the company employed three hundred and twelve (312) persons on a global basis, including employees at its headquarters in Dublin, Ireland; its U.S. subsidiary offices; and its European operations. This employee count is below the five hundred (500) employee threshold established for small-entity qualification under 37 C.F.R. § 1.27(a)(2).
Applicant does not qualify as a micro entity under 35 U.S.C. § 123 and 37 C.F.R. § 1.29, as the gross income of Solstice Biomedical Devices Ltd. exceeds the applicable threshold for micro-entity qualification under the statute and regulations. Accordingly, all fees submitted herewith are calculated at the small-entity rate, and Applicant does not claim micro-entity status.
Applicant has not conveyed, and is not under any obligation to convey, a license or other rights in the Application to any entity that would not itself qualify as a small entity under 37 C.F.R. § 1.27. Applicant is not aware of any change in circumstances since the original assertion of small-entity status in this Application that would affect its eligibility for small-entity treatment.
All fees submitted in connection with this petition are calculated at the small-entity rate, and the small-entity status previously established in this Application remains in effect.
X. POWER OF ATTORNEY AND CORRESPONDENCE INFORMATION
This petition is filed by Peter Vassiliev (Reg. No. 72,340), an attorney registered to practice before the United States Patent and Trademark Office, of Calderwood & Harkness LLP. The existing power of attorney on file for this Application, naming Calderwood & Harkness LLP and its registered practitioners as attorneys of record, remains in full force and effect and has not been revoked or superseded. No new power of attorney is submitted with this petition, as the existing power of attorney is sufficient.
All correspondence relating to this petition and to the Application should be directed to the following address:
Calderwood & Harkness LLP 600 Lexington Avenue, 22nd Floor New York, NY 10022 Telephone: (212) 555-3400 Facsimile: (212) 555-3401
Email: peter.vassiliev@calderwoodharkness.com
Applicant's U.S. subsidiary for service and domestic correspondence purposes is:
Solstice Biomedical Inc. 200 Chestnut Ridge Road, Suite 310 Woodcliff Lake, NJ 07677 (Delaware corporation, Secretary of State File No. 7291456)
XI. REQUEST FOR RELIEF
Applicant respectfully requests that the Commissioner for Patents grant the following relief:
1.  Grant this Petition to Revive under 37 C.F.R. § 1.137(a), thereby reviving U.S. Application No. 17/702,489 from its abandoned status and restoring the Application to active status before the Office;
2.  Accept the issue fee of $540.00 (small-entity rate) submitted herewith as the required reply, completing the outstanding obligation under the Notice of Allowance mailed April 10, 2023;
3.  Proceed with issuance of the patent on U.S. Application No. 17/702,489 in due course, in accordance with the Notice of Allowance and 35 U.S.C. § 151; and
4.  Charge the petition fee of $1,050.00 (small-entity rate) and any additional required fees to the designated deposit account of Calderwood & Harkness LLP, as authorized herein.
XII. CONCLUSION
For the foregoing reasons, Applicant respectfully submits that all requirements for revival of this Application under 37 C.F.R. § 1.137(a) have been satisfied, including:
(a) The required reply — i.e., payment of the issue fee in the amount of $540.00 (small entity) — is submitted concurrently herewith;
(b) The petition fee in the amount of $1,050.00 (small entity) is submitted concurrently herewith; and
(c) A statement that the entire delay in filing the required reply from the due date (July 10, 2023) to the filing of this petition was unintentional has been provided, as set forth in Section V above.
Applicant respectfully requests favorable action on this petition at the earliest opportunity, and that the Office proceed with issuance of the patent on U.S. Application No. 17/702,489 upon the granting of this petition.
Respectfully submitted,
CALDERWOOD & HARKNESS LLP
By: ________
Peter Vassiliev Registered Patent Attorney Registration No. 72,340 600 Lexington Avenue, 22nd Floor New York, NY 10022 Telephone: (212) 555-3400
Email: peter.vassiliev@calderwoodharkness.com
Date: ________
NOTICE TO CLIENT — FOR INTERNAL REVIEW ONLY
This draft petition has been prepared for review and authorization by Solstice Biomedical Devices Ltd. This document is a draft and has not been filed with the United States Patent and Trademark Office. Filing will proceed only upon written instructions from Ronan Gallagher, General Counsel, Solstice Biomedical Devices Ltd., or his authorized designee.
Professional Fees: Professional fees for preparation and filing of this petition are estimated at $4,500–$6,000, in addition to the $1,590.00 in government fees described above. Actual fees will depend on any additional correspondence with the Office and any supplementary filings that may be required.
Engagement Team:
•  Responsible Partner: Alan Ngo (Reg. No. 58,412)
•  Billing Partner: Marcus Delgado (Reg. No. 51,987)
•  Technical Review: Dr. Claire Nakamura, Patent Agent (Reg. No. 66,203)
•  Drafted by: Wendy Schultz (Reg. No. 78,115)
•  Filing Attorney: Peter Vassiliev (Reg. No. 72,340)
Client Authorization Required Before Filing.
CERTIFICATE OF ELECTRONIC FILING (PLACEHOLDER — TO BE COMPLETED UPON FILING)
I hereby certify that the foregoing Petition to Revive an Application Pursuant to 37 C.F.R. § 1.137(a), together with all accompanying documents and fee transmittals, was filed electronically via the USPTO Patent Center system on ___, 20__, addressed to:
Commissioner for Patents United States Patent and Trademark Office P.O. Box 1450 Alexandria, VA 22313-1450
The following documents were included with the electronic filing:
1.  Petition to Revive an Application Pursuant to 37 C.F.R. § 1.137(a)
2.  Issue Fee Payment (PTOL-85B or equivalent electronic submission) — $540.00 (small entity)
3.  Petition Fee Payment — $1,050.00 (small entity)
4.  Fee Authorization and Deposit Account Charge Authorization
________________________________________
Peter Vassiliev Registered Patent Attorney Registration No. 72,340 Calderwood & Harkness LLP
Date: ________
RELATED PENDING APPLICATIONS — CRYONOVA PATENT FAMILY (For Internal Reference Only)
The following applications and patents are related to U.S. Application No. 17/702,489 and are part of the CryoNova patent family. Counsel notes the following status and upcoming deadlines for client awareness:
Applicant's General Counsel, Ronan Gallagher, has been advised of all pending deadlines in the CryoNova patent family as part of the portfolio review initiated on October 28, 2024. Separate correspondence regarding the Office Action response due in U.S. App. No. 17/851,216 and the maintenance fee due for U.S. Patent No. 11,284,561 has been provided under separate cover.
Fee Description | Amount | Authority
Petition Fee — Unintentional Delay (small entity) | $1,050.00 | 37 C.F.R. § 1.17(m)
Issue Fee (small entity) | $540.00 | 37 C.F.R. § 1.18(a)
Total Government Fees | $1,590.00
Application / Patent | Docket No. | Status | Key Deadline
U.S. Patent No. 11,284,561 (Parent) | SBD-001 | Issued March 22, 2022 | 3.5-year maintenance fee of $1,000.00 (small entity) due September 22, 2025
U.S. App. No. 17/702,489 (CON-1) | SBD-001-CON1 | Abandoned — Revival Pending (this petition) | Issue fee and petition fee due upon filing
U.S. App. No. 17/851,216 (CON-2) | SBD-002-CON2 | Pending — Office Action outstanding | Office Action response due January 15, 2025 (extendable to April 15, 2025)
U.S. App. No. 18/109,744 (CON-3) | SBD-003-CON3 | Pending — Awaiting first Office Action | No current deadline