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

extension-of-time-request-con2.docx DOCUMENT Litigation

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REQUEST FOR EXTENSION OF TIME UNDER 37 C.F.R. § 1.136(a)

Filed Via USPTO Patent Center (Electronic Filing)

Firm Reference / Matter No.: SBD-IP-2021-003 Docket No.: SBD-001-CON2

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

Attention: Mail Stop Amendment

Primary Examiner: James R. Dougherty Supervisory Patent Examiner: Linda M. Kowalski Art Unit: 3794 Technology Center: Surgical Instruments — Cryotherapy

IN RE APPLICATION OF:

Dear Commissioner:

Applicant, Solstice Biomedical Devices Ltd., by and through its undersigned attorneys of record, Calderwood & Harkness LLP, hereby respectfully requests an extension of time to respond to the outstanding Office Action in the above-identified application, as set forth more fully below.

I. IDENTIFICATION OF THE OUTSTANDING OFFICE ACTION

On September 15, 2024, the United States Patent and Trademark Office mailed a Non-Final Office Action in the above-captioned application, U.S. Application No. 17/851,216 (hereinafter, the "Office Action"). Pursuant to 35 U.S.C. § 133 and 37 C.F.R. § 1.134, the shortened statutory period for response to the Office Action is three months from its mailing date. Accordingly, the initial response deadline is January 15, 2025.

The Office Action includes the following substantive rejections and objections, which are summarized here solely for purposes of identifying the pending matters necessitating the extension of time:

(a) Rejections of Claims 1–8 under 35 U.S.C. § 103 as being unpatentable over asserted combinations of prior art references, including inter alia U.S. Patent No. 10,561,457 to Yamamoto et al. in view of U.S. Patent Application Publication No. 2019/0183567 to Reddy et al., and further in view of Kolandaivelu, G. et al., "Catheter-Based Impedance Mapping During Cryoablation," Journal of Interventional Cardiac Electrophysiology, Vol. 58, No. 3 (2020);

(b) Rejections of Claims 9–14 under 35 U.S.C. § 112(a) (written description requirement), wherein the Examiner asserted that the specification does not provide adequate written description support for certain claimed electrode configurations and impedance measurement protocols recited in dependent Claims 9–14; and

(c) Objections to Claims 15–20 on the basis of informalities, including claim dependency issues and alleged antecedent basis deficiencies in certain claim limitations.

Applicant intends to prepare a substantive response to each of the foregoing rejections and objections. However, for the reasons set forth herein, Applicant requires additional time beyond the initial three-month response period to prepare such a response.

II. STATEMENT OF THE EXTENSION REQUESTED

Applicant hereby respectfully requests a three-month extension of time under 37 C.F.R. § 1.136(a) to respond to the Non-Final Office Action mailed September 15, 2024. The requested extension consists of three successive one-month extensions of time, as follows:

(1) A first one-month extension of time, extending the response deadline from January 15, 2025 to February 15, 2025;

(2) A second one-month extension of time, extending the response deadline from February 15, 2025 to March 15, 2025; and

(3) A third one-month extension of time, extending the response deadline from March 15, 2025 to April 15, 2025.

Upon the grant of this three-month extension, the extended response deadline will be April 15, 2025, which is six months from the mailing date of the Office Action (September 15, 2024). Applicant respectfully notes that this extended deadline represents the maximum period permitted for response under 37 C.F.R. § 1.136(a), consistent with the six-month outer limit established by 35 U.S.C. § 133.

The additional time is necessary to permit Applicant and undersigned counsel to conduct a thorough technical and legal analysis of the rejections under 35 U.S.C. § 103, particularly in light of the complex interplay among the multiple prior art references cited by the Examiner. Additionally, the rejections under 35 U.S.C. § 112(a) require careful coordination with the named inventors, Dr. Connolly and Dr. Brennan, and Applicant's internal engineering staff in Dublin, Ireland, to confirm the level of written description support in the specification for the subject matter of Claims 9–14 and to prepare any necessary declarations or supplementary evidence. The time zone difference, ongoing clinical trial schedules, and the need to coordinate across multiple technical disciplines further necessitate the extended response period.

III. STATUTORY BASIS

This request is made pursuant to 37 C.F.R. § 1.136(a), which provides that the time for filing a response to an Office Action may be extended, upon the filing of a petition therefor and the payment of the applicable fee(s), in increments of one month, up to a maximum of the six-month statutory period for response set forth in 35 U.S.C. § 133. Extensions of time under 37 C.F.R. § 1.136(a) are available as a matter of right upon timely filing of the petition and payment of the prescribed fees.

Applicant respectfully submits that all requirements for the grant of this extension have been met or will be met by the concurrent payment of the required fees, as detailed in the Fee Transmittal Section below.

IV. ENTITY SIZE CERTIFICATION

Applicant, Solstice Biomedical Devices Ltd., hereby certifies that it qualifies as a small entity under 37 C.F.R. § 1.27 for the purpose of paying reduced patent fees in connection with the above-identified application.

Solstice Biomedical Devices Ltd. is a private limited company incorporated under the laws of Ireland, with registered office at Unit 4, Liffey Innovation Campus, Parkgate Street, Dublin 8, D08 XR29, Ireland (Companies Registration Office No. 647832). As of December 31, 2023, Solstice Biomedical Devices Ltd. and its affiliates, including its wholly owned U.S. subsidiary, Solstice Biomedical Inc., employed a total of 312 persons globally. Accordingly, Applicant meets the employee threshold for small entity status under 37 C.F.R. § 1.27(a)(2).

Applicant further certifies that it has not assigned, granted, conveyed, or otherwise licensed any rights in the subject application to any entity that would not independently qualify as a small entity under 37 C.F.R. § 1.27. All extension fees set forth herein are calculated at the applicable small-entity rate as published in the current USPTO fee schedule.

Applicant does not qualify as a micro entity under 37 C.F.R. § 1.29, as the gross income of Solstice Biomedical Devices Ltd. for the calendar year preceding the filing of this paper exceeds the applicable threshold set forth in 35 U.S.C. § 123(a).

V. FEE TRANSMITTAL

A. Fee Calculation

The fees required for the requested three-month extension of time, calculated at the small-entity rate, are as follows:

B. Payment Authorization

The Director of the United States Patent and Trademark Office is hereby authorized to charge the total fees of $1,380.00 to Deposit Account No. 50-3917 of Calderwood & Harkness LLP maintained at the United States Patent and Trademark Office. In the alternative, payment may be made via credit card authorization filed concurrently with this Request via the USPTO Patent Center electronic filing system.

The Director is further authorized to charge any additional fees that may be required in connection with this filing, or to credit any overpayment, to the above-identified Deposit Account No. 50-3917. This authorization extends to any fees that may become due under 37 C.F.R. §§ 1.16 and 1.17 in connection with the processing of this Request.

VI. CONDITIONAL PETITION FOR EXTENSION OF TIME

Should the United States Patent and Trademark Office determine that a greater or different extension of time fee is required than as set forth in Section V above — whether due to a change in the fee schedule, a recalculation of the applicable response period, a change in entity status, or any other reason — the Commissioner is hereby authorized to treat this paper as a petition for an extension of time for the appropriate period, and to charge any and all additional fees required to effect such extension to Deposit Account No. 50-3917 of Calderwood & Harkness LLP.

This authorization is made pursuant to 37 C.F.R. § 1.136(a) to ensure that the Applicant's right to respond to the Office Action is preserved and to avoid any inadvertent abandonment of U.S. Application No. 17/851,216 that might otherwise result from an insufficient fee payment or an incorrect calculation of the extension period. Applicant does not intend by this conditional authorization to waive any right to contest the propriety of any fees so charged.

VII. CERTIFICATE OF ELECTRONIC FILING

I hereby certify that this Request for Extension of Time Under 37 C.F.R. § 1.136(a), together with the accompanying Fee Transmittal, is being filed electronically via the United States Patent and Trademark Office Patent Center electronic filing system on the date set forth below. The filing is directed to U.S. Application No. 17/851,216, Confirmation No. 4817, assigned to Art Unit 3794.

VIII. SIGNATURE

Respectfully submitted,

CALDERWOOD & HARKNESS LLP

/Wendy Schultz/

Wendy Schultz Registration No.: 78,115 Associate, intellectual Property — Patent Prosecution

Calderwood & Harkness LLP 600 Lexington Avenue, 22nd Floor New York, NY 10022 Telephone: (212) 848-6200 Facsimile: (212) 848-6201

Email: wschultz@calderwoodharkness.com

Date: ________

IX. CUSTOMER NUMBER AND CORRESPONDENCE ADDRESS

All correspondence related to this application should be directed to the following:

Customer Number: 74291

Correspondence Address: Calderwood & Harkness LLP 600 Lexington Avenue, 22nd Floor New York, NY 10022

Attention: Wendy Schultz / Peter Vassiliev

Matter No.: SBD-IP-2021-003

X. APPLICANT INFORMATION

Applicant / Assignee of Record: Solstice Biomedical Devices Ltd. Unit 4, Liffey Innovation Campus Parkgate Street Dublin 8, D08 XR29 Ireland Companies Registration Office No. 647832

U.S. Subsidiary (for correspondence purposes): Solstice Biomedical Inc. 200 Chestnut Ridge Road, Suite 310 Woodcliff Lake, NJ 07677 Delaware File No.: 7291456

CERTIFICATE OF SERVICE / TRANSMISSION

I hereby certify that a true and correct copy of this Request for Extension of Time Under 37 C.F.R. § 1.136(a) and the accompanying Fee Transmittal has been filed with the United States Patent and Trademark Office via the USPTO Patent Center electronic filing system on the date indicated below.

I further certify that a copy of this filing has been transmitted to the client on the date indicated below, directed to:

Ronan Gallagher General Counsel & Company Secretary Solstice Biomedical Devices Ltd. Unit 4, Liffey Innovation Campus Parkgate Street Dublin 8, D08 XR29 Ireland

Email: rgallagher@solsticebiomedical.ie