1037-00005 · Solstice Biomedical Devices Ltd · Correspondence

maintenance-fee-reminder-letter.docx DOCUMENT Litigation

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PRIVILEGED & CONFIDENTIAL

CALDERWOOD & HARKNESS LLP 600 Lexington Avenue, 22nd Floor New York, New York 10022

intellectual Property — Patent Prosecution Practice Group

December 9, 2024

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

Re: Maintenance Fee Reminder — U.S. Patent No. 11,284,561

Our Matter No.: SBD-IP-2021-003

Patent Title: "Cryoablation Catheter System with Variable-Zone Cooling"

Patent Application No. (Original): U.S. 16/914,337

Issue Date: March 22, 2022

Patent Owner: Solstice Biomedical Devices Ltd.

Dear Ronan:

1. Purpose of This Letter

Calderwood & Harkness LLP is writing in its capacity as outside patent counsel for Solstice Biomedical Devices Ltd. ("SBD" or the "Company") in connection with the CryoNova cryoablation catheter patent family. The purpose of this letter is to advise SBD of the upcoming obligation to pay the first (3.5-year) maintenance fee for U.S. Patent No. 11,284,561 (the "Patent"), which was granted by the United States Patent and Trademark Office ("USPTO") on March 22, 2022.

We are sending this letter well in advance of the statutory deadline to allow sufficient time for board-level consideration and formal authorization, particularly in light of the ongoing portfolio review and strategic assessment currently under discussion between our firm and SBD's management team. As you are aware, the treatment of the Patent is one of several action items arising from the broader portfolio strategy analysis, and we wish to ensure that no maintenance fee deadline is inadvertently missed while the Company deliberates on the appropriate go-forward approach. The details set forth below should provide SBD's leadership with the information necessary to make an informed and timely decision regarding this fee obligation.

2. Maintenance Fee Details — 3.5-Year Fee

U.S. Patent No. 11,284,561 was issued on March 22, 2022, with twenty-four (24) claims directed to a "Cryoablation Catheter System with Variable-Zone Cooling." Under the provisions of 35 U.S.C. § 41(b), the owner of a U.S. utility patent must pay periodic maintenance fees in order to keep the patent in force for the full twenty-year term measured from the earliest effective filing date. The first such maintenance fee is due no later than three and one-half (3.5) years after the date of issuance.

Accordingly, the key dates and amounts applicable to the first maintenance fee for the Patent are as follows:

Statutory Due Date: September 22, 2025

Early Payment Window (No Surcharge): The maintenance fee may be paid without surcharge during the six-month window immediately preceding the due date — that is, beginning on March 22, 2025 and ending on September 22, 2025.

Grace Period (With Surcharge): A six-month grace period following the September 22, 2025 due date is available under 37 C.F.R. § 1.362(e), extending through March 22, 2026. However, payment during this grace period requires the payment of a surcharge in addition to the base maintenance fee. At the current small-entity rate, the grace-period surcharge is $80.00.

Amount Due: The 3.5-year maintenance fee at the small-entity rate, as set forth in 37 C.F.R. § 1.20(e), is $1,000.00. If payment were to be made during the grace period, the total amount due would be $1,080.00 (inclusive of the surcharge).

It is our strong recommendation that the maintenance fee be paid during the early payment window (March 22, 2025 through September 22, 2025) to avoid the need for surcharge payments and to eliminate any risk of inadvertent lapse.

3. Consequence of Non-Payment

Failure to pay the 3.5-year maintenance fee — including during the six-month grace period with the applicable surcharge — will result in the Patent expiring by operation of law under 35 U.S.C. § 41(b). Expiration for non-payment of maintenance fees is automatic and does not require any affirmative action by the USPTO. Once the grace period closes on March 22, 2026, the Patent would be deemed expired and the subject matter of the Patent would pass into the public domain.

Once expired for non-payment of maintenance fees, a patent may be revived only upon the filing of a petition under 37 C.F.R. § 1.378, accompanied by a statement that the delay in payment was "unintentional," together with payment of the outstanding maintenance fee, the applicable surcharge, and a petition fee (currently $1,050.00 at the small-entity rate). We note that the "unintentional" standard, while more lenient than the prior "unavoidable" standard, still requires a genuine showing that the failure to pay was not a deliberate decision to abandon the patent. Moreover, the USPTO retains discretion in evaluating such petitions, and the revival process can involve significant delays and administrative burden. In certain circumstances, intervening rights may also accrue to third parties who relied on the expired status of the Patent during the lapse period, potentially diminishing the enforceability and commercial value of the Patent even if revival is ultimately obtained.

For these reasons, SBD should treat the September 22, 2025 deadline as firm and should plan to authorize payment well in advance of that date. Calderwood & Harkness strongly advises against any course of action that relies upon the grace period or the revival petition process as a fallback.

4. Small-Entity Status Confirmation

SBD currently qualifies as a "small entity" within the meaning of 37 C.F.R. § 1.27 for purposes of paying reduced fees to the USPTO. This status was asserted at the time of filing and has been maintained throughout prosecution and post-issuance maintenance of the Patent.

The basis for SBD's small-entity qualification is as follows:

(a) SBD has fewer than 500 employees. As of December 31, 2023, SBD reported a global headcount of approximately 312 employees across its Dublin headquarters and satellite facilities.

(b) SBD has no obligation to assign, grant, or convey a license or other rights in the Patent to any entity that would not itself qualify as a small entity under 37 C.F.R. § 1.27.

The maintenance fee amounts quoted in this letter reflect the small-entity rate, which is set at fifty percent (50%) of the standard large-entity rate. For reference, the large-entity rate for the 3.5-year maintenance fee is currently $2,000.00; SBD's small-entity rate is $1,000.00.

We note that SBD does not qualify as a "micro entity" under 37 C.F.R. § 1.29, as we understand that the Company's gross income exceeds the applicable threshold established by the USPTO for micro-entity eligibility (currently set at three times the median household income as reported by the U.S. Bureau of the Census). The micro-entity rate would represent a further reduction to twenty-five percent (25%) of the large-entity rate, but this rate is not available to SBD under its current financial profile.

Calderwood & Harkness respectfully requests that SBD promptly notify the firm if its entity-size status changes at any time prior to the payment of maintenance fees — or at any other time during the life of the Patent. Events that could affect SBD's eligibility for small-entity status include, but are not limited to:

(i) the execution of a licensing transaction, joint development agreement, or other arrangement with or for the benefit of an entity that does not qualify as a small entity (e.g., a large multinational corporation);

(ii) an acquisition of SBD by, or merger with, an entity having 500 or more employees;

(iii) an increase in SBD's own employee headcount beyond 500; or

(iv) the grant, assignment, or conveyance of any rights in the Patent to a non-small-entity.

Improperly claiming small-entity status before the USPTO can have serious consequences, including but not limited to the potential unenforceability of the Patent. Accordingly, the accurate maintenance of entity-size determinations is of critical importance, and we ask that SBD treat this obligation with appropriate diligence.

5. Future Maintenance Fee Schedule

For planning and budgeting purposes, we set forth below the full maintenance fee schedule for U.S. Patent No. 11,284,561 at the current small-entity rates as published by the USPTO:

Each of the above fees may be paid without surcharge during the six-month window preceding the stated due date and may be paid with a surcharge during the six-month grace period following the stated due date. The total cost of maintaining the Patent in force through its full statutory term, at the current small-entity rates, is $6,760.00 in maintenance fees alone.

Please note that the USPTO periodically adjusts its fee schedules — typically through rulemaking published in the Federal Register — and the 7.5-year and 11.5-year amounts listed above are current as of calendar year 2024. These amounts may change before the respective fees become due. Calderwood & Harkness monitors fee schedule updates as part of our ongoing docketing and patent management activities, and we will send reminder letters to SBD well in advance of each subsequent maintenance fee window, specifying the then-current amounts due.

6. Relationship to Portfolio Strategy Review

As discussed in the Portfolio Strategy Memorandum transmitted separately to SBD and its board of directors, the go-forward treatment of U.S. Patent No. 11,284,561 is one component of the broader strategic review of SBD's CryoNova patent family. The board's forthcoming decision among the three identified portfolio scenarios will directly determine whether the 3.5-year maintenance fee should be paid:

Scenario 1 — Maintain Full Portfolio: Under this scenario, SBD would pay the 3.5-year maintenance fee and keep the issued Patent in force, alongside continued prosecution of all pending applications in the CryoNova family. This approach preserves the full breadth of SBD's patent protection and maximizes the Company's licensing leverage, including the potential out-licensing opportunities with Helios Surgical Technologies, Inc. or Vantage Cryosurgical Systems, Inc. that Pinnacle Health Ventures has identified as part of the ongoing commercialization assessment. Under Scenario 1, the maintenance fee payment is a straightforward and uncontroversial expenditure.

Scenario 2 — Selective Prosecution: Under this scenario, SBD would pay the 3.5-year maintenance fee for the issued Patent while making selective decisions about the continuation of pending applications and foreign filings, based on a cost-benefit analysis specific to each filing. Maintaining the issued Patent is a centerpiece of Scenario 2, as the Patent provides the strongest and most immediately enforceable protection in the portfolio and anchors the commercial value proposition for prospective licensees, including Helios Surgical Technologies, Inc. and Vantage Cryosurgical Systems, Inc. The maintenance fee payment under this scenario is likewise clearly warranted.

Scenario 3 — Full Abandonment: Under this scenario, SBD would elect not to pay the maintenance fee, allowing the Patent to expire at the 3.5-year window. This scenario would be appropriate only if the board determines that the entire CryoNova patent family has insufficient commercial value to justify even the modest costs of maintenance and that none of the identified licensing or strategic partnering opportunities are likely to materialize.

As set forth in the Portfolio Strategy Memorandum, Calderwood & Harkness's recommendation is Scenario 2 (Selective Prosecution), under which the maintenance fee for U.S. Patent No. 11,284,561 would be paid. We believe this approach strikes the appropriate balance between cost discipline and the preservation of SBD's core intellectual property assets, particularly given the substantial investment that has already been made in obtaining the Patent and the credible licensing opportunities that have been identified.

Regardless of the board's ultimate decision on the broader portfolio strategy, we respectfully request that a timely authorization be provided with respect to the maintenance fee for the Patent. The payment window opens on March 22, 2025, and we wish to ensure that the firm can calendar the payment and execute it in an orderly fashion, without any risk of inadvertent lapse due to administrative delays or scheduling conflicts.

7. Request for Written Authorization

In order for Calderwood & Harkness to proceed with the maintenance fee payment on SBD's behalf, we respectfully request that SBD provide written authorization — whether by email or signed letter on Company letterhead — directing the firm to undertake the following:

1. Pay the 3.5-year maintenance fee of $1,000.00 to the USPTO on behalf of SBD during the payment window commencing March 22, 2025, and no later than the statutory due date of September 22, 2025, in connection with U.S. Patent No. 11,284,561.

2. Invoice SBD for the government fee disbursement of $1,000.00 plus any associated professional fees for the preparation and filing of the maintenance fee payment. We anticipate that the professional fees for this administrative processing will be nominal, consisting primarily of the time required to prepare and submit the electronic fee payment through the USPTO's Patent Maintenance Fees Storefront, verify acceptance, and update our records and docket accordingly. We estimate total professional fees for this task at approximately $350.00–$500.00, exclusive of the government fee itself.

Authorization should be directed to the undersigned, Alan Ngo, at Calderwood & Harkness LLP, at the contact information set forth in the signature block below. Alternatively, authorization may be directed to Peter Vassiliev, Lead Associate on the matter, who can be reached at pvassiliev@calderwoodharkness.com or at (212) 554-7190.

Calderwood & Harkness recommends that SBD provide this authorization no later than February 28, 2025, in order to allow adequate lead time for internal processing, fee payment preparation, and any follow-up communications that may be necessary prior to the opening of the payment window on March 22, 2025. While the statutory deadline is not until September 22, 2025, early authorization will allow us to manage the payment with appropriate care and to avoid any last-minute complications.

If the board determines to proceed under Scenario 3 (Full Abandonment) and elects not to pay the maintenance fee, we request that SBD similarly communicate that decision in writing to the firm no later than February 28, 2025, so that we may update our records and docket accordingly and close out the relevant reminders.

8. Disclaimer / Scope of Representation

This letter is limited in scope to U.S. patent maintenance obligations within the scope of Calderwood & Harkness's engagement for SBD under Matter No. SBD-IP-2021-003. Our representation covers the prosecution and maintenance of the CryoNova patent family before the United States Patent and Trademark Office and does not extend to patent maintenance obligations in any other jurisdiction.

In particular, we note that maintenance or annuity obligations for corresponding foreign filings — including but not limited to the following — fall outside the scope of Calderwood & Harkness's engagement and must be separately confirmed and managed by the respective foreign counsel:

• European Patent Application No. 21 741 632.8, which we understand is being handled by Dunmore & Firth Patent Attorneys, Dublin, Ireland; and

• Japanese Patent Application No. 2023-500714, which we understand is being handled by Takeda & Morioka Patent Office, Tokyo, Japan.

SBD should confirm directly with Dunmore & Firth and Takeda & Morioka that all annuity and renewal obligations for the foregoing foreign applications are current and properly calendared. Calderwood & Harkness bears no responsibility for monitoring or ensuring compliance with foreign patent maintenance deadlines.

Additionally, as noted in Section 4 above, Calderwood & Harkness does not independently monitor or guarantee SBD's entity-size status. The determination of whether the Company qualifies as a small entity under 37 C.F.R. § 1.27 — and the obligation to pay the correct fee amount — remains the responsibility of SBD. While we are pleased to assist SBD in analyzing its entity-size status upon request, the Company is ultimately responsible for ensuring that all representations made to the USPTO regarding its status are accurate and current at the time each fee payment is made.

We trust this letter provides SBD with the information necessary to take timely action on the upcoming maintenance fee obligation. We remain available to discuss the contents of this letter, or any related matters pertaining to the CryoNova patent family, at your convenience. Please do not hesitate to contact me or Peter Vassiliev with any questions.

Very truly yours,

CALDERWOOD & HARKNESS LLP

By: ________

Alan Ngo Partner, intellectual Property Registered Patent Attorney, USPTO Reg. No. 58,412

600 Lexington Avenue, 22nd Floor New York, New York 10022 Tel: (212) 554-7100

Email:ango@calderwoodharkness.com

cc: Dr. Fiona Tierney, CEO & Co-Founder, Solstice Biomedical Devices Ltd.

cc: Marcus Delgado, Billing Partner, Calderwood & Harkness LLP

cc: Peter Vassiliev, Lead Associate, Calderwood & Harkness LLP

Enclosures: Sent under separate cover: Portfolio Strategy Memorandum; Patent Family Status Report & Docket Summary

Maintenance Fee Window	Due Date	Amount (Small Entity)
3.5-year (first maintenance fee)	September 22, 2025	$1,000.00
7.5-year (second maintenance fee)	September 22, 2029	$1,880.00
11.5-year (third maintenance fee)	September 22, 2033	$3,880.00

PRIVILEGED & CONFIDENTIAL
CALDERWOOD & HARKNESS LLP 600 Lexington Avenue, 22nd Floor New York, New York 10022
intellectual Property — Patent Prosecution Practice Group
December 9, 2024
Ronan Gallagher General Counsel & Company Secretary Solstice Biomedical Devices Ltd. Unit 4, Liffey Innovation Campus Parkgate Street Dublin 8, D08 XR29 Ireland
Re: Maintenance Fee Reminder — U.S. Patent No. 11,284,561
Our Matter No.: SBD-IP-2021-003
Patent Title: "Cryoablation Catheter System with Variable-Zone Cooling"
Patent Application No. (Original): U.S. 16/914,337
Issue Date: March 22, 2022
Patent Owner: Solstice Biomedical Devices Ltd.
Dear Ronan:
1. Purpose of This Letter
Calderwood & Harkness LLP is writing in its capacity as outside patent counsel for Solstice Biomedical Devices Ltd. ("SBD" or the "Company") in connection with the CryoNova cryoablation catheter patent family. The purpose of this letter is to advise SBD of the upcoming obligation to pay the first (3.5-year) maintenance fee for U.S. Patent No. 11,284,561 (the "Patent"), which was granted by the United States Patent and Trademark Office ("USPTO") on March 22, 2022.
We are sending this letter well in advance of the statutory deadline to allow sufficient time for board-level consideration and formal authorization, particularly in light of the ongoing portfolio review and strategic assessment currently under discussion between our firm and SBD's management team. As you are aware, the treatment of the Patent is one of several action items arising from the broader portfolio strategy analysis, and we wish to ensure that no maintenance fee deadline is inadvertently missed while the Company deliberates on the appropriate go-forward approach. The details set forth below should provide SBD's leadership with the information necessary to make an informed and timely decision regarding this fee obligation.
2. Maintenance Fee Details — 3.5-Year Fee
U.S. Patent No. 11,284,561 was issued on March 22, 2022, with twenty-four (24) claims directed to a "Cryoablation Catheter System with Variable-Zone Cooling." Under the provisions of 35 U.S.C. § 41(b), the owner of a U.S. utility patent must pay periodic maintenance fees in order to keep the patent in force for the full twenty-year term measured from the earliest effective filing date. The first such maintenance fee is due no later than three and one-half (3.5) years after the date of issuance.
Accordingly, the key dates and amounts applicable to the first maintenance fee for the Patent are as follows:
Statutory Due Date: September 22, 2025
Early Payment Window (No Surcharge): The maintenance fee may be paid without surcharge during the six-month window immediately preceding the due date — that is, beginning on March 22, 2025 and ending on September 22, 2025.
Grace Period (With Surcharge): A six-month grace period following the September 22, 2025 due date is available under 37 C.F.R. § 1.362(e), extending through March 22, 2026. However, payment during this grace period requires the payment of a surcharge in addition to the base maintenance fee. At the current small-entity rate, the grace-period surcharge is $80.00.
Amount Due: The 3.5-year maintenance fee at the small-entity rate, as set forth in 37 C.F.R. § 1.20(e), is $1,000.00. If payment were to be made during the grace period, the total amount due would be $1,080.00 (inclusive of the surcharge).
It is our strong recommendation that the maintenance fee be paid during the early payment window (March 22, 2025 through September 22, 2025) to avoid the need for surcharge payments and to eliminate any risk of inadvertent lapse.
3. Consequence of Non-Payment
Failure to pay the 3.5-year maintenance fee — including during the six-month grace period with the applicable surcharge — will result in the Patent expiring by operation of law under 35 U.S.C. § 41(b). Expiration for non-payment of maintenance fees is automatic and does not require any affirmative action by the USPTO. Once the grace period closes on March 22, 2026, the Patent would be deemed expired and the subject matter of the Patent would pass into the public domain.
Once expired for non-payment of maintenance fees, a patent may be revived only upon the filing of a petition under 37 C.F.R. § 1.378, accompanied by a statement that the delay in payment was "unintentional," together with payment of the outstanding maintenance fee, the applicable surcharge, and a petition fee (currently $1,050.00 at the small-entity rate). We note that the "unintentional" standard, while more lenient than the prior "unavoidable" standard, still requires a genuine showing that the failure to pay was not a deliberate decision to abandon the patent. Moreover, the USPTO retains discretion in evaluating such petitions, and the revival process can involve significant delays and administrative burden. In certain circumstances, intervening rights may also accrue to third parties who relied on the expired status of the Patent during the lapse period, potentially diminishing the enforceability and commercial value of the Patent even if revival is ultimately obtained.
For these reasons, SBD should treat the September 22, 2025 deadline as firm and should plan to authorize payment well in advance of that date. Calderwood & Harkness strongly advises against any course of action that relies upon the grace period or the revival petition process as a fallback.
4. Small-Entity Status Confirmation
SBD currently qualifies as a "small entity" within the meaning of 37 C.F.R. § 1.27 for purposes of paying reduced fees to the USPTO. This status was asserted at the time of filing and has been maintained throughout prosecution and post-issuance maintenance of the Patent.
The basis for SBD's small-entity qualification is as follows:
(a) SBD has fewer than 500 employees. As of December 31, 2023, SBD reported a global headcount of approximately 312 employees across its Dublin headquarters and satellite facilities.
(b) SBD has no obligation to assign, grant, or convey a license or other rights in the Patent to any entity that would not itself qualify as a small entity under 37 C.F.R. § 1.27.
The maintenance fee amounts quoted in this letter reflect the small-entity rate, which is set at fifty percent (50%) of the standard large-entity rate. For reference, the large-entity rate for the 3.5-year maintenance fee is currently $2,000.00; SBD's small-entity rate is $1,000.00.
We note that SBD does not qualify as a "micro entity" under 37 C.F.R. § 1.29, as we understand that the Company's gross income exceeds the applicable threshold established by the USPTO for micro-entity eligibility (currently set at three times the median household income as reported by the U.S. Bureau of the Census). The micro-entity rate would represent a further reduction to twenty-five percent (25%) of the large-entity rate, but this rate is not available to SBD under its current financial profile.
Calderwood & Harkness respectfully requests that SBD promptly notify the firm if its entity-size status changes at any time prior to the payment of maintenance fees — or at any other time during the life of the Patent. Events that could affect SBD's eligibility for small-entity status include, but are not limited to:
(i) the execution of a licensing transaction, joint development agreement, or other arrangement with or for the benefit of an entity that does not qualify as a small entity (e.g., a large multinational corporation);
(ii) an acquisition of SBD by, or merger with, an entity having 500 or more employees;
(iii) an increase in SBD's own employee headcount beyond 500; or
(iv) the grant, assignment, or conveyance of any rights in the Patent to a non-small-entity.
Improperly claiming small-entity status before the USPTO can have serious consequences, including but not limited to the potential unenforceability of the Patent. Accordingly, the accurate maintenance of entity-size determinations is of critical importance, and we ask that SBD treat this obligation with appropriate diligence.
5. Future Maintenance Fee Schedule
For planning and budgeting purposes, we set forth below the full maintenance fee schedule for U.S. Patent No. 11,284,561 at the current small-entity rates as published by the USPTO:
Each of the above fees may be paid without surcharge during the six-month window preceding the stated due date and may be paid with a surcharge during the six-month grace period following the stated due date. The total cost of maintaining the Patent in force through its full statutory term, at the current small-entity rates, is $6,760.00 in maintenance fees alone.
Please note that the USPTO periodically adjusts its fee schedules — typically through rulemaking published in the Federal Register — and the 7.5-year and 11.5-year amounts listed above are current as of calendar year 2024. These amounts may change before the respective fees become due. Calderwood & Harkness monitors fee schedule updates as part of our ongoing docketing and patent management activities, and we will send reminder letters to SBD well in advance of each subsequent maintenance fee window, specifying the then-current amounts due.
6. Relationship to Portfolio Strategy Review
As discussed in the Portfolio Strategy Memorandum transmitted separately to SBD and its board of directors, the go-forward treatment of U.S. Patent No. 11,284,561 is one component of the broader strategic review of SBD's CryoNova patent family. The board's forthcoming decision among the three identified portfolio scenarios will directly determine whether the 3.5-year maintenance fee should be paid:
Scenario 1 — Maintain Full Portfolio: Under this scenario, SBD would pay the 3.5-year maintenance fee and keep the issued Patent in force, alongside continued prosecution of all pending applications in the CryoNova family. This approach preserves the full breadth of SBD's patent protection and maximizes the Company's licensing leverage, including the potential out-licensing opportunities with Helios Surgical Technologies, Inc. or Vantage Cryosurgical Systems, Inc. that Pinnacle Health Ventures has identified as part of the ongoing commercialization assessment. Under Scenario 1, the maintenance fee payment is a straightforward and uncontroversial expenditure.
Scenario 2 — Selective Prosecution: Under this scenario, SBD would pay the 3.5-year maintenance fee for the issued Patent while making selective decisions about the continuation of pending applications and foreign filings, based on a cost-benefit analysis specific to each filing. Maintaining the issued Patent is a centerpiece of Scenario 2, as the Patent provides the strongest and most immediately enforceable protection in the portfolio and anchors the commercial value proposition for prospective licensees, including Helios Surgical Technologies, Inc. and Vantage Cryosurgical Systems, Inc. The maintenance fee payment under this scenario is likewise clearly warranted.
Scenario 3 — Full Abandonment: Under this scenario, SBD would elect not to pay the maintenance fee, allowing the Patent to expire at the 3.5-year window. This scenario would be appropriate only if the board determines that the entire CryoNova patent family has insufficient commercial value to justify even the modest costs of maintenance and that none of the identified licensing or strategic partnering opportunities are likely to materialize.
As set forth in the Portfolio Strategy Memorandum, Calderwood & Harkness's recommendation is Scenario 2 (Selective Prosecution), under which the maintenance fee for U.S. Patent No. 11,284,561 would be paid. We believe this approach strikes the appropriate balance between cost discipline and the preservation of SBD's core intellectual property assets, particularly given the substantial investment that has already been made in obtaining the Patent and the credible licensing opportunities that have been identified.
Regardless of the board's ultimate decision on the broader portfolio strategy, we respectfully request that a timely authorization be provided with respect to the maintenance fee for the Patent. The payment window opens on March 22, 2025, and we wish to ensure that the firm can calendar the payment and execute it in an orderly fashion, without any risk of inadvertent lapse due to administrative delays or scheduling conflicts.
7. Request for Written Authorization
In order for Calderwood & Harkness to proceed with the maintenance fee payment on SBD's behalf, we respectfully request that SBD provide written authorization — whether by email or signed letter on Company letterhead — directing the firm to undertake the following:
1. Pay the 3.5-year maintenance fee of $1,000.00 to the USPTO on behalf of SBD during the payment window commencing March 22, 2025, and no later than the statutory due date of September 22, 2025, in connection with U.S. Patent No. 11,284,561.
2. Invoice SBD for the government fee disbursement of $1,000.00 plus any associated professional fees for the preparation and filing of the maintenance fee payment. We anticipate that the professional fees for this administrative processing will be nominal, consisting primarily of the time required to prepare and submit the electronic fee payment through the USPTO's Patent Maintenance Fees Storefront, verify acceptance, and update our records and docket accordingly. We estimate total professional fees for this task at approximately $350.00–$500.00, exclusive of the government fee itself.
Authorization should be directed to the undersigned, Alan Ngo, at Calderwood & Harkness LLP, at the contact information set forth in the signature block below. Alternatively, authorization may be directed to Peter Vassiliev, Lead Associate on the matter, who can be reached at pvassiliev@calderwoodharkness.com or at (212) 554-7190.
Calderwood & Harkness recommends that SBD provide this authorization no later than February 28, 2025, in order to allow adequate lead time for internal processing, fee payment preparation, and any follow-up communications that may be necessary prior to the opening of the payment window on March 22, 2025. While the statutory deadline is not until September 22, 2025, early authorization will allow us to manage the payment with appropriate care and to avoid any last-minute complications.
If the board determines to proceed under Scenario 3 (Full Abandonment) and elects not to pay the maintenance fee, we request that SBD similarly communicate that decision in writing to the firm no later than February 28, 2025, so that we may update our records and docket accordingly and close out the relevant reminders.
8. Disclaimer / Scope of Representation
This letter is limited in scope to U.S. patent maintenance obligations within the scope of Calderwood & Harkness's engagement for SBD under Matter No. SBD-IP-2021-003. Our representation covers the prosecution and maintenance of the CryoNova patent family before the United States Patent and Trademark Office and does not extend to patent maintenance obligations in any other jurisdiction.
In particular, we note that maintenance or annuity obligations for corresponding foreign filings — including but not limited to the following — fall outside the scope of Calderwood & Harkness's engagement and must be separately confirmed and managed by the respective foreign counsel:
• European Patent Application No. 21 741 632.8, which we understand is being handled by Dunmore & Firth Patent Attorneys, Dublin, Ireland; and
• Japanese Patent Application No. 2023-500714, which we understand is being handled by Takeda & Morioka Patent Office, Tokyo, Japan.
SBD should confirm directly with Dunmore & Firth and Takeda & Morioka that all annuity and renewal obligations for the foregoing foreign applications are current and properly calendared. Calderwood & Harkness bears no responsibility for monitoring or ensuring compliance with foreign patent maintenance deadlines.
Additionally, as noted in Section 4 above, Calderwood & Harkness does not independently monitor or guarantee SBD's entity-size status. The determination of whether the Company qualifies as a small entity under 37 C.F.R. § 1.27 — and the obligation to pay the correct fee amount — remains the responsibility of SBD. While we are pleased to assist SBD in analyzing its entity-size status upon request, the Company is ultimately responsible for ensuring that all representations made to the USPTO regarding its status are accurate and current at the time each fee payment is made.
We trust this letter provides SBD with the information necessary to take timely action on the upcoming maintenance fee obligation. We remain available to discuss the contents of this letter, or any related matters pertaining to the CryoNova patent family, at your convenience. Please do not hesitate to contact me or Peter Vassiliev with any questions.
Very truly yours,
CALDERWOOD & HARKNESS LLP
By: ________
Alan Ngo Partner, intellectual Property Registered Patent Attorney, USPTO Reg. No. 58,412
600 Lexington Avenue, 22nd Floor New York, New York 10022 Tel: (212) 554-7100
Email:ango@calderwoodharkness.com
cc: Dr. Fiona Tierney, CEO & Co-Founder, Solstice Biomedical Devices Ltd.
cc: Marcus Delgado, Billing Partner, Calderwood & Harkness LLP
cc: Peter Vassiliev, Lead Associate, Calderwood & Harkness LLP
Enclosures: Sent under separate cover: Portfolio Strategy Memorandum; Patent Family Status Report & Docket Summary
Maintenance Fee Window | Due Date | Amount (Small Entity)
3.5-year (first maintenance fee) | September 22, 2025 | $1,000.00
7.5-year (second maintenance fee) | September 22, 2029 | $1,880.00
11.5-year (third maintenance fee) | September 22, 2033 | $3,880.00

PRIVILEGED & CONFIDENTIAL

CALDERWOOD & HARKNESS LLP

Record

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Dates

Amounts