PRIVILEGED & CONFIDENTIAL — ATTORNEY WORK PRODUCT
MEMORANDUM
CALDERWOOD & HARKNESS LLP 600 Lexington Avenue, 22nd Floor New York, NY 10022
October 30, 2024
TO:
Alan Ngo, Responsible Partner, intellectual Property (Reg. No. 58,412)
Marcus Delgado, Billing Partner, intellectual Property (Reg. No. 51,987)
Wendy Schultz, Working Associate, intellectual Property (Reg. No. 78,115)
Dr. Claire Nakamura, Patent Agent / Of Counsel, Technical Specialist (Reg. No. 66,203)
FROM:
Peter Vassiliev, Lead Associate, intellectual Property (Reg. No. 72,340)
RE:
Reactivation of Dormant Patent Prosecution Docket — Solstice Biomedical Devices Ltd. / CryoNova Patent Family — Matter No. SBD-IP-2021-003
CLIENT:
Solstice Biomedical Devices Ltd. ("SBD"), an Irish private limited company (CRO No. 647832), headquartered at Unit 4, Liffey Innovation Campus, Parkgate Street, Dublin 8, D08 XR29, Ireland
U.S. SUBSIDIARY:
Solstice Biomedical Inc., a Delaware corporation (DE File No. 7291456), 200 Chestnut Ridge Road, Suite 310, Woodcliff Lake, NJ 07677
CLIENT CONTACT:
Ronan Gallagher, General Counsel & Company Secretary, Solstice Biomedical Devices Ltd.
I. Purpose and Background
This memorandum serves to formally document the reactivation of dormant Matter No. SBD-IP-2021-003 and to coordinate immediate work assignments and deadlines among the Calderwood & Harkness IP prosecution team following a client request for a full portfolio review and go-forward recommendation for the CryoNova cryoablation catheter patent family.
On October 28, 2024, Ronan Gallagher, General Counsel and Company Secretary of Solstice Biomedical Devices Ltd., emailed Alan Ngo requesting that the firm reactivate the CryoNova patent prosecution docket, conduct a comprehensive review of the current status and value of the existing U.S. patent portfolio, and prepare a recommendation that the SBD board of directors can use to determine the appropriate go-forward strategy. This memorandum is being circulated to the team to ensure that all members understand the current posture of each application, the applicable deadlines, the open risks, and their respective assignments.
The engagement was originally opened on October 5, 2021, to cover U.S. patent prosecution for continuation applications claiming the benefit of the parent application, U.S. Application No. 16/914,337, which relates to SBD's CryoNova cryoablation catheter system with variable-zone cooling technology. At its peak, the matter involved the prosecution of four U.S. applications — a parent and three continuations — as well as coordination with SBD's European and Japanese foreign counsel.
The docket has been dormant since July 3, 2023, when I filed a two-month extension of time in CON-2 (U.S. Application No. 17/851,216) in response to a restriction requirement. No prosecution activity has occurred on any member of the patent family since that date.
The primary reason for the dormancy was SBD's decision to shelve the CryoNova product program. On May 17, 2023, SBD publicly announced the failure of the FROST-AF pivotal IDE trial (IDE No. G210047), a multicenter, prospective, randomized controlled trial involving 220 patients. The trial failed to meet its primary efficacy endpoint of freedom from atrial arrhythmia at twelve months: the study arm achieved a freedom-from-arrhythmia rate of 58.2%, falling short of the pre-specified target of 65% (p=0.14). Following the announcement, and after an internal strategic review, SBD's management formally shelved the CryoNova product program on June 8, 2023. The CryoNova development team was reassigned to other programs, and patent prosecution activities were deprioritized. Unfortunately, as discussed further in Section II.B below, this reorganization contributed to a docketing lapse that resulted in the unintentional abandonment of one of the continuation applications.
SBD's board of directors, which includes representatives of the company's lead investors — Pinnacle Health Ventures (holding approximately 34% of SBD's equity) and Cloverfield Partners (holding approximately 22% of SBD's equity) — is now actively considering three go-forward scenarios for the CryoNova patent portfolio:
Scenario 1 — Maintain Full Portfolio: Revive the abandoned CON-1 application, prosecute the pending CON-2 and CON-3 applications to issuance, and maintain the issued parent patent.
Scenario 2 — Selective Prosecution: Maintain the parent patent and the pending CON-2 application (which covers the commercially most valuable claims relating to integrated impedance mapping electrodes) while allowing CON-1 to remain abandoned and taking no proactive steps on CON-3.
Scenario 3 — Full Abandonment: Abandon the entire U.S. portfolio, including allowing the parent patent to lapse by nonpayment of maintenance fees.
In connection with its evaluation of these scenarios, Pinnacle Health Ventures has expressed interest in the potential out-licensing of the CryoNova intellectual property. Two potential licensees have been identified: Helios Surgical Technologies, Inc. (750 Bering Drive, Suite 400, Houston, TX 77057; CEO Martin Cheswick) and Vantage Cryosurgical Systems, Inc. (1420 Gateway Boulevard, South San Francisco, CA 94080; CEO Gerald "Gerry" Whitford). The involvement of Vantage as a potential licensee is particularly noteworthy given that Vantage is the assignee of two of the three prior-art references cited in the pending CON-2 office action, as discussed in detail below.
Alan Ngo is preparing a confidential Portfolio Strategy Memorandum for Ronan Gallagher that will analyze each scenario, provide cost estimates, and assess the licensing value of the portfolio under each path. This internal memorandum coordinates the team's immediate work assignments and deadlines in support of that effort and in connection with the time-sensitive prosecution obligations that must be addressed irrespective of the board's ultimate decision.
II. Patent Family Summary
The CryoNova patent family presently consists of four U.S. applications. A summary of each application, its current status, and the next required action is set forth below. The team should use this section as a reference when performing the task assignments described in Section IV.
A. SBD-001 (Parent) — U.S. Application No. 16/914,337
Filed: June 28, 2021
Title: "Cryoablation Catheter System with Variable-Zone Cooling"
Status: Issued as U.S. Patent No. 11,284,561 on March 22, 2022 (24 claims)
Named Inventors: Dr. Aisling Connolly, Dr. Tomás Brennan, Dr. Henrik Paulsen
Examiner: James R. Dougherty, Art Unit 3794
Prosecution History Summary: The parent application was filed with 24 original claims directed to a cryoablation catheter system featuring a multi-zone cooling architecture capable of independently modulating cryogenic delivery across discrete longitudinal segments of the catheter tip. The application received a single non-final office action, to which the firm filed a response with minor claim amendments. A notice of allowance was issued thereafter, and the patent issued with all 24 claims on March 22, 2022.
Next Action: The 3.5-year maintenance fee of $1,000 (small entity) is due September 22, 2025. A six-month grace period is available upon payment of a surcharge, but timely payment is recommended. No other action is currently required.
B. SBD-001-CON1 — U.S. Application No. 17/702,489
Filed: March 23, 2022 (the day after the parent patent issued)
Title: "Methods of Cryoablation Using Variable-Zone Cooling Catheter"
Claims Benefit of: U.S. Application No. 16/914,337
Named Inventors: Dr. Aisling Connolly, Dr. Tomás Brennan, Dr. Henrik Paulsen
Status: Abandoned — An Examiner's Amendment and Notice of Allowance was mailed on April 10, 2023. The issue fee of $540 (small entity) was due on or before July 10, 2023. The issue fee was not paid, and the application was deemed abandoned as of July 11, 2023.
Cause of Abandonment: The abandonment was the result of an internal docketing lapse at SBD. When the CryoNova product program was shelved on June 8, 2023, the members of the CryoNova development team — including the in-house patent coordinator who was responsible for forwarding USPTO correspondence and authorizing fee payments — were reassigned to other product lines. The issue fee deadline for CON-1 fell on July 10, 2023, approximately one month after the program was shelved. The client did not forward instructions or authorization to pay the issue fee, and the firm's own follow-up communications (sent June 15 and June 28, 2023) went unanswered. By the time the docket was flagged for review in mid-July 2023, the deadline had passed.
Remedy: A petition to revive the application may be filed under 37 C.F.R. § 1.137(a) based on unintentional delay. The petition must be accompanied by (i) a statement that the entire delay in filing the required reply from the due date for the reply until the filing of a grantable petition was unintentional, (ii) the required issue fee of $540 (small entity), and (iii) the petition fee of $1,050 (small entity). There is no statutory deadline for filing a petition under § 1.137(a); however, practitioners and USPTO guidance consistently recommend that such petitions be filed as soon as practicable. Longer delays increase the potential for USPTO scrutiny of the "unintentional" characterization, and any intervening rights issues may become more complex with the passage of time.
Additional Note: Dr. Henrik Paulsen is a named co-inventor on this application. Dr. Paulsen departed SBD in July 2022 and is now employed by Arclight Therapeutics GmbH in Germany. If CON-1 is revived, the team should confirm that all assignment records are current and in order, and that no inventor cooperation issues exist with respect to Dr. Paulsen. See Section VIII.B below for additional discussion.
C. SBD-001-CON2 — U.S. Application No. 17/851,216
Filed: June 27, 2022
Title: "Cryoablation Catheter with Integrated Impedance Mapping Electrodes"
Claims Benefit of: U.S. Application No. 16/914,337
Named Inventors: Dr. Aisling Connolly, Dr. Tomás Brennan
Examiner: James R. Dougherty, Art Unit 3794; Supervisory Patent Examiner Linda M. Kowalski
Status: Pending — A Non-Final Office Action was mailed on September 15, 2024.
Claims Pending: 20
Rejections and Objections:
The Non-Final Office Action contains the following substantive rejections and objections:
(i) Claims 1–8 — Rejected under 35 U.S.C. § 103 as allegedly obvious over U.S. Patent No. 10,537,418 ("Whitford et al.," assigned to Vantage Cryosurgical Systems, Inc.) in view of U.S. Patent No. 9,861,432 ("Chen et al.," also assigned to Vantage Cryosurgical Systems, Inc.) and U.S. Publication No. 2019/0183567 ("Cheswick et al.," assigned to Helios Surgical Technologies, Inc.). The Examiner's position is that the combination of these three references renders obvious the claimed combination of variable-zone cryoablation with integrated impedance mapping functionality.
(ii) Claims 9–14 — Rejected under 35 U.S.C. § 112(a) for lack of written description. The Examiner asserts that the specification does not provide adequate written-description support for the impedance mapping calibration algorithm recited in Claims 9–14. Specifically, the Examiner contends that the specification describes the algorithm only at a high level of generality and does not disclose the particular calibration parameters and feedback loop mechanisms recited in the dependent claims.
(iii) Claims 15–20 — Objected to as being dependent upon a rejected base claim but indicated as containing allowable subject matter. The Examiner has stated that Claims 15–20, which are directed to a specific electrode array configuration with per-zone impedance thresholding, would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response Deadline: The statutory three-month response deadline is January 15, 2025 (three months from the September 15, 2024 mailing date of the Non-Final Office Action).
Maximum Extended Deadline: The response deadline may be extended to April 15, 2025 by filing three successive one-month extensions of time under 37 C.F.R. § 1.136(a). The cumulative extension fees (small entity) are $230 (first month) + $460 (second month) + $690 (third month) = $1,380 total.
This application represents the highest-priority item on the reactivated docket. CON-2 covers what is widely regarded as the most commercially valuable aspect of the CryoNova technology — the integration of impedance mapping electrodes with the variable-zone cryoablation catheter — and the claims indicated as containing allowable subject matter (Claims 15–20) present a clear path to issuance. A well-crafted response has a reasonable probability of securing allowance of a meaningful claim set.
D. SBD-001-CON3 — U.S. Application No. 18/109,744
Filed: February 14, 2023
Title: "Control Unit and Algorithm for Multi-Zone Cryoablation Delivery"
Claims Benefit of: U.S. Application No. 16/914,337
Named Inventors: Dr. Aisling Connolly, Dr. Tomás Brennan
Status: Pending — No substantive action has been taken by the USPTO. The application is awaiting its first Office Action.
Next Action: No immediate deadline is pending. The application should be docketed for ongoing monitoring. Given the current backlog in Art Unit 3794, the timeframe for receipt of a first Office Action is uncertain, though historical data for this art unit suggests an average first-action pendency of approximately 18–24 months from the filing date, which would place the expected first action window between August 2024 and February 2025. It is possible that a first Office Action may issue at any time.
This application covers the software and control-unit aspects of the CryoNova system. While less commercially critical than CON-2 in the context of a catheter-focused licensing strategy, the control-unit claims may have independent value depending on the scope of any licensing arrangement and the potential licensee's existing control-unit technology.
E. Corresponding Foreign Filings (For Reference / Coordination Only)
For completeness, the team should be aware of the following corresponding foreign filings. These filings are not within the scope of Calderwood & Harkness's representation, but coordination with foreign counsel may be necessary to ensure consistency of claim scope and prosecution positions across jurisdictions.
European Patent Application No. 21 741 632.8 — Entered the European regional phase in January 2023 via PCT/EP2021/067891 (filed June 28, 2021). Prosecution is handled by Dunmore & Firth Patent Attorneys, with Siobhán Firth as the lead practitioner. Dunmore & Firth's address is 15 Fitzwilliam Square East, Dublin 2, D02 CR18, Ireland.
Japanese Patent Application No. 2023-500714 — Prosecution is handled by Takeda & Morioka Patent Office in Tokyo.
Neither the European nor the Japanese prosecution falls within our scope of engagement. However, when preparing the CON-2 Office Action response and any amendments, the team should coordinate with Dunmore & Firth to ensure that any claim amendments made in the U.S. prosecution do not create inconsistencies with the claims being prosecuted in Europe, and to avoid any arguments that might be used against the European claims by the EPO or by third-party opponents.
III. Critical Deadlines — Reactivated Docket Calendar
This section identifies and prioritizes the critical deadlines that must be managed in connection with the reactivated docket. The team should treat the dates listed below as firm calendar entries, subject to adjustment only upon documented client instruction.
A. Immediate Deadline: CON-2 Office Action Response (U.S. 17/851,216)
The most pressing deadline on the reactivated docket is the response to the Non-Final Office Action mailed September 15, 2024, in CON-2.
Statutory Deadline: January 15, 2025 (three months from the September 15, 2024 mailing date)
Maximum Extended Deadline: April 15, 2025, available under 37 C.F.R. § 1.136(a) upon payment of cumulative extension fees of $1,380 (small entity)
Recommended Course of Action: I recommend that the team file a request for a three-month extension of time immediately — that is, no later than November 15, 2024 — to preserve the April 15, 2025 extended deadline. This will provide adequate time for the team to complete the prior-art analysis, prepare claim amendments, draft a Rule 132 declaration from Dr. Connolly, circulate the response to the client for review and comment, and incorporate any feedback before filing. Filing the extension request well in advance of the statutory deadline also eliminates any risk of an inadvertent lapse.
It is important to note that while the extension of time may be filed at any time before April 15, 2025, the extension must be filed no later than January 15, 2025 to avoid a gap in the response period. An extension filed after the statutory deadline but before the end of the extension period is permissible under § 1.136(a), but best practice dictates early filing to preserve the full window.
B. Near-Term Priority: CON-1 Petition to Revive (U.S. 17/702,489)
There is no statutory deadline for filing a petition to revive under 37 C.F.R. § 1.137(a). The petition may be filed at any time so long as the entire delay in filing was unintentional. However, it is well established in practice that the longer the delay between abandonment and the filing of the petition, the greater the likelihood that the USPTO may inquire into the circumstances surrounding the characterization of the delay as "unintentional." While the current delay (approximately 15 months as of the date of this memorandum) is not unusually long, it is advisable to file the petition as soon as practicable after receiving client authorization.
I recommend that Wendy Schultz prepare the draft petition by November 30, 2024, and hold it in final form pending receipt of instructions from SBD's board. If the board selects Scenario 1 (maintain full portfolio), the petition should be filed promptly upon receipt of authorization. If the board selects Scenario 2 (selective prosecution), this task will be cancelled and CON-1 will remain abandoned.
Important Coordination Issue: Dr. Henrik Paulsen, who is now employed by Arclight Therapeutics GmbH in Germany, is a named co-inventor on CON-1. Before filing the petition to revive, the team should confirm with Ronan Gallagher that SBD possesses executed assignment documents from Dr. Paulsen covering the CON-1 application and that no inventor cooperation issues exist. This is discussed further in Section VIII.B.
C. Medium-Term: Parent Maintenance Fee (U.S. Patent No. 11,284,561)
The 3.5-year maintenance fee for the issued parent patent, U.S. Patent No. 11,284,561, is due on September 22, 2025. The fee amount is $1,000 at the small-entity rate. A six-month grace period is available through March 22, 2026, upon payment of an additional surcharge, but timely payment is strongly recommended to avoid any risk of inadvertent lapse.
This maintenance fee obligation exists regardless of which go-forward scenario the board selects under Scenarios 1 or 2. Only under Scenario 3 (full abandonment) would SBD elect not to pay this fee. Accordingly, a formal maintenance fee reminder letter should be transmitted to Ronan Gallagher in connection with the portfolio strategy memorandum, requesting authorization and instructions for payment.
D. Monitoring: CON-3 First Office Action (U.S. 18/109,744)
U.S. Application No. 18/109,744 (CON-3) is pending and awaiting its first Office Action. No deadline is currently pending for this application. The application should be docketed for regular monitoring via the USPTO's Patent Center system. Given the typical backlog in Art Unit 3794, the team should be prepared to receive a first Office Action at any time. When a first Office Action issues, the team will need to promptly notify the client and seek instructions regarding prosecution strategy.
IV. Task Assignments
The following task assignments are designed to ensure that all time-sensitive prosecution obligations are met and that the team is prepared to support Alan Ngo's Portfolio Strategy Memorandum. Each task includes the assigned team member(s), a description of the work to be performed, the target completion date, and any relevant notes or prerequisites.
A. Extension of Time Request — CON-2 (U.S. 17/851,216)
Assigned to: Wendy Schultz
Task: Draft, finalize, and file a request for a three-month extension of time under 37 C.F.R. § 1.136(a) to extend the response deadline for the Non-Final Office Action in CON-2 from January 15, 2025, to April 15, 2025. Prepare the accompanying fee transmittal for the cumulative extension fees of $1,380 (small entity), comprising $230 for the first month, $460 for the second month, and $690 for the third month.
Target Completion: File via the USPTO Patent Center electronic filing system by November 15, 2024. This filing date is well ahead of the statutory deadline of January 15, 2025, and ensures that the extended deadline is preserved with ample margin.
Review: Peter Vassiliev will review the request and fee transmittal before filing.
Note: This extension of time should be filed proactively regardless of the board's pending decision on the go-forward scenario. The cost is modest ($1,380 in government fees plus minimal professional time), and the extension preserves full optionality for the client. If the board ultimately selects Scenario 3 (full abandonment), the extension fees will have been expended, but the downside of failing to extend — a potential loss of the ability to respond to the office action — far outweighs this cost.
B. Prior-Art Analysis Memorandum — CON-2 Office Action
Assigned to: Peter Vassiliev (lead) and Dr. Claire Nakamura (technical analysis)
Task: Prepare a detailed internal memorandum analyzing Examiner Dougherty's rejections and objections in the CON-2 Non-Final Office Action. The memorandum should address the following:
(i) Section 103 Analysis (Claims 1–8): Map Claims 1–8, element by element, against the three cited prior-art references — U.S. Patent No. 10,537,418 ("Whitford et al.," assigned to Vantage Cryosurgical Systems, Inc.), U.S. Patent No. 9,861,432 ("Chen et al.," also assigned to Vantage Cryosurgical Systems, Inc.), and U.S. Publication No. 2019/0183567 ("Cheswick et al.," assigned to Helios Surgical Technologies, Inc.). Identify the specific limitations that the Examiner contends are disclosed or suggested by each reference, identify gaps in the Examiner's mapping, and assess the strength of potential arguments for non-obviousness. In particular, Dr. Nakamura should evaluate the technical distinctions between CryoNova's multi-zone variable cooling with integrated impedance mapping and Vantage's single-zone balloon cryoablation design, and whether the cited combination provides a reasonable motivation to combine with a reasonable expectation of success.
(ii) Section 112(a) Analysis (Claims 9–14): Analyze the written-description rejection for Claims 9–14 with respect to the impedance mapping calibration algorithm. Identify specific disclosure in the parent specification (U.S. Patent No. 11,284,561) and the CON-2 specification that supports the algorithm limitations recited in Claims 9–14. Assess whether additional disclosure from SBD's internal technical documentation could be referenced in a Rule 132 declaration to bolster the written-description argument.
(iii) Claims 15–20 Strategy: Evaluate the Examiner's indication that Claims 15–20 contain allowable subject matter and assess the strategy of rewriting these claims in independent form. Consider whether the independent claims should be rewritten to incorporate all limitations of the base claim and intervening claims, or whether a more streamlined approach is available. Also assess whether additional dependent claims should be added to further strengthen the scope of protection around the allowable subject matter.
Potential Third-Party Search: Consider engaging Caravel Prior Art Services LLC (contact: Daniel Yoon, 8500 Leesburg Pike, Suite 700, Tysons, VA 22182) for an updated prior-art landscape search if the team determines that additional prior art may be needed to support arguments of distinction or if an understanding of the broader prior-art landscape would assist in claim drafting. The estimated cost of an updated Caravel search is $5,000–$8,000, and the decision to commission such a search should be made by Peter Vassiliev and Dr. Nakamura after initial review of the cited references, with Alan Ngo's approval.
Target Completion: Draft memorandum to be circulated to the team by December 15, 2024.
C. Draft Office Action Response — CON-2
Assigned to: Peter Vassiliev (drafting), Dr. Claire Nakamura (technical review), and Wendy Schultz (claim amendment comparison chart)
Task: Prepare a complete draft response to the CON-2 Non-Final Office Action, including:
(a) Amended claims, incorporating any narrowing amendments necessary to overcome the § 103 rejection while preserving commercially meaningful claim scope;
(b) Remarks section traversing the § 103 rejection of Claims 1–8, arguing non-obviousness based on the distinctions identified in the prior-art analysis memorandum;
(c) Arguments overcoming the § 112(a) written-description rejection of Claims 9–14, with citations to supporting disclosure in the specification and, if applicable, the Rule 132 declaration;
(d) A request that Claims 15–20 be allowed in independent form, with rewritten independent claims; and
(e) A claim amendment comparison chart (clean and marked-up versions) to be prepared by Wendy Schultz.
Target Completion:
• First draft: January 15, 2025
• Final draft for client review: February 15, 2025
• Filing target: March 15, 2025 (one month ahead of the extended deadline of April 15, 2025, to provide a buffer for any last-minute revisions or client comments)
Note: If the prior-art analysis reveals that an examiner interview would be productive, Peter Vassiliev should schedule an interview with Examiner Dougherty (and/or Supervisory Patent Examiner Kowalski) prior to filing the response. An examiner interview can be an efficient way to clarify the Examiner's position and narrow the issues in dispute. Any such interview should be attended by Peter Vassiliev and Dr. Nakamura.
D. Draft Declaration of Dr. Aisling Connolly Under 37 C.F.R. § 1.132
Assigned to: Peter Vassiliev (drafting); Dr. Claire Nakamura (technical input)
Task: Prepare a Rule 132 inventor declaration to accompany the CON-2 Office Action response. The declaration should be executed by Dr. Aisling Connolly, Vice President of Research and Development at SBD, in her capacity as a named inventor on CON-2. The declaration should address the following:
(a) Factual distinction of the CryoNova variable-zone cooling catheter with integrated impedance mapping electrodes from Vantage's single-zone balloon cryoablation design, including technical details regarding the independent modulation capability and the integration of impedance feedback into the cryoablation delivery algorithm;
(b) Factual support for the written-description basis of the impedance mapping calibration algorithm recited in Claims 9–14, including a description of the development process, the calibration parameters, and the feedback loop mechanisms, with specific citations to the corresponding disclosure in the filed specification; and
(c) Any additional factual statements that would support the patentability of the pending claims over the cited prior art.
Coordination: The declaration will require review and execution by Dr. Aisling Connolly. All communications with Dr. Connolly should be coordinated through Ronan Gallagher. Peter Vassiliev should transmit the draft declaration to Ronan Gallagher with a request to schedule a call with Dr. Connolly to discuss the substance of the declaration and make any necessary revisions before execution.
Target Completion: Draft to be ready by January 31, 2025, to allow adequate time for client review, revision, and execution before the filing target of March 15, 2025.
E. Petition to Revive — CON-1 (U.S. 17/702,489)
Assigned to: Wendy Schultz (drafting); Peter Vassiliev (review)
Task: Draft a petition to revive the abandoned CON-1 application under 37 C.F.R. § 1.137(a) for unintentional delay. The petition should include the following:
(a) A clear and accurate statement of facts, setting forth the following chronology:
• Notice of Allowance and Examiner's Amendment mailed April 10, 2023;
• Issue fee of $540 (small entity) due July 10, 2023;
• SBD shelved the CryoNova product program on June 8, 2023, following the failure of the FROST-AF pivotal IDE trial;
• In-house patent coordination staff reassigned; issue fee deadline missed due to internal docketing lapse;
• Application deemed abandoned as of July 11, 2023;
• Entire delay in filing the required reply (from the due date of July 10, 2023, to the date of filing the petition) was unintentional.
(b) A signed statement, on behalf of the applicant, that the entire delay in filing the required reply from the due date for the reply until the filing of a grantable petition under 37 C.F.R. § 1.137 was unintentional.
(c) The required fee transmittal, as follows:
• Petition fee: $1,050 (small entity)
• Issue fee: $540 (small entity)
• Total government fees: $1,590
Prerequisite: This task requires client authorization before the petition can be filed. The board's decision on the go-forward scenario is pending, and the revival of CON-1 is relevant only under Scenario 1 (maintain full portfolio). If the board selects Scenario 2 (selective prosecution) or Scenario 3 (full abandonment), this task will be cancelled and CON-1 will remain abandoned.
Target Completion: Draft to be ready by November 30, 2024, and held in final form pending receipt of client instructions. Filing will occur promptly upon receipt of authorization from the client.
F. Portfolio Strategy Memorandum
Assigned to: Alan Ngo (lead author); Peter Vassiliev (supporting analysis and cost estimates)
Task: Prepare a confidential Portfolio Strategy Memorandum addressed to Ronan Gallagher, analyzing the three board scenarios (maintain full portfolio, selective prosecution, and full abandonment) and providing, for each scenario:
• A summary of the applications and patents that would be maintained, prosecuted, revived, or abandoned;
• Estimated costs (professional fees and government fees) over the relevant prosecution horizon;
• An assessment of the commercial and licensing value of the portfolio under each scenario, with particular attention to the potential interest from Helios Surgical Technologies, Inc. and Vantage Cryosurgical Systems, Inc.;
• Risk factors, including the competitor awareness issues discussed in Section VIII.D and the Dr. Paulsen coordination issue discussed in Section VIII.B; and
• A recommendation as to the preferred course of action, supported by the analysis.
Target Completion: Transmit to client before year-end, with a target delivery date in late November 2024.
G. Maintenance Fee Reminder Letter
Assigned to: Wendy Schultz
Task: Prepare a formal letter addressed to Ronan Gallagher advising of the upcoming 3.5-year maintenance fee for U.S. Patent No. 11,284,561. The letter should state the fee amount ($1,000, small entity), the due date (September 22, 2025), the availability of the six-month grace period with surcharge, and a request for authorization and instructions to proceed with payment. The letter should also note the importance of timely payment to avoid any risk of patent lapse.
Target Completion: Include with the portfolio strategy memorandum transmittal package in late November 2024.
V. Entity-Size Confirmation
All government fee calculations in this memorandum are based on small-entity rates. The team should be aware of the following with respect to SBD's entity-size qualification:
Small Entity Status. SBD qualifies as a small entity under 37 C.F.R. § 1.27. As of December 31, 2023, SBD had 312 employees globally, which is fewer than the 500-employee threshold for small-entity status. Additionally, SBD does not have any licensing obligation to a large entity that would disqualify it from claiming small-entity status under the applicable regulations.
Micro Entity Status. SBD does not qualify as a micro entity under 37 C.F.R. § 1.29. Although SBD meets the employee-count threshold, its gross income exceeds the micro-entity income threshold. Specifically, SBD reported fiscal year 2023 annual revenue of €74.3 million from its other product lines (unrelated to CryoNova), which exceeds the applicable gross income limit for micro-entity qualification.
Reconfirmation Requirement. The team should reconfirm SBD's small-entity status with Ronan Gallagher before filing any papers with the USPTO, particularly in light of the potential licensing discussions with Vantage Cryosurgical Systems, Inc. and Helios Surgical Technologies, Inc. If SBD enters into a licensing agreement with Vantage (which is a large entity) or Helios, SBD may need to reassess its small-entity eligibility depending on the terms of any such license. Under 37 C.F.R. § 1.27(a)(2), a small-business concern loses small-entity status if it has assigned, granted, conveyed, or is under an obligation to assign, grant, or convey a license or other rights in the subject application or patent to any person, concern, or organization that does not qualify as a small entity. The team should monitor this issue closely and advise the client accordingly as licensing discussions progress.
VI. Budget Estimates
The following budget estimates cover the anticipated professional fees, government fees, and related costs for the prosecution activities identified in this memorandum. All professional fee estimates are based on the firm's 2024 standard hourly rates for the assigned timekeepers. All government fee estimates are based on small-entity rates.
A. CON-2 Office Action Response (U.S. 17/851,216)
Professional Fees: $18,000–$25,000 (estimated)
Breakdown by timekeeper (estimated hours at 2024 rates):
Note: The above range has been rounded to $18,000–$25,000 to account for potential efficiencies and to provide a reasonable estimate for client budgeting purposes. Marcus Delgado's involvement ($875/hr) will be limited to billing oversight; no substantive hours are anticipated, and his time will not be billed to the matter.
Government Fees: $1,380 (three-month extension of time: $230 + $460 + $690, small entity)
Subtotal (CON-2): $19,380–$26,380
B. CON-1 Petition to Revive (U.S. 17/702,489)
Professional Fees: $4,500–$6,000 (estimated)
Note: The above range has been rounded to $4,500–$6,000 for budgeting purposes.
Government Fees: $1,590 ($1,050 petition fee + $540 issue fee, small entity)
Subtotal (CON-1): $6,090–$7,590
C. Parent Maintenance Fee (U.S. Patent No. 11,284,561)
Government Fee: $1,000 (3.5-year maintenance fee, small entity, due September 22, 2025)
Professional Fees: Nominal — preparation and filing of the maintenance fee payment will be included in general docket management and is not expected to generate separately billable time.
D. Additional Potential Costs
The following additional costs may be incurred depending on prosecution strategy decisions:
Caravel Prior Art Services LLC Updated Search: If commissioned, the estimated cost of an updated prior-art landscape search is $5,000–$8,000. The decision to commission this search will be made after the prior-art analysis memorandum is completed and the team has assessed whether additional prior art is needed to support arguments of distinction.
Examiner Interview (CON-2): If the team determines that an examiner interview with Examiner Dougherty would be productive, the interview and related preparation would add approximately 2–3 hours of attorney time (Peter Vassiliev at $625/hr, and potentially Dr. Nakamura at $475/hr), for an estimated additional cost of $1,250–$1,875.
E. Aggregate Budget Summary
The following table summarizes the estimated aggregate costs under each of the three board scenarios:
Note: The Scenario 1 and Scenario 2 estimates do not include the cost of prosecuting CON-3 (U.S. 18/109,744) following receipt of a first Office Action, as the timing and substance of that action are uncertain. Those costs will be estimated when a first Office Action is received. The portfolio strategy memorandum will include broader, longer-horizon cost projections as appropriate.
VII. Financial Summary — Matter to Date
For reference and to assist with the portfolio strategy memorandum, the following is a summary of all fees and costs billed to Matter No. SBD-IP-2021-003 from the engagement opening through the last billing entry:
Total Fees Billed (October 2021 – July 2023): $287,450
Reconciliation: $214,600 + $38,350 + $22,500 + $12,000 = $287,450
Outstanding Accounts Receivable: $0. All invoices issued through July 2023 have been paid in full. There are no outstanding balances or disputed charges.
Reactivation Billing: No new time or costs have been billed to this matter since July 2023. Reactivation billing will commence with the October 2024 work described in this memorandum. All timekeepers should ensure that their time-entry records are current and that all time expended on this matter from October 28, 2024 forward is properly recorded under Matter No. SBD-IP-2021-003.
VIII. Open Items and Risk Flags
The following items require attention from the team and/or resolution with the client. Each is flagged here to ensure that no issue is overlooked as the docket is reactivated.
A. Client Authorization Pending