Ronan,
I hope this finds you well. Following up on your October 28 email requesting a full portfolio review and go-forward recommendation for the CryoNova patent family, our team has now completed its analysis and I am transmitting the attached materials for the board's consideration. As you know, the docket has been dormant since July 2023 following the board's decision to shelve the CryoNova program, and several time-sensitive deadlines now require attention. I would ask that the board provide instructions to us before year-end so that we can act accordingly and avoid any irreversible losses.
**Attached Documents**
I am enclosing two documents:
1. **Portfolio Strategy Memorandum** — "CryoNova Patent Family — Go-Forward Recommendation" (November 2024). This memorandum provides a detailed analysis of three go-forward scenarios, with cost estimates, risk assessments, and licensing-value considerations for each.
2. **Patent Family Status Report & Docket Summary** — An Excel spreadsheet listing all four U.S. applications (the issued parent patent and three continuation applications), with current status, key deadlines, government fees due, and cross-references to the corresponding European (EP Application No. 21 741 632.8), PCT (PCT/EP2021/067891), and Japanese (JP Application No. 2023-500714) filings. As you know, the EP and JP applications are handled respectively by Dunmore & Firth Patent Attorneys and Takeda & Morioka Patent Office and remain outside the scope of our engagement.
**Current Posture of the Patent Family**
To orient you and the board, here is a brief summary of where each member of the family stands:
**1. SBD-001 (Parent) — U.S. Patent No. 11,284,561** — "Cryoablation Catheter System with Variable-Zone Cooling" Issued March 22, 2022, with 24 claims. The patent is currently in force. The 3.5-year maintenance fee of $1,000 (small-entity rate) is due September 22, 2025. No immediate action required.
**2. SBD-001-CON1 — U.S. Application No. 17/702,489** — "Methods of Cryoablation Using Variable-Zone Cooling Catheter" Filed March 23, 2022, claiming benefit of the parent (U.S. 16/914,337). A Notice of Allowance with an Examiner's Amendment was mailed on April 10, 2023. Unfortunately, the issue fee of $540 (small entity) that was due July 10, 2023 was not paid. This appears to have resulted from an internal docketing lapse when the CryoNova team was reassigned following the FROST-AF trial results and the board's June 8, 2023 shelving decision. The application was deemed abandoned as of July 11, 2023.
The application is revivable via a petition under 37 C.F.R. § 1.137(a) (unintentional delay). Government fees for revival would total $1,590 ($1,050 petition fee + $540 issue fee, both at small-entity rates). We estimate professional fees in the range of $4,500–$6,000 for preparing and filing the petition.
**3. SBD-001-CON2 — U.S. Application No. 17/851,216** — "Cryoablation Catheter with Integrated Impedance Mapping Electrodes" Filed June 27, 2022, claiming benefit of the parent (U.S. 16/914,337). A Non-Final Office Action was mailed on September 15, 2024 by Examiner James R. Dougherty (Art Unit 3794). The rejections are as follows:
- *Claims 1–8* rejected under 35 U.S.C. § 103 (obviousness) over three cited prior-art references: two Vantage Cryosurgical Systems patents (U.S. 10,537,418 and U.S. 9,861,432) and one Helios Surgical Technologies publication (U.S. Pub. No. 2019/0183567). - *Claims 9–14* rejected under 35 U.S.C. § 112(a) (written description) relating to the impedance mapping calibration algorithm. - *Claims 15–20* objected to as depending from rejected base claims but noted as containing allowable subject matter.
**The response deadline is January 15, 2025** (three-month statutory period from mailing). This deadline is extendable up to three additional months — to **April 15, 2025** — with payment of extension fees totaling $1,380 at small-entity rates ($230 for the first month, $460 for the second, and $690 for the third). We estimate professional fees for preparing the Office Action response at $18,000–$25,000.
Importantly, our team believes the § 103 rejection is traversable and that the § 112(a) written description issue can be overcome by pointing to supporting disclosure in the parent specification. A detailed prior-art analysis is currently in preparation.
**4. SBD-001-CON3 — U.S. Application No. 18/109,744** — "Control Unit and Algorithm for Multi-Zone Cryoablation Delivery" Filed February 14, 2023, claiming benefit of the parent (U.S. 16/914,337). The application is pending with no substantive action — it is still awaiting a first Office Action from the USPTO. There is no immediate deadline, but the application remains active.
**Three Board Scenarios — High-Level Summary**
The memorandum analyzes three strategic paths in detail. In brief:
**Scenario 1 — Maintain Full Portfolio.** Respond to the CON-2 Office Action, revive CON-1, maintain CON-3, and pay parent maintenance fees as they come due. This preserves maximum optionality for licensing, a future product restart, or a portfolio sale. Estimated total incremental cost (professional fees + government fees): approximately **$25,470–$34,970**. Best suited if the board anticipates active licensing discussions or a potential restart of development.
**Scenario 2 — Selective Prosecution (Recommended).** Maintain the issued parent patent (U.S. 11,284,561) and prosecute CON-2 (the impedance mapping claims have independent commercial and licensing value distinct from the CryoNova catheter product itself). Allow CON-1 to remain abandoned and CON-3 to go abandoned. Estimated total incremental cost: approximately **$19,380–$26,380**. Notably, the impedance mapping technology covered by CON-2 may have stand-alone licensing value to competitors or to an IP holding/licensing entity such as Helios Surgical Technologies, Inc. I also understand from prior conversations that Pinnacle Health Ventures has expressed interest in exploring out-licensing opportunities, potentially to Helios or even to Vantage Cryosurgical Systems.
**Scenario 3 — Full Abandonment.** Allow all pending applications to go abandoned and let the issued parent patent lapse at the 3.5-year maintenance window (September 22, 2025). Incremental cost: **$0**. This path is appropriate only if SBD has determined the IP has no residual licensing, defensive, or strategic value whatsoever.
Our recommendation, as set forth in the memorandum, is **Scenario 2 (selective prosecution)** as the optimal path balancing cost efficiency with preservation of the most commercially valuable claims. This recommendation takes into account the outcome of the FROST-AF pivotal trial — specifically, the primary efficacy endpoint of 58.2% freedom from atrial arrhythmia at 12 months versus the 65% target (p = 0.14) — and the resulting shelving of the CryoNova product program. The impedance mapping claims in CON-2 retain value independent of the CryoNova product line and, in our view, warrant continued prosecution.
**Immediate Action Items & Timing**
I want to flag five items that require your attention:
**1. Extension of Time for CON-2 (Urgent).** I recommend that we file a three-month extension of time request immediately — even before receiving full board instructions on overall strategy — to extend the CON-2 response deadline from January 15, 2025 to April 15, 2025. The cost is $1,380 in government fees. This is a prudent step that buys the board adequate time to deliberate without any risk of losing the application through inadvertence. **I would appreciate your authorization to file this extension as soon as possible.**
**2. Board Decision on Portfolio Strategy.** I would ask that you present the three scenarios to the SBD board — including Dr. Fiona Tierney and the Pinnacle Health Ventures and Cloverfield Partners board representatives — and provide instructions to us by **no later than mid-December 2024**. This will give our team sufficient lead time to prepare the CON-2 response, the CON-1 petition to revive (if applicable under Scenario 1), and any related filings.
**3. CON-1 Revival Window.** While there is no hard statutory deadline for filing the petition to revive under 37 C.F.R. § 1.137(a), the USPTO requires a showing that the "entire delay" in responding was unintentional, and the longer the delay persists, the more scrutiny the petition may receive. If the board elects to revive CON-1 (under Scenario 1), I would recommend filing sooner rather than later.
**4. Inventor Cooperation.** If the board proceeds with CON-2 prosecution, we anticipate submitting a declaration from **Dr. Aisling Connolly** under 37 C.F.R. § 1.132 to support our patentability arguments, particularly with respect to the § 112(a) written description rejection. Could you please confirm Dr. Connolly's availability and willingness to cooperate? We may also need **Dr. Tomás Brennan** as a declarant. For awareness, I should note that **Dr. Henrik Paulsen** (formerly of SBD, now at Arclight Therapeutics GmbH) is a named co-inventor on the parent and CON-1 but is not a named inventor on CON-2 or CON-3. His cooperation should not be needed for any of the currently contemplated filings, but I wanted to flag this for your records.
**5. Small-Entity Status Confirmation.** Could you please confirm that SBD continues to qualify as a small entity under 37 C.F.R. § 1.27? Specifically, we need confirmation that SBD's employee count remains below 500 and that there is no obligation to assign, grant, or convey any rights in the patent applications to any entity that would not itself qualify as a small entity. Our records show SBD's last confirmed employee count was 312 as of December 31, 2023, and that SBD does not qualify as a micro entity. If there have been any changes — including any new investment, acquisition, or licensing arrangements that might affect entity status — please let us know.
**Fee Estimates & Billing**
Detailed cost estimates for each of the three scenarios are set forth in the attached memorandum. For the record, all prior invoices through July 2023 — totaling $287,450 across the engagement — have been paid in full, with $0 outstanding. Once the board selects a path forward, we will provide a formal fee estimate and, if desired, an updated engagement letter or budget authorization for the reactivated prosecution work. Our current 2024 billing rates are set forth in the memorandum.
**Foreign Filings**
For completeness, I should note that the corresponding European application (EP Application No. 21 741 632.8) and Japanese application (JP Application No. 2023-500714) are being prosecuted respectively by Dunmore & Firth Patent Attorneys (Siobhán Firth) and Takeda & Morioka Patent Office, and remain outside the scope of our engagement. You may wish to conduct a parallel review of those filings with the respective foreign counsel, particularly if the board opts for Scenario 3 (full abandonment), so that a coordinated global decision can be made.
**Next Steps**
We are ready to discuss the memorandum and docket summary by phone or video call at your convenience — please feel free to suggest a time that works for you. We would also be happy to present directly to the SBD board or to Dr. Tierney if that would be helpful in facilitating the decision-making process.
I want to reiterate the importance of receiving instructions in advance of year-end given the January 15, 2025 statutory deadline on CON-2. Filing the extension of time at the earliest opportunity will provide a meaningful cushion, and I would be grateful for your go-ahead on that front as soon as practicable.
Thank you, Ronan. I look forward to hearing from you.
Best regards,
**Alan Ngo** Partner, intellectual Property — Patent Prosecution Calderwood & Harkness LLP 600 Lexington Avenue, 22nd Floor New York, NY 10022 T: (212) 554-7100
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