[sheet: Docket Summary]

[sheet: Docket Summary]
Docket No. | Application No. | Patent No. | Filing Date | Title | Named Inventors | Examiner / Art Unit | Entity Size | Current Status | Claims Pending / Issued | Next Deadline | Deadline Description | Government Fees Due | Fee Description | Priority / Benefit Claim | Corresponding Foreign Filings | Foreign Filing Counsel | Notes
SBD-001 (Parent) | U.S. 16/914,337 | U.S. 11,284,561 | 2021-06-28 | Cryoablation Catheter System with Variable-Zone Cooling | Dr. Aisling Connolly; Dr. Tomás Brennan; Dr. Henrik Paulsen | James R. Dougherty / Art Unit 3794 | Small Entity (37 C.F.R. § 1.27) | ISSUED — 24 claims; issued March 22, 2022 | 24 claims issued | 2025-09-22 | 3.5-year maintenance fee due | $1,000 | 3.5-year maintenance fee (small entity) | Original filing | EP 21 741 632.8 (via PCT/EP2021/067891); JP 2023-500714 | Dunmore & Firth Patent Attorneys (EP/PCT — Siobhán Firth); Takeda & Morioka Patent Office (JP) | Patent in force. Next maintenance fees: 7.5-yr $1,880; 11.5-yr $3,880 (small entity rates). Failure to pay 3.5-yr fee by Sept. 22, 2025 will result in expiration.
SBD-001-CON1 | U.S. 17/702,489 | N/A — not yet issued | 2022-03-23 | Methods of Cryoablation Using Variable-Zone Cooling Catheter | Dr. Aisling Connolly; Dr. Tomás Brennan; Dr. Henrik Paulsen | James R. Dougherty / Art Unit 3794 | Small Entity (37 C.F.R. § 1.27) | ABANDONED — Issue fee not paid by July 10, 2023; deemed abandoned July 11, 2023. Eligible for petition to revive under 37 C.F.R. § 1.137(a) (unintentional delay). | Claims allowed under Examiner's Amendment (Notice of Allowance mailed April 10, 2023) | N/A (no statutory deadline; petition to revive recommended ASAP) | Petition to revive required to restore application | $1,590 | Petition fee $1,050 + Issue fee $540 (small entity) | Claims benefit of U.S. 16/914,337 (filed 2021-06-28) | N/A — U.S. continuation only | N/A | Abandonment was unintentional — caused by internal docketing lapse at SBD when CryoNova team was reassigned following FROST-AF trial failure (announced May 17, 2023) and Board decision to shelve program (June 8, 2023). Estimated professional fees for revival: $4,500–$6,000.
SBD-001-CON2 | U.S. 17/851,216 | N/A — pending | 2022-06-27 | Cryoablation Catheter with Integrated Impedance Mapping Electrodes | Dr. Aisling Connolly; Dr. Tomás Brennan | James R. Dougherty / Art Unit 3794 | Small Entity (37 C.F.R. § 1.27) | PENDING — Non-Final Office Action mailed September 15, 2024. Claims 1–8 rejected under § 103; Claims 9–14 rejected under § 112(a); Claims 15–20 objected to (allowable subject matter in dependent form). | 20 claims pending | 2025-01-15 | Response to Non-Final Office Action due (3-month statutory deadline); extendable to April 15, 2025 with 3 one-month extensions | $1,380 | Maximum extension fees: $230 (1st mo.) + $460 (2nd mo.) + $690 (3rd mo.) = $1,380 (small entity) | Claims benefit of U.S. 16/914,337 (filed 2021-06-28) | N/A — U.S. continuation only | N/A | § 103 rejection based on U.S. 10,537,418 (Vantage) in view of U.S. 9,861,432 (Vantage) and U.S. Pub. No. 2019/0183567 (Helios Surgical Technologies, Inc.). § 112(a) rejection for lack of written description re impedance mapping calibration algorithm. Claims 15–20 contain allowable subject matter. Estimated professional fees for OA response: $18,000–$25,000. Last prosecution activity: July 3, 2023 (extension of time filed by P. Vassiliev).
SBD-001-CON3 | U.S. 18/109,744 | N/A — pending | 2023-02-14 | Control Unit and Algorithm for Multi-Zone Cryoablation Delivery | Dr. Aisling Connolly; Dr. Tomás Brennan | James R. Dougherty / Art Unit 3794 | Small Entity (37 C.F.R. § 1.27) | PENDING — No substantive action; awaiting first Office Action from USPTO | Claims pending (as filed) | N/A — awaiting USPTO action | No current client deadline; monitoring for first Office Action | $0 | No government fees currently due | Claims benefit of U.S. 16/914,337 (filed 2021-06-28) | N/A — U.S. continuation only | N/A | Application filed shortly before CryoNova program was shelved. No prosecution activity since filing. Board to decide whether to maintain or expressly abandon.
[sheet: Key Dates & Deadlines]
Date | Docket No. | Application / Patent No. | Event Description | Action Required | Responsible Attorney | Status
2021-06-28 | SBD-001 (Parent) | U.S. 16/914,337 | Parent application filed; PCT/EP2021/067891 also filed same date | N/A — completed | Alan Ngo | Complete
2021-10-05 | ALL | N/A | Calderwood & Harkness LLP engagement opened (Matter No. SBD-IP-2021-003) | N/A — completed | Alan Ngo | Complete
2022-03-22 | SBD-001 (Parent) | U.S. 11,284,561 | U.S. Patent No. 11,284,561 issued (24 claims) | N/A — completed | Alan Ngo | Complete
2022-03-23 | SBD-001-CON1 | U.S. 17/702,489 | CON-1 filed (day after parent issuance) | N/A — completed | Peter Vassiliev | Complete
2022-06-27 | SBD-001-CON2 | U.S. 17/851,216 | CON-2 filed | N/A — completed | Peter Vassiliev | Complete
2023-01-XX | SBD-001 (Parent) | EP 21 741 632.8 | EP application entered European regional phase (handled by Dunmore & Firth) | N/A — informational only (outside C&H scope) | Siobhán Firth (Dunmore & Firth) | Complete
2023-02-14 | SBD-001-CON3 | U.S. 18/109,744 | CON-3 filed | N/A — completed | Peter Vassiliev | Complete
2023-04-10 | SBD-001-CON1 | U.S. 17/702,489 | Notice of Allowance and Examiner's Amendment mailed | Issue fee payment required | Peter Vassiliev | Complete (but fee not paid — see below)
2023-05-17 | ALL | N/A | FROST-AF pivotal trial failure announced (IDE G210047; primary endpoint: 58.2% vs. 65% target; p = 0.14; n = 220) | N/A — clinical event; impacts portfolio strategy | N/A | Complete
2023-06-08 | ALL | N/A | SBD Board decision to shelve CryoNova program | N/A — business decision | N/A | Complete
2023-07-03 | SBD-001-CON2 | U.S. 17/851,216 | Last prosecution activity: two-month extension of time filed by Peter Vassiliev | N/A — completed | Peter Vassiliev | Complete
2023-07-10 | SBD-001-CON1 | U.S. 17/702,489 | Issue fee deadline ($540 small entity) — NOT PAID | Issue fee should have been paid | Peter Vassiliev | MISSED — docketing lapse
2023-07-11 | SBD-001-CON1 | U.S. 17/702,489 | Application deemed abandoned by USPTO for non-payment of issue fee | Petition to revive under 37 C.F.R. § 1.137(a) now required | Peter Vassiliev | Abandoned — revival pending client instruction
2024-09-15 | SBD-001-CON2 | U.S. 17/851,216 | Non-Final Office Action mailed by Examiner Dougherty | Response required | Peter Vassiliev / Wendy Schultz | Action required
2024-10-28 | ALL | N/A | Ronan Gallagher (SBD GC) emailed Alan Ngo requesting full portfolio review | Prepare portfolio strategy memorandum; reactivate docket | Alan Ngo | In progress
2025-01-15 | SBD-001-CON2 | U.S. 17/851,216 | CON-2 Office Action response deadline (3-month statutory period) | File response OR file extension of time (extendable to April 15, 2025 for $1,380 in extension fees) | Peter Vassiliev / Wendy Schultz | UPCOMING — CRITICAL
2025-04-15 | SBD-001-CON2 | U.S. 17/851,216 | CON-2 Office Action maximum extended deadline (3 one-month extensions) | File response — final deadline; no further extensions available | Peter Vassiliev / Wendy Schultz | UPCOMING — HARD DEADLINE
2025-09-22 | SBD-001 (Parent) | U.S. 11,284,561 | 3.5-year maintenance fee due ($1,000 small entity) | Pay maintenance fee or patent expires | Alan Ngo | UPCOMING
[sheet: Prior Art References]
Reference No. | Patent / Publication No. | Title | Assignee | Rejection Basis | Claims Affected | Cited In | Notes
1 | U.S. 10,537,418 | [Vantage cryoablation patent — title per examiner citation] | Vantage Cryosurgical Systems, Inc. | 35 U.S.C. § 103 (primary reference) | Claims 1–8 | CON-2 Non-Final OA (Sept. 15, 2024) | Primary reference in § 103 obviousness combination. Vantage's single-zone balloon cryoablation design. VP IP: Sandra Leung; outside counsel: Rachel Okafor, Kessler Brandt & Okafor LLP.
2 | U.S. 9,861,432 | [Vantage cryoablation patent — title per examiner citation] | Vantage Cryosurgical Systems, Inc. | 35 U.S.C. § 103 (secondary reference) | Claims 1–8 | CON-2 Non-Final OA (Sept. 15, 2024) | Secondary reference combined with U.S. 10,537,418 and U.S. Pub. No. 2019/0183567.
3 | U.S. Pub. No. 2019/0183567 | [Helios surgical technology publication — title per examiner citation] | Helios Surgical Technologies, Inc. | 35 U.S.C. § 103 (secondary reference) | Claims 1–8 | CON-2 Non-Final OA (Sept. 15, 2024) | Helios is a medical-device IP holding and licensing company (CEO: Martin Cheswick; 750 Bering Drive, Suite 400, Houston, TX 77057). Also identified by Pinnacle Health Ventures as a potential licensee.
[sheet: Inventor Directory]
Inventor Name | Citizenship | Current Title / Role | Current Affiliation | Employment Status re SBD | Named on Applications | Notes
Dr. Aisling Connolly | Irish | VP of Research & Development | Solstice Biomedical Devices Ltd. | Active employee | SBD-001 (Parent), SBD-001-CON1, SBD-001-CON2, SBD-001-CON3 (all four applications) | Ph.D., Biomedical Engineering, Trinity College Dublin. Co-inventor on entire family. Available for Rule 1.132 declarations.
Dr. Tomás Brennan | Irish | Chief Medical Officer & Co-Founder | Solstice Biomedical Devices Ltd. | Active employee | SBD-001 (Parent), SBD-001-CON1, SBD-001-CON2, SBD-001-CON3 (all four applications) | M.D., Royal College of Surgeons in Ireland. Co-inventor on entire family.
Dr. Henrik Paulsen | Danish | Engineer (role at current employer unknown) | Arclight Therapeutics GmbH (Germany) | Departed SBD July 2022 | SBD-001 (Parent) and SBD-001-CON1 only | Formerly Senior Engineer at SBD. Not named on CON-2 or CON-3. May require coordination for any declarations related to Parent or CON-1.
[sheet: Foreign Filing Cross-Reference]
U.S. Parent Docket No. | U.S. Parent Application No. | Foreign Filing Route | Foreign Application No. | Filing / Entry Date | Current Phase | Foreign Counsel Firm | Foreign Counsel Lead Attorney | Foreign Counsel Address | Notes
SBD-001 (Parent) | U.S. 16/914,337 | PCT → European Regional Phase | PCT/EP2021/067891 → EP 21 741 632.8 | PCT filed 2021-06-28; EP regional phase entered January 2023 | European regional phase prosecution | Dunmore & Firth Patent Attorneys | Siobhán Firth (European Patent Attorney) | 15 Fitzwilliam Square East, Dublin 2, D02 CR18, Ireland | Outside Calderwood & Harkness scope. Coordination as needed for family consistency.
SBD-001 (Parent) | U.S. 16/914,337 | PCT → Japan National Phase | JP 2023-500714 | National phase entry (date per Takeda & Morioka records) | Japanese national phase prosecution | Takeda & Morioka Patent Office | [Lead attorney per Takeda & Morioka] | Tokyo, Japan | Outside Calderwood & Harkness scope. Coordination as needed for family consistency.
[sheet: Cost Summary & Fee Schedule]
Line Item | Category | Amount | Notes
HISTORICAL COSTS (Oct 2021 – Jul 2023)
Professional fees (C&H) | Historical — Professional | $214,600 | Calderwood & Harkness attorney and patent agent time
USPTO government fees | Historical — Government | $38,350 | Filing fees, search fees, examination fees, etc.
Prior-art search fees (Caravel Prior Art Services LLC) | Historical — Third Party | $22,500 | Freedom-to-operate and prior-art landscape searches (Daniel Yoon)
Miscellaneous disbursements | Historical — Disbursements | $12,000 | Drawings, courier, filing fees
TOTAL FEES BILLED TO DATE | Historical — Total | $287,450 | Reconciles: $214,600 + $38,350 + $22,500 + $12,000 = $287,450
Outstanding accounts receivable | Historical — A/R | $0 | All invoices paid through July 2023
CURRENT / UPCOMING FEES
CON-2 OA response — professional fees (estimate) | Projected — Professional | $18,000–$25,000 | Claim amendments, arguments, Rule 1.132 declaration preparation
CON-2 extension of time fees (maximum 3 months) | Projected — Government | $1,380 | $230 (1st mo.) + $460 (2nd mo.) + $690 (3rd mo.) — small entity rates
CON-1 petition to revive — professional fees (estimate) | Projected — Professional | $4,500–$6,000 | Petition drafting and filing under 37 C.F.R. § 1.137(a)
CON-1 petition to revive — government fees | Projected — Government | $1,590 | Petition fee $1,050 + issue fee $540 — small entity rates
Parent 3.5-year maintenance fee | Projected — Government | $1,000 | Small entity rate; due September 22, 2025
SCENARIO 1: MAINTAIN FULL PORTFOLIO (estimated total) | Scenario | $25,470–$34,970 | All OA responses, CON-1 revival, maintenance fees; supports licensing or future restart
SCENARIO 2: SELECTIVE PROSECUTION (estimated total) | Scenario | $19,380–$26,380 | Maintain parent + CON-2; abandon CON-1 and CON-3; recommended by C&H
SCENARIO 3: FULL ABANDONMENT | Scenario | $0 | No incremental cost; all pending apps abandoned; parent lapses at 3.5-yr window
FUTURE MAINTENANCE FEE SCHEDULE (Parent — U.S. 11,284,561)
3.5-year maintenance fee | Future — Government | $1,000 | Due September 22, 2025 (small entity)
7.5-year maintenance fee | Future — Government | $1,880 | Due September 22, 2029 (small entity)
11.5-year maintenance fee | Future — Government | $3,880 | Due September 22, 2033 (small entity)