Prosecution Insights
Last updated: April 19, 2026
Application No. 18/541,105

PROSTHETIC HEART VALVE DEVICES AND ASSOCIATED SYSTEMS AND METHODS

Non-Final OA §103
Filed
Dec 15, 2023
Examiner
SHI, KATHERINE MENGLIN
Art Unit
3771
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Twelve, Inc.
OA Round
1 (Non-Final)
78%
Grant Probability
Favorable
1-2
OA Rounds
3y 1m
To Grant
99%
With Interview

Examiner Intelligence

Grants 78% — above average
78%
Career Allow Rate
675 granted / 861 resolved
+8.4% vs TC avg
Strong +22% interview lift
Without
With
+22.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
36 currently pending
Career history
897
Total Applications
across all art units

Statute-Specific Performance

§101
0.9%
-39.1% vs TC avg
§103
36.9%
-3.1% vs TC avg
§102
26.2%
-13.8% vs TC avg
§112
23.6%
-16.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 861 resolved cases

Office Action

§103
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Objections Claim 10 is objected to because of the following informalities: “adjacent later edges” should recite - - adjacent lateral edges - - . Appropriate correction is required. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness . Claim(s) 1-3, 6, 7, 9, 12 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Morris et al (US 2016/0038280) . Morris et al discloses the following limitations: Claim 1. A prosthetic heart valve device (Figs. 72, 80A, 98C) comprising: an anchoring member (110) having an annular fixation frame, the fixation frame including a first fixation end (top inflow end) and a second fixation end (bottom outflow end) ([0024]) ; a tubular valve support (120) having a first portion (123) coupled to the second end of the fixation frame and a second portion (121) spaced radially inward from the first end of the fixation frame (Fig. 80A; [0239]) ; a valve assembly (130) coupled to the valve support and having at least one leaflet movable from a closed position in which blood flow is blocked through the valve support and an open position in which blood flow is allowed through the valve support in a downstream direction ([0235]) ; and an extension member (2100) (Fig. 98C) coupled to the fixation frame and extending radially outward therefrom, wherein the extension member comprises a plurality of discrete fabric segments (2124) having a first end (at connector 2142) at the anchoring member and a second end (free opposite end) spaced apart from the anchoring member, wherein each discrete fabric segment includes lateral edges (left and right sides of the circular shaped fabric segments) extending from the first end to the second end of the discrete fabric segment ([0428], [0462]) . It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention that with the prosthetic heart valve device in a radially expanded deployed state, the discrete fabric segments are configured to move circumferentially relative to each other such that adjacent lateral edges of adjacent fabric segments move between a first overlapping configuration (collapsed configuration) in which the adjacent lateral edges overlap each other by a first distance ([0188], [0227]; when compressed into its collapsed configuration, it would have been obvious to one of ordinary skill in the art the fabric segments 2154 would overlap into order to achieve its smaller profile to fit into the delivery catheter) and a second configuration in which the adjacent lateral edges do not overlap each other (Fig. 98C) , in response to forces exerted on the extension member ([0181], [0254]; when transitioning to its expanded configuration, the anchoring member pushes radially outward therefore causing the fabric segments to move circumferentially to open into its expanded configuration) . Claim 2 . The prosthetic valve of claim 1, wherein the adjacent lateral edges of the adjacent fabric segments are not attached to each other (Fig. 98C; [0462]) . Claim 3 . The prosthetic valve of claim 1, wherein the adjacent fabric segments are loosely coupled together ([0462]; via connectors 2142 which allow for a flexible connection and movement and is therefore considered as encompassing the claimed limitation of “loosely coupled”) . Claim 6 . The prosthetic valve of claim 1, wherein the extension member further includes a structural member (2141) ([0462]) . Claim 7 . The prosthetic valve of claim 6, wherein the structural member is a wire (2141) ([0462]) . Claim 9 . The prosthetic valve of claim 1, wherein the extension member is directly attached to the fixation frame (Fig. 98C; [0462]) . Claim 12 . The prosthetic valve of claim 1, wherein the second ends of the fabric segments coincide with an outer circumference of the extension member (Fig. 98C) . Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morriss et al in view of Zamani et al (US 2019/0374337). Claim s 4 and 5 . Morris et al discloses the invention substantially as claimed above, but fails to disclose wherein the adjacent fabric segments are loosely coupled together via an elastic (as per claim 4) or wherein the adjacent fabric segments are loosely coupled together via sutures (as per claim 5). However, in the same field of endeavor, Zamani et al teaches a prosthetic heart valve, wherein movable portions of the prosthetic heart valve are attached to one another via elastic sutures ([0264]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the flexible connection via connectors (2142) to elastic sutures as taught by Zamani et al to allow for resilient stretching and relaxing of the prosthetic heart valve during movement of each heartbeat. Allowable Subject Matter Claims 8, 10 and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Morris et al (US 2016/0038280) discloses the invention substantially as claimed above. In regards to claim 8 , t he prior art of record does not disclose or fairly suggest either singly or in combination the claimed prosthetic heart valve device comprising, inter alia, the anchoring member further includes a sealing member coupled to the fixation frame, wherein the extension member is attached to the sealing member such that the extension member is not directly attached to the fixation frame. In regards to c laim 10 , t he prior art of record does not disclose or fairly suggest either singly or in combination the claimed prosthetic heart valve device comprising, inter alia, the adjacent lateral edges are attached to each other via a flexible portion, and wherein in the second configuration the adjacent later edges are spaced apart from each other by no more than a length of the flexible portion. Instead, the lateral edges of Morriss et al remains unattached. In other embodiments where the lateral edges are attached, they are attached by the fabric 2124 (Fig. 98B) and not a plurality of discrete fabric segments. In regards to c laim 11 , t he prior art of record does not disclose or fairly suggest either singly or in combination the claimed prosthetic heart valve device comprising, inter alia, the fabric segments do not include a separate structural member. Instead, the fabric segments each contain a structural wire 2141. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT KATHERINE M SHI whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-5620 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon-Thurs, 8-5 EST . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Darwin Erezo can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571)272-4695 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KATHERINE M SHI/ Primary Examiner, Art Unit 3771
Read full office action

Prosecution Timeline

Dec 15, 2023
Application Filed
Mar 17, 2026
Examiner Interview (Telephonic)
Mar 17, 2026
Non-Final Rejection — §103 (current)

Precedent Cases

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
78%
Grant Probability
99%
With Interview (+22.0%)
3y 1m
Median Time to Grant
Low
PTA Risk
Based on 861 resolved cases by this examiner. Grant probability derived from career allow rate.

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