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 .
Response to Amendment
This office action is responsive to the amendment filed on 06/12/2026. As directed by the amendment: claims 1, 13, 16-17 and 20 have been amended, claims 7-12, 18-19 have been canceled, and new claims 21-24 have been added. Thus, claims 1-6, 13-17, 20-24 are presently pending in the application.
Response to Arguments
The amendment to claim 1 to include the limitation wherein the single piece prosthetic valve is coupled to the stent structure such that the valve prosthesis is a supra-annular valve has overcome the current 103 rejection over Arcaro et al. U.S. Publication 2019/0091014 A1 in view of Vonderwalde et al. WO 2009/156471 A1. However, upon further consideration, a new ground of rejection is made over Arcaro et al. U.S. Publication 2019/0091014 A1 in view of Vonderwalde et al. WO 2009/156471 A1 and further in view of Peterson et al. U.S. Publication 2021/0275298 A1.
Applicant’s arguments, see pages 5-6, filed 06/12/2026, with respect to the art Shitrit not being prior art as it does not overcome the provisional application date of 09/12/2022 have been fully considered and are persuasive. The 103 rejections of claims 13-15 over Peterson in view of Vonderwalde and Shitrit has been withdrawn.
The amendment to claim 16 to further include “a second portion extending distally from the respective outflow inferior crown, wherein each commissure is attached to at least the second portion of a respective commissure post of the commissure posts” is persuasive. Therefore, the examiner has withdrawn the previous 103 rejections over Biadillah et al. WO 2012/032187 A1 in view of Vonderwalde et al. WO 2009/156471 A1.
Allowable Subject Matter
Claims 13-15, 23 are allowed. The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to teach nor render obvious an internal radius of the superior crowns being within a range of 0.3 to 0.5 millimeters (mm).
Claims 16-17, 21, 24 are allowed. The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to teach nor render obvious a second portion extending distally from the respective outflow inferior crown, wherein each commissure is attached to at least the second portion of a respective commissure post of the commissure posts.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-6 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arcaro et al. U.S. Publication 2019/0091014 A1 in view of Vonderwalde et al. WO 2009/156471 A1 and further in view of Peterson et al. U.S. Publication 2021/0275298 A1.
Regarding Claims 1, 23, Arcaro et al. discloses a valve prosthesis 100 in Figures 1-4 comprising: a prosthetic valve 104 and a stent structure 1102 comprising an outflow portion Os (paragraph [0089]), the outflow portion Os being tapered and having a minimum diameter at an outflow end of the valve prosthesis (as seen in Figures 2-3 and paragraphs [0008], [0092]). However, Arcaro et al. does not expressly disclose a single pieced prosthetic valve that is molded. Vonderwalde et al. teaches a prosthetic valve in the same field of endeavor for use with a stent structure 20’, the prosthetic valve 1 is formed as a one piece using a mold (see Figures 1-3a and page 5, lines 10-20) for the purpose of making a more homogenous heart valve that does not need to be cut into several pieces and having sutures and prevent stress concentrations caused by sutures (page 2, lines 17-31 and page 4, lines 10-20). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Arcaro’s prosthetic valve to be a single piece prosthetic valve that is molded as taught by Vonderwalde et al. for the purpose of making a more homogenous heart valve that does not need to be cut into several pieces and having sutures thereby preventing stress concentrations caused by sutures. However, Arcaro et al. does not expressly disclose wherein the valve prosthesis is a supra-annular valve. Peterson et al. teaches a valve prosthesis in the same field of endeavor comprising: a prosthetic valve 132 (as seen in Figures 1-3 and paragraph [0024]); and a stent structure 102 having an outflow portion and an inflow portion, wherein the stent structure 102 is configured for supra-annular placement within the native valve (paragraphs [0011], [0109]) for the purpose of anchoring the device beyond the annulus of the native valve and prevent migration of the device. (as seen in Figure 3 and paragraph [0109]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Arcaro’s prosthetic valve to be configured for supra-annular placement as taught by Peterson et al. for the purpose of anchoring the device beyond the annulus of the native valve and prevent migration of the device.
Regarding Claim 2, Arcaro et al. discloses wherein the stent structure 1102 further comprises an inflow portion Is (as seen in Figure 2, paragraph [0089]), the outflow portion Os having a first diameter where the outflow portion connects to the inflow portion Is and a second diameter at the outflow end (as seen in Figures 2-3 and paragraphs [0089] and [0092]), the second diameter being smaller than the first diameter (as seen in Figure 3 and paragraph [0092]).
Regarding Claim 3, Arcaro et al. discloses wherein the outflow portion Os uniformly tapers between the first diameter and the second diameter (paragraph [0092] and as seen in Figure 3).
Regarding Claim 4, Arcaro et al. discloses wherein the inflow portion Is has a uniform diameter (paragraph [0092]).
Regarding Claim 5, Arcaro et al. discloses wherein the stent structure 1102 further comprises struts 1122 of different lengths that upon expansion cause the outflow portion to be tapered (paragraph [0114] and as seen in Figure 3).
Regarding Claim 6, Arcaro et al. discloses wherein the valve prosthesis 108 has a first diameter at an inflow end of the valve prosthesis and a second diameter at the outflow end of the valve prosthesis, the valve prosthesis uniformly tapering 1202a between the first diameter and the second diameter (as seen in Figure 11, from end 1204a to 1210a, there is uniform tapering, see paragraphs [0132-0133], wherein Arcaro discloses the leaflet body portion is defined by the body portion that is attached to the stent structure 102 which contribute to the ultimate shape of the body portion, therefore having a tapered stent structure, it would be inherent that the leaflet design should also be tapering to allow for better attachment to the stent frame).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
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