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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-6, 13-20, drawn to valve prosthesis, classified in A61F2/2409.
II. Claims 7-12, drawn to a method of using a valve prosthesis, classified in A61F2/2433.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the process for using the product as claimed can be practiced with another materially different product, such as a self-expanding valve prosthesis that has the tapered shape and one piece molded prosthetic valve and does not require the use of a balloon.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The invention listed above requires different cpc and text search.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Albert Ferro on Monday, February 2, 2026 a provisional election was made without traverse to prosecute the invention of group I, valve prosthesis, claim 1-6, 13-20. Affirmation of this election must be made by applicant in replying to this Office action. Claims 7-12 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 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.
Regarding Claim 1, 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 one piece molded prosthetic valve. 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 one piece molded prosthetic valve 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.
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 1122of 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).
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterson et al. U.S. Publication 2021/0275298 A1 in view of Vonderwalde et al. WO 2009/156471 A1 and further in view of Shitrit et al. U.S. Publication 2025/0248810 A1 (provisional application filed on 11/18/2022).
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Regarding Claim 13, Peterson et al. discloses a valve prosthesis 2900 comprising: a prosthetic valve 132 (as seen in Figures 1-2 and paragraph [0024]); and a stent structure 102 comprising an outflow crown ring (see annotated Figure 1), the outflow crown ring comprising: inferior crowns; superior crowns (the undulations by portion 142), outflow crown struts connected to the superior crowns and the inferior crowns (as seen in the annotated Figure 1 above). However, Peterson et al. does not expressly disclose a one piece molded prosthetic valve. 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 Peterson’s prosthetic valve to be a one piece molded prosthetic valve 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, Peterson et al. as modified does not expressly disclose an internal radius of the superior crowns being within a range of 0.3 to 0.5 millimeters (mm). Shitrit et al. teaches a valve prosthesis in the same field of endeavor comprising a prosthetic valve 104 and a stent structure 102 having an outflow crown having outflow crown struts 134 and superior crowns 152 and inferior crowns, wherein the internal radius of the superior crowns are in the range of greater than 1 mm, wherein Shitrit et al. teaches the radius of curvature 176 varies based on the amount of angle desired in the angled struts 136, therefore Shitrit teaches the radius being a result effective variable in that having a smaller radius would create less width/ less angle in the crowns of the superior crowns. 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 Peterson’s superior crowns to have a very small radius of curvature as taught by Shitrit for the purpose creating a less width/less angle in the crowns of the superior row. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the superior crowns to have an internal radius within the claimed range, as it involves only adjusting the radius of a component disclosed to be adjustable. 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 the internal radius to be specifically within the claimed range of 0.3 to 0.5 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 14, Peterson et al. discloses wherein the superior crowns lie within a cylindrical shape of the stent structure (as seen in Figure 1).
Regarding Claim 15, Peterson et al. discloses wherein the superior crowns are atraumatic (the superior crowns are curved, thus forming an atraumatic tip, see Figure 28 and paragraph [0172]).
Claim(s) 16-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biadillah et al. WO 2012/032187 A1 in view of Vonderwalde et al. WO 2009/156471 A1.
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Regarding Claim 16, Biadillah et al. discloses a valve prosthesis comprising: a prosthetic valve 5 (as seen in Figures 5a-5d and page 17, lines 16-30) comprising: valve leaflets 31 comprising free edges (as seen in annotated Figure 5d page 18, lines 21-28) and a stent structure 20 comprising an outflow portion comprising an outflow crown ring 21 (see annotated Figure 1), the free edges being inferior to the outflow crown ring (as seen in the annotated Figure 5d). However, Peterson et al. does not expressly disclose a one piece molded prosthetic valve. 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 Biadillah’s prosthetic valve to be a one piece molded prosthetic valve 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.
Regarding Claim 17, Biadillah et al. discloses wherein there is a longitudinal space between the valve leaflets 31 and the outflow crown ring 21 (as seen in the annotated Figure 5d above).
Regarding Claim 18, Biadillah et al. discloses wherein the prosthetic valve 5 further comprises protruding commissures 30 (e.g. tabs that extend around the commissure post) attached to trident posts 22, 22a of the outflow portion of the stent structure 20 (as seen in Figure 1 and annotated Figure 5d).
Regarding Claim 20, Biadillah et al. discloses wherein the prosthetic valve 5 further comprises commissures 30 attached to commissure posts 22, 22a inferior to the outflow crown ring (as seen in Figures 1 and annotated Figure 5d).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biadillah et al. WO 2012/032187 A1 in view of Vonderwalde et al. WO 2009/156471 A1 as applied to the claim rejections above and further in view of Peterson et al. U.S. Publication 2021/0275298 a1.
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Regarding Claim 19, Biadillah et al. does not expressly disclose wherein the prosthetic valve further comprises commissures attached to axial frame members 22b of the outflow portion. Peterson et al. teaches a valve prosthesis 3000 as seen in Figure 30 in the same field of endeavor comprising: a prosthetic valve 132 (as seen in Figures 1-2 and paragraph [0024]) and a stent structure 3002, the stent structure comprises a commissure post having a trident post and an axial member for the purpose of having a lengthened commissure post that are formed to a greater axial length to reinforce or strengthen the commissure region of the valve prosthesis (paragraph [0181]). 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 Biadillah’s commissure structure to include an axial frame member to each to respective commissures of the prosthetic valve for the purpose of having a lengthened commissure post that can reinforce and strengthen the commissure region on the valve prosthesis.
Conclusion
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