DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Claim(s) 2-21 is/are pending. Claim(s) 14 is/are withdrawn.
Allowable Subject Matter
Claim 4 is 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.
Election/Restriction
Applicant’s election without traverse of Species 1-1 in the reply filed on 7/20/2026 is acknowledged.
Claim 14 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species 1-2, there being no allowable generic or linking /claim. Election was made without traverse in the reply filed on 7/20/2026.
Information Disclosure Statement
The information disclosure statement filed 4/4/2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because (1) FOR citations #s 2, 3 were not provided with an English equivalent and (2) NPL #s 5, 12 were either not provided or provided with the wrong date. The Examiner notes two documents for European Application No. 12165625 were provided but have dates of 11/29/2013 and they appear to be two copies of the same document. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
All non-lined through citations were considered.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application will determine what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 2-3, 5, 8, 10, 12, and 15-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) see Tables I and II below of U.S. Patent No. see Tables I and II below. Although the claims at issue are not identical, they are not patentably distinct from each other because the following prior claims contain the limitations claimed by the current Application as indicated in the following table.
Table I
Current Application
Prior Patent
US 11,974,915
Prior Patent
US 10,485,662
2
1
1, 16
3
16
3
5
6
--
8
8
--
10
5
14, 15
12
--
1
15
3
8, 17
16
17
--
17
--
13
18
--
7
19
11
--
20
13
--
21
12
--
Table II
Current Application
Prior Patent
US 9,949,826
Prior Patent
US 9,421,097
Prior Patent
US 8,728,154
2
6, 17
12
12
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 6 recites the limitation "the first connecting strut". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “a first connecting strut”.
Claim 6 recites the limitation "the second connecting strut". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “a second connecting strut”.
Claim 6 recites the limitation "the associated pair of connecting struts". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “an associated pair of connecting struts”.
The Examiner notes each of these limitations was introduced in claim 3, but claim 6 does not depend from claim 3 with or without intervening claims.
Claim(s) 7 are rejected as dependent from a rejected claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 2-3, 5-13, 15-16, and 18-21 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Stacchino, et al (Stacchino) (US 2006/0178740 A1).
Regarding Claim 2, Stacchino teaches a prosthetic heart valve (e.g. Figure 3, abstract), comprising:
a stent frame having an expanded condition and a collapsed condition (e.g. Figure 3, [0007]), the stent frame extending from a proximal end to a distal end and including an inflow portion at the proximal end (annular ring #20a), an outflow portion at the distal end (annular ring #20b), a plurality of connecting struts connecting the inflow portion to the outflow portion (#s 22), and a plurality of commissure structures spaced from one another in an annular direction around the inflow portion (#s 24), each of the commissure structures having a first portion and a second portion (e.g. annotated Figure 3(1) below), the commissure structure being connected only to a respective pair of points on a remaining structure of the inflow portion (e.g. annotated Figure 3(1) below), the second portion of the commissure structure being cantilevered from the first portion (e.g. annotated Figure 3(1) below), the second portion having a free end (e.g. annotated Figure 3(1) below); and
a plurality of valve leaflets supported by the inflow portion (e.g. Figures 1, 3, #s 3a, b, c).
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Annotated Figure 3(1), Stacchino
Regarding Claim 3, each of the commissure structures has an associated pair of the connecting struts, the associated pair of connecting struts including a first connecting strut disposed on one side of the commissure structure in the annular direction and a second connecting strut disposed on another side of the commissure structure in the annular direction (e.g. annotated Figure 3(1) above).
Regarding Claim 5, the inflow portion of the stent frame includes a plurality of diamond-shaped cells, a group of the diamond-shaped cells being interposed between adjacent ones of the commissure structures (e.g. Figure 3).
Regarding Claim 6, the inflow portion of the stent includes a further diamond-shaped cell interposed between the first connecting strut and the second connecting strut in the associated pair of connecting struts (e.g. annotated Figure 3(2) below; dotted curved line is the group of claim 5).
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776
920
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Annotated Figure 3(2), Stacchino
Regarding Claim 7, the further diamond-shaped cell includes the first portion of the commissure structure (e.g. annotated Figure 3(1) above; the first portion is connected to the left side of the diamond).
Regarding Claim 8, the outflow portion of the stent frame includes a plurality of diamond-shaped cells arranged in a row in the annular direction (e.g. Figure 3).
Regarding Claim 9, each of the connecting struts bulges radially outwardly in the expanded condition of the stent frame (e.g. Figure 3).
Regarding Claim 10, each of the commissure structures includes a plurality of apertures (e.g. Figure 3).
Regarding Claim 11, at least a portion of the apertures are located in the second portions of the commissure structures (e.g. annotated Figure 3(1) above).
Regarding Claim 12, the second portion of each of the commissure structures is cantilevered from a single point on the first portion (e.g. annotated Figure 3(1) above).
Regarding Claim 13, the second portion of each of the commissure structures includes a post member extending from the single point toward the distal end of the stent frame (e.g. annotated Figure 3(1) above).
Regarding Claim 15, the proximal end of the stent frame includes a recessed edge portion aligned with a respective one of the commissure structures (e.g. Figure 3), the recessed edge portion being closer to the distal end of the stent frame than other portions of the proximal end of the stent frame (e.g. Figure 3, as it is recessed, it is closer than the crowns that are more proximal).
Regarding Claim 16, the outflow portion of the stent frame is annularly continuous all the way around the stent frame (e.g. Figure 3).
Regarding Claim 18, each of the connecting struts has an end connected to the inflow portion of the stent frame at a respective point that is farther from the distal end of the stent frame than a point at which the second portion of each of the commissure structures is connected to the first portion (e.g. annotated Figure 3(1) above).
Regarding Claim 19, the inflow portion of the stent frame includes a single row of struts arranged in a zig-zag pattern, a first group of the struts being interposed between adjacent ones of the commissure structures (e.g. Figure 3; the diamond structure is 2 zig-zag patterns).
Regarding Claim 20, the zig-zag pattern includes a plurality of apices that collectively define the proximal end of the stent frame (e.g. Figure 3), each of the connecting struts having an end connected to the inflow portion of the stent frame at a respective one of the apices (e.g. Figure 3; as broadly claimed, both the distal and proximal crowns are apices).
Regarding Claim 21, the outflow portion of the stent frame includes a single row of struts arranged in a zig-zag pattern that includes a plurality of apices that collectively define the distal end of the stent frame (e.g. Figure 3), each of the connecting struts having an end connected to the outflow portion of the stent frame at a respective one of the apices (e.g. Figure 3; as broadly claimed, both the distal and proximal crowns are apices).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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) 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stacchino, et al (Stacchino) (US 2006/0178740 A1) as discussed supra and further in view of Seguine, et al (Seguine) (US 2004/0093060 A1).
Regarding Claim 17, Stacchino discloses the invention substantially as claimed but fails to teach there are a plurality of anchor members that are resiliently biased to incline outwardly from the stent frame in the expanded condition, the anchor members being connected to the stent frame only at positions that are not between the inflow portion and the outflow portion.
Seguine teaches a plurality of anchor members that are resiliently biased to incline outwardly from the stent frame in the expanded condition and connected to the stent frame only at positions that are not between the inflow portion and the outflow portion (e.g. Figure 19).
Seguine and Stacchino are concerned with the same field of endeavor as the claimed invention, namely heart valves having annular, diamond-shaped inflow and outflow portions.
it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Stacchino such that the inflow and outflow portions having the anchor members as taught by Seguine in order to immobilize the heart valve at the implantation site (e.g. Seguine, [0020]).
Relevant Prior Art
US 2013/0096664 A1 to Goetz, et al teaches a heart valve frame having vertical commissure posts extending between two annular rings with no additional stent structure between those rings (e.g. Figure 1).
US 2007/0100432 A1 to Case, et al teaches a heart valve frame having vertical commissure posts extending between two annular rings with no additional stent structure between those rings (e.g. Figure 6).
US 2006/0235509 A1 to Lafontaine teaches a heart valve frame having vertical commissure posts extending between two annular rings with no additional stent structure between those rings (e.g. Figure 3).
US 2005/0197695 A1 to Stacchino teaches a heart valve having a frame with proximal and distal annular rings, pairs of connecting struts between fenestrated commissure posts (e.g. Figures 1-2).
US 2007/0288087 A1 to Fearnot, et al teaches a blood flow valve having a frame with proximal and distal annular rings, connecting struts between fenestrated commissure posts (e.g. Figure 4).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 8/7/2026
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