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) 1-20 is/are pending. Claim(s) 4, 8, 11, and 19 is/are withdrawn.
Election/Restriction
Applicant’s election without traverse of (1) c[h]ord of claim 2, (2) Species 2-1, and (3) Species 3-1 in the reply filed on 7/27/2026 is acknowledged.
Claims 4, 8, 11, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/27/2026.
Claim Objections
Claim 2 is objected to because of the following informalities:
Claim 2 recites “wire”, which should be “a wire”.
Appropriate correction is required.
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.
Claim see Table I below rejected on the ground of nonstatutory double patenting as being unpatentable over claim see Table I below of U.S. Patent No. see Table I 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 10,722,350
Prior Patent
US 11,986,386
1
3, 15
8, 14
2-3
15
19
5
--
20
7
4
9, 15
9
3
8, 14
10
15
14
12
--
17
13
--
18
15
15
8, 14
16
--
20
18
16
9, 15
20
18
8, 14
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.
Claim 3 is 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 3 recites “a cord”, “wire”, and “suture”. In each case it is unclear if these are the same feature as introduced in claim 2 or a new instance of each. For purposes of examination the Examiner considers this language to be “the cord”, “the wire”, and “the suture”.
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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1, 5-7, 9-10, 12-13, 15-18, and 20 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Levi, et al (Levi) (US 2012/0123529 A1).
Regarding Claim 1, Levi teaches a prosthetic heart valve (e.g. abstract), comprising:
a collapsible and expandable stent having a proximal end, a distal end (e.g. abstract, Figures 38-43), an annulus section adjacent the proximal end (e.g. Figures 39-40, at the bottom, as shown), an aortic section adjacent the distal end (e.g. Figures 39-40, at the top, as shown), and a plurality of commissure features disposed on the stent (e.g. Figure 11, #60, where the tabs of the leaflets attach);
a collapsible and expandable valve assembly (e.g. Figures 24-25, 39-40, 17, abstract), the valve assembly including a plurality of leaflets (#s 40) connected to the plurality of commissure features (e.g. Figures 24-25, and 36-37, at #s 112, 116), each of the plurality of leaflets having a body portion (e.g. Figure 21), a free edge adapted to coapt with free edges of adjacent leaflets (#110), and an attachment portion opposite each free edge (e.g. Figures 21-22, lower, as shown, U-like portion where #72 is attached);
a plurality of reinforcements (#s 72), each of the plurality of reinforcements having a complementary shape to the attachment portion of a selected leaflet (e.g. Figures 21-22);
a first suture pattern coupling a selected one of the plurality of reinforcements to a selected attachment portion (e.g. Figures 36, 38; pattern #154); and
a second suture pattern at least partially overlapping the first suture pattern (e.g. Figures 36, 38; pattern #156; at least axially overlapping).
Regarding Claim 5, the first suture pattern is a reverse running stitch (e.g. Figure 38, pattern #154 is made either by backstitching or by stitching every other stitch in one direction and then the gaps in the reverse direction; in each case there is a reverse component and the stitches are running (continuous along their pathway); the Examiner notes [0080] and Figures 16A-B of Applicants Specification and Drawings are the only indicators of what is meant by reverse running stitch, which do not provide details contrary to Examiner’s interpretation herein).
Regarding Claim 6, the first suture pattern is spaced from the free edge of the selected leaflet (e.g. Figure 38).
Regarding Claim 7, the second suture pattern wraps around the attachment portion (e.g. Figures 36, 38; [0083]).
Regarding Claim 9, the second suture pattern couples to the stent (e.g. [0083], Figures 39-40; as the sutures are immediately adjacent the stent, they are “coupled” to it; there is no requirement the second suture patter wrap around the stent material).
Regarding Claim 10, there is a cuff disposed on a surface of the stent (e.g. Figures 39-40; #16).
Regarding Claim 12, each leaflet includes tabs disposed on two sides of the free edge and connected to the plurality of commissure features (e.g. Figure 21, each pair of #112/114 is a tab; Figure 24, adjacent tabs are connected to each other; Figure 30, tabs are connected to the commissure features of the frame).
Regarding Claim 13, the plurality of reinforcements is bounded by the tabs of the selected leaflet (e.g. Figures 21-22).
Regarding Claim 15, Levi teaches a method of making a prosthetic heart valve (see following), comprising:
providing a collapsible and expandable stent having a proximal end, a distal end (e.g. abstract, Figures 38-43), an annulus section adjacent the proximal end (e.g. Figures 39-40, at the bottom, as shown), an aortic section adjacent the distal end (e.g. Figures 39-40, at the top, as shown), and a plurality of commissure features disposed on the stent (e.g. Figure 11, #60, where the tabs of the leaflets attach);
coupling a collapsible and expandable valve assembly to the stent (e.g. Figures 24-25, 39-40, 17, abstract), the valve assembly including a plurality of leaflets (#s 40) connected to the plurality of commissure features (e.g. Figures 24-25, and 36-37, at #s 112, 116), each of the plurality of leaflets having a body portion (e.g. Figure 21), a free edge adapted to coapt with free edges of adjacent leaflets (#110), and an attachment portion opposite each free edge (e.g. Figures 21-22, lower, as shown, U-like portion where #72 is attached);
providing a plurality of reinforcements (#s 72), each of the plurality of reinforcements having a complementary shape to the attachment portion of a selected leaflet (e.g. Figures 21-22);
coupling a selected one of the plurality of reinforcements to a selected attachment portion via a first suture pattern (e.g. Figures 36, 38; pattern #154); and
at least partially overlapping the first suture pattern with a second suture pattern (e.g. Figures 36, 38; pattern #156; at least axially overlapping).
Regarding Claim 16, the limitations of claim 16 are discussed supra for claim 5.
Regarding Claim 17, the limitations of claim 17 are discussed supra for claim 6.
Regarding Claim 18, the limitations of claim 18 are discussed supra for claim 7.
Regarding Claim 20, the limitations of claim 20 are discussed supra for claim 9.
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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 2-3 and 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Levi, et al (Levi) (US 2012/0123529 A1) as discussed supra, alone.
Regarding Claims 2-3, Levi discloses the invention substantially as claimed but fails to teach the plurality of reinforcements comprise a cord.
Levi teaches the reinforcements are made of PET (e.g. [0065]) and reinforcements for the tabs are also made of woven PET (e.g. [0100]).
Both embodiments of Levi are concerned with the same field of endeavor as the claimed invention, namely reinforcement material used between components in a stented heart valve.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the leaflet reinforcement such that it is made specifically of woven PET as taught by Levi as it is a simple substitution of one known element (here, reinforcement material, per Levi) for another to obtain predictable results (MPEP 2143(I)) of providing a flexible and tear resistant buffer material (e.g. Levi, [0100]).
In this combination, the cord is the yarn of the weave forming the woven PET.
Regarding Claim 14, the first suture pattern is spaced from an edge of the attachment portion (e.g. Figure 36, 38).
Relevant Prior Art
US 2003/0078652 A1 to Sutherland teaches heart valve leaflets having a suture pattern around it attachment portion (e.g. Figures 5, 8, [0057]-[0058]).
US 2002/0173842 A1 to Buchanan teaches a heart valve having a reinforcing cord along the leaflet edges (e.g. Figure 2A).
US 2010/0036484 A1 to Hariton, et al teaches a heart valve having reinforced leaflets (e.g. Figures 1, 14).
US 2006/0276888 A1 to Lee, et al teaches a heart valve having reinforced leaflets and a suture pattern (e.g. Figure 7A, abstract).
US 2003/0027332 A1 to Lafrance, et al teaches a heart valve having reinforced leaflets (e.g. Figure 25, abstract).
US 2006/0259136 A1 to Nguyen, et al teaches a heart valve having reinforced leaflets (e.g. Figure 4B, abstract).
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.
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, JERRAH EDWARDS can be reached at (408)918-7557. 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.
/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 8/20/2026
Prosecution Insights