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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any specific references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Examiner’s Note
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gurovich et al. (US PG Pub. 2018/0028310), as disclosed in the IDS dated 02/12/2025, hereinafter Gurovich, in view of Schraut et al. (US PG Pub. 2014/0277417), as disclosed in the IDS dated 02/12/2025, hereinafter Schraut.
Regarding claims 18 and 19, Gurovich discloses a prosthetic heart valve (10), illustrated in Figures 1A and 1B, comprising a radially collapsible and expandable frame (12) comprising an inflow end and an outflow end, wherein the frame (12) comprises a plurality of struts (22); and a plurality of leaflets (20) arranged within the frame (12), illustrated in Figures 1A, 1B and 8 ([0096]; [0097], Lines 1-3; [0099] & [0101]), wherein each leaflet (20) comprises two tabs (60) disposed on opposite sides of the leaflet and a cusp edge portion (102) extending between the two tabs; wherein the cusp edge portion (102) of each leaflet is connected to the frame (12) by a connecting skirt (100), wherein each connecting skirt (100) comprises a central portion (CP) and opposing side base portions (SBP) on opposite sides of the central portion (CP), and wherein each connecting skirt (100) further comprises side extension portions (106) that extend axially and circumferentially away from the cusp edge portion (102) of the leaflet, across multiple open cells of the frame (12) that are defined by struts (22) of the plurality of interconnected struts that are disposed between cusp edge portions (102) of adjacent leaflets, to an adjacent side extension portion of an adjacent connecting skirt, illustrated in Figures 8-12B and modified figure 9, below ([0113] – [0116]); but does not specifically teach each side extension portion of each connecting skirt is triangular.
PNG
media_image1.png
352
641
media_image1.png
Greyscale
However Schraut teaches a prosthetic heart valve, in the same field of endeavor, comprising leaflets connected to a frame (102) by a connecting skirt (300), wherein the connecting skirt (300) comprises a central portion (CP), opposing side base portions (SP) and a side extension portion (304), wherein the side extension portions (304) is triangular, illustrated in Figueres 3A-3C and modified figure 3A, below ([0059], Last 3 Lines ).
PNG
media_image2.png
280
556
media_image2.png
Greyscale
In view of the teachings of Schraut, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for each side extension portion, of each connecting skirt of the prosthetic heart valve of Gurovich, to be triangular, as taught by Schraut, since doing so amounts to a mere change in shape/form of a known part which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04).
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines 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/apply/applying-online/eterminal-disclaimer.
Claims 12-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-16 of U.S. Patent No. 12,004,947. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims disclose a method of assembling a prosthetic heart valve comprising forming a plurality of leaflet assemblies with a plurality of leaflets, wherein each leaflet assembly is formed by securing a central portion and side base portions of a connecting skirt to a cusp edge portion of a leaflet, wherein each connecting skirt comprises two side portions, one arranged on either side of the central portion, and wherein each side portion comprises a corresponding side base portion of the side base portions and a side extension portion extending outward and away from the corresponding side base portion; securing each connecting skirt of each leaflet assembly to a frame of the prosthetic heart valve, the frame comprising a plurality of interconnected struts that define a plurality of open cells, the securing including: securing the central portion and side base portions of the connecting skirt to a first portion of struts of the plurality of struts; and extending each side extension portion of the connecting skirt across a second portion of struts of the plurality of struts and multiple cells of the plurality of open cells that are disposed between cusp edge portions of adjacent leaflets.
Allowable Subject Matter
Claims 1-11 are allowed.
Claims 12-17 would be allowable if the Double Patenting rejection, set forth above, is overcome by filing an e-Terminal Disclaimer.
The following is a statement of reasons for the indication of allowable subject matter: no prior art, by itself, or in combination with other art, could be found that discloses or fairly teaches a prosthetic heart valve and/or a method of assembling a prosthetic heart valve including all the structural limitations set forth in the independent claims 1 and 12. The closest related art of Gurovich, teaches all the limitations set forth in the claims, except does not teach the prosthesis comprising the side extension portions, of each connecting skirt, covering at least one entire cell of the portion of cells defined by the plurality of struts of the frame of the prosthetic heart valve; and does not teach the method including the step of securing the central and side base portions, of the connecting skirt, to a first portion of struts, of the plurality of struts of the frame of the prosthetic valve; and extending each side extension portion, of the connecting skirt, across a second portion of struts, of the plurality of struts, and multiple cells, of the plurality of open cells defined by the plurality of struts of the frame of the prosthetic valve, that are disposed between cusp edge portions of adjacent leaflets.
Claim 20 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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.
/DINAH BARIA/Primary Examiner, Art Unit 3774 06/23/2026
Prosecution Insights