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
Please note any references listed in the specification not cited in a prior parent application 17/178802 have not been considered. A proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. A listing of the information from the parent application need not be resubmitted in this continuation application unless the applicant desires the information to be printed on the patent. The Examiner has considered the IDS submissions of 17/178802.
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.
Claim 1-9,11-18,20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10,13 of U.S. Patent No. 10952842 in view of Bruchman et al. (8961599). US ‘842 disclose/claims a frame or support structure with an inflow end portion and an outflow end portion along with a leaflet disposed within the support. Additionally US ‘842 disclose/claims the leaflet has a first and second component such that each of the first leaflet component and the second leaflet component is attached to the frame and the first leaflet component is attached to the frame upstream of the second leaflet component; wherein a leaflet is moveable between an open position that permits antegrade flow through the prosthetic valve and a closed position to prevent regurgitant flow through the prosthetic valve and the first leaflet component and the second leaflet component have a gap disposed therebetween, the gap operable to permit flow of fluid from a first surface of the leaflet to a second surface of the leaflet. However, US ‘842 was silent as to the prosthetic valve comprising a plurality of leaflets or the frame or support structure is annular. Bruchman et al. teach that a prosthetic valve can be constructed with an annular support frame 600 and can include a plurality of leaflets 802 for a tricuspid valve. It would have been obvious to one of ordinary skill in the art to utilize an annular support structure or frame along with three leaflets as taught by Bruchman et al. in the prosthetic valve of US ‘842 such that it can be placed at a heart valve location and have sufficient valve flow control measures using a plurality of leaflets. With respect to claim 2, see claim 1 of US ‘842. Regarding claim 3, see claim 4 of US ‘842. With respect to claims 4,18 see claim 2 of US ‘842. Regarding claim 5, see claim 1 of US ‘842. Regarding claim 6, see claim 1 of US ‘842. Regarding claim 7, see claim 1 of US ‘842. Regarding claim 8, see claim 6 of US ‘842. Regarding claim 9, see claim 6 of US ‘842. With respect to claim 11, Bruchman teaches the prosthetic valve is to include three leaflets in a tricuspid arrangement. Regarding claim 12, see claim 10 of US ‘842. Regarding claim 13, see claim 13 of US ‘842. Regarding claim 15, see claim 1 of US ‘842 stating alternative arrangements. Regarding claim 16, see claim 1 of US ‘842. With respect to claim 17, see claims 4-6 of US ‘842.
Claims 10,19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and dependents of U.S. Patent No. 10952842 in view of Bruchman et al. (8961599) and Bailey et al. (2008/0183279). US ‘842 in view of Bruchman ‘599 is explained supra. However, US ‘842 in view of Bruchman ‘599 did not claim the inflow free edge defines a space between the second leaflet component and the frame. Bailey et al. teach (Fig. 7A) that the inflow free edge defines a space 706 between the second leaflet component 700 and the frame. It would have been obvious to one of ordinary skill in the art to arrange the inflow free edge to define a space between the second leaflet component and the frame as taught by Bailey et al. in the valve prosthesis of US ‘842 as modified with Bruchman et al. such that it is enabled to permit controlled retrograde flow, see Bailey.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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