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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Murad 2023/0210657 or alternatively by Murad 11,931,251.
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
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Regarding claim 1, Murad discloses a system for crimping a prosthetic heart valve to a delivery apparatus, comprising: a support body (1010) having a central channel (1030) and a support surface (1012) that extends around the central channel, wherein the support surface has a tapered shape (see fig. 45 supra), wherein the support surface is configured to receive the prosthetic heart valve thereon and support one or more leaflets of the prosthetic heart valve in an open position, and wherein the central channel is configured for the delivery apparatus to extend therethrough; and
a crimping device (1084) including a channel (see [0399] and 1090) configured to receive the prosthetic heart valve and a first opening to the channel on a first side of the crimping device, the first opening configured to receive the support body therethrough.
Regarding claim 2, Murad discloses wherein the support body comprises a first portion and a second portion, the second portion comprising the support surface that tapers from a wider end disposed adjacent the first portion to a narrower end, and wherein the first portion comprises an axially extending alignment device (element 1024 and [0400]).
Regarding claims 3, 5 and 16 “…first opening of the crimping device includes a cut out portion configured to receive the alignment device and rotationally align the support body with the crimping device.” (the current specification recites a proximal opening and distal opening). Murad disclose proximal opening (which is interpreted as the first opening “94”) and distal opening (which is interpreted as the second opening “106”) which are configured to receive the alignment device and rotationally align the support body with the crimping device (see [0406]).
Regarding claim 4 see pressing surfaces (1000) and [00399]).
Regarding claim 6, this is functional language (see MPEOP 2114); The device of Murad is capable of performing the function (see [0408]).
Regarding claim 7, see [0014; 0171] frame (12) which carries the leaflets.
Regarding claim 8, see delivery apparatus (100) in Fig. 3.
Regarding claims 9 and 11, see indicators [0419] and “1050”.
Regarding claims 10 and 18, see explanation with regards to claim 1 supra and further see the ring body (aka alignment ring) as mentioned in [0405] fig. 48; element “1038”.
Regarding claim 12, see indicators 105 and fig. 46 [0419].
Regarding claim 13, “wherein the ring body includes a first arm and a second arm, with the first arm coupled to the second arm at a pivot, and wherein the first arm and the second arm are rotatable about the pivot (1060) from a closed position where the first and second arms of the ring body are closed around the support body to an open position where ends of the first and second arms are moved away from one another and the ring body is removable from the support body (see arms 1052 and 1054 [0423-0424]).
Regarding claim 14, “wherein the ring body includes an axially extending coupler, and wherein the first portion of the support body includes a recess configured to receive the coupler and rotationally align the ring body with the support body (see [0406 and 0423] The coupler e.g. 1013 (also can be referred to as a coupling interface).
Regarding claim 15, see crimping device as mentioned with regards to claim 1.
Regarding claim 16, see supra.
Regarding claim 17, see [0291; 0316; 0465] which discusses rotationally alignment of the commissures of the valve.
Regarding claim 18, see discussion supra.
Regarding claim 19 see element “1070” and [0405].
Regarding claim 20, see discussion supra in claim 2 with regards to the axially extending alignment device.
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 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,944,559 (hereafter ‘559) in view of U.S.11,931,251 (hereafter ‘251) Murad. Although the claims at issue are not identical, they are not patentably distinct from each other. For example current application clams 1 and 2 recite:
“1. A system for crimping a prosthetic heart valve to a delivery apparatus, comprising: a support body having a central channel and a support surface that extends around the central channel, wherein the support surface has a tapered shape, wherein the support surface is configured to receive the prosthetic heart valve thereon and support one or more leaflets of the prosthetic heart valve in an open position, and wherein the central channel is configured for the delivery apparatus to extend therethrough; and a crimping device including a channel configured to receive the prosthetic heart valve and a first opening to the channel on a first side of the crimping device, the first opening configured to receive the support body therethrough.”
“2. The system of claim 1, wherein the support body comprises a first portion and a second portion, the second portion comprising the support surface that tapers from a wider end disposed adjacent the first portion to a narrower end, and wherein the first portion comprises an axially extending alignment device.
Pat. ‘599 claim 1 recites:
“1. A support body for a prosthetic heart valve, comprising: a first portion comprising an alignment device configured to couple with a crimping device; a second portion comprising a support surface that tapers from a wider end disposed adjacent the first portion to a narrower end, wherein the support surface is configured to receive the prosthetic heart valve thereon and hold one or more leaflets of the prosthetic heart valve in an open position; and a central channel extending through the first portion and the second portion, the central channel configured to receive a delivery apparatus for the prosthetic heart valve therethrough.”
It is obvious to one having ordinary skill in the art that the subject matter of the current claim 1 is merely recited in a varied manner and that claim ‘559 is narrower in scope requiring more limitations such as the alignment device etc. Further pat. ‘599 recites an axially extending alignment device in claim 2.
Pat. 599 further recites a ring body with a coupler configured to rotationally align the prosthetic heart valve on the support surface (see claim 5).
Murad teaches all of the other limitations throughout the disclosure as explained supra (with reference to 2023/0210657). It would have been obvious to combine these feature with the pat. ‘559 in order to provide an improved delivery apparatuses for deploying balloon-expandable prosthetic heart valves in a desired rotational orientation relative to the native valve, such that prosthetic heat valve commissures are in alignment with the native valve commissures.
Conclusion
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. 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:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 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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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 July 14, 2026
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