DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: gap 117a, 117b, 117c in [0078]. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 11-13, 18-20 is/are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Alkhatib (WO 2009/045331).
Alkhatib discloses the following limitations:
Claim 11. An implantable prosthetic valve ([0002]) comprising:
a radially collapsible and expandable annular frame (10 + 100) comprising a plurality of rows of circumferentially extending struts (see annotated figure below), including an uppermost, first row of circumferentially extending struts (two struts in the annotated figure are pointed to below, however the entire row containing these struts is considered the claimed first row), a second row of circumferentially extending struts (two struts in the annotated figure are pointed to below, however the entire row containing these struts is considered the claimed second row) upstream of the first row of circumferentially extending struts, and a lowermost, third row of circumferentially extending struts two struts in the annotated figure are pointed to below, however the entire row containing these struts is considered the claimed third row), wherein the circumferentially extending struts are arranged to form a plurality of circumferentially extending rows of closed cells, including an uppermost row of closed cells at least partially defined by the first and second rows of circumferentially extending struts (the first row of struts define the top of the uppermost row of closed cells and the second struts define the bottom of the uppermost row of closed cells) and a lowermost row of closed cells at least partially defined by the third row of circumferentially extending struts (third row of struts defines the bottom of the lowermost row of closed cells), and
a leaflet structure (200) positioned within the frame, the leaflet structure comprising a plurality of leaflet sections (210a, 210b, 210c) joined to one another to form commissures of the leaflet structure (Fig. 1B, 11A, 11B; [0047], [0050], [0062]),
wherein the frame comprises a plurality of commissure support portions (110) supporting respective commissures of the leaflet structure ([0048], [0051]-[0054], [0076]), and
wherein each closed cell of the uppermost row of closed cells has a circumferential width that is greater than a circumferential width of each closed cell of the lowermost row of closed cells (Figs. 1, 6, 8, 9).
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Claim 12. The implantable prosthetic valve of claim 11, wherein each closed cell of the uppermost row of closed cells has an axial height (Fig. 1A; height of sections 30 + 40) that is greater than an axial height (height of section 20) of each closed cell of the lowermost row of closed cells (Figs. 1, 6, 8, 9).
Claim 13. The implantable prosthetic valve of claim 11, wherein the lowermost row of closed cells comprises a greater number of closed cells than the uppermost row of closed cells (Figs. 1, 6, 8, 9).
Claim 18. The implantable prosthetic valve of claim 11, wherein each commissure support portion comprises a pair of struts ([0053]; “two members that make up each commissure post 110”) extending parallel to each other and spaced apart from each other so as to define an opening of the commissure support portion therebetween (Fig. 11A, 11B; [0076]).
Claim 19. The implantable prosthetic valve of claim 18, wherein each commissure extends radially outwardly through the opening of a respective commissure support portion and are secured to the commissure support portion outside of the frame (Fig. 11A, 11B; [0076]).
Claim 20. The implantable prosthetic valve of claim 11, wherein the lowermost row of closed cells comprises exactly twelve inflow apices at an inflow end of the frame. (Figs. 7A, 7B, 12).
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11596515.
Although the claims at issue are not identical, they are not patentably distinct from each other because the elements of claims 1-20 of the instant application are to be found in claims 1-20 of the patent. Thus the difference between claims 1-20 of the instant application and claims 1-20 of the patent lies in the fact that the patent claims include many more elements and is thus much more specific. Thus, the invention of claims 1-20 of the patent is in effect a “species” of the “generic” invention of claims 1-20 of the instant application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims1-20 are anticipated by claims 1-20 of the patent, it is not patentably distinct from claims 1-20 of the patent.
Allowable Subject Matter
Claims 1-10 are allowed if the above double patenting rejection is obviated.
Claims 14-17 are 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 and if the above double patenting rejection is obviated.
The following is a statement of reasons for the indication of allowable subject matter:
In regards to claim 1, the closest prior art of record, Alkhatib, discloses an implantable prosthetic valve comprising: a radially collapsible and expandable annular frame (10 + 100) comprising a plurality of circumferentially extending struts (see annotated figure from the rejection of claim 11 above), wherein the circumferentially extending struts are arranged to form a plurality of circumferentially extending rows of closed cells see annotated figure from the rejection of claim 11 above), including an uppermost row of closed cells and a lowermost row of closed cells; and a leaflet structure (200) positioned within the frame ([0049], [0062], [0076]), the leaflet structure comprising a plurality of leaflet sections (210a, 210b, 210c) joined to one another to form commissures of the leaflet structure (Fig. 11a, 11b; [0076]), wherein the frame comprises a plurality of pairs of posts ([0053]; “two members that make up each commissure post 110”) adjacent to each of the commissures (Fig. 11a, 11b; [0076]), the posts of each pair being spaced apart from each other so as to define an opening therebetween, wherein each commissure extends radially outwardly through the opening of a respective pair of posts (Fig. 11a, 11b; [0076]), and wherein the lowermost row of closed cells comprises a greater number of closed cells than the uppermost row of closed cells (Figs. 1, 6, 8, 9). The prior art of record does not disclose or fairly suggest either singly or in combination the claimed implantable prosthetic valve comprising, inter alia, the pairs of posts have respective lower ends that are axially spaced from a lower end of the frame, wherein the uppermost row of closed cells is formed partly by an uppermost row of circumferentially extending struts of the frame interconnecting circumferentially adjacent posts.
In regards to claim 14, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed implantable prosthetic valve comprising, inter alia, the plurality of rows of circumferentially extending struts further comprises one or more intermediate rows of circumferentially extending struts positioned between the second and third rows of circumferentially extending struts. The prosthetic valve of Alkhatib only discloses the rows of struts as labeled in the annotated figure from claim 11.
In regards to claim 15, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed implantable prosthetic valve comprising, inter alia, the one or more intermediate rows of circumferentially extending struts comprises three or more intermediate rows of circumferentially extending struts. The prosthetic valve of Alkhatib only discloses the rows of struts as labeled in the annotated figure from claim 11. Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
In regards to claim 16, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed implantable prosthetic valve comprising, inter alia, each circumferentially extending strut of the first row of circumferentially extending struts is curved. The struts of Alkhatib are instead straight. There is no need to modify the struts of Alkhatib to be curved as these struts do not directly support the curved leaflets.
In regards to claim 17, Alkhatib discloses a cloth member (300) that is sutured (310) to the frame (Fig. 14; [0062]) the prior art of record does not disclose or fairly suggest either singly or in combination the claimed implantable prosthetic valve comprising, inter alia, a lower edge portion of each leaflet section is sutured to the cloth member. Instead, Alkhatib discloses a separate, additional cuff (300) can be sutured to the anchoring frame (10) for the leaflets ([0074]). It would not have been obvious to one of ordinary skill at the time the invention was made to modify the prosthetic valve of Alkhatib such that the leaflets are sutured to the same cloth member as the frame since the Alkhatib disclose a two-stage delivery where frame portion (100) is delivered separate from frame portion (10).
Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771