DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
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Claims 2-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,957,573 (hereinafter “the ‘573 patent”) in view of Morriss et al. (Pub. No.: US 2013/0310928 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because all of the structural elements of the present application are disclosed by the granted patent. Regarding independent claim 2 of the present application, the stent-valve of the application corresponds to the stent-valve of claims 1 and 15 of the patent. The stent with apertures of the application corresponds to the stent with apertures of the lattice of the patent. The leaflets of the prosthetic valve of the application correspond to the leaflets defining the prosthetic valve of the patent. The paravalve seal with the inner skirt, outer skirt, open mouth, and opposite closed end of the application corresponds to the paravalve seal with the inner skirt, outer skirt, and open mouth, and closed end of the patent. The ‘573 patent does not explicitly claim that the apertures have diamond shapes. Morriss teaches that it is well known in the art that the lattice structures of stents comprise a variety of aperture/cell shapes and configurations, including a diamond shape (e.g., Fig. 7A1; para. 0150), as would be needed to provide the stent with the desired shape and mechanical properties needed to suit the implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the shapes of the apertures, according to the teachings of Morriss, in order to provide the stent with the desired shape and mechanical properties needed to suit the implantation site.
The limitations of claims 3 and 6 of the application correspond to claim 4 of the patent. The limitations of claim 4 of the application correspond to claim 2 of the patent. The limitations of claim 5 of the application correspond to claim 3 of the patent. The limitations of claim 7 of the application correspond to claim 5 of the patent. The limitations of claim 8 of the application correspond to claim 6 of the patent. The limitations of claim 9 of the application correspond to claim 7 of the patent. The limitations of claim 10 of the application correspond to claim 8 of the patent. The limitations of claim 11 of the application correspond to claims 9-10 of the patent. The limitations of claim 12 of the application correspond to claims 12 and 16 of the patent. The limitations of claim 13 of the application correspond to claim 14 of the patent.
Claim Objections
Claims 1 and 3 are objected to because of the following informalities: claim 1 appears to have a misplaced semi-colon in line 3. Claim 3 appears to be missing a period. Appropriate correction is required.
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.
Claims 6 and its dependent claims are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 6 recites that the cantilever elements can have an integral construction with the stent. This contradicts claim 3, which requires that the cantilever elements are fixed directly to the stent. Appropriate correction is required.
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) 2-13 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Morriss et al. (Pub. No.: US 2013/0310928 A1; hereinafter “Morriss”).
Morriss discloses the following regarding claim 2: a stent-valve for transcatheter implantation to replace a cardiac valve, the stent-valve (100) (e.g., Figs. 2E to 2F2-B) being compressible to a compressed state for delivery (paras. 0106-0107), and expandable to an operative state for implantation (paras. 0106-0107), the stent-valve comprising; a stent (110, 140) having an inflow end (165) and an outflow end (164), the stent including a lattice structure (140) having a plurality of apertures (open cells of the stent), the plurality of apertures includes diamond shaped apertures (e.g., Figs. 2H-2 and 7A1; para. 0150) disposed around the stent near the inflow end (e.g., Figs. 2E to 2F2-B, 2H-2, 7A1); a plurality of leaflets (150) for defining a prosthetic valve (para. 0155) disposed at least in part within the stent (e.g., Fig. 2F); a paravalve seal (160, 160A, 160B, 151, 166) for sealing against surrounding tissue (paras. 0205-0208), wherein the paravalve seal comprises a skirt (paras. 0205-0208), the skirt including an inner skirt (e.g., 151, 166) disposed on an interior of the stent (Figs. 2E to 2F2-B; paras. 0205-0208) and an outer skirt (e.g., 160A, 160B, 163) disposed on an exterior of the stent (Figs. 2E to 2F2-B; paras. 0205-0208), the inner skirt and outer skirt together defining one or more pocket (openings formed by elements 160, 160A, 160B, 151, 166), wherein the outer skirt or portions thereof is biased radially outwardly to distend away from the body of the stent at the diamond shaped apertures (paras. 0150, 0208) such that each pocket defines an open mouth facing towards an outlet end of the stent (e.g., Figs. 2E to 2F2-B, 2H-2, 7A to 7B; paras. 0205-0208), and an end of the pocket opposite the mouth is closed (e.g., Figs. 2E to 2F2-B, 2H-2, 7A to 7B; paras. 0205-0208).
Morriss discloses the following regarding claim 3: the stent-valve of claim 2, including a seal support comprises a plurality of cantilever elements (e.g., sutures or arms) fixed directly to the stent and biased radially outward from the stent and holding the mouth of the pocket open and radially outward away from the stent (paras. 0205-0208, 0241-0243)
Morriss discloses the following regarding claim 4: the stent-valve of claim 3, wherein each of the cantilever elements comprises a single strut or plural struts (paras. 0205-0208, 0241-0243).
Morriss discloses the following regarding claim 5: the stent-valve of claim 4, wherein each of the cantilever elements is associated with a respective aperture of a lattice structure (140) of the stent (e.g., Figs. 2E to 2F2-B, 2H-2, 7A to 7B; paras. 0205-0208, as the elements and the lattice are linked together).
As best interpreted, Morriss discloses the following regarding claim 6: the stent-valve of claim 5, wherein each of the cantilever elements has one end coupled directly to or integral with the stent, and an opposite or remote end that is free to deploy outwardly (e.g., Figs. 2E to 2F2-B; paras. 0205-0208, 0241-0243).
Morriss discloses the following regarding claim 7: the stent-valve of claim 6, wherein the cantilever elements extend generally in the same direction as each other, or, where the cantilever elements are arranged in two opposite directions or in a variety of different directions (e.g., Figs. 2E to 2F2-B).
Morriss discloses the following regarding claim 8: the stent-valve of claim 7, wherein the pocket is pushed outwardly by the cantilever elements (paras. 0206-0208).
Morriss discloses the following regarding claim 9: the stent-valve of claim 8, wherein the pocket is positioned such that back-pressure of blood, or para-valvular blood flow in the reverse direction from outlet to inlet end of the stent, fills the pocket to cause the pocket to further to distend, thereby enhancing the seal effect to obstruct para-valvular flow (paras. 0205-0208).
Morriss discloses the following regarding claim 10: the stent-valve of claim 9, wherein the seal support at least partly biases the skirt outwardly into engagement with surrounding tissue (para. 0208).
Morriss discloses the following regarding claim 11: the stent-valve of claim 2, including a seal support, wherein the seal support is defined by an upper crown of the stent (where the paravalve seal elements are connected to the upper crown portions of the stent) (e.g., Figs. 2F to 2F2-B).
Morriss discloses the following regarding claim 12: the stent-valve of claim 2, wherein one wall of each pocket is defined by a portion of the outer skirt and another wall of each pocket is defined by a portion of the inner skirt (e.g., Figs. 2F to 2F2-B).
Morriss discloses the following regarding claim 13: the stent-valve of claim 2, wherein a portion of the stent extends beyond the pocket towards both an inflow end and an outflow end of the stent-valve (Fig. 2F2-A).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
