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 .
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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,575,928. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claim is merely broader than the patent claim. Here, all of the elements of application claims 1-15 are found in patent claims 1-18. The difference between the claims is that the patent claim includes many more elements and thus is much more specific. Thus, the invention of claims 1-18 of the patent is in effect a “species” of the “generic” invention of application claims 1-15. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims 1-15 are anticipated by patent claims 1-18, the claims are not patentably distinct.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Christianson et al. (U.S. Pat. No.: 10,758,346)
Christianson et al. (hereinafter, Christianson) discloses an implantable heart-valve apparatus (abstract), comprising:
a tubular body 102 having an inflow end and an outflow end, wherein the tubular body comprises a braided frame (col. 13 lines 43-50);
an atrial sealing skirt 103 extending outwardly from the inflow end to form a flange, wherein the atrial sealing skirt comprises a fabric covering configured to seal against atrial tissue (fig. 1, col. 4 lines 11-20); and
a plurality of engagement attachments extending from the outflow end and comprising a leaflet anchor 111 and a U-shaped stabilization anchor 269, wherein the U-shaped stabilization anchor extends in a direction toward the inflow end and is configured to be positioned behind one or more native valve leaflets (fig. 1, 14a-c), and wherein at least one of the plurality of engagement attachments and the tubular body define a singular component (fig. 1).
For claim 2, Christianson discloses the implantable heart-valve apparatus of claim 1, wherein at least one of the plurality of engagement attachments 123 is grafted onto the braided frame (e.g., fig. 4-5).
For claim 4, Christianson discloses the implantable heart-valve apparatus of claim 1, wherein the braided frame comprises a first wire and at least one of the plurality of engagement attachments comprises a second wire attached to the first wire (e.g., fig. 4-5).
For claim 5, Christianson discloses the implantable heart-valve apparatus of claim 2, wherein the U- shaped stabilization anchor is a first U-shaped stabilization anchor 269, and wherein the implantable heart-valve apparatus comprises a second U-shaped stabilization anchor 270 position between 120 to 180 degrees apart from the first U-shaped stabilization anchor (e.g., fig. 16).
For claim 6, Christianson discloses the implantable heart-valve apparatus of claim 1, wherein the braided frame carries a replacement heart valve 258.
For claim 7, Christianson discloses the implantable heart-valve apparatus of claim 1, wherein the U-shaped stabilization anchor has a bend in a free end of the U-shaped stabilization member (e.g., fig. 1).
For claim 8, Christianson discloses an implantable heart valve device, comprising:
a braided (col. 13 lines 43-50) frame 102 having an inflow end and an outflow end;
a flange 103 extending radially outward from the inflow end and configured to form a seal against atrial tissue surrounding a native valve annulus (fig. 1); and
a plurality of engagement attachments extending outwardly from the outflow end of the braided frame, the engagement attachments comprising a leaflet clip 111 and a U-shaped stabilization anchor 269, wherein the U-shaped stabilization anchor extends in a direction toward the inflow end (e.g., fig. 1), and wherein at least one of the plurality of engagement attachments is integrally formed with the braided frame (e.g., fig. 1).
For claim 9, Christianson discloses the implantable heart-valve system of claim 8, wherein at least one of the plurality of engagement attachments is attached to the braided frame via welding or grafting (fig. 4-5).
For claim 10, Christianson discloses the implantable heart-valve system of claim 8, wherein the braided frame comprises a first wire and at least one of the plurality of engagement attachments comprises a second wire attached to the first wire (fig. 4-5).
For claim 11, Christianson discloses the implantable heart-valve system of claim 8, wherein the braided frame and the engagement attachments are integrally formed as a single component (fig. 1, 16).
For claim 12, Christianson discloses the implantable heart-valve system of claim 8, wherein the braided frame is configured to receive a replacement heart valve 258.
For claim 13, Christianson discloses the implantable heart-valve system of claim 8, further comprising a valve structure 231 varied by the braded frame (col. 19 lines 30-38).
For claim 14, Christianson discloses the implantable heart-valve system of claim 8, wherein the flange comprises a fabric covering configured to fill space around the native valve annulus (fig. 1).
For claim 15, Christianson discloses the implantable heart-valve system of claim 8, further comprising a delivery component having at least one suture line 311 connected to at least one of the plurality of engagement attachments (e.g., fig. 21).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Christianson et al. (U.S. Pat. No.: 10,758,346)
Christianson does not specifically disclose at least one of the plurality of engagement attachments is welded onto the braided frame. Christianson does disclose engagement attachment 111 attached at attachment points 119 (e.g., fig. 4), however does not specify the form of this attachment. Welding is a well-known and obvious attachment for wire components; therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided attachment point 119 as a weld as an obvious selection of a known attachment between wire components. This modification would have occurred using known methods and would have yielded predictable results.
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774
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