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 § 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 9, 11-12, 14, 21, 22-26, and 30 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.
Regarding claims 9, 21, 26, and 30, the claims recite that a structure “comprises a radial force when in a compressed state”. It is unclear how a structure can “comprise a radial force”. A radial force can act upon a structure, or a structure can be responsive to a force acted upon it, but a structure itself cannot merely comprise a “radial force”. Therefore, the claims are indefinite. For examination purposes, it will be presumed that a radial force is exerted upon the structure when the structure is in a compressed state.
Regarding claims 11 and 22, the claims recite that the commissure tab is at an inflow end. Claim 1 recites that the commissure tab is at the outflow end. As known in the art (and evidenced by the references cited below), commissure tabs are understood to be located at the outflow end of prosthetic heart valve. A quick search of the prior art failed to find instances of commissure tabs being at the inflow end of the valve. The specification and disclosure of the instant application do not teach and/or discuss commissure ends at the inflow ends of the valve. Therefore, it is unclear how commissure tabs could be arranged at the inflow end of the valve, rendering the claims indefinite. Claims 12, 14, 21, and 23-26 are indefinite by virtue of their dependencies on indefinite base claims 11 and 22.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-9, 10, 13, 15-21, 22-26, and 27-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2011/0319988 A1 to Schankereli et al. (hereinafter “Schankereli”) (cited in an IDS dated 08/06/2025).
Regarding claim 1, Schankereli discloses (see abstract; Figs. 1-13; and [0077]-[0164]) a device (as shown in Figs. 1-13) for assisting the functioning of a heart valve (see at least [0077]-[0078]), comprising: a tubular braided frame (112, see Fig. 1 and [0125]-[0126]) comprising an inflow end (near #110, Fig. 1) and an outflow end (near #114, Fig. 1); a flange structure (116) at the inflow end of the tubular braided frame (see Fig. 1); at least one anchor (114 + 138) at the outflow end of the tubular braided frame (see Figs. 1/5 and [0127]/[0140]); at least one commissure tab (146) at the outflow end of the tubular braided frame (see Figs. 3E/6 and [0138]); and a leaflet assembly (120) connected to the at least one commissure tab (see [0138] and [0097]-[0099]), wherein the leaflet assembly is configured to provide a seal between the inflow end and the outflow end of the tubular braided frame (see [0099]).
Schankereli further discloses (claim 2) wherein the tubular braided frame further comprises at least one braided wire wound in a helical spiral direction (see [0092]/[0095]), wherein the helical spiral direction begins at the inflow end and ends at the outflow end (see [0092]/[0095]); and wherein the tubular braided frame is configured to lengthen and compress in relation to a heart contraction (see [0092]/[0093]; [0095]/[0096]; and [0085]-[0090], the braided frame is made of the same nitinol wire as the cuff, the discussion about the cuff being able to lengthen and compress in response to heart contraction or other forces imposed on it would be understood to be equally applicable to the braided frame); (claim 3) wherein the at least one braided wire comprises a first material type of wire, wherein the first material type of wire comprises a first wire type (nitinol or other alloys listed at [0092], see [0092]/[0093] and [0095]/[0096]); (claim 4) wherein one or both of the flange structure and the at least one anchor comprises one or both of the first wire type and a second material type of wire, wherein the second material type of wire comprises a second wire type (see [0086]/[0090], can be nitinol or other alloys listed at [0090], thus allowing the braided frame wire to be either the same or different material as the flange wire); (claim 5) wherein one or both of the flange structure and the at least anchor is configured to be radially overlapping with the tubular braided frame (see Figs. 7-8, radially overlap immediately adjacent to connection point between cuff and stent body); (claim 6) wherein a layer of material extends over one or more of the following: an outside portion of the tubular braided frame, an inside portion of the tubular braided frame, a top portion of the flange structure, a bottom portion of the flange structure, a top portion of the at least one anchor, and a bottom portion of the at least one anchor (see [0113] and [0136]); (claim 7) wherein the tubular braided frame further comprises an engagement attachment, wherein the engagement attachment comprises a barb (158) (see Fig. 11 and [0147]); (claim 8) wherein the layer of material extending over the outside portion of the tubular braided frame comprises one or more belt loops at one or both of the inflow end and the outflow end of the tubular braided frame (see Figs. 5/7 showing layer of material on outside of frame (as per [0113]/[0136]) covering 114 forming a belt loop); and (claim 9) wherein the tubular braided frame comprises a radial force when in a compressed state; wherein the tubular braided frame is configured to expand in relation to the radial force when the device is delivered to the heart valve (see [0093]/[0126]).
Regarding claim 10, Schankereli discloses (see abstract; Figs. 1-13; and [0077]-[0164]) a device (as shown in Figs. 1-13) for assisting the functioning of a heart valve (see at least [0077]-[0078]), comprising: an adapter (112, see Fig. 1 and [0125]-[0126]) comprising a tubular braided adapter frame (see [0125]-[0126]) that comprises an inflow end (near #110, Fig. 1) and an outflow end (near #114, Fig. 1); a flange structure (116) at the inflow end of the tubular braided adapter frame (see Fig. 1); and at least one anchor (114 + 138) at the outflow end of the tubular braided adapter frame (see Figs. 1/5 and [0127]/[0140]).
Schankereli further discloses (claim 13) wherein the tubular braided frame further comprises at least one braided wire wound in a helical spiral direction (see [0092]/[0095]), wherein the helical spiral direction begins at the inflow end and ends at the outflow end (see [0092]/[0095]); and wherein the tubular braided frame is configured to lengthen and compress in relation to a heart contraction (see [0092]/[0093]; [0095]/[0096]; and [0085]-[0090], the braided frame is made of the same nitinol wire as the cuff, the discussion about the cuff being able to lengthen and compress in response to heart contraction or other forces imposed on it would be understood to be equally applicable to the braided frame); (claim 15) wherein the at least one braided wire comprises a first material type of wire, wherein the first material type of wire comprises a first wire type (nitinol or other alloys listed at [0092], see [0092]/[0093] and [0095]/[0096]); (claim 16) wherein one or both of the flange structure and the at least one anchor comprises one or both of the first wire type and a second material type of wire, wherein the second material type of wire comprises a second wire type (see [0086]/[0090], can be nitinol or other alloys listed at [0090], thus allowing the braided frame wire to be either the same or different material as the flange wire); (claim 17) wherein one or both of the flange structure and the at least anchor is configured to be radially overlapping with the tubular braided frame (see Figs. 7-8, radially overlap immediately adjacent to connection point between cuff and stent body); (claim 18) wherein a layer of material extends over one or more of the following: an outside portion of the tubular braided frame, an inside portion of the tubular braided frame, a top portion of the flange structure, a bottom portion of the flange structure, a top portion of the at least one anchor, and a bottom portion of the at least one anchor (see [0113] and [0136]); (claim 19) wherein the tubular braided frame further comprises an engagement attachment, wherein the engagement attachment comprises a barb (158) (see Fig. 11 and [0147]); (claim 20) wherein the layer of material extending over the outside portion of the tubular braided frame comprises one or more belt loops at one or both of the inflow end and the outflow end of the tubular braided frame (see Figs. 5/7 showing layer of material on outside of frame (as per [0113]/[0136]) covering 114 forming a belt loop); and (claim 21) wherein the tubular braided frame comprises a radial force when in a compressed state; wherein the tubular braided frame is configured to expand in relation to the radial force when the device is delivered to the heart valve (see [0093]/[0126]).
Regarding claim 22, Schankereli discloses (see abstract; Figs. 1-13; and [0077]-[0164]) a device (as shown in Figs. 1-13) for assisting the functioning of a heart valve (see at least [0077]-[0078]), comprising: a valve assembly (as shown in Fig. 1) comprising a tubular braided frame (112, see Fig. 1 and [0125]-[0126]), wherein the valve assembly comprises inflow end (near #110, Fig. 1) and an outflow end (near #114, Fig. 1); wherein the valve assembly comprises at least one commissure tab (146) at the inflow end (see Figs. 3E/6 and [0138] and [0104], depending on the native valve being treated, the directionality of the prosthesis could change such that the inflow and outflow ends are reversed); and a leaflet assembly (120) connected to the at least one commissure tab (see [0138] and [0097]-[0099]), wherein the leaflet assembly is configured to provide a seal between the inflow end and the outflow end of the tubular braided frame (see [0099]).
Schankereli further discloses (claim 23) wherein the tubular braided frame further comprises at least one braided wire wound in a helical spiral direction (see [0092]/[0095]), wherein the helical spiral direction begins at the inflow end and ends at the outflow end (see [0092]/[0095]); and wherein the tubular braided frame is configured to lengthen and compress in relation to a heart contraction (see [0092]/[0093]; [0095]/[0096]; and [0085]-[0090], the braided frame is made of the same nitinol wire as the cuff, the discussion about the cuff being able to lengthen and compress in response to heart contraction or other forces imposed on it would be understood to be equally applicable to the braided frame); (claim 24) wherein the valve assembly comprises a first material type of wire, wherein the first material type of wire comprises a first wire type (nitinol or other alloys listed at [0092], see [0092]/[0093] and [0095]/[0096]); (claim 25) wherein a layer of material extends over one or both of an outside portion of the valve assembly and an inside portion of the valve assembly (see [0113] and [0136]); and (claim 26) wherein the tubular braided frame comprises a radial force when in a compressed state; wherein the tubular braided frame is configured to expand in relation to the radial force when the device is delivered to the heart valve (see [0093]/[0126]).
Regarding claim 27, Schankereli discloses (see abstract; Figs. 1-13; and [0077]-[0164]) a device (as shown in Figs. 1-13) for assisting the functioning of a heart valve (see at least [0077]-[0078]), comprising: a tubular frame (112, see Fig. 1 and [0125]-[0126]) comprising an inflow end (near #110, Fig. 1) and an outflow end (near #114, Fig. 1); wherein the tubular frame further comprises at least one braided wire wound in a helical spiral direction (see [0092]/[0095]), wherein the helical spiral direction begins at the inflow end and ends at the outflow end (see [0092]/[0095]); and wherein the tubular braided frame is configured to lengthen and compress in relation to a heart contraction (see [0092]/[0093]; [0095]/[0096]; and [0085]-[0090], the braided frame is made of the same nitinol wire as the cuff, the discussion about the cuff being able to lengthen and compress in response to heart contraction or other forces imposed on it would be understood to be equally applicable to the braided frame).
Schankereli further discloses (claim 28) wherein the tubular frame comprises a first material type of wire, wherein the first material type of wire comprises a first wire type (nitinol or other alloys listed at [0092], see [0092]/[0093] and [0095]/[0096]); (claim 29) wherein a layer of material extends over one or both of an outside portion of the tubular frame and an inside portion of the tubular frame (see [0113] and [0136]); and (claim 30) wherein the tubular frame comprises a radial force when in a compressed state; wherein the tubular frame is configured to expand in relation to the radial force when the device is delivered to the heart valve (see [0093]/[0126]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 10-12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0029072 A1 to Gabbay (hereinafter “Gabbay”) in view of Schankereli.
Regarding claim 10, Gabbay discloses (see abstract; Figs. 1-7; and [0020]-[0071]) a device (as shown in the Figures) for assisting the functioning of a heart valve (see at least [0020]), comprising: an adapter (10) comprising a tubular adapter frame (20 + 22) that comprises an inflow end (at #20, Fig. 1) and an outflow end (at #22, Fig. 1); a flange structure (14, see Fig. 2) at the inflow end of the tubular braided adapter frame (see [0027]-[0028]); and at least one anchor (34) at the outflow end of the tubular braided adapter frame (see Figs. 1-2 and [0026]).
Gabbay further discloses (claim 11) a valve assembly (12 + 16); wherein the valve assembly comprises a tubular valve-assembly frame (12) comprising a second inflow end (near #78, Fig. 2) and a second outflow end (near #80, Fig. 2); wherein the valve assembly comprises at least one commissure tab (80) at the second inflow end (see Fig. 2 and [0036]); wherein the valve assembly comprises a leaflet assembly (76/82) connected to the at least one commissure tab (see Fig. 2 and [0036]); wherein the leaflet assembly is configured to provide a seal between the second inflow end and the second outflow end (see [0036]); and (claim 12) wherein the valve assembly is configured to removably engage with the adapter, wherein the inflow end of the adapter is proximal in location to the second inflow end and the outflow end of the adapter is proximal in location to the second outflow end (see Figs. 3-5 and [0042]-[0043], capable of being removed by removing the sutures).
Gabbay fails to specifically disclose, with respect to claim 10, wherein the tubular adapter frame is braided; with respect to claim 11, wherein the tubular valve-assembly frame is braided; and with respect to claim 14, wherein the tubular braided valve-assembly frame further comprises at least one braided wire wound in a helical spiral direction, wherein the helical spiral direction begins at the second inflow end and ends at the second outflow end; and wherein the at least one braided wire wound in a helical spiral direction is configured to lengthen and compress in relation to a heart contraction. Gabbay discloses that both support structures 10 and 12 are formed of a shape memory alloy such as nitinol (see [0033]), but fails to disclose that the nitinol wires are braided (Gabbay is silent as to how the nitinol is formed to construct the frame).
Schankereli discloses, in the same field of endeavor, (see abstract; Figs. 1-13; and [0077]-[0164]) a device (as shown in Figs. 1-13) for assisting the functioning of a heart valve (see at least [0077]-[0078]), comprising: an adapter (112, see Fig. 1 and [0125]-[0126]) comprising a tubular adapter frame (see [0125]-[0126]) that comprises an inflow end (near #110, Fig. 1) and an outflow end (near #114, Fig. 1); a flange structure (116) at the inflow end of the tubular braided adapter frame (see Fig. 1); and at least one anchor (114 + 138) at the outflow end of the tubular braided adapter frame (see Figs. 1/5 and [0127]/[0140]), wherein the tubular adapter frame is braided (see [0092]/[0095]) such that the frame comprises at least one braided wire wound in a helical spiral direction (see [0093]/[0095]), wherein the helical spiral direction begins at the inflow end and ends at the outflow end (see [0093]/[0095]); and wherein the tubular braided frame is configured to lengthen and compress in relation to a heart contraction (see [0092]/[0093]; [0095]/[0096]; and [0085]-[0090], the braided frame is made of the same nitinol wire as the cuff, the discussion about the cuff being able to lengthen and compress in response to heart contraction or other forces imposed on it would be understood to be equally applicable to the braided frame), and further discloses wherein the tubular braided frame is made of nitinol (see [0092]/[0095]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of use of a known technique to improve similar devices in the same way, (see KSR International Co. v. Teleflex Inc., 550 U.S. 398,82 USPQ2d 1385,1395- 97(2007)), to obtain the predictable result of a nitinol frame suitable for use in a heart valve prosthesis, by making the nitinol frame out of a braided wire material since Schankereli discloses the known technique of fabricating heart valve stents out of braided nitinol frame, and thus one of ordinary skill would have found it predictable without undue experimentation and with a reasonable expectation of success to fabricate Gabbay's frame out of braided nitinol, as taught by Schankereli, as a suitable fabrication technique to arrive at the nitinol frame contemplated by Gabbay.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 10, 13, 17-21, 27-30 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 5, 9-13, 19-22 of copending Application No. 18/694,897 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claims 10-21, 22-26, and 27-30 of this application is patentably indistinct from claims 1-13, 14-18, and 19-22 of Application No. 18/694,897 (noting the 112b rejection of inflow/outflow end as discussed above). Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
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 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-37 of copending Application No. 18/694,897 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the current claims are broader than and thus are “anticipated by” the claims of ‘897 as follows:
Current claim 1 is fully anticipated by claim 29 of ‘897.
Dependent claims 2-9 correspond to dependent claims 30-37 of the ‘897 application
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771