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 .
Information Disclosure Statement
The claims of the instant invention are specifically directed to an anchoring system of an prosthetic valve prosthesis within a native valve using a tether. A review of the citations and their apparent relevance as they relate to the claimed invention has been evaluated for the numerous IDS submissions and particularly that filed 9/24/25. This IDS was found to have at least 23 documents irrelevant to the claims. Applicant is advised that in submitting information relevant to the claimed invention, to supply information that caused it to be submitted. It is noted that failing to provide the factual basis for each reference cited in any IDS might be held to be a non bona fide submission when large numbers of references or total IDS submissions are presented before the office.
Claim Objections
Claim 2 is objected to because of the following informalities: the clause “around a least” is grammatically incorrect. Appropriate correction is required.
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.
Claim(s) 1,4,10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gandhi (9579425). Gandhi discloses (col. 3, lines 51-57) a system for anchoring a valve prosthesis. Fig. 5a shows the system comprising: an anchor comprising a wire 24 having a shape and size to engage with chordae tendineae and/or leaflets of a native valve; and a tether 52 releasably coupled to a proximal end of the anchor, the tether configured to maintain or adjust a position of the anchor, the tether comprising a cable 54 housed within a tubular housing 60. Please note claims are given their broadest reasonable interpretation and in this instance the claim fails to recite any degree of specificity how much the cable is required to be within the housing, thus the scope can encompass any amount, even a minimal degree of encasing. Thus, it is inherent that the end of the cable must be within the housing to some extent to enable it to be coupled thereto. It can be seen (Figs. 5a,b) a distal end of the tubular housing having a connector 64 with an opening sized and shaped to accept and engage with an engagement feature 28 at the proximal end of the anchor, the connector configured to transition between a locked state (Fig. 5b) to secure the anchor with the tether, and an unlocked state (Fig. 5a) to decouple the anchor and the tether. Regarding claim 4, it can be construed that at a distal end of the cable 54 there is a corresponding engagement feature 64 configured to engage with the engagement feature of the anchor. With respect to claim 10, Gandhi discloses (col. 5, lines 17-20) the stent has a diameter of 0.05 inches and since the tether is smaller in diameter than the stent, see Fig. 4, the tether clearly has a diameter that falls within the claimed range of 0.03 – 0.05 inches.
Claim(s) 1,2,4,5,7-9,11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khairkhahan (2019/0175344). Khairkhahan disclose (paragraph 28) a system for anchoring a valve repair implant. Fig. 9C shows the system comprising: an anchor 800 comprising a wire having a shape and size to engage with chordae tendineae and/or leaflets of a native valve, see Fig. 9A. Fig. 9C also shows there is a tether 1235 releasably coupled to a proximal end of the anchor, the tether configured to maintain or adjust a position of the anchor, the tether comprising a cable housed within a tubular housing 1220, a distal end of the tubular housing having a connector 1225 with an opening sized and shaped to accept and engage with an engagement feature 1230 at the proximal end of the anchor, the connector configured to transition between a locked state to secure the anchor with the tether (square and cannot rotate), and an unlocked state to decouple the anchor and the tether, when disengaged or not coupled. Additionally Fig. 9B shows a further variation where a pin could be used to lock features of the tether and couple with the anchor, but can be disengaged to not lock together. Regarding claim 2, Fig. 9A shows the anchor as a spiral 815 which is fully capable of extending around at least a portion of a chordae tendineae. With respect to claim 4, Fig. 9C shows a distal end of the cable comprises a corresponding engagement feature (release screw) configured to engage with the engagement feature of the anchor, see paragraph 228. Regarding claim 5, it can be understood upon placement of the connector on the engagement feature of the anchor (see Fig. 9C), the connector is configured to radially surround the engagement feature of the anchor and the corresponding engagement feature of the cable when the connector is in the locked state. Regarding claim 11, Fig. 9B shows the connector comprises a retention wire 1210 that runs through the tubular housing and is threaded 1215 through an opening of the anchor to engage the tether with the anchor, see paragraph 227. Regarding claim 7, it can be construed that the anchor is rotationally locked with respect to the tether when the connector is in the locked state since it prevents rotation due to the shape. With respect to claim 8, Fig. 9C the anchor and the tether are rotationally locked with respect to the tubular housing when the connector is in the locked state since it cannot move regarding the shape preventing rotation and the elements are integral.
Claim(s) 1-3,6,16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Webler et al. (2004/0133274). Fig. 25 shows a system for anchoring a valve prosthesis 4400. Webler et al. also disclose (paragraph 87) the system can be constructed an anchor (annuloplasty device) disclosed by PGPUB (2005/0038506 referenced by applicant as examples-note applicant had the wrong app. # and corrected) comprising a wire 1010 having a shape and size to engage with leaflets of a native valve 210 see Fig. 60 of PUB ‘506. Fig. 25 also shows a tether 4428 releasably coupled to a proximal end of the anchor, the tether configured to maintain or adjust a position of the anchor, the tether comprising a cable housed within a tubular housing 4008, a distal end of the tubular housing having a connector 412 with an opening 418 sized and shaped to accept and engage with an engagement feature 4022 at the proximal end of the anchor 4006 (see Fig. 9), the connector configured to transition between a locked state (Fig. 25) to secure the anchor with the tether, and an unlocked state (Fig. 26) to decouple the anchor and the tether. With respect to claims 2,3 Webler et al. disclose (see Fig. 61A of PUB ‘506 referenced in paragraph 87) the wire 1004 has a spiral shape configured to extend around (please note claims are given BRI and thus this is very broad and can be near) a least a portion of the chordae tendineae, see paragraph 65 of PUB ‘506 referenced in paragraph 88 of Webler “274. Fig. 60 of Webler PUB ‘506 referenced by Webler Pub ‘274 the wire is configured to extend around (please note claims are given BRI and thus this is very broad and can be near) the valve prosthesis. Also note these are product claims and not methods and just intended uses as the chordae and valve prosthesis are not positively required features. Regarding claim 6, it is noted that Webler disclose (Fig. 7) the tether 4036 can be constructed with an actuator 4040 at a proximal end 4038 of the tether (looping) , the actuator configured to transition the connector between the locked and unlocked states, paragraph 59. With respect to claim 16, it can be construed (Fig. 25) that the tubular housing 4008 radially surrounds a distal end of the cable 4428 and the proximal end (relative terminology encompasses an end region) of the anchor 4006 when the connector is in the locked state.
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(s) 2,3 are rejected under 35 U.S.C. 103 as being unpatentable over Gandhi (9579425) in view of Keranen et al. (10130471). Gandhi is explained supra. Gandhi also disclosed (col. 5, lines 25-50) alternative embodiments of the anchoring is within the scope of the disclosure. However, Gandhi did not disclose explicitly a spiral shape configured to extend around at least a portion of the chordae tendineae or around the heart valve prosthesis. Keranen et al. show a spiral shape anchor for engagement with chordae tendineae and can also have the anchoring structure around a heart valve prosthesis, col. 9, lines 51-67. It would have been obvious to one of ordinary skill in the art to utilize a spiral shape as taught by Keranen et al. with the anchor of Gandhi such that it can capture tissue and keep restrained or surround a tissue such as the valve in order to provide the tension on the leaflets to maintain coaptation and closure.
Claim(s) 4,17,18 are rejected under 35 U.S.C. 103 as being unpatentable over Webler et al. (2004/0133274) in view of Alferness et al. (2003/0105520). Webler et al. is explained supra. However, Webler et al. did not show a distal end of the cable comprises a corresponding engagement feature configured to engage with the engagement feature of the anchor. Alferness et al. teach (Fig. 5) an anchor 36 with an engagement feature 38 on its end to engage with a corresponding engagement feature 40 of a distal end of the cable 42 to deliver the anchor. It would have been obvious to one of ordinary skill in the art to alternatively provide an arrangement to use engagement features on the cable and anchor end as taught by Alferness et al. with the anchoring system of Webler et al. such that one can releasably interlock (see paragraph 34 of Alferness) the two ends and not have to use excess length cable. Regarding claim 17, Webler et al. did not show a retention feature of the anchor is configured to interlock with a corresponding retention feature of the cable within the tubular housing. Alferness et al. teach (Fig. 5) an anchor 36 with a retention feature 38 on its end to engage with a corresponding retention feature 40 of a distal end of the cable 42 to deliver the anchor. It would have been obvious to one of ordinary skill in the art to alternatively provide an arrangement to use retention features on the cable and anchor end as taught by Alferness et al. with the anchoring system of Webler et al. such that one can releasably interlock (see paragraph 34 of Alferness) the two ends and not have to use excess length cable. Regarding claim 18, per the modification with Alferness the tubular housing of the system of Webler will provide the tubular housing is configured to radially surround the retention features of the anchor and the cable to maintain the anchor secured to the cable in the locked state.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Khairkhahan (2019/0175344) in view of Aoba et al. (EP 1867305). Khairkhahan is explained supra. However, Khairkhahan did not disclose the retention wire is configured to disengage from the anchor when pulled proximally. It is noted a pin is taught by Khairkhahan to release the anchor, but not the wire alone. Aoba et al. teach (Figs. 7-9) an anchor uses a retention wire as means to couple with a delivery system via a looping arrangement and holes in the anchor to be positioned and then disengage by pulling proximally. It would have been obvious to one of ordinary skill in the art to use a loop of a retention wire and configuration as taught by Aoba et al. to disengage when pulled and alternatively provide in the system in Khairkhahan such that it simplifies the number of parts to avoid a separate pin and just enables the surgeon to disengage by a pulling force, see paragraph 23.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,7,8,14 of copending Application No. 18/693856 (reference appl. Pub. 2024/0390144) in view of Bolea et al. (2002/0188344).
This is a provisional nonstatutory double patenting rejection. Reminder dependent claims are essentially independent claims with all features recited from which they depend on. Claim 1 of PGPUB ‘144 recites a system for anchoring a valve prosthesis, the system comprising: an anchor comprising a wire (spiral) having a shape and size to engage with chordae tendineae and/or leaflets of a native valve; and a tether releasably coupled to a proximal end of the anchor, the tether configured to maintain or adjust a position of the anchor. Claim 7 recites the tether comprising a cable housed within a tubular housing. Claim 14 further recites a distal end of the tubular housing having a connector with an opening (slit tube). However, the claimed invention (cl14) did not recite the connector sized and shaped to accept and engage with an engagement feature at the proximal end of the anchor, the connector configured to transition between a locked state to secure the anchor with the tether, and an unlocked state to decouple the anchor and the tether. Bolea et al. teach (Fig. 24) a connector 200 sized and shaped to accept and engage with an engagement feature at the proximal end of the anchor (paragraph 67), the connector configured to transition between a locked state (paragraph 67) to secure the anchor with the tether, and an unlocked state to decouple the anchor and the tether. It would have been obvious to one of ordinary skill in the art to utilize a connector as taught by Bolea et al. with the claimed invention of PGPUB ‘144 such that a user/surgeon has the ability to release and decouple from a locked position once the tethered anchor is in place, see Bolea paragraph 67 for delivery and removal.
Allowable Subject Matter
Claims 13-15,19,20 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.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799