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.
Claim 4 is 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 4 depends from claim 1, which sets forth the parameter of “a fourth control wire slidably disposed in the one or more lumens and releasably coupled to the posterior flap” (emphasis added); and claim 4 further sets forth the parameter of “the fourth control wire comprises a fourth wire loop that extends out of the one or more lumens and that is releasably coupled to the outflow end portion” (emphasis added), however this parameter is found to be confusing since it is not clear what exact portion of the system the fourth control wire is actually coupled to. Specifically, is the fourth control wire coupled to the posterior flap, as set forth in claim 1, or is it coupled to the outflow end portion, as set forth in claim 4, or is it coupled to both; and if it’s coupled to both, it is further unclear how exactly, structurally, the fourth control wire is coupled to both the posterior flap and the outflow end portion, and such a scenario would also raise new matter issues, since such a parameter was never mentioned or suggested in the originally filed disclosure. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite. For the purpose of examination, as can be gleaned from the originally filed disclosure, the parameter of claim 4 shall be interpreted as the fourth control wire “is releasably coupled to the posterior flap”.
Examiner’s Notes
It is to be noted that in device/apparatus claims, such as claims 1-10, only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Iyer et al. (US PG Pub. 2021/0244535), as disclosed in the IDS dated 02/09/2024, hereinafter Iyer, in view of Ganesan et al. (PG Pub. 2018/0338832), hereinafter Ganesan.
Regarding claims 1-6 and 10, Iyer disclose a prosthetic valve system, illustrated in Figures 6C, 8C and 26-33, comprising a prosthetic heart valve (300) comprising a main body (MB) including an inflow end portion (IF) and an outflow end portion (OF), the main body defining a central axis extending between the inflow and outflow end portions; one or more anterior flaps (AF/380) extending from the outflow end portion (OF) in a first direction that is transverse to the central axis; and a posterior flap (PF/390) extending from the outflow end portion (OF) in a second direction that is transverse to the central axis, illustrated in Figures 6C, 8C, 32, 33 and modified figure 8C, below ([0017]; [0038] & [0105]); and a valve deployment system (50) comprising an elongate control catheter/inner distal hold catheter (30) defining one or more lumens, and a deflectable catheter/sheath catheter (10), defining a lumen and having a distal end portion selectively deflectable by manipulating a user control mechanism coupled to a proximal end of the valve deployment system, wherein a portion of the control catheter/inner distal hold catheter (30) is slidably disposable within the lumen of the deflectable catheter/sheath catheter (10), illustrated in Figures 26a and 26b ([0072], Lines 10-14; [0105] & [0107]); control sutures slidably disposed in the one or more lumens and releasably coupled to the main body; a third control suture slidably disposed in the one or more lumens and releasably coupled to the one or more anterior flaps (380), wherein the third control suture comprises a single suture segment that extends out of the one or more lumens, releasably couples with the one or more anterior flaps (380), and terminates in releasable engagement with a distal tip portion of the control catheter/inner distal hold catheter (30); and a fourth control suture slidably disposed in the one or more lumens and releasably coupled to the posterior flap (390), illustrated in Figures 26-33 ([0108] & [0110] – [0112]); and though it is not specifically disclosed that the control sutures comprise first and second sutures coupled to the inflow and outflow end portions, respectively, of the main body, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step; it would have been obvious and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate amount/number of, and attachment location(s) for, the control sutures coupled to the main body, including having first and second sutures coupled to the inflow and outflow end portions, respectively, of the main body, since doing so amounts to a mere duplication of the essential working parts, which has been held to involve only routine skill in the art (see MPEP 2144.04); however Iyer does not specifically disclose the control sutures are wires and that the first, second and fourth control wires comprise a loop.
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Ganesan teaches a valve system, in the same filed of endeavor, comprising control wires are used for coupling, wherein the control wire comprises a loop of suture material ([0078]).
In view of the teaching of Ganesan, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the control sutures, of the prosthetic valve system of Iyer, to be wires and further for the first, second and fourth control wires comprise a loop, as taught by Ganesan; since it has been held to be within the general skill of one having ordinary skill in the art to select a known material on the basis of its suitability for the intended use and that a change in the shape/form of the control wires, i.e. being looped, is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.07 & 2144.04).
Regarding claims 7-9, Iyer in view of Ganesan disclose the prosthetic valve system of claim 6, wherein Iyer further teaches the prosthetic heart valve further comprises a posterior arm/atrial shelf (PA) extending from the inflow end portion (IF) of the main body, illustrated in Figures 6C, 8C and modified figure 8C, above (Iyer: [0017]; [0022] & [0038]); and though it is not specifically disclosed that there is a fifth control wire comprises a single wire segment that releasably couples with the posterior arm and terminates in releasable engagement with a distal tip portion of the deflectable catheter/sheath catheter, Iyer does teach that portions of the prosthetic heart valve are releasably coupled to the delivery system/catheter via sutures (Iyer: [0108] – [0112]) and Ganesan teaches that it is known for control wires to comprise suture material (Ganesan: [0078]). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the prosthetic heart valve, of Iyer in view of Ganesan, to further comprise a fifth control suture, comprising a single wire segment, to releasably couple to the posterior arm and a distal tip portion of the deflectable catheter/sheath catheter, in order to aid in the delivery and deployment of the prosthetic heart valve via the valve deployment system, as taught by Iyer and Ganesan, and doing so amounts to a mere duplication of the essential working parts/wires, which has been held to involve only routine skill in the art (see MPEP 2144.04).
Regarding claim 11, Iyer discloses a method of deploying a prosthetic heart valve at a native heart valve location, illustrated in Figures 26-33 ([0105], Lines 1-3), comprising advancing the prosthetic heart valve while the prosthetic heart valve is releasably coupled to an elongate control catheter/inner distal hold catheter (30) by: a control suture slidably disposed in one or more lumens of the control catheter/inner distal hold catheter (30) and releasably coupled to a main body of the prosthetic heart valve; a third control suture slidably disposed in the one or more lumens and releasably coupled to one or more anterior flaps (380) extending transversely from the outflow end portion of the prosthetic heart valve; and a fourth control suture slidably disposed in the one or more lumens and releasably coupled to a posterior flap (390) extending transversely from the outflow end portion of the prosthetic heart valve; and with the prosthetic heart valve at the native heart valve location, releasing: the control suture from being coupled to the main body; the fourth control suture from being coupled to the posterior flap (390); and the third control suture from being coupled to the one or more anterior flaps (380), illustrated in Figures 26-33 ([0105] – [0113]); and though it is not specifically disclosed that the control sutures comprise first and second sutures coupled to inflow and outflow end portions, respectively, of the main body, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step; it would have been obvious and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate amount/number of, and attachment location(s) for, the control sutures coupled to the main body, including having first and second sutures coupled to the inflow and outflow end portions, respectively, of the main body, since doing so amounts to a mere duplication of the essential working parts, which has been held to involve only routine skill in the art (see MPEP 2144.04); but does not specifically disclose the control sutures are wires.
However, Ganesan teaches a valve system, in the same filed of endeavor, comprising control wires are used for coupling, wherein the control wire comprises a suture material ([0078]).
In view of the teaching of Ganesan, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the control sutures, of the method of deploying a prosthetic valve system of Iyer, to be wires, as taught by Ganesan, since it has been held to be within the general skill of one having ordinary skill in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07).
Regarding claims 12 and 13, Iyer in view of Ganesan disclose the method of claim 11, wherein Iyer further teaches adjustably deflecting a distal portion of a deflectable catheter (20) that defines a lumen in which at least a portion of the control catheter/inner distal hold catheter (30) is slidably disposed, and during the advancing, the prosthetic heart valve (300), the control catheter/inner distal hold catheter (30), and the deflectable catheter (20) are positioned within a lumen of a delivery sheath catheter (10), illustrated in Figures 26-26b (Iyer: [0073] & [0105] – [0107]).
Regarding claim 14, Iyer in view of Ganesan disclose the method of claim 13, wherein Iyer further teaches prior to the releasing, pulling the delivery sheath catheter (10) proximally to distally express the prosthetic heart valve (300), a distal end portion of the control catheter/inner distal hold catheter (30), and a distal end portion of the deflectable catheter (20) from the lumen of the delivery sheath catheter (10), illustrated in Figure 26 (Iyer: [0109]).
Regarding claim 15, Iyer in view of Ganesan disclose the method of claim 11, wherein Iyer further teaches the native heart valve location is a tricuspid valve, and wherein the releasing the third control wire from being coupled to the one or more anterior flaps (380) allows the one or more anterior flaps to extend into a right ventricular outflow tract (RVOT), illustrated in Figure 27 (Iyer: [0105], Lines 1-3; [0108] & [0110]).
Regarding claim 16, Iyer in view of Ganesan disclose the method of claim 15, wherein Iyer further teaches the advancing is via a superior vena cava or an inferior vena cava (Iyer: [0025]; [0076] & [0107]).
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 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 12,303,389. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims disclose a prosthetic heart valve system comprising a prosthetic heart valve comprising a main body having inflow and outflow end portions; one or more anterior flaps extending from the outflow end portion in a first direction that is transverse to a central axis of the main body; and a posterior flap extending from the outflow end portion in a second direction that is transverse to the central axis; and a valve deployment system comprising an elongate control catheter defining one or more lumens; a first control wire slidably disposed in the one or more lumens and releasably coupled to the inflow end portion; a second control wire slidably disposed in the one or more lumens and releasably coupled to the outflow end portion; a third control wire slidably disposed in the one or more lumens and releasably coupled to the one or more anterior flaps; and a fourth control wire slidably disposed in the one or more lumens and releasably coupled to the posterior flap. Additionally, both sets of claims also disclose the first control wire comprise a first wire loop, and/or the second control wire comprise a second wire loop, and/or the fourth control wire comprises a fourth wire loop, and/or the third control wire comprises a single wire segment extending out of the one or more lumens, releasably coupled to the anterior flap(s) and terminating in releasable engagement with a distal tip portion of the control catheter, and/or the valve deployment system further comprising a deflectable catheter defining a lumen wherein a portion of the control catheter is slidably disposable within the lumen of the deflectable catheter, and/or a posterior arm extending from the inflow end portion of the main body, and/or a fifth control wire comprising a single wire segment releasably coupled with the posterior arm and terminating in releasable engagement with a distal tip portion of the deflectable catheter, and/or a distal end portion of the deflectable catheter being selectively deflectable by manipulating a user control mechanism coupled to a proximal end of the valve deployment system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774
04/14/2026