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 .
Priority
The present application is a continuation of now-allowed U.S. patent application Ser. No. 17/590,571, filed Feb. 1, 2022; which is a continuation of U.S. patent application Ser. No. 16/944,818, filed Jul. 31, 2020, and patented as U.S. Pat. No. 11,273,038; which is a continuation of International Application No. PCT/US19/50231, filed Sep. 9, 2019; which claims priority to U.S. Patent Application No. 62/728,346, filed Sep. 7, 2018.
Claim Objections
Claim 13 is objected to because of the following informalities: a period is missing at the end of claim 13. 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.
Claim 14 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 14 recites the limitation "the delivery catheter" in line 7. There is insufficient antecedent basis for this limitation in the claim. For examination purpose, this limitation has been interpreted as “a delivery catheter.”
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, 3-5, 7-9, and 11-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Duhay et al. (US 2012/0271411, which is cited in the Information Disclosure Statement filed August 21, 2024, hereinafter “Duhay”).
Referring to claim 1, Duhay discloses a delivery system for a transcatheter heart valve (THV) 12 to a subject (FIGS. 9A-9B and para. [0009]), the delivery system comprising:
a delivery catheter that is sized for housing the THV 12 therein (FIG. 1; para. [0038]: “Note that the catheter distal portion may include a sheath configured to be slid over the prosthetic valve in its unexpanded/delivery diameter.” FIG. 8A-8B shows sheath 70 covers the prosthetic valve; para. [0051]: “For example, a prosthetic valve 12 or other implant may be a self-expanding device restrained by a sheath 70 configured to be slid over all or a portion of the implant holding section 30 to restrain the prosthetic valve 12 therein, as depicted in FIG. 8A, for delivery of the prosthetic valve 12 to the treatment site. The retractable members 36 can be extended to assist in accurately positioning the prosthetic valve 12, and the sheath 70 can then be slidingly retracted from the implant holding section to release the prosthetic valve 12, which then self-expands, as depicted in FIG. 8B.”);
an elongated member (elongated member 62 as shown in FIGS. 6A-6B, which are reproduced below; para. [0049]. Catheter 14, which includes an implant holding section 30 for receiving THV 12 as shown in FIGS. 1-5 and 7A-8B can be interpreted as an elongated member) for receiving the THV 12 thereon (FIGS. 6A-6B shows prosthetic valve 12 surrounded elongated shaft 62. Catheter 14, which includes an implant holding section 30 for receiving THV 12 as shown in FIGS. 1-5 and 7A-8B); and
a plurality of projections 36 extending radially relative to the THV 12 and spaced apart from the THV 12 during delivery thereof (FIGS. 3A-4B, 6A-6B and 8A-8B), wherein the projections 36 rotate during delivery of the THV for alignment of the THV at a desired angle relative to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle during delivery of the THV 12 (Duhay discloses the projections 36 is configured to allow the surgeon to align the prosthetic valve 12 with a location on the native valve (para. [0049]: “In a method of using such an embodiment, the user can extend the retractable member(s) 36 to an expanded/deployed position, depicted in FIG. 6A, and use the deployed member(s) 36 to properly position the implant holding section 30 and/or balloon 32 (with prosthetic valve 12 thereon) at the desired deployment location.”). In FIG. 1 and paragraphs [0035]-[0036] Duhay discloses handle 26 has one or more controls 27, 28, 29 to control the movement of distal portion of the catheter. Thus, rotating the handle 26 would rotate the distal portion of the catheter to align the commissure of the prosthetic valve 12 and projections with respect to the commissure of the native heart valve).
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Referring to claim 3, Duhay discloses the delivery system according to claim 1, wherein the projections 36 include substantially linear portions (FIGS. 3B and 6A-6B).
Referring to claim 4, Duhay discloses the delivery system according to claim 1, wherein the projections 36 include portions that are integral with the elongated member (FIG. 6B shows projections 36 are attached to the distal portion of elongated member 62).
Referring to claim 5, Duhay discloses a delivery system for a transcatheter heart valve (THV) to a subject, the delivery system comprising:
a delivery catheter (see rejection of claim 1 above) that is sized for housing the THV 12 therein;
an elongated member for receiving the THV 12 thereon (Catheter 14, which includes an implant holding section 30 for receiving THV 12 as shown in FIGS. 1-5 and 7A-8B can be interpreted as an elongated member); and
a plurality of projections 36 (see rejection of claim 1 above) extending radially relative to the THV and spaced apart from the THV during delivery thereof, wherein at least some of the projections are disposed proximally relative to the THV 12 during delivery (FIGS. 11A-11B shows projections 36 located proximally relative to the THV 12; para. [0056]), and wherein the projections 36 rotate during delivery of the THV for alignment of the THV at a desired angle relative to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle during delivery of the THV (see rejection of claim 1 above).
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Referring to claim 7, Duhay discloses the delivery system according to claim 5, wherein the projections include substantially linear portions (FIGS. 3B and 6A-6B).
Referring to claim 8, Duhay discloses the delivery system according to claim 5, wherein the projections include portions that are integral with the elongated member 14 (FIGS. 7A-7B is attached to body 18 of catheter 14).
Referring to claim 9, Duhay discloses a delivery system for a transcatheter heart valve (THV) 12 to a subject (FIGS. 9A-9B and para. [0009]), the delivery system comprising:
an elongated member (see rejection of claims 1 and 5 above) for receiving the THV 12 thereon; and
a plurality of projections 36 (see rejection of claims 1 and 5 above) extending radially relative to the THV 12 and spaced apart from the THV during delivery thereof and being configured to extend from and retract within a delivery catheter (FIG. 1; para. [0038]: “Note that the catheter distal portion may include a sheath configured to be slid over the prosthetic valve in its unexpanded/delivery diameter.” FIG. 8A-8B shows sheath 70 covers the prosthetic valve, para. [0051]), wherein the projections 36 rotate during delivery of the THV 12 for alignment of the THV at a desired angle relative to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle during delivery of the THV (see rejection of claim 1 above).
Referring to claim 11, Duhay discloses the delivery system according to claim 9, wherein the projections include substantially linear portions (FIGS. 3B, 6A-6B and 8A-8B).
Referring to claim 12, Duhay discloses the delivery system according to claim 9, wherein at least some of the projections 36 are disposed proximally relative to the THV 12 during delivery (FIGS. 7A-7B are reproduced below).
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Referring to claim 13, Duhay discloses the delivery system according to claim 9, wherein the projections 36 include portions that are integral with the elongated member (FIG. 6B shows projections 36 are attached to the distal portion of elongated member 62. FIGS. 7A-7B is attached to body 18 of catheter 14).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 2, 6, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duhay et al. (US 2012/0271411, which is cited in the Information Disclosure Statement filed August 21, 2024, hereinafter “Duhay”).
Referring to claims 2, 6, and 10, Duhay discloses the delivery system according to claims 1, 5 and 9, respectively, but fails to disclose wherein the projections 36 include loop shaped portions. In paragraph [0042] Duhay discloses free end 46 of projection 36 is rounded at the tip to prevent unnecessary trauma to tissue. In view of this disclosure, examiner contends that one of ordinary skill in the art will understand that making the free end 46 of the projection 36 in the form of a rounded loop would also provide an atraumatic tip. Examiner notes that modifying a rounded tip to a loop shape is viewed as a matter of choice which a person of ordinary skill in the art would have found obvious and it does not require a leap of inventiveness.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duhay et al. (US 2012/0271411, which is cited in the Information Disclosure Statement filed August 21, 2024, hereinafter “Duhay”) in view of O’Connell et al. (US 2015/00138944, hereinafter “O’Connell”).
Referring to claim 14, Duhay discloses a method for delivery of a transcatheter heart valve (THV) 12 to a subject (FIGS. 11A-11B, which are reproduced above) comprising:
providing an elongated member (catheter 14 as shown in FIG. 1 or catheter 62 as shown in FIGS. 6A-6B) for receiving the THV 12 thereon and a plurality of projections 36 extending radially relative to the THV 12 and spaced apart from the THV 12 during delivery thereof (FIGS. 3A and 5-6B);
extending the projections 36 radially relative to the THV 12 (FIGS. 3A and 5-6B);
deploying the elongated member and THV from the delivery catheter at the native valve location (FIG. 1; para. [0038]: “Note that the catheter distal portion may include a sheath configured to be slid over the prosthetic valve in its unexpanded/delivery diameter.” FIG. 8A-8B shows sheath 70 covers the prosthetic valve; para. [0051]: “For example, a prosthetic valve 12 or other implant may be a self-expanding device restrained by a sheath 70 configured to be slid over all or a portion of the implant holding section 30 to restrain the prosthetic valve 12 therein, as depicted in FIG. 8A, for delivery of the prosthetic valve 12 to the treatment site. The retractable members 36 can be extended to assist in accurately positioning the prosthetic valve 12, and the sheath 70 can then be slidingly retracted from the implant holding section to release the prosthetic valve 12, which then self-expands, as depicted in FIG. 8B.”)
Duhay discloses the invention substantially as claimed except for disclosing the step of effecting rotation of the projections to align the THV with respect to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle.
However, in the same field of endeavor, which is a method for delivery of a transcatheter heart valve to a subject (abstract), O’Connell discloses incorrect positioning of a heart valve prosthesis can lead to patient complications (para. [0002]). O’Connell further discloses markers are incorporate to the prosthetic heart valve to allow the surgeon to view the prosthetic heart valve and to rotate the heart valve to align the commissural posts of the prosthetic heart valve with the commissure of the native valve under a fluoroscopic image (para. [0021])
Examiner notes that Duhay discloses the projections 36, which includes maker 58 at the free end of each projection (para. [0048]), are configured to allow the surgeon to align the prosthetic valve 12 with a location on the native valve (para. [0049]: “In a method of using such an embodiment, the user can extend the retractable member(s) 36 to an expanded/deployed position, depicted in FIG. 6A, and use the deployed member(s) 36 to properly position the implant holding section 30 and/or balloon 32 (with prosthetic valve 12 thereon) at the desired deployment location.”). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have provided markers to the prosthetic heart valve 12 of Duhay to allow the surgeon to view the prosthetic heart valve under fluoroscopic image and to rotationally align the commissural posts of the prosthetic heart valve 12 with the commissure of the native valve under a fluoroscopic image.
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, 2, 5, 9, 10 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5 and 19, of U.S. Patent No. 11,273,038 (hereinafter “the patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because all limitation in claims 1, 2, 5, 9, and 14 can be found in claims 1, 2, 5 and 19 of the patent.
The claims match-up with respect to one another as listed below:
US Patent Application No. 18/663,189
US Patent No. 11,273,038
Claim 1. A delivery system for a transcatheter heart valve (THV) to a subject, the delivery system comprising:
a delivery catheter that is sized for housing the THV therein;
an elongated member for receiving the THV thereon; and
a plurality of projections extending radially relative to the THV and spaced apart from the THV during delivery thereof, wherein the projections rotate during delivery of the THV for alignment of the THV at a desired angle relative to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle during delivery of the THV.
Claim 1. A delivery system for a transcatheter heart valve (THV) to a subject, the delivery system comprising:
a delivery catheter sized for housing the THV therein;
an elongated member for receiving the THV thereon and having an accessory extending from the distal portion thereof, the accessory comprising a plurality of radially outwardly extending projections disposed distally from the THV during delivery of the THV for alignment of the THV with respect to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle during delivery of the THV, the elongated member and accessory independently rotatable with respect to the delivery catheter, wherein the projections are configured to be extended from the elongated member and retracted within the elongated member; and
a rotational member connected to the elongated member to rotate the accessory and THV together to align with a native or bioprosthetic valve commissure or a valve leaflet at a desired angle.
Claim 2. The delivery system according to claim 1, wherein the projections include loop shaped portions.
Claim 5. The delivery system of claim 1, wherein the projections are loop-shaped projections.
Claim 5. A delivery system for a transcatheter heart valve (THV) to a subject, the delivery system comprising:
a delivery catheter that is sized for housing the THV therein;
an elongated member for receiving the THV thereon; and
a plurality of projections extending radially relative to the THV and spaced apart from the THV during delivery thereof, wherein at least some of the projections are disposed proximally relative to the THV during delivery, and wherein the projections rotate during delivery of the THV for alignment of the THV at a desired angle relative to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle during delivery of the THV.
Claims 1 and 2.
Claim 1. A delivery system for a transcatheter heart valve (THV) to a subject, the delivery system comprising:
a delivery catheter sized for housing the THV therein;
an elongated member for receiving the THV thereon and having an accessory extending from the distal portion thereof, the accessory comprising a plurality of radially outwardly extending projections disposed distally from the THV during delivery of the THV for alignment of the THV with respect to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle during delivery of the THV, the elongated member and accessory independently rotatable with respect to the delivery catheter, wherein the projections are configured to be extended from the elongated member and retracted within the elongated member; and a rotational member connected to the elongated member to rotate the accessory and THV together to align with a native or bioprosthetic valve commissure or a valve leaflet at a desired angle.
Claim 2. The delivery system of claim 1, further comprising projections disposed at a proximal portion of the THV during delivery of the THV.
Claim 9. A delivery system for a transcatheter heart valve (THV) to a subject, the delivery system comprising:
an elongated member for receiving the THV thereon; and
a plurality of projections extending radially relative to the THV and spaced apart from the THV during delivery thereof and being configured to extend from and retract within a delivery catheter, wherein the projections rotate during delivery of the THV for alignment of the THV at a desired angle relative to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle during delivery of the THV.
Claim 1. A delivery system for a transcatheter heart valve (THV) to a subject, the delivery system comprising:
a delivery catheter sized for housing the THV therein;
an elongated member for receiving the THV thereon and having an accessory extending from the distal portion thereof, the accessory comprising a plurality of radially outwardly extending projections disposed distally from the THV during delivery of the THV for alignment of the THV with respect to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle during delivery of the THV, the elongated member and accessory independently rotatable with respect to the delivery catheter, wherein the projections are configured to be extended from the elongated member and retracted within the elongated member; and
a rotational member connected to the elongated member to rotate the accessory and THV together to align with a native or bioprosthetic valve commissure or a valve leaflet at a desired angle.
Claim 10. The delivery system according to claim 9, wherein the projections include loop shaped portions.
Claim 5. The delivery system of claim 1, wherein the projections are loop-shaped projections.
Claim 14. A method for delivery of a transcatheter heart valve (THV) to a subject comprising:
providing an elongated member for receiving the THV thereon and
a plurality of projections extending radially relative to the THV and spaced apart from the THV during delivery thereof;
extending the projections radially relative to the THV;
deploying the elongated member and THV from the delivery catheter at the native valve location; and,
effecting rotation of the projections to align the THV with respect to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle.
Claim 19. A method for delivery of a transcatheter heart valve (THV) to a subject comprising:
providing an elongated member for receiving the THV thereon and
having an accessory extending from the distal portion thereof, the accessory comprising a plurality of radially outwardly extending projections disposed at a distal portion of the THV, the elongated member and accessory housed within and independently rotatable with respect to a delivery catheter wherein the projections are configured to be extended from the elongated member and retracted within the elongated member;
deploying the elongated member and THV from the delivery catheter at the native valve location;
rotating the accessory to align the THV with respect to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle; and
expanding the THV in the valve location.
Referring to claim 14, claim 19 of the patent fails to positively recite the step of extending the projections radially relative to the THV. However, claim 19 of the patent discloses “the projections are configured to be extended from the elongated member and retracted within the elongated member” (underline text in claim 19). Therefore, it would have been obvious to perform the step of extending the projections radially outward relative to the THV to allow the surgeon to view the projections with respect to a desired location on the native valve to ensure that the prosthetic valve is position at a correct location with respect to the native valve be fore releasing of the prosthetic valve.
Claims 1, 5, 9 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 11, of U.S. Patent No. 12,016,775 (hereinafter “the patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because all limitation in claims 1, 5, 9 and 14 can be found in claims 1, 2 and 11 of the patent.
The claims match-up with respect to one another as listed below:
US Patent Application No. 18/663,189
US Patent No. 12,016,775
Claim 1. A delivery system for a transcatheter heart valve (THV) to a subject, the delivery system comprising:
an elongated member for receiving the THV thereon; and
a plurality of projections extending radially relative to the THV and spaced apart from the THV during delivery thereof, wherein the projections rotate during delivery of the THV for alignment of the THV at a desired angle relative to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle during delivery of the THV;
a delivery catheter that is sized for housing the THV therein;
Claim 1. A medical device for delivery of a transcatheter heart valve (THV) to a subject, the device comprising:
an elongated member;
a THV;
an accessory for receiving the THV thereon and extending from a distal portion of the elongated member, the accessory comprising a plurality of radially outwardly extending projections configured and spaced to align with a leaflet or a commissure of a native or bioprosthetic valve and disposed distally and spaced apart from the THV during delivery of the THV for alignment of the THV with respect to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle during delivery of the THV and wherein the radially outwardly extending projections are spaced apart from the THV, the medical device further comprising projections disposed at a proximal portion of the THV during delivery of the THV, and a rotational member connected to the elongated member to rotate the accessory and THV together to align with the native or bioprosthetic valve commissure or the valve leaflet at a desired angle.
Claim 2. The medical device of claim 1, further comprising a delivery catheter housing the THV therein, wherein the delivery catheter and the accessory are independently rotatable.
Claim 5. A delivery system for a transcatheter heart valve (THV) to a subject, the delivery system comprising:
an elongated member for receiving the THV thereon; and
a plurality of projections extending radially relative to the THV and spaced apart from the THV during delivery thereof, wherein at least some of the projections are disposed proximally relative to the THV during delivery, and wherein the projections rotate during delivery of the THV for alignment of the THV at a desired angle relative to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle during delivery of the THV;
a delivery catheter that is sized for housing the THV therein;
Claim 1. A medical device for delivery of a transcatheter heart valve (THV) to a subject, the device comprising:
an elongated member;
a THV;
an accessory for receiving the THV thereon and extending from a distal portion of the elongated member, the accessory comprising a plurality of radially outwardly extending projections configured and spaced to align with a leaflet or a commissure of a native or bioprosthetic valve and disposed distally and spaced apart from the THV during delivery of the THV for alignment of the THV with respect to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle during delivery of the THV and wherein the radially outwardly extending projections are spaced apart from the THV, the medical device further comprising projections disposed at a proximal portion of the THV during delivery of the THV, and a rotational member connected to the elongated member to rotate the accessory and THV together to align with the native or bioprosthetic valve commissure or the valve leaflet at a desired angle.
Claim 2. The medical device of claim 1, further comprising a delivery catheter housing the THV therein, wherein the delivery catheter and the accessory are independently rotatable.
Claim 9. A delivery system for a transcatheter heart valve (THV) to a subject, the delivery system comprising:
an elongated member for receiving the THV thereon; and
a plurality of projections extending radially relative to the THV and spaced apart from the THV during delivery thereof and being configured to extend from and retract within
a delivery catheter, wherein the projections rotate during delivery of the THV for alignment of the THV at a desired angle relative to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle during delivery of the THV.
Claim 1. A medical device for delivery of a transcatheter heart valve (THV) to a subject, the device comprising:
an elongated member;
a THV;
an accessory for receiving the THV thereon and extending from a distal portion of the elongated member, the accessory comprising a plurality of radially outwardly extending projections configured and spaced to align with a leaflet or a commissure of a native or bioprosthetic valve and disposed distally and spaced apart from the THV during delivery of the THV for alignment of the THV with respect to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle during delivery of the THV and wherein the radially outwardly extending projections are spaced apart from the THV, the medical device further comprising projections disposed at a proximal portion of the THV during delivery of the THV, and a rotational member connected to the elongated member to rotate the accessory and THV together to align with the native or bioprosthetic valve commissure or the valve leaflet at a desired angle.
Claim 2. The medical device of claim 1, further comprising a delivery catheter housing the THV therein, wherein the delivery catheter and the accessory are independently rotatable.
Claim 14. A method for delivery of a transcatheter heart valve (THV) to a subject comprising:
providing an elongated member for receiving the THV thereon and
a plurality of projections extending radially relative to the THV and spaced apart from the THV during delivery thereof; extending the projections radially relative to the THV;
deploying the elongated member and THV from the delivery catheter at the native valve location; and,
effecting rotation of the projections to align the THV with respect to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle.
Claim 11. A method for delivery of a transcatheter heart valve (THV) to a subject comprising:
providing an elongated member for receiving the THV thereon and having an accessory extending from the distal portion thereof, the accessory comprising a plurality of radially outwardly extending projections disposed at a distal portion of the THV and spaced apart therefrom, the elongated member and accessory housed within and independently rotatable with respect to a delivery catheter;
deploying the elongated member and THV from the delivery catheter at the native valve location;
extending the projections from the elongated member;
rotating the accessory to align the THV with respect to a native or bioprosthetic valve commissure or a valve leaflet at a desired angle; and
expanding the THV in the valve location.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tuval et al. (US 2009/0138079) discloses handle 50 includes a knob 52 to allow the surgeon to rotate tip 102 of the delivery catheter to align commissures of prosthetic valve with commissures of native valve.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771