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 .
Specification
The disclosure is objected to because of the following informalities: the instant spec. fails to disclose the implant comprising a replacement valve and further comprising an arterial stent graft (see claim 12).
Appropriate correction is required.
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) 1-2, 4, 7-10, 14-17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thorson (US 2022/0133514 A1).
Regarding claim 1, Thorson discloses (see abstract; paras. [0022]-[0048]; figs. 1a-10) a device for extracting an implant from a patient’s circulatory system (abstract), comprising:
a cylindrical body (cylindrical body of first ring portion 54, para. [0031]; fig. 4) having a distal opening (35, para. [0027]), an opposing opening (formed at proximal end of first ring portion 54 by opening 50, fig. 4) opposite the distal opening (annotated fig. 4), and a sidewall (42) surrounding a hollow bore (43 extending through first ring portion 54) of the cylindrical body (fig. 4);
a trough (formed by opening 50) extending from the cylindrical body proximate the opposing opening having a first side wall (portion of 42 opposite opening 50) and a second side wall (portion of 42 forming opening 50, fig. 4); and
a handle (second ring portion 58, considered to function as a handle or a structure that can be grasped, para. [0031]) extending from the trough (fig. 4);
wherein a thickness of the sidewall at the distal opening tapers toward the opposing opening (decreases in width from proximate first aperture 35 to proximate opening 50, para. [0032]; fig. 5a) such that the hollow bore proximate the distal opening is narrower than the hollow bore proximate the opposing opening (hollow bore is narrower proximate first aperture 35, para. [0032]) such that a diameter of the opposing opening is larger than a diameter of the distal opening (para. [0032]).
PNG
media_image1.png
536
812
media_image1.png
Greyscale
Annotated Figure 4 of Thorson
Regarding claim 2, Thorson discloses the device of claim 1. Thorson further discloses wherein the device follows a first curvature at the trough (concave curvature at opening 50, para. [0030]), and a second curvature at the handle (curved along an arc, depicted in fig. 4).
Regarding claim 4, Thorson discloses the device of claim 1. Thorson further discloses wherein the handle follows a convex curvature relative to the trough such that the handle curves away from the distal opening of the cylindrical body (opening 50 formed in convex portion of the body, considered to encompass second ring portion 58 curving convexly relative to first ring portion 54, para. [0030]).
Regarding claim 7, Thorson discloses the device of claim 1. Thorson further discloses wherein the cylindrical body has an outer diameter of approximately 19-33 millimeters (19 millimeters, para. [0029]).
Regarding claim 8, Thorson discloses the device of claim 1. Thorson further discloses wherein a first blunt edge (70, para. [0033]) of the cylindrical body at the distal opening (fig. 5a) and a second blunt edge (second blunt edge 70) of the cylindrical body at the opposing opening are rounded to provide a smooth edge (para. [0033]; fig. 5a).
Regarding claim 9, Thorson discloses the device of claim 1. Thorson further discloses wherein the first side wall and the second side wall taper toward the handle (considered to taper as diameter of aperture 35 transitions towards diameter of aperture 39, see also decrease in thickness at opening 50, fig. 4) such that a depth of the trough is greater proximate the cylindrical body than proximate the handle (outer diameter of aperture 35 is larger than aperture 39, such that depth of side walls forming trough is considered to be greater proximate aperture 35 than proximate aperture 39, annotated fig. 4).
PNG
media_image2.png
568
800
media_image2.png
Greyscale
Annotated Figure 4 of Thorson
Regarding claim 10, Thorson discloses (see abstract; paras. [0022]-[0048]; figs. 1a-10) a method of extracting an implant from a vessel (paras. [0034]-[0038]; figs. 6a-e), comprising:
inserting an extraction device into the vessel (para. [0035]), the extraction device comprising:
a cylindrical body (cylindrical body of first ring portion 54, para. [0031]; fig. 4) having a distal opening (35, para. [0027]), an opposing opening (formed at proximal end of first ring portion 54 by opening 50, fig. 4) opposite the distal opening (annotated fig. 4), and a sidewall (42) surrounding a hollow bore (43 extending through first ring portion 54) of the cylindrical body (fig. 4);
a trough (formed by opening 50) extending from the cylindrical body proximate the opposing opening having a first side wall (portion of 42 opposite opening 50) and a second side wall (portion of 42 forming opening 50, fig. 4); and
a handle (second ring portion 58, considered to function as a handle or a structure that can be grasped, para. [0031]) extending from the trough (fig. 4);
wherein a thickness of the sidewall proximate the distal opening tapers toward the opposing opening (decreases in width from proximate first aperture 35 to proximate opening 50, para. [0032]; fig. 5a) such that the hollow bore proximate the distal opening is narrower than the hollow bore proximate the opposing opening (hollow bore is narrower proximate first aperture 35, para. [0032]) such that the opposing opening has a diameter that is larger than a diameter of the distal opening (para. [0032]);
sliding the extraction device over the implant until the extraction device causes the implant to release from the vessel (paras. [0036]-[0037]); and
removing at least one of the implant or the extraction device from the vessel while the sidewall of the extraction device is located at least partially between the implant and the vessel (paras. [0037]-[0038]).
Regarding claim 14, Thorson discloses the method of claim 10. Thorson further discloses wherein removing at least one of the implant and the extraction device from the vessel while the sidewall of the extraction device is located at least partially between the implant and the vessel further comprises removing the implant and the extraction device from the vessel concurrently (para. [0038]).
Regarding claim 15, Thorson discloses the method of claim 10. Thorson further discloses further comprising 3-D printing the extraction device according to preferred specifications for a specific patient prior to inserting the extraction device into the vessel (para. [0027]).
Regarding claim 16, Thorson discloses the method of claim 10. Thorson further discloses further comprising sterilizing the extraction device at least one of prior to inserting the extraction device into the vessel or after removing the extraction device from the vessel (para. [0027]; claim 16).
Regarding claim 17, Thorson discloses the method of claim 10. Thorson further discloses wherein the extraction device follows a first curvature at the trough (concave curvature at opening 50, para. [0030]) and a second curvature at the handle (curved along an arc, depicted in fig. 4).
Regarding claim 20, Thorson discloses (see abstract; paras. [0022]-[0048]; figs. 1a-10) a device for extracting an endovascular implant from a vessel (abstract), comprising:
a cylindrical body (cylindrical body of first ring portion 54, para. [0031]; fig. 4) having a distal opening (35, para. [0027]), an opposing opening (formed at proximal end of first ring portion 54 by opening 50, fig. 4) opposite the distal opening (annotated fig. 4), and a sidewall (42) surrounding a hollow bore (43 extending through first ring portion 54) of the cylindrical body (fig. 4); and
a trough (formed by opening 50) extending from the cylindrical body proximate the opposing opening having a first side wall (portion of 42 opposite opening 50) and a second side wall (portion of 42 forming opening 50, fig. 4);
wherein a thickness of the sidewall at the distal opening tapers toward the opposing opening (decreases in width from proximate first aperture 35 to proximate opening 50, para. [0032]; fig. 5a) such that the hollow bore proximate the distal opening is narrower than the hollow bore proximate the opposing opening (hollow bore is narrower proximate first aperture 35, para. [0032]) thereby forming the opening opposite the distal opening with a diameter that is larger than a diameter of the distal opening (para. [0032]); and
wherein the first side wall and the second side wall taper away from the cylindrical body (considered to taper as diameter of aperture 35 transitions towards diameter of aperture 39, see also decrease in thickness at opening 50, fig. 4) such that a depth of the trough is greater proximate the cylindrical body than away from the cylindrical body (outer diameter of aperture 35 is larger than aperture 39, such that depth of side walls forming trough is considered to be greater proximate aperture 35 than proximate aperture 39, annotated fig. 4).
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.
Claim(s) 3 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Thorson in view of Carpentier (US 2012/0136434 A1).
Regarding claim 3, Thorson discloses the device of claim 2.
Thorson further discloses wherein the first curvature is a concave curvature relative to the trough (para. [0030]).
However, Thorson fails to disclose the second curvature is a convex curvature relative to the trough.
Carpentier teaches (para. [0030]; fig. 3), in the analogous art of the claimed invention, a holder for a prosthesis (abstract) comprising a handle (32) having a first concave curvature (112) and a second convex curvature (110), for the purpose of enhancing visibility of the holder and the valve for the surgeon and providing an unobstructed view (para. [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the curvature of ring portion 58 to be convex relative to opening 50 of Thorson, in order to enhance visibility and provide an unobstructed view of the implant to the surgeon when desired, based on the suggestions and teachings of Carpentier (para. [0030]).
Regarding claim 18, Thorson discloses the method of claim 17.
Thorson further discloses wherein the first curvature is a concave curvature relative to the trough (para. [0030]).
However, Thorson fails to disclose the second curvature is a convex curvature relative to the trough.
Carpentier teaches (para. [0030]; fig. 3), in the analogous art of the claimed invention, a holder for a prosthesis (abstract) comprising a handle (32) having a first concave curvature (112) and a second convex curvature (110), for the purpose of enhancing visibility of the holder and the valve for the surgeon and providing an unobstructed view (para. [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the curvature of ring portion 58 to be convex relative to opening 50 of Thorson, in order to enhance visibility and provide an unobstructed view of the implant to the surgeon when desired, based on the suggestions and teachings of Carpentier (para. [0030]).
Claim(s) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Thorson.
Regarding claim 5, Thorson discloses the device of claim 1.
Thorson further discloses the length of the entire structure from aperture 34 to aperture 39 being approximately 100-150 mm (para. [0029]).
However, Thorson fails to explicitly disclose wherein the cylindrical body is approximately 14-18 millimeters in length.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select the length of the first ring portion 54 to be approximately 14-18 millimeters in length, since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see para. [0033] of the published application describing approximate lengths and stating the ring “may” be other lengths).
Regarding claim 6, Thorson discloses the device of claim 1.
Thorson further discloses the length of the entire structure from aperture 34 to aperture 39 being approximately 100-150 mm (para. [0029]).
However, Thorson fails to explicitly disclose wherein the cylindrical body is approximately 48-52 millimeters in length.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select the length of the first ring portion 54 to be approximately 48-52 millimeters in length, since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see para. [0033] of the published application describing approximate lengths and stating the ring “may” be other lengths).
Claim(s) 11-13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Thorson in view of Baig (US 2014/0171958 A1).
Regarding claim 11, Thorson discloses the method of claim 10.
Thorson further discloses wherein the implant comprises a stent graft (10, para. [0025]).
However, Thorson fails to disclose wherein the implant comprises a replacement valve.
Baig teaches (paras. [0012], [0023] and [0026]; fig. 1), in the same field of endeavor, a device for extracting an implant (para. [0026]), wherein the implant comprises a replacement valve (heart valve prosthesis), for the purpose of providing the ability to treat a patient during a TAVI procedure (paras. [0001]-[0004] and [0012]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant of Thorson to include a replacement valve when desired, in order to provide the ability to treat a wider variety of tissue including a heart valve, based on the teachings of Baig (paras. [0001]-[0004] and [0012]).
Regarding claim 12, Thorson (as modified) teaches the method of claim 11. Thorson (as modified) further teaches wherein the implant comprises an arterial stent graft (combination considered to further teach stent graft 10 including a heart valve prosthesis, para. [0025]; figs. 1a-b and 6a-e of Thorson, para. [0012] of Baig).
Regarding claim 13, Thorson (as modified) teaches the method of claim 12. Thorson further discloses wherein the first side wall and the second side wall taper toward the handle (considered to taper as diameter of aperture 35 transitions towards diameter of aperture 39, see also decrease in thickness at opening 50, fig. 4) such that a depth of the trough is greater proximate the cylindrical body than proximate the handle (outer diameter of aperture 35 is larger than aperture 39, such that depth of side walls forming trough is considered to be greater proximate aperture 35 than proximate aperture 39, annotated fig. 4).
Regarding claim 19, Thorson (as modified) teaches the method of claim 12. Thorson further discloses wherein a first blunt edge (70, para. [0033]) of the cylindrical body at the distal opening (fig. 5a) and a second blunt edge (second blunt edge 70) of the cylindrical body at the opposing opening are rounded to provide a smooth edge (para. [0033]; fig. 5a).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIGID K BYRD/Examiner, Art Unit 3771
Prosecution Insights