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 § 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.
Claims 11, 16, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilson et al. (US 2014/0371846 A1).
Regarding claim 11, Wilson discloses a method of suturing an opening in a target tissue (see Fig. 20-21 and paragraphs [0125] and [0155]-[0157]), the method comprising: forming a first purse-string suture, using a first suture, along a first path around an opening in a target tissue; and forming a second purse-string suture, using a second suture, along a second path around the opening and concentric with the first purse-string suture (Wilson discloses securing one or more purse-string sutures around the shaft of introducer 2026 and puncture 36; the purse string-sutures would be concentric since their respective paths would be arranged about the same opening, see [0125] and Fig. 21).
Regarding claim 16, Wilson discloses the method of claim 11, further comprising coupling a plurality of pads to each of the first and second sutures and positioning the plurality of pads at respective positions around the opening along the first and second paths (each of the purse-string sutures may be coupled to a plurality of pledgets 2101 located at respective positions around the shaft, see [0125] and Fig. 21).
Regarding claim 19, Wilson discloses the method of claim 16, wherein positioning the plurality of pads at respective positions around the opening comprises aligning at least one of the plurality of pads with a posterior mitral valve leaflet direction (pledgets 2101 are aligned with the direction of the mitral valve leaflet 66, see Fig. 21).
Regarding claim 20, Wilson discloses the method of claim 11, wherein forming the first purse-string suture and forming the second purse-string suture each comprise forming a purse-string suture having a circular shape (Wilson discloses the sutures passing around the shaft in a continuous loop, see [0125]).
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 1-2, 6, 8, 10 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson.
Regarding claims 1, 2 and 6, Wilson discloses a method of suturing an opening in a target tissue (see [0125], [0155]-[0157] and Fig. 20-21), the method comprising stitching a plurality of sutures to tissue adjacent an opening (36) to form a plurality of purse-string sutures, each suture coupled to a plurality of pads. Wilson further teaches the sutures are passed through the pads each time they enter tissue, thereby providing suture portions over respective upper surfaces of each pad (see [0125]). However, Wilson does not expressly teach the first and second purse-string sutures are each stitched through the same first, second and third pads.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrange the purse-string sutures and pads in the method of Wilson such that the first and second purse-string sutures pass through common pads, as a matter of being obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)) to obtain the predictable result of securing the pads to tissue about the opening. Wilson expressly contemplates varying the number of sutures and pads, thereby providing one of ordinary skill in the art with a finite number of predictable arrangements for the disclosed sutures and pads. Using common pads would have constituted one such arrangement and one of ordinary skill in the art would have had a reasonable expectation of success without undue experimentation.
Regarding claim 8, “ wherein: forming the first purse-string suture comprises stitching the first suture through the target tissue from each of two opposing sides of the first pad along the first path; and forming the second purse-string suture comprises stitching the second suture through the target tissue from each of two opposing sides of the first pad along the second path” (Wilson teaches “each time the suture passes through tissue, the suture also passes through a small pledget”, which means the suture is stitched from opposing sides of the pledget as it continues its path around the opening see [0125]).
Regarding claim 10, Wilson further teaches stitching the first pad to the first tissue area comprises stitching the first pad to a first pericardium tissue area adjacent to an opening in a target pericardium tissue (pledgets 2101 are stitched to pericardium adjacent to an opening in the pericardium, see Fig. 21).
Regarding claim 13, Wilson discloses the method of claim 11 and the use of a plurality of pads with a plurality of purse-string sutures where the sutures are passed through the pads each time they enter tissue, thereby providing suture portions over respective upper surfaces of each pad (see [0125]). Wilson does not expressly teach the first and second purse-string sutures are each stitched through the same first and second pads.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrange the purse-string sutures and pads in the method of Wilson such that the first and second purse-string sutures pass through common pads, as a matter of being obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)) to obtain the predictable result of securing the pads to tissue about the opening. Wilson expressly contemplates varying the number of sutures and pads, thereby providing one of ordinary skill in the art with a finite number of predictable arrangements for the disclosed sutures and pads. Using common pads would have constituted one such arrangement and one of ordinary skill in the art would have had a reasonable expectation of success without undue experimentation.
Regarding claim 14, “wherein stitching the first suture to the first pad comprises providing one first suture stitch over an upper surface of the first pad and stitching the second suture to the first pad comprises providing one second suture stitch over the upper surface of the first pad, the one first suture stitch and the one second suture stitch being parallel to one another” (once the first and second purse-string sutures are arranged to pass through common pads, providing the respective sutures with portions over the pad in parallel would have been a predictable arrangement resulting from routing the first and second sutures through the common pledget while continuing their respective paths around the opening).
Regarding claim 15, “ wherein: forming the first purse-string suture comprises stitching the first suture to the target tissue from each of two opposing sides of the first pad along the first path; and forming the second purse-string suture comprises stitching the second suture to the target tissue from each of two opposing sides of the first pad along the second path” (Wilson teaches “each time the suture passes through tissue, the suture also passes through a small pledget”, which means the suture is stitched from opposing sides of the pledget as it continues its path around the opening see [0125]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson and further in view of Northrup (US 5,593,424 A).
Regarding claim 3, Wilson fails to expressly teach providing the first pad with one first suture stitch over the upper surface of the first pad comprises providing a first suture stitch having distal ends about 1 millimeter (mm) to about 2 millimeters (mm) from respective nearest edges of the first pad; and providing the first pad with one second suture stitch over the upper surface of the first pad comprises providing a second suture stitch having distal ends about 1 millimeter (mm) to about 2 millimeters (mm) from respective nearest edges of the first pad.
Northrup, in the same field of art, teaches a related method of suturing tissue using a plurality of sutures and pads (see Fig. 1-4) where the distance between the distal ends of each suture stich and the outside edge of each pad is 1 mm to minimize the chance of overlap of overlap and abutment of adjacent pads (see col. 5, lines 1-10).
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 method of Wilson so that the distal ends of each suture stitch is 1mm from the edge of the pad, as taught by Northrup, since doing so would minimize the chance of overlap of overlap and abutment of adjacent pads.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson, as applied to claim 11 above, and further in view of Carpentier et al. (US 5,972,020 A).
Regarding claim 12, Wilson discloses the method of claim 11, but fails to expressly teach forming the first purse-string suture comprises threading the first suture through a first corresponding portion of a pericardium, an epicardium and at least a portion of a myocardium; and forming the second purse-string suture comprises threading the second suture through a second corresponding portion of the pericardium, the epicardium and at least a portion of the myocardium.
It is noted that Wilson teaches forming purse-string sutures for the purpose of securing tissue around a shaft being introduced into the heart (see [0125] of Wilson).
Carpentier, in the same field of art, teaches a related method of forming a purse-string suture where the thread is installed in the pericardium and myocardium to seal the tissue around the body of a shaft being introduced into the heart (see col. 5, lines 1-13 and element 41 in Fig. 17). Although Carpentier does not expressly teach threading the suture through the epicardium, it is understood that in order for the suture to be installed in the myocardium and pericardium, as disclosed, the thread would have to pass through the epicardium which is located between the myocardium and pericardium.
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 method of Wilson, to include the step of threading the suture through a portion of the pericardium, epicardium and myocardium, as taught by Carpentier, since doing so would have aided in sealing the tissue around the shaft.
Claims 4-5, 7, 9 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson and further in view of Colli (US 10,213,306 B2).
Regarding claim 4, as discussed above with respect to claims 1 and 2, Wilson teaches using a plurality of pads with a plurality of purse-string sutures (see [0125]) and it would have been obvious to try coupling a multiple sutures to the same pads. However, Wilson fails to expressly teach positioning the second pad over a second tissue area adjacent to the opening in the target tissue and at an opposing position relative to the first pad around the opening.
However, it is noted that Wilson the number (and arrangement) of pads may vary and that these arrangements would be obvious to one of ordinary skill in the art (see [0125]).
Colli, in the same field of art, teaches a related method of suturing an opening in a target tissue by forming a purse-string suture 13 and including the step of positioning a plurality of pads such that there are first and second pads each at an opposing positions about the opening (see Fig. 9A and col. 7, lines 50-57).
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 arrangement of the pads in the method of Wilson so that the first and second pads are positioned at opposing positions about the opening, as taught by Colli, since Wilson teaches that the number of pads may vary in a purse-string suture (see Wilson [0125]) and Colli teaches one such possible arrangement of pads in a purse-string suture.
Regarding claim 5, Wilson further teaches aligning both the first and second pads with a posterior mitral valve leaflet direction (pledgets 2101 are aligned with the direction of the mitral valve leaflet 66, see Fig. 21).
Regarding claim 7, Wilson fails to expressly teach evenly distributing the first, second and third pads around the opening in the target tissue.
However, it is noted that Wilson the number (and arrangement) of pads may vary and that these arrangements would be obvious to one of ordinary skill in the art (see [0125]).
Colli, in the same field of art, teaches a related method of suturing an opening in a target tissue by forming a purse-string suture 13 and including the step of positioning a plurality of pads such that the pads are evenly distributed about the opening (see Fig. 9A and col. 7, lines 50-57).
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 arrangement of the pads in the method of Wilson so that the pads are evenly distributed about the opening, as taught by Colli, since Wilson teaches that the number of pads may vary in a purse-string suture (see Wilson [0125]) and Colli teaches one such possible arrangement of pads in a purse-string suture.
Regarding claim 9, Wilson fails to expressly teach stitching the first pad to the first tissue area comprises stitching a rectangular pad to the first tissue area and orienting a longer edge of the rectangular pad toward the opening in the target tissue.
However, it is noted that Wilson the number (and arrangement) of pads may vary and that these arrangements would be obvious to one of ordinary skill in the art (see [0125]).
Colli, in the same field of art, teaches a related method of suturing an opening in a target tissue by forming a purse-string suture 13 and including the step of positioning a plurality of rectangular pads such that a longer edge of each pad is oriented towards the opening (see Fig. 9A and col. 7, lines 50-57).
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 arrangement of the pads in the method of Wilson so that the pads are rectangular and oriented such that the longer edge faces the opening, as taught by Colli, since Wilson teaches that the number of pads may vary in a purse-string suture (see Wilson [0125]) and Colli teaches one such possible arrangement of pads in a purse-string suture.
Regarding claims 17 and 18, Wilson discloses the method of claim 16, but fails to expressly teach positioning the plurality of pads at respective positions around the opening along the first and second paths comprises evenly distributing the plurality of pads around the opening and wherein coupling the plurality of pads to each of the first and second sutures comprises coupling a plurality of rectangular pads to each of the first and second sutures; and positioning the plurality of pads at respective positions around the opening comprises orienting a first longer edge of each of the plurality of rectangular pads toward the opening in the target tissue and a second longer edge of each of the plurality of rectangular pads away from the opening.
It is noted however that Wilson teaches that the number of pads and their placements may vary and that various pad arrangements would be appreciated by one of ordinary skill in the art (see [0125]).
Colli, in the same field of art, teaches a related method of suturing an opening in a target tissue by forming a purse-string suture 13 and including the step of positioning a plurality of rectangular pads around the opening such that the pads are evenly distributed about the opening and such that a first longer edge of each pad is oriented towards the opening and a second longer edge of each pad is oriented away from the opening (see Fig. 9A and col. 7, lines 50-57).
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 arrangement of the pads in the method of Wilson so that the pads are rectangular and evenly distributed about the opening such that the longer edges are facing towards/away from the opening, as taught by Colli, since Wilson teaches that the number of pads may vary in a purse-string suture (see Wilson [0125]) and Colli teaches one such possible arrangement of pads in a purse-string suture.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
All of the documents in the attached PTO-892 teach related methods of forming a purse string suture and/or attaching pledgets to tissue.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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