DETAILED ACTION
The following Office Action is in response to the Amendment filed on September 8, 2025. Claims 2-17 are currently pending.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
Concerning the “Claim Objections” section on page 5 of the Applicant’s Response filed on September 8, 2025, the amendment to claim 2 to address the informality has obviated the necessity of the objection to the claim. Therefore, the objection is withdrawn.
Response to Arguments
Concerning the “Claim Rejections under 35 U.S.C. §§ 102 and 103” section on pages 5-6 of the Applicant’s Response filed on September 8, 2025, the applicant’s arguments have been fully considered, but they are moot in view of the new ground(s) of rejection.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 4-7, 9-11, and 13-17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gresl et al. (US 5,507,755) in view of Nobles et al. (US 2010/0030242, hereinafter Nobles).
Concerning claims 2, 5, and 6, the Gresl et al. prior art reference teaches a method of suturing tissue, comprising positioning a suturing device (Figure 1; 10) comprising an elongated body (Figure 1; 12) through the tissue (Figure 9A); extending a single pivoting arm from the elongate body of the suturing device without damaging the tissue to be sutured (Figure 9B; 16); positioning the arm at or near the tissue (Figure 9C; 16); advancing a first needle connected to a first one of a plurality of suture portions through the tissue at a first location (Figure 9D; 88, 102); retracting the first needle through the tissue after inserting the first suture portion through tissue (Figure 9E; 88); advancing a second needle connected to a second one of a plurality of suture portions through the tissue at a second location (Figure 9G; 88a, 102), retracting the second needle through the tissue after inserting the second suture portion through the tissue (Figure 9H), and closing a distance between the first and second locations with said suture portions placed through said locations (Figure 9I), but it does not specifically teach the arm carrying the plurality of suture portions, advancing the first needle into contact with the first one of the plurality of suture portions and retracting the first needle through the tissue to draw the first suture portion through the tissue, or advancing the second needle into contact with the first one of the plurality of suture portions and retracting the first needle through the tissue to draw the first suture portion through the tissue.
However, the Nobles reference teaches a similar method of suturing tissue, comprising positioning a suturing device (Figure 29; 100) comprising an elongated body (Figure 29; 102) through tissue (Figure 29; 132AB); extending a single pivoting arm from the elongate body of the suturing device without damaging the tissue to be sutured (Figure 30; 104), the arm carrying a plurality of suture portions (Figure 31; 130); positioning the arm at or near the tissue (Figure 30; 132A); advancing a first needle through the tissue at a first location and into contact with a first one of a plurality of suture portions (Figure 31; 106), retracting the first needle through the tissue to draw the first suture portion through the tissue (Figure 32; 130); advancing a second needle through tissue at a second location, and into contact with a second one of a plurality of suture portions (Figure 35; 106); retracting the second needle through the tissue to draw the second suture portion through the tissue (Figure 36; 130), and closing the distance between the first and second locations (Figure 37).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to have the method of the Gresl reference include the steps of advancing the first needle into contact with the first one of the plurality of suture portions and retracting the first needle through the tissue to draw the first suture portion through the tissue, and advancing the second needle into contact with the first one of the plurality of suture portions and retracting the second needle through the tissue to draw the second suture portion through the tissue as in the Nobles reference to allow the method to be utilized specifically to suture an anatomical valve such as a mitral valve (Nobles; [¶ 0086, 0090]).
Although the Nobles reference teaches inserting two suturing devices having two different arms, the Gresl teaches the use of a single suturing arm and two needles being used to insert needles via a single pivoting arm, and a person having ordinary skill in the art at the time of invention would recognize that the two suture portions may be carried by the single arm of the Gresl reference.
Concerning claim 4, the combination of the Gresl and Nobles references as discussed above teaches the method of claim 2, wherein Gresel reference further teaches the first and second needles being advanced sequentially (Figures 29-36).
Concerning claim 7, the combination of the Gresl and Nobles references as discussed above teaches the method of claim 2, wherein the Nobles reference further teaches the method comprising delivering the suturing device through a transapical opening ([¶ 0063]).
Concerning claim 9, the combination of the Gresl and Nobles references as discussed above teaches the method of claim 2, wherein the Nobles reference teaches the arm comprising a suture mount for releasably holding at least one of the plurality of suture portions (Figure 17; 104), wherein in the modification, a person having ordinary skill in the art would find it obvious to include a pair of suture mounts to accommodate for the two suture portions carried by the single arm.
Concerning claims 10 and 14, the Gresl et al. prior art reference teaches a method of applying a suture to tissue, comprising providing a suturing device, the suturing device comprising a proximal end and a distal end (Figure 1; 10) an elongated body extending between the proximal end and the distal end (Figure 1; 12), and a handle at the proximal end (Figure 9A; 14); delivering the distal end of the suturing device to a location adjacent the tissue (Figure 9A); extending a single pivoting arm from the elongate body form a first position wherein the arm is retracted into the elongate body (Figure 9A; 16) to a second position wherein the arm has a single free end extending away from the elongate body (Figure 9B; 16); positioning the arm adjacent a first side of the tissue (Figure 9C; 16); advancing a first needle connected to a first one of a plurality of suture portions through the tissue at a first location (Figure 9D; 88, 102); retracting the first needle through the tissue after inserting the first suture portion through tissue (Figure 9E; 88); advancing a second needle connected to a second one of a plurality of suture portions through the tissue at a second location (Figure 9G; 88a, 102), retracting the second needle through the tissue after inserting the second suture portion through the tissue (Figure 9H), wherein the arm is configured to move between the first position and the second position without damaging the tissue to be sutured, but it does not specifically teach the arm carrying the plurality of suture portions, advancing the first needle into contact with the first one of the plurality of suture portions and retracting the first needle through the tissue to draw the first suture portion through the tissue, or advancing the second needle into contact with the first one of the plurality of suture portions and retracting the first needle through the tissue to draw the first suture portion through the tissue.
However, the Nobles reference teaches a similar method of suture tissue, comprising positioning a suturing device (Figure 29; 100) comprising an elongated body (Figure 29; 102) through tissue (Figure 29; 132AB); extending a single pivoting arm from the elongate body of the suturing device without damaging the tissue to be sutured (Figure 30; 104), the arm carrying a plurality of suture portions (Figure 31; 130); positioning the arm at or near the tissue (Figure 30; 132A); advancing a first needle through the tissue at a first location and into contact with a first one of a plurality of suture portions (Figure 31; 106), retracting the first needle through the tissue to draw the first suture portion through the tissue (Figure 32; 130); advancing a second needle through tissue at a second location, and into contact with a second one of a plurality of suture portions (Figure 35; 106); retracting the second needle through the tissue to draw the second suture portion through the tissue (Figure 36; 130), and closing the distance between the first and second locations (Figure 37).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to have the method of the Gresl reference include the steps of advancing the first needle into contact with the first one of the plurality of suture portions and retracting the first needle through the tissue to draw the first suture portion through the tissue, and advancing the second needle into contact with the first one of the plurality of suture portions and retracting the second needle through the tissue to draw the second suture portion through the tissue as in the Nobles reference to allow the method to suture an anatomical valve such as a mitral valve (Nobles; [¶ 0086, 0090]).
Although the Nobles reference teaches inserting two suturing devices having two different arms, the Gresl teaches the use of a single suturing arm and two needles being used to insert needles via a single pivoting arm, and a person having ordinary skill in the art at the time of invention would recognize that the two suture portions may be carried by the single arm of the Gresel reference.
Concerning claim 11, the combination of the Gresl and Nobles references as discussed above teaches the method of claim 10, wherein the Gresl reference further comprises tightening the first suture portion and the second suture portion to draw the first and second location closer together (Figure 37).
Concerning claim 13, the combination of the Gresl and Nobles references as discussed above teaches the method of claim 10, wherein Gresel reference further teaches the first and second needles being advanced sequentially (Figures 29-36).
Concerning claim 15, the combination of the Gresl and Nobles references as discussed above teaches the method of claim 10, wherein Nobles reference further teaches delivering the suturing device transapically into the left ventricle of the heart (Figure 2; 9), and wherein the positioning of the arm adjacent the first side of the tissue comprises positioning the arm at or near a base of the valve on the atrial side of the valve (Figure 19; 132A).
Concerning claims 16 and 17, the combination of the Gresl and Nobles references as discussed above teaches the method of claim 10, wherein Nobles reference further teaches the first suture portion and the second portions being ends of the same suture ([¶ 0098]), while the reference also teaches that the single suture may be a plurality of different sutures ([¶ 0112]).
Claims 3 and 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gresl et al. (US 5,507,755) in view of Nobles et al. (US 2010/0030242, hereinafter Nobles) as applied to claims 2, 4-7, 9-11, and 13-17 above, and further in view of Nobles et al. (US 2002/0049453, hereinafter Nobles ‘453).
Concerning claims 3 and 12, the combination of the Gresl and Nobles references as discussed above teaches the methods of claims 2 and 10, but does not teach the first and second needles being advanced simultaneously.
However, the Nobles ‘453 reference teaches a method of suturing tissue including a suturing device comprising an elongate body (Figure 21; 500), extending an arm from the elongate body (Figure 21; 504’), the arm carrying multiple suture portions, wherein a first needle and second needle are advanced through tissue at a location and into contact with the multiple suture portions simultaneously, and retracting the first and second needles through the tissue to draw the multiple suture portions through tissue ([¶ 0090]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to advance the first and second needles of the Gresl and Nobles combination simultaneously as in the Nobles ‘453 reference to allow for a parallel deployment of the sutures (Nobles ‘453; [¶ 0089]).
Claim 8 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gresl et al. (US 5,507,755) in view of Nobles et al. (US 2010/0030242, hereinafter Nobles) as applied to claims 2, 4-7, 9-11, and 13-17 above, and further in view of Weiss (US 2007/0049952).
Concerning claim 8, the combination of the Nobles and Gresl references as discussed above teaches the method of claim 2, but does not specifically teach advancing the first needle and the second needle through tissue of a beating heart.
However, the Weiss reference teaches a method of repairing the mitral valve of a heart via the suturing of tissue within the heart, therein being in the same field of endeavor as the Nobles reference, wherein the Weiss reference teaches that the procedure is performed within a heart that is still beating (Weiss; [¶ 0011]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to perform the method of the Gresl and Nobles combination within a heart that is still beating as in the Weiss reference to allow the procedure to be performed without cardiopulmonary bypass (Weiss; [¶ 0008]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MARTIN T TON/Examiner, Art Unit 3771 11/25/2025