DETAILED ACTION
Applicant's amendments and remarks, filed 7/29/26 are fully acknowledged by the Examiner. Currently, claims 1-2, 8, 12-24, 26-27, 29, and 31-39 are pending with claims 3-7, 9-11, 25, 28, 30 canceled, claims 31-39 added, and claims 1, 2, 12, 16, 19, 21, 26, 27, and 29 amended. Applicant's cancellation of claim 30 has made moot the previously filed 35 USC 112(b) rejection. The following is a complete response to the 7/29/26 communication.
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 .
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.
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.
Claim(s) 1-2 and 13-24, 26-27, 29, 31-39 is/are rejected under 35 U.S.C. 103 as unpatentable over Taft (US 2017/0106176) in view of Guyton (US 2016/0235439).
Regarding claim 1, Taft teaches a method comprising:
advancing a guidewire to a coronary sinus (par. [0020]);
advancing a catheter to the coronary sinus over the guidewire (par. [0021] advance catheter along the guidewire);
creating a puncture in a tissue wall between the coronary sinus and a left atrium with the catheter (par. [0023] create a puncture hole);
advancing a puncture expander through the puncture in the tissue wall (puncture expander 40);expanding the puncture expander to widen the puncture in the tissue wall to create an opening (40 expanding as in Figs. 3i-3j), wherein the opening creates a blood flow path between the coronary sinus and the left atrium (par. [0009]).
Taft is not explicit regarding ablating an area of tissue around the opening in the tissue wall to prevent in-growth of tissue at the opening, wherein ablating the area of tissue around the opening in the tissue wall comprises applying an electrical cauterizing tool directly to the area of tissue to electrically cauterize the area of tissue and maintain a size of the opening.
However, Guyton teaches treating an area of tissue around an opening formed in the heart using an electrical cauterizing tool directly to the area of tissue to cauterize the area of tissue and maintain a size of the opening (par. [0086], [0184)] and a tissue stabilizing heat to increase structural stability of tissue [0167]).It would have been obvious to one of ordinary skill in the art to modify Taft with the electrosurgical tool use of Guyton, to allow for stabilizing the puncture (par. [0184]).
Regarding claim 2, Taft teaches a method comprising:advancing a catheter to the coronary sinus (catheter 22 to coronary sinus as in at least Fig. 3b);creating a puncture in a tissue wall between a coronary sinus and a left atrium with the catheter (Fig. 3d with puncture needle to puncture the wall between the coronary sinus and left atrium as in par. [0056]);positioning a puncture expander in the puncture in the tissue wall (puncture expander 40 positioned in as in Fig. 3h);expanding the puncture expander to expand the puncture in the tissue wall to widen the puncture and create an opening (Fig. 3j 40 expanded as in par. [0060]), wherein the opening creates a blood flow path between the coronary sinus and the left atrium (par. [0068]); and
treating an area of tissue around the opening to prevent in-growth of tissue at the opening (installing a shunt 150).Taft is silent wherein treating an area of tissue around the opening comprises applying an electrical cauterizing tool directly to the area of tissue to electrically cauterize the area of tissue and maintain a size of the opening.However, Guyton teaches treating an area of tissue around an opening formed in the heart using an electrical cauterizing tool directly to the area of tissue to cauterize the area of tissue and maintain a size of the opening (par. [0086], [0184)] and a tissue stabilizing heat to increase structural stability of tissue [0167]).It would have been obvious to one of ordinary skill in the art to modify Taft with the electrosurgical tool use of Guyton, to allow for stabilizing the puncture (par. [0184]).
Regarding claim 13, Taft teaches wherein the area of tissue has an elliptical shape (par. [0081] oval shape).
Regarding claim 14, Taft teaches wherein the area of tissue has a circular shape (par. [0081] circular shape).
Regarding claim 15, Taft teaches wherein the area of tissue completely surrounds the opening in
the tissue wall (opening is defined and surrounded by tissue as in at least Fig. 3Q-V).
Regarding claim 16, Taft teaches wherein the tissue wall comprises a first surface and an opposing second surface, the opening extends from the first surface to the second surface (surface facing coronary sinus and opposing surface facing left atrium) area of tissue includes a portion of the first surface of the tissue wall surrounding the opening (at least Fig. 3p).
Regarding claim 17, Taft teaches wherein the area of tissue includes an inner surface of the
opening in the tissue wall (Fig. 3p).
Regarding claim 18, Taft teaches wherein the area of tissue includes a portion of an outer
surface of the tissue wall surrounding the opening and an inner surface of the opening in the tissue wall (at least Fig. 3p with inner and outer surface of the tissue wall).
Regarding claim 19, Taft teaches wherein treating the area of tissue around the opening includes treating a first area of tissue around the opening (flanges 152 on one side of the wall), and further comprising:
treating a second area of tissue around the opening (154 on the other side of the wall);
wherein the first area of tissue around the opening is on a side of the tissue wall in the left atrium and the second area of tissue is on a side of the tissue wall in the coronary sinus (Fig. 3v).Taft is not explicit regarding the treatment being the cauterizing as in claim 2. However, Guyton teaches the treating of tissue as cauterizing as in claim 2.It would have been obvious to one of ordinary skill in the art to modify Taft with the electrosurgical tool use of Guyton, to allow for stabilizing the puncture (par. [0184]).
Regarding claim 20, Taft teaches shunting blood from the left atrium to the coronary sinus through the opening (par. [0081]).
Regarding claim 21, Taft teaches the method further comprising:
advancing a guidewire to the coronary sinus (par. [0053] guidewire 20); advancing a catheter to the coronary sinus over the guidewire (par. [0053] catheter 22 advanced over the guidewire to the sinus).
Regarding claim 22, Taft teaches wherein advancing the guidewire to the coronary sinus further comprises:
advancing the guidewire from a right atrium into the coronary sinus through a coronary sinus ostium (par. [0053] advancing guidewire 20 through right atrium to coronary sinus through ostium, as in Fig. 3a).
Regarding claim 23, Taft teaches wherein the catheter is a puncture catheter having a needle (par. [0056] puncture catheter 22 with needle 34).
Regarding claim 24, Taft teaches wherein creating the puncture in the tissue wall with the catheter further comprises: puncturing through the tissue wall and into the left atrium using the needle of the puncture catheter (par. [0056]).
Regarding claim 26, Taft teaches wherein the puncture expander is an inflatable balloon (par. [0059]).
Regarding claim 27, Taft teaches wherein expanding the puncture expander comprises:
inflating the inflatable balloon radially outward to widen the puncture and create the opening in the tissue wall (par. [0060] expanding 40 to widen the puncture into an opening).
Regarding claim 29, Taft teaches a method comprising:
advancing a guidewire to a coronary sinus (par. [0020]);
advancing a catheter to the coronary sinus over the guidewire (par. [0021] advance catheter along the guidewire);
creating a puncture in a tissue wall between the coronary sinus and a left atrium with the catheter (par. [0056] create a puncture, Fig. 3d), advancing a puncture expander through the puncture in the tissue wall (expander 40 advanced through the puncture as in at least Fig. 3h),expanding the puncture expander to expand the puncture to widen the puncture and create an opening in the tissue wall (Fig. 3j, 40 expanded to create a hole from the puncture),
wherein the opening creates a blood flow path between the coronary sinus and the left atrium (par. [0009]); and
treating an area of tissue around the opening in the tissue wall to prevent in-growth of tissue at the opening (installing a shunt).Taft is silent regarding cauterizing the area of tissue comprise applying an electrical cauterizing tool directly to the area of tissue to electrically cauterize the area of tissue and maintain a size of the opening.However, Guyton teaches treating an area of tissue around an opening formed in the heart using an electrical cauterizing tool directly to the area of tissue to cauterize the area of tissue and maintain a size of the opening (par. [0086], [0184)] and a tissue stabilizing heat to increase structural stability of tissue [0167]).It would have been obvious to one of ordinary skill in the art to modify Taft with the electrosurgical tool use of Guyton, to allow for stabilizing the puncture (par. [0184]).
Regarding claim 31, Taft teaches wherein the puncture expander comprises an inflatable ballon (40 as a balloon); andexpanding the puncture expander to expand the puncture to widen the puncture and create the opening comprises inflating the inflatable balloon (40 inflates to widen the hole as in Fig. 3j).
Regarding claim 32, Taft teaches wherein the tissue wall comprises a first surface in the left atrium and an opposing, second surface in the coronary sinus (Fig. 3a-v tissue wall with two surfaces); andthe opening extends from the first surface to the second surface and the tissue wall comprises an annular inner surface circumscribing the opening (at least Fig. 3v with the opening through the first and second surfaces with an annular inner surface).
Regarding claim 33, Taft is not explicit regarding cauterizing the area of tissue comprises cauterizing an annular inner surface circumscribing the opening. However, Guyton teaches cauterizing a wall of a hole in the heart (par. [0086], [0184)] and a tissue stabilizing heat to increase structural stability of tissue [0167]).It would have been obvious to one of ordinary skill in the art to modify Taft with the electrosurgical tool use of Guyton, to allow for stabilizing the puncture (par. [0184]).
Regarding claim 34, Taft is not explicit wherein the cauterizing portion of the first surface completely surrounds the opening.However, Guyton teaches cauterizing a wall of a hole in the heart (par. [0086], [0184)] and a tissue stabilizing heat to increase structural stability of tissue [0167]).It would have been obvious to one of ordinary skill in the art to modify Taft with the electrosurgical tool use of Guyton, to allow for stabilizing the puncture (par. [0184]).
Regarding claim 35, Taft is not explicit wherein cauterizing the area of tissue comprises cauterizing a portion of the second surface adjacent the opening.However, Guyton teaches cauterizing a wall of a hole in the heart (par. [0086], [0184)] and a tissue stabilizing heat to increase structural stability of tissue [0167]).It would have been obvious to one of ordinary skill in the art to modify Taft with the electrosurgical tool use of Guyton, to allow for stabilizing the puncture (par. [0184]).
Regarding claim 36, Taft is not explicit wherein the cauterized portion of the second surface completely surrounds the opening.However, Guyton teaches cauterizing a wall of a hole in the heart (par. [0086], [0184)] and a tissue stabilizing heat to increase structural stability of tissue [0167]).It would have been obvious to one of ordinary skill in the art to modify Taft with the electrosurgical tool use of Guyton, to allow for stabilizing the puncture (par. [0184]).
Regarding claim 37, Taft teaches wherein cauterizing the area of tissue comprises:cauterizing a portion of the first surface adjacent the opening; andcauterizing a portion of the second surface adjacent the opening.However, Guyton teaches cauterizing a wall of a hole in the heart (par. [0086], [0184)] and a tissue stabilizing heat to increase structural stability of tissue [0167]).It would have been obvious to one of ordinary skill in the art to modify Taft with the electrosurgical tool use of Guyton, to allow for stabilizing the puncture (par. [0184]).
Regarding claim 38, Taft is silent wherein the cauterized portion of the first surface completely surrounds the opening; and the cauterized portion of the second surface completely surrounds the opening.However, Guyton teaches cauterizing a wall of a hole in the heart (par. [0086], [0184)] and a tissue stabilizing heat to increase structural stability of tissue [0167]).It would have been obvious to one of ordinary skill in the art to modify Taft with the electrosurgical tool use of Guyton, to allow for stabilizing the puncture (par. [0184]).
Regarding claim 39, Taft is silent wherein cauterizing the area of tissue comprises cauterizing the annular inner surface circumscribing the opening.However, Guyton teaches cauterizing a wall of a hole in the heart (par. [0086], [0184)] and a tissue stabilizing heat to increase structural stability of tissue [0167]).It would have been obvious to one of ordinary skill in the art to modify Taft with the electrosurgical tool use of Guyton, to allow for stabilizing the puncture (par. [0184]).
Claim(s) 8 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taft in view of Celermajer (US 2013/0267885).
Regarding claim 8, Taft is not explicit wherein treating the area of tissue around the opening
comprises scarring the area of tissue around the opening.
However, Celermajer teaches stabilizing tissue to a cardiac tissue wall via energy delivery as scarring (par. [0017] with scarring tissue near an opening to improve tissue).
It would have been obvious to one of ordinary skill in the art to modify Taft with energy delivery causing scarring of Celermajer to stabilize tissue.
Regarding claim 12, Taft is silent wherein applying the electrically cauterizing tool directly to the area of tissue around the opening produces a controlled scarring pattern.
However, Celermajer teaches stabilizing tissue to a cardiac tissue wall via energy delivery as cauterizing (par. [0016] with burning tissue near an opening to improve tissue and cause scarring as in par. [0017]).
It would have been obvious to one of ordinary skill in the art to modify Taft with energy delivery as cauterizing of Celermajer to stabilize tissue.
Response to Arguments
Applicant’s arguments, see the remarks, filed 7/29/26, with respect to the rejection(s) of claim(s) 1-30 under 35 USC 102(a)(1) or 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Guyton as a secondary reference.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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