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 .
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 § 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 30 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 30 recites the limitation "a catheter" in the claim. It is unclear to examiner if this is the same “a catheter” as in claim 29, or a separate catheter. Examiner suggests amending to the catheter.
Claim Rejections - 35 USC § 102
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) 2 and 13-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taft (US 2017/0106176).
Regarding claim 2, Taft teaches a method comprising:
creating an opening in a tissue wall between a coronary sinus and a left atrium (par. [0023] create a puncture hole), 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).
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 area of tissue includes a portion of an outer 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).
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 wherein creating the opening in the tissue wall between the coronary sinus and the left atrium comprises:
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); and
creating a puncture in the tissue wall with the catheter (par. [0056]).
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 25, Taft teaches expanding the puncture in the tissue wall using a puncture expander to create the opening (par. [0060] expander 40 to widen the puncture).
Regarding claim 26, Taft teaches wherein the puncture expander is an inflatable balloon (par. [0059]).
Regarding claim 27, Taft teaches wherein expanding the puncture in the tissue wall using the puncture expander to create the opening further comprises:
inflating the inflatable balloon radially outward to widen the opening in the tissue wall (par. [0060] expanding 40).
Regarding claim 28, Taft teaches advancing the puncture expander through the puncture in the tissue wall (Figs. 3h-j and par. [0059]-[0060]).
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 an opening in a tissue wall between the coronary sinus and a left atrium with the catheter (par. [0023] create a puncture hole), 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).
Regarding claim 30, Taft teaches wherein creating the opening in the tissue wall between the coronary sinus and the left atrium with a catheter further comprises:creating a puncture in the tissue wall between the coronary sinus and the left atrium (par. [0023] create a puncture hole);
advancing a puncture expander through the puncture in the tissue wall (puncture expander 40); and expanding the puncture in the tissue wall using the puncture expander to create the opening (40 expanding as in Figs. 3i-3j).
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, 3-9, and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taft in view of Celermajer (US 2013/0267885).
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 in the tissue wall using the puncture expander 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.However, Celermajer teaches stabilizing tissue to a cardiac tissue wall via energy delivery (par. [0044] with ablating 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 as ablation of Celermajer to stabilize tissue.
Regarding claim 3, Taft is not explicit wherein treating the area of tissue around the opening comprises ablating the area of tissue around the opening.However, Celermajer teaches stabilizing tissue to a cardiac tissue wall via energy delivery (par. [0044] with ablating 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 as ablation of Celermajer to stabilize tissue.
Regarding claim 4, Taft is not explicit wherein ablating the area of tissue around the opening comprises electrically ablating the area of tissue around the opening.However, Celermajer teaches stabilizing tissue to a cardiac tissue wall via energy delivery (par. [0044] with ablating 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 as ablation of Celermajer to stabilize tissue.
Regarding claim 5, Taft is not explicit wherein treating the area of tissue around the opening comprises burning the area of tissue around the opening.However, Celermajer teaches stabilizing tissue to a cardiac tissue wall via energy delivery as burning (par. [0016] with burning 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 as burning of Celermajer to stabilize tissue.
Regarding claim 6, Taft is not explicit wherein treating the area of tissue around the opening comprises cauterizing the area of tissue around the opening.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).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.
Regarding claim 7, Taft is not explicit wherein cauterizing the area of tissue around the opening comprises electrically cauterizing the area of tissue around the opening.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).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.
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 9, Taft is silent wherein treating the area of tissue around the opening comprises cutting the area of tissue around the opening.
However, Celermajer teaches cutting features to cut tissue to dilate an opening (par. [0042]).
It would have been obvious to one of ordinary skill in the art to modify Taft with the cutting ability of Celermajer to stabilize tissue.
Regarding claim 11, Taft is silent wherein treating the area of tissue around the opening further comprises:
advancing an electrical cauterizing tool to the opening in the tissue wall; and
electrically cauterizing the area of tissue around the opening with the electrical cauterizing tool.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).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.
Regarding claim 12, Taft is silent wherein electrically cauterizing the area of tissue around the opening includes electrically cauterizing the area of tissue around the opening with the electrical cauterizing tool to cause 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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taft in view of Celermajer, in further view of Stevens (US 6,029,671).
Regarding claim 10, Taft is silent wherein treating the area of tissue around the opening further comprises:
advancing a laser to the opening in the tissue wall; and burning the area of tissue around the opening with the laser.However, Stevens teaches advancing a laser to a wall and treating the wall area with laser (col. 23, line 55 to col. 24, line 18).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Guyton (US 2016/0235439) teaches stabilizing tissue with energy delivery.
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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