DETAILED ACTION
Applicant's amendments and remarks, filed 2/18/26, are fully acknowledged by the Examiner. Currently, claims 1-11, 13-17, 19-22 are pending with and claims 1-2, 8, and 14 amended. The following is a complete response to the 2/18/26 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/18/26 has been entered.
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, 3-11, 13-17, 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taft (US 2017/0106176) in view of Guyton (US 2016/0235439).
Regarding claim 1, Taft teaches a method of forming an opening between a left atrium and a coronary sinus for reducing left atrial pressure, the method comprising: advancing a guidewire through the right atrium and into the coronary sinus (par. [0020]); delivering a puncture catheter and an electrical cauterizing tool through an introducer sheath and over the guidewire (side extending needle over guidewire through first catheter as sheath as in par. [0021]- [0023]), wherein the puncture catheter includes a sharp tip (needle 34 with a sharp tip as in par. [0056]) and at least one radiopaque marker (par. [0054]); positioning a distal end portion of the puncture catheter at a target location within the coronary sinus (needle 34 faces wall 30 as in par. [0055]); advancing the puncture catheter to create the opening in a wall between the coronary sinus and the left atrium (par. [0056] needle punctures wall); wherein the opening creates a blood flow path between the left atrium and the coronary sinus for reducing left atrial pressure, thereby alleviating symptoms of diastolic heart failure (par. [0005)]), and removing the device from the coronary sinus (removing after treatment).
Taft is silent regarding an electrical cauterizing tool, treating an area of tissue around the opening by applying the electrical cauterizing tool directly to the area of tissue to electrically ablate and cause a controlled scarring pattern at the area of tissue to maintain a size of the opening; placing a medical device within the opening after treating the area of tissue; and removing the puncture catheter and the electrical cauterizing tool from the coronary sinus.
However, Guyton teaches an electrosurgical tool and treating an area of tissue around the opening using the electrical tool to cause a controlled scarring pattern at the area of tissue to maintain a size of the opening (par. [0086], [0184)] and a tissue stabilizing heat to increase structural stability of tissue [0167]), and placing a seal after treating the tissue. Guyton further teaches placing a seal in the opening after treating the area of tissue (2420 and par. [0185]).It would have been obvious to one of ordinary skill in the art to modify Taft with the electrosurgical tool of Guyton, to allow for stabilizing the puncture (par. [(0184]).
Regarding claim 3, Taft teaches wherein the guidewire is advanced through a femoral vein, an
inferior vena cava, and into the right atrium (par. [0048]).
Regarding claim 4, Taft teaches wherein the guidewire is advanced through a superior vena cava and into the right atrium (par. [0048]).
Regarding claim 5, Taft teaches expanding the opening using a balloon (par. [0059)).
Regarding claim 6, Taft teaches wherein the balloon is in a deflated form during delivery and is inflated to an inflated form while positioned within the opening (par. [0059], balloon inflated when positioned in the opening).
Regarding claim 7, Taft teaches dilating the opening before treating the area of tissue (dilating
the puncture as in par. [0059] before shunt put in).
Regarding claim 8, Taft teaches a method of forming an opening between a left atrium and a coronary sinus of a heart, the method comprising:
delivering a puncture catheter (par. [0021]-[0023]), a puncture expander (40), to a target location within a coronary sinus of a heart via a catheter (par. [0048));
puncturing a wall between the coronary sinus and a left atrium to form an opening in the wall using the puncture catheter (needle 34 punctures wall 30 as in par. [0055));
expanding the opening using the puncture expander (par. [0059] expanded with 40);
removing the puncture catheter, puncture expander, and ablation device from the heart (removing the device after treatment).
Taft is silent regarding an ablation device, and treating an area of tissue within the opening using the ablation device to maintain the expanded opening, and placing a medical device within the opening after treating the area of tissue.
However, Guyton teaches an electrosurgical tool and treating an area of tissue around the opening using the electrical tool to cause a controlled scarring pattern at the area of tissue (par. [0086], [0184)]). Guyton further teaches placing a seal in the opening after treating the area of tissue (2420 and par. [0185]).It would have been obvious to one of ordinary skill in the art to modify Taft with the electrosurgical tool of Guyton, to allow for stabilizing the puncture (par. [(0184]).
Regarding claim 9, Taft teaches further comprising delivering the puncture catheter and the ablation device to the target location within the coronary sinus via a right atrium of the heart (par. [0048)]).
Regarding claim 10, Taft teaches further comprising advancing a guidewire the target location within the coronary sinus, wherein delivering the puncture catheter involves advancing the puncture catheter over the guidewire (advancing catheter over guidewire 20 as in Fig. 3a-b).
Regarding claim 11, Taft is silent regarding wherein the ablation device comprises an electrical cauterizing tool and wherein treating the area of tissue within the opening involves scarring the area of tissue within the opening using the electrical cauterizing tool.
However, Guyton teaches an electrosurgical tool and treating an area of tissue around the opening using the electrical tool to cause a controlled scarring pattern at the area of tissue (par. [0086], [0184)]).It would have been obvious to one of ordinary skill in the art to modify Taft with the electrosurgical tool of Guyton, to allow for stabilizing the puncture (par. [(0184]).
Regarding claim 13, Taft teaches wherein the opening is expanded before treating the area of tissue (dilating the puncture as in par. [0059] before shunt put in).
Regarding claim 14, Taft teaches a method of forming an opening between a coronary sinus and
a left atrium of a heart, the method comprising:
delivering a puncture catheter, a puncture expander, to a tissue wall between the coronary sinus and the left atrium via a catheter (side extending needle over guidewire through first catheter as sheath as in par. [0021]-[0023)]);
puncturing an opening at the tissue wall using the puncture catheter (34 to puncture tissue wall);
expanding the opening using the puncture expander (expanding puncture using 40);
removing the device from the heart (removing the device after treatment).
Taft is silent regarding an ablation device treating one or more areas of tissue around the opening using the ablation device to prevent in-growth of tissue at the opening and maintain a size of the opening. Taft is further silent regarding placing a medical device within the opening after treating the one or more areas of tissue.
However, Guyton teaches an electrosurgical tool and treating an area of tissue around the opening using the electrical tool to cause a controlled scarring pattern at the area of tissue (par. [0086], [0184)]). Guyton further teaches placing a seal in the opening after treating the area of tissue (2420 and par. [0185]).
It would have been obvious to one of ordinary skill in the art to modify Taft with the electrosurgical tool of Guyton, to allow for stabilizing the puncture (par. [(0184]).
Regarding claim 15, Taft teaches further comprising delivering the puncture catheter and the ablation device to the tissue wall within the coronary sinus via a right atrium of the heart (par. [0048]).
Regarding claim 16, Taft teaches further comprising advancing a guidewire to the tissue wall, wherein delivering the puncture catheter involves advancing the puncture catheter over the guidewire (advancing catheter over guidewire 20 as in Fig. 3a-b).
Regarding claim 17, Taft wherein the one or more areas of tissue are along a coronary sinus side of the tissue wall (coronary sinus side of wall as in par. [0055]).
Regarding claim 19, Taft is silent wherein there is a gap of tissue outside the opening between the opening and a first area of tissue of the one or more areas of tissue.
However, Guyton teaches treatment of tissue in the heart, and treating tissue away from the opening (par. [0150-0151]).
It would have been obvious to one of ordinary skill in the art to modify Taft with the treatment of Guyton, allowing for treatment of the heart.
Regarding claim 20, Taft is not explicit wherein treating one or more areas of tissue involves treating a first area of tissue and treating a second area of tissue, wherein the first area of tissue is closer to the opening than the second area of tissue.
However, Guyton teaches treatment of tissue in the heart in multiple areas, and treating tissue away from the opening (par. [0150-0151] electrodes on spines to treat the heart).
It would have been obvious to one of ordinary skill in the art to modify Taft with the treatment of Guyton, allowing for treatment of the heart.
Regarding claim 21, Taft does not teach wherein a diameter of the area of tissue is greater than a diameter of the opening.
However, Guyton teaches wherein a diameter of the area of tissue is greater than a diameter of the opening (Fig. 9 with area of effected tissue 82 greater than a diameter of the opening).
It would have been obvious to one of ordinary skill in the art to modify Taft with a diameter of the area of tissue greater than the diameter of the opening as in Guyton, as the tissue area surrounds and forms the inner diameter defining the opening.
Regarding claim 22, Taft does not teach directly treating the area of tissue within the opening by applying electrical energy directly to the area of tissue via the ablation device.
However, Guyton teaches an energy-transducing element configured to apply electrical energy directly to the area of tissue via the ablation device (par. [0085], [0086] energy-transducing element to heat or provide other electrical energy directly to tissue).
It would have been obvious to one of ordinary skill in the art to modify Taft with the electrosurgical tool of Guyton, to allow for stabilizing the puncture (par. [(0184]).
Response to Arguments
Applicant's arguments filed 2/18/26 have been fully considered but they are not persuasive. Applicant argues that the claims as amended are not taught by the prior art. However, Guyton teaches placing a medical device within the opening after treating the area of tissue in the form of a seal. However, examiner notes that amending such that the opening remains open after removing the catheter/tools would overcome the rejection given the seal blocks the opening.
Allowable Subject Matter
Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 2 remains objected to for the same reasoning in the 12/18/25 rejection.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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