DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/27/2026 has been entered.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-31 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Demarais et al. US 20070135875 A1).
Regarding claim 1, Demarais et al. (‘875) teach a method of treating a mammalian patient with a kidney, a vasculature including a main renal artery and at least one distal branch of the main renal artery, the at least one distal branch having a vessel wall, and at least one renal nerve associated with the at least one distal branch, the method comprising: inserting a catheter into the vasculature of the patient, said catheter comprising a distal end (see [0052]-[0054]); advancing said distal end of said catheter through the vasculature into the at least one distal branch (see [0052]-[0054]); and applying radiofrequency energy to the at least one distal branch to heat the vessel wall of the at least one distal branch and ablate the at least one renal nerve associated with the at least one distal branch in which said distal end of said catheter is positioned (see [0052]-[0054]).
Regarding claim 2, Demarais et al. (‘875) teach the method of claim 1, further comprising stabilizing at least part of said catheter relative to the at least one distal branch after said advancing and before said ablating (see [0055]).
Regarding claim 3, Demarais et al. (‘875) teach the method of claim 2, wherein said catheter further comprises a balloon at a distal end thereof, and wherein said stabilizing further comprises inflating said balloon to center said distal end of said catheter in the at least one distal branch (see [0055]).
Regarding claim 4, Demarais et al. (‘875) teach the method of claim 1, wherein said catheter further comprises a plurality of electrodes in proximity to said distal end of said catheter, wherein said applying is performed by delivering electrical current to said electrodes (see [0055]).
Regarding claim 5, Demarais et al. (‘875) teach the method of claim 4, wherein applying radiofrequency energy to the at least one distal branch to heat the vessel wall of the at least one distal branch comprises forming a lesion in a spiral shape (see [0055]).
Regarding claim 6, Demarais et al. (‘875) teach the method of claim 1, further comprising: monitoring a temperature of the wall of the at least one distal branch during said applying, at a location adjacent to said applying (see [0057]).
Regarding claim 7, Demarais et al. (‘875) teach the method of claim 6, wherein said applying comprises limiting the temperature of the wall of the at least one distal branch to 55 C (see [0103]).
Regarding claim 8, Demarais et al. (‘875) teach the method of claim 6, wherein said applying comprises limiting the temperature of the wall of the at least one distal branch to 60 C (see [0103]).
Regarding claim 9, Demarais et al. (‘875) teach the method of claim 6, wherein said applying comprises limiting the temperature of the wall of the at least one distal branch to 65 C (see [0103]).
Regarding claim 10, Demarais et al. (‘875) teach the method of claim 6, wherein said applying comprises limiting the temperature of the wall of the at least one distal branch within a specified level for a specified time (see [0103]).
Regarding claim 11, Demarais et al. (‘875) teach the method of claim 6, wherein said applying comprises limiting the temperature of the wall of the at least one distal branch to 60 C. for 60 seconds (see [0103]).
Regarding claim 12, Demarais et al. (‘875) teach the method of claim 6, wherein said applying comprises limiting the temperature of the wall of the at least one distal branch to 65 C. for 60 seconds (see [0103]).
Regarding claim 13, Demarais et al. (‘875) teach the method of claim 6, further comprising stopping said applying when said monitoring monitors a temperature over a threshold (see [0103]).
Regarding claim 14, Demarais et al. (‘875) teach the method of claim 6, wherein said threshold is 65 C (see [0103]).
Regarding claim 15, Demarais et al. (‘875) teach the method of claim 6, further comprising displaying said temperature (see [0057]).
Regarding claim 16, Demarais et al. (‘875) teach the method of claim 1, further comprising monitoring a position of said distal end of said catheter within the at least one distal branch during said applying (see [0052]-[0054]).
Regarding claim 17, Demarais et al. (‘875) teach the method of claim 1, further comprising monitoring radiofrequency delivery of energy to the vessel wall of the at least one distal branch during said applying (see [0052]-[0054]).
Regarding claim 18, Demarais et al. (‘875) teach the method of claim 1, further comprising making adequate contact between said distal end of said catheter and the vessel wall of the at least one distal branch before said applying (see [0052]-[0054]).
Regarding claim 19, Demarais et al. (‘875) teach the method of claim 1, further comprising repeating said applying to the vessel wall of the at least one distal branch (see [0052]-[0054]).
Regarding claim 20, Demarais et al. (‘875) teach the method of claim 1, further comprising: after said applying, retracting said distal end of said catheter from the at least one distal branch (see [0052]-[0054]); selecting a second at least one distal branch for treatment (see [0052]-[0054]); advancing said distal end of said catheter through the vasculature at least partially into a second at least one distal branch (see [0052]-[0054]); and applying radiofrequency energy to the second at least one distal branch to heat the second at least one distal branch and ablate the at least one renal nerve associated with the second at least one distal branch in which said distal end of said catheter is positioned (see [0052]-[0054]).
Regarding claim 21, Demarais et al. (‘875) teach the method of claim 1, wherein said applying radiofrequency energy to the at least one distal branch is performed for a sufficient duration to provide a therapeutically effective treatment (see [0103]).
Regarding claim 22, Demarais et al. (‘875) teach a method of treating a mammalian patient with a kidney, a renal artery having a vessel wall, and at least one renal nerve associated with the renal artery, the method comprising: providing a catheter comprising a distal end and a plurality of electrodes in proximity to said distal end (see [0052]-[0054]); inserting said catheter into the vasculature of the patient (see [0052]-[0054]); advancing said distal end of said catheter through the vasculature into the renal artery (see [0052]-[0054]); stabilizing at least part of said catheter relative to the renal artery (see [0055]); applying radiofrequency energy to the vessel wall of the renal artery in a spiral shape, by delivering electric power to said electrodes, to heat at least a majority of a circumference of the vessel wall of the renal artery in which said distal end of said catheter is positioned (see [0055]); monitoring a temperature of the vessel wall of the renal artery during said applying, at a location adjacent to said applying (see [0057]), and displaying the temperature; and in response to said monitoring, ceasing said applying upon determining that a condition has been met (see [0057], [0103]).
Regarding claim 23, Demarais et al. (‘875) teach the method of claim 22, wherein said condition is a temperature over 65 C (see [0103]).
Regarding claim 24, Demarais et al. (‘875) teach the method of claim 22, wherein said condition is performing said applying for 60 seconds (see [0103]).
Regarding claim 25, Demarais et al. (‘875) teach the method of claim 22, further comprising repeating said applying within the renal artery (see [0052]-[0054]).
Regarding claim 26, Demarais et al. (‘875) teach the method of claim 22, further comprising repeating said applying within a hepatic artery (see [0052]-[0054]).
Regarding claim 27, Demarais et al. (‘875) teach the method of claim 22, further comprising repeating said applying within a superior mesenteric artery (see [0052]-[0054]).
Regarding claim 28, Demarais et al. (‘875) teach the method of claim 22, further comprising repeating said applying within an inferior mesenteric artery (see [0052]-[0054]).
Regarding claim 29, Demarais et al. (‘875) teach the method of claim 22, further comprising repeating said applying within a portal vein (see [0052]-[0054]).
Regarding claim 30, Demarais et al. (‘875) teach the method of claim 22, further comprising repeating said applying within a pulmonary artery (see [0052]-[0054]).
Regarding claim 31, Demarais et al. (‘875) teach the method of claim 22, further comprising delivering ablative energy to a celiac plexus (see [0052]-[0054]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK REMALY whose telephone number is (571)270-1491. The examiner can normally be reached Mon - Fri 9:00 - 6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK D REMALY/Primary Examiner, Art Unit 3797
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