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 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09 July 2026 has been entered.
Status of Claims
Claims 1-18 are pending and currently under consideration for patentability; claims 1 and 11 have been amended; claims 19 and 20 have been cancelled.
Response to Arguments
Applicant’s arguments dated 09 July 2026 have been fully considered, but they are not persuasive or moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant has amended the independent claim to recite an anesthetic regimen that does not suppress a hemodynamic response, further defining the hemodynamic response to one of heart rate, blood pressure, and autonomic reflex mediated blood pressure. The Examiner has addressed the amended limitation in the updated text of the rejection below.
Applicant argues that the previously-presented reference of Lefer does not disclose or suggest the amended limitations, as Lefer uses isoflurane, which is an anesthetic that suppresses hemodynamic responses. The Examiner has not relied upon the Lefer reference in the updated rejection below, rendering moot Applicant’s arguments.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Harrington et al. (US 2018/0177549 A1) in view of Rivlin (US 2016/0206372 A1), further as evidenced by Williams et al. (Williams LM, Boyd KL, Fitzgerald BM. Etomidate. [Updated 2023 Jun 26]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK535364/).
Regarding claim 1, Harrington describes a method of renal denervation, comprising the step of administering ablation therapy to an aorticorenal ganglion ([0022]). Harrington does not explicitly disclose providing an anesthetic regimen that does not suppress a hemodynamic response, wherein the hemodynamic response includes blood pressure. However, Rivlin also describes a nerve therapy method, including providing an anesthetic regimen that does not suppress hemodynamic response such as blood pressure ([0045], etomidate). As evidence of etomidate’s property of not suppressing a hemodynamic response, the Examiner respectfully directs Applicant to Williams’s statement that “etomidate has a favorable hemodynamic profile on induction, with minimal blood pressure depression,” which in turn summarizes the findings of Dumps et al. (Medikamente zur intravenösen Narkoseinduktion: Etomidat [Etomidate for intravenous induction of anaesthesia]. Anaesthesist. 2017 Dec;66(12):969-980). As Rivlin is also directed towards nerve therapy and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide an anesthetic regimen similar to that described by Rivlin when using the method described by Harrington, as doing so advantageously allows the resulting method to provide the ablation therapy and monitor the subsequent response free of any response that could be attributed to the anesthesia.
Regarding claim 2, Harrington describes wherein the ablation therapy is performed endovascularly through the inferior vena cava and renal vein ([0022]).
Regarding claim 3, Harrington describes wherein the ARG is selected from a left ARG, a right ARG, or both ([0093], [0104]).
Regarding claim 4, Harrington describes wherein ablation therapy is applied to the left ARG at a location positioned adjacent to a superior mesenteric ganglion and on a posterior side of a left renal vein ([0092], [0104], position of aorticorenal ganglion as described, [0202]).
Regarding claim 5, Harrington describes wherein ablation therapy is applied to the right ARG at a location positioned between an inferior vena cava and descending aorta, superior to a right renal artery, on a posterior side of a right renal vein ([0092], [0104], position of aorticorenal ganglion as described, [0202]).
Regarding claim 6, Harrington describes wherein the ablation therapy is radiofrequency ablation ([0022]).
Regarding claim 7, Harrington describes wherein the ablation therapy is radiofrequency ablation at 20 W ([0097], 0.1 W - 100 W) using an irrigated catheter ([0024], use of through holes manufactured into the electrode element) for at least 30 seconds ([0097]: 5 seconds to 5 minutes). Although neither Harrington nor Rivlin explicitly disclose using a flow rate of 8 mL/second, Harrington does describe that the number, design, and power of the cooling electrodes may be varied as necessary based on a desired tissue temperature ([0024], 0097], [0115]). Therefore, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure Harrington’s ablation therapy such that it had a flow rate of 8 mL/sec, as doing so advantageously ensures that the nerves and tissues are cooled as necessary for a desired therapy. Specifically regarding the power and duration of the ablation therapy, the Examiner respectfully submits that, as the claimed values lie inside the ranges disclosed by the prior art (20 W as claimed lies inside the disclosed range 0.1 W - 100 W, at least 30 seconds as claimed lies within the disclosed range of 5 seconds to 5 minutes), a prima facie case of obviousness exists (please see MPEP 2155.05).
Regarding claim 8, Harrington describes recording a baseline hemodynamic response before the step of administering ablation therapy ([0042]).
Regarding claim 9, Harrington describes wherein the step of administering ablation therapy generates an increase in the hemodynamic response ([0019]).
Regarding claim 10, Harrington describes wherein the method further comprises a step of ceasing ablation therapy once the hemodynamic response returns to baseline ([0042], [0184], therapy continues until the response meets a predetermined criteria compared to the baseline response).
Regarding claim 11, Harrington describes wherein the baseline hemodynamic response is blood pressure ([0091], [0116]).
Regarding claim 12, Harrington describes wherein the method is effective in treating systemic adrenergic activation ([0022], [0134], determining success of procedure; Applicant’s Specification describes that administering ablation therapy to the aorticorenal ganglion is a method of reducing systemic adrenergic activation).
Regarding claim 13, Harrington describes wherein the method is effective in treating a cardiovascular disease or disorder ([0021]).
Regarding claim 14, Harrington describes wherein the cardiovascular disease or disorder is hypertension ([0021]).
Regarding claim 15, Harrington describes wherein the ablation therapy suppresses sympathetic nerve activation ([0006], [0009]).
Regarding claim 16, Harrington describes wherein the ablation therapy suppresses effect of renal artery stimulation ([0022], [0035] - [0036]).
Regarding claim 18, Rivlin describes wherein the anesthetic regimen does not influence hemodynamic response to ARG stimulation ([0045], please see discussion of claim 1, above).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Harrington in view of Rivlin, further in view of Neidert et al. (US 2019/0223785 A1).
Regarding claim 17, Harrington in view of Rivlin suggests the method of claim 1, but neither Harrington nor Rivlin explicitly disclose wherein the method is configured to modulate ventricular arrhythmia. However, Neidert also describes a method of renal denervation ([0014], [0081]), including by administering therapy to the aorticorenal ganglion ([0067] - [0068]), wherein the method is configured to modulate ventricular arrhythmia ([0074]). As Neidert is also directed towards renal denervation and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use the method described by Harrington and Rivlin in order to modulate ventricular arrhythmia, as described by Neidert, as doing to advantageously allows the resulting method to treat a larger number of cardiovascular conditions.
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the Examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel, can be reached by telephone at 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796
Prosecution Insights