DETAILED ACTION
The Examiner acknowledges the amendments received 18 December 2025. Claims 5 and 9 are cancelled; claims 1-4, 6-8 and 10-18 are pending.
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 .
Response to Arguments
Applicant's arguments filed 18 December 2025 have been fully considered but they are not persuasive. The arguments pertain to the amendments, and will be addressed below in the prior art rejection.
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.
Claims 10-11 are 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. Claims 10-11 recite the limitation "The system of claim 9" in line 1. Since claim 9 is cancelled, there is insufficient antecedent basis for this limitation in the claim.
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 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.
Claims 1-4, 6-8 and 10-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ghaffari et al (U.S. 2014/0249520). Ghaffari discloses (par. 0191-0211) a processor circuit configured for communication with an anatomical measurement device, wherein the processor circuit is configured to: receive, from the anatomical measurement device, a first metric associated with a first sympathetic response of the patient while a sympathetic nervous system of the patient is not under stimulation; generate a visual representation of the first metric; receive, from the anatomical measurement device, a second metric associated with a second sympathetic response of the patient while the sympathetic nervous system of the patient is under the stimulation, wherein the stimulation of the sympathetic nervous system comprises stimulation of a carotid body (par. 0012) of the patient, wherein the anatomical measurement device is configured to obtain the first metric and the second metric while positioned within a renal artery of the patient such that the anatomical measurement device and the carotid body are spaced from another (par. 0093 and 0192); generate a visual representation of the second metric; and output a screen display to a display in communication with the processor circuit, wherein the screen display comprises the visual representation of the first metric and the visual representation of the second metric.
Regarding claim 2, Ghaffari discloses (par. 0215) the processor circuit is configured to: perform a comparison of the first metric and the second metric; and determine, based on the comparison, a likelihood of success of a future renal denervation procedure for the patient, wherein the screen display comprises a visual representation based on the likelihood of success.
Regarding claim 3, Ghaffari discloses (par. 0215) the processor circuit is configured to: perform a comparison of the first metric and the second metric; and determine, based on the comparison, a degree of success a completed renal denervation procedure for the patient, wherein the screen display comprises a visual representation based on the degree of success.
Regarding claim 4, Ghaffari discloses (par. 0192) at least an endovascular catheter.
Regarding claim 6, Ghaffari discloses (par. 0249) one or more pressure sensors and one or more flow sensors, and wherein the processor circuit is configured to determine a fluid resistance measurement (par. 0268) based on data received from the one or more pressure sensors and the one or more flow sensors.
Regarding claim 7, Ghaffari discloses (par. 0247) a strain sensor.
Regarding claim 8, Ghaffari discloses (par. 0191) one or more electrodes configured to measure an electrical field.
Regarding claim 10, Ghaffari discloses (par. 0247) the anatomical measurement device comprises a strain sensor.
Regarding claim 11, Ghaffari discloses (par. 0191) the anatomical measurement device includes one or more electrodes configured to measure an electrical field.
Regarding claim 12, Ghaffari discloses (par. 0228) the processor circuit is configured for communication with a stimulation device, and wherein the processor circuit is configured to control the stimulation device to provide the stimulation of the carotid body.
Regarding claim 13, Ghaffari discloses (par. 0012) the stimulation device comprising an endovascular catheter or guidewire configured to be positioned within a carotid artery of the patient.
Regarding claim 14, Ghaffari discloses (par. 0120) the stimulation device is configured to be positioned outside of the patient.
Regarding claim 15, Ghaffari discloses (par. 0191) the stimulation device comprises one or more electrodes configured to provide the stimulation of the carotid body.
As to claim 16, the functional language and statement of intended use have been carefully considered but are not considered to impart any further structural limitations over the prior art. Since Ghaffari utilizes stimulation of the carotid body as claimed by the applicant, Ghaffari is therefore capable of being used in application of external pressure to a neck of the patient at a region comprising the carotid body. In addition, nothing prevents Ghaffari’s system from being used in this way. Therefore, they are capable of applying external pressure to a neck of a patient.
Regarding claim 17, Ghaffari discloses (par. 0191-0211) receiving, with a processor circuit, first metric associated with a first sympathetic response of the patient from an anatomical measurement device in communication with the processor circuit, wherein the first metric is obtained by the anatomical measurement device while a sympathetic nervous system of the patient is not under stimulation; generating, with the processor circuit, a visual representation of the first metric; receiving, with the processor circuit, a second metric associated with a second sympathetic response of the patient from the anatomical measurement device, wherein the second metric is obtained by the anatomical measurement device while the sympathetic nervous system of the patient is under stimulation, wherein the stimulation of the sympathetic nervous system comprises stimulation of a carotid body (par. 0012) of the patient, wherein the anatomical measurement device obtains the first metric and the second metric while positioned within a renal artery of the patient such that the anatomical measurement device and the carotid body are spaced from another (par. 0093 and 0192); generating, with the processor circuit, a visual representation of the second metric; and outputting, with the processor circuit, a screen display to a display in communication with the processor circuit, wherein the screen display comprises the visual representation of the first metric and the visual representation of the second metric.
Regarding claim 18, Ghaffari discloses (par. 0191-0211) an anatomical measurement device; and a processor circuit configured for communication with the anatomical measurement device and a display, wherein the processor circuit is configured to: receive, from the anatomical measurement device, a first metric associated with a first sympathetic nervous system response of a patient while a carotid body (par. 0012) of the patient is not under stimulation; receive, from the anatomical measurement device, a second metric associated with a second sympathetic nervous system response of a patient while the carotid body is under the stimulation, the stimulation of the carotid body causing a change from the first sympathetic nervous system response to the second sympathetic nervous system response, wherein the anatomical measurement device is configured to obtain the first metric and the second metric while positioned within a renal artery of the patient such that the anatomical measurement device and the carotid body are spaced from another (par. 0093 and 0192); generate a screen display comprising a visual representation of the first metric and a visual representation of the second metric; and output the screen display to the display.
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 DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
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