DETAILED ACTION
The Examiner acknowledges the amendments received 24 August 2026. Claims 5 and 9 are cancelled; new claim 19 is added; claims 1-4, 6-8 and 10-19 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 .
Claim Rejections - 35 USC § 112
In view of the amendments received 24 August 2026, the Examiner withdraws the rejection of claims 1-18 under 35 USC 112(a)/35 USC 112, first paragraph, and 35 USC 112(b)/35 USC 112, second paragraph.
Response to Arguments
Applicant's arguments filed 24 August 2026 have been fully considered but they are not persuasive. The Applicant argues (page 11, “Remarks”) “Ghaffari's single catheter cannot be within the renal artery and at the carotid body at the same time. Ghaffari's disclosed structure therefore physically cannot satisfy the recited combination of features in amended independent claim 1. Thus, Ghaffari does not disclose or suggest each and every feature of claim 1. A prima facie case of anticipation has not been established with respect to claim 1.”
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “within the renal artery and the carotid body at the same time”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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, 10-16 and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ghaffari et al (U.S. 2014/0249520). Ghaffari discloses (par. 0010) an anatomical measurement device configured to be positioned within a renal artery of a patient, the renal artery extending between an abdominal aorta of the patient and a kidney of the patient; and a processor circuit (par. 0191-0211) configured for communication with the 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 and while the anatomical measurement device is positioned within the renal artery; 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 second metric while the carotid body is being stimulated and while the anatomical measurement device remains positioned within the renal artery (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.
As to the functional language and statement of intended use, these have been carefully considered but are not considered to impart any further structural limitations over the prior art. Since Ghaffari utilizes renal or carotid sinus denervation (par. 0012) as claimed by the applicant, Ghaffari is therefore capable of being used to stimulate a carotid body within the neck of the patient, and such that the stimulation of the carotid body and the anatomical measurement device obtaining the second metric occur concurrently at locations spatially separated from one another within the patient. In addition, nothing prevents Ghaffari’s system from being used in this way. Therefore, they are capable of stimulating a carotid body within the neck of the patient, and such that the stimulation of the carotid body and the anatomical measurement device obtaining the second metric occur concurrently at locations spatially separated from one another within the patient.
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 of 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 (Fig. 20) a stimulation device that is separate from the anatomical measurement device, wherein the processor circuit (par. 0228) 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 while the anatomical measurement device is positioned within the renal artery.
As to the functional language and statement of intended use, these have been carefully considered but are not considered to impart any further structural limitations over the prior art. Since Ghaffari utilizes renal or carotid sinus denervation (par. 0012) as claimed by the applicant, Ghaffari is therefore capable of being positioned within the neck or on an outer surface of the neck. In addition, nothing prevents Ghaffari’s system from being used in this way. Therefore, they are capable of being positioned within the neck or on an outer surface of the neck.
Regarding claim 13, Ghaffari discloses (par. 0012) the stimulation device comprises 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 18, Ghaffari discloses (par. 0191-0211 and 0012) the stimulation of the carotid body is configured to cause a change from the first sympathetic response to the second sympathetic response.
Regarding claim 19, Ghaffari discloses (par. 0191-0211) the processor circuit is further configured to: receive, from the anatomical measurement device, a third metric and a fourth metric obtained after a renal denervation procedure has been performed on the patient, the third metric being obtained while the sympathetic nervous system is not under stimulation and the fourth metric being obtained while the carotid body is being stimulated; determine a first difference between the first metric and the second metric and a second difference between the third metric and the fourth metric; and determine, based on a comparison of the first difference and the second difference, a degree of success of the renal denervation procedure.
Allowable Subject Matter
Claim 17 is allowed.
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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