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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 30 April 2026 has been entered.
Claims 5 and 9 are cancelled; claims 1-4, 6-8 and 10-18 are pending.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1 and 17-18, as amended, require “the stimulation of the carotid body is spatially separated from the anatomical measurement device obtaining the second metric”. While the Specification and Drawings disclose that the stimulation device and the anatomical measurement unit may be either a single device or a separate device (see par. 0050 of the Published Application), there is no inherent or explicit requirement that the devices be spatially separate from each other, such as in the claims as amended that the stimulation device is in the neck and the measurement device is “proximate” to a kidney. Furthermore, there is no disclosure in the disclosure, amendments, or accompanying arguments as to what “proximate” to a kidney entails, as explained below.
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 1-18 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. The term “proximate to a kidney” in claims 1 and 17-18 is a relative term which renders the claim indefinite. The term “proximate” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, it is unclear where in the body each module is to be placed, or what the structural dimensions are that would differentiate them from the prior art.
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 10-16 and 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, wherein the carotid body is within a neck of the patient and the renal artery is proximate to a kidney (see above rejection under 35 USC 112(b), as “proximate to a kidney” is broadly interpreted as within the body at a renal artery as in Ghaffari; 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 in renal and carotid body placement that are separate from each other. In addition nothing prevents Ghaffari’s system from being used in this way. Therefore, they are capable of carotid stimulation separated spatially from renal sensing.
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 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 wherein the carotid body is within a neck of the patient and the renal artery is proximate to a kidney (see above rejection under 35 USC 112(b), as “proximate to a kidney” is broadly interpreted as within the body at a renal artery as in Ghaffari; 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.
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 in renal and carotid body placement that are separate from each other. In addition nothing prevents Ghaffari’s system from being used in this way. Therefore, they are capable of carotid stimulation separated spatially from renal sensing.
Conclusion
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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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
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