DETAILED ACTION
Applicant’s preliminary amendment, filed October 30, 2025, is fully acknowledged by the Examiner. Currently, claims 21-40 are pending with claims 1-20 cancelled, and claims 21, 22, 25-29, 31, 33-35 and 37-40 amended. The following is a complete response to the October 30, 2025 communication.
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 Objections
Claim 38 is objected to because of the following informalities: the claim currently recites the limitation of “but” in line 1 of the claim. The Examiner respectfully requests that the limitation be amended to “by” to correct the language of the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 21, 24-28, 33, 34, 36-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hastings et al. (US Pat. Pub. 2011/0257523 A1).
Regarding claim 21, Hastings provides for a neuromodulation system comprising:
a catheter including an ultrasound transducer at a distal portion of the catheter (catheter 51 with the ultrasound unit 50 at the distal end) and a controller (151) configured to determine, based on signals received by the ultrasound transducer, a proximity of the ultrasound transducer relative to a dense structure (see at least [0090], [0182] and [0183] providing for the locating of target nerves with the internal ultrasound arrangement providing for imaging through structures that can readily be considered “dense structures” in view of at least Applicant’s notation of the tissue in [0203] of the filed Specification including the intima 32, the media 34 and the adventitia 36 as in [0075]; in a broader interpretation, the locating of the ganglion 24/22 relative to the kidney 12 would provide for a general determination of proximity to the kidney) and control the ultrasound transducer to deliver ultrasound energy to one or more nerves proximate a hepatic blood vessel based on the proximity of the ultrasound transducer relative to the dense structure (see, for example, [0183] providing for the electronic focusing of the transducers after the imaging to determine the focus depth).
Regarding claim 24, Hastings provides that the controller is configured to generate, for output on a display, information indicative of the determined proximity of the ultrasound transducer to the dense structure (see [0050], [0177] and [0179]).
Regarding claim 25, in view of the broader interpretation in the rejection of claim 21 above, Hastings further provides that the dense structure includes one or more of a liver, a pancreas, a stomach, and a small intestine, and a kidney (kidney 12).
Regarding claim 26, Hastings provides that, to control the ultrasound transducer to deliver ultrasound energy to the one or more nerves proximate the hepatic blood vessel based on the proximity of the ultrasound transducer relative to the dense structure, the controller is configured to select one or more of a power level, an intensity level, a treatment duration, a target temperature, and a frequency of ultrasound energy based on the proximity of the ultrasound transducer relative to the dense structure (see [0049], [0052], [0150], [0171] and [0173]).
Regarding claim 27, Hastings provides that the proximity of the ultrasound transducer relative to the dense structure indicates a concentration or density of nerves surrounding the hepatic blood vessel (via the locating of the nerves of the ganglion 24/22), and
wherein to control the ultrasound transducer, the controller is configured to control the ultrasound transducer to deliver the ultrasound energy to one or more nerves proximate the hepatic blood vessel based on the proximity of the ultrasound transducer indicating a relatively high concentration or density of nerves surrounding the hepatic blood vessel (see [0183] providing for the electronic focusing of the transducers after the imaging to determine the focus depth; see further [0102] providing for the focused delivery to destroy tissue of 14 or 24/22).
Regarding claim 28, Hastings provides that T the proximity of the ultrasound transducer relative to the dense structure indicates a distance of the one or more nerves from the hepatic blood vessel (see again, the disclosure in at least [0090], [0182] and [0183] providing for the locating of target nerves with the internal ultrasound arrangement providing for imaging through structures that can readily be considered “dense structures” in view of at least Applicant’s notation of the tissue in [0203] of the filed Specification including the intima 32, the media 34 and the adventitia 36 as in [0075]), and
wherein to control the ultrasound transducer, the controller is configured to control the ultrasound transducer to deliver the ultrasound energy to one or more nerves proximate the hepatic blood vessel based on the proximity of the ultrasound transducer indicating the distance of the one or nerves from the hepatic blood vessel is sufficiently close (via the focusing to the target depth as in at least [0183]).
Regarding claim 33, Hastings provides that the hepatic blood vessel includes a hepatic artery or a renal artery (12 is the renal artery).
Regarding claim 34, Hastings provides for a method comprising:
determining, by a controller and based on signals received by an ultrasound transducer at a distal portion of a catheter, a proximity of the ultrasound transducer relative to a dense structure (see at least [0090], [0182] and [0183] providing for the locating of target nerves with the internal ultrasound arrangement providing for imaging through structures that can readily be considered “dense structures” in view of at least Applicant’s notation of the tissue in [0203] of the filed Specification including the intima 32, the media 34 and the adventitia 36 as in [0075]; in a broader interpretation, the locating of the ganglion 24/22 relative to the kidney 12 would provide for a general determination of proximity to the kidney), and
controlling, by the controller, the ultrasound transducer to deliver ultrasound energy to one or more nerves proximate a hepatic blood vessel based on the proximity of the ultrasound transducer relative to the dense structure (see, for example, [0183] providing for the electronic focusing of the transducers after the imaging to determine the focus depth).
Regarding claim 36, Hastings provides for generating, by the controller and for output on a display, information indicative of the determined proximity of the ultrasound transducer to the dense structure (see [0050], [0177] and [0179]).
Regarding claim 37, in view of the broader interpretation in the rejection of claim 34 above, Hastings further provides that the dense structure includes one or more of a liver, a pancreas, a stomach, and a small intestine, and a kidney (kidney 12).
Regarding claim 38, Hastings provides that the controlling, by the controller, the ultrasound transducer to deliver ultrasound energy to the one or more nerves proximate the hepatic blood vessel based on the proximity of the ultrasound transducer relative to the dense structure includes selecting, by the controller, one or more of a power level, an intensity level, a treatment duration, a target temperature, and a frequency of ultrasound energy based on the proximity of the ultrasound transducer relative to the dense structure (see [0049], [0052], [0150], [0171] and [0173]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 22, 23 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Hastings et al. (US Pat. Pub. 2011/0257523 A1).
Regarding claims 22 and 35, Hastings provides that the controller is configured to control the ultrasound transducer to deliver ultrasound energy within a first frequency range sufficient for determining the proximity of the ultrasound transducer relative to the dense structure (see [0046] providing for 5-60MHz for imaging), and wherein the controller is configured to control the ultrasound transducer to deliver ultrasound energy within a second frequency range sufficient for ablating the nerves proximate the hepatic blood vessel (See [0046] providing for 2-5MHz for treatment; see also [0147] proving for a range of 1-5MHz). Hastings, while implying that the first frequency range does not overlap with the second frequency range, fails to explicitly recite the upper end of the ablation energy frequency and the lower end of the imaging energy frequency do not overlap.
However, it is the Examiner’s position that such would have been an obvious consideration to one of ordinary skill in the art in view of the direction set forth in [0046] and [0147] of Hastings, and further in view of the general distinction between imaging and ablation ultrasound energy. The Examiner further finds that the selection of such a value would have been an obvious consideration since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233
Regarding claim 23, in view of the combination in the rejection of claims 22 above, Hasting provides that the second frequency would be within the range of 1 MHz to 10 MHz (see [0046] and [0147]).
Allowable Subject Matter
Claims 29-32, 39 and 40 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: During the search of the prior above, the Examiner has identified the above-cited Hastings reference as the closest prior art to the subject matter set forth in each of independent claims 21 and 34. While Hastings provides for the disclosure of location sensing one or more nerves proximate a hepatic blood vessel, the imaging to provide such location determination is concerned with a distance of the nerves from ultrasound transducer for generating ablative ultrasound energy. Such differs from claims 29 and 39 in that Hastings does not configure its controller (claim 29) nor specifically operate in use (claim 39) to make a determination that the transducer, itself, is within a threshold distance from the dense structure. Similarly, with respect to claims 31 and 40, Hastings does not configure its controller (claim 31) nor specifically operate in use (claim 40) to make a determination that the transducer, itself, is within a minimum threshold distance from the dense structure.
The Examiner notes that Govari has been cited below as particularly relevant to the instant claims. Govari fails to disclose, fairly suggest or render obvious, whether taken alone or in any reasonable combination, for the features set forth in each of claims 29-32, 39 and 40.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Govari (EP 1579889) is considered particularly pertinent in its disclosure of a catheter including an ultrasound transducer at a distal portion of the catheter as in figure 1 with the catheter 10 and ultrasound transducer 20. Govari further provides for overall system functionality to determine, based on signals received by the ultrasound transducer, a proximity of the ultrasound transducer relative to a dense structure as in the disclosure of paragraphs [0050] and [0051] to image and identify target and non-target tissue. Paragraph [0054] further provides for treatment within a hepatic blood vessel. Lastly, Govari also contemplates the control of the ultrasound transducer to deliver ultrasound energy to one or more nerves proximate a hepatic blood vessel based on the proximity of the ultrasound transducer relative to the dense structure in view of the disclosure in paragraphs [0050], [0051] and [0054] providing for the targeting desired tissue by the system while avoiding non-target tissue relative to a hepatic blood vessel.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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