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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/11/26 has been entered.
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.
Claim(s) 1-4, 11-12, and 20-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hettrick et al. (US 2016/0095535; hereinafter Hettrick).
Hettrick shows a method and system for evaluating an outcome of renal denervation of a sympathetic nerve ([0019]), comprising: injecting a vasodilator into a first region of a renal blood vessel, the first region comprising a renal artery of the renal blood vessel ([0035], [0039]); activating the vasodilator in a second region of the renal blood vessel, the second region comprising a renal arteriole or renal capillary of the renal blood vessel (where the natural anatomic structures of the renal system include a renal artery connected to renal arterioles and renal capillaries, and therefore injection of a vasodilator into the bloodstream of a renal artery will necessarily result in the vasodilator flowing into the connected renal arterioles and renal capillaries and provide the desired pharmacological activation; [0035], [0039]); acquiring first blood flow data from a first region ([0035], [0039]); and performing the renal denervation with a denervation catheter, then acquiring second blood flow data from the first region ([0037], [0041]).
Hettrick also shows comparing the first blood flow data and the second blood flow data as a result of a comparison of the first blood flow data and the second blood flow data ([0038]-[0042]); wherein the renal denervation is evaluated according to a result of the comparison of the first blood flow data and the second blood flow data ([0038]-[0042]); wherein, if the result of the comparison is lower than a predetermined threshold, re-performing renal denervation is repeated ([0049]); wherein, if the result of the comparison result is lower than a predetermined threshold, re-performing renal denervation is repeated ([0049]); wherein the base blood flow data is acquired before injecting the vasodilator, or between acquiring the first blood flow data and performing the renal denervation ([0035]-[0037]); wherein the second region comprises a renal arteriole or renal capillary ([0046]-[0047]; Fig. 3); wherein the vasodilator comprises at least one of dopamine, dobutamine, adenosine, prostacyclin, nitric oxide, bradykinin, papaverine, dipyridamolum, diuretin, theophylline, minoxidil, and isosorbide ([0035]); a display unit configured to display an evaluation result of the evaluation unit ([0033]); an output unit configured to output an audio signal or video signal, according to the evaluation result of the evaluation unit ([0033]); wherein the first blood flow data, the second blood flow data, and the base blood flow data are acquired from blood flow information detected by a detection means disposed on the catheter ([0036]); wherein the blood flow information comprises at least one of blood flow volume, blood flow rate, and blood flow resistance ([0024], [0049], [0114]); wherein the detection means comprises at least one of an ultrasonic sensor, an impedance sensor, and an optical sensor ({0037]); wherein the ultrasonic sensor comprises a Doppler sensor ([0037]); wherein an impedance value is detected by an electrode of the catheter or detected by a separate sensor ([0021]); wherein the catheter comprises a vasodilator injection unit ([0035]-[0036]).
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.
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.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hettrick et al. (US 2016/0095535; hereinafter Hettrick).
Hettrick shows the invention substantially as described in the 102 rejection above.
Hettrick fails to explicitly state wherein base blood flow data or the second blood flow data is acquired when a half-life has elapsed after the vasodilator is injected into the first region.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have obtained the measurements of Hettrick when a half-life has elapsed in order to ensure enough time for the vasodilator to achieve its desired affect on the patient’s blood flow state. It would be within the level of one of ordinary skill in the art to select the timing of the measurement after administration of the vasodilator, in order to ensure an accurate measurement according to the type of pharmacological agent provided.
Claim(s) 5-8 and 13-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hettrick et al. (US 2016/0095535; hereinafter Hettrick) in view of Gillberg et al. (US 2016/0045744; hereinafter Gillberg).
Hettrick shows the invention substantially as described in the 102 rejection above.
Hettrick fails to show calculating a first difference value representing a difference value between the first blood flow data and base blood flow data; calculating a second difference value representing a difference between the second blood flow data and the base blood flow data; and comparing the first difference value and the second difference value a result of a comparison of the first difference value and the second difference value ; wherein an outcome of the renal denervation is evaluated according to a result of the comparison of the first difference value and the second difference value; a first calculation unit configured to calculate a ratio between the first blood flow data input by the first input unit and the second blood flow data input by the second input unit; an evaluation unit configured to evaluate an outcome of renal denervation by comparing a ratio between the first blood flow data and the second blood flow data calculated by the first calculation unit with a first threshold value as an evaluation result; a third input unit configured to input base blood flow data from the first region before injection of the vasodilator; a second calculation unit configured to calculate a ratio between a first difference value and a second difference value, wherein the first difference value comprises a difference value between the first blood flow data and the base blood flow data, and wherein the second difference value comprises a difference value between the second blood flow data and the base blood flow data; an evaluation unit configured to evaluate the outcome of renal denervation by comparing a ratio between the first difference value and the second difference value calculated by the second calculation unit with a second threshold value.
Gillberg discloses systems and methods for evaluating cardiac therapy. Gillberg teaches a first calculation unit configured to calculate a ratio between the first blood flow data input by the first input unit and the second blood flow data input by the second input unit ([0091]-[0092]); an evaluation unit configured to evaluate an outcome of renal denervation by comparing a ratio between the first blood flow data and the second blood flow data calculated by the first calculation unit with a first threshold value as an evaluation result ([0091]-[0092]); a third input unit configured to input base blood flow data from the first region before injection of the vasodilator ([0061], [0080]-[0081]); a second calculation unit configured to calculate a ratio between a first difference value and a second difference value, wherein the first difference value comprises a difference value between the first blood flow data and the base blood flow data, and wherein the second difference value comprises a difference value between the second blood flow data and the base blood flow data ([0091]-[0092]); an evaluation unit configured to evaluate the outcome of renal denervation by comparing a ratio between the first difference value and the second difference value calculated by the second calculation unit with a second threshold value ([0091]-[0092]).
It would have been an obvious design choice to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Hettrick to utilize other suitably equivalent mathematical representations of the diagnostic data, such as the form of a ratio as taught by Gillberg, as a ratio is a known type of mathematical value used in hemodynamic therapy monitoring as described by Gillberg ([0092]), and in order to provide the same end result of comparison of obtained hemodynamic data to baseline data. It is noted that Hettrick teaches determining percentages, and/or another suitable value associated with effective neuromodulation ([0049]).
Furthermore, it is noted that Hettrick teaches calculating various blood flow data comparisons to base data including obtaining differences ([0038]-[0042], [0049]).
It would be within the level of one of ordinary skill in the art to provide suitably equivalent mathematical calculations to compare the obtained data, such as by performing common mathematical operations including taking a first difference between base and first blood flow data a second difference between base and second blood flow data, and to compare those difference values; or obtaining a ratio between obtained values, in order to provide the same end result of obtaining a diagnostically relevant comparison for evaluating an outcome of renal denervation based upon measurement data acquired before and after neuromodulation as desired by Hettrick.
Response to Arguments
Applicant's arguments filed 8/28/26 have been fully considered but they are not persuasive.
In response to applicant’s arguments regarding Hettrick, examiner respectfully disagrees. Applicant argues that Hettrick fails to show injecting a vasodilator into a renal artery and activating the vasodilator in a renal capillary or arteriole. However, the examiner notes that Hettrick shows injecting the vasodilator into a renal artery ([0035]). While Hettrick does not explicitly refer to capillaries or arterioles, the natural anatomic structures of the renal system include a renal artery connected to renal arterioles and renal capillaries, and therefore injection of a vasodilator into the bloodstream of a renal artery will necessarily result in the vasodilator flowing into the connected renal arterioles and renal capillaries and providing the desired pharmacological activation in both the renal artery and connected arterioles and capillaries.
The examiner would suggest further amending the claims to detail the steps of injecting and activating, such that the residence time of the vasodilator in the renal artery is minimized, so that the vasodilator is mainly activated in the renal arterioles without significantly affecting the diameter or size of renal artery vessels in order to accurately measure the maximum blood flow in the renal artery unique to each patient as described in applicant’s specification ([0025]-[0027])
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN CWERN/ Primary Examiner, Art Unit 3797
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