DETAILED ACTION
Election/Restrictions
Claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/03/26.
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.
Claim 17 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
As to claim 17, the claim recites comparing the calculated stiffness and measured BP to “known tissue properties at a reference blood pressure” to determine the normalized stiffness of the blood vessel. It is noted that the specifications fail to articulate what kind of tissue properties are used, nor does it teach any equations or explain how the tissue property is used to normalize stiffness. Absent any such details, it is impossible for the examiner to know what properties are usable, much less relate how said properties can be used to normalize stiffness of the blood vessel.
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) 15 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sata et al. (“Ambulatory arterial stiffness index as a predictor of blood pressure response to renal denervation”).
As to claim 15, Sata teaches a method of assessing stiffness of a blood vessel, comprising: measuring a blood pressure of a patient (p1415 – measurement of DBP and SBP); calculating a stiffness of a blood vessel identified for receiving denervation therapy and normalizing the calculated stiffness of the blood vessel relative to the measured blood pressure of the patient (p1415 – calculation of AASI (ambulatory arterial stiffness index), which is an inherently BP-normalized stiffness metric as it is derived from a relationship between diastolic and systolic BP); and determining that the patient is likely to experience a positive response to a denervation when the normalized stiffness is greater than a predetermined value (p1417 – prediction of blood pressure response to renal denervation).
As to claim 18, Sata teaches measuring a blood pressure of a plurality of patients; calculating a stiffness of a blood vessel for the plurality of patients; and correlating the measured blood pressure and calculated blood vessel stiffness of the plurality of patients to an expected outcome of denervation of the blood vessel (p1416 – Table 1; p1418).
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.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sata et al. (“Ambulatory arterial stiffness index as a predictor of blood pressure response to renal denervation”).
As to claim 16, while Sata teaches that its stiffness data is normalized via comparison to a database (as it uses a population of 111 patients), it does not teach the use of a measured mean aortic pressure. However, it is noted that this value is merely a value that is derived from measured systolic and diastolic pressure values (calculated by (SBP + 2 (DBP))/(3)). Accordingly, one of ordinary skill in the art could utilize MAP values instead, as it is no different than converting temperature from Celsius to Fahrenheit, and would result in equivalent results.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sata et al. (“Ambulatory arterial stiffness index as a predictor of blood pressure response to renal denervation”) in view of Kim et al. (“Comparable Parameter related to arterial stiffness in Blood Pressure Estimation Method”)
As to claims 19 and 20, Sata does not teach the application of a stimulus to further normalize the calculated stiffness, the stimulus being indicative of a likelihood a patient of a patient experiencing a positive response to a denervation of the blood vessel. Kim teaches the use of the Valsalva Maneuver to account for arterial stiffness in the detection of diastolic blood pressure (Abstract). It would have been obvious to modify Sata with Kim to enable the use of a Valsalva maneuver to further normalize the calculated stiffness to obtain more accurate results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Okon et al. (“Invasive aortic pulse wave velocity as a marker for arterial stiffness predicts outcome of renal sympathetic denervation”) teaches the influence of arterial stiffness to the response success of renal sympathetic denervation.
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 5/21
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