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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Claim(s) 1-2 and 10-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zarins (US 2008/0255642).
Regarding claim 1, Zarins discloses a catheter for mapping renal nerves distributed on a renal blood vessel, comprising: a catheter tip comprising a plurality of bipolar electrodes [electrodes 108 can be bipolar], wherein each of said plurality of bipolar electrodes comprises an anode and a cathode (bipolar electrodes send electricity from one to another thereby having an anode and cathode); said plurality of bipolar electrodes are disposed along said catheter tip to form at least one loop (view figure 7A), wherein an electrical stimulation is configured to be delivered-between a pair of electrodes, wherein said pair of electrodes comprises an anode from a first bipolar electrode and a cathode from a second bipolar electrode, wherein said electrical stimulation is limited to a section of said renal vessel between said pair of electrodes, wherein a shorter path will be used to precisely locate the nerve when a physiological response is observed after said electrical stimulation [Para 0012 discusses stimulation; Para 0051-0058 and 0061-0068 discuss placing the device near a renal artery or vein with feedback systems and parameters as well as positioning elements to indicate neuromodulation of nerves].
Regarding claim 2, Zarins discloses the catheter of claim 1, wherein said plurality of bipolar electrodes cover one-third the length of said renal blood vessel (view figure 3B).
Regarding claim 10, Zarins discloses the catheter of claim 1, wherein said plurality of bipolar electrodes is adapted for delivering ablative energy [Para 0036].
Regarding claim 11, Zarins discloses the catheter of claim 1, wherein said at least one loop has a diameter of 2 to 15 mm [Para 0106].
Regarding claim 12, Zarins discloses a system for mapping innervated areas in a renal artery based on the position(s) of bipolar electrodes on a catheter, comprising:(i) the catheter of claim 1; (ii) one or more measuring devices for measuring one or more physiological parameters associated with innervation of said renal artery [Para 064-0065]; (iii) a computing device coupled to said one or more measuring devices and is configured for computing any increase or decrease in the physiological parameters against a baseline [Para 0047, 0053, 0056-0058]; and (iv) a display device for displaying the location or identity of a parasympathetic or sympathetic nerve innervating said renal artery, said location is based on the position(s) of bipolar electrodes on said catheter [Para 0052, 0057, 0061, and 0144].
Regarding claim 13, Zarins discloses the system of claim 12, wherein said display device comprises a display screen showing results of electrical stimulation applied between any pair of electrodes among said plurality of bipolar electrodes [Para 0144].
Allowable Subject Matter
Claims 3-9 (claims 4-5, 7 and 9 are objected to due to their dependencies on claims 3, 6 and 8 and are not independently allowable) 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: While the prior art contemplates renal locating and denervating, it fails to disclose the specific catheter arrangements as claimed including the structural limitations claimed in claims 3, 6 and 8.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Deem (US 2016/0220305) also discusses methods and apparatus for Renal neuromodulation.
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/A.L.Z/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794