DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The disclosure is objected to because of the following informalities: The first paragraph of the specification should be amended to include updated patent information.
Appropriate correction is required.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-3 and 20 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Pikus (US 2012/0065554).
Regarding claim 1, Pikus discloses a method for treating kidney disease in a human subject, the method comprising: advancing a collapsible effector carrying an array of radiofrequency (RF) electrodes through a urinary tract of the subject in a collapsed form and into a position in a renal pelvis and/or a region of a ureter adjacent the renal pelvis; deploying the collapsible effector from the collapsed form to an expanded form to engage at least a portion of an interior wall of the renal pelvis; and delivering RF energy to the array of RF electrodes to target afferent nerves proximate the interior wall of the renal pelvis to inhibit or destroy function of the afferent nerves [Para 0005-0006, 0053-0054].
Regarding claim 2, Pikus discloses the method of claim 1, wherein targeting afferent nerves proximate the interior wall of the renal pelvis comprises directing RF energy to urothelial and submucosal layers present in and adjacent the interior wall of the renal pelvis [Para 0035-0039 discusses the tissue layers targeted during ablation].
Regarding claim 3, Pikus discloses the method of claim 2, further comprising targeting afferent nerves present between smooth muscle layers adjacent the inner wall of the renal pelvis [Para 0035-0039 discusses the tissue layers targeted during ablation].
Regarding claim 20, Pikus discloses the method of claim 1, wherein the treated kidney disease comprises at least one of chronic kidney disease and polycystic kidney disease.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 4-6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pikus (US 2012/065554) in view of McDaniel (US 2008/0086073).
Regarding claims 4-5, Pikus discloses the method of claim 2, but fails to disclose wherein delivering RF energy comprises delivering RF energy to raise a temperature of a region containing the afferent nerves to a temperature in a range between 45 C and 60 C and wherein raising the temperature of the region comprises raising the temperature to a temperature in the range for 1 to 2 minutes. However, McDaniel discloses an expandable device which operates to raise the temperature of a region containing nerves in a range between 45 and 60C for a time of 1 to 2 minutes [Para 0081 and 0184]. It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to have the kidney disease treatment of Pikus utilize the temperature and timing of the treatment as taught by McDaniel. Doing so would allow for a circumferential treatment with a circumferential pattern of energy disclosed by the expandable treatment member of McDaniel.
Regarding claim 6, Pikus discloses the method of claim 5, wherein the array of RF electrodes are monopolar electrodes and delivering RF energy to the array comprises delivering RF energy between the array of RF electrodes and a dispersive electrode (view figure 9 with return electrode).
Double Patenting
While no double patenting rejection is issued, upon changes or amendments, double patenting may be issued.
Allowable Subject Matter
Claims 7-19 are objected to as being dependent upon a rejected base claim, claims 8-15 and 17-19 are objected due to their dependencies on claims 7 and 16 and are not separately allowable, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art fails to disclose selecting the subject as a candidate for the method based on inclusion criteria that include a measured or estimated subject pre-treatment glomerular filtration rate (GFR) that lies within a target range.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. (US 2011/0207758) Sobotka discloses methods for Renal Denervation.
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/A.L.Z/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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