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 .
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 11 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. Claim 11 recites “wherein the very low frequency current has a frequency in a range from about 10 to 15 Hz or a value of about 5 Hz.” The specification as originally filed does not describe very low frequencies to be in the range of 10 to 15 Haz or about 5 Hz. Paragraph 21 of the present application does teach that “very low frequencies are used to relax the bladder (e.g., 1 to 15 Hz, with preferred value of about 5 Hz) to cease urination.” There is no explanation in the specification as to why a range of 10 to 15 Hz would be beneficial/preferred. It is believed that the claim should recite a range of about 1 to 15 Hz rather than 10 to 15 Hz.
It is noted that the if the claim is amended to recite “from about 1 to 15 Hz or a value of about 5Hz”, that a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 – 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites positioning at least one stimulating electrode within an external urinary sphincter (EUS) of the patient, wherein the at least one stimulating electrode is secured within the EUS by means of an anchor at least partially positioned within the EUS. The term “within” is unclear in the context of the claim. Is the electrode implanted within the musculature? Is it adjacent to?
Dependent claims 2 – 11 do not cure the deficiencies of independent claim 1 from which they depend.
Furthermore, the term “very low frequency” in claim 10 is a relative term which renders the claim indefinite. The term “very low frequency” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what frequency would be considered to be very low.
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.
(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 – 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Imran (US PGPUB 2017/0252560 – in IDS).
Regarding claim 1, Imran discloses a method for treating initiating and/or controlling urination in a patient who has neurogenic bladder (e.g. ¶ 18), the method comprising: positioning at least one stimulating electrode within an external urinary sphincter (EUS) of the patient (e.g. ABSTRACT and Fig. 5), wherein the at least one stimulating electrode is secured within the EUS by means of an anchor (e.g. 22) at least partially positioned within the EUS and operatively coupled to the at least one stimulating electrode (e.g. ¶ 29); and using the at least one stimulating electrode to deliver a high frequency current to the EUS to block signals from the patient’s pudendal nerve to relax the EUS and open the patients’ urethra for the passage of urine (e.g. ¶ 18 – 19 and 29; The catheter will also include at least one nerve stimulation electrode 43 for delivering high frequency current to the pudendal nerve to relax the urinary sphincter).
Regarding claim 2, Imran discloses the at least one stimulating electrode and the anchor are disposed on a catheter implanted in the patient (e.g. ¶ 29 and Fig. 1, 3A).
Regarding claim 3, Imran discloses the at least one stimulating electrode comprises at least two stimulating electrodes (e.g. ¶ 29; In many embodiments the at least one electrode 43 will comprise at least two electrodes…).
Regarding claims 4 and 5, Imran discloses a frequency in a range from about 4 to 25 kHz and from about 5 to 6 kHz (e.g. ¶ 28, a frequency above 4kHz is considered to be from about 5 to 6 kHz).
Regarding claim 6, Imran discloses the delivery of the high frequency current causes no substantial pain or injury to the patient (e.g. ¶ 33).
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) 7 – 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of Chancellor et al. (US PGPUB 2014/0249595 – in IDS).
Regarding claims 7 – 11, Imran discloses the invention as previously described, but does not explicitly recite further comprising delivering a low frequency current to the patient’s sacral nerve or surrounding tissue to contract the patient’s bladder.
Chancellor teaches it is known to stimulate the sacral nerve using a low frequency signal of 20 Hz (i.e. about 10 to 15 Hz), in order to relax the bladder (e.g. ¶ 16 and 96). It would have been obvious to one having ordinary skill in the art to modify the invention as taught by Imran with the low frequency sacral stimulation as taught by Chancellor, since such a modification would provide the predictable results of improving voiding of the bladder.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796
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