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.
Claims 1 – 9 are 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. The claims recite an in vivo method for increasing likelihood of embryonal nidation in a subject. This differs from parent case USPN 12,486,500, which claims an in vitro process for increasing expression of a gene in endometrial cells. While the specification as originally filed does say the method of the invention can be carried out either with in-vitro endometrial cells and with in-vivo endometrial cells, this is not enough to enable of skilled in the art to use this invention. There is no description or study of implantation, no description of electrode placement that actually delivers the about 4 MHz sinusoid wave to the subject, and no showing that the delivery of the waveform to the cells cause a higher nidation rate. A person having ordinary skill in the art would be left to determine how to get the waves to the target tissue and whether the in-vitro upregulation even occurs in-vivo.
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 – 9 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.
Claim 1 recites “applying one or more electrodes in proximity to endometrial cells of the subject…” It is unclear what is meant by “in proximity.” For example, would surface electrodes on an abdomen of a patient be considered “in proximity to endometrial cells”?
Claims 2 – 9 are rejected as being dependent upon rejected claim 1 and do not cure the deficiencies of claim 1.
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 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) 1 – 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross (USPN 2011/0202108).
Regarding claims 1 – 9, Gross discloses a method of applying one or more electrodes in proximity to endometrial cells of the subject and applying a stimulation to the cells in order to increase the fertility of the subject (e.g. ¶ 80 – 82). Gross fails to teach that the current comprises a sinusoidal waveform having a fundamental frequency higher than 2 MHz. However, all patients react differently to different stimulation parameters. Finding the optimal parameters would require only routine skill in the art in order to achieve increased fertility. It would have been obvious to try stimulating using a sinusoidal waveform having a fundamental frequency higher than 2 MHz, since finding the optimal parameters would require only routine skill in the art.
Claims 2 – 9 recite further changes to parameters which are non-obvious for the reasons listed above.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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