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 1-10 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 claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claim.
Claims are broadly drawn to methods of inhibiting expression and activity of ghrelin by introducing to a cell a disruptor of ghrelin (DOG) which comprises RNAi, wherein the RNAi comprises an antisense strand and comprises SEQ ID NO: 42.
Instant specification does not provide any working examples involving any DOGs of instant invention. Instant specification teaches that instant SEQ ID NO: 42 is a sense strand (see paragraph [0024]). Instant specification teaches that DOGs of the invention have to be double-stranded to activate RISC (see paragraphs [0017, 0023, 0024]).
The prior art of record, Szentirmai et al (US 2010/0196396, August 2010, cited from IDS), teaches design of siRNAs targeting ghrelin in order to inhibit its expression, pointing out that successful siRNA comprises a region substantially identical to a region of mRNA of target gene (see Abstract, paragraphs [0036-0038]). Instant SEQ ID NO: 42 is not complementary or identical to any part of ghrelin mRNA.
Instant specification fails to provide guidance on how to use DOG comprising instant SEQ ID NO: 42 for the purpose of decreasing expression of ghrelin.
In the absence of guidance, undue trial and error experimentation would have been required by one skilled in the art at the time invention was made to inhibit expression of ghrelin using DOG comprising SEQ ID NO: 42 as instantly claimed. Given the breadth of the claims, the state of the prior art and lack of guidance of the specification, as discussed above, undue experimentation would be required by one skilled in the art to make and use the claimed invention commensurate in scope with the claims.
Response to Arguments
Applicant's arguments filed 11/24/2025 have been fully considered but they are not persuasive.
Previous written description rejection and 112(d) rejection are withdrawn in view of new amendments, arguments are moot.
No specific arguments were provided concerning enablement rejection. The rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637