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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-5, 7, 8 and 12-14 in the reply filed on 2/11/2026 is acknowledged.
Claims 10 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/11/2026.
Claim Rejections - 35 USC § 112
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.
Claim 12 is 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 12, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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, 4, 5, 7, 8 and 12-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schrum et al. (US Pat. No. 8,759,313 B2, issued 6/24/2014).
Regarding claims 1, 5 and 12, Schrum et al. teach a method for the treatment and/or prevention of fibrosis (of the liver) and of diseases associated with fibrosis comprising administering an effective amount of a nucleic acid coding for miR-34c to a patient in need thereof (see Abstract, claim 1, col. 9 lines 43-63 and col. 10 lines 3-23).
Regarding claim 2, Schrum teaches that the agent comprises double-stranded RNA molecule 22 to 25 base pairs in length comprising an active strand comprising miR-34c and a passenger strand that is complementary to the active strand (col. 6 line 49 bridge col. 7 line 47).
Regarding claims 4, 8, 13 and 14, Schrum teaches that the agent can be in a delivery vehicle such as AAV (col. 11 lines 56-61 and col. 12 lines 8-23).
Regarding claim 7, Schrum teaches that a host cell can be transformed with a vector (col. 9 lines 26-40).
Thus the teachings of Schum clearly anticipate the invention of claims 1, 2, 4, 5, 7, 8 and 12-14.
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.
Claim(s) 1 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schrum et al. (US Pat. No. 8,759,313 B2, issued 6/24/2014) in view of Xu et al. (2020, J. Agric. Food Chem., Vol. 68, pgs. 3954-3962).
Regarding claim 1, Schrum et al. teach a method for the treatment and/or prevention of fibrosis (of the liver) and of diseases associated with fibrosis comprising administering an effective amount of a nucleic acid coding for miR-34c to a patient in need thereof (see Abstract, claim 1, col. 9 lines 43-63 and col. 10 lines 3-23).
Schrum does not teach:
SEQ ID NO: 9.
Regarding a miR-34c comprising SEQ ID NO: 9, Xu et al. profiling miRNA’s and teaches a miRNA which is 100% identical to the miRNA set forth in SEQ ID NO: 9.
Thus, at the time of filing the ordinary artisan would have found it prima facie obvious to combine the teachings of Schrum regarding a method of treating fibrosis with miR-34c with Xu regarding a sequence for miR-34c to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make such a combination since the nucleotide sequence for miR-34c was known in the prior art as taught by Xu.
There would have been a reasonable expectation of success that the nucleic acid of SEQ ID NO: 9 could be used in the method of Schrum since SEQ ID NO: 9 is the sequence for miR-34c.
Thus the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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/DAVID A MONTANARI/Examiner, Art Unit 1632
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