DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to the communication filed 9-29-22.
Claims 1-22 are pending in the instant application.
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.
Claims 1-22 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.
Claims 1, 7, 9, and 15 recite the acronyms “OMe” and “MOE”. Please provide the full terms defining these acronyms.
Appropriate corrections are required.
Claims 8, 11, 12, 14, 17, 20 recite the abbreviations or acronyms “ps” and “nps”.
Please provide the full terms defining these abbreviations or acronyms.
Appropriate corrections are required.
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.
The applied references have a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claim(s) 1-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gryaznov et al (US 2018/0119147), Gryaznov et al (WO 2018/053185) and Ebneth et al (WO 2019/175260).
The claims are drawn to pharmaceutical compositions and methods of treating a viral infection comprising the administration of nucleic acid polymers comprising 8 to 50 nucleoside subunits linked by intersubunit linkages, which nucleic acid polymers comprise (A) one or more 3-5’ thiophosphoramidate intersubunit linkages and the remaining intersubunit linkages are 3’-5’ thiophosphate intersubunit linkages, and/or (B) at least 40% of the nucleoside subunits contain a 2’-MOE substituent, or which nucleic acid polymer comprises five or more 3’-5’ thiophosphoramidate intersubunit linkages and the remaining intersubunit linkages are 3’-5’ thiophosphate intersubunit linkages, or wherein half the intersubunit linkages are 3’-5’ thiophosphoramidate intersubunit linkages and the remaining intersubunit linkages are 3’-5’ thiophosphate intersubunit linkages, which nucleoside subunits each independently contain a nucleobase selected from adenine, guanine, cytosine, 5-methylcytosine, and uracil, which nucleoside subunits are optionally substituted at the 2’ position with OMe or MOE,
or which nucleic acid polymers are represented by Formula I of claim 8 or one of the nucleic acid polymers of claim 20
Gryaznov et al (US 2018/0119147) teach pharmaceutical compositions comprising nucleic acid polymers comprising 8 to 50 nucleoside subunits linked by intersubunit linkages comprising one or more 3-5’ thiophosphoramidate intersubunit linkages and 3’-5’ thiophosphate intersubunit linkages, which nucleoside subunits optionally comprise adenine, guanine, cytosine, 5-methylcytosine, and/or uracil, and which nucleoside subunits optionally comprise 2’-O-alkyl (see esp. the Abstract, pages 3, 6-7, 10, 13-14).
Gryaznov et al (WO 2018/053185) teach methods of treating viral infections comprising administration of pharmaceutical compositions comprising nucleic acid polymers comprising 8 to 50 nucleoside subunits linked by intersubunit linkages comprising one or more 3-5’ thiophosphoramidate intersubunit linkages and 3’-5’ thiophosphate intersubunit linkages, which nucleoside subunits optionally comprise adenine, guanine, cytosine, 5-methylcytosine, and/or uracil, and which nucleoside subunits optionally comprise 2’-O-methyl (see esp. pages 1, 5-9, 25, 27, Table B, pages 28-52, 95, 113, 157).
Ebneth et al (WO 2019/175260) teach methods of treatment comprising administration of pharmaceutical compositions comprising nucleic acid polymers comprising 8 to 50 nucleoside subunits linked by intersubunit linkages comprising one 3-5’ thiophosphoramidate intersubunit linkages and 3’-5’ thiophosphate intersubunit linkages, which nucleoside subunits optionally comprise adenine, guanine, cytosine, 5-methylcytosine, and/or uracil, and which nucleoside subunits optionally comprise 2’-O-methyl (see esp. pages 1-10, Tables A-D, claims 1-89).
It would have been obvious to design and construct the instantly claimed nucleic acid polymers because the incorporation of 3’-5’ thiophosphoramidate and 3’-5- thiophosphate intersubunit linkages, and the incorporation of 2’O-alkyl groups into nucleic acid polymers were routine in the art as illustrated in the teachings of Gryaznov, Gryaznov and Ebneth. The formulae instantly claimed are routine arrangements of nucleic acid polymers with these well-known internucleotide and sugar modifications and one would have reasonably expected the formulae and modifications claimed would enhance the stability of nucleic acid polymers and provide enhanced therapeutic effects by having enhanced stability and enhanced target gene silencing, as illustrated in the prior art of record.
For these reasons, the instant invention would have been obvious to one of ordinary skill in the art prior to the filing of the instant application.
Conclusion
Certain papers related to this application may be submitted to Art Unit 1637 by facsimile transmission. The faxing of such papers must conform with the notices published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 C.F.R. ' 1.6(d)). The official fax telephone number for the Group is 571-273-8300. NOTE: If Applicant does submit a paper by fax, the original signed copy should be retained by applicant or applicant's representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED so as to avoid the processing of duplicate papers in the Office.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jane Zara whose telephone number is (571) 272-0765. The examiner’s office hours are generally Monday-Friday, 10:30am - 7pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jennifer Dunston, can be reached on (571)-272-2916. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (703) 308-0196.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Jane Zara
9-15-25
/JANE J ZARA/Primary Examiner, Art Unit 1637