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 § 102
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, 3, 71-82, 85-88 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aygun et al (US 2008/0293655, November 2008, cited from IDS).
Concerning claims 1, 81-82 Aygun disclose tandem oligoribonucleotides which encode two inhibitory RNA molecules such as siRNAs, wherein each siRNA may be specific for the same or a different gene (see paragraph [0026]). Such oligoribonucleotide comprises consecutive nucleotides wherein a first segment of such nucleotides encodes a first inhibitory RNA molecule and a second segment of such nucleotides encodes a second inhibitory RNA molecule. Each of the first and the second segment may comprise one strand of a double stranded RNA, and the first and second segments may be joined together by a linker (see paragraph [0027]). One of the oligoribonucleotides is of the following structure (see paragraph [0030]):
5' oligo1 (sense) LINKER A oligo2 (antisense) 3'
3' oligo2 (sense) LINKER B oligo1 (antisense) 5', wherein either LINKER A or LINKER B is present. Further, Aygun disclose that each nucleotide of siRNA can be modified (see paragraph [0075]). Thus, compounds disclosed by Aygun satisfy structural requirements of instant claim 1, anticipating it.
Concerning claims 3, 71-72 Aygun disclose that such tandem oligoribonucleotide can be 40-60 nucleotides in length (see paragraph [0082]).
Concerning claims 73-75 Aygun disclose that siRNA strands can be 19-20 nucleotides long (see paragraphs [0075-0077]).
Concerning claims 76-78 Aygun disclose that the linker can be polynucleotide (see paragraph [0027]) such as comprising eight phosphodiester thymines (see paragraph [0032]).
Concerning claim 79 Aygun disclose that each nucleotide can be modified with 2’-O-methyl and 2’-fluoro (see paragraphs [0028 and 0075]).
Concerning claim 80 Aygun disclose that oligoribonucleotide can comprise phosphorothioate linkages (see paragraph [0088]).
Concerning claim 85 Aygun disclose that oligoribonucleotide can comprise three siRNAs connected by linkers as described above, such siRNAs targeting same or different genes (see paragraph [0026]).
Concerning claims 86-87 Aygun disclose pharmaceutical compositions comprising oligoribonucleotides of the invention and pharmaceutically acceptable carriers (see paragraphs [0012, 0046]).
Concerning claim 88 Aygun disclose that oligoribonucleotides of the invention can be conjugated to antibodies (see paragraph [0236]).
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.
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, 83-84 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aygun, above, and in further view of Liu (US 2018/0105815, April 2018) and in further view of Podsypanina et al (PNAS, 2008, vol.105, no.13: 5242-5247).
Teachings of Aygun are discussed above.
Aygun do not teach oligoribonucleotides comprising siRNAs targeting c-Myc and KRAS.
Liu teaches bivalent siRNAs combined in one compound targeting two or more genes (see Abstract, Figure 1A). Such genes to target include MYC (same as c-Myc) and KRAS (see paragraph [0076]).
Podsypanina teach that inhibiting both or each MYC and KRAS oncogenes leads to tumor regression (see Abstract).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to create oligoribonucleotides as described by Aygun targeting c-Myc gene or targeting both c-Myc and KRAS gene based on teachings of Liu and Podsypanina. One of the ordinary skill in the art would be motivated to do so because Liu teaches bivalent siRNAs targeting one or several genes such as c-Myc and KRAS, similar to oligoribonucleotides taught by Aygun, and Podsypanina specify that c-Myc and KRAS inhibited in combination or individually lead to tumor regression, motivating one of the art to combine such siRNAs targeting c-Myc and KRAS or two different siRNAs targeting c-Myc in one compound as taught by Aygun, arriving at instant invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 71-88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-33 of copending Application No. 19/459,626 (reference application) in view of Liu and Podsypanina, above. Claims from '626 recite pairs of sense and antisense strands of siRNAs targeting c-Myc, similar to ones instantly claimed. Further, specification of '626 teach that such siRNAs can be arranged with sense strand of first siRNA connected through a linker to an antisense strand of the second siRNA (see paragraph [0006] of '626 specification). Such arrangement would lead to the same compounds as instantly claimed. Teachings of Liu and Podsypanina are discussed above. It would have been obvious to combine siRNAs from ‘626 with siRNAs targeting KRAS based on teachings of Liu and Liu and Podsypanina, arriving at instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 07/20/2026 have been fully considered but they are not persuasive.
Previous 112 rejection is withdrawn in view of new amendments, arguments are moot.
Concerning 102 rejection Applicant argues that Aygun reference does not teach fully modified siRNAs. In response the reference does teach fully modified siRNAs in paragraph [0075] (see amended rejection above).
Further Applicant argues that Examples 8-10 show unexpected results of higher activity and stability of “inverted chimeras” as claimed. In response the results are related only to siRNAs targeting c-Myc and KRAS, therefore the scope of results is much narrower than the scope of instant claims claiming “inverted chimeras” of any possible siRNAs combinations. Therefore, the results are not sufficient to overcome rejections.
Concerning double patenting rejection Applicant argues that the rejection relies on specification thus it is not appropriate. In response it is appropriate to use specification as a dictionary (see MPEP 804(II)(B)(1)) and Figure 7 of the disclosure does present siRNAs connected with a linker the same way as instantly claimed. Rejection is modified and maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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 Dunston can be reached at (571)272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
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