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
Claims 4-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions
.
Response to Amendment
This action is written in response to applicant’s amendments received on 1/29/26.
Any objection or rejection not reiterated herein has been overcome by amendment
Amended claim 1-3 are under examination herein.
Priority
Application claims priority to 62/320,819 provisional application with an effective filing date of 3/17/22. Claims 1 and 3 of the instant application are supported by the provisional application and thus have a priority date of 3/18/22. Claim 2 requires SEQ ID NO:3 which is not in the priority document and therefore has a priority date of 3/16/23.
Information Disclosure Statement
The IDS filed on 3/16/23 has been fully considered except where references have been lined through.
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.
Modified rejection necessitated by amendment. Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Williams (US20160194613A1), Hajjar (US20220372519A1) and 653 (CN102260653A).. While Hajjar was published after the effective filing date of instant application, it claims priority to 12/22/21 and therefore is valid prior art under 35 USC 102(a)(2).
Regarding claim 1, Williams teaches a virus like particle (VLP) enclosing RNA (mRNA) comprising coat proteins (capsid) of bacteriophage capable of self assembly (claim 1). Williams teaches the VLP can encode multiple RNAs ([0008]). Williams teaches capsid binding tags (capsid protein tag/recognition sequence) can be incorporated into the RNA ([0014] and claims 19 and 20). Williams teaches a bacterium is transformed with plasmids that express the RNA of interest and the coat protein (first and second vector) (section Expression of VLP Genes and RNA). Williams teaches their VLPs result in storage of RNA for long periods, and provide the ability to deliver RNA in stable form that is readily taken up by cells and is readily expressed in cells (abstract). Williams teaches that the VLP packaged RNA can be long or short, single stranded, double stranded, and can be of any sequence ([0068]). Further, Williams points out that RNAs can be kilobases in length ([0010]).
Williams does not explicitly teach SEQ ID NO 1 or the mRNA.
Hajjar teaches a viral capsid encapsulating an effector (VLP) ([0005]). Hajjar teaches the VLP contains mRNA encoding an effector (claim 1). Hajjar teaches that the effector can be a human protein (claim 3). Hajjar teaches their method is useful to deliver the nucleic acid effector to subjects to treat diseases ([0210]).
653 teaches vectors comprising pig uricase and their host cells (abstract). 653 teaches a 100% match to claimed SEQ ID NO 1 (appendix). 653 teaches their invention has good treatment effects (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the vector of 653 in the VLP comprising an mRNA effector of Hajjar and Williams. One of ordinary skill in the art would be motivated to do so because Williams teaches the VLPs provide the ability to deliver RNA in stable form that is readily taken up by cells and is readily expressed in cells, Hajjar teaches their method is useful to deliver the nucleic acid effector to subjects to treat diseases, and 653 teaches their invention has good treatment effects. There would be a reasonable expectation of success as Hajjar, Williams and 653 are in the same field of endeavor of nucleic acids.
Maintained rejection Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Williams (US20160194613A1), Hajjar (US20220372519A1) and 653 (CN102260653A), as applied to claim 1 above, and further in view of Witherell ("Specific RNA binding by Q. beta. coat protein." Biochemistry 28.1 (1989): 71-76).
Regarding claim 2, Williams teaches a 100% match to claimed SEQ ID 3 (appendix). Williams teaches the capsid tags (recognition sequence) can be taught by Witherell, et al., Biochemistry, 28:71-76 (1989).
Witherell teaches a 100% match to claimed SEQ ID 2 (fig 7-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the sequence of Witherell in the invention of Williams. One of ordinary skill in the art would be motivated to do so because Williams teaches that the capsid tags of Witherell can be used in their invention. There would be a reasonable expectation of success as both Williams and Witherell are in the same field of endeavor of capsid tags.
Maintained rejection Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Williams (US20160194613A1), Hajjar (US20220372519A1) and 653 (CN102260653A) as applied to claim 1 above, and further in view of Houdebine (Internal ribosome entry sites (IRESs): reality and use. Transgenic Res 8, 157–177 (1999). https://doi.org/10.1023/A:1008909908180).
Regarding claim 3, Williams, Hajjar and 653 do not explicitly teach the use of an IRES.
Houdebine teaches that IRES are commonly used to express the second cistrons of mRNAs. Therefore, it would be obvious to one of ordinary sill in the arts to use a IRES between the two mRNAs on the vector.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an IRES as taught by Houdebin in the VLPs of Williams and 653 above. One of ordinary skill in the art would be motivated to do so because Houdebine teaches IRES are commonly used between cistrons. Further, one of ordinary skill in the art would be motivated to do so because these IRES have been successfully used to express proteins one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. There would be a reasonable expectation of success as Williams, 653, and Houdebine are in the same field of endeavor of mRNA/protein.
Response to Arguments
Applicant's arguments filed 1/29/26 have been fully considered but they are not persuasive. Applicant argues that Williams is directed to specific groups of RNA (p4-5). As applicant correctly points out prior to pointing out specific instances when Williams discusses smaller RNAs, Williams teaches that the VLP packaged RNA can be long or short, single stranded, double stranded, and can be of any sequence ([0068]). Further, Williams points out that RNAs can be kilobases in length ([0010]).
Applicant argues that there is no suggestion of incorporating mRNA into the invention of Williams (p5 first full paragraph). Williams teaches that the RNAs in the VLP are typically derived from eukaryotic mRNA ([0011]). Hajjar teaches mRNAs can be used in VLPs to deliver effectors.
Applicant argues Rong (‘653) is directed to a different technique than instant application, namely that the protein is created then administered exogenously (p5 2nd full paragraph). 653 teaches that their invention encompasses the nucleic acid sequence (p2-3 bridging paragraph). 653 is not relied upon for the method of administration, simply for the nucleic acid sequence. See the rejection above.
Applicant asserts that treatments of protein and mRNA require different considerations (p5-6 bridging paragraph). MPEP 716.01(c) makes clear that arguments of counsel cannot take the place of evidence in the record.
Applicant argues that the mechanisms and purposes of Williams and 653 are not comparable (p6 first paragraph). This is unpersuasive, Williams teaches that any mRNA sequence can be used, Hajjar teaches specific mRNA effectors, and 653 provides a sequence, see the response to arguments above.
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 TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR KANE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
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