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Claims 8, 10-11, 32, 34, 36 and 38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/25/25.
Rejections Maintained
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.
Claims 1, 4, 19, 24-26, 28-29, 40, 43, 48, 52 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Sarnow et al. (WO 97/07825).
For claims 1, 4, and 19, Sarnow et al. teach circular polyribonucleotides encoding one or more antigens (page 14 full paragraph). For claims 24 and 26, Sarnow et al. teach an ORF encoding multiple antigens can be separated by cleavage sites to release the individual antigens (para spanning 14-15). For claim 25, Sarnow et al. teach the antigen sequence can have a linker (page 40, line 13). For claims 28-29, Sarnow et al. teach each peptide encoding sequence is linked to an IRES (page 15, lines 10-12). For claims 40, 43, 48, 52, and 54, Sarnow et al. teach pharmaceutical excipient (page 4 line 8), and method of treating (end of abstract). The circular nucleic acid as taught by Sarnow is used in vaccines (page 33, lines 24-25) and thus would be expected to express polypeptides that are immunogenic when administered.
While Sarnow et al. do not explicitely state two different pathogens, one of ordinary skill in the art prior to the instant effective filing date to have known that one or more sequences encoding polypeptides used for a vaccine or to treat can comprise antigens to multiple pathogens as they are known in the art before the effective date of filing. One of ordinary skill in the art prior to the effective filing date would have known that one or more includes “at least three” of claim 19.
One of ordinary skill in the art prior to the effective filing date would have known that prime boost administration and heterologous antigen form prime boost are known in the art.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to modify the expressed two or more viral envelope protein polypeptides from circular RNAs by Sarnow et al. by using different virus to arrive at the presently claimed invention and have the expectation of success knowing that circular polyribonucleotides have been used to express multiple polypeptides.
Applicant argues that the office does not articulate rational for antigens from two pathogens, the reference does not teach it, and does not address co-expression, immunogenic competition, and unpredictable immune response. Applicant submits the application shows these features and points to Ex 34 etc., Exp 2 in Example 31 etc., and consistent with results of Ex 30 exp 1 etc. Applicant argues that immune responses could not have been predicted based on the cited reference and again reiterates lack of rational by the examiner.
Applicant’s arguments have been fully considered and not found persuasive.
The examiner does set out rational as to why it would be obvious to one of ordinary skill in the art before the effective filing date and this is why the rejection was based on obviousness. The immune completion and co-expression as well as immunogenic interference are known in the art. The claims are drawn to any immunogens so there is no particular combination that is superior or unexpected. Overcoming specific interference can be known in the prior art or shown by applicant and then applicant can show how their invention overcomes this. The examples pointed to by applicant are not commensurate with the claim. In example 34, the claims are much broader and there is no indication that the result was unexpected. Additionally, the claims recite immune response. Example 31 is not commensurate because it uses two circular polyribonucleotides. And last, Example 30 shows expression, not immune response as required by the claims. The circular nucleic acid is taught by Sarnow to be used in vaccines (page 33, lines 24-25) and thus would be expected to express polypeptides that are immunogenic.
Claims 41, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Sarnow et al. as applied to claims 1, 4, 19, 24-26, 28-29, 40, 43, 48, 52 and 54 above, and further in view of Polacek et al. (USPgPub 20200268873).
Sarnow et al. is discussed above.
Sarnow et al. does not teach adjuvant
Polacek et al. teach that adjuvant can be used with circular polyribonucleotide when administered (para 4).
One of ordinary skill in the art prior to the effective filing date would have been motivated to use adjuvants because they are known to increase the immune response to immunogens and have the expectation of success knowing adjuvants have been used in the art for many years.
One of ordinary skill in the art prior to the effective filing date would have known that prime boost administration and heterologous antigen form prime boost are known in the art.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to modify the expressed two or more viral protein polypeptides from different virus from circular RNAs by Sarnow et al. by using adjuvant as taught by Polacek et al.
Applicant argues the reference does not cure the deficiencies of Sarnow or lack of rational by the examiner.
Applicant’s arguments have been fully considered and not found persuasive.
The rational was pointed out above and the deficiencies addressed.
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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 19, 24, 25, 26, 28, 29, 40, 43, 48-49, 52, and 54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 35, 39, 43, of copending Application No. 18024542 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference makes obvious the present claims.
For claims 1, 4, and 19, the reference teaches circular with multiple different pathogens (claim 35, immunogen is defined in the spec, PGPub para 8).
For claim 24, each ORF is linked to an IRES (claim 43).
For claims 25-26 and 28-29, each ORF can have a linker or cleavage site or single IRES or multiple IRES (claims 39 and 43).
For claims 40, 43, 48-49, 52 and 54, One of ordinary skill in the art would know about making and using pharmaceutical compositions, methods to immunize, prime-boost type administrations, using heterologous antigens (protein and nucleic acid), and including adjuvant (claim 1).
Thus, the claims are obvious over the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
In reply to the rejection, applicant requests that the double patenting rejection be held in abeyance until allowable subject matter is indicated.
Applicant’s request has been considered, but is denied. According to 37 CFR 1.111, applicant is required to respond to every ground of rejection. Only objections or requirements as to form not necessary to further consideration may be held in abeyance, not rejections. With regard to overcoming all types of non-statutory double patenting, MPEP § 804.02 states that these rejections can be overcome by 1) amending the claims so that the rejection is no longer applicable, or 2) filing a terminal disclaimer. The examiner's claim amendments on January 14, 2015 in '572 still render the instant claims prima facie obvious and the instant double patenting rejection is not obviated.
Applicant has done neither of these two remedies in the instant case. Subsequent lack of attention to this matter may be treated as non-responsive.
Claims 1, 4, and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15, 21-22, and 24 of copending Application No. 17925920 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference makes obvious the present claims.
For claims 1, 4, the reference teaches circular with multiple different pathogens (claims 1, 15, and 21-22).
For claim 48, the reference teaches a method of administering (claim 24).
Thus, the claims are obvious over the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
In reply to the rejection, applicant requests that the double patenting rejection be held in abeyance until allowable subject matter is indicated.
Applicant’s request has been considered, but is denied. According to 37 CFR 1.111, applicant is required to respond to every ground of rejection. Only objections or requirements as to form not necessary to further consideration may be held in abeyance, not rejections. With regard to overcoming all types of non-statutory double patenting, MPEP § 804.02 states that these rejections can be overcome by 1) amending the claims so that the rejection is no longer applicable, or 2) filing a terminal disclaimer. The examiner's claim amendments on January 14, 2015 in '572 still render the instant claims prima facie obvious and the instant double patenting rejection is not obviated.
Applicant has done neither of these two remedies in the instant case. Subsequent lack of attention to this matter may be treated as non-responsive.
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 MYRON G HILL whose telephone number is (571)272-0901. The examiner can normally be reached Mon-Fri.
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, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671
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