DETAILED ACTION
Applicant’s amendment and remarks filed April 28, 2026 are acknowledged and entered. Claims 1-4, 6, 7, 21, 40, 96, 114, 187, 198 and 200-204 are under examination with regard to the elected species of SEQ ID NO: 3 and SEQ ID NO: 29362 (SIINFEKL).
Any prior objection or rejection that is not repeated or addressed below is either moot or withdrawn in view of Applicant’s amendment.
Claims Summary
Claims 1, 6, 7, 21, 40, 96, 114, 187 and 198
Claim 1 is directed to a method for stimulating an immune response in a subject comprising:
Administering, as a priming dose, a composition for delivery of a ChAdV-based expression system; and,
Administering, as two or more boosting dose(s), a composition for delivery of a self-replicating alphavirus-based expression system;
wherein at least one period between doses is greater than 1 year and less than 2 years. Two or more boosting doses are administered (claim 6), and the at least one period between doses is in between the two or more boosting doses (claim 7).
In claim 21, the composition for delivery of the self-replicating alphavirus-based expression system comprises said expression system and a LNP that encapsulates the expression system. The expression system comprises one or more vectors comprising:
An RNA alphavirus backbone comprising at least one promoter nucleotide sequence and at least one polyA sequence; the backbone comprises at least one nucleotide sequence of a VEEV comprising SEQ ID NO: 3 having a deletion between nt 7544 and 11175 (claim 40); the deletion between nt 7544 and 11175 represents the deletion of sequences encoding the structural proteins of VEE located 3′ of the 26S subgenomic promoter; and
A cassette comprising at least one antigen-encoding nucleic acid sequence comprising an epitope-encoding nucleic acid sequence (SEQ ID NO: 29362 (SIINFEKL) (claim 187)); the cassette is inserted at position 7544 of the backbone to replace the deletion between 7544 and 11175 (claim 40).
In claim 96, the ChAdV vector comprises:
a ChAdV backbone comprising at least one promoter nucleotide sequence and at least one polyA sequence; in claim 114, the ChAdV backbone is a ChAdV68 backbone that comprises at least nt 2 to 36518 of SEQ ID NO: 1, with a deletion of nt 577 to 3403 (corresponding to an E1 deletion), a deletion of nt 27125 to 31825 (corresponding to an E3 deletion), and nt 34916 to 35642 (corresponding to a partial E4 deletion); and
a cassette comprising at least one antigen-encoding nucleic acid sequence comprising an epitope-encoding nucleic acid sequence (SEQ ID NO: 29362 (SIINFEKL) (claim 198)); wherein the cassette is operably linked to the at least one promoter and the at least one polyA sequence.
Claims 2-4 and 200-204
Claim 2 is directed to a method for stimulating an immune response in a subject comprising administering a composition for delivery of a self-replication adenovirus-based expression system, wherein the composition is administered as one or more doses, and wherein at least one period between doses is greater than 1 year and less than 2 years. At least one of the doses is a priming dose (claim 3). At least one period between doses is between a priming dose and a boosting dose (claim 4). Two or more boosting doses are administered (claim 200), and the at least one period between doses is in between the two or more boosting doses (claim 201).
In claim 202, the composition for delivery of the self-replicating alphavirus-based expression system comprises said expression system and a LNP that encapsulates the expression system. The expression system comprises one or more vectors comprising:
An RNA alphavirus backbone comprising at least one promoter nucleotide sequence and at least one polyA sequence; the backbone comprises at least one nucleotide sequence of a VEEV comprising SEQ ID NO: 3 having a deletion between nt 7544 and 11175 (claim 204); and
A cassette comprising at least one antigen-encoding nucleic acid sequence comprising an epitope-encoding nucleic acid sequence (SEQ ID NO: 29362 (SIINFEKL) (claim 203)); the cassette is inserted at position 7544 of the backbone to replace the deletion between 7544 and 11175 (claim 204).
Claim Objections
Claim 201 is objected to because of the following informalities:
The phrase “doses in between” should be “doses is between” [emphasis added].
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
(New Rejection) Claims 1-4, 6, 7, 21, 40, 96, 114, 187, 198 and 200-204 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claims 1, 2 and all dependent recite a period of time between booster doses of greater than 1 year and less than 2 years. The limitation of “less than 2 years” does not appear to be supported the specification or claims as originally filed. Applicant has not pointed to any other portions of the specification, claims or drawings that would support “less than 2 years”.
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, 6, 7, 21, 40, 96, 114, 187, 98 and 200-204 are rejected under 35 U.S.C. 103 as being unpatentable over Blair et al. (WO2018/098362 A1, cited in the IDS filed 10/18/2022, “Blair”) in view of Graham et al. (US 2011/0091496 A1, cited in the IDS filed 10/18/2022, “Graham”), evidenced by the instant specification (published application US 20230047979). The claims are summarized above and correlated with the teachings of the prior art in bold font below.
Blair discloses methods of treating cancer in a subject by inducing an immune response via the administration of vaccines in the form of viral vectors (see paragraphs [0044]-[0045]). Blair discloses the administration of a ChAdV vector followed by administration of a self-replicating RNA vector (see paragraph [0045]) (claim 1). Additionally, Blair discloses self-replicating VEE vector homologous prime/boost (see paragraph [00714] and Table 16) (claim 2).
Regarding the ChAdV vector, Blair discloses a ChAdV68 vector backbone comprising SEQ ID NO: 1 (see paragraph [00670], compared with Applicant’s SEQ ID NO: 1 described in paragraph [0489] of the published application US 20230047979), having a deletion of nt 577 to 3404 (E1 deletion), a deletion of nt 27125 to 31825 (E3 deletion), or all of E1-E4 (see paragraphs [0011]-[0112] and [0029]) (claim 114). The ChAdV68 vector additionally comprises a CMV promoter sequence, a polyA sequence, a cassette comprising a neoantigen epitope-encoding sequence having linker sequences (see Blair’s claims 1 and 2) (claim 96). One of the epitopes is SIINFEKL (see paragraph [0097) (claim 198).
Regarding the self-replicating RNA vector, Blair discloses a VEE backbone vector comprising SEQ ID NO: 3 (see Blair page 215, compared with Applicant’s SEQ ID NO: 3 described in paragraph [0662] of the published application US 20230047979) having a deletion of nt 7544 to 11175, and replaced with a cassette comprising a neoantigen epitope-encoding sequence, additionally having a promoter and polyA tail, formulated in a LNP (see paragraphs [00312], [00315], [00705] and [00722]) (claims 21, 40, 202 and 204). One of the epitopes is SIINFEKL (see paragraph [0097) (claims 187 and 203).
Regarding booster doses, Blair teaches that boosters are administered as desired for achieving a certain level of immunity, suggesting a booster every 1-10 weeks (see paragraphs [00364], [00374] and [00388]). Blair does not disclose a period of greater than 1 year and less than 2 years between boosting doses, nor between a prime and a boost dose. However, it would have been obvious to have boosted after a period of greater than 1 year and less than 2 years. Graham is directed to viral vector immunization, including prime boost regimens with viral vectors (see paragraph [0192]), selected from vectors including chimp adenovirus and VEE (see paragraph [0188]). Graham discloses administration of multiple doses separated by any period of time required to achieve the desired effect, including years, which encompasses more than 1 year (see paragraph [0226]), as well as about 12 months, which would reasonably include periods of time less than and greater than 12 months (i.e., less than 2 years) (see paragraph [0243]) (claims 1-4, 6, 7, 200 and 201). One would have been motivated to arrive at the period of time, as Graham teaches, that achieves the desired effect, which includes periods of time that encompass years. The period between prime and boost, or between subsequent boosts, and the desired effect of immunogenicity is a result effective variable, thus it would have been obvious to have optimized the period of time between doses, with a reasonable expectation of success.
Applicant’s arguments have been carefully considered but fail to persuade. Applicant’s arguments are primarily directed to the following:
Applicant argues that Blair and Graham do not teach “greater than 1 year and less than 2 years”. In response, the Office recognizes that the explicit teaching of “greater than 1 year and less than 2 years” is not found in either reference. However, Graham discloses administration of multiple doses separated by any period of time required to achieve the desired effect, including years, which encompasses more than 1 year (see paragraph [0226]), as well as about 12 months, which would reasonably include periods of time less than and greater than 12 months (i.e., less than 2 years) (see paragraph [0243]) (claims 1-4, 6, 7, 200 and 201). One would have been motivated to arrive at the period of time, as Graham teaches, that achieves the desired effect, which includes periods of time that encompass about 12 months, for example. The period between prime and boost, or between subsequent boosts, and the desired effect of immunogenicity is a result effective variable, thus it would have been obvious to have optimized the period of time between doses, with a reasonable expectation of success.
Applicant argues that Graham’s teachings about VEE are highly generalized (see Graham paragraph [0188]), and the exemplified teachings are not directed to alphavirus vectors. In response, examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiment. In this case, while Graham does not exemplify an alphavirus vector, the teachings concerning VEE are still valid. The level of generality with regard to the list of viruses in paragraph [0188] does not take away from what Graham teaches, lacking any evidence to the contrary concerning alphaviruses in particular.
Applicant argues that one would not have had a reasonable expectation of success that the claimed method would have generated T cells that were functional and demonstrated killing of peptide loaded target cells as shown in Figure 49 and Table 49 of the instant specification. In response, Applicant’s results are noted, but there is no evidence that those results are surprising or unexpected. Further, any results that Applicant observed would have been a natural outcome of doing what the prior art suggests.
In response to Applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, Graham teaches that the number of doses and period of time between doses is for achieving the desired effect (i.e., immunization/vaccination), and include any period of time, such as months, years, and “about 12 months”. Given Applicant’s span of time “greater than 1 year and less than 2 years”, and the result-effective variable of achieving immunization/vaccination, Graham’s teachings render the claims obvious.
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 2-4, 200-202 and 204 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 170, 173, 177, 180, 192, 193, 198 and 199 of copending Application No. 17/058,128 (reference application) in view of Blair et al. (WO2018/098362 A1, cited in the IDS filed 10/18/2022, “Blair”) and Graham et al. (US 2011/0091496 A1, cited in the IDS filed 10/18/2022, “Graham”). Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending claims are directed to compositions comprising VEE vector expression systems comprising a VEE vector backbone, a promoter nucleotide sequence, a polyA sequence and an antigen cassette comprising epitope-encoding nucleic acid sequences. The co-pending composition claims render obvious the instant method claims directed to stimulating an immune response by administering a self-replicating alphavirus-based (VEE) expression system.
The copending claims do not specify that the VEE vector is a self-replicating vector, nor the aspect of booster doses. It would have been obvious to have claimed the particular embodiment of a self-replicating vector, with a reasonable expectation of success, as it would spread and continue to induce immune responses. It would have been obvious to have claimed booster doses, with a reasonable expectation of success. Blair discloses self-replicating VEE vector homologous prime/boost (see paragraph [00714] and Table 16).
The copending claims do not specify a time between doses. However, it would have been obvious to have claimed a period of time between booster doses, or between a prime and a booster, of greater than 1 year and less than 2 years. Graham is directed to viral vector immunization, including prime boost regimens with viral vectors (see paragraph [0192]), selected from vectors including chimp adenovirus and VEE (see paragraph [0188]). Graham discloses administration of multiple doses separated by any period of time required to achieve the desired effect, including years, which encompasses more than 1 year (see paragraph [0226]), as well as about 12 months, which would reasonably include periods of time less than and greater than 12 months (i.e., less than 2 years) (see paragraph [0243]). One would have been motivated to arrive at the period of time, as Graham teaches, that achieves the desired effect, which includes periods of time that encompass years. The period between prime and boost, or between subsequent boosts, and the desired effect of immunogenicity is a result effective variable, thus it would have been obvious to have optimized the period of time between doses, with a reasonable expectation of success.
The copending claims do not require that the self-replicating expression system be encapsulated by a LNP. However, it would have been obvious to have claimed this embodiment in view of Blair’s teaching that the self-replicating VEE vectors are formulated in a LNP (see Blair, paragraph [00722]). One would have been motivated to improve the immunogenicity of the vector with the LNP, with a reasonable expectation of success (see Blair, paragraph [00319]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Applicant’s arguments concerning the teachings of Blair and Graham have been addressed above.
Claims 2-4, 200-202 and 204 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 10, 11, 22, 23, 39, 50, 99, 105 and 190 of copending Application No. 17/817,312 (reference application) in view of Blair et al. (WO2018/098362 A1, cited in the IDS filed 10/18/2022, “Blair”) and Graham et al. (US 2011/0091496 A1, cited in the IDS filed 10/18/2022, “Graham”). Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending claims are directed to compositions comprising VEE vector expression systems comprising a VEE vector backbone, a promoter nucleotide sequence, a polyA sequence and an antigen cassette comprising epitope-encoding nucleic acid sequences. The co-pending are also directed to methods of inducing an immune response or treating by administering the vector expression system.
The copending claims do not specify that the VEE vector is a self-replicating vector, nor the aspect of booster doses. It would have been obvious to have claimed the particular embodiment of a self-replicating vector, with a reasonable expectation of success, as it would spread and continue to induce immune responses. It would have been obvious to have claimed booster doses, with a reasonable expectation of success. Blair discloses self-replicating VEE vector homologous prime/boost (see paragraph [00714] and Table 16).
The copending claims do not specify a time between doses. However, it would have been obvious to have claimed a period of time between booster doses, or between a prime and a booster, of greater than 1 year and less than 2 years. Graham is directed to viral vector immunization, including prime boost regimens with viral vectors (see paragraph [0192]), selected from vectors including chimp adenovirus and VEE (see paragraph [0188]). Graham discloses administration of multiple doses separated by any period of time required to achieve the desired effect, including years, which encompasses more than 1 year (see paragraph [0226]), as well as about 12 months, which would reasonably include periods of time less than and greater than 12 months (i.e., less than 2 years) (see paragraph [0243]). One would have been motivated to arrive at the period of time, as Graham teaches, that achieves the desired effect, which includes periods of time that encompass years. The period between prime and boost, or between subsequent boosts, and the desired effect of immunogenicity is a result effective variable, thus it would have been obvious to have optimized the period of time between doses, with a reasonable expectation of success.
The copending claims do not require that the self-replicating expression system be encapsulated by a LNP. However, it would have been obvious to have claimed this embodiment in view of Blair’s teaching that the self-replicating VEE vectors are formulated in a LNP (see Blair, paragraph [00722]). One would have been motivated to improve the immunogenicity of the vector with the LNP, with a reasonable expectation of success (see Blair, paragraph [00319]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Applicant’s arguments concerning the teachings of Blair and Graham have been addressed above.
Claims 2-4, 200-202 and 204 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of copending Application No. 18/404,681 (reference application) in view of Blair et al. (WO2018/098362 A1, cited in the IDS filed 10/18/2022, “Blair”) and Graham et al. (US 2011/0091496 A1, cited in the IDS filed 10/18/2022, “Graham”). Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending claims are directed to a method for treating cancer in a subject by administering a first and second vector, wherein the vectors are ChAdV68 and self-replicating VEE, as a prime and boost. The vectors can also be the same for prime and boost. As for the details of the ChAdV68 and VEE structures and the epitope, these are disclosed in Blair as outlined above in the obviousness rejection.
The copending claims do not specify a time between doses. However, it would have been obvious to have claimed a period of time between booster doses, or between a prime and a booster, of greater than 1 year and less than 2 years. Graham is directed to viral vector immunization, including prime boost regimens with viral vectors (see paragraph [0192]), selected from vectors including chimp adenovirus and VEE (see paragraph [0188]). Graham discloses administration of multiple doses separated by any period of time required to achieve the desired effect, including years, which encompasses more than 1 year (see paragraph [0226]), as well as about 12 months, which would reasonably include periods of time less than and greater than 12 months (i.e., less than 2 years) (see paragraph [0243]). One would have been motivated to arrive at the period of time, as Graham teaches, that achieves the desired effect, which includes periods of time that encompass years. The period between prime and boost, or between subsequent boosts, and the desired effect of immunogenicity is a result effective variable, thus it would have been obvious to have optimized the period of time between doses, with a reasonable expectation of success.
The copending claim does not require that the self-replicating expression system be encapsulated by a LNP. However, it would have been obvious to have claimed this embodiment in view of Blair’s teaching that the self-replicating VEE vectors are formulated in a LNP (see Blair, paragraph [00722]). One would have been motivated to improve the immunogenicity of the vector with the LNP, with a reasonable expectation of success (see Blair, paragraph [00319]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Applicant’s arguments concerning the teachings of Blair and Graham have been addressed above.
Claims 1-4, 6, 7, 21, 40, 96, 114, 200-202 and 204 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12 and 44 of copending Application No. 18/607,061 (reference application) in view of Blair et al. (WO2018/098362 A1, cited in the IDS filed 10/18/2022, “Blair”) and Graham et al. (US 2011/0091496 A1, cited in the IDS filed 10/18/2022, “Graham”). Although the claims at issue are not identical, they are not patentably distinct from each other.
The copending claims are directed to a method for treating cancer in a subject by administering a first and second vector, wherein the vectors are ChAdV and self-replicating VEE, as a prime and boost. The vectors can also be the same for prime and boost. As for the details of the ChAdV68 and VEE structures and the epitope, these are disclosed in Blair as outlined above in the obviousness rejection.
The copending claims do not specify a time between doses. However, it would have been obvious to have claimed a period of time between booster doses, or between a prime and a booster, of greater than 1 year and less than 2 years. Graham is directed to viral vector immunization, including prime boost regimens with viral vectors (see paragraph [0192]), selected from vectors including chimp adenovirus and VEE (see paragraph [0188]). Graham discloses administration of multiple doses separated by any period of time required to achieve the desired effect, including years, which encompasses more than 1 year (see paragraph [0226]), as well as about 12 months, which would reasonably include periods of time less than and greater than 12 months (i.e., less than 2 years) (see paragraph [0243]). One would have been motivated to arrive at the period of time, as Graham teaches, that achieves the desired effect, which includes periods of time that encompass years. The period between prime and boost, or between subsequent boosts, and the desired effect of immunogenicity is a result effective variable, thus it would have been obvious to have optimized the period of time between doses, with a reasonable expectation of success.
The copending claims do not require that the self-replicating expression system be encapsulated by a LNP. However, it would have been obvious to have claimed this embodiment in view of Blair’s teaching that the self-replicating VEE vectors are formulated in a LNP (see Blair, paragraph [00722]). One would have been motivated to improve the immunogenicity of the vector with the LNP, with a reasonable expectation of success (see Blair, paragraph [00319]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Applicant’s arguments concerning the teachings of Blair and Graham have been addressed above.
Claims 1-4, 6, 7, 21, 40, 96, 114, 187, 198 and 200-204 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13, 14, 16, and 18 of U.S. Patent No. 12,616,746 in view of in view of Graham et al. (US 2011/0091496 A1, cited in the IDS filed 10/18/2022, “Graham”). Previously, this was a provisional rejection over Application No. 17/937,751 in view of Graham et al. (US 2011/0091496 A1, cited in the IDS filed 10/18/2022, “Graham”). Now that the application has issued as a patent, this rejection is no longer provisional. Although the claims at issue are not identical, they are not patentably distinct from each other.
The patented claims are directed to a method for stimulating an immune response by administering a ChAdV-based expression system as a priming dose and a self-replicating alphavirus-based expression system as one or more boosting doses, or the self-replicating alphavirus-based expression system as a priming dose and one or more boosting doses.
The patented claims do not specify a period of time between doses. It would have been obvious to have claimed a period of time between booster doses, or between a prime and a booster, of greater than 1 year and less than 2 years. Graham is directed to viral vector immunization, including prime boost regimens with viral vectors (see paragraph [0192]), selected from vectors including chimp adenovirus and VEE (see paragraph [0188]). Graham discloses administration of multiple doses separated by any period of time required to achieve the desired effect, including years, which encompasses more than 1 year (see paragraph [0226]), as well as about 12 months, which would reasonably include periods of time less than and greater than 12 months (i.e., less than 2 years) (see paragraph [0243]). One would have been motivated to arrive at the period of time, as Graham teaches, that achieves the desired effect, which includes periods of time that encompass years. The period between prime and boost, or between subsequent boosts, and the desired effect of immunogenicity is a result effective variable, thus it would have been obvious to have optimized the period of time between doses, with a reasonable expectation of success.
Applicant’s arguments against the Graham reference have been addressed above.
Conclusion
No claim is allowed.
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.
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/STACY B CHEN/Primary Examiner, Art Unit 1672
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