DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of the species SEQ ID NO: 3 and SEQ ID NO: 29362, in the reply filed on September 3, 2025 is acknowledged. SEQ ID NO: 29362, according to the sequence listing is SIINFEKL. In Applicant’s response, the sequence for SEQ ID NO: 29362 was indicated to be VVGAVGVGK. The examiner has proceeded with search and examination of SEQ ID NO: 29362 according to the sequence listing, which is SIINFEKL.
Drawings
The drawings are objected to because Figures 2B, 5B and 6B contain amino acid sequences that need to be referenced by a sequence identifier (SEQ ID NO).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In lieu of filing replacement figures, Applicant may amend the specification’s description of the figures to include the sequence identifiers.
Specification
The disclosure is objected to because the description of Figure 49 is mislabeled as a description of Figure 48. See paragraphs [00131]-[00132]. Appropriate correction is required.
Claims Summary
Claims 1, 5-7, 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 one 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, or greater than 2 years (claim 5). 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 199-204
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, or greater than 2 years (claim 199). 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 7 is objected to because of the following informalities:
Claim 7 should read “wherein the at least one period between doses is between the two or more boosting doses” [emphasis added], or equivalent language. Appropriate correction is required.
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.
Claim 114 is 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.
Claim 114 recites the limitation "the ChASdV68 backbone" in claim 96. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-7, 21, 40, 96, 114, 187 and 198-204 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 between boosting doses, nor between a prime and a boost dose, nor a period of greater than 2 years. However, it would have been obvious to have boosted after a period of greater than 1 year, or greater 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, and more than 2 years (see paragraph [0226]) (claims 1-7 and 199-201). 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.
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, 199-202 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).
It would have been obvious to have claimed a period between booster doses, or between a prime and a booster, of greater 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 2 years (see paragraph [0226]). 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.
Claims 2-4, 199-202 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, 113, 114, 190, 206 and 207 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).
It would have been obvious to have claimed a period between booster doses, or between a prime and a booster, of greater 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 2 years (see paragraph [0226]). 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.
Claims 1-7, 21, 40, 96, 114, 187 and 198-204 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 403-405 of copending Application No. 17/937,751 (reference application) in view of 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 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. Details of the vector structures and epitope are found in copending claims 388-402.
The copending claims do not specify a period of time between doses. It would have been obvious to have claimed a period between booster doses, or between a prime and a booster, of greater than 1 year or greater 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 2 years (see paragraph [0226]). 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5-7, 21, 40, 96, 114, 187 and 198 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 216 of copending Application No. 18/048,403 (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 claim is 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. Details of the vector structures and epitope are found in copending claims 74, 86 and 165.
The copending claim does 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 period of time between doses. It would have been obvious to have claimed a period between booster doses, or between a prime and a booster, of greater than 1 year, or greater 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 2 years (see paragraph [0226]). 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.
Claims 2-4, 199-202 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 claim is 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 claim does not specify a period of time between doses. It would have been obvious to have claimed a period between booster doses, or between a prime and a booster, of greater than 1 year, or greater 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 2 years (see paragraph [0226]). 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.
Claims 1-7, 21, 40, 96, 114, 199-202 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 claim does not specify a period of time between doses that is greater than 1 year, or greater than 2 years. It would have been obvious to have claimed a period between booster doses, or between a prime and a booster, of greater than 1 year, or greater 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 2 years (see paragraph [0226]). 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.
Conclusion
No claim is allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672