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 .
Claims 1-9, 11-20 are pending.
This office action is in response to the amendment filed on 1/23/2026.
All previous rejection not reiterated in this office action are withdrawn.
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.
Claims 1-9 and 11-20 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.
Newly amended claim 1 recites “a recombinant synthetic modified vaccinia Ankara (rsMVA) virus reconstituted from homologous recombination of three DNA fragments, F1, F2 and F3, wherein each of F1 and F3 comprises a first heterologous DNA sequence or a second heterologous DNA sequence.” The response stated that this amendment is supported throughout the specification and in the original claims. However, a review of the specification and claims as originally filed does not reveal any teaching that directed to the reconstitute rsMVA virus using F1, F2 and F3 as claimed. Therefore, the newly added limitation constitute new matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-9, 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tscherne et al (IDS), in view of Tucker (WO2021/0248017).
Claim 1 is drawn to a composition comprising a recombinant MVA virus reconstituted from homologous recombinant of three DNA fragments, two of which comprises a first heterologous sequence or a second heterologous sequence. This is a product by process limitation. Since the specification does not describe how the creation said MVA differs from other MVA in structure and/or function, it has not been given patentable weight for how the rsMVA is made, but only for the resultant rsMVA having the claimed structure (i)-(iii).
Tscherne et al. teach MVA serves as an advanced vaccine technology platform for developing new vector vaccines against infectious disease including emerging viruses and cancer (page 2, 1st col., 2nd paragraph, lines 4-7). Tscherne et al. teach the MVA vector vaccine platform allows rapid generation of experimental SARS-CoV-2-specific vaccines in response to the pandemic, and previous work addressed MVA candidate vaccine against MERS with immunizations in animal models demonstrating safety, immunogenicity, and protective efficacy of MVA induced MERS-CoV S-antigen-specific immunity (page 2, 1st col., 2nd paragraph). Tscherne et al. teach when tested as a vaccine in BALB/c mice, recombinant MVA expressing the S protein induced SARS-CoV-2-specific T cells and antibodies, and robustly protected vaccinated animals against lung infection up SARS-CoV-2 challenge.
The teaching from Tscherne et al. differs from claim 1 for the antigen is only S protein, not both S and N protein from SARS-CoV-2, or whether the vaccine composition elicits cross-reactive neutralizing activity against one or more SARS-CoV-2 variants of concern (VOC) that comprises a D614G in the S protein.
Tucker teaches expression vectors that comprises two different SARS-CoV-2 proteins (paragraph [0005]). Tucker teaches the first and second SARS-CoV-2 protein is N protein and S protein (paragraph [0008] and [0025]). Tucker teaches while an attenuated adenovirus can be used to express a SARS-CoV-2 N protein and second antigenic protein, other vectors can be used including MVA vectors (paragraph [0088]). Tucker teaches that variants of SARS-CoV-2 protein, e.g., variants of the SARS-CoV-S protein emerge rapidly, which includes UK B.1.1.1.1.7, South African B.1.51 501Y.V2, Brazil variant P.1 and an Indian variant B.1.617 (L452, E484, D614G) (paragraph [0079]). Tucker teaches in some of the embodiments the SARS-CoV-2 S protein sequence is a variant sequence identified in a patient population.
It would have been obvious to an ordinary skilled in the art reading Tscherne and Tucker to recognize rsMVA is a suitable vector for vaccine development of infectious disease including SARS-CoV-2 because it allows rapid generation of experimental SARS-CoV-2-specific vaccines in response to the pandemic, and previous work addressed MVA candidate vaccine against MERS with immunizations in animal models demonstrating safety, immunogenicity, and protective efficacy of MVA induced MERS-CoV S-antigen-specific immunity (page 2, 1st col., 2nd paragraph). The ordinary skilled in the art reading Tucker would be motivated to add N protein to the MVA vector as a second antigen to mitigate potential vaccine-driven escape problem because N protein is highly conserved among β-coronaviruses contains several immunodominant T cell epitopes and long term memory to N can be found in SARS-CoV recovered subjects as well as people with no known exposure to SARS-CoV or SARS-CoV-2 (paragraph [0159]). The ordinary skilled in the art would also use variants of S protein having D614G mutation in the S protein to be antigen because this mutation presents in different variants from patients population, such as Indian and Brazil strains that causes very severe cases of COVID 19. Therefore, the claimed invention of claim 1 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Regarding claim 2, Tscherne teaches S protein is inserted into the deletion site III (Figure 1 and legend).
Regarding claim 3, Tscherne teaches S protein is under the control of mH5 promoter (Figure 1A and legend).
Regarding claim 4, Tucker teaches the immunogenic composition in pharmaceutically acceptable carrier (paragraph [0024]).
Regarding claims 5 and 16, Tscherne teaches the vaccine formulated to intramuscular injection, and administered intramuscularly (page 7, 1st col., 2nd paragraph).
Regarding claims 6 and 17, Tucker teaches the vaccine is formulated to intranasal administration (paragraph [0026]), and administered intranasally (paragraph [0150]).
Regarding claims 7 and 8, both Tscherne and Tucker teaches administering the viral composition to a subject (Figure 3 and legend in Tscherne, and paragraph [0026] in Tucker).
Regarding claim 9, the wherein clause has not been given patentable weight because it simply states the intended result without any steps being positively recited.
Regarding claim 11-15, Tucker teaches all variants (paragraph [0079]).
Regarding claims 18-20, Tucker teaches dosage of the immunogenic composition may vary from individual to individual, in some embodiment is between 1-10 doses (paragraph [0130]).
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.
Claim 1-2, 4-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 49, 52, 62-63 of copending Application No. 17/999,170 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the rsMVA reconstituted from the plasmid system claimed in claim 49 and 52 of ‘170 application anticipates the vaccine composition claimed in claim 1 of present application.
Regarding claim 2, claims 62 and 63 of ‘170 application recites same limitation that S and N protein is inserted at Del2 or Del3.
Regarding claim 4-9, formulating the rsMVA in pharmaceutically acceptable carrier for intramuscular and/or intranasal administration, and administer to a subject would have been routine practice in the vaccination art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 42 of copending Application No. 17/999,170 in view of Feinberg.
Claim 42 of ’170 application recites a vaccine composition that comprises sMVA encoding S and N protein of coronavirus. However, claim 42 does not teach the DNA encoding N and S protein are under the control of a mH5 promoter.
Feinberg teaches MVA vaccines that comprises a MVA vector and heterologous antigen (abstract). Feinberg teaches strong promoter mH5 has been recombined into MVA sites II and III for direct expression of the antigen (paragraph [0138]).
It would have been obvious to an ordinary skilled in the art that mH5 promoter directs strong gene expression in MVA viral vector based on the teaching from Feinberg. The ordinary skilled in the art would be motivated to use mH5 promoter to direct expression of S and N protein of coronavirus in the MVA vector claimed in claim 42 of ‘170 application to achieve strong immunogenic response. Therefore, the claimed invention of claim 3 of present application would have been obvious in view of claim 42 of ‘170 application and teaching from Feinberg.
This is a provisional nonstatutory double patenting rejection.
Claim 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2, 3, 10 of copending Application No. 18/711,073(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the vaccine composition claimed in claim 1 of ‘073 anticipates the vaccine composition claimed in claim 1 of present application.
Regarding claims 2-4, claims 2, 3 and 10 of ‘073 application recites the same limitation of inserting into Del2/Del3, having mH5 promoter and comprising pharmaceutically acceptable carrier.
Regarding claim 5-9, formulating the rsMVA in pharmaceutically acceptable carrier for intramuscular and/or intranasal administration, and administer to a subject would have been routine practice in the vaccination art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4-9, 16-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/711,088 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the composition used in the method of protecting a subject from coronavirus claimed in claim 1 of the ‘088 application anticipates the vaccine composition of claim 1 of present application.
Regarding claim 5-9 and 16-20, formulating the rsMVA in pharmaceutically acceptable carrier for intramuscular and/or intranasal administration, and administer to a subject would have been routine practice in the vaccination art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 4-9 and 16-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/711,338 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the composition used in the method of protecting a subject from coronavirus claimed in claim 1 of the ‘338 application anticipates the vaccine composition of claim 1 of present application.
Regarding claim 4-9 and 16-20, formulating the rsMVA in pharmaceutically acceptable carrier for intramuscular and/or intranasal administration, and administer to a subject would have been routine practice in the vaccination art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 2, 4-9, 16-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 4, 5, 6, 7, 8 and 11 of copending Application No. 19/076,904 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘904 claims a vaccine composition that anticipates the vaccine composition of claim 1 of present application.
Regarding claim 2, claims 4-7 of ‘904 recites the insertion site being Del2 or Del3.
Regarding claim 4-9 and 16-20, formulating the rsMVA in pharmaceutically acceptable carrier for intramuscular and/or intranasal administration, and administer to a subject would have been routine practice in the vaccination art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/076,904 in view of Feinberg.
Claim 1 of ’904 application recites a vaccine composition that comprises sMVA encoding S and N protein of coronavirus. However, claim 1 does not teach the DNA encoding N and S protein are under the control of a mH5 promoter.
Feinberg teaches MVA vaccines that comprises a MVA vector and heterologous antigen (abstract). Feinberg teaches strong promoter mH5 has been recombined into MVA sites II and III for direct expression of the antigen (paragraph [0138]).
It would have been obvious to an ordinary skilled in the art that mH5 promoter directs strong gene expression in MVA viral vector based on the teaching from Feinberg. The ordinary skilled in the art would be motivated to use mH5 promoter to direct expression of S and N protein of coronavirus in the MVA vector claimed in claim 1 of ‘904 application to achieve strong immunogenic response. Therefore, the claimed invention of claim 3 of present application would have been obvious in view of claim 1 of ‘904 application and teaching from Feinberg.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 4-9 and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 9 and 17 of U.S. Patent No. 12,584,146. Although the claims at issue are not identical, they are not patentably distinct from each other because the vaccine composition claimed in claim 1 of ‘146 patent anticipates the claimed vaccine composition claimed in claim 1 of present application.
Regarding claim 2, claim 6 of ‘146 patent recites the insertion occurs at Del2 or Del3.
Regarding claim 4-9 and 16-20, formulating the rsMVA in pharmaceutically acceptable carrier for intramuscular and/or intranasal administration, and administer to a subject would have been routine practice in the vaccination art as claimed in claim 9 and 17 of ‘146 patent.
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/183,257 in view of Feinberg.
Claim 1 of ’146 patent recites a vaccine composition that comprises sMVA encoding S and N protein of coronavirus. However, claim 1 does not teach the DNA encoding N and S protein are under the control of a mH5 promoter.
Feinberg teaches MVA vaccines that comprises a MVA vector and heterologous antigen (abstract). Feinberg teaches strong promoter mH5 has been recombined into MVA sites II and III for direct expression of the antigen (paragraph [0138]).
It would have been obvious to an ordinary skilled in the art that mH5 promoter directs strong gene expression in MVA viral vector based on the teaching from Feinberg. The ordinary skilled in the art would be motivated to use mH5 promoter to direct expression of S and N protein of coronavirus in the MVA vector claimed in claim 1 of ‘146 patent to achieve strong immunogenic response. Therefore, the claimed invention of claim 3 of present application would have been obvious in view of claim 1 of ‘146 patent and teaching from Feinberg.
Response to Amendment
Applicant argues that amendment to the claim 1 obviates the NSDP.
This is not persuasive because claim 1 recites how the vaccine is made, but does not indicate how the structure and/or function would be distinct from the claims from the above cited patent or application due the process of making. As such, the NSDP rejections are still proper and thus maintained.
No claims are allowed.
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 CELINE X QIAN whose telephone number is (571)272-0777. The examiner can normally be reached M-F (8-4:00).
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/CELINE X QIAN/ Primary Examiner, Art Unit 1637
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