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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/15/2023, 8/08/2024 and 12/18/2024 have been considered by the examiner.
Claim Objections
Claim 5-20 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot reference back to another multiple dependent claim. Claims 5 and 6 refers back to claim 1-4, wherein claim 4 is a multiple dependent claim. Claims 7 and 8 (and dependent claims thereof) refers back to claims 1-6, which comprises multiple dependent claims 5 and 6. See MPEP § 608.01(n). Accordingly, the claims 5-20 has not been further treated on the merits.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 4 is/are rejected under 35 U.S.C. 102(a1)(a2) as being anticipated by Lederman (US2021/0260182, IDS).
Lederman teaches a composition that comprises a synthetic DNA fragment comprising MVA, and one or more DNA encoding S protein and N protein of a coronavirus (paragraph [0077], 4th line from bottom, and [0093]). Lederman teaches said recombinant virus is useful toward the method of inducing an immune response against a SARS-CoV-2 virus and a poxvirus comprising administering an immunological effective amount of pharmaceutical composition comprising said virus (paragraph [0116]). Therefore, the teaching from Lederman anticipates the claimed invention of claim 1 and 4.
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lederman, in view of Wussow (WO 2019/014569).
The teaching from Lederman has been discussed above. However, Lederman does not teach one or more DNA encoding S and N protein are inserted into Del2/Del3 sites.
Wussow teaches construction of MVA expressing P2A-cleavable HCMV PC subunits into commonly used MVA insertion site including Del2, Del3 (paragraph [0076], and Figure 1C).
It would have been obvious to an ordinary skilled in the art the that Del2 and Del3 are commonly used insertion site in MVA vector for inserting heterologous subunit antigen based on the teaching from Wussow. The ordinary skilled in the art would be motivated to insert DNA encoding S and N protein into these sites because they are commonly used sites for expressing antigen. . Combining prior art known elements to achieve their intended purpose would have been within the capability of an ordinary artisan. Therefore, the claimed invention of claim 3 would have been prima facie obvious at the time the application was filed.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lederman, in view of Feinberg (US 2007/0275010, IDS).
The teaching from Lederman has been discussed above. However, Lederman 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 taught by Lederman to achieve strong immunogenic response. Combining prior art known elements to achieve a predictable result would have been within the capability of an ordinary artisan. Therefore, the claimed invention of claim 3 would have been prima facie obvious at the time the application was filed.
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 and 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 42, 47, 48 and 53 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 vaccine composition claimed in claim 42 of ‘170 application anticipates the vaccine composition claimed in claim 1 of present application.
Regarding claim 2, claims 47 and 48 of ‘170 application recites same limitation that S and N protein is inserted at Del2 or Del3.
Regarding claim 4, claim 53 of ’70 application recites same limitation of the composition further comprises pharmaceutically acceptable carrier.
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 1-4 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of copending Application No. 18/997,465 (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 stimulating an immune response against a coronavirus and an orthopoxvirus in a subject claimed in claim 18 of the ‘465 application anticipates the vaccine composition of claim 1 of present application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 2 and 4 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 4, 5, 6, 7 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, it would have been obvious to an ordinary skilled in the art that vaccine composition comprises pharmaceutically acceptable carrier.
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.
Claim 1, 2 and 4 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 4, 5, 6, 7 of copending Application No. 19/183,257 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘257 claims a vaccine composition that anticipates the vaccine composition of claim 1 of present application.
Regarding claim 2, claims 4-7 of ‘257 recites the insertion site being Del2 or Del3.
Regarding claim 4, it would have been obvious to an ordinary skilled in the art that vaccine composition comprises pharmaceutically acceptable carrier.
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. 19/183,257 in view of Feinberg.
Claim 1 of ’257 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 ‘257 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 ‘257 application and teaching from Feinberg.
This is a provisional nonstatutory double patenting rejection.
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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