DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's amendment and remarks, filed 2/5/26, are acknowledged.
Claims 1, 10, 14, 19-20, 27, 38, 41 have been amended.
Claims 1, 10-11, 14, 19-20, 27, 35, 38, 40-41, 44-46 are pending and are under examination.
Acknowledgment is made of applicant's claim for domestic priority under 35 U.S.C. 119(e). However, the provisional application USSN 63/156,109 upon which priority is claimed fails to provide adequate support under 35 U.S.C. 112 for claims 19 and 44 of this application. The ‘109 application does not disclose the claimed limitation of SARS-CoV-2 variants including alpha, beta, Gamma, Epsilon, Eta, Iota, Kappa, 1.617.3, Mu, Omicron, and Zeta. Consequently, claims 19 and 44 have been accorded the priority of the filing date of the PCT application, i.e. 2/25/22.
In view of Applicant’s claim amendments, only the following rejection remains.
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 45-46 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification disclosure is insufficient to enable one skilled in the art to practice the invention as claimed without an undue amount of experimentation. Undue experimentation must be considered in light of factors including: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill in the art, the level of predictability of the art, the amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention, see In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) states, “The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.” “The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling” (MPEP 2164.03). The MPEP further states that physiological activity can be considered inherently unpredictable. With these teachings in mind, an enabling disclosure, commensurate in scope with the breadth of the claimed invention, is required.
Regarding claims 45-46, the claims encompass preventing infection, which given its broadest reasonable interpretation encompasses a complete prevention such that not a single cell becomes infected with SARS-CoV-2, which would be highly unpredictable.
Thus, based on the unpredictability of the art, the instant specification must provide a sufficient and enabling disclosure commensurate in scope with the instant claims. No examples or guidance are provided regarding preventing infection. Thus, based on the unpredictability of the art and the lack of guidance provided by the instant specification, it would require undue experimentation to make and use a rVSV having full length spike protein (SF) for preventing infection.
Applicant’s arguments filed 2/5/26 have been fully considered, but they are not persuasive.
Applicant argues that the specification on page 32 describes that the vaccine can induce IgG titers which can prevent infection, and that the examples demonstrate that mice vaccinated with the claimed VSV constructs survive SARS-CoV-2 challenge.
Neutralizing antibodies can reduce infection, but do not completely prevent infection. The examples demonstrate that the treated mice survive SARS-CoV-2, but still become infected and exhibit viral loads (see Fig. 17). As noted above, the claims encompass preventing infection, which given its broadest reasonable interpretation encompasses a complete prevention such that not a single cell becomes infected with SARS-CoV-2. The specification does not enable prevention.
The following are new grounds of rejection necessitated by Applicant’s claim amendments.
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.
Claims 1, 10-11, 14, 19-20, 27, 35, 38, 40-41, 44-46 are 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.
Claims 1 and 27 are indefinite in the recitation of a gene that encodes for a full length SF protein of SARS-CoV-2 having “one or more modifications”. It is unclear how the protein can have “one” modification, when the claim sets forth two separate modifications, one to the signal peptide and one to the transmembrane and cytoplasmic tail.
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.
Claim 1, 10-11, 14, 19-20, 27, 35, 38, 40-41, 44-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0144022, in view of US 2021/0338804, 2019, and Buonocore, 2002.
The ‘022 publication teaches an avirulent rVSV for use in inducing immune responses against an antigen of interest, which can replicate to a high titer and has less chance of reverting back to a wild type phenotype (See pages 1-4 and Fig. 2, in particular). The ‘022 publication teaches that the recombinant attenuated VSV expresses a VSV G gene and variant M protein that can be used as a VSV based prime-boost vaccine to induce long-lasting immune response against foreign antigens expressed by the VSV carrying foreign genes (see pages 1-4, in particular). The ‘022 publication teaches a M mutant of VSV Indiana serotype (VSVind)-GML, and that having an M protein mutation makes the rVSV avirulent and safer (see page 8, in particular). The ‘022 publication teaches the G21E/L111F/M51R substitutions in an M (i.e. VSVInd, , i.e. SEQ I D, NO: 4 see page 8, in particular). The ‘022 publication teaches that the prime boost vaccine combination can be two of the same or different VSV serotypes with mutated M, expressing the same foreign gene, and that doing so induces stronger immune responses, and also teaches boosting with VSVNJ having G22E/M48R/M51R, i.e. VSVNJ-GMM, SEQ ID NO: 10, See entire document). The ‘022 publication teaches that the antigen of interest can be expressed by replacing the native signal peptide with melittin signal peptide, which dramatically increased the rates of expression and enhances induction of T and B cell immune responses (See paragraph 203, in particular).
The references differ from the claimed invention in that they does not explicitly teach a modified full length spike protein of SARS-CoV-2 with replacement of the transmembrane and cytoplasmic tail with VSV G protein transmembrane domain and cytoplasmic tail.
The ‘804 publication teaches that SARS-CoV-2 has emerged as a novel coronavirus and there is an urgent need for a safe and effective vaccine. The ‘804 publication teaches that rVSV vectors can be used to express SARS-CoV-2 S protein for providing an immunogenic composition to induce an immune response in a subject. The ‘804 publication teaches SARs-CoV-2 full length S protein with a replacement of the transmembrane and cytoplasmic domains with those of the transmembrane and cytoplasmic domains from G protein form VSVInd (See Table 1, and Fig. 4, in particular). The ‘804 publication teaches Wuhan SARS-CoV-2 spike protein (i.e. wild type, See entire document).
Buonocore teaches that viral proteins can be modified with VSV G transmembrane and cytoplasmic domain by replacing the transmembrane and cytoplasmic domain of a viral protein (that contains ER retention signals) with the transmembrane and cytoplasmic domains of VSV G, to allow for cell surface expression (see page 6865, in particular).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use a spike protein of SARS-CoV-2, as taught by the ‘804 publication and Buonocore, as the foreign antigen in recombinant VSV of the ‘022 publication. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because the ‘804 teaches that there is an urgent need for immunogenic compositions that can be used to induce an immune response against SARS-CoV2 coronavirus. The ordinary artisan would be motivated to further modify the spike protein, by replacing the transmembrane and cytoplasmic domain with those of VSV G, as taught by Buonocore and the ‘804 publication, since the references teach that allows for surface expression.
Claim 1, 10-11, 14, 19-20, 27, 35, 38, 40-41, 44-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0144022, in view of Ozharovskaia, 2019, Buonocore, 2002, US 20210260180 (of record).
The ‘022 publication teaches an avirulent rVSV for use in inducing immune responses against an antigen of interest, which can replicate to a high titer and has less chance of reverting back to a wild type phenotype (See pages 1-4 and Fig. 2, in particular). The ‘022 publication teaches that the recombinant attenuated VSV expresses a VSV G gene and variant M protein that can be used as a VSV based prime-boost vaccine to induce long-lasting immune response against foreign antigens expressed by the VSV carrying foreign genes (see pages 1-4, in particular). The ‘022 publication teaches a M mutant of VSV Indiana serotype (VSVind)-GML, and that having an M protein mutation makes the rVSV avirulent and safer (see page 8, in particular). The ‘022 publication teaches the G21E/L111F/M51R substitutions in an M (i.e. VSVInd, , i.e. SEQ I D, NO: 4 see page 8, in particular). The ‘022 publication teaches that the prime boost vaccine combination can be two of the same or different VSV serotypes with mutated M, expressing the same foreign gene, and that doing so induces stronger immune responses, and also teaches boosting with VSVNJ having G22E/M48R/M51R, i.e. VSVNJ-GMM, SEQ ID NO: 10, See entire document). The ‘022 publication teaches that the antigen of interest can be expressed by replacing the native signal peptide with melittin signal peptide, which dramatically increased the rates of expression and enhances induction of T and B cell immune responses (See paragraph 203, in particular).
The references differ from the claimed invention in that they does not explicitly teach a modified full length spike protein of SARS-CoV-2 with replacement of the transmembrane and cytoplasmic tail with VSV G protein transmembrane domain and cytoplasmic tail.
The ‘180 publication teaches that coronaviruses include MERS and SARS-COV-2, and that there is an urgent need for immunogenic compositions that can be used to induce an immune response against SARS-CoV2 coronavirus (see paragraph 8, in particular). The ‘180 publication teaches using one or more SARS-CoV-2 antigens expressed in a viral vector for inducing immune responses to treat COVID-19, and teaches a full length spike protein of SARS-CoV-2 (see paragraph 9-10 and 122, in particular). The ‘180 publication teaches spike protein from the Wuhan isolate, i.e. wildtype, see paragraph 122, in particular. The ‘180 publication teaches using the viral vectors for inducing an immune response and for treating SARS-COV-2. The ‘180 publication teaches that modifications to the SARS-COV-2 spike protein can be made, including those that show efficacy in related coronaviruses like MERS-CoV S antigen (See paragraph 122 and 175, in particular).
Buonocore teaches that viral proteins can be modified with VSV G transmembrane and cytoplasmic domain by replacing the transmembrane and cytoplasmic domain of a viral protein (that contains ER retention signals) with the transmembrane and cytoplasmic domains of VSV G, to allow for cell surface expression (see page 6865, in particular).
Ozharovskaia teaches modification of a full length MERS-COV S protein, wherein the COOH ER localization signal in the S protein is deleted and replaced with transmembrane domains of VSV G glycoprotein (see pages 37-38, in particular). Ozharovskaia teaches that doing so allows for the S protein to be expressed as a transmembrane form localized to the plasma membrane of the cell (see page 39, in particular). Ozharovskaia teaches that the recombinant virus carrying said modified S protein induces a strong antibody and T cell response as well as production of neutralizing antibodies (See page 45, in particular).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use a spike protein of SARS-CoV-2, as taught by the ‘180 publication, as the foreign antigen in recombinant VSV of the ‘022 publication. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because the ‘180 teaches that there is an urgent need for immunogenic compositions that can be used to induce an immune response against SARS-CoV2 coronavirus. The ordinary artisan would be motivated to further modify the spike protein, by replacing the transmembrane and cytoplasmic domain with those of VSV G, as taught by Buonocore and Ozharovskaia, since the references teach that doing so removes ER retention signals and allows for surface expression which induces a strong antibody and T cell response. Furthermore, the ordinary artisan would have a reasonable expectation of success in doing so, since the ‘180 publication teaches that SARS-CoV-2 S protein can be modified using those modifications that show efficacy in related coronavirus S proteins from MERS-CoV.
Claim 1, 10-11, 14, 19-20, 27, 35, 38, 40-41, 44-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/010860 (of record), in view of US 2016/0144022, Ozharovskaia, 2019, Buonocore, 2002, and US 20210260180 (of record).
WO 2022/010860 teaches a rVSV carrying a gene that encodes for a full length wild-type spike protein of SARS-CoV-2, and an immunogenic or vaccine composition comprising said rVSV for inducing an immune response to SARS-CoV-2, see entire document, page 4, in particular. WO 2022/010860 teaches multiple separate volumes of said immunogenic composition for repeated administration, i.e. a prime boost combination, see pages 53-54, in particular).
The references differ from the claimed invention in that it does not explicitly teach rVSVInd or rVSVNJ having a G gene or a mutant matrix protein, or a modified SARS-CoV-2 S protein wither melittin signal peptide and with replacement of the transmembrane and cytoplasmic tail with VSV G protein transmembrane domain and cytoplasmic tail.
The ‘022 publication teaches an avirulent rVSV that is capable of inducing immune responses against an antigen of interest, which can replicate to a high titer and has less chance of reverting back to a wild type phenotype (See pages 1-4 and Fig. 2, in particular). The ‘022 publication teaches a recombinant attenuated VSV expresses a VSV G gene and variant M protein that can be used as a VSV based prime-boost vaccine to induce long-lasting immune response against foreign antigens expressed by the VSV carrying foreign genes (see pages 1-4, in particular). The ‘022 publication teaches a M mutant of VSV Indiana serotype (VSVind)-GML, i.e. ) that have an M protein mutation making them avirulent and safer (see page 8, in particular). The ‘022 publication teaches the G21E/L111F/M51R substitutions in an M (i.e. VSVInd, , i.e. SEQ I DNO: 4 see page 8, in particular). The ‘022 publication teaches that the prime boost vaccine combination can be two the same or different VSV serotypes with mutated M, expressing the same foreign gene, and that doing so induces stronger immune responses, and also teaches boosting with VSVNJ having G22E/M48R/M51R, i.e. VSVMHGMM, SEQ ID NO: 10, See entire document). The ‘022 publication teaches that the antigen of interest can be expressed by replacing the native signal peptide with melittin signal peptide (See paragraph 203, in particular).
The ‘180 publication teaches that modifications to the SARS-COV-2 spike protein can be made, including those that show efficacy in related coronaviruses like MERS-CoV S antigen (See paragraph 122 and 175, in particular).
Buonocore teaches that viral proteins can be modified with VSV G transmembrane and cytoplasmic domain by replacing the transmembrane and cytoplasmic domain of a viral protein (that contains ER retention signals) with the transmembrane and cytoplasmic domains of VSV G, to allow for cell surface expression (see page 6865, in particular).
Ozharovskaia teaches modification of a full length MERS-COV S protein, wherein the COOH ER localization signal in the S protein is deleted and replaced with transmembrane domains of VSV G glycoprotein (see pages 37-38, in particular). Ozharovskaia teaches that doing so allows for the S protein to be expressed as a transmembrane form localized to the plasma membrane of the cell (see page 39, in particular). Ozharovskaia teaches that the recombinant virus carrying said modified S protein induces a strong antibody and T cell response as well as production of neutralizing antibodies (See page 45, in particular).
Therefore, the ordinary artisan would be motivated to use the VSVInd and or rVSVNJ serotype having a G gene and with mutated M protein of the ‘043 publication as the type of rVSV in WO 2022/010860, since the ‘043 publication teaches that it induces long-lasting immune responses against expressed foreign genes, and is avirulent and safer. Additionally, the ordinary artisan would be motivated to provide a prime-boost combination using said VSVInd with mutated M protein, or with a different serotype VSV with mutant M, since the ‘043 publication teaches that such prime -boost combinations can induce stronger immune responses.
Furthermore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to replace the signal peptide with melittin signal peptide as taught by the ‘022 publication, since the reference teaches that doing so dramatically increased the rates of expression and enhanced inducing of T and B cell immune responses. The ordinary artisan would also be motivated to further modify the spike protein, by replacing the transmembrane and cytoplasmic domain with those of VSV G, as taught by Buonocore and Ozharovskaia, since the references teach that doing so removes ER retention signals and allows for surface expression which induces a strong antibody and T cell response. Furthermore, the ordinary artisan would have a reasonable expectation of success in doing so, since the ‘180 publication teaches that SARS-CoV-2 S protein can be modified using those modifications that show efficacy in related coronavirus S proteins from MERS-CoV.
Applicant argues that WO 2022/010860 was published on January 13, 2022, which is after the effective filing date of the claimed invention, and is thus not prior art. WO 2022/010860 has a filing date of 7/6/21, and claims priority to provisional application 63/048,918 filed on 7/7/20. Thus, WO 2022/010860 qualifies as prior art under 102 (a)(2), since it was described in an application for patent effectively filed before the effective filing date of the claimed invention. See MPEP 2152.02, WIPO published applications qualify as prior art under 102(a)(2) as of their effective filing date.
Claim 1, 10-11, 14, 19-20, 27, 35, 38, 40-41, 44-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2021/207848 (of record), in view of 2016/0144022, Buonocore, 2002, and US 20210260180..
WO2021/207848 teaches a replication competent rVSV comprising a G gene and a full length spike protein of MERS-CoV for use in inducing an immune response in a mammal (see page 2 and the drawings). WO2021/207848 teaches that the full length spike protein have been modified to have a honeybee melittin signal peptide at the NH2 terminus and a VSV G protein transmembrane domain and cytoplasmic tail at the COOH terminus (see page 11, in particular). WO2021/207848 teaches a vaccine composition comprising said VSV for induing an immune response to MERS-CoV (see page 11, in particular). WO2021/207848 teaches VSVInd or VSVNJ, and said VSV having a mutant M gene including a GMM and GML mutations and having the same sequences of the instant claims (See page 3 in particular). WO2021/207848 also teaches a prime boost composition or immunization regimen comprising said rVSV, where the prime vaccine and booster vaccine are the same or different rVSV serotypes (See page 4-6, in particular).
The reference differs from the claimed invention in that it does not explicitly teach the full length spike protein of SARS-CoV-2, or that said modification with said signal peptide and G protein transmembrane domain is a replacement.
Buonocore explains that modification with VSV G transmembrane and cytoplasmic domain is performed by replacing the transmembrane and cytoplasmic domain of a viral protein (that contains ER retention signals) of with the transmembrane and cytoplasmic domains of VSV G, to allow for cell surface expression (see page 6865, in particular).
The ‘022 publication teaches that the antigen of interest in recombinant attenuated VSV carrying foreign genes can be expressed by replacing the native signal peptide with melittin signal peptide, which dramatically increases the rates of expression and enhances induction of T and B cell immune responses (See paragraph 203, in particular).
The ‘180 publication teaches that there is an urgent need for immunogenic compositions that can be used to induce an immune response against SARS-CoV2 coronavirus (see paragraph 8, in particular). The ‘180 publication teaches using one or more SARS-CoV-2 antigens expressed in a viral vector for inducing immune responses to treat or prevent COVID-19, and teaches a full length spike protein of SARS-CoV-2 (see paragraph 9-10 and 122, in particular). The ‘180 publication teaches spike protein from the Wuhan isolate, i.e. wildtype, see paragraph 122, in particular. The ‘180 publication teaches using the viral vectors for inducing an immune response and for treating SARS-COV-2. The ‘180 publication teaches that modifications to the SARS-COV-2 spike protein can be made, including those that show efficacy in related coronaviruses like MERS-CoV S antigen (See paragraph 122 and 175, in particular).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to substitute the full length spike protein of SARS-CoV-2, as taught by the ‘180 publication, for the full length MERS spike protein in the recombinant VSV of WO2021/207848. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because they are homologous and equivalent spike proteins from related coronaviruses and the ‘180 teaches that there is an urgent need for immunogenic compositions that can be used to induce an immune response against SARS-CoV2 coronavirus.
Furthermore, it would be obvious that the full length spike protein in WO2021/207848 should be modified with the melittin signal peptide and G protein transmembrane and cytoplasmic domain by replacement of the native signal peptide and transmembrane and cytoplasmic domains, as taught by the ‘022 publication and Buonocore. The ordinary artisan would be motivated to modify by replacement since the ‘022 publication and Buonocore teaches that doing so enhances expression or surface expression and increases immune responses.
Applicant’s arguments and declaration under 1.130 have been fully considered, but they are not persuasive.
Applicant argues that WO2021/207848 is not prior art under 35 U.S.C. 102(a)(1) because an exception under 102(b)(1) and (2) applies based on the 1.130 declaration.
WO2021/207848 qualifies as prior art under 35 U.S.C. 102(a)(2) as of its filing date (for claims 19 and 44 it also qualifies under 102(a)(1)). The 102(b)1) exception can be invoked if the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; and 102(b)(2) exception can be invoked if (A) the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor.
The declaration sates that Inventor Saeedian, named on the instant application, did not contribute to the conception of the invention of WO2021/207848. However, this does not establish that the subject matter disclosed in WO2021/207848 was obtained from Inventors Chil-Yong Kang, Gyoung Nyoun Kim and Kunyu Wu of the instant application. WO2021/207848 names Sangkyun Lee as an inventor, which is not a named Inventor of the instant application. The declaration does not provide any explanation as to the presence of additional inventor Sangkyun Lee on the cited prior art, and therefore the declaration is not effective to demonstrate that the prior art represents an inventor originated disclosure.
Applicant also argues that the present application and WO2021/207848 are owned by the same person. However, to invoke the common ownership exception (which only applies to 102(a)(2)), Applicant must submit a statement that the subject matter disclosed and the claimed invention, were not later than the effective filing date of the claimed invention, owned by or subject to an obligation of assignment, to the same person. It is also noted that the statement concerning common ownership should be clear and conspicuous (e.g., on a separate piece of paper or in a separately labeled section).
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 1, 10-11, 14, 19-20, 27, 35, 38, 40-41, 44-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-17, 20, 22-26, 31-32, 36, 40-41, and 46 of copending Application No. 17/918,244, in view of US 20210260180, Buonocore, 2002, US 2021/0338804.
The ‘244 application claims a recombinant VSV carrying a VSV G gene and a gene that encodes for a full length spike protein of MERS-CoV (SF), wherein the signal peptide of the SF is replaced with melittin signal peptide and the transmembrane domain of the SF is replaced with VSV G protein transmembrane and cytoplasmic tail. The ‘244 application claims that the rVSV is rVSVInd serotype have a GML mutation in the matrix protein or rVSVNJ serotype with GMM, which would have the same sequences as the mutant M proteins of the instant claims. The ‘244 application claims a vaccine or immunological composition comprising said rVSV, and a prime boost combination comprising a prime vaccine and a booster vaccine comprising said rVSV, wherein the rVSV is replication competent. The ‘244 application claims a prime boost using the same or different rVSV serotype.
Although the ‘244 application does not claim using the spike protein of SARS-CoV-2, it would be obvious to do so based on the teachings of the ‘804 publication for the same reasons set forth above. Additionally, replacement of the transmembrane and cytoplasmic domains with said G protein transmembrane domains would be obvious based on the teachings of the ‘804 publication and Buonocore for the same reasons set forth above.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 10-11, 14, 19-20, 27, 35, 38, 40-41, 44-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-42 of U.S. Patent No. 9,943,593, or claims 1-14 of 9,630,996, or claims 1-16 of 9,731,006, or claims 1-19 of 9,737,597, or claims 1-12 of 9,248,178, in view of US 2016/0144022, Ozharovskaia, 2019, Buonocore, 2002, and US 2021/0338804 and US 20210260180.
The patents all claim a vaccine comprising a rVSV including a modified matrix protein, wherein the serotype is VSVInd, and wherein the VSV encodes a foreign antigen. The patents also claim that the rVSV encodes a G gene, or alternatively, VSVInd serotype inherently comprises a G gene (or it would be obvious to include the G gene based on the ‘022 publication).
Although the patents do not specifically claim that the foreign antigen is a full length spike protein of SARS-CoV-2, it would be obvious to use the full length spike protein thereof as the foreign antigen, including with the claimed modifications, with a reasonable expectation of success, based on the teachings of the ‘022 publication, Ozharovskaia, Buonocore, and the ‘804 publication and the ‘180 publication for the reasons set forth above.
The patents claim the GML and GMM mutations and rVSVind and rVSVnj in said matrix protein, or alternatively said mutations are obvious over the teachings of the ‘022 publication for the reasons set forth above. The patents claims a prime boost composition employing different VSV serotypes. Additionally, it would be obvious to use the same or different VSV serotype based on the ‘022 publication.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644