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 .
Specification
Applicant should update the first paragraph of the specification to provide the complete continuing information.
The disclosure is objected to because of the following informalities: Figures 18-21 contain nucleotide and/or amino acid sequences without the appropriate sequence identifier (e.g., SEQ ID NO: X). 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.
Claims 11, 19, 21 and 99 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.
Claim 11 recites “(3) in four doses, wherein at least one of the doses is a booster dose (4) four doses, wherein at least one of the doses is a booster dose”. This phrase does not make sense. Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claim.
Claim 19 recites the limitation “additional booster doses" in line 2. There is insufficient antecedent basis for this limitation in the claim. Additionally, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 21 recites the limitation “additional booster doses" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 99 recites the limitation “additional booster doses" in line 2. There is insufficient antecedent basis for this limitation in the claim. Additionally, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim(s) 1, 5, 7, 9, 11, 15, 16, 19, 21, and 100 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chiuppesi et al. (bioRxiv preprint doi: https://doi.org/10.1101/2020.07.01.183236; this version posted July 2, 2020).
The instant claims are directed to a method of vaccinating or protecting a subject against coronavirus disease 2019 (COVID-19) or preventing or reducing the severity of COVID-19 caused by a coronavirus infection or boosting an immune response to coronavirus infection in a subject, comprising administering a composition comprising a synthetic modified vaccinia Ankara (sMVA) vector or virus capable of expressing one or more DNA sequences encoding a spike (S) protein and a nucleocapsid (N) protein or variants or mutants thereof, wherein the method (i) prevents the coronavirus infection or (ii) prevents or reduces the severity of COVID-19 caused by the coronavirus infection.
Chiuppesi et al. teaches synthetic MVA (sMVA) vectors co-expressing SARS-CoV-2 spike and nucleocapsid antigens, two immunodominant antigens implicated in protective immunity. Mice immunized with the sMVA vectors developed robust SARS-CoV-2 antigen-specific humoral and cellular immune responses, including potent neutralizing antibodies (see the Abstract, Introduction, and Figures 4B and 5). Chiuppesi et al. further teaches that the sMVA vectors can be used to treat COVID-19 or induce robust humoral and cellular immune responses to S and N antigens.
For claim 7, because Chiuppesi et al. teaches the claimed method step of administering to a subject a composition comprising a synthetic modified vaccinia Ankara (sMVA) vector or virus capable of expressing one or more DNA sequences encoding a spike (S) protein and a nucleocapsid (N) protein, the method of Chiuppesi et al. will prevent or reduce the severity of COVID-19 caused by the Wuhan-Hu-1 strain or a variant of concern recited in claim 7.
For claims 9, 11, 15, 16 and 19, Chiuppesi et al. teaches 6 weeks old C57BL/6 (C57BL/6J, 000664) or Balb/c (BALB/cJ, 000651) mice were immunized twice in three week intervals by intraperitoneal route with 5x107 PFU (high dose) or 1x107 PFU (low dose) of sMVA, wtMVA, or sMVA-CoV2 vectors. The two doses (two vaccinations), which can be a priming dose and a booster dose, are separated by 3 weeks.
For claims 21 and 100, Chiuppesi et al. teaches that mice were immunized twice with 5x107 PFU (high dose) or 1x107 PFU (low dose) of the sMVA vectors.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 8, 10, 17, 18 and 99 are rejected under 35 U.S.C. 103 as being unpatentable over Chiuppesi et al. (bioRxiv preprint doi: https://doi.org/10.1101/2020.07.01.183236; this version posted July 2, 2020) as applied to claims 1, 5, 7, 9, 11, 15, 16, 19, 21, and 100 above.
The instant claims are directed to the method of claim 1, where the composition is administered by intramuscular injection, intranasal instillation, intradermal injection or scarification (claim 8), where the composition is administer to the subject as a single dose (claim 10), where the composition is administered in a prime dose, a first booster dose, and two or more additional booster doses (claim 17), where the interval between each booster dose ranges from 8 weeks to more than 1 year (claim 18), or where the prime or booster doses range from 1 X 107 to 5 X 108 (claim 99).
The teachings of Chiuppesi et al. are outline above and incorporated herein. Chiuppesi et al. does not teach the limitations of claims 8, 10, 17, 18 and 99. However, according to section 2144.05 of the MPEP, “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”)
In the instant application, the conditions [administration route, number of doses, dosing protocol and amount of PFUs] used by Chiuppesi et al. were sufficient to induce robust SARS-CoV-2 antigen-specific humoral and cellular immune responses. Therefore, determining other optimum or workable routes of administration, number of dosages, dosing protocols and amount of PFUs is routine experimentation. Further, applicant has not demonstrated unexpected or superior results using the recited administration routes (claim 8), a single dose (claim 10), different dosing protocols (claims 17 and 18), or using different amounts of PFUs (claim 99).
Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention
Claim(s) 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Chiuppesi et al. (bioRxiv preprint doi: https://doi.org/10.1101/2020.07.01.183236; this version posted July 2, 2020) as applied to claims 1, 5, 7, 9, 11, 15, 16, 19, 21, and 100 above, and further in view of Jackson et al. (N Engl J Med, 2020, 383:1920-1931).
The instant claims are directed to the method of claim 1 where the subject has previously received a different SARS-CoV-2 vaccine.
The teachings of Chiuppesi et al. are outline above and incorporated herein. Chiuppesi et al. further teaches that:
Many vaccine candidates are currently under rapid development to control this global pandemic, some of which have entered into clinical trials with unprecedented pace. Most of these approaches employ antigenic forms of the Spike (S) protein as it is considered the primary target of protective immunity. The S protein mediates SARS-CoV-2 entry into a host cell through binding to angiotensin-converting enzyme 2 (ACE) and is the major target of neutralizing antibodies (NAb). Studies in rhesus macaques show that vaccine strategies based on the S antigen can prevent SARS-CoV-2 infection and disease in this relevant animal model, indicating that the S antigen may be sufficient as a vaccine immunogen to elicit SARS-CoV-2 protective immunity. However, a recent study demonstrated that even patients without measurable NAb can recover from SARS-CoV-2 infection, suggesting that protection against SARS-CoV-2 infection is mediated by both humoral and cellular immunity to multiple immunodominant antigens, including S and nucleocapsid (N) antigens.
(emphasis added)
The sMVA vectors of Chiuppesi et al. induced robust SARS-CoV-2 antigen-specific humoral and cellular immune responses.
Jackson et al. teaches that Moderna’s mRNA vaccine against SARS-CoV-2 induced neutralizing antibodies against the spike protein. However, CD8 T-cell responses to the spike protein were detected at low levels after the second vaccination in the 100 µg dose group (see page 1925, left column).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the composition of Chiuppesi et al. to subjects that has been previously vaccinated with a different vaccine, such as the Mocerna mRNA spike vaccine to induced robust SARS-CoV-2 antigen-specific humoral and cellular immune responses. One would have been motivated to do so and there would have been a reasonable expectation of success given the teaching of Jackson et al. [CD8 T-cell responses to Moderna’s spike mRNA vaccine were detected at low levels] and given the teachings of Chiuppesi et al. [protection against SARS-CoV-2 infection is mediated by both humoral and cellular immunity to multiple immunodominant antigens, including S and nucleocapsid (N) antigens].
Regarding claim 26, because Chiuppesi et al. teaches the claimed method step of administering to a subject a composition comprising a synthetic modified vaccinia Ankara (sMVA) vector or virus capable of expressing one or more DNA sequences encoding a spike (S) protein and a nucleocapsid (N) protein, the method of Chiuppesi et al. will elicit a Th1-biased immune response in the subject.
Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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 1, 5, 7-10 and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-9, 11, and 16-20 of copending Application No. 17/932239 (reference application).
The instant claims are directed to a method of vaccinating or protecting a subject against coronavirus disease 2019 (COVID-19) or preventing or reducing the severity of COVID-19 caused by a coronavirus infection or boosting an immune response to coronavirus infection in a subject, comprising administering a composition comprising a synthetic modified vaccinia Ankara (sMVA) vector or virus capable of expressing one or more DNA sequences encoding a spike (S) protein and a nucleocapsid (N) protein or variants or mutants thereof, wherein the method (i) prevents the coronavirus infection or (ii) prevents or reduces the severity of COVID-19 caused by the coronavirus infection.
The copending claims are directed to a method of preventing a coronavirus infection in a subject comprising administering the vaccine composition of claim 1. The composition of claim 1 comprises a rsMVA expressing the N and S proteins from SARS-CoV-2.
Instant claim 7 is taught by copending claim 11.
Instant claim 8 is taught by copending claims 16 and 17.
Instant claims 9 and 10 are taught by copending claim 18.
Instant claim 26 is taught by copending claim 9.
Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5, and 7-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-18 of copending Application No. 18/711073 (reference application).
The instant claims are directed to a method of vaccinating or protecting a subject against coronavirus disease 2019 (COVID-19) or preventing or reducing the severity of COVID-19 caused by a coronavirus infection or boosting an immune response to coronavirus infection in a subject, comprising administering a composition comprising a synthetic modified vaccinia Ankara (sMVA) vector or virus capable of expressing one or more DNA sequences encoding a spike (S) protein and a nucleocapsid (N) protein or variants or mutants thereof, wherein the method (i) prevents the coronavirus infection or (ii) prevents or reduces the severity of COVID-19 caused by the coronavirus infection.
The copending claims are directed to a method of preventing or treating a SARS-CoV-2 infection in a subject comprising administering a composition comprising a sMVA expressing the N and S proteins from SARS-CoV-2.
Instant claim 7 is taught by copending claims 13 and 14.
Instant claim 8 is taught by copending claim 15.
Instant claims 9 and 10 are taught by copending claims 16-18.
Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 and 19 of copending Application No. 19/555730 (reference application).
The instant claims are directed to a method of vaccinating or protecting a subject against coronavirus disease 2019 (COVID-19) or preventing or reducing the severity of COVID-19 caused by a coronavirus infection or boosting an immune response to coronavirus infection in a subject, comprising administering a composition comprising a synthetic modified vaccinia Ankara (sMVA) vector or virus capable of expressing one or more DNA sequences encoding a spike (S) protein and a nucleocapsid (N) protein or variants or mutants thereof, wherein the method (i) prevents the coronavirus infection or (ii) prevents or reduces the severity of COVID-19 caused by the coronavirus infection.
The copending claims are directed to a method of inducing an immune response to SARS-CoV-2 by administering a vaccine composition comprising a sMVA expressing the N and S proteins from SARS-CoV-2.
Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9 and 17 of U.S. Patent No. 12584146 (reference application).
The instant claims are directed to a method of vaccinating or protecting a subject against coronavirus disease 2019 (COVID-19) or preventing or reducing the severity of COVID-19 caused by a coronavirus infection or boosting an immune response to coronavirus infection in a subject, comprising administering a composition comprising a synthetic modified vaccinia Ankara (sMVA) vector or virus capable of expressing one or more DNA sequences encoding a spike (S) protein and a nucleocapsid (N) protein or variants or mutants thereof, wherein the method (i) prevents the coronavirus infection or (ii) prevents or reduces the severity of COVID-19 caused by the coronavirus infection.
The patented claims are directed to a method of inducing an immune response to SARS-CoV-2 by administering a vaccine composition comprising a sMVA expressing the N and S proteins from SARS-CoV-2.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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