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 .
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on May 16, 2024. Claims 1 and 17-34 are pending and are currently examined.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites abbreviation MVA without spelling it out the first time it appears in the claim set.
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 1 and 17-34 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.
The base claim 1 recites a term “reducing” that renders the claims indefinite. It is not clear how the method of vaccinating “reducing” the severity of COVID-19 and where it is the results. The specification also does not provide descriptions on how the “reducing” effects are approached.
The recitation “reducing’ is a relative term having no definite meaning and it is unclear how “reducing” is determined or what degree of reduction is necessary. Applicant has not defined the degree of reduction (e.g., 2-fold, 5-fold, etc.).
The specification does not define “reducing” such that one of ordinary skill in the art would know if virus production is reduced. Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claim.
The base claim also recites a term “variants or mutants” that renders the claims indefinite. It is unclear how much difference or mutation in the claimed spike (S) protein and a nucleocapsid (N) protein can be considered as ““variants or mutants”.
Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claim.
Regarding claims 24 and 25, 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 § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 17-34 are rejected under 35 U.S.C. 103 as being unpatentable over Prow et al. (US 2021/0299245 A1, published on Sep. 30, 2021, submitted in IDS filed on 08/09/2024, hereinafter, “Prow”) in view of Tamari et al. (Blood Cancer Discov. 2021 Sep 13;2(6):577-585, submitted in IDS filed on 08/09/2024, hereinafter, “Tamari”).
The base claim 1 is directed to method of vaccinating or protecting a subject against coronavirus disease 2019 (COVID-19); preventing a coronavirus infection; preventing, treating, or reducing the severity of COVID-19; or treating COVID-19 caused by a coronavirus infection, comprising administering to the subject a composition comprising a synthetic MVA (sMVA) vector comprising or 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 subject is a blood cancer patient that (1) has been treated for a hematological malignancy with a cellular therapy or (2) has had or is likely to have a poor immune response to a different COVID-19 vaccination.
Prow teaches a method of inducing a protective immune response in a subject against SARS-CoV-2 virus infection by administering to the subject the composition (See [0047] to [0049]), here the composition comprises an attenuated poxvirus for expressing heterologous coronavirus antigens which can be used as a vaccine for inducing an immune response and/or a neutralizing antibody response against coronavirus infection (See [0247]). Prow further teaches that in an embodiment disclosed herein, the attenuated poxvirus is an attenuated vaccinia virus. Illustrative examples of vaccinia virus strains include MVA (See [0251) as claimed, and the antigenic sequences for the vaccines of the instant invention comprise the spike protein, membrane, nucleocapsid, and envelope proteins of SARS-CoV-2 (See [0020]).
Accordingly, Prow teaches a method of vaccinating or protecting a subject against Sars-COV-2 by administering a composition comprising a MVA vector that expresses one or more DNA sequences encoding a spike (S) protein and a nucleocapsid (N) protein of SARS-COV-2. However, it is silent on the subject is a blood cancer patient as claimed.
Tamari studies the humoral response to SARS-CoV-2 Vaccination after hematopoietic Cell Transplantation and CAR T-cell Therapy, and teaches that cellular therapies including allogeneic hematopoietic cell transplant (allo-HCT) and autologous hematopoietic cell transplant (auto-HCT) and chimeric antigen receptor (CAR) T-cell therapy render patients severely immunocompromised for extended periods after therapy, and vaccination against COVID-19 is an important component of post–cellular therapy care, and predictors of quantitative and qualitative response are critical in informing clinical decisions about optimal timing of vaccines and the requirement for booster doses (See Abstract).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings from Prow and Tamari to arrive at an invention as claimed. One of skill in the art would have been motivated to do so because Prow teaches a MVA vector comprising a heterologous sequence comprising SARS-CoV-2 spike and nucleocapsid proteins, and Tamari discloses SARS-CoV-2 vaccination of blood cancer patients who have received a cellular therapy. Thus, this would simply allow the vaccination of a particular group of patients in need thereof, affording any improved or altered immune system response and associated improvement in patient clinical outcome, thereby increasing the applicability and therefore value of the method of Prow. There would be a reasonable expectation of success to develop such a method of vaccination for treatment of blood cancer patients treated for a hematological malignancy with a cellular therapy as claimed.
The description above also teaches claim 17 at the cellular therapy is selected from the group consisting of an autologous hematopoietic cell transplant
Thus, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 18, Prow and Tamari, in combination, make obvious the method of claim 1. Tamari discloses that the patients were vaccinated as early as 2 months after cellular treatment (day 63), with a median time between treatment and the first dose of the vaccine of 1,007 days [interquartile range (IQR), 488–1,761; 2.75 years] (See Page 578, left column, paragraph 4).
Regarding claim 19, Prow teaches that the genetic sequence of human coronavirus SARS-CoV-2 strains/isolates is made available via the Global Initiative on Sharing All Influenza Data (GISAID) and includes genomic sequence data from various strain isolates of SARS-CoV-2 including, for example, Wuhan/ IVDC-HB-01/2019 (GISAID accession ID: EPI_ISL_ 402119-121) (See [0246]), and three specific viral lineages reflecting variants of concern (VOC) have emerged: 0.11.7, 8.1.351, and 8.1.1.28.1 (See [0243]), and also used the variants of concern refer to the B.1.1.17, B.1.351, and B.1.1.28.1 (See [0244]).
Regarding claim 20, Prow teaches an administration via intramuscular injection in young mice and aging mice (See [0390]).
Regarding claim 21, Prow teaches FIG. 12: Pre-existing immunity does not affect the quantity and quality of spike-specific antibody responses following administration of a single-dose of SCV-COVID 19C vaccine (See [0144]).
Regarding 22, Prow teaches that a levels of S1-specific antibodies for mice with and without pre-existing immunity on days 28 (pre-boost) and days 14 and 50 post-booster dose in SCV-COVID19C homologous prime-boost vaccination (See [0148]).
Regarding claim 23, Prow teaches that levels of S1-specific antibodies for mice with and without pre-existing immunity on days 28 (pre-boost) and days 14 and 50 post-booster dose in SCV-COVID19C homologous prime-boost vaccination (See [0148]), where 50 days interval is about 7 weeks as claimed.
Regarding claim 24, Prow teaches that naive mouse/no vaccine, (2) mice vaccinated with vector-only control SMX06, and (3) mice vaccinated with a single dose of SCV-COVID19C (10^7 PFU) (See e.g., [0362]).
Regarding claims 25 and 26, Prow teaches that twenty-eight (28) days after receiving a first shot (prime dose) of the SCV-COVID19C (10^7 PFU) vaccine, a boost of SCV-COVID19C (10^7 PFU) was administered via intramuscular injection in young mice and aging mice (See [0390]), where teaches boost dose as claimed in claim 25, and the booster dose is administered in a dosage the same as the prime dose as claimed in claim 26.
Regarding claim 27, Prow teaches that a vaccination dose for Swiss mice can be 10^8 PFU dose for increasing the neutralizing antibody (See [0338]), and a boost dose can be 10^7 PFU (See [0390]). One of skill in the art can use this 10^8 PFU as a prime dose and 10^7 PFU as a boost dose that teaches the claim 27 at “the booster dose is administered in a dosage lower than the prime dose”.
Regarding claim 28, Prow and Tamari, in combination, make obvious the method of claim 28. Tamari teaches that patients were vaccinated as early as 2 months after cellular treatment (day 63), with a median time between treatment and the first dose of the vaccine of 1,007 days [interquartile range (IQR), 488–1,761; 2.75 years] (See page 578, left column, paragraph 4). Here it indicates that the patent suffers from or previously suffered from a hematologic malignancy.
Regarding claim 29, Prow in view of Tamari teaches the patient characteristics in the Table 1 that teaches the different types of hematological malignancy including the MDS as claimed (See Table 1, page 578 and below).
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Regarding claim 30, Prow teaches that it will be understood that inducing an immune response as contemplated herein includes eliciting or stimulating an immune response and/or enhancing a previously existing immune response (See [0204]), here it is reasonable to consider that the existing immune response can include the natural infection and/or vaccination induced immune responses.
Regarding claims 31 and 32, Prow makes obvious the method of claim 30, and discloses enhancing a previously existing immune response (para [0204]), but Prow does not specifically disclose if previously received COVID-19 vaccine is an mRNA-, adenovirus-, or protein-based vaccine.
Tamari teaches there are currently two mRNA vaccines against SARS-CoV-2: the BNT162b2 (Pfizer–BioNTech; ref. 8), which is FDA approved, and mRNA-1273 (Moderna; ref. 9), which is approved under an Emergency Use Authorization protocol, both administered as two-dose series separated by 21 days (Pfizer–BioNTech) or 28 days (Moderna). Both mRNA vaccines are highly effective in healthy individuals, with >90% prevention of severe disease and mortality (See page 578, left column, paragraph 2), and achieve high response rates to anti–SARS-CoV-2 mRNA vaccines among patients post–cellular therapy while highlighting the variability in degree of response based on immune reconstitution at that time (See page 584, left column, paragraph 4).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings from Prow and Tamari to arrive at an invention as claimed. One of skill in the art would have been motivated to do so because the mRNA COVID-19 vaccine can induce both high immune responses to both healthy individuals and a patient with a cellular therapy. There would be a reasonable expectation of success to develop such a method of using the mRNA-based vaccine as the first or previous vaccine. Here the description teaches claim 31.
Because Tamari teaches the mRNA vaccine can be Pfizer–BioNTech (See page 578, left column, paragraph 2). It would be obvious for one of ordinary skill in the art to select Pfizer-BioNTech COVID-19 vaccine and the result would be predictable for treating and preventing SARS_COV-2 infection. Here it teaches claim 32.
Regarding claim 33, Prow teaches that the composition comprises an attenuated poxvirus, and especially a vaccinia virus, wherein the attenuated poxvirus genome comprises a coronavirus SARS-CoV-2 nucleic acid sequence encoding the spike protein polypeptide.
Regarding claim 34, Prow teaches a subject that received a SCV-COVID19C vaccine and 3 months post-boost following SCV-COVID19C homologous prime-boost vaccination (See [0158]).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUIXUE WANG whose telephone number is (571)272-7960. The examiner can normally be reached Monday-Friday 8:00 am to 4:30 pm, EST.
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/RUIXUE WANG/Examiner, Art Unit 1672
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