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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed on 12 June 2024. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 1-6 are pending, all of which have been considered on the merits.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 1 is objected to because of the following informalities:
“Vaccine preparation” should read “The vaccine preparation” and
“comprises in addition to the vaccine at least” should read “comprises, in addition to the vaccine, at least”.
Claims 2-6 are objected to because of the following informalities:
“Preparation according to claim” should read “The vaccine preparation according to claim”.
Claim 2 is objected to because of the following informalities:
“mRNA-vaccine” should read “mRNA vaccine”.
Claims 2-3 are objected to because of the following informalities:
“a mRNA” should read “an mRNA”.
Claim 4 is objected to because of the following informalities:
“the vasoconstrictive agent is at least one selected from” should read “the at least one vasoconstrictive agent is selected from”,
“adrenaline/epinephrine,norepinephrine” should read “adrenaline/epinephrine, norepinephrine”, and
“levonordephrine and alpha-noradrenaline/norepinephrine” should read “levonordephrine, and alpha-noradrenaline/norepinephrine.
Claim 6 is objected to because of the following informalities:
“contains in addition to the vaccine from” should read “contains, in addition to, from”,
“0,005 to 0,1” should read “0.005 to 0.1”, and
“0,01 to 0,05” should read “0.01 to 0.05”.
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 4 and 6 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.
Regarding claim 4, the Markush group of vasoconstrictive agents is indefinite because it requires material selected from an open list of alternatives, “comprising”, rather than a closed group of alternatives, “consisting”. It is unclear as to what other alternatives are encompassed by the claim.
Regarding claim 6, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention or merely a preference. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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.
Claims 1 and 4-5 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Dhabhar (US 20030147899 A1, US-IDS, filed 09/12/2024).
Regarding claims 1 and 4, Dhabhar discloses a vaccine with epinephrine as an adjuvant, along with a carrier or diluent (Abstract).
Regarding claim 5, Dhabhar discloses that vaccine, comprising epinephrine, is formulated to be administered intramuscularly (¶0067).
Accordingly, the claimed invention was anticipated by Dhabhar.
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.
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.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Dhabhar as applied to claims 1 and 4-5 above and further in view of Baden, et al. (N Engl J Med. 2021 Feb 4;384(5):403-416., NPL-IDS, filed, 09/12/2024, hereinafter Baden).
As discussed above, claims 1 and 4-5 were anticipated by Dhabhar.
Regarding claims 2-3, Dhabhar teaches that epinephrine is used in a composition comprising a vaccine and the adjuvant (Claim 5). Dhabhar does not explicitly teach that the vaccine is an mRNA vaccine against COVID-19. However, Baden teaches the SARS-CoV-2 vaccine mRNA-1272 which is a lipid nanoparticle-encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of SARS-CoV-2, the virus that causes COVID-19 (abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the vaccine taught by Dhabhar for the SARS-CoV-2 mRNA vaccine taught by Baden. Dhabhar teaches that many different vaccines can be used with the epinephrine adjuvant (claim 5). One of skill in the art would have substituted the vaccine taught by Dhabhar with the SARS-CoV-2 mRNA vaccine taught by Baden to create a vaccine composition with the SARS-CoV-2 mRNA vaccine and the epinephrine adjuvant. One of skill in the art would have had a reasonable expectation of success of substituting the vaccines because they are both vaccines.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Dhabhar.
As discussed above, claims 1 and 4-5 were anticipated by Dhabhar.
Regarding claim 6, Dhabhar teaches that the epinephrine adjuvant is administered in doses of 2-5 micrograms/kilogram in humans (¶0065). Dhabhar does not explicitly teach that the epinephrine be administered in doses from 0.005 to 0.1 mg.
However, routine optimization of Dhabhar’s dosage (µg/kg) of epinephrine would have led to the claimed range of 0.005 to 0.1 mg because the total amount of epinephrine administered is based on the subject’s weight, the dosage of 2-5 µg/kg taught by Dhabhar (¶0065) would translate to 0.005 to 0.1 mg for subjects 1-50kg in weight. The person of ordinary skill in the art would have found it obvious to optimize the dosage taught by Dhabhar and determining the final dose by using the subject’s weight in order to calculate the appropriate final dose of epinephrine.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary
Conclusion
NO CLAIMS ARE ALLOWED
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cassandra Senn Grizer whose telephone number is (571)272-2292. The examiner can normally be reached M-Th 0630 - 1700 ET.
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/CASSANDRA SENN GRIZER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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