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 .
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 2, 12-13, and 22 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.
In claims 2 and 12-13, it is not clear the metes and bounds of “derived” is. Is it from the sequence listed or is it changed in some way? It is treated as the sequence is the specific potion.
Claim 13 refers to tables in the specification. MPEP 2173.05(s) Reference to Figures or Tables Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no
practical way to define the invention in words and where it is more concise to incorporate
by reference than duplicating a drawing or table into the claim. Incorporation by reference
is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27
USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Applicant should incorporate the matter into the claim.
In claim 22, the term synthetic is not specifically defined. The closest is at para 74 “e.g., a non-wild-type or synthetic ITR sequence” but this is just an example and does not say the synthetic means not wild type. The recombinant vectors produce synthesized (synthetic) ITRs that include both wild type and non-wild type ITRs. It is not clear what it refers to.
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)(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, 6, 12, 13, 22, 24-26, 33, 35-36, 38, 41, 45-46, 48-49, 54 is/are rejected under 35 U.S.C. 102a2 as being anticipated by Kotlin et al. (US20200283794A1).
For claim 1, Kotlin et al. claim a non-viral capsid-free DNA vector with covalently-closed ends (ceDNA vector), wherein the ceDNA vector comprises at least one heterologous nucleotide sequence operably positioned between asymmetric inverted terminal repeat sequences (asymmetric ITRs), wherein at least one of the asymmetric ITRs comprises a functional terminal resolution site and a Rep binding site. (claim 1). The heterologous nucleic acid can be for immunogenic polypeptide or vaccine (para 132).
For claim 6, a 3’ UTR is connected to the promoter via the transgene (example 2)(that is connected to the promoter (figure 1a for example). For claim 12, the ITRs are derived from AAV (abstract). For claim 13, the ITRs are asymmetric (claim 1). For claim 22, the ITRs can be synthetic (mutant) (Figure 1a shows both mutant and wild type ITRs). For claims 24-26, the ITRs are modified by a deletion, insertion, and/or substitution in at least one of the ITR regions selected from A, A′, B, B′, C, C′, D, and D′ and this results in all or part deletion of stem-loop structure (claims 7-12). For claims 33 and 49, the ceDNA vector can be encapsulated in a lipid nanoparticle (claim 27). For claim 35, the protein can be expressed in a host cell (claim 41). For claim 36, the sequence can be codon optimized (para 412). For claims 38 and 41, can be used to treat or prevent a disease (claim 42). For claims 45-46, 48, and 54, the ceDNA can be a pharmaceutical composition and can be administered by intramuscular injection (para 349). A pharmaceutical composition to treat or prevent is a vaccine. The “kit” comprises the product and does not add to the patentability of the product.
Thus, the claims are anticipated.
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kotlin et al. (US20200283794A1) as applied to claims 1, 6, 12, 13, 22, 24-26, 33, 35-36, 38, 41, 45-46, 48-49, 54 above, and further in view of McIntyre et al. (DOI: 10.18773/austprescr.2020.084. 2020).
Kotlin et al. is discussed above.
Kotlin et al. does not teach SARS-CoV-2.
McIntyre et al. teach that SARS-CoV-2 spike glycoprotein is the antigen is used in all the vaccine trials and induces immunity to the virus (Summary).
One of ordinary skill in the art before the effective filing date would have been motivated to make a COVID-19 vaccine because of the pandemic and the expectation of success use the spike protein as it induces immunity.
Thus, it would have been prima facie obvious before the effective time of filing to modify the ceDNA vector of Kotlin et al. with the SARS-CoV-2 spike glycoprotein of McIntyre et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYRON G HILL whose telephone number is (571)272-0901. The examiner can normally be reached Mon-Fri.
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/ Examiner, Art Unit 1671
/Shanon A. Foley/ Primary Examiner, Art Unit 1671