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 .
Election/Restrictions
Applicant’s species election of SEQ ID # 1160 in the reply filed on 3/20/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Specification
Sequence Requirements
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth on as follows:
The specification does not contain sequence identifiers (SEQ ID#s) in all locations where sequences are disclosed, see at least Table 7, and there is no computer readable form (CRF).
Full compliance with the sequence rules is required in response to this Office Action. A complete response to this office action should include both compliance with the sequence rules and a response to the Office Action set forth below. Failure to fully comply with both these requirements in the time period set forth in this Office Action will be held non-responsive.
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, 12, and 21 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 claims are incomplete.
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).
Reference characters corresponding to elements recited in the detailed description and
the drawings may be used in conjunction with the recitation of the same element or group
of elements in the claims. See MPEP § 608.01(m).
Claim Interpretation
“A” can mean one or more. The claims refer to peptides comprising epitope and heterologous sequence. This is interpreted as two sequences and not a fusion.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10, 12, and 16-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural product SEQ ID# 1160, see ORFAB SARS-Cov-2 and the tables identify the sequences as natural, without significantly more. The claim(s) recite(s) SEQ ID# 1160. This judicial exception is not integrated into a practical application because it is the natural sequence. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because claims 1-6 and 12 are to a natural product. For claims 7-9, include the natural virus as a vector and any infected cell. For claims 10 and 16-17, the additional elements are routine in the art and there is no evidence that the natural product is changed by the excipient or the container.
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.
Claim(s) 1-12 and 16-17 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Li (CN 111228483A 05 Jun.2020(05.06.2020)).
For claims 1-5, Li teaches the sequence of T cell epitope: GYQPYRVVVL (one T cell epitope set forth in Table 3 of the present invention) and the sequence of B cell epitope: DVVNQNAQALNTLVKQL (one B cell epitope set forth in Table 4 of the present invention) (see paragraphs 0051 and 0060 in Example 1)
For claims 4-5, a combined antigen including recombinant S protein of novel coronavirus and atypical pneumonia virus (SARS-CoV-1) can be made (claim 3 and Example 1 part 2).
For claims 6-9, the summary indicates that the sequences are from an RNA virus and it expresses the protein and infects subjects (Summary of invention).
For claim 10-11, the antigen is mixed with adjuvant, the volume containing the antigen must be pharmaceutically acceptable because the volume is mixed wth adjuvant and injected. (Example 1).
For claim 12, because some of the epitopes are the same between SARS-CoV-1 and 2, the combination antigen can come those listed in the tables as pointed out above.
For claim 16-17, the kit only contains the peptide antigens and containers are inherent as the peptides must be contained in something.
Thus, Li anticipates the claimed invention.
Claim(s) 1, 10-11, and 13-15 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Zhang (CN 111440229A 24 Jul.2020(24.07.2020)).
Zhang teaches SEQ ID NO: 2, an epitope peptide (LSPRWYFYY, one T cell epitope set forth in Table 3 of the present invention).
“The epitope peptide of the present invention or a vaccine comprising antigen-presenting cells presenting the epitope peptide can be prepared by a method known in the art. For example, as the vaccine, there are injections or solid doses containing the epitope peptide of the present invention as an active ingredient. The epitope peptide can be formulated in neutral or salt form, and examples of pharmaceutically acceptable salts include inorganic salts such as hydrochloric acid and phosphoric acid, and organic acids such as acetic acid and tartaric acid. In addition, the antigen-presenting cells presenting the epitope peptides of the present invention can use excipients that are pharmaceutically acceptable and compatible with the activity of the peptides or the cells, such as water, saline, glucose, ethanol, glycerol , DMSO (dimethyl sulphoxide, dimethyl sulfoxide), and other adjuvants, etc., or a combination thereof. Moreover, auxiliary agents, such as albumin, a wetting agent, and an emulsifier, may be added as needed.
The vaccine of the present invention can be administered by parenteral administration and oral administration, and in general, parenteral administration is preferred. Parenteral administration includes injections such as nasal administration, subcutaneous injection, intramuscular injection, and intravenous injection, suppositories, and the like. In addition, for oral administration, it can be prepared as a mixture with excipients such as starch, mannitol, lactose, magnesium stearate, and cellulose.” (Google translation, para 31 and 32).
Thus, the Zhang anticipates the peptide, pharmaceutical excipients, adjuvants, a method of administering intramuscularly to induce an immune response.
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) 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li (CN 111228483A) and Jiang (20230160890).
Li is discussed above.
Li doe not teach detecting activated T cells.
For claims 18-19 and 21, Jiang teach detecting activated T-cells, claims 1, 2, 6, 18, and 20.
For claim 20, the disclosure uses flow cytometry to detect the activated cells (para 102).
Detecting activated T cells from a subject is well known in the art and is routine in laboratories. One of ordinary skill in the art before the effective time of filing would be motivated to detect prior infection by detecting activated T cells and have the expectation of success knowing the method is routine.
Thus, it would have been prima facie obvious before the effective date of filing to use peptides of Li in the assay of Jiang to detect activated T cell to SARS-CoV-2.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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
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