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 .
Nucleotide and/or Amino Acid Sequence Disclosures
The amino acid sequence CCPPPP in claim 2 is not identified by a sequence identifier in accordance with 37 CFR 1.821(d).
Applicant must amend claim 2 to insert (SEQ ID NO: 7) after the sequence.
Priority
Applicant cannot rely upon the certified copy of the foreign priority applications to overcome the prior art rejection made below because a translation of said applications have not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Claim Rejections - 35 USC § 112/101
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 12-19 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.
Claims 12-19 are indefinite because they merely recite a use without any active, positive steps delimiting how this use is actually practiced.
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 12-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because they recite a use rather than a process, machine, manufacture, or composition of matter.
Claim Rejections - 35 USC § 112
Claims 1-4, and 12-19 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 claims 2, 4, 12, and 13, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. Dependent claims 14-19 fail to remedy this issue and are likewise rejected.
In claim 1, the structure of the polypeptide composition is indefinite because the claim states that the polypeptide comprises one or more of KVp-N, KVp-R, and KVp-C, wherein KVp-N contains SEQ ID NO: 1, KVp-R contains SEQ ID NO:3, and KVp-C contains SEQ ID NO:5. However, according to the sequence listing, SEQ ID NOs: 1 and 5 are identical. It is not clear whether there is an error in the sequence listing or if the claim allows for different versions of polypeptides comprising the same sequence. Dependent claims 2-4 and 12-19 fail to remedy this issue and are likewise rejected. In addition, for claim 3, SEQ ID NOs: 2 and 6 are identical according to the sequence listing.
Claim 3 recites the limitation "the amino acid sequence…modified with a sulfhydryl-containing peptide fragment" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (Synthetic Neutralizing Peptides Inhibit the Host Cell Binding of Spike Protein and Block Infection of SARS-CoV-2. J. Med. Chem. 2021 64 (19), 14887-14894; published online September 17, 2021).1
Wang et al. teach peptide compositions comprising peptides identical to SEQ ID NOs: 1-6 (i.e. N1N, thiolated N1N, R14N, thiolated R14N, N1N, and thiolated N1N in Table 1, respectively). Wang et al. teach that the peptides have high affinity to the S1 subunit of the spike protein and wild-type SARS-CoV-2 pseudovirus (Figure 1), satisfying all of the limiations of claims 1-3.
Regarding claim 4, Wang et al. teach a combination of the peptides at a molar ratio of 1:1 achieved a significantly higher inhibitory rate of SARS-CoV-2 infection (Section 2.5).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MARCHETTI BRADLEY whose telephone number is (571)272-9044. The examiner can normally be reached Monday-Friday, 7 am - 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA BRADLEY/Primary Examiner, Art Unit 1654
1 Wang et al. qualifies as prior art under 35 U.S.C. 102(a)(1) because it was published September 17, 2021, whichh is prior to the earliest effective filing date of the instant application, the filing date of PCT/CN2022/078627, March 1, 2022. Wang et al. lists authors Zhaoyi Zhai and Zhiyou Wang that are not listed as inventors of the instant application. Applicant cannot rely upon the certified copy of the foreign priority applications to overcome the prior art rejection made below because a translation of said applications have not been made of record in accordance with 37 CFR 1.55.
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