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
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 24 August 2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group III, corresponding to claim 12 and the sequence combination of SEQ ID NOs: 1, 2, and 15 in the reply filed 13 March 2026 is acknowledged. Claims 1-11 and 13-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 16 March 2026.
Specification
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.
The disclosure is objected to because of the following informalities:
“SEQ ID NO” should read “SEQ ID NO:”
“SEQ ID NOS” should read “SEQ ID NOs:”
Appropriate correction is required.
Claim Objections
Claim 12 is objected to because of the following informalities:
“SEQ ID NO” should read “SEQ ID NO:”
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.
Claim 12 is 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 claim 12, it is unclear if the claim encompasses peptides that comprise (must contain claimed sequence but peptides that are longer than claimed sequence are also claimed, i.e. SEQ ID NO:12 is 12 aa long, an amino acid sequence that contains residues 1-12 and an additional residue would also read on the claim) or consist (only the claimed sequence is claimed, i.e. SEQ ID NO: 1 is 12 aa long, a 13 aa long peptide does not read on the claim) of the claimed sequences.
For the purposes of compact prosecution and applying prior art, claim 12 was interpreted as peptides consisting of the amino acid sequences of SEQ ID NOs: 1, 2, and 15.
It is noted that any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than the posited by the Examiner, additional rejection and art may be readily applied in a subsequent final Office action.
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.
Claim 12 is rejected under 25 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP § 2106 for analysis framework.
The instant claims are broadly drawn to a diagnostic assay or kit comprising a combination of 3 peptides (SEQ ID NOs: 1, 2, and 15). As such, the instant claims are drawn to a composition of matter, which is a statutory category of invention (STEP 1: YES).
The instant Specification evidences that the peptides (SEQ ID NOs: 1, 2, and 15) are from the proteome of SARS-CoV-2 and are not altered (pg. 2 line 12). As such, the peptides (SEQ ID NOs: 1, 2, and 15) constitute fragments of naturally occurring proteins of SARS-CoV-2. Isolating or producing SARS-CoV-2 peptides, corresponding to naturally occurring fragments of larger SARS-CoV-2 proteins, would not, absent evidence to the contrary, result in any markedly different characteristics with respect to structure, function, or any other property to distinguish the claimed peptides from the their naturally occurring counterparts, i.e., the peptide fragments as contained within their respective SARS-CoV-2 proteins.
Accordingly, the instant claims recite a natural phenomenon, which is a judicial exception (JE) (STEP 2A, Prong One: YES).
The instant claims are drawn solely to the JE, and not a method of using the JE for, e.g. a specific treatment or prophylaxis. As such the instant claims do not recite any additional elements that integrate the JE into a practical application (STEP 2A, Prong Two: NO).
Since the instant claims are limited to only the JE, the instant claims do not recite any additional elements that amount to significantly more than the JE (STEP 2B: NO).
In view of the foregoing, the instant claims do not constitute patent eligible subject matter under 35 U.S.C. § 101.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J. Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CASSANDRA SENN GRIZER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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