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 .
Election/Restrictions and Claim Status
Applicant’s election without traverse of Group 1 and the species of SEQ ID NO:15 in the reply filed on 1/8/26 is acknowledged.
Claims 7-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/8/26.
The elected species is such that X is Arg, Z is Asn-Lys, m is 1, n is 2 and q is 0. As such, claims 5-6, 12-13, 15 and 17 are drawn to non-elected species. Claims to the elected species are rejected as set forth below. Any relevant art that was uncovered during the search for the elected species is cited herein in order to advance prosecution.
Claims 5-6, 12-13, 15 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/8/26.
Claims 1-4, 14 and 16 are being examined.
Priority
The priority information is found in the filing receipt of 9/25/23.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4/25/23 and 10/29/25 have been considered by the examiner.
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 1-4, 14 and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (product of nature) without significantly more. The claim(s) recite(s) peptides which correspond to products of nature (fragments of proteins as discussed in detail below). This judicial exception is not integrated into a practical application because there is no additional elements that apply or use the judicial exception. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception as discussed below.
This 101 rejection is consistent with the most recent training provided by the office which will be referred to as 'guidance' (MPEP 2106).
In comparison to the subject matter eligibility test as set forth in the guidance, the claims are drawn to peptides. Thus the answer to step 1 is yes.
Bremel et al. (US 2013/0330335; ‘Bremel’) teach sequences including SEQ ID NO:2755356 (sections 0043 and 0267). Page 60 of Bremel states that the sequence listing can be found at a specific web site. SEQ ID NO: 2755356 entry for US 20130330335 (retrieved from ttp://seqdata.uspto.gov/?pageRequest=docDetail&DocID=US20130330335A1 on 3/2/26, 2 pages) is the sequence information for SEQ ID NO: 2755356 and reveals that SEQ ID NO: 2755356 comprises Arg-Asn-Lys-Pro from organism Entamoeba invadens. Thus, the elected Arg-Asn-Lys-Pro is a fragment of a natural protein. Further, the claims encompass many other tripeptides and tetrapeptides. In relation to prong one of step 2a of the guidance the answer is yes because the peptides correspond to fragments of known proteins (i.e. products of nature which are a natural phenomenon).
In relation to prong two of step 2a, the instant claims are product claims and do not require any additional elements that apply the judicial exception in a manner that imposes a meaningful limit on the judicial exception. Thus the answer to prong two of step 2a is no.
The instant claims recite SEQ ID NO:15 which is a fragment of a known protein. The Myriad Supreme Court decision (Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 12-398 (2013)) stated: “Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together” (page 2 and 14). In the instant case, applicants’ claims are not saved by the fact that the peptides of the instant claims correspond to fragments (the protein with severed bonds).
In relation to step 2b, the claims are drawn to peptides. Even if the claims recited compositions, compositions can correspond to the peptide in water which itself is naturally occurring. Such compositions are like the novel bacterial mixture of Funk Brothers which contained multiple naturally occurring components, which was held ineligible because each species of bacteria in the mixture (like each component in the peptide composition) continued to have “the same effect it always had”, i.e., it lacked markedly different characteristics. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948), discussed in Myriad Genetics, 133 S. Ct. at 2117 (explaining that the bacterial mixture of Funk Brothers “was not patent eligible because the patent holder did not alter the bacteria in any way”). The claims do not require any additional features that add significantly more to the exceptions.
Further, there is no evidence of any markedly different characteristic. MPEP 2106.04(c) II C recognizes that a change cannot be an inherent or innate characteristic on the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Thus the answer to step 2b is no because there is not adequate evidence to conclude that the claims include significantly more than the judicial exception.
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.
Claim(s) 1-3, 14 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bremel et al. (US 2013/0330335; ‘Bremel’).
Page 60 of Bremel states that the sequence listing can be found at a specific web site. SEQ ID NO: 2755356 entry for US 20130330335 (retrieved from ttp://seqdata.uspto.gov/?pageRequest=docDetail&DocID=US20130330335A1 on 3/2/26, 2 pages) is the sequence information for SEQ ID NO: 2755356.
Bremel teach particular sequences including SEQ ID NO:2755356 (sections 0043 and 0267).
SEQ ID NO: 2755356 entry for US 20130330335 (retrieved from ttp://seqdata.uspto.gov/?pageRequest=docDetail&DocID=US20130330335A1 on 3/2/26, 2 pages) is the sequence information for SEQ ID NO: 2755356 and reveals that SEQ ID NO: 2755356 is Phe-Arg-Asn-Lys-Pro.
In relation to the peptide of claims 1-3, 14 and 16, Phe-Arg-Asn-Lys-Pro is 5 amino acids in length and comprises formula I and is such that X is Arg, Z is Asn-Lys, m is 1, n is 2 and q is 0. Since claim 1 uses the open-ended comprising language the peptide can contain a residue at the N-terminal end in addition to Xm as long as the total length falls within the recited 3 to 8 amino acids.
Claim(s) 1-4, 14 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khan et al. (WO 2009/126037 as cited with IDS 10/29/25).
Khan teach the peptide FNKP (section 0015 specifically the last line of section 0015 on page 5).
In relation to the peptide of claims 1-4, 14 and 16, Phe-Asn-Lys-Pro is 4 amino acids in length and comprises formula I and is such that X is Phe, Z is Asn-Lys, m is 1, n is 2 and q is 0. Phe-Asn-Lys-Pro is instant SEQ ID NO:13.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658