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 .
DETAILED ACTION
Claim Status
Claims 3-6 are pending. Claim 3 has been amended. Claim 3 is being examined in this application. In the response to the restriction requirement, Applicants elected Group I. Claims 4-6 are withdrawn as being drawn to a nonelected invention.
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.
This rejection is maintained.
Claim 3 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim 3 is directed to a law of nature/natural principle. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The rationale for this determination is explained below:
Instant claim 3 is drawn to a polypeptide having anti-aging activity, or pharmaceutically acceptable salts thereof, comprising the amino acid sequence TAFAA (SEQ ID NO:2).
As evidenced by NCBI WP412012550.1 (LacI family DNA-binding transcriptional regulator [Nocardia arseniciresistens]), SEQ ID NO: 2 is a fragment of a naturally occurring protein.
The Office has prepared interim guidance (2014 Interim Guidance on Patent Subject Matter Eligibility) (Federal Register/Vol. 79, No. 241, Dec. 16, 2014) for use by USPTO personnel under 35 U.S.C. 101 in view of recent U.S. Supreme Court decisions. The 2014 Interim Eligibility Guidance supersedes the March 4, 2014 Process for Subject Matter Eligibility Analysis of Claims Reciting or Involving Laws of Nature/Natural Principles, Natural Phenomena, and/or Natural Products.
The current Interim Guidance provides subject eligibility test or products and processes (See Flow Chart, p. 74621):
Step 1: The instant claims are directed to a statutory patent-eligible subject matter category, a composition of matter.
Step 2A: The claims involve a judicial exception, a product of nature.
Specifically, the claims are drawn to a fragment a the naturally occurring protein.
Step 2B: The claims do not recite additional elements that amount to significantly more that the judicial exception.
Markedly different characteristics can be expressed as the product's structure, function, and/or other properties and is evaluated based on what is recited in the claim. In accordance with this analysis, a product that is purified or isolated will be eligible when there is a resultant change in characteristics sufficient to show a marked difference from the products naturally occurring counterpart.
The Applicants have not shown a marked difference from the products naturally occurring counterpart.
Myriad clarified that not every change to a product will result in a marked difference, and that the mere recitation of particular words (e.g., “isolated”) in the claims does not automatically confer eligibility. Id. at 2119. See also Mayo, 132 S. Ct. at 1294 (eligibility does not “depend simply on the draftsman’s art”). The instant claims do not show any additional ingredients for the composition that imparts markedly different characteristic from any naturally occurring counterparts.
Therefore, the claim is drawn to a judicial exception and are considered patent ineligible.
Response to Arguments
Applicant’s arguments filed on 2/16/2026 have been fully considered but they are not persuasive.
Applicant argues that “[t]he claimed polypeptide is not merely an isolated fragment; it is a specific functional unit. While the sequence "TAFAA" might exist as a internal structural motif within a larger natural protein, its isolation as a discrete five-amino-acid peptide results in markedly different characteristics. In its natural state, this sequence is a structural component of a DNA-binding transcriptional regulator, which does not exhibit anti-aging effects on eukaryotic organisms. By isolating this specific sequence, Applicant has "unlocked" a latent anti-aging function that is not present or utilized in the naturally occurring counterpart. Under the 2014 Interim Eligibility Guidance, a change in function and property constitutes a marked difference, rendering the claim patent-eligible”.
Applicant’s arguments are not persuasive because the claimed polypeptide is NOT a 5 amino acid polypeptide. The open language “comprising” encompasses any polypeptide of any length “comprising” the amino acid sequence TAFAA.
As admitted by the Applicant, the polypeptide having anti-aging activity is the pentapeptide consisting of the amino acid sequence TAFAA.
Furthermore, since the Office does not have the facilities for examining and comparing applicants’ polypeptide with the polypeptide of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed product and the product of the prior art (i.e., that the polypeptide of the prior art does not possess the same material structural and functional characteristics of the claimed polypeptide). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
For the reasons stated above the rejection is maintained.
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.
This rejection is maintained.
Claim 3 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Silver et al. (WO 2015/048342).
Silver et al. teach SEQ ID NO: 02999, which comprises instantly claimed SEQ ID NO: 2.
With respect to the claimed “anti-aging activity”, it is noted that the peptide of Silver et la. comprises the required SEQ ID NO: 2, thus it must necessarily have the same properties (e.g. anti-aging activity).
Response to Arguments
Applicant’s arguments filed on 2/16/2026 have been fully considered but they are not persuasive.
Applicant argues that “[A] review of the specific sequence for SEQ ID NO: 02999 shows a massive polypeptide of approximately 840 amino acids. The five-amino-acid sequence "TAFAA" is a minute, internal fragment buried within this 840-residue structure. It is well-established in biotechnology that the biological activity of a peptide is highly dependent on its three-dimensional conformation and accessibility. (1) Lack of Enablement for Function: Silver et al. is directed to different utilities and provides no teaching or evidence that their 840-amino-acid protein possesses anti-aging activity. There is no "inherency" here; it is scientifically unsound to assume that an internal five-residue motif in a giant protein would exhibit the same biological property as a small, isolated five-residue peptide. (2) Structural Distinction: The claimed invention is a polypeptide comprising TAFAA. In legal and technical terms, the isolated peptide is a distinct chemical entity from the 840-residue protein of Silver et al. The prior art does not disclose the specific, discrete TAFAA peptide as a functional anti-aging agent. Consequently, Silver et al. does not "describe" the claimed invention within the meaning of 35 U.S.C. § 102(a)(1), as it fails to disclose the specific peptide in a manner that enables the claimed anti-aging function”.
Applicant’s arguments are not persuasive because the claimed polypeptide is NOT a 5 amino acid polypeptide. The open language “comprising” encompasses any polypeptide of any length “comprising” the amino acid sequence TAFAA, such as the polypeptide of Silver et al.
Furthermore, Silver et al. teach that SEQ ID NO: 02999 is used for the treatment of sarcopenia (claims 6 and 8), which is an age-related disease (paras [00150], [00164], [00579], [00628]).
Therefore, it is clear that the polypeptide of Silver et al. has anti-aging activity.
Furthermore, since the Office does not have the facilities for examining and comparing applicants’ polypeptide with the polypeptide of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed product and the product of the prior art (i.e., that the polypeptide of the prior art does not possess the same material structural and functional characteristics of the claimed polypeptide). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
For the reasons stated above the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658