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 . 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.
Information Disclosure Statement
The information disclosure statements filed on 14 Sept, 2023 and 20 Dec, 2024 fail to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. Each information disclosure statement has a reference in Korean, with no English language explanation of the relevance of the reference. Thus, they were not considered.
Election/Restrictions
Applicant’s election without traverse of group I (peptides) and chemical formula 1-1 in the reply filed on 13 April, 2026 is acknowledged.
The requirement is deemed proper and is therefore made FINAL.
Applicants have elected compound 1-1. A search was conducted for this invention, and it was determined to be both novel and unobvious over the prior art. The closest prior art found was Sun et al (Org Lett (2019) 21 p1453-1457, cited by applicants). This reference discusses compounds similar to applicants (ring polypeptides with cinnamic acid derivatives attached to the N-terminus). However, there was no suggestion in either this reference, or any other reference found, to modify the structures of Sun et al to form those of applicants. Thus, these compounds are both novel and unobvious over the prior art (although non-art rejections apply).
Examiner’s Note
Applicants point out a preliminary amendment dated 14 Sept, 2023 to be examined, however, the examination is based on the latest claim set filed, which is the claim set of 2 Oct, 2023.
Claims Status
Claims 1-20 are pending.
Claims 2, 4, 7, and 17-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 13 April, 2026.
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, 3, 5, 6, and 8-16 are rejected under 35 U.S.C. 101 because they read on a judicial exception (natural phenomenon).
The Supreme Court has given a two part test for eligibility under this statute.
Are the claims drawn to a process, machine, manufacture, or composition of matter?
2a) If the first test is passed, does a judicial exception apply?
2b) If a judicial exception applies, is there anything beyond the judicial exception?
Applying the test:
The claims are drawn to polypeptides and compositions of polypeptides, a composition of matter.
2a) The claimed compounds were isolated from a bacterium, Streptomyces rapamycinicus (paragraphs 29, 77, 80, 91, 152). The bacterium was isolated from soil, and is not described as having been genetically manipulated (paragraph 148). In other words, these compounds were produced by a naturally occurring bacterium in culture, and would reasonably be expected to produce the same compounds in nature. Claims 1, 3, 5, 6, 8, and 9 are met by the compound itself. Claim 10 has a product by process limitation that does not change the structure of the compounds. Claims 11-15 have intended uses for the compounds, none of which require anything beyond the compounds themselves. Claim 16 requires the material be a food composition; this can be met by the pure peptide, or the peptide mixed with a food product, which can be naturally occurring (such as a salad or a banana).
2b) All the rejected claims can be met with just the naturally produced compounds. As such, there are embodiments that read on the claims that cannot be anything beyond the naturally produced product. Thus, the claims lack patent eligibility.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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