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 of Group 1 and the species of SEQ ID NO:9 in the reply filed on 1/14/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1/14/26.
The elected species does not contain the amino acid sequence of claims 2 and 5 (for example there is no LKSP) or the features of claims 3 and 7-10. Any relevant art that was uncovered during the search for the elected species is cited herein in order to advance prosecution.
Claims 2-3, 5 and 7-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 1/14/26.
Claims 1, 4, 6 and 11-13 are being examined.
Priority
The priority information is found in the filing receipt of 10/4/23.
Information Disclosure Statement
The US Patent application publication listed on the IDS of 5/3/23 recites publication number 2014/0146378 and an applicant that is Lebrilla. However, the correct publication number is 2014/0148378.
The information disclosure statement (IDS) submitted on 4/16/25 and 5/3/23 have been considered by the examiner.
Claim Interpretation
Claim 1 recites ‘polypeptide of 8-200 amino acids in length’. Thus the maximum length of any polypeptide is 200 amino acids. The minimum length of any polypeptide or fragment is 8 amino acids. Claim 4 has been interpreted as comprising one of the recited sequences and excluding sequences with 1, 2 or 3 amino acid changes.
Claim Objections
Claim 13 is objected to because of the following informalities:
Claim 13 line 2 and line 3 each recite ‘acetic acid’. There is no need to recite ‘acetic acid’ twice within the same group.
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.
Claims 1, 4, 6 and 11-13 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.
Claim 1 recites ‘isolated’. The instant specification defines such term (section 0022 on page 6) and recites ‘essentially free of other cellular components’. MPEP 2111.01 IV A recognizes “Where an explicit definition is provided by the applicant for a term, that definition will control interpretation of the term as it is used in the claim”. The term “essentially free” is a relative term which renders the claim indefinite. The term “essentially free” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Further, the definition is confusing because the term is defined in terms of ‘other cellular components’. The specification recognizes human milk as a source of peptides (section 0069 page 16). It is unclear how to determine ‘other cellular components’ in relation to milk (since milk is not necessarily a cell). It is also unclear how to apply this definition to peptides that are synthesized (using solid phase peptide synthesis for example) and purified as they are not present with cells. As such, the scope of claim 1 and dependent claims is unclear.
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, 6 and 11-13 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) polypeptides/compositions which correspond to products of nature (fragments of and/or the actual full length protein 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' (see MPEP 2106).
In comparison to the subject matter eligibility test as set forth in the guidance, the claims are drawn to polypeptides/compositions. Thus the answer to step 1 is yes.
The instant specification teach casein as the source of peptides (page 7 section 0043). The instant specification (page 17 section 0072) teach that instant SEQ ID NO:1 corresponds to residues 113-124 of a human casein protein. Instant SEQ ID NO:8 corresponds to residues 12-21 of human alpha S1 casein where the protein is less than 200 amino acids in length (see figure 3 and figure 3 caption section 0027). Claim 1 recites 2 or 3 amino acid changes and when 2 amino acids of SEQ ID NO:9 are changed (R3L and R4A) the result is instant SEQ ID NO:8. In relation to prong one of step 2a of the guidance the answer is yes because polypeptides correspond to domains or fragments of human 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:1 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, claim 11 recites a composition and claim 13 refers to further components. The compositions of claims 11-12 can correspond to the polypeptide in water which itself is naturally occurring.
Xi et al. (‘Short-chain fatty acids in breast milk and their relationship with the infant gut microbiota’ Frontiers in Microbiology February 2024 pages 1-13) teach that butyric acid (C4) is present in breastmilk (page 1 ‘Results’, page 2 first paragraph of materials and methods, page 3 last complete paragraph and Table 2). Thus claim 13 can correspond to a combination of naturally occurring components (or to milk itself). The instantly claimed 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. There is no indication that mixing of the peptide and an excipient (such as water) changes the structure, function or other properties of the peptide or the water. 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, 4, 6 and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lebrilla et al. (US 2014/0148378; first cited 11/19/25; ‘Lebrilla’).
Lebrilla teach peptides isolated from mammalian milk (abstract). On pages 16 and 44, Lebrilla teach the peptide AKDTVYTKGRVMPVLK (SEQ ID NO:74). Lebrilla teach the peptide from human milk (Table 3 heading on page 44 and section 0166).
In relation to the peptide of claims 1, 4 and 6, on pages 16 and 44, Lebrilla teach the peptide AKDTVYTKGRVMPVLK (SEQ ID NO:74) which is 16 amino acids in length and comprises instant SEQ ID NO:6. Lebrilla teach peptides isolated from mammalian milk (abstract).
In relation to the composition of claims 11-12, Lebrilla teach the peptide from human milk (Table 3 heading on page 44 and section 0166).
Claim(s) 1, 4, 6 and 11-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lebrilla et al. (US 2014/0148378; first cited 11/19/25; ‘Lebrilla’) as evidenced by Xi et al. (‘Short-chain fatty acids in breast milk and their relationship with the infant gut microbiota’ Frontiers in Microbiology February 2024 pages 1-13; ‘Xi’).
Xi is cited to show a universal fact related to known components of human milk (MPEP 2124). Xi et al. (‘Short-chain fatty acids in breast milk and their relationship with the infant gut microbiota’ Frontiers in Microbiology February 2024 pages 1-13) teach that butyric acid (C4) is present in human breastmilk (page 1 ‘Results’, page 2 first paragraph of materials and methods, page 3 last complete paragraph and Table 2).
Lebrilla teach peptides isolated from mammalian milk (abstract). On pages 16 and 44, Lebrilla teach the peptide AKDTVYTKGRVMPVLK (SEQ ID NO:74). Lebrilla teach the peptide from human milk (Table 3 heading on page 44 and section 0166).
In relation to the peptide of claims 1, 4 and 6, on pages 16 and 44, Lebrilla teach the peptide AKDTVYTKGRVMPVLK (SEQ ID NO:74) which is 16 amino acids in length and comprises instant SEQ ID NO:6. Lebrilla teach peptides isolated from mammalian milk (abstract).
In relation to the composition of claims 11-12, Lebrilla teach the peptide from human milk (Table 3 heading on page 44 and section 0166).
In relation to claim 13, Lebrilla teach the peptide from human milk (Table 3 heading on page 44 and section 0166) which as evidenced by Xi contains butyric acid.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4, 6 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lebrilla et al. (US 2014/0148378; first cited 11/19/25; ‘Lebrilla’) in view of Miyazaki et al. (US 5,916,619; ‘Miyazaki’).
Lebrilla teach peptides isolated from mammalian milk (abstract and section 0047 and section 0084 and example 1). On pages 16 and 44, Lebrilla teach the peptide AKDTVYTKGRVMPVLK (SEQ ID NO:74) which is identified as being from casein. Lebrilla teach the peptide from human milk (Table 3 heading on page 44 and section 0166). Lebrilla teach as antibacterial (abstract and section 0205). Lebrilla teach compositions comprising the peptide in a buffer with pH adjusting agents (section 0105).
Lebrilla does not expressly recite phosphoric acid.
Miyazaki teach casein solutions specifically those that are buffered using phosphoric acid buffer solution (column 7 lines 11-21).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Lebrilla based on the specific teachings and suggestions of Lebrilla. Since Lebrilla teach the peptide AKDTVYTKGRVMPVLK (SEQ ID NO:74) as antibacterial (pages 16 and 44) one would have been motivated to isolate and prepare for such use. Since Lebrilla teach compositions comprising the peptide in a buffer with pH adjusting agents (section 0105) one would have been motivated to use the known phosphoric acid buffer solution taught by Miyazaki (column 7 lines 11-21). One would have had a reasonable expectation of success because Lebrilla teach the peptides as antibacterial (abstract and section 0205). Further, Miyazaki teach casein solutions specifically those that are buffered using phosphoric acid buffer solution (column 7 lines 11-21).
In relation to the peptide of claims 1, 4 and 6, on pages 16 and 44, Lebrilla teach the peptide AKDTVYTKGRVMPVLK (SEQ ID NO:74) which is 16 amino acids in length and comprises instant SEQ ID NO:6. Lebrilla teach peptides isolated from mammalian milk (abstract and section 0047 and section 0084 and example 1).
In relation to the composition of claims 11-12, Lebrilla teach the peptide from human milk (Table 3 heading on page 44 and section 0166).
Further in relation to claims 11-13, Lebrilla teach compositions comprising the peptide in a buffer with pH adjusting agents (section 0105) and Miyazaki teach casein solutions specifically those that are buffered using phosphoric acid buffer solution (column 7 lines 11-21).
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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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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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658