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 in the reply filed on 8/12/26 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Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 8/12/26.
Applicant’s election of the species of MFIGAF001 in the reply filed on 8/12/26 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)).
As recognized by the applicant, claims 4, 6 and 9 do not read on the elected species. Since claim 4 does not read on the elected species, claim 5 (which depends on claim 4) is also to a non-elected species. In accord with MPEP 803.02 the search was extended to the extent necessary to determine patentability.
Claims 4-6 and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 8/12/26.
Claim 11 has been canceled.
Claims 1-3, 7-8 and 10 are being examined.
Priority
The priority information is found in the filing receipt of 8/6/25.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/12/26, 10/3/24 and 12/21/23 have been considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
37 CFR 1.821(d) (this application has an international filing date before 7/1/22 and is treated under ST.25) states that each occurrence in the specification of a sequence set forth in the sequence listing should include the corresponding sequence identifier. At least page 3 lines 16-17, page 6 2nd-3rd compounds, page 7 last compound, page 24 Table 6, page 25 last entry of Table 7 and Table 8 4th entry on page 26 recite sequences but do not include the corresponding sequence identifier.
MPEP 2421.02 recognizes that D-amino acid containing sequences are not embraced by the sequence rules.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (page 18 line 28 and page 29 line 16). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities:
37 CFR 1.821(d) (this application has an international filing date before 7/1/22 and is treated under ST.25) states that each occurrence of a sequence set forth in the sequence listing should include the corresponding sequence identifier. The 2nd-3rd lines of claim 1 do not include the corresponding sequence identifiers.
Appropriate correction is required.
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 1-3, 8 and 10 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 that ‘Zaa* is said unnatural amino acid functionalized with or bearing a fluorophore’. It is unclear what is meant by ‘said unnatural amino acid’ because the claim previously refers to 2 separate unnatural amino acids: one having a hydrophobic side chain and one having a free amine, azide or alkyne side chains. As such, the scope of Zaa* (and Yaa) is unclear. None of dependent claims 2-3 and 10 clarify the claim scope.
Claim 8 recites ‘fluorophore-labelled MFIGAF001’. MFIGAF001 as set forth on page 5 is a specific compound. With respect to labeling, claim 1 refers to Zaa* as bearing a fluorophore. However, MFIGAF001 itself is such that Yaa is Gly (not Zaa*). As such, the acceptable locations for the fluorophore of claim 8 are unclear. It is not clear if claim 8 is a proper dependent claim.
Although unclear, the claims have been given the broadest reasonable interpretation consistent with the specification.
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 and 10 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) compounds/compositions which correspond to products of nature (fragments of natural 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' (MPEP 2106).
In comparison to the subject matter eligibility test as set forth in the guidance, the claims are drawn to compounds/compositions. Thus the answer to step 1 is yes.
NCBI entry for MAG (retrieved from https://www.ncbi.nlm.nih.gov/protein/MHF1111863.1?report=genbank&log$=protalign&blast_rank=1&RID=8Y6FT8NN016 on 8/26/26, 2 pages) reveals that a particular bacterium has a MFS transporter that comprises RKKFWFWG (beginning at residue 81) where such sequence corresponds to formula II where Xaa is Phe and Yaa is Gly. Thus formula II corresponds to a fragment of a known protein. In relation to prong one of step 2a of the guidance the answer is yes because the peptides correspond to domains of natural 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 Formula II 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 10 recites a composition. The compositions of claim 10 can correspond to the compound in water which itself is naturally occurring. Thus, claim 10 can correspond to a combination of naturally occurring components. 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) 1-3 and 10 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Diamond (US 6,632,435; ‘Diamond’).
Diamond teach a C-hydroxyl (H-A1-Y9-COOH) L-amino acid combinatorial nonapeptide library arranged in a positional scanning format (example 6 columns 15-16). Diamond teach that each library consists of 180 mixtures in the OX8 format where O represents one each of the 20 natural L-amino acids and X represents any of the 20 natural amino acids with the exception of cysteine in each of the remaining positions (example 6 columns 15-16). Diamond teach that each mixture consisted of 198 different nonamer peptides (example 6 columns 15-16).
In relation to claims 1-3, the nonapeptide library of Diamond is of sequence OX8 where O represents one each of the 20 natural L-amino acids and X represents any of the 20 natural amino acids with the exception of cysteine in each of the remaining positions (example 6 columns 15-16). Diamond teach that each mixture consisted of 198 different nonamer peptides (example 6 columns 15-16). Thus, when O is Arg, the library necessarily comprises Arg-Lys-Lys-Phe-Trp-Phe-Trp-Lys-Gly which is of formula II where R1 is H, Xaa is Phe, Yaa is Lys-Gly and R2 is OH.
In relation to claim 10, Diamond teach that each mixture consisted of 198 different nonamer peptides (example 6 columns 15-16).
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
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