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/Restriction
Applicant's election with traverse of Group I (Claims 1-3, 5 and 18) in the reply filed on 05 March 2026 is acknowledged. The traversal is on the ground that US 6,303,317 fails to disclose or suggest distinguishing technical features of claim 1 due to US 6,303,317 not teaching any one of the instant SEQ ID NOs: 1-15 (See pg. ). This is not found persuasive because the probe as amended is not a special technical feature, and is found in the art.
In view of the claim amendments filed 05 March 2026, the addition of “a sequence of the amino acid residues of the polypeptide probe includes at least one of SEQ ID NO: 1 to SEQ ID NO: 15.”makes the common technical feature between the inventive groups “the polypeptide probe”.
In the instant case, Groups I-IV lack unity of invention because even though the inventions of these groups require the technical feature of “the polypeptide probe” of claim 1, this technical feature is not a special technical feature, as it does not make a contribution over the prior art in view of Condon et al., hereafter “Condon” (“Comparative Genome Structure, Secondary Metabolite, and Effector Coding Capacity across Cochliobolus Pathogens.” (2013) PLoS Genet 9(1): e1003233. https://doi.org/10.1371/journal.pgen.1003233).
Regarding Group I-IV and the special tenchical feature being a “polypeptide probe” including SEQ ID NOs: 1-15 of the instant application, Condon discloses a peptide that comprises the amino acid sequence “HCWRDL” (instant SEQ ID NO: 12). See the uncharacterized protein of Cochliobolus carbonum (strain 26-R-13) (Maize leaf spot fungus) (Bipolaris zeicola) (amino acids 16-21) (pg. 1, “The genomes of five Cochliobolus heterostrophus strains, two Cochliobolus sativus strains, three additional Cochliobolus species (Cochliobolus victoriae, Cochliobolus carbonum…”). The peptide of Condon contains at least two hydrophobic amino acid residues (“W” and “L”), and the hydrophobic amino acids make up one-third of the polypeptide.
In view of the teaching of Codon, the shared technical feature is not a special technical feature.
The requirement is still deemed proper and is therefore made FINAL.
Status of Claims
The claim listing filed 05 March 2026 is pending. In response to the restriction requirement mailed on 07 January 2026, Applicants elected, with traverse, Group I, claims 1-3, 5, and 18. Claim 1 was amended. Claim 4 was cancelled in the response to election/restriction requirement filed 05 March 2026. Claims 6-17 and 19-20 are withdrawn from further consideration for the reasons set forth above, 37 CFR 1.142(b). Claims 1-3, 5, and 18 are being examined on the merits in this office action.
Priority
The present application claims status as a 371 (National Stage) of PCT/CN2022/083202 filed 25 March, 2022, and claims priority under 119(a)-(d) to Chinese Patent Application No. CN117136193A filed 25 March, 2022.
Receipt is acknowledged of certified copies of papers submitted under 35 USC 119(a)-(d) for WIPO Application No. WO 2023/178704 A1, which papers have been placed of record in the file. Please note that the application is in Chinese and thus cannot be verified.
Please note that Applicants cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 20 September 2023, has been considered by the Examiner. However, the IDS fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. All references have been considered, except where lined through.
Foreign patent CN101120021 A is not attached with an English abstract, as required by 37 CFR 1.98(a)(2), therefore the reference has not been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c). Throughout the specification, the sequence identifier is preceded by “SEQ ID NO.” rather than “SEQ ID NO:” as set forth in 37 CFR 1.821(d). The colon must be used in place of the period in all occurrences.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the
required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claims 1-3, 5 and 18 are objected to because of the following informalities: Claims 1 and 5 recite “SEQ ID NO.” instead of “SEQ ID NO:” as set forth in 37 CFR 1.821(d). The colon must be used in place of the period in the instant claims. For improved clarity, please amend claim 1 to say “A polypeptide probe, comprising: at least two hydrophobic amino acid residues; wherein a number of the hydrophobic amino acid residues accounts for one-fourth to two-thirds of a total number of amino acid residues of the polypeptide probe; and a sequence of the amino acid residues of the polypeptide probe includes at least one of SEQ ID NO: 1 to SEQ ID NO: 15.”, and claim 5 to say “The polypeptide probe according to claim 1, wherein the sequence of the amino acid residues of the polypeptide probe is SEQ ID NO: 6.”.Appropriate correction is required.
Claims 2-3 and 18 are objected to because they depend from an objected claim 1. If claim 1 is amended to overcome the above objection, this objection will become moot.
Claims 1-3 and 18 are objected to because of the following informalities: Claim 1 is directed towards a polypeptide probe SEQ ID NOs: 1-15, and SEQ ID NOs: 1 and 6 are duplicates of the same sequence “HCWRGF”. Appropriate correction is required.
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 and 2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a composition comprising natural products without significantly more, due to the results of the following subject matter eligibility test using the generic claim, claim 1.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes. The claim is to “A polypeptide probe, comprising: at least two hydrophobic amino acid residues; wherein a number of the hydrophobic amino acid residues accounts for one-fourth to two- thirds of a total number of amino acid residues of the polypeptide probe; and a sequence of the amino acid residues of the polypeptide probe includes at least one of SEQ ID NO. 1 to SEQ ID NO. 15.”.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon or an abstract idea?
Yes. The claim is directed to a natural phenomenon (a peptide comprising a peptide found in nature). The closest natural counterpart to SEQ ID NOs: 1-15 of the instant invention are listed below.
SEQ ID NOs: 1 and 6 are found in a putative secreted protein of Anopheles darlingi (Mosquito) (UniProt Entry: A0A2M4D2X4_ANODA).
SEQ ID NO: 2 is found in an uncharacterized protein of Rhizophora mucronata (Asiatic mangrove) (36-41).
SEQ ID NO: 3 is found in an uncharacterized protein of Ciona savignyi (Pacific transparent sea squirt) (38-43).
SEQ ID NO: 4 is found in an uncharacterized protein of Magallana gigas (Pacific oyster) (Crassostrea gigas) (62-67).
SEQ ID NO: 5 is found in the transcriptional regulator of Parastrongyloides trichosuri (Possum-specific nematode worm) (161-166).
SEQ ID NO: 7 is found in the Tir chaperone of Candidatus Williamhamiltonella defendens (60-65).
SEQ ID NO: 8 is found in the fatty acid hydroxylase of Chitinophaga agrisoli (43-48).
SEQ ID NO: 9 is found in a putative secreted protein of Anopheles darlingi (Mosquito) (UniProt Entry: A0A2M4D060_ANODA).
SEQ ID NOs: 10 and 13 are found in an uncharacterized protein of Araneus ventricosus (Orbweaver spider) (Epeira ventricosa) (amino acids 5-10 and 762-767).
SEQ ID NO: 11 is found in the Methyltransferase type 11 domain protein of Mycobacterium xenopi 4042 (19-24).
SEQ ID NO: 12 is found in an uncharacterized protein of Cochliobolus carbonum (strain 26-R-13) (Maize leaf spot fungus) (Bipolaris zeicola) (16-21).
SEQ ID NO: 14 is found in an uncharacterized protein of Blastopirellula marina (11-16).
SEQ ID NO: 15 is found in an uncharacterized protein the marine sediment metagenome (63-68).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No. The claim recites the limitation "A polypeptide probe, comprising: … and a sequence of the amino acid residues of the polypeptide probe includes at least one of SEQ ID NO.1 to SEQ ID NO.15.". The peptide segments detailed in the instant invention are not markedly different from the naturally occurring peptides. This judicial exception is not integrated into a practical application because the claim recites a product of nature “a polypeptide probe” and no additional limitation.
Therefore, claim 1 of the instant application does not recite a composition with elements that amount to significantly more than the judicial exception and is subject to this rejection.
Claims 2-3, 5, and 18 do not include any additional elements that are sufficient enough to amount to significantly more that the judicial exception because while the claims recite specifics on the amino acids present in the sequences, the limitations do not overcome the rejection under 35 U.S.C. 101 due to each of the amino acids and the sequence of invention already being in the natural product.
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.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Condon et al., hereafter “Condon” (“Comparative Genome Structure, Secondary Metabolite, and Effector Coding Capacity across Cochliobolus Pathogens.” (2013) PLoS Genet 9(1): e1003233. https://doi.org/10.1371/journal.pgen.1003233).
Regarding claim 1, Condon discloses a peptide that comprises the amino acid sequence “HCWRDL” (instant SEQ ID NO: 12). See the uncharacterized protein of Cochliobolus carbonum (strain 26-R-13) (Maize leaf spot fungus) (Bipolaris zeicola) (amino acids 16-21) (pg. 1, “The genomes of five Cochliobolus heterostrophus strains, two Cochliobolus sativus strains, three additional Cochliobolus species (Cochliobolus victoriae, Cochliobolus carbonum…”). The peptide of Condon contains at least two hydrophobic amino acid residues (“W” and “L”), and the hydrophobic amino acids make up one-third of the polypeptide. With regard to the limitation of the polypeptide being a “a polypeptide probe”, the peptide as taught by Condon comprises the amino acid sequence that is claimed to be a polypeptide probe and because a chemical composition and its properties are inseparable, a person of ordinary skill in the art would reasonably expect the peptide of Condon to also function as a polypeptide probe. MPEP 2112.01 (II).
Regarding claim 2, Condon discloses a peptide comprising a sequence identical to the instant “HCWRDL” (instant SEQ ID NO: 12) that contains a cysteine, a tryptophan, an arginine, a leucine, and an aspartic acid. See the uncharacterized protein of Cochliobolus carbonum (strain 26-R-13) (Maize leaf spot fungus) (Bipolaris zeicola) (amino acids 16-21) (pg. 1, “The genomes of five Cochliobolus heterostrophus strains, two Cochliobolus sativus strains, three additional Cochliobolus species (Cochliobolus victoriae, Cochliobolus carbonum…”).
Examiner Comment
The length of the amino acid sequence as described in claim 3 was not found in the prior art. The closest prior art is described in Condon et al., hereafter “Condon” (“Comparative Genome Structure, Secondary Metabolite, and Effector Coding Capacity across Cochliobolus Pathogens.” (2013) PLoS Genet 9(1): e1003233. https://doi.org/10.1371/journal.pgen.1003233). The peptide of Condon contains “HCWRDL” (instant SEQ ID NO: 12), but the total sequence is 93 amino acids in length. See the uncharacterized protein of Cochliobolus carbonum (strain 26-R-13) (Maize leaf spot fungus) (Bipolaris zeicola) (amino acids 16-21) (pg. 1, “The genomes of five Cochliobolus heterostrophus strains, two Cochliobolus sativus strains, three additional Cochliobolus species (Cochliobolus victoriae, Cochliobolus carbonum…”).
The peptide probe said to have the sequence of SEQ ID NO: 6, as described in claim 5, was not found in the prior art. The closest prior art is described in Ribeiro et al., hereafter “Ribeiro”, (“An insight into the sialome of Amazonian anophelines.”). The peptide of Ribeiro contains SEQ ID NO: 6 (“HCWRGF”), the sequence is 90 amino acids in length. See the putative secreted protein of Anopheles darlingi (Mosquito).
The peptide probe said to have a total number of 6 amino acids, as described in claim 18, was not found in the prior art. The closest prior art is described in Condon et al., hereafter “Condon” (“Comparative Genome Structure, Secondary Metabolite, and Effector Coding Capacity across Cochliobolus Pathogens.” (2013) PLoS Genet 9(1): e1003233. https://doi.org/10.1371/journal.pgen.1003233). The peptide of Condon contains “HCWRDL” (instant SEQ ID NO: 12), but the total sequence is 93 amino acids in length. See the uncharacterized protein of Cochliobolus carbonum (strain 26-R-13) (Maize leaf spot fungus) (Bipolaris zeicola) (amino acids 16-21) (pg. 1, “The genomes of five Cochliobolus heterostrophus strains, two Cochliobolus sativus strains, three additional Cochliobolus species (Cochliobolus victoriae, Cochliobolus carbonum…”).
Summary
Claims 1-3, 5 and 18 are objected to. Claims 1-3, 5 and 18 are rejected under 35 U.S.C. 101. Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1).
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Daliyah M. Brown whose telephone number is (571)272-0136. The examiner can normally be reached Monday-Thursday 9:00 am - 4:30 pm.
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/Daliyah M. Brown/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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