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 .
Examiner Assignment
This application has been transferred from Examiner Young J Kim to Examiner Tian Yu. All future correspondence should be directed to Examiner Tian Yu whose contact information appears at the end of this Office Action.
Status of Claims
This office action is in response to Applicant's Response to Election / Restriction and Amendment filed on May 08, 2026.
Claims 1-11 are currently pending, with claims 1-3, 9 and 11 withdrawn.
Claims 4-8 and 10 are under examination. This is the first action on the merits.
Election/Restrictions
Applicant’s election without traverse of Group III (claims 4-8 and 10) in the reply filed on May 08, 2026 is acknowledged 1.
The requirement for species election for Species of DNA Barcode and Species of combination of primers, set forth in the office action mailed on April 1, 2026 has been withdrawn.
Claims 1-3, 9 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Examination on the merits commences on claims 4-8 and 10.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c).
Where a sequence is presented in a drawing, reference must be made to the sequence by use of the sequence identifier (§ 1.832(a) ), either in the drawing or in the Brief Description of the Drawings, where the correlation between multiple sequences in the drawing and their sequence identifiers (§ 1.832(a) ) in the Brief Description is clear.
Specifically, FIGS. 2-5 contains nucleotide sequences with 10 or more specifically defined and enumerated residues, that are not identified with sequence identifiers.
Claim Objections
Claims 4-8 and 10 are objected to because of the following informalities:
A) In claim 4, line 3, to improve consistency within the claim, it should read:
"S1, extracting genomic DNA of a sample of the Floccularia luteovirens to be tested."
B) In claim 4, lines 4-6, it should read:
"S2, taking the genomic DNA in S1 as a template, and performing a fluorescent PCR amplification reaction with a primer group to obtain an amplification product."
C) In claim 4, lines 7-9, to improve consistency within the claim,
"a nucleotide sequence of the primer group comprises one or more groups of: SEQ ID NO: 1 and SEQ ID NO:2 … " should read:
"the primer group comprises the nucleotide sequences in one or more groups of: SEQ ID NO: 1 and SEQ ID NO:2… " for improved consistency with the recitation of a primer group that comprises multiple primers and, therefore, more than one nucleotide sequence.
Claims 5-8 depend from claim 4 and are objected to for the same reasons.
D) In claim 10, lines 6-8, to improve consistency within the claim,
"a nucleotide sequence of the primer group comprises one or more groups of SEQ ID NO: 1 and SEQ ID NO:2 … " should read: "the primer group comprises the nucleotide sequences in one or more groups of SEQ ID NO: 1 and SEQ ID NO:2… " for improved consistency with the recitation of a primer group that comprises multiple primers and, therefore, more than one nucleotide sequence.
Priority
The effective filling date of the instant claims 4-8 and 10 is 01/19/2024, the filling date of the instant U.S. nonprovisional application.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Specifically, Applicant's claim to domestic priority is acknowledged as a continuation of PCT/CN2022/109954. Applicant's claim to foreign priority to CHINA Application 202111401645.2 is also acknowledged. However, neither of the priority documents is in English, and English translations have not been submitted.
The domestic benefit date may be the effective filing date of the claimed invention if:
• the earlier application to which domestic benefit is claimed supports the claimed invention under 35 U.S.C. 112(a).
The foreign priority date may be the effective filing date of the claimed invention if:
• the foreign application supports the claimed invention under 35 U.S.C. 112(a), AND
• the applicant has perfected the right of priority by providing a certified copy of the priority application, and a translation of the certified copy (if not in English) along with a statement that the translation of the certified copy is accurate.
See MPEP 213.04 and 216; See also MPEP 2304.01(c)
In this instant case, the priority documents submitted are not in English; without an English translation, the examiner is unable to verify whether the earlier applications provide written description support for the claimed invention under 35 U.S.C. 112(a). Thus, since an English translation of the priority application has not been filed, the effective filing date (EFD) of the claimed invention is the filing date of the application.
However, if applicant perfects the right of priority by providing an certified English translation of the priority application that supports the claimed invention under 35 U.S.C. 112(a), the effective filing date will be the filing date of the foreign application.
Claim Interpretation
In evaluating the patentability of the claims presented in this application, claim terms have been given their broadest reasonable interpretation (BRI) consistent with the specification, as understood by one of ordinary skill in the art, as outlined in MPEP§ 2111.
Regarding all claims, the term "DNA barcode" is described in the specification as follows:
"A DNA barcode molecular identification technology is a molecular biology technology based on DNA barcodes (conserved and stable genetic DNA sequences in a genome) to recognize and identify species and excellent quality. " ([0004] lines 7-10)
Accordingly, in the context of the claimed invention and in light of the specification, the term "DNA barcode" is interpreted as having the same meaning as a genomic sequence.
Regarding claim 7, the claim recites "wherein the concentrations of the forward primer, the reverse primer and the M13 primer with fluorescence are all 10µM."
In light of the specification ([0079]), and under BRI, the recited primer concentrations are interpreted as the concentrations of the primer stock solutions.
Claim Rejections - 35 USC § 112(b)
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.
Claims 4-8 are rejected under 35 U.S.C. 112(b), 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 4 recites:
"S3, detecting the amplification product of S2 by capillary fluorescence electrophoresis, and judging by the number of fragments, the number of SSR loci, SSR repetitive elements and repeating times of the amplification product."
The phrase "judging by the number of fragments, the number of SSR loci, SSR repetitive elements and repeating times of the amplification product" reads as an incomplete phrase because it does not identify what is being judged. The scope of the "judging" step is therefore unclear.
Specifically, it is unclear whether the step requires determining Floccularia luteovirens with an antioxidant activity index, as recited in the preamble, or merely analyzing the number of fragments, the number of SSR loci, SSR repetitive elements and repeating times of the amplification product. Accordingly, the metes and bounds of the claim are unclear.
For the purpose of compact prosecution and applying prior art, the phrase reciting "judging by… " is interpreted under BRI as "analyzing the number of fragments, the number of SSR loci, SSR repetitive elements and repeating times of the amplification product."
Claims 5-8 are rejected for depending from claim 4 and not remedying the indefiniteness.
Reasons for Lack of Rejection for Ineligible Subject Matter (35 USC 101)
The claimed invention in claims 4-8 and 10 meets the criteria for patent-eligible subject matter under the guidelines set forth in MPEP § 2106.
The subject matter eligibility test is below:
Step 1 - Whether the Claim is to a Statutory Category : YES. The claims are drawn to a method, therefore to one of the four statutory categories.
Step 2A Prong 1 - Whether the Claim Recite an Abstract idea, Law of Nature, or Natural Phenomenon: Yes.
The claims recites a judicial exception, namely a law of nature and natural phenomenon. Specifically, the claims are directed to the naturally occurring correlation between the naturally existing DNA sequences (i.e., simple sequence repeats (SSR)) in the genome of floccularia luteovirens and the mushroom's antioxidant activity.
Step 2A Prong 2- Whether the Claim Recite Additional Elements that Integrate the Judicial Exception into a Practical Application: No.
Claims 4 and 10 recite generating amplification products using primers specific to the DNA biomarkers. Claim 4 further recites detecting and analyzing the amplification products. These steps amount to data gathering and reflect extra-solution activities used to observe the recite natural relationship. They do not integrate the judicial exception into a practical application. See MPEP §2106.04(d).
Step 2B- Whether a Claim Amounts to Significantly More: Yes. In this instant case, the claims, when considered as a whole, recite additional elements that amount to significantly more than the judicial exception. Specifically, the claims require steps using specific combinations of primers that are not considered well-known, routine and conventional in the art.
Therefore, the claims are patent eligible because they recite additional elements that amount to significantly more than the judicial exception.
Subject Matter Not Taught/Suggested in Prior Art
No references were found teaching or suggesting claims 4-8 and 10, but they are rejected and/or objected to for reasons given above. The claims would be allowable if rewritten to overcome the objections and rejections under 35 U.S.C. 112(b) set forth in this Office action.
The following subject matter is not taught or suggested in the prior art:
Regarding independent claims 1 and 10, the prior art fails to teach or suggest all the claimed limitations. No prior art teach or fairly suggest the specific combinations of primers as required by the claims ꟷ namely, a primer group comprises one or more groups of:
SEQ ID NO: 1 and SEQ ID NO:2, and/or
SEQ ID NO:5 and SEQ ID NO:6, and/or
SEQ ID NO:10 and SEQ ID NO:11, and/or
SEQ ID NO:15 and SEQ ID NO:16.
Li 2 teaches analyzing for SSR Markers in Floccularia Luteovirens (see Abstract).
Liu 3 teaches antioxidant properties in Floccularia luteovirens (see Abstract).
However, no prior art teaches or suggests primers comprising SEQ ID NOs: 1, 2, 5, 6, 10, or 15. Thus, no prior art teaches or suggests the primer combinations required by the claim.
Therefore, claims 4 and 10 possess a novel and non-obvious combination of elements, particularly a primer set composed of at least one pair of primers each having a nucleotide sequence comprising SEQ ID NO: 1 and SEQ ID NO:2, or SEQ ID NO:5 and SEQ ID NO:6, or SEQ ID NO:10 and SEQ ID NO:11, or SEQ ID NO:15 and SEQ ID NO:16, that is neither taught nor suggested by the prior art.
Conclusion
Claims 4-8 are rejected; claims 4-8 and 10 are objected to; no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIAN NMN YU whose telephone number is (703)756-4694. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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/TIAN NMN YU/Examiner , Art Unit 1681
1 Claims 1-3, 9 and 11 are withdrawn as being drawn to non-elected groups I-II and IV.
2 Li, Kairui, et al. "Characteristics of SSR Markers in Floccularia Luteo-virens by RNA-Sequencing." Biomedical Journal of Scientific & Technical Research 2.1 (2018): 2264-2266.
3 Liu et al., Chen Q. Chemical characterization, antioxidant properties and anticancer activity of exopolysaccharides from Floccularia luteovirens. Carbohydr Polym. 2020 Feb 1;229:115432. doi: 10.1016/j.carbpol.2019.115432. Epub 2019 Oct 8. PMID: 31826528.
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