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 .
Claim Status
Claims 1-11 are pending (1/19/2024), and thus claims 1-11 are under examination (1/19/2024).
Priority
Claims 1-11 receive a priority date of 11/19/2021, the effective filing date of CN202111399048.0; however, no Foreign Priority Documents have been received.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure
statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information
submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be
incorporated into the specification but must be submitted in a separate paper." Therefore, unless
the references have been cited by the examiner on form PTO-892, they have not been
considered.
No information disclosure statements (IDS) were submitted to consider.
Specification
The disclosure is objected to because of the following informalities (see MPEP § 608.01):
The use of the terms “MISA” (p. 6), “Enhanced” (p. 7), and “Beyotime Biotechnology Co., Ltd (p. 7) which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Drawings
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 (Figures 2-4):
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, 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 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 3 and 6-7 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.
Regarding claim 3 at line 3, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 6 contains the trademark/trade name “Taq PCR Master Mix”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a reaction system protocol for fluorescent PCR amplification and, accordingly, the identification/description is indefinite.
Claim 7 is included in this rejection due to its dependency on claim 6.
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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
The claims recite DNA barcodes and primer groups comprising nucleotide sequences derived from Floccularia luteovirens, as well as methods and products that use the naturally occurring nucleotide sequences to screen Floccularia luteovirens based on naturally occurring characteristics, such as total soluble protein or antioxidant content. Specifically, the claimed nucleotide sequences correspond to genetic material naturally present in , and the association between the genetic markers and the identified characteristic represents a naturally occurring relationship.
This judicial exception is not integrated into a practical application because the claimed DNA sequences are not markedly different from their naturally occurring counterparts, and the additional PCR amplification, electrophoresis, and detection steps merely detect and evaluate the naturally occurring genetic relationship. The claims do not include additional elements that are sufficient to amount to the polynucleotide structures being markedly different than the judicial exception because the claims do not include additional elements, when considered separately and in combination, that are sufficient to be markedly different than the judicial exception.
Subject Matter Eligibility Test for Products and Processes
Step 1 - Is the Claim to a Process, Machine, Manufacture or Composition of Matter? YES.
The claims provide for a DNA barcodes comprising specified nucleotide sequences of (claim 1), primer groups comprising specific nucleotide sequences (claims 2-3), methods employing the DNA barcodes and primer groups for screening (claims 4-8), applications thereof (claims 9-10), and a product comprising the primer groups (claim 11). Thus, the claims are directed to a statutory category (i.e., a process or composition of matter).
Step 2A, Prong One — Does the Claim Recite a Product of Nature? YES.
The claims recite nucleotide sequences corresponding to naturally occurring genetic sequences of Floccularia luteovirens and relationships between those genetic markers and naturally occurring characteristics of Floccularia luteovirens. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, whether isolated or not, such naturally-occurring nucleotide sequences are deemed to fall under the judicial exception of natural products, and as such, are not patent-eligible subject matter pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., -- U.S. -- (June 13, 2013).
In Myriad, the Supreme Court considered the patent eligibility of several claims directed to isolated DNA related to the human BRCA1 and BRCA2 cancer susceptibility genes. The Supreme Court held that certain of Myriad Genetics' claims to isolated DNA are not patent-eligible, because they read on isolated naturally-occurring DNA that is a "product of nature." The Court held that isolating a "gene from its surrounding genetic material is not an act of invention." The Supreme Court held that other claims are patent eligible, because they are limited to cDNA, which is a type of man-made DNA composition that is not naturally occurring. The Court held that "cDNA is not a 'product of nature' and is patent eligible under §101.”
Step 2A, Prong Two — Does the Claim Recite an Additional Elements that Integrate the Judicial Exception into a Practical Application? NO.
The Supreme Court has long distinguished between principles themselves, which are not patent eligible, and the integration of those principles into practical applications, which are patent eligible. However, absent are any additional elements recited in the claim beyond the judicial exceptions which integrate the exception into a practical application of the exception. The “integration into a practical application” requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception. The claim limitations directed to DNA barcodes comprising specified nucleotide sequences, primer groups comprising nucleotide sequences, and the use of such sequences for screening Floccularia luteovirens are not indicative of integration into a practical application. The above claim limitations are considered simply as the recitation of a naturally-occurring product and their relationship to characteristics of Floccularia luteovirens. Thus, the claims do not provide for any element/step that integrates the law of nature into a practical application.
Step 2B - Does the Claim Recite Additional Elements that Amount to Significantly More than the Judicial Exception? NO.
The Supreme Court has identified a number of considerations for determining whether a claim with additional elements amounts to “significantly more” than the judicial exception(s) itself. The claims as a whole are analyzed to determine whether any additional element/step, or combination of additional elements/steps, in addition to the identified judicial exception(s) is sufficient to ensure that the claim amounts to “significantly more” than the exception(s).
However, the additional elements of the instant application, individually and in combination, do not amount to “significantly more” or “markedly different.” Under the Step 2B analysis, the “physical” elements of the claims are considered to be the same as those found in nature.
For example, Liu et al. (“The Genomic and Transcriptomic Analyses of Floccularia luteovirens, a Rare Edible Fungus in the Qinghai–Tibet Plateau, Provide Insights into the Taxonomy Placement and Fruiting Body Formation”, Journal of Fungi, published 10/20/2021) discloses genomic analysis of naturally occurring Floccularia luteovirens (Abstract). Liu discloses sequencing the genome of Floccularia luteovirens strain C10 and obtaining a 27 Mb draft genome comprising 23 contigs, and further identifies coding genes and interspersed repetitive sequences within the naturally occurring genome (Sections 2.2, 2.4, 3.1; Figure 1). Thus, Liu establishes that the genomic nucleotide sequences and repetitive sequence regions of Floccularia luteovirens are naturally occurring genetic features of the organism.
Further Zhai et al. (“Overexpression of soybean GmERF9 enhances the tolerance
to drought and cold in the transgenic tobacco”, Plant Cell Tissue Organ Culture, published 2017) discloses naturally occurring soybean nucleotide sequences, including the GmERF9 gene, and the use of specific primer pairs to amplify and analyze such sequences (p. 608-609; Table 1). Zhai further discloses extracting total RNA, performing reverse transcription and qPCR, and using gene-specific primers to analyze gene expression (p. 608-610). Thus, Zhai establishes that amplification and analysis using specific primers and conventional PCR techniques are routine techniques for detecting and evaluation naturally occurring nucleotide sequences.
Additionally, AlFadhli et al. (“Association of Hashimoto’s thyroiditis with cytotoxic
T lymphocyte-associated antigen-4 (CTLA-4) and inducible co-stimulator (ICOS) genes in a Kuwaiti population”, Endocrine, published 2013) discloses naturally occurring microsatellite repeat polymorphisms, including CTLA-4 3’UTR (AT)n and ICOS (GT)n repeats, and analyzes these generic markers using fluorescent OCR and fragment analysis (p. 666-668). AlFadhli further discloses amplification using specific primers, fluorescently labeled PCR products, and separation using a genetic analyzer to determine fragment sizes and repeat numbers (p. 667-668). Thus, AlFadhli establishes that PCR amplification and fluorescent fragment analysis of naturally occurring repetitive genetic markers are routine techniques for detecting and characterizing naturally occurring nucleotide variations.
Therefore, the claimed DNA barcodes and primer groups are not markedly different from nucleotide sequences found in nature. Merely identifying the naturally occurring sequences as DNA barcodes or primers for screening Floccularia luteovirens is insufficient to distinguish the claimed nucleotide sequences from naturally occurring genetic material.
Thus, when viewed both individually and as an ordered combination, the claimed elements, in addition to the identified judicial exception are found insufficient to supply an inventive concept because the elements are not deemed to be markedly different from those found in nature. Accordingly, the claims do not qualify as patent-eligible subject matter.
Allowable Subject Matter
Regarding claims 1-11, while the claims are presently rejected under 35 USC 101, and claims 3 and 6-7 are additionally rejected under 35 USC 112 (b), SEQ ID NOs: 1-12 are considered allowable over the prior art of record. As previously showcased, Liu discloses the genome and genomic characteristics of Floccularia luteovirens, including genomic sequencing and analysis of repetitive sequences; however, Liu does not teach or suggest the specific primer sequences recited as SEQ ID NOs: 1-12 or their use for amplification of the claimed SSR loci.
Further, it would not have been obvious to modify known primers to arrive at the specifically claimed sequences because primer function and specificity depend upon the particular target and flanking sequences, and modification could alter hybridization and amplification specificity without a reasonable expectation of successfully obtaining the claimed primers. Accordingly, claims 1-11 contain allowable subject matter over the prior art of record.
Therefore, claims 1-11 would be allowable if amended to overcome the outstanding 101 rejection, and with respect to claims 3 and 6-7, the 112(b) rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH ROSE LAFAVE whose telephone number is (703)756-4747. The examiner can normally be reached Compressed Bi-Week: M-F 7:30-4:30.
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/ELIZABETH ROSE LAFAVE/Examiner, Art Unit 1684
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684
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