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 .
Notice of New Examiner
Please note that the correspondence for this application has changed.
Claim Status
The amended claim set filed 20 April 2026 is acknowledged. Claims 1, 3-7, 9, 11, and 14-15 are currently pending. Of those, no claims are currently amended, and no claims are new. Claims 3, 9, 11, and 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3 Nov 2025. Claims 2, 8, 10, and 12-13 are cancelled. Claims 1 and 4-7 will be examined on the merits herein.
For clarity, references to the specification in this action will use paragraph numbers from the original specification filed 23 Oct 2023.
Response to Arguments
The Applicants’ arguments filed 20 April 2026 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 21 Jan 2026 will be referred to as “NFOA.”
Priority
The application claims priority to CN202210619560.X (filed 2 June 2022) and is a 371 of PCT/CN2023/095948 (filed 24 May 2023). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, support for the claimed subject matter in the foreign priority document cannot be assessed because an English translation has not been filed. So for the sake of searching the art, the effective filing date used is 24 May 2023 for all claims.
The Office is not requiring that the foreign priority document be translated, but applicant cannot rely upon the earlier date from the certified copy of the foreign priority application to overcome an art 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 application 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 23 Oct 2023 has been considered by the new examiner. A signed copy of the statement is not attached because it has previously been signed and returned.
Objection(s) and Rejection(s) Withdrawn
The warning about substantial duplicate claims (NFOA par. 1) is moot because claims 2, 8, 10, and 12-13 were cancelled.
The rejection of claims 1-2, 4-8, 10, and 12-13 under 35 U.S.C. 112(a) (NFOA par. 2) is withdrawn in view of the deposit as described in the instant specification at [0007] and [0041] and the statement about public availability in the Remarks (pg. 7) that “it is certified that the deposit meets the criteria set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05.” The rules cited include 37 CFR 1.808(a)(2) that “Subject to paragraph (b) of this section, all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.”
The rejection of claim 2 under 35 U.S.C. 112(d) (NFOA par. 3) is moot because the claim has been cancelled.
The rejections of claims 1-2, 4-8, 10, and 12-13 under 35 U.S.C. 102(a)(2) as being anticipated by Han et al. (WO 2023/231854, NFOA par. 4) and also under 35 U.S.C. 102(a)(2) as being anticipated by Han et al. (US Publication 2025/0075169, NFOA par. 5) is withdrawn because the Remarks (pg. 8-9) argue that the references are inventor disclosures because the inventors of the prior invention include all inventors of the Han references and because the disclosures are entitled to a 102(b)(2)(C) exception due to their common ownership. Although the arguments only address the rejection over the WO publication, the argument that all inventors of the Han publication are also inventors on the instant application also applies to the US publication.
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 – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Specifically, the sequences are found on pg. 11-14.
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.
New Rejection(s)
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 4-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
Regarding claim 1, the claim recites “A Bacillus subtilis FNFH_BS06, with a preservation number of CGMCC No. 24836.” This claim is a composition of matter (Step 1: YES). The instant specification teaches that the FNFH_BS06 isolate was isolated from “5 g of a fermented soybean sample” by growing the bacterial suspension on media and isolating single colonies [0025]. The bacteria that were in the soybean sample are natural products, so the B. subtilis FNFH_BS06 isolate is a natural product that has been modified by isolation its natural state on the soybean sample. See MPEP 2106.04(c): “In Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. … The Supreme Court concluded that these isolated but otherwise unchanged genes were not eligible, because they were not different enough from what exists in nature to avoid improperly tying up the future use and study of the naturally occurring BRCA genes. See, e.g., Myriad, 569 U.S. at 585, 106 USPQ2d at 1977 ("Myriad's patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes … But isolation is necessary to conduct genetic testing") and 569 U.S. at 593, 106 USPQ2d at 1980 (describing how would-be infringers could not avoid the scope of Myriad’s claims). In sum, the claimed genes were different, but not markedly different, from their naturally occurring counterparts (the BRCA genes), and thus were product of nature exceptions.” The instant specification does not disclose any properties of the FNFH_BS06 strain that are markedly different as a result of the isolation. Therefore, it appears that, like in Myriad, the bacteria are different due to isolation but not markedly different and therefore the claim recites a product of nature exception. (Step 2A, Prong 1: YES)
This judicial exception is not integrated into a practical application because the claim does not recite any additional elements beyond the bacteria that might integrate the judicial exception into a practical application (Step 2A, Prong 2: NO). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite any additional elements beyond the bacteria that might amount to significantly more (Step 2B: NO).
Regarding claims 4-7, the claims recite methods of “applying the Bacillus subtilis FNFH_BS06 of claim 1 to” “a substrate comprising glycinin and/or β-conglycinin” (claim 4) or “a soybean meal containing comprising glycinin and/or β-conglycinin” (claims 5-7). These claims are processes (Step 1: YES). The instant specification teaches that this method step happens as a natural process because the isolate was purified from a soybean sample [0025]. So, B. subtilis FNFH_BS06 must have been naturally “applied” to the soybean meal in order to be present there for isolation. (Step 2A, Prong 1: YES)
Because the only step of the methods occurs naturally, the additional elements are the preambles of the methods. The preambles of these methods only recite intended uses for the method rather than limiting the application step. See MPEP 2111.02: “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. … See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation");” The preambles do not limit the method step because they discuss effects that are performed by the bacteria on its own after the application occurs (“degrading glycinin and/or β-conglycinin”, claims 4 and 6-7; “fermenting soybean meal”, claim 5), rather than discussing actions that are performed by the human user of the method during the application step that is claimed. Therefore, the preambles are given no weight.
This judicial exception is not integrated into a practical application because the claim does not recite any additional elements beyond natural step of applying the bacteria that might integrate the judicial exception into a practical application (Step 2A, Prong 2: NO). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite any additional elements beyond the step of applying the bacteria that might amount to significantly more (Step 2B: NO).
As a suggestion, the claim rejections could be overcome by adding limitations to the product/method claims to exclude the natural product/method, while being careful to not introduce new matter.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA N DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-F 8:30-4:30 (EDT/EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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