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
Applicant's election with traverse of Group 1 (Bacillus subtilis FNFH_BS08 bacteria, claims 1-2) in the reply filed on 12 Jan 2026 is acknowledged. The traversal is on the ground(s) that claims 4-18 are amended to method steps and that the claims fulfill unity of invention by the special technical feature of B. subtilis FNFH_BS08, which is a different strain from the B. subtilis strain disclosed in Ramos et al.
This is not found persuasive for Group II (a fermented product) because it is drawn to a fermented product rather than a bacteria and there is no requirement in the claim that the fermented product comprise any of the B. subtilis FNFH_BS08 bacteria. The restriction argued that the fermented product (eg. lactate, acetate, 2,3-butanediol) was known in the art, which has a defined chemical structure that would be identical even if it was made by a different B. subtilis strain. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production or point of isolation. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
However, claims 4-10, 13, and 15-16 are rejoined because they recite the technical feature of the Bacillus subtilis FNFH_BS08 bacteria. Claims 11-12, 14, and 17-18 recite methods of using the fermented product and remain withdrawn.
Claims 3, 11-12, 14, and 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12 Jan 2026.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
The amended claim set filed 12 Jan 2026 is acknowledged. Claims 1-18 are currently pending. Of those, claims 4-18 are currently amended, and no claims are new. Claims 3, 11-12, 14, and 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12 Jan 2026. No claims are cancelled. Claims 1-2, 4-10, 13, and 15-16 will be examined on the merits herein.
Priority
The application claims priority to CN202210619567.1 (filed 2 June 2022) and is a 371 of PCT/CN2023/095949 (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 filed 16 Oct 2023 fails to fully comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. The NPL references #6-7, the international search report and written opinion, are not in the English language and the references were not submitted with a summary of the relevance. The IDS has been marked to indicate that these references were not considered. Also, NPL reference #1 was submitted with an English abstract as the explanation of the relevance. The IDS has been marked to indicate that only the abstract has been considered. Other references in the IDS comply with the provisions of 37 CFR 1.97 and have been considered by the examiner. A signed copy of the statement is attached with this action.
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 16S rRNA sequence and gyrB sequence on pg. 19-21 of the specification do not have sequence identifiers.
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
Applicant is advised that should claims 4-8 be found allowable, claims 9-10, 13, and 15-16, respectively, will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claims 9-10, 13, and 15-16 recite methods using the bacterial agent of claim 2, but calling the B. subtilis strain a bacterial agent in no way changes the composition (e.g., further comprising a pharmaceutically acceptable carrier, excipient, etc.) These method claims are substantial duplicates of claims 4-8, which are methods using the strain itself, for the same reasons that claim 2 does not further limit claim 1 (see 112(d) rejection below).
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites “A bacterial agent” containing the Bacillus subtilis FNFH BS06 of claim 1. However, calling the B. subtilis strain a bacterial agent in no way changes the composition (e.g., further comprising a pharmaceutically acceptable carrier, excipient, etc.) As the composition remains structurally identical, claim 2 fails to further limit the composition of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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 7 and 15 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.
The term “improving a nutritional value” in claims 7 and 15 is a relative term which renders the claim indefinite. The terms “improving” and “nutritional value” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. “Improving” recites a value judgement, where one of ordinary skill may or may not have the opinion that a value has improved by a change (as contrasted with a measurable change such as an increase or decrease). Also, “nutritional value” is a vague term because it could be measured many different ways (for example, total calories available, amounts of certain macro- or micro-nutrients, etc.) and would differ for different organisms (based on the species of the organism, dietary sensitivities, daily caloric needs, etc.). Therefore, one of ordinary skill in the art could not objectively determine what the “nutritional value” is and whether it has been “improved”. Claims 8 and 16 are not included in this rejection because they define the term “improving the nutritional value”.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 4-10, 13, and 15-16 would have been rejected as being not enabled but for the deposit of the B. subtilis FNFH_BS08 strain. Deposit conditions were described in the instant specification [0062], and the attorney of record Daniel Hsieh stated in the Remarks filed 12 Jan 2026 “it is certified that the deposit meets the criteria set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05.” (Remarks pg. 9). 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.” This is not a rejection.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chen et al. (WO 2023231853 A1, priority claim to 2 June 2022; hereafter Chen; PTO-892). References to locations in Chen refer to the machine translation attached with this document, unless otherwise specified.
Chen discloses the Bacillus subtilis FNFH_BS08 strain (description of Figure 4, pg. 4). This disclosure is supported by the foreign priority document (see pg. 6, the strain name “FNFH_BS08” is written in English characters).
Applicant 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 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.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-10, 13, 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (WO-2023231853-A1, priority claim to 2 June 2022; hereafter Chen; PTO-892) in view of Wang et al. (CN-106167782-A, published 2016; hereafter Wang; PTO-892). References to page numbers refer to English machine translations that are attached with this action.
Chen discloses the Bacillus subtilis FNFH_BS08 strain (description of Figure 4, pg. 4).
Chen does not disclose method of adding B. subtilis FNFH_BS08 to a substrate containing antigen proteins and/or non-starch polysaccharides, as in claims 4 and 9. Chen does not disclose the antigen proteins comprise glycinin and B-conglycinin, and the non-starch polysaccharides comprise cellulose, xylan, mannan, and pectin, as in claims 5 and 10. Chen does not disclose methods of fermenting soybean meal, improving nutritional value of soybean meal in fermentation of the soybean meal, where the methods comprise adding the B. subtilis FNFH_BS08 to the soybean meal, as in claims 6-7, 13 and 15. Chen does not teach that the intended use of a nutritional value of soybean meal is specifically manifested by a decrease in content of antigen proteins, non-starch polysaccharides, oligosaccharides and a trypsin inhibitor, an increase in content of a crude protein and a water-soluble protein, and an increase in protein solubility in fermented soybean meal, as in claims 8 and 16.
Wang teaches that soybean meal comprises anti-nutritional factors such as antigen protein, trypsin inhibiting factor, phytic acid, which are commonly degraded by fermentation and commonly used strains include Bacillus (pg. 1-2 “Background technique” section). Wang teaches that soybean meal comprises glycinin and β-conglycinin (pg. 3 Embodiment 1 “3. Re-screening” section). Wang also teaches that specifically B. subtilis can be used to ferment soybean meal (Abstract).
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to modify the B. subtilis FNFH_BS08 strain of Chen by using to ferment soybean meal (i.e. a substrate containing antigen proteins and/or non-starch polysaccharides) as taught by Wang, thereby arriving at the claimed invention, because Wang teaches that Bacillus such as B. subtilis are commonly used for this purpose. Therefore, the combination leads to expected results and would have a reasonable expectation of success because the element performs the same function that it is commonly used for. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that applying a known technique to a known device, method or product ready for improvement is obvious because a particular known technique is recognized as part of the ordinary capabilities of one skilled in the art. In the instant case, Chen contains a “base” product of B. subtilis FNFH_BS08; and Wang contains a similar method for using Bacillus to ferment soybean meal wherein the technique of fermentation is taught as advantageous to remove antigenic proteins and other anti-nutritional factors. Thus, one of ordinary skill in the art would have recognized that applying the known technique taught by Wang would have yielded predictable results (i.e. the same advantages) and an improved system.
Regarding the functional limitations in the preamble’s intended use, “degrading antigen proteins and/or non-starch polysaccharides”, “improving a nutritional value of soybean meal”, and “the improving a nutritional value of soybean meal is specifically manifested by a decrease in content of antigen proteins, non-starch polysaccharides, oligosaccharides and a trypsin inhibitor, an increase in content of a crude protein and a water-soluble protein, and an increase in protein solubility in fermented soybean meal”: MPEP 2111.02 states “to satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)”. The instant specification demonstrates that the B. subtilis FNFH_BS08 is capable of performing the intended uses when used to ferment soybean meal (Experimental Embodiment 3). Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA NICOLE DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-R 8:30-4:30, and every other F 8:30-4:30 (EDT/EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dan Kolker can be reached at (571) 272-3181. 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
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645