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 .
The amendment filed 1/23/26 has been entered. Claims 16-17 have been added. Claims 1-9 have been amended.
Claims 1-17 are pending in the application. Claims 5-6 and 12-15 are withdrawn.
Claims 1-4, 7-11 and 16-17 are under examination.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 1/23/26 and the election of SEQ ID NO: 22 as the species of the DNA is acknowledged. Applicants state the claims 1-4, 7-9 and 16-17 read on the elected species. Group I in the restriction mailed on 9/26/25 is drawn to a composition. Applicant in the reply to the restriction has converted the claims of Group I to a method of using the composition for preventing or treating deterioration in brain function, or for maintaining or improving brain function in a subject in need thereof. Claims 10-11 remain product claims but since they were included Group I, they are rejoined for examination of the Group I claims now drawn to a method of administering the composition.
Claims 5-6 and 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/23/26.
Information Disclosure Statement
Information disclosure statements filed 5/31/23, 1/16/25, 5/22/25 and 10/27/25 have been considered and initialed copies are enclosed.
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:
The size of the sequence listing is in kilobytes but should be in bytes.
Specification
The disclosure is objected to because of the following informalities: the font in table 1 and table 2 is indecipherable.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on p. 97 line 16, Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-4, 7-9 and 16-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claim 1 is drawn to a method for preventing or treating deterioration in brain function, or for maintaining or improving brain function in a subject in need thereof,Faecalibacterium prausnitzii, a component of the microorganism, or a culture of the microorganism, said microorganism having a DNA including a nucleotide sequence encoding an amino acid sequence having 40% or more homology to the amino acid sequence encoded by the nucleotide sequence set forth in SEQ ID NO: 22.
The claims require a genus of Faecalibacterium prausnitzii wherein the members of this genus have different DNA including a nucleotide sequence encoding an amino acid sequence having 40% or more homology to the amino acid sequence encoded by the nucleotide sequence set forth in SEQ ID NO: 22.
The claims also require a genus of components derived from the said microorganism wherein the genus encompasses different subcellular components, polysaccharide structures, lipids, plasmids, genomic DNA and these can be derived from a microorganism of Faecalibacterium prausnitzii, said microorganism having a DNA including a nucleotide sequence encoding an amino acid sequence having 40% or more homology to the amino acid sequence encoded by the nucleotide sequence set forth in SEQ ID NO: 22.
The specification identifies two strains Faecalibacterium prausnitzii Fp14 and Fp360 isolated from feces of healthy patients were suggested to be effective in both the Y-maze test and the passive avoidance test in a mice model of brain function, and were found to potentially have an improvement effect on the deterioration in brain function, such as learning and memory disorders.
The specification teaches that the culture supernatants and dead bacterial bodies of these two strains were also evaluated for the degree of improvement in learning and memory disorders. Based on the results of the Y-maze test, as shown in FIG. 5, an improvement effect and improvement trend was observed for both Fp14 and Fp360.
The specification teaches that the genome of the Fp14 and Fp360 strains was analyzed and the coding regions were predicted. Based on predicted gene information, orthologs were identified and were primarily clustered at an identity of 70% or more in BLASTP homology.
Orthologs of gene sequence unique to Fp14 and Fp360 strains was identified and the sequences of these genes are set forth in SEQ ID NOs: 1 to 27 and 29 to 57, respectively. Additionally, ICBIDGAJ_00537 and BLCPAMOF_00623 (SEQ ID NOs: 28 and 422) were extracted as genes corresponding to the unique KO1684 that characterizes Fp14 and Fp360.
The specification teaches that as shown in FIG. 11, the administration of Fp14 was observed to tend to decrease the amount of amyloid-β accumulated in the hippocampus of the AD model mice. The specification teaches that the onset and progression of AD are believed to be due to the fibrillization, aggregation, and accumulation of amyloid-β produced in the brain and conclude that conjunction with the results of Example 3 (Efficacy Animal Test), Fp14 at least has demonstrated potential effectiveness for the prevention, treatment, and improvement of AD.
However, the specification does not describe any component derived from Faecalibacterium prausnitzii that can prevent or treat deterioration in brain function or maintaining or improving brain function.
In addition, the specification does not describe the common structure of the genus of Faecalibacterium prausnitzii wherein the members of this genus have different DNA including a nucleotide sequence encoding an amino acid sequence having 40% or more homology to the amino acid sequence encoded by the nucleotide sequence set forth in SEQ ID NO: 22 that correlates with preventing or treating deterioration in brain function or maintaining or improving brain function.
The disclosure of the Fp14 and Fp360 F. prausnitzii strains is insufficient to describe the genus of components derived from F. prausnitzii and describe the genus of Faecalibacterium prausnitzii wherein the members of this genus have different DNA including a nucleotide sequence encoding an amino acid sequence having 40% or more homology to the amino acid sequence encoded by the nucleotide sequence set forth in SEQ ID NO: 22 that can prevent or treat deterioration in brain function or maintain or improve brain function.
The only strains described are Fp14 and Fp360 correlated with preventing or treating deterioration in brain function or maintaining or improving brain function.
Although one of ordinary skill in the art could have screened members of the genus of components and members of the genus of Faecalibacterium prausnitzii for those that can prevent or treat deterioration in brain function or for maintaining or improving bran function, the written description provision of 35 U.S.C. § 112 are severable from its enablement provision Vas-Cath, Inc. v. Mahurkar, 1115 and possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69USPQ2d at 1895.
In view of these considerations, as of the effective filing date of the instant invention Applicants were not in possession of the genus of components and the genus of Faecalibacterium prausnitzii wherein the members of this genus have different DNA including a nucleotide sequence encoding an amino acid sequence having 40% or more homology to the amino acid sequence encoded by the nucleotide sequence set forth in SEQ ID NO: 22 that can prevent or treat deterioration in brain function or maintain or improve brain function. Applicants as of the effective filing date were in possession of the Fp14 strain (NITE BP-03169) comprising SEQ ID NO: 1-28 and Fp360 (NITE BP-03196) which comprises SEQ ID NO: 29-57 and 422.
Claims 10-11 and 16-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification lacks complete deposit information for the deposit of strain deposited as NITE BP-03169 (Fp14) and NITE BP-03196 (Fp360). Because it is not clear that these bacteria are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the claims these strains, a suitable deposit for patent purposes is required. Exact replication of the strains is an unpredictable event.
Applicant's referral to the deposit of the strains on p. 102-103 is an insufficient assurance that all required deposits have been made and all the conditions of 37 CFR §1.801-1.809 have been met.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of deposit and the complete name and full street address of the depository is required.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request;
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application;
(c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become nonviable or non-replicable.
In addition, a deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit. Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application and must contain:
1) The name and address of the depository;
2) The name and address of the depositor;
3) The date of deposit;
4) The identity of the deposit and the accession number given by the depository;
5) The date of the viability test;
6) The procedures used to obtain a sample if the test is not done by the depository; and
7) A statement that the deposit is capable of reproduction.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
Applicant's attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
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 1-4, 7-9 and 16-17 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 claims recite “microorganism of Faecalibacterium prausnitzii” is vague and indefinite. Faecalibacterium prausnitzii is a species of the genus Faecalibacterium. It is not clear what microorganism of Faecalibacterium prausnitzii means since Faecalibacterium prausnitzii is recited at the species level.
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 10-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claim(s) recite(s) a microorganism which is specified by accession number NITE BP-03169 and NITE BP-03196.
A microorganism which is specified by accession number NITE BP-03169 and NITE BP-03196 is isolated from feces of human subject as taught by the instant specification.
“Natural phenomena, including naturally occurring organisms, are not patentable.”. See In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1335-1336 (Fed. Cir. 2014). Supreme Court precedent teaches that neither isolating natural products nor combining them together represents an act of invention that would transform these naturally occurring products into patent eligible subject matter unless their combination results in something "markedly different”. See Ass 'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2117 (2013).
Thus, the claims as a whole does not amount to significantly more than the “product of nature” by itself. Thus, the claims does not qualify as eligible subject matter under 35 USC 101.
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)(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.
Claim(s) 1-4, 7-11 and 16-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ueda et al. Cell Reports Medicine 2, 100398, September 21, 2021, cited in IDS.
Claim 1, 3: Ueda et al disclose a method for preventing or treating deterioration in brain function, or for maintaining or improving brain function in a subject in need thereof,Faecalibacterium prausnitzii strain Fp360 or strain Fp14 or a culture of the microorganism, said Faecalibacterium prausnitzii strain Fp360 or strain Fp14 having a DNA including a nucleotide sequence encoding an amino acid sequence having 40% or more homology to the amino acid sequence encoded by the nucleotide sequence set forth in SEQ ID NO: 22.
The instant specification teaches that Faecalibacterium prausnitzii strain Fp360 or strain Fp14 has a DNA including a nucleotide sequence encoding an amino acid sequence having 40% or more homology to the amino acid sequence encoded by the nucleotide sequence set forth in SEQ ID NO: 22.
See abstract, p. 4 under F. prausnitzii isolates improved Ab-induced cognitive impairment, figure 3, p. 5 under The selected Fp14 and Fp360 improved Ab-induced cognitive impairment in different bacterial forms (pasteurized or live), figure 4, p. 7 and discussion.
Claim 2 and claim 4: According to the instant specification, Fp14 and Fp360 has the 28 DNAs (1) to (28), respectively and Ueda et al at figure 5, table S5.
Claim 7: Ueda et al disclose the brain function is cognitive function. See figure 4.
Claim 8-9: The composition of Ueda et al is a pharmaceutical composition and can be considered a food composition as it was administered orally and no other components are recited as part of the pharmaceutical or food composition.
Claims 10-11 and 16-17: According to the instant specification FP14 and Fp360 are the same microorganisms specified under accession # NITE BP-03169 and BP-03196, respectively.
Status of Claims
Claims 5-6 and 12-15 are withdrawn.
Claims 1-4, 7-11 and 16-17 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645