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 .
DETAILED ACTION
Applicant’s amendment filed on 17 July 2025 is entered. Claims 1-30 are amended. Claims 1-30 are pending.
Election/Restriction
Applicant’s election without traverse of group II, claims 8, 16, 23, and 30 in the reply filed on 17 July 2025 is acknowledged.
Claims 1-7, 9-15, 17-22, and 24-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 17 July 2025.
Claims 8, 16, 23, and 30 are under examination.
Priority
Acknowledgment is made of Applicant’s claim for priority to the filing date of JP2020-105650 filed 18 June 2020 and PCT/JP2021/016150 filed 21 April 2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
However, the certified copy of JP2020-105650 is in Japanese. Applicant’s claim to the foreign priority filing date of JP2020-105650 filed 18 June 2020 can be perfected by filing an English translation of the certified copy.
The effective filing date is 21 April 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 15 December 2022, 07 June 2023, 19 October 2023, 23 October 2023, and 06 February 2024 are being considered by the examiner.
Duplicate Claim Warning
Applicant is advised that should claim 23 be found allowable, claim 30 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).
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 8, 16, 23, and 30 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, 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.
It is apparent that biological material Bifidobacterium breve FERM BP-11175 is required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the biological material Bifidobacterium breve FERM BP-11175.
The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the biological material Bifidobacterium breve FERM BP-11175 that is considered necessary to make and use the invention is both known and readily available to the public.
Therefore, a deposit at a recognized depository may be made to obviate this rejection.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that all restrictions imposed by the depositor on the availability to the public on the deposited material will be irrevocably removed upon granting of the patent, would satisfy the deposit requirement made herein.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) The deposit will be maintained in a public depository for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
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 8, 16, 23, and 30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a natural phenomenon without significantly more.
The claims are drawn to the statutory category of a process (Step 1: Yes).
Claim 8 recites a process of making an agent for improving cognitive function in a subject who has not developed dementia, comprising formulating one or both of Bifidobacterium breve FERM BP-11175 and a culture of Bifidobacterium breve FERM BP-11175 into a dosage form for administration to said subject. Claim 16 recites a process of making an agent for maintaining cognitive function in a subject who has not developed dementia, comprising formulating one or both of Bifidobacterium breve FERM BP-11175 and a culture of Bifidobacterium breve FERM BP-11175 into a dosage form for administration to said subject. Claims 23 and 30 recite a process of making an agent for improving hippocampus function in a subject in need thereof, comprising formulating one or both of Bifidobacterium breve FERM BP-11175 and a culture of Bifidobacterium breve FERM BP-11175 into a dosage form for administration to said subject.
Each of the processes in claims 8, 16, 23, and 30 recite the same active step of formulating one or both of Bifidobacterium breve FERM BP-11175 and a culture of Bifidobacterium breve FERM BP-11175 into a dosage form. The term “formulating” does not have a special definition within the specification, so the plain meaning of “to prepare” is applied. The BRI of the “formulating” step includes the natural phenomenon of growth processes of Bifidobacterium breve FERM BP-11175, which itself is a naturally occurring bacteria isolated from human infant feces, as evidenced by pg. 8 sec. Preparation of Probiotics in Kobayashi et al. (Therapeutic potential of Bifidobacterium breve strain A1 for preventing cognitive impairment in Alzheimer’s disease, Scientific Reports 7:13510, published 18 October 2017). Thus, the claimed methods recite a natural process performed by a natural bacteria, Bifidobacterium breve FERM BP-11175, and are therefore drawn to the judicial exception of a natural phenomenon. (Step 2A Prong One: Yes).
This judicial exception is not integrated into a practical application and do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed methods recite a process of making an agent comprising a naturally occurring bacteria Bifidobacterium breve FERM BP-11175, and do not recite any active step of applying the claimed process for a particular purpose. The claimed methods do not improve a technology or technical field, apply the natural phenomenon to effect a particular treatment, or effect a transformation of a particular article to a different state or thing. The process step of formulating is recited at a high level of generality and thus is mere instructions to apply an exception, or is insignificant extra-solution activity.
Although the claims recite the limitations “for improving cognitive function in a subject who has not developed dementia”, “for maintaining cognitive function in a subject who has not developed dementia”, and “for improving hippocampus function in a subject in need thereof”, these limitations are interpreted as being desired uses of the agents that are produced by the methods of claims 8, 16, 23, and 30, but these limitations do not recite any active steps that apply the natural phenomenon for any particular therapeutic purpose. Therefore, the claims are directed to the judicial exception of a natural phenomenon without significantly more (Step 2A Prong Two and Step 2B: No), so the instant invention is not patent eligible subject matter under 35 USC §101.
Claim Rejections - 35 USC § 102
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.
Claims 8, 16, 23, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kobayashi et al. (Therapeutic potential of Bifidobacterium breve strain A1 for preventing cognitive impairment in Alzheimer’s disease, Scientific Reports 7:13510, published 18 October 2017), as evidenced by Xiao et al. (Probiotic Bifidobacterium breve in Improving Cognitive Functions of Older Adults with Suspected Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled Trial, Journal of Alzheimer’s Disease 77 (2020) 139–147), and the instant specification.
Claim 8 recites “for improving cognitive function in a subject who has not developed dementia”, claim 16 recites “for maintaining cognitive function in a subject who has not developed dementia”, and claims 23 and 30 recite “for improving hippocampus function in a subject in need thereof”. These limitations are interpreted as being desired uses of the agents that are produced by the methods of claims 8, 16, 23, and 30, but they do not recite any active steps that limit the processes of making the agents; thus, if the prior art teaches a method of making a composition by formulating one or both of Bifidobacterium breve FERM BP-11175 and a culture of Bifidobacterium breve FERM BP-11175 into a dosage form, claims 8, 16, 23, and 30 will be considered to be anticipated.
Kobayashi teaches a process of preparing a culture of Bifidobacterium breve strain A1 and a saline suspended cell formulation comprising Bifidobacterium breve strain A1, which are suitable for administration (Kobayashi pg. 8 sec. Preparation of Probiotics). Bifidobacterium breve strain A1 is the same strain as Bifidobacterium breve MCC1274, as evidenced by Xiao (Xiao Abstract), and Bifidobacterium breve MCC1274 is also equivalent to instant strain Bifidobacterium breve FERM BP-11175, as evidenced by the instant specification (Instant specification [0024]).
Therefore, Kobayashi teaches a process of preparing a culture and a saline suspended cell formulation comprising Bifidobacterium breve strain A1, and necessarily teaches a process of preparing a culture and a saline suspended cell formulation comprising Bifidobacterium breve FERM BP-11175.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Instant claims 8, 16, 23, and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending claims 8 and 14 of conflicting Application No. 17/299,390 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims anticipate the instant claims.
Instant claim 8 recites “for improving cognitive function in a subject who has not developed dementia”, instant claim 16 recites “for maintaining cognitive function in a subject who has not developed dementia”, and instant claims 23 and 30 recite “for improving hippocampus function in a subject in need thereof”. These limitations are interpreted as being desired uses of the agents that are produced by the methods of instant claims 8, 16, 23, and 30, but do not recite any active steps that limit the processes of making the agents.
Conflicting claim 8 recites a method of manufacturing a composition comprising formulating Bifidobacterium breve into a composition, and conflicting claim 14 limits the Bifidobacterium breve to Bifidobacterium breve FERM BP-11175.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander M Duryee whose telephone number is (571)272-9377. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/Alexander M Duryee/Examiner, Art Unit 1657