DETAILED ACTION
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, 3, 5 and 7-11 are rejected under 35 U.S.C. 101 because is directed to non-statutory subject matter because the claims are drawn to a bacterial strain which exists in nature. Bifidobacterium breve MCC1274 (FERM-11175). The claimed bacterial strain is not markedly different from what naturally exists in nature. Even though isolation structurally changes a strain from its natural state, the resultant difference is no enough to render the isolated strain markedly different because the genetic structure and cell has not been altered. See Myriad, 133 S.Ct. at 2166-18. A “food, drink, supplement, medicine” is an intended use only. The recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the product of nature. The “food, drink, supplement, medicine, etc.” do not require any additional ingredients.
Claim Rejections - 35 USC § 112-Deposit Information
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 1-11 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 Bifidobacterium breve MCC1274 (FERM-11175). Because it is not clear that the properties of the strains are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the best mode disclosed by the specification requires the use of the strains, a suitable deposit for patent purposes is required.
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 the 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 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 the 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;
© the deposits will be maintained in a public depository for a period of at least thirty years from the date of the deposit or for the enforceable life of the patent 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 non-viable or non-replicable.
In addition, a deposit of the biological material that is capable of self-replication either directly or indirectly must be viable at the time of the 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.
If the deposit was made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by Applicants, assignees or a statement by an attorney of record over his or her signature and registration number stating that 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 a deposit is 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 the deposit and the complete name and address of the depository is required.
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.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the cell line described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant's possession at the time the application was filed.
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
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.
(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.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kobayashi et al (US 2019/0083549; published March 21, 2019).
Kobayashi et al teach a novel agent useful for improving brain function. The active ingredient in this agent is a Bifidobacterium breve and/or a Bifidobacterium breve-containing cultured material. Paragraph [0009] teaches the agent or composition that improves the function of the brain having a Bifidobacterium breve and/or a cultured material containing Bifidobacterium breve may be Bifidobacterium breve MCC1274 (FERM BP-11175) and/or Bifidobacterium breve M-16V (BCCM LMG23729). [0013] This pharmaceutical may contain the aforementioned Bifidobacterium breve at 1×10.sup.6 to 1×10.sup.12 CFU/g. [0014] Furthermore, a food and beverage product able to improve brain function containing a Bifidobacterium breve and/or a cultured material containing a Bifidobacterium breve is also provided. [0015] Moreover, a Bifidobacterium breve and/or a cultured material containing Bifidobacterium breve for use toward prevention, treatment, and/or improvement of symptoms or diseases resulting from one or more reduced brain functions such as dementia, depression, schizophrenia, and/or delirium is also provided. In this case, the aforementioned Bifidobacterium breve may be Bifidobacterium breve MCC1274 (FERM BP-11175) and/or Bifidobacterium breve M-16V (BCCM LMG23729). [0065] When the agent or composition useful for improving brain function is used as a pharmaceutical, it may be used as it is, or concentrated, or processed into a solid, granular, or powder product. [0066] The pharmaceutical as described herein can be formulated into an appropriate and desired dosage form depending on the administration method, such as oral administration or parenteral administration. While such a dosage form is not limited, when administering orally, formulations including solid formulations such as powder formulations, granule formulations, tablets, troches, capsules; and liquid formulations such as solution formulations, syrups, suspensions, and emulsions can be used. When administering parenterally, formulations such as suppositories, spray formulations, inhalation formulations, ointments, patches, and injection formulations can be used. [0042] The agent or composition that is able to improve brain function can specifically be used, for example, in prevention, treatment, and/or improvement of symptoms of dementia, depression, schizophrenia, delirium, amnesia, reduced ability to make decisions or judgements, or to think, reduced cognitive ability, and dysfunction of intelligence. Kobayashi et al teach: [0045] Generally, in a patient having Alzheimer's disease, brain atrophy (atrophy of cerebral cortex and hippocampus, and enlarged ventricle) is observed and the cerebral cortex exhibits a pathological finding called a senile plaque. A major component of this senile plaque is known to be amyloid beta protein, hereinafter referred to also as “Aβ”. [0046] While the cause of Alzheimer's disease has not been definitively determined, it is assumed that the major factor is neurotoxicity that occurs during aggregation and accumulation of the Aβ present in the senile plaques formed in the brain, which degenerates the neurofibrils and eventually leads to nerve cell death. [0047] In view of the results of the Examples described below, the agent or composition that can be used to improve brain function as described herein is considered useful especially in Alzheimer's disease, among the aforementioned dementias. It is also noted that claims 1, 3, 5 and 7-11 are drawn to a product. The steps of a)-e) in claims 1 and 3 and the uses in claims 8-11, (medicine, supplement, etc.) are intended uses only. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xiao et al Journal of Alzheimer`s Disease, Vol. 77, no. 1, 2020, pages 139-147; provided by Applicants).
Xiao et al studies the effects of the probiotic bacterial strain Bifidobacterium breve A1 (MCC1274) on restoring cognitive function in a group of healthy people with suspected mild cognitive impairment (MCI), i.e., a method for suppressing brain atrophy, while the culture is administered as part of capsules (oral administration form) in an amount of 2X1010CFU in a randomized, double blind, placebo-controlled trial, 80 healthy older adults suffering from MCI were given capsules comprising probiotic (B. breve A1); cognitive function was assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBS), and when the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and the Japanese version of the MCI Screening (JMCIS) tests were used as the main assessment categories, RBANS total score was significantly improved, with significant improvement being seen particularly in domain scores of immediate memory, visuospatial/ constructional memory, and delayed memory; JMCIS score was also improved versus placebo; B. breve A1 is a safe and effective approach for improving memory functions in suspected MCI subjects; and the same is used as a food (abstract, tables 2, 3, fig. 2, p. 144, left column). The steps of a)-e) in claims 1 and 3 and the uses in claims 8-11, (medicine, supplement, etc.) and “for suppressing brain atrophy” are intended uses only. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 10,980,849. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims disclose Bifidobacterium breve MCC1274 (FERM BP-1175) as itself or in a culture for improvement of reduced brain function, yet the instant claims recite ‘brain atrophy.’ Generally, in a patient having Alzheimer's disease, brain atrophy (atrophy of cerebral cortex and hippocampus, and enlarged ventricle) is observed so the patented method of treating, reducing or/improvement in brain function, including Alzheimer’s disease is encompassed in the ‘treating brain atrophy’ as instantly claimed, particularly since the same strain is utilized
Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 18/009,966 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite composition comprising Bifidobacterium breve MCC1274 (FERM BP-1175) or a culture comprising Bifidobacterium breve MCC1274 (FERM BP-1175) and improving cognitive function. In the instant claims that is ‘brain atrophy suppression.” Accordingly, the scope of the claims is not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 19/431,257(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite composition comprising Bifidobacterium breve MCC1274 (FERM BP-1175) or a culture comprising Bifidobacterium breve MCC1274 (FERM BP-1175) and improving cognitive function. In the instant claims that is ‘brain atrophy suppression.” Accordingly, the scope of the claims is not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Prior art not presently relied upon:
Bernier et al (Journal of Alzheimer's Disease, IOS Press, NL, vol. 81, no. 2, 18 May 2021 (2021-05-18), pages 493-497); see abstract, fig. 1, 2, table 1, p. 494, left column.
Ohno et al (Journal of clinical and experimental medicine, Biomedical drugs publication, JP, vol. 276, no. 11, 13 March 2021 (2021-03-13), pages 1070-1072, see p. 1070, right column, third paragraph top. 1071, left column, second paragraph, fig. 1, conclusion).
JP 6 853821 B2 (MORINAGA MILK INDUSTRY CO LTD) 16 March 2021 (2021-03-16); indicates the use of Bifidobacterium breve MCC1274 (FERM BP-11175) for preventing decreased brain function such as dementia, amnesia, and reduced cognitive ability (claim 1, etc.), and indicates that: a culture of said bacterial strain is used in improving brain function; foods indicated as being for improving brain function are produced (paragraphs [0067], [0068]); and the culture is extremely useful because it is highly safe and poses no risk of side effects even when administered continuously for a prolonged period (paragraph [0082]).
WO 2021/256077 A1 (MORINAGA MILK INDUSTRY CO LTD [JP]) 23 December 2021 (2021-12-23); discloses that in Alzheimer-type dementia hippocampal atrophy occurs, resulting in deterioration of hippocampal function
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Daniel E. Kolker, can be reached on (571) 272-3181.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/Primary Examiner, Art Unit 1645 3/17/26
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