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 .
Claims 1-11 are pending in this application and are being examined.
Objection(s):
Claims 1 and 5 are objected to because of the following informalities:
In claim 1, line 11, after 15210 (end of the sentence), insert, --the composition increases enterochromaffin cell number and reduces cortisol level--.
In claim 1, line 6, replace “with” with –under--, line 8, replace “with” with –under--, and line 10, replace “with” with –under--.
In claim 5, line 7, replace “with” with –under--, line 9, replace “with” with –under--, and line 11, replace “with” with –under--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Requirement for Deposit of Biological Material
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 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The invention appears to employ a specific strains: Lactobacillus plantarum LPL28, Lactobacillus acidophilus TYCA06, and Bifidobacterium breve CCFM1025.
It is not clear if the written description is sufficiently repeatable to avoid the need for a deposit.
Further it is unclear if the starting materials were readily available to the public at the time of invention.
It appears that a deposit was made in this application as filed as noted in applicant’s specification (See for example, p. 8 of table 1). However, it is not clear if the deposit meets all of the criteria set forth in 37 CFR 1.801-1.809. Applicant or applicant's representative may provide assurance of compliance with the requirements of 35 U.S.C § 112, first paragraph, in the following manner.
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and averring the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material.
1. Identifies declarant.
2. States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
3. States that the deposited material has been accorded a specific (recited) accession number.
4. States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
5. States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
6. States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
7. That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g. see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
Copy of deposit receipt is/are required.
Prior art teachings:
Although Szala-Rycaj et al. teach Bifidobacterium breve CCFM1025 strain, and Lactobacillus plantarum and their beneficial effect on the colon microflora and on stress (See p. 328 right-hand column last paragraph and p. 331 Table 2. ), and further teach improvement of mood in rats treated with probiotics including Lactobacillus acidophilus (See for example, p. 329 left-hand column 1st paragraph).
The claimed bacterial strain composition comprising: a Bifidobacterium breve CCFM1025 strain, a Lactobacillus plantarum LPL28 strain, and a Lactobacillus acidophilus TYCA06 strain; wherein the Bifidobacterium breve CCFM1025 strain is deposited at the Guangdong Microbial Culture Center with a deposition number of GDMCC 60386; the Lactobacillus plantarum LPL28 strain is deposited at the China General Microbiological Culture Collection Center with a deposition number of CGMCC 17954; the Lactobacillus acidophilus TYCA06 strain is deposited at the China General Microbiological Culture Collection Center with a deposition number of CGMCC 15210, is not taught by prior art.
Conclusion(s):
No claim(s) is allowed at this time.
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/KADE ARIANI/Primary Examiner, Art Unit 1651
