DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-14 are currently pending.
Election/Restrictions
Applicant’s election with traverse of Group III, Claims 12-14, and of species hypercholesterolemia, in the reply filed on 1/12/2026 is acknowledged. The traversal is on the ground(s) that there would be no undue burden to search all groups together. This is not found persuasive because as indicated by the rejections below, the groups do not share the special technical feature which contributes over the prior art at the time the invention was made. Upon further consideration, species election in Group III is withdrawn.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-11 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking claims.
Claims 12-14 are being examined in this application.
Claim Objections
Claim 13 is objected to because of the following informalities: the recitation of “herein” on line 1 is suggested to read “wherein”. 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 12-14 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 claims contain 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 employs Lactobacillus gasseri LG050 under the accession number “LMG P-29638” and Bifidobacterium lactis BL050 under the accession number “DSM 25566”. 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. Therefore, a deposit for patent purposes is required.
It appears that deposits were made in this application as filed as noted on page 3 last para, page 4 para 1 & 5, page 5 last para, and page 6 para 2 of the instant specification. However, it is not clear if these deposits meet 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.
Both Budapest Treaty and non-Budapest Treaty deposits must provide assurances that:
(1) Access to deposited material will be available, during pendency of a patent application making reference to it, to anyone determined by the Director to be entitled to access under 37 CFR 1.14 and 35 U.S.C. 122 (see In re Lundak, 227 USPQ 90, 94-95 (Fed. Cir. 1985)(citing 35 U.S.C. 114)); and
(2) Subject to paragraph (b) of 37 CFR 1.808, 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.
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.
In the instant case, the address of the depository is missing. In addition, it is not clear if a viability statement for Lactobacillus gasseri LG050 under the accession number “LMG P-29638” and Bifidobacterium lactis BL050 under the accession number “DSM 25566” is available. 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 § 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 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 of this title, 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.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (CN107550942A; 1/9/2018.).
The instant claims recite a method of treating a metabolic syndrome comprising: administering to a subject in need thereof a probiotic combination comprising two or more strains belonging to different species selected from: Lactobacillus gasseri and Bifidobacterium lactis, wherein said probiotic combination comprises the bacterial strain of Lactobacillus gasseri LG050 deposited at BCCM (Belgian Coordinated Collections of Micro-organisms) - LMG (Laboratorium voor Microbiologie - Bacteriënverzamelig) under the accession number “LMG P-29638” on 24/05/2016 and the bacterial strain of Bifidobacterium lactis BL050 deposited at DSMZ - DeutscheSammlung von Mikroorganismen und Zellkulturen GmbH under the accession number “DSM 25566” on 17/01/2012.
Liu teaches a method of treating metabolic diseases (Title), comprising administering a composition (p.3 para 5) comprises Lactobacillus gasseri and Bifidobacterium lactis BB12 (p.3 para 4), wherein the composition treats type II diabetes, obesity and hyperlipidemia (p.6 para 1).
Liu does not teach the bacterial strains with the claimed deposit numbers (claim 14).
However, Liu does teach the composition comprises Lactobacillus gasseri and Bifidobacterium lactis BB12 can be used to treat metabolic diseases. Therefore, the reference strains would nevertheless have rendered the claimed strains obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the clear, close relationship between the strains as evidenced by their belonging to the same species and their essential characteristic – treating a metabolic syndrome.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (CN107550942A; 1/9/2018.) as applied to claims 12-13 above, further in view of Lewis et al (US 2020/0023021 A1; 1/23/2020.).
Liu does not teach the method wherein the combination is administered in a physiologically acceptable excipient (claim 14).
However, Liu does teach the composition can be used to treat type II diabetes, obesity and hyperlipidemia, and the composition comprises excipients (p.3 para 5). Lewis teaches a weight loss composition that is capable of aiding weight loss (para 0007), comprising excipients that have the proven ability to support the growth of one or more of probiotic strains (para 0036) including Lactobacillus gasseri and Bifidobacterium lactis BB12 (Claims 1 and 11), wherein suitable excipients include fructo-oligosaccharide and inulin (para 0036, Claim 8).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate a physiologically acceptable excipient such as fructo-oligosaccharide and inulin, since Liu discloses a composition comprises probiotics and excipients useful for treating type II diabetes, obesity and hyperlipidemia, and Lewis discloses that fructo-oligosaccharide and inulin are well-known excipients and routinely used to support the growth of one or more of probiotic strains. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to incorporate a physiologically acceptable excipient such as fructo-oligosaccharide and inulin, with a reasonable expectation for successfully treating metabolic diseases.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759