DETAILED ACTION
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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-6, and species “a dried product” in claim 3 and “freeze-dried powder” in claim 4 in the reply filed on 12/08/2025 is acknowledged. The traversal is on the ground(s) that “the multiple groups can be searched and examined together without undue burden”. This is not found persuasive because inventions of Group I and Group II relate as product and process of use and are distinct because the process for using the product as claimed can be practiced with another materially different product such as different lactic acid bacteria or bacterial combinations as described in the restriction rejection and groups acquire separate status in the art in view of different classification and different field of search, i.e. bacterial composition in Group I and prevention or treatment of allergy in Group II.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/08/2025.
Claims 1-20 are pending. Claims 1-6 (claim set filed 08/24/2025) are examined on the merits herein.
Priority
This application claims benefit of provisional application 63/400,777 filed 08/25/2022. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/24/2023 complies with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 2 is 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.
Claim 2 is directed to Lactobacillus paragasseri BBM171 deposited under DSMZ Accession No. DSM 34311. It is apparent that strain Lactobacillus paragasseri BBM171 is required to practice the claimed invention. As such the biological material must be readily available or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112, first paragraph, may be satisfied by a deposit of the strain.
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 materials considered necessary to make and use the invention is both known and readily available to the public. The prior art of Singroha (Singroha et al. Intl. J. Food. Ferment., 2017, 6, 71-83) teaches isolation and screening of Lactobacillus gasseri strains from different sources (Abstract). 34 strains were isolated and characterized. Strains exhibited different properties, for instance 9 strains were shown to be most acid tolerant, 3 strains had highest viability and four strains were found to assimilate cholesterol (Abstract). Thus, a person skilled in the art could not make or use the invention defined without access to the specific biological material.
It is noted that Lactobacillus paragasseri BBM171 deposited under Budapest Treaty: “Lactobacillus paragasseri BBM171 has been deposited under Budapest Treaty at Leibniz Institute DSMZ-Gerrnan Collection of Microorganisms and Cell Cultures (Inhoffenstr. 7 B, D-38124 Braunschweig, Gem1any) on June 21, 2022 and has been given the DSMZ Accession No. DSM 34311 by the International Depositary Authority. This biological material was subjected to the viability test and passed” (specification, p. 11, lines 10-14). The depositary information and the viability statement filed 08/24/2023 are acknowledged, however, there is no indication as to public availability statement.
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 the instant invention will be irrevocably and without restriction released to the public upon the issuance of a 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 Applicant, 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 depositary 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 1-3, 5 and 6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. The claim 1 recites a composition comprising Lactobacillus paragasseri and a carrier. Lactobacillus paragasseri are naturally occurring bacterial species as evidenced by Hashikawa-Hobara (Hashikawa-Hobara et al. Frontiers in Neuroscience, 2022, 16, 918953, 1-13) teaching L. paragasseri strain isolated from human feces (Abstract). The carrier is defined in the specification as: “… the term "carrier" may comprise, but is not limited to, a solvent, a dispersion medium, a coating, an antibacterial and antifungal agent, or an isotonic and absorption delaying agent, etc. which is suitable for pharmaceutical administration” (specification, p. 7, lines 21-23). Since the carrier is not specified, it can be water serving as a solvent and water is a natural product.
This judicial exception is not integrated into a practical application because the additional information in claim 1 recites the amount of bacteria of at least 1x106 CFU and the intended use, i.e. for oral delivery. The recited amount of bacteria is broad and does not change the judicial exception of Lactobacillus paragasseri to make it markedly different. The intended use is recited at high level of generality and adds insignificant extra solution description to the judicial exception.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the amount of bacteria and intended use are recited at a high level of generality and are routine and conventional as evidenced by Hashikawa-Hobara teaching composition comprising 2x109 CFU/day of L. paragasseri OLL2809 mixed with chow and tap water for oral delivery (p. 2, right column, last paragraph).
Based on the above claim 1 is rejected as ineligible.
Dependent claim 2 recites Lactobacillus paragasseri BBM171 deposited under DSMZ Accession No. DSM 34311. Lactobacillus paragasseri BBM171 is a natural strain isolated from breast milk (specification, p. 11, lines 6-7). The strain was not modified and hence its characteristics are not markedly different from those of naturally occurring strain.
This judicial exception is not integrated into a practical application because in addition to bacterial strain claim 2 recites deposition accession number that is insignificant extra solution.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the accession numbers are recited at a high level of generality and it is routine and conventional to provide accession numbers to selected strains.
Based on the above, claim 2 is rejected as ineligible.
Dependent claims 3 and 5 recite the form of the composition as a dried product (claim 3) and heat-inactivated bacterium (claim 5). Claim 6 recites the intended use of the composition to be dietary or pharmaceutical composition. These features are recited at high level of generality and are not sufficient to amount to significantly more than the judicial exceptions because they do not impart a structural limitation and do not alter the judicial exception or make it markedly different. Besides, the form of the strain composition and the intended use are recited at a high level of generality and are routine and conventional as evidenced by Young (US 20220370522 A1) teaching different forms of Lactobacillus bacterial composition, including dried and heat-inactivated bacterium (paragraphs 0022). Regarding the intended use of the composition, Young describes formulating Lactobacillus composition as a pharmaceutical composition or as a food product and hence providing dietary composition (paragraphs 0026 and 0027). Therefore, claims 3, 5 and 6 are rejected a ineligible. Applicant elected freeze dried in claim 4 and therefore is not included in this rejection.
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.
(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.
Claims 1 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hashikawa-Hobara (Hashikawa-Hobara et al. Frontiers in Neuroscience, 2022, 16, 918953, 1-13).
Regarding claim 1, Hashikawa-Hobara teaches Lactobacillus paragasseri OLL2809 strain isolated from healthy human feces. The OLL2809 strain was shown to improve depression-like behavior in C57BL5 male mice and increase beneficial gut microbiota (Abstract). Hashikawa-Hobara mentions that L. paragasseri OLL2809 strain may have potential in microbiome therapeutics (Abstract). Hashikawa-Hobara describes preparation of the composition comprising 2x109 CFU/day of L. paragasseri OLL2809 mixed with chow and tap water for oral delivery (p. 2, right column, last paragraph) that reads on limitations of claim 1. Thus, Hashikawa-Hobara teaching anticipates claim 1.
Regarding claim 6, Hashikawa-Hobara teaches feeding the composition of L. paragasseri OLL2809 strain in the form of dumplings to mice (p. 2, right column, last paragraph) and hence the composition can be considered dietary composition. Thus, Hashikawa-Hobara teaching anticipates claim 6.
Claim 2 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hashikawa-Hobara (Hashikawa-Hobara et al. Frontiers in Neuroscience, 2022, 16, 918953, 1-13).
Hashikawa-Hobara teaches Lactobacillus paragasseri OLL2809 strain isolated from healthy human feces having potential in microbiome therapeutics as described above (Abstract). Hashikawa-Hobara does not identify strain as Lactobacillus paragasseri BBM171 deposited under DSMZ Accesssion No. DSM 34311.
However, since these strains: (i) are natural strains isolated from humans, (ii) belong to the same species, L. paragasseri, and are expected to have similar properties and (iii) both were used for oral delivery, the two strains appear to be identical and therefore claim 2 is rejected under anticipation.
However, if the prior art strain and the instant claimed strain are not the same, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that instant L. paragasseri BBM171 strain is an obvious variant of L. paragasseri OLL2809 strain described by Hashikawa-Hobara. One would have been reasonably made come to this conclusion since these strains are from the same species, have the same origin and method of use as described above and are expected to have same properties. Therefore, absent evidence to the contrary, the use of an obvious variant of L. paragasseri in instant composition is obvious. Thus, Hashikawa-Hobara teaching anticipates or in the alternative renders claim 2 obvious.
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 (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 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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Hashikawa-Hobara (Hashikawa-Hobara et al. Frontiers in Neuroscience, 2022, 16, 918953, 1-13) as applied to claim 1 above, and further in view of Jury (US 20210267232 A1).
The teaching of Hashikawa-Hobara has been set forth above.
Hashikawa-Hobara does not teach the composition to be in the form of dried product, freeze-dried powder and lactic acid bacterium to be in the form of heat-inactivated bacterium.
Regarding claims 3 and 4, Jury teaches Lactobacillus composition for administration to animal to enhance one or more health characteristics of an animal (Abstract, paragraph 0008). The composition comprises one or more Lactobacillus strains (paragraph 0007). The Lactobacillus bacteria that are suitable for the composition include L. paragasseri (paragraph 0072). Jury describes that the composition can be combined with feed, including food or drink (paragraph 0037). Jury mentions that the composition can be in a liquid or solid form as a powder composition (paragraphs 0123, 0124). Jury discloses that it is considered advantageous to prepare and store composition in freeze-dried form especially for long-term storage or transport purposes and describes that freeze-dried composition can be in a powder form (paragraphs 0235-0238).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine teachings of Hashikawa-Hobara and Jury and prepare composition of Hashikawa-Hobara strain OLL2809 as a dried product in a freeze-dried powder form as described by Jury. One would have been motivated to do so since Jury teaches that the freeze-dried form is advantageous for storage and transport. A skilled artisan would have reasonably expected success in that because Hashikawa-Hobara and Jury teach compositions including L. paragasseri for oral delivery. Thus, Hashikawa-Hobara and Jury teachings render claims 3 and 4 obvious.
Regarding claim 5, Jury teaches that the bacterium in the composition may be provided as predominantly dead or inactivated by heat or irradiation (paragraph 0134).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow Jury teaching and prepare composition of Hashikawa-Hobara strain OLL2809 in a heat-inactivated form as described by Jury. One would have been motivated to do so to prevent bacterial reproduction and hence increase safety of treatment while preserving bacterial metabolites. A skilled artisan would have reasonably expected success in that because Hashikawa-Hobara provided L. paragasseri strain OLL2809 increasing beneficial gut microbes and Jury described different forms of bacterium including heat-inactivated bacterium suitable for Lactobacillus bacterial composition used to improve health characteristics of animals. Thus, Hashikawa-Hobara and Jury teachings render claim 5 obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIOUBOV G KOROTCHKINA whose telephone number is (571)270-0911. The examiner can normally be reached Monday-Friday: 8:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila G Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G.K./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653