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 .
The amendment and response filed on December 16, 2025 is received.
Claims 1-17 are pending in this application, claims 1-7 are withdrawn from further consideration and claims 8-17 are being examined (Also, see Restriction/Election below).
Restriction/Election:
Applicant’s election without traverse of Group II, claims 8-17, in the reply filed on 12/16/2025 is acknowledged.
Claims 1-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (Group I), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/16/2025.
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 8-17 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: LLimosilactobacillus reuteri GL-104 and Lacticaseibacillus rhamnosus F-1.
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 (pages 9-10 and 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.
Copies of deposit receipts are required.
Claim Rejections - 35 USC § 103
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.
Claims 8-17 are rejected under 35 U.S.C. 103 as being unpatentable over CN109512854B (English machine translation, 10 pages of PDF) and Steiner et al. (Int Arch Allergy Immunol. 2021;182(9):807-818. Epub 2021 Apr 21).
Regarding claim 8, CN109512854B teach a method for treating or preventing allergic rhinitis, comprising administering a lactic acid bacterial composition to a subject in need thereof, the composition comprising one or more of a Lactobacillus reuteri (a.k.a. Limosilactobacillus reuteri) and a Lactobacillus rhamnosus (a.k.a. Lacticaseibacillus rhamnosus) (administering a probiotic composition for preventing and treating allergic rhinitis the composition preferably comprising one or more Lactobacillus reuteri and Lactobacillus rhamnosus, etc.) (See for example, p. 2 of PDF “Disclosure of Invention” lines 4-12).
Regarding claim 8, although strains Lactobacillus reuteri and Lactobacillus rhamnosus taught by CN109512854B do not have the claimed designation numbers GL-104 strain CCTCC M209138 and F-1 strain CCTCC M2011124 , however the strains appears to be the same as the claimed Lactobacillus reuteri and Lactobacillus rhamnosus. It should be noted that a single strain can be deposited under different deposit numbers.
In this case, even if the Lactobacillus reuteri and Lactobacillus rhamnosus strains taught by CN109512854B are not the same as the claimed Lactobacillus reuteri and Lactobacillus rhamnosus strains, a person of ordinary skill in the art before the effective filing date of the invention knowing that Lactobacillus reuteri and Lactobacillus rhamnosus can treat or prevent allergic rhinitis (teachings of CN109512854B), said person would have been motivated to isolate Lactobacillus reuteri and Lactobacillus rhamnosus by known and available techniques taught by the prior art and obtain deposit numbers and combine them in a composition to provide the claimed composition (Combining Equivalents for the same purpose) based on the teachings of prior art, and further administer the composition according to the method taught by CN109512854B with a reasonable expectation or success in providing the claimed compositions and the claimed method for treating or preventing allergic rhinitis.
Regarding claims 9 and 10, the composition is administered for reducing production of pro-inflammatory cytokine CXCL10 by an immune cell to treat or prevent allergic rhinitis (claim 9), and wherein the composition is administered for increasing a ratio of CD206 to CD86 on a surface of an immune cell to treat or prevent allergic rhinitis (claim 10), the "wherein” clause in claims 9 and 10 are not given weight because they simply express the intended results of the method step positively recited by CN109512854B.
Regarding claim 11, CN109512854B teach wherein relative to a total bacterial count of the GL-104 strain and the F-1 strain, the GL-104 strain is present at 10% to 90%, and the F-1 strain is present at 10% to 90% (107 to 1010 CFU) (See for example, p. 2 of PDF “Disclosure of Invention” line 4).
Regarding claim 14, CN109512854B teach wherein the GL-104 strain is a viable strain or an inactivated strain, and the F-1 strain is a viable strain or an inactivated strain (viable bacteria) (See for example, p. 7 Table 2).
Regarding claim 15, CN109512854B teach wherein the lactic acid bacterial composition further comprises: (c) an excipient, diluent, or carrier (probiotic composition in nasal or medical gel) (See for example, p. 3 lines 1-2).
Regarding claim 16, CN109512854B teach wherein the excipient, diluent, or carrier is a food-acceptable excipient, diluent, or carrier, or a pharmaceutical-acceptable excipient, diluent, or carrier (probiotic composition in nasal or medical gel) (See for example, p. 3 lines 1-2)
CN109512854B do not teach the relative to a total bacterial count of the GL-104 strain and the F-1 strain, the GL-104 strain is present at 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90%, and the F-1 strain is present at 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% (claim 12), relative to a total bacterial count of the GL-104 strain and the F-1 strain, the GL-104 strain is present at 30%, and the F-1 strain is present at 70% (claim 13), and the composition is administered at a total bacterial count of the GL-104 strain and the F-1 strain from 106 to 1010 CFU/kg of body weight of the subject per day.
In addition, before the effective filing date of the invention, Steiner et al. teach the ability of Lactobacillus bacteria to intervene in the production of cytokines is dose-dependent (see for example, p. 812 right-hand column last paragraph -Continued on p. 813 left-hand column 1st paragraph).
Therefore, the “%” amount of the strains in the composition being administered in the method taught by the prior art, and the “CFU/kg of body weight of the subject per day” of the strains being administered in the method taught by the prior art would have been optimized by routine experimentation by a person of ordinary skill in the art before the effective filing date of the invention. The motivation would be for example, because Steiner et al. teach the ability of Lactobacillus bacteria to intervene in the production of cytokines is dose-dependent.
Conclusion(s):
No claim(s) is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KADE ARIANI whose telephone number is (571)272-6083. The examiner can normally be reached IFP, Monday - Friday, 8:00 AM -4:00 PM EST.
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/KADE ARIANI/Primary Examiner, Art Unit 1651