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 .
DETAILED ACTION
Claims 1-2, 4-11, and 14-17 are pending. Claims 8-11 and 14-16 are withdrawn.
Response to Amendment
The objection to the drawings is withdrawn in view of the amendment.
The objection to the specification is withdrawn in view of the amendment.
The rejection of claims 1-2, 4-7, and 17 under 35 U.S.C. 103 is withdrawn in view of the amendment.
The rejection of claims 1-2, 4-7, and 17 on the ground of nonstatutory double patenting is withdrawn in view of the amendment.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 06/17/2026 is acknowledged and has been considered.
New Rejection Necessitated by the Amendment
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 1-2, 4-7, and 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 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.
In making a determination that a disclosure does not satisfy the enablement requirement, the factors that may be considered include: (A) the breadth of the claims, (B) the nature of the invention, (C) the state of the prior art, (D) the level of one of ordinary skill, (E) the level of predictability in the art, (F) the amount of direction provided by the inventor, (G) the existence of working examples, and (H) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. While it is not essential that every factor be examined in detail, those factors deemed most relevant should be considered.
Nature of the invention. Claim 1 is drawn to a method for reducing the amount of phosphonates in a human subject comprising administering to a subject that has accumulation of phosphonates a mixture comprising at least one isolated bacterial strain belonging to the species Lactobacillus brevis, wherein said strain is selected from the group consisting of Lactobacillus brevis LBR01 identified under deposit number DSM 23034, Lactobacillus brevis LBR02, identified under deposit number DSM 29404; and mixtures thereof optionally combined with at least one isolated bacterial strain belonging to the species Lactobacillus plantarum and/or at least one isolated bacterial strain belonging to the species Lactobacillus pentosus, and wherein the mixture comprising the at least one isolated bacterial strain reduces the amount of
phosphonates in the subject.
Breadth of the claims. The breadth of the claimed invention is exceedingly large and fails to receive adequate support in the specification. Claim 1 encompasses reducing the amount of phosphonates in a human. Claim 7 limits the phosphonates to glyphosate contained in a glyphosate-based herbicide (GBH).
State of the prior art and Unpredictability: Prior art Wan (US 2019/0177807, of record in Office Correspondence mailed on 02/20/2026) reports administering to model organisms, fruit flies and mice, a composition comprising probiotics to enhance the subject’s resistance to a pesticide such as glyphosate, and teaches the probiotic is Lactobacillus brevis or Lactobacillus plantarum ([Abstract, [0006], [0010]). Prior art Mogna (US 20140065116, of record in IDS filed on 10/06/2022) reports Lactobacillus brevis LBR01 has an antioxidant activity and reports oxidative stress is associated with atherosclerosis, arterial hypertension, Parkinson's disease, Alzheimer's disease, diabetes mellitus, colitis, rheumatoid arthritis ([0001]-[0002]). Applicant argues that, at the time of filling of the instant application, the art reports that the species L. brevis does not predict strain-level function (See Remarks filed on 06/17/2026 Appendix A). No prior art shows the reduction of phosphonates in a human that has an accumulation of phoshonates by administering a composition comprising Lactobacillus brevis LBR01 and/or Lactobacillus brevis LBR02. Therefore, the claimed method is highly unpredictable.
Guidance in the specification and working examples. The guidance in the specification is not commensurate in scope with the claimed invention. The description is limited to reducing the concentration of glyphosate in vitro in the growth medium by strain Lactobacillus brevis LBR01 (page 18 Tables 4 and 5). The specification fails to provide guidance pertaining to reducing the amount of phosphonates in a human subject by administering a composition comprising Lactobacillus brevis LBR01 or Lactobacillus brevis LBR02.
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 4-7, and 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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