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 Claims 8-11 and 14-16 are withdrawn.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/23/2025 has been entered.
Drawings
The drawings are objected to because the formatting of FIG. 2 filed on 07/29/2025 is not clear. Part of the text/illustration is hindered by other parts. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 3 line 22. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The specification discloses description of sequences on page 14. Applicant should amend the specification to recite “SEQ ID NO:” and to number the sequences according to the sequences disclosed in the Sequence Listing filed on 04/06/2023.
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 1-2, 4-7, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Wan (US 2019/0177807, published 06/13/2019) in view of Mogna (US 20140065116, of record in IDS filed on 10/06/2022).
Regarding claims 1-2, 4-7 and 17, Wan teaches a probiotic composition for enhancing a subject's resistance to a pesticide comprising a microorganism capable of expressing one or more enzymes for metabolizing the pesticide, and a feed ingredient for a subject, and teaches a method for enhancing a subject's resistance to a pesticide comprising administering to a subject the probiotic composition (Abstract). Wan teaches that the pesticide exposure in through ingestion of water or food ([0067]). Wan teaches the microorganism is Lactobacillus brevis or Lactobacillus plantarum ([0010]) and teaches the pesticide is glyphosate ([0006]). Wan teaches the species sequenced have complete plasmid and viral sequences that expand the metabolic potential of these microorganisms ([004]). Wan does not teach Lactobacillus brevis is Lactobacillus brevis LBR01 with DSM 23034.
However, Mogna teaches a composition comprising Lactobacillus brevis LBR01 DSM 23034 administered to subject to treat treating oxidative stress (claim 10). Mogna teaches that the composition can further comprise one or more bacterial strains among those listed in Table 2 [0037]. Table 2 includes Lactobacillus plantarum LMG P-21021.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Wan by substituting a composition comprising Lactobacillus brevis LBR01 and Lactobacillus plantarum LMG P-21021 as suggested by Monga for Wan’s Lactobacillus brevis and Lactobacillus plantarum composition. One of ordinary skill in the art would be motivated to do so in order to metabolize glyphosate, as suggested by Wan. Since Wan teaches Lactobacillus brevis and Lactobacillus plantarum have plasmid and sequences that expand their metabolic potential to metabolize pesticides such as glyphosate, and since Mogna teaches that Lactobacillus brevis LBR01 and Lactobacillus plantarum LMG P-21021 are safe for consumption and have beneficial health effect, there is a reasonable expectation of success. MPEP 2144.06 II states that it is obvious to substitute equivalents know for the same purpose. Thus, it is obvious to substitute known probiotics such as Lactobacillus brevis LBR01 and Lactobacillus plantarum LMG P-21021 for other Lactobacillus brevis and Lactobacillus plantarum.
The limitation of “wherein the mixture comprising the at least one isolated bacterial strain reduces the amount of phosphonates in the subject” is the result of the active method steps. A wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited and claim scope is not limited by claim language that suggest or makes optional but does not require steps to be performed. See MPEP 2111.04.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4-7, and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/560643 in view of Wan (US 2019/0177807, published 06/13/2019).
Regarding instant claims 1-2, 4-7, and 17, copending claim 1 recites a strain of bacteria selected from the group consisting of (i) Lactobacillus brevis LBR01 (DSM 23034) and (v) lactobacillus plantarum LP01 (LMG P-21021). Copending claim does not recite administering the strains to reduce the amount of phosphonates in a subject.
However, Wan teaches a probiotic composition for enhancing a subject's resistance to a pesticide comprising a microorganism capable of expressing one or more enzymes for metabolizing the pesticide, and a feed ingredient for a subject, and teaches a method for enhancing a subject's resistance to a pesticide comprising administering to a subject the probiotic composition (Abstract). Wan teaches that the pesticide exposure in through ingestion of water or food ([0067]). Wan teaches the microorganism is a Lactobacillus species, such as Lactobacillus brevis or Lactobacillus plantarum ([0010]) and teaches the pesticide is glyphosate ([0006]). Wan teaches the species sequenced have complete plasmid and viral sequences that expand the metabolic potential of these microorganisms ([004]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in copending claim 1 by combining (i) Lactobacillus brevis LBR01 (DSM 23034) and (v) Lactobacillus plantarum LP01 (LMG P-21021) and administering the composition to a subject who ingested glyphosate, as suggested by Wan. One of ordinary skill in the art would be motivated to do so in order to metabolize the pesticide and enhance the subject's resistance to the pesticide.
This is a provisional nonstatutory double patenting rejection.
Claims 1-2, 4-7, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,458,176 in view of Wan and Mogna.
Regarding instant claims 1-2, 4-7, and 17, patent claim 1 recites a method for modulating the mood of a subject comprising administering to the subject a therapeutically effective amount of a composition (C) comprising: a bacteria strains mixture (M) comprising or consisting of a bacterium strain of the Lactobacillus plantarum species identified as the Lactobacillus plantarum LP01 LMG P-21021 bacterium strain, and/or a bacterium strain of the Lactobacillus plantarum species identified as the Lactobacillus plantarum LP02 LMG P-21020 bacterium strain. Patent claim 1 does not recite reducing the amount of phosphonates in a subject.
However, Wan teaches a probiotic composition for enhancing a subject's resistance to a pesticide comprising a microorganism capable of expressing one or more enzymes for metabolizing the pesticide, and a feed ingredient for a subject, and teaches a method for enhancing a subject's resistance to a pesticide comprising administering to a subject the probiotic composition (Abstract). Wan teaches that the pesticide exposure in through ingestion of water or food ([0067]). Wan teaches the microorganism is a Lactobacillus species, such as Lactobacillus brevis or Lactobacillus plantarum ([0010]) and teaches the pesticide is glyphosate ([0006]). Wan teaches the species sequenced have complete plasmid and viral sequences that expand the metabolic potential of these microorganisms ([004]).
Patent claim 1 does not recite Lactobacillus brevis LBR01.
However, Mogna teaches a composition comprising Lactobacillus brevis LBR01 DSM 23034 administered to subject to treat treating oxidative stress (claim 10). Mogna teaches that the composition can further comprise one or more bacterial strains among those listed in Table 2 [0037]. Table 2 includes Lactobacillus plantarum LMG P-21021.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in patent claim 1 by adding Lactobacillus brevis LBR01 (DSM 23034) as suggested by Mogna, and administering the composition to a subject who ingested glyphosate, as suggested by Wan. One of ordinary skill in the art would be motivated to do so in order to metabolize the pesticide and enhance the subject's resistance to the pesticide.
Claims 1-2, 4-7, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,679,135 in view of Wan and Mogna.
Regarding instant claims 1-2, 4-7, and 17, patent claim 1 recites a method for treating a sleep disorder and/or improving sleep quality in a patient, comprising administering to the patient a composition (C) comprising: (a) a bacterial strains mixture (M) comprising: bacterium strain of the Lactobacillus plantarum species selected from the group consisting of: (a) a bacterium strain identified as the Lactobacillus plantarum LP01 LMG P-21021 bacterium strain and (b) a bacterium identified as the Lactobacillus plantarum LP02 LMG P-21020 bacterium strain. Patent claim 1 does not recite reducing the amount of phosphonates in a subject.
However, Wan teaches a probiotic composition for enhancing a subject's resistance to a pesticide comprising a microorganism capable of expressing one or more enzymes for metabolizing the pesticide, and a feed ingredient for a subject, and teaches a method for enhancing a subject's resistance to a pesticide comprising administering to a subject the probiotic composition (Abstract). Wan teaches that the pesticide exposure in through ingestion of water or food ([0067]). Wan teaches the microorganism is a Lactobacillus species, such as Lactobacillus brevis or Lactobacillus plantarum ([0010]) and teaches the pesticide is glyphosate ([0006]). Wan teaches the species sequenced have complete plasmid and viral sequences that expand the metabolic potential of these microorganisms ([004]).
Patent claim 1 does not recite Lactobacillus brevis LBR01.
However, Mogna teaches a composition comprising Lactobacillus brevis LBR01 DSM 23034 administered to subject to treat treating oxidative stress (claim 10). Mogna teaches that the composition can further comprise one or more bacterial strains among those listed in Table 2 [0037]. Table 2 includes Lactobacillus plantarum LMG P-21021.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in patent claim 1 by adding Lactobacillus brevis LBR01 (DSM 23034) as suggested by Mogna, and administering the composition to a subject who ingested glyphosate, as suggested by Wan. One of ordinary skill in the art would be motivated to do so in order to metabolize the pesticide and enhance the subject's resistance to the pesticide.
Claims 1-2, 4-7, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,998,578 in view of Wan and Mogna.
Regarding instant claims 1-2, 4-7, and 17, patent claim 1 recites a composition comprising a bacterium strain of the Lactobacillus plantarum species identified as Lactobacillus plantarum LP01 LMG P-21021 and/or a bacterium strain of the Lactobacillus plantarum species identified as Lactobacillus plantarum LP02 LMG P-21020. Patent claim 1 does not recite administering the composition to reduce the amount of phosphonates in a subject.
However, Wan teaches a probiotic composition for enhancing a subject's resistance to a pesticide comprising a microorganism capable of expressing one or more enzymes for metabolizing the pesticide, and a feed ingredient for a subject, and teaches a method for enhancing a subject's resistance to a pesticide comprising administering to a subject the probiotic composition (Abstract). Wan teaches that the pesticide exposure in through ingestion of water or food ([0067]). Wan teaches the microorganism is a Lactobacillus species, such as Lactobacillus brevis or Lactobacillus plantarum ([0010]) and teaches the pesticide is glyphosate ([0006]). Wan teaches the species sequenced have complete plasmid and viral sequences that expand the metabolic potential of these microorganisms ([004]).
Patent claim 1 does not recite Lactobacillus brevis LBR01.
However, Mogna teaches a composition comprising Lactobacillus brevis LBR01 DSM 23034 administered to subject to treat treating oxidative stress (claim 10). Mogna teaches that the composition can further comprise one or more bacterial strains among those listed in Table 2 [0037]. Table 2 includes Lactobacillus plantarum LMG P-21021.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in patent claim 1 by adding Lactobacillus brevis LBR01 (DSM 23034) as suggested by Mogna, and administering the composition to a subject who ingested glyphosate, as suggested by Wan. One of ordinary skill in the art would be motivated to do so in order to metabolize the pesticide and enhance the subject's resistance to the pesticide.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive.
Applicant argues Mogna does not teach methods for reducing the amount of phosphonates in a subject, by administering a mixture comprising at least one isolated bacterial strain to a subject that has an accumulation of phosphonates, and argues the claims are not obvious over Application 18/560,643 in view of Mogna.
In response to the argument, Monga is relied upon for teaching the claimed bacterial strains. New prior art Wan teaches a method of administering a probiotic composition such as Lactobacillus brevis or Lactobacillus plantarum to enhance a subject's resistance to a pesticide such as glyphosate ingested through food or water. Wan teaches the microorganism is capable of expressing one or more enzymes for metabolizing the pesticide, and teaches the species sequenced have complete plasmid and viral sequences that expand the metabolic potential of these microorganisms ([004]).
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699