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
Applicant’s preliminary amendment filed on 19 December 2025 is entered. Claims 1, 5-6, 8, 10-14, 17-20 are amended, claims 2-4, 7, 9, 15-16 are canceled, and claims 21-30 are new. Claims 1, 5-6, 8, 10-14, 17-30 are pending and under examination.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim is missing the word "and", "or", or "and/or" between the phrase “treating neuropsychiatric disorder” and “ameliorating and/or reducing symptoms of a neuropsychiatric disorder”.
Appropriate correction is 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.
(New necessitated by amendment) Claims 1, 5-6, 8, 10-14,17-26, and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Halverson et al. (Gut microbes in neurocognitive and mental health disorders, Annals of Medicine, 52:8, 423-443, published 31 August 2020) in view of Wadstrom et al. (EP 2672980 B1, published 06 December 2017, made of record in IDS filed 12 May 2023) and Ljungh et al. (EP 1624762 B1, published 28 February 2007, made of record in IDS filed 12 May 2023).
Regarding claims 1, 5-6, 10-11, 14, 21, and 23, Halverson teaches the administration of probiotic and prebiotic compositions comprising Lactobacillus and Bifidobacterium species to treat and/or ameliorate the symptoms of several neurological disorders, including dementia and depression (Halverson pg. 431 right col. paras. 2 and 4), obsessive compulsive disorder(OCD) (Halverson pg. 433 left col. para. 2), and anxiety and bipolar disorder (Halverson pg. 433 right col. paras. 1-2). Halverson teaches that neurological disorders are accompanied with microbial dysbiosis through the microbiota-gut brain axis, and suggests that the administration of probiotic compositions have a role in clinical management of mental health disorders (Halverson Abstract and pg. 437 Conclusions).
Halverson does not teach the administered probiotic/synbiotic compositions comprise Lactobacillus plantarum LMG P-20606, Lactobacillus paracasei LMG P-17806, Lactobacillus paracasei LMG P-26118, Pediococcus pentosaceus LMG P-20608, and Leuconostoc mesenteroides LMG P-20607, and dietary fibers inulin, pectin, beta glucan, resistant starch, galacto-oligosaccharides, isomalto-oligosaccharides, or rice fibers.
Wadstrom teaches a synbiotic composition comprising Lactobacillus paracasei LMG P-26118 (also designated as LAB LU 33 and L. paracasei F8) and Lactobacillus plantarum strains (Wadstrom [0009]-[0012] and the table under [0073]), and dietary fiber prebiotics pectin, inulin, beta glucan, galacto-oligosaccharides, isomalto-oligosaccharides, and resistant starches (Wadstrom [0009]-[0013]). Furthermore, Wadstrom teaches their synbiotic composition effectively colonizes the intestinal mucosa of a subject (Wadstrom [0016]).
Wadstrom does not teach bacterial strains Lactobacillus plantarum LMG P-20606, Lactobacillus paracasei LMG P-17806, Pediococcus pentosaceus LMG P-20608, or Leuconostoc mesenteroides LMG P-20607.
Ljungh teaches a probiotic composition comprising Lactobacillus plantarum LMG P-20606, Lactobacillus paracasei LMG P-17806, Pediococcus pentosaceus LMG P-20608, and Leuconostoc mesenteroides LMG P-20607 (Ljungh [0018]-[0021]), and that the bacterial strains of their probiotic composition colonize and bind to the gastrointestinal tract of a host (Ljungh [0025] and claim 1).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to modify Halverson’s method (administering compositions comprising probiotics and prebiotics to a subject to treat and/or ameliorate the symptoms of neuropsychiatric disorders such as OCD) by combining Halverson’s administered composition with Wadstrom’s synbiotic composition comprising Lactobacillus paracasei LMG P-26118 and Lactobacillus plantarum, and prebiotics pectin, inulin, beta glucan, galacto-oligosaccharides, isomalto-oligosaccharides, and resistant starches, and further combined with Ljungh’s probiotic composition comprising Lactobacillus plantarum LMG P-20606, Lactobacillus paracasei LMG P-17806, Pediococcus pentosaceus LMG P-20608, and Leuconostoc mesenteroides LMG P-20607.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Halverson teaches that administration of probiotic and/or prebiotic compositions can treat and/or ameliorate symptoms of neuropsychiatric disorders, including OCD, and that there is an association between gut dysbiosis and neurological disorders through the microbiota-gut brain axis, and suggests that the administration of probiotic compositions have a role in clinical management of mental health disorders. Wadstrom and Ljungh teach that their synbiotic compositions are effective at colonizing the gastrointestinal tract of subjects and comprise Lactobacillus strains, which Halverson teaches are deficient in the microbiota of subjects with many neuropsychiatric disorders (Halverson Table 1). Halverson also teaches that microbial and probiotic therapies administered to treat neuropsychiatric diseases comprise Lactobacillus species (Halverson Table 1).
Therefore, one of ordinary skill in the art would have a reasonable expectation that administering a composition comprising Lactobacillus plantarum LMG P-20606, Lactobacillus paracasei LMG P-17806, Lactobacillus paracasei LMG P-26118, Pediococcus pentosaceus LMG P-20608, and Leuconostoc mesenteroides LMG P-20607, and prebiotics pectin, inulin, beta glucan, galacto-oligosaccharides, isomalto-oligosaccharides, and resistant starches would effectively colonize the gastrointestinal system of a subject with neuropsychiatric disorders such as OCD, and thereby treat and/or ameliorate the symptoms of neuropsychiatric disorders as taught by Halverson.
Regarding claims 8 and 22, Wadstrom teaches their synbiotic composition comprises Bifidobacterium breve LMG-P-26117 (also designated as Bif LU 10 and B. breve Bif 8:8)
Regarding claims 12, 24, and 26, Wadstrom teaches that their synbiotic composition comprises 108 to 1013 CFU/g of the bacterial strains ([0062]). Ljungh teaches their probiotic composition comprises at least 1010 CFU/g of the bacterial strains (Ljungh [0056]).
Regarding claims 13 and 25-26, Wadstrom teaches that the prebiotic component of their synbiotic composition is 5 to 99% by weight of the total weight of the composition ([0060]).
Although Wadstrom does not specifically teach the total amount of prebiotics in the composition is between 0.1 to 20 g, 2 to 15g, or 10g as recited in the claims, Wadstrom’s teaching that the amount of prebiotics/dietary fibers in their composition are in terms of weight percent means that one embodiment of Wadstrom’s teachings includes a composition whose amount of prebiotics overlaps with the instant invention’s ranges. For example, 40g of Wadstrom’s composition would comprise 2 to 39.6g of the prebiotic because Wadstrom teaches their composition comprises 5 to 99% prebiotics by weight of the total composition (2g being 5% by weight of the 40g of total composition, and 39.6 grams being 99% by weight of the 40g); thus Wadstrom teaches, with sufficient specificity, embodiments of compositions which would overlap with the claimed range of 0.1 to 20 g, 2 to 15g, or 10g of dietary fiber/prebiotic as recited in the claims.
Regarding claims 17-18 and 29-30, Wadstrom teaches the oral administration of the synbiotic composition for 5 days once a day as a single dose (Wadstrom [115] and [127]), but also teaches it may be administered in multiple doses as well (Wadstrom [59]).
Regarding claim 19, Wadstrom teaches the composition is in the form of powders, capsules, tablets, lozenges, liquids, and emulsions ([0063]).
Regarding claim 20, Wadstrom teaches the composition is a food supplement, food product, nutritional supplement, and a pharmaceutical product ([0064]).
Regarding claim 28, Halverson teaches probiotic treatment of OCD and its symptoms with prebiotic mixtures of Lactobacillus and Bifidobacterium reduced OCD-like behaviors (Halverson pg. 433 left col. para. 2). Halverson also teaches a common symptom of depression is dysregulation of emotion, and that depression can be treated by restoring the gut bacteria with probiotics (Halverson pg. 431 right col. para. 4 and pg. 433 left col. para. 1).
(New necessitated by amendment) Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Halverson in view of Wadstom and Ljungh as applied to claims 1, 5-6, 8, 10-14,17-26, and 28-30 above, and further as evidenced by Dailey et al. (Mania, [Updated 2023 Jul 17]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK493168/).
Halverson teaches the probiotic treatment of bipolar disorder, which is a chronic mental health condition characterized by mood swings between depression and mania/hypomania. Symptoms of mania and/or hypomania include distractibility (inattention) and increased goal-oriented activity (hyperactivity), as evidenced by Dailey (pg. 1 para. 1).
Therefore, the obvious method of ameliorating the symptoms of bipolar disorder of Halverson in view of Wadstrom and Ljungh would alleviate the symptoms of inattention and hyperactivity.
Response to Arguments
Applicant’s arguments, see Remarks, filed 19 December 2025, with respect the to 35 USC 112(a) enablement rejection have been fully considered and are persuasive. The statement that all restrictions imposed by the depositor on the availability to the public on the deposited material will be irrevocably removed upon granting of the patent on pg. 11 of the remarks fulfills the requirement for the public availability of the claimed biological materials. The 35 USC 112(a) rejection of claims 2-9 is withdrawn.
Applicant’s arguments with respect to claims 1-20 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 Alexander M Duryee whose telephone number is (571)272-9377. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/Alexander M Duryee/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657