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 amendment filed on 19 December 2025 is entered. Claims 1, 3-7, 10-21 are amended, claims 2 and 8-9 are canceled, and claims 22-33 are new.
Claims 1, 3-7, and 10-33 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 13 October 2025 is being considered by the examiner.
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.
(New necessitated by amendment) Claims 1, 3-7, 10-13 and 17-33 are rejected under 35 U.S.C. 103 as being unpatentable over Oka et al. (Microbial-Based and Microbial-Targeted Therapies for Inflammatory Bowel Diseases, Dig Dis Sci. 2020 March; 65(3): 757–788) 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, 10-11, 17-18, and 27, Oka teaches that synbiotics, the mixture of probiotics and prebiotics, benefit the administered host by improving the survival and implantation of live microbes in the gastrointestinal tract by stimulating the growth and/or activating the metabolism of health-promoting bacteria (Oka pg. 12 sec. Synbiotics). Oka teaches that IBD patients harbor less beneficial intestinal bacteria, and that administration of synbiotics may improve treatment of IBD (Oka Table 1 and pg. 12 sec. Synbiotics).
Oka teaches that a cocktail of different strains may be more efficient than a single strain in treating ulcerative colitis IBD, and administration of an exemplary probiotic cocktail VSL#3, which includes Lactobacillus plantarum and Bifidobacterium breve strains, was able to improve remission and relapse rates in ulcerative colitis patients. Furthermore, SER-287 treated individuals exhibited decreased expression of inflammatory genes and increased expression of homeostatic mediators (Oka pgs. 7-8 sec. Ulcerative Colitis). Oka also teaches that administration of synbiotics comprising Bifidobacterium strains significantly improve remission rates, clinical activity, and histological scores in Crohn’s Disease patients with active disease compared to placebo (Oka pg. 8 sec. Crohn’s Disease).
Therefore, Oka teaches that administration of synbiotics comprising probiotic cocktails and prebiotics to ulcerative colitis and Crohn’s disease patients is an effective method of treating or alleviating symptoms of those diseases.
However, Oka does not teach the administration of a synbiotic comprising Lactobacillus plantarum LMG P-20606, Bifidobacterium breve LMG-P-26117, at least one Lactobacillus paracasei strain, and a dietary fiber selected from the group consisting of: inulin, pectin, beta-glucan, resistant starch, galacto-oligosaccharide, isomalto-oligosaccharide, and rice fiber.
Wadstrom teaches oral administration of a synbiotic probiotic composition comprising strains of probiotics Lactobacillus plantarum, Bifidobacterium breve, and Lactobacillus paracasei ([0009]-[0012] and [0063]-[0064]), and the Bifidobacterium breve strain may be Bifidobacterium breve LMG-P-26117 (also designated as Bif LU 10 and B. breve Bif 8:8) (Wadstrom [0011] and the table under [0073]). Wadstrom also teaches that the composition comprises prebiotics pectin, inulin, beta glucan, galacto-oligosaccharides, isomalto-oligosaccharides, and resistant starches (Wadstrom [0009]-[0010] and [0013]). Furthermore, Wadstrom teaches the synbiotic composition effectively colonizes the intestinal mucosa of a subject (Wadstrom [0016]).
However, Wadstrom does not teach bacterial strain Lactobacillus plantarum LMG P-20606.
Ljungh teaches administration of a probiotic composition comprising Lactobacillus plantarum LMG P-20606 (also known as Lactobacillus plantarum 2592) (Ljungh [0018]-[0021] and [0029]), and that the bacterial strains of their probiotic composition effectively colonize and bind to the gastrointestinal tract of a host (Ljungh [0025] and claim 1).
Therefore, 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 Oka’s methods of administering synbiotic compositions comprising both probiotics and prebiotics for treating and ameliorating the symptoms of IBDs such as ulcerative colitis and Crohn’s disease in a subject by administering the Wadstrom’s synbiotic composition comprising Lactobacillus plantarum, Bifidobacterium breve LMG-P-26117, Lactobacillus paracasei, and prebiotics pectin, inulin, beta glucan, galacto-oligosaccharides, isomalto-oligosaccharides, and resistant starches combined with Ljungh’s probiotic composition comprising Lactobacillus plantarum LMG P-20606.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Oka teaches that administration of synbiotics, which improve survival and implantation of live microbes in the gastrointestinal tract, may improve treatment of IBDs such as ulcerative colitis and Crohn’s disease patients by improving remission rates, clinical activity, and histological scores, decreasing expression of inflammatory genes, and increasing expression of homeostatic mediators in the host. Oka also teaches that IBD patients harbor less beneficial intestinal bacteria in their gastrointestinal tract, but synbiotics can improve the survival and implantation of live microbes into the gastrointestinal tract. Wadstrom and Ljungh teach that their synbiotic compositions are effective at colonizing the gastrointestinal tract. Therefore, one of ordinary skill in the art would have a reasonable expectation that administering a composition comprising Lactobacillus plantarum LMG P-20606, Bifidobacterium breve LMG-P-26117, at least one Lactobacillus paracasei strain, and a dietary fiber prebiotic such as pectin, inulin, beta glucan, galacto-oligosaccharides, isomalto-oligosaccharides, and resistant starches would effectively colonize the gastrointestinal system of an IBD patient and provide the health benefits that Oka teaches.
Regarding claims 12 and 28-31, 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 29-31, 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, 3.75 g, or 7.5 g 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, 3.75 g, or 7.5 g of dietary fiber/prebiotic as recited in the claims.
Regarding claims 3, 5, and 24, Ljungh teaches their probiotic composition comprises Lactobacillus paracasei LMG P-17806 (Ljungh [0018]-[0021]) and Wadstrom teaches their synbiotic composition comprises Lactobacillus paracasei LMG P-26118 (also designated as LAB LU 33 and L. paracasei F8) (Wadstrom [0011] and the table under [0073]).
Regarding claims 4, 6-7, 22-23, and 25-26, Ljungh teaches their probiotic composition comprises Pediococcus pentosaceus LMG P-20608 and Leuconostoc mesenteroides LMG P-20607 (Ljungh [0018]-[0021]).
Regarding claims 19 and 32-33, Wadstrom teaches the 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 20, Wadstrom teaches the composition is in the form of powders, capsules, tablets, lozenges, liquids, and emulsions ([0063]).
Regarding claim 21, Wadstrom teaches the composition is a food supplement, food product, nutritional supplement, and a pharmaceutical product ([0064]).
(New necessitated by amendment) Claims 1, 3-7, 10-15, and 18-33 are rejected under 35 U.S.C. 103 as being unpatentable over Shinde et al. (Microbiota Modulating Nutritional Approaches to Countering the Effects of Viral Respiratory Infections Including SARS-CoV-2 through Promoting Metabolic and Immune Fitness with Probiotics and Plant Bioactives, Microorganisms 17 June 2020, 8(6), 921) 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, 10-11, 14-15, 18, 27, Shinde teaches that synbiotic combinations of probiotics and dietary fibers/prebiotics augment the production of short-chain fatty acids (SCFAs) such as butyrate that help to regulate immune responses to both restrain VRIs and temper the neutrophil response that can lead to acute respiratory distress syndrome (ARDS), such as that caused by influenza virus, respiratory syncytial virus (RSV), coronavirus, adenovirus, rhinovirus, SARS-CoV, MERS-CoV, and SARS-CoV2 (Shinde abstract, pg. 2 sec. 1 para. 1). Shinde teaches that acute viral respiratory infections (VRIs) are associated with microbial dysbiosis which affects the optimal functioning of the immune system (Shinde pg. 4 sec 3 para. 1), and administering synbiotics can attenuate VRIs and is a pragmatic approach for enhanced protection against the acute morbidities associated with VRIs (Shinde fig. 2 and pg. 11 sec. 9).
However, Shinde does not teach the administration of a synbiotic comprising Lactobacillus plantarum LMG P-20606, Bifidobacterium breve LMG-P-26117, at least one Lactobacillus paracasei strain, and a dietary fiber selected from the group consisting of: inulin, pectin, beta-glucan, resistant starch, galacto-oligosaccharide, isomalto-oligosaccharide, and rice fiber.
Wadstrom teaches oral administration of a synbiotic probiotic composition comprising strains of probiotics Lactobacillus plantarum, Bifidobacterium breve, and Lactobacillus paracasei ([0009]-[0012] and [0063]-[0064]), and the Bifidobacterium breve strain may be Bifidobacterium breve LMG-P-26117 (also designated as Bif LU 10 and B. breve Bif 8:8) (Wadstrom [0011] and the table under [0073]). Wadstrom also teaches that the composition comprises prebiotics pectin, inulin, beta glucan, galacto-oligosaccharides, isomalto-oligosaccharides, and resistant starches (Wadstrom [0009]-[0010] and [0013]). Furthermore, Wadstrom teaches the synbiotic composition effectively colonizes the intestinal mucosa of a subject (Wadstrom [0016]).
However, Wadstrom does not teach bacterial strain Lactobacillus plantarum LMG P-20606.
Ljungh teaches administration of a probiotic composition comprising Lactobacillus plantarum LMG P-20606 (also known as Lactobacillus plantarum 2592) (Ljungh [0018]-[0021] and [0029]), and that the bacterial strains of their probiotic composition effectively colonize and bind to the gastrointestinal tract of a host (Ljungh [0025] and claim 1).
Therefore, 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 Shinde’s proposed methods of administering synbiotic compositions for treating and ameliorating the symptoms of viral respiratory infections caused by influenza virus, coronavirus, adenovirus, rhinovirus, SARS-CoV, MERS-CoV, and SARS-CoV2 in a subject by administering Wadstrom’s synbiotic composition comprising Lactobacillus plantarum, Bifidobacterium breve LMG-P-26117, Lactobacillus paracasei, and prebiotics pectin, inulin, beta glucan, galacto-oligosaccharides, isomalto-oligosaccharides, and resistant starches combined with Ljungh’s probiotic composition comprising Lactobacillus plantarum LMG P-20606.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Shinde teaches that acute viral respiratory infections (VRIs) are associated with microbial dysbiosis which affect the optimal functioning of the immune system, but administering synbiotics can attenuate VRIs and is a pragmatic approach for enhanced protection against the acute morbidities associated with VRIs. Wadstrom and Ljungh teach that their synbiotic compositions are effective at colonizing the gastrointestinal tract. Therefore, one of ordinary skill in the art would have a reasonable expectation that administering a composition comprising Lactobacillus plantarum LMG P-20606, Bifidobacterium breve LMG-P-26117, at least one Lactobacillus paracasei strain, and a dietary fiber prebiotic such as pectin, inulin, beta glucan, galacto-oligosaccharides, isomalto-oligosaccharides, and resistant starches would effectively colonize the gastrointestinal system of patient and treat and/or ameliorate the symptoms of VRIs.
Regarding claims 12 and 28-31, 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 29-31, 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, 3.75 g, or 7.5 g 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, 3.75 g, or 7.5 g of dietary fiber/prebiotic as recited in the claims.
Regarding claims 3, 5, and 24, Ljungh teaches their probiotic composition comprises Lactobacillus paracasei LMG P-17806 (Ljungh [0018]-[0021]) and Wadstrom teaches their synbiotic composition comprises Lactobacillus paracasei LMG P-26118 (also designated as LAB LU 33 and L. paracasei F8) (Wadstrom [0011] and the table under [0073]).
Regarding claims 4, 6-7, 22-23, and 25-26, Ljungh teaches their probiotic composition comprises Pediococcus pentosaceus LMG P-20608 and Leuconostoc mesenteroides LMG P-20607 (Ljungh [0018]-[0021]).
Regarding claims 19 and 32-33, Wadstrom teaches the 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 20, Wadstrom teaches the composition is in the form of powders, capsules, tablets, lozenges, liquids, and emulsions ([0063]).
Regarding claim 21, Wadstrom teaches the composition is a food supplement, food product, nutritional supplement, and a pharmaceutical product ([0064]).
(New necessitated by amendment) Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Shinde in view of Wadstrom and Ljungh as applied to claims 1, 3-7, 10-15, and 18-33 above, and further as evidenced by Pathak et al. (Role of Gut Microbiota in Long COVID: Impact on Immune Function and Organ System Health, Arch Microbiol Immunol. 2025; 9(1): 38–53).
Shinde, Wadstrom, and Ljungh do not teach any symptoms in individuals with long-term effects after SARS-CoV-2 infection.
However, the long term effects of COVID-19 include alterations in the gut microbiota, which are associated with long-term COVID symptoms, including respiratory dysfunction, fatigue, and chest tightness, as evidenced by Pathak pg. 4 sec. Gut Microbiota.
Since Wadstrom and Ljungh teach that their synbiotic compositions effectively colonize the gastrointestinal tract, thereby treating microbiota dysbiosis, the obvious method of Shinde in view of Wadstrom and Ljungh comprising administering a combined synbiotic composition of Wadstrom and Ljungh treats, prevents, ameliorates, or reduces symptoms of long-term COVID, namely gut dysbiosis, respiratory dysfunction, fatigue, and chest tightness.
Response to Arguments
Applicant’s arguments with respect to claims 1, 3-7, and 10-33 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