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
The office acknowledges Applicants filing of the claim amendments and arguments on 10/29/2025. Claims 1-4 have been amended and claim 5 has been added new. Rejections not reiterated from previous office actions are hereby withdrawn. Arguments, which are directed to withdrawn rejections, are thus rendered moot. The arguments in regards to the reiterated rejections/references from the previous office action are addressed below. The claim amendments necessitated the new and the modified rejections in this action. The action is made final. Claims 1-5 are pending and are examined based on the merits herein.
Response to Applicants’ Arguments
112(1) rejection: Applicants argue that the amendments presented are believed to address all issues that prompted the rejections there against under 35 USC §§112(a) and (b). Withdrawal of such rejections is therefore in order.
In response, Applicants arguments have been fully considered but the amendments do not overcome the rejection. The claim has been amended to the administration of the combination of Vitamin B2 and Vitamin C to an animal in need thereof. Applicants have provided evidence regarding administration of vitamin A, vitamin D3 and a combination of vitamin B2 and C to healthy subjects for four weeks that led to an increase in Dialister relative abundance when compared to placebo and this was in contrast to what was observed for vitamin C (Fig. 1C). However there is no evidence that the subject population included in the study had any disease or condition(s) associated with a decreased population of Dialister spp. There is no support or data in the specification to indicate that a subject with any of the disorder associated with decreased population of Dialister spp. were tested or included in the experimental study or administered a combination of Vitamin B2 and Vitamin C in any type of administration including directly administering to the large intestine of the animal to be treated. From the data provided in the specification, a person of ordinary skill in the art will not be able to predict that the combination of Vitamin B2 and Vitamin C will treat all the claimed conditions. In fact the specification do not even provide a complete list of all the diseases or adverse conditions associated with a decreased population of Dialister spp. in the gut microbiome. As per claim 3, the diseases to be treated include irritable bowel syndrome, autism spectrum disorder, impaired calcium absorption, food allergies and sensitization, generalized anxiety disorder, childhood obesity, impaired growth and morbidity of infants, immune-mediated inflammatory disease; atopic disorders, Crohn's Disease, rheumatoid arthritis and osteoarthritis, early-onset preeclampsia, Type 1 Diabetes, juvenile idiopathic arthritis, depression, attention- deficit hyperactive disorder (ADHD), chronic hepatitis B, major depressive disorder, airway allergy, multiple sclerosis, chronic inflammation, and Alzheimer's disease. For example, immune-mediated inflammatory diseases (IMIDs) are a group of chronic conditions characterized by dysregulation of the immune system, leading to inflammation and tissue damage, asthma is allergy condition and Alzheimer’s disease is a neurodegenerative condition. Each disease has a different and distinct etiology and pathophysiological manifestations, and that each is differently treated. Disease states herein claimed do not flow from a single biochemical lesion, but form a range of physiological activities. Hence it will be an undue experimentation to a person of ordinary skill in the art to arrive at the claimed method. The rejection is proper and thus maintained.
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 2-4, 5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for an increase in Dialister relative abundance with select agents like vitamin A, vitamin D3 and a combination of vitamin B2 and Vitamin C in healthy subjects and the prior art teaching the combination of Vitamin B2 and Vitamin C in improving the intestinal health in an animal having irritable bowel syndrome and other specific conditions, does not reasonably provide enablement for treating all the diseases or adverse conditions associated with a decreased population of Dialister spp. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to the invention commensurate in scope with these claims.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, "The Federal Circuit has repeatedly held that "the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation." In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)" (emphasis added). The "make and use the full scope of the invention without undue experimentation" language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: "A lack of enablement for the full scope of a claim, however, is a legitimate rejection." The principle was explicitly affirmed most recently in Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 82 USPQ2d 1113; Auto. Tech. Int'l, Inc. v. BMWofN. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc.,503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008).
In evaluating the enablement question, several factors are to be considered. Note In re Wands, 8 USPQ2d 1400 and Ex parte Forman, 230 USPQ 546. The factors include: 1) The nature of the invention, 2) the breadth of the claims, 3) the predictability or lack thereof in the art, 4) the state of the prior art, 5) the presence or absence of working examples, 6) the amount of direction or guidance present, 7) the relative skill of those in the art and 8) the quantity of experimentation needed.
(1)/(2) The nature of the invention & breadth of claims:
The instant claims 2 and 3 are directed to:
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The scope of the disease or adverse condition which is associated with a decreased population of Dialister spp. and to the subject population, animal(s) is large. The specification do not provide a complete list of all the diseases or adverse conditions associated with a decreased population of Dialister spp. in the gut microbiome. The specification has listed some specific diseases or adverse conditions associated with a decreased population of Dialister spp. (see claim 3 and p 3, lines 2-8).
(3) the predictability or lack thereof in the art, (4) the state of the prior art, (7) the relative skill of those in the art:
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute.
As to the state of the art, the prior art Zhou teach a method for treating a condition or disease associated with insufficient gastrointestinal system motility in a subject in need thereof, comprising administering a composition comprising B vitamins and C vitamins to the subject (see claim 1). The condition or disease to be treated include irritable bowel syndrome (See col. 7, lines 66-67).
The prior art teach administration of Vitamins and/or EPA or DHA to select patients such as IBD, autism spectrum disorder, ADHD, anxiety, depression (See Gubler, Morris, Horrobin above). The prior art teach regarding gut microbiome, effects of Vitamin D3 supplementation in adults with cystic fibrosis (See Kanhere, J Clin Endocrinol Metab, Feb 2018, 564-574).
According to Bloch, polyunsaturated fatty acid supplementation has demonstrated evidence of efficacy in meta-analysis of randomized, placebo-controlled trials in ADHD. The benefits of polyunsaturated fatty acid appear small compared to the effect sizes observed for traditional pharmacological treatments of ADHD (Abstract). Rigorous, randomized, placebo-controlled clinical trials examining the efficacy of dietary supplements in the treatment of ADHD are needed. Many of these supplements are commonly utilized by families despite a lack of convincing evidence of efficacy (Conclusion) (Bloch, Clin Adolesc Psychiartr Clin N Am 2014). For example, infant morbidity refers to any illness or health condition experienced by an infant in the first year of life. There is no data or evidence that vitamin B2 and Vitamin C supplementation for infants results in a reduction in infant morbidity. Further allergies in children can be due to food (e.g. peanuts, tree nuts, milk, eggs, soy, wheat, fish, and shellfish), environmental (e.g. pollen, dust mites, mold, pet dander, and insect stings), or medications.
In summary, Vitamins are known in the art to treat symptoms or reduce the occurrence of specific conditions. However the specification and/or the art do not teach that the agents claim will treat all the diseases or adverse conditions associated with decreased population of Dialister spp or the conditions listed in claims 3 or 4. Further ‘decreased population’ is a relative term and the decrease in population of Dialister spp may be specific for specific disease treatment or reduction of the symptoms associated with the condition(s). From the data provided in the specification and in the art a skilled artisan would not be able to predict that all the adverse conditions associated with decreased population of Dialister spp will be treated with the combination of Vitamin B2 and Vitamin C as claimed.
Applicants in page 7 teach,
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It is not clear or predictable from the data provided how conditions like ADHD, Alzheimer’s disease or multiple sclerosis in animals like dogs, cats or horses or swine or chicken can be treated.
The relative skill in the art is fairly high, with the typical practitioner having a medical degree and/or an advanced degree in the biochemical, chemistry or pharmaceutical-related arts.
(5) the presence or absence of working examples, (6) the amount of direction or guidance present:
Applicants have provided examples of fermentation study with select agents (Examples 1, 2, Figs. 1A, 1B) and a clinical study in humans with select agents. Applicants have demonstrated that administration of vitamin A, vitamin D3 and a combination of vitamin B2 and C for four weeks led to an increase in Dialister relative abundance when compared to placebo. This was in contrast to what was observed for vitamin C (Fig. 1C). It is noted that the participants in the study had good health and there is no mention of subject population included in the study with any diseases or conditions associated with a decreased population of Dialister spp.
There is no evidence in the specification that combination of Vitamin C and Vitamin B2 was administered for treatment to a subject with diseases associated with decrease in Dialister spp.
The specification do not provide a complete listing of all the diseases or adverse conditions associated with a decreased population of Dialister spp, The prior art or the specification do not provide direction or guidance to how the conditions will be treated with the agents as claimed. The specification does not provide any guidance to one of ordinary skill in the art to extrapolate the biological data to the treatment of all of the diseases of the instant claims having diverse mechanisms.
(8) The quantity of experimentation necessary:
Because of the known unpredictability of the art, and experimental evidence limited to specific conditions or diseases to be treated, no one skilled in the art would accept the assertion that the combination of Vitamin B2 and Vitamin C as claimed could be predictably used for treating all the conditions associated with a decreased population of Dialister spp or all the conditions. A skilled artisan would have to undergo exhaustive studies to evaluate the agents for the treatment of various conditions to be treated as claimed in order to be able to fully carry out the invention to commensurate in scope with the claims. For example, immune-mediated inflammatory diseases (IMIDs) are a group of chronic conditions characterized by dysregulation of the immune system, leading to inflammation and tissue damage, asthma is allergy condition and Alzheimer’s disease is a neurodegenerative condition. Each disease has a different and distinct etiology and pathophysiological manifestations, and that each is differently treated. Disease states herein claimed do not flow from a single biochemical lesion, but form a range of physiological activities. Hence it will be an undue experimentation to a person of ordinary skill in the art to arrive at the claimed method. The rejection is proper and thus maintained. The determination that “undue experimentation” would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. Genetech, 108 F. 3d at 1366 states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimation of general ideas that may or may not be workable. MPEP 2164.01(a) states, "A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)."
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5 are rejected under 35 U.S.C. 103 as being unpatentable over Bruins et al. (WO 2020043797 A1, published: 3/5/2020, Intl. filing date:28 Aug 2019) and Li et al. (CN 105543385, see English translation).
Bruins teach formulations comprises riboflavin (Vitamin B2) and Vitamin C to increase the microbiome diversity for delivery in colon of an animal and a method for improving gut health administering such composition and the method treats or lessens the symptoms of irritable bowl syndrome (See abstract, claims 1, 23). Bruins teach a delayed release formulation for delivery of an active agent to the intestine, comprising the active agent and an enteric layer or an enteric shell, wherein said active agent consists of 1 -85 mg riboflavin, 0.2-0.4 mg vitamin A, 400-600 mg vitamin C, 5- 80 pg vitamin D, 80-120 mg vitamin E, 80-140 pg vitamin K, 0.3-0.5 mg folic acid, 80-120 mg omega-3 fatty acid(s) or combinations thereof, and wherein the release of the active agent is delayed until the intestine; the delayed release formulation of the present invention is administered once per day or administered twice daily, or every second day; the malls is a human (See p 39, lines 6-11, p 40, lines 8-16).
Li et al. teach Dialister microorganism as a marker for irritable bowel syndrome and a medicine for treating IBS and increasing the relative abundance of Dialister (See abstract, claims 1 and 9).
From the teachings of Bruins a person skilled in the art before the effective filing date of the invention would have found it obvious to administer a composition comprising riboflavin (Vitamin B2) and Vitamin C to subjects with irritable bowel syndrome (IBS) delivered directly to colon. A person skilled in the art from Li would have found it obvious that Dialister microorganism species is a marker for IBS and the relative abundance need to be increased to treat IBS. A person skilled in the art would have been motivated to arrive to administer the combination of Vitamin B2 (riboflavin) and Vitamin C by direct delivery to colon (main part of the large intestine) of treating a disease (associated with a decrease in Dialister spp, e.g. irritable bowel syndrome) with a reasonable expectation of success and treat the symptoms associated with IBS. Further administration of an effective amount of the same set of agents in combination, herein Vitamin B2 (riboflavin) and Vitamin C by direct delivery to colon in treating IBS would result in an increase in the Dialister spp. Thus claims 1-3, 5 would have been obvious over the combined teachings of the prior art.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites limitations: ‘food allergies and sensitization is an allergy or sensitization to a food selected from the group consisting of milk, eggs, peanuts, soy, walnut and wheat’ and ‘atopic disorders are selected rom the group consisting of asthma and allergies in children’. Allergies in children include food allergies.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, the scope of allergies in children includes food allergies. The subjects for the disorder ‘food allergies and sensitization’ to be treated include children.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Appropriate correction is required.
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 1-3, 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-21 of U.S. Patent No. 12508280 (‘280) or claims 1-19 of co-pending application 17798778 (‘778) or claims 1-12 of co-pending application 18548797 (‘797), claims 1-6 of co-pending application 18550642 (642) or claims 1-8 of co-pending application 18014387 (‘387) or claims 1-14 of co-pending application 18871675 (‘675) and Li et al. (CN 105543385, see English translation).
The instant claims are directed to:
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The dependent claims are limited to specific disorders and to animal, human.
‘280 reference claims are directed to a method of improving intestinal health in an animal wherein said improvement comprises one or more of: (i) increasing the concentration of at least one short-chain fatty acid or a salt thereof in the intestine; (ii) increasing microbiome diversity in the intestine; (iii) increasing the abundance of a beneficial bacteria in the intestine; (iv) promoting or increasing the butyrate synthesis pathway in the intestine; (v) improving the barrier function of the intestine; (vi) reducing the amount of gas produced in the intestine; and, (vii) stimulating intestinal immune responses, wherein said method comprises administering to the animal active agents comprising a daily dose of riboflavin and vitamin C, wherein the active agents are present in a formulation comprising an effective dose of the active agents and the active agents are delivered to the large intestine; wherein the improving the barrier function is a method of treating or lessening the symptoms of a condition selected from the group consisting of irritable bowel disease, Crohn's disease, ulcerative colitis, leaky gut and malnutrition; wherein said method comprises administering to the animal active agents consisting of a daily dose of riboflavin (1-85 mg) and vitamin C (400-600 mg); the animal is a mammal, human.
‘778 reference claims are directed to a composition consisting essentially of: an effective dose of at least two antioxidants selected from the group consisting of: Vitamin C, Vitamin B2, beta-carotene and Vitamin E for use in improving intestinal health in an animal, including a human, wherein said improvement comprises or consists of: i. Increasing the activity of the microbiome; ii. increasing the concentration of at least one short-chain fatty acid or a salt thereof in the intestine; iii. reducing the amount of ammonia formed in the gut; iv. increasing microbiome diversity in the intestine; v. increasing the abundance of a beneficial bacteria in the intestine; vi. improving the barrier function of the intestine; and/or vii. decreasing the abundance of pathogens in the intestine; said composition delivering the antioxidants to the large intestine; wherein the animal is a human and the effective dose of the antioxidant is delivered by a delayed release formulation; and to a method of using the composition, wherein the animal, including a human is experiencing a condition selected from the group consisting of: metabolic disorder, Type 2 Diabetes, obesity, Crohn's disease, ulcerative colitis, inflammatory bowel disease, irritable bowel syndrome, leaky gut, malnutrition, chronic inflammation, and cardiovascular disease.
‘797 reference claims are directed to a method of increasing the population of Blautia sp. in the gut microbiome comprising directly delivering to the large intestine at least one antioxidant selected from the group consisting of Vitamin B2, Vitamin C, beta-carotene, Vitamin E and wherein the person is experiencing Crohn's disease, ulcerative colitis, inflammatory bowel disease with Clostridium difficile infection.
‘642 reference claims are directed to a method of decreasing the population of a Fusobacterium spp. in a person's gut, comprising directly delivering to the person's large intestine, at least one antioxidant selected from the group consisting of: Vitamin C, Vitamin E, riboflavin, and beta-carotene, and mixtures thereof; wherein the person receiving the directly delivered antioxidant is a person who is experiencing, or is at risk of experiencing a condition associated with an elevated population of Fusobacterium selected from the group consisting of:- a person over 40 years of age; a digestive disorder selected from the group consisting of: Ulcerative colitis, Chron's disease, and pediatric or adult inflammatory bowel disease or to use of the composition comprising Vitamin C and riboflavin.
‘387 reference claims are directed to the use of a vitamin or vitamin combination selected from the group consisting of: a combination of riboflavin and vitamin C, vitamin D3, beta-carotene, and vitamin B5, which is formulated for direct delivery to the gut microbiome of an animal, preferably a human, wherein upon delivery, it increases the population of Coprococcus spp. in the gut microbiome; herein the human is a person at risk for or experiencing a disease or adverse condition, Irritable Bowel Syndrome, Inflammatory Bowel Disease.
‘675 reference claims are directed to Vitamin B2, vitamin C, and/or vitamin D for use in increasing the abundance of Bifidobacterium animalis ssp. lactis in the intestine of an animal, preferably a human, wherein said use comprises delivering the vitamin(s) to the large intestine and its use in the animal, including a human, is experiencing at least one condition selected from the group consisting of: irritable bowel syndrome, functional intestinal gas symptoms, upper respiratory symptoms, airway infections.
Li et al. teach Dialister microorganism as a marker for irritable bowel syndrome and a medicine for treating IBS and increasing the relative abundance of Dialister (See abstract, claims 1 and 9).
A person skilled in the art from Li would have found it obvious that Dialister microorganism species is a marker for IBS and the relative abundance need to be increased to treat IBS. From the teachings of the reference claims a person skilled in the art would have found it obvious to administer a composition comprising riboflavin (Vitamin B2) and Vitamin C to subjects with irritable bowel syndrome (IBS) delivered directly to colon (large intestine) to an animal in need thereof, e.g. human. As to claim 1, administration of an effective amount of the same set of agents in combination, herein Vitamin B2 (riboflavin) and Vitamin C by direct delivery to colon in treating IBS to an animal in need thereof, e.g. human would result in an increase in the Dialister spp. Thus claims 1-3, 5 would have been obvious over the reference claims and prior art.
Conclusion
Applicant's amendment necessitated the new and modified 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 UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
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/Umamaheswari Ramachandran/ Primary Examiner, Art Unit 1627