Prosecution Insights
Last updated: April 19, 2026
Application No. 18/548,797

METHOD OF INCREASING THE POPULATION OF BLAUTIA SPP. IN THE GUT MICROBIOME

Non-Final OA §102§103§112§DP
Filed
Sep 01, 2023
Examiner
PIHONAK, SARAH
Art Unit
1627
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
DSM IP ASSETS B.V.
OA Round
1 (Non-Final)
61%
Grant Probability
Moderate
1-2
OA Rounds
2y 11m
To Grant
99%
With Interview

Examiner Intelligence

Grants 61% of resolved cases
61%
Career Allow Rate
900 granted / 1477 resolved
+0.9% vs TC avg
Strong +44% interview lift
Without
With
+43.7%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
47 currently pending
Career history
1524
Total Applications
across all art units

Statute-Specific Performance

§101
1.7%
-38.3% vs TC avg
§103
39.9%
-0.1% vs TC avg
§102
11.0%
-29.0% vs TC avg
§112
20.5%
-19.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1477 resolved cases

Office Action

§102 §103 §112 §DP
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. Priority This application, filed 09/01/2023 is a National Stage entry of PCT/EP2022/055332, International Filing Date: 03/03/2022. PCT/EP2022/055332 claims foreign priority to 21160879.9, filed 03/05/2021. A certified copy of the foreign priority document is of record. Status of Claims Claims 1-12 are currently pending. Claims 1-12 were examined and are rejected. 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 appl icant regards as his invention. Claims 4 and 10 are 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. Claims 4 and 10 each recite a broad limitation and narrow limitation, which introduces indefiniteness. For instance, each of these claims recite “digestive diseases during pregnancy” followed by “(including constipation; vomiting; and fatty liver)” . 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). 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. To provide compact prosecution, claims 4 and 10 were examined with respect to the broader limitation. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claims 6 and 12 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 6 and 12 recite the antioxidants to be delivered directly to the gut, while claims 1 and 7, from which claims 6 and 12 depend from respectively, recites the antioxidants to be delivered to the large intestine. The gut encompasses the large intestine as well as parts of the digestive tract that fall outside of the large intestine , including the small intestine and stomach . Therefore, claims 6 and 12 don’t further limit claims 1 and 7 with respect to delivery and in fact encompass delivery to parts of the digestive tract outside of the large intestine. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Rejections-35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claim(s) 1-2, 4-8, and 10-12 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Bruins et. al., WO 2020043797 A1, publ. 3/5/2020, international filing date 8/28/2019 . Bruins discloses delayed release formulations for improving gut health, wherein an active agent is delivered to the colon of an animal, resulting in increased concentration of short-chain fatty acid(s) in the intestine, increased microbiome diversity, increased beneficial bacteria in the intestine, improved intestinal barrier function, increased butyrate synthesis, stimulation of intestinal immune responses, and reduced gas production in the intestine (title & abstract; p. 1, lines 3-11 ; p. 2, line 22-p. 3, line 10 ). Bruins teaches administration of the formulation for treating an inflammatory disorder characterized by chronic inflammation (p. 3, lines 24-28). Bruins discloses an embodiment wherein the formulation contains the combination of riboflavin (vitamin B2) , vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, folic acid, beta-carotene, vitamin B1, biotin, and omega-3 fatty acids, and is administered to the colon of the animal for treating symptoms of irritable bowel syndrome (IBS) , metabolic disease, obesity, ulcerative colitis, Crohn’s disease, and inflammation (p. 30, lines 17-24 ; p. 34, lines 15-21 ). Bruins discloses the same active steps as recited by the instant claims, i.e. administration to the large intestine, i.e., colon of an animal a formulation comprising vitamin B2, vitamin C, beta-carotene, and vitamin E, for the treatment of chronic inflammation, IBS, ulcerative colitis, Crohn’s disease, and obesity. Therefore, the effect of treatment would have necessarily been the same, and the population of Blautia sp. in the gut microbiome, including Blautia wexlerae as recited by instant claim 2, would have increased. See MPEP 2112.02(II): The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978). Bruins therefore anticipates the claims. 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. 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) 3 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruins et. al., WO 2020043797 A1, as applied to claims 1-2, 4-8, and 10-12 as discussed previously . The disclosure and teachings of Bruins as discussed previously are incorporated herein. As discussed in the previous section, Bruins discloses the method for increasing beneficial bacteria in the intestine, wherein an increase in such beneficial bacteria can treat, prevent, and lessen symptoms of IBS, metabolic disease, obesity, ulcerative colitis, Crohn’s disease, and inflammatory conditions, wherein intestine includes the large intestine (p. 1, lines 3-11; p. 24, lines 6-7; p. 30, line 26-p. 30, line 24). In particular, Bruins teaches the beneficial bacteria increased in the intestine/colon include Blautia sp. (p. 23, lines 19-26; p. 30, line 26-p. 31, line 2; p. 100, claims 6-8). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have administered the antioxidant composition as disclosed previously by Bruins to a subject having a decreased population of Blautia prior to administration, since Bruins teaches the composition to increase the population of such beneficial bacteria in the intestine . One of ordinary skill in the art would have been motivated to have administered the composition to a subject who had a decreased population of Blautia prior to administration, and have had a reasonable expectation that administration of the antioxidant composition would have increased the population of this bacteria. Claim Rejections-Nonstatutory 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 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 17798778 (reference application) in view of Bruins et. al., WO 2020043797 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims involve administration of the same antioxidants to the large intestine, vitamin C, vitamin B2, beta-carotene, and vitamin E. The copending claims recite a composition comprising the above antioxidants and a method of improving the intestinal health in an animal by administering the composition directly to the large intestine. By administering the same antioxidant composition directly to the large intestine, the effects of treatment would have necessarily been the same, i.e., the population of Blautia would have been increased by practicing the method of the copending claims, and intestinal health would have been improved by practicing the method of the instant claims. Both sets of claims further recite treating the same patient populations, patients suffering from obesity, type 2 diabetes, and Crohn’s disease (see copending claim 15 and instant claim 4). Although the copending claims don’t explicitly recite a patient having a decreased population of Blautia prior to administration as recited by instant claims 3 and 9 , treatment of this patient population would have been prima facie obvious in view of Bruins. Bruins discloses formulations for improving gut health, wherein an active agent is delivered to the colon of an animal, resulting in increased concentration of short-chain fatty acid(s) in the intestine, increased microbiome diversity, increased beneficial bacteria in the intestine, improved intestinal barrier function, increased butyrate synthesis, stimulation of intestinal immune responses, and reduced gas production in the intestine (title & abstract; p. 1, lines 3-11; p. 2, line 22-p. 3, line 10). Bruins teaches administration of the formulation for treating an inflammatory disorder characterized by chronic inflammation (p. 3, lines 24-28). Bruins discloses an embodiment wherein the formulation contains the combination of riboflavin (vitamin B2), vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, folic acid, beta-carotene, vitamin B1, biotin, and omega-3 fatty acids, and is administered to the colon of the animal for treating symptoms of irritable bowel syndrome (IBS), metabolic disease, obesity, and inflammation (p. 30, lines 17-24). In particular, Bruins teaches the beneficial bacteria increased in the intestine/colon include Blautia sp. (p. 23, lines 19-26; p. 30, line 26-p. 31, line 2; p. 100, claims 6-8). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have administered the antioxidant composition as disclosed previously by Bruins to a subject having a decreased population of Blautia prior to administration, since Bruins teaches the composition to increase the population of such beneficial bacteria in the colon. The instant and copending claims are therefore not patentably distinct, being drawn to administration of the same antioxidant composition directly to the large intestine. Copending claim 2 recites the antioxidant in a delayed release formulation; although this limitation is not explicitly recited by the instant claims, Bruins teaches the antioxidant composition in a delayed release formulation for delivery to the large intestine (p. 2, line 22-p. 3, line 10). As such, it would have been prima facie obvious to have administered the antioxidant composition of the instant claims in a delayed release formulation, with a reasonable expectation of success. The instant and copending claims are therefore not patentably distinct, being drawn to administration of the same antioxidant composition directly to the large intestine. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18014387 (reference application) in view of Bruins et. al., WO 2020043797 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims involve administration of the same antioxidants to the large intestine, at least one selected from vitamin C, vitamin B2 (riboflavin), and beta-carotene. The copending claims recite a composition comprising the above antioxidants and a method of increasing the population of Coprococcus sp. in the gut microbiome by administering the composition directly to the large intestine. By administering the same antioxidant composition directly to the large intestine, the effects of treatment would have necessarily been the same, i.e., the population of Blautia would have been increased by practicing the method of the copending claims, and the population of Coprococcus sp. in the gut microbiome would have been i ncreased by practicing the method of the instant claims. Both sets of claims further recite treating the same patient populations, patients suffering from Parkinson’s disease, ulcerative colitis and Crohn’s disease (see copending claim 5 and instant claim 4). Although the copending claims don’t explicitly recite a patient having a decreased population of Blautia prior to administration as recited by instant claims 3 and 9, treatment of this patient population would have been prima facie obvious in view of Bruins. Bruins discloses formulations for improving gut health, wherein an active agent is delivered to the colon of an animal, resulting in increased concentration of short-chain fatty acid(s) in the intestine, increased microbiome diversity, increased beneficial bacteria in the intestine, improved intestinal barrier function, increased butyrate synthesis, stimulation of intestinal immune responses, and reduced gas production in the intestine (title & abstract; p. 1, lines 3-11; p. 2, line 22-p. 3, line 10). Bruins teaches administration of the formulation for treating an inflammatory disorder characterized by chronic inflammation (p. 3, lines 24-28). Bruins discloses an embodiment wherein the formulation contains the combination of riboflavin (vitamin B2), vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, folic acid, beta-carotene, vitamin B1, biotin, and omega-3 fatty acids, and is administered to the colon of the animal for treating symptoms of irritable bowel syndrome (IBS), metabolic disease, obesity, and inflammation (p. 30, lines 17-24). In particular, Bruins teaches the beneficial bacteria increased in the intestine/colon include Blautia sp. (p. 23, lines 19-26; p. 30, line 26-p. 31, line 2; p. 100, claims 6-8). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have administered the antioxidant composition as disclosed previously by Bruins to a subject having a decreased population of Blautia prior to administration, since Bruins teaches the composition to increase the population of such beneficial bacteria in the colon. The instant and copending claims are therefore not patentably distinct, being drawn to administration of the same antioxidant composition directly to the large intestine. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 3 and 5 of copending Application No. 18014 780 (reference application) in view of Bruins et. al., WO 2020043797 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims involve administration of the same antioxidants to the large intestine, a combination of vitamin C and vitamin B2 (riboflavin). The copending claims recite a method of increasing the population of Dialister sp p . in the gut microbiome by administering the composition directly to the large intestine. By administering the same antioxidant composition directly to the large intestine, the effects of treatment would have necessarily been the same, i.e., the population of Blautia would have been increased by practicing the method of the copending claims, and the population of Dialister spp. in the gut microbiome would have been i ncreased by practicing the method of the instant claims. Both sets of claims further recite treating the same patient populations, patients suffering from Alzheimer’s disease and Crohn’s disease (see copending claim 3 and instant claim 4). Although the copending claims don’t explicitly recite a patient having a decreased population of Blautia prior to administration as recited by instant claims 3 and 9, treatment of this patient population would have been prima facie obvious in view of Bruins. Bruins discloses formulations for improving gut health, wherein an active agent is delivered to the colon of an animal, resulting in increased concentration of short-chain fatty acid(s) in the intestine, increased microbiome diversity, increased beneficial bacteria in the intestine, improved intestinal barrier function, increased butyrate synthesis, stimulation of intestinal immune responses, and reduced gas production in the intestine (title & abstract; p. 1, lines 3-11; p. 2, line 22-p. 3, line 10). Bruins teaches administration of the formulation for treating an inflammatory disorder characterized by chronic inflammation (p. 3, lines 24-28). Bruins discloses an embodiment wherein the formulation contains the combination of riboflavin (vitamin B2), vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, folic acid, beta-carotene, vitamin B1, biotin, and omega-3 fatty acids, and is administered to the colon of the animal for treating symptoms of irritable bowel syndrome (IBS), metabolic disease, obesity, and inflammation (p. 30, lines 17-24). In particular, Bruins teaches the beneficial bacteria increased in the intestine/colon include Blautia sp. (p. 23, lines 19-26; p. 30, line 26-p. 31, line 2; p. 100, claims 6-8). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have administered the antioxidant composition as disclosed previously by Bruins to a subject having a decreased population of Blautia prior to administration, since Bruins teaches the composition to increase the population of such beneficial bacteria in the colon. The instant and copending claims are therefore not patentably distinct, being drawn to administration of the same antioxidant composition directly to the large intestine. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 18550642 (reference application) in view of Bruins et. al., WO 2020043797 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims involve administration of the same antioxidants to the large intestine, vitamin C, vitamin E, beta-carotene, and vitamin B2 (riboflavin). The copending claims recite a method of increasing the population of Fusobacterium spp. in the gut microbiome by administering the composition directly to the large intestine. By administering the same antioxidant composition directly to the large intestine, the effects of treatment would have necessarily been the same, i.e., the population of Blautia would have been increased by practicing the method of the copending claims, and the population of Fusobacterium spp. in the gut microbiome would have been increased by practicing the method of the instant claims. Both sets of claims further recite treating the same patient populations, patients suffering from ulcerative colitis and Crohn’s disease (see copending claim 2 and instant claim 4). Although the copending claims don’t explicitly recite a patient having a decreased population of Blautia prior to administration as recited by instant claims 3 and 9, treatment of this patient population would have been prima facie obvious in view of Bruins. Bruins discloses formulations for improving gut health, wherein an active agent is delivered to the colon of an animal, resulting in increased concentration of short-chain fatty acid(s) in the intestine, increased microbiome diversity, increased beneficial bacteria in the intestine, improved intestinal barrier function, increased butyrate synthesis, stimulation of intestinal immune responses, and reduced gas production in the intestine (title & abstract; p. 1, lines 3-11; p. 2, line 22-p. 3, line 10). Bruins teaches administration of the formulation for treating an inflammatory disorder characterized by chronic inflammation (p. 3, lines 24-28). Bruins discloses an embodiment wherein the formulation contains the combination of riboflavin (vitamin B2), vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, folic acid, beta-carotene, vitamin B1, biotin, and omega-3 fatty acids, and is administered to the colon of the animal for treating symptoms of irritable bowel syndrome (IBS), metabolic disease, obesity, and inflammation (p. 30, lines 17-24). In particular, Bruins teaches the beneficial bacteria increased in the intestine/colon include Blautia sp. (p. 23, lines 19-26; p. 30, line 26-p. 31, line 2; p. 100, claims 6-8). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have administered the antioxidant composition as disclosed previously by Bruins to a subject having a decreased population of Blautia prior to administration, since Bruins teaches the composition to increase the population of such beneficial bacteria in the colon. The instant and copending claims are therefore not patentably distinct, being drawn to administration of the same antioxidant composition directly to the large intestine. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, and 8-14 of copending Application No. 18871675 (reference application) in view of Bruins et. al., WO 2020043797 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims involve administration of the same antioxidants to the large intestine, vitamin C and vitamin B2 (riboflavin). The copending claims recite a method of increasing the population of Bifidobacterium animalis ssp. lactis spp. in the intestine by administering the composition directly to the large intestine. By administering the same antioxidant composition directly to the large intestine, the effects of treatment would have necessarily been the same, i.e., the population of Blautia would have been increased by practicing the method of the copending claims, and the population of the population of Bifidobacterium animalis ssp. lactis spp. would have been increased by practicing the method of the instant claims. Both sets of claims further recite treating the same patient populations, patients suffering from constipation (see copending claim 5 and instant claim 4). Although the copending claims don’t explicitly recite a patient having a decreased population of Blautia prior to administration as recited by instant claims 3 and 9, treatment of this patient population would have been prima facie obvious in view of Bruins. Bruins discloses formulations for improving gut health, wherein an active agent is delivered to the colon of an animal, resulting in increased concentration of short-chain fatty acid(s) in the intestine, increased microbiome diversity, increased beneficial bacteria in the intestine, improved intestinal barrier function, increased butyrate synthesis, stimulation of intestinal immune responses, and reduced gas production in the intestine (title & abstract; p. 1, lines 3-11; p. 2, line 22-p. 3, line 10). Bruins teaches administration of the formulation for treating an inflammatory disorder characterized by chronic inflammation (p. 3, lines 24-28). Bruins discloses an embodiment wherein the formulation contains the combination of riboflavin (vitamin B2), vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, folic acid, beta-carotene, vitamin B1, biotin, and omega-3 fatty acids, and is administered to the colon of the animal for treating symptoms of irritable bowel syndrome (IBS), metabolic disease, obesity, and inflammation (p. 30, lines 17-24). In particular, Bruins teaches the beneficial bacteria increased in the intestine/colon include Blautia sp. (p. 23, lines 19-26; p. 30, line 26-p. 31, line 2; p. 100, claims 6-8). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have administered the antioxidant composition as disclosed previously by Bruins to a subject having a decreased population of Blautia prior to administration, since Bruins teaches the composition to increase the population of such beneficial bacteria in the colon. The instant and copending claims are therefore not patentably distinct, being drawn to administration of the same antioxidant composition directly to the large intestine. Copending claim 11 recites the antioxidant in a delayed release formulation; although this limitation is not explicitly recited by the instant claims, Bruins teaches the antioxidant composition in a delayed release formulation for delivery to the large intestine (p. 2, line 22-p. 3, line 10). As such, it would have been prima facie obvious to have administered the antioxidant composition of the instant claims in a delayed release formulation, with a reasonable expectation of success. The instant and copending claims are therefore not patentably distinct, being drawn to administration of the same antioxidant composition directly to the large intestine. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-12 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-11 of U.S. Patent No. 12508280 B2 in view of Bruins et. al., WO 2020043797 A1 . Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims involve the same active step, administration of the same antioxidants, riboflavin (vitamin B2) and vitamin C directly to the large intestine of an animal . The patented claims are drawn to improving intestinal health in an animal by administering directly to the large intestine the same antioxidants. By administering the same antioxidant composition directly to the large intestine, the effects of treatment would have necessarily been the same, i.e., the population of Blautia would have been increased by practicing the method of the patented claims, and the intestinal health would have been improved by practicing the method of the instant claims. Both sets of claims further recite treating the same patient populations, patients suffering from ulcerative colitis, chronic inflammation, and Crohn’s disease (see patented claims 3 and 9, and instant claim 4). Although the patented claims don’t explicitly recite a patient having a decreased population of Blautia prior to administration as recited by instant claims 3 and 9, treatment of this patient population would have been prima facie obvious in view of Bruins. Bruins discloses formulations for improving gut health, wherein an active agent is delivered to the colon of an animal, resulting in increased concentration of short-chain fatty acid(s) in the intestine, increased microbiome diversity, increased beneficial bacteria in the intestine, improved intestinal barrier function, increased butyrate synthesis, stimulation of intestinal immune responses, and reduced gas production in the intestine (title & abstract; p. 1, lines 3-11; p. 2, line 22-p. 3, line 10). Bruins teaches administration of the formulation for treating an inflammatory disorder characterized by chronic inflammation (p. 3, lines 24-28). Bruins discloses an embodiment wherein the formulation contains the combination of riboflavin (vitamin B2), vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, folic acid, beta-carotene, vitamin B1, biotin, and omega-3 fatty acids, and is administered to the colon of the animal for treating symptoms of irritable bowel syndrome (IBS), metabolic disease, obesity, and inflammation (p. 30, lines 17-24). In particular, Bruins teaches the beneficial bacteria increased in the intestine/colon include Blautia sp. (p. 23, lines 19-26; p. 30, line 26-p. 31, line 2; p. 100, claims 6-8). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have administered the antioxidant composition as disclosed previously by Bruins to a subject having a decreased population of Blautia prior to administration, since Bruins teaches the composition to increase the population of such beneficial bacteria in the colon. The instant and patented claims are therefore not patentably distinct, being drawn to administration of the same antioxidant composition directly to the large intestine. Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6, 9-11, and 13-14 of copending Application No. 18872488 (reference application) in view of Bruins et. al., WO 2020043797 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims involve administration of the same antioxidants to the large intestine, at least one selected from vitamin B2 (riboflavin). The copending claims recite a composition comprising the above antioxidant and a method of increasing the abundance of Lactobacillus rhamnosus in the intestine by administering the composition directly to the large intestine. By administering the same antioxidant composition directly to the large intestine, the effects of treatment would have necessarily been the same, i.e., the population of Blautia would have been increased by practicing the method of the copending claims, and the abundance of Lactobacillus rhamnosus in the intestine would have been increased by practicing the method of the instant claims. Both sets of claims further recite treating the same patient populations, patients suffering from inflammatory bowel disease (IBD) (see copending claim 13 and instant claim 4). Although the copending claims don’t explicitly recite a patient having a decreased population of Blautia prior to administration as recited by instant claims 3 and 9, treatment of this patient population would have been prima facie obvious in view of Bruins. Bruins discloses formulations for improving gut health, wherein an active agent is delivered to the colon of an animal, resulting in increased concentration of short-chain fatty acid(s) in the intestine, increased microbiome diversity, increased beneficial bacteria in the intestine, improved intestinal barrier function, increased butyrate synthesis, stimulation of intestinal immune responses, and reduced gas production in the intestine (title & abstract; p. 1, lines 3-11; p. 2, line 22-p. 3, line 10). Bruins teaches administration of the formulation for treating an inflammatory disorder characterized by chronic inflammation (p. 3, lines 24-28). Bruins discloses an embodiment wherein the formulation contains the combination of riboflavin (vitamin B2), vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, folic acid, beta-carotene, vitamin B1, biotin, and omega-3 fatty acids, and is administered to the colon of the animal for treating symptoms of irritable bowel syndrome (IBS), metabolic disease, obesity, and inflammation (p. 30, lines 17-24). In particular, Bruins teaches the beneficial bacteria increased in the intestine/colon include Blautia sp. (p. 23, lines 19-26; p. 30, line 26-p. 31, line 2; p. 100, claims 6-8). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have administered the antioxidant composition as disclosed previously by Bruins to a subject having a decreased population of Blautia prior to administration, since Bruins teaches the composition to increase the population of such beneficial bacteria in the colon. Copending claim 11 recites the antioxidant in a delayed release formulation; although this limitation is not explicitly recited by the instant claims, Bruins teaches the antioxidant composition in a delayed release formulation for delivery to the large intestine (p. 2, line 22-p. 3, line 10). As such, it would have been prima facie obvious to have administered the antioxidant composition of the instant claims in a delayed release formulation, with a reasonable expectation of success. The instant and copending claims are therefore not patentably distinct, being drawn to administration of the same antioxidant composition directly to the large intestine. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 26-27, 29, 31-32, 35, 37, 39-40, and 42 of copending Application No. 19312760 (reference application) in view of Bruins et. al., WO 2020043797 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims involve administration of the same antioxidants to the large intestine, at least one selected from vitamin C. The copending claims recite a composition comprising the above antioxidant and a method of improving the intestinal health in an animal by administering the composition directly to the large intestine. By administering the same antioxidant composition directly to the large intestine, the effects of treatment would have necessarily been the same, i.e., the population of Blautia would have been increased by practicing the method of the copending claims, and the intestinal health would have been improved by practicing the method of the instant claims. Both sets of claims further recite treating the same patient populations, patients suffering from type 2 diabetes, obesity, and chronic inflammation (see copending claim 27 and instant claim 4). Although the copending claims don’t explicitly recite a patient having a decreased population of Blautia prior to administration as recited by instant claims 3 and 9, treatment of this patient population would have been prima facie obvious in view of Bruins. Bruins discloses formulations for improving gut health, wherein an active agent is delivered to the colon of an animal, resulting in increased concentration of short-chain fatty acid(s) in the intestine, increased microbiome diversity, increased beneficial bacteria in the intestine, improved intestinal barrier function, increased butyrate synthesis, stimulation of intestinal immune responses, and reduced gas production in the intestine (title & abstract; p. 1, lines 3-11; p. 2, line 22-p. 3, line 10). Bruins teaches administration of the formulation for treating an inflammatory disorder characterized by chronic inflammation (p. 3, lines 24-28). Bruins discloses an embodiment wherein the formulation contains the combination of riboflavin (vitamin B2), vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, folic acid, beta-carotene, vitamin B1, biotin, and omega-3 fatty acids, and is administered to the colon of the animal for treating symptoms of irritable bowel syndrome (IBS), metabolic disease, obesity, and inflammation (p. 30, lines 17-24). In particular, Bruins teaches the beneficial bacteria increased in the intestine/colon include Blautia sp. (p. 23, lines 19-26; p. 30, line 26-p. 31, line 2; p. 100, claims 6-8). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have administered the antioxidant composition as disclosed previously by Bruins to a subject having a decreased population of Blautia prior to administration, since Bruins teaches the composition to increase the population of such beneficial bacteria in the colon. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 19429458 (reference application) in view of Bruins et. al., WO 2020043797 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims involve administration of the same antioxidants to the large intestine, at least one selected from vitamin B2 (riboflavin), vitamin C, beta-carotene, and vitamin E. The copending claims recite a method of improving the intestinal health in an animal by administering the composition directly to the large intestine. By administering the same antioxidant composition directly to the large intestine, the effects of treatment would have necessarily been the same, i.e., the population of Blautia would have been increased by practicing the method of the copending claims, and the intestinal health in an animal would have been improved by practicing the method of the instant claims. Both sets of claims further recite treating the same patient populations, patients suffering from type 2 diabetes, obesity, Crohn’s disease, and ulcerative colitis (see copending claim 5 and instant claim 4). Although the copending claims don’t explicitly recite a patient having a decreased population of Blautia prior to administration as recited by instant claims 3 and 9, treatment of this patient population would have been prima facie obvious in view of Bruins. Bruins discloses formulations for improving gut health, wherein an active agent is delivered to the colon of an animal, resulting in increased concentration of short-chain fatty acid(s) in the intestine, increased microbiome diversity, increased beneficial bacteria in the intestine, improved intestinal barrier function, increased butyrate synthesis, stimulation of intestinal immune responses, and reduced gas production in the intestine (title & abstract; p. 1, lines 3-11; p. 2, line 22-p. 3, line 10). Bruins teaches administration of the formulation for treating an inflammatory disorder characterized by chronic inflammation (p. 3, lines 24-28). Bruins discloses an embodiment wherein the formulation contains the combination of riboflavin (vitamin B2), vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, folic acid, beta-carotene, vitamin B1, biotin, and omega-3 fatty acids, and is administered to the colon of the animal for treating symptoms of irritable bowel syndrome (IBS), metabolic disease, obesity, and inflammation (p. 30, lines 17-24). In particular, Bruins teaches the beneficial bacteria increased in the intestine/colon include Blautia sp. (p. 23, lines 19-26; p. 30, line 26-p. 31, line 2; p. 100, claims 6-8). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have administered the antioxidant composition as disclosed previously by Bruins to a subject having a decreased population of Blautia prior to administration, since Bruins teaches the composition to increase the population of such beneficial bacteria in the colon. Copending claim 11 recites the antioxidant in a delayed release formulation; although this limitation is not explicitly recited by the instant claims, Bruins teaches the antioxidant composition in a delayed release formulation for delivery to the large intestine (p. 2, line 22-p. 3, line 10). As such, it would have been prima facie obvious to have administered the antioxidant composition of the instant claims in a delayed release formulation, with a reasonable expectation of success. The instant and copending claims are therefore not patentably distinct, being drawn to administration of the same antioxidant composition directly to the large intestine. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Information Disclosure Statement The IDS filed on 9/1/23 has been considered. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SARAH PIHONAK whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-7710 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 9:00-5:30 EST . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Kortney Klinkel can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-5239 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. FILLIN "Examiner Stamp" \* MERGEFORMAT SARAH . PIHONAK Primary Examiner Art Unit 1627 /SARAH PIHONAK/ Primary Examiner, Art Unit 1627
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Prosecution Timeline

Sep 01, 2023
Application Filed
Mar 27, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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2y 11m
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