DETAILED ACTION
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 .
Status of the Claims
Claims 1-6 are pending in the instant application and subject to examination herein.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. PCT/EP2022/056947, filed on 03/17/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/14/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 2 and 5 are objected to because of the following informalities: In each of claims 2 and 5, the disease known as “Crohn’s disease” is misspelled as “Chron’s disease”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1 and 3 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.
Claim 1 is drawn to a method for decreasing the population of Fusobacterium spp. in a person’s gut, comprising directly delivering to the person’s large intestine at least one antioxidant selected from a Markush group including vitamins C, E and B2 (riboflavin) and beta-carotene, and mixtures thereof. The claim is indefinite because it is drawn to an indeterminate patient population, as the claim does not require that the subject is in need of decreasing the population of Fusobacterium spp. in their gut. Claim 3 depends from claim 1 and does not resolve the indefiniteness of the indeterminate patient population.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 4-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims are “use” claims and do not fall within at least one of the four categories of patent eligible subject matter because they do not recite any method, machine, manufacture, or composition of matter as the claimed invention, but rather are directed to the "use" of an antioxidant.
Claim Rejections - 35 USC § 112(a)
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 1-2 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 is drawn to a method for decreasing the population of Fusobacterium spp. in a person’s gut, comprising directly delivering to the person’s large intestine at least one antioxidant selected from a Markush group including vitamins C, E and B2 (riboflavin) and beta-carotene, and mixtures thereof.
The Invention in General
Applicant has disclosed an invention in the field of dietary modulation of intestinal microbiota.
The Claimed Invention
The claimed invention (e.g., claim 1) is directed toward a method for decreasing the population of Fusobacterium specie(s) in a person’s gut comprising administering, in a delayed-release formulation, at least one antioxidant selected from Markush group that includes vitamin C, vitamin E, vitamin B2 (riboflavin) and beta-carotene, and mixtures thereof.
The Supporting Disclosure
The supporting disclosure includes an exemplary assay utilizing a modified/expanded SHIME (Simulator of Human Intestinal Microbiome Ecosystem) apparatus to establish a simulated human microbiome initiated from fecal samples from human donor(s), and then examining the modulation of the microbiome with respect to Fusobacterium spp. population upon adding a specific antioxidant blend (“AOB”) or fructooligosaccharides (FOS). According to the instant disclosure, the SHIME apparatus is a multichamber apparatus that simulates the separate zones/stages of the human intestine, including (1) stomach, (2) small intestine, (3) ascending colon, (4) transverse colon, and (5) descending colon; however the instant example used a modification compressing the latter three stages, for the colon, into two stages: proximal colon (PC) and distal colon (DC). In the instant example, Applicant separately studies the perturbation of the microbiota in the DC chamber during a two-week period when the nutritional mix fed to the microbiota was supplemented with either the antioxidant blend (AOB) or the fructooligosaccharides (FOS). The specific antioxidant blend consists of the following (page 13):
Antioxidant
Dose (mg/day)
Riboflavin
75
Ascorbic acid
500
Vitamin E (50 wt% dry powder)
200
Beta-carotene (10 wt% dry powder)
1200
Applicant’s exemplary study, as described above, demonstrates a reduction in abundance of Fusobacterium nucleatum in the microbial community fed with the antioxidant blend (AOB) relative to the control samples and the samples fed with fructooligosaccharides (FOS) (page 13, lines 14-17 and Figure 2). However, Applicant’s exemplary results are not commensurate in scope with the breadth of instant claim 1, which claims a method of reducing Fusobacterium spp. in a person’s gut upon administration (“direct delivery”) of any of the listed antioxidants (vitamins C, E, B2 and beta-carotene) alone or in any mixture of the Markush group members, while the exemplary data regards only a specific blend that includes all the members of the Markush group in a specific mass ratio. The exemplary data does not inform or support the claimed method as employed with any of the antioxidants individually, or in mixtures that do not include the entire group of antioxidants, or in alternate ratios than exhibited in the trial study provided by Applicant.
The State of the Art
The study of microbiome perturbation by changes in input feed, particularly wherein the relevant input regards antioxidant compounds, is known in the prior art. The Simulator of the Human Intestinal Microbial Ecosystem (SHIME) is a model of studying the intestinal microbiome, per the teaching of Van de Wiele (Van de Wiele, et al.; The Impact of Food Bioactives on Health, In Vitro and Ex Vivo Models, Chapter 27: “The Simulator of the Human Intestinal Microbial Ecosystem”; pp.305-318; Verhoeckx, K., et al., eds.; Springer Cham Heidelberg, New York; 2015). Van de Wiele teaches that the SHIME is a multicompartment dynamic simulator of a human gut developed in 1993, as the last in a generation of gut simulators developed to simulate the different conditions of the colon lumen, a very heterogeneous region with clear differences in substrate availability, fermentation activity, microbial composition and several environmental conditions (page 306). Van de Wiele further teaches that the SHIME model is the sole in vitro model that integrates the entire gastrointestinal transit into one system. The SHIME model has a strong emphasis on the ecological aspects of the colon microbiome. This entails that incubation experiments with the SHIME reactor are seldomly short and commonly take several weeks. This is put in place to look at the gradual adaptation of the microbiome to incoming substrates of interest (e.g. prebiotics or pharmaceuticals) or to evaluate the resilience of the microbial community against colonization by a (opportunistic) pathogen (page 311).
Specific SHIME studies wherein the input feed comprises antioxidants as part of food extracts are known in the prior art. De Boever (De Boever, et al.; The Journal of Nutrition, v130, pp.2599-2606; 2000) teaches a SHIME study on the effect of soygerm, including the antioxidant tocopherol (vitamin E) on human microbiota, but does not note any effect on Fusobacterium spp.. Wu (Wu, et al.; Molecular Nutrition & Food Research, v62, article 1800607, pp1-10; 2018) teaches a SHIME study on the effect of the juice of the aronia plant (black chokeberry), including polyphenol antioxidant(s), on human microbiota, but does not note any effect on Fusobacterium spp.. Rocha Faria Duque (Rocha Faria Duque, et al.; Food Research International, v84, pp160-169; 2016) teaches a SHIME study on the effect of orange juice, including the antioxidant ascorbic acid, on human microbiota, but does not note any effect on Fusobacterium spp.. Queipo-Ortuño (Queipo-Ortuño, et al.; The American Journal of Clinical Nutrition, v95, pp1323-1334; 2012) teaches a SHIME study on the effect of wine polyphenols on human microbiota, and reports that Fusobacteria were among a set of bacteria that showed population/concentration increase upon feeding the microbiota with red wine, whereas in a parallel experiment using de-alcoholized red wine, Fusobacteria concentration increased without accompanying increase of the other bacteria that were increased with red wine (page 1329). Giuliani (Giuliani, et al.; Molecules, v24, article 3791, pp1-17; 2019) teaches a SHIME study on the effect(s) on human microbiota of feeding with either olive paste (leftover from pressing oil out of olive seeds) or pomegranate mesocarp (white flesh between outer peel and the seed compartments), both of which include polyphenolic antioxidant(s). Giuliani teaches that Fusobacteria were suppressed, relative to control trial, after feeding with pomegranate mesocarp or olive paste, with the effect more pronounced in the trial with pomegranate mesocarp (page 3791, including Figure 4a).
Predictability in the Field of Art
As shown in the section above, prior art on the effects of antioxidants on Fusobacterium spp., based on food/drink extracts containing polyphenols rather than any of the specific antioxidants of instant claim 1, shows contradictory results, with Queipo-Ortuño showing increase in Fusobacteria population upon exposure to red wine and Giuliani showing suppression of Fusobacteria upon exposure to olive paste or pomegranate mesocarp. Evidence on the effect(s) on Fusobacterium spp. of antioxidant(s) added from pure reagent stock into microbial feedstock is provided by La Scola (La Scola, et al.; European Journal of Clinical Microbiology & Infectious Diseases, v33, pp1781-1783; 2014)1, who teaches that Fusobacterium necrophorum, cultured in Schaedler medium tubes or in Petri dishes fed with Schaedler agar, grows more quickly when the antioxidant ascorbic acid is added to the growth medium (page 1781, Abstract, and page 1782, including Figure 1). Thus, prior art provides inconsistent results as to whether antioxidants in general would be expected to promote or suppress Fusobacterium spp., and does not specifically support ascorbic acid (vitamin C) as an inhibitor of Fusobacterium spp. growth/population. In the light of these inconsistent and unsupportive results on the effects of antioxidants on Fusobacterium spp., the suppression of Fusobacterium spp. by treatment with any individual antioxidant claimed in instant claim 1, or mixtures not including the full group of antioxidants therein claimed, or mixtures including all the antioxidants in other ratios than as demonstrated in Applicant’s exemplary results, cannot be predicted.
Claim 2 depends from claim 1, and does not resolve the lack of support in the instant disclosure, in light of the unpredictability in the field of art, for the claimed method of instant claim 1 in the administration by “direct delivery” of individual antioxidant(s) disclosed in claim 1, or in mixtures thereof that do not include all the listed antioxidants that are exemplified in the results provided in the instant disclosure, or in mixtures thereof that do include all the antioxidants but not in the same ratio as exemplified in the results provided by Applicant in the instant disclosure.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 are anticipated by Lu.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lu (US PG Pub 2023/0277605 A1)2.
Claim 1 is drawn to a method for decreasing the population of Fusobacterium spp. in a person’s gut, comprising directly delivering to the person’s large intestine at least one antioxidant selected from a Markush group including vitamins C, E and B2 (riboflavin) and beta-carotene, and mixtures thereof. Lu discloses a whole bacteria capsule, preparation thereof, and use thereof (Abstract), with the use of the whole bacteria capsule pertaining to the treatment of diseases, including inflammatory bowel disease (paragraphs [0060]-[0061]). Lu discloses that the preparation of the whole bacteria capsule includes the following steps (paragraphs [0049]-[0052]):
identifying a suitable donor of fecal bacteria;
collecting the feces of the donor and processing the feces to obtain a fecal bacteria liquid;
mixing the fecal bacteria liquid with a lyophilizing protective agent that includes the antioxidant vitamin C;
lyophilizing the liquid to obtain a lyophilized powder;
loading the lyophilized powder into an enteric capsule shell.
Lu further discloses that the enteric capsule shell can effectively resist the decomposition of gastric juice, release an effective flora in the capsule only under a condition of intestinal pH value, thereby effectively protecting the flora to reach the intestinal tract (paragraph [0047]). Lu discloses a particular “Example 5” wherein a batch of prepared fecal bacterial liquid is mixed with lyophilized protective agent that includes 5% vitamin C, lyophilized into a powder, and loaded into an enteric capsule shell (paragraph [0097]) and further discloses an “Example 8” wherein patients with irritable bowel syndrome were administrated three doses of the whole bacteria capsule prepared in Example 5: once a week for three weeks (paragraph [0100]).
While Lu does not disclose any effect on Fusobacterum spp., this aspect of claim 1 is understood to be an intended result of the claimed method, and does not limit the method in regard to the structure of the step(s) to be performed, namely the administration of any of the claimed antioxidants in a manner that ensures “direct delivery” of the antioxidant to the intestinal tract.
Thus, claim 1 is anticipated by the disclosure of Lu.
Claim 2 further limits claim 1 to wherein the person receiving the directly delivered antioxidant is a person who is experiencing, or is at risk of experiencing a condition selected from a Markush group that includes adult inflammatory bowel disease. Lu discloses that the invention disclosed therein includes the use of the whole bacteria capsule disclosed therein for treating a disease, including a Markush group of diseases that includes inflammatory bowel disease (paragraphs [0060]-[0061]).
Thus, claim 2 is anticipated by the disclosure of Lu.
Claim 1 is anticipated by Brostrom.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Brostrom (US PG Pub 2018/0280318 A1).
The limitations of claim 1 are discussed in the rejection above and hereby incorporated into the instant rejection.
Brostrom discloses an oral delivery system for the administration of polyunsaturated fatty acids, and their metabolites and derivatives (Abstract). Brostrom specifically discloses “Example 16”, wherein a Phase 1 clinical trial was conducted in Australia with healthy male and female subjects to evaluate safety, tolerability and pharmacokinetics for CMX-0203, an analog of arachidonic acid (CMX-020: paragraph [0097]; Example 16: paragraphs [0140]-[0142]). In the clinical trial, CMX-020 was formulated with mixed tocopherols (i.e., vitamin E) and encapsulated in an enterically coated softgel (paragraph [0141]). Brostrom further discloses that enteric coated systems are only soluble at pH 6 and above, and thereby provide delivery of the oral composition to the colon (paragraph [0067]).
Thus, claim 1 is anticipated by the disclosure of Brostrom.
Claims 1-2 are anticipated by Heil.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Heil (US PG Pub 2012/0237489 A1).
The limitations of claims 1-2 are discussed in the rejection above and hereby incorporated into the instant rejection.
Heil discloses a suppository for rectal, vaginal or urethral administration, including a method to prepare such a suppository (Abstract). Heil further discloses that the suppository according to the invention is used for treating and/or preventing all kind of acute and chronic inflammations and bacterial infections, especially of the gastrointestinal, vaginal or urethral tract. For example, the suppository is used to restore the mucosal flora and to treat and/or prevent inflammatory bowel diseases (paragraph [0033]). Heil discloses a method for administration of an antibiotic and/or a probiotic comprising preparing the suppository comprising an antiobiotic or probiotic and at least one unsaturated nonesterified fatty acid, and administering the suppository rectally, vaginally or urethrally (claim 11). Heil specifically discloses a formulation for a suppository, which includes beneficial bacteria Lactobacillus grasseri and Bifidobacterium longum, and also includes tocopherol (vitamin E) and linolenic acid (paragraphs [0034]-[0039]). Heil also discloses that the rectum comprises the last 12-19 cm of the large intestine (paragraph [0005]). A person of ordinary skill in the art would at once envisage that Heil’s disclosed method of administration of an antibiotic or probiotic suppository, employed with Heil’s specific formulation of a suppository formulated with vitamin E and administered to the rectum meets the limitations of instant claim 1 with regard to the “direct delivery” of an antioxidant to a person’s large intestine.
Thus, claim 1 is anticipated by the disclosure of Heil.
Regarding claim 2, as discussed above, Heil discloses the use of the invention disclosed therein for the treatment of inflammatory bowel diseases.
Thus, claim 2 is anticipated by the disclosure of Heil.
Claim 1 is anticipated by Penhasi.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Penhasi (US PG Pub 2009/0196889 A1).
The limitations of claim 1 are discussed in the rejection above and hereby incorporated into the instant rejection.
Penhasi discloses a formulation for the controlled absorption of a medication, and in particular, to a formulation for the delayed onset, modified release of HMG-CoA reductase inhibitors (statins) predominantly in the lower gastrointestinal (GI) tract (paragraph [0001]). Penhasi discloses a specific formulation of Simvastatin that includes ascorbic acid (vitamin C) in the tablet core (paragraphs [0191]-[0196] and Table 1). The tablets are further coated with an enteric coating and tested in dissolution tests in Penhasi’s “Example 3”, showing that the enterically coated tablets can hold up for over 1 hour win 0.1 N HCl (paragraphs [0208]-[0210] and Tables 6-7).
Thus, claim 1 is anticipated by the disclosure of Penhasi.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-10, 12-14 and 18-20 of U.S. Patent No. 12,508,280 B2 (hereafter referred to as “Bruins”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Bruins anticipate the instant claims.
The limitations of instant claims 1-2 are discussed in the rejection above and hereby incorporated into the instant rejection.
Bruins’ claim 1 is drawn to a method of improving intestinal health comprising administering, to an 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. Bruins’ claim 9 depends indirectly from claim 1 and further limits the method to wherein it is a method for treating or lessening the symptoms of a condition selected from a group that includes irritable bowel disease and ulcerative colitis. Claim 10 further limits claim 1 to wherein the animal to be treated is a human. Bruins’ claim 12 is drawn to a method of improving intestinal health in an animal comprising a Markush group of intended results and a step of administering to the animal a delayed release formulation for delivery of active agents to the intestine, comprising the active agents and an enteric layer or an enteric shell, wherein said active agents comprise up to 200 mg riboflavin and up to 2000 mg vitamin C. Claims 13-14 and 18-19 further limit claim 12, each to specific ranges/doses of each of the riboflavin and vitamin C. Bruins’ claim 20 is drawn to a method of improving intestinal health in an animal comprising administering to the animal active agents comprising a daily dose of up to 2.9 mg riboflavin and up to 28.6 mg vitamin C, wherein the active agents are delivered to the large intestine.
While Bruins does not disclose any effect on Fusobacterum spp., this aspect of claim 1 is understood to be an intended result of the claimed method, and does not limit the method in regard to the structure of the step(s) to be performed, namely the administration of any of the claimed antioxidants in a manner that ensures “direct delivery” of the antioxidant to the intestinal tract.
Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-19 of copending Application No. 17/798,778 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Application No. 17/798,778 anticipate the instant claims.
The limitations of instant claims 1-2 are discussed in the rejection above and hereby incorporated into the instant rejection.
Claim 12 of Application No. 17/798,778 is drawn to a method of improving intestinal health in an animal, including a human, comprising administering to the animal a composition consisting of at least two antioxidants selected from the group consisting of: vitamins C, B2 and E, and beta-carotene, said composition delivering the antioxidants to the large intestine. Claim 13 further limits claim 12 to wherein all the listed antioxidants are included in the composition. Claims 15, 17 and 19 further limit claim 12 to wherein the method treats a condition selected from a Markush group that includes, in each claim, inflammatory bowel disease. Claims 14, 16 and 18 further limit claim 12 with regard to intended results of the method.
While Application No. 17/798,778 does not disclose any effect on Fusobacterum spp., this aspect of claim 1 is understood to be an intended result of the claimed method, and does not limit the method in regard to the structure of the step(s) to be performed, namely the administration of any of the claimed antioxidants in a manner that ensures “direct delivery” of the antioxidant to the intestinal tract.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5 of copending Application No. 18/014,780 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of 18/014,780 anticipate the instant claims.
The limitations of instant claims 1-2 are discussed in the rejection above and hereby incorporated into the instant rejection.
Claim 2 further limits claim 1 to wherein the person receiving the directly delivered antioxidant is a person who is experiencing, or is at risk of experiencing a condition selected from a Markush group that includes Crohn’s disease.
Claim 1 of Application 18/014,780 is drawn to a method of increasing the population of Dialister spp. in the gut microbiome in an animal in need thereof, comprising administering directly to the large intestine an effective amount of a combination of vitamins B2 and C. Claim 2 further limits claim 1 to wherein the method treats a disease or adverse condition. Claim 3 further limits claim 2 to wherein the disease or adverse condition to be treated is selected from a Markush group that includes Crohn’s disease. Claim 5 further limits the method to wherein the animal is a human.
While Application No. 18/014,780 does not disclose any effect on Fusobacterum spp., this aspect of claim 1 is understood to be an intended result of the claimed method, and does not limit the method in regard to the structure of the step(s) to be performed, namely the administration of any of the claimed antioxidants in a manner that ensures “direct delivery” of the antioxidant to the intestinal tract.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 6-9 of copending Application No. 18/250,377 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Application No. 18/250,377 anticipate the instant claims.
The limitations of instant claims 1-2 are discussed in the rejection above and hereby incorporated into the instant rejection.
Claim 1 of Application No. 18/250,377 is drawn to a method of decreasing a population of pathogenic bacteria present in the intestine comprising administering a composition comprising vitamin C directly to the intestine. Claim 3 further limits claim 1 to wherein additional vitamins are included in the composition. Claim 6 is drawn to the use of a directly delivered composition comprising vitamin C to decrease the population of pathogenic bacteria in the distal gut. Claims 7-8 further limit claim 6, each to wherein additional vitamins are included in the composition. Claim 9 further limits claim 6 to wherein the method prevents or treats diseases or adverse conditions selected from a Markush group that includes Crohn’s disease and inflammatory bowel disease.
While Application No. 18/250,377 does not disclose any effect on Fusobacterum spp., this aspect of claim 1 is understood to be an intended result of the claimed method, and does not limit the method in regard to the structure of the step(s) to be performed, namely the administration of any of the claimed antioxidants in a manner that ensures “direct delivery” of the antioxidant to the intestinal tract.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6-7, 10 and 12 of copending Application No. 18/548,797 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Application No. 18/548,797 anticipate the instant claims.
The limitations of instant claims 1-3 are discussed in the rejections above and hereby incorporated into the instant rejection.
Claim 1 of Application No. 18/548,797 is drawn to a method of increasing the population of Blautia spp. in the gut microbiome comprising directly delivering to the large intestine at least one antioxidant selected from the group consisting of vitamins B2, C, E and beta carotene. Claim 4 further limits claim 1 to wherein “a person”4 is experiencing or is at risk of experiencing a condition selected from a Markush group that includes Crohn’s disease and inflammatory bowel disease. Claim 6 is drawn to a method wherein vitamin B2, vitamin C, vitamin E and beta-carotene are delivered directly to the gut. Claim 7 is drawn to the use of at least one antioxidant selected from a Markush group that includes vitamins B2, C, E and beta-carotene, directly delivered to the large intestine to increase the population of Blautia spp. in the gut microbiome. Claim 10 further limits claim 7 to wherein “a person”5 is experiencing or is at risk of experiencing at least condition selected from a Markush group that includes Crohn’s disease and inflammatory bowel disease. Claim 12 further limits claim 7 to wherein vitamins B2, C, E and beta-carotene are directly delivered to the gut.
While Application No. 18/548,797 does not disclose any effect on Fusobacterum spp., this aspect of claim 1 is understood to be an intended result of the claimed method, and does not limit the method in regard to the structure of the step(s) to be performed, namely the administration of any of the claimed antioxidants in a manner that ensures “direct delivery” of the antioxidant to the intestinal tract.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-11 and 13 of copending Application No. 18/871,658 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Application No. 18/871,658 anticipate the instant claims.
The limitations of instant claims 1-2 are discussed in the rejection above and hereby incorporated into the instant rejection.
Claim 10 of Application No. 18/871,658 is drawn to a combination comprising vitamin C and Lactobacillus rhamnosus for use in increasing the concentration of butyrate in the large intestine of an animal, preferably a human, wherein said use comprises administering or delivering the vitamin C and the Lactobacillus rhamnosus to the large intestine. Claim 11 further limits claim 10 to wherein the vitamin C and the Lactobacillus rhamnosus are administered or delivered to the large intestine by a delayed-release formulation. Claim 13 further limits claim 10 to wherein the animal, including a human, is experiencing at least one condition selected from a Markush group that includes inflammatory bowel disease.
While Application No. 18/871,658 does not disclose any effect on Fusobacterum spp., this aspect of claim 1 is understood to be an intended result of the claimed method, and does not limit the method in regard to the structure of the step(s) to be performed, namely the administration of any of the claimed antioxidants in a manner that ensures “direct delivery” of the antioxidant to the intestinal tract.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-11 and 13 of copending Application No. 18/871,675 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Application No. 18/871,675 anticipate the instant claims.
The limitations of instant claims 1-2 are discussed in the rejection above and hereby incorporated into the instant rejection.
Claim 2 further limits claim 1 to wherein the person receiving the directly delivered antioxidant is a person who is experiencing, or is at risk of experiencing a condition selected from a Markush group that includes colorectal cancer. Claim 9 of Application No. 18/871,675 is drawn to a method of increasing the abundance of Bifidobacterium animalis ssp lactis comprising administering to the animal a formulation comprising an effective dose of vitamin B2, vitamin C and/or vitamin D. Claim 10 further limits claim 9 to wherein the animal is a human and the vitamin is delivered to the large intestine. Claim 11 further limits claim 9 to wherein the vitamin is delivered by a delayed-release formulation. Claim 13 further limits claim 9 to wherein the method is a method of treating, preventing or lessening the symptoms of a Markush group of conditions that includes colon cancer.
While Application No. 18/871,675 does not disclose any effect on Fusobacterum spp., this aspect of claim 1 is understood to be an intended result of the claimed method, and does not limit the method in regard to the structure of the step(s) to be performed, namely the administration of any of the claimed antioxidants in a manner that ensures “direct delivery” of the antioxidant to the intestinal tract.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-11 and 13 of copending Application No. 18/872,488 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Application No. 18/872,488 anticipate the instant claims.
The limitations of instant claims 1-2 are discussed in the rejection above and hereby incorporated into the instant rejection.
Claim 9 of Application No. 18/872,488 is drawn to a method of increasing the abundance of Lactobacillus rhamnosus in the intestine of an animal, preferably a human, comprising administering to the animal a formulation comprising an effective dose of vitamin B2. Claim 10 further limits claim 9 to wherein the animal is a human and the vitamin B2 is delivered to the large intestine. Claim 11 further limits claim 9 to wherein the vitamin B2 is delivered by a delayed-release formulation. Claim 13 further limits claim 9 to wherein the method is a method of treating, preventing or lessening the symptoms of a condition selected from a Markush group that includes inflammatory bowel disease.
While Application No. 18/872,488 does not disclose any effect on Fusobacterum spp., this aspect of claim 1 is understood to be an intended result of the claimed method, and does not limit the method in regard to the structure of the step(s) to be performed, namely the administration of any of the claimed antioxidants in a manner that ensures “direct delivery” of the antioxidant to the intestinal tract.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23, 40 and 42 of copending Application No. 19/312,760 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Application No. 19/312,760 anticipate the instant claims.
The limitations of instant claims 1-2 are discussed in the rejection above and hereby incorporated into the instant rejection.
Claim 23 of Application No. 19/312,760 is drawn to a method of improving intestinal health in an animal, including a human, wherein said improvement comprises administering to the animal vitamin C as an active agent, wherein the active agent is present in a formulation comprising an effective dose of the active agent and the active agent is delivered to the large intestine. Claim 39 further limits claim 23 to wherein the method is a method of treating, preventing or lessening the symptoms of a condition selected from a Markush group that includes Crohn’s disease. Claim 42 further limits claim 23 to wherein “the mammal”6 is a human.
While Application No. 19/312,760 does not disclose any effect on Fusobacterum spp., this aspect of claim 1 is understood to be an intended result of the claimed method, and does not limit the method in regard to the structure of the step(s) to be performed, namely the administration of any of the claimed antioxidants in a manner that ensures “direct delivery” of the antioxidant to the intestinal tract.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 8 and 10-11 of copending Application No. 19/429,458 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Application No. 19/429,458 anticipate the instant claims.
Claim 1 of Application No. 19/429,458 is drawn to a method of improving intestinal health in an animal, including a human, comprising administering to the animal a composition consisting of an effective dose of at least two antioxidants selected from the group consisting of vitamins C, B2, E and beta-carotene, wherein the composition delivers the antioxidants to the large intestine. Claim 2 further limits claim 1 to wherein the composition includes all the antioxidants from the Markush group of claim 1. Claim 5 further limits claim 1 to wherein the animal is experiencing a condition selected from a Markush group that includes Crohn’s disease and inflammatory bowel disease. Claims 8 and 10 further limit claim 1, each to a method of treating, preventing or lessening a symptom of a condition selected from a Markush group that includes Crohn’s disease and inflammatory bowel disease. Claim 11 further limits claim 1 to wherein the animal is a human and the effective dose of the at least two antioxidants is delivered by a delayed release formulation.
While Application No. 19/429,458 does not disclose any effect on Fusobacterum spp., this aspect of claim 1 is understood to be an intended result of the claimed method, and does not limit the method in regard to the structure of the step(s) to be performed, namely the administration of any of the claimed antioxidants in a manner that ensures “direct delivery” of the antioxidant to the intestinal tract.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.J.Y./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 Cited in Applicant’s Information Disclosure Statement dated 09/14/2023.
2 Effective Filing Date: 09/20/2020.
3 (5Z,8Z,11Z)-N-Cyclopropyl-14-[(1-methylethyl)(1-oxohexyl)amino]-5,8,11-tetradecatrienamide
4 Although the claim is unclear with regard to the antecedence of “a person”, for purposes of examination herein, the claim language “a person” is interpreted to refer to the person within whom is the large intestine to which the antioxidant(s) is “directly delivered”.
5 Although the claim is unclear with regard to the antecedence of “a person”, for purposes of examination herein, the claim language “a person” is interpreted to refer to the person within whom is the large intestine to which the antioxidant(s) is “directly delivered”.
6 While the claim is indefinite for lack of antecedent for “the mammal” in claim 23 of Application 19/312,760, for purpose of examination, the term “the mammal” is interpreted to refer to the “animal” of the parent claim 23.