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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-27 and 42-45 in the reply filed on 10/21/2025 is acknowledged.
Claims 28-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/25/2025.
Priority
This application is a 371 of PCT/US2020/066634 (12/22/2020) which claims benefit of 62/953,005 (12/23/2019) as reflected in the filing receipt issued on 10/24/2022.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 9/26/2022, 2/13/2024, 8/8/2024, 11/19/2024, and 1/15/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to for the following reasons:
37 CFR 1.84(u)(1) states “View numbers must be preceded by the abbreviation “FIG.”.
In the current case, the view numbers for Figures 1-9 are preceded by the word “Figure” instead of the abbreviation “FIG.”. View numbers should be updated to recite the abbreviation “FIG.”. Any changes to the drawings should also be reflected in the specification.
37 CFR 1.84(u)(1) states “Reference characters (numerals are preferred), sheet numbers, and view numbers must be plain and legible, and must not be used in association with brackets or inverted commas, or enclosed within outlines, e.g., encircled. They must be oriented in the same direction as the view so as to avoid having to rotate the sheet. Reference characters should be arranged to follow the profile of the object depicted.”
In the current case, the view numbers for Figures 4 and 5 are not oriented in the same direction as the view. View numbers should be updated to be oriented in the same direction as the view.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 17-19 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claims. See MPEP § 608.01(n). As claim 19 depends on claim 18, which is an improper multiple dependent, the dependency of claim 19 is also unclear. Accordingly, claims 17-19 have not been further treated on the merits.
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 1-16, 22-23, 25-26, and 42-45 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, a product of nature, without significantly more.
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP § 2106:
Step (1): Is the claim directed to a process, machine, manufacture, or composition of matter?
Yes. Claims 1-16, 22-23, 25-26, 42-45 are directed to a composition of matter, a microbial composition.
Step (2A): Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Prong 1: Does the claim recite a law of nature, natural phenomenon, or an abstract idea?
Yes. The claims recite a product of nature, a composition comprising naturally occurring, unaltered microbes that do not exhibit markedly different characteristics from their natural state.
Claims 15 and 16 recite the additional intended use limitations “wherein the composition reduces visceral motor reflex in the colon of subject treated with the composition” and “wherein the composition reduces pain in response to colorectal distension in a subject treated with the composition”. However, these intended use limitations do not limit the product structurally, and the claims are still directed to a natural product, a microbial composition.
Claims 22 and 23 recite a composition of naturally occurring microbes and a prebiotic. A prebiotic can include a number of natural products such as inulin, carbohydrates, or oligosaccharides, which can serve as an energy source for the microbial formulations (instant Specification pg. 38 para. 285). However, the inclusion of a microbe and a naturally occurring energy source in a single composition does not result in markedly different characteristics of the components compared to their counterparts as they exist in nature, and therefore claims 22-23 are still directed to a product of nature.
Claims 25 and 26 recite the additional limitations that the microbes in the composition are viable or non-viable. However, these additional limitations merely specify the form that the naturally occurring microbes are in, and the microbes do not exhibit markedly different characteristics from the microbes as they occur in nature, which can be naturally viable or non-viable.
Claims 42-45 recite various formulations of the microbial composition i.e. as a pharmaceutical, a nutritional supplement, a dietary supplement, or medical food. “Pharmaceutical formulation” is defined as any composition or formulation designed for administration (specification pg. 17 para. 158), and further states that a pharmaceutical can be formulated as a sterile aqueous solution (specification pg. 41 para. 303). “Nutritional supplement”, “dietary supplement”, and “medical food” are not specifically defined in the disclosure, however the specification states that non-limiting examples of formulations of the pharmaceutical, dietary, or nutritional supplements include a variety of forms such as a liquid form (specification pg. 37 para. 280), which would encompass the microbes suspended in water, for example, and such an embodiment reads on the naturally occurring bacterial composition.
Prong 2: If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
No. Claims 1-14 do not recite any limitations or elements aside from the naturally occurring microbes.
Claims 15 and 16 recite the additional intended use limitations “wherein the composition reduces visceral motor reflex in the colon of subject treated with the composition” and “wherein the composition reduces pain in response to colorectal distension in a subject treated with the composition”. However, these intended use limitations do not limit the product structurally and do not integrate the additional elements into a practical application, and therefore the claims are still directed to a natural product, a microbial composition.
Claims 22 and 23 recite a composition of naturally occurring microbes and a prebiotic. A prebiotic can include a number of natural products such as inulin, carbohydrates, or oligosaccharides, which can serve as an energy source for the microbial formulations (instant Specification pg. 38 para. 285). However, the inclusion of a microbe and a naturally occurring energy source in a single composition does not integrate the product into a practical application, and the claims are still directed to a product of nature exception.
Claims 25 and 26 recite the additional limitations that the microbes in the composition are viable or non-viable, but this does not integrate the judicial exception into a practical application. These additional limitations merely specify the form that the naturally occurring microbes are in and do not integrate the product into a practical application.
Claims 42-45 recite various formulations of the microbial composition i.e. as a pharmaceutical, a nutritional supplement, a dietary supplement, or medical food. As discussed above, these limitations still read on a naturally occurring microbe, and the formulation of the product does not integrate the product into a practical application.
Step (2B): If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly more than the judicial exception?
No. Claims 1-14 do not recite any limitations or elements aside from the naturally occurring microbes. Claims 15 and 16 recite intended use limitations that do not limit the product structurally and thus do not amount to more than the judicial exception. The additional limitation of a prebiotic in claims 22 and 23, which includes natural products such as oligosaccharides that are used as an energy source for the bacteria, does not amount to more than the judicial exception. The limitation that the microorganisms can be viable or non-viable in claims 25 and 26 does not amount to more than the judicial exception, as this merely specifies the state that the microorganisms are in, both of which are natural states for these microbes. The formulations in claims 42-45 read on a naturally occurring microbe composition and do not amount to significantly more than the judicial exception, as these limitations merely specify the form that the naturally occurring microbes are in.
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 1-16, 20-25, and 42-45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cutcliffe et al., US 2016/0271189 A1.
Regarding claims 1-5, Cutcliffe teaches a microbial composition comprising Akkermansia sp., Anaerostipes sp., Bifidobacterium sp., Clostridium sp., Coprococcus sp., Eubacterium sp., and Ruminococcus sp. (Cutcliffe pg. 19 para. 220).
Regarding claims 6-9, Cutcliffe teaches that microbes in the composition include Akkermansia muciniphila ATCC BAA-835, Anaerostipes caccae DSM 14662, Bifidobacterium adolescentis ATCC 15703, Bifidobacterium infantis ATCC 15697, Bifidobacterium longum ATCC 15697, and Clostridium beijerinckii NCIMB 8052 (Cutcliffe pg. 4 para. 8, 10, 14, 15, 23). Cutcliffe teaches that the 16S rRNA sequence is highly conserved evolutionarily and can be used to identify microorganisms, thus each of the above microorganisms would necessarily have an identical 16S rRNA sequence of the corresponding strain (Cutcliffe pg. 7 para. 80).
Regarding claims 10-13, Cutcliffe teaches that the composition comprises at least one of Akkermansia muciniphila, Anaerostipes caccae, Bifidobacterium adolescentis, Bifidobacterium infantis, Bifidobacterium longum, Clostridium butyricum, Clostridium beijerinckii, Clostridium sporogenes, and Eubacterium hallii (Cutcliffe pg. 19 para. 220).
Regarding claim 14, Cutcliffe teaches that the microbes of the composition have a 16S rRNA sequence comprising at least 95% identity to the full length of a 16S rRNA sequence of a
microbe selected from the group consisting of Akkermansia muciniphila, Anaerostipes
caccae, Eubactrium hallii, Bifidobacterium bifidum, Bifidobacterium infantis, Bifidobacterium longum, Butyrivibrio fibrisolvens, Clostridium acetobutylicum, Clostridium aminophilum, Clostridium beijerinckii, Clostridium butyricum, Clostridium colinum, Clostridium indolis, Clostridium orbiscindens, Enterococcus faecium, Eubacterium rectale, Faecalibacterium prausnitzii, Fibrobacter succinogenes, Oscillospira guilliermondii, Roseburia cecicola, Roseburia
inulinivorans, Ruminococcus flavefaciens, Ruminococcus gnavus, Ruminococcus obeum,
Streptococcus cremoris, Streptococcus faecium, Streptococcus infantis, Streptococcus
mutans, Streptococcus thermophilus, Anaerofustis stercorihominis, and Anaerostipes hadrus (Cutcliffe pg. 20 para. 223).
Regarding claims 15 and 16, these claims recited intended use limitations “wherein the composition reduces visceral motor reflex in the colon of subject treated with the composition” and “wherein the composition reduces pain in response to colorectal distension in a subject treated with the composition”. Any product having this same structure is capable of performing the intended use. Thus, as Cutcliffe teaches a microbial composition according to claims 1-13 as set forth above, the teachings of Cutcliffe anticipate claims 15 and 16.
Regarding claim 20, Cutcliffe teaches that the composition is in the form of an enteric-coated capsule (Cutcliffe pg. 27 para. 327).
Regarding claim 21, Cutcliffe teaches that the composition comprises a preservative (Cutcliffe pg. 29 para. 351).
Regarding claim 22, Cutcliffe teaches that the composition comprises a prebiotic (Cutcliffe pg. 30 para. 367).
Regarding claim 23, Cutcliffe teaches that the prebiotic is inulin (Cutcliffe pg. 30 para. 367).
Regarding claim 24, Cutcliffe teaches that the composition can be lyophilized (Cutcliffe pg. 27 para. 327).
Regarding claim 25, Cutcliffe teaches that the composition can be formulated so that the microbes are viable (Cutcliffe pg. 27 para. 326).
Regarding claim 42, Cutcliffe teaches that the composition can be formulated as a pharmaceutical (Cutcliffe pg. 26 para. 313).
Regarding claim 43, Cutcliffe teaches that the composition can be formulated as a nutritional supplement (Cutcliffe pg. 26 para. 313).
Regarding claim 44, Cutcliffe teaches that the composition can be formulated as a dietary supplement (Cutcliffe pg. 26 para. 324).
Regarding claim 45, Cutcliffe teaches that the composition can be formulated as a food, which can be consumed for therapeutic purposes, i.e. a medical food (Cutcliffe pg. 26 para. 313).
Claims 1, 6, 10, 15-16, 22-23, 26-27, and 42-45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cani et al., US 2018/0250347 A1.
Regarding claims 1 and 10, Cani teaches a probiotic composition comprising Akkermansia sp., Akkermansia muciniphila (Cani pg. 2 para. 23). Thus, Cani teaches a composition comprising one of the microbes selected from the group in claim 1 (Akkermansia sp.) and at one microbe selected from the group in claim 10 (Akkermansia muciniphila).
Regarding claim 6, Cani teaches that the Akkermansia muciniphila is A. muciniphila ATTC BAA-835, and therefore teaches a microbe with at least 95% identity to the 16S rRNA sequence of Akkermansia muciniphila ATCC BAA-835 (Cani pg. 14 para. 196).
Regarding claims 15 and 16, these claims recited intended use limitations “wherein the composition reduces visceral motor reflex in the colon of subject treated with the composition” and “wherein the composition reduces pain in response to colorectal distension in a subject treated with the composition”. Any product having this same structure is capable of performing the intended use. Thus, as Cani teaches a microbial composition according to claim 1 as set forth above, the teachings of Cani anticipate claims 15 and 16.
Regarding claim 22, Cani teaches that the composition further comprises a prebiotic (Cani pg. 10 para. 155).
Regarding claim 23, Cani teaches that the prebiotic includes inulin, fructooligosaccharides, galacto-oligosaccharides, oligofructose, beta-glucans, fructooligosaccharides, galacto-oligosaccharides, fermentable carbohydrates, or unprocessed oatmeal (Cani pg. 10 para. 156).
Regarding claims 26 and 27, Cani teaches that the Akkermansia muciniphila of the invention are non-viable, pasteurized cells (Cani pg. 2 para. 14; pg. 4 para. 55).
Regarding claim 42, Cani teaches that the composition comprising Akkermansia sp. is a pharmaceutical (Cani pg. 2 para. 25).
Regarding claim 43, Cani teaches that the composition comprising Akkermansia sp. is a nutritional supplement (Cani pg. 2 para. 24).
Regarding claim 44, Cani teaches that the composition comprising Akkermansia sp. is a dietary supplement (Cani pg. 11 para. 163).
Regarding claim 45, Cani teaches that the composition or medicament comprising Akkermansia sp. is a medical food (Cani pg. 11 para. 163).
Claims 1, 10, 15-16, 25, and 42-45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson et al., Digestive diseases and sciences; 56(11):3179-86.
Regarding claims 1 and 10, Johnson teaches a composition comprising a probiotic microbe, Bifidobacterium sp., specifically Bifidobacterium infantis (Johnson pg. 3179 “Abstract”). Thus, Johnson teaches a composition comprising one of the microbes selected from the group in claim 1 (Bifidobacterium sp.) and one microbe selected from the group in claim 10 (Bifidobacterium infantis).
Regarding claims 15 and 16, as discussed above, these claims recited intended use limitations “wherein the composition reduces visceral motor reflex in the colon of subject treated with the composition” and “wherein the composition reduces pain in response to colorectal distension in a subject treated with the composition”. Any product having this same structure is capable of performing the intended use.
However, regarding claim 15, Johnson teaches administering Bifidobacterium infantis compositions to rats to reduce visceral hypersensitivity in the colon (Johnson pg. 3180 para. 2). The instant specification, pg. 51, states that visceral hypersensitivity was tested by measuring visceral motor reflection (VMR) via electromyography recordings of the abdominal muscles in response to colorectal distension (CRD). Johnson teaches that the visceromotor response (VMR) to colorectal distension (CRD) is determined based on abdominal contractions during distension (Johnson pg. 3180 “Measurement of Visceromotor Behavioral Response”). Johnson teaches that daily dosing of rats with B. infantis resulted in a 57% decrease in the mean VMR, and rats that received 15 days of dosing with B. infantis had a significantly lower VMR to CRD (30 mmHg) compared to the vehicle group (Johnson pg. 3812 “Effect of B. infantis 35624 on Colonic Sensitivity”). Thus, Johnson teaches that a composition comprising Bifidobacterium reduces visceral motor reflex in the colon of subject treated with the composition.
Regarding claim 16, Johnson teaches that B. infantis compositions reduces pain behavior associated with colorectal distension when administered to rats (Johnson pg. 3183 para. 1).
Regarding claim 25, Johnson teaches that the Bifidobacterium is cultured, and therefore viable (Johnson pg. 3180 “Preparation of Bifidobacterium”).
Regarding claim 42, the instant specification, pg. 17 para. 158, states that "pharmaceutical formulation" is any composition or formulation designed for administration to a subject. Johnson teaches that the composition is administered to a subject, rats, and thus is a pharmaceutical formulation (Johnson pg. 3180 “Dosing”).
Regarding claims 43-45, “nutritional supplement”, “dietary supplement”, and “medical food” are not specifically defined in the disclosure, however the specification states that non-limiting examples of formulations of the microbial composition include a variety of forms such as a liquid form (specification pg. 37 para. 280). As Johnson teaches delivery of the microbial composition in a liquid form, the composition of Johnson anticipates claims 43-45.
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 1-5, 10-16, 20, 21-23, and 42 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7, 10-12, and 14-15 of U.S. Patent No. US11583558B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
Regarding instant claim 1, claim 14 of ‘558 recites a microbial composition comprising Akkermansia muciniphila as a primary fermenter, Bifidobacterium infantis as a primary fermenter, Eubacterium hallii as a secondary fermenter, Clostridium beijerinckii as a secondary fermenter, and Clostridium butyricum as a secondary fermenter.
Regarding claims 15-16, these claims recited intended use limitations “wherein the composition reduces visceral motor reflex in the colon of subject treated with the composition” and “wherein the composition reduces pain in response to colorectal distension in a subject treated with the composition”. Any product having this same structure is capable of performing the intended use. As set forth above, ‘558 teaches the product of claim 1.
Regarding claims 2-5, 10-14, 20, 21-23, and 42, the limitations of these dependent claims are recited in claims 1, 5, 7, 10-12, and 14-15 of US Patent ‘558.
Claims 1-5, 10-16, 20-26, and 42-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5, 7, 10, 12-14, 17, and 19 of copending Application No. 18/847,148 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
Regarding instant claim 1, claim 5 of ‘148 recites a composition comprising bacteria, wherein the bacteria is an Akkermansia muciniphila strain.
Regarding claims 15-16, these claims recited intended use limitations “wherein the composition reduces visceral motor reflex in the colon of subject treated with the composition” and “wherein the composition reduces pain in response to colorectal distension in a subject treated with the composition”. Any product having this same structure is capable of performing the intended use. As set forth above, ‘148 teaches the product of claim 1.
Regarding claims 2-5, 10-14, 20-26, and 42-45, the limitations of these dependent claims are recited in claims 5, 7, 10, 12-14, 17, and 19 of copending ‘148.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5, 10-16, 20, and 22-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-12 of copending Application No. 18/569,805 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
Regarding instant claim 1, claim 3 of ‘805 recites administering a composition comprising bacterial strains Akkermansia muciniphila, Clostridiumbutyricum, Anerobutyricum hallii, Clostridium beijerinckii, Bifidobacterium infantis, and any combination of bacterial strains thereof.
Regarding claims 15-16, these claims recited intended use limitations “wherein the composition reduces visceral motor reflex in the colon of subject treated with the composition” and “wherein the composition reduces pain in response to colorectal distension in a subject treated with the composition”. Any product having this same structure is capable of performing the intended use. As set forth above, ‘805 teaches the product of claim 1.
Regarding claims 2-5, 10-14, 20, and 22-23, the limitations of these dependent claims are recited in claims 1-7 and 9-12 of copending ‘805.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 10-16, and 22-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 63-75 of copending Application No. 17/787,258 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
Regarding instant claim 1, claims 66-67 of ‘258 recite a composition comprising bacteria selected from the group consisting of Anaerostipes caccae, Bifidobacterium adolescentis, Bifidobacteriumbifidum, Bifidobacterium infantis, Bifidobacteriumlongum, Butyrivibrio fibrisolvens,Clostridium acetobutylicum, Clostridiumaminophilum, Clostridium beijerinckii, Clostridium butyricum, Clostridium colinum, Clostridium indolis, Clostridium orbiscindens,Enterococcusfaecium, Eubacterium hallii, Eubacterium rectale, Faecalibacterium prausnitzii, Fibrobacter succinogenes, Oscillospira guilliermondii, Roseburia cecicola,Roseburia inulinivorans, Ruminococcus flavefaciens, Ruminococcus gnavus, Ruminococcus obeum, Streptococcus cremoris, Streptococcus faecium, Streptococcus infantis,Streptococcus mutans, Streptococcus thermophilus, Anaerofustis stercorihominis,Anaerostipes hadrus, Anaerotruncus colihominis, Clostridium sporogenes, Clostridium tetani, Coprococcus eutactus, Eubacterium cylindroides, Eubacterium dolichum,Eubacterium ventriosum, Roseburiafaeccis, Roseburia hominis, Roseburia intestinalis, and all combinations thereof.
Regarding claims 15-16, these claims recited intended use limitations “wherein the composition reduces visceral motor reflex in the colon of subject treated with the composition” and “wherein the composition reduces pain in response to colorectal distension in a subject treated with the composition”. Any product having this same structure is capable of performing the intended use. As set forth above, ‘258 teaches the product of claim 1.
Regarding claims 2-6, 10-14, and 22-24, the limitations of these dependent claims are recited in claims 63-75 of copending ‘258.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4-5, 10-12, 14-16, 20, 25-26, and 42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33-35 and 44-45 of copending Application No. 17/604,284 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
Regarding instant claim 1, claims 33-34 of ‘284 recite a composition comprising Akkermansia muciniphila, Bifidobacterium adolescentis, Bifidobacterium infantis, Bifidobacterium longum, Clostridium beijerinckii, Clostridium butyricum, Clostridium indolis, Eubacterium hallii, or any combination thereof.
Regarding claims 15-16, these claims recited intended use limitations “wherein the composition reduces visceral motor reflex in the colon of subject treated with the composition” and “wherein the composition reduces pain in response to colorectal distension in a subject treated with the composition”. Any product having this same structure is capable of performing the intended use. As set forth above, ‘284 teaches the product of claim 1.
Regarding claims 2, 4-5, 10-12, 14, 20, 25-26, and 42, the limitations of these dependent claims are recited in claims 33-35 and 44-45 of copending ‘284.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-16, 20-27, and 42-45 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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/EMILY F EIX/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653