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 .
The Response of 6 Feb. 2026 and the Supplemental Response of 13 May 2026 (in response to the Misc. Action of 26 March 2026) have been entered. The species elections in the Response of 13 May 2026 are entered for further examination.
Claims 1-9, 11-14, 16, 17 and 19-23 are currently pending.
Election/Restrictions
Applicant’s election without traverse of the species of: acacia fiber as the prebiotic, tributyrin as the postbiotic, a seedbiotic as the additional component, a composition that contains a probiotic, and a capsule as the dosage form in the reply filed on 13 May 2026 is acknowledged.
Claims 5, 7, 8, 13, 14, 17 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 13 May 2026.
Claims 1-4, 6, 9, 11, 12, 16 and 20-23 are considered here with respect to the elected species.
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.
Claims 1-4, 6, 9, 11, 16 and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of US20160263245 to Donovan et al. in view of US20120269865 to Roughead et al., optionally in view of Donovan et al., Journal of food science 81.9 (2016): S2252-S2257 ("Donovan 2016").
Regarding claims 1-4, 6, 16, 20 and 22, Donovan teaches a composition in the form of a nutritional supplement for delivery to a subject's GI tract, comprising tributyrin (i.e. a postbiotic) microencapsulated in a cyclodextrin-based inclusion body that releases butyric acid in the small intestine and/or colon via hydrolysis of butyric acid by endogenous lipases/esterases (entire doc, including [0010]; [0020]-[0023]; [0040]; [0060]; [0079]-[0091]). Donovan teaches that butyric acid is effective in treating IBD but that direct administration of butyric acid to the intended site of action in the small intestine/colon is difficult due to its short half-life, and that such difficulties can be overcome by the microencapsulated compositions ([0008]-[0010]). The composition can comprise an effective amount of tributyrin for treatment of inflammatory bowel disease (IBD) or another disease treatable with tributyrin ([0024]-[0029]; [0070]). Donovan further teaches that butyric acid can be produced in the gut via the action of gut microorganisms on dietary fiber ([0008]-[00010]), and that: "[T]he present disclosure provides an inclusion complex suitable for use in the preparation of dietary supplements (for example beverages, foods), pills or other similar products suitable for use in regulating the functions of the human body. Dietary fiber includes polysaccharides, oligosaccharides, lignin, and associated plant substances. Dietary fibers promote beneficial physiologic effects, including laxation, blood cholesterol attenuation, and/or blood glucose attenuation. Dietary supplementation with vitamins, minerals, herbs, and other dietary ingredients, together “dietary ingredient”, is within the purview of those skilled in the art" ([0083]). Thus, it would have been obvious in view of Donovan to include a fiber (i.e. prebiotic) component in the composition to allow for production of additional butyric acid via the action of gut microorganisms and/or to achieve the additional beneficial physiologic effects noted above.
Regarding the recitation in claim 1 that the "composition is formulated or configured to release the prebiotic in the stomach and/or small intestine and release the postbiotic in at least the large intestine and optionally a portion of the small intestine", Donovan teaches that the capsules are advantageously configured to release the ingredients (which would include the prebiotic and the microencapsulated tributyrin) in the small intestine such that the tributyrin is released in the small intestine and the large intestine (colon) ([0079]-[0080]; Example 4). For example, Donovan shows that tributyrin release (expressed as butyrate) occurs in the small intestine ([0149]; Table 4) and throughout the large intestine ([0154]-[0157]; Figs. 6-8). Thus, the composition of Donovan would release the prebiotic in the small intestine and release the postbiotic in at least the large intestine and a portion of the small intestine.
Regarding the recitation in claim 1 that the postbiotic is in the amount of 25 mg to 10 g, Donovan teaches that the tributyrin can be present in an effective amount for treating IBD which can be readily determined by one of ordinary skill in the art ([0070]). Thus, it would have been obvious to use routine experimentation to find the workable and/or optimal dosage range for tributyrin in the composition of Donovan (see MPEP 2144.05). Alternatively, Donovan 2016 teaches, with regard to a cyclodextrin-based microencapsulated tributyrin, that "studies have observed physiological benefits using butyric acid in quantities of 9 mmol (roughly 0.79 g of butyric acid) … This concentration is also similar to the normal physiologic levels of butyric acid" (S2254, 1st ¶). It would have been obvious in view of Donovan 2016 to include tributyrin in an amount of approximately 0.8 g, corresponding to levels shown to levels known to provide physiological benefits as well as normal physiologic levels of butyric acid.
Regarding claim 6, Donovan teaches that the composition releases butyrate throughout the large intestine ([0154]-[0157]; Figs. 6-8).
Regarding claims 11, 16 and 20, Donovan teaches that the composition can be formulated in a capsule for oral delivery (e.g., an enteric coated capsule) ([0040]; [0080]).
Claims 1-4, 6, 9, 11, 16 and 20-23 differ from Donovan optionally in view of Donovan 2016 in that: the prebiotic comprises acacia fiber in the amount of 100 mg to 20 g (claims 1, 16 and 20; elected species of prebiotic); the composition further comprises a probiotic (claims 9, 16, 20-22); and the probiotic comprises one or more Bacillus and one or more Bifidobacteria (claim 23).
Roughead teaches oral nutritional supplement compositions useful for treating GI conditions including IBD and for promoting gut health, comprising a prebiotic which is acacia gum (i.e. acacia fiber) and a probiotic which can comprise Bacillus and Bifidobacteria species ([0022]-[0030]; [0044]; [0086]; [0146]-[0181]). The composition can be in a dry powdered form ([0030]; [0132]). Roughead teaches that acacia gum is a highly branched, high molecular weight molecule that is more slowly fermented and increases production of short-chain fatty acids (SCFA), such as butyric acid, in the gut to a greater extent compared to other soluble fibers, and that it provides various benefits in the distal colon including inhibiting pathogenic bacteria and providing anti-inflammatory effects ([0023]; [0036]; [0138]; [0164]; Example 3). Roughead further teaches that acacia gum doses of 3 g/day have been shown to have prebiotic effects and to support the growth of beneficial Bifidobacteria ([0023]), and it would have thus been obvious to include acacia gum in the nutritional composition of the cited combination in such amounts.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to make a nutritional composition comprising tributyrin and fiber as taught by Donovan wherein the fiber comprises acacia gum as taught by Roughead because it would have been obvious to combine prior art elements according to known methods to yield predictable results. One of ordinary skill would have been motivated to use acacia gum as a source of fiber in the composition of Donovan because Roughead teaches that acacia fiber is more slowly fermented and increases production of short-chain fatty acids (SCFA), such as butyric acid, in the gut to a greater extent compared to other soluble fibers, and provides benefits in the distal colon including inhibiting pathogenic bacteria and providing anti-inflammatory effects. Using acacia fiber as a source of fiber in the composition of Donovan would have led to predictable results with a reasonable expectation of success because Roughead teaches the use of acacia fiber as a prebiotic fiber source in a similar nutritional composition for the same purpose of treating IBD and/or improving gut health. Moreover, Donovan teaches the use of dietary fiber generally, and it would have been prima facie obvious in view of Donovan to use any known type/source of fiber.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Donovan in view of Roughead optionally in view of Donovan 2016, as applied to claims 1-4, 6, 9, 11, 16 and 20-23, further in view of US20190008781 to Puckett.
Claim 12 differs from the combination of Donovan in view of Roughead optionally in view of Donovan 2016, as applied to claims 1-4, 6, 9, 11, 16 and 20-23, in that: the composition further comprises a dual chamber capsule having an outer chamber and an inner chamber, wherein the prebiotic component is contained in the outer chamber and the postbiotic component is contained in the inner chamber.
Puckett teaches a dual chamber capsule dosage form comprising two chambers which can be filled with different ingredients, e.g. ingredients that have undesirable interactions when packaged together ([0031]-[0047]; Figs. 1-3). Puckett teaches that the first chamber can include a probiotic and the second chamber can include a prebiotic capable of supporting the probiotic, wherein the dual chambers prevent the prebiotic from prematurely activating and/or affecting the probiotic before the dosage form is consumed ([0046]-[0047]; [0090]-[0092]). Puckett teaches that the prebiotic can include fiber such as arabinogalactan (i.e. main component of acacia fiber) and butyric acid ([0092]). The two chambers can provide for substantially simultaneous release of the different ingredients ([0035]), and the capsule can comprise an enteric coating that allows for release at a desired portion of the GI tract ([0076]-[0079]). Regarding the recitation in claim 12 of "inner" and "outer" chambers, the chambers of Puckett can be considered inner/outer chambers, e.g. with respect to a vertical axis (e.g., where the left chamber in Fig. 1 is an "outer" chamber and the right chamber is an "inner" chamber). Claim 12 does not require any particular configuration of chambers (cf. description in Published Spec. US20250381214, [0105], which requires an inner capsule within an outer capsule).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to make a capsule comprising tributyrin, acacia fiber and optionally a probiotic as taught by Donovan in view of Roughead wherein the capsule is a dual chambered capsule with acacia fiber/tributyrin in one chamber and the probiotic in a second chamber as taught by Puckett because it would have been obvious to combine prior art elements according to known methods to yield predictable results. One of ordinary skill would have been motivated to use a dual chambered capsule as taught by Puckett in order to keep the acacia fiber/tributyrin, which are capable of modulating growth of probiotics, separate from the probiotic (e.g. to enhance shelf stability). Using a dual chambered capsule as taught by Puckett with acacia fiber/tributyrin in one chamber and the probiotic in a second chamber as the capsule for the composition of Donovan in view of Roughead would have led to predictable results with a reasonable expectation of success because Puckett teaches that the capsule is useful for delivering prebiotics including fiber and butyric acid in one chamber and probiotics in the other chamber. Moreover, the capsule of Puckett can be enteric coated and targeted for substantially simultaneous release in a targeted portion of the GI tract, which is consistent with the teachings of Donovan.
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 1-4, 6, 9, 11, 12, 16 and 20-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12472200. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the '200 Patent render the instant claims obvious.
Regarding instant claims 1-4, 6, 9, 11, 16 and 20-22, the '200 claims recite an autobiotic composition comprising 100mg to 20g of a prebiotic which can be acacia fiber, 25mg to 10g of a postbiotic that can be tributyrin and a probiotic ('200, claims 1, 6, 9, 10), wherein the composition is in the form of a capsule ('200, claim 11) and the composition releases the prebiotic in the small intestine and the postbiotic in the large intestine ('200, claim 1).
Regarding instant claim 12, the '200 claims further recite a dual chamber capsule having an outer chamber and an inner chamber, wherein the prebiotic component is contained in the outer chamber and the postbiotic component is contained in the inner chamber ('200, claim 12).
Claim 23 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12472200 in view of Roughead (cited above).
The recitations of the '200 claims are set forth above. Claim 23 differs from the '200 claims in that the probiotic comprises at least one Bacillus and at least one Bifidobacteria species.
Roughead teaches oral nutritional supplement compositions useful for treating GI conditions including IBD and for promoting gut health, comprising a prebiotic which is acacia gum (i.e. acacia fiber) and a probiotic which can comprise Bacillus and Bifidobacteria species ([0022]-[0030]; [0044]; [0086]; [0146]-[0181]). It would have been obvious to one of ordinary skill in the art to make a composition comprising a prebiotic (acacia), a postbiotic (tributyrin) and a probiotic as taught by the '200 claims wherein the probiotic comprises Bacillus and Bifidobacteria species as taught by Roughead because one of ordinary skill would recognize that any known beneficial gut probiotic bacteria could be used in the composition, and Roughead teaches use of such probiotics in a similar composition to that of the instant claims comprising both an acacia fiber prebiotic and probiotics.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J YAMASAKI whose telephone number is (571)270-5467. The examiner can normally be reached M-F 930-6 PST.
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, Louise Humphrey can be reached at 571-272-5543. 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.
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
Prosecution Insights