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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/9/2025 and 1/7/2026 has been entered.
Status of the Claims
Claims 1-17 are pending and under current examination.
Withdrawn Claim Rejections
All double patenting rejections over claims 1-16 of copending Application No. 17/756,871 have been withdrawn in view of the amendments to the claims filed 10/9/2025.
All rejections not reiterated have been withdrawn.
Claim Objections
Claim 11 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 8. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections – 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 8-17 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 3 recites the limitation “total butyrate moiety containing triglycerides in the composition". This renders the claim indefinite because it is not clear if weight percentage of compounds of formula 1 and 2 is calculated relative only to those compounds recited by claim 1 or if there are other butyrate moiety containing triglycerides included in the calculation.
Claims 8 and 9 recite the limitation “the total triglycerides in the composition”. This renders the claim indefinite because it is not clear if weight percentage of compounds of formula 5 and 6 is calculated relative only to those compounds recited by the claim or if there are other triglycerides included in the calculation.
Claims 11, 12, 13, and 17 recite the limitation “the total butyrate moiety containing triglycerides in the composition”. This renders the claim indefinite because it is not clear if weight percentage of compounds of formula 5, 6, 7 and 8 is calculated relative only to those compounds recited by the claims or if there are other butyrate moiety containing triglycerides included in the calculation.
Regarding claims 10, 14, 15, and 16, claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
Response to Arguments
Applicant’s arguments, see page 8, filed 10/9/2025, with respect to the rejection(s) of claims 3, 8, 11-13, 15, and 17 under 35 U.S.C. 112(b) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made as described above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Froekjaer (WO 91/09597, publication date: 07/11/1991, of record), in view of Cresci et. al. (Journal of Parenteral and Enteral Nutrition, pg. 1-20; publication year: 2014).
Applicant’s Invention
Applicant’s claim 1 is drawn to a method for use in recovery from antibiotic mediated gut microbiota disturbance, the method comprising administering to the subject a compound having the formula
PNG
media_image1.png
121
650
media_image1.png
Greyscale
or combinations thereof, wherein R1, R2, R3, R4, R5 and R6 are independently selected from the group consisting of a long chain fatty acid having between 16 and 20 carbons.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1, 2, 4, and 5, Froekjaer teaches a material composed mainly of triglycerides as an agent with biological effect on the intestinal mucosa, especially an agent which prevents development of and reconstitutes atrophic mucosa (pg. 1, lines 4-7). The triglycerides may contain a linear saturated or unsaturated acyl group containing 2-5 carbon atoms or a linear saturated or unsaturated acyl group containing 16-24 carbon atoms with the general formula:
PNG
media_image2.png
199
908
media_image2.png
Greyscale
wherein R1 and R3 are identical or different, each representing a linear, saturated or unsaturated acyl group containing 2-5 carbon atoms and wherein R2 and R4 are identical or different, each representing a linear saturated or unsaturated alkyl group containing 16-24 carbon atoms.
Regarding claim 3, Froekjaer teaches a triglyceride composition that contains 22% butyrate by total weight of triglycerides in the composition and 47.4% moles butyrate (pg. 4, Example 1).
Regarding claims 6 and 7, Froekjaer teaches a triglyceride composition that contains 70.6% by weight and 47.5% moles of oleic acid (C18:1) as the fatty acid present in the butyrate triglycerides (pg. 4, Example 1).
Regarding claims 8-14 and 17, Froekjaer teaches the relevant limitations of claim 1 as described above. Froekjaer also teaches a triglyceride composition that contains 22% butyrate by total weight of triglycerides in the composition and 47.4% moles butyrate and 70.6% by weight and 47.5% moles of oleic acid (pg. 4, Example 1).
Regarding claims 15 and 16, Froekjaer teaches that in a preferred embodiment of the invention, the preparation is for enteral use (pg. 3 line 4). The instant specification defines a nutritional composition to encompass an “enteral nutritional composition” (pg. 9, lines 6-7).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 1, 8, and 11, Froekjaer does not teach that the triglyceride material may be used in recovery from antibiotic-mediated gut microbiota. However, this deficiency is cured by Cresci.
Cresci teaches that since antibiotic usage can cause profound changes in gut microbiota, it is likely that there is a consequential reduction of butyrate produced in the GI tract and that altered gut microbiota from antibiotic therapy affects the expression of genes involved with water and electrolyte absorption as well as those dependent on butyrate for expression (pg. 3, fourth paragraph). Cresci also teaches that oral supplementation with tributyrin, a source of butyrate, counteracts the negative effects induced by antibiotic therapy on expression of genes and their protein products involved with water and electrolyte absorption and gut barrier function in the intestinal tract (pg. 2, third paragraph and pg. 10, fourth paragraph).
Regarding claims 2, 4, 8, and 11, Froekjaer does not teach a combination of triglyceride materials.
Regarding claims 3, 8, 9, 11, 12, and 13 Froekjaer does not teach a specific weight percentage of compounds having formula 1, 2, 5, 6, or 7 present in the composition.
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 1, 2, 4, 5, 8, and 11 based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to substitute equivalents, each of which is taught by the prior art to be useful for the same purpose (the tributyrin of Cresci and the butyric glycerides of Froekjaer as dietary sources of butyrate). See MPEP 2144.06 (II).
Regarding claims 2, 4, 8, and 11, based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to combine two compositions, each of which is taught by the prior art to be useful for the same purpose (butyrate triglycerides of formulas 1-4 for the purpose of forming a composition to treat antibiotic mediated gut microbiota disturbance), in order to form a third composition to be used for the very same purpose. See MPEP 2144.06 (I).
Regarding claims 3, 8, 9, 11, 12, 13, and 17, the weight percentage of compounds of formula 1, 2, 5, 6, and 7 present in the composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal weight percentage in order to best achieve the desired results as such would provide the optimal desired dose of butyrate. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Froekjaer teaches the compounds of formula 1, 2, 5, 6, and 7 may be used as dietary sources of butyrate, each containing either one or two butyrate moieties (pg. 1, lines 4-7 and Examples 1-4) . The Examiner considers it prima facie obvious to optimize the weight percentage of compounds of compounds of formula 1, 2, 5, 6, and 7 present in the composition, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the weight percentage of compounds of formula 1, 2, 5, 6, and 7 would have a direct effect on the dose of butyrate administered to the subject and therefore be an optimizable variable.
Response to Arguments
Applicant's arguments filed 10/9/2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to the rejection of claims 1-5 under 35 U.S.C. 103 over Froekjaer in view of Ohkuma and PubChem, Oleic Acid have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
On pages 10 and 12, Applicant argues that the claimed compounds were unexpectedly more efficacious at providing recovery from antibiotic mediated gut microbiota disturbance than tributyrin and have an unexpectedly improved taste. This is not found persuasive. Please refer to MPEP 716.02 (b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
Differences in results are in fact unexpected and unobvious: With regard to the unexpectedly improved taste of the instant compounds, Froekjaer teaches that the compounds of the invention overcome the bad smell and taste of free fatty acids (pg. 1 lines 16-17 and pg. 2 lines 11-12). A more efficacious recovery from antibiotic mediated gut microbiota disturbance rendered by the compounds of the instant invention versus tributyrin is unexpected.
Differences are of both practical and statistical significance: The evidence of unexpected results amounts to increased microbiota diversity following treatment with the compounds of the claimed invention compared to treatment with tributyrin following antibiotic mediated gut microbiota disturbance, therefore the differences are of practical significance. However, while the data presented in Figure 4 appears to indicate a larger range of microbiota diversity values on day 2 for the group treated with the compounds of the claimed invention (Group 5), there is no significant statistical difference in the diversity observed between the group treated with tributyrin (Group 4) and the group treated with the claimed invention. Group 4 appears to have a median diversity value nearly equal to or even higher than the Group 5 for every time point reported. Therefore, the differences are not of statistical significance. The evidence of unexpected improvement in taste is of both practical and statistical significance.
Evidence of unexpected properties must be in commensurate scope with the claims: The evidence of unexpected properties relates to an improvement in microbiota diversity following antibiotic-mediated gut microbiota disturbance and improved taste compared to tributyrin. The evidence pertaining to an improvement in microbiota diversity is commensurate in scope with the claims, but the evidence of improved taste is not.
Thus, the Applicant’s argument is not persuasive and the rejection is maintained.
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 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 4, 11-22, and 25-29 of copending Application No. 17/044,684, in view of Froekjaer (WO 91/09597, publication date: 07/11/1991, of record) and Cresci et. al. (Journal of Parenteral and Enteral Nutrition, pg. 1-20; publication year: 2014).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the ‘684 application embrace a method for providing a source of butyrate in an individual in need thereof, the method comprising administering to the individual a combination of a first and second compound having the formula
PNG
media_image3.png
123
329
media_image3.png
Greyscale
wherein R1, R2, and R3 are independently a long chain fatty acid having between 16 and 20 carbons. R1, R2, and R3 is selected from the group consisting of oleic acid, palmitic acid, and linoleic acid. A combination of formula 1 and formula 2 may be used in the composition wherein formula 1 is present in an amount of at least 10% by weight of the total butyrate moiety containing triglycerides and formula 2 is present in an amount of at least 10% by weight of the total butyrate moiety containing triglycerides. The non-butyric substituents on the triglyceride may be unsaturated fatty acids, specifically oleic, palmitic and linoleic acid.
The claims of the ‘684 application also embrace a composition comprising compounds having the formulas
PNG
media_image4.png
145
619
media_image4.png
Greyscale
wherein formula 5 comprises at least 10% or 15% by weight of total triglycerides in the composition and formula 6 comprises at least 10% or 20% by weight of total triglycerides in the composition. The claims of the ‘684 application also embrace a composition comprising a third and/or fourth compound having the formula
PNG
media_image5.png
161
303
media_image5.png
Greyscale
and
PNG
media_image6.png
152
290
media_image6.png
Greyscale
Wherein formula (7) comprises at least 2% by weight of the total butyrate moiety containing triglycerides in the composition. The composition may also include at least one of 1,3-dibutyryl-2-linoleoylglycerol, 1,3-dibutyryl-2-stearoylglycerol, 1- butyryl-2-oleoyl-3-palmitoylglycerol, 1-palmitoyl-2-oleoyl-3-butyrylglycerol, 1- butyryl-2-oleoyl-3-palmitoylglycerol, 1-linoleoyl-2-oleoyl-3-butyrylglycerol, 1-oleoyl-2-butyryl-3- linoleoylglycerol, 1-linoleoyl-2-butyryl-3-oleoylglycerol, and 1-butyryl-2-linoleoyl-3-oleoylglycerol, among others. The composition is a nutritional composition and may be used as a dietary supplement, infant formula or follow-on formula. The claims of the ‘684 application recite the same active method steps as in the instant claims, therefore the outcome, of recovery from antibiotic mediated gut microbiota disturbance and preventing and/or treating gastrointestinal infections, is considered inherent.
The claims of the ‘684 application do not embrace a method that comprises a combination of any of the disclosed formulas and does not disclose use of the composition to treat antibiotic mediated gut microbiota disturbance. However, this deficiency is cured by Cresci.
Cresci teaches that since antibiotic usage can cause profound changes in gut microbiota, it is likely that there is a consequential reduction of butyrate produced in the GI tract and that altered gut microbiota from antibiotic therapy affects the expression of genes involved with water and electrolyte absorption as well as those dependent on butyrate for expression (pg. 3, fourth paragraph). Cresci also teaches that oral supplementation with tributyrin, a source of butyrate, counteracts the negative effects induced by antibiotic therapy on expression of genes and their protein products involved with water and electrolyte absorption and gut barrier function in the intestinal tract (pg. 2, third paragraph and pg. 10, fourth paragraph). Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to substitute equivalents, each of which is taught by the prior art to be useful for the same purpose (the tributyrin of Cresci and the butyric glycerides of Froekjaer as dietary sources of butyrate). See MPEP 2144.06 (II).
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to combine two compositions, each of which is taught by the prior art to be useful for the same purpose (butyrate triglycerides of formulas 1-4 for the purpose of forming a composition to treat antibiotic mediated gut microbiota disturbance), in order to form a third composition to be used for the very same purpose. See MPEP 2144.06 (I).
The weight percentage of compounds of formula 1, 2, 5, 6, and 7 present in the composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal weight percentage in order to best achieve the desired results as such would provide the optimal desired dose of butyrate. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Froekjaer teaches the compounds of formula 1, 2, 5, 6, and 7 may be used as dietary sources of butyrate, each containing either one or two butyrate moieties (pg. 1, lines 4-7 and Examples 1-4) . The Examiner considers it prima facie obvious to optimize the weight percentage of compounds of compounds of formula 1, 2, 5, 6, and 7 present in the composition, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the weight percentage of compounds of formula 1, 2, 5, 6, and 7 would have a direct effect on the dose of butyrate administered to the subject and therefore be an optimizable variable.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 10/9/2025 have been fully considered but they are not persuasive.
Applicants’ request for the double patenting rejection of record to be held in abeyance is acknowledged. However, this request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an objection or requirements as to form (see MPEP 37 CFR 1.111(b) and 714.02). Accordingly, the rejection will be maintained until a terminal disclaimer is filed or claims are amended to obviate the rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH ANNE MEYERS whose telephone number is (571)272-2271. The examiner can normally be reached Monday-Friday 8am-5pm ET.
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, Ali Soroush can be reached at 571-272-9925. 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.
ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614