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 1-17 are pending and under current examination.
Withdrawn Claim Objections and Rejections
All objections to claim 11 are withdrawn in view of the amendments to the claims filed 6/4/2026.
All rejections under 35 U.S.C. 112(b) are withdrawn in view of the amendments to the claims filed 6/4/2026.
All rejections not reiterated have been withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s amendments to the claims filed 6/4/2026 have necessitated the new grounds of rejection.
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, of record).
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
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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:
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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. Froekjaer also 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). The triglycerides may be included in a preparation for enteral use (Claim 4) and may be administered perorally (Example 4).
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 6/4/2026 have been fully considered but they are not persuasive.
On page 11, Applicant argues that irrespective of how the teachings of Froekjaer and Cresci are combined, these documents simply could not have provided the skilled person with a reasonable expectation of success that these compounds would be more efficacious than tributyrin at providing recovery from antibiotic mediated gut microbiota disturbance. This is not found persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Furthermore, all arguments lie in the allegation that there was no reasonable expectation of success to combine or modify teachings. Conclusive proof of efficacy is not required to show a reasonable expectation of success, and obviousness does not require absolute predictability, but at least some degree of predictability is required. See MPEP 2143.02 (I) and (II). In response to Applicant’s argument that there that the teachings of Froekjaer and Cresci provide no reasonable expectation of success in achieving more efficacious recovery from antibiotic mediated gut microbiota disturbance compared to tributyrin, the Examiner directs attention to the response to arguments regarding unexpected results below.
On page 12, Applicant argues that the inventive compounds are unexpectedly more efficacious at providing recovery from antibiotic mediated gut microbiota disturbance compared to tributyrin. This is not found persuasive. In response, 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: The evidence of unexpected results amounts to increased efficacy of the inventive compounds in recovery from antibiotic mediated gut microbiota disturbance compared to tributyrin. An improvement of the inventive compounds in recovery from antibiotic mediated gut microbiota disturbance would be an unexpected result.
Differences are of both practical and statistical significance: The evidence of unexpected results amounts to increased efficacy of the inventive compounds in recovery from antibiotic mediated gut microbiota disturbance compared to tributyrin. Therefore, the evidence of unexpected results would be of practical significance. However, there is no significant difference in lactate production of colonic epithelial rendered by Group 4 (tributyrin) and Group 5 (inventive compounds) (Figure 3). Regarding the Shannon diversity of the fecal samples, 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). However, 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.
Evidence of unexpected properties must be in commensurate scope with the claims: The evidence pertaining to an improvement in microbiota diversity is commensurate in scope with the claims.
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, of record).
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
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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
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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
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and
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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 and the compounds have reduced bitterness in comparison to tributyrin. 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 6/4/2026 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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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.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617
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