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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/17/2026, has been entered.
Withdrawn Rejections:
The rejection of claims 3-4, 11-22 and 25-29 under 35 U.S.C. 103 as being unpatentable over:
1) Wheeler of record (U.S. Patent No. 5,662,953);
2) Wheeler of record (U.S. Patent No. 5,662,953), in view of Gonzalez of record (U.S. Pub. No. 20170127693); and
3) Wheeler of record (U.S. Patent No. 5,662,953), in view of Scheppach of record (Gastroenterology, 1992),
is overcome by the Applicants’ amendments and is hereby withdrawn. Specifically, claim 3 is amended to newly introduced the limitation of compounds of formula (1) and formula (2) having a reduced bitterness in comparison to tributyrin.
Response to Applicants’ Arguments/Remarks
Applicants’ arguments (see pages 4-8 of Remarks filed on 02/19/2026), have been fully considered, but they are rendered moot in view of the Applicants’ amendments. For example, Applicants’ amendment of claim 3 to newly introduced the limitation of compounds of formula (1) and formula (2) having a reduced bitterness in comparison to tributyrin, necessitates new grounds of rejection set forth below in the instant rejection.
Status of the Claims
Claims 3-4,11-13, 25-26 and 28-29 are pending.
Applicants’ arguments, filed on 02/19/2026, have been fully considered. Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Applicants’ amendments, filed on 02/19/2026, have each been entered into the record. Applicants have amended claim 3. Applicants have cancelled claims 14-22 and 27. Therefore, claims 3-4,11-13, 25-26 and 28-29 are subject of the Office action below.
Maintained Rejections
Non-Statutory Obviousness-Type Double Patenting-Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 3-4,11-13, 25-26 and 28-29 on the ground of nonstatutory double patenting as being unpatentable over claims:
i) 1-16 of U.S. Patent Application No. 17/756,872;
ii) 1-16 of U.S. Patent Application No. 17/756,871;
iii) 1-8 and 9-18 of U.S. Patent Application No. 17/756,887;
iv) 1-18 of U.S. Patent Application No. 17/595,330;
v) 1-20 of U.S. Patent Application No. 17/595,539;
vi) 1-19 and 21 of U.S. Patent Application No. 17/595,629;
vii) 1-18 of U.S. Patent Application No. 17/595,567;
viii) 1-15 of U.S. Patent Application No. 17/595,581;
ix) 1-16 of U.S. Patent Application No. 17/595,516;
x) 1-19 of U.S. Patent Application No. 17/595,451;
xi) 1-16 of U.S. Patent Application No. 17/595,446;
xii) 1-16 of U.S. Patent Application No. 17/595,363;
xiii) 1-18 of U.S. Patent Application No. 17/416,577; and
xiv) 1-16 of U.S. Patent Application No. 17/413,991,
is maintained for the reasons of record set forth in the previous Office action.
Response to Applicants’ Arguments/Remarks
Applicants have not properly addressed the specific grounds of rejections as discussed in the previous Office action setting. Applicants request that the obvious-type double patenting rejections be held in abeyance. Please see pages 8-9 of Remarks filed on 02/19/2026.
Response
Applicants’ comments are acknowledged. However, the rejections will be maintained until a terminal disclaimer is filed or the claims are amended to obviate the rejections.
Claim Rejections - 35 USC § 103
New Grounds of Rejection Necessitated By Applicants’ Amendments
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.
Claims 3 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wheeler of record (U.S. Patent No. 5,662,953) in view of Yu et al (hereinafter “Yu”, JAOCS, 2000, 77, 911-915).
By way of a background, Applicants’ invention is drawn to a method for producing a source of butyrate with reduced bitterness, comprising interesterification between a short chain triglyceride (tributyrin) and long chain fatty acids (see e.g., pages 1-10, 19, 25-26 of the specification and page10 of Remarks filed on 05/13/2024).
Under the broadest reasonable interpretation (BRI), consistent with the specification, Applicants’ invention is being interpreted as a method for providing a source of butyrate to an individual in need thereof, comprising orally administering to the individual, a composition comprising a compound of formula (1):
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and a compound of formula (2):
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, wherein:
a) each of R1, R2, and R3 = a C16-C20 long chain fatty acid;
b) each of compound of formula (1) and compound of formula (2), is present in a in an amount of at least 10% by weight of total butyrate moiety:
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, containing triglycerides in the composition; and
c) each of compound of formula (1) and compound of formula (2), has reduced bitterness in comparison to tributyrin.
Similar to the Applicants’ invention (see discussions above), Wheeler relates to mixtures enriched with one or more triglycerides having C16-C22 long chain fatty acid residues and C2-C4 short chain fatty acid residues and method for using the mixtures in edible compositions such as food products (see abstract). The triglycerides are produced by the interesterification between a short chain triglyceride (tributyrin) and long chain fatty acids (see e.g., columns 6-7, 11-12, 17, 22 and 33-54).
Specifically, Wheeler describes a genus of triglyceride butyrate source compounds comprising mixtures enriched with one or more triglycerides having both long, saturated fatty acid residues (“L”) and short acid residues (“S”):
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,where each R, independently, is a long chain saturated fatty acid residue having between C16 and C40, and each R’, independently, is a short chain acid residue having C2 to C5 carbons. Please see column 5, lines 37-64. A short chain acid of C4 would be butyrate moiety:
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, recited in instant claim 3.
Wheeler exemplifies an embodiment of the invention, namely:
1) a mixture of 1-butyryl-2,3-distearoyl glyceride:
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, which is a compound of formula (2), wherein R2 = R3 = C18, and 2-ibutyryl-1,3-distearoyl glyceride:
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(see columns 24-25, example 2); and
2) a mixture of 1,2-dibutyryl-3-stearoyl glyceride:
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(Applicants’ formula (4), see discussions above) and 1,3-dibutyryl-2-stearoyl glyceride:
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, which is a compound of formula (1), wherein R1 = C18. Please see column 26, example 5; and
Wheeler also teaches various formulations with sources of butyrate. Please see Examples 13 and 14, starting at column 29, line 57, through column 31, line 11.
Although Wheeler is not explicit in teaching a specific combination comprising a compound of formula (1) and a compound of formula (2), the claimed invention would have been obvious over Wheeler. This is because Wheeler teaches that mixtures are enriched with one or more triglycerides (see discussions above).
Therefore, at the time of the instant invention, a person skilled in the art would have understood that Wheeler envisioned a mixture enriched with one or more triglycerides such as SLS (formula (1)) and LLS (formula (2)). Accordingly, one skilled in the art would have readily envisaged a mixture enriched with one or more triglycerides such as SLS (formula (1)) and LLS (formula (2)), from the Wheeler reference.
Claim 3 further requires that each of compound of formula (1) and compound of formula (2), is present in the composition in an amount of at least 10% by weight of total butyrate moiety containing triglycerides.
The specification (see page 9), discloses “fatty acid moiety” as the part of the triglyceride that originates from a fatty acid in an esterification reaction with glycerol and disclose that the triglycerides used in the present invention comprise at least one butyric acid moiety and at least one long chain fatty acid moiety.
Although Wheeler teaches that SSL and SLS species range at least about 75% by weight and that LLS and LSL species range between about 0.1 and about 25% by weight (see column 6, lines 28-32), Wheeler does not explicitly suggest the % weight of the butyrate moiety containing triglycerides in the composition. However, one of ordinary skill in the art would have had a reasonable expectation that SLS (i.e., formula (1)) at 75% by weight and LLS (i.e., formula (2)) at 25% by weight would independently yield at least 10% by weight of the total butyrate moiety containing triglycerides in the composition.
Regarding the requirement that compounds of claim 3 have reduced bitterness in comparison to tributyrin, at the time of the instant invention, it was known in the art that bitter taste of short chain triglycerides (e.g., tributyrin), can be reduced by the interesterification between a short chain triglycerides and long chain fatty acids. For example, Yu discloses that that bitter taste of short chain triglycerides was found to be reduced by the interesterification between a short chain triglycerides and long chain fatty acids (see abstract).
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02). F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
Therefore, claim 3 is obvious over Wheeler and Yu.
Regarding claims 11-13, Wheeler (see column 8, lines 37-53), states:
“R may be derived from any synthetic or natural, straight or branched saturated organic acid including, but not limited to, palmitic (hexadecanoic), Stearic (octadecanoic), arachidic (eicosanoic), behenic (docosanoic), lignoceric (tetracosaenoic), cerotic (hexacosanoic), montanic (octacosanoic), melissic (triacontanoic), and the like acids. R may also be derived by hydrogenating an unsaturated acid including, but not limited to, palmitoleic (9-hexadecenoic), oleic (cis-9-octadecenoic), elaidic (trans-9-octadecenoic), vaccenic (trans-11-octadecenoic), linoleic (cis, cis-9,12 octadecedienoic), linolenic (9,12,15-octadecatrienoic and 6,9,12-octadecatrienoic), eleostearic (9,11,13 octadecatrienoic), arachidonic (5,8,11,14-eicosatetraenoic), nervonic (cis-15-tetracosenoic), eicosapentaenoic, docosatetraenoic, docosapentaenoic, docosahexaenoic, and the like acids. Chemical names include isomeric variations.” Emphasis added.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited reference.
Claims 3-4 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Wheeler of record (U.S. Patent No. 5,662,953) in view of Yu (JAOCS, 2000, 77, 911-915), as applied to claim 3 above, and further in view of Gonzalez of record (U.S. Pub. No. 20170127693).
The limitations of claim 3, as well as the corresponding teachings of Wheeler and Yu are described above, and hereby incorporated into the instant rejection.
The invention of claims 4 and 25-26 are similar to claim 3, however, claims 4 and 25-26 differ slightly from claim 3 in that the claims require a composition that is: i) formulated in the form of a capsule, tablet, sachet or powder (claim 4); ii) an infant or follow-on formulation (claim 25); and iii) a dietary supplement (claim 26).
Wheeler and Yu differ from the claims 4 and 25-26 only insofar as the cited references do not combine to explicitly teach the limitation of claims 4 and 25-26.
However, the claimed inventions would have been obvious over Wheeler and Yu. This is because, Gonzalez discloses nutritional compositions comprising dietary butyrate, which may refer to liquids, powders, gels, pastes, solids, concentrates, suspensions, or ready-to-use forms of enteral formulas, oral formulas, formulas for infants, formulas for pediatric subjects, formulas for children, growing-up milks and/or formulas for adults (see ¶ 0012).
Accordingly, at the time of the instant invention, one skilled in the art would have had a reasonable expectation of success in combining the teachings of Wheeler, Yu and Gonzalez to arrive at a pharmaceutical composition to provide a source of butyrate in the form of: i) a capsule, tablet, sachet or powder (claim 4); ii) an infant or follow-on formulation (claim 25); and iii) a dietary supplement (claim 26).
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02). F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited reference.
Claims 3 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Wheeler of record (U.S. Patent No. 5,662,953) in view of Yu (JAOCS, 2000, 77, 911-915), as applied to claim 3 above, and further in view of Scheppach of record (Gastroenterology, 1992).
The limitations of claim 3, as well as the corresponding teachings of Wheeler and Yu are described above, and hereby incorporated into the instant rejection.
The invention of claims 28-29 are similar to claim 3, however, claims 28-29 differ slightly from claim 3 in that the claims require that the individual has an inflammatory bowel disease (claim 28), such as Crohn’s disease or Ulcerative Colitis (claim 29).
Wheeler and Yu differ from the claims 28-29 only insofar as the cited references do not combine to explicitly teach the limitation of claims 28-29.
However, the claimed inventions would have been obvious over Wheeler and Yu, because at the tie of the instant invention, it was known in the art that Ulcerative Colitis can be treated with a butyrate composition. For example, Scheppach discloses a method for treating Ulcerative Colitis with a butyrate composition (see ¶ abstract and discussions therein).
Accordingly, at the time of the instant invention, one skilled in the art would have found it obvious to administer a composition comprising combination of triglyceride butyrate source of Wheeler and Yu (see discussions above), to an individual suffering from Ulcerative Colitis, with a reasonable expectation of treating Ulcerative Colitis in the individual.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02). F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited reference.
Conclusion
No claim is allowed.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
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Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY S LUNDGREN whose telephone number is (571)272-5541. The examiner can normally be reached on M_F.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629