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 Claims
Claims 1, 4-7, 9-11, 13-16 and 18-22 are pending in the instant application. Claims 1, 9-11 and 13-15 are amended via the amendment filed May 6th, 2026 and claims 2-3, 8, 12 and 17 were previously cancelled.
Priority
This is a 35 U.S.C. 371 National Stage filing of International Application No. PCT/EP2020/064076 filed May 20th, 2020, which claims priority under 35 U.S.C. 119(a-d) to EP19175535.4, filed May 21st, 2019. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d).
Maintained Rejections
Applicant's arguments filed May 6th, 2026, with respect to the 35 U.S.C. 103 rejection of claims 1, 4-7, 9-11, 13-16 and 18-22 over Wheeler, Schoemaker and Finley have been fully considered but they are not persuasive.
See response to remarks.
Applicant's arguments filed May 6th, 2026, with respect to the double patenting rejections of claims 1, 4-7, 9-11, 13-16 and 18-22 over copending Application No. 17/044,684 and 17/595,446 in view of Wheeler, Schoemaker and Finley have been fully considered but they are not persuasive.
See response to remarks.
Response to Remarks
In the response filed May 6th, 2026, Applicant traverses the 35 U.S.C. 103 rejection of claims 1, 4-7, 9-11, 13-16 and 18-22 over Wheeler, Schoemaker and Finley. However, Applicant’s arguments are not persuasive for the reasons explained below.
On p. 8-9 of the remarks, Applicant argues that the cited references alone or in combination do not disclosure administering a composition comprising the claimed compounds in the claimed weight percentages.
However, as stated in the previous Office action, Wheeler discloses the claimed compounds in general weight percentages that would lead a person of ordinary skill in the art to optimize the concentrations to arrive at the instantly claimed weight percentages. Wheeler teaches specific weight percentages of the triglyceride mixtures. As stated in the previous Office action, Wheeler teaches low calorie triglycerides generally contain 33 to 67 % short acid residues, up to 20% of unsaturated ling fatty acid and the function properties of triglycerides can be tuned/modified by selection of S and L groups by ratio of SSS, SLS, SSL, LLS, LSL components in the mixture (column 6, lines 28-34; column 10, lines 24-35). Wheeler further teaches butyryl-stearoyl glyceride mixtures of LSS, SLS, LLS, LSL, comprising 56.4% SSL/SLS, 30% LSL/LLS (Example 8, 14-16, 21; column 27, column 31, lines 9-10). The ranges overlap with the instantly claimed percentages. See MPEP 2144.05.
On p. 10 of the remarks, Applicant argues that the present specification includes examples which demonstrate the criticality of the claimed weight percentages. Specifically, Applicant points to Table 1 and Examples 2-3 of the instant specification, which show that the claimed composition exhibits a decreases “cheese” smell and a less bitter taste. Examiner acknowledges the data, but respectfully disagrees with the argument that it demonstrates the criticality of the claimed weight percentages.
Firstly, as stated in the previous Office action, Wheeler teaches that the compositions containing the compounds as instantly claimed have excellent organoleptic properties. Therefore, a person of ordinary skill in the art would have had reasonable expectation that the composition as instantly claimed would have improved organoleptic properties, at an optimized weight percentage.
Secondly, even if the examples were considered evidence of unexpected results, the evidence would not be commensurate in scope with the instant claims since, the instant invention is drawn to compositions comprising specific triglycerides and a method for using the compositions. However, Applicants appear to be comparing the organoleptic properties the claimed compounds with the organoleptic properties of tributyrin.
As such, the 103 rejection is maintained.
On p. 10 of the remarks, Applicant argues that this stage in prosecution is premature for terminal disclaimers. Only matters of form may be held in abeyance, and provisional ODPs are to be maintained at the earliest time of prosecution. The double patenting rejections are maintained.
Maintained 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.
Claim(s) 1, 4-7, 9-11, 13-16 and 18-22 stand rejected under 35 U.S.C. 103 as being unpatentable over Wheeler et al (US 5,662,953, as cited on the IDS dated 11/17/2021) in view of Schoemaker et al (WO 2018/108931 A2) and Finley et al (US 2004/0086621 A1).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Wheeler teaches fat mixture enriched with triglycerides having long, saturated, preferably, C16 to C22, fatty acid residues and short, preferably C2 to C4, acid residues that are employed in edible compositions as low calories fats (abstract). Wheeler also teaches correlation of calories ingested and animal body weight gain and in-vivo testing wherein low calories triglycerides were administered to rats and weight gain was measured (column 37, example 26). Wheeler further teaches that in these observations, animals fed the low calorie triglycerides had lower body weight gains observed. Wheeler teaches that especially advantageous fat formulations of the invention contain butyric acid (column 21). Further, Wheeler teaches that the triglyceride mixtures have excellent organoleptic properties (column 5) and are to be used as a component for pharmaceuticals (column 12).
Wheeler teaches that the triglycerides are of the following formulas (column 5):
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Wheeler teaches that the mixture of triglycerides includes the following (columns 13-16):
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, this compound reads on instant formula 1;
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, this compound reads on instant formula 2;
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, this compound reads on instant formula 3; and
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, this compound reads on instant formula 4.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Wheeler does not explicitly teach the exact weight percentages, that the triglyceride mixture is used in a method of treating metabolic syndrome or includes the exact instant formulas 5-8.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Wheeler teaches specific weight percentages of the triglyceride mixtures. Wheeler teaches low calorie triglycerides generally contain 33 to 67 % short acid residues, up to 20% of unsaturated ling fatty acid and the function properties of triglycerides can be tuned/modified by selection of S and L groups by ratio of SSS, SLS, SSL, LLS, LSL components in the mixture (column 6, lines 28-34; column 10, lines 24-35). Wheeler further teaches butyryl-stearoyl glyceride mixtures of LSS, SLS, LLS, LSL, comprising 56.4% SSL/SLS, 30% LSL/LLS (Example 8, 14-16, 21; column 27, column 31, lines 9-10). Further, see MPEP 2144.05: generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here 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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In reHoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In reKulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was “unexpectedly good”); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”).
Further, Schoemaker teaches a method for reducing the incidence of obesity and a metabolic syndrome in a target subject, the method comprising the step of administering a nutritional composition comprising dietary butyrate (claim 1). Schoemaker further teaches that the dietary butyrate is to be provided in the form of butyrate triglycerides (paragraph [0004]) and also triglyceride bound forms of butyrate (paragraph [0058]).
Regarding claims 1 and 4, as such, one of ordinary skill in the art would have been motivated to administer the triglyceride mixture of Wheeler (a mixture of instant formulas 1-4, in the claimed weight percentages) as a method of treating metabolic syndrome as Wheeler teaches a source of butyrate with improved organoleptic properties and ability to control weight and Schoemaker teaches a method of treating obesity and metabolic syndrome with a source of butyrate, specifically triglycerides that contain butyrate.
Regarding instant formula 5-8, Wheeler does not explicitly teach exemplary triglycerides comprising oleoyl and butyrate moieties. However, Wheeler does teach that the triglycerides of the mixture are of the following general formula (column 5):
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wherein long chain fatty acid residue R can incorporate unsaturated acid moieties (e.g. oleic, linoleic, etc.), wherein the low calories triglyceride contains up to 20% unsaturated fatty acid residue (column 12, line 34; claims 29 and 31). Wheeler also teaches that oleic acid moiety provides advantageous property compared with saturated stearyl group, e.g. better absorption, lower melting point for formulation (column 2, lines 16-20, 42-45).
Further, Finley teaches triglyceride compositions comprising unsaturated long chain fatty acid moiety (e.g. oleic acid) and short chain acid (e.g. butyric acid) with reduced calorie for promoting weight loss (abstract, paragraphs [0012]-[0017]; claims 1-21):
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Finley teaches examples of unsaturated long chain fatty acids are oleic acid, linoleic acid and linolenic acid and short chain fatty acids are acetic acid, propionic acid and butyric acid (claims 5, 10, 17 and 21). Finely teaches triglyceride embodiment comprising oleoyl moiety and butyrate moiety and a preferred embodiment is 1,3-dioleyl-2-butyrlglycerol (paragraph [0017]). It is noted that 1,3-dioleyl-2-butyrlglycerol is a regioisomer of instantly claimed formula 6 which also reads on instantly claimed formula 7.
As Wheeler teaches a mixture of fatty acids of instant formulas 1-4 for weight management, one of ordinary skill in the art would have been motivated to include oleic acid in the triglycerides as Wheeler teaches that oleic acid moiety provides advantageous property compared with saturated stearyl group and Finley teaches triglycerides, also for weight management, of butyric acid and unsaturated long chain fatty acids, including oleic acid one of ordinary skill in the art would have been motivated to include oleic acid in the triglyceride formulas as taught by Wheeler. Regarding claims 5-7, 9, 11, 13 and 15, as such it would have been obvious to include oleic acid in the formulas as taught by Wheeler to give instant formulas 5-8.
Regarding claims 10 and 14, as seen above, Wheeler also teaches specific weight percentages of the triglyceride mixtures. Wheeler teaches low calorie triglycerides generally contain 33 to 67 % short acid residues, up to 20% of unsaturated ling fatty acid and the function properties of triglycerides can be tuned/modified by selection of S and L groups by ratio of SSS, SLS, SSL, LLS, LSL components in the mixture (column 6, lines 28-34; column 10, lines 24-35). Wheeler further teaches butyryl-stearoyl glyceride mixtures of LSS, SLS, LLS, LSL, comprising 56.4% SSL/SLS, 30% LSL/LLS (Example 8, 14-16, 21; column 27, column 31, lines 9-10). See also MPEP 2144.05.
Regarding claim 16, Klemann teaches 1-stearoyl-3-oleoyl-2-butyryl glycerol which is the regio-isomer of instant claimed 1-stearoyl-2-oleoyl-3-butyrylglycerol.
Regarding claim 18, Wheeler teaches that the triglyceride is employed in an edible composition, which is intended for nutrition (column 12).
Regarding claim 19, Schoemaker teaches that the method includes the administration of the dietary butyrate as an infant formula (paragraph [0052]).
Regarding claims 20-22, Schoemaker teaches that the administration and dietary supplementation prevents insulin resistance and improves insulin sensitivity (paragraph [00051]).
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, 4-7, 9-11, 13-16 and 18-22 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 8-20 of copending Application No. 17/044,684 in view of Wheeler et al (US 5,662,953, as cited on the IDS dated 11/17/2021), Schoemaker et al (WO 2018/108931 A2) and Finley et al (US 2004/0086621 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method of treating metabolic disorders comprising administering a compound of formulas 1-8.
The copending claims are directed a method of providing a source of butyrate to an individual in need of same comprising administering a compound having a formula 1-4, which appear to be the same as instantly claimed formulas 1-4. Moreover, the copending claims are directed to compositions comprising compounds of formulas 5-8, which appear to be the same as instantly claimed formulas 5-8, further comprising compounds of instant claim 16. The copending claims do not teach that the method of providing a source of butyrate is for treating a metabolic disorder.
A person of ordinary skill in the art would have been motivated to apply the compounds of the copending application to treat a metabolic disorder. The teachings of Wheeler, Schoemaker and Finley relative to claims 1, 4-7, 9-11, 13-16 and 18-22 are incorporated herein by reference.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4-7, 9-11, 13-16 and 18-22 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 17/595, 446 in view of Wheeler et al (US 5,662,953, as cited on the IDS dated 11/17/2021), Schoemaker et al (WO 2018/108931 A2) and Finley et al (US 2004/0086621 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method of treating metabolic disorders comprising administering a compound of formulas 1-8.
The copending claims are directed to compounds of formula 1-8. The compounds having a formula 1-4, which appear to be the same as instantly claimed formulas 1-4. Moreover, the copending claims are directed to compositions comprising compounds of formulas 5-8, which appear to be the same as instantly claimed formulas 5-8, further comprising compounds of instant claim 16. The copending claims do not teach that the method of providing a source of butyrate is for treating a metabolic disorder.
A person of ordinary skill in the art would have been motivated to apply the compounds of the copending application to treat a metabolic disorder. The teachings of Wheeler, Schoemaker and Finley relative to claims 1, 4-7, 9-11, 13-16 and 18-22 are incorporated herein by reference.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 Anna Grace Kuckla whose telephone number is (703)756-5610. The examiner can normally be reached Monday-Friday 7:30-5.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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