DETAILED ACTION
This office action is in response to applicant’s filing dated April 20, 2026.
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 .
Notice of Change of Examiner
Please note that the Examiner prosecuting this application has been changed to Examiner Elena Vishnyakova of Art Unit 1691. Please address all future correspondences to Examiner Vishnyakova.
Status of claims
Claims 68 - 80 are pending in the instant application. Acknowledgment is made of Applicant’s amendments filed April 20, 2026. Acknowledgment is made of Applicant’s cancelation of claims 62 – 67 and 81 - 82.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 68 - 80, drawn to a product, a triglyceride of C5-C12 fatty acids, in the reply filed on April 20, 2026 is acknowledged. Claims, drawn to non-elected inventions are cancelled by Applicant in the reply filed on April 20, 2026.
Claims 68 - 80 are under examination in the present office action.
Priority
The present application is a 371 of PCT/EP2021/064134, filed May 27, 2021, and claims the benefits of priority to PCT/EP2021/063582, filed May 21, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/15/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claim 68 is 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 68 is unclear because it depends directly or indirectly from canceled claim 62. It is therefore, unclear what is encompassed by the composition claim 68. Therefore, the abovementioned claim 68 will not be further treated on the merits. It is suggested to amend or cancel claim 68 in order to obviate this rejection.
Claims 69 – 71 and 76 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. Claims 69 – 71 and 76 are drawn to a compound triglyceride of C5-C12-fatty acids or a mixture of compounds triglycerides of C5-C12-fatty acids, corresponding to formula: CH2 [O - C(O)R1] - CH [O - C(O)R2]- CH2 [O - C(O)R3], wherein, R1, R2 and R3 is C4-C11-alkyl radical and is the same or different. Claims further recite: “wherein triglyceride of C5-C12-fatty acids exhibit properties (1) through (5), an acid value (AV), a hydroxyl value (OHV), a triglyceride content, content of fatty acid esters of monochloropropanediols, and glycidol esters of fatty acids, respectively. Since claims recite chemical compounds rather than industrial products, it is unclear how the discrete compound of formula: CH2 [O - C(O)R1] - CH [O - C(O)R2]- CH2 [O - C(O)R3], can have an acid value, a hydroxyl value, fatty acid esters of monochloropropanediols, and glycidol esters of fatty acids, when the compound itself does not contain an acid, a hydroxyl, a fatty acid ester of monochhoropropanediol, or a glycidol ester of fatty acids. Furthermore, sub-parts (1) through (5) recite measurements according to "Ph. Eur. 2.5.1 of European Pharmacopoeia 10.0", "Ph. Eur. 2.5.3 of European Pharmacopoeia 10.0", 'Ph. Eur. 2.2.28 of European Pharmacopoeia 10.0", "DGF C-VI 18 (10) (Einheitsmethode der Deutschen Gesellschaft für Fettwissenschaft [Standard method of German Society Fettwissenschaft e.V. [Standard method of German Society for Fat Science])". Referring to references in the claims is not proper since the references may change over time. The specification does not provide further clarification regarding these documents, their contents, and any added value/significance to the instantly claimed compound of formula CH2 [O - C(O)R1] - CH [O - C(O)R2]- CH2 [O - C(O)R3].
Claim 80 is 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.
The claim recites: “An additive for use…”. It is unclear if the claims are intended to encompass a composition comprising at least one triglyceride of C5-C12-fatty acids, which has an intended use as an additive component of composition or if the claims are intended to encompass a method of preparation of formulation comprising at least one triglyceride of C5-C12-fatty acids as an additive. The claims as written can be interpreted as either product or method of use of the product.
In the instant office action, in the interest of compact prosecution, for the purposes of applying art, the claim have been construed as a product, “An additive, wherein the additive comprises at least one triglyceride of C5-C12-fatty acids”.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 69 – 80 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Boulos et al (WO 2013/126990 A1, cited in IDS, filed 06/15/2026, hereinafter Boulos).
Instant claims are drawn to a compound triglyceride of C5-C12-fatty acids, corresponding to formula: CH2 [O - C(O)R1] - CH [O - C(O)R2]- CH2 [O - C(O)R3], wherein, R1, R2 and R3 are same (e.g. triheptanoin and tricaprylin) or different, and independently represent a linear or branched, saturated or unsaturated aliphatic C4-C11-alkyl radical. Instant claims are further drawn to a mixture of triglycerides, wherein the mixture comprises at least two different triglycerides of C5-C12-fatty acids.
Furthermore, instant claims are drawn to a pharmaceutical composition comprising at least one triglyceride of C5-C12-fatty acids and a physiologically acceptable excipient, or a food-based product or a cosmetic composition, wherein the food-based product or a cosmetic composition comprises at least one triglyceride of C5-C12-fatty acids. The triglycerides of C5-C12-fatty acids can be further used as an additive (e.g. a carrier, excipient, a solubilizer, a release agent etc.).
Boulos teaches triglycerides of a medium-chain fatty acids of formula:
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92
137
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, where R is CH3(CH2)n, and n = 4-10 (page 11, [0038]). According to the method of preparation of triglycerides of a medium-chain fatty acids, glycerol was mixed with an excess of medium-chain fatty acids, wherein each of the medium-chain fatty acids contains a chain of 6 to 12 carbons (page 3, [006]). This indicates that glycerol can be mixed with the same or different fatty acids to obtain desired triglyceride. One of the examples of said triglycerides of a medium-chain fatty acids taught by Boulos is tricaprylate (tricaprylin).
Further, Boulos teaches that medium-chain triglyceride(s) (MCTs) are usually commercially available as a mixture of glycerol esters of C8 and C10 fatty acids, with small amounts of glycerol esters of C6 (hexanoic acid or caproic acid) and C12 (dodecanoic acid or lauric acid), and are used in the food and pharmaceutical industries (page 1, [002]).
Boulos teaches pharmaceutical formulations comprising the triglyceride of medium-chain length fatty acids as an excipient or as an active ingredient (page 8, [0025] and [0028]). Boulos also teaches that triglyceride of medium-chain length fatty acids find usefulness in the cosmetics and toiletries industries (page 11, [0037]).
Thus, Boulos teaches triglycerides of medium-chain fatty acids, where said triglycerides have the same structure (e.g. tricaprylin) and is useful for the same purposes (as ingredients in pharmaceutical, cosmetic and food industry) as instantly claimed.
Therefore, teachings of Boulos anticipate instantly claimed compound and compositions.
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 69 – 73 and 77 - 80 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 52 - 58 of copending Application No. 18/562,270 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims are directed to a triglyceride of C5-C12-fatty acids, corresponding to formula: CH2 [O - C(O)R1] - CH [O - C(O)R2]- CH2 [O - C(O)R3], wherein, R1, R2 and R3 are same (e.g. tricaprylin) or different, and independently represent a linear or branched, saturated or unsaturated aliphatic C4-C11-alkyl radical. Instant claims are further drawn to a pharmaceutical composition comprising at least one triglyceride of C5-C12-fatty acids and a physiologically acceptable excipient, or a food-based product or a cosmetic composition, wherein the food-based product or a cosmetic composition comprises at least one triglyceride of C5-C12-fatty acids. The triglycerides of C5-C12-fatty acids can be further used as an additive (e.g. a carrier, excipient, a solubilizer, a release agent etc.).
Claims of copending application are directed to a product tricaprylin and pharmaceutical composition where tricaprylin can be an active ingredient or an additive, cosmetic composition or food-based product comprising tricaprylin.
Thus, instant and reference claims are drawn to the same product without adding anything more, and therefore would anticipate instantly claimed product.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 68 – 80 are rejected. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELENA V VISHNYAKOVA whose telephone number is (571)272-3781. The examiner can normally be reached 7:30am - 5pm ET.
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/E.V.V./Examiner, Art Unit 1691
/SAVITHA M RAO/Primary Examiner, Art Unit 1691
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