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 .
Election/Restrictions
Applicant’s election without traverse of Group II, encompassed by claims 52-55, drawn to a product, tricaprylin, and pharmaceutical composition, in the reply filed on March 26, 2026 is acknowledged.
Applicant has not pointed to any errors in Examiner’s analysis of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Claims 46-51 and 56-61 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 26, 2026.
Application and Claims Status
Claims 46-61 were pending. In the amendment as filed on March 26,2026, applicants have amended no claims; cancelled no claims; added no new claims; and withdrew claims 46-51 and 56-61. Therefore, claims 52-55 are currently pending.
Information Disclosure Statement
No IDS has been filed, and as such, has not been considered.
Priority
The instant application is a 35 U.S.C. § 371 of International Application PCT/EP2021/064135, filed May 27, 2021, which claims priority to PCT/EP2021/063583, filed May 21, 2021.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
The abstract of the disclosure is objected to because: for compounds, the general nature of the compound should be given as well as its use; and for processes, the type of reaction, reagents, and process conditions should be stated. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 52-54 are objected to because of the following informality: each claim recites “…wherein the tricaprylin of formula (II) is exhibits the following properties…” (emphasis added). The “is” should be removed to recite “…wherein the tricaprylin of formula (II) exhibits the following properties…”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 52-55 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 52-55 claim a product and composition of tricaprylin. Claims 52-54 then go on to recite, wherein the tricaprylin has, in sub-parts (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. It is unclear how the discrete compound of tricaprylin, shown below:
PNG
media_image1.png
290
414
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Greyscale
can have an acid value, a hydroxyl value, fatty acid esters of monochloropropanediols, and glycidol esters of fatty acids, when tricaprylin 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 for Fat Science])”, and “DGF C-VI 18 (10) (Einheitsmethode der Deutschen Gesellschaft für 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, tricaprylin. Also, the use of non-English terms in the claims is not allowed, unless accompanied by an English translation, per 37 CFR 1.52(b)(1)(ii).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 52-55 recite the broad recitation “a triglyceride content”, and the claim also recites “tricaprylin” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 53-55 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 52 is drawn to “a tricaprylin”, and only lists physical data, which are inherent properties to tricaprylin. The dependent claims only further list physical data, which is not considered further limiting. Therefore, claims 53-54 are not further narrowing the scope of “a tricaprylin” of claim 52.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
Claim(s) 52-54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hershberg (“Preparation of Tricaprylin”, published December 1939, cited by Examiner in Restriction Requirement sent 1/26/2026)(hereinafter, ‘Hershberg’).
Hershberg teaches tricaprylin and a method for producing tricaprylin through the reaction of octanoyl chloride and glycerol. Claims 52-54 are drawn to tricaprylin and only further list physical data regarding tricaprylin. These properties are all inherent properties of tricaprylin so tricaprylin necessarily meets all of the qualifications enumerated in claims 52-54. MPEP § 2112(I) states that a claim to something which is old does not become patentable upon the discovery of a new property. Further, per MPEP § 2112(II): “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.” (emphasis added).
Claim 55 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Singh et al. (US 2020/0405822 A1, published December 31, 2020)(hereinafter, ‘Singh’).
Singh teaches a pharmaceutical composition of various formulations and methods of preparing the same (Abstract). Reference claim 12 and 13 are drawn to a pharmaceutical composition, comprising pharmaceutically acceptable excipients, wherein the excipients are selected from “a diluent, a binder, a disintegrating agent, a lubricant, a glidant, coating agent, a solvent, and combinations thereof”. Singh teaches (page 8, [0107]), that the solvent is “selected from…tricaprylin”. Therefore, Singh teaches a pharmaceutical composition, comprising tricaprylin (as the solvent) and other excipients (e.g. diluent, binder, disintegrating agent…).
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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 52-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 69-73 of copending Application No. 18/562,267 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The same reasons provided in the 102 rejection above are equally applicable here.
Claims 52-55 of instant application are drawn to product and composition of tricaprylin. Claims 69-73, 77 are drawn to a triglyceride product and composition of C5-C12 fatty acids, of which tricaprylin is (C8). Reference claim 73 is drawn specifically to tricaprylin. For the same reason of inherency, both instant and reference claims are drawn to the same product without adding anything more.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 52-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 19/651,980. Although the claims at issue are not identical, they are not patentably distinct from each other because the tricaprylin of instant independent claim 52 overlaps in claimed matter with at least claims 1-2 of the copending application.
In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See also Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008);Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Here, the same compounds of instant Formula (I) are recited in both the instant application and the ‘980, by the same process of making.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner Comments
Examiner notes that 18/273,563 does not qualify as a nonstatutory double patenting rejection because the claims are drawn to C12-C22 fatty acid esters of polyglycerol. Instantly claimed tricaprylin does not fit within this carbon range and has a glycerol, not polyglycerol, backbone.
Conclusion
No claims are allowed.
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUKE ALAN BORALSKY whose telephone number is (571)272-9746. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 am.
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/L.A.B./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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