NON-FINAL REJECTION
This application is a 35 U.S.C. 371 (national stage) application of PCT/JP2022/012042, filed Mar. 16, 2022, which claims benefit of foreign priority to JP 2021-053119, filed Mar. 26, 2021.
Claims 1-4 and 6, as amended, are pending.
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 .
Priority
Acknowledgment is made of applicant's claim to foreign priority under 35 U.S.C. 119(a)-(d).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on Apr. 25, 2024, Jan. 15, 2025, and Oct. 6, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Claim Rejections - 35 U.S.C. § 112(b) – Indefiniteness
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 1-4 and 6 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.
Specifically, the claims recite methods of maintaining or promoting slim body shape, reduction of obesity, suppression of postprandial elevation of blood glucose, or treating diabetes by increasing blood decanoic acid concentration, by administering the claimed triglyceride.
However, the specification fails to define or clearly circumscribe the claimed patient populations: obese persons; diabetics, those seeking to attain or maintain a slim body shape; or those in need of suppression of postprandial blood glucose levels. Because no particular patient population is defined, and are not understood in the art to have a single, clear-cut definition, the claimed patient population(s) are ambiguous and not limited in any particular way.
For example, subjects in need of maintaining or promoting slim body shape, is not particularly limited, or even identifiable, e.g., by a physician's diagnosis, a biomarker, or other objectively measurable criteria, that would unambiguously distinguish between subjects included in the claimed patient population(s), and those excluded. Because infringing activity cannot be distinguished from non-infringing activity, the metes and bounds of the claims are indefinite.
Furthermore, the only guidance provided by the specification (para. [0008]) is methods of administering the claimed triglyceride to increase blood decanoic acid concentration,
"wherein slim body shape, prevention of obesity, or improvement in obesity is promoted by increasing the blood decanoic acid concentration";
"wherein postprandial elevation of blood glucose level is suppressed and diabetes is treated or prevented by increasing a blood decanoic acid concentration"; and
an unsubstantiated assertion that "the effects of e.g. slim body shape, obesity prevention or improvement, suppression of postprandial elevation of blood glucose level, and diabetes treatment or prevention could be expected" (para. [0059]; emphasis added).
As recognized by MPEP § 2111.04, claim scope is not limited by claim language that does not require steps to be performed, or by claim language that does not limit a claim to a particular structure (or, as here, to a particular patient population). Giving the claims the broadest reasonable interpretation in light of the specification, the active method step to be carried out is administering the claimed compounds to a subject to increase blood decanoic acid concentration, which in turn is alleged to achieve certain downstream results or effects.
As recognized by MPEP § 2111.04, "a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited." Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005).
Thus, for examination purposes, the terms "for maintaining or promoting slim body shape, reduction of obesity, suppression of postprandial elevation of blood glucose or treating diabetes" are construed as intended use limitations and are given no patentable weight.
Claim Rejections - 35 U.S.C. § 112(a) – Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 and 6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to methods for maintaining or promoting slim body shape, reduction of obesity, suppression of postprandial elevation of blood glucose, or treating or preventing diabetes in a subject in need thereof by increasing blood decanoic acid concentration, comprising administering to the subject a triglyceride having decanoic acid and a long chain fatty acid having 14 to 24 carbon atoms as constituent fatty acids.
However, the instant specification merely asserts that "the effects of e.g. slim body shape, obesity prevention or improvement, suppression of postprandial elevation of blood glucose level, and diabetes treatment or prevention could be expected" (para. [0059]; emphasis added).
The sole example demonstrates that administering the claimed compounds to rats results in an increase in blood decanoic acid concentration (para. [0059]). Beyond that, the specification presents no evidence that administering the claimed compounds actually results in slim body shape, reduced obesity, suppressed postprandial blood glucose levels, or treatment of diabetes.
The purpose of the written description requirement is to ensure that the inventor had possession of the specific subject matter claimed as of the filing date of the application. As recognized by MPEP §2163:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Because the claims lack written descriptive support for the claimed patient populations, (which are also indefinite, as discussed supra), the claims are construed as drawn to general methods of administering the claimed triglycerides.
Claim Rejections – 35 U.S.C. § 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.
Claims 1-4 and 6 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Hansen et al. (WO 90/03787, cited on PTO-892).
Hansen et al. disclose and claim emulsions for parenteral administration comprising the triglycerides 2-oleyl-1,3-di(octanoyl/decanoyl) glycerol, having a purity of at least 90% (claims 1, 4, and 5). The emulsions show superior absorption ability and are advantageous for nutrition in severely ill patients, e.g., post-operatively (p. 3, lines 1-11).
The term "2-oleyl-l,3-di(octanoyl/decanoyl) glycerol" encompasses the pure 1,3-didecanoyl triglyceride, the 2-position being occupied by oleic acid (p. 1, lines 27-33).
Regarding the structure of 2-oleyl-1,3-didecanoyl glycerol, two of the constituent fatty acids are decanoic acid, and one is an unsaturated C14-24 long chain fatty acid (oleic acid, C18:1 = 18 carbon atoms and one double bond), as recited by claims 1-4.
Hansen et al. disclose that the 2-position in all cases is oleic acid, which reads on the long chain fatty acid content of 50 mass % or more, as recited by claim 2.
Hansen et al. do not explicitly disclose that administration of the emulsion increases blood decanoic acid concentration, as recited by claims 1 and 6.
However, by disclosing the administration of an emulsion comprising the claimed triglyceride, 2-oleyl-1,3-didecanoyl glycerol, to a patient in need thereof, the resulting increase in blood decanoic acid concentration is intrinsic in the methods of Hansen et al., even if that effect or result was not known or appreciated.
As evidenced by, e.g., the instant specification, administration of 2-oleyl-1,3-didecanoyl glycerol ("TG2") increases the blood decanoic acid concentration by 9 times or more higher than that in the TG1 group, and about 2.5 times higher than that in the TG4 group (para. [0059]; Fig. 1; Table 4).
Thus, all the molecular and cellular mechanisms by which a compound exerts its therapeutic effects are intrinsic in the methods of Hansen et al., and occur each time 2-oleyl-1,3-didecanoyl glycerol ("TG2") is administered to patients, regardless of whether anyone was aware of those molecular and cellular mechanisms.
The claims are drawn to the results of administering 2-oleyl-1,3-didecanoyl glycerol ("TG2"). While the cited reference does not explicitly recognize those results, their discovery is tantamount only to finding a new property intrinsic in carrying out an old method.
For the foregoing reasons, Hansen et al. anticipates claims 1-4 and 6.
Citation of Additional Prior Art
Additional references made of record are considered pertinent to applicant's disclosure:
USPN 4,753,963; WO 01/91587; and Kasai et al. (2003), all cited on PTO-892.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 9:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA ELIZABETH TOWNSLEY/Examiner, Art Unit 1629
