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 .
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.
Claims 54-63 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.
Claim 57 recites the limitation "wherein the one or more ketone esters or ketone body precursors" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 57 depends from claim 54 which does not recite the above limitation. Applicants should amend claim 57 to depend from 56.
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:
Claim 61 recites the broad recitation mammals, and the claim also recites primates and humans 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 60 recites the broad recitation conditions associated with elevated plasma levels, and the claim also recites conditions caused by or exacerbated by 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 54 recites the broad recitation compound according to claim 1, and the claim also recites compound XXXI 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. Compound of claim 1 includes compounds X, XII, XVI and XVIII, which are species of compound XXXI. Claims 55-58 depend from an indefinite claim and are are therefore also indefinite.
Claims 59, 62 and 63 are directed to the compound of claim 1 wherein the compound is comprised in a composition (59) and food ingredient (62 and 63). The claims appear to be claims a composition, not a compound. Examiner suggests amending the claims to recite a composition (59) and food ingredient (62 and 63) comprising compound of claim 1.
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.
Claim(s) 1, 52 and 53 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hirakura et al (International Journal of Pharmaceutics, 2006, 325, 26-38).
On page 29 Hirakura discloses 1,2-propanediol-2-lactate (Figure 2 B):
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The compound is anticipatory to herein rejected claims. While Hirakura does not specify the stereochemistry of the compound, lactic acid is a chiral acid and has stereochemistry as depicted in compound XXXVI of claim 52. With regards to stereochemistry of the alcohol component of the lactate ester, Hirakura does not identify a specific stereoisomer, however since a stereocenter is present, both R and S isomers are represented. Since there are only two possibilities, a skilled artisan would readily envision both R and S isomers in the alcohol portion of the molecule.
Allowed claims
Claims 64-70, directed to a method preparation of compounds encompassed by claim 1 are allowed. Hirakura is closest art because it teaches compound of claim 1. However, Hirakura does not teach a method of making the compound as recited in the allowed claims.
Conclusion
Claims 1 and 52-70 are pending
Claims 1 and 52-63 are rejected
Claims 64-70 are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628