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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 29, 2026 has been entered.
Response to Amendment
2. Claims 1, 11, 14, 18, 52, 57 and 62 have been amended, claims 10, 17, 56, 59, 60, 63 and 64 canceled and claims 65-68 added as requested in the amendment filed on September 22, 2025. Following the amendment, claims 1, 5, 11-14, 18, 19, 52, 57, 58, 61, 62 and 65-68 are pending in the instant application.
3. Claims 1, 5, 11-14, 18, 19, 52, 57, 58, 61, 62 and 65-68 are under examination in the instant office action.
4. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
5. Applicant’s arguments filed on January 29, 2026 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
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.
6. Claims 1, 5, 11-14, 18, 19, 57, 58, 61 and 65-68 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.
7. Claim 1 stands indefinite for reasons of record in section 7 of Paper mailed on November 05, 2025. Applicant traverses the rejection at pp. 7-10 of the Response. Specifically, Applicant submits that the claim has been amended and now recites specific steps that are not indefinite. Applicant’s arguments have been fully considered but are not persuasive for reasons that follow.
As fully explained earlier, claim 1 is being limited to one active step of determining the levels of cholesteryl oleate in a sample, which is further defined by “wherein” limitations. Note that to meet the claim’s limitations, all the “wherein” steps must be practiced. The Examiner maintains that it is not obvious what stands for “determining the levels of cholesteryl oleate” in a sample wherein the level is compared to the reference level, lower level is indicative of impaired cognitive function, which in turn is indicative of a presence, risk (which is absence of the pathology at the moment with a risk to develop one in the future), progression and/or severity of Alzheimer’s (AD) and/or Mild Cognitive Impairment (MCI), and the level is monitored over time. Applicant is advised to rewrite the claim so to set forth every step or element of the claimed process to avoid the ambiguity of claim interpretation.
8. Claim 14 is vague and ambiguous for reasons that follow. The claim, as written, encompasses a method to evaluate cognitive function in a subject with AD and/or MCI, wherein higher levels of cholesteryl palmitate or palmitoleate are indicative of impaired cognitive function. Note that AD and MCI are pathologies generally recognized as being specifically associated with impaired cognitive function as a significant symptom. This renders the claim indefinite.
9. Claims 18, 65 and 67 are vague and indefinite insofar as they employ the term “anti-Alzheimer’s compound” as a limitation. This term is not known in the relevant prior art of record as being associated with well-defined genus of molecular embodiments. Moreover, because the instant specification does not identify that property or combination of properties which is unique to and, therefore, definitive of an “anti-Alzheimer’s compound”, an artisan cannot determine if a compound which meets all of the other limitations of a claim would then be included or excluded from the claimed subject matter by the presence of this limitation.
10. Claims 5, 11-13, 19, 57, 58, 61, 66 and 68 are indefinite for being dependent from indefinite claim(s).
Conclusion
11. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
March 3, 2026