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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/10/2026 has been entered.
Terminal Disclaimer
Applicant, on 02/10/2026, has submitted a Terminal Disclaimer over the claims of copending application 18/617,255. The Terminal Disclaimer is sufficient to overcome the outstanding double patenting rejections.
Claim Rejections - 35 USC § 112 Second Paragraph – New Grounds of Rejection
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 20 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 20 is rejected for reciting the phrase “wherein the administering enhances cognition in the subject” because a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim. The instant claim simply recites a result of carrying out the method of claim 1 and provides no actionable structure to the method itself. Applicant is directed to MPEP 2111.04(I):
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) "adapted to" or "adapted for" clauses;
(B) "wherein" clauses; and
(C) "whereby" clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps"). In In re Giannelli, 739 F.3d 1375, 1378, 109 USPQ2d 1333, 1336 (Fed. Cir. 2014), the court found that an "adapted to" clause limited a machine claim where "the written description makes clear that 'adapted to,' as used in the [patent] application, has a narrower meaning, viz., that the claimed machine is designed or constructed to be used as a rowing machine whereby a pulling force is exerted on the handles." In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
In the case of the instant claim, the recitation equates to a “wherein” clause stating the intended result of the administration of the compound of claim 1. This rejection may be overcome by the cancelation of claim 20.
Double Patenting - Withdrawn
Rejections of claims 1-20:
In light of Applicant’s submission of Terminal Disclaimer, the rejections are hereby withdrawn. Applicant’s submitted Terminal Disclaimer over the claims of copending application 18/617,255 are sufficient to overcome the outstanding rejections.
Allowable Subject Matter
The prior art does not teach or reasonably suggest the method of use of compounds of Formula I. The closest prior art found is Castagnoli (WO 98/22110).
Castagnoli teaches compounds, methods of synthesizing said compounds, and methods of use of said compounds for the treatment of Parkinson’s disease. Of particular relevance to the instant invention is the following compound (page 34, claim 8):
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254
435
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The compound of Castagnoli meets the following limitations of claim 1 with regards to Formula I:
R1 is heterocyclyl
R2 is alkyl
R3-R14 are each H
The differentiating factor between the compound above and the compound of the instant claims is the group at the corresponding X position. In the compound above, the group at the corresponding X position is CH3. However, claim 1 recites X as halogen, an amino acid residue, substituted amino acid residue, ester, or H but only when R1 is pyridyl. Castagnoli provides no indication or suggestion of altering the terminal methyl group in the X position. Castagnoli further provides additional exemplary species (pages 32-35), however each of these species do not contain a central morpholine ring like the compounds of the instant claim. Furthermore, the compounds of Castagnoli are based upon the following generic formula (page 32, claim 1):
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156
131
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The above formula indicates that the moiety of the N containing heterocycle and terminal methyl group are core to the compounds of Castagnoli.
Conclusion
Claims 1-19 are in condition for allowance.
Claim 20 is rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC TRAN whose telephone number is (571)272-7854. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey 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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/ERIC TRAN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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