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 .
Status of the Application
Claims 1-19 and 26-42 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 08/17/2026 are acknowledged. Claims under consideration in the instant office action are claims 1-30.
Applicants' arguments, filed 08/17/2026, have been fully considered but they are not deemed to be persuasive. The rejection of claim 1 under 35 U.S.C. 112 has been withdrawn regarding the term “clinically significant” due to Applicant’s amendments. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 11-13 and 31-41 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.
The term “strong” in claims 11-13, 32-35, and 38-41 is a relative term which renders the claim indefinite. The term “strong” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what the criteria is to determine a strong CYP2D6 inhibitor.
Response to Arguments
Applicant argues that “With respect to the rejection of claims 11 and 12 concerning the phrase "strong CYP2D6 inhibitor", Applicant has presently resubmitted the documentary evidence that the phrase in question has a well-known meaning among those skilled in the art.” The Examiner respectfully disagrees since although Applicant’s submissions may provide examples of specific drugs that have been referred to as a "strong CYP2D6 inhibitor", page 19 of the reference “Clinical Drug Interaction Studies – Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry” discloses that CYP inhibitors can be categorized by AUC levels for a typical investigational drug, which means such metrics can be changed over time. The reference also states that there is no standard classification system for such inhibitors (pg. 19). Thus, the prior art fails to provide the metes and bounds as to the determination of which drugs are classified as a “strong” CYP2D6 inhibitor.
Conclusion
Claims 11-13 and 31-41 are rejected.
Claims 1-10, 14-19, 26-30, and 42 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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