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 1-30 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 05/29/2026 are acknowledged. Claims under consideration in the instant office action are claims 1-30.
Applicants' arguments, filed 05/29/2026, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 1-30 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 “clinically significant” in claim 1 is a relative term which renders the claim indefinite. The term “clinically significant” 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 threshold is for an adverse event to be clinically significant since the disclosure does not provide a metric for such a threshold.
The term “strong” in claims 11-12 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 for a strong CYP2D6 inhibitor.
Response to Arguments
Applicant argues that “While the Applicant recognizes that relative terminology can in some circumstances render unclear the scope of a claim, in the present instance the terminology in question has been clearly defined in Applicant's specification (see, e.g., paragraphs [0308], [0485]), thereby satisfactorily apprising those of ordinary skill in the art regarding the metes and bounds of the claims in which the phrase appears.” The Examiner respectfully disagrees since the term “clinically significant” as broadly defined in Application’s specification (paragraphs 0308, 0485), is disclosed as “a) moderate or severe in intensity”, which are themselves relative terms of degree. Such a definition does not provide the metes and bounds of the claimed invention. Omitting the term “clinically significant” and reciting only “adverse event” would overcome the indefiniteness issue, given that adverse event is clearly defined (see paragraphs 0300, 0301, 0307).
Applicant also argues that “These documents therefore demonstrate that the phrase "strong CYP2D6 inhibitor" has a well-understood meaning among those skilled in the art, and therefore that Applicant's claims 11-12 containing the phrase are not unclear.” The Examiner respectfully disagrees since such documents have not been provided, and it is unclear if they demonstrate that the phrase "strong CYP2D6 inhibitor" has a well-understood meaning among those skilled in the art.
Conclusion
Claims 1-30 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
Prosecution Insights