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 1-22 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 1-22.
Applicants' arguments, filed 05/29/2026, have been fully considered but they are not deemed to be persuasive regarding claim 16. The rejection of claims 1, 17, 19, and 21 under 35 U.S.C. 112 are withdrawn since Applicant’s arguments are persuasive.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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, 16, 19, and 21 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 “tolerated” in claim 1 is a relative term which renders the claim indefinite. The term “tolerated” 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 for tolerated is since claim 1 does not provide a metric for tolerability.
The term “strong” in claim 16 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 degree of strength of a CYP2D6 inhibitor is since claim 16 does not provide a criteria for determining strength.
The term “much or very much” in claim 19 is a relative term which renders the claim indefinite. The term “much or very much” 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 degree of improvement is since claim 19 does not provide a metric for much or very much.
The term “adequate” in claims 1 and 21 is a relative term which renders the claim indefinite. The term “adequate” 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 for adequate is since claim 21 does not provide a metric for what is adequate.
The term “tolerable” in claim 21 is a relative term which renders the claim indefinite. The term “tolerable” 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 for tolerable is since claim 21 does not provide a metric for what is tolerable.
Response to Arguments
Applicant 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 claim 16 containing the phrase is 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.
Applicant also argues that “the specification describes how a seven-point Likert scale
is used to assess a patient's clinical global impression of change (CGIC). In at least this respect,
the specification satisfactorily apprises those of ordinary skill in the art regarding the metes and
bounds of the claims in which the terms "much" or "very much" appear.” The Examiner respectfully disagrees since the CGIC does not provide which scores correlate to a level of “much” improvement or “very much” improvement, and thus does not provide the requisite guidance to ascertain what is encompassed by the terms.
Applicant also argues that “the present specification provides a clear definition concerning how the term in question is to be understood in reference to control of abnormal muscular activity or abnormal involuntary movement in a subject. In at least this respect, the specification satisfactorily apprises those of ordinary skill in the art regarding the metes and bounds of the claims in which the term "adequate" appears.” The Examiner respectfully disagrees since although “adequate” is defined in paragraph 0309 of the specification, the specification only discloses that adequacy is determined by the practitioner as well as factors affecting adequacy, but the specification does not provide a threshold or scale to ascertain what is “adequate”.
Applicant also argues that “the specification describes that by a subject tolerability of a daily amount of deutetrabenazine can be assessed in terms of the whether or not the subject displays one or more of certain listed symptoms (id.). 1 In at least this respect, the specification satisfactorily apprises those of ordinary skill in the art regarding the metes and bounds of the claims in which the term "tolerable" appears.” The Examiner respectfully disagrees since although the specification discloses factors that may determine tolerability, the specification does not provide an overall metric or criteria to determine whether deutetrabenazine is tolerable.
Conclusion
Claims 1-22 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.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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