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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Current Status of 18/836,650
This Office Action is responsive to the amended claims of 17 February 2025.
Claims 1-13, 15-16, and 20-22 have been examined on the merits. Claims 1-2 4, 10-11, and 15-16 are original. Claims 3, 5-9, 12-13, and 20-22 are currently amended.
Priority
The effective filing date is 15 February 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 20 January 2026; and 7 August 2024, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 8, 20, and 22 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.
Claim 8 contains two occurrences of “preferably” which render the metes and bounds of claim 8 undefined (hence rendering claim 8 indefinite under 35 USC 112(b)). The artisan does not know if the limitations following “preferably” are required limitations or merely exemplary.
Claims 20 and 22 have the same issue: these claims contain “preferably”. These claims 20 and 22 are also rejected as indefinite under 35 USC 112(b) for the same rationale, as above.
Please delete “preferably” to render moot this rejection.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Dependent claim 16, which depends on canceled claim 14, is rejected under 35 USC 112(d). A claim cannot depend on a canceled claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
Claims 8, 16, 20, and 22 are not presently allowable as written.
Claims 1-7, 9-13, 15, and 21 are presently allowable as written.
There is no known prior art reference that either teaches or anticipates a crystal form of (+)-tetrabenazine with the X-ray diffraction spectrum of instant claims 1, 10, and 15.
The instant claims 1, 10, and 15 are drawn to polymorph forms of (+)-tetrabenazine. Polymorphs are highly-specific forms of the tetrabenazine compound that are unique to the compound being measured and the X-ray diffraction spectra are a product of the specific device measuring the compound.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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