-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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 13, 2026 has been entered.
Priority
This application is a CON of 16/115,105 filed on 08/28/2018, which is a CON of
14/601,920 filed on 01/21/2015, which claims benefit in provisional application 62/050,626 filed
on 09/15/2014 and claims benefit in provisional application 61/930,358 filed on 01/22/2014.
This application repeats a substantial portion of prior Application No. 16/115,105, filed 08/28/2018, and adds disclosure not presented in the prior application. Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Claims 1-7 filed on October 23, 2023 do not have support in any of the priority documents. Thus, the effective filing date of claims 1-7 is October 23, 2023.
Pages 27-29 of the specification describe a method of making pridopidine granules where all granulation ingredients are added to the granulator bowl and pre-blend for a sufficient time to ensure uniformity. Granulations liquid was added and blend. Tables 3.1, 3.2, and 3.3 describe the ingredients. The specification does not describe any other methods of making a granule or a tablet, including the claimed tablet.
Claim Status
Claims 1-7 are pending and examined. Claim 1 was amended.
Withdrawn Claim Rejections - 35 USC § 103
Rejections of claims 1-3 and 5-7 over Waters (US 2013/0267552 Al Published October 10, 2013 - of record in IDS dated 01/28/2024), Staniforth (US 5,741,524 Date of Patent April 21, 1998), Singla (WO 2012/172461 Al Published December 20, 2012), and Nangia (US 2010/0316712 Al Publication Date December 16, 2010) and rejection of claim 4 over Waters, Staniforth, Singla, Nangia, and Ryoshi are withdrawn because the claims were amended to require the wet granulation step to exclude a rate controlling excipient, and this limitation would not have been obvious over the cited references. Arguments filed against these rejections are moot because rejections are withdrawn.
Claim Rejections – 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 was amended to require step (a) to exclude a rate controlling excipient in the wet granulation step. This limitation is new matter because it is not supported in the application as originally filed. Applicant’s reply does not state where the limitation is supported.
Pages 27-29 of the specification describe a method of making pridopidine granules where all granulation ingredients are added to the granulator bowl and pre-blend for a sufficient time to ensure uniformity. Granulations liquid was added and blend. Tables 3.1, 3.2, and 3.3 describe the ingredients used to make the granule compositions. The specification does not describe any other methods of making a granule or a tablet, including the claimed tablet. Therefore, the newly added limitation is not supported in the application as filed.
Claims 2-7 are rejected for new matter because the claims depend from claim 1.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to Alma - Pipic whose telephone number is (571)270-7459. The
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/ALMA PIPIC/Primary Examiner, Art Unit 1617
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