-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 .
Applicant’s response dated May 26, 2026 is acknowledged.
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 l. l 7(w)(l) 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 l.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. No claims were amended, canceled, nor newly added.
Maintained Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. l 12(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. l 12(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 requires 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 exclusion of a rate controlling excipient in step a) is not supported in the application as filed.
Claims 2-7 are rejected for new matter because the claims depend from claim 1.
Response to Arguments
Applicant’s arguments submitted in the remarks dated May 26, 2026 were fully considered but are not persuasive for the following reasons.
The examiner cited pages 27-29 of the specification because it is the only place in the specification that teaches a method of making granules. The title of the section is
“Manufacture of Modified Release (MR) Pridopidine dosage forms”. The purpose of citing this section is to show that the presently claimed method is not supported in the specification.
Applicant’s argument that exclusion of a rate controlling excipient in step a) is supported because step a) does not recite a rate controlling excipient and step b) teaches adding a rate controlling excipient to granules of step a) after drying is not persuasive because exclusion of a rate controlling excipient from step a) does not have basis in the original disclosure.
The specification, on pages 27-29, teaches a method of making granules where all components are combined and blended followed by granulation and drying. The specification does not provide support for the three distinct steps a), b), and c) as required by claims dated October 23, 2023. In the claims, step a) requires preparing granules comprising pridopidine or a pharmaceutically acceptable salt by high shear wet granulation achieving mixture uniformity. Claim 1 is the only place where the method of step a) is mentioned. Based on the teachings in the specification, step a) was never even contemplated. There are no teachings or even a suggestion in the specification to perform a wet granulation of the drug with or without a rate controlling excipient or any other excipient to form dry granules that are subsequently combined with a rate controlling excipient and compressed into a tablet. Excluding a rate controlling excipient from step a) constitutes new matter because the disclosure does not provide embodiments or teachings where step a) is performed in the presence of a rate controlling excipient. Excluding a rate controlling excipient from step a) would be supported if the disclosure provided either explicit support where the excipient is excluded from step a) or an embodiment where step a) was performed with a rate controlling excipient. In the instant case, the specification does not even mention step a) much less alternative embodiments suggesting what excipients or other components may or may not be present in the method of step a).
Any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) ("[the] specification, having described the whole, necessarily described the part remaining."). See also Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983), aff’d mem., 738 F.2d 453 (Fed. Cir. 1984). In describing alternative features, the applicant need not articulate advantages or disadvantages of each feature in order to later exclude the alternative features. See Inphi Corporation v. Netlist, Inc., 805 F.3d 1350, 1356-57, 116 USPQ2d 2006, 2010-11 (Fed. Cir. 2015).
Literal support for a negative limitation is not required in the application. However, the absence of a rate controlling excipient in step a) is not sufficient to provide support for excluding the excipient from step a). In the present case, the specification does not provide any teachings or even a mention of distinct steps a) and b). The disclosure does not reasonably convey to the skilled artisan that the applicant was in possession of step a) as claimed and it cannot be established that excluding a rate controlling excipient from step a) would be necessarily present in the disclosure. Requiring a rate controlling excipient in step b) does not necessarily mean that a rate controlling excipient has to be absent from step a).
The mere absence of a positive recitation is not basis for an exclusion. However, a lack of literal basis in the specification for a negative limitation may not be sufficient to establish a prima facie case for lack of descriptive support. Ex parte Parks, 30 USPQ2d 1234, 1236 (Bd. Pat. App. & Inter. 1993). "Rather, as with positive limitations, the disclosure must only 'reasonably convey[] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.' ... While silence will not generally suffice to support a negative claim limitation, there may be circumstances in which it can be established that a skilled artisan would understand a negative limitation to necessarily be present in a disclosure." Novartis Pharms. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013, 2022 USPQ2d 569 (Fed. Cir. 2022) (quoting Ariad Pharm. Inc. v. Eli Lilly & Co., 589 F.3d 1336, 1351, 94 USPQ2d 1161, 1172). Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. See MPEP § 2163 - § 2163.07(b) for a discussion of the written description requirement of 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph.
Conclusion
No claims are allowed.
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 Alma - Pipic whose telephone number is (571)270-7459. The examiner can normally be reached M-F 9:00am-5:00pm.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617
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