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 Claims
The Office Action is in response to the application filed June 22, 2026. Claims 1-15 are being examined on the merits herein.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 1-8, 13, and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of US 11,207,310. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to method of treating prodromal Huntington Disease (HD) in a subject who has at least 36 CAG repeats in the huntingtin (Htt) gene, wherein said method comprises administering a composition comprising pridopidine or a pharmaceutically acceptable salt thereof (claim 1); in doses ranging from 10 mg/day -225 mg/day (claim 8); employing various diagnostics to define the patient population, TCF 13 (claim 2), HD subject in Stage 1 or Stage 2 (claim 6).
The patented claims are drawn to a method of (a) maintaining functional capacity, or (b) improving functional capacity, in a human patient afflicted with early stage Huntington disease (HD1 and HD2, TFC 7-13) comprising periodically orally administering to the patient a pharmaceutical composition comprising pridopidine or a pharmaceutically acceptable salt thereof such that a dose of 90-225 mg of pridopidine is administered to the patient per day, wherein the pharmaceutical composition is administered for at least 26 weeks, so as to thereby maintain functional capacity, or improve functional capacity in the human patient.
Thus, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time it was made.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-8, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hayden (US 2018/0055832) of record.
Hayden teaches method of maintaining functional capacity, improving functional capacity, or lessening the decline of functional capacity in a human patient in need thereof comprising periodically orally administering to the patient a pharmaceutical composition comprising pridopidine such that a dose of 90-225 mg of pridopidine is administered to the patient per day, so as to thereby maintain functional capacity, improve functional capacity, or lessen decline of functional capacity in the human patient (claim 1; [0014]).
Hayden teaches the patient has greater than or equal to 36 CAG repeats in the huntingtin gene, the human patient is afflicted with Huntington's disease, the human patient has a baseline TFC score which is greater than or equal to 9, the human patient has a baseline TFC score which is greater than or equal to 7, the human patient has a baseline TFC score of 11-13, the human patient has a baseline TFC score of 7-10, the pridopidine is pridopidine hydrochloride (claim 46).
Hayden teaches a change in UHDRS TFC indicates delay/reduction in functional decline [0246].
Hayden teaches FIGS. 44a-44c are graphs which show multiple ambulation-related endpoints demonstrating trends favoring pridopidine in early HD (stage 1-2 patients). Data for TMS showed a strong placebo effect. A trend towards improvement in TMS was observed at 52 weeks [0295].
Hayden teaches a HD patient is classified as an early-stage patient, for example, as a stage 1 or stage 2 HD (HD1 or HD2) patient. The patient has a baseline TFC score of 7-13 or at least 7, at least 8, at least 9, at least 10, at least 11, at least 12, 13 or 7-10 or 11-13. The functional capacity of a patient is measured using the Total Functional Capacity (TFC) scale of the Unified Huntington's Disease Rating Scale (UHDRS), UHDRS-TFC or TFC [0013].
Hayden teaches a method of achieving a reduced change from baseline in the Symbol Digit Modalities test (SDMT) test in a human HD patient comprising periodically orally administering to the patient a pharmaceutical composition comprising pridopidine such that a dose of 90-180 mg of pridopidine is administered to the patient per day, so as to thereby reduce the change in the SDMT test in the patient compared to a HD subject not receiving pridopidine [0018].
Hayden teaches the PRIDE-HD study was the first large study to include the HD-Cognitive Assessment Battery (HD-CAB) assessments. The HD-CAB was designed to detect symptomatic, “pro-cognitive” effects (6 months-1 year) and slowing rate of cognitive decline (>1 year) in late pre-manifest, HD1 and HD2 patients. It covers cognitive domains most impacted in HD, using tests with good psychometric properties. The battery includes the following tests: Symbol Digit Modalities Test, Emotion Recognition, Trail Making Test B, Hopkins Verbal Learning Test (revised), Paced Tapping at 3 Hz, and One Touch Stockings of Cambridge [0769].
Hayden does not specifically teach treating Huntington Disease in the prodromal stage. Nonetheless, as discussed above, Hayden teaches a HD patient is classified as an early-stage patient, for example, as a stage 1 or stage 2 HD (HD1 or HD2) patient, having a baseline TFC score of 7-13.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have known that a patient population with the parameters described would obviously be afflicted with prodromal Huntington's disease. The diagnostic assessments recited by the claims of the instant application are employed by Hayden and well known in the art as common diagnostic tools used to define the patient population which is afflicted with prodromal Huntington's disease. The score obtained from each diagnostic evaluation is a tool within the purview of the skilled artisan to employ in order to embrace the patient population of interest.
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Claims 9-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hayden (US 2018/0055832) of record, as applied to claims 1-8, 13, and 15 in the 103 rejection above, and Sonesson (WO 2005/121092).
Hayden is discussed above.
Hayden does not the addition of compound 1 or compound 4 combined with the composition as required by the limitations of the instant claims.
Sonesson teaches compounds having therapeutic effect again CNS disorders, namely Huntington’s disease (page 14, lines 20-23).
Sonesson teaches specifically exemplifies compound 1 as an agent that may be employed for said treatment (page 10, compound 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed pridopidine for the treatment of prodromal Huntington Disease as taught by Hayden and combined said therapeutic with compound 1 as taught by Sonesson. As taught by Sonesson, compound 1 is also taught for the treatment of Huntington Disease. The examiner respectfully points out the following from MPEP 2144.06: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose ....[T]he idea of combining them flows logically from their having been individually taught in the prior art.', In re Kerkhoven, 626 F.2d 846, 850,205 USPQ 1069, 1072 (CCPA 1980).
The concentration of the two components relative to one another is a parameter within the purview of the skilled artisan to modify. Generally, mere optimization of ranges will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "When the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimal or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also In re Peterson, 315 F. 3d at 1330, 65 USPQ 2d at 1382 "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." MPEP 2114.04.
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Conclusion
Claims 1-15 are not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAHAR JAVANMARD whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622
