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
This Office Action is in response to applicant’s arguments filed on 12/12/25. Claims 16-24 are pending and examined herein.
Applicant’s arguments have been fully considered but found not persuasive. The rejection of the last Office Action is maintained for reasons of record and repeated below for Applicant’s convenience.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 16-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Piette et al. (“Masitinib as an adjunct therapy for mild-to-moderate Alzheimer’s disease: a randomised, placebo-controlled phase 2 trial,” Alzheimer’s Research & Therapy, 2011, 3, 16, pages 1-11, of record).
Piette et al. teach a randomized, placebo-controlled, phase 2 study performed on patients with mild-to-moderate Alzheimer’s disease, receiving masitinib as an adjunct to cholinesterase inhibitor and/or memantine. Patients were randomly assigned to receive masitinib (starting dose of 3 or 6 mg/kg/day) or placebo, administered twice daily for 24 weeks. The primary endpoint was change from baseline in the Alzheimer’s Disease Assessment Scale- cognitive subscale (ADAS-Cog) to assess cognitive function and the related patient response rate. The results showed that masitinib administered as add-on therapy to standard care during 24 weeks was associated with slower cognitive decline in Alzheimer’s disease, with an acceptable tolerance profile (abstract). A total of 34 patients were randomized: 26 patients into the masitinib group (having a ADAS-Cog score of 18.8) and 8 patients into the placebo group (having a ADAS-Cog score of 25.6) (page 3, right column, first full paragraph). The masitinib group also had a MMSE score of 19.1 ± 3.9, a CDR score of 21, a ADCD-ADL score of 47.1, and a time since diagnosis of 1.7 years. (Table 1). Masitinib mesilate was the investigatory drug of the present study (page 2, left column, second full paragraph) and administered orally (page 2, left column, last two paragraphs). The mean actual masitinib dose received was 4.1 ± 1.3 and 6.2 ± 0.6 mg/ kg/day in the theoretical 3 and 6 mg/kg/day groups, respectively, reflecting that dose increments occurred more frequently in the initial 3 mg/kg/day group (page 3, right column, second full paragraph). Blinded dose adjustments of 1.5 mg/kg/day were permitted according to efficacy and safety outcome, with the dosage being incremented in cases of insufficient response accompanied by minimal toxicity at weeks 4 and 8 to a maximum dose of 7.5 mg/kg/day (that is, one additional 100 mg tablet is required for a 66 kg patient previously receiving 6 mg/kg/day to achieve the theoretical dose of 495 mg) (page 2, right column, first full paragraph).
Response to Arguments
Applicant argues that Piette does not teach the claimed subpopulations of Alzheimer’s disease, according to their individual ADCS-ADL, MMSE, or ADAS-Cog score range. Instead, Piette teaches Alzheimer’s disease populations defined by their mean value.
This is not persuasive because if the mean value is within the claimed range, it is inherent that at least one patient has a specific value within the claimed range. For example, the instant claim 16 recites that the subpopulation must be a patient with Alzheimer’s disease with a MMSE score equal to or greater than 13. Piette teaches an Alzheimer’s disease patient with a mean MMSE score of 19.1 ± 3.9, which at the lower end would still be greater than the claimed value of 13.
Conclusion
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 extension fee 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 Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623
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