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 4/27/26. Claim 11 has been cancelled. Claims 1-10, 12-23 are pending. Claims 1, 9-10 have been amended. Claims 7-8, 12-22 have been withdrawn. Claims 1-6, 9-10, 23 are examined herein.
The claim amendments have rendered the 112 and 103 rejections of the last Office Action moot, therefore hereby withdrawn.
Applicant’s arguments with regard to the 103 rejection have been fully considered but found not persuasive, therefore maintained for reasons of record and modified below due to the claim amendments.
Claim Rejections - 35 USC § 103
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-6, 9-10, 23 are rejected under 35 U.S.C. 103 as being unpatentable over Buntinx (US Patent Application 2005/0119249, of record) in view of Emir et al. (US Patent Application 2004/0229913, of record).
The instant claims are directed to a method of treating the cognitive disorder, Alzheimer’s dementia, in a subject with a MMSE score ranging from 25 to 30, by administering pipamperone.
Buntinx teaches methods of treating cognitive disorders by administering a compound having D4 antagonistic, partial agonistic, or inverse agonistic activity (abstract and paragraph 0002), for example pipamperone (paragraphs 0013, 0078). A preferred cognitive disorder is dementia caused by Alzheimer’s disease (paragraphs 0049, 0061, 0063, 0064, 0106). Preferred dosages range from 5-15 mg per day, for example 5, 6, 7,8, 9, 10, 11, 12, 13, 14, 15 mg (paragraphs 0084, 0085). The term “treating” includes encompass preventing the onset of the disease and/or including reducing the severity of the disease or symptoms associated therewith prior to affliction with said disease (paragraph 0091).
However, Buntinx fails to teach wherein the subject has a MMSE score ranging from 25 to 30.
Emir et al. teach Mini-Mental State Examination (MMSE) is used as an objective standard to gauge the severity of impairment to cognitive function in Alzheimer’s dementia. MMSE is in wide use internationally and tests using simple questions about time, location, and the naming of objects. In the test, the severity of dementia is indicated with a score from 30 to 0--the closer the score to 30, the more normal the cognitive function, while the closer the score to 0, the greater the severity of impairment to cognitive function (paragraph 0033)
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have selected a subject having a MMSE score between 25 to 30, as taught by Emir et al., in the method of treating Alzheimer’s dementia by administering with pipamperone, as taught by Buntinx.
A person of ordinary skill in the art would have been motivated to select a subject having a MMSE score between 25 to 30 because Emir et al. teaches that any score below 30 indicates an increased risk of having or developing cognitive impairment due to Alzheimer’s dementia. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in treating a subject with Alzheimer’s dementia having a MMSE score between 25 to 30 by administering with pipamperone
Response to Arguments
Applicant argues that Buntinx fails to teach or suggest the use of pipamperone for preventing, delaying, or postponing the onset of a cognitive disorder, such as Alzheimer’s dementia, since no experimental data is provided.
This is not persuasive because Buntinx clearly teaches methods of treating and preventing cognitive disorders by administering (abstract and paragraph 0002), for example pipamperone (paragraphs 0013, 0078). A preferred cognitive disorder is dementia caused by Alzheimer’s disease (paragraphs 0049, 0061, 0063, 0064, 0106). No experimental data is required to meet the limitations of the claims.
Applicant argues that pipamperone has a different purpose other than for preventing or treating Alzheimer’s disease. It is the cholinesterase which is responsible for the therapeutic effect, not pipamperone.
This is not persuasive because pipamperone is being administered to a subject with Alzheimer’s disease, therefore the treating or preventing will obviously occur since the elemental method steps have been taught. Administration of cholinesterase is not precluded nor is it relevant what active agent is responsible for what effect as long as the combination of active agents is being administered to a subject with Alzheimer’s disease.
Applicant argues that the present invention demonstrates that “treatment” of Alzheimer’s disease with pipamperone is not feasible, as evidenced by Figure 2B, in which administration of pipamperone to an Alzheimer’s disease patient did not result in cognitive improvement, whereas administration to an at risk subject resulted in cognitive improvement.
This is not persuasive because Applicant is reminded that the teachings of Buntinx encompass preventing the onset of the disease and/or including reducing the severity of the disease or symptoms associated therewith prior to affliction with said disease (paragraph 0091).
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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