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
Claims 1-23 are pending.
During a telephone conversation with Mr. Eric Balicky on 9/16/25 a provisional election was made without traverse to prosecute the invention of the species, Alzheimer’s dementia and pipamperone, claims 1-6, 9-11, 23. Affirmation of this election must be made by applicant in replying to this Office action.
Claims 7-8, 12-22 have withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claims 1-6, 9-11, 23 are examined insofar as it reads on the elected species.
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112(b):
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 9-10 are rejected under 35 U.S.C. 112(b) or 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Regarding claim 1, the phrase "relative gamma power" renders the claim indefinite because it is unclear what the metes and bounds are for the term “relative.”
Regarding claims 9-10, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrases are part of the claimed invention. See MPEP § 2173.05(d).
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 1-6, 9-10, 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Buntinx (US Patent Application 2005/0119249, of record).
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).
It is noted that the limitation regarding “gamma power in the subject is maintained or increased” is inherent because it is considered a mechanism of action that will necessarily occur when the same claimed active agent is administered to the same claimed patient population.
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Buntinx (US Patent Application 2005/0119249, of record), as applied to claims 1-6, 9-10, 23, in view of Emir et al. (US Patent Application 2004/0229913).
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 as discussed above, however, fail 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
Conclusion
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