DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Application
Applicant's election of Group I, drawn to a method for the prophylaxis and/or treatment of behavioral and psychological symptoms associated with neurodegenerative disease in a patient by administering 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one, and the species, dementia, in the reply filed on 9/10/26 is acknowledged.
Claims 1-24 are pending. Claims 3, 13-23 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim 12 has been withdrawn from further consideration as being drawn to a non-elected species. Claims 1-2, 4-11, 24 are examined herein insofar as they read on the elected invention and species.
This is a CON of applicant's earlier Application No. 16/456,334. All claims are drawn to the same invention claimed in the earlier application and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham vs 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(a) 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-2, 4-11, 24 are rejected under 35 U.S.C. 103(a) as being obvious over Yamashita et al. (US Patent 2015/0087655 A1, of record).
The instant claims are directed to a method for the prophylaxis and/or treatment of behavioral and psychological symptoms associated with neurodegenerative disease in a patient by administering 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one, wherein the neurodegenerative disease is dementia.
Yamashita et al. teach the use of 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one as a superior therapeutic agent for central nervous system diseases (abstract), for example behavioral and psychological symptoms of dementia caused by cognitive impairment, and cognitive impairment associated with Alzheimer's disease, Parkinson's disease, and other neurodegenerative diseases (paragraph 0126).
However, Yamashita et al. fail to disclose specifically dementia with Lewy bodies, frontotemporal dementia, cerebrovascular dementia, and dementia associated with Huntington's disease.
It would have been prima facie obvious to a person of ordinary skill in the art, at the time the claimed invention was made, to treat a patient with dementia with Lewy bodies, frontotemporal dementia, cerebrovascular dementia, and dementia associated with Huntington's disease by administering 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one, as taught by Yamashita et al.
A person of ordinary skill in the art would have been motivated to treat dementia with Lewy bodies, frontotemporal dementia, cerebrovascular dementia, and dementia associated with Huntington's disease by administering 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one because Yamashita et al. teach the treatment of dementia, in general. No matter what the underlying cause or etiology is, the symptoms of dementia are the same, therefore one of ordinary skill in the art would have expected a similar level of efficacy in treating various forms of dementia by administering 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one.
The Examiner notes that the limitations regarding where the patient cannot receive a sufficient effect for behavioral and psychological symptoms associated with neurodegenerative disease from a generally available antipsychotic agent or therapeutic drug is obvious because whether the patient has developed tolerance to a particular antipsychotic agent or therapeutic drug has no bearing on a method of treating dementia in a patient by administering 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one. One of ordinary skill in the art would have had a reasonable expectation of success in treating dementia by administering 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one regardless of whether the patient receives or cannot receive a sufficient effect from a generally available antipsychotic agent or therapeutic drug.
Examiner also notes that this is a typical genus/species situation. Once a prima facie case of obviousness is established, the burden is shifted to the Applicant for objective evidence for nonobviousness. See MPEP 2144.08.
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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