DETAILED ACTION
Claims 1-9 are pending.
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 .
Priority
The instant application filed 6/1/2023 is a National Stage entry of PCT/US21/61973, International Filing Date of 12/6/2021. PCT/US21/61973 Claims Priority from Provisional Application 63122251, filed 12/7/2020.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 2/7/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statement is being considered by the Examiner.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Steffen et al. US 2004/0142859 A1 published July 22, 2004 and Sonninen, TM., Hämäläinen, R.H., Koskuvi, M. et al. Metabolic alterations in Parkinson’s disease astrocytes. Sci Rep 10, 14474 (2020).
Claim 1 is generally directed towards a method of treating a polyamine imbalance-related disorder, the method comprising administering phenylbutyrate to a subject in need thereof, thereby treating the polyamine imbalance-related disorder.
Steffen teaches a method of treating Parkinson's disease in a patient, comprising identifying a patient at risk for Parkinson's disease; and administering to the patient a therapeutically effective amount of a deacetylase inhibitor (claim 37), wherein the deacetylase inhibitor is sodium phenylbutyrate (claim 40).
Steffen is silent on a polyamine imbalance in PD.
Sonninen teaches that in PD, there are alterations in the disease and specifically in polyamines. Sonninen states, “PD astroglial cells manifest increased levels of polyamines and polyamine precursors while lysophosphatidylethanolamine levels are decreased, both of these changes have been reported also in PD brain.”
Sonninen teaches in the Discussion on page 8:
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Sonninen teaches that there is a polyamine “imbalance” in PD.
A person of ordinary skill in the art would know to treat PD with sodium phenylbutyrate as taught in the art, and in doing so would be treating a polyamine imbalance disorder as the disease is shown to be one in light of Sonninen. As such claim 1 in obvious in view of the art.
Claim 6 requires sodium phenylbutyrate, this is taught by Steffen.
Sonninen also teaches facts about PD rendering claims 2 and 7 obvious. Sonninen states:
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Sonninen is noting that the LRRK2 mutation plays a role in the diagnosis and polyamine imbalance in PD. Therefore providing motivation to screen patients for the mutation when treating the disease for diagnostic value.
Therefore a person of ordinary skill would be motivated to diagnose and screen patients using genetics to look for an LRRK2 mutation in order to indicate PD, and then given the diagnosis one would look to treat PD with the available methods including those of Steffen by using sodium phenylbutyrate as taught in the art. Therefore claims 2 and 7 are obvious at the time of filing.
Allowable Subject Matter
Claims 3-4 and 8-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J SCHMITT whose telephone number is (571)270-7047. The examiner can normally be reached M-F 8-6 MidDay Flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J SCHMITT/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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