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 .
DETAILED ACTION
Claims 1-3, 5-6, 11, 13, 15, 17-19, 21, 26-29, 32, 34-35, and 41 are pending in the instant application.
Claims 1-3, 5-6, 11, 13, 15, 17-19, 21, 26-29, 34-35, and 41 are amended.
Claims 1-3, 5-6, 11, 13, 15, 17-19, 21, 26-29, 32, 34-35, and 41 are examined herein.
Priority
The instant application claims benefit of priority to U.S. Provisional Application No. 63/233,619, filed on 16 August 2021 and PCT/CA2022/051242, filed on 16 August 2022. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 16 August 2021.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 08 October 2024 and 08 October 2024, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Arguments
The amendment filed on 24 June 2026 has been entered.
In view of applicant amendment to claims 1 and 5, the objections of record are withdrawn.
In view of applicant amendment to claim 1, the 112(a)-written description rejection of record is withdrawn.
In view of applicant amendments to claims 3, 13, 17, 19, 29, and 34, the 112(b) rejections of record are withdrawn.
In addition, new 102(a)(1) and 103 rejections are necessitated by amendment (see below).
All rejections and objections not found below have been withdrawn.
NEW REJECTIONS NECESITATED BY AMENDMENT
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-2, 11, and 27-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen (Evaluating Efficacy In Vitro and In Vivo of Small Molecules Predicted by Artificial Intelligence to Reduce Alpha-Synuclein Oligomers. 2020. 1-137).
Regarding claims 1 and 27, Chen teaches the method of treating α-synuclein aggregation comprising contacting a cell with rifabutin (page 52 and 84).
Regarding claim 2 and 29, Chen teaches the subject is a mammal (page 52).
Regarding claims 11 and 28, Chen teaches rifabutin.
Claim(s) 1-3, 5-6, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated Cohen et al. (US 20120270836 A1).
Regarding claim 1, Cohen teaches the method of treating Alzheimer’s disease, a α-synucleinopathy neurodegenerative disorder, comprising administering aminocaproic acid and rifabutin (claim 2).
Regarding claim 2, Cohen teaches the subject is a mammal (claim 1).
Regarding claim 3, Cohen teaches the subject to be human (paragraph [0217]).
Regarding claims 5 and 6, Cohen teaches Alzheimer’s disease (claim 1)
Regarding claim 11, Cohen teaches rifabutin (claim 2).
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.
Claim(s) 1-3, 5-6, 11, 13, 15, 17-19, 21, 26-29, 32, 34-35, and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (cited above).
The teachings of Chen are disclosed above and incorporated by reference herein.
Regarding claim 3, Chen does not teach the method for use in humans.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious.
In this case at least prong B of KSR applies – substitution of one known element for another. It would be prima facie obvious to substitute one mammal for another. Additionally, Chen’s work is focused on repurposing known drugs to treat α-synuclein aggregation and the skilled artisan would recognize that the work of Chen lays the groundwork for progression to human application.
Thus, all of the elements of claims were known to one of ordinary skill in the art at the time the invention was made and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of invention. Therefore, the claimed invention, as a whole, would have been obvious to one of ordinary skill in that art at the time the invention was made.
Regarding claims 5 and 6, Chen teaches the implications of inhibiting α-synuclein aggregation for Parkinson’s disease.
Regarding claims 13-19, 21, and 26, it would be prima facie obvious to one of ordinary skill in the art to administer the rifabutin to a patient at high risk of developing Parkinson’s disease to prevent the α-synuclein aggregation from occurring.
Regarding claims 32, 34-35, and 41, again it would be prima facie obvious to one of ordinary skill in the art that the work of Chen lays the groundwork for progression to human application and administering the rifabutin to a patient with or at risk of developing Parkinson’s disease would be obvious.
Conclusion
Claim(s) 1-3, 5-6, 11, 13, 15, 17-19, 21, 26-29, 32, 34-35, and 41 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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