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 Claims
Claims 8-19 are pending.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to Application Serial No. PCT/EP2022/069200, filed 7/08/2022; and further claims priority to foreign application number EP21305945.4, filed 7/08/2021.
Information Disclosure Statement
All references from IDS(s) received on 04/24/2024 have been considered unless marked with a strikethrough.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 8-11, 14, and 17-19 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Bird, P. (WO2013007698A1; cited in IDS filed 424/2024; “Bird”).
Bird teaches the use of pharmaceutical compositions for the treatment of neurological disorders, particularly those associated with cognitive processing including neurodegenerative disorders (e.g. dementia and Parkinson's disease) (Abstract). Bird teaches the pharmaceutical composition may include a stimulant such as zylofuramine(Claim 18), which has an overlapping genus structure with independent claim 8 and 14, as well as anticipates the structural limitations required by dependent claims 9-11. Bird also teaches the composition to be delivered via oral or parenteral administration including through injection (Page 52, Lines 29-34), as required by instant claims 17-19.
Therefore, Bird anticipates instant claims 8-11, 14, and 17-19.
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.
Claims 8-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bird, P. (WO2013007698A1; cited in IDS filed 424/2024; “Bird”) in further view of Clarke, R. et al. (J. Med. Chem. 1962, 5, 1, 77–95; cited in IDS filed 424/2024; “Clarke”).
Bird teaches the use of pharmaceutical compositions for the treatment of neurological disorders, particularly those associated with cognitive processing including neurodegenerative disorders (e.g. dementia and Parkinson's disease) (Abstract). Bird teaches the pharmaceutical composition may include a stimulant such as zylofuramine(Claim 18), which has an overlapping genus structure with independent claim 8 and 14, as well as teaches the structural limitations required by dependent claims 9-11. Bird also teaches the composition to be delivered via oral or parenteral administration including through injection (Page 52, Lines 29-34), as required by instant claims 17-19.
Bird fails to explicitly teach a dosage for zylofuramine.
Clarke teaches compounds with overlapping genus structures as psychomotor stimulants. Clarke teaches ranging threshold and maximum effect dosages ranging from 2mg/kg to 128mg/kg, which result in approximately 0.06mg to 3.5 mg (based on the weight of the rats). Clarke fails to explicitly teaches the exact dosage ranges required by instant claims 12-13 and 15-16, however Clarke does teach overlapping ranges. Therefore, it would be obvious to a person skilled in the art to arrive at the dosing range of the instant claims. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); See MPEP 2144.05(I).
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (A), it would have been prima facie obvious to extract the stimulant compound taught by Bird for use in dementia and parkinson’s and administer the compound in the dosages taught by Clarke. A person skilled in the art would have been motivated to do so because Clarke teaches the compounds also as psychomotor stimulants and for use as individual agents rather than in a composition, as taught by Bird. Therefore, claims 8-19 would have been obvious to a person who is skilled in the art prior to the effective filing date.
Conclusion
Claims 8-19 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621