DETAILED ACTION
This office action is in response to applicant’s filing dated April 3, 2024.
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 claims
Claims 7 -11 and 21 - 25 are pending in the instant application. Acknowledgment is made of Applicant’s amendments filed April 3, 2024. Acknowledgment is made of Applicant’s cancelation of claims 1 – 6 and 12 - 20 and addition of a new claims 21 – 25.
Priority
This application is a CON of Application No. 18/147,128 filed December 28, 2022, which is a CON of Application No. 17/753,406 filed March 2, 2022, which is a 371 of PCT/EP2020/074602, filed on September 3, 2020, and claims benefit of priority to European Patent Application No. 19382751.6, filed on September 3, 2019, and European Patent Application No. 19382855.5, filed on October 3, 2019.
Drawings
Acknowledgement is made of the drawings received on August 24, 2023. These drawings are accepted.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
Claim 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. This claim is an omnibus type claim.
Accordingly, claim 25 has not been further treated on the merits.
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)(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 7 -11 and 21 - 24 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Maes et al (WO 2019/025588 A1, hereinafter Maes).
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Instant claims are drawn to a method for treating autism spectrum disorder (ASD) in a human patient, wherein ASD is an adult autism spectrum disorder. The method is comprising administering to the patient a therapeutically effective amount of vafidemstat (
PNG
media_image1.png
144
486
media_image1.png
Greyscale
) (page 18, specification) or a pharmaceutically acceptable salt or solvate thereof, wherein therapeutically effective amount of vafidemstat or a pharmaceutically acceptable salt or solvate thereof is orally administered.
Maes teaches a method for treating a behavior alteration in a patient (preferably a human), where the behavior alteration is social withdrawal associated with CNS disease, such as an autism spectrum disorder (ASD) (page 5, line 1). The method is comprising administering to the patient a therapeutically effective amount of 5-((((1R,2S)-2-(4-(benzyloxy)phenyl)cyclopropyl)amino)methyl)-1,3,4-oxadiazol-2-amine:
PNG
media_image2.png
168
477
media_image2.png
Greyscale
(vafidemstat) (page 9, lines 2 – 4), or a pharmaceutically acceptable salt or solvate thereof, wherein therapeutically effective amount of vafidemstat or a pharmaceutically acceptable salt or solvate thereof is orally administered (page 22, lines 16 – 17).
Regarding the limitation of claim 10, which recites the method for treating an adult autism spectrum disorder, Maes teaches the method for treating a behavior alteration associated with ASD in a human patient in general, without specifying the age of a patient, which would indicate that human patient of any age including adult, can be treated with the described method.
Thus, the method of Maes would anticipate the method of claims 7 -11 and 21 – 24.
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 7 -11 and 21 – 24 are rejected under 35 U.S.C. 103 as being unpatentable over Muñoz et al (US 9,181,198 B2, hereinafter Muñoz) in view of Matsuda et al (Neuropsychopharmacology (2019) 44:1505–1512).
Instant claims are drawn to a method for treating autism spectrum disorder (ASD) in a human patient, wherein ASD is an adult autism spectrum disorder. The method is comprising administering to the patient a therapeutically effective amount of vafidemstat (
PNG
media_image1.png
144
486
media_image1.png
Greyscale
) (page 18, specification) or a pharmaceutically acceptable salt or solvate thereof, wherein therapeutically effective amount of vafidemstat or a pharmaceutically acceptable salt or solvate thereof is orally administered.
Muñoz teaches a method of treating or preventing a disease or condition associated with LSD1, comprising administering to a patient (preferably a human) in need of treatment a therapeutically effective amount of a pharmaceutical composition comprising a compound of Formula (I):
PNG
media_image3.png
65
176
media_image3.png
Greyscale
, such as compound
PNG
media_image4.png
111
315
media_image4.png
Greyscale
, 5-(((trans)-2-(4-(benzyloxy)phenyl)cyclopropylamino)methyl)-1,3,4-oxadiazol-2-amine (column 79, lines 17 – 30, ex.10). The compound of Formula (I) such as compound of ex.10 acts as LSD1 inhibitor (column 6, lines 3 – 6) and is suitable for oral formulations (column 54, line 31).
Although the image above shows (1S,2R) stereoisomer, whereas instantly claimed compound vafidemstat has (1R,2S) configuration of stereocenters, Muñoz explains that “trans” as a part of the name of the compound indicates that the compounds were synthesized in the Examples as mixtures having both configurations (1R, 2S) and (1S, 2R), and chiral separation was further performed (column 63, lines 8 – 12).
Regarding the limitation of claim 10, which recites the method for treating an adult autism spectrum disorder, Muñoz teaches the method for treating a disease or condition associated with LSD1 in a human patient in general, without specifying the age of a patient, which would indicate that human patient of any age, including adult, can be treated with the described method.
Muñoz does not teach that disease or condition associated with LSD1 is the autism spectrum disorder (ASD).
However, Matsuda teaches LSD1 inhibitor T-448, which ameliorated learning dysfunction in mice with N-methyl-D-aspartate receptor (NMDAR) hypofunction, a preclinical model of schizophrenia and ASD. Matsuda concludes that according to experimental evidence, LSD1 inhibitors may provide a novel therapeutic opportunity for central nervous system (CNS) diseases associated with epigenetic dysregulation such as schizophrenia and ASD (page 1506, left column 1st paragraph, and page 1511, left column 1st paragraph).
Thus, since Muñoz teaches a method for treating a disease or condition associated with LSD1, comprising administering to a patient LSD1 inhibitor such as vafidemstat, Matsuda teaches a method to treat ASD with LSD1 inhibitor, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention to substitute LSD1 inhibitor in the method taught by Matsuda with another agent possessing the same mechanism of action (LSD1 inhibitor) to arrive at claimed method. The one of ordinary skills would be motivated to do so in search of an effective method for treatment of ASD with the reasonable expectation of success.
Therefore, taking all together, taught by prior art, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
Claims 7 -11 and 21 – 25 are rejected. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELENA V VISHNYAKOVA whose telephone number is (571)272-3781. The examiner can normally be reached 7:30am - 5pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RENEE CLAYTOR can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/E.V.V./Examiner, Art Unit 1691
/SAVITHA M RAO/Primary Examiner, Art Unit 1691