`
`VA West Haven 2039373472 >>
`
`,
`
`\
`
`.
`
`P 2/2
`
`[N THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`l
`
`in re US Patent No.:
`
`10,519,175
`
`11
`
`Issued:
`
`For:
`
`December 31, 2919
`
`PSlLOCYBlN,‘ DIFFERENT
`PREPARATlON: OF
`POLYMORPHlC
`FORMS,
`lNTERMEDlATES,
`FORMULATIONS AND THElR use
`
`Attorney Docket No:
`
`0314.00011
`
`DECLARATION
`
`l, Jordan Slcshower, MD, being duly sworn, do hereby state that:
`1.
`I am 'skilied in the art and have wjorked extensively in the field of clinical
`psychiatry and mental health research with a focus on major depressive disorder.
`(Please state your qualifications for attesting to: the below statements)
`2.
`The following applies to the discussion of the references Nichols
`(2016) and Carhart—Harris, et al.
`It should be understood that treatment-refractory
`depression (TRD, also known as drug resistiant depression) is not a separate or
`different condition from major depressive disorider MDD. Rather, it refers to a subset
`of patients with MDD who do not respond to conventional treatments. TRD is not a
`condition described'in the Diagnostic and Statistical Manual 5 (DSM-5) (American
`Psychiatric Association, 2013). Therefore. based on Nichols and Carhart—Harris,
`one would use psilocybin'to treat both MDD land TRD. Any medication that would
`successfully treat TRD would also be effective in the treatment of MDD.
`The undersigned declares
`further
`all
`statements made herein of his
`knowledge are true and that all statements made upon information and belief are
`believed to be true, and further that the statements were made with the knowledge
`that willful and false statements and the like: so made are punishable by fine or
`imprisonment, or both, under Section 1001 of Title 18 of the United States Code and
`that such willful false statements may jeopardizje the validity of the application or any
`patent issuing thereon.
`
`:il
`
`Date:
`
`January 22, 2020
`
`
`
`#9
`
`EXHIBIT Q
`
`
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