`
`In re US. Patent No:
`
`10,519.175
`
`Issued:
`
`For:
`
`December 31, 2019
`
`DIFFERENT
`PSiLOCYBiN,
`OF
`PREPARATION
`FORMS,
`INTERMEDIATES,
`POLYMORPHIC
`FORMULATIONS AND THEIR USE
`
`Attorney Docket No:
`
`031400011
`
`DECLARATION
`
`I, Charles L. Raison, MD, being duly sworn, do hereby state that:
`
`l.
`
`i am skilled in the art and have worked extensively in the field of ciinical
`
`psychiatry and mental health research with a focus on major depressive disorder.
`
`2.
`
`The following applies to the discussion of the references Nichols
`
`(2016) and Carhart-Harris, et at.
`
`It should be understood that treatment-refractory
`
`depression (TRD, also known as drug resistant depression) is not a separate or
`
`different condition from major depressive disorder 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-S) (American
`
`Psychiatric Association, 2013). Therefore, based on Nichols and Carhart-Harris,
`
`one would use psilocybin to treat both MDD and TRD. Any medication that would
`
`successfully treat TRD would also be effective in the treatment of MDD.
`
`
`
`EXHIBIT R
`
`
`
`USPN 10,519,175
`
`Attorney Docket No. 0314.00011
`
`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 jeopardize the validity of the application or any
`
`patent issuing thereon.
`
`Date:
`
`I (22.
`
`.2020
`
`C HWLGF L IQfl/fo/l/ 470
`
`
`
`
`
`
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