US. Serial No. 16/908,426
`Response to Fmal Office Action mailed September 9, 2022
`
`Attomey Docket No. 46682-7013 17
`
`REMARKS
`
`Status of the Clans
`
`Claims 31-35, 37, 39-45 and 49-83 are pending. No newmatter is added.
`
`Claim Rerections -35 U0.8.C. § 103
`
`Claims 31-45 and 49-53 are rejected as being allegedly unpatentable over Fang
`
`(Prescription of atropine eye drops among children diagnosed with myopia in Taiwan from 2000 to
`
`2007, a nationwide study, Eye (2013) 27, 418-424: hereinafter “Fang’) andin viewof
`
`WoldeMussie etal (US 5,716,952, hereinafter “WoideMussie”). Claims 36 and 38 were
`
`cancelled and were not pending at the time of the Final Office Action mailed September 9, 2022.
`
`Additionally, the prior, non-final office action relied upon the combination of Morris (U.S. Patent
`
`4,952,536) and WoideMussie et al (U_S. Patent 5,716,952), but here the Office cited Fang as the
`
`primary reference. In the bodyof the Final Office Action, the Office relies on “[t]he ‘586 patent,”
`
`which the Applicant presumes to refer to Morris, even though Morris is not cited in any rejection
`
`in the present Final Office Action. The response below assumes that Morris is the intended
`
`reference, rather than Fang.
`
`Morris and WoldeMussie fail te describe or provide a reason to arrive at a monotherapenutic
`
`
`pharmaceutical composition comprising a buffering agent to provide a pH of from about 4.8
`to about 6.4
`
`
`
`Amended claim | recites, infer alia, “a buffering agent to provide a pH of from about 48 to
`
`about 6.4.” Morris fails to describe or provide a reason to arrive at an aqueous solution comprising
`
`atropine or atropine sulfate wherein the aqueous solution has a pHfrom about 4.8 to about 6.4.
`
`Morris does not teach a pH range of 4.8 to 6.4 for its composition of endrophoim and atropine. In
`
`fact, Morris teaches a ratio of edrophonium to atropine of 30:1 to 100:1. See Claim |. A person of
`
`skill in the art would have no reason to modify Morris to stabilize atropine at the claimed pHrange
`
`because atropine is not the primaryactive ingredient, and thus stabilization of atropine is nota
`
`problem considered by Morns. Furthermore, WoldeMussie does not correct these deficiencies of
`
`Morris. WoldeMussie fails to describe or provide a reason to arrive at an aqueous solution
`
`comprising atropine or atropine sulfate wherein the aqueous solution has a pH from about 4.8 to
`
`about6.4. WoldeMussie also does not consider or provide any motivation to stabilize atropine, at
`
`

`

`US. Serial No. 16/908,426
`Response to Fmal Office Action mailed September 9, 2022
`
`Attomey Docket No. 46682-7013 17
`
`least because WoldeMussie does nat disclose atropine. In fact, WoldeMussie teaches
`
`compositions intended to treat glaucoma or interocular hypertension, i.e. compositions that contain
`
`muscarinic antagonists that reduce interocular pressure. Atropine, in contrast, is known to
`
`significantly increase intraocular pressure. A person of skill in the art would not iock to the
`
`compositions of WoldeMussie, which do not include atropine and are used for a purpose contrary
`
`to the effect of atropine, to modify Morris, in which atropine is not the primaryactive ingredient,
`
`to the pH determined through extensive studies by the Applicant to arrive at the claimed pH range
`
`for a monotherapeutic composition of atropine.
`
`
`
`and deeradation of atranme.WoldeMussie and Morris are silent with respect to the stabilits
`
`The Office concedes that WoldeMussie and Morris are silent with respect to the stability and
`
`degradation of atropine, and therefore do not consider the problem of atropine stability and pH
`
`stability that has been identified and solved by Applicant throughthe claimed pH range whichis
`
`not taught by WoldeMussie or Morris. The Office gives the reason for dismissal of this element of
`
`the composition ofthe kit being “the instant claims are not drawn to the [sic] methodofstabilizing
`
`a compound, ratherthe instant claims are drawntoa kit.” Thisis not sufficient. Beyond the
`
`deficiencies discussed above, a person of skill in the art would have no motivation from Morris or
`
`WoldeMussie to modify the pH range of WoideMussie to the optimal pH range identified bythe
`
`Applicant. The first step of the obvious to try rational of an obviousness rejection is “a finding that
`
`at the time of the invention, there had been a recognized problem or need in the art.” MPEP §
`
`2143 (BE). Here, there is no recognized problem or need to stabilize atropine described in Morris or
`
`WoldeMussie, and thus a person of skill in the art would have no motivation to arrive atthe
`
`presently claimed pHrange.
`
`For at least the reasons described above, Applicant submits that claims 31-35, 37, 39-45
`
`and 49-53 are non-obvious over the asserted combination of WoldeMussie and Morris.
`
`Application respectfully requests that the rejections of claims 31-35,37, 39-45 and 49-53 be
`
`withdrawn.
`
`

`

`US. Serial No. 16/908,426
`Response to Fmal Office Action mailed September 9, 2022
`
`Attomey Docket No. 46682-7013 17
`
`CONCLUSION
`
`Applicant respectfully solicits the Examiner to expedite prosecution of this patent
`
`application to issuance. Should the Examiner have any questions, the Examineris encouragedto
`
`telephone the undersigned attomeyat (858) 350-2314. The Commissioneris hereby authorized to
`
`charge any fees that maybe required, or credit any overpayment to Deposit Account No. 23-2415,
`
`referencing Attorney Docket No. 46682-701.317.
`
`Respectfully submitted,
`
`WILSON SONSINI GOODRICH & ROSATI
`A Professional Corporation
`
`By:
`
`/Pyler Bird/
`Tyler Bird
`Registration No. 79,511
`
`Date: March 8, 2023
`
`650 Page Mill Road
`Palo Alte, CA 94304
`($58) 350-23 14
`Customer No. 021971
`
`