Application No. 16/908,426
`Response to Non-Final Office Action Mailed April 1, 2024
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`REMARKS
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`Claims 31-35, 37, 39-45, and 49-53 were pending prior to entry of the amendments
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`presented in this response. Claims 31, 34, 44 and 45 are herein amended. No newclaims have
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`been added. Claim 35 is herein cancelled. No new matter is added by any of these amendments.
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`Accordingly, claims 31-34, 37, 39-45 and 49-53 are currently pending.
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`This listing of claims will replace all prior versions, andlistings of claimsin this
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`application. Applicant reserves the right to pursue any subject matter of any canceled claims in
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`this or any other appropriate patent application. Reconsideration and allowanceis respectfully
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`requested in light of the abovementioned amendments and the following remarks.
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`Claims Rejections Under 35 U.S.C.
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`§112
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`Claim 44 is allegedly indefinite for reciting an improper Markush group. Applicant has
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`amended claim 44.
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`Claims Rejections Under 35 U.S.C.
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`§103
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`Claims 31-33, 37, 39-45, and 49-53 are rejected under 35 U.S.C. 103 as being
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`unpatentable over the non-patent publication FDA Drug Label Archive for Atropine Sulfate
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`Solution, NDC code 17478-215-02, first published in 2010 (hereinafter, “Akorn’’), in view of the
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`non-patent publication, Stability of atropine in aqueoussolution, J. Am. Pharm. Assoc., 46, pgs.
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`531-535 (1957) by Kondritzeret al. (hereinafter, “Kondritzer’’), further in view of the non-patent
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`publication, Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 0.1%,
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`and 0.01% doses (Atropine for the Treatment of Myopia 2), Ophthalm., 119, pgs. 347-354
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`(2011) by Chia et al., (hereinafter, “Chia’’), and furtherstill in view of U.S. Patent Application
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`Publication No. 2013/0303502 to Cavanaughetal. (hereinafter, “Cavanaugh”).
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`Without conceding in the basis of the rejection, and solely to expedite prosecution ofthis
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`application, Applicant has amendedclaim 31 to further clarify the claimed subject matter.
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`Applicant submits that claim 31 is novel and inventive over the asserted combination of Akorn,
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`Kondritzer, Chia, and Cavanaughfor at least the reason that these references, taken alone or in
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`combination, do not meet each and every element of claim 31.
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`Atty. Docket No.: 46682-701.317
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`Application No. 16/908,426
`Response to Non-Final Office Action Mailed April 1, 2024
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`For example, none of Akorn, Kondritzer, Chia, or Cavanaughteach or disclose “a buffer
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`to provide a pH from about4.8 to about 5.8, wherein the buffer comprises a buffering agent
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`selected from a citrate buffering agent and an acetate buffering agent”as recited by claim 31.
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`(emphasis added). The Office acknowledges the asserted combination of Akorn, Kondritzer,
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`Chia, or Cavanaugh does not teach this element. See Office Action at pg. 7.
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`In the pending 35 U.S.C. 103 rejection of claims 34-35, the Office relies on the non-
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`patent publication, Recent Challenges and Advances in Ophthalmic Drug Delivery System, The
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`PharmaInnov., 1, pgs. 1-15 (2012) by Kumaretal. (hereinafter, “Kumar’’) to cure these
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`deficiencies. Applicant submits that claim 31 is non-obvious over the asserted combination of
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`Akorn, Kondritzer, Chia, Cavanaugh, and further in view of Kumarforat least the reasonsthat 1)
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`a person ofskill in the art, reading Kumar, would not be motivated to add a strong buffer to a
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`solution at pH 4.8 to about 5.8, and 11) substituting the phosphates of Akorn fora citrate
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`buffering agent or acetate buffering agent would frustrate the purpose of Akorn.
`Kumar does not motivate a POSA to modify Akorn with a strong buffer
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`1)
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`Kumarteachesthat “the limited buffer capacity of the lachrymal fluid precludes the use
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`of strong buffers outside the pH range of 6.8 - 7.6.” Page 5 paragraph 4. Thecitrate buffering
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`agent and acetate buffering agent of claim 31 are strong buffers at the claimed pH of4.8 to 5.8.
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`Therefore, Kumar teaches against the asserted modification of Akorn.
`Substituting the phosphates of Akorn frustrates the purpose of Akorn
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`II)
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`Akorn recites dibasic and monobasic sodium phosphate in an ophthalmic solution at a pH
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`between 3.5 and 6.0. Phosphates have pKa values of 2.12, 7.21, 12.44. The phosphates of
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`Akornallow a rapid rise in pH of the ophthalmic solution upon administration to the lachrymal
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`fluid of the eye. In contrast, the citrate and acetate buffering agents presently claimed buffer the
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`solution and prevent such rapid rise in pH upon administration to the eye. Therefore,
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`substituting the phosphates of Akorn with a citrate or acetate buffering agent would frustrate the
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`purpose of Akorn.
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`Accordingly, Applicant submits that claim 31 is non-obvious over the asserted
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`combination of Akorn, Kondritzer, Chia, Cavanaugh and in further view of Kumar. Claims 32-
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`34, 37, 39-45, and 49-53 depend from andincludeall of the elements of claim 31, and recite
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`additional elements of particular advantage andutility. Applicant respectfully requests that the §
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`-6-
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`Atty. Docket No.: 46682-701.317
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`Application No. 16/908,426
`Response to Non-Final Office Action Mailed April 1, 2024
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`103 rejections of claims 31-34, 37, 39-45, and 49-53 be withdrawn. Claim 35 has been cancelled
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`and the rejection under § 103 is moot.
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`3
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`It shall be understood herein that any instance in which Applicant has addressed certain
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`comments set forth by the Office shall not be construed as a concession to other comments or
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`arguments advancedby the Office. Any circumstance in which Applicant has amendedor
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`cancelled a claim also does not mean that Applicant concedes to the arguments or positions
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`advancedby the Office with respect to that claim or other claims pending herein.
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`Atty. Docket No.: 46682-701.317
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`Application No. 16/908,426
`Response to Non-Final Office Action Mailed April 1, 2024
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`CONCLUSION
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`In light of the remarksset forth above, Applicant believes that the pending claimsare
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`under condition for allowance. Applicant respectfully solicits the Examiner to expedite the
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`prosecution of this patent application to issuance. Should the Examiner have any questions, the
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`Examineris encouraged to telephone the undersigned at (415) 947-2155.
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`The Commissioneris authorized to charge any underpaymentor credit any overpayment
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`to Deposit account No. 23-2415 (Attorney Docket No. 46682-701.317).
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`Respectfully submitted,
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`/Tyler Bird/
`Tyler Bird
`Reg. No. 79,511
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`Date:
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`June 26, 2024
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`By:
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`WILSON SONSINI GOODRICH & ROSATI
`650 Page Mill Road
`Palo Alto, CA 94304-1050
`Phone:
`(650) 493-9300
`Customer No. 21971
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`Atty. Docket No.: 46682-701.317
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