Approvedfor use through 11/30/2020. OMB 0651-0031
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no personsare required to respond to a collection of information unlessit contains a valid OMB control number.
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`Complete if Known
`Substitute for form 1449/PTO
`
`INFORMATION DISCLOSURE EE
`STATEMENTBY APPLICANT Sauntexe
`(Use as many sheets as necessary) [ExaminerName__|SHOWALTER, ALEXANDER KEITH
`
`Attorney Docket Number
`46682-701.317
`
`16/908 426
`Application Number
`-22-
`Filing
`Dat
`
`
`U. S. PATENT DOCUMENTS
`
`Publication Date
`Nameof Patentee or
`Examiner
`Pages, Columns, Lines, Where
`Initials*
`MM-DD-YYYY
`Applicant of Cited Document
`Relevant Passages or Relevant
`Figures Appear
`
`Document Number
`
`.
`
`
`
`
`
`
`
`
`
`Number-Kind Code? “'ew)
`
`US-5710182
`
`01-20-1998
`
`REUNAMAKIetal.
`
`
`US-20020190079
`12-19-2002
`HAMAMOTO; Keiji
`
`US-20120064123
`03-15-2012
`SAWAYA; Assad S.
`
`Us-20140336618|11-13-2014 WILKERSON, Jonathan
`Ryan et al.
`
`
`US-20200222369
`07-16-2020
`FEINBAUM; Claesetal.
`
`US-20230091 109
`
`03-23-2023
`
`OSTROW; Gregory I. et al.
`
`US-20240139166
`
`05-02-2024
`
`OSTROW; Gregory I. et al.
`
`008
`
`US-20240165098
`
`05-23-2024
`
`OSTROW; Gregory I. et al.
`
`
`
`FOREIGN PATENT DOCUMENTS
`Examiner
`Foreign Patent Document
`Publication
`Nameof Patentee or
`Pages, Columns,Lines,
`Initials*
`Cit
`Date
`Applicant of Cited Document
`WhereRelevant Passages
`le
`MM-DD-YYYY
`Or Relevant Figures Appear
`Té
`
`Country Code*Number*Kind Code® (if known)
`
`
`
` WO-2018209051-A1 11-15-2018 Us) INC
`
`OCUPHIRE
`WO-2020087021-A1 04-30-2020|PraRMa INC [US]
`
`
`
`
`
`
`
`003|WO-2022169959-A1 08-11-2022|gy o
`
`Examiner
`Signature
`
`/ALEZANDER E. SHOWALTER/
`
`;
`é 9 8 /2 8 é 2 6G 2 4 }
`
`Date
`Considered
`
`1
`2
`*EXAMINER: Initial if reference considered, whetherornot citation is in conformance with MPEP 609. Drawline through citation if not in conformance and not
`3
`4
`considered. Include copy of this form with next communication to applicant. Applicant's unique citation designation number (optional). See Kinds Codes of USPTO Patent
`5
`Documentsat vwayw.tspio.goyor MPEP 901.04. Enter Office that issued the document, by the two-letter code (WIPO Standard ST.3). For Japanese patent documents, the
`6
`indication of the year of the reign of the Emperor must precede the serial numberof the patent document. Kind of document by the appropriate symbols as indicated on the
`document under WIPO Standard ST.16 if possible. Applicant is to place a check mark here if English language Translation is attached. This collection of information is required by
`37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit by the public which is to file (and by the USPTO to process) an application. Confidentiality is
`governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to complete, including gathering, preparing, and submitting the completed application
`form to the USPTO. Timewill vary depending upon the individual case. Any comments on the amountof time you require to complete this form and/or suggestions for reducing this
`burden, should be sent to the Chief Information Officer, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED
`FORMS TO THIS ADDRESS. SEND TO: Commissionerfor Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, call 1-800-PTO-9199 (1-800-786-9199) and select option 2.
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`/A.K.S./
`
`

`

`Approvedfor use through 11/30/2020. OMB 0651-0031
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no personsare required to respond to a collection of information unlessit contains a valid OMB control number.
`
`Complete if Known
`Substitute for form 1449/PTO
`
`INFORMATION DISCLOSURE EE
`STATEMENTBY APPLICANT Sauntexe
`(Use as many sheets as necessary) [ExaminerName__|SHOWALTER, ALEXANDER KEITH
`
`Attorney Docket Number
`46682-701.317
`
`16/908 426
`Application Number
`-22-
`Filing
`Dat
`
`
`NON-PATENT LITERATURE DOCUMENTS
`
`Examiner
`Initials*
`
`Include name of the author(in CAPITAL LETTERS),title of the article(when appropriate), title of
`the item (book, magazine,journal,serial,symposium,catalog,etc.),date, page(s), volume-issue
`number(s),publisher, city and/or country where published.
`
`
`;
`
` PCT/US2022/015092 International Search Report and Written Opinion dated May 30, 2022. a|
`
`
`ABELSON, MarkBet al. Demystifying Dumulcents. Review of Ophthalmology. Retrieved from
`Internet URL: bites:/Awwwreviewofoohthalmology comvsrticie/demystifying-dumuloants. (pp. 1-
`O
`4) (2006).
`
`ALONSO, et al. The Potential of Chitosan in Ocular Drug Delivery. The Journal of Pharmacy
`and Pharmacology 55(11):1451-1463 (2003).
`
`"Beckman-Coulter", available at www.beckman.com/resources/industry-standards/usp-790
`(2021).
`
`CHOWHAN, Masood, et al., Chapter 28: Essentials of Pharmaceuticals. Ophthalmic
`Preparations. (pgs 541-552) (2012).
`
`MATTHEWS, Brian, et al., Stability Storage and Testing of Ophthalmic Products for Global
`Registration. Drug Developmentand Industrial Pharmacy 26(12):1227-1237 (2000).
`
`PRAMAR, Y. Compounding Ophthalmic Liquids. Xavier University of Louisiana, College of
`Pharmacy, New Orleans, Louisiana (pp. 1-11) (2012).
`
`Examiner
`Signature
`
`/ALEXANDER K. SHOWALTER/
`
`(08/28/2024}
`
`Date
`Considered
`
`*EXAMINER: Initial if reference considered, whetheror notcitation is in conformance with MPEP 609. Drawline through citation if not in conformance and not considered. Include
`copy of this form with next communication to applicant. ' Applicant's uniquecitation designation number (optional). 2 Applicant is to place a check mark here if English language
`Translation is attached. This collection of information is required by 37 CFR 1.98. The information is required to obtain or retain a benefit by the public whichis tofile (and by the
`USPTOto process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to complete, including gathering,
`preparing, and submitting the completed application form to the USPTO. Time will vary depending uponthe individual case. Any comments on the amount of time you require to
`complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA
`22313-1450. DO NOT SEND FEES OR COMPLETED FORMSTO THIS ADDRESS. SEND TO: Commissionerfor Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, call 1-800-PTO-9199 (1-800-786-9199) and select option 2.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/A.K.S./
`
`

`

`Approvedfor use through 11/30/2020. OMB 0651-0031
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no personsare required to respond to a collection of information unlessit contains a valid OMB control number.
`
`Complete if Known
`Substitute for form 1449/PTO
`Application Number
`16/908 426
`Filing
`Dat
`-22-
`
`
`INFORMATION DISCLOSURE EE
`STATEMENTBY APPLICANT Sauntexe
`(Use as many sheets as necessary) [ExaminerName__|SHOWALTER, ALEXANDER KEITH
`
`Attorney Docket Number
`46682-701.317
`
`NON-PATENT LITERATURE DOCUMENTS
`
`Examiner
`Initials*
`
`;
`
`Include name of the author(in CAPITAL LETTERS),title of the article(when appropriate), title of
`the item (book, magazine,journal,serial,symposium,catalog,etc.),date, page(s), volume-issue
`number(s),publisher, city and/or country where published.
`
`. U.S. Serial No. 17/894,882 Office Action dated June 17, 2024
`
` a|
`
`012
`
`.
`
`,
`
`E
`
`i
`
`Dat
`
`*EXAMINER: Initial if reference considered, whetheror notcitation is in conformance with MPEP 609. Drawline through citation if not in conformance and not considered. Include
`copy of this form with next communication to applicant. ' Applicant's uniquecitation designation number (optional). 2 Applicant is to place a check mark here if English language
`Translation is attached. This collection of information is required by 37 CFR 1.98. The information is required to obtain or retain a benefit by the public whichis tofile (and by the
`USPTOto process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 2 hours to complete, including gathering,
`preparing, and submitting the completed application form to the USPTO. Time will vary depending uponthe individual case. Any comments on the amount of time you require to
`complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA
`22313-1450. DO NOT SEND FEES OR COMPLETED FORMSTO THIS ADDRESS. SEND TO: Commissionerfor Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, call 1-800-PTO-9199 (1-800-786-9199) and select option 2.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/A.K.8./
`
`

`

`Approvedfor use through 11/30/2020. OMB 0651-0031
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no personsare required to respond to a collection of information unlessit contains a valid OMB control number.
`
`Complete if Known
`Substitute for form 1449/PTO
`Application Number
`16/908426
`
`
`STATEMENT BY APPLICANT
`(Use as many sheets as necessary)
`|ExaminerName(SHOWALTER, ALEXANDER KEITH
`Attorney Docket Number
`46682-701.317
`
`Please see 37 CFR 1.97 and 1.98 to makethe appropriate selection(s):
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`CERTIFICATION STATEMENT
`
`[]
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`That eachitem of information contained in the information disclosure statement wasfirst cited in any
`communication from a foreign patentoffice in a counterpart foreign application not more than three monthsprior to
`the filing of the information disclosure statement. See 37 CFR 1.97(e)(1).
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`That no item of information contained in the information disclosure statement wascited in a communication from a
`foreign patent office in a counterpart foreign application, and,
`to the knowledge of the person signing the
`certification after making reasonable inquiry, no item of information contained in the information disclosure
`statement was knownto any individual designated in 37 CFR 1.56(c) more than three monthsprior to the filing of
`the information disclosure statement. See 37 CFR 1.97(e)(2).
`
`See attached certification statement.
`
`Fee set forth in 37 CFR 1.17 (p) has been submitted herewith.
`
`DX] Acertification statement is not submitted herewith.
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`SIGNATURE
`A signature of the applicant or representative is required in accordance with CFR 1.33, 10.18. Please see CFR 1.4(d) for
`the form of the signature.
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`
`
`
`
`Date (YYYY-MM-DD)
`
`2024-06-27
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`Registration Number
`
`79511
`
`Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
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`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit
`by the public whichis to file (and by the USPTOto process) an application. Confidentiality is governed by 35 U.S.C. 122
`and 37 CFR1.14. This collection is estimated to take 1 hour to complete, including gathering, preparing and submitting the
`completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on the
`amountof time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief
`Information Officer, U.S. Patent and Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA
`22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for
`
`Signature
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`Name/Print
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`/Tyler Bird/
`
`Tyler Bird
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`

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