Approved for use through 11/30/2020. OMB 0651-0031
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`Complete if Known
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`Brion2
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`INFORMATION DISCLOSURE
`(Use as many sheets as necessary)|ErarinarNaneCRUZ KATHRIEN ANN
`
`STATEMENT BY APPLICANT
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`aT
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`Attorney Docket Number
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`46682-701.317
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`U. S. PATENT DOCUMENTS
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`Publication Date
`Nameof Patentee or
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`i
`Pages, Columns, Lines, Where
`Initials*
`MM-DD-YYYY
`Applicant of Cited Document
`Relevant Passagesor Relevant
`Figures Appear
`
`.
`
`Document Number
`
`Number-Kind Code? “kw
`
`
`
`
`
`
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`
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`001|US-5249712 10-05-1993 ae Jean-Pierreet
`
`
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`002|US-5496471 03-05-1996 HEYLet al.
`
`
`
`
`
`US-20150297800|10-22-2015 WEIKART: Christopher et al.
`
`
`
`US-20150366854_|12-24-2015 OSTROW:Gregory |. et al.
`
`US-20170224531
`08-10-2017
`CHAUHAN; Anyjet al.
`
`
`US-20190255018
`
`08-22-2019
`
`CORR; Stuart etal.
`
`US-20200163951
`
`05-28-2020
`
`OUYANG; Hui et al.
`
`US-20210393649
`
`12-23-2021
`
`OSTROW; Gregory I. et al.
`
`008
`
`
`
`FOREIGN PATENT DOCUMENTS
`Examiner
`Foreign Patent Document
`Publication
`Nameof Patentee or
`Pages, Columns, Lines,
`Initials*
`Cit
`Date
`Applicant of Cited Document
`Where Relevant Passages
`te
`MM-DD-YYYY
`Or Relevant Figures Appear
`Té
`
`Country Code*Number*Kind Code?(if known)
`
`
`
`
`
`001
`
`WO-2014182620-A1
`
`KAOHSIUNG
`CHANG GUNG
`11-13-2014 MEMORIAL
`HOSPITAL., et al.
`
`Oo
`
`
`
`Examiner
`Signature
`
`Date
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`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
`Documents at www uspic.goy or 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 number of 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 uponthe 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
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`Approved for use through 11/30/2020. OMB 0651-0031
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`Under the Paperwork Reduction Act of 1995, no persons are 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
`Application Number
`16/908426
`
`
`STATEMENTBY APPLICANT a
`(Use as many sheets as necessary)
`[ExaninerName—|GRUZ, KATHRIEN ANN
`Attorney Docket Number
`46682-701.317
`
`Examiner
`Initials*
`
`Include nameof 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.
`
`
`;
`
`
`
`
`Akorn Atropine CareTM (Atropine Sulfate Ophthalmic Solution, 1%), Product Label Rev. 06/08.
`
`
`Akorn Atropine CareTM (atropine sulfate ophthalmic solution), Advertisement Rev. 08/11.
`
`Akorn Atropine CareTM (atropine sulfate ophthalmic solution), NDA 206289 Product Label
`(Revised July 2014).
`
`
`Application Number: 206289Orig1s000 Summary Review, U.S. FDA CTR. FOR DRUG
`EVALUATION & RES. (July 18, 2014).
`
`Declaration of Dr. Stephen Byrn, Ph. D., dated January 7, 2022 (US10888557).
`
`
`Declaration of Dr. Stephen Byrn, Ph. D., dated January 7, 2022 (US10940145).
`
`Declaration of Dr. Stephen Byrn, Ph.D., dated December 29, 2021 (US10842787).
`
`
`Drugs@FDA: FDA-Approved Drugs: AKORN NDA 206289, U.S. FDA,
`https:/Awww.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overvi
`ew.process&AppINo=206289.
`
`FLETCHER etal. The effect of solution tonicity on the eye. Clin. & Exp. Optom. 76.1:17-21
`(1993).
`
`MAIR et al. The Detection of Atropine and Its Degradation Products by Thin-Layer
`Chromatography. J. Clin. Pharm. 2:101-104 (1977).
`
`PARMARet al. The solution, solid state stability and kinetic investigation in degradation studies
`of lercanidipine: study of excipients compatibility of lercanidipine. Pharm. Dev. Technol.
`17(6):730-740 (2011).
`
`Examiner
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`*EXAMINER: Initial if reference considered, whetheror not citation 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. 1 Applicant’s unique citation designation number(optional). 2 Applicant is to place a check mark hereif 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 to file (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. Timewill vary depending uponthe 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 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.
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`/K.A.C/
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`

`Approved for use through 11/30/2020. OMB 0651-0031
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`Complete if Known
`Substitute for form 1449/PTO
`Application Number
`16/908426
`
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`STATEMENTBY APPLICANT a
`(Use as many sheets as necessary)
`[ExaninerName—|GRUZ, KATHRIEN ANN
`Attorney Docket Number
`46682-701.317
`
`NON-PATENT LITERATURE DOCUMENTS
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`Examiner
`Initials*
`
`i
`|
`
`Include nameof 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.
`
`SCHUBERTet al., Sterility of Anesthetic Multiple-Dose Vials after Opening.
`ANESTHESIOLOGY62:634-636 (1985).
`
`
`TAYLORetal. A critical appraisal of drug stability testing methods. Pharm. Res. 4(3):177-80
`(1987).
`
`UNKNOWN. Modern Physical Organic Chemistry. Notes Chapter 8 (2) Under the isotope effect.
`Available at https:/Awww.zhihu.com/tardis/sogou/art/163777237 (Edited 2020).
`
`
`U.S. Patent No. 10,842,787 File History.
`
`(2000).
` U.S.PatentNo.10,842,787PetitionforInterPartesReviewdatedDecember29,2021(Case °
`
`No. IPR2022-00384).
`
`
`U.S. Patent No. 10,888,557 File History.
`
`U.S. Patent No. 10,888,557 Petition for Inter Partes Review dated January 7, 2022 (Case No.
`IPR2022-00415).
`
`
`U.S. Patent No. 10,940,145 File History.
`
`U.S. Patent No. 10,940,145 Petition for Inter Partes Review dated January 7, 2022 (Case No.
`IPR2022-00414).
`
`021
`
`U.S. Serial No. 16/765,144 Office Action dated March 29, 2022.
`
`U.S. Serial No. 16/785,411 Office Action dated January 24, 2022.
`
`USP 24 Official Monographs/ Atropine, THE UNITED STATES PHARMACOPEIA 177-180
`
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`copy of this form with next communication to applicant. 1 Applicant’s unique citation designation number(optional). 2 Applicant is to place a check mark hereif 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 to file (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. Timewill vary depending uponthe 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 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.
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`

`Approved for use through 11/30/2020. OMB 0651-0031
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`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unlessit contains a valid OMB control number.
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`Substitute for form 1449/PTO
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`Brion2
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`INFORMATION DISCLOSURE
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`
`Forms Pharmaceutical Theory And Practice 87-124 (Yihong Qiu et al. eds., 2009).
`
`STATEMENT BY APPLICANT
`
`aT
`
`Attorney Docket Number
`
`46682-701.317
`
`Examiner
`Initials*
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`i
`;
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`NON-PATENT LITERATURE DOCUMENTS
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`Include nameof 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
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`
`
`
`/em YOSHIOKAetal.STABILITYOFDRUGSANDDOSAGEFORMS228(2007). a|ZHOU etal. Chapter 5 - Drug Stability and Degradation Studies. Developing Solid Oral Dosage
`
`/KATHRIEN A CRUZ /
`
`09/01/2022
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`*EXAMINER: Initial if reference considered, whetheror not citation 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. 1 Applicant’s unique citation designation number(optional). 2 Applicant is to place a check mark hereif 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 to file (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,
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`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.
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`/K.A.C/
`
`