Approved for 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 persons are 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
`Filing Dat
`
`
`INFORMATION DISCLOSURE sonst—Bern oy Latar
`
`(Use as many sheets as necessary)|ExarinarNaneaTHRIEN ANN HARTSFIELD
`
`STATEMENT BY APPLICANT
`
`Attorney Docket Number
`
`46682-701.317
`
`U. S. PATENT DOCUMENTS
`
`Publication Date
`Nameof Patentee or
`Examiner
`i
`Pages, Columns, Lines, Where
`Initials*
`MM-DD-YYYY
`Applicant of Cited Document
`Relevant Passagesor Relevant
`Figures Appear
`
`Document Number
`
`.
`
`06-24-2021
`
`
`
`
`Number-Kind Code? “kw
`
`US-20040136915
`
`07-15-2004
`
`DUGGER, Ill; Harry A.et al.
`
`
`
`11-10-2005US-20050251254 BRADY; Daniel G. etal.
`
`
`
`US-20080021 106
`
`01-24-2008
`
`PETIT, Il; Robert G. et al.
`
`US-20180000950
`
`01-04-2018
`
`SAVEL; Robert etal.
`
`US-20180193326
`
`07-12-2018
`
`OSTROW; Gregory I. et al.
`
`US-20180325888
`
`11-15-2018
`
`PURI; Navneetet al.
`
`US-20220265631
`
`08-25-2022
`
`OSTROW; Gregory I. et al.
`
`US-20220265632|08-25-2022_|OSTROW;Gregory |. et al.
`
`
`US-20220378775|12-01-2022|OSTROW;Gregory |. et al.
`
`US-20220409603
`
`OSTROW;Gregory |. et al.
`
`US-20220409604|12-29-2022_|OSTROW;Gregory |. et al.
`
`US-20220409605|12-29-2022|OSTROW;Gregory |. et al.
`
`US-20230041788
`
`02-09-2023
`
`OSTROW; Gregory I. et al.
`
`
`
`FOREIGN PATENT DOCUMENTS
`
`Examiner
`Foreign Patent Document
`Publication
`Nameof Patentee or
`Pages, Columns, Lines,
`Initials*
`Date
`Applicant of Cited Document
`Where Relevant Passages
`MM-DD-YYYY
`Or Relevant Figures Appear
`
`:
`
`WO-2021126874-A1
`
`SYDNEXIS INC
`[US]
`
`Examiner
`Signature
`
`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
`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
`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.
`
`

`

`Approved for 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 persons are 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 KATHRIEN ANN HARTSFIELD
`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.
`
`
`;
`
`U.S. Patent No. 10,076,515 File History.
`
`
`Co-pending U.S. Application No. 18/055,940, inventors OSTROW, Gregory I. et al., filed on
`November 16, 2022.
`
`
`Co-pending U.S. Application No. 18/055,945, inventors OSTROW, Gregory I. et al., filed on
`November 16, 2022.
`
`
`Co-pending U.S. Application No. 18/055,949, inventors OSTROW, Gregory I. et al., filed on
`November 16, 2022.
`
`
`GANESANetal. Pharmaceutical intervention for myopia control. Expert Rev Ophthalmol
`5(6):759-787 (2010).
`
`
`HOWARD. Chapter 17: Special Solutions and Suspensions. Ansel's Pharmaceutical Dosage
`Forms and Drug Delivery Systems. pg. 607 (December 2013).
`
`PCT/US2020/065149 International Search Report and Written Opinion dated March 22, 2021.
`
`RUBINSON. Practical corrections for p(H,D) measurements in mixed H20/D20 biological
`buffers. Anal. Methods 9:2744-2750 (2017).
`
`SHARMAetal. A quantitative NMR protocol for the simultaneous analysis of atropine and
`obidoxime in parenteral injection devices. J Pharm Biomed Anal 49(4):1092-1096 (2009).
`
`U.S. Patent No. 10,076,515 Decision Denying Institution of Inter Partes Review dated
`November 7, 2022 (Case No. IPR2022-00965).
`
`Examiner
`Signature
`
`Date
`Considered
`
`*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. ' Applicant's uniquecitation designation number (optional). * 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 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.
`
`

`

`Approved for 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 persons are 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
`STATEMENT BY APPLICANT
`(Use as many sheets as necessary)
`|ExaminerName KATHRIEN ANN HARTSFIELD
`Attorney Docket Number
`46682-701.317
`
`16/908 426
`Application Number
`
`
`NON-PATENT LITERATURE DOCUMENTS
`
`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.
`
`
`
` 8, 2022 (Case No. IPR2022-00963).
`
`U.S. Patent No. 10,076,515 Patent Owner's Preliminary Response dated August 11, 2022
`(Case No. IPR2022-00965).
`
`U.S. Patent No. 10,076,515 Petition for Inter Partes Review dated May 3, 2022 (Case No.
`IPR2022-00965).
`
`U.S. Patent No. 10,201,534 Decision Denying Institution of Inter Partes Review dated
`November 7, 2022 (Case No. IPR2022-00966).
`
`U.S. Patent No. 10,201,534 File History.
`
`U.S. Patent No. 10,201,534 Patent Owner's Preliminary Response dated August 11, 2022
`(Case No. IPR2022-00966).
`
`U.S. Patent No. 10,201,534 Petition for Inter Partes Review dated May 3, 2022 (Case No.
`IPR2022-00966).
`
`U.S. Patent No. 10,251,875 File History.
`
`U.S. Patent No. 10,842,787 Decision dated July 15, 2022 (Case No. IPR2022-00384).
`
`U.S. Patent No. 10,888,557 Decision dated July 15, 2022 (Case No. IPR2022-00415).
`
`U.S. Patent No. 10,940,145 Decision dated July 15, 2022 (Case No. IPR2022-00414).
`
`U.S. Patent No. 9,421,199 Decision Denying Institution of Inter Partes Review dated November
`
`Oo
`U.S. Patent No. 9,421,199 File History.
`022
`
`
`Examiner
`Signature
`
`Date
`Considered
`
`*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. ' Applicant's uniquecitation designation number (optional). * 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 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.
`
`

`

`Approved for 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 persons are 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
`STATEMENT BY APPLICANT=fgruprgrom CresIt a.
`
`(Use as many sheets as necessary)
`|ExaminerName KATHRIEN ANN HARTSFIELD
`Attorney Docket Number
`46682-701.317
`
`16/908 426
`Application Number
`
`
`NON-PATENT LITERATURE DOCUMENTS
`
`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.
`
`U.S. Patent No. 9,421,199 Patent Owner's Preliminary Response dated August 11, 2022 (Case
`No. IPR2022-00963).
`
`U.S. Patent No. 9,421,199 Petition for Inter Partes Review dated May 3, 2022 (Case No.
`IPR2022-00963).
`
`U.S. Patent No. 9,770,447 Decision Denying Institution of Inter Partes Review dated November
`7, 2022 (Case No. IPR2022-00964).
`
`U.S. Patent No. 9,770,447 File History.
`
`U.S. Serial No. 17/335,490 Office Action dated November 4, 2022.
`
`
`
`U.S. Patent No. 9,770,447 Patent Owner's Preliminary Response dated August 11, 2022 (Case
`No. IPR2022-00964).
`
`U.S. Patent No. 9,770,447 Petition for Inter Partes Review dated May 3, 2022 (Case No.
`IPR2022-00964).
`
`U.S. Serial No. 16/765,144 Office Action dated February 2, 2023.
`
`U.S. Serial No. 16/765,144 Office Action dated September 2, 2022.
`
`U.S. Serial No. 16/785,411 Office Action dated September 9, 2022.
`
`U.S. Serial No. 17/097,930 Office Action dated June 15, 2022.
`
`034
`
`U.S. Serial No. 17/894 ,882 Office Action dated November 9, 2022.
`
`Oo
`
`Examiner
`Signature
`
`Date
`Considered
`
`*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. ' Applicant's uniquecitation designation number (optional). * 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 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.
`
`

`

`Approved for 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 persons are required to respond to a collection of information unlessit contains a valid OMB control number.
`
`.
`Substitute for form 1449/PTO
`
` 035
`
`
`INFORMATION DISCLOSURE sonst—Bern oy Latar
`
`(Use as many sheets as necessary)|ExarinarNaneaTHRIEN ANN HARTSFIELD
`
`STATEMENT BY APPLICANT
`
`Complete if Known
`
`Application Number
`Filing Dat
`
`
`Attorney Docket Number
`
`46682-701.317
`
`Examiner
`Initials*
`
`i
`;
`
`NON-PATENT LITERATURE DOCUMENTS
`
`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.
`
`
`
`U.S. Serial No. 17/894,884 Office Action dated November9, 2022. a|
`
`U.S. Serial No. 17/894 ,885 Office Action dated November 9, 2022.
`
`YAMetal. Effect of Low-Concentration Atropine Eyedrops vs Placebo on Myopia Incidencein
`Children: The LAMP2 RandomizedClinical Trial. JAMA 329(6):472-481 (2023).
`
`Examiner
`Signature
`
`Date
`Considered
`
`*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. ' Applicant's uniquecitation designation number (optional). * 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 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.
`
`