Based on Form PTO/SB/08a; SB/08b
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Substitute for form 1449/PTO
`_
`
`Complete if Known
`
`Application Number
`
`14859042
`
`0021:3333]:2312:; Inventor I——
`
`
`INFORMATION DISCLOSURE
`1521
`MU”,
`STATEMENT BY APPLICANT
`rem
`(Use as many sheets as was...” ——
`—Fay, 20hreh A
`Attorney DocketNumber
`45682—701 501
`
`Examiner
`lnitials*
`
`.
`
`Document Number
`
`U. S. PATENT DOCUMENTS
`Publication Date
`Name of Patentee or
`MM-DD-YYYY
`Applicant of Cited Document
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`
`
`
` 1
`
`Number-Kind Codez (it knew”)
`
`US-3863633
`
`US-4014335
`
`US-4474751
`
`US-5259998
`
`U3-5715952
`US_5858375
`
`US-5900360
`
`US-6218428
`
`US-6270954
`
`US-6410048
`
`US-6720001
`
`US-7691099
`
`US-7858582
`
`US-8333985
`
`US-20030157187
`
`US-20050249770
`
`US-20060159771
`
`
`
`02-10-1998
`
`RYDE; Emma Marta et al.
`
`ARNOLD; Randall K.
`
`HASLAM; John L. et al.
`
`RElCH; Cary et al.
`
`\e/YCaDILDEMUSSIE; Elizabeth
`:iEhMeEStEaT; lan George
`
`WELCH; William J. et al.
`
`CHYNN; Emil
`
`WELCH; William J. et al.
`
`FOTINOS; Spiros
`
`CHEN; Feng-Jing et al.
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`BERRY; MiChaelJ.
`
`JIN; Lei etal.
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`KNAACK; David et al.
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`HUNTER; William L.
`
`HUNTER; William L.
`
`KADRMAS; Eddie F. et al.
`
`US-20070207192
`
`HOLL; Richard et al.
`
`Examiner
`Signature
`
`Date
`Considered
`
`lnitial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and not
`EXAMINER:
`considered. lnclude copy of this form with next communication to applicant. 1Applicant’s unique citation designation number (optional). 2See Kinds Codes of USPTO
`Patent Documents at y;yyy.;._g§_gt_g>_._gg>_y_or MPEP 901.04.
`3 Enter Office that issued the document, by the two-letter code (WIPO Standard ST.3). 4 For Japanese patent
`documents, the indication ofthe year ofthe reign ofthe Emperor must precede the serial number of the patent document. 5Kind of document by the appropriate symbols as
`indicated on the document under WlPO Standard ST.16 if possible. 6Applicant 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 bythe
`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. Time will vary depending upon the 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, US. Patent and Trademark Office, PO.
`Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND
`TO: Commissioner for Patents, P.0. Box 1450, Alexandria, VA 2231 3-1 450.
`If you need assistance in completing the form; call 1-800-PTO-9199 (1-800-786-9199) and select option 2.
`
`

`

`Based on Form PTO/SB/08a; SB/08b
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Substitute for form 1449/PTO
`
`Complete if Known
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`(Use as many sheets as necessary)
`
`Attorney DocketNumber
`
`45682—701 501
`
`Or Relevant Figures Appear
`
`
`
`
`Examiner
`|nitials*
`
`DocumentNumber
`
`Number-Kind Code2("k”°w”)
`
`U. S. PATENT DOCUMENTS
`Publication Date
`Name of Patentee or
`MM-DD-YYYY
`Applicant of Cited Document
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`
`US-20070280992
`
`12-06-2007
`
`MARGARON; Philippe MC.
`et al.
`
`US-20080113035
`
`05-15-2008
`
`US-20080153900
`
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`
`HUNTER; William L.
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`HUNTER; William L.
`
`US-20100022495
`
`01-28-2010
`
`HOTAMISLIGIL; Gokhan S.
`et al.
`
`US-20100196285
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`08-05-2010
`
`BAYERL; Thomas
`
`US-20120015035
`
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`
`05-31-2012
`
`US-20120203161
`
`08-09-2012
`
`US-20130302855
`
`11-14-2013
`
`U
`
`S-20140011761
`
`01-09-2014
`
`WILDSOET; Christine F. et
`al.
`
`BAYERL; Thomas
`
`HEREKAR; Satish V.
`
`SELBER; Klaus et al.
`
`HOTAMISLIGIL; Gokhan S.
`et al.
`
`US-20140088199
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`SHARMA; Anant
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`HOVNANIAN; Alain et al.
`
`US-20150290125
`
`10-15-2015
`
`HORN; Gerald et al.
`
`Examiner
`lnitials*
`
`Cite
`No1
`
`Foreign Patent Document
`
`FOREIGN PATENT DOCUMENTS
`Pu
`blication
`Name of Patentee or
`Date
`Applicant of Cited Document
`MM-DD-YYYY
`
`Pages, Columns, Lines,
`Where Relevant Passages
`
`Country Codea’Number’I’Kind Code5 (if known)
`
`Examiner
`Signature
`
`Date
`Considered
`
`lnitial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and not
`EXAMINER:
`considered. lnclude copy of this form with next communication to applicant. 1Applicant’s unique citation designation number (optional). 2See Kinds Codes of USPTO
`Patent Documents at y;yyy.;._g§_gt_g>_._gg>_y_or MPEP 901.04.
`3 Enter Office that issued the document, by the two-letter code (WIPO Standard ST.3). 4 For Japanese patent
`documents, the indication ofthe year ofthe reign ofthe Emperor must precede the serial number of the patent document. 5Kind of document by the appropriate symbols as
`place a check mark here if English language Translation is attached.
`indicated on the document under WlPO Standard ST.16 if possible. 6Applicant is to
`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 bythe
`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. Time will vary depending upon the 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, US. Patent and Trademark Office, PO.
`Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND
`TO: Commissioner for Patents, P.0. 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.
`
`

`

`Based on Form PTO/SB/08a; SB/08b
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`SubstItute for form 1449/PTO
`_
`
`Complete if Known
`
`Application Number
`
`14859042
`
`0021:3333]:2312:; Inventor I——
`
`
`INFORMATION DISCLOSURE
`1521
`MU”,
`STATEMENT BY APPLICANT
`rem
`(Use as many sheets .5 mm.” ——
`—Fay, 20hreh A
`Attorney DocketNumber
`45682—701 501
`
`Examiner
`lnitials*
`
`Foreign Patent Document
`
`Publication
`Date
`MM-DD-YYYY
`
`Name of Patentee or
`Applicant of Cited Document
`
`Pages, Columns, Lines,
`Where Relevant Passages
`Or Relevant Figures Appear
`
`03
`
`Country Codea’NumberA’Kind Code5 (if known)
`
`FOREIGN PATENT DOCUMENTS
`
`
`
`
`
`CN-101327216-A
`
`12-24-2008
`
`[ZCHNfiNGL'AN X'AO
`
`Abstract:
`
`CN-1456161-A
`
`11-19-2003
`
`LIU JIDONG [CN]
`
`Abstract:
`
`EP-0332826-A1
`
`09-20-1989
`
`TEVA PHARMA
`
`WO-0049990-A2
`
`08-31-2000
`
`WO-02096418-A1
`
`12-05-2002
`
`[IL]
`
`KHAMAR
`BAKULESH
`
`MAFATLAL [IN]
`VALLEY FORGE
`PHARMACEUTICA
`
`LS [US], et al.
`
`WO-2008005053-A1
`
`01-10-2008
`
`CYDEX INC [US],
`et al.
`
`WO-2011098578—A2
`
`08-18-2011
`
`BIONEER AS [DK],
`et al.
`
`WO-2012161655-A1
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`11-29-2012
`
`SINGAPORE
`HEALTH SERV
`
`PTE LTD [SC], et
`al.
`D2 BIOSCIENCE
`
`WO-2014140105-A1
`
`09-18-2014 GROUP LTD., et
`al.
`
`Examiner
`Signature
`
`Date
`Considered
`
`EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and not
`considered. Include copy of this form with next communication to applicant. 1Applicant’s unique citation designation number (optional). 2See Kinds Codes of USPTO
`Patent Documents at y;yyy.;._g§_gt_g>_._gg>_y_or MPEP 901.04.
`3 Enter Office that issued the document, by the two-letter code (WIPO Standard ST.3). 4 For Japanese patent
`documents, the indication ofthe year ofthe reign ofthe Emperor must precede the serial number of the patent document. 5Kind of document by the appropriate symbols as
`indicated on the document under WIPO Standard ST.16 if possible. 6Applicant 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 bythe
`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. Time will vary depending upon the 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, US. Patent and Trademark Office, PO.
`Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND
`TO: Commissioner for Patents, P.0. Box 1450, Alexandria, VA 2231 3-1 450.
`If you need assistance in completing the form, call 1-800-PTO-9199 (1-800-786-9199) and select option 2.
`
`

`

`Based on Form PTO/SB/O8a; SB/O8b
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`SubstItute for form 1449/PTO
`_
`
`Complete if Known
`
`Application Number
`
`14859042
`
`0021:3333]:239$; Inventor I——
`
`
`INFORMATION DISCLOSURE
`521
`Am,
`STATEMENT BY APPLICANT
`rem
`(Use as many sheets as mes...” —_
`—Fay, 20hreh A
`Attorney Docket Number
`
`FOREIGN PATENT DOCUMENTS
`
`
`
`Name of Patentee or
`Applicant of Cited Document
`
`Pages, Columns, Lines,
`Where Relevant Passages
`Or Relevant Figures Appear
`
`PASTEUR
`
`Abstract:
`
`
`
`03
`
`N
`
`
`
`Examiner
`Initials*
`
`.
`
`Foreign Patent Document
`
`Publication
`Date
`MM-DD-YYYY
`
`Country Codea’Number’I’Kind Code5 (if known)
`
`WO-9421298—A1
`
`WO-9624331-A1
`
`09-29-1994
`
`INSTITUT [FR], et
`al.
`USTAV
`MAKROMOLEKUL
`08-15-1996 ARNICHEMIE
`[CZ],etal.
`
`WO-9716192-A1
`
`05-09-1997
`
`MERCK & CO INC
`[US], et a"
`
`NON-PATENT LITERATURE DOCUMENTS
`
`Examiner
`Initials*
`
`'
`.
`
`Include name ofthe 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.
`
`ABRAHAM et al. Draize rabbit eye test compatibility with eye irritation thresholds in humans: a
`quantitative structure-activity relationship analysis. Toxicol Sci 76:384-391 (2003).
`
`BADARO et al. Retinal biocompatibility of brilliant Blue G with deuterated water for
`chromovitrectomy. J. Ophthalmic and Vision Research 9(2): 204-209 (2014).
`
`CHENG et al. Water movement in the rabbit eye. Exp. Eye Res. 52:337-339 (1991).
`
`Examiner
`Signature
`
`Date
`Considered
`
`EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and not
`considered Include copy of this form with next communication to applicant. 1Applicant’s unique citation designation number (optional). 2See Kinds Codes of USPTO
`Patent Documents at M_yyy._._g§_gt_g>_._gg>_y_or MPEP 901. 04. 3Enter Office that issued the document, by the two-letter code (VVIPO Standard ST.3). 4 For Japanese patent
`documents, the indication ofthe year ofthe reign ofthe Emperor must precede the serial number of the patent document. 5Kind of document by the appropriate symbols as
`indicated on the document under WIPO Standard ST.16 if possible. 6Applicant 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 bythe
`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. Time will vary depending upon the 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, US. Patent and Trademark Office, PO.
`Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND
`TO: Commissioner for Patents, P.0. Box 1450, Alexandria, VA 2231 3-1 450.
`If you need assistance in completing the form, call 1-800-PTO-9199 (1-800-786-9199) and select option 2.
`
`

`

`Based on Form PTO/SB/08a; SB/08b
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Substitute for form 1449/PTO
`_
`
`Complete if Known
`
`Application Number
`
`14859042
`
`0021:3333]:Eggfl‘devemor I——
`
`
`INFORMATION DISCLOSURE
`521
`Am,
`STATEMENT BY APPLICANT
`rem
`(Use as many sheets as new...” —_
`FaylohrehA
`
`Attorney Docket Number
`
`NON-PATENT LITERATURE DOCUMENTS
`
`Examiner
`|nitia|s*
`
`'
`.
`
`Include name ofthe 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.
`
` N
`
`
`
`CHENG. Fate of water in the soft contact lens immediately after lens placement onto the
`cornea. Optometry and Vision Science 68(6):414-417 (1991).
`
`CHIRIERI et al. Investigations concerning the changes induced by deuterium for hydrogen
`substitution in bioelectric activity of the frog retina. Physiologie 14(2):119-123 (1977).
`
`Co-pending US patent application No. US14/726139, filed on 05-29-2015.
`
`GANEA. Heavy water effect on certain energetic processes in retina. Physiologie 6(1):59-62
`(1979).
`
`GETTINGS et al. A comparison of low volume, Draize and in vitro eye irritation test data. Ill.
`Surfactant-based formulations. Food Chem Toxicol 36(3):209-231 (1998).
`
`GLASOE et al. Use of glass electrodes to measure acidities in deuterium oxide. Journal of
`Physical Chemistry. 64:188-190 (1960).
`
`JANUSCHOWSKI et al. Evaluating retinal toxicity of a new heavy intraocular dye, using a model
`of perfused and isolated retinal cultures of bovine and human origins. Graefes Arch Clin Exp
`Ophthalmol. 250:1013-1022 (2012).
`
`JEONG et al. Biodegradable block copolymers as injectable drug-delivery systems. Nature
`388(6645):860-862 (1997).
`
`Examiner
`Signature
`
`Date
`Considered
`
`EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and not
`considered. Include copy of this form with next communication to applicant. 1Applicant’s unique citation designation number (optional). 2See Kinds Codes of USPTO
`Patent Documents at M;yyy._._u___gt_9_._g_9_y_or MPEP 901. 04. 3Enter Office that issued the document, by the two-letter code (VVIPO Standard ST.3). 4 For Japanese patent
`documents, the indication ofthe year ofthe reign ofthe Emperor must precede the serial number of the patent document. 5Kind of document by the appropriate symbols as
`indicated on the document under WIPO Standard ST.16 if possible. 6Applicant 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 bythe
`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. Time will vary depending upon the 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, US. Patent and Trademark Office, PO.
`Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND
`TO: Commissioner for Patents, P.0. Box 1450, Alexandria, VA 2231 3-1 450.
`If you need assistance in completing the form, call 1-800-PTO-9199 (1-800-786-9199) and select option 2.
`
`

`

`Based on Form PTO/SB/O8a; SB/O8b
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`SubstItute for form 1449/PTO
`_
`
`Complete if Known
`
`Application Number
`
`14859042
`
`0021:3333]:Eggflimnvem I——
`
`
`INFORMATION DISCLOSURE
`521
`Am,
`STATEMENT BY APPLICANT
`rem
`(Use as many sheets as new...” —_
`FaylohrehA
`
`Attorney Docket Number
`
`NON-PATENT LITERATURE DOCUMENTS
`
`Examiner
`|nitia|s*
`
`'
`.
`
`Include name ofthe 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.
`
`
`
`
`
`JEONG et al. Drug release from biodegradable injectable thermosensitive hydrogel of PEG-
`PLGA-PEG triblock copolymers. J Control Release 63(1-2):155-163 (2000).
`
`JEONG et al. Thermosensitive sol-gel reversible hydrogels. Advanced Drug Delivery Reviews
`54:37-51 (2002).
`
`KREZEL et al. A formula for correlating pKa values determined in D20 and H20. Journal of
`Inorganic Chemistry 98:161-166 (2008).
`
`LAI et al. Rapid transport of large polymeric nanoparticles in fresh undiluted human mucus.
`PNAS USA 104(5):1482-1487 (2007).
`
`LUND et al. The Kinetics of atropine and apoatropine in aqueous solutions. ACTA Chemica
`Scandinavica 22:3085-3097 (1968).
`
`MCCALL et al. Mechanisms of corneal tissue cross-linking in response to treatment with topical
`riboflavin and long-wavelength ultraviolet radiation (UVA). Investigative Ophthalmology & Visual
`Science 51(1):129-138 (2010).
`
`OBATA et al. Deuterium magnetic resonance imaging of rabbit eye in Vivo. Magnetic
`Resonance in Medicine. 33(4):569-572 (1995).
`
`OBATA et al. Deuterium MR in vivo imaging ofthe rat eye using 2H20. Acta Radiologica,
`36:552-555 (1995).
`
`Examiner
`Signature
`
`Date
`Considered
`
`EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and not
`considered. Include copy of this form with next communication to applicant. 1Applicant’s unique citation designation number (optional). 2See Kinds Codes of USPTO
`Patent Documents at M;yyy._._u___gt_9_._g_9_y_or MPEP 901. 04. 3Enter Office that issued the document, by the two-letter code (WIPO Standard ST.3). 4 For Japanese patent
`documents, the indication ofthe year ofthe reign ofthe Emperor must precede the serial number of the patent document. 5Kind of document by the appropriate symbols as
`indicated on the document under WIPO Standard ST.16 if possible. 6Applicant 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 bythe
`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. Time will vary depending upon the 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, US. Patent and Trademark Office, PO.
`Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND
`TO: Commissioner for Patents, P.0. Box 1450, Alexandria, VA 2231 3-1 450.
`If you need assistance in completing the form, call 1-800-PTO-9199 (1-800-786-9199) and select option 2.
`
`

`

`Based on Form PTO/SB/08a; SB/08b
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`SubstItute for form 1449/PTO
`_
`
`Complete if Known
`
`Application Number
`
`14859042
`
`0021:3333]:Eggflimnvem I——
`
`
`INFORMATION DISCLOSURE
`521
`Am,
`STATEMENT BY APPLICANT
`rem
`(Use as many sheets .5 mm.” —_
`FaylohrehA
`
`Attorney Docket Number
`
`NON-PATENT LITERATURE DOCUMENTS
`
`Examiner
`|nitia|s*
`
`'
`.
`
`Include name ofthe 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/US2015/037249 International Search Report and Written Opinion dated September 30,
`2015.
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`
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`RICHARD et al. Effects of sterilizing-grade filters on the physico-chemical properties of onion-
`Iike vesicles. International Journal of Pharmaceutics 312(1-2):144-150 (2006).
`
`SIEGEL et al. Stability of procaine in deuterium oxide. Journal of Pharmaceutical Sciences
`53:978—979 (1964).
`
`TAKTAK et al. Assay of Pyrogens by Interleukin-6 Release from Monocytic Cell Lines. J.
`Pharm. Pharmacol. 43:578—582 (1991).
`
`The U. S. Food and Drug Administration has provided regulatory guidance in the publication:
`Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing. available at: &It;a
`href="http://www.fda.gov/cder/guidance/5882fn1.htm">http://www.fda.gov/cder/guidance/588
`2fn1.htm</a> (August 2003).
`
`VIEGAS et al. Osmotic behavior of poloxamer 407 and other non-ionic surfactants in aqueous
`solutions. Int J Pharm 160:157-162 (1998).
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