PTO/SB/08a (07-09)
`Approved for use through 11/30/2020. OMB 0651-0031
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Underthe Paerwork Reduction Act of 1995, no ersons are re uired to res ond to a collection of information unless it contains a valid OMB control number.
`
`Subsiiiuieioriormimp-o
`
`15/808,632-C0nf. #8457
`
`INFORMATION DISCLOSURE
`
`Novembere. 2017
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`.
`
`Gregory D. Jay
`1658
`
`L. N. Komatsu
`
`Examiner
`Initials*
`
`Cite _ocumentNumber
`
`
`No.1
`
`Publication Date
`MM-DD-YYYY
`
`Name of Patentee or
`Applicant of Cited Document
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`
`U. S. PATENT DOCUMENTS
`
`US—2006/0240037
`US—2007/0111327
`US-2007/0249557
`US-2008/0139458
`US—2008/0287369
`US—2009/0068247
`US—2009/0104148
`US-2009/0155200-A1
`US-2010/0092484-A1
`US-2010/0204087
`US-2012/0052077-A1g:301 2-012
`US-2013/0039865
`02- 14-2013
`US-2013/0116186
`05-09-2013
`US-2013/0315973
`11-28—201 3
`US-2014/0179611
`06-26-2014
`US-2016/0250286
`09-01-2016
`US-2016/0304572
`10-20-2016
`
`A1
`A2
`A3
`A4
`A5
`A6
`A7
`A8
`A9
`A10
`A11
`A12
`A13
`A14
`A15
`A16
`A17
`
`
`
`
`
`08-31-2017
`US-2017/0246246-A1
`A18
` —A19 US-2017/0312335-A1 11-02-2017
`
`
`
`
`
`
`
`Ja
`Truitt, III et al.
`Truitt, III et al.
`Jay
`Jay
`Ja
`Schmidt
`Schmidt et aI.
`
`Jay et aI.
`Truitt, III et aI.
`
`Examiner
`Initials*
`
`Cite
`No. 1
`
`Foreign Patent Document
`
`Count Code3Number‘ Kind Code5 ifknown
`
`FOREIGN PATENT DOCUMENTS
`Publication
`Name of Patentee or
`Date
`Applicant of Cited Document
`MMDDYYYY
`
`Pages Columns Lines
`Where Relevant Passages
`Or Relevant Figures Appear
`
`--
`
`B1** WO-2000/064930-A2
`
`-- wo-2005/000331-A2
`B3** WO-2005/102363-A2
`
`-- WO-2006/012492-A2
`-- WO-2006/060473-A2
`-- WO-2008/143816-A1
`Examiner
`Signature
`
`11- 02-2000
`
`Rhode Island Hospital, A
`
`Lifespan Partner
`
`01 -0-62005 Mucosal Theraeutics, Inc. —-
`11-03-2005 mucosa” Therapemics “-0
`and Jay, Gregory D.
`02-02-2006 Mucosal Therapeutics LLC —-
`06-08-2006 Mucosal Therapeutics LLC —-
`11-27-2008 Mucosal Theraeutics, inc. —-
`Date
`Considered
`
`if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and not
`Initial
`*EXAMINER:
`considered. Include copy of this form with next communication to applicant.
`1Applicant's unique citation designation number (optional).
`2 See Kinds Codes of
`
`{TN or MPEP 901.04.
`3 Enter Office that issued the document, by the two-letter code (WIPO Standard ST.3).
`4 For
`
`of the year of the reign of the Emperor must precede the serial number of the patent document. 5Kind of document by
`Japanese patent documents, the in
`the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible.
`6 Applicant is to place a check mark here if English language
`Translation is attached.
`
`|PTS/100960385.1
`
`

`

`PTO/SB/08a (07-09)
`Approved for use through 11/30/2020. OMB 0651-0031
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`Underthe Paerwork Reduction Act of 1995, no ersons are re uired to res ond to a collection of information unless it contains a valid OMB control number.
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`Subsiiiuieioriorm14mm
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`15/808,632-Conf. #8457
`
`INFORMATION DISCLOSURE
`
`Novembere. 2017
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`.
`
`Gregory 0. Jay
`1658
`
`L. N. Komatsu
`
`Examiner
`lnitials*
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`Cite _ocumentNumber
`
`
`No.1
`
`Publication Date
`MM-DD-YYYY
`
`Name of Patentee or
`Applicant of Cited Document
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`
`U. S. PATENT DOCUMENTS
`
`A20
`A21
`A22
`A23
`A24
`A25
`A26
`A27
`A28
`A29
`
`US-2018/0015141 -A1
`US-2018/0140546-A1
`US-6i433,142
`US-6i743,774
`US-6.960.562
`US-7.001.881
`US-7,030,233
`US-7i361i738
`US-7 415 381
`US-7618 941 _Ja
`Flannery et 011
`Jay
`Sullivan et al.
`Sullivan et al.
`Sullivan et al.
`Jay
`Sullivan et al.
`Truitt, III et al.
`Sullivan et al.
`
`
`
`90--:272011
`US-8, 026,346
`A31
`08- 13-2013
`US-8,506,944
`A32
`10-08-2013
`US-8,551,467
`A33
`10-22-2013
`US-8,563,028
`A34
`03-25-2014
`US-8,680,057
`A35
`02-03-2015
`US-8,945,604
`A36
`03-17-2015
`US-8,980,840
`A37
`
` —A38 US-9,107,885 08-18-2015
`
`
`
`
`FOREIGN PATENT DOCUMENTS
`
`
`
`Count Code3Number‘ Kind Code5 ifknown
`
`lnitials*
`
`No. 1
`
`H
`
`Foreign PatentDocument
`-- WO-2009/137217-A2
`B8** WO-2009/137602-A1
`
`
`
`Date
`MMDDYYYY
`
`Applicant of Cited Document
`
`Where Relevant Passages
`Or Relevant Figures Appear
`
`Pages,Columns, Lines, I
`Publication
`11-12-2009 of California et al. _.
`11-12-2009 The 3696115 ofthe U”'Ver5'ty
`of California
`
`The Regents ofthe University
`
`00-
`
`The Regents ofthe University
`
`-- WO-2010/083239-A2
`-- WO-2o10/135736-A2
`--WO-2011/019963-A2
`Examiner
`Signature
`
`07-22-2010 Truitt, Edward R et al. —-
`11-25-2010 _—-
`02-17-2011 Singularis, Inc —-
`Date
`Considered
`
`if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and not
`Initial
`*EXAMINER:
`
`considered. Include copy of this
`ith next communication to applicant.
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`2 See Kinds Codes of
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`USPTO Patent Documents at 3
`3'13;3_33_ 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
`of the year of the reign of the 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.
`6 Applicant is to place a check mark here if English language
`Translation is attached.
`
`|PTS/100960385.1
`
`

`

`PTO/SB/08a (07-09)
`Approved for use through 11/30/2020. OMB 0651-0031
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Underthe Paerwork Reduction Act of 1995, no ersons are re uired to res ond to a collection of information unless it contains a valid OMB control number.
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`Substituteforform1449mm
`
`15/808,632-Conf. #8457
`
`INFORMATION DISCLOSURE
`
`Novembere. 2017
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`.
`
`Gregory D. Jay
`1658
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`L. N. Komatsu
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`Examiner
`lnitials*
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`Cite _ocumentNumber
`
`
`No.1
`
`Publication Date
`MM-DD-YYYY
`
`Name of Patentee or
`Applicant of Cited Document
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`
`U. S. PATENT DOCUMENTS
`
`A39
`A40
`A41
`A42
`A43
`A44
`A45
`A46
`A47
`
`US-9 138 457
`US-9,248,161
`US-9,393,285
`US-9,421 ,241
`US-9.585.936
`US-9.730.865
`US-9,730,978
`US-9,982,027
`US-10,383,796
`
`
`
`——
`
`
`
`—
`
`
`
`Examiner
`
`lnitials*
`
`Cite
`
`No.1
`
`Foreign Patent Document
`
`FOREIGN PATENT DOCUMENTS
`Publication
`Name of Patentee or
`
`Pages, Columns, Lines,
`
`Count Code3'Number4'Kind Code5 ifknown
`
`Date
`MM'DD'YWY
`
`Applicant of Cited Document
`
`Where Relevant Passages
`Or Relevant F'gures Appear
`
`T6
`
`--————-
`--————-
`--———-
`--————-
`--————-
`--————-
`Examiner
`Date
`Signature
`Considered
`
`if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and not
`Initial
`*EXAMINER:
`considered. Include copy of this form with next communication to applicant.
`1Applicant's unique citation designation number (optional).
`2 See Kinds Codes of
`
`USPTO Patent Documents at 5.3.:
`‘33:; 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 of the year of the reign of the 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.
`6 Applicant is to place a check mark here if English language
`Translation is attached.
`
`|PTS/100960385.1
`
`

`

`PTO/SB/08a (07-09)
`Approved for use through 11/30/2020. OMB 0651-0031
`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`Underthe Paerwork Reduction Act of 1995, no ersons are re uired to res ond to a collection of information unless it contains a valid OMB control number.
`
`Substitute 10.10..“14494-0
`
`15/808,632-Conf. #8457
`
`INFORMATION DISCLOSURE
`
`Novembere. 2017
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`.
`
`Gregory D. Jay
`1658
`
`L. N. Komatsu
`
`Examiner
`lnitials*
`
`Cite
`No.1
`
`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
`
`
`
`
`
`
`
`Examiner
`
`'
`
`Foreign Patent Document
`
`FOREIGN PATENT DOCUMENTS
`Publication
`Name of Patentee or
`Date
`Applicant of Cited Document
`
`Count Code3'Number4'Kind Code5 ifknown
`
`Pages, Columns, Lines,
`Where Relevant Passages
`Or Relevant Flgures Appear
`
`-- WO-2016/123123-A1
`-- WO-2016/187414-A1
`
`08-04-2016 Lubris LLC —-
`11-24-2016 Lubris Llc —-
`
`Examiner
`Signature
`
`Date
`Considered
`
`if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and not
`Initial
`*EXAMINER:
`
`considered. Include copy of this form with next communication to applicant.
`1Applicant's unique citation designation number (optional).
`2 See Kinds Codes of
`USPTO Patent Documents at
`g: 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 in ica ion 0 the year of the reign of the 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.
`6 Applicant is to place a check mark here if English language
`Translation is attached.
`
`|PTS/100960385.1
`
`

`

`PTO/SB/08b (07-09)
`Approved for use through 11/30/2020. OMB 0651-0031
`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 to. term Mtg/pm
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`,
`
`
`
`15/808,632-Conf. #8457
`
`November9. 2017
`
`Gregory D. Jay
`1658
`
`L. N. Komatsu
`
`
`
`Examiner
`Initials*
`
`'
`
`.
`
`C1**
`
`
`
`
`
`NON PATENT LITERATURE DOCUMENTS
`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
`, cublisher, cit and/or countr where ublished.
`
`AI-Sharif et aI., "Lubricin/Proteoglycan 4 binding to CD44 receptor: A mechanism of the
`suppression of proinflammatory cytokine-induced synoviocyte proliferation by Lubricin," Arthritis
`Rheumatol., 2015, 67( 6):1503-1513.
`
`
`
`
`
`CZ” Aruffo, "CD44: One Ligand, Two Functions," J. Clin. Invest, July 8, 2014: 98(10):2191-2192.
`
`Cs**
`
`Campo et al., "Molecular size hyaluronan differently modulates toll-like receptor-4 in LPS—induced
`inflammation in mouse chondrocytes," Biochimie, October 20, 2009, 92:204-215.
`
`C4** Campo et aI., "Small hyaluronan oligosaccharides induce inflammation by engaging both toll-Iike-4
`and CD44 receotors in human chondroc es," Biochemical Pharmacolo , 2010, 80:480-490.
`Cuff et al., "The adhesion receptor CD44 promotes atherosclerosis by mediating inflammatory cell
`recruitment and vascular cell activation," J. Clin. Invest, 2001, 108(7): 1031-1040.
`
`05**
`
`C6**
`
`C7**
`
`C8**
`
`Cutly et al., "The hyaluronan receptor (CD44) participates in the uptake and degradation of
`h aluronan," J. Cell Biol., 1992, 116 4 :1055-1062.
`Estrella et al., "The glycosylation of human synovial Iubricin: implications for its role in
`inflammation," Biochem. J., 2010, 429(2):359-67.
`
`Flannery et aI., "Prevention of cartilage degeneration in a rat mode of osteoarthritis by
`intraarticular treatment with recombinant Lubricin," Arthritis Rheum, 2009, 60:840-847.
`
`09”
`
`Fleenor et aI., "TGFB2-Induced Changes in Human Trabecular Meshwork: Implications for
`Intraocular Pressure," Investigative Ophthalmology & Visual Science, 2006, 47(1): 226-234.
`Fuchs et aI., "Expression ofthe CD44 variant isoform 5 in the human osteoarthritic knee joint:
`C10** correlation with radiological, histomorphological, and biochemical parameters," J. Orthopaedic
`Res, 2004, 22(4):?74-80.
`
`Examiner
`Signature
`
`Date
`Considered
`
`Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and not
`*EXAMINER:
`Include copy ofthis form with next communication to applicant.
`considered.
`1Applicant's unique citation designation number (optional). 2Applicant is to place a check mark here if English language Translation is attached.
`
`|PTS/100960385.1
`
`

`

`
`
`Grisar et al., "Expression Patterns of CD44 and CD44 Splice Variants in Patients with Rheumatoid
`Arthritis," Clin. Exp. Rheumatol., 2012, 30(1):64-72.
`Harada et al., "CD44-dependent intracellular and extracellular catabolism of hyaluronic acid by
`h aluronidase-1 and -2," J. Biol., Chem, 2007, 282 8 :5597-607.
`International Search Report for International Application No. PCT/US2016/014952 mailed June
`15, 2016 (7 pages).
`
`C12
`013*,
`
`014*,
`
`C15**
`
`C16**
`
`C17**
`
`Iqbal et al., "Lubricin/Proteoglycan 4 binds to and regulates the activity of toll-like receptors in
`vitro," Sci. Rec., 2016, 6118910. doi:10.1038/sreo18910.
`Jay et al., "Boundary lubrication by Iubricin is mediated by O-Iinked beta(1-3)GaI-GaINAc
`oligosaccharides," Glucoconj. J., 2001, 18(10):807-15.
`Jin et al., "Human synovial Iubricin expresses Sialyl Lewis X determinant and Has L-selectin
`Iiand activit
`J. Biol. Chem, 2012, 287 43 :35922-35933.
`Johnson et al., "CD44 and its role in inflammation and inflammatory diseases," Inflammation &
`Allergy Drug Targets, 2009, 8(3):208—220.
`Knepper et al., "Hypophosphorylation of aqueous humor sCD44 and primary open-angle
`.Iaucoma," Investiative Oo-hthalmolo & Visual Science, 2005, 46 8 :2829-2837.
`C18
`019*, Knudson et al., "CD44 and integrin matrix receptors participate in cartilage homeostasis," Cell Mol.
`Life SOL, 2002, 59:36-44.
`
`
`
`
`
`PTO/SB/08b (07-09)
`Approved for use through 11/30/2020. OMB 0651-0031
`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 to. term Mtg/pm
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`,
`
`15/808,632-Conf. #8457
`
`November9. 2017
`
`Gregory D. Jay
`1658
`
`L. N. Komatsu
`
`Examiner
`Initials*
`
`'
`
`.
`
`NON PATENT LITERATURE DOCUMENTS
`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
`
`, cublisher, cit and/or countr where ublished.
`
`
`
`
`
`020*, Knudson et al., "CD44-mediated uptake and degradation of hyaluronan", Matrix Biol., 2002, 21 :15-
`23.
`
`Examiner
`
`Signature
`
`Date
`
`Considered
`
`Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and not
`*EXAMINER:
`Include copy ofthis form with next communication to applicant.
`considered.
`1Applicant's unique citation designation number (optional). 2Applicant is to place a check mark here if English language Translation is attached.
`
`|PTS/100960385.1
`
`

`

`PTO/SB/08b (07-09)
`Approved for use through 11/30/2020. OMB 0651-0031
`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 to. term Mtg/pm
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`,
`
`
`
`15/808,632-Conf. #8457
`
`November9. 2017
`
`Gregory D. Jay
`1658
`
`L. N. Komatsu
`
`Examiner
`Initials*
`
`'
`
`.
`
`NON PATENT LITERATURE DOCUMENTS
`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
`, cublisher, cit and/or countr where ublished.
`
`
`
`
`
`
`
`Korolkova et al., "Characterization of serum cytokine profile in predominantly colonic inflammatory
`C21** bowel disease to delineate ulcerative and crohn's colitides,"Clinical Medicine Insights:
`Gastroenterology, 2015, 8:29-44.
`Lacey et al., "Control of fibroblast-like synoviocyte proliferation by macrophage migration inhibitory
`factor," Arthritis & Rheumatism, 2003, 48 1
`:103-109.
`Larché et al., "Immunological mechanisms of allergen-specific immunotherapy," Nat. Rev.
`Immunol., 2006, 6(10):761-71.
`
`022“
`
`023“
`
`C24** Leslie, "Inflammation's stop signals," Science, 2015, 347(6217):19-21.
`
`Li et al., "Effect of CD44 suppression by antisense oligonucleotide and attachment of human
`C25** trabecular meshwork cells to HA," Journal of Huazhong University of Science and Technology,
`2004, 24(5):486-489.
`Mechanisms of Carcinogenesis, Secition 3, 2008, International Agency for Research on Cancer,
`pages 1-37.
`Misra et al., "Hyaluronan, CD44, and cyclooxygenase-2 in colon cancer," Connective Tissue
`Research, 2008, 49:219-224.
`Mokbel et al., "Erythropoietin and soluble CD44 levels in patients with primary open-angle
`glaucoma," Clinical & Experimental Ophthalmology, 2010, 38:560-565.
`
`026
`
`027“
`
`028“
`
`C29** Murdoch et al., "Chronic inflammation and asthma," Mutation Research, 2010, 690: (16 pages).
`
`030“
`
`Muto et al., "Engagement of CD44 by hyaluronan suppresses TLR4 signaling and the septic
`response to LPS," Molecular Immunology, 2009, 47:449-456.
`
`
`
`
`
`Examiner
`Signature
`
`Date
`Considered
`
`Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and not
`*EXAMINER:
`Include copy ofthis form with next communication to applicant.
`considered.
`1Applicant's unique citation designation number (optional). 2Applicant is to place a check mark here if English language Translation is attached.
`
`|PTS/100960385.1
`
`

`

`PTO/SB/08b (07-09)
`Approved for use through 11/30/2020. OMB 0651-0031
`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 to. term Mtg/pm
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`,
`
`15/808,632-Conf. #8457
`
`November9. 2017
`
`Gregory D. Jay
`1658
`
`L. N. Komatsu
`
`Examiner
`Initials*
`
`'
`
`.
`
`NON PATENT LITERATURE DOCUMENTS
`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
`
`, cublisher, cit and/or countr where ublished.
`
`
`
`
`
`
`
`
`
`
`
`C31** Naor et al., "CD44 in rheumatoid arthritis," Arthritis Research & Therapy, 2003, 5(3):105-115.
`
`032*, Naor et al., "CD44: Structure, function, and associate with the malignant process," Adv. Cancer
`Res, 1997, 71 :241-319.
`
`033*, Ohwada et al., "CD44 and hyaluronan engagement promotes dexamethasone resistance in
`human myeloma cells," Eur. J. Haematol, 2008, 80:245.
`
`034
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`Reginato et al., "Anti-Inflammatory Role of Lubricin/PRG4 in Monosodium Urate-crystal induced
`arthritis", Abstract 2260, ACRI ARHP Annual Meetin, Setember28, 2016 2 o-aes .
`
`035*, Rhee et al., "The secreted glycoprotein lubricin protects cartilage surfaces and inhibits synovial
`cell overgrowth," J. Clin. Invest, 2005, 115(3):622-631.
`
`C36** Rouschop et al., "Protection against renal ischemia reperfusion injury by CD44 disruption,"
`American Socnet of Neo-hrolo ,2005,16:2034-2043.
`
`037*, Runnels et al., "PF-0347.59.52: a potent and neutralizing fully human anti-CD44 antibody for
`therapeutic applications In Inflammatory diseases," Advances In Therapy, 2010, 27(3):168—180.
`
`C38** Schmidt et al., "Transcription, translation, and function of lubricin, a boundary lubricant, at the
`ocularsurface," Jama Oohthalmol., 2013, 131 6 :766-76. d0|:10.1001/ama0ohthalmol.2013.2385.
`
`039*, Tibesku et al., "Expression of the matrix receptor CD44v5 on chondrocytes changes with
`osteoarthritis: an experimental Investigation In the rabbit," Ann. Rheum. DIS., 2006, 65105-65108.
`
`C40
`
`Timothy R. Orchard, "Management of Arthritis in Patients with Inflammatory Bowel Disease",
`Gastroenterology & Hepatology Volume 8, Issue 5 May 2012, pages 327-329.
`
`Examiner
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`Signature
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`Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and not
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`considered.
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`
`|PTS/100960385.1
`
`

`

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`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`,
`
`15/808,632-Conf. #8457
`
`November9. 2017
`
`Gregory D. Jay
`1658
`
`L. N. Komatsu
`
`Examiner
`Initials*
`
`'
`
`.
`
`NON PATENT LITERATURE DOCUMENTS
`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
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`
`
` C41** Waller et al., "Role of lubricin and boundary lubrication in the prevention of chondrocyte
`
`apoptosis,"PNAS, 2013, 110(15):5852-5857.
`
`C42** Wang et al., "CD44 deficiency leads to enhanced neutrophil migration and lung injury escherichia
`coli oneumonia in mice," Am. J. Patholo , 2002, 161 :2219-2228.
`
`C43** Ward et al., "Airway wall remodelling: the influence of corticosteroids," Current Opinion in Allergy
`and Clinical Immunology, 2005, 5:43-48.
`
`C44** V\fibulswas et al., "The CD44v7/8 epitope as a target to restrain proliferation of fibroblast-like
`s novioc es in rheumatoid arthritis," Am. J. Patholo ,2000, 157:2037-2044.
`
`C45** Written Opinion ofthe International Searching Authority for International Application No.
`PCT/US2016/014952 mailed June 15, 2016 (6 pages)
`
`C46** Xu et al., "Involvement of CD44 in leukocyte trafficking at the blood-retinal barrier," Journal of
`Leukoc e Biolo-
`,2002; 72 6 :1133-41.
`
`C47** Zhang et al., "Expression of CD44 in articular cartilage is associated with disease severity in knee
`osteoarthritis," Mod. Rheumatol., 2013, 23(6):1186-91.
`
`
`
`
`
`Examiner
`Signature
`
`Date
`Considered
`
`Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance and not
`*EXAMINER:
`Include copy ofthis form with next communication to applicant.
`considered.
`1Applicant's unique citation designation number (optional). 2Applicant is to place a check mark here if English language Translation is attached.
`
`|PTS/100960385.1
`
`