Receipt date: 07/20/2029
`
`15/808,632 - GAE}: 1658
`
`PTO/SB/O8a (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 for form 1449/PTO
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`Examiner
`lnitials*
`
`Cite _ocumentNumber
`
`
`No.1
`
`Publication Date
`MM-DD-YYYY
`
`Name of Patentee or
`Applicant ofCited Document
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`
`U. S. PATENT DOCUMENTS
`
`A49 US-2009/0191287-A107-30-2009
`
`Johnson
`
`Or Relevant Figures Appear
`
`
`
`
`
`
`
`FOREIGN PATENT DOCUMENTS
`Publication
`Name of Patentee or
`Applicant of Cited Document
`
`Pages, Columns, Lines,
`Where Relevant Passages
`
`Examiner
`
`Date
`
`09/30/2020
`Considered
`fLI N KOMATSU/
`Signature
`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.
`1 Applicants unique citation designation number (optional).
`2 See Kinds Codes of
`
`USPTO Patent Documents at
`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, t e In Ica non 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.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/L..NK/
`
`

`

`Receipt: date: 07/20/2020
`
`15/808,632 _. GAE}:
`
`1658
`
`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.
`
`Substituteforform1449mm
`
`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*
`
`'
`
`.
`
`NONPATENTLHERATUREDOCUMENTS
`Include name of the author (in CAPITAL LETTERS), title ofthe article (when appropriate), title of
`the item (book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue
`
`number s , ublisher, cit and/or countr where ublished.
`
`
`
`
`
`
`
`
`
`C48
`
`Alquraini A, Garguilo S, D'Souza G, et al. The interaction of lubricin/proteoglycan 4 (PRG4) with
`toll-like receptors 2 and 4: an anti-inflammatory role of PRG4 in synovial fluid. Arthritis Res Ther.
`2015;17:353. Published 2015 Dec 4. doi:10.1186/s13075-015-0877-x
`
`C49
`
`Bitik B, Ozttirk MA. An old disease with new insights: Update on diagnosis and treatment of gout.
`EurJRheumatol. 2014;1 2 :72—77. doi:10.5152/eur'rheumatol.2014.021
`Liu-Bryan R, Scott P, Sydlaske A, Rose DM, Terkeltaub R. Innate immunity conferred by Toll-like
`receptors 2 and 4 and myeloid differentiation factor 88 expression is pivotal to monosodium urate
`C50 monohydrate crystal-induced inflammation. Arthritis Rheum. 2005;52(9):2936-2946.
`doi:10.1002/art.21238
`
`051
`
`052
`
`053
`
`054
`
`055
`
`056
`
`057
`
`Busso N, 80 A. Mechanisms of inflammation in gout. Arthritis Res Ther. 2010;12(2):206.
`doi:10.1186/ar2952
`
`Chen CJ, Shi Y, Hearn A, et al. MyD88-dependent lL-1 receptorsignaling is essential forgouty
`inflammation stimulated by monosodium urate crystals. J Clin Invest. 2006;116(8):2262—2271.
`doi:10.1172/JCI28075
`
`Coderre TJ, Wall PD. Ankle joint urate arthritis (AJUA) in rats: an alternative animal model of
`arthritis to that produced by Freund's adjuvant. Pain. 1987;28(3):379-393. doi:10.1016/0304-
`3959(87)90072—8
`Crisan TO, Cleophas MC, Oosting M, et al. Soluble uric acid primes TLR-induced proinflammatory
`cytokine production by human primary cells via inhibition of lL-1 Ra. Ann Rheum Dis.
`2016;75 4 :755-762. doi:10.1136/annrheumdis-2014-206564
`Cui Z, Xu C, Li X, Song J, Yu B. Treatment with recombinant lubricin attenuates osteoarthritis by
`positive feedback loop between articular cartilage and subchondral bone in ovariectomized rats.
`Bone. 2015;74:37-47. doi:10.1016/j.bone.2014.12.065
`di Giovine FS, Malawista SE, Thornton E, Duff GW. Urate crystals stimulate production oftumor
`necrosis factor alpha from human blood monocytes and synovial cells. Cytokine mRNA and
`protein kinetics, and cellular distribution. J Clin Invest. 1991 ;87(4):1375-1381.
`doi:10.1172/JCI115142
`
`Edwards NL, 80 A. Emerging therapies for gout. Rheum Dis Clin North Am. 2014;40(2):375-387.
`doi:10.1016/j.rdc.2014.01.013
`
`Examiner
`
`[LI N KOMATSU/
`
`Date
`
`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 of this 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.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/L..NK/
`
`

`

`Receipt: date: 07/20/2020
`
`15/808,632 _. GAE}:
`
`1658
`
`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.
`
`Substituteforform1449mm
`
`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
`lnitials*
`
`'
`
`.
`
`NONPATENTLHERATUREDOCUMENTS
`Include name of the author (in CAPITAL LETTERS), title ofthe article (when appropriate), title of
`the item (book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue
`number s , ublisher, cit and/or countr where ublished.
`
`
`
`
`
`058
`
`059
`
`C60
`
`C61
`
`C62
`
`063
`
`C64
`
`C65
`
`C66
`
`C67
`
`
`
`Flannery CR, Hughes CE, Schumacher BL, et al. Articular cartilage superficial zone protein (SZP)
`is homologous to megakaryocyte stimulating factor precursor and Is a multifunctional proteoglycan
`with potential growth-promoting, cytoprotective, and lubricating properties in cartilage metabolism.
`Biochem Biophys Res Commun. 1999;254(3):535-541. doi:10.1006/bbrc.1998.0104
`
`Hill A.’ 'Waller KA, Cui Y, et al. Lubricin restoration in a mouse model of congenital deficiency.
`Arthritis Rheumatol. 2015;67 11 :3070—3081.dor:10.1002/art.39276
`
`Jay GD, Torres JR, Rhee DK, et al. Association between friction and wear in diarthrodialjoints
`lacking lubricin. Arthritis Rheum. 2007;56(11):3662—3669. doi:10.1002/ar‘t22974
`Jay GD, Fleming BC, Watkins BA, et al. Prevention of cartilage degeneration and restoration of
`chondroprotection by lubricin tribosupplementation in the rat following anterior cruciate ligament
`transection. Arthritis Rheum. 2010;62(8):2382-2391. doi:10.1002/art.27550
`Jay GD, Elsaid KA, Kelly KA, et al. Prevention of cartilage degeneration and gait asymmetry by
`lubricin tribosupplementation in the rat following anterior cruciate ligament transection. Arthritis
`Rheum. 2012;64 4 :1162-1171. doi:10.1002/art.33461
`Jay GD, Tantravahi U, Britt DE, Barrach HJ, Cha CJ. Homology of lubricin and superficial zone
`protein (SZP): products of megakaryocyte stimulating factor (MSF) gene expression by human
`synovial fibroblasts and articular chondrocytes localized to chromosome 1q25. J Orthop Res.
`2001 ;19(4):677-687. doi:10.1016/SO736-0266(00)00040—1
`
`Jay GD, Britt DE, Cha CJ. Lubricin is a product of megakaryocyte stimulating factor gene
`exression b human s novral fibroblasts. JRheumatol. 2000;27 3 :594-600.
`
`Jay GD, Waller KA. The biology of lubricin: near frictionless joint motion. Matrix Biol. 2014;39:17-
`24. d0|:10.1016/J.matb|o.2014.08.008
`
`Jones AR, Gleghorn JP, Hughes CE, et al. Binding and localization of recombinant lubricin to
`articular cartilae surfaces. J Ortho Res. 2007;25 3 :283-292. doi:10.1002/‘or.20325
`Joosten LA, Netea MG, Mylona E, et al. Engagement of fatty acids with Toll-like receptor 2 drives
`interleukin-1B production via the ASC/caspase 1 pathway in monosodium urate monohydrate
`crystal-induced gouty arthritis. Arthritis Rheum. 2010;62(11):3237-3248. doi:10.1002/art.27667
`
`
`
`
`
`Examiner
`
`Date
`
`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 of this 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.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/L..NK/
`
`

`

`Receipt date: 07/20/2020
`
`15/808,632 u GAU:
`
`1658
`
`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.
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`
`
`“’56“ma"ys"“m"e°e“a”’
`
`Examiner
`Initials*
`
`'
`
`.
`
`NONPATENTLHERATUREDOCUMENTS
`Include name of the author (in CAPITAL LETTERS), title ofthe article (when appropriate), title of
`the item (book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue
`number s , ublisher, cit and/or countr where ublished.
`
`Kosinska MK, Ludwig TE, Liebisch G, et aI. Articular Joint Lubricants during Osteoarthritis and
`Rheumatoid Arthritis Display Altered Levels and Molecular Species. PLoS One.
`2015;10(5):e0125192. Published 2015 May 1. doi:10.1371/journal.pone.0125192
`Kuo CF, Grainge MJ, Zhang W, Doherty M. Global epidemiology of gout: prevalence, incidence
`and risk factors. Nat Rev Rheumatol. 2015;11 11 :649-662. doi:10.1038lnrrheum.2015.91
`Lee HS, Lee CH, Tsai HC, Salter DM. Inhibition of cyclooxygenase 2 expression by diallyl sulfide
`on joint inflammation induced by urate crystal and IL-1beta. Osteoarthritis Cartilage.
`2009;17(1):91-99. doi:10.1016/j.joca.2008.05.010
`Malik A, Schumacher HR, Dinnella JE, Clayburne GM. Clinical diagnostic criteria for gout:
`comparison with the gold standard of synovial fluid crystal analysis. J Clin Rheumatol.
`2009;15(1):22-24. doi:10.1097/RHU.0b013e3181945b79
`Martin WJ, Walton M, Harper J. Resident macrophages initiating and driving inflammation in a
`C72 monosodium urate monohydrate crystal-induced murine peritoneal model of acute gout. Arthritis
`Rheum. 2009;60 1
`:281-289. doi:10.1002/art.24185
`Martinon F, Tschopp J. Inflammatory caspases and inflammasomes: master switches of
`inflammation. Cell Death Differ. 2007;14(1):10-22. doi:10.1038/sj.cdd.4402038
`Martinon F, Burns K, Tschopp J. The inflammasome: a molecular platform triggering activation of
`inflammatory caspases and processing of proIL-beta. Mol Cell. 2002;10(2):417-426.
`doi:10.1016/s1097-2765 02 00599-3
`
`
`
`C68
`
`C69
`
`C70
`
`C71
`
`C73
`
`C74
`
`C75
`
`C76
`
`C77
`
`Examiner
`Signature
`
`[1.1 N ROMATSU/
`
`Date.
`Consndered
`
`09/30/2020
`
`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 of this 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.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/L..NK/
`
`
`
`
`
`Martinon F, Pétrilli V, MayorA, Tardivel A, Tschopp J. Gout-associated uric acid crystals activate
`the NALP3 inflammasome. Nature. 2006;440(7081):237-241. doi:10.1038/nature04516
`Nishimura A, Akahoshi T, Takahashi M, et aI. Attenuation of monosodium urate crystal-induced
`arthritis in rabbits by a neutralizing antibody against interleukin-8. J Leukoc Biol. 1997;62(4):444-
`449. doi:10.1002/‘Ib.62.4.444
`
`Orlowsky EW, Stabler TV, Montell E, Verges J, Kraus VB. Monosodium urate crystal induced
`macrophage inflammation is attenuated by chondroitin sulphate: pre-clinical model for gout
`prophylaxis?. BMC Musculoskelet Disord. 2014;15:318. Published 2014 Sep 27.
`doi:10.1186/1471-2474-15-318
`
`
`
`
`
`

`

`Receipt: date: 07/20/2020
`
`15/808,632 - GAE}:
`
`1658
`
`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 for form 1449/PTO
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessary)
`
`
`
`Complete if Known
`
`15/808,632—Conf. #8457
`
`November 9, 2017
`
`—eregowo.day
`1050
`
`L. N. Komatsu
`
`Examiner
`Initials*
`
`NON PATENT LITERATURE DOCUMENTS
`Include name of the author (in CAPITAL LETTERS), title ofthe article (when appropriate), title of
`the item (book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue
`number s , ublisher, cit and/or countr where ublished.
`
`
`
` 080
`
`081
`
`082
`
`083
`
`084
`
`085
`
`086
`
`087
`
`
`
`Ottaviani S, Molté A, Ea HK, et al. Efficacy of anakinra in gouty arthritis: a retrospective study of
`40 cases. Arthritis Res Ther. 2013;15(5):R123. doi:10.1186/ar4303
`Pascual E, Addadi L, Andrés M, Sivera F. Mechanisms of crystal formation in gout-a structural
`a oroach. Nat Rev Rheumatol. 2015;11 12 :725-730. doi:10.1038/nrrheum.2015.125
`Pazar B, Ea HK, Narayan S, et at. Basic calcium phosphate crystals induce
`monocyte/macrophage IL-1B secretion through the NLRP3 inflammasome in vitro. J Immunol.
`2011;186(4):2495-2502. doi:10.4049/jimmunol.1001284
`Pessler F, Mayer CT, Jung SM, et al. Identification of novel monosodium urate crystal regulated
`mRNAs by transcript profiling ofdissected murine air pouch membranes. Arthritis Res Ther.
`2008;10 3 :R64. doi:10.1186/ar2435
`Pope RM, Tschopp J. The role of interleukin-1 and the inflammasome in gout: implications for
`therapy. Arthritis Rheum. 2007;56(10):3183-3188. doi:10.1002/art.22938
`Samsom ML, Morrison S, Masala N, et al. Characterization of full-length recombinant human
`Proteoglycan 4 as an ocular surface boundary lubricant. Exp Eye Res. 2014;127:14-19.
`doi:10.1016/j.exer.2014.06.015
`Schlesinger N. Treatment of acute gout. Rheum Dis Clin North Am. 2014;40(2):329-341.
`doi:10.1016/j.rdc.2014.01.008
`Silva CR, Oliveira SM, Hoffmeister C, et al. The role of kinin B1 receptor and the effect of
`angiotensin I-converting enzyme inhibition on acute gout attacks in rodents. Ann Rheum Dis.
`2016;75(1):260-268. doi:10.1136/annrheumdis-2014-205739
`Smith E, Hoy D, Cross M, et al. The global burden of gout: estimates from the Global Burden of
`Disease 2010 study. Ann Rheum Dis. 2014;73(8):1470—1476. doi:10.1136/annrheumdis-2013-
`204647
`
`Stewart S, Dalbeth N, Vandal AC, Rome K. The first metatarsophalangeal joint in gout: a
`systematic review and meta-analysis. BMC Muscu/oske/et Disord. 2016;17:69. Published 2016
`Feb 11. doi:10.1186/s12891-016-0919-9
`
`
`
`
`
`Examiner
`
`Signature
`
`Date
`
`00000000
`
`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 of this 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.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/L..NK/
`
`

`

`Receipt: date: 07/20/2020
`
`15/808,632 _. GAE}:
`
`1658
`
`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.
`
`Substituteforform1449mm
`
`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
`lnitials*
`
`'
`
`.
`
`NONPATENTLHERATUREDOCUMENTS
`Include name of the author (in CAPITAL LETTERS), title ofthe 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.
`
`
`
`Teeple E, Elsaid KA, Jay GD, et al. Effects of supplemental intra-articular lubricin and hyaluronic
`acid on the progression of posttraumatic arthritis in the anterior cruciate ligament-deficient rat
`knee. Am J Sports Med. 2011;39(1):164-172. doi:10.1177/0363546510378088
`Torres R, Macdonald L, Croll SD, et al. Hyperalgesia, synovitis and multiple biomarkers of
`inflammation are suppressed by interleukin 1
`inhibition in a novel animal model of gouty arthritis.
`Ann Rheum Dis. 2009;68 10 :1602-1608. doi:10.1136/ard.2009.109355
`Zappone B, Ruths M, Greene GW, Jay GD, Israelachvili JN. Adsorption, lubrication, and wear of
`lubricin on model surfaces: polymer brush-like behavior of a glycoprotein. Biophys J.
`2007;92(5):1693-1708. doi:10.1529/biophysj.106.088799
`Zhu Y, Pandya BJ, Choi HK. Prevalence of gout and hyperuricemia in the US general population:
`the National Health and Nutrition Examination Survey 2007-2008. Arthritis Rheum.
`2011;63(10):3136-3141. doi:10.1002/art.30520
`
`C88
`
`C89
`
`C90
`
`C91
`
`
`
`
`
`
`
`
`
`Examiner
`Signature
`
`’iLI N KOMATSU/
`
`Date
`Considered
`
`09/30/2020
`
`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 of this 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.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/L..NK/
`
`