Preliminary Amendment
`Submission dated July 20, 2020
`US. Application No.: 15/808,632
`Attomey Docket No.: LUB-030
`Page 2 of 6
`
`AMENDMENTS TO THE CLAIMS
`
`Please amend the claims as indicated below:
`
`1.
`
`(Previously Presented) A method of reducing joint pain in a subject with gout or
`
`pseudogout, the method comprising administering to the subject a composition comprising
`
`proteoglycan 4 (PRG4) consisting of the amino acid residues 25-1404 of SEQ ID NO: 1.
`
`2.
`
`(Previously Presented) A method of treating gout or pseudogout in a subject in need
`
`thereof, the method comprising administering to the subject a composition comprising
`
`proteoglycan 4 (PRG4) consisting of the amino acid residues 25-1404 of SEQ ID NO: 1.
`
`3.
`
`4.
`
`(Canceled)
`
`(Previously Presented) The method of claim 2, wherein treating the gout or pseudogout
`
`is achieved by reducing inflammation associated with gout.
`
`5.
`
`(Previously Presented) The method of claim 1, wherein the PRG4 is recombinant human
`
`PRG4.
`
`6.
`
`(Previously Presented) The method of claim 1, wherein the PRG4 is administered to the
`
`subject intra-articularly by injection into a joint having gout.
`
`7.
`
`(Original) The method of claim 6, wherein the joint is selected from knee, ankle, elbow,
`
`shoulder, finger, thumb, wrist, or toe joint.
`
`8.
`
`(Original) The method of claim 1, wherein the PRG4 is administered to the subject
`
`intravenously.
`
`9.
`
`(Previously Presented) The method of claim 1, wherein the PRG4 is administered to the
`
`subject by injection into an area of the subject’s body affected by gout.
`
`10.
`
`(Currently Amended) The method of claim 9, wherein the PRG4 is administered to
`
`a[[the]] heel or instep of the—patientis afoot of the subject.
`
`
`Submission dated July 20, 2020
`US. Application No.: 15/808,632
`Attomey Docket No.: LUB-030
`Page 2 of 6
`
`AMENDMENTS TO THE CLAIMS
`
`Please amend the claims as indicated below:
`
`1.
`
`(Previously Presented) A method of reducing joint pain in a subject with gout or
`
`pseudogout, the method comprising administering to the subject a composition comprising
`
`proteoglycan 4 (PRG4) consisting of the amino acid residues 25-1404 of SEQ ID NO: 1.
`
`2.
`
`(Previously Presented) A method of treating gout or pseudogout in a subject in need
`
`thereof, the method comprising administering to the subject a composition comprising
`
`proteoglycan 4 (PRG4) consisting of the amino acid residues 25-1404 of SEQ ID NO: 1.
`
`3.
`
`4.
`
`(Canceled)
`
`(Previously Presented) The method of claim 2, wherein treating the gout or pseudogout
`
`is achieved by reducing inflammation associated with gout.
`
`5.
`
`(Previously Presented) The method of claim 1, wherein the PRG4 is recombinant human
`
`PRG4.
`
`6.
`
`(Previously Presented) The method of claim 1, wherein the PRG4 is administered to the
`
`subject intra-articularly by injection into a joint having gout.
`
`7.
`
`(Original) The method of claim 6, wherein the joint is selected from knee, ankle, elbow,
`
`shoulder, finger, thumb, wrist, or toe joint.
`
`8.
`
`(Original) The method of claim 1, wherein the PRG4 is administered to the subject
`
`intravenously.
`
`9.
`
`(Previously Presented) The method of claim 1, wherein the PRG4 is administered to the
`
`subject by injection into an area of the subject’s body affected by gout.
`
`10.
`
`(Currently Amended) The method of claim 9, wherein the PRG4 is administered to
`
`a[[the]] heel or instep of the—patientis afoot of the subject.
`
`
`
`Preliminary Amendment
`Submission dated July 20, 2020
`US. Application No.: 15/808,632
`Attomey Docket No.: LUB-030
`Page 3 of 6
`
`11.
`
`(Previously Presented) The method of claim 1, wherein the composition further
`
`comprises a pharmaceutical carrier.
`
`12.
`
`(Currently Amended) The method of claim 1, wherein the PRG4 is administered in an
`
`amount [[of ]]insufficient to provide boundary lubrication, but sufficient to treat joint pain or
`
`allodynia.
`
`13.
`
`(Currently Amended) The method of claim 1, wherein the ameunt—ef—PRG4 i_s
`
`administered in an amount [[is ]]in the range of 0.1 ug/kg to 4000 ug/kg, or 0.1 ug/kg to 1000
`
`ug/kg, or 0.1 ug/kg to 100 ug/kg, or 0.1 to 50 ug/kg.
`
`14.
`
`(Currently Amended) The method of claim 1, wherein the ameunt—ef—PRG4 i_s
`
`administered in an amount [[is ]]in the range of 0.1 ug/mL to 30 mg/mL, or 1 ug/mL to 10
`
`mg/mL, or 10 ug/mL to 1 mg/mL.
`
`15.
`
`(Currently Amended) The method of claim 1, wherein the ameunt—ef—PRG4 i_s
`
`administered in an amount that is sufficient to achieve a concentration of PRG4 in a synovial
`
`fluid of a joint of the subject of at least 200 ug/ml, at least 300 ug/ml, at least 400 ug/ml, at least
`
`500 ug/ml, or at least 1000 ug/ml.
`
`16.
`
`(Currently Amended) The method of claim 1, wherein the ameunt—ef—PRG4 i_s
`
`administered in an amount [[is ]]in the range of2 mg to 10 mg, 2 mg to 5 mg, or 5 mg to 10 mg.
`
`17.
`
`(Currently Amended) The method of claim 1, wherein the ameunt—ef—PRG4 i_s
`
`administered in an amount [[is ]] greater than 10 mg.
`
`18.
`
`(Previously Presented) The method of claim 1, wherein the subject is a mammal.
`
`19.
`
`(Previously Presented) The method of claim 18, wherein the subject is a human, a horse,
`
`a sheep, a pig, a dog, or a cat.
`
`
`
`Preliminary Amendment
`Submission dated July 20, 2020
`US. Application No.: 15/808,632
`Attorney Docket No.: LUB-030
`Page 4 of 6
`
`20.
`
`(Previously Presented) The method of claim 1, wherein the PRG4 is administered
`
`weekly, biweekly, monthly or quarterly.
`
`21-27. (Canceled)
`
`28.
`
`(Previously Presented) The method of claim 1, wherein the PRG4 is administered in an
`
`amount sufficient to decrease phagocytosis of monosodium urate monohydrate crystals by a
`
`macrophage in a joint.
`
`29.
`
`(New) The method of claim 2, wherein the PRG4 is recombinant human PRG4.
`
`30.
`
`(New) The method of claim 2, wherein the PRG4 is administered to the subject
`
`intra-articularly by injection into a joint having gout.
`
`31.
`
`(New) The method of claim 30, wherein the joint is selected from knee, ankle, elbow,
`
`shoulder, finger, thumb, wrist, or toe joint.
`
`32.
`
`(New) The method of claim 2, wherein the PRG4 is administered to the subject
`
`intravenously.
`
`33.
`
`(New) The method of claim 2, wherein the PRG4 is administered to the subject by
`
`injection into an area of the subject’s body affected by gout.
`
`34.
`
`(New) The method of claim 33, wherein the PRG4 is administered to a heel or instep of
`
`a foot of the subject.
`
`35.
`
`(New) The method of claim 2, wherein the composition further comprises a
`
`pharmaceutical carrier.
`
`36.
`
`(New) The method of claim 2, wherein the PRG4 is administered in an amount
`
`insufficient to provide boundary lubrication, but sufficient to treat joint pain or allodynia.
`
`
`
`Preliminary Amendment
`Submission dated July 20, 2020
`US. Application No.: 15/808,632
`Attorney Docket No.: LUB-030
`Page 5 of 6
`
`37.
`
`(New) The method of claim 2, wherein the PRG4 is administered in an amount in the
`
`range of 0.1 ug/kg to 4000 ug/kg, or 0.1 ug/kg to 1000 ug/kg, or 0.1 ug/kg to 100 ug/kg, or 0.1
`
`to 50 ug/kg.
`
`38.
`
`(New) The method of claim 2, wherein the PRG4 is administered in an amount in the
`
`range of 0.1 ug/mL to 30 mg/mL, or 1 ug/mL to 10 mg/mL, or 10 ug/mL to 1 mg/mL.
`
`39.
`
`(New) The method of claim 2, wherein the PRG4 is administered in an amount that is
`
`sufficient to achieve a concentration of PRG4 in a synovial fluid of a joint of the subject of at
`
`least 200 ug/ml, at least 300 ug/ml, at least 400 ug/ml, at least 500 ug/ml, or at least 1000 ug/ml.
`
`40.
`
`(New) The method of claim 2, wherein the PRG4 is administered in an amount in the
`
`range of2 mg to 10 mg, 2 mg to 5 mg, or 5 mg to 10 mg.
`
`41.
`
`(New) The method of claim 2, wherein the PRG4 is administered in an amount greater
`
`than 10 mg.
`
`42.
`
`(New) The method of claim 2, wherein the subject is a mammal.
`
`43.
`
`(New) The method of claim 42, wherein the subject is a human, a horse, a sheep, a pig, a
`
`dog, or a cat.
`
`44.
`
`(New) The method of claim 2, wherein the PRG4 is administered weekly, biweekly,
`
`monthly or quarterly.
`
`
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