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Amendment and Response to Restriction Requirement mailed September 21, 2018
`Submission dated January 17, 2019
`US. Application No.: 15/808,632
`Attorney Docket No.: LUB -030
`Page 2 of 7
`
`AMENDMENTS TO THE CLAIMS
`
`Please amend the claims as indicated below:
`
`1.
`
`(Original) A method of reducing joint pain in a subject with gout or pseudogout, the
`
`method comprising administering to the subject a composition comprising PRG4 or a
`
`biologically active fragment thereof.
`
`2.
`
`(Original) A method of treating gout or pseudogout in a subject, the method comprising
`
`administering to a subject a composition comprising PRG4 or a biologically active fragment
`
`thereof.
`
`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.
`
`(Previously Presented) 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 area of the patient’s body affected by gout.
`
`

`

`Amendment and Response to Restriction Requirement mailed September 21, 2018
`Submission dated January 17, 2019
`U.S. Application No.: 15/808,632
`Attorney Docket No.: LUB -030
`Page 3 of 7
`
`10.
`
`(Original) The method of claim 9, wherein the PRG4 is administered to the heel or instep
`
`of the patient’s foot.
`
`11.
`
`(Previously Presented) The method of claim 1, wherein the composition further
`
`comprises a pharmaceutical carrier.
`
`12.
`
`(Previously Presented) 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 l[[2]], wherein the amount of PRG4
`
`administered 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 l[[2]], wherein the amount of PRG4
`
`administered 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 l[[2]], wherein the amount of PRG4
`
`administered 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 l[[2]], wherein the amount of PRG4
`
`administered is in the range of 2 mg to 10 mg, 2 mg to 5 mg, or 5 mg to 10 mg.
`
`17.
`
`(Currently Amended) The method of claim l[[2]], wherein the amount of PRG4
`
`administered is greater than 10 mg.
`
`18.
`
`(Previously Presented) The method of claim 1, wherein the subject is a mammal.
`
`

`

`Amendment and Response to Restriction Requirement mailed September 21, 2018
`Submission dated January 17, 2019
`U.S. Application No.: 15/808,632
`Attorney Docket No.: LUB -030
`Page 4 of 7
`
`19.
`
`(Original) The method of claim 18, wherein the subject is a human, horse, sheep, pig,
`
`dog, or cat.
`
`20.
`
`(Currently Amended) The method of claim l[[2]], wherein the PRG4 is a administered
`
`weekly, biweekly, monthly or quarterly.
`
`21—27. (Canceled)
`
`28.
`
`(New) 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.
`
`

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