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 5 of 7
`
`REMARKS
`
`Claim Amendments
`
`Claims 1—20 were pending in this application. Applicant has herein canceled claim 3,
`
`introduced new claim 28, and amended claims 13—17 and 20. After entry of this amendment,
`
`claims 1, 2, 4—20, and 28 will be pending and are presented for consideration.
`
`Amendments to the Claims
`
`Claims 13—17 and 20 have been amended to depend from claim 1.
`
`New claim 28 has been introduced, support for which is found at least, for example, in
`
`original claim 3 and at paragraph 10 of the application as originally filed.
`
`Applicant submits that these amendments introduce no new matter.
`
`Election of Invention
`
`The Office has set forth a restriction requirement under 35 U.S.C. § 121 requiring
`
`Applicant to elect one of the following inventions for prosecution on the merits:
`
`1) Group 1: claims 1, 2 and 4—20, drawn to a method of reducing joint pain in a subject
`
`with gout or pseudogout, and/or a method of treating gout or pseudogout in a subject,
`
`the method comprising administering to the subject a composition comprising PRG4
`
`or a biologically active fragment thereof, classified in class A61P, subclass 19/02, for
`
`example; and
`
`2) Group 2: claim 3, drawn to a method of decreasing phagocytosis of monosodium
`
`urate monohydrate (MSU) crystals by a macrophage in a patient, the method
`
`comprising administering to the subject a composition comprising PRG4 or a
`
`biologically active fragment thereof, classified in class A61K, subclass 38/17, for
`
`example.
`
`Applicant elects without traverse Group 1. Applicant submits that claims 1, 2, 4—20
`
`and 28 read on the elected invention.
`
`
`Submission dated January 17, 2019
`US. Application No.: 15/808,632
`Attorney Docket No.: LUB -030
`Page 5 of 7
`
`REMARKS
`
`Claim Amendments
`
`Claims 1—20 were pending in this application. Applicant has herein canceled claim 3,
`
`introduced new claim 28, and amended claims 13—17 and 20. After entry of this amendment,
`
`claims 1, 2, 4—20, and 28 will be pending and are presented for consideration.
`
`Amendments to the Claims
`
`Claims 13—17 and 20 have been amended to depend from claim 1.
`
`New claim 28 has been introduced, support for which is found at least, for example, in
`
`original claim 3 and at paragraph 10 of the application as originally filed.
`
`Applicant submits that these amendments introduce no new matter.
`
`Election of Invention
`
`The Office has set forth a restriction requirement under 35 U.S.C. § 121 requiring
`
`Applicant to elect one of the following inventions for prosecution on the merits:
`
`1) Group 1: claims 1, 2 and 4—20, drawn to a method of reducing joint pain in a subject
`
`with gout or pseudogout, and/or a method of treating gout or pseudogout in a subject,
`
`the method comprising administering to the subject a composition comprising PRG4
`
`or a biologically active fragment thereof, classified in class A61P, subclass 19/02, for
`
`example; and
`
`2) Group 2: claim 3, drawn to a method of decreasing phagocytosis of monosodium
`
`urate monohydrate (MSU) crystals by a macrophage in a patient, the method
`
`comprising administering to the subject a composition comprising PRG4 or a
`
`biologically active fragment thereof, classified in class A61K, subclass 38/17, for
`
`example.
`
`Applicant elects without traverse Group 1. Applicant submits that claims 1, 2, 4—20
`
`and 28 read on the elected invention.
`
`
`
`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 6 of 7
`
`Election of SQecies
`
`PRG4
`
`Applicant is required to elect a specific PRG4 or biologically active fragment thereof
`
`consisting of a defined amino acid sequence for prosecution on the merits to which the claims
`
`shall be restricted if no generic claim is finally held allowable. Applicant elects the PRG4
`
`sequence of residues 25—1404 of SEQ ID NO:1 as disclosed in Figure 7 and described at
`
`paragraph 28 of the application as originally filed. This election is made without traverse.
`
`Applicant submits that claims 1, 2, 4—20 and 28 read on the elected species.
`
`Route of Administration
`
`Applicant is required to elect a specific route of administering the PRG4 or a biologically
`
`active fragment thereof for prosecution on the merits to which the claims shall be restricted if no
`
`generic claim is finally held allowable. Applicant elects administration by injection. This
`
`election is made without traverse. Applicant submits that claims 1, 2, 4—20 and 28 read on the
`
`elected species.
`
`Joint
`
`Applicant is required to elect a specific joint from claim 7 to which the claims shall be
`
`restricted if no generic claim is finally held allowable. Applicant elects the toe. This election is
`
`made without traverse. Applicant submits that claims 1, 2, 4—7, 9—20 and 28 read on the elected
`
`species.
`
`Area of Foot
`
`Applicant is required to elect a specific area of the patient’s foot from claim 10 for
`
`prosecution on the merits to which the claims shall be restricted if no generic claim is finally
`
`held allowable. Applicant elects the heel. This election is made without traverse. Applicant
`
`submits that claims 1, 2, 4, 5, 9—20 and 28 read on the elected species.
`
`
`
`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 7 of 7
`
`Amount of PRG4
`
`Applicant is required to elect an amount of PRG4 or a biologically fragment thereof for
`
`prosecution on the merits to which the claims shall be restricted if no generic claim is finally
`
`held allowable. Applicant elects administration of an amount of PRG4 sufficient to achieve a
`
`concentration of PRG4 in a synovial fluid of a joint of the subject of at least 200 ug/ml.
`
`Applicant submits that claims 1, 2, 4—20, and 28 read on the elected species.
`
`Subject
`
`Applicant is required to elect a specific subject from claim 19 for prosecution on the
`
`merits to which the claims shall be restricted if no generic claim is finally held allowable.
`
`Applicant elects a human. Applicant submits that claims 1, 2, 4—20, and 28 read on the elected
`
`species.
`
`Administration Scheme
`
`Applicant is required to elect a specific administration scheme from claim 20 for
`
`prosecution on the merits to which the claims shall be restricted if no generic claim is finally
`
`held allowable. Applicant elects weekly administration. Applicant submits that claims 1, 2, 4—
`
`20, and 28 read on the elected species.
`
`Conclusion
`
`The Examiner is invited to telephone the undersigned with any questions regarding this
`
`submission.
`
`Dated: January 17, 2019
`
`Respectfully submitted,
`
`Tel. No.: 617—570—1513
`Fax No.: 617—523—1231
`
`ACTIVE/981514771
`
`/Crystal A. Komm]
`Crystal A. Komm
`Registration No.: 67,343
`Attorney for the Applicant
`GOODWIN PROCTER LLP
`
`100 Northern Avenue
`
`Boston, Massachusetts 02210
`
`
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