Amendment and Response to Non-Final Office Action mailed April 8, 2019
`Submission dated October 8, 2019
`US. Application No.: 15/808,632
`Attorney Docket No.: LUB-030
`Page 6 of 9
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`REMARKS
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`Claim Amendments
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`Claims 1, 2, 4-20, and 28 were pending in this application. Applicant has herein
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`amended claims 1, 2, 9, l9, and 20. Claims 8 and 10 have been withdrawn for being directed to
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`non-elected species. After entry of this amendment, claims 1, 2, 4-20, and 28 will be pending
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`and are presented for consideration.
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`Amendments to the Claims
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`Claims 1 and 2 are amended to recite a composition comprising proteoglycan 4 (PRG4)
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`comprising the amino acid sequence of residues 25-1404 of SEQ ID NO: 1. Support for this
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`amendment is found in the application as originally filed, for example, at least in paragraphs 28
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`and 42, and in Figure 7.
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`Claims 9, l9, and 20 have been amended to provide clarity, for antecedent basis
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`purposes, and to correct minor typographical and grammatical errors.
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`Applicant submits that these amendments introduce no new matter.
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`Objections to the Specification
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`Claim 1 is objected to for reciting the acronym PRG4. Applicant has amended claim 1 to
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`define the acronym as proteoglycan 4. In view of this amendment, Applicant believes the
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`objection should be obviated.
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`Claim 2 is objected to for the reason outlined on page 5, paragraph 12 of the Office
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`action. Applicant has amended claim 2 to recite “a method of treating gout or pseudo gout in a
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`subject in need thereof, the method comprising administering to the subject...” as requested by
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`the Examiner. Accordingly, the objection should be obviated.
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`Claim 9 is objected to for the reason outlined on page 5, paragraph 13 of the Office
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`action. Applicant has amended claim 9 to replace the recitation of “patient” with “subject,”
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`thereby obviating the objection.
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`Claim 19 is objected to for minor informalities in wording. Applicant has amended the
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`claim to provide clarity and believes the rejection should be obviated.
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`

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`Amendment and Response to Non-Final Office Action mailed April 8, 2019
`Submission dated October 8, 2019
`US. Application No.: 15/808,632
`Attorney Docket No.: LUB-030
`Page 7 of 9
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`Claim 20 is objected to for having an errant “a” which Applicant has removed by
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`amendment, thereby obviating the objection.
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`Reieclion under 35 U.S.C. § 102(a)(1)
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`Claims 1, 2, 4-7, 9, 11-19, and 28 stand rejected as being anticipated under 35 U.S.C. §
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`102(a)(1) by US. Patent Application Publication No. 2013/0116186 to Jay (“Jay”) as evidenced
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`by Fryar, 2018, National Health Statistics Reports 122: 1-16 (“Fryar”).
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`According to the Office action at page 5, which refers to paragraph 29 of Jay, “Jay
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`teaches a method of treating [a] subject with an episodic case of gout or pseudo-gout” by “intra-
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`articularly injecting lubricin (PRG4) into the joints such as the knee, toe,” etc. However, no
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`where does Jay teach administering PRG4 having the amino acid sequence of residues 25-1404
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`of SEQ ID NO:1.
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`“A claim is anticipated only if each and every element as set forth in the claim is found,
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`either expressly or inherently described, in a single prior art reference.” Verdegaal Bros. v.
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`Union Oil Co. ofCalifornia, 814 F.2d 628, 631, USPQ2d 1051, 1053 (Fed. Cir. 1987).
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`Accordingly, Applicant submits that independent claim 1 as amended and its dependents, as well
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`as independent claim 2 as amended, are not anticipated by the teachings of Jay. Fryar has
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`nothing to do with lubricin (PRG4) and therefore also does not anticipate the claimed invention
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`as amended.
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`For at least these reasons, the rejection of claim 1, 2, 4-7, 9, 11-19, and 28 as being
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`anticipated by Jay should be reconsidered and withdrawn.
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`Reieclion under 35 U.S.C. § 103(a)(1)
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`Claims 1, 2, 4-7, 9, 11-20, and 28 stand rejected as being obvious under 35 U.S.C. § 103
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`over Jay as evidenced by Fryar.
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`According to the Office action, the difference between the anticipation rejection above
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`and this obviousness rejection is that Jay “does not explicitly teach weekly administration as the
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`elected species of administering. .
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`. and the limitation of instant claim 20.” (Office action,
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`page 12). However, the Office states that one of ordinary skill in the art would have been
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`

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`Amendment and Response to Non-Final Office Action mailed April 8, 2019
`Submission dated October 8, 2019
`US. Application No.: 15/808,632
`Attorney Docket No.: LUB-030
`Page 8 of 9
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`motivated to optimize the administering scheme to reduce joint pain including weekly
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`administration.”
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`Whether or not this is motivation exists, a point that Applicant will not acquiesce to, Jay
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`still fails to teach a species of PRG4 having the amino acid sequence of residues 25-1404 of SEQ
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`ID NO:1 as claimed. The Examiner has provided no reasoning why this particular feature of the
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`claimed invention is obvious. The teachings of Fryar fail to remedy the deficiencies of Jay as
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`Fryar is not even concerned with lubricin (PRG4).
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`Accordingly, in view of the amendments to claims 1 and 2, Applicant submits that these
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`claims and any claims dependent thereon are not obvious under 35 U.S.C. § 103 over Jay as
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`evidenced by Fryar. Applicant therefore requests that the rejection be reconsidered and
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`withdrawn.
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`Provisional Obviousness-zgge Double Parenting
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`Claims 1, 2, 4, 5, 9, 11-13 stand provisionally rejected on the ground of non-statutory
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`obviousness-type double patenting as being unpatentable over claims 1, 2, 4, 6, 8, 11, 12, 14, 15,
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`21, 33, and 43 of co-pending Application No. 15/546,192 (“the ’ 192 application”). Applicant
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`respectfully requests that this provisional rejection be withdrawn as the claims in the ’192
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`application were amended on May 7, 2019. Independent claim 1 (from which claims 2, 4, 6, 8,
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`11, 12, 14, and 15 depend) of the ’192 application is now directed to a method of reducing or
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`inhibiting an inflammatory response associated with inflammatory bowel disease. Independent
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`claim 21 (from which claim 33 depends) has also been amended and is now directed to a method
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`of treating inflammation associated with inflammatory bowel disease. Claim 43 has been
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`canceled. Accordingly, the claims of the ’192 application are no longer directed treating gout or
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`pseudogout; the instant claims are therefore patentably distinct from the claims of the ’192
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`application. For these reasons, Applicant respectfully requests that this provisional double
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`patenting rejection be reconsidered and withdrawn.
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`Amendment and Response to Non-Final Office Action mailed April 8, 2019
`Submission dated October 8, 2019
`US. Application No.: 15/808,632
`Attorney Docket No.: LUB-030
`Page 9 of 9
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`Conclusion
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`Applicant submits that the claims are now in condition for allowance. The Examiner is
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`invited to telephone the undersigned with any questions regarding this submission.
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`Dated: October 8, 2019
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`Respectfully submitted,
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`Tel. No.: 617-570-1513
`Fax No: 617-523-1231
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`ACTIVE/981514771
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`/Cflstal A. Komm/
`Crystal A. Komm
`Registration No.: 67,343
`Attorney for the Applicant
`GOODWIN PROCTER LLP
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`100 Northern Avenue
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`Boston, Massachusetts 02210
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