`USSN 12/536,807
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicants:
`
`VERMEERSCH, Hans Wim Pieter et al.
`
`Serial No.:
`
`12/536,807
`
`Art Unit: 1614
`
`Filed:
`
`For :
`
`August 6, 2009
`
`Confirmation #4088
`
`PSEUDOPOLYMORPHIC FORMS OF A HIV PROTEASE INHIBITOR
`
`CERTIFICATE OF EFS TRANSMISSION
`
`I hereby certify that this paper (along with amy paper referred to as being attached or enclosed) is being transmitted to
`the United States Patent aaad Trademark Office on the date shown below via the "Electronic Filing System" in
`accordaaace with 37 C.F.R. § 1.6(a)(4).
`
`Evelina Smith
`
`Type or print name
`
`/Evelina Smith/
`
`Signature
`
`July 2, 2010
`
`Date
`
`Mail Stop PCT
`Commissioner for Patents
`P. O. Box 1450
`Alexandria, VA 22313-1450
`
`SUPPLEMENTAL PRELIMINARY AMENDMENT
`
`Dear Sir:
`
`Prior to examination and calculation of fees due, please amend the above-
`
`identified application as follows.
`
`Amendments to the Specification begin on page
`
`of this paper.
`
`[]
`
`Amendments to the claims are reflected in the listing of the claims that
`begins on page 2 of this paper.
`
`Amendments to the Drawings begin on page
`include an attached replacement sheet.
`
`of this paper and
`
`Remarks begin on 4 of this paper.
`
`1 of 5
`
`Lupin Ex. 1008 (Page 1 of 5)
`
`
`
`Attorney Docket No. TIP0033USDIV1
`USSN 12/536,807
`
`Listing of Claims:
`
`This listing of claims replaces all prior versions, and listings, of claims in the
`
`captioned application.
`
`Claims 1- 14 Cancelled
`
`15. (New) A hydrate of the compound (3 R,3 aS,6aR)-hexahydrofuro [2,3-b] furan-
`
`3-yl (1 S,2R)-3-[[(4-aminophenyl) sulfonyl] (isobutyl) amino]-l-benzyl-2-
`
`hydroxypropylcarbamate~-in which the ratio of compound to ethanol is about
`
`1:1.
`
`16. (New) A solvate having the formula:
`
`H
`
`¯ H20
`
`OH
`
`17. (New) A composition comprising an hydrate of the compound (3R,3aS,6aR)-
`
`hexahydrofuro [2,3-b] furan-3-yl (1 S,2R)-3-[[(4-aminophenyl)sulfonyl]
`
`(isobutyl) amino]-l-benzyl-2- hydroxypropylcarbamate, in which the ratio of
`
`compound to ethanol is about 1:1, and an inert carrier.
`
`18. (New) A composition comprising a solvate having the formula:
`
`H
`
`¯ H20
`
`OH
`
`and an inert carrier.
`
`2 of 5
`
`Lupin Ex. 1008 (Page 2 of 5)
`
`
`
`Attorney Docket No. TIP0033USDIV1
`USSN 12/536,807
`
`19. (New) The composition of claim 16 wherein the inert carrier is a
`
`pharmaceutically acceptable carrier.
`
`20. (New) The composition of claim 17 wherein the inert carrier is a
`
`pharmaceutically acceptable carrier.
`
`21. (New) The composition of claim 319 wherein the pharmaceutically
`
`acceptable carrier is a solid inert carrier.
`
`22. (New) The composition of claim 20 wherein the pharmaceutically acceptable
`
`carrier is a solid inert carrier.
`
`3 of 5
`
`Lupin Ex. 1008 (Page 3 of 5)
`
`
`
`Attorney Docket No. TIP0033USDIV1
`USSN 12/536,807
`
`REMARKS
`
`Consideration of the captioned application in view of the foregoing amendments
`
`and following remarks is requested.
`
`This application is a divisional of U.S.S.N. 10/514,352. Claims 1-13 are hereby
`
`cancelled without disclaimer of, or prejudice to, the subject matter therein. Claim 14
`
`was cancelled in the Preliminary Amendment. New claims 15-22 are hereby added. No
`
`new matter has been added.
`
`In the parent application (U.S.S.N. 10/514,352), the Examiner issued a restriction
`
`requirement among three groups. See Office Action mailed August 29, 2007 at page 2:
`
`group is ~l~ted, a f’u~h~r el¢cti.on of’~ s[~g~.¢ disck~.se~ ~olvat~ comtxmnd is also req~ited.
`
`hexahydrott~ro [2,3-b] f~ra~- )-,yt (1 S,2R73.~[ [(4-ami~x~f~he~yt) sul~myll (isobutyt.) amb:~o~-~-
`benzyl-2~ hydr(~xypropylc~rbamate s~l. e~c~m~passed by g~ps [ aud I1. If ~t~is ~up i~ elected,
`
`New claims 15-22 read on Group II.
`
`Early favourable action on the merits is respectfully requested.
`
`4of5
`
`Lupin Ex. 1008 (Page 4 of 5)
`
`
`
`Attorney Docket No. TIP0033USDIV1
`USSN 12/536,807
`
`Applicant respectfully requests that a timely Notice of Allowance of claims 15-
`
`22 be issued in this case.
`
`Respectfully submitted,
`
`By:
`
`/Alana G. Kriegsman/
`
`Alana Kriegsman, Esq.
`Reg. No. 41,747
`
`Johnson & Johnson
`One Johnson & Johnson Plaza
`New Brunswick, NJ 08933-7003
`(732) 524-1495
`Dated: July 2, 2010
`
`5 of 5
`
`Lupin Ex. 1008 (Page 5 of 5)
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