IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant(s): Yang et al.
`
`EXaIniner: Lee, Edmund H.
`
`Application No.: 10/856,176
`
`Group Art Unit: 1791
`
`Filed: May 28, 2004
`
`Docket: 1199-26
`
`For:
`
`POLYETHYLENE OXiDE(cid:173)
`BASED FILMS AND DRUG
`DELIVERY SYSTEMS MADE
`THEREFROM
`
`Dated: January 14,2008
`
`Certificate of EFS-Web Transmission
`1 hereby certify that this correspondence is being
`transmitted to the US Palent and Trademark Office via
`the Office's electronic fiiing system.
`
`_______________________ 1. _______ ('
`
`~)" __ -'"'"
`
`Dated: Januarv 14 200Y·""-. -.~
`Signature: Barbara Tho?nas/ ~.
`
`~~""-.;.:-.-.."~~~
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 223]3-1450
`
`AIVIENDlVIENT AND RESPONSE TO RESTRICTION REQUIREMENT
`
`Sir:
`
`In response to the Requirement for Restriction, mailed December 14,2007, a response to
`
`which is due January 14, 2008, please amend the above-identified application as follows.
`
`Amendments to the Claims are retlected in the listing of claims which begins on page 2
`
`of this paper.
`
`Remarks begin on page 6 of this paper.
`
`MonoSol2011-0001
`
`Dr. Reddys v. MonoSol
`IPR2016-01112
`
`
`
`Applicant(s): Yang et al.
`
`EXaIniner: Lee, Edmund H.
`
`Application No.: 10/856,176
`
`Group Art Unit: 1791
`
`Filed: May 28, 2004
`
`Docket: 1199-26
`
`For:
`
`POLYETHYLENE OXiDE(cid:173)
`BASED FILMS AND DRUG
`DELIVERY SYSTEMS MADE
`THEREFROM
`
`Dated: January 14,2008
`
`Certificate of EFS-Web Transmission
`1 hereby certify that this correspondence is being
`transmitted to the US Palent and Trademark Office via
`the Office's electronic fiiing system.
`
`_______________________ 1. _______ ('
`
`~)" __ -'"'"
`
`Dated: Januarv 14 200Y·""-. -.~
`Signature: Barbara Tho?nas/ ~.
`
`~~""-.;.:-.-.."~~~
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 223]3-1450
`
`AIVIENDlVIENT AND RESPONSE TO RESTRICTION REQUIREMENT
`
`Sir:
`
`In response to the Requirement for Restriction, mailed December 14,2007, a response to
`
`which is due January 14, 2008, please amend the above-identified application as follows.
`
`Amendments to the Claims are retlected in the listing of claims which begins on page 2
`
`of this paper.
`
`Remarks begin on page 6 of this paper.
`
`MonoSol2011-0001
`
`Dr. Reddys v. MonoSol
`IPR2016-01112
`
`
`
`Appl1cant: Yang et al.
`Application No.: 1 O!856, 176
`Response to Restriction Requirement dated January 14, 2008
`Restriction Requirement dated December 14, 2007
`Page 2
`
`Amendments to the Claims:
`
`This listing of claims will replace all prior versions, and listings, of claims in the
`
`appl ication:
`
`Listing of Claims:
`
`1-27.
`
`(Canceled)
`
`28.
`
`(Original) A process for making a film having a substantially uniform distribution of
`
`components, comprising the steps of:
`
`(a) combining at least one water-soluble polymer comprising polyethylene oxide alone or
`
`in combination with a hydrophilic cellulosic polymer, a solvent, and an active component to
`
`form a matrix with a uniform distribution of said components;
`
`(b) fonning a film from said matrix; and
`
`(c) drying said film,
`
`wherein said film is free of added plasticizers.
`
`29,
`
`(Original) The process according to Claim 28, wherein the step of forming a film from
`
`said matrix further comprises casting said matrix onto a surface having top and bottom sides.
`
`30.
`
`(Original) The process according to Claim 28, wherein the step of drying said film
`
`further comprises applying heat to said bottom side of said surface.
`
`31.
`
`(Original) A process for making a film having a substantially uniform distribution of
`
`components, comprising the steps of:
`
`(a) combining at least one water-soluble polymer comprising polyethylene oxide alone or
`
`in combination with a hydrophilic cellulosic polymer, and an active component to fom1 a matrix
`
`with a uniform distribution of said components; and
`
`(b) extruding said matrix to fonn a film,
`
`MonoSol2011-0002
`
`
`
`Applicant: Yang et al.
`Application No.: 10/856,176
`Response to Restriction Requirement dated January 14, 2008
`Restriction Requirement dated December J 4, 2007
`Page 3
`
`wherein said film is free of added plasticizers.
`
`32.
`
`(Original) The process according to Claim 31, further comprising the step of cooling said
`
`extruded film.
`
`33-36. (Canceled)
`
`37.
`
`(New) The process according to Claim 28, wherein said at least one water-soluble
`
`polymer comprises at least about 20% by weight polyethylene oxide.
`
`38.
`
`(New) The process according to Claim 28, wherein said at least one water-soluble
`
`polymer comprises up to about 100% by weight polyethylene oxide.
`
`39.
`
`(New) The process according to Claim 28, wherein said at least one water-soluble
`
`polymer comprises up to about 80% by weight polyethylene oxide.
`
`40.
`
`(New) The process according to Claim 28, wherein said hydrophilic cellulosic poly111er
`
`comprises about 0% to about 80% hydroxypropylmcthyJ cellulose.
`
`41.
`
`(New) The process according to Claim 28, wherein said hydrophilic cellulosic polymer
`
`comprises about 0(% to about 80% hydroxypropyl cellulose.
`
`4")
`
`L.
`
`(New) The process according to Claim 28, wherein said water-soluble polymer
`
`comprises said hydrophilic cellulosic polymer in a ratio of up to about 4: 1 with polyethylene
`
`oxide.
`
`MonoSol2011-0003
`
`
`
`Applicant: Yang et aI.
`Application No.: 10/856,176
`Response to Restriction Requirement dated] anuary 14, 2008
`Restriction Reauirement dated December 14. 2007
`"
`'
`Page 4
`
`.
`
`43.
`
`(New) The process according to Claim 28, wherein said at least one water-soluble
`
`polymer comprises polyethylene oxide having a molecular weight of about 100,000 to about
`
`900,000.
`
`44.
`
`(New) The process according to Claim 28, wherein said at least one water-soluble
`
`polymer comprises polyethylene oxide having a molecular weight of about 100,000 to about 4
`
`million.
`
`45.
`
`(New) The process according to Claim 28, wherein said at least one water-soluble
`
`polymer comprises polyethylene oxide having a molecular weight of about 100,000 to about
`
`300,000 in combination with polyethylene oxide having a molecular weight of about 600,000 to
`
`about 900,000.
`
`46.
`
`(New) The process according to Claim 28, wherein said at least one water-soluble
`
`polymer comprises at least 1 mg polyethylene oxide.
`
`47.
`
`(New) The process according to Claim 28, wherein said at least one water-soluble
`
`polymer comprises no greater than about 200mg polyethylene oxide.
`
`48.
`
`(New) The process according to Claim 28, wherein said active component is selected
`
`from the group consisting of cosmetic agents, phannaceutical agents, bioactive agents, and
`
`com binations thereof.
`
`49.
`
`(New) The process according to Clairn 28, wherein said matrix of step (a) further
`
`comprises a d(:nsifying agent.
`
`50,
`
`(New) The process according to Claim 49, wherein said densifying agent is simethicone.
`
`MonoSol2011-0004
`
`
`
`Applicant: Yang ct al.
`Application No.: 10/856,176
`Response to Restriction Requirement dated January 14, 2008
`Restriction Requirement dated December 14, 2007
`Page 5
`
`51.
`
`(New) The process according to Claim 28, wherein said matrix of step (a) further
`
`comprises a solubility enhancing agent.
`
`MonoSol2011-0005
`
`
`
`Claims 28-32 and 37-51 are currently pending in this application. Claims 1-27 and 33-36
`,i have been canceled as the result of a restriction requirement. Applicants retain the right to
`II
`present claims 1-27 and 33-36 in a divisional application. New claims 37-51 have been added.
`ii 11 II
`
`The new claims are all dependent upon original claim 28. No new matter has been added.
`
`In the Office Action, the Examiner has required restriction under 35 V.S.c. § 121 between
`
`one of the following Groups, which the Examiner has identified as distinct inventions:
`
`Group 1: Claims 1-27 and 33-36, drawn to a rapid-dissolve film and
`
`composition, classified in class 424, subclass 443.
`
`Group ll: Claims 28-32, drawn to a method of making the film, classified
`
`in class 264, subclass 176.1.
`
`Applicants elect to prosecute Group II, claims 28-32, drawn to a method of making the
`
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`
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`
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`
`filrn, classified in class 264, subclass 176.1.
`
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`ii
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`Ii drawn to a method of making a film. Claims 37-51 therefore correspond to the election of the
`Ii Ii Group II claims made herein.
`
`Applicants have added new claims 37-51 herein, which depend from claim 28 and are
`
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`
`MonoSol2011-0006
`
`
`
`:;
`!! Applicant: Yang et al.
`" Application No.: 10/856,176
`II Response to Restriction Requirement dbated January 14,2008
`i:: Restriction Requirement dated Decem er 14, 2007
`j
`Page 7
`Ii
`
`Applicants respectfuily request that consideration of the Group II claims on the merits be
`
`commenced. Should the Examiner have any questions, the Examiner is respectfully invited to
`
`contact the undersigned attomey at the telephone number set forth below.
`
`Respectfully submitted,
`I
`/
`
`'. \./ .... \'::/;:tL "'"'''''''''''''' .
`J ami·~;:~:. Larci~
`
`j
`
`Registration No. 48,623
`Attorney for Applicants
`
`II n
`
`II
`
`\:
`
`:\:
`
`II 1]
`il
`II HOFFMANN & BARON, LLP
`6900 Jericho Turnpike
`Syosset, NY 11791
`(973) 331-1700
`
`II
`
`11 n n
`I:
`
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`I
`
`MonoSol2011-0007
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