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`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`CERTIFICATE OF CORRECTION
`
`PATENT NO.
`APPLICATION NO.
`
`: 7,357,891 C1
`: 90/012098
`
`DATED
`INVENTOR(S)
`
`: August 21, 2012
`: Yang et 211.
`
`Page 1 of]
`
`It is certified that error appears in the above-identified patent and that said Letters Patent is hereby corrected as shown below:
`
`Title page, item [73], Assignee: Reexamination Certificate should read: MonoSol Rx, LLC.
`
`Signed and Sealed this
`
`Twenty-third Day of October, 2012
`
`
`
`17‘ 3: {was
`
`David J. Kappos
`
`Page 59
`
`

`

`(12) EX PARTE REEXAMINATION CERTIFICATE (9222nd)
`United States Patent
`US 7,357,891 C1
`(10) Number:
`
` (45) Certificate Issued: Aug. 21, 2012
`Yang et al.
`
`USOO7357891C1
`
`(54) PROCESS FOR MAKING AN INGESTIBLE
`FILM
`
`(51)
`
`(75)
`
`Inventors: Robert K. Yang, Flushing, NY (US);
`Richard C. Fuisz, McLean, VA (US);
`Gary L. Myers, Kingsport, TN (US);
`Joseph M. Elisz, McLean, VA (US)
`
`(73) Assignee: White Oak Global Advisors, LLC, San
`Francisco, CA (US)
`
`Reexamination Request:
`No. 90/012,098, Jan. 20, 2012
`
`Reexamination Certificate for:
`Patent No.:
`7,357,891
`Issued:
`Apr. 15, 2008
`Appl. No.:
`10/768,809
`Filed:
`Jan. 30, 2004
`
`Certificate of Correction issued Jul. 15, 2008.
`
`Related US. Application Data
`
`Int. Cl.
`329C 47/88
`A61K 9/00
`A61K 9/70
`F26B 13/10
`F26B 13/20
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`.................... 264/211.12; 264/234; 264/260
`(52) US. Cl.
`(58) Field of Classification Search
`None
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`To view the complete listing of prior art documents cited
`during the proceeding for Reexamination Control Number
`90/012,098, please refer to the USPTO’s public Patent
`Application Information Retrieval (PAIR) system under the
`Display References tab.
`
`Primary Examiner—Alan Diamond
`
`(57)
`
`ABSTRACT
`
`(63) Continuation-impart of application No. PCT/USOZ/32575.
`filed on Oct. 11. 2002, and a continuation-in-part of applica-
`tion No. PCT/USOZ/32594, filed on Oct. 11, 2002, and a
`continuation-in-part of application No. PCT/USOZ/32542.
`filed on Oct. 11,2002
`12,
`l’mvisiunrli
`tipplicnlinn Nu. 001335.358, filed on Oct
`200i. pwvlsioual application NI}. 60/136,037. filed on Jun.
`‘1‘.
`.2003. pmvisinnal applicaliun Nu. 6t)xdl4.27€a.
`filed on
`Sep. 2?. 2002. pi'uvisinnnl application No. (“J/Ii? | .9610. liled
`on Apr
`it, 2002, and provisional application Nu. 6111443,
`741, filed on Jan. 30, 2003.
`
`(60)
`
`The invention relates to film products containing desired 1ev~
`els of active components and methods of their preparation.
`Desirably, the films disintegrate in water and may be formed
`by a controlled drying process, or other process that main-
`tains the required uniformity of the film. Desirably, the films
`may be exposed to temperatures above that at which the
`active components typically degrade without concern for
`loss of the desired activity.
`
`20
`
`
`
`Page 60
`
`

`

`US 7,357,891 C1
`
`1
`EX PARTE
`
`REEXAMINATION CERTIFICATE
`
`ISSUED UNDER 35 U.S.C. 307
`
`2
`tained at said desired level, wherein said desired level is
`measured by substantially equally-sized individual unit
`doses which do not vary by more than 10% ofsaidpharma—
`ceutical or biological active component.
`
`THE PATENT IS HEREBY AMENDED AS
`INDICATED BELOW.
`
`12. Theprocess ofclaim 10, wherein said matrix is in the
`form ofa solution, emulsion, or suspension.
`
`Matter enclosed in heavy brackets [ ] appeared in the
`patent, but has been deleted and is no longer a part of the
`patent; matter printed in Italics indicates additions made
`to the patent.
`
`AS A RESULT OF REEXAMINATION, IT HAS BEEN
`DETERMINED THAT:
`
`Claims 1-9 are cancelled.
`
`New claims 10—28 are added and determined to be patent-
`able.
`
`20
`
`13. The process ofclaim 11, wherein said matrix is in the
`form ofa solution, emulsion, or suspension.
`
`10
`
`14. The process ofclaim 10, wherein said hot air currents
`have a temperature of 70° C. to 100° C.
`
`15. The process ofclaim 10, wherein said hot air currents
`have a temperature ofabout 80° C. to about 100° C.
`
`16. The process ofclaim 11, wherein said step ofapplying
`heat comprises applying heat at a temperature of 70° C. to
`100° C.
`
`1 7. The process ofclaim 11, wherein the step ofapplying
`heat comprises applying heat at a temperature ofabout 80°
`C. to about 100° C.
`
`18. The process ofclaim 10, wherein any hot air current
`velocities on the top side of said surface are insuficient to
`overcome the inherent viscosity ofsaidfilm.
`
`30
`
`19. The process of claim 10, wherein said drying step
`maintains a non-self-aggregating uniform heterogeneity of
`said components throughout saidfilm.
`
`20. The process ofclaim 10, wherein saidfilm isflexible
`when dried.
`
`21. The process of claim 10, wherein said film is self-
`supporting.
`
`40
`
`22. The process ofclaim 10, wherein said drying ofsaid
`film reduces the weight percent ofsaid water to about 10%
`or less.
`
`4s
`
`50
`
`23. The process of claim 11, wherein said drying step
`maintains a non-seIf-aggregating uniform heterogeneity of
`said components throughout saidfilm.
`
`24. The process ofclaim 11, wherein saidfilrn isflexible
`when dried.
`
`25. The process of claim 11, wherein said film is self-
`supporting.
`
`26. The process ofclaim 11, wherein said drying ofsaid
`film reduces the weight percent ofsaid water to about 10%
`or less.
`
`SS
`
`27. The process of claim 10, wherein the step (d) offeed—
`ing saidfilm onto said top side of said surface comprises
`feeding saidfilm onto the top side ofan already-formedfilm
`layer.
`
`28. The process ofclaim 11, wherein the step (g) offeed-
`ing saidfilm onto said top side of said surface comprises
`feeding saidfilm onto the top side afan already-formedfilm
`layer.
`
`60
`
`65
`
`10. A processfor making an ingestiblefilrn having a sub-
`stantially unwrrm distribution ofcomponents and a desired
`level of a pharmaceutical or biological active component,
`comprising the steps of: (a) combining a polymer compo—
`nent, water and a pharmaceutical or biological active corn—
`ponent tofirrm a matrix with a uniform distribution ofsaid
`components; (b)forming afilmfrom said matrix; (c) provid—
`ing a conveyor surface having top and bottom sides; (d)
`feeding saidfilm onto said top side of said surface; and (e)
`drying saidfilm within about 10 minutes or ewer by apply—
`ing hot air currents to said bottom side of said conveyor
`surface with substantially no hot air currents on the top side
`of said surface and exposing said film to a temperature
`above a degradation temperature ofsaid pharmaceutical or
`biological active component, wherein said degradation tem—
`perature is 70° C. or higher; wherein saidpharmaceutical or
`biological active component is maintained at said desired
`level, wherein said desired level is measured by substantially
`equially-sized individual unit doses which do not vary by
`more than 10% ofsaid pharmaceutical or biological active
`component.
`
`11. A processfor making an ingestiblefilrn having a sub-
`stantially uniform distribution of components and a desired
`level of a pharmaceutical or biological active component,
`comprising the steps of: (a)forming a masterbatch premix of
`a water-solublepolymer component and water; (b)feeding a
`predetermined amount ofsaid premix to at least one mixer;
`(c) adding a pharmaceutical or biological active component
`to said at least one mixer; (d) mixing saidpharmaceutical or
`biological active component and saidpredetermined amount
`ofsaidpremix toform a matrix having a uniform distribution
`of components; (e) forming a film from said matrix; (D pro—
`viding a conveyor surface having top and bottom sides; (g)
`feeding saidfilrn onto said top side ofsaidsury’ace; and (h)
`drying saidfilm by applying heat to said bottom side ofsaid
`conveyor surface and exposing saidfilm to a temperature
`above a degradation temperature ofsaid pharmaceutical or
`biological active component, wherein said degradation tern—
`perature is 70° C. or higher; wherein said drying stepfurther
`comprises rapidly forming a visco-elastic film within about
`the first 4.0 minutes by applying hot air currents to said
`bottom side ofsaid surface in the absence ofhot air currents
`on the top side ofsaid surface; and drying said visco-e/astic
`
`Page 61
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