PTO/SB/14 (06-07)
`Approved for use through 06/30/2010. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
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`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`1199-4B CIP
`
`Application Number
`
`Title of Invention
`
`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING
`COMPOSITIONS
`
`The application data sheet is part of the provisional or nonprovisional application for which it is being submitted. The following form contains the
`bibliographic data arranged in a format specified by the United States Patent and Trademark Office as outlined in 37 CFR 1.76.
`This document may be completed electronically and submitted to the Office in electronic format using the Electronic Filing System (EFS) or the
`document may be printed and included in a paper filed application.
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`Secrecy Order 37 CFR 5.2
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`Applicant Information:
`Applicant 1 (cid:9)
`Applicant Authority ®Inventor
`Prefix Given Name
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`°Legal Representative under 35 U.S.C. 117
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`0Party of Interest under 35 U.S.C. 118
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`Middle Name
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`Family Name
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`Suffix
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`Yang
`K.
`Robert
`Residence Information (Select One) (cid:9) ® US Residency (cid:9) 0 (cid:9) Non US Residency (cid:9)
`0 Active US Military Service
`City
`State/Province
`Country of Residence i US
`Flushing
`NY
`
`Citizenship under 37 CFR 1.41(b) i
`Mailing Address of Applicant:
`138-10 Franklin Avenue, Apt. 2C
`Address 1
`
`US
`
`Address 2
`
`City
`
`Flushing
`
`State/Province
`
`NY
`
`Postal Code
`
`11355
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`Countryi US
`
`Applicant 2 (cid:9)
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`Prefix Given Name
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`°Legal Representative under 35 U.S.C. 117
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`°Party of Interest under 35 U.S.C. 118
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`Family Name
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`Fuisz
`C.
`Richard
`Residence Information (Select One) (cid:9) ® US Residency (cid:9) 0 (cid:9) Non US Residency (cid:9)
`0 Active US Military Service
`City McLean
`State/Province
`Country of Residence i US
`VA
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`Citizenship under 37 CFR 1.41(b) i
`Mailing Address of Applicant:
`Address 1
`1127 Langley Lane
`
`US
`
`Address 2
`
`City
`
`McLean
`
`State/Province
`
`VA
`
`Postal Code
`
`22101
`
`Countryi US
`
`Applicant 3 (cid:9)
`Applicant Authority ®Inventor OLegal Representative under 35 U.S.C. 117
`Prefix Given Name
`Middle Name
`Family Name
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`[Party of Interest under 35 U.S.C. 118
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`Myers
`L.
`Garry
`0 Active US Military Service
`Residence Information (Select One) (cid:9) ® US Residency (cid:9) 0 (cid:9) Non US Residency (cid:9)
`Country of Residence i US
`Kingsport
`City
`State/Province
`TN
`
`EFS Web 2.2.0
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`Par Pharm., Inc., et al.
`Exhibit 1004
`Page 001
`
`

`

`PTO/SB/14 (06-07)
`Approved for use through 06/30/2010. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`1199-4B CIP
`
`Application Number
`
`Title of Invention
`
`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING
`COMPOSITIONS
`
`Citizenship under 37 CFR 1.41(b) i
`Mailing Address of Applicant:
`Address 1
`
`908 Colfax Avenue
`
`US
`
`Address 2
`
`City
`
`Kingsport
`
`State/Province
`
`TN
`
`Postal Code
`
`37660
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`Countryi US
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`Applicant 4 (cid:9)
`Applicant Authority (D Inventor
`Prefix Given Name
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`°Legal Representative under 35 U.S.C. 117
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`°Party of Interest under 35 U.S.C. 118
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`Middle Name
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`Family Name
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`Fuisz
`M.
`Joseph
`Residence Information (Select One) (cid:9) C) US Residency (cid:9) 0 (cid:9) Non US Residency (cid:9)
`0 Active US Military Service
`City Washington
`State/Province
`Country of Residence i US
`
`DC
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`Citizenship under 37 CFR 1.41(b) i
`Mailing Address of Applicant:
`Address 1
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`US
`
`1200 23rd Street, Apt. 905
`
`Address 2
`
`City
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`Washington
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`State/Province
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`DC
`
`Postal Code
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`20037
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`- (cid:9)
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`jlarmann@hoffmannbaron.com
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`Attorney Docket Number 1199-4B CIP
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`Title of the Invention
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`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING
`
`Small Entity Status Claimed (cid:9) X
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`Application Type
`
`Nonprovisional
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`Subject Matter
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`Utility
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`Suggested Class (if any)
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`Suggested Technology Center (if any)
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`Total Number of Drawing Sheets (if any)
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`34
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`Suggested Figure for Publication (if any)
`
`1
`
`EFS Web 2.2.0
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`Par Pharm., Inc., et al.
`Exhibit 1004
`Page 002
`
`

`

`PTO/SB/14 (06-07)
`Approved for use through 06/30/2010. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`1199-4B CIP
`
`Application Number
`
`Title of Invention
`
`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING
`COMPOSITIONS
`
`(cid:9) (cid:9) C. 122(b) and certify that the invention disclosed in the attached application has not and will not be the subject of
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`Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`Request Not to Publish. I hereby request that the attached application not be published under 35 U.S.
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`an application filed in another country, or under a multilateral international agreement, that requires publication at
`eighteen months after filing.
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`(4), and need not otherwise be made part of the specification.
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`10768809
`
`2004-01-30
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`10768809
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`non provisional of
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`60443741
`
`2003-01-30
`
`Prior Application Status Expired
`
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`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing Date (YYYY-MM-DD)
`
`10768809
`
`Continuation in part of
`
`PCT/US02132575
`
`2002-10-11
`
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`
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`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing Date (YYYY-MM-DD)
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`PCT/US02/32575
`
`non provisional of
`
`60386937
`
`2002-06-07
`
`Prior Application Status Pending
`
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`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing Date (YYYY-MM-DD)
`
`PCT/US02/32575
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`non provisional of
`
`10074272
`
`2002-02-14
`
`Prior Application Status Expired
`
`Remove
`
`EFS Web 2.2.0
`
`Par Pharm., Inc., et al.
`Exhibit 1004
`Page 003
`
`

`

`PTO/SB/14 (06-07)
`Approved for use through 06/30/2010. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`1199-4B CIP
`
`Application Number
`
`Title of Invention
`
`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING
`COMPOSITIONS
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing Date (YYYY-MM-DD)
`
`10074272
`
`non provisional of
`
`60328868
`
`2001-10-12
`
`Prior Application Status Expired
`
`Remove
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`Application Number
`
`Continuity Type
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`Prior Application Number
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`Filing Date (YYYY-MM-DD)
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`10768809
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`Continuation in part of
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`PCT1US02132594
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`2002-10-11
`
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`
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`
`Application Number
`
`Continuity Type
`
`Prior Application Number
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`Filing Date (YYYY-MM-DD)
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`PCT1US02132594
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`non provisional of
`
`60414276
`
`2002-09-27
`
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`
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`
`Application Number
`
`Continuity Type
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`Prior Application Number
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`PCT/US02/32594
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`non provisional of
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`60386937
`
`2002-06-07
`
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`
`Remove
`
`Application Number
`
`Continuity Type
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`Prior Application Number
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`Filing Date (YYYY-MM-DD)
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`PCT1US02132594
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`non provisional of
`
`10074272
`
`2002-02-14
`
`Prior Application Status Expired
`
`Remove
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing Date (YYYY-MM-DD)
`
`non provisional of
`
`60328868
`
`2001-10-12
`
`10074272
`
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`
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`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing Date (YYYY-MM-DD)
`
`10768809
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`Continuation in part of
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`PCT1US02132542
`
`2002-10-11
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`
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`Prior Application Number
`
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`PCT/US02/32542
`
`non provisional of
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`60386937
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`2002-06-07
`
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`Application Number
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`non provisional of
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`60371940
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`2002-04-11
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`Continuity Type
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`Prior Application Number
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`Filing Date (YYYY-MM-DD)
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`10074272
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`2002-02-14
`
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`
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`Prior Application Number
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`10074272
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`non provisional of
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`60328868
`
`2001-10-12
`
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`Application Number
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`Prior Application Number
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`Continuation in part of
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`10856176
`
`2004-05-28
`
`Prior Application Status Expired
`
`EFS Web 2.2.0
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`Remove
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`Par Pharm., Inc., et al.
`Exhibit 1004
`Page 004
`
`

`

`PTO/SB/14 (06-07)
`Approved for use through 06/30/2010. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`1199-4B CIP
`
`Application Number
`
`Title of Invention
`
`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING
`COMPOSITIONS
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing Date (YYYY-MM-DD)
`
`10856176
`
`non provisional of
`
`60473902
`
`Prior Application Status Pending
`
`2003-05-28
`
`Remove
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing Date (YYYY-MM-DD)
`
`10856176
`
`Continuation in part of
`
`10768809
`
`2004-01-30
`
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`Organization Name
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`MonoSolRx LLC
`
`Mailing Address Information:
`
`Address 1
`
`Address 2
`
`City
`
`Country i US
`
`Phone Number
`
`Email Address
`
`6560 Melton Road
`
`Portage
`
`State/Province
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`IN
`
`Postal Code
`
`Fax Number
`
`46368
`
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`
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`Signature:
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`CFR 1.4(d) for the form of the signature.
`
`Signature
`
`/Jamie M. Larmann/
`
`Date (YYYY-MM-DD) 2007-07-10
`
`First Name
`
`Jamie
`
`Last Name
`
`Larmann
`
`Registration Number
`
`48623
`
`EFS Web 2.2.0
`
`Par Pharm., Inc., et al.
`Exhibit 1004
`Page 005
`
`

`

`PTO/SB/14 (06-07)
`Approved for use through 06/30/2010. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`1199-4B CIP
`
`Application Number
`
`Title of Invention
`
`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING
`COMPOSITIONS
`
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`Par Pharm., Inc., et al.
`Exhibit 1004
`Page 006
`
`

`

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`Par Pharm., Inc., et al.
`Exhibit 1004
`Page 007
`
`

`

`1199-4B CIP
`
`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM
`INCORPORATING TASTE-MASKING COMPOSITIONS
`
`CROSS-REFERENCE TO RELATED APPLICATIONS
`[0001] (cid:9)
`
`This application is a continuation-in-part of U.S. Application No. 10/768,809,
`
`filed January 30, 2004, which claims benefit to U.S. Provisional Application No. 60/443,741
`
`filed January 30, 2003; U.S. Application No. 10/768,809 is also a continuation-in-part of
`
`PCT/US02/32575, filed October 11, 2002, which claims priority to U.S. Provisional Application
`
`No. 60/386,937, filed June 7, 2002, and U.S. Application No. 10/074,272, filed February 14,
`
`2002, which claims priority to U.S. Provisional Application No. 60/328,868, filed October 12,
`
`2001; U.S. Application No. 10/768,809 is also a continuation-in-part of PCT/US02/32594, filed
`
`October 11, 2002, which claims priority to U.S. Provisional Application No. 60/414,276, filed
`
`September 27, 2002, U.S. Provisional Application No. 60/386,937, filed June 7, 2002, and U.S.
`
`Application No. 10/074,272, filed February 14, 2002, which claims priority to U.S. Provisional
`
`Application No. 60/328,868, filed October 12, 2001; and U.S. Application No. 10/768,809 is
`
`also a continuation-in-part of PCT/US02/32542, filed October 11, 2002, which claims priority to
`
`U.S. Provisional Application No. 60/386,937, filed June 7, 2002, U.S. Provisional Application
`
`No. 60/371,940, filed April 11, 2002, and U.S. Application No. 10/074,272, filed February 14,
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`2002, which claims priority to U.S. Provisional Application No. 60/328,868, filed October 12,
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`2001; this application is also a continuation-in-part of U.S. Application No. 10/856,176, filed
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`May 28, 2004, which claims priority to U.S. Provisional Application No. 60/473,902, filed May
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`28, 2003; U.S. Application No. 10/856,176 is also a continuation-in-part of U.S. Application No.
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`10/768,809; the contents all of which are incorporated herein by reference.
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`FIELD OF THE INVENTION
`[0002] (cid:9)
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`The present invention relates to rapidly dissolving films and methods of their
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`preparation. The films contain a polymer component and active ingredients as taste-masked or
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`controlled-release coated particles uniformly distributed throughout the film.
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`1
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`Par Pharm., Inc., et al.
`Exhibit 1004
`Page 008
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`1199-4B CIP
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`BACKGROUND OF THE RELATED TECHNOLOGY
`[0003] (cid:9)
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`Active ingredients, such as drugs or pharmaceuticals, may be prepared in a tablet
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`form to allow for accurate and consistent dosing. However, this form of preparing and
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`dispensing medications has many disadvantages including that a large proportion of adjuvants
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`that must be added to obtain a size able to be handled, that a larger medication form requires
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`additional storage space, and that dispensing includes counting the tablets which has a tendency
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`for inaccuracy. In addition, many persons, estimated to be as much as 28% of the population,
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`have difficulty swallowing tablets. While tablets may be broken into smaller pieces or even
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`crushed as a means of overcoming swallowing difficulties, this is not a suitable solution for
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`many tablet or pill forms. For example, crushing or destroying the tablet or pill form to facilitate
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`ingestion, alone or in admixture with food, may also destroy the controlled release properties.
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`[0004] (cid:9)
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`As an alternative to tablets and pills, films may be used to carry active ingredients
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`such as drugs, pharmaceuticals, and the like. However, historically films and the process of
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`making drug delivery systems therefrom have suffered from a number of unfavorable
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`characteristics that have not allowed them to be used in practice.
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`[0005] (cid:9)
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`Films that incorporate a pharmaceutically active ingredient are disclosed in
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`expired U.S. Patent No. 4,136,145 to Fuchs, et al. ("Fuchs"). These films may be formed into a
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`sheet, dried and then cut into individual doses. The Fuchs disclosure alleges the fabrication of a
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`uniform film, which includes the combination of water-soluble polymers, surfactants, flavors,
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`sweeteners, plasticizers and drugs. These allegedly flexible films are disclosed as being useful
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`for oral, topical or enteral use. Examples of specific uses disclosed by Fuchs include application
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`of the films to mucosal membrane areas of the body, including the mouth, rectal, vaginal, nasal
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`and ear areas.
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`[0006] (cid:9)
`however, reveals that such films suffer from the aggregation or conglomeration of particles, i.e.,
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`Examination of films made in accordance with the process disclosed in Fuchs,
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`self-aggregation, making them inherently non-uniform. This result can be attributed to Fuchs'
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`process parameters, which although not disclosed likely include the use of relatively long drying
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`2
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`Par Pharm., Inc., et al.
`Exhibit 1004
`Page 009
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`1199-4B CIP
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`times, thereby facilitating intermolecular attractive forces, convection forces, air flow and the
`like to form such agglomeration.
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`[0007] (cid:9)
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`The formation of agglomerates randomly distributes the film components and any
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`active present as well. When large dosages are involved, a small change in the dimensions of the
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`film would lead to a large difference in the amount of active per film. If such films were to
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`include low dosages of active, it is possible that portions of the film may be substantially devoid
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`of any active. Since sheets of film are usually cut into unit doses, certain doses may therefore be
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`devoid of or contain an insufficient amount of active for the recommended treatment. Failure to
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`achieve a high degree of accuracy with respect to the amount of active ingredient in the cut film
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`can be harmful to the patient. For this reason, dosage forms formed by processes such as Fuchs,
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`would not likely meet the stringent standards of governmental or regulatory agencies, such as the
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`U.S. Federal Drug Administration ("FDA"), relating to the variation of active in dosage forms.
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`Currently, as required by various world regulatory authorities, dosage forms may not vary more
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`than 10% in the amount of active present. When applied to dosage units based on films, this
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`virtually mandates that uniformity in the film be present.
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`[0008] (cid:9)
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`The problems of self-aggregation leading to non-uniformity of a film were
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`addressed in U.S. Patent No. 4,849,246 to Schmidt ("Schmidt"). Schmidt specifically pointed
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`out that the methods disclosed by Fuchs did not provide a uniform film and recognized that that
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`the creation of a non-uniform film necessarily prevents accurate dosing, which as discussed
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`above is especially important in the pharmaceutical area. Schmidt abandoned the idea that a
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`mono-layer film, such as described by Fuchs, may provide an accurate dosage form and instead
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`attempted to solve this problem by forming a multi-layered film. Moreover, his process is a
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`multi-step process that adds expense and complexity and is not practical for commercial use.
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`[0009] (cid:9)
`and non-uniformity inherent in conventional film forming techniques. In one attempt to
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`Other U.S. Patents directly addressed the problems of particle self-aggregation
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`overcome non-uniformity, U.S. Patent 5,629,003 to Horstmann et al. and U.S. Patent 5,948,430
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`to Zerbe et al. incorporated additional ingredients, i.e. gel formers and polyhydric alcohols
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`respectively, to increase the viscosity of the film prior to drying in an effort to reduce
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`3
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`Par Pharm., Inc., et al.
`Exhibit 1004
`Page 010
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`aggregation of the components in the film. These methods have the disadvantage of requiring
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`additional components, which translates to additional cost and manufacturing steps.
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`Furthermore, both methods employ the use the conventional time-consuming drying methods
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`such as a high-temperature air-bath using a drying oven, drying tunnel, vacuum drier, or other
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`such drying equipment. The long length of drying time aids in promoting the aggregation of the
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`active and other adjuvant, notwithstanding the use of viscosity modifiers. Such processes also
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`run the risk of exposing the active, i.e., a drug, or vitamin C, or other components to prolonged
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`exposure to moisture and elevated temperatures, which may render it ineffective or even
`harmful.
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`[0010] (cid:9)
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`In addition to the concerns associated with degradation of an active during
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`extended exposure to moisture, the conventional drying methods themselves are unable to
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`provide uniform films. The length of heat exposure during conventional processing, often
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`referred to as the "heat history", and the manner in which such heat is applied, have a direct
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`effect on the formation and morphology of the resultant film product. Uniformity is particularly
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`difficult to achieve via conventional drying methods where a relatively thicker film, which is
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`well-suited for the incorporation of a drug active, is desired. Thicker uniform films are more
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`difficult to achieve because the surfaces of the film and the inner portions of the film do not
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`experience the same external conditions simultaneously during drying. Thus, observation of
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`relatively thick films made from such conventional processing shows a non-uniform structure
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`caused by convection and intermolecular forces and requires greater than 10% moisture to
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`remain flexible. The amount of free moisture can often interfere over time with the drug leading
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`to potency issues and therefore inconsistency in the final product.
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`[0011] (cid:9)
`drying oven, drying tunnel, and the like. The difficulty in achieving a uniform film is directly
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`Conventional drying methods generally include the use of forced hot air using a
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`related to the rheological properties and the process of water evaporation in the film-forming
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`composition. When the surface of an aqueous polymer solution is contacted with a high
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`temperature air current, such as a film-forming composition passing through a hot air oven, the
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`surface water is immediately evaporated forming a polymer film or skin on the surface. This
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`seals the remainder of the aqueous film-forming composition beneath the surface, forming a
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`4
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`Par Pharm., Inc., et al.
`Exhibit 1004
`Page 011
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`1199-4B CIP
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`barrier through which the remaining water must force itself as it is evaporated in order to achieve
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`a dried film. As the temperature outside the film continues to increase, water vapor pressure
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`builds up under the surface of the film, stretching the surface of the film, and ultimately ripping
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`the film surface open allowing the water vapor to escape. As soon as the water vapor has
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`escaped, the polymer film surface reforms, and this process is repeated, until the film is
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`completely dried. The result of the repeated destruction and reformation of the film surface is
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`observed as a "ripple effect" which produces an uneven, and therefore non-uniform film.
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`Frequently, depending on the polymer, a surface will seal so tightly that the remaining water is
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`difficult to remove, leading to very long drying times, higher temperatures, and higher energy
`costs.
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`[0012] (cid:9)
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`Other factors, such as mixing techniques, also play a role in the manufacture of a
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`pharmaceutical film suitable for commercialization and regulatory approval. Air can be trapped
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`in the composition during the mixing process or later during the film making process, which can
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`leave voids in the film product as the moisture evaporates during the drying stage. The film
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`frequently collapse around the voids resulting in an uneven film surface and therefore, non-
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`uniformity of the final film product. Uniformity is still affected even if the voids in the film
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`caused by air bubbles do not collapse. This situation also provides a non-uniform film in that the
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`spaces, which are not uniformly distributed, are occupying area that would otherwise be
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`occupied by the film composition. None of the above-mentioned patents either addresses or
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`proposes a solution to the problems caused by air that has been introduced to the film.
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`[0013] (cid:9)
`use a minimal number of materials or components, and which provide a substantially non-self-
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`Therefore, there is a need for methods and compositions for film products, which
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`aggregating uniform heterogeneity throughout the area of the films. Desirably, such films are
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`produced through a selection of a polymer or combination of polymers that will provide a
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`desired viscosity, a film-forming process such as reverse roll coating, and a controlled, and
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`desirably rapid, drying process which serves to maintain the uniform distribution of non-self-
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`aggregated components without the necessary addition of gel formers or polyhydric alcohols and
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`the like which appear to be required in the products and for the processes of prior patents, such
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`as the aforementioned Horstmann and Zerbe patents. Desirably, the films will also incorporate
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`5
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`Par Pharm., Inc., et al.
`Exhibit 1004
`Page 012
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`1199-4B CIP
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`compositions and methods of manufacture that substantially reduce or eliminate air in the film,
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`thereby promoting uniformity in the final film product.
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`SUMMARY OF THE INVENTION
`[0014] (cid:9)
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`In one aspect, this invention provides rapid-dissolve film prod