`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
` (cid:9)
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Dr. Reddy's - EX1004
`Page 1
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
` (cid:9)
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Page 2
`
`

`

`(cid:9) (cid:9)
`
`PTO/SBI14 (06—07)
`
`Approved for use through 06/302010. OMB 0651—0032
`
`
`
`
`
`
`US. Patent and Trademark Office; US. 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
`
`
`_
`_
`Application Number
`
`
`
`
`
`
`1199—43 CIP
`
`
`
`
`
`
`
`
`Publication Information:
`|:| 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 US
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Cl C. 122(b) and certify that the invention disclosed in the attached application has not and will not be the subject of
`an application filed in another country, or under a multilateral international agreement. that requires publication at
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`eighteen months after filing.
`
`
`
`
`
`Title of Invention
`
`
`
`
`
`
`
`
`
`
`
`
`
`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING
`COMPOSITIONS
`
`
`
`
`
`
`
`Representative Information:
`
`
`
`Representative information should be provided for all practitioners having a power of attorney in the application. Providing
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`this information in the Application Data Sheet does not constitute a power of attorney in the application (see 37 CFR 1.32).
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`sections
`Enter
`either Customer Number
`complete
`Representative Name
`below.
`both
`or
`section
`If
`the
`
`
`
`
`
`
`
`
`
`
`
`
`
`are completed the Customer Number will be used for the Representative Information during processing.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Please Select One:
`Customer Number
`
`
`
`
`
`
`
`
`
`
`@ Customer Number
`
`
`
`0 US Patent Practitioner
`
`
`
`
`
`
`0 Limited Recongnition (37 CFR 11.9)
`
`
`
`
`
`
`
`
`
`
`
`
`
`Domestic Benefit Information:
`This section allows for the applicant to claim benefit under 35 U.S.C. 119(e), 120, 121, or 365(0). Providing this information in the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`application data sheet constitutes the specific reference required by 35 U.S.C. 119(e) or 120, and 37 CFR 1.78(a)(2) or CFR 1.78(a)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`(4), and need not otherwise be made part of the specification.
`
`
`
`
`
`
`
`
`
`
`
`
`Prior Application Status
`Pending
`
`
`
`
`
`Filing Date (YYYY-MM-DD)
`Prior Application Number
`Continuity Type
`Application Number
`
`
`
`
`
`
`
`
`
`
`
`Continuation in part of
`10768809
`2004-01-30
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Expired
`Prior Application Status
`
`
`Application Number
`Continuity Type
`Prior Application Number
`Filing Date (YYYY-MM-DD)
`
`
`
`
`
`
`
`
`
`
`60443741
`2003—01—30
`
`10768809
`
`
`
`non provisional of
`
`
`
`
`
`
`
`
`
`EFS Web 2.2.0
`
`
`
`
`
`Prior Application Status
`
`
`
`
`
`Application Number
`Continuity Type
`Prior Application Number
`Filing Date (YYYY-MM-DD)
`
`
`
`
`
`
`
`
`
`
`
`Expired
`
`
`
`10768809
`
`Continuation in part of
`
`
`
`
`
`
`
`
`Prior Application Status
`Expired
`
`
`
`
`
`
`PCT/U802/32575
`
`2002-10-11
`
`Filing Date (YYYY-MM-DD)
`Prior Application Number
`Continuity Type
`Application Number
`
`
`
`
`
`
`
`
`
`
`
`PCT/USOZ/32575
`60386937
`2002-06-07
`non provisional of
`
`
`
`
`
`
`
`Prior Application Status
`
`
`
`
`
`Pending
`
`
`
`
`
`Application Number
`
`PCT/USOZ/32575
`
`
`
`Continuity Type
`
`
`
`
`
`
`Prior Application Number
`
`
`10074272
`
`Filing Date (YYYY-MM-DD)
`
`
`2002—02—14
`
`non provisional of
`
`
`
`
`
`
`
`Prior Application Status Expired
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Page 3
`
`

`

`PTO/SBI‘M (06—07)
`
`Approved for use through 06/302010. OMB 0651—0032
`
`
`
`
`
`
`US. Patent and Trademark Office; US. 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.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1199—43 CIP
`Attorney Docket Number
`
`
`
`
`
`
`
`
`
`
`
`
`Application Data Sheet 37 CFR 1.76
`Application Number
`
`
`
`
`
`
`
`
`
`
`
`
`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING
`COMPOSITIONS
`
`
`
`
`Title of Invention
`
`
`
`
`
`
`Application Number
`Continuity Type
`Prior Application Number
`Filing Date (YYYY-MM-DD)
`
`
`
`
`
`
`
`
`
`
`60328868
`2001—10—12
`
`10074272
`
`
`
`non provisional of
`
`
`
`
`
`
`
`
`
`
`Expired
`Prior Application Status
`
`
`
`
`
`Application Number
`Continuity Type
`Prior Application Number
`Filing Date (YYYY-MM-DD)
`
`
`
`
`
`
`
`
`
`
`Continuation in part of
`PCT/USO2/32594
`2002-10-11
`
`
`
`
`
`
`
`
`
`
`
`
`Prior Application Status
`Expired
`
`
`10768809
`
`Filing Date (YYYY-MM-DD)
`Prior Application Number
`Continuity Type
`Application Number
`
`
`
`
`
`
`
`
`
`
`
`PCT/USOZ/32594
`60414276
`2002-09-27
`non provisional of
`
`
`
`
`
`
`
`
`Expired
`Prior Application Status
`
`
`
`
`
`Application Number
`Continuity Type
`Prior Application Number
`Filing Date (YYYY-MM-DD)
`
`
`
`
`
`
`
`
`
`
`PCT/U802/32594
`60386937
`2002—06—07
`
`non provisional of
`
`
`
`
`
`
`
`
`Prior Application Status
`Pending
`
`
`
`
`
`Filing Date (YYYY-MM-DD)
`Prior Application Number
`Continuity Type
`Application Number
`
`
`
`
`
`
`
`
`
`
`
`PCT/US02/32594
`10074272
`2002-02-14
`non provisional of
`
`
`
`
`
`
`
`
`
`
`
`Expired
`Prior Application Status
`
`
`Application Number
`Continuity Type
`Prior Application Number
`Filing Date (YYYY-MM-DD)
`
`
`
`
`
`
`
`
`
`
`60328868
`2001—10—12
`
`10074272
`
`
`
`non provisional of
`
`
`
`
`
`
`
`
`
`10768809
`
`Remove
`Expired
`Prior Application Status
`
`
`
`
`
`
`Application Number
`Continuity Type
`Prior Application Number
`Filing Date (YYYY-MM-DD)
`
`
`
`
`
`
`
`
`
`
`Continuation in part of
`PCT/USO2/32542
`2002-10-11
`
`
`
`
`
`
`
`
`
`
`
`
`Prior Application Status
`Expired
`
`Filing Date (YYYY-MM-DD)
`Prior Application Number
`Continuity Type
`Application Number
`
`
`
`
`
`
`
`
`
`
`
`PCT/U802/32542
`60386937
`2002-06-07
`non provisional of
`
`
`
`
`
`
`
`
`Expired
`Prior Application Status
`
`
`
`
`
`Application Number
`Continuity Type
`Prior Application Number
`Filing Date (YYYY-MM-DD)
`
`
`
`
`
`
`
`
`
`
`PCT/U802/32542
`60371940
`2002—04—11
`
`non provisional of
`
`
`
`
`
`
`
`
`Prior Application Status
`Pending
`
`
`
`
`
`Filing Date (YYYY-MM-DD)
`Prior Application Number
`Continuity Type
`Application Number
`
`
`
`
`
`
`
`
`
`
`
`PCT/US02/32542
`10074272
`2002-02-14
`non provisional of
`
`
`
`
`
`
`
`
`
`
`
`Expired
`Prior Application Status
`
`
`Application Number
`Continuity Type
`Prior Application Number
`Filing Date (YYYY-MM-DD)
`
`
`
`
`
`
`
`
`
`
`60328868
`2001—10—12
`
`10074272
`
`
`
`non provisional of
`
`
`
`
`
`
`
`
`
`EFS Web 2.2.0
`
`
`
`
`Remove
`Pending
`Prior Application Status
`
`
`
`
`
`
`Application Number
`Continuity Type
`Prior Application Number
`Filing Date (YYYY-MM-DD)
`
`
`
`
`
`
`
`
`
`
`Continuation in part of
`10856176
`2004—05—28
`
`
`
`
`
`
`
`
`
`
`Prior Application Status
`
`
`
`
`
`
`
`
`
`
`
`Expired
`
`
`
`
`
`Page 4
`
`

`

`PTO/SBI‘M (06—07)
`
`Approved for use through 06/302010. OMB 0651—0032
`
`
`
`
`
`
`US. Patent and Trademark Office; US. 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
`
`
`_
`_
`Application Number
`
`
`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING
`
`
`
`
`
`
`
`
`COMPOSITIONS
`
`
`
`
`1199—43 CIP
`
`
`
`
`
`
`
`
`Title of Invention
`
`
`
`
`
`
`EFS Web 2.2.0
`
`Filing Date (YYYY-MM-DD)
`Prior Application Number
`Continuity Type
`Application Number
`
`
`
`
`
`
`
`
`
`
`
`60473902
`2003—05—28
`10856176
`non provisional of
`
`
`
`
`
`
`
`
`
`
`
`Prior Application Status
`
`
`
`Application Number
`
`
`
`
`
`
`10856176
`
`
`
`Pending
`
`
`
`Continuity Type
`
`Continuation in part of
`
`
`
`
`
`
`
`
`Prior Application Number
`
`
`10768809
`
`
`
`
`
`
`
`Filing Date (YYYY-MM-DD)
`
`
`2004-01-30
`
`
`
`
`
`Additional Domestic Priority Data may be generated within this form by selecting
`
`
`
`
`
`
`
`
`
`
`
`
`the Add button.
`
`
`
`
`
`
`
`
`
`Foreign Priority Information:
`This section allows for the applicant to claim benefit of foreign priority and to identify any prior foreign application for which priority is
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`not claimed. Providing this information in the application data sheet constitutes the claim for priority as required by 35 U.S.C. 119(b)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`and 37 CFR 1.55(a).
`
`
`
`
`
`
`
`
`Remove
`
`
`
`
`
`
`
`
`
`
`
`
`Priority Claimed
`Parent Filing Date (YYYY-MM-DD)
`Country i
`Application Number
`
`
`
`@ Yes O No
`
`
`
`Additional Foreign Priority Data may be generated within this form by selecting the
`
`
`
`
`
`
`
`
`
`
`
` (cid:9)
`
`
`Add button.
`
`
`
`
`
`Assignee Information:
`Providing this information in the application data sheet does not substitute for compliance with any requirement of part 3 of Title 37
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`of the CFR to have an assignment recorded in the Office.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Assignee 1
`
`
`
`
`
`
`
` (cid:9)
`
`
`If the Assignee is an Organization check here.
`
`Organization Name Monosoin LLC
`
`
`
`
`
`
`
`Mailing Address Information:
`
`
`
`6560 Melton Road
`Address 1
`
`
`
`
`
`
`Address 2
`
`
`
`
`StatelProvince
`
`
`
`
`
`Postal Code
`
`
`
`
`
`——
`
`
`
`
`Email Address
`
`
`Additional Assignee Data may be generated within this form by selecting the Add
`
`
`
`
`
`
`
`
`
`
`
`
`button.
`
`
`
`
`
`
`
`
`Signature:
`
`
`A signature of the applicant or representative is required in accordance with 37 CFR 1.33 and 10.18. Please see 37
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`CFR 1.4(d) for the form of the signature.
`
`
`
`
`
`
`
`
`
`
`
`2007—07—10
`Signature
`Date (YYYY-MM-DD)
`/Jamie M. Larmann/
`
`
`
`
`
`
`
`
`
`
`Registration Number
`First Name
`Jamie
`Last Name
`Larmann
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Page 5
`
`

`

`PTO/SBI14 (06—07)
`
`Approved for use through 06/302010. OMB 0651—0032
`
`
`
`
`
`
`US. Patent and Trademark Office; US. 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
`
`
`_
`_
`Application Number
`
`
`
`
`
`
`1199—43 CIP
`
`
`
`
`This collection of information is required by 37 CFR 1.76. The information is required to obtain or retain a benefit by the public which
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`is to file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`collection is estimated to take 23 minutes to complete, including gathering, preparing, and submitting the completed application data
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`sheet form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount oftime you require to
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, US. Patent and
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Trademark Office, US. Department of Commerce, PO. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`EFS Web 2.2.0
`
`
`
`
`Title of Invention
`
`
`
`
`
`
`
`
`
`
`
`
`
`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING
`COMPOSITIONS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Page 6
`
`

`

`
`
`Privacy Act Statement
`
`
`
`The information provided by you in this form will be subject to the following routine uses:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1.
`
`
`
`The information on this form will be treated confidentially to the extent allowed underthe Freedom of Information Act (5 U.S.C. 552)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`and the Privacy Act (5 U.S.C. 552a). Records from this system of records may be disclosed to the Department of Justice to determine
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`whether the Freedom of Information Act requires disclosure of these records.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`The Privacy Act of 1974 (PL. 93—579) requires that you be given certain information in connection with your submission of the attached form related to
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`a patent application or patent. Accordingly, pursuant to the requirements of the Act, please be advised that:
`(1) the general authority for the collection
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`of this information is 35 U.S.C. 2(b)(2); (2) furnishing of the information solicited is voluntary; and (3) the principal purpose for which the information is
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`used by the US. Patent and Trademark Office is to process and/or examine your submission related to a patent application or patent.
`If you do not
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`furnish the requested information, the US. Patent and Trademark Office may not be able to process andlor examine your submission, which may
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`result in termination of proceedings or abandonment of the application or expiration of the patent.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`EFS Web 2.2.0
`
`A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a court, magistrate, or
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`administrative tribunal, including disclosures to opposing counsel in the course of settlement negotiations.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a request involving an
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`individual, to whom the record pertains, when the individual has requested assistance from the Member with respect to the subject matter of
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`the record.
`
`
`
`
`
`A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having need for the information in
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`order to perform a contract. Recipients of information shall be required to comply with the requirements of the Privacy Act of 1974, as
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`amended, pursuant to 5 U.S.C. 552a(m).
`
`
`
`
`
`
`
`
`A record related to an International Application filed under the Patent Cooperation Treaty in this system of records may be disclosed,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`as a routine use, to the International Bureau of the World Intellectual Property Organization, pursuant to the Patent Cooperation Treaty.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`A record in this system of records may be disclosed, as a routine use, to anotherfederal agency for purposes of National Security
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C. 218(c)).
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services, or hislher designee,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`during an inspection of records conducted by GSA as part of that agency's responsibility to recommend improvements in records
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`management practices and programs, under authority of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`GSA regulations governing inspection of records for this purpose, and any other relevant (i.e., GSA or Commerce) directive. Such
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`disclosure shall not be used to make determinations about individuals.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`A record from this system of records may be disclosed, as a routine use, to the public after either publication of the application pursuan
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`to 35 U.S.C. 122(b) or issuance ofa patent pursuant to 35 U.S.C. 151. Further, a record may be disclosed, subject to the limitations of 37
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`CFR 1.14, as a routine use, to the public if the record was filed in an application which became abandoned or in which the proceedings were
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`terminated and which application is referenced by either a published application, an application open to public inspections or an issued
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`patent.
`
`
`
`
`
`
`A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law enforcement agency, if the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`USPTO becomes aware of a violation or potential violation of law or regulation.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Page 7
`
`

`

`1 199-4B CIP
`
`
`
`
`
`
`
`
`
`
`
`
`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM
`
`
`
`INCORPORATING TASTE-MASKING COMPOSITIONS
`
`controlled—release coated particles uniformly distributed throughout the film.
`
`
`
`
`CROSS-REFERENCE TO RELATED APPLICATIONS
`
`
`
` (cid:9)
`[0001]
`
`
`
`
`
`
`
`
`
`This application is a continuation-in-part of US. Application No. 10/768,809,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`filed January 30, 2004, which claims benefit to US. Provisional Application No. 60/443,741
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`filed January 30, 2003; US. Application No. 10/768,809 is also a continuation-in—part of
`
`
`
`
`
`
`
`
`
`
`
`
`PCT/USOZ/32575, filed October 11, 2002, which claims priority to US. Provisional Application
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`No. 60/386,937, filed June 7, 2002, and US, Application No. 10/074,272, filed February 14,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2002, which claims priority to US. Provisional Application No. 60/328,868, filed October 12,
`
`
`
`
`
`
`
`
`
`
`
`
`
`2001; US. Application No. 10/768,809 is also a continuation-in-part of PCT/USOZ/32594, filed
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`October 11, 2002, which claims priority to US. Provisional Application No. 60/414,276, filed
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`September 27, 2002, US. Provisional Application No. 60/386,937, filed June 7, 2002, and US.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Application No. 10/074,272, filed February 14, 2002, which claims priority to US. Provisional
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Application No. 60/328,868, filed October 12, 2001; and US. Application No. lO/768,809 is
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`also a continuation-in-part of PCT/US02/32542, filed October 1 1, 2002, which claims priority to
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`US. Provisional Application No. 60/386,937, filed June 7, 2002, US. Provisional Application
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`No. 60/371,940, filed April 11, 2002, and US. Application No. 10/074,272, filed February 14,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2002, which claims priority to US. Provisional Application No. 60/328,868, filed October 12,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2001; this application is also a continuation—in-part of US. Application No. 10/856,176, filed
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`May 28, 2004, which claims priority to US. Provisional Application No. 60/473,902, filed May
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`28, 2003; US. Application No. 10/856,176 is also a continuation-in-part of US. Application No.
`
`
`
`
`
`
`
`
`
`
`
`
`
`lO/768,809; the contents all of which are incorporated herein by reference.
`
`
`
`FIELD OF THE INVENTION
`
`
`
`
`
`
` (cid:9)
`[0002]
`
`
`
`
`
`
`
`
`
`
`
`
`
`The present invention relates to rapidly dissolving films and methods of their
`
`
`
`
`
`
`
`
`
`
`
`
`
`preparation. The films contain a polymer component and active ingredients as taste-masked or
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Page 8
`
`

`

`1 199-4B CIP
`
`
`
`
`
`
`
`
`BACKGROUND OF THE RELATED TECHNOLOGY
`
`
`
`[0003]
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`
`Active ingredients, such as drugs or pharmaceuticals, may be prepared in a tablet
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`form to allow for accurate and consistent dosing. However, this form of preparing and
`
`
`
`
`
`
`
`
`
`
`
`
`
`dispensing medications has many disadvantages including that a large proportion of adjuvants
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`that must be added to obtain a size able to be handled, that a larger medication form requires
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`additional storage space, and that dispensing includes counting the tablets which has a tendency
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`for inaccuracy. In addition, many persons, estimated to be as much as 28% of the population,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`have difficulty swallowing tablets. While tablets may be broken into smaller pieces or even
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`crushed as a means of overcoming swallowing difficulties, this is not a suitable solution for
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`many tablet or pill forms. For example, crushing or destroying the tablet or pill form to facilitate
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`ingestion, alone or in admixture with food, may also destroy the controlled release properties.
`
`
`
` (cid:9)
`[0004]
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`As an alternative to tablets and pills, films may be used to carry active ingredients
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`such as drugs, pharmaceuticals, and the like. However, historically films and the process of
`
`
`
`
`
`
`
`
`
`
`
`making drug delivery systems therefrom have suffered from a number of unfavorable
`
`
`
`
`
`
`
`
`
`
`
`
`
`characteristics that have not allowed them to be used in practice.
`
`
`
` (cid:9)
`[0005]
`
`
`
`
`
`
`
`
`
`Films that incorporate a pharmaceutically active ingredient are disclosed in
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`expired US. Patent No. 4,136,145 to Fuchs, et a1. ("Fuchs"). These films may be formed into a
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`sheet, dried and then cut into individual doses. The Fuchs disclosure alleges the fabrication of a
`
`
`
`
`
`
`
`
`
`
`
`uniform film, which includes the combination of water-soluble polymers, surfactants, flavors,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`sweeteners, plasticizers and drugs. These allegedly flexible films are disclosed as being useful
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`for oral, topical or enteral use. Examples of specific uses disclosed by Fuchs include application
`
`
`
`
`
`
`
` (cid:9)
`[0006]
`
`
`
`
`
`
`
`
`
`
`
`
`Examination of films made in accordance with the process disclosed in Fuchs,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`however, reveals that such films suffer from the aggregation or conglomeration of particles, i.e.,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`self-aggregation, making them inherently non-uniform. This result can be attributed to Fuchs’
`
`
`
`process parameters, which although not disclosed likely include the use of relatively long drying
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`of the films to mucosa] membrane areas of the body, including the mouth, rectal, vaginal, nasal
`and ear areas.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Page 9
`
`

`

`1 1 99-4B CIP
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`times, thereby facilitating intermolecular attractive forces, convection forces, air flow and the
`
`
`
`
`like to form such agglomeration.
`
`respectively, to increase the viscosity of the film prior to drying in an effort to reduce
`
`[0007]
`
` (cid:9)
`
`
`
`
`
`
`
`
`
`
`
`The formation of agglomerates randomly distributes the film components and any
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`active present as well. When large dosages are involved, a small change in the dimensions of the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`film would lead to a large difference in the amount of active per film. If such films were to
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`include low dosages of active, it is possible that portions of the film may be substantially devoid
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`of any active. Since sheets of film are usually cut into unit doses, certain doses may therefore be
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`devoid of or contain an insufficient amount of active for the recommended treatment. Failure to
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`achieve a high degree of accuracy with respect to the amount of active ingredient in the cut film
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`can be harmful to the patient. For this reason, dosage forms formed by processes such as Fuchs,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`would not likely meet the stringent standards of governmental or regulatory agencies, such as the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`US. Federal Drug Administration (“FDA”), relating to the variation of active in dosage forms.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Currently, as required by various world regulatory authorities, dosage forms may not vary more
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`than 10% in the amount of active present. When applied to dosage units based on films, this
`
`
`
`
`
`
`
`
`
`
`
`virtually mandates that uniformity in the film be present.
`
`
`
` (cid:9)
`[0008]
`
`
`
`
`
`
`
`
`
`
`The problems of self-aggregation leading to non-uniformity of a film were
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`addressed in US. Patent No. 4,849,246 to Schmidt ("Schmidt"). Schmidt specifically pointed
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`out that the methods disclosed by Fuchs did not provide a uniform film and recognized that that
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`the creation of a non-uniform film necessarily prevents accurate dosing, which as discussed
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`above is especially important in the pharmaceutical area. Schmidt abandoned the idea that a
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`mono-layer film, such as described by Fuchs, may provide an accurate dosage form and instead
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`attempted to solve this problem by forming a multi—layered film. Moreover, his process is a
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`multi-step process that adds expense and complexity and is not practical for commercial use.
`
`
`
` (cid:9)
`[0009]
`
`
`
`
`
`
`
`
`
`
`
`Other US. Patents directly addressed the problems of palticle self-aggregation
`
`
`
`
`
`
`
`
`
`
`
`
`and non-uniformity inherent in conventional film forming techniques. In one attempt to
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`overcome non-uniformity, US. Patent 5,629,003 to Horstmann et al. and US. Patent 5,948,430
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`to Zerbe et a1. incorporated additional ingredients, i.e. gel formers and polyhydric alcohols
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Page 10
`
`

`

`1199-4B CIP
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`aggregation of the components in the film. These methods have the disadvantage of requiring
`
`
`
`
`
`
`
`
`
`
`additional components, which translates to additional cost and manufacturing steps.
`
`
`
`
`
`
`
`
`
`
`
`
`
`Furthermore, both methods employ the use the conventional time-consuming drying methods
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`such as a high-temperature air-bath using a drying oven, drying tunnel, vacuum drier, or other
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`such drying equipment. The long length of drying time aids in promoting the aggregation of the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`active and other adjuvant, notwithstanding the use of viscosity modifiers. Such processes also
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`run the risk of exposing the active, Le, a drug, or vitamin C, or other components to prolonged
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`exposure to moisture and elevated temperatures, which may render it ineffective or even
`
`harmful.
`
`
`
` (cid:9)
`[0010]
`
`
`
`
`
`
`
`
`
`
`
`
`In addition to the concerns associated with degradation of an active during
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`extended exposure to moisture, the conventional drying methods themselves are unable to
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`provide uniform films. The length of heat exposure during conventional processing, often
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`referred to as the “heat history”, and the manner in which such heat is applied, have a direct
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`effect on the formation and morphology of the resultant film product. Uniformity is particularly
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`difficult to achieve via conventional drying methods where a relatively thicker film, which is
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`well-suited for the incorporation of a drug active, is desired. Thicker uniform films are more
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`difficult to achieve because the surfaces of the film and the inner portions of the film do not
`
`
`
`
`
`
`
`
`
`
`
`
`experience the same external conditions simultaneously during drying. Thus, observation of
`
`
`
`
`
`
`
`
`
`
`
`relatively thick films made from such conventional processing shows a non—uniform structure
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`caused by convection and intermolecular forces and requires greater than 10% moisture to
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`remain flexible. The amount of free moisture can often interfere over time with the drug leading
`
`
`
`
`
`
`
`
`
`
`
`
`to potency issues and therefore inconsistency in the final product.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Conventional drying methods generally include the use of forced hot air using a
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`related to the rheological properties and the process of water evaporation in the film-forming
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`composition. When the surface of an aqueous polymer solution is contacted with a high
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`temperature air current, such as a film-forming composition passing through a hot air oven, the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`surface water is immediately evaporated forming a polymer film or skin on the surface. This
`
`
`
`
`
`seals the remainder of the aqueous film-forming composition beneath the surface, forming a
`
` (cid:9)
`[0011]
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`drying oven, drying tunnel, and the like. The difficulty in achieving a uniform film is directly
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Page 11
`
`

`

`11 99-43 CIP
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`barrier through which the remaining water must force itself as it is evaporated in order to achieve
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`a dried film. As the temperature ou