11111111111111111111111111#111110111111!111)1111111111111111111111111
`
`1111111111111111111111111111111111111111111111111111111111111
`US008603514B2
`
`111111
`
`(10) Patent No.: (cid:9)
`(10) Patent No.:
`(45) Date of Patent:
`(45) Date of Patent: (cid:9)
`
`US 8,603,514 B2
`US 8,603,514 B2
`Dec. 10, 2013
`Dec. 10, 2013
`
`(12) United States Patent (cid:9)
`c12) United States Patent
`Yang et al. (cid:9)
`Yang et al.
`
`(75)
`(75)
`
`(54) UNIFORM FILMS FOR RAPID DISSOLVE
`UNIFORM FILMS FOR RAPID DISSOLVE
`(54)
`DOSAGE FORM INCORPORATING
`DOSAGE FORM INCORPORATING
`TASTE-MASKING COMPOSITIONS
`TASTE-MASKING COMPOSITIONS
`Inventors: Robert K. Yang, Pushing, NY (US);
`Inventors: Robert K. Yang, Fushing, NY (US);
`Richard C. Fuisz, McLean, VA (US);
`Richard C. Fuisz, McLean, VA (US);
`Garry L. Myers, Kingsport, TN (US);
`Garry L. Myers, Kingsport, TN (US);
`Joseph M. Fuisz, Washington, DC (US)
`Joseph M. Fuisz, Washington, DC (US)
`(73) Assignee: MonoSol RX, LLC, Warren, NJ (US)
`Assignee: MonoSol RX, LLC, Warren, NJ (US)
`(73)
`( *) Notice:
`Subject to any disclaimer, the term of this
`Notice:
`Subject to any disclaimer, the term of this
`* )
`patent is extended or adjusted under 35
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 779 days.
`U.S.C. 154(b) by 779 days.
`(21) Appl. No.: 11/775,484
`Appl. No.: 11/775,484
`(21)
`
`Jul. 10, 2007 Jul. 10, 2007
`(22) Filed:
`Filed: (cid:9)
`(22)
`Prior Publication Data
`Prior Publication Data
`(65)
`(65)
`
`Feb. 21, 2008
`US 2008/0044454 AI
`Feb. 21, 2008
`US 2008/0044454 Al (cid:9)
`Related U.S. Application Data
`Related U.S. Application Data
`
`(63) Continuation-in-part of application No. 10/768,809,
`Continuation-in-part of application No. 10/768,809,
`(63)
`filed on Jan. 30, 2004, now Pat. No. 7,357,891, and a
`filed on Jan. 30, 2004, now Pat. No. 7,357,891, and a
`continuation-in-part
`of
`application
`No.
`continuation-in-part (cid:9)
`of (cid:9)
`application (cid:9)
`No.
`PCT/US02/32575, filed on Oct. 11, 2002, and a
`PCT/US02/32575, filed on Oct. 11, 2002, and a
`continuation-in-part of application No. 10/074,272,
`continuation-in-part of application No. 10/074,272,
`filed on Feb. 14, 2002, now Pat. No. 7,425,292, said
`filed on Feb. 14, 2002, now Pat. No. 7,425,292, said
`application No. 10/768,809 is a continuation-in-part of
`application No. 10/768,809 is a continuation-in-part of
`application No. PCT/US02/32594, filed on Oct. 11,
`application No. PCT/US02/32594, filed on Oct. 11,
`2002, and a continuation-in-part of application No.
`2002, and a continuation-in-part of application No.
`10/074,272, said application No. 10/768,809 is a
`10/074,272, said application No. 10/768,809 is a
`continuation-in-part
`of
`application
`No.
`continuation-in-part (cid:9)
`of (cid:9)
`application (cid:9)
`No.
`PCT/US02/32542, filed on Oct. 11, 2002, and a
`PCT/US02/32542, filed on Oct. 11, 2002, and a
`continuation-in-part of application No. 10/074,272,
`continuation-in-part of application No. 10/074,272,
`application No.
`11/775,484, which
`is
`a
`application No. 11/775,484, which is a
`continuation-in-part of application No. 10/856,176,
`continuation-in-part of application No. 10/856,176,
`filed on May 28, 2004, now Pat. No. 7,666,337, and a
`filed on May 28, 2004, now Pat. No. 7,666,337, and a
`continuation-in-part of application No. 10/768,809.
`continuation-in-part of application No. 10/768,809.
`
`(60) Provisional application No. 60/443,741, filed on Jan.
`(60) Provisional application No. 60/443,741, filed on Jan.
`30, 2003, provisional application No. 60/386,937,
`30, 2003, provisional application No. 60/386,937,
`filed on Jun. 7, 2002, provisional application No.
`filed on Jun. 7, 2002, provisional application No.
`60/328,868, filed on Oct. 12, 2001, provisional
`60/328,868, filed on Oct. 12, 2001, provisional
`application No. 60/414,276, filed on Sep. 27, 2002,
`application No. 60/414,276, filed on Sep. 27, 2002,
`provisional application No. 60/473,902, filed on May
`provisional application No. 60/473,902, filed on May
`28, 2003.
`28, 2003.
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`Int. Cl.
`Int. Cl.
`A 61F 13/00 (cid:9)
`A61F 13100
`A 61K 9/00 (cid:9)
`A61K9/00
`A 61K 9/70 (cid:9)
`A61K9170
`(52) U.S. Cl.
`U.S. Cl.
`(52)
`USPC ........................................... 424/435; 424/484
` 424/435; 424/484
`USPC (cid:9)
`(58) Field of Classification Search
`(58) Field of Classification Search
`None
`None
`See application file for complete search history.
`See application file for complete search history.
`
`References Cited References Cited
`
`(51)
`(51)
`
`(56)
`(56)
`
`U.S. PATENT DOCUMENTS
`U.S. PATENT DOCUMENTS
`
`307,537 A
`307,537 A
`688,446 A
`688,446 A
`
`11/1884 Foulks
`1111884 Foulks
`12/1901 Stempel
`12/1901 Stempel
`(Continued)
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`FOREIGN PATENT DOCUMENTS
`
`DE
`DE
`DE
`DE
`
`1/1976
`2432925 (cid:9)
`111976
`2432925
`4/1976
`2449865 (cid:9)
`4/1976
`2449865
`(Continued)
`(Continued)
`OTHER PUBLICATIONS
`OTHER PUBLICATIONS
`
`Lazaridou et al.; Thermophysical properties of chitosan, chitosan-
`Lazaridou et a!.; Thermophysical properties of chitosan, chi to san(cid:173)
`starch and chitosan-pullulan films near the glass transition; Carbo-
`starch and chitosan-pullulan films near the glass transition; Carbo(cid:173)
`hydrate Polymers, Applied Science Publishers, Ltd; Barking, GB,
`hydrate Polymers, Applied Science Publishers, Ltd; Barking, GB,
`vol. 48, No. 2, May 1, 2002, pp. 170-190.
`vol. 48, No.2, May 1, 2002, pp. 170-190.
`
`(Continued)
`(Continued)
`Primary Examiner- Anand Desai
`Primary Examiner - Anand Desai
`Assistant Examiner- Melissa Mercier
`Assistant Examiner - Melissa Mercier
`(74) Attorney, Agent, or Firm- Hoffmann & Baron, LLP
`(74) Attorney, Agent, or Firm - Hoffmann & Baron, LLP
`ABSTRACT
`ABSTRACT
`(57)
`(57) (cid:9)
`The present invention relates to rapid dissolve thin film drug
`The present invention relates to rapid dissolve thin film drug
`delivery compositions for the oral administration of active
`delivery compositions for the oral administration of active
`components. The active components are provided as taste(cid:173)
`components. The active components are provided as taste-
`masked or controlled-release coated particles uniformly dis(cid:173)
`masked or controlled-release coated particles uniformly dis-
`tributed throughout the film composition. The compositions
`tributed throughout the film composition. The compositions
`may be formed by wet casting methods, where the film is cast
`may be formed by wet casting methods, where the film is cast
`and controllably dried, or alternatively by an extrusion
`and controllably dried, or alternatively by an extrusion
`method.
`method.
`
`76 Claims, 34 Drawing Sheets
`76 Claims, 34 Drawing Sheets
`
`10
`10
`,-/
`
`14
`14
`
`12
`12
`
`14
`14
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 001
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`US 8,603,514 B2
`US 8,603,514 B2
`Page 2
`Page 2
`
`(56)
`(56)
`
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`6,800,329 B2
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`7,005,142 B2
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`7,005,142 B2
`2/2006 Leon eta!.
`7,067,116 B1 * 6/2006 Bess eta!. .................... 424/78.1
` 424/78.1
`7,067,116 B1 *
`6/2006 Bess et al. (cid:9)
`7,579,019 B2
`8/2009 Tapolsky eta!.
`7,579,019 B2
`8/2009 Tapolsky et al.
`2002/0127254 Al
`9/2002 Fotinos et al.
`2002/0127254 A1
`9/2002 Fotinos et a!.
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`2003/0124176 Al
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`2004/0156901 A1 * 8/2004 Thakur et al . ................. 424/471
` 424/471
`2004/0156901 Al *
`8/2004 Thakur et al. (cid:9)
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 002
`
`(cid:9)
`(cid:9)
`

`

`US 8,603,514 B2
`US 8,603,514 B2
`Page 3
`Page 3
`
`(56) (cid:9)
`(56)
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`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 003
`
`

`

`U.S. Patent
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 1 of 34
`Sheet 1 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`10
`10
`
`14
`14
`
`/
`
`12
`12
`
`14
`14
`
`FIG. 1
`FIG. 1
`
`10
`10
`~
`
`1 o'
`10'
`r!
`
`I
`,_ 16
`FIG. 2
`10
`
`10'
`
`FIG. 3
`FIG. 3
`
`FIG. 4
`FIG. 4
`
`18
`
`10' 16 10
`
`FIG. 5
`FIG. 5
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 004
`
`(cid:9)
`(cid:9)
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 2 of 34 (cid:9)
`Sheet 2 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`20
`20
`
`,--/
`
`W
`
`24
`
`22
`22
`
`26
`
`28
`
`32
`
`30
`
`38
`
`8
`4
`
`42
`
`\ 6heaf
`
`Aheat
`
`44
`
`46
`46
`
`FIG. 6
`FIG. 6
`
`32'
`
`30'
`
`34'-/
`36
`40
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 005
`
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 3 of 34 (cid:9)
`Sheet 3 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`44
`44 (cid:9)
`
`64' f.—c-
`
`i -•
`
`62'
`58'
`62' 58'
`
`W/'>~'»)))i
`60~ ~ ..
`z<-"-
`60'
`64'~ ~ ~ ~64
`o r (cid:9) i \ ------ (cid:9)
`62
`58
`62
`58 (cid:9)
`
`42
`42
`
`,..... (cid:9)
`
`II..-
`
`;60
`(cid:9)60
`
`64
`
`56
`56
`
`54
`54
`
`50
`,50
`
`52
`— 52
`
`FIG. 7
`FIG. 7
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 006
`
`(cid:9)
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 4 of 34 (cid:9)
`Sheet 4 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`SECTION C
`
`co
`Co
`.
`d
`(.9
`u.
`LL
`
`co
`<:
`a
`j::::
`~
`
`SECTION B
`
`a
`lv)
`
`SECTION A
`
`:::::..
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 007
`
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 5 of 34 (cid:9)
`Sheet 5 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`110
`
`100
`100
`
`FIG. 9
`FIG. 9
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 008
`
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 6 of 34 (cid:9)
`Sheet 6 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`110
`
`100
`100
`
`FIG. 10
`FIG. 10
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 009
`
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013
`Dec. 10, 2013 (cid:9)
`
`
`Sheet 7 of 34
`Sheet 7 of 34 (cid:9)
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`110
`110
`
`
`
`FIG. 11 FIG. 11
`
`100
`100
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 010
`
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 8 of 34 (cid:9)
`Sheet 8 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`IN - \',,..J„.7.:::'-„..„..!.%,;:,:•-•-•-:''''":71:1:1.21.,,M
`
`,,:„..., ..........
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`\\•::: \ az \\\, \ ::::: \ Z.N
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`M. (cid:9)
`\.\\ (cid:9)
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`
`\`....•
`
`110
`
`100
`100
`
`FIG. 12
`FIG. 12
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 011
`
`

`

`U.S. Patent
`U.S. Patent
`
`Dec. 10, 2013
`Dec. 10, 2013
`
`Sheet 9 of 34
`Sheet 9 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`.............
`...........
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`mk,
`
`\ \ZZZ \ \ \ \
`
`ZZZ' (cid:9)
`
``ss'kzzz ,
`
`1 1 0
`110
`
`100
`100
`
`FIG. 13
`FIG. 13
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 012
`
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013
`Dec. 10, 2013 (cid:9)
`
`Sheet 10 of 34
`Sheet 10 of 34 (cid:9)
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`, (cid:9)
`
`, ' \\s (cid:9)
`. (cid:9)
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`'s (cid:9)
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`\,\4. ' ** % (cid:9)
`%., (cid:9)
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`- " (cid:9)
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`
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`
`1 1 0 (cid:9)
`110
`
`100
`100
`
`FIG. 14
`FIG. 14
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 013
`
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 11 of 34
`Sheet 11 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`110
`
`100
`100
`
`FIG. 15
`FIG. 15
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 014
`
`(cid:9)
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 12 of 34 (cid:9)
`Sheet 12 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`110
`
`1
`100
`
`FIG. 16
`FIG. 16
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 015
`
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 13 of 34 (cid:9)
`Sheet 13 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`200
`
`FIG. 17
`FIG. 17
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 016
`
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 14 of 34 (cid:9)
`Sheet 14 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`500
`500
`
`FIG. 18
`FIG. 18
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 017
`
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 15 of 34 (cid:9)
`Sheet 15 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`500
`500
`
`FIG. 19
`FIG. 19
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 018
`
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013
`Dec. 10, 2013
`
`Sheet 16 of 34
`Sheet 16 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`(223X) 100um
`
`500
`500
`
`FIG. 20
`FIG. 20
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 019
`
`(cid:9)
`(cid:9)
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 17 of 34 (cid:9)
`Sheet 17 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`500
`500
`
`FIG. 21
`FIG. 21
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 020
`
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 18 of 34
`Sheet 18 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`500
`500
`
`FIG. 22
`FIG. 22
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 021
`
`(cid:9)
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013
`Dec. 10, 2013
`
`Sheet 19 of 34 (cid:9)
`Sheet 19 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`N.\•••••:\'
`
`\ \ \ ' (cid:9)
`
`\
`
`\s;,
`
`500
`500
`
`FIG. 23
`FIG. 23
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 022
`
`(cid:9)
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 20 of 34 (cid:9)
`Sheet 20 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`500
`500
`
`FIG. 24
`FIG. 24
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 023
`
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 21 of 34 (cid:9)
`Sheet 21 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`.........
`
`"""'"'
`
`500
`500
`
`FIG. 25
`FIG. 25
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 024
`
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013
`Dec. 10, 2013
`
`Sheet 22 of 34
`Sheet 22 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`\\\\
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`FIG. 26
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 025
`
`(cid:9)
`(cid:9)
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013
`Dec. 10, 2013
`
`Sheet 23 of 34 (cid:9)
`Sheet 23 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`FIG. 27
`FIG. 27
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 026
`
`(cid:9)
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 24 of 34 (cid:9)
`Sheet 24 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`500
`500
`
`FIG. 28
`FIG. 28
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 027
`
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 25 of 34 (cid:9)
`Sheet 25 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
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`500
`500
`
`FIG. 29
`FIG. 29
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 028
`
`(cid:9)
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 26 of 34 (cid:9)
`Sheet 26 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`500
`500
`
`FIG. 30
`FIG. 30
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 029
`
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 27 of 34 (cid:9)
`Sheet 27 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
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`FIG. 31
`FIG. 31
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 030
`
`

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`Selected Gene List:
`Selected Gene List: (cid:9)
`X-axis:
`X-axis: (cid:9)
`Y -axis:
`Y-axis: (cid:9)
`
`all genes (1235)
`all genes (1235) (cid:9)
`joe cumm1ns (Default lnterpretationl: .. .
`joe cummins (Default Interpretation):... (cid:9)
`JOe cummins (Default Interpretation : .. .
`oe cummins (Default Interpretation): ...
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`joe cummins (Default Interpretation)
`Colored by: joe cummins (Default Interpretation)
`Gene List:
`all genes ( 1235)
`Gene List: (cid:9)
`all genes (1235)
`
`
`Normalized to GAPDH, most of the ISGs are induced. Normalized to GAPDH, most of the ISGs are induced.
`FIG. 32
`FIG. 32
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 031
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 29 of 34 (cid:9)
`Sheet 29 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
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`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 032
`
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 30 of 34 (cid:9)
`Sheet 30 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
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`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 033
`
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 31 of 34 (cid:9)
`Sheet 31 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`100
`100
`
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`
`120
`120 (cid:9)
`
`101
`101
`
`102
`102
`
`103
`103
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`FIG. 35
`FIG. 35
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 034
`
`(cid:9)
`(cid:9)
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 32 of 34 (cid:9)
`Sheet 32 of 34
`
`US 8,603,514 B2
`US 8,603,514 B2
`
`200
`200
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`
`201
`201 (cid:9)
`
`202
`202 (cid:9)
`
`203
`203
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`
`FIG. 36
`FIG. 36
`
`Par Pharm., Inc., et al.
`Exhibit 1001
`Page 035
`
`(cid:9)
`

`

`U.S. Patent (cid:9)
`U.S. Patent
`
`Dec. 10, 2013 (cid:9)
`Dec. 10, 2013
`
`Sheet 33 of 34 (cid:9)
`Sheet 33 of 34
`
`US 8,603,514