IPR2020-01060
`U.S. Patent No. 7,326,708
`Declaration of Joseph M. Fortunak, Ph.D.
`Attorney Docket No. REDDY 7.1R-024
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`DR. REDDY’S LABORATORIES, INC.
`AND DR. REDDY’S LABORATORIES, LTD.,
`Petitioner,
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`U.S. Patent No. 7,326,708 to Cypes et al.
`Issue Date: February 5, 2008
`Title: Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
`Inter Partes Review No. IPR2020-01060
`
`DECLARATION OF JOSEPH M. FORTUNAK, Ph.D.
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`DRL Ex. 1017, p. 001
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`U.S. Patent No. 7,326,708
`Declaration of Joseph M. Fortunak, Ph.D.
`Attorney Docket No. REDDY 7.1R-024
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`DR. REDDY’S LABORATORIES, INC.
`AND DR. REDDY’S LABORATORIES, LTD.,
`Petitioner,
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`U.S. Patent No. 7,326,708 to Cypes et al.
`Issue Date: February 5, 2008
`Title: Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
`Inter Partes Review No. IPR2020-01060
`
`DECLARATION OF JOSEPH M. FORTUNAK, Ph.D.
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`DRL Ex. 1017, p. 001
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
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`TABLE OF CONTENTS
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`Page
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`I.
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`INTRODUCTION ............................................................................................... 1
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`II. MY EXPERIENCE AND QUALIFICATIONS ................................................. 3
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`III. LIST OF MATERIALS CONSIDERED ....................................................... 11
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`EXHIBIT LIST ........................................................................................................ 12
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`IV. LEGAL STANDARD .................................................................................... 13
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`A. Anticipation ................................................................................... 13
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`B. Obviousness ................................................................................... 14
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`V. BACKGROUND ............................................................................................... 18
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`VI. PERSON OF ORDINARY
`SKILL IN THE ART (“POSA”) ................................................................... 18
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`VII. THE ’708 PATENT ........................................................................................ 20
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`VIII. CLAIM CONSTRUCTION ........................................................................... 25
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`IX. ANTICIPATION ............................................................................................ 27
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`A. Ground 1: WO 03/004498 Anticipates
`Claims 1-3, 17, 19, And 21-23 Of The ’708 Patent .......................... 27
`1.
`Disclosure Of WO ’498 ............................................................ 27
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`2.
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`3.
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`4.
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`5.
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`Claim 1 Of The ’708 Patent ...................................................... 37
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`Claim 2 Of The ’708 Patent ...................................................... 41
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`Claim 3 Of The ’708 Patent ...................................................... 41
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`Claim 17 Of The ’708 Patent .................................................... 42
`i
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`DRL Ex. 1017, p. 002
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
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`aa..
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`A pharmaceutical composition comprising .................... 42
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`bb..
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`cc..
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`a therapeutically effective amount of the salt
`according to claim 2 ........................................................ 42
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`in association with one or more
`pharmaceutically acceptable carriers .............................. 43
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`6.
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`Claim 19 Of The ’708 Patent .................................................... 43
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`a.
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`b.
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`A method for the treatment of type 2
`diabetes comprising ........................................................ 44
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`administering to a patient in need of such
`treatment a therapeutically effective amount
`of the salt according to claim 2 or a hydrate
`thereof ............................................................................. 44
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`7.
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`8.
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`Claims 21-22 Of The ’708 Patent ............................................. 44
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`Claim 23 Of The ’708 Patent .................................................... 46
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`B. Ground 2: Claims 1-3, 17, 19, And 22-23
`Are Anticipated By The ’871 Patent .................................................. 47
`1.
`Disclosure Of The ’871 Patent .................................................. 47
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`2.
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`3.
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`4.
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`5.
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`6.
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`7.
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`Claims 1 And 2 ......................................................................... 48
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`Claim 3 ...................................................................................... 49
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`Claims 17 And 19 ..................................................................... 50
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`Claim 21 .................................................................................... 52
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`Claim 22 .................................................................................... 53
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`Claim 23 .................................................................................... 54
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`ii
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`DRL Ex. 1017, p. 003
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
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`X. OBVIOUSNESS ................................................................................................ 54
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`A. Ground 3: Claims 3, 17, 19, And 21-23 Would
`Have Been Obvious In View of WO ’498 .......................................... 55
`1.
`The Level Of Ordinary Skill In The Pertinent Art .................... 55
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`2.
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`The Scope And Content Of
`The Prior Art: WO ’498 (EX1004) ........................................... 55
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`aa..
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`bb..
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`Claim 3 ............................................................................ 55
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`Claim 17 .......................................................................... 56
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`ii..
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`iiii..
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`iiiiii..
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`“A pharmaceutical composition comprising” ...... 56
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`“A therapeutically effective amount of
`the salt according to claim 2” .............................. 57
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`“In association with one or more
`pharmaceutically acceptable carriers” .................. 57
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`cc..
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`Claim 19 .......................................................................... 58
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`ii..
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`iiii..
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`“A method for the treatment of type 2
`diabetes comprising” ............................................ 58
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`“administering to a patient in need of such
`treatment a therapeutically effective amount
`of the salt according to claim 2 or a hydrate
`thereof” ................................................................. 58
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`dd..
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`ee..
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`ff..
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`Claim 21 .......................................................................... 58
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`Claim 22 .......................................................................... 60
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`Claim 23 .......................................................................... 60
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`iii
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`DRL Ex. 1017, p. 004
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
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`B. Ground 4: Claims 1-3, 17, 19, And 21-23 Would Have
`Been Obvious In View Of WO ’498 And Bastin ................................ 60
`1.
`The Level Of Ordinary Skill In The Pertinent Art .................... 60
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`2.
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`The Scope And Content Of The Prior Art ................................ 60
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`aa.. WO ’498 (EX1004) ........................................................ 60
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`bb..
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`Bastin (EX1006) ............................................................. 61
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`3.
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`The Differences Between
`The Claims And Prior Art ......................................................... 62
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`aa..
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`Claim 1 ............................................................................ 62
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`ii.. WO ’498 And Bastin Would Have
`Rendered The Phosphoric Acid Salt
`Obvious ................................................................ 63
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`Claims 2 And 3 ............................................................... 67
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`Claims 17 And 19 ........................................................... 68
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`Claims 21-23 ................................................................... 69
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`bb..
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`cc..
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`dd..
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`C. Ground 5: Claim 4 Would Have Been
`Obvious In View Of WO ’498, Bastin, and Brittain ............................ 70
`1.
`The Level Of Ordinary Skill In The Pertinent Art .................... 70
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`2.
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`The Scope And Content Of The Prior Art ................................ 70
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`a. WO ’498 (EX1004) And
`Bastin (EX1006) ............................................................. 70
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`b.
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`Brittain (EX1005) ........................................................... 70
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`3.
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`The Differences Between The Claim And Prior Art ................ 72
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`DRL Ex. 1017, p. 005
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
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`aa..
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`Claim 4 ............................................................................ 72
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`D. Ground 6: Claim 4 Would Have Been
`Obvious In View Of WO ’498 And Brittain ........................................ 73
`1.
`The Level Of Ordinary Skill In The Pertinent Art .................... 73
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`2.
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`The Scope And Content Of The Prior Art ................................ 73
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`aa.. WO ’498 (EX1004) And
`Brittain (EX1005) ........................................................... 73
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`3.
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`The Differences Between The Claim And Prior Art ................ 73
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`XI. SECONDARY CONSIDERATIONS ............................................................ 75
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`DRL Ex. 1017, p. 006
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`I, JOSEPH M. FORTUNAK Ph.D., do hereby declare and state as follows:
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`1.
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`I have been asked to provide testimony as to what one of ordinary skill
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`in the art would have understood with respect to the patent at issue and various prior
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`art discussed herein. I provide this testimony below:
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`I.
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`INTRODUCTION
`2.
`I am over the age of 18 and otherwise competent to make this
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`Declaration.
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`3.
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`I have been retained on behalf of Petitioners Dr. Reddy’s Laboratories,
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`Inc. and Dr. Reddy’s Laboratories, Ltd. for the above-captioned inter partes
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`review (“IPR”). I am being compensated for my time in connection with this IPR
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`at my standard consulting rate, which is $650 per hour. My compensation does not
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`depend in any way on the outcome of the IPR.
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`4.
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`It is my understanding that the Petition for Inter Partes Review in this
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`matter (the “Petition”) involves U.S. Patent No. 7,326,708 (“the ’708 Patent”)
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`(EX1001).
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`5.
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`The ’708 Patent names Stephen Howard Cypes, Alex Minhua Chen,
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`Russell R. Ferlita, Karl Hansen, Ivan Lee, Vicky K. Vydra, and Robert M. Wenslow,
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`Jr. as the purported inventors.
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`6.
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`For the purposes of this declaration, I have been told to assume the
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`relevant priority date of the ’708 Patent is June 24, 2003—the filing date of U.S.
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`DRL Ex. 1017, p. 007
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
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`Provisional Application No. 60/482,161.1 I further understand that the ’708 Patent
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`is assigned to Merck, Sharpe & Dohme Corp. (“Merck,” “Patentee,” or “Patent
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`Owner”).
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`7.
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`As explained below, it is my opinion that claims 1-4, 17, 19, and 21-23
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`of the ’708 Patent2 are anticipated or would have been obvious to the skilled
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`artisan as of the time of the priority date of the ’708 Patent. Therefore, these
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`claims are invalid.
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`1 I have not been asked to analyze whether this is indeed the correct priority date
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`but rather assume that it is for the purposes of my declaration. I understand that
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`Patent Owner has recently contended that the priority date is earlier than June 24,
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`2003. (EX1015 Interrog. 10.) I express no opinion at this time as to whether
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`June 24, 2003 is, in fact, the correct priority date. However, should this become an
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`issue during the proceeding, I may be called upon to offer my opinion.
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`2 I have not been asked to express an opinion about any other claim of the
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`’708 Patent, nor do I express such opinion because I have not undertaken such an
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`analysis.
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`DRL Ex. 1017, p. 008
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
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`II. MY EXPERIENCE AND QUALIFICATIONS3
`8.
`I am a Professor of Chemistry and Pharmaceutical Sciences at
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`Howard University, in Washington, DC, where I regularly teach courses in
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`Organic Chemistry to undergraduate students. I also teach courses in drug
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`discovery, drug development, pharmaceutical chemistry, pharmaceutical sciences,
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`and green chemistry/chemical synthesis to PharmD and PhD students in Chemistry
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`and Pharmacy. I am an expert in the field of medicinal chemistry, and I have been
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`an expert in this field since well before June 24, 2003. Throughout my career, I
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`have discovered drugs and provided synthetic chemistry and pharmaceutical drug
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`development expertise
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`in both academic
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`laboratories and pharmaceutical
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`companies. In formulating my opinions, I have relied upon my training, knowledge,
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`and experience in the relevant art. A copy of my current curriculum vitae is
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`attached to this Declaration as EX1018 and it provides a description of my
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`academic and employment history.4
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`3 I reserve the right to explain my background and qualifications during any
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`deposition or in any subsequent Reply.
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`4 I reserve the right to supplement my academic and employment history
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`during any subsequent deposition.
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`DRL Ex. 1017, p. 009
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
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`9.
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`As an expert in the relevant field since prior to June 24, 2003, I am
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`qualified to provide an opinion as to what a Person of Ordinary Skill in the Art
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`(“POSA” or “the skilled artisan”) would have understood, known, or concluded as
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`of June 24, 2003. Indeed, since 1976, I have accumulated significant training and
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`experience in the fields of medicinal chemistry/drug discovery and design, drug
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`development, drug regulation, solid-state chemistry (i.e. crystalline forms,
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`polymorphs, solvates, hydrates and amorphous forms), enzyme interactions
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`(including the design of enzyme inhibitors), pharmacology, pre-formulation and
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`formulation design, and organic and process chemistry.
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`10.
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`I received my Bachelor of Science in Chemistry from Purdue
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`University in 1976, and my Doctorate in Philosophy in Organic Chemistry from
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`the University of Wisconsin-Madison in 1981. After earning my Ph.D., I was a
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`postdoctoral fellow and a research assistant professor at Cambridge University in
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`the United Kingdom from 1981-1983.
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`11. My career has spanned both the industrial and academic sectors,
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`including senior managerial and academic appointments.
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`12. From 1983-1993, I worked at SmithKline Beecham Pharmaceutical
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`Corp., and served as Associate Senior Research Investigator, Senior Research
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`Investigator and Assistant Director. During that time, I was primarily responsible
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`DRL Ex. 1017, p. 010
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
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`for inventing processes to synthesize active pharmaceutical ingredients (“APIs”)
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`for investigational new drugs, including the drugs halofantrine, ropinerole,
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`topotecan, and eprosartan, which the U.S. Food and Drug Administration (“FDA”)
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`has approved.
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`13. From 1993-2000, I worked at DuPont Pharmaceutical Company
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`(“DuPont”), and served as Associate Director, Director, Senior Director and
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`Executive Director. During my tenure at DuPont, among other responsibilities, I
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`led the API development team for the major anti-HIV drug efavirenz, which is an
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`inhibitor of HIV-1 reverse transcriptase. I was also responsible for building a
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`pre-formulations group of experts in organic, solid-state chemistry, and for
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`managing the interface(s) between the API, Formulations, and Analytical groups at
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`DuPont.
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`14. From 1993-1999 I also served on the Scientific Advisory Board for
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`NaPro Biotherapeutics
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`in Boulder, Colorado, working on a commercial
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`semi-synthesis of the anti-cancer drug paclitaxcel from renewable biomass.
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`15. From 2000-2004, I worked at Abbott Laboratories as the Head of
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`Global Chemical Development. In that position I was responsible for managing
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`chemistry, engineering, and analytical development for all of Abbott’s new drug
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`candidates. During that time, I built a Process Engineering Department with
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`DRL Ex. 1017, p. 011
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
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`expertise in separation sciences, solids engineering, and process modeling. I also
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`was responsible for process validation for four New Drug Applications, including
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`XIENCE™ V drug-device combination (a coronary stent), and emtricitabine, an
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`anti-HIV drug
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`that
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`is a nucleoside reverse
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`transcriptase
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`inhibitor. My
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`responsibilities in this role included oversight for the API and physiochemical pre-
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`formulation activities for all new drug candidates, route discovery, polymorph
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`control, clinical supplies, analytical & process development and validation for
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`Abbott Labs and external customers. I was responsible for manufacturing several
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`small volume, commercial products for Abbott Labs and external customers.
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`16.
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`I have, in the past, served as an industry representative to the
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`FDA/ICH Q7A Committee on guidelines for active pharmaceutical ingredients. I
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`have also served as Chair of the Regulatory and Compliance Section for the
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`Midwest Pharmaceutical Process Chemistry Consortium.
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`17. While employed as a scientist and manager in the innovator
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`pharmaceutical industry (1983-2004), I contributed to over 100 new chemical
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`entities that moved from discovery into development. I also contributed to the
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`development and approval of twelve new drug applications (“NDAs”) approved
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`for marketing and a substantial number (approximately 20+) of generic products.
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`DRL Ex. 1017, p. 012
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
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`18.
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`I have consulted with a number of pharmaceutical companies on
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`issues relating
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`to drug discovery, drug development, API and Finished
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`Pharmaceutical Product drug development and drug production.
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`19. From 2004 to the present, as noted above, I have served as a Professor
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`of Chemistry and Pharmaceutical Sciences at Howard University in Washington,
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`DC. My research group of PhD/PharmD/MSc and undergraduate students develops
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`new science to decrease the cost of and increase access to quality-assured
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`medicines for low- and middle-income countries. We have contributed to new
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`chemistry and technologies that have improved production and reduced cost of
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`several drugs for HIV/AIDS, Malaria, TB, and opportunistic infections, including
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`the antiviral (HIV) drugs efavirenz, tenofovir disoproxil fumarate, darunavir,
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`dolutegravir, and atazanavir.
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`20.
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`In 2005, I helped found the Drug Access Technical Team of the
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`William J. Clinton Health Access Initiative where I contributed to increasing
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`global access to medications of assured quality at affordable prices, including
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`HIV/AIDS, malaria and tuberculosis medications.
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`21.
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`I presently work with organizations including the World Health
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`Organization, USAID/USP, UNITAID, and the TB Alliance on novel chemistry,
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`DRL Ex. 1017, p. 013
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
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`formulations, and regulatory sciences for manufacturing, market dynamics and
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`regulation of quality-assured medicines for low- and middle-income countries.
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`22. Since 2008 I have regularly taught a curriculum in drug discovery,
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`development, and manufacturing at the St. Luke Foundation/Kilimanjaro School of
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`Pharmacy (“KSP”) in Moshi, Tanzania, and the School of Pharmacy/Center for
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`Drug Discovery, Development, and Pharmaceutical Production (CDDDP) at the
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`University of Ibadan in Nigeria. This curriculum focuses on the science and
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`practice of drug discovery and development. Participants in this training include
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`pharmaceutical professionals, national drug regulators, and university professors.
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`As part of the curriculum, students learn how to formulate drugs, including dosage
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`form design, granulation, milling, drying, compression, coating, and process
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`validation. This teaching includes a focus on crystalline forms of pharmaceutical
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`solids including polymorphs, hydrates, solvates, and amorphous forms and their
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`impact on APIs and drug products. This curriculum has received numerous awards,
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`including a 2013 US FDA Honor Award for excellence and innovation in teaching
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`and drug regulatory sciences.
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`23.
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`I also have served or currently serve as an adjunct professor at the
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`University of Alabama, Green Chemistry Manufacturing Institute, the Kilimanjaro
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`School of Pharmacy, and the University of Ibadan in Nigeria. I am on the
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`DRL Ex. 1017, p. 014
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
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`Scientific Advisory Board of the Royal Society of Chemistry (UK) as an expert in
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`Green Chemistry.
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`24.
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`I have published over 75 peer-reviewed papers, book chapters, and
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`monographs. I have made hundreds of presentations in the areas of my expertise. I
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`am also an inventor on approximately 35 patent applications worldwide in the
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`areas of chemical synthesis, green chemistry, drug synthesis, and drug
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`manufacturing. I have managed approximately 800 professionals in the course of
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`my career, approximately 500 of whom are PhD-level scientists.
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`25. From 2006-2011, I was on the editorial board of the journal Current
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`Opinion in Drug Development. I am currently on the editorial boards of the
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`Journal of Tropical Pharmaceutical Research and the Journal Sustainability:
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`Chemistry.
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`26.
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`I have received several honors and awards for my research and
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`teaching work. Among many others, I have been awarded the Howard University
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`Faculty Senate Award for contributions to Africa and the African Diaspora, the
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`American Chemical Society “Astellas Foundation” Prize for Chemistry Impact on
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`Human Health, for, among other things, global access to anti-HIV drugs, the
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`African Union award for Corporate Social Responsibility, and a Corporate Award
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`DRL Ex. 1017, p. 015
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
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`from Abbott Labs for manufacturing improvements that reduced volatile organic
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`emissions (VOEs) over the island of Puerto Rico by over 60%.
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`27. My research has focused on the study of new synthetic chemistry and
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`methodology for the manufacture of essential medicines for the treatment of
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`HIV/AIDS, malaria, and tuberculosis. I also currently work on new technologies
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`for Green Chemistry, safety and waste reduction. I am also heavily involved in
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`teaching drug development and industrial pharmacy in Low- and Middle-Income
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`Countries to enable local production of essential medicines according to
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`international standards of Current Good Manufacturing Practice (cGMP). Among
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`other things, I have managed research and development activities in dipeptidyl
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`peptidase IV (DPP-IV) inhibitors, in the areas of drug discovery, candidate
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`selection, and crystalline forms. Moreover, prior to my involvement with this
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`declaration, through the literature and my own work and teaching, I am familiar
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`with the drugs known as sitagliptin, saxagliptin, linagliptin, and alogliptin, as well
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`as others spanning the therapeutic spectrum. I have studied these with a view to
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`alleviating the cardiovascular problems inherent in anti-diabetes drug candidates. I
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`have also studied all these compounds in combination with statins and
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`anti-hypertensive drugs.
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`DRL Ex. 1017, p. 016
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
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`III. LIST OF MATERIALS CONSIDERED
`In formulating my opinions, I have considered the materials referenced
`28.
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`in this Declaration and the Exhibit List below. I have also reviewed the
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`’708 Patent (EX1001) and its prosecution history, as well as each of the documents
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`cited herein in light of the general knowledge in the state of the art as of June 24,
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`2003.
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`DRL Ex. 1017, p. 017
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
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`EXHIBIT LIST
`Description
`U.S. Patent No. 7,326,708
`Declaration of Dr. Mukund Chorghade
`CV of Dr. Mukund Chorghade
`WO 03/004498 to Edmonson
`Brittain, “Polymorphism in Pharmaceutical Solids”
`Bastin et al. “Salt Selection and Optimisation [sic] Procedures for
`Pharmaceutical New Chemical Entities”
`U.S. Patent No 6,699,871
`Orange Book Entry for Janumet®
`Orange Book Entry for Januvia®
`Complete copy of the prosecution history of the ’708 Patent as
`available for download from the USPTO website
`U.S. Patent No. 4,572,909
`U.S. Provisional Application No. 60/303,475, filed July 6, 2001
`Prescribing Information for Janumet®
`Prescribing Information for Januvia®
`Merck Sharpe & Dohme’s Responses and Objections to
`Defendants’ First Set of Joint Interrogatories (1-10)
`Brown et al., Chemistry: The Central Science 615-618 (8th rev. ed.
`2002)
`Declaration of Joseph M. Fortunak, Ph.D.
`CV of Joseph M. Fortunak, Ph.D.
`
`Pet’r Exh. #
`1001
`1002
`1003
`1004
`1005
`1006
`
`1007
`1008
`1009
`1010
`
`1011
`1012
`1013
`1014
`1015
`
`1016
`
`1017
`1018
`
`
`
`12
`
`DRL Ex. 1017, p. 018
`
`
`
`
`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
`
`
`IV. LEGAL STANDARD
`29. Although I am not a lawyer, I have been informed by counsel and
`
`provide my general understanding of the law of anticipation and obviousness. I used
`
`these principles in conducting my analysis and drawing any conclusions.
`
`30.
`
`I understand that the first step in determining whether a patent claim
`
`would have been anticipated or obvious is to construe the claims to determine claim
`
`scope and meaning. I understand that in IPR proceedings, the claims must generally
`
`be given “the meaning that the term would have to a person of ordinary skill in the
`
`art in question at the time of the invention.”
`
`A. Anticipation
`31.
`I understand that anticipation requires that each and every element of
`
`the claimed invention be disclosed expressly or inherently in a single prior art
`
`reference. I also understand that a reference can anticipate a claim even if it does
`
`not expressly spell out all the limitations arranged or combined as in the claim. For
`
`example, I understand that an element may be inherent in the prior art where the
`
`prior art necessarily functions in accordance with or includes the claimed limitations.
`
`I am also informed that inherency may exist even if a POSA would not appreciate
`
`or recognize the inherent characteristics of the prior art, as the discovery of a
`
`previously unappreciated property does not make an old composition patentable.
`
`
`
`13
`
`DRL Ex. 1017, p. 019
`
`
`
`
`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
`
`
`
`32. Moreover, a reference anticipates a claim if it discloses the claimed
`
`invention such that a skilled artisan could take its teachings in combination with his
`
`own knowledge of the particular art and be in possession of the invention. In an
`
`anticipation inquiry, it is proper to take into account not only specific teachings of
`
`the reference but also the inferences that one skilled in the art would reasonably be
`
`expected to draw therefrom. It is also my understanding that proof of efficacy is
`
`not required in order for a reference to be enabled for purposes of anticipation, or
`
`for that matter, anticipation does not require actual performance of suggestions in a
`
`disclosure. I also understand that a prior art reference must enable a POSA to make
`
`and use a claimed invention in order to anticipate a patent claim, although I
`
`understand that in an IPR, prior art references are presumed to be enabled.
`
`B. Obviousness
`33.
`I understand that a patent claim is invalid if the differences between the
`
`claimed invention and prior art are such that the subject matter as a whole would
`
`have been obvious at the time the invention was made to a POSA.
`
`34.
`
`I have been told the following factors (sometimes referred to as the
`
`Graham factors) are used in making an obviousness determination: ( a) the scope
`
`and content of the prior art; (b) the differences between the prior art and the
`
`claimed invention; (c) the level of ordinary skill in the pertinent art; and (d) any
`14
`
`
`
`DRL Ex. 1017, p. 020
`
`
`
`
`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
`
`
`secondary considerations evidencing nonobviousness. The obviousness analysis
`
`looks to the state of the art that existed at the time the invention was made.
`
`Moreover, obviousness does not require absolute predictability of success; all that
`
`is required is a reasonable expectation of success. Moreover, I have been
`
`informed that the person of ordinary skill need only have a reasonable expectation
`
`of success of developing the claimed invention. Finally, obviousness cannot be
`
`avoided simply by a showing of some degree of unpredictability in the art so long
`
`as there was a reasonable probability of success.
`
`35.
`
`I also understand that obviousness can be established by combining or
`
`modifying the teachings of the prior art. A claimed invention can be obvious when,
`
`for example, there is some teaching, suggestion, or motivation in the prior art that
`
`would have led a POSA to modify the prior art reference or to combine prior art
`
`reference teachings to arrive at the claimed invention.5
`
`
`5 As a general matter, in my view in science and technology, a POSA would not
`
`view any single disclosure as complete, and thus, look no further. Were that the
`
`case, society would have halted technological progress long ago. Instead, ordinary
`
`artisans always seek improvement in their respective fields, and especially so in
`
`science and technology.
`
`
`
`15
`
`DRL Ex. 1017, p. 021
`
`
`
`
`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
`
`
`
`36.
`
`I also understand that the prior art references themselves do not have to
`
`provide an explicit teaching, suggestion, or motivation to combine prior art
`
`teachings; rather, the analysis may rely on interrelated teachings, market demands,
`
`the background knowledge possessed by a POSA, and/or common sense. Moreover,
`
`the POSA can also take account of the inferences and creative steps that he or she
`
`would employ. Put another way, the motivation to combine or modify prior art
`
`references can come from any reason to do so and is not limited to the reasons that
`
`may have motivated the patentee.
`
`37.
`
`I am also informed that a combination of familiar elements according
`
`to known methods is likely to be obvious when it does no more than yield predictable
`
`results. I also understand that when a POSA would have reached the claimed
`
`invention through routine experimentation, the invention may be deemed obvious.
`
`38.
`
`I understand that various rationales are utilized to determine whether a
`
`claim
`
`is obvious,
`
`including,
`
`among others: (i) simple
`
`substitution or
`
`interchangeability of one known element for another to obtain predictable results;
`
`(ii) use of known techniques to improve similar methods or products in the same
`
`way; (iii) applying a known technique to a known method or product ready for
`
`improvement to yield predictable results; (iv) “obvious to try”—choosing from a
`
`finite number of identified, predictable solutions, with a reasonable expectation of
`16
`
`
`
`DRL Ex. 1017, p. 022
`
`
`
`
`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Declaration of Joseph M. Fortunak, Ph.D.
`
`
`success; and (v) known work in one field of endeavor prompting variations of it for
`
`use in either the same field or a different one based on design incentives or other
`
`market forces if the variations would have been predictable to one of ordinary skill
`
`in the art.
`
`39. As stated above, I understand that secondary considerations of non-
`
`obviousness are part of the obviousness inquiry. I understand that these secondary
`
`considerations may include failure of others, copying, unexpectedly superior
`
`results, perception in the industry, commercial success, and long-felt but unmet
`
`need. I also understand that for secondary considerations of non-obviousness to be
`
`applicable, they must have a nexus to the claimed subject matter. I understand that
`
`this nexus (i.e., link) includes a connection between the subject matter of the claim
`
`and the alleged secondary considerations.
`
`40.
`
`I understand that I cannot use hindsight in any obviousness analysis. In
`
`connection with my opinions, I did not use hindsight, nor did I use the claims and/or
`
`the disclosure of the ’708 Patent as a blueprint for piecing together the prior art to
`
`arrive at the claimed invention. As part of the obviousness analysis, and to avoid
`
`hindsight, I thought back to the time of invention (i.e., the relevant priority date
`
`(discussed further below)) and considered th
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