UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`V.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner
`
`Case No. IPR2018-01670
`Case No. IPR2018-01675
`Case No. IPR2018-01676
`Case No. IPR2018-01678
`Case No. IPR2018-01679
`Case No. IPR2018-01680
`Case No. IPR2018-01682
`Case No. IPR2018-01684
`Case No. IPR2019-00122
`U.S. Patent No. 8,603,044
`U.S. Patent No. 8,679,069
`U.S. Patent No. 8,992,486
`U.S. Patent No. 9,526,844
`U.S. Patent No. 9,604,008
`
`DECLARATION OF ALEXANDER SLOCUM, PH.D. IN SUPPORT OF
`PATENT OWNER RESPONSES
`
`WEIL:\97083094\5\71937.0127
`
`Sanofi Exhibit 2107.001
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`TABLE OF CONTENTS
`
`PAGES
`
`INTRODUCTION .......................................................................................... . 1
`I.
`QUALIFICATIONS ........................................................................................ 1
`II.
`III. MATERIALS CONSIDERED ........................................................................ 6
`IV. LEGAL STANDARDS ................................................................................... 6
`V.
`BACKGROUND OF THE TECHNOLOGY .................................................. 8
`
`A.
`B.
`
`Insulin Pen Injectors .............................................................................. 9
`Screw and Nut Physics ....................................................................... . 11
`1.
`Overview .................................................................................. . 11
`Reactive Forces in Screw-Nut Systems ................................... .13
`2.
`Friction in Screw-Nut Systems ................................................ .14
`3.
`Screw-Nut Systems in Pen Injector Design ............................. .16
`4.
`Injector Pen Design Considerations for Diabetic Patients ................. .18
`1.
`Diabetic Hand and Wrist Conditions ....................................... .20
`2.
`Design Considerations for Diabetic Patients ........................... .27
`VI. OVERVIEW OF THE CHALLENGED PATENTS .................................... 32
`The Disclosure of the Challenged Patents .......................................... 33
`A.
`1.
`The First Depicted Embodiment ............................................... 34
`
`C.
`
`The Second Depicted Embodiment .......................................... 39
`2.
`The Third Embodiment ............................................................ .40
`3.
`The Challenged Claims of the Challenged Patents ............................ .45
`The Priority Date of the Challenged Patents ....................................... 51
`
`B.
`C.
`
`VII. LEVEL OF ORDINARY SKILL IN THE ART ........................................... 59
`VIII. CLAIM CONSTRUCTION .......................................................................... 61
`"
`. h
`. "
`68
`A
`main ous1ng ................................................................................... .
`.
`B.
`"tubular clutch" ................................................................................... 73
`C.
`"an interior of a flange" ....................................................................... 7 4
`
`WEIL:\97083094\5\71937.0127
`
`1
`
`Sanofi Exhibit 2107.002
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`IX. OVERVIEW OF THE PRIOR ART IDENTIFIED IN THE
`GROUNDS .................................................................................................... 83
`A.
`Burroughs ............................................................................................ 83
`B.
`Steenfeldt-Jensen ................................................................................. 89
`Steenfeldt-Jensen's First Embodiment .................................. 91
`1.
`2.
`Steenfeldt-Jensen's Second Embodiment.. ............................ 92
`3.
`Steenfeldt-Jensen's Fifth Embodiment. .................................... 96
`C. M0ller ................................................................................................ 100
`D.
`Giambattista ....................................................................................... 105
`E.
`Klitgaard ............................................................................................ 110
`OVERVIEW OF THE GROUNDS ............................................................. 110
`X.
`XI. THE ASSERTED GROUNDS DO NOT TEACH OR RENDER
`OBVIOUS CERTAIN CLAIMS OF THE CHALLENGED
`PATENTS .................................................................................................... 113
`A.
`Burroughs Does Not Render Obvious The Challenged Claims
`of the '069, '044, or '486 Patents [IPR2018-01670 Ground 1,
`IPR2018-0167 5 Ground 1, IPR2019-00122 Ground 1] ................... .113
`1.
`Burroughs Does Not Disclose Or Render Obvious A
`"Helical Groove Provided Along An Outer Surface Of
`Said Dose Dial Sleeve" ['069 Patent Claim 1; '044 Patent
`Claim 11] or A "Dose Dial Sleeve Comprising A Helical
`Groove Configured To Engage A Threading Provided By
`Said Main Housing" [' 486 Patent Claim 1] ........................... .114
`Burroughs Does Not Disclose Or Render Obvious That
`The "Helical Groove Of The Dose Dial Sleeve Has A
`First Lead And Said Internal Threading Of Said Drive
`Sleeve Has A Second Lead, And Wherein Said First
`Lead And Said Second Lead Are Different" ['044 Patent
`Claim 11] ................................................................................. 13 2
`Burroughs Does Not Disclose Or Render Obvious A
`"Tubular Clutch Located Adjacent A Distal End Of Said
`Dose [Dial Sleeve ]/[Knob], Said Tubular Clutch
`Operatively Coupled To Said Dose [Dial
`Sleeve ]/[Knob]" [069 patent Claim 1; 044 Patent Claim
`11; 486 Patent Claim l] .......................................................... 137
`
`2.
`
`3.
`
`..
`11
`
`Sanofi Exhibit 2107.003
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`B.
`
`C.
`
`2.
`
`3.
`
`4.
`
`Steenfeldt-Jensen Alone, or in Combination with Klitgaard,
`Does Not Render Obvious the Challenged Claims of the 069,
`044, 486, or 844 Patents [IPR2018-01670 (069) Ground 2,
`IPR2018-01676 (044-B) Ground 1, IPR2018-01678 (486-A2)
`Ground 1, 2018-01682 (844-B) Grounds 1 and 2]. .......................... .142
`1.
`Steenfeldt-Jensen Does Not Teach or Render Obvious "a
`drive sleeve comprising an internal threading" [IPR2018-
`01670 (069), IPR2018-01676 (044-B)], a "driver
`comprising an internal threading" [IPR2018-016 7 8 ( 486-
`A2)], or a "driving member comprising a third thread"
`[IPR2018-01682 (844-B)] ....................................................... 143
`Steenfeldt-Jensen Does Not Teach or Render Obvious a
`Dose Dial Sleeve That "comprises at least one radial
`stop, said radial stop positioned near an end of said
`helical groove" [IPR2018-01678 (486-A2) Claims 30 and
`32] ........................................................................................... 172
`Steenfeldt-Jensen Does Not Teach or Render Obvious
`"where the piston rod has a circular cross-section"
`[IPR2018-01682 (844-B) Claim 22] ...................................... .181
`Steenfeldt-Jensen Combined with Klitgaard Does Not
`Teach or Render Obvious "a nut that tracks each set dose
`of medicament delivered" [IPR2018-01682 (844-B)
`Claim 30] ................................................................................. 183
`The Combination of M0ller and Steenfeldt-Jensen's Fifth
`Embodiment Does Not Render Obvious the Challenged Claims
`of the 069, 044, or 486 Patents [IPR2018-01670 (069) Ground
`3, IPR2018-01676 (044-B) Ground 2, IPR2018-01678 (486-
`A2) Ground 2] ................................................................................... 183
`1.
`The Combination of M0ller and Steenfeldt-Jensen Does
`Not Teach or Render Obvious "a drive sleeve extending
`along a portion of said piston rod" [069 Patent Claim 1;
`044 Patent Claim 11] .............................................................. 184
`A POSA Would Not Have Been Motivated to Combine
`M0ller With Steenfeldt-Jensen [069 Patent Claim 1; 044
`Patent Claim 11; 486 Patent Claim 1] ................................... .194
`The Combination of M0ller and Steenfeldt-Jensen Does
`Not Teach or Render Obvious "said dose dial sleeve
`
`2.
`
`3.
`
`111
`
`Sanofi Exhibit 2107.004
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`comprising a helical groove configured to engage a
`threading provided by said main housing" [069 Patent
`Claim 1; 044 Patent Claim 11; 486 Patent Claim 1] and
`"said helical groove provided along an outer surface of
`said dose dial sleeve" [069 Patent Claim 1; 044 Patent
`Claim ll] ................................................................................. 202
`
`M0ller Does Not Disclose a Dose Dial Sleeve That
`Engages a Threading of a "Main Housing" ........................... .205
`A POSA Would Not Have Been Motivated to Modify
`M0ller's Internally-Threaded Dose Dial Sleeve to Be
`Externally-Threaded ............................................................... .209
`The Combination of M0ller and Steenfeldt-Jensen Does
`Not Teach or Render Obvious "at least one flexible arm
`... and at least one spline ... to provide said audible
`feedback" [044 Patent Claim 15] ........................................... .212
`The Combination ofM0ller and Steenfeldt-Jensen Does
`Not Teach or Render Obvious "wherein said main
`housing further comprises a helical rib ... adapted to be
`seated in said helical groove provided along said outer
`surface of said dose dial sleeve" [044 Patent Claim 19] ....... .214
`M0ller Does Not Teach or Render Obvious "a helical rib
`provided on an inner surface of said outer housing" [ 486
`Patent Claim 4] ....................................................................... .215
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`M0ller Does Not Teach or Render Obvious a Driver
`Comprising "a cylindrical shape" [ 486 Patent Claim 5] ....... .216
`10. M0ller Does Not Teach or Render Obvious a Clicker
`Comprising "at least one flexible [ extending] arm" [ 486
`Patent Claims 18 and 20] ....................................................... .217
`11. M0ller Does Not Teach or Render Obvious a Dose Dial
`Sleeve That Is "radially inward of said main housing"
`[486 Patent Claim 26] ............................................................ .218
`12. M0ller Combined With Steenfeldt-Jensen Does Not
`Teach or Render Obvious a "radial stop positioned near
`an end of [a] helical groove" or "near a distal end of said
`helical groove" [486 Patent Claims 30 and 32] ..................... .221
`
`IV
`
`Sanofi Exhibit 2107.005
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`D.
`
`E.
`
`F.
`
`Neither M0ller nor Steenfeldt-Jensen Teaches or Renders
`Obvious Claim 56 of the 486 Patent [IPR2018-01679 (486-B)
`Grounds 3, 4, and 6] ......................................................................... .222
`1.
`Steenfeldt-Jensen Does Not Teach Claim 56 [IPR2018-
`01679 (486-B) Ground 3] ...................................................... .223
`Steenfeldt-Jensen Does Not Render Obvious Claim 56
`[IPR2018-01679 (486-B) Ground 4] ..................................... .227
`
`2.
`
`3. M0ller Does Not Teach Claim 56 [IPR2018-01679 (486-
`B) Ground 6] ........................................................................... 228
`The Combination of M0ller and Steenfeldt-Jensen's Second
`Embodiment Does Not Render Obvious the Challenged Claims
`of the 008 Patent [IPR2018-01684 (008) Claims 1, 3, 7-8, 11,
`and 17] ............................................................................................... 231
`1.
`A POSA Would Not Have Been Motivated to Combine
`the Teachings of M0ller and Steenfeldt-Jensen as
`Petitioner Contend .................................................................. .231
`Giambasttista, Whether Alone in Combination with Steenfeldt(cid:173)
`Jensen or Klitgaard Do Not Render Challenged Claims 21-30 of
`the 844 Patent Un patentable [IPR2018-01680 (844-A) Grounds
`1, 2, 3] ................................................................................................ 256
`1.
`Giambattista Is Not Prior Art ................................................. .256
`2.
`Giambattista Does Not Disclose a Piston Rod With a
`Circular Cross Section ........................................................... .257
`
`3.
`
`Giambattista in combination with Klitgaard Does Not
`Render Claim 30 Obvious ...................................................... .260
`XII. OBJECTIVE INDICIA ............................................................................... .267
`A.
`The SoloSTAR Practices the Challenged Claims ............................ .267
`1.
`SoloSTAR Components ......................................................... .267
`2.
`SoloSTAR Operation ............................................................. .277
`3.
`The '069 Patent SoloSTAR® Analysis .................................. .280
`4.
`The '486 Patent SoloSTAR® Analysis .................................. .297
`5.
`The '844 Patent SoloSTAR® Analysis ................................... 311
`6.
`The '008 Patent SoloSTAR® Analysis ................................... 331
`
`V
`
`Sanofi Exhibit 2107.006
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`The OptiClik Does Not Practice the Challenged Claims .................. 343
`B.
`Benefits of the Claims of the Challenged Patents ............................. 345
`C.
`XIII. CONCLUSION AND JURAT .................................................................... 346
`
`Vl
`
`Sanofi Exhibit 2107.007
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`I, Alexander Slocum, declare as follows:
`
`I.
`
`INTRODUCTION
`
`1.
`
`I have been retained by Weil, Gotshal & Manges LLP, counsel for
`
`Patent Owner Sanofi-Aventis Deutschland GmbH, to submit declarations in
`
`connection with the Inter Partes Reviews that have been instituted on Sanofi's
`
`U.S. Patent Nos. 8,603,044 (the "044 Patent"), 8,679,069 (the "069 Patent"),
`
`8,992,486 (the "486 Patent"), 9,526,844 (the "844 Patent"), and 9,604,008 (the
`
`"008 Patent") ( collectively, the "challenged patents").
`
`II. QUALIFICATIONS
`
`2.
`
`I have summarized in this section my educational background, career
`
`history, awards, publications, and other relevant qualifications. My Curriculum
`
`Vitae (CV), which includes my qualifications as well as my publications is
`
`attached as Exhibit 2108.
`
`3. My principal field of experience is mechanical engineering with a
`
`focus on precision engineering, and precision machine design. I have written two
`
`books on machine design, as well as a section of another book, and approximately
`
`170 papers published in refereed journals and in proceedings of refereed
`
`conferences.
`
`I have taught courses on mechanical design, including precision
`
`machine design, continuously since 1991. I have also taught courses on medical
`
`device design continuously since 2001. I also regularly consult for companies to
`
`assist them with various types of design challenges.
`
`1
`
`Sanofi Exhibit 2107.008
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`4.
`
`I graduated from the Massachusetts Institute of Technology in 1982
`
`with a Bachelors of Science degree in Mechanical Engineering.
`
`I received my
`
`Master of Science in Mechanical Engineering from MIT in 1983, and my Doctor
`
`of Philosophy degree from MIT in 1985. My doctoral thesis was entitled "Sensor
`
`System Design to Determine Position and Orientation of Articulated Structures."
`
`While working on my Doctoral Thesis, I was a full-time employee of the US
`
`National Bureau of Standards (now NIST) where I was in charge of multiple
`
`projects related to precision instruments and automated systems that led to many
`
`awards, patents and publications.
`
`5.
`
`After receiving my Doctorate in 1985, I came to MIT as an Assistant
`
`Professor in Civil Engineering to do research on automating construction processes
`
`and to teach courses in civil engineering ( construction automation), and precision
`
`machine design. From 1989 to 1990, I accepted a Royal Society Fellowship and
`
`an Oak Ridge National Laboratory Optics Fellowship to enable me to become a
`
`Visiting Professor at the Cranfield Institute of Technology in Cranfield, United
`
`Kingdom where my focus was on precision machines in support of creating optics
`
`for the "Star Wars" missile defense system program.
`
`6.
`
`I returned to MIT in 1991 as an Assistant Professor in the Mechanical
`
`Engineering Department.
`
`I continued to do research in and teach courses on
`
`precision machine design.
`
`I became a Chaired Associate Professor in 1992, a
`
`2
`
`Sanofi Exhibit 2107.009
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Chaired Tenured Associate Professor in 1995, and a Chaired full Professor in
`
`1998.
`
`I am currently the Walter M. May and A. Hazel May Professor of
`
`Mechanical Engineering.
`
`7.
`
`In 2001, I co-taught a course in "Medical Innovation" and ever since
`
`have taught courses with multiple term projects on medical device design,
`
`including course number 2.75 titled "Design of Medical Devices".
`
`8.
`
`I have served on numerous advisory and review panels and
`
`professional committees, as set forth in my CV. See Ex. 2108.
`
`9.
`
`I am an inventor on approximately 133 United States patents, many of
`
`which relate to machine elements, tools, and medical devices, and these are listed
`
`in my CV. My earliest patents on mechanisms issued over thirty years ago,
`
`including patents on leadscrew and nut arrangements.
`
`See Ex. 2108 at 4
`
`(US4685661, "Method And Mechanism For Fixturing Objects", 8/11/1987;
`
`US4765668, "Robot End Effector", 8/23/1988; US4836042, "System To Convert
`
`Rotary Motion To Linear Motion", 6/6/1989), 6 (US5839769 "Expanding Gripper
`
`With Elastically Variable Pitch Screw", 11/24/1998).
`
`I also have patents on
`
`telescoping or collapsing robotic tube structures having an arrangement of
`
`concentric structures containing precision mechanisms including nested concentric
`
`leadscrews. See 2108 at 5 (US5733096, "Multi-Stage Telescoping Structure",
`
`3/31/1998). With regard to syringes and low forces, for example, I have a patent
`
`3
`
`Sanofi Exhibit 2107.010
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`on a pressure measuring syringe. See 2108 at 8 (US8291768 "Pressure Measuring
`
`Syringe", 10/23/2012).
`
`10.
`
`In 1986 I was awarded the US Dept. of Commerce Bronze Medal
`
`Award for Superior Federal Service (precision machine design for the Automated
`
`Manufacturing Research Facility). In 1994, I received the American Society of
`
`Civil Engineers Thomas Fitch Rowland Prize. In 1997, I was awarded an NSF
`
`Presidential Young Investigator Award and the Society of Mechanical Engineers
`
`Frederick W. Taylor Research Medal. In 1999, I received the Martin Luther King
`
`Jr. Leadership Award and in 2000 the Massachusetts Professor of the Year Award,
`
`In 2004 I received the American Society of Mechanical Engineers Leonardo da
`
`Vinci Award, the ASME Machine Design Award in 2008, and the ASME Thar
`
`Energy Award in 2014.
`
`In 2014, I received the Association of Manufacturing
`
`Technology Charlie Carter Award.
`
`11.
`
`In addition, I have helped products win 11 R&D 100 Awards for Best
`
`New Scientific and Technical Products as determined by R&D Magazine. A full
`
`list of my awards is provided in my Curriculum Vitae.
`
`12. My CV also lists all of the publications authored by me. Some of
`
`these publications describe my work on medical devices, including, among other
`
`things, my work on teaching medical device design, on ultrasound devices in 1993
`
`and on endoscopic mechanisms in the 2000s. See Ex. 2108 at 13 ("The Design of
`
`4
`
`Sanofi Exhibit 2107.011
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`a Precision Bilaminar Resonating Transducer Assembly Tool", Jou. Int. Soc. of
`
`Precision Engineering and Nanotechnology, October 1993), 18 ("Classroom to
`
`Clinic: Merging Education and Research to Efficiently Prototype Medical
`
`Devices," IEEE Journal of Translational Engineering in Health and Medicine,
`
`August
`
`15,
`
`2013,
`
`available
`
`at
`
`https://www.ncbi.nlm.nih.gov/pmc/articles/PMC484 7 4 77 /),
`
`24
`
`("A Needle
`
`Guidance System For Percutaneous Lung Biopsy" ASME 2005 International
`
`Design Engineering Technical Conferences & Computers and Information in
`
`Engineering Conference, September 24-28 2005).
`
`13.
`
`Since 1983 (starting at NBS), my R&D work for industry and
`
`government agencies has included extensive studies of fluid systems from
`
`hydraulic values and actuators to pressurized liquid bearings, as well as medical
`
`devices. In 2010, I served on Energy Secretary Chu's special DoE Science Team
`
`working on the Gulf Oil Spill, and in 2013 I served in the Office of Science and
`
`Technology Policy in the Executive Office of the President as the Assistant
`
`Director for Advanced Manufacturing. I was elected to the National Academy of
`
`Engineering in 2017 for my work on precision machine design, manufacturing, and
`
`teaching.
`
`5
`
`Sanofi Exhibit 2107.012
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`14.
`
`I am being compensated for the time I am spending on this case at my
`
`normal consulting rate of $700 per hour. My compensation is not based on either
`
`the content of my opinions or the outcome of the case.
`
`III. MATERIALS CONSIDERED
`
`15.
`
`In connection with my work on this matter, I have reviewed and
`
`considered the materials listed in the table of Appendix G to my declaration.
`
`16.
`
`In addition to the documents identified in the table of Appendix G, my
`
`opinions herein are based on my personal experience, knowledge, skill, and
`
`expertise, and any other materials cited herein.
`
`IV. LEGALSTANDARDS
`
`17.
`
`I am not a lawyer, and I offer no legal opinions in this declaration. I
`
`have been informed by counsel as to various legal standards that apply to the
`
`technical issues I address in this declaration, and I have applied those standards in
`
`arriving at my conclusions.
`
`18.
`
`I understand that a Petitioner in an inter part es review proceeding
`
`must prove invalidity of the challenged claims by a preponderance of the evidence.
`
`19.
`
`I have been informed that, when determining whether the challenged
`
`claims of a Patent are invalid as anticipated, one must determine whether each and
`
`every claim limitation as arranged in a claim is found in a single prior art
`
`reference, expressly or inherently. I have been informed that a claim limitation is
`
`6
`
`Sanofi Exhibit 2107.013
`Mylan v. Sanofi
`IPR2018-01675
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`

`

`inherent only when a pnor art reference necessarily includes the unstated
`
`limitation.
`
`20.
`
`I have been informed that a prior art reference does not anticipate a
`
`claim if it is missing even one claim limitation. I also understand that a prior art
`
`reference does not anticipate if it is not enabling. A prior art reference is enabling
`
`if it enables persons of ordinary skill to make the invention without undue
`
`experimentation.
`
`21.
`
`I have been informed that, when analyzing whether the challenged
`
`claims of the challenged patents are invalid as obvious, one must determine
`
`whether the invention in each challenged claim as a whole would have been
`
`obvious to a person of ordinary skill in the art, taking into account I) the scope and
`
`content of the prior art; 2) the differences between the prior art and the claimed
`
`invention; 3) the level of ordinary skill in the art; and 4) any secondary
`
`considerations of nonobviousness. I understand that a determination of whether a
`
`patent claim is invalid as obvious requires consideration of all four of these factors,
`
`and it is error to reach a conclusion of obviousness until all those factors are
`
`considered.
`
`22.
`
`I have been informed that a determination of obviousness requires that
`
`a person of ordinary skill in the art would have had a reason to modify or combine
`
`prior art references to achieve the claimed invention. I understand that this reason
`
`7
`
`Sanofi Exhibit 2107.014
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`to modify or combine is not based on whether a person of ordinary skill in the art
`
`could combine prior art references, but whether a person of ordinary skill in the art
`
`would have been motivated to do that at the time of the invention.
`
`23.
`
`I have also been informed that a determination of obviousness
`
`requires that a person of ordinary skill have a reasonable expectation of success in
`
`combining the prior art references to achieve the claimed invention.
`
`24.
`
`I have been informed that secondary considerations may show that the
`
`claimed subject matter is not obvious. These secondary considerations can include,
`
`for example, commercial success ( evidence of commercial success that can be
`
`attributed to the merits of the invention), failure of others ( evidence that others
`
`have tried and failed to solve the problem or satisfy the need resolved by the
`
`claimed invention), and skepticism ( evidence that those of skill in the art were
`
`skeptical as to the merits of the invention, or even taught away from the invention).
`
`I understand that secondary considerations play an important role as a guard
`
`against prohibited hindsight reasoning in the obviousness analysis.
`
`V.
`
`BACKGROUND OF THE TECHNOLOGY
`
`25.
`
`I have been asked to provide a background of the relevant technology
`
`and design principles, which I describe below.
`
`8
`
`Sanofi Exhibit 2107.015
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`A.
`
`Insulin Pen Injectors
`
`26.
`
`Pen injectors come in reusable and prefilled varieties. Reusable
`
`injection pens allow the user to reset the drive mechanism and replace the
`
`medicament cartridge after the remaining dose is expelled. Ex. 2123 at 2. Prefilled
`
`pens ( or disposable pens) are intended to be discarded after the contents of the
`
`prefilled cartridge runs out. Ex. 2123 at 2. Because prefilled pens are typically
`
`smaller, lighter, and simpler to use, patients typically prefer them over the reusable
`
`variety. Ex. 2123 at 4; see also Ex. 2113 at 7. Usually, prefilled pens are also less
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`expensive since the components can be manufactured using plastics and cheaper
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`materials. See e.g., Ex. 2120 at 2; Reusable pens, on the other hand, include
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`additional components necessary to reset the drive mechanism and are constructed
`
`of more rugged and durable materials since a single reusable device may be used
`
`for several years. Ex. 2113 at 6, 7.
`
`27. Reusable pens were the first to enter the market in 1985 when Novo
`
`introduced the NovoPen®. Ex. 2137 at 25, 65; Ex. 2160 at 1. The NovoPen®
`
`measured and administered two units of insulin, corresponding to two clicks per
`
`depression. Ex. 2144 at 4. In 1986, Nordisk introduced its own reusable insulin
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`pen, called Insuject®. Ex. 2137 at 25. Three years later, in 1989, Novo introduced
`
`the NovoLet®, the world's first prefilled insulin pen. Id.
`
`9
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`Sanofi Exhibit 2107.016
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`28.
`
`In 2001, Novo introduced the FlexPen, a prefilled disposable injector,
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`"designed for easy and discrete use." Ex. 2137 at 53, 66; Ex. 2136 at 22. Based on
`
`my review of the FlexPen, it has two modes of operation - dose setting and dose
`
`injection. To set a dose, the user dials a dose by rotating a dose knob to select the
`
`amount of medicament to be dispensed. To inject a dose, the user applied force to
`
`the dose button and causing the dose knob to rotate back into the housing.
`
`29. While the FlexPen was considered a leading pen at the time, it had
`
`many drawbacks. Notably, the FlexPen had high injection force, long dial
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`extension, and only permitted a user to select 60 units of insulin. Ex. 2144 at 8; Ex.
`
`2100 at 3. Based on my analysis of the FlexPen, it is my opinion that main
`
`contributing factor to the FlexPen's high injection force resulted from having to
`
`overcome the ratchet mechanism between the driver tube and the housing. It was
`
`not until 2008 (7 years after the launch of the FlexPen) that Novo introduced the
`
`New Generation FlexPen (NGFP), which included redesigned components in order
`
`to reduce the injection force. Ex. 2136 at 71. I understand from my discussions
`
`with Rob Veasey (an inventor of the challenged patents), and my own analysis,
`
`that Steenfeld-Jensen's fifth embodiment closely corresponds to the disposable
`
`FlexPen.
`
`10
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`Sanofi Exhibit 2107.017
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`B.
`
`Screw and Nut Physics
`
`1.
`
`Overview
`
`30. Many pen injector designs, including those covered by the challenged
`
`patents, operate using screw and nut mechanisms. When evaluating such pen
`
`injectors, the physics of a "screw" working in concert with a "nut" needs to be
`
`considered carefully. For the purposes of describing the physics of operation,
`
`consider the case where the "screw" is a shaft with external threads and the "nut" is
`
`a component with internal threads that mate with the screw's external threads.
`
`Relative rotation between a screw and a nut is required to have axial motion
`
`between the two. This axial motion can occur by causing the screw or the nut to
`
`rotate while the other is prevented from rotating and, similarly, by preventing one
`
`of the two components from translating (i.e., moving axially). In all cases, there
`
`will be relative rotation and translation of the sliding contact interface between the
`
`screw's threads and the nut's threads.
`
`31. Newton's 3rd law tells us that for every action there is an equal and
`
`opposite reaction. In the case of the thread interface between the screw and nut,
`
`because the threads are helical, which means they are in effect ramps or wedges,
`
`they convert rotational motion to axial motion, or vice versa. Most people have
`
`experience with wedges and know that they can use a wedge to generate much
`
`larger forces on an object than they could if they pushed directly on the object. For
`
`11
`
`Sanofi Exhibit 2107.018
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`example, a wedge can be driven between two objects to lift one away from the
`
`other or driven into an object, as is the case with an axe and a log, to separate it.
`
`Most people also know that the distance the wedge moves in is less than the
`
`distance it makes the object move up. This is a result of the conservation of
`
`energy: the product of an applied force with the distance over which it is applied
`
`(times the efficiency of the system, which is governed by friction) will equal the
`
`product of the resulting output force over the distance which it acts. The wedge is
`
`a simple transmission that makes life easier for people by helping them amplify the
`
`small forces they create with their body in order to do useful work. The same is
`
`true with screws and nuts, which are essentially rotary wedges.
`
`32. As mentioned above, in a screw-nut system the application of torque
`
`to either a screw or a nut can cause one of the two to move axially, depending on
`
`which component is axially fixed and which is rotationally fixed. The application
`
`of axial force to one of the components, however, may or may not impart rotation
`
`to the other component depending on the circumstances. For example, most
`
`people know that if they were to push down on the nut instead of rotating it, the nut
`
`will not move. This is because of a small thread angle and high friction. In this
`
`case, the threads act as self-locking wedges, and, which is the case where if the
`
`wedge angle is small, typically less than 15 degrees, the wedge will not dislodge
`
`itself once the user stops applying force to push it in to pry apart objects.
`
`12
`
`Sanofi Exhibit 2107.019
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`33. Conversely, if the thread angle is large enough and the coefficient of
`
`friction small enough, applying strictly axial force to either the screw or the nut can
`
`cause relative rotation and axial motion between the two. Such a system is referred
`
`to as being "backdriveable" and the term "backdrive" or "backdriving" is used to
`
`describe applying an axial force to screw or nut element and causing helical
`
`movement thereof. Ex. 2214.
`
`2.
`
`Reactive Forces in Screw-Nut Systems
`
`34. Newton's 3rd law tells us that any external axial force applied to the
`
`screw will be resisted by an equal and opposite force applied to the screw by the
`
`nut's threads. This also means that there must be an external force acting on the
`
`nut to act against the force on the nut threads by the screw. This external force on
`
`the nut would be supplied by another element connected to or supporting the nut.
`
`Ultimately, there must be structural elements connecting the equal and opposite
`
`forces acting on the screw and the nut. This loop of forces through elements is
`
`called the "structural loop".
`
`35.
`
`In the case of an injector pen, a person can hold the injector pen in the
`
`air with one hand and push the button and fl