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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`PFIZER INC.,
`Petitioner,
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`v.
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`SANOFI-AVENTIS DEUTSCHLAND GMBH
`Patent Owner.
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`Patent No. 8,679,069
`Patent No. 8,603,044
`Patent No. 8,992,486
`Patent No. 9,526,844
`Patent No. 9,604,008
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`DECLARATION OF MR. CHARLES E. CLEMENS
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`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
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`

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`
`TABLE OF CONTENTS
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`Page
`QUALIFICATIONS ........................................................................................ 1
`I.
`SCOPE OF WORK.......................................................................................... 3
`II.
`III. LEGAL STANDARDS ................................................................................... 5
`IV. OVERVIEW OF THE CHALLENGED PATENTS ...................................... 9
`A. Overview of the Components .............................................................. 20
`B.
`Overview of Injector’s Operation ....................................................... 42
`C.
`Overview of the Second and Third Embodiments of the ’008
`Patent ................................................................................................... 49
`Relevant Timeframe of the Challenged Patents .................................. 52
`D.
`V. OVERVIEW OF THE LEVEL OF SKILL ................................................... 56
`VI. CLAIM CONSTRUCTION .......................................................................... 57
`VII. OVERVIEW OF THE SCOPE AND CONTENT OF THE ART ................ 61
`A.
`Background of injector pen design ..................................................... 61
`B.
`Burroughs ............................................................................................ 68
`C.
`Steenfeldt-Jensen ................................................................................. 72
`D. Møller .................................................................................................. 80
`E.
`Giambattista ......................................................................................... 88
`F.
`Klitgaard .............................................................................................. 91
`VIII. Detailed Explanation Of The Grounds Of Unpatentability ........................... 92
`1.
`The ʼ069 grounds: ..................................................................... 92
`2.
`The ʼ044-A grounds: ................................................................. 93
`3.
`The ʼ044-B grounds: ................................................................. 93
`4.
`The ʼ486-A1 ground: ................................................................ 94
`5.
`The ʼ486-A2 grounds: ............................................................... 94
`6.
`The ʼ486-B grounds: ................................................................. 95
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`-i-
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`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
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`A.
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`B.
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`C.
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`2.
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`2.
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`7.
`The ʼ844-A grounds: ................................................................. 95
`The ʼ844-B grounds: ................................................................. 96
`8.
`The ʼ008-A grounds: ................................................................. 96
`9.
`[ʼ069] Ground 1: Claim 1 is Obvious over Burroughs; [ʼ044-A]
`Ground 1: Claims 11, 14, 15, and 18-19 are Obvious over
`Burroughs; [ʼ486-A1] Ground 1: Claims 1-6, 12-18, 20, 23, 26-
`30, 32-33, 36, and 38-40 are Obvious over Burroughs ....................... 97
`1.
`Independent claim 1 of the ʼ069 patent, independent
`claim 11 of the ʼ044 patent, and independent claim 1 of
`the ʼ486 patent ........................................................................... 97
`Dependent claims 14-15 and 18-19 of the ʼ044 patent and
`dependent claims 2-6, 12-18, 20, 23, 26-30, 32-33, 36,
`and 38-40 of the ʼ486 patent ...................................................125
`[ʼ069] Ground 2: Claim 1 is Obvious over Steenfeldt-Jensen;
`[ʼ044-B] Ground 1: Claims 11, 14-15, and 18-19 are Obvious
`over Steenfeldt-Jensen; [ʼ486-A2] Ground 1: Claims 1-6, 12-
`18, 20, 23, 26-30, 32-33, 36, and 38-40 are Obvious over
`Steenfeldt-Jensen ...............................................................................154
`1.
`Independent claim 1 of the ʼ069 patent, independent
`claim 11 of the ʼ044 patent, and independent claim 1 of
`the ʼ486 patent .........................................................................154
`Dependent claims 14-15 and 18-19 of the ’044 patent and
`dependent claims 2-6, 12-18. 20, 23, 26-30, 32-33, 36,
`and 38-40 of the ʼ486 patent ...................................................173
`[ʼ069] Ground 3: Claim 1 is Obvious over Møller in
`combination with Steenfeldt-Jensen; [ʼ044-B] Ground 2:
`Claims 11, 14-15, and 18-19 are Obvious over Møller in
`combination with Steenfeldt-Jensen; [ʼ486-A2] Ground 2:
`Claims 1-6, 12-18, 20, 23, 26-30, 32-33, 36, and 38-40 are
`Obvious over Møller in combination with Steenfeldt-Jensen ...........201
`1.
`Independent claim 1 of the ’069 patent, independent
`claim 11 of the ’044 patent, and independent claim 1 of
`the ’486 patent .........................................................................202
`Dependent claims 14-15 and 18-19 of the ʼ044 patent and
`dependent claims 2-6, 12-18, 20, 23, 27-30, 32-33, 36,
`and 38-40 of the ’486 patent ...................................................232
`-ii-
`Pfizer Exhibit – 1011
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`Pfizer v. Sanofi
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`2.
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`D.
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`E.
`F.
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`G.
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`H.
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`I.
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`J.
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`K.
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`L.
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`M.
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`N.
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`[’486-B] Ground 1: Claims 51-55 and 57 are Anticipated by
`Burroughs ..........................................................................................263
`1.
`Independent claim 51 of the ’486 patent ................................263
`2.
`Dependent claims 52-55 and 57 of the ’486 patent ................268
`[’486-B] Ground 2: Claims 54-55 are Obvious over Burroughs ......276
`[’486-B] Ground 3: Claims 51-53 and 56-57 are Anticipated by
`Steenfeldt-Jensen ...............................................................................278
`1.
`Independent claim 51 of the ’486 patent ................................278
`2.
`Dependent claims 52-53 and 56-57 of the ’486 patent ...........283
`[’486-B] Ground 4: Claim 56 is Obvious over Steenfeldt-Jensen
`[’486] Claim 56: The clutch of claim 51, further comprising a
`plurality of axially extending teeth formed in an interior of a
`flange of said clutch. .........................................................................288
`[’486-B] Ground 5: Claims 54-55 are Obvious over Steenfeldt-
`Jensen in combination with Burroughs .............................................289
`[’486-B] Ground 6: Claims 51-53 and 56-57 are Anticipated by
`Møller ................................................................................................293
`1.
`Independent claim 51 of the ’486 patent ................................294
`2.
`Dependent claims 52-53 and 56-57 of the ’486 patent ...........300
`[’486-B] Ground 7: Claims 54-55 are Obvious over Møller in
`combination with Burroughs .............................................................307
`[’844-A] Ground 1: Claims 21-29 are Anticipated by
`Giambattista .......................................................................................311
`1.
`Independent claim 21 of the ’844 Patent ................................312
`2.
`Dependent claims 22-29 of the ’844 patent ............................330
`[’844-A] Ground 2: Claims 24-29 are Obvious over
`Giambattista in combination with Steenfeldt-Jensen ........................343
`[’844-A] Ground 3: Claim 30 is Obvious over Giambattista in
`combination with Klitgaard ...............................................................345
`[’844-B] Ground 1: Claims 21-29 is Obvious over Steenfeldt-
`Jensen ................................................................................................350
`1.
`Independent claim 21 ..............................................................350
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`-iii-
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`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
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`

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`O.
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`P.
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`2.
`Dependent claims 22-29 of the ’844 patent ............................370
`[’844-B] Ground 2: Claim 30 is Obvious over Steenfeldt-Jensen
`in combination with Klitgaard .........................................................381
`[’844-C] Ground 1: Claims 21-29 are Obvious over Møller in
`combination with Steenfeldt-Jensen .................................................386
`1.
`Independent claim 21 of the ’844 patent ................................387
`2.
`Dependent claims 22-29 of the ’844 patent ............................417
`[’844-C] Ground 2: Claim 30 is Obvious over Møller in
`combination with Steenfeldt-Jensen and Klitgaard ..........................429
`[’008] Ground 1: Claims 1, 3, 7-8, 11, and 17 are Obvious over
`Møller in combination with Steenfeldt-Jensen .................................434
`1.
`Independent claim 1 of the ’008 patent ..................................435
`2.
`Dependent claims 3, 7, 8, 11, and 17 of the ’008 patent ........457
`[ʼ069] Ground 1: Claims 2-3 are Obvious over Burroughs ..............465
`S.
`IX. Concluding Statements ................................................................................468
`X. Appendix - List of Exhibits .........................................................................470
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`-iv-
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`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
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`

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`I.
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`I, Charles E. Clemens, declare as follows:
`QUALIFICATIONS
`1.
`I have been retained by counsel on behalf of Petitioner, Pfizer Inc.
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`(“Pfizer”), to provide technical analysis and opinions in this matter related to my
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`experience and expertise. My opinions are based on my skills, knowledge, training,
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`education, and experience in matters of this nature, and my examination of the
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`materials utilized in preparing this report.
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`2.
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`I received a Bachelor’s Degree in Mechanical Engineering from San
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`Diego State University in 1979.
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`3.
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`I have over 40 years of experience as an engineer, executive and
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`consultant in the medical device industry.
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`4.
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`From 1981 to 1995, I worked at IVAC Corporation (now CareFusion a
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`subsidiary of Becton Dickinson), a company that pioneered intravenous medication
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`delivery systems. During my time at IVAC, I worked in multiple roles, including as
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`a product designer, engineering manager, and technical director for the largest
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`medication delivery system program the company had ever attempted, which
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`resulted in launching the product in both the US and European markets. My work at
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`IVAC involved design, development, marketing, launch, and manufacturing of
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`numerous drug delivery devices and vital sign monitoring systems. My design and
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`development work at IVAC lead to filing five patents on which I was a named
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`-1-
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`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
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`inventor. The focus of my work was on small mechanisms, plastic injection molded
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`parts produced in quantities of millions, and precision assembly of parts to achieve
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`high production quality and functional reliability. The mechanisms I designed with
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`my group at IVAC commonly included mechanical components such as bearings,
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`ratchets, rotating parts, and precision interfaces that could interact with electronics,
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`for example, to count and set doses for intravenous injection systems. In 1990, I
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`established and managed training for specialized design tools for Design for
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`Manufacturing and Assembly (DFMA), a design process for optimizing assemblies
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`and part count for small plastic devices produced in high quantities.
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`5.
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`From 1995 to the present, I have been operating a medical device design
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`and development consulting company as the Founder and Principal Consultant. My
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`consulting company focuses on developing innovative medical device products and
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`bringing them to market. During this time, I have worked extensively on dozens of
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`medical device designs across many Clients in the areas of (a) liquid medication
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`delivery devices, including intravenous (“IV”) systems, (b) pen injectors, (c)
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`respiratory care devices such as personal inhalers, (d) hemodialysis and other blood
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`handling systems, and (e) in-vitro diagnostic systems utilizing small mechanisms
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`that require controlling rotational and axial movements (among others). From 2005
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`to 2006, I also analyzed and optimized single and multiple use injector pen designs
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`-2-
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`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
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`for Verus Pharmaceuticals, which is a product that is now marketed as the
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`Adrenaclick auto-injector.
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`6.
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`I am identified as an inventor on 10 issued patents and 3 applications in
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`the field of medical devices, including small mechanisms, plastic injection molding
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`and assembly, patient medication delivery devices, and fluidic control devices.
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`7.
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`I have worked with hundreds of plastic medical device assemblies and
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`mechanisms throughout my career and have significant experience with medication
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`delivery systems including pen type injection devices, prior art injection devices,
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`and the injection devices that are disclosed by the challenged patents.
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`8.
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`A copy of my curriculum vitae, attached as Exhibit 1012, contains
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`further details on my education, experience, publications, patents, and other
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`qualifications to render an expert opinion in this matter.
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`II.
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`SCOPE OF WORK
`9.
`I understand that petitions are being filed with the United States Patent
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`and Trademark Office for inter partes review of:
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`(1) U.S. Patent No. 8,679,069 to Veasey et al. (“the ʼ069 patent,”
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`EX1001), entitled “Pen-Type Injector”;
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`(2) U.S. Patent No. 8,603,044 to Veasey et al. (“the ʼ044 patent,”
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`EX1002), entitled “Pen-Type Injector”;
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`-3-
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`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
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`(3) U.S. Patent No. 8,992,486 to Veasey et al. (“the ʼ486 patent,”
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`EX1003), entitled “Pen-Type Injector”;
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`(4) U.S. Patent No. 9,526,844 to Veasey et al. (“the ʼ844 patent,”
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`EX1004), entitled “Pen-Type Injector”; and
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`(5) U.S. Patent No. 9,604,008 to Veasey (“the ʼ008 patent,”
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`EX1005), entitled “Drive Mechanisms Suitable for Use in Drug Delivery
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`Devices.”1
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`10.
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`I have been retained by Pfizer Inc. (“Pfizer”) to offer an expert opinion
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`on the patentability of the claims of the challenged patents. I receive hourly
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`compensation for my services at a rate of $350 per hour, with half rate for non-
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`working travel time. No part of my compensation is dependent on my opinions or
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`on the outcome of this proceeding.
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`11.
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`I have been specifically asked to provide my opinions on:
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`(1)
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`(2)
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`Independent claim 1 and dependent claims 2-3 of the ʼ069 patent;
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`Independent claim 11 and dependent claims 14-15 and 18-19 of
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`the ʼ044 patent;
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`(3)
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`Independent claim 1 and dependent claims 2-6, 12-18, 20, 23,
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`26-30, 32-33, 36, and 38-40 of the ʼ486 patent;
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`1 I will refer to these patents collectively as “the challenged patents.”
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`-4-
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`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
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`(4)
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`Independent claim 51 and dependent claims 52-57 of the ʼ486
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`patent;
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`(5)
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`Independent claim 21 and dependent claims 22-30 of the ʼ844
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`patent; and
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`(6)
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`Independent claim 1 and dependent claims 3, 7-8, 11, and 17 of
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`the ʼ008 patent.2
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`12.
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`In connection with this analysis, I have reviewed the challenged
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`patents and relevant parts of their file histories (EX1006-EX1010). I have also
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`reviewed and considered various other documents in arriving at my opinions, and
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`may cite to them in this declaration. For convenience, a list of exhibits considered in
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`arriving at my opinions is included as an appendix to this declaration.
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`III. LEGAL STANDARDS
`13.
`I have been advised that a claim is not patentable under 35 U.S.C.
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`§ 1023 if the claimed invention is not new. For the claim to be unpatentable because
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`it is anticipated, all of its requirements must have been described in a single prior art
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`reference, such as a publication or patent that predates the claimed invention.
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`2 I will refer to these claims collectively as “the challenged claims.”
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`3 Citations are to the relevant pre-AIA sections of Title 35 of the United States Code.
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`-5-
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`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
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`14.
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`I have also been advised that the description in the prior art reference
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`does not have to be in the same words as the claim, but all of the requirements of the
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`claim must be there, either stated or necessarily implied, so that someone of ordinary
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`skill in the relevant field looking at that one reference would be able to make and
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`use the claimed invention.
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`15.
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`I have been advised that a claimed invention is not patentable under 35
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`U.S.C. § 103 if it is obvious. A patent claim is unpatentable if the claimed invention
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`would have been obvious to a person of ordinary skill in the field at the time the
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`claimed invention was made. This means that even if all of the requirements of the
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`claim cannot be found in a single prior art reference that would anticipate the claim,
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`a person of ordinary skill in the relevant field who knew about all this prior art would
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`have come up with the claimed invention.
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`16.
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`I have further been advised that the ultimate conclusion of whether a
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`claim is obvious should be based upon several factual determinations. That is, a
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`determination of obviousness requires inquiries into: (1) the level of ordinary skill
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`in the field; (2) the scope and content of the prior art; (3) what difference, if any,
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`existed between the claimed invention and the prior art; and (4) any secondary
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`evidence bearing on obviousness.
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`17.
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`I have been advised that, in determining the level of ordinary skill in
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`the field that someone would have had at the time the claimed invention was made,
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`-6-
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`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
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`I should consider: (1) the levels of education and experience of persons working in
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`the field; (2) the types of problems encountered in the field; and (3) the sophistication
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`of the technology.
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`18.
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`I have also been advised that, in determining the scope and content of
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`the prior art, in order to be considered as prior art, a reference must be reasonably
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`related to the claimed invention of the patent. A reference is reasonably related if it
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`is in the same field as the claimed invention or is from another field to which a person
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`of ordinary skill in the field would look to solve a known problem.
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`19.
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`I have been advised that any secondary evidence of nonobviousness
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`may be considered as an indication that the claimed invention would not have been
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`obvious at the time the claimed invention was made, and any secondary evidence of
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`obviousness may be considered as an indication that the claimed invention would
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`have been obvious at such time. Although I should consider any such evidence, I
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`should also assign it appropriate relevance and importance when deciding whether
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`the claimed invention would have been obvious.
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`20.
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`I have been advised that a patent claim composed of several elements
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`is not proved obvious merely by demonstrating that each of its elements was
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`independently known in the prior art. In evaluating whether such a claim would have
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`been obvious, I may consider whether there is a reason that would have prompted a
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`-7-
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`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
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`person of ordinary skill in the field to combine the elements or concepts from the
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`prior art in the same way as in the claimed invention.
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`21.
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`I have been further advised that there is no single way to define the line
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`between true inventiveness on the one hand (which is patentable) and the application
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`of common sense and ordinary skill to solve a problem on the other hand (which is
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`not patentable). For example, market forces or other design incentives may be what
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`produced a change, rather than true inventiveness. I may consider whether the
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`change was merely the predictable result of using prior art elements according to
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`their known functions, or whether it was the result of true inventiveness. I may also
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`consider whether there is some teaching or suggestion in the prior art to make the
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`modification or combination of elements claimed in the patent. I may consider
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`whether the innovation applies a known technique that had been used to improve a
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`similar device or method in a similar way. I may also consider whether the claimed
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`invention would have been obvious to try, meaning that the claimed innovation was
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`one of a relatively small number of possible approaches to the problem with a
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`reasonable expectation of success by those skilled in the art.
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`22.
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`I have also been advised, however, that I must be careful not to
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`determine obviousness using the benefit of hindsight; many true inventions might
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`seem obvious after the fact. I should put myself in the position of a person of ordinary
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`-8-
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`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
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`skill in the field at the time the claimed invention was made and I should not consider
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`what is known today or what is learned from the teaching of the patent.
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`23. Finally, I have been advised that a means-plus-function limitation
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`requires identification of both the claimed function and the structure in the written
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`description necessary to perform that function. I have been advised that the statute
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`does not permit limitation of a means-plus-function claim by adopting a function
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`different from that explicitly recited in the claim. I have also been advised that the
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`statute does not permit incorporating structure from the written description that is
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`beyond what is necessary to perform the claimed function.
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`IV. OVERVIEW OF THE CHALLENGED PATENTS
`24. The challenged patents relate to a pen-type injector for the
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`self-administration of medicine, such as insulin and insulin analogs. See EX1001,
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`Title, 1:13-22.4 According to the challenged patents, users of pen-type injectors are
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`4 I note that the challenged patents share a common specification, except the
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`specification of the ʼ008 patent, which, in addition to the description found in the
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`other challenged patents, describes two other embodiments (described more below)
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`and includes a different background and summary than that contained in the other
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`challenged patents. See infra, section IV.C. For simplicity, except where I
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`-9-
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`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
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`typically patients who do not have formal medical training, such as patients with
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`diabetes. See id., 1:18-22. As such, the challenged patents explain that the injector
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`should be easy to use, as patients using the device may have impaired vision or other
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`physical infirmities. Id., 1:24-28. As an overview, I reproduce below the independent
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`claims that I have been asked to analyze.
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`25.
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`Independent claim 1 of the ’069 patent claims a housing part containing
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`a drive mechanism for dispensing medicine from a pen-type injector. See id.,
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`Abstract, claim 1. Claim 1 of the ’069 patent recites:
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`1.
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`A housing part for a medication dispensing
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`apparatus, said housing part comprising:
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`
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`a main housing, said main housing extending from
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`a distal end to a proximal end;
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`a dose dial sleeve positioned within said housing,
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`said dose dial sleeve comprising a helical groove
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`configured to engage a threading provided by said main
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`housing, said helical groove provided along an outer
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`surface of said dose dial sleeve;
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`specifically note, citations to the challenged patents’ disclosure in this overview will
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`be to the ʼ069 patent (EX1001).
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`-10-
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`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
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`a dose dial grip disposed near a proximal end of said
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`dose dial sleeve;
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`a piston rod provided within said housing, said
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`piston rod is non-rotatable during a dose setting step
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`relative to said main housing;
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`
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`a drive sleeve extending along a portion of said
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`piston rod, said drive sleeve comprising an internal
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`threading near a distal portion of said drive sleeve, said
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`internal threading adapted to engage an external thread of
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`said piston rod; and
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`
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`a tubular clutch located adjacent a distal end of said
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`dose dial grip, said tubular clutch operatively coupled to
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`said dose dial grip,
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`
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`wherein
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`said
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`dose
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`dial
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`sleeve
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`extends
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`circumferentially around at least a portion of said tubular
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`clutch.
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`Id., 6:37-60.
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`26.
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`Independent claim 11 of the ʼ044 patent similarly claims a housing part
`
`for a medication dispensing apparatus that contains substantially the same
`
`
`
`
`-11-
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`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
`
`

`

`
`
`limitations as claim 1 of the ʼ069 patent. See EX1002, Abstract, claim 11. Claim 11
`
`of the ʼ044 patent recites:
`
`
`
`1.
`
`A housing part for a medication dispensing
`
`apparatus, said housing part comprising:
`
`
`
`a main housing, said main housing extending from
`
`a distal end to a proximal end;
`
`
`
`a dose dial sleeve positioned within said housing,
`
`said dose dial sleeve comprising a helical groove
`
`configured to engage a threading provided by said main
`
`housing, said helical groove provided along an outer
`
`surface of said dose dial sleeve;
`
`
`
`a dose dial grip disposed near a proximal end of said
`
`dose dial sleeve;
`
`
`
`a piston rod provided within said housing, said
`
`piston rod is non-rotatable during a dose setting step
`
`relative to said main housing;
`
`
`
`a drive sleeve extending along a portion of said
`
`piston rod, said drive sleeve comprising an internal
`
`threading near a distal portion of said drive sleeve, said
`
`
`
`
`-12-
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`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
`
`

`

`
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`internal threading adapted to engage an external thread of
`
`said piston rod; and
`
`
`
`a tubular clutch located adjacent a distal end of said
`
`dose dial grip, said tubular clutch operatively coupled to
`
`said dose dial grip,
`
`
`
`wherein
`
`said
`
`dose
`
`dial
`
`sleeve
`
`extends
`
`circumferentially around at least a portion of said tubular
`
`clutch, and
`
`
`
`wherein said 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.
`
`Id., 8:7-35.
`
`27.
`
`Independent claim 1 of the ʼ486 patent also claims a housing part for a
`
`medication dispensing apparatus. See EX1003, claim 1. Claim 1 of the ʼ486 patent
`
`recites:
`
`
`
`1.
`
`A housing part for a medication dispensing
`
`apparatus, said housing part comprising:
`
`
`
`a main housing, said main housing extending from
`
`a distal end to a proximal end;
`
`
`
`
`-13-
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`
`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
`
`

`

`
`
`
`
`a dose dial sleeve positioned within said housing,
`
`said dose dial sleeve comprising a helical groove
`
`configured to engage a threading provided by said main
`
`housing;
`
`
`
`a dose knob disposed near a proximal end of said
`
`dose dial sleeve;
`
`
`
`a piston rod provided within said housing, said
`
`piston rod is non-rotatable during a dose setting step
`
`relative to said main housing;
`
`
`
`a driver extending along a portion of said piston rod,
`
`said driver comprising an internal threading near a distal
`
`portion of said driver, said internal threading adapted to
`
`engage an external thread of said piston rod; and,
`
`
`
`a tubular clutch located adjacent a distal end of said
`
`dose knob, said tubular clutch operatively coupled to said
`
`dose knob,
`
`
`
`wherein
`
`said
`
`dose
`
`dial
`
`sleeve
`
`extends
`
`circumferentially around at least a portion of said tubular
`
`clutch.
`
`Id., 6:59-7:12.
`
`
`
`
`-14-
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`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
`
`

`

`
`
`28.
`
`Independent claim 51 of the ʼ486 patent claims a clutch for use within
`
`a pen type drug delivery device. See id., claim 51. Claim 51 of the ʼ486 patent recites:
`
`
`
`51. A clutch for use within a pen type drug
`
`delivery device, said clutch comprising:
`
`
`
`a tubular body, said tubular body extending from a
`
`distal end to a proximal end; and
`
`
`
`said distal end of said tubular body having a
`
`diameter sized such that said distal end of said tubular
`
`body may be positioned within a proximal end of a dial
`
`member.
`
`Id., 10:31-37.
`
`29.
`
`Independent claim 21 of the ʼ844 patent claims a drug delivery device.
`
`See EX1005, claim 21. Claim 21 of the ʼ844 patent recites:
`
`
`
`
`
`21. A drug delivery device comprising:
`
`a housing comprising a dose dispensing end and a
`
`first thread;
`
`
`
`a dose indicator comprising a second thread that
`
`engages with the first thread;
`
`
`
`a driving member comprising a third thread;
`
`
`
`
`-15-
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`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
`
`

`

`
`
`
`
`
`
`
`a sleeve that is (i) disposed between the dose
`
`indicator and the driving member and (ii) releasably
`
`connected to the dose indicator;
`
`
`
`a piston rod comprising either an internal or an
`
`external fourth thread that is engaged with the third thread;
`
`
`
`a piston rod holder that is rotatably fixed relative to
`
`the housing and configured to (i) prevent the piston rod
`
`from rotating during dose setting and (ii) permit the piston
`
`rod to traverse axially towards the distal end during dose
`
`dispensing;
`
`wherein:
`
`
`
`the housing is disposed at an outermost position of
`
`the drug delivery device;
`
`
`
`the dose indicator is disposed between the housing
`
`and the sleeve and is configured to (i) rotate and traverse
`
`axially away from the dose dispensing end during dose
`
`setting and (ii) rotate and traverse axially towards the dose
`
`dispensing end during dose dispensing;
`
`
`
`the driving member is configured to rotate relative
`
`to the piston rod;
`
`-16-
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`
`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
`
`

`

`
`
`
`
`the sleeve is rotatably fixed relative to the driving
`
`member and configured to traverse axially with the dose
`
`indicator; and
`
`
`
`the piston rod and the driving member are
`
`configured to rotate relative to one another during dose
`
`dispensing;
`
`
`
`and the piston rod is configured to traverse axially
`
`towards the dose dispensing end during dose dispensing.
`
`Id., 8:16-49.
`
`30.
`
`Independent claim 1 of the ʼ008 patent claims a drive mechanism for
`
`use in a drug delivery device. See EX1005, claim 1. Claim 1 of the ʼ008 patent
`
`recites:
`
`
`
`1.
`
`A drive mechanism for use in a drug delivery
`
`device comprising:
`
`
`
`
`
`a housing comprising a helical thread;
`
`a dose dial sleeve having a threaded surface that is
`
`engaged with the helical thread of the housing,
`
`
`
`an insert provided in the housing, where the insert
`
`has a threaded circular opening;
`
`
`
`
`-17-
`
`
`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
`
`

`

`
`
`
`
`a drive sleeve releasably connected to the dose dial
`
`sleeve and having an internal helical thread;
`
`
`
`a piston rod having a first thread and a second
`
`thread, wherein the first thread is engaged with the
`
`threading circular opening of the insert and the second
`
`thread is engaged with the internal helical thread of the
`
`drive sleeve; and
`
`
`
`a clutch located between the dose dial sleeve and the
`
`drive sleeve, wherein the clutch is located (i) radially
`
`outward of the drive sleeve and (ii) radially inward of the
`
`dose dial sleeve.
`
`Id., 17:28-45.
`
`31. Below, I provide a brief overview of the injector device described in
`
`the challenged patents and claimed in varying scope. First, I explain the embodiment
`
`common to all the challenged patents. I explain each of the components that form
`
`the device of that embodiment. I follow this explanation with a description of how
`
`the components move relative to one another during the device’s operation. I then
`
`provide a brief explanation of the second and third embodiments described in the
`
`ʼ008 patent, focusing on the differences between those embodiments compared to
`
`the first embodiment.
`
`
`
`
`-18-
`
`
`Pfizer Exhibit – 1011
`Pfizer v. Sanofi
`
`

`

`
`
`32. Throughout my analysis, when I discuss the challenged patents and the
`
`prior art, I will refer to the positioning and movement of components as relative to
`
`the “button-end” of the device (i.e., the end at which the user presses a button or
`
`otherwise applies force to dispense medicine) and the “needle-end” of the device
`
`(i.e., the end by which the medicine is dispensed from the device).
`
`33.
`
`I note here that the specifications of the challenged patents refer to the
`
`button-end of the device or a component as its “second end,” and the needle-end o