UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`MYLAN PHARMACEUTICALS INC. and
`PFIZER INC.,
`Petitioners,
`
`v.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH
`Patent Owner.
`
`_____________________________
`
`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
`_____________________________
`
`REPLY DECLARATION OF KARL R. LEINSING, MSME, PE
`
`Mylan Ex.1095
`Mylan v. Sanofi - IPR2018-01675
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`TABLE OF CONTENTS
`
`BACKGROUND ............................................................................................. 1
`I.
`LEGAL STANDARDS ................................................................................... 2
`II.
`III. OVERVIEW OF THE LEVEL OF SKILL ..................................................... 2
`IV. RELEVANT TIMEFRAME OF THE ’844 PATENT .................................... 3
`V.
`CLAIM CONSTRUCTION .......................................................................... 10
`A.
`“an interior of a flange” ....................................................................... 10
`B.
`“main housing” .................................................................................... 23
`C.
`“tubular clutch” ................................................................................... 25
`VI. DETAILED EXPLANATION OF OPINIONS ............................................ 26
`A.
`[’069] Ground 1: Claim 1 is Obvious over Burroughs; [’044-A]
`Ground 1: Claims 11, 14, and 18-19 are Obvious over
`Burroughs; [’486-A1] Ground 1: Claims 1-6, 12-18, 20, 23, 26-
`30, 32-33, 36, and 38-40 are Obvious over Burroughs ....................... 27
`i.
`[’069, ’044-A, ’486-A1] Burroughs renders obvious a
`dose dial sleeve having a helical groove that engages
`with a threading on a main housing .......................................... 28
`[’069, ’044-A, ’486-A1] Burroughs teaches a tubular
`clutch ......................................................................................... 31
`[’044] Burroughs renders obvious a dose dial sleeve
`having a helical groove with a lead that is different from
`the lead of an internal threading of a drive sleeve .................... 34
`[’069] Ground 2: Claim 1 is Obvious over Steenfeldt-Jensen;
`[’044-B] Ground 1: Claims 11, 14-15, and 18-19 are Obvious
`over Steenfeldt-Jensen; [’486-A2] Ground 1: Claims 1-6, 12-
`18, 20, 23, 27-30, 32-33, 36, and 38 are Obvious over
`Steenfeldt-Jensen; [’844-B] Ground 1: Claims 21-29 are
`Obvious over Steenfeldt-Jensen .......................................................... 41
`
`iii.
`
`ii.
`
`B.
`
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`i.
`
`ii.
`
`iii.
`
`C.
`
`D.
`
`E.
`
`[’069, ’044-B, ’486-A2, ’844-B] Steenfeldt-Jensen
`teaches a “drive sleeve,” “driver,” or “driving member”
`having an internal threading ...................................................... 42
`[’486-A2] Claims 30 and 32: Steenfeldt-Jensen teaches a
`dose dial sleeve having a radial stop near an end of a
`helical groove ............................................................................ 55
`[’844-B] Claim 22: Steenfeldt-Jensen teaches a piston
`rod having a circular cross-section ........................................... 57
`[’844-B] Ground 2: Claim 30 is Obvious over Steenfeldt-Jensen
`and Klitgaard ....................................................................................... 60
`[’486-B] Ground 3: Claim 56 is Anticipated by Steenfeldt-
`Jensen; [’486-B] Ground 4: Claim 56 is Obvious over
`Steenfeldt-Jensen ................................................................................. 60
`[’069] Ground 3: Claim 1 is Obvious over Møller and
`Steenfeldt-Jensen; [’044-B] Ground 2: Claims 11, 14-15, and
`18-19 are Obvious over Møller and Steenfeldt-Jensen; [’486-
`A2] Ground 2: Claims 1-6, 12-18, 20, 23, 27-30, 32-33, 36, and
`38-40 are Obvious over Møller and Steenfeldt-Jensen ....................... 63
`i.
`[’069, ’044-B] Møller and Steenfeldt-Jensen teach a
`drive sleeve that extends along a portion of the piston rod ...... 64
`[’069, ’044-B, ’486-A2] Møller and Steenfeldt-Jensen
`teach a dose dial sleeve having a helical groove ...................... 68
`[’486-A2] Møller discloses a dose dial sleeve having a
`threading that engages a threading provided on a main
`housing ...................................................................................... 74
`[’044-B] Claim 19: Møller and Steenfeldt-Jensen teach a
`main housing having a helical rib that is adapted to be
`seated in the helical groove of the dose dial sleeve; [’486-
`A2] Claim 4: Møller and Steenfeldt-Jensen teach a
`helical rib provided on an inner surface of the main
`housing. ..................................................................................... 76
`[’486-A2] Claim 5: Møller teaches a driver having “a
`cylindrical shape” ...................................................................... 76
`[’044-B] Claim 15: Møller and Steenfeldt-Jensen teach a
`clicker having a flexible arm and a spline to provide
`audible feedback; [’486-A2] Claims 18 and 20: Møller
`and Steenfeldt-Jensen teach a clicker having at least one
`flexible extending arm .............................................................. 77
`-ii-
`
`ii.
`
`iii.
`
`iv.
`
`v.
`
`vi.
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`vii.
`
`viii.
`
`I.
`
`F.
`G.
`H.
`
`[’486-A2] Claim 26: Møller and Steenfeldt-Jensen teach
`the dose dial sleeve is radially inward of the main
`housing ...................................................................................... 78
`[’486-A2] Claims 30 and 32: Møller and Steenfeldt-
`Jensen teach a radial stop positioned near an end or near
`a distal end of the helical groove .............................................. 78
`[’486-B] Ground 6: Claim 56 is Anticipated by Møller ..................... 78
`[’844-A] Ground 1: Claim 22 is Anticipated by Giambattista............ 83
`[’844-A] Ground 3: Claim 30 is Obvious over Giambattista and
`Klitgaard .............................................................................................. 87
`[’008] Ground 1: Claims 1, 3, 7-8, 11, and 17 are Obvious over
`Møller and Steenfeldt-Jensen .............................................................. 92
`i.
`[’008] A person of ordinary skill would have combined
`the teachings of Møller and Steenfeldt-Jensen ......................... 92
`[’008] Møller and Steenfeldt-Jensen teach a threaded
`housing and a threaded insert .................................................... 99
`[’008] Claim 3: Møller and Steenfeldt-Jensen teaches an
`insert secured in the housing against rotational and
`longitudinal movement ........................................................... 101
`[’008] Claim 11: Møller and Steenfeldt-Jensen teach an
`internally threaded housing ..................................................... 102
`Secondary Considerations ................................................................. 104
`J.
`VII. CONCLUDING STATEMENTS ................................................................ 105
`VIII. APPENDIX - LIST OF EXHIBITS ............................................................ 107
`
`ii.
`
`iii.
`
`iv.
`
`-iii-
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`I, Karl Leinsing, declare as follows:
`
`I.
`
`BACKGROUND
`1.
`I submitted an expert declaration in support of Petitioner Mylan’s
`
`Petitions for inter partes review (IPR) of U.S. Patent Nos. 8,679,069 (“the ’069
`
`patent,” EX1001), 8,603,044 ( “the ’044 patent,” EX1002), 8,992,486 ( “the ’486
`
`patent,” EX1003), 9,526,844 (“the ’844 patent,” EX1004), and 9,604,008 (“the
`
`’008 patent,” EX1005) (collectively, “the challenged patents”). See generally
`
`EX1011. I understand that IPRs were instituted in the following proceedings1:
`
`IPR2018-01670 (’069), IPR2018-01675 (’044-A), IPR2018-01676 (’044-B),
`
`IPR2018-01678 (’486-A2), IPR2018-01679 (’486-B), IPR2018-01680 (’844-A),
`
`IPR2018-01682 (’844-B), IPR2018-01684 (’008), and IPR2019-00122 (’486-A1).
`
`I also understand that Patent Owner Sanofi submitted Responses to Mylan’s
`
`Petitions in each of these proceedings. I submit this expert declaration in support
`
`of Mylan’s and Pfizer Inc.’s Reply to Sanofi’s Responses.
`
`2.
`
`In preparation for this declaration, I have reviewed Sanofi’s
`
`Responses and the Declaration of Dr. Alexander Slocum in support of those
`
`1 For ease of reference, I will refer to the proceedings by the labels I used in my
`
`prior declaration, which are shown in parenthesis following the proceeding
`
`number.
`
`1
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`Responses. I have also considered the deposition testimony of Dr. Slocum. A list
`
`of the materials I have considered in developing this declaration is provided in
`
`Appendix A.
`
`3.
`
`I continue to receive hourly compensation for my services at a rate of
`
`$500 per hour. No part of my compensation is dependent upon my opinions given
`
`or the outcome of this case.
`
`II.
`
`LEGAL STANDARDS
`4.
`I understand that my opinions in this declaration require applying the
`
`legal principles outlined in my first declaration. As was done previously, I have
`
`applied those same legal principles in forming my opinions here.
`
`III. OVERVIEW OF THE LEVEL OF SKILL
`5.
`In this declaration, I have applied the same definition of a person of
`
`ordinary skill in the art that was included in my first declaration. See EX1011,
`
`¶¶104-07. In addition, I am aware that Sanofi and Dr. Slocum provided their own
`
`definition. See, e.g., IPR2018-01670, Paper 30, 4-5; EX2107, ¶¶101-04. I believe
`
`the definition is substantially similar to the one provided in my first declaration,
`
`and my opinions presented here would not change even applying that definition.
`
`6.
`
`In addition, I also note that, in my experience, a person of ordinary
`
`skill in the art would not have approached the problems addressed in Dr. Slocum’s
`
`declaration in the manner that he suggests. A person of ordinary skill would never
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`have the luxury of consulting multiple PhDs and spending hundreds of hours on
`
`force equations, as I understand Dr. Slocum did to arrive at his opinions. Instead,
`
`in my experience as a real-world injection-pen designer, a person of ordinary skill
`
`would have proceeded by adapting tried and tested solutions known in the industry,
`
`using ordinary creativity to modify the prototypes to overcome the minor problems
`
`encountered. As I explain more below in my detailed explanation of my opinions,
`
`because a person of ordinary skill would have approached the problems at issue
`
`more flexibly and practically than Dr. Slocum proposes in his declaration, the
`
`person of ordinary skill would have been unlikely to have end up in the blind alleys
`
`that he pursued.
`
`IV. RELEVANT TIMEFRAME OF THE ’844 PATENT
`7.
`I explained in my first declaration how the earlier applications to
`
`which the ’844 patent claims priority lack written description support for “a piston
`
`rod comprising . . . an internal . . . fourth thread that is engaged with [a] third
`
`thread” of a “driving member,” as recited in independent claim 21 of the ’844
`
`patent. See EX1011, ¶¶100-102. Specifically, I noted that the applications
`
`exclusively describe a pen injector having a piston rod with external threading that
`
`is adapted to engage internal threading of a drive sleeve and an insert, both of
`
`which are located between the piston rod and the housing. Id., ¶101. The
`
`applications also do not describe, either generally or specifically, replacing the
`
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`described external threads of the piston rod with internal threads for engaging the
`
`threading of a driving member. Id.
`
`8.
`
`I understand that Dr. Slocum contends that the application to which
`
`the ’844 patent claims priority to a March 3, 2003 filing date—Great Britain
`
`Application No. 0304822.0 (EX1026)—“broadly discloses a piston rod with
`
`threads engaged to a drive sleeve with threads.” EX2107, ¶92. I understand that
`
`Dr. Slocum specifically cites to EX1026 at pages 7-8 (1:25-2:9) as support and
`
`argues that a person of ordinary skill would have understood from this disclosure
`
`that the threaded engagement could be implemented as (1) a piston rod with
`
`“external threads that engage internal threads of a drive sleeve” (i.e., the pen
`
`injector described in the ’844 patent), or (2) a piston rod with “internal threads that
`
`engage external threads of a drive sleeve.” Id. For the latter configuration, Dr.
`
`Slocum argues that this type of drive mechanism was “conventional” at the time
`
`the GB application was filed, citing to three patents involving infusion pumps or
`
`other motor-driven injection devices. See id., ¶¶92, 95-97 (citing EX2169-
`
`EX2171). During his deposition, Dr. Slocum sketched a proposed drive
`
`mechanism having an internally-threaded piston rod. See EX1053, 122:20-125:21;
`
`EX1051 (hand-drawing of modified drive mechanism containing “stinger” welded
`
`to drive sleeve).
`
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`9.
`
`I disagree with Dr. Slocum’s testimony because, when reading the
`
`cited disclosure as a whole, a person of ordinary skill in the art would have
`
`understood the GB application as describing a pen injector having a concentric
`
`arrangement of parts in which a drive sleeve, arranged around the piston rod, drives
`
`the piston rod.
`
`10.
`
`First, I disagree with Dr. Slocum’s suggestion that the GB application
`
`describes a “conventional lead screw” or a “drive screw” that drives an internally-
`
`threaded piston rod. Nowhere does the GB application describe that the piston rod
`
`is driven by a leadscrew or a “stinger” having a drive sleeve disposed
`
`concentrically around it. Instead, the GB application makes clear that it is the
`
`sleeve, which is located between the piston rod and the housing, that moves axially
`
`to drive the piston rod. See, e.g., EX1026, 7 (1:30). A person of ordinary skill
`
`would not have understood a leadscrew or a stinger to be a drive sleeve, which, I
`
`note, was acknowledged by Dr. Slocum. See, e.g., EX1053, 156:11-19.
`
`11.
`
`Second, in the context of the GB application, the disclosure that Dr.
`
`Slocum cites to on pages 7 through 8 would have been understood by a person of
`
`ordinary skill to describe only an externally-threaded piston rod. For example, I
`
`note that the text describes a dose dial sleeve that is “located between the housing
`
`and the piston rod” and a drive sleeve that is “located between the dose dial sleeve
`
`and the piston rod.” Id., 7 (1:28-30). A person of ordinary skill would have
`
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`understood this disclosure as detailing a concentric arrangement of parts where the
`
`piston rod is disposed within the drive sleeve, which is disposed within the dose
`
`dial sleeve, which is disposed within the housing. Indeed, this concentric
`
`arrangement is one that is uniformly depicted and described in the GB
`
`application—that is, in describing the only embodiment shown in the figures, the
`
`GB application begins with the radially innermost component, the piston rod 20,
`
`followed by the drive sleeve 30 disposed around the piston rod 20, the clicker 50
`
`and the clutch 60 disposed around the drive sleeve 30, and the dose dial sleeve 70
`
`disposed around the clicker 50 and the clutch 60. See id., 11-14 (5:25-8:7). Thus,
`
`a person of ordinary skill would have understood the GB application as
`
`contemplating that the threaded portions of the piston rod are external threads
`
`along its outer surface, which engage with internal threads on the internal surface
`
`of a component disposed concentrically around it (i.e., the “helical groove” on the
`
`drive sleeve). See id., 7-8 (1:30-2:9); see also id., 12 (6:12-14) (further explaining
`
`“a helical groove 38 extends along the internal surface of the drive sleeve 30” and
`
`a “second thread 24 of the piston rod is adapted to work within the helical groove
`
`38”).
`
`12.
`
`I understand that, in response, Dr. Slocum argues that the word
`
`“between” as used in the cited disclosure would have been understood to refer to
`
`either the radial and axial direction. See EX2107, ¶¶93-94. To support this
`
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`assertion, Dr. Slocum points to the GB application’s description of “an
`
`intermediate thread 36” of the drive sleeve 30, which “extend[s] between the first
`
`flange 32 and the second flange 34” of the drive sleeve 30, the flanges being
`
`disposed axially apart from one another. Id., ¶93 (citing EX1026, 6:8-12). I
`
`disagree with this interpretation because it overlooks the cited disclosure’s
`
`description of multiple “sleeves” disposed between one another, which would have
`
`suggested to the person of ordinary skill that the term was referring only to the
`
`radial direction. For example, assuming that the disclosure’s description that the
`
`dose dial sleeve is located “between” the housing and the piston rod, and the drive
`
`sleeve is located “between” the dose dial sleeve and the piston rod, would have
`
`been understood to also encompass the axial direction, the result would be an
`
`extremely long pen injector where the dose dial sleeve would extend axially from
`
`the housing, the drive sleeve extends axially from the dose dial sleeve, and the
`
`piston rod extends axially from the drive sleeve. A person of ordinary skill would
`
`not have understood the GB application as disclosing this type of arrangement.
`
`13.
`
`In addition, Dr. Slocum overlooks that the cited disclosure describes
`
`“a first threaded portion” of the piston rod that rotates “through” an “insert or
`
`radially inwardly extending flange” located in the housing. See EX1026, 8 (2:1-5).
`
`This is consistent with the GB application’s description of concentric parts where
`
`the piston rod’s threaded portions are positioned so as to mate with internal threads
`
`-7-
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`of components located between the piston rod and the housing, and providing
`
`internal threading to mate with these components would have made little sense to
`
`the person of ordinary skill. Indeed, as accepted elsewhere by Dr. Slocum, the
`
`piston rod, as the innermost component, is already very thin, typically having a
`
`root diameter of only a few millimeters. See EX2107, ¶242 (showing root
`
`diameter of 3.3 mm of the piston rod of Steenfeldt-Jensen). Under his stinger
`
`approach, Dr. Slocum proposes adding an additional component to the drive sleeve
`
`having a helical groove for engaging the piston rod, which would result in an even
`
`thinner component. See EX1053, 114:11-115:16 (stating that the stinger can just
`
`be placed within a recess of the piston rod without requiring an increase in the
`
`device’s width). Aside from adding manufacturing steps and complexities to the
`
`production of such a component, it would have also created structural concerns,
`
`including concerns over buckling of the stinger, especially during dose-dispensing
`
`when the drive sleeve has been fully retracted out from the housing. In my
`
`opinion, a person of ordinary skill would not have understood the GB application
`
`as disclosing this type of arrangement, especially in view of the application’s
`
`description of “[an] injector [that] must be robust in construction” and “easier to
`
`manufacture.” EX1026, 1:14, 5:31-6:1. Thus, the person of ordinary skill would
`
`have understood the GB application as only disclosing external threading on both
`
`the first and second ends of the piston rod.
`
`-8-
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`14.
`
`Finally, it is my opinion that Dr. Slocum’s reliance on EX1069-
`
`EX1071 to support his position that employing a drive mechanism with an
`
`internally-threaded piston rod was conventional is misplaced. See EX2107, ¶¶95-
`
`97. Each of these exhibits discloses using an externally-threaded screw that is
`
`rotated by a motor to drive the piston. See EX2169, Abstract (stating “[a] motor
`
`rotates a short drive screw, which engages the threads of the drive member” also
`
`called a piston member); EX2170, 6:34-42 (describing a “drive screw 23 coupled
`
`to a reversible stepper motor 24”); EX2171, 2:26-27(“As previously noted, these
`
`lead screw drive systems use gears which are external to the motor.”), 2:55-58
`
`(“Thus the motor 306 rotates the drive screw 305 which engages the threads of the
`
`piston member 303 to displace the piston head 304 in the axial direction d.”). They
`
`do not describe a piston rod with internal threads that engage external threads of a
`
`drive sleeve in a concentrically-arranged injection device. As I noted above, lines
`
`7:25-8:9 of EX1026 do not describe a “driving member”—they describe a “drive
`
`sleeve,” which, through clutch means, rotates relative to a dose dial sleeve when a
`
`button is depressed, allowing the piston rod to be driven. EX1026, 8:10-13. Thus,
`
`unlike the “conventional” motor-driven leadscrew mechanisms of EX2169-
`
`EX2171, a person of ordinary skill would have understood from the GB
`
`application that it must be the sleeve, arranged between the dose dial sleeve and the
`
`piston rod, that drives the piston rod. Thus, in my opinion, a person of ordinary
`
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`skill would not have considered these exhibits in understanding how to implement
`
`the drive mechanism disclosed in the GB application.
`
`15. Accordingly, it remains my opinion that the GB application to which
`
`the ’844 patent claims priority lacks written description support for “a piston rod
`
`comprising . . . an internal . . . fourth thread that is engaged with [a] third thread”
`
`of a “driving member,” as recited in independent claim 21 of the ’844 patent.
`
`V.
`
`CLAIM CONSTRUCTION
`16.
`I apply the same principles for the meaning of claims that I outlined in
`
`my first declaration. EX1011, ¶108. I also understand that Sanofi and Dr. Slocum
`
`have offered their own constructions for certain claim terms. I particularly address
`
`these proposed constructions below.
`
`A.
`17.
`
`“an interior of a flange”
`I understand that Dr. Slocum argues that the broadest reasonable
`
`interpretation of the term “an interior of a flange” as recited in dependent claim 56
`
`of the ’486 patent is “at the inner diameter of a flange.” EX2107, ¶123. According
`
`to Dr. Slocum, the term does not include “the outer diameter of a flange (i.e., the
`
`exterior of the flange), the distal side of a flange (i.e., the needle-side of a flange),
`
`or at the proximal side of a flange (i.e., the button-side of a flange).” Id., ¶126.
`
`18.
`
`I understand that Dr. Slocum’s interpretation is based on the
`
`embodiment disclosed in the ’486 patent, which apparently shows “a plurality of
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`EX2107, ¶124 (left); EX1050, 4 (right).
`
`21.
`
`I disagree with Dr. Slocum’s reading of the ’486 patent. As I explain
`
`below, it is my opinion that the ’486 patent shows an embodiment where dog teeth
`
`65 are formed at the proximal (or button) side of the flange 62, radially inward of
`
`the flange’s outer diameter.
`
`22.
`
`The ’486 patent describes having a drive sleeve 30 that includes a
`
`shoulder 37 “formed between a second end [i.e., button-end] of the drive sleeve 30
`
`and an extension 38 provided at the second end of the drive sleeve 30.” EX1003,
`
`4:27-29, FIG. 1. The extension “has reduced inner and outer diameters in
`
`comparison to the remainder of the drive sleeve 30.” Id., 4:29-31. The extension
`
`has, at its button-end, “a radially outwardly directed flange 39.” Id., 4:31-32. The
`
`’486 patent explains that the flange 62 of the clutch 60 “is disposed between the
`
`shoulder 37 of the drive sleeve 30 and the radially outwardly directed flange 39 of
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`the extension 38.” Id., 4:55-58. The ’486 patent also explains that dog teeth 65 are
`
`configured to “to engage with a second end [i.e., button-end] of” the dose dial
`
`sleeve 70. Id., 2:17-19, 6:29-31. As shown in the figures, the dose dial sleeve 70
`
`is positioned radially outward relative to the clutch 60, which is, in turn, positioned
`
`radially outward relative to the drive sleeve 30. See id., 4:33-35, 5:3-5, FIGS. 1, 9-
`
`11.
`
`23. Based on this description, a person of ordinary skill would have
`
`understood two features regarding the relative positions of the dog teeth 65 and the
`
`flange 62. First, a person of ordinary skill would have understood that the dog
`
`teeth 65 must be positioned sufficiently outward radially so that it can engage with
`
`the dose dial sleeve 70. Second, the person of ordinary skill would have
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`understood that the flange 62 must extend sufficiently inward radially so that it can
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`be disposed between the shoulder 37 and the flange 39 of the drive sleeve 30. In
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`view of these two features, a person of ordinary skill would have understood that
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`the flange 62 should extend radially inward past dog teeth 65. This is confirmed
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`by FIG. 8 of the ’486 patent (reproduced and annotated below), which shows that
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`dog teeth 65 are formed near the outer diameter of the flange 62, and axially
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`extend from the button side of the flange 62 toward the button-end of the pen
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`injector.
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`25.
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`I also note that this understanding is further supported by the figures
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`of EX2157, which I understand is a copy of the GB priority application as filed
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`with the UK Patent Office. See EX2157. I understand that Dr. Slocum
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`acknowledged that the EX2157 describes and shows the same embodiment as the
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`figures in the ’486 patent (EX1053, 106:13-107:15), and based on my review of
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`the document, I agree. Specifically, the application includes colored figures that
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`correspond to the figures shown in the ’486 patent and shows, in clearer detail, the
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`various components of the pen-injector embodiment described in the specification.
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`26.
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`For example, in FIG. 1 (partially reproduced below), the clutch 60 is
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`highlighted in blue and its top, button-end portion (i.e., flange 62) is shown
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`extending radially inward so that it is disposed between the shoulder 37 and the
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`flange 39 of the drive sleeve 30 (highlighted in red). I note that if dog teeth 65
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`were formed along the inner or inner diameter of the flange 62 (annotated), the
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`teeth would be spaced away from dose dial sleeve 70 (green) and would not be
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`able to engage the dose dial sleeve.
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`Id., FIGS. 8 (left), 11 (right).
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`28. Dr. Slocum confirmed the location of the dog teeth 65 and the flange
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`62 when asked to annotate FIG. 11 of EX2157. Below, I have reproduced a copy
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`of Dr. Slocum’s original annotations (top) and provided a clearer reproduction of
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`those annotations (bottom). As shown in these figures, Dr. Slocum identified the
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`dog teeth 65 as being formed on the button side of the flange, not at its inner
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`diameter. See id., 181:4-182:17, 186:21-189:23, 191:21-193:4.
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`¶127 (citing EX2163, 148:18-19, 151:18-159:6; EX2102). I note, however, that
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`claim 56 recites that the axially-extending teeth are formed “in an interior of a
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`flange,” not “on an interior side of a flange” or “on an interior surface of a flange.”
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`A person of ordinary skill would not have interpreted the phrase “an interior” of a
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`flange to be equivalent to or limited to the interior “sides” or “surfaces” of the
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`flange, especially in the context of claim 56 and the ’486 patent as a whole. Dr.
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`Slocum is thus incorrect that I agreed with his interpretation, since the questions
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`focused on “sides” and “surfaces.”
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`31.
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`Finally, during his deposition, Dr. Slocum changed his position on the
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`understanding of the axially-extending projection shown in FIG. 8 of the ’486
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`patent, ultimately arguing that the projection is a “tangus” of the clutch for
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`interacting with the button during dose-dispensing. As support for this
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`understanding, Dr. Slocum points to the component identified as the clutch of the
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`SoloSTAR device. See EX1054, 392:19-398:18 (citing EX2107, ¶451). I
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`understand that Dr. Slocum contends that the SoloSTAR is a commercial
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`embodiment of claim 1 of the ’486 patent (see EX2107, ¶¶513-50), but I am not
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`aware of any evidence that the same clutch is described as part of the specification
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`of the ’486 patent or otherwise known to those skilled in the art prior to filing date
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`of the ’486 patent. Indeed, I note several structural differences between the clutch
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`described in the ’486 patent and the one described in Dr. Slocum’s declaration with
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`EX1003, FIG. 6 (left, rotated; showing arm 52 of clicker 50); EX2107, ¶454 (right,
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`rotated; clicker arm annotated in yellow box). Thus, it is my opinion that a person
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`of ordinary skill would not have known or considered the SoloSTAR clutch to
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`have informed the structure of the clutch described in the ’486 patent.
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`32. Accordingly, in view of the above, it is my opinion that Dr. Slocum’s
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`proposed construction for the claim term “an interior of a flange” as recited in
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`claim 56 of the ’486 patent is inconsistent with the specification of the ’486 patent,
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`as confirmed by Dr. Slocum’s deposition testimony and Sanofi’s own submitted
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`animation. Contrary to Dr. Slocum’s assessment, which is based on a
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`misinterpretation of the specification, a person of ordinary skill would not have
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`understood claim 56 to require that the teeth be formed at the flange’s inner
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`diameter or to exclude teeth formed on a button side or needle side of the flange.
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`B.
`33.
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`“main housing”
`I also understand that, for the ’069 patent, the ’044 patent, and the
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`’486 patent, Dr. Slocum contends that the term “main housing” excludes portions
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`of the housing that extend into the device’s interior (i.e., it only includes the
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`“outermost housing”). See EX2107, ¶¶113-20. Dr. Slocum’s position primarily
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`rests on a description of the term “main housing” provided in the ’008 patent,
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`which is not present in any of the other challenged patents. Dr. Slocum uses this
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`construction to argue that Møller does not teach a dose dial sleeve threadedly
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`engaged to a “main housing” because Møller’s dose setting drum threadedly
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`engages a tubular element 5 of housing 1. See id., ¶¶299-302; infra, section
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`VI.E.iii.
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`34. As I noted in my previous declaration, I applied Sanofi’s proposed
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`claim construction of the term “main housing,” which was “[a]n exterior unitary or
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`multipart component configured to house, fix, protect, guide, and/or engage with
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`one or more inner components.” EX1011, ¶109. A person of ordinary skill would
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`have understood this would include portions of the component that extend into the
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`device’s interior, and that “house, fix, protect, guide, and/or engage with one more
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`inner components.” In my opinion, this interpretation is reasonable when the
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`claims of the ’069 patent, the ’044 patent, and the ’486 patent are considered as a
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`whole. If, as Dr. Slocum contends, the “main housing” is limited only to its
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`“outermost” part, then claim 1 of the ’069 patent and claim 11 of the ’044 patent
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`would not need to recite that the helical groove of the dose dial sleeve, which is
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`“positioned within said housing,” is “provided along an outer surface of said dose
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`dial sleeve.” This is because if the “main housing” can only be the housing’s
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`outermost part, then the helical groove of the dose dial sleeve must be provided
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`along the sleeve’s outer surface in order “to engage a threading provided by said
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`main housing.” Similarly, under Dr. Slocum’s construction, claim 1 of the ’486
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`patent, which only recites that the dose dial sleeve includes “a helical groove
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`configured to engage a threading provided by said main housing,” would be
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`limited to a dose dial sleeve having a helical groove along its outer surface.
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`Moreover, dependent claim 27 would not need to further specify that “said helical
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`groove [is] provided along an outer surface of said dose dial sleeve.” Accordingly,
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`Dr. Slocum’s construction fails to consider the claims as a whole. A person of
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`ordinary skill would not have viewed the te