Case 1:17-cv-00227-JFB-SRF Document 61 Filed 06/26/18 Page 1 of 17 PageID #: 861
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`NOVO NORDISK INC. and NOVO
`NORDISK NS,
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`Plaintiffs,
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`V.
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`TEVA PHARMACEUTICALS USA, INC.,
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`Defendant.
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`C.A. No. 17-227-JFB-SRF
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`REPORT AND RECOMMENDATION
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`I.
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`INTRODUCTION
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`On March 3, 2017, Novo Nordisk, Inc. and Novo Nordisk NS (collectively, "Novo
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`Nordisk" or "plaintiffs"), brought this action against Defendant Teva Pharmaceuticals
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`USA, Inc. ("Teva" or "defendant") alleging infringement of U.S. Patent Nos. 6,268,343
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`("the '343 patent"); 8,114,833 ("the '833 patent"); 8,846,618 ("the '618 patent");
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`9,265,893 ("the '893 patent"); and RE41,956 ("the '956 patent"). 1 Presently, the parties
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`dispute claim terms from the '833, '893 and '956 patents. 2
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`A Markman hearing was held on May 17, 2018. The court recommends that the
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`district court construe the disputed claim terms as is set forth below.
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`1 D.I. 1.
`2 D.I. 39.
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`II.
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`CLAIM CONSTRUCTION
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`A.
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`'833 Patent
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`1. "About:" 3 when used in connection with pH, means"+ or- 0.1 pH units from
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`[the stated number]."4
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`2. "Replacing the isotonicity agent previously utilized in said formulation
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`with propylene glycol,"; 5 "the propylene glycol-containing formulation relative to
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`that observed for the formulation containing the previously utilized isotonicity
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`agent,"6 and "the isotonicity agent to be replaced by propylene glycol:"7 "Having
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`a first formulation that utilized an isotonicity agent other than propylene glycol and
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`having a second formulation wherein the isotonicity agent used in the first formulation is
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`substituted or replaced with propylene glycol[.]"8 Independent claim 23 of the '833
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`patent recites:
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`23. A method for reducing deposits on production equipment
`during production of a GLP-1 agonist formulation, said method
`comprising replacing the isotonicity agent previously utilized
`in said formulation with propylene glycol at a concentration of
`between 1-100 mg/ml, and wherein said GLP-1 agonist
`formulation comprises a disodium phosphate dihydrate buffer. 9
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`Claims 23-31 are process claims. 10 The specification is clear that, for the intended
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`application, propylene glycol is superior to mannitol and related substances, because
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`3 Found in claims 1, 5, 6, 7, 16, 20, 21, and 22 of the '833 patent.
`4 The parties agree to this construction. D.I. 52 at 4.
`5 Found in claims 23, 26, and 29 of the '833 patent.
`6 Found in claims 24, 27, and 30 of the '833 patent.
`7 Found in claims 25, 28, and 31 of the '833 patent.
`8 The court adopts defendant's proposal. Plaintiff had proposed "utilizing
`propylene glycol in lieu of another isotonicity agent evaluated for use in a GLP-1 agonist
`pharmaceutical formulation." D.I. 39 at 3 of 11--4 of 11; D.I. 52 at 6.
`9 '833 patent, 24:7-13 (emphasis added).
`10 Id., 24:7-59.
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`2
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`"mannitol results in clogging of injection devices[.]"1 1 Moreover, in describing various
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`embodiments, the specification explains, for example, that "during production of a
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`peptide formulation, [] the method comprises replacing the isotonicity agent previously
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`utilized in said formulation with propylene glycol[.]"12
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`The claimed process requires that "during production of a ... formulation[,]"1 3
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`there is an "isotonicity agent [that was] previously utilized in said formulation[,]"1 4 that is
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`replaced "with propylene glycol[.]"1 5 The specification does not discuss (or claim) a
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`process for removing the previously used isotonicity agent from the formulation and
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`then replacing the isotonicity agent with propylene glycol. 16 In fact, the parties agree
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`that the formulation containing propylene glycol is separate and distinct from the
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`formulation in which another isotonicity agent was "previously utilized[.]"1 7 Therefore, in
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`order for the method to comprise "replacing the isotonicity agent previously utilized in
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`said formulation with propylene glycol[,]"18 there must be a separate prior formulation
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`containing this other isotonicity agent. 19
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`11 Id. , 1 :30-49.
`12 Id. , 14:16-19.
`13 Id. , 24:8.
`14 Id., 24:9-10.
`15 Id., 24:11 .
`16 E.g., id. at 24:7-13.
`17 See D.I. 52 at 6 (defendant proposing the "first-second" formulation
`construction) ; cf id. at 7 (emphasis added) (plaintiff proposing "utilizing propylene glycol
`in lieu of another isotonicity agent[.]")
`18 '833 patent, 24:9-10.
`19 Plaintiff argues that "the '833 patent's focus is not chronology; it does not
`describe a sequential process of formulation development, one made after the other,
`but instead a broad evaluation of multiple formulations, leading to use of propylene
`glycol over the others they made and tested because it had the best properties. This is
`the 'replacement' they made to reduce the unwanted deposits and clogs." D.I. 52 at 8.
`In essence, in the context of the claims, plaintiff contends that "replacing the isotonicity
`agent previously utilized in said formulation with propylene glycol[,]" '833 patent, 24:9-
`10), has the same meaning as "utilizing propylene glycol in lieu of another isotonicity
`agent[,]" D.I. 52 at 6-8). Plaintiffs proposed construction reads the "isotonicity agent
`previously utilized" limitation from the claims and is, therefore, not appropriate.
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`3
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`B.
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`'893 Patent
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`3. "Driving part:"20 "a part that transfers force from the push button."21 Claim 1
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`recites:
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`1. A push button connection for an injection device
`comprising:
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`a push button mountable on a driving part being rotatable
`relatively to the push button and which push button further
`comprises a bore with a bottom surface and which bore
`surrounds a protrusion on the driving part which protrusion
`has a top surface and wherein a pivot bearing is formed
`between the bottom surface and the top surface, wherein
`when a user presses on the push button the force is
`directed toward the driving part and wherein the driving part
`rotates relative to the push button. 22
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`In the context of this "push button connection[,]"23 when "the user pushes the push
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`button 10[,]"24 this action "moves the driving part 20 axially forward in the injection
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`device."25 "During this'forward movement of the driving part 20 it also rotates."26 Thus,
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`the "driving part" transfers force from the push button.
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`4. Meanwhile, defendant's proposal of "component with a protrusion that inserts
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`into the push button that is used to transfer axial force from the push button to the
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`2° Found in claims 1, 2, and 5 of the '893 patent.
`21 The court adopts plaintiffs construction, which relies on the plain meaning .
`D. I. 3 9 at 5 of 11 .
`22 '893 patent, 4:40-51.
`23 Id., 4:40.
`24 Id., 3:38; see also Fig. 1.
`25 '893 patent, 3:38-39.
`26 Id., 3:40-41; see also id., 3:42-43 ("Such injection device is described in
`details in EP 1.003.581."); id., 1 :24-26 ("U.S. Pat. No. 6,235,004 [("the '004 patent")]
`discloses an injection device in which according to FIG. 15-16 a dose is set by rotating
`the scale drum out of the housing in a threaded connection."). Figures 15-16 of
`European Patent No. 1003581 (the "EP '581 ") show the entirety of an injection device,
`(EP '581 patent at 17), as do similar figures in the '004 patent, '004 patent, figs. 15-16).
`The elements corresponding to the "driving part" of the '893 patent are described in the
`'004 patent according to various names that include "a tubular injection element 70[,]"
`'004 patent, 10:24; Fig. 14), and a "bushing 82[,]" id., 11:26; Fig. 16).
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`4
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`injector[,]"27 is not supported by the specification. First, the court agrees with plaintiff
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`that defendant's proposed "component with a protrusion" is redundant with limitations
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`present in the claim. 28 Second, as to defendant's proposed "transfer axial force"
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`limitation, defendant argues that, in view of Figure 2, "the only force that the driving part
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`transfers from the push button is an axial force."29 The specification says otherwise:
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`When the user applies an injection force A at the peripheral
`area of the push button 10, a vertical reaction force B will
`appear at the pivot point 22, 18, at the same time a radial
`force C will occur at the upper radial bearing 13, 23. Since
`the upper radial bearing 13, 23 are located at the top part 23
`having the smaller diameter, the resulting torque is relatively
`small. Further, a radial force D will occur at the lower radial
`bearing 14, 25, however due to the distance between the
`upper radial bearing 13, 23 and the lower radial bearing 14,
`25, the force resulting on the lower radial bearing 14, 25 is
`relatively small. 30
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`Although these forces are relatively small, the "force pair" of "C" and "D" in Figure 2 is
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`something the inventors sought to minimize. 31 Nonetheless, the specification
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`recognizes that "the offset applied push button forces[]" result in a "bending force"
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`applied to the protrusion of the driving part. 32 Therefore, to limit the driving part to solely
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`transmitting axial forces would read the Figure 2 embodiment, which is discussed
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`extensively in the specification, from the claim.
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`27 D.I. 39 at 5 of 11 .
`28 D.I. 52 at 50-51 . The "push button connection" in claim 1 is limited as follows:
`"which push button further comprises a bore with a bottom surface and which bore
`surrounds a protrusion on the driving part[.]" '893 patent, 4:43-45.
`29 D.I. 52 at 50.
`30 '893 patent, 4:23-32.
`31 Id. , 2:4.
`32 Id. , 2:9-14. In at least one embodiment, the bending force applied to the
`"driving part" would, in turn, transmit those forces to other elements within the injection
`device. Compare '893 patent, Fig. 2 (showing forces "C" and "D" on the "driving part),
`with EP '581, Fig. 16 (showing "bushing 82" (which is equivalent to the "driving part" in
`the '893 patent) in contact with "scale drum 80").
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`5
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`5. "Pivot bearing:" 33 "a bearing that supports an end of a rotating shaft subject
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`to an axial load."34 The specification does not define the structure of "pivot bearing" and
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`instead provides functional descriptions of the structure. For example, the specification
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`explains:
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`When a user pushes on the injection button, the force
`applied is directed to the forward movement of the driving
`part, however, since the push button and the driving part
`rotate relatively to each other a friction between these
`rotating parts will occur. The user therefore also has to
`apply a force large enough to overcome this friction. One
`way of minimizing the force a user must apply in order to
`perform an injection is therefore to minimize this friction. By
`forming a pivot bearing between the two parts, the surface
`area of interaction between the two objects can be
`minimized and the radius of the resulting friction force can be
`kept at a minimum. 35
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`In this description, the "pivot bearing" somehow minimizes "the surface area of
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`interaction" and, therefore, keeps "the resulting friction force ... at a minimum."36
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`Confusingly, the specification describes an embodiment in which a "pivot bearing" is
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`formed with a "pivot" element in the bearing, 37 which seems to suggest a meaning of
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`"pivot bearing" that deviates from the plain meaning. 38 However, other than this
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`33 Found in claim 1 of the '893 patent.
`34 Plaintiff proposed a plain meaning definition. D.I. 52 at 24. The court agrees
`that a plain meaning definition is appropriate. For the reasons discussed herein, the
`court relies on extrinsic evidence for a plain meaning definition of "pivot bearing" in light
`of the specification.
`35 '893 patent, 1 :46-56.
`36 Id. The court addresses the question of minimizing forces herein.
`37 Id., 2:27-31 (emphasis added) ("[t]he push button used in the connection has a
`central bore dedicated to engage the protrusion provided on the driving part. The
`bottom of the bore is preferable [sic] formed with a pivot. This pivot bears on a
`surface of the protrusion thus forming a pivot bearing."); see also id., 4:11-14 ("In this
`position, the pivot 18 formed in the most proximal bottom surface 17 of the bore 12
`bears on the top surface 22 of the protrusion 21 thus forming a pivot bearing 22, 18.").
`38 As is discussed herein, the extrinsic evidence demonstrates that the plain
`meaning of pivot bearing refers to the rotating shaft as the "pivot" and the surface
`supporting the shaft as the bearing-there appears to be no requirement that the pivot
`(i.e., the rotating shaft) be able to pivot around the surface of the bearing as is
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`preferred embodiment nothing else in the intrinsic record 39 suggests that the applicant
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`intended a different definition.40 The definitions proposed by the parties share two
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`common elements: (1) a definition of the bearing, including its shape, and (2) a
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`reference to friction reduction .41 The court addresses these two components of the
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`definition in sequence.
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`6. First, the bearing surface can take any number of
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`shapes. The specification does not describe these shapes,
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`and claim 1 does not limit the pivot bearing to a specific
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`shape.42 The court, therefore, turns to extrinsic evidence.43
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`A textbook on the subject of statics explains that "[p]ivot and
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`collar bearings are commonly used in machines to support an
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`Pi~Ol bearing
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`discussed with respect to the embodiment disclosed in Figures 1 and 2 of the '893
`patent. See D. I. 52-1 , ex. E at 38 of 208, 40 of 208 (referring to the rotating shaft as the
`"pivot"); see also id., ex. A at 4 of 208 & Fig. 8-21 (a) ("Pivot . .. bearings are commonly
`used in machines to support an axial load on a rotating shaft.").
`39 Defendant argues that during prosecution, the applicant "distinguished the
`term 'pivot bearing' from prior art on the basis of this [pivoting-element-in-the-pivot
`bearing] embodiment. D.I. 52 at 36; see also supra note 37. Specifically, defendant
`contends that plaintiff "distinguished the '893 patent [application] from [the Gallay] prior
`art on the basis of this particular spherical 'raised pointer' pivot bearing embodiment."
`Id. at 37. Upon review of the record , the applicant cited the embodiment discussed in
`the specification and argued that "Gallay is directed to a completely different application
`and therefor [sic] lacks a pivot bearing as recited in claim 1." D.I. 39-1, ex. D at 55 of
`118. The applicant did not distinguish between one pivot bearing in the application and
`a second pivot bearing in the prior art; rather the applicant averred that "[t]here is no
`corresponding bearing in Gallay[.]" Id. at 58 of 118.
`4° For example, the pivoting-element-in-the-pivot bearing embodiment is not
`claimed, or discussed, in claim 1. '893 patent, 4:43-48.
`41 Compare D.I. 39 at 4 (Plaintiff proposing the "plain meaning, which is 'a
`machine part in which another part turns, where friction along the axis of rotation is
`reduced at the contacting surfaces of the two parts[.]"'), with id. (Defendant proposing "a
`conical or spherical surface in contact with another surface to reduce friction between
`two parts that are subjected to axial thrust and rotation[.]").
`42 '893 patent, 4:40-51 .
`43 The applicant relied on a dictionary definition of "bearing" during prosecution of
`the '893 patent. D. I. 39-1 , ex. D at 68 of 118. Plaintiff contends that this definition "is
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`axial load on a rotating shaft[,]"44 which is depicted in an accompanying figure. 45 In
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`comparison to collar bearings, which support an axial load in the middle of a rotating
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`shaft, it is plain that pivot bearings support an end of the rotating shaft. 46 The textbooks
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`and journal articles provided by the parties refer to the rotating shaft as the "pivot" and
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`the surface supporting the shaft as the bearing. 47 In claim 1, the pivot bearing is formed
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`from the "top surface" of the "protrusion on the driving part" and the "bottom surface" of
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`the "bore" in the "push button."48 Therefore, the court concludes that the pivot bearing
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`in the "push button connection" consists of a pivot, which is the "protrusion on the
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`driving part" (which rotates) and a receiving bearing, which is the "bore" in the "push
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`button" (which does not rotate). 49 Thus, the extrinsic evidence suggests a definition of
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`pivot bearing as a bearing5° that supports an end of a rotating shaft subject to an axial
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`load.
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`the clearest indication of what the applicants understood pivot bearing to mean[,]"
`D.I. 52 at 30 (citation omitted)), because "'prior art cited in a patent or cited in the
`prosecution history of the patent constitutes intrinsic evidence' for purposes of claim
`construction. " Id. (emphasis added) (citing Kumar v. Ovonic Battery Co., 351 F.3d 1364
`(Fed. Cir. 2003). In Kumar, the Federal Circuit explained that "[o]ur cases have
`recognized that although the dictionary can be an important tool in claim construction by
`providing a starting point for determining the ordinary meaning of a term to a person of
`skill in the art, 'the intrinsic record ' can resolve ambiguity in claim language or, where
`clear, trump an inconsistent dictionary definition." Kumar, 351 F.3d 1367-68 (citation
`omitted). The dictionary definition is not prior art discussed by the applicant or the
`examiner during prosecution. Therefore, it is not part of the intrinsic record, and for
`purposes of claim construction, the court will consider it along with the other extrinsic
`evidence provided by the parties.
`44 D.I. 52-1 , ex. A at 4 of 208.
`45 Id. at Fig. 8-21 .
`46 Id.
`47 (E.g., D.I. 52-1 , ex. Eat 38 of 208 ("The bearing area is, therefore, the area of
`the end of the pivot[.]"); id. at 40 of 208 ("The end of the pivot should be of steel, and it
`may be flat on the end or slightly cup shaped .").
`48 '893 patent, 4:43-48.
`49 Id., 4:40-51 .
`50 The parties had sought to further define "bearing" as either "a machine part in
`which another part turns" (Plaintiff) or "a conical or spherical surface in contact with
`another surface" (Defendant). D.I. 39 at 4. Plaintiff acknowledges that its definition
`"could apply to both the pivot bearing and the radial bearing" claimed in the '893 patent.
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`8
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`7. Second, with respect to reducing friction, the specification explains that the
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`reason for using a pivot bearing between the "push button" and the "driving part" is to
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`minimize the friction between these two parts so that, in the injection device, "the force a
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`user must apply [to the push button] in order to perform an injection" is as small as
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`possible. 51 Both parties seek to translate the stated design objective of minimizing
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`friction into a definitional requirement that the pivot bearing "reduce[s]" friction. 52 The
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`court notes that bearings reduce friction between moving parts, and an inclusion of
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`friction reduction in the definition of "bearing" is redundant. Moreover, it is unclear what
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`the reference point is for friction reduction as proposed by the parties. For example, the
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`specification is clear that, in comparison with designs in the prior art,53 the pivot bearing
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`itself is the design choice that minimizes the friction between these two parts, because
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`D.I. 52 at 25. Since the applicant sought to differentiate between these two machine
`elements by giving them different names and using them in different claim limitations, a
`common definition blurs the necessary distinction in the claims between the "pivot
`bearing" and the "radial bearing." As to defendant's "conical or spherical surface"
`construction, this appears to be based entirely on attorney argument, without any
`citation to the specification. Id. at 28 (emphasis in original) ("[A] flat bearing surface
`would actually maximize the surface of interaction and could be further minimized by
`creating a curved or pointed bearing at the surface of interaction. Therefore, a POSA
`would understand that the pivot bearing in the '893 Patent could not be a flat bearing
`and must either be curved (i.e. spherical) or pointed (i.e. conical)[.]"). Plaintiffs
`opposing attorney argument, including citation to extrinsic evidence, is not especially
`persuasive, either. Id. at 27, 30-34. Absent clear direction from the specification or the
`extrinsic evidence, the court declines to read a limitation on the shape of either the pivot
`surface or the bearing surface.
`51 '893 patent, 1 :46-56.
`52 Compare D.I. 39 at 4 (Plaintiff proposing the "where friction along the axis of
`rotation is reduced at the contacting surfaces of the two parts[.]"'), with id. (Defendant
`proposing "to reduce friction between two parts that are subjected to axial thrust and
`rotation[.]").
`53 A reference point for the friction involved is discussed in the specification in
`relation to the '004 patent. '893 patent, 1 :29-34 (citing Figs. 15-16 of the '004 patent)
`("[T]he push button and the bushing rotates relatively to each other. The friction
`occurring between these relatively rotatable parts contributes to the force a user needs
`to apply in order to push back the bushing and the scale drum in order to inject the set
`dose."). The '004 patent disclosed "an injection button 88 is rotatably mounted with a
`pivot pin 94 journaled [with a collar bearing] in an end wall of the bushing 82." '004
`patent, 11 :49-51, Figs. 15-16. For a rotating shaft of a given radius, in comparison to
`the collar bearing disclosed in the '004 patent, a pivot bearing would result in less
`friction. E.g., D.I. 52-1, ex. A at 5 of 208, equations 8-7 and 8-8.
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`9
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`"the radius of the resulting friction force can be kept at a minimum."54 According to the
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`extrinsic evidence, "in the case of a pivot bearing" with a flat end, the moment (turning
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`force) required to overcome the static friction in the bearing is directly proportional to the
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`axial force and the radius55 of the bearing. 56 Therefore, minimizing the radius (and
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`hence the diameter) of the "protrusion" of the "driving part" minimizes "the radius of the
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`resulting friction force," which, in turn, minimizes friction between the "push button" and
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`the "driving part." Claim 1 recites a limitation that includes a pivot bearing, and the
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`specification explains that, in this "injection device" application, a pivot bearing is
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`superior to other design choices, because in comparison to those other designs it
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`reduces the amount of force required to inject the medication. However, were the court
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`to employ the term "bearing" in the definition of "pivot bearing," nothing in the intrinsic
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`record57 suggests that the proposed reductions in friction would further distinguish a
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`"pivot bearing" from any other bearing. Therefore, the court defines pivot bearing as a
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`bearing that supports an end of a rotating shaft subject to an axial load.
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`8. "Radial bearing:"58 "a bearing that supports a load on a shaft that is
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`perpendicular to the axis of rotation."59 Claim 2 recites "[a] push button connection
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`54 '893 patent, 1 :55-56. Defendant contends that while "[t]he parties agree that a
`pivot bearing is used to reduce rotational friction between parts, . . . this is simply an
`inherent property of a 'pivot bearing' in mechanical engineering." D.I. 52 at 27. Based
`upon the specification, and the extrinsic evidence, the court agrees.
`55 By "radius, " the court refers to the geometric property that is one half of the
`diameter of the protrusion on the driving shaft.
`56 D.I. 52-1, ex. A at 5 of 208, equation 8-8 ("M = 2/3 µ5 PR "where µsis the
`coefficient of static friction for the material, Pis the axial force, and R is the radius of the
`pivot).
`57 Both parties seek to include statements made by the applicant during
`prosecution, specifically in an appeal to the Board of Patent Appeals and Interferences.
`D.I. 39-1, ex. D. The court has reviewed these materials and finds the layers of attorney
`argument contained in in the BPAI appeal briefs and in the parties claim construction
`briefing referencing these materials unpersuasive in narrowing the definition of "pivot
`bearing" to specific embodiments or to dictionary definitions discussed by the applicant.
`58 Found in claims 2, 3, 4 of the '893 patent.
`59 The court agrees with plaintiff and adopts a plain meaning definition.
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`according to claim 1, in which at least one radial bearing between the push button and
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`the driving part is provided. 60 The specification discusses, but does not define, the
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`radial bearing term. 61 For example, the specification states: "[i]n order to secure the fit
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`between the push button and the driving part and on the same time direct forces applied
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`on the periphery of the push button to the driving part at least one radial bearing
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`between the push button and the protrusion is formed. "62 As with the "pivot bearing"
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`term , the court declines to engage in defining "radial bearing" according to "reducing"
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`friction objectives associated with bearings and instead uses the term "bearing" in its
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`construction . 63
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`9. According to the extrinsic evidence, "[a] bearing can [] be classified as a radial
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`bearing or a thrust bearing, depending on whether the bearing load is in the radial or
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`axial direction , respectively, of the shaft."64 "The load on the shaft can be divided into
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`radial and axial components . . .. [and] the radial load component is in the direction
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`normal [or perpendicular] to the shaft axis. "65 "Certain bearings . . . can support radial
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`as well as thrust forces. [But c]ertain other bearings .. . are applied only for radial
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`60 '893 patent, 4:53-55.
`61 See id. , 4:14-16 ("the push button 10 is radially supported by the protrusion 21
`at the top part 23 forming a radial top bearing 23, 13."); id., 4:22-25 ("When the user
`applies an injection force A at the peripheral area of the push button 10 a vertical
`reaction force B will appear at the pivot point 22, 18, at the same time a radial force C
`will occur at the upper radial bearing 13, 23.").
`62 Id. , 1 :57-61.
`63 For example, plaintiff argues that "[t]he radial bearings 'have the least possible
`radius of friction[.]"' D.I. 52 at 38 (quoting '893 patent, 1 :62-67). This is a preferred
`embodiment, '893 patent, 1 :62 (introducing embodiment with "[p]referably"), and plaintiff
`does not explain why the claim should be limited to this embodiment. As with "pivot
`bearing," defendant argues that all bearings function "in part to reduce friction between
`two parts. " D.I. 52 at 39.
`64 D.I. 52-1, ex. Fat 3.
`65 Id.
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`Case 1:17-cv-00227-JFB-SRF Document 61 Filed 06/26/18 Page 12 of 17 PageID #: 872
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`loads."66 Therefore, the court defines radial bearing according to the plain meaning as a
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`bearing that supports a load on a shaft that is perpendicular to the axis of rotation.
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`C.
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`'956 Patent
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`10. Claims 1 and 2 of the '956 pat~nt recite:
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`1. A limiting mechanism that prevents setting of a dose that
`exceeds the injectable amount of liquid left in a cartridge of an
`injection device wherein a dose is set by rotating a dose setting
`member relative to a driver and away from a fixed stop in the
`injection device, and the dose is injected by pressing an injection
`button which rotates back the dose setting member which during
`this rotation carries the driver with it to rotate this driver which
`moves the piston rod forward, wherein the driver is provided with
`a track having a length which is related to the total injectable
`amount of medicament in the cartridge and which track is
`engaged by a track follower coupled to the dose setting member
`to follow rotation of this dose setting member and wherein the
`driver is disk shaped and the track has a spiral shape which is
`engaged by the track follower which is flexibly coupled to the
`dose setting member so that the track follower can be moved
`radially when it follows the track of the driver element.
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`2. A limiting mechanism that prevents setting of a dose that
`exceeds the amount of liquid left in a cartridge of an injection
`device wherein a dose is set by rotating a dose setting member
`relative to a driver and away from a fixed stop in the injection
`device, and the dose is injected by rotating back the dose setting
`member which during this rotation carries the driver with it to
`rotate this driver which moves the piston rod forward, wherein
`the driver is provided with a track having a length which is
`related to the total amount of medicament in the cartridge and
`which track is engaged by a track follower coupled to the dose
`setting member to follow rotation of this dose setting member
`and wherein the driver is cylindrical and the track has a helical
`shape which is engaged by the track follower which is coupled to
`the dose setting member so that the track follower can be moved
`rotationally when it follows the track of the driver element.67
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`66 Id.
`67 '956 patent, 4:61-5:27.
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`Case 1:17-cv-00227-JFB-SRF Document 61 Filed 06/26/18 Page 13 of 17 PageID #: 873
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`11. "Driver:"68 "a part that transfers force from the injection button."69 The
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`specification explains that:
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`An object of the invention is to provide a limiting mechanism
`which prevents setting of a dose that exceeds the amount of
`liquid left in a cartridge of an injection device of the geared
`type wherein a dose is set by rotating a dose setting member
`relative to a driver and away from a fixed stop in the injection
`device, and the dose is injected by rotating back the dose
`setting member which during this rotation carries the driver
`element with it to rotate this driver element which moves the
`piston rod forward. 70
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`Therefore, the driver moves the piston rod forward to inject the medication . In the two
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`embodiments disclosed, this process is initiated "when the injection button is
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`pressed [. ]"71
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`12. "Track:"72 "a path along which a part moves."73 Claim 1 describes that "the
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`driver is provided with a track . . . which track is engaged by a track follower ... [which]
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`can be moved radially when it follows the track of the driver element."74 In claim 2, "the
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`driver is provided with a track ... which track is engaged by a track follower ... [which]
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`can be moved rotationally when it follows the track of the driver element"75 Claim 5
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`68 Found in claims 1, 2, 3, 4 of the '956 patent.
`69 The court adopts plaintiff's construction. D.I. 39at 6. Defendant had proposed
`"a disk-shaped or cylindrical component with a helical track on its outer surface[,]" id.,
`which is redundant with limitations already present in the claims, '956 patent, 5:6-7,
`5:23-24.
`70 Id., 2:14-22.
`71 Id., 3:56-65; see also id., 4:38-50 ("When the dose is injected by pressing a[n]
`. . . injection button .... rotation will be transmitted to the driver.").
`72 Found in claims 1, 2, 5 of the '956 patent.
`73 The court adopts plaintiff's construction . D.I. 39 at 7. The court declines to
`follow defendant's proposal of "a helical groove on the outer surface of the driver," id.,
`which is limited to an embodiment in the specification, because "a POSA would
`understand that [both spiral and helical] shapes may[] be described as 'helical."' D.I. 52
`at 58 (citing D.I. 39-1, ex. Eat 100 of 118 (arguing that "by definition a thread is
`helical.")). This argument is not persuasive.
`74 '956 patent, 5:2-11.
`75 Id., 5:19-27.
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`Case 1:17-cv-00227-JFB-SRF Document 61 Filed 06/26/18 Page 14 of 17 PageID #: 874
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`recites an "assembly [that] comprises: (a) a helical track ... and (b) a follower that
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`engages the helical track; wherein the follower moves along the helical track[.]"76
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`13. "Track follower:"77 "a part that moves along a path."78 As discussed above
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`in relation to the "track" term, it is apparent in claims 1, 2, and 5, that the "track follower"
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`moves along the track, which the court has defi