Novo Nordisk Inc. et al v. Teva Pharmaceuticals USA, Inc.

Filing 61

REPORT AND RECOMMENDATIONS re: Claim Construction. Please note that when filing Objections pursuant to Federal Rule of Civil Procedure 72(b)(2), briefing consists solely of the Objections (no longer than ten (10) pages) and the Response to the Objections (no longer than ten (10) pages). No further briefing shall be permitted with respect to objections without leave of the Court. Objections to R&R due by 7/10/2018. Signed by Judge Mary Pat Thynge on 6/26/2018. (fms)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
NOVO NORDISK INC. and NOVO
NORDISK NS,
Plaintiffs,
C.A. No. 17-227-JFB-SRF

V.

TEVA PHARMACEUTICALS USA, INC.,
Defendant.
REPORT AND RECOMMENDATION

I.

INTRODUCTION
On March 3, 2017, Novo Nordisk, Inc. and Novo Nordisk NS (collectively, "Novo

Nordisk" or "plaintiffs"), brought this action against Defendant Teva Pharmaceuticals
USA, Inc. ("Teva" or "defendant") alleging infringement of U.S. Patent Nos. 6,268,343
("the '343 patent"); 8,114,833 ("the '833 patent"); 8,846,618 ("the '618 patent");
9,265,893 ("the '893 patent"); and RE41,956 ("the '956 patent"). 1 Presently, the parties
dispute claim terms from the '833, '893 and '956 patents. 2
A Markman hearing was held on May 17, 2018. The court recommends that the
district court construe the disputed claim terms as is set forth below.

1

D.I. 1.

2

D.I. 39.

II.

CLAIM CONSTRUCTION
A.

'833 Patent

1. "About:" 3 when used in connection with pH, means"+ or- 0.1 pH units from
[the stated number]."4
2. "Replacing the isotonicity agent previously utilized in said formulation

with propylene glycol,"; 5 "the propylene glycol-containing formulation relative to
that observed for the formulation containing the previously utilized isotonicity
agent," 6 and "the isotonicity agent to be replaced by propylene glycol:" 7 "Having
a first formulation that utilized an isotonicity agent other than propylene glycol and
having a second formulation wherein the isotonicity agent used in the first formulation is
substituted or replaced with propylene glycol[.]" 8 Independent claim 23 of the '833
patent recites:
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
Claims 23-31 are process claims. 10 The specification is clear that, for the intended
application, propylene glycol is superior to mannitol and related substances, because

3
4

5

Found in claims 1, 5, 6, 7, 16, 20, 21, and 22 of the '833 patent.
The parties agree to this construction. D.I. 52 at 4.
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.

2

"mannitol results in clogging of injection devices[.]"1 1 Moreover, in describing various
embodiments, the specification explains, for example, that "during production of a
peptide formulation, [] the method comprises replacing the isotonicity agent previously
utilized in said formulation with propylene glycol[.]" 12
The claimed process requires that "during production of a ... formulation[,]"1 3
there is an "isotonicity agent [that was] previously utilized in said formulation[,]"1 4 that is
replaced "with propylene glycol[.]"1 5 The specification does not discuss (or claim) a
process for removing the previously used isotonicity agent from the formulation and
then replacing the isotonicity agent with propylene glycol. 16 In fact, the parties agree
that the formulation containing propylene glycol is separate and distinct from the
formulation in which another isotonicity agent was "previously utilized[.]"1 7 Therefore, in
order for the method to comprise "replacing the isotonicity agent previously utilized in
said formulation with propylene glycol[,]" 18 there must be a separate prior formulation
containing this other isotonicity agent. 19

11

12
13
14

Id. , 1:30-49.
Id. , 14:16-19.
Id. , 24:8.
Id., 24:9-10.

15

Id., 24:11 .
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, 24:910), 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.
16

3

B.

'893 Patent

3. "Driving part:" 20 "a part that transfers force from the push button ."21 Claim 1
recites :
1. A push button connection for an injection device
comprising:
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
In the context of this "push button connection[,]" 23 when "the user pushes the push
button 10[,]"24 this action "moves the driving part 20 axially forward in the injection
device."25 "During this'forward movement of the driving part 20 it also rotates." 26 Thus,
the "driving part" transfers force from the push button.

4 . Meanwhile, defendant's proposal of "component with a protrusion that inserts
into the push button that is used to transfer axial force from the push button to the

°Found in claims 1, 2, and 5 of the '893 patent.

2

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).

4

injector[,]"27 is not supported by the specification. First, the court agrees with plaintiff
that defendant's proposed "component with a protrusion" is redundant with limitations
present in the claim. 28 Second, as to defendant's proposed "transfer axial force"
limitation, defendant argues that, in view of Figure 2, "the only force that the driving part
transfers from the push button is an axial force."29 The specification says otherwise:
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
Although these forces are relatively small, the "force pair" of "C" and "D" in Figure 2 is
something the inventors sought to minimize. 31 Nonetheless, the specification
recognizes that "the offset applied push button forces[]" result in a "bending force"
applied to the protrusion of the driving part. 32 Therefore, to limit the driving part to solely
transmitting axial forces would read the Figure 2 embodiment, which is discussed
extensively in the specification, from the claim.

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").

5

5. "Pivot bearing:" 33 "a bearing that supports an end of a rotating shaft subject
to an axial load." 34 The specification does not define the structure of "pivot bearing" and
instead provides functional descriptions of the structure. For example, the specification
explains:
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
In this description, the "pivot bearing" somehow minimizes "the surface area of
interaction" and, therefore, keeps "the resulting friction force ... at a minimum." 36
Confusingly, the specification describes an embodiment in which a "pivot bearing" is
formed with a "pivot" element in the bearing, 37 which seems to suggest a meaning of
"pivot bearing" that deviates from the plain meaning. 38 However, other than this
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

6

preferred embodiment nothing else in the intrinsic record 39 suggests that the applicant
intended a different definition. 40 The definitions proposed by the parties share two
common elements: (1) a definition of the bearing , including its shape, and (2) a
reference to friction reduction .41 The court addresses these two components of the
definition in sequence.
6. First, the bearing surface can take any number of
shapes. The specification does not describe these shapes,
and claim 1 does not limit the pivot bearing to a specific
shape.42 The court, therefore, turns to extrinsic evidence. 43
A textbook on the subject of statics explains that "[p]ivot and
collar bearings are commonly used in machines to support an
Pi~Ol bearing

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
con ical 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

7

axial load on a rotating shaft[,]"44 which is depicted in an accompanying figure. 45 In
comparison to collar bearings, which support an axial load in the middle of a rotating
shaft, it is plain that pivot bearings support an end of the rotating shaft. 46 The textbooks
and journal articles provided by the parties refer to the rotating shaft as the "pivot" and
the surface supporting the shaft as the bearing. 47 In claim 1, the pivot bearing is formed
from the "top surface" of the "protrusion on the driving part" and the "bottom surface" of
the "bore" in the "push button ."48 Therefore, the court concludes that the pivot bearing
in the "push button connection" consists of a pivot, which is the "protrusion on the
driving part" (which rotates) and a receiving bearing, which is the "bore" in the "push
button" (which does not rotate). 49 Thus, the extrinsic evidence suggests a definition of
pivot bearing as a bearing5° that supports an end of a rotating shaft subject to an axial
load.

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
49

'893 patent, 4:43-48.
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.
8

7. Second, with respect to reducing friction, the specification explains that the
reason for using a pivot bearing between the "push button" and the "driving part" is to
minimize the friction between these two parts so that, in the injection device, "the force a
user must apply [to the push button] in order to perform an injection" is as small as
possible. 51 Both parties seek to translate the stated design objective of minimizing
friction into a definitional requirement that the pivot bearing "reduce[s]" friction. 52 The
court notes that bearings reduce friction between moving parts, and an inclusion of
friction reduction in the definition of "bearing" is redundant. Moreover, it is unclear what
the reference point is for friction reduction as proposed by the parties. For example, the
specification is clear that, in comparison with designs in the prior art, 53 the pivot bearing
itself is the design choice that minimizes the friction between these two parts, because
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.

9

"the radius of the resulting friction force can be kept at a minimum." 54 According to the
extrinsic evidence, "in the case of a pivot bearing" with a flat end, the moment (turning
force) required to overcome the static friction in the bearing is directly proportional to the
axial force and the radius 55 of the bearing. 56 Therefore, minimizing the radius (and
hence the diameter) of the "protrusion" of the "driving part" minimizes "the radius of the
resulting friction force," which, in turn, minimizes friction between the "push button" and
the "driving part." Claim 1 recites a limitation that includes a pivot bearing, and the
specification explains that, in this "injection device" application , a pivot bearing is
superior to other design choices, because in comparison to those other designs it
reduces the amount of force required to inject the medication. However, were the court
to employ the term "bearing" in the definition of "pivot bearing," nothing in the intrinsic
record 57 suggests that the proposed reductions in friction would further distinguish a
"pivot bearing" from any other bearing. Therefore, the court defines pivot bearing as a

bearing that supports an end of a rotating shaft subject to an axial load.
8. "Radial bearing:" 58 "a bearing that supports a load on a shaft that is
perpendicular to the axis of rotation." 59 Claim 2 recites "[a] push button connection
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 µ PR "where µsis the
5
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.

10

according to claim 1, in which at least one radial bearing between the push button and
the driving part is provided. 60 The specification discusses, but does not define, the
radial bearing term. 61 For example, the specification states: "[i]n order to secure the fit
between the push button and the driving part and on the same time direct forces applied
on the periphery of the push button to the driving part at least one radial bearing
between the push button and the protrusion is formed. "62 As with the "pivot bearing"
term , the court declines to engage in defining "radial bearing" according to "reducing"
friction objectives associated with bearings and instead uses the term "bearing" in its
construction .63
9. According to the extrinsic evidence, "[a] bearing can [] be classified as a radial
bearing or a thrust bearing , depending on whether the bearing load is in the radial or
axial direction , respectively, of the shaft."64 "The load on the shaft can be divided into
radial and axial components . . .. [and] the radial load component is in the direction
normal [or perpendicular] to the shaft axis. "65 "Certain bearings . . . can support radial
as well as thrust forces. [But c]ertain other bearings .. . are applied only for radial

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.

11

loads."66 Therefore, the court defines radial bearing according to the plain meaning as a

bearing that supports a load on a shaft that is perpendicular to the axis of rotation.

C.

'956 Patent

10. Claims 1 and 2 of the '956 pat~nt recite:
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.
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

66

Id.

67

'956 patent, 4:61-5:27.

12

11. "Driver:" 68 "a part that transfers force from the injection button."69 The
specification explains that:
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
Therefore, the driver moves the piston rod forward to inject the medication . In the two
embodiments disclosed, this process is initiated "when the injection button is
pressed [. ]"71
12. "Track:" 72 "a path along which a part moves." 73 Claim 1 describes that "the
driver is provided with a track . . . which track is engaged by a track follower ... [which]
can be moved radially when it follows the track of the driver element." 74 In claim 2, "the
driver is provided with a track ... which track is engaged by a track follower ... [which]
can be moved rotationally when it follows the track of the driver element"75 Claim 5
68

Found in claims 1, 2, 3, 4 of the '956 patent.
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 .
69

13

recites an "assembly [that] comprises: (a) a helical track ... and (b) a follower that
engages the helical track; wherein the follower moves along the helical track[.]"76

13. "Track follower:" 77 "a part that moves along a path." 78 As discussed above
in relation to the "track" term, it is apparent in claims 1, 2, and 5, that the "track follower"
moves along the track, which the court has defined as "a path along which a part
moves." 79

14. "Track having a length:" 80 "the length of the track that the track follower
can move along." 81 Claim 1 states that "the driver is provided with a track having a
length which is related to the total injectable amount of medicament in the cartridge[.]"82
The motion of the track follower along the track is critical to setting the dosage, and if
there is insufficient medication in the cartridge, the dosage cannot be set. 83 Moreover,
during prosecution, the applicant argued that "[a]s the follower moves along the track ..
. only during dose setting, it acts as a summation machine for the set and injected
doses. Thus, the length which the follower can move along the track (or the track along

76

Id., 5:48-53.
Found in claims 1, 2, 4 of the '956 patent.
78 The court adopts plaintiff's proposal. 0.1. 39 at 8. Defendant had proposed
"movable lever that follows a pre-determined path and is coupled to the dose setting
member." Id. Claim 1 states that the "track is engaged by a track follower coupled to
the dose setting member[.]" '956 patent, 5:4-5; see also id., 5:25-26 ("the track
follower[] is coupled to the dose setting member."). In light of the claim language,
defendant's construction is redundant.
79 Id. , 5:2-11 ; 5:19-27; 5:48-53.
8 Found in claims 1, 2 of the '956 patent.
81 The court adopts plaintiff's proposal. 0.1. 39 at 9. Defendant had proposed a
plain meaning, which it contends is the total length of the track. Id.; 0.1. 52 at 64-65.
82
'956 patent, 5:2--4.
83 Id., 4:10-16 ("[T]he position of the cam in the track reflects the total amount of
medicine administered . When the cam 21 abuts the end wall 24 of the track 20 the set
dose cannot be increased and by adapting the length of the track to the total amount of
medicine in the cartridge it is ensured that a dose larger than the amount of medicine
remaining in the cartridge cannot be set.").
77

°

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the follower) defines the volume of the drug that remains in the pen syringe that is
available to be injected ."84

ORDER: THE COURT'S CLAIM CONSTRUCTION
At Wilmington this 25th day of June, 2018, having heard oral argument, having
reviewed the papers submitted with the parties' proposed claim constructions, and
having considered all of the parties' arguments (whether or not explicitly discussed
herein);
IT IS ORDERED that the disputed claim language of U.S. Patent Nos. 8,114,833
("the '833 patent"); 9,265,893 ("the '893 patent"); and RE41,956 ("the '956 patent") shall
be construed consistent with the tenets of claim construction set forth by the United
States Court of Appeals for the Federal Circuit in Phillips v. AWH Corp., 85 as follows:

Claim Term

Construction
+ or - 0.1 pH units from [the stated number]

about
('833 patent, els. 1, 5, 6, 7, 16, 20,
21, 22)

84

D.I. 39-1 at 93-94 of 118 & n.6.
85 415 F.3d 1303 (Fed. Cir. 2005) (en bane).

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Claim Term
replacing the isotonicity agent
previously utilized in said
formulation with propylene glycol
('833 patent, els. 23, 26, 29)

Construction
having a first formulation that utilized an
isotonicity agent other than propylene glycol and
having a second formulation wherein the
isotonicity agent used in the first formulation is
substituted or replaced with propylene glycol

the propylene glycol-containing
formulation relative to that
observed for the formulation
containing the previously utilized
isotonicity agent
('833 patent, els. 24, 27, 30)
the isotonicity agent to be
replaced by propylene glycol
('833 patent, els. 25, 28, 31)
driving part

a part that transfers force from the push button

('893 patent, els. 1, 2, 5
pivot bearing
('893 patent, cl. 1)
radial bearing
('893 patent, els. 2, 3, 4)
driver
('956 patent, els. 1, 2, 3, 4)

a bearing that supports an end of a rotating shaft
subject to an axial load
a bearing that supports a load on a shaft that is
perpendicular to the axis of rotation
a part that transfers force from the injection
button
a path along which a part moves

track
('956 patent, els. 1, 2, 4)
track follower

a part that moves along a path

('956 patent, els. 1, 2, 4)
track having a length
('956 patent, els. 1, 2)

the length of the track that the track follower can
move along

Pursuant to 28 U.S.C. § 636(b)(1)(B), Fed. R. Civ. P. 72 (b)(1), and D. Del. LR
72.1, any objections to the Report and Recommendation shall be filed within fourteen

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( 14) days limited to ten ( 10) pages after being served with the same. Any response
shall be limited to ten (10) pages.
The parties are directed to the Court's Standing Order in Non-Pro Se Matters for
Objections Filed under Fed. R. Civ. P. 72 dated October 9, 2013, a copy of which is
found on the Court's website (www.ded.uscourts.gov.)

Dated :

June 26, 2018

/s/ Mary Pat Thynge
Chief U.S. Magistrate Judge

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