Court Opinion

ID: 210722
Source: CourtListenerOpinion
Date Created: 2011-03-13 08:15:45+00
Date Added: 2024-06-11T13:15:45.835757
License: Public Domain

United States Court of Appeals for the Federal Circuit

                                    06-1156, -1157

                           LIEBEL-FLARSHEIM COMPANY
                             and MALLINCKRODT, INC.,

                                                       Plaintiffs-Appellants,

                                           v.

                                   MEDRAD, INC.,

                                                       Defendant-Cross Appellant.

        J. Robert Chambers, Wood, Herron & Evans, L.L.P., of Cincinnati, Ohio, argued
for plaintiffs-appellants. With him on the brief was Theodore R. Remaklus.

      W. Thomas McGough, Jr., Reed Smith LLP, of Pittsburgh, Pennsylvania,
argued for defendant-cross appellant. With him on the brief were Frederick H. Colen,
Barry J. Coyne, and Kirsten R. Rydstrom. Of counsel on the brief was Gregory L.
Bradley, Medrad Inc., of Indianola, Pennsylvania.

Appealed from: United States District Court for the Southern District of Ohio

Chief Judge Sandra S. Beckwith
     United States Court of Appeals for the Federal Circuit

                                   06-1156, -1157

                           LIEBEL-FLARSHEIM COMPANY
                             and MALLINCKRODT, INC.,

                                                     Plaintiffs-Appellants,

                                          v.

                                   MEDRAD, INC.,

                                                     Defendant-Cross Appellant.

                               ____________________

                             DECIDED: March 22, 2007
                              ____________________

Before LOURIE, RADER, and BRYSON, Circuit Judges.

LOURIE, Circuit Judge.

      Liebel-Flarsheim Company and Mallinckrodt Inc. (collectively “Liebel”) appeal

from the decision of the United States District Court for the Southern District of Ohio

granting Medrad’s motion for summary judgment that four of Liebel’s patents are invalid

under 35 U.S.C. §§ 112 and 102. Liebel-Flarsheim Co. v. Medrad, Inc., No. 01-CV-98-

858 (S.D. Ohio Oct. 28, 2005). Medrad cross-appeals from the decision of the district

court granting Liebel’s motion for summary judgment that Medrad infringed the asserted

patents and that the inventorship designation on Liebel’s patents is correct. Medrad
also cross-appeals from the holding that the inequitable conduct counterclaim was moot

in light of the district court’s invalidity rulings.   Because we conclude that Liebel’s

patents are invalid, the front-loading patents for lack of enablement and the syringe-

sensing patents on anticipation, we affirm the district court’s judgment of invalidity. As a

result, the cross-appeals on infringement and inventorship need not be reached. We

also affirm the court’s decision that the inequitable conduct counterclaim is presently

moot.

                                      BACKGROUND

        This is the second time this case has been on appeal in our court. The detailed

facts of the case are presented in our previous opinion, and we present here only those

facts relevant to this appeal. See Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898

(Fed. Cir. 2004) (“Liebel I”). This appeal concerns asserted claims of four of Liebel’s

patents: claims 10, 11, 13, and 16-19 of U.S. Patent 5,456,669; claims 1, 8, 9, 11-13,

15, 16, 18, 22, 27, 28, 30-33, and 34-37 of U.S. Patent 5,658,261; claims 7, 8, 10, and

11 of U.S. Patent 5,662,612; and claims 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 16, 17, 19, 20,

22, and 23 of U.S. Patent 5,928,197. The ’669 and ’261 patents (hereinafter the “front-

loading patents”) share a common specification and are directed to a front-loading fluid

injector with a replaceable syringe capable of withstanding high pressures for delivering

a contrast agent to a patient. The ’612 and ’197 patents (hereinafter the “syringe-

sensing patents”) also share a common specification and are directed to a computer-

controlled injector wherein a motor advances and retracts a plunger located within the

syringe.

06-1156, -1157                                2
       With regard to the asserted claims of the front-loading patents, this appeal

challenges the district court’s holding of invalidity following our prior claim construction

regarding a pressure jacket.      Claim 10 of the ’669 patent is representative of the

asserted claims of the front-loading patents and reads as follows:

       A method of loading a tubular replacement syringe into a high pressure
       power injector for injecting fluid into an animal, the method comprising the
       steps of:
              providing a power injector having:
              a syringe receiving opening with a generally circular periphery
                 therein adapted to receive a rearward end of a syringe having a
                 generally circular rim,
              a ram and a motor linked to the ram and operable to reciprocate the
                 ram along a segment of a line projecting through the opening;
                 and providing a hollow tubular syringe that includes:
              a cylindrical body having an axis, a generally circular rim, a
                 rearward end and a closed forward end with a fluid discharge
                 orifice therein, and
              a plunger axially slidable in the body, the syringe body being
                 structurally capable of withstanding, at least from the rim to the
                 orifice, fluid at an operating pressure of at least 100 psi within the
                 interior thereof;
       then:
              inserting into the opening, by generally rearward axial movement of
                 the syringe, the rearward end of the body;
              rotating the syringe in the opening a fraction of a turn to thereby
                 lock the body around the rim to the injector around the periphery
                 of the opening; and
              engaging the plunger with the ram;
       then:
              energizing the motor and thereby driving the ram forward along the
                 line and parallel to the axis to move the plunger axially forward at
                 a programmed speed to inject the fluid at the operating pressure
                 from within the syringe and through the orifice at a programmed
                 rate into the animal.

06-1156, -1157                                3
’669 patent, col.15 ll.17-50.      The claims in the originally-filed application 1 explicitly

recited a pressure jacket in front of the syringe receiving opening.              During the

prosecution of the front-loading patents, Liebel removed all references in the claims to a

pressure jacket.     Medrad asserted, and the district court agreed, that during the

prosecution of the front-loading patents, the applicants became aware of Medrad’s

jacketless injector system and then deleted all references to a pressure jacket in the

asserted claims in order to encompass Medrad’s injector within the scope of the claims.

The examiner allowed the claims, and the claims as issued do not contain an explicit

recitation of a pressure jacket.

       Even though the claims do not expressly recite a pressure jacket, the district

court initially construed the asserted claims of the front-loading patents as requiring a

pressure jacket.    Based on that construction, the district court granted summary

judgment of noninfringement in favor of Medrad because Medrad’s accused devices do

not contain a pressure jacket.

       In the first appeal to this court, we reversed the district court’s claim construction

and determined that the asserted claims of the front-loading patents do not require a

pressure jacket. We first considered the language of the claims and observed that

neither claim 10 of the ’669 patent nor any of the other asserted claims expressly

mentions a pressure jacket. We further rejected the district court’s conclusion that the

term “opening” in independent claim 10 of the ’669 patent must be limited to an opening

in a pressure jacket.     We then considered the specification and determined that,

       1
              In 1991, Liebel filed Application Serial No. 07/712,110, which issued as
U.S. Patent 5,300,031. The claims of the ’031 patent include a pressure jacket
limitation. The ’669 and ’261 patents, which do not recite a pressure jacket limitation,
resulted from continuation applications, claiming priority from the ’110 application.

06-1156, -1157                                 4
although all the described embodiments include a pressure jacket, the disclosure did

not clearly disavow embodiments lacking a pressure jacket. We also observed that the

prosecution history indicates that the asserted claims purposefully did not include a

pressure jacket limitation in order to cover devices that lacked a pressure jacket. In light

of the intrinsic evidence, we declined to limit the claims to require a pressure jacket.

Although Medrad argued that we should construe the claims narrowly to preserve their

validity, we declined to do so, stating that the question of validity was a separate issue

that could be addressed on remand. Liebel I, 383 F.3d at 912.

       On remand and in light of our claim construction, the district court concluded that

Medrad’s devices did infringe the asserted claims of the front-loading patents, but that

those claims were invalid for lack of compliance with the written description and

enablement requirements of the statute. The district court reasoned that the claims

were invalid for lack of written description because the specification does not describe a

jacketless injector.   The court noted that the written description of the invention is

directed to the improvement of “loading and unloading a syringe given the constraints

presented by the pressure jacket.”

       The district court also concluded that the asserted claims were invalid for lack of

enablement after considering the specification and the factors set forth in In re Wands,

858 F.2d 731 (Fed. Cir. 1988).        The court observed that a pressure jacket was

necessary to “maintain the integrity of the syringe housing against pressures the syringe

encounters during operation of the injector.” The court further noted that the inventors

themselves testified as to the importance of the pressure jacket around the syringe and

that the experiments with and testing of jacketless systems were unsuccessful. The

06-1156, -1157                               5
court also relied on testimony of Liebel’s engineers that a jacketless system was not a

mere design option and that one skilled in the art would not know how to make a

jacketless system. The court further found that no prototypes of a jacketless injector

had been made or described at the time of filing, and that the state of the art was such

that a jacketless system with a disposable syringe would have been a “true innovation.”

Thus, the court concluded that Medrad had proffered clear and convincing evidence that

the specification does not satisfy the written description and enablement requirements.

       With respect to the syringe-sensing patents, this appeal challenges the holding of

invalidity following our construction of the term “physical indicia” and its relationship to

the properties of the syringe.     Claim 7 of the ’612 patent is representative of the

asserted claims of the syringe-sensing patents and reads as follows:

       An injector of the type having a motor which advances and retracts a
       plunger located within a syringe toward and away from a nozzle located at
       a distal end of the syringe to inject fluid into or out of an animal subject,
       adapted for use with syringe assemblies which have differing capacities,
       comprising:
              a detector located proximate to a syringe installed on said injector
                 for detecting a physical indicia [sic] on said syringe related to the
                 capacity of said syringe, and generating an electrical signal
                 representative of said physical indicia, and
              a control circuit which causes said motor to move and tracks the
                 location of said motor while moving said motor, wherein said
                 control circuit computes the location of a plunger within said
                 syringe relative to an end of said syringe, by relating said
                 electrical signal to the tracked location of said motor.

’612 patent, col.18 ll.36-52 (emphases added).      The remaining asserted claims of the

’197 and ’612 patents differ from representative claim 7 of the ’612 patent in that some

are directed to a method of controlling an injector (claims 4, 5, 10, 11, 16, 17, 22, and

23 of the ’197 patent and claim 10 of the ’612 patent), and some are dependent claims

that recite the additional limitation of ceasing motion of the motor and plunger when the

06-1156, -1157                               6
plunger or ram connected to the plunger has reached the end of the syringe (claims 2,

5, 8, 11, 14, 17, 20, and 23 of the ’197 patent and claims 8 and 11 of the ’612 patent).

In addition, the asserted claims of the syringe-sensing patents recite physical indicia

related to properties of the syringe other than the “capacity of said syringe” as recited in

representative claim 7 of the ’612 patent. Such properties include the distance of the

plunger or ram coupled to the plunger from an end of the syringe (claims 1, 4, 13, and

16 of the ’197 patent), the range of travel of an injector ram coupled to the plunger

(claims 19 and 22 of the ’197 patent), and the amount of fluid in the syringe (claims 7

and 10 of the ’197 patent).

       In its claim construction prior to our decision in Liebel I, the district court had

considered the meaning of the term “physical indicia.” It disagreed with Medrad that the

term should be limited to indicia representing the length of the extender. The court

determined that the claim language was broader than Medrad’s proposed construction

because the claims recited syringe properties other than the length of the extender.

       On appeal, in Liebel I, Medrad had argued that we should construe the term

“physical indicia” to be limited to features that indicate the length of the extender. Liebel

I, 358 F.3d at 912. After considering the language of the claims, the specification, and

the prosecution history, we determined that the district court correctly concluded that the

term “physical indicia” is not limited to indicia related to the length of an extender. Id. at

914.    We again stated that we would not construe the claims narrowly because of

invalidity concerns, and that the issue of invalidity could be addressed on remand. Id.

       On remand and in light of our construction, the district court determined that

Medrad’s accused device did infringe the asserted claims of the syringe-sensing

06-1156, -1157                                7
patents, but that those claims were invalid for failure to comply with the requirements of

§ 112 and because of anticipation by Medrad’s U.S. Patent 5,383,858. With regard to

written description, the district court stated that there was “nothing in the written

description that describes an invention for detecting indicia (e.g., ‘a tangible mark’) on

the syringe–other than the limited, alternative reference to physical indicia relating to the

length of the extender.” The district court noted that the preferred embodiment “teaches

that it is the injector’s face plate, which is removable and interchangeable, that is

‘detected’ by a sensor, which in turn tells the circuit board the size of the syringe

installed.”   The court also observed that the written description and enablement

requirements often rise and fall together and determined that the asserted claims of the

front-loading patents “are of a far greater scope than [Liebel’s] specification of what it

invented or possessed when it filed its application.”       The court concluded that the

specification failed to fulfill both the written description and enablement requirements set

forth in § 112, ¶ 1.

       With regard to anticipation, the court found that even if it had concluded that

Liebel’s patents were not invalid under § 112, the asserted claims of the syringe-

sensing patents were anticipated by the prior art ’858 patent. The court found that the

’858 patent clearly describes an indicator mechanism for injecting fluid from a syringe

into a patient, and that mechanism includes an injector controller and a sensor. The

court further determined that the ’858 patent discloses “physical indicia” by describing

the use of a bar code or another readable device on the syringe that stores information

about the syringe and that can be read by a sensor. The court determined that the only

difference between the asserted claims of the syringe-sensing patents and the invention

06-1156, -1157                               8
disclosed in the ’858 patent was the description of the types of indicia detected. For

example, the ’858 patent describes that the bar code on the syringe can include

information relating to the “dimensions” of the syringe, whereas the asserted claims

recite the “capacity” of the syringe.       The court found that these were “semantic

differences” that did not affect its conclusion of anticipation. Hence, the court concluded

that the ’858 patent anticipates the syringe-sensing patents.

       In a separate order, the district court considered whether the inventorship

designated on the patents was correct, and granted Liebel’s motion for partial summary

judgment that it was correct. The court determined that the alleged omitted inventor,

Kelly, did not contribute to the conception of the design and thus was not properly a co-

inventor. The court found that the evidence established that Kelly only attended “brain-

storming” sessions, but that there was no clear and convincing evidence of his being an

inventor.

       The court further determined, after resolving the invalidity motions, that Medrad’s

inequitable conduct claim was moot in light of its invalidity rulings.

       Liebel timely appealed, and Medrad cross-appealed. We have jurisdiction

pursuant to 28 U.S.C. § 1295(a)(1).

                                       DISCUSSION

       We review the district court’s grant of summary judgment de novo, reapplying the

standard applicable at the district court. See Rodime PLC v. Seagate Tech., Inc., 174

F.3d 1294, 1301 (Fed. Cir. 1999). Summary judgment is appropriate “if the pleadings,

depositions, answers to interrogatories, and admission on file, together with the

affidavits, if any, show that there is no genuine issue as to any material fact and that the

06-1156, -1157                                9
moving party is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(c). In

addition, in deciding a motion for summary judgment, “[t]he evidence of the nonmovant

is to be believed, and all justifiable inferences are to be drawn in his favor.” Anderson v.

Liberty Lobby, Inc., 477 U.S. 242, 255 (1986).             Whether a claim satisfies the

enablement requirement of 35 U.S.C. § 112, ¶ 1 is a question of law. Invitrogen Corp.

v. Clontech Labs. Inc., 429 F.3d 1052, 1070 (Fed. Cir. 2005). Anticipation is a question

of fact, but validity is a question of law. Atofina v. Great Lakes Chem. Corp., 441 F.3d

991, 995 (Fed. Cir. 2006). Because a patent is presumed to be valid, the evidentiary

burden to show facts supporting a conclusion of invalidity is one of clear and convincing

evidence. AK Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, 1238-39 (Fed. Cir. 2003).

A.     The Front-Loading ’669 and ’261 Patents

       On appeal, Liebel argues that the court erred in determining that the asserted

claims of the front-loading patents are invalid for lack of written description and

enablement. With regard to enablement, Liebel contends that the court erroneously

considered whether an injector without a pressure jacket was enabled, rather than

limiting its inquiry to whether an injector with a pressure jacket was enabled, as it clearly

was. Liebel points out that the asserted claims do not recite or require the absence of a

pressure jacket and the court improperly focused on such an embodiment. Because it

is undisputed that Liebel provided an enabling disclosure of what it calls its preferred

embodiment, viz., an injector with a pressure jacket, Liebel asserts that the court should

have held that the disclosure was enabling for the full scope of the claims. Liebel

further asserts that the court erred in concluding, after considering the Wands factors,

that undue experimentation would be required to practice the claimed invention without

06-1156, -1157                               10
a pressure jacket. According to Liebel, the testimony that the court relied upon only

showed that additional work, not undue experimentation, was required to develop an

injector without a pressure jacket. Liebel also ascribes error to the court’s consideration

of various other pieces of testimony as support for its determination that producing the

invention without a pressure jacket would require undue experimentation.

       Medrad responds that the district court correctly determined that, under our claim

construction, the asserted claims are invalid for lack of enablement. Medrad argues

that the court was correct in determining that the full scope of the invention, including

the injector without a pressure jacket, is not enabled.   According to Medrad, although

every embodiment of a claim does not need to be disclosed in the specification, the

disclosure must teach the full range of embodiments in order for the claims to be

enabled, and here the disclosure does not teach an injector without a pressure jacket.

According to Medrad, consideration of the Wands factors also supports a determination

that the asserted claims are not enabled. Medrad observes that Liebel’s own inventors

admitted that they could not produce a successful pressure-jacketless system and that

that was compelling evidence of lack of enablement. Medrad also cites other testimony

that supports a finding of undue experimentation.

       We agree with Medrad that the district court correctly determined that the

asserted claims of the front-loading patents are invalid for lack of enablement. The

enablement requirement is set forth in 35 U.S.C. § 112, ¶ 1 and provides in pertinent

part that the specification shall describe “the manner and process of making and using

[the invention], in such full, clear, concise, and exact terms as to enable any person

skilled in the art to which it pertains, or with which it is most nearly connected, to make

06-1156, -1157                              11
and use the [invention].” We have stated that the “enablement requirement is satisfied

when one skilled in the art, after reading the specification, could practice the claimed

invention without undue experimentation.”         AK Steel, 344 F.3d at 1244; see also

Wands, 858 F.2d at 736-37.

       We have previously construed the claims of the front-loading patents such that

they are not limited to an injector with a pressure jacket, and therefore the full scope of

the claimed inventions includes injectors with and without a pressure jacket. That full

scope must be enabled, and the district court was correct that it was not enabled.

       Turning first to consideration of the specification, we find that nowhere does the

specification describe an injector with a disposable syringe without a pressure jacket. In

fact, the specification teaches away from such an invention. In the “Background of the

Invention,” the specification describes general injectors and explains that during the

injection phase, a plunger is driven forward and pressure develops in the syringe,

ranging from 25 psi to over 1000 psi. Without a pressure jacket, syringes that are able

to withstand such high pressures are “expensive and therefore impractical where the

syringes are to be disposable.      Accordingly, many such injectors . . . have been

provided with pressure jackets fixed to the injector units and into which the syringes are

inserted.”   ’669 patent, col.1 ll.23-31.   The specification thus teaches away from a

disposable syringe without a pressure jacket by stating that such syringes are

“impractical.”   As we have held previously, where the specification teaches against a

purported aspect of an invention, such a teaching “is itself evidence that at least a

significant amount of experimentation would have been necessary to practice the

claimed invention.”    AK Steel, 344 F.3d at 1244.       Moreover, consideration of the

06-1156, -1157                               12
remainder of the specification reveals that there is no guidance or suggestion of how to

make or use a disposable syringe for high pressure use without a pressure jacket. All

the figures in the patents depict a pressure jacket and all discussion of them refers to

the pressure jacket.

       Furthermore, consideration of the testimonial evidence presented supports a

conclusion that no genuine issue of material fact exists as to whether undue

experimentation would have been required to make and use the injector without a

pressure jacket. The inventors admitted that they tried unsuccessfully to produce a

pressure-jacketless system and that producing such a system would have required

more experimentation and testing. The inventors decided not to pursue such a system

because it was “too risky.” The district court relied on various statements in the record

by the inventors that testing of a syringe without a pressure jacket proved unsuccessful

and that the inventors were not aware of any other similar testing being conducted at

that time. Moreover, there was no indication of any prototype of a pressure-jacketless

injector having been made.

       Liebel argues that language in Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d

1524 (Fed. Cir. 1987), that states that if an invention pertains to an art where the results

are predictable, e.g., in the mechanical arts, then disclosure of a single embodiment can

enable a broad claim, supports its position.          Liebel asserts that because the

specification enables one mode of making and using the invention in its preferred

embodiment, viz., an injector with a pressure jacket, the enablement requirement is

satisfied and the inquiry should end there. See Engle Indus., Inc. v. Lockformer Co.,

946 F.2d 1528 (Fed. Cir. 1991).

06-1156, -1157                              13
       Liebel’s reliance on Spectra-Physics is misplaced. In that case, the specification

disclosed different “attachment means” for making the claimed invention such as moly-

manganese brazing and pulse-soldering, but failed to disclose the best attachment

means known to the inventors. We held that the asserted claims of the patent were

invalid for failure to comply with the best mode requirement of § 112, even though the

specification enabled the practice of the claims. We did note that the specifications of

other patents identified TiCuSil brazing as a suitable alternative attachment technique

and thus that the asserted patent’s failure to mention TiCuSil brazing as an attachment

means was “not fatal to enablement under § 112.” Spectra-Physics, 827 F.2d at 1533.

Indeed, in that case, disclosure of one attachment means permitted one skilled in the art

to make and use the invention as broadly as it was claimed, which included other

attachment means known to one of ordinary skill in the art. In contrast, in this case,

disclosure of an injector system with a pressure jacket does not permit one skilled in the

art to make and use the invention as broadly as it was claimed, including without a

pressure jacket.

       The facts of this case are, in fact, more analogous to AK Steel than to Spectra-

Physics. In AK Steel, the patentee argued, as it does here, that the patent disclosed

several embodiments within the properly construed claim, and that the specification

need not teach the full claimed scope in order for the claims to be enabled. 344 F.3d at

1243. The claims in AK Steel read on steel strips containing either a Type 1 or a Type 2

aluminum coating. The specification clearly described only Type 2 aluminum coating.

We stated, however, that “as part of the quid pro quo of the patent bargain, the

applicant’s specification must enable one of ordinary skill in the art to practice the full

06-1156, -1157                              14
scope of the claimed invention.” Id. at 1244 (latter emphasis added). We explained that

the specification need not necessarily describe how to make and use every embodiment

of the invention “because the artisan’s knowledge of the prior art and routine

experimentation can often fill in the gaps.” Id. However, because the full scope of the

claims included both Type 1 and Type 2 aluminum coating, the relevant inquiry became

whether one skilled in the art would have been able to make and use a steel strip

containing a Type 1 aluminum coating at the time of the patent’s effective filing date. Id.

We held that the specification taught against using a Type 1 aluminum coating, and

therefore that the claims were invalid for lack of enablement.

       Similarly, in this case, the asserted claims read on, and the full scope of the

claimed invention includes, an injector system with and without a pressure jacket.

There must be “reasonable enablement of the scope of the range” which, in this case,

includes both injector systems with and without a pressure jacket. Id.

       The specification’s reference that teaches away from an injector system with a

disposable syringe without a pressure jacket, combined with the testimonial evidence

that such a system could not have been produced at the time of filing, supports the

district court’s conclusion that the specification fails to fulfill the enablement requirement

of § 112.   Because we are resolving this issue on the enablement ground, we do not

need to consider the written description holding of invalidity.

       The irony of this situation is that Liebel successfully pressed to have its claims

include a jacketless system, but, having won that battle, it then had to show that such a

claim was fully enabled, a challenge it could not meet. The motto, “beware of what one

asks for,” might be applicable here.

06-1156, -1157                               15
B.    The Syringe-Sensing ’612 and ’197 Patents

      On appeal, Liebel argues that Medrad failed to provide clear and convincing

evidence that the ’858 patent anticipates the asserted claims of the syringe-sensing

patents. In particular, Liebel asserts that the ’858 patent does not disclose a control

circuit that computes the location of the plunger within the syringe, stops the motor and

plunger, or determines that the plunger is at the end of the syringe, as required by the

claims.

      Medrad responds that the district court correctly decided that the ’858 patent

anticipates the asserted claims of the syringe-sensing patents. Medrad asserts that the

the ’858 patent expressly discloses an injector control that controls a motor and plunger

by computing the location of the plunger. Medrad also asserts that the district court

held that measuring actual plunger movement is accomplished by “long-established

potentiometer technology,” and that the ’858 patent incorporates two patents that

discuss measuring plunger movement. Medrad finally contends that the ’858 patent

discloses detecting the same physical indicia as the syringe-sensing patents.

      We agree with Medrad that the district court correctly determined that there is no

genuine issue of material fact that the ’858 patent anticipates 2 the asserted claims of

the syringe-sensing patents. A determination that a patent is invalid as anticipated

under 35 U.S.C. § 102 requires that a prior art reference disclose every limitation of the

claimed invention, either explicitly or inherently.   Telemac Cellular Corp. v. Topp

Telecom, Inc., 247 F.3d 1316, 1327 (Fed. Cir. 2001).      The prior art reference in this

      2
                Because we determine that the asserted claims of the syringe-sensing
patents are invalid by reason of anticipation by the ’858 patent, we need not address
written description or enablement issues, which were the other grounds on which the
district court found the syringe-sensing patents to be invalid.

06-1156, -1157                             16
case is Medrad’s ’858 patent, which was cited to the PTO during the prosecution of the

syringe-sensing patents.     Although the burden of showing invalidity is “especially

difficult” when the prior art reference was before the examiner during prosecution, we

find that Medrad has met that burden here. See Glaxo Group Ltd. v. Apotex, Inc., 376

F.3d 1339, 1348 (Fed. Cir. 2004).

       Liebel first argues that the ’858 patent fails to disclose the closed control circuit

that computes the location of a plunger, as required by claim 7 of the ’612 patent. We

disagree.   There is no genuine issue of material fact as to what the ’858 patent

discloses. The ’858 patent discloses a syringe that is rotatably mountable on a front

wall of an injector housing with an interference fit.      Although that patent expressly

mentions an injector controller, it does not discuss the details of how the controller

interacts with the motor and plunger.        However, the ’858 patent incorporates by

reference 3 U.S. Patent 4,006,736, assigned to Medrad, which clearly does discuss the

details of the control circuit and its interaction with the plunger.       The ’736 patent

discloses a system for injecting fluid into a patient and it is replete with discussion of the

control unit of that system operating the motor and tracking the plunger movement. For

example, the patent expressly states that “as the motor drives the plunger, the

potentiometer tracks it, so that the rate of movement and position may be derived.” ’736

patent, col.20 ll.21-24 (reference characters omitted). The ’736 patent further states

that “the volume circuit monitors the position of plunger after an injection begins to

       3
               We have stated that “material not explicitly contained in the single, prior
art document may still be considered for purposes of anticipation if that material is
incorporated by reference into the document.” Advanced Display Sys., Inc. v. Kent
State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000). We have further explained that
material incorporated by reference “is effectively part of the host document as if it were
explicitly contained therein.” Id.

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determine how much volume of contrast media has been delivered. And when the

plunger has delivered the set volume, the volume circuit sends a signal to the time

circuit to stop injecting.” ’736 patent, col.19 ll.32-37 (reference characters omitted). The

’858 patent, which incorporates by reference the ’736 patent, therefore discloses a

claimed control circuit that computes the location of a plunger. In addition, the limitation

recited in some of the dependent claims of the syringe-sensing patents—using the

control circuit to stop movement of the motor and plunger when the plunger is at the end

of the syringe—is similarly disclosed in the ’736 patent in the discussion pertaining to

moving and retracting the plunger.

       Liebel next asserts that the ’858 patent fails to disclose physical indicia related to

various parameters or properties of the syringe. We disagree again. In our claim

construction, we determined that the term “physical indicia,” as Liebel has argued, is not

limited to indicia related to the length of the extender. Thus, the full scope of the claims

includes the detection of physical indicia other than detection of the length of the

extender. Those physical indicia recited in the claims are: the capacity of the syringe,

the distance of the plunger from an end of the syringe, the amount of fluid in the syringe,

and the end of the travel position of an injector ram coupled to the plunger.

       The ’858 patent discloses using an encoding device, such as a bar code, located

on the syringe, and a sensor, located on the injector, for reading the encoded device

and forwarding signals to the injector controller to modify the injector apparatus

accordingly. ’858 patent, col.6 ll.31-45.      The ’858 patent also states that as an

alternative to the encoding device being a bar code with spaced bars, the encoding

device can include raised surfaces corresponding to the spaced bars that would be read

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by an injector sensor, or can include mechanically readable devices such as a slot,

hold, or projection on the syringe or plunger that would send information concerning the

type of syringe used to the circuits of the injector. ’858 patent, col.6 ll.51-65. The ’858

patent provides the following examples of the information that can be included in the

encoding device: “dimensions of the syringe, content of the syringe in the case of a pre-

filled syringe, manufacturing information such as lot numbers, dates and tool cavity

number, recommended contrast media flow rates and pressures, and loading/injection

sequences.” ’858 patent col.6 ll.45-51. Thus, the ’858 patent clearly discloses the

detection of various parameters of the syringe through the use of a bar code or other

marks on the syringe.

       Liebel asserts that “dimensions of the syringe” are not the same as “capacity of

the syringe,” as recited in the asserted claims. As the district court observed, detecting

dimensions of the syringe permits calculation of capacity using a basic volumetric

formula.   Moreover, the ’858 patent expressly lists as an example of the type of

information that can be included in the bar code the “content of the syringe,” which can

encompass the capacity of the syringe as well as the amount of fluid in the syringe.

The ’858 patent also states that the encoding device can include the “loading/injection

sequences,” which can encompass information related to the initial position of the

plunger. Moreover, although the ’858 patent only provides a few examples of the types

of information that can be stored in the encoding device, the list is not exclusive and

may include other information logically related to the “dimensions” of the syringe or the

“content” of the syringe, such as the initial plunger position. Thus, there is no genuine

issue of material fact that the ’858 patent, including the disclosure of the ’736 patent that

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is incorporated by reference, clearly discloses the limitations of the asserted claims of

the syringe-sensing patents. The district court therefore did not err in concluding that

the syringe-sensing patents are invalid for anticipation as a matter of law.

       Liebel argued for a broad construction of the term “physical indicia” and in fact

broadened its claims during prosecution to recite physical indicia other than those

indicating the length of an extender. Once again, Liebel argued for a broad meaning,

and succeeded, but suffers a Pyrrhic victory.

C.     Cross-Appeals

       Because we affirm the district court’s conclusion that the asserted claims of the

patents at issue are invalid, we need not reach Medrad’s cross-appealed issues

concerning infringement and inventorship, the latter actually being an alternative ground

for a holding of invalidity, not a proper basis for a cross-appeal. 4

D.     Inequitable Conduct

       Medrad finally argues that the district court should not have dismissed as moot

its counterclaim asserting inequitable conduct. Medrad asserts that that counterclaim is

independent and distinct from an invalidity claim, and it may be the basis for two

additional remedies: a determination that the entire patent is unenforceable and an

award of attorney fees under 35 U.S.C. § 285.

       We agree with the district court that the inequitable conduct counterclaim is moot.

With regard to the argument that an inequitable conduct determination may render the

entire patent unenforceable, Medrad admitted during oral arguments that such relief is

       4
             Medrad concedes that the arguments made on infringement provide
alternate bases to find in its favor and that the arguments need only be addressed if we
were to reverse on the issue of validity. Reply Br. n.1

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not meaningful to Medrad at this time. The only other additional relief that may be

available to Medrad by an inequitable conduct determination is attorney fees under 35

U.S.C. § 285.      Medrad admitted during oral arguments that, although it plans to

predicate an attorney fee application on inequitable conduct, it has not filed that

application yet.    We therefore affirm the decision that the inequitable conduct

counterclaim is presently moot.

                                     CONCLUSION

       Because the district court correctly granted summary judgment that Liebel’s

patents are invalid, we affirm the conclusion that all the asserted claims are invalid, the

front-loading patents on enablement and the syringe-sensing patents on anticipation

grounds. Because we find no error in the district court’s holding that the inequitable

conduct counterclaim is moot, we affirm that decision as well.

                                       AFFIRMED

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