Petition for Inter Partes Review of U.S. Patent No. 5,782,805
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`CAREFUSION CORPORATION,
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`Petitioner,
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`v.
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`BAXTER INTERNATIONAL, INC.,
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`Patent Owner.
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`Patent No. 5,782,805
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`Issue Date: July 21, 1998
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`Title: MEDICAL INFUSION PUMP
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`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 5,782,805
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`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.1-.80 & 42.100-.123
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`Petition for Inter Partes Review of U.S. Patent No. 5,782,805
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`TABLE OF CONTENTS
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`I. 
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`II. 
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`COMPLIANCE WITH REQUIREMENTS FOR A PETITION FOR
`INTER PARTES REVIEW ............................................................................... 1 
`A.  Grounds for Standing (37 CFR § 42.104 (a)) ....................................... 1 
`Fee for Inter Partes Review (37 CFR § 42.15(a)) ................................ 2 
`B. 
`C.  Mandatory Notices (37 CFR § 42.8(b)) ................................................ 2 
`i. 
`Real Party in Interest (37 CFR § 42.8(b)(1)) .............................. 2 
`ii. 
`Other Proceedings (37 CFR § 42.8(b)(2)) .................................. 2 
`iii.  Designation of Counsel and Service Information (37 CFR
`§§ 42.8(b)(3)-(4)) ........................................................................ 2 
`Proof of Service (37 CFR §§ 42.6(e) and 42.105(a)) ............................ 3 
`D. 
`INTRODUCTION AND IDENTIFICATION OF THE CLAIMS
`BEING CHALLENGED (37 CFR § 42.104(B)(1)) ........................................ 3 
`III.  BACKGROUND OF THE ʼ805 PATENT ..................................................... 6 
`A. 
`Effective Filing and Priority Dates of the ʼ805 Patent .......................... 6 
`B. 
`Relevant Prosecution History of the ʼ805 Patent .................................. 6 
`C. 
`Person of Ordinary Skill in the Art ....................................................... 8 
`IV.  CLAIM CONSTRUCTION (37 CFR § 42.104(B)(3)) ................................... 9 
`“Microprocessor Means… for Generating User Interface
`A. 
`Information” ........................................................................................ 10 
`“Removably Secured” ......................................................................... 11 
`“Means for Applying Pumping Action” ............................................. 12 
`“Means for Generating a Plurality of Pictoral Graphic
`Representations” .................................................................................. 12 
`“Means for Entering Values” .............................................................. 12 
`“Means Responsive to the Entered Values for Calculating [a
`Dose / an Infusion Profile]” ................................................................ 13 
`“Means for Sensing Tube Restrictions” .............................................. 14 
`“Means for Storing User Interface Information” ................................ 15 
`“Means for Clearing the Stored User Interface Information” ............. 15 
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`B. 
`C. 
`D. 
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`E. 
`F. 
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`G. 
`H. 
`I. 
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`-i-
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`Petition for Inter Partes Review of U.S. Patent No. 5,782,805
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`V. 
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`IDENTIFICATION OF SPECIFIC STATUTORY GROUNDS FOR
`CHALLENGE (37 CFR § 42.104(B)(2)) ...................................................... 15 
`VI.  DETAILED EXPLANATION AND EVIDENCE SUPPORTING
`GROUNDS FOR CHALLENGE (37 CFR §§ 42.104(b)(4)-(5)) ................. 16 
`A.  Ground 1: Anticipation of Claims 1-4, 8-19, and 23 Based on
`Eggers .................................................................................................. 16 
`i. 
`Disclosure of Eggers ................................................................. 16 
`ii. 
`Comparison of Claims 1-4, 8-19, and 23 to Eggers ................. 17 
`B.  Ground 2: Obviousness of Claims 1-4, 8-19, and 23 Based on
`Eggers .................................................................................................. 39 
`i. 
`Disclosure of Eggers ................................................................. 39 
`ii. 
`Obviousness Based on Eggers .................................................. 39 
`C.  Ground 3: Obviousness of Claims 5, 20, 24-26, 28-32, and 35
`Based on Eggers in Combination with Voss ....................................... 40 
`i. 
`Disclosure of Eggers ................................................................. 40 
`ii. 
`Disclosure of Voss .................................................................... 40 
`iii.  Rationale for Combining the Teachings of Eggers and
`Voss ........................................................................................... 41 
`iv.  Comparison of Claims 5, 20, 24-26, 28-32, and 35 to
`Eggers and Voss ........................................................................ 43 
`VII.  CONCLUSION .............................................................................................. 51 
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`Attachment A. Proof of Service of the Petition
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`Attachment B. List of Evidence and Exhibits Relied Upon in Petition
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`Attachment C. Word Count Compliance Certificate
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`-ii-
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`Petition for Inter Partes Review of U.S. Patent No. 5,782,805
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`Petitioner CareFusion Corporation (“CareFusion” or “Petitioner”)
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`respectfully petitions for inter partes review of claims 1-5, 8-20, 23-26, 28-32, and
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`35 of U.S. Patent No. 5,782,805 (“the ʼ805 patent”) (Ex. 1001) in accordance with
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`35 U.S.C. §§ 311-319 and 37 C.F.R. § 42.100 et seq.
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`I. COMPLIANCE WITH REQUIREMENTS FOR A PETITION FOR
`INTER PARTES REVIEW
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`A. Grounds for Standing (37 CFR § 42.104 (a))
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`Petitioner certifies it is not barred or estopped from requesting inter partes
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`review of the ʼ805 patent. Neither Petitioner, nor any party in privity with
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`Petitioner, has filed a civil action challenging the validity of any claim of the ʼ805
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`patent. The ʼ805 patent has not been the subject of a prior inter partes review by
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`Petitioner or a privy of Petitioner.
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`Petitioner also certifies this petition for inter partes review is filed within
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`one year of the date of service of a complaint alleging infringement of a patent.
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`Petitioner was served with a complaint alleging infringement of the ʼ805 patent on
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`or about November 9, 2015, Civil No. 1:15-cv-9986 in the U.S. District Court for
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`the Northern District of Illinois. A copy of Baxter’s original Complaint is attached
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`as Exhibit 1009.
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`Because the date of this petition is less than one year from November 9,
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`2015, this petition complies with 35 U.S.C. § 315(b).
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`-1-
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`Petition for Inter Partes Review of U.S. Patent No. 5,782,805
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`B.
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`Fee for Inter Partes Review (37 CFR § 42.15(a))
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`The Director is authorized to charge the fee specified by 37 CFR § 42.15(a)
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`to Deposit Account No. 06-1910.
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`C. Mandatory Notices (37 CFR § 42.8(b))
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`i. Real Party in Interest (37 CFR § 42.8(b)(1))
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`The real parties in interest for this petition are Petitioner CareFusion
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`Corporation, located at 3750 Torrey View Court, San Diego, California 92130,
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`and/or its corporate parent, Becton, Dickinson and Company, located at 1 Becton
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`Drive, Franklin Lakes, New Jersey 07417.
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`ii. Other Proceedings (37 CFR § 42.8(b)(2))
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`The ʼ805 patent is the subject of a civil action in the U.S. District Court for
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`the Northern District of Illinois, captioned Baxter International, Inc. v. CareFusion
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`Corporation and Becton, Dickinson and Company, No. 1:15-cv-9986 (“the district
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`court lawsuit”).
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`iii. Designation of Counsel and Service Information (37 CFR §§
`42.8(b)(3)-(4))
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`Petitioner identifies the following counsel (a power of attorney accompanies
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`this Petition):
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`Lead Counsel
`Kurt J. Niederluecke
`Reg. No. 40,102
`kniederluecke@fredlaw.com
`(612) 492-7328
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`Backup Counsel
`Adam R. Steinert
`pro hac vice to be filed
`asteinert@fredlaw.com
`(612) 492-7436
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`Petition for Inter Partes Review of U.S. Patent No. 5,782,805
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`Fredrikson & Byron, P.A.
`200 South 6th Street, Suite 4000
`Minneapolis, MN 55402
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`Nikola L. Datzov
`pro hac vice to be filed
`ndatzov@fredlaw.com
`(612) 492-7889
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`Fredrikson & Byron, P.A.
`200 South 6th Street, Suite 4000
`Minneapolis, MN 55402
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`Service information for counsel is provided above. Counsel may also be
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`served by fax at (612) 492-7077.
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`D.
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`Proof of Service (37 CFR §§ 42.6(e) and 42.105(a))
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`Proof of service of this Petition is provided in Attachment A.
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`II.
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`INTRODUCTION AND IDENTIFICATION OF THE CLAIMS
`BEING CHALLENGED (37 CFR § 42.104(B)(1))
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`This is a petition for inter partes review of claims 1-5, 8-20, 23-26, 28-32,
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`and 35 of U.S. Patent No. 5,782,805 (“the ʼ805 patent”), titled “Medical Infusion
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`Pump,” issued on July 21, 1998, to Meinzer et al. A copy of the ʼ805 patent is
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`included in Exhibit 1001. The ʼ805 patent is generally directed to a modular
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`medical infusion pump with a central graphical user interface unit that controls and
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`displays information regarding the attached pump modules. Baxter International,
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`Inc., (“Baxter”) asserts that it “is the sole owner of, and has the sole right to sue
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`upon, the ʼ805 Patent[.]” (Ex. 1009 at ¶ 17.)
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`The ʼ805 patent has four independent claims, claims 1, 11, 24, and 36, all of
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`which are apparatus claims. Claim 1 is representative of the alleged invention:
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`Petition for Inter Partes Review of U.S. Patent No. 5,782,805
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`1. An infusion pump comprising:
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`a main body portion;
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`a display contained on the main body portion for displaying user
`interface information;
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`at least one pump module removably secured to the main body portion
`and adapted to receive a tube, the pump module having means for
`applying pumping action to the tube;
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`an auxiliary display contained on the pump module for displaying
`supplemental user interface information;
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`microprocessor means contained in the main body portion for
`generating user interface information on the display areas; and
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`means for generating a plurality of pictoral graphic representations as
`user interface information on the main display;
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`wherein a plurality of sets of configuration parameters are included as
`user interface information such that a user can select which of the
`plurality of sets of configuration parameters to configure the
`infusion pump.
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`(Ex. 1001, Cl. 1.)
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`The prior art references cited and discussed in this petition are two U.S.
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`patents, both of which belong to CareFusion’s predecessors. The primary cited
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`reference (“Eggers”) is based on the prototype of CareFusion’s accused Alaris
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`system. To the extent that the accused features of the Alaris system fall within
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`Petition for Inter Partes Review of U.S. Patent No. 5,782,805
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`Baxter’s claims, nearly all of them are expressly disclosed in the prior art Eggers
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`patent.
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`The secondary reference (“Voss”) is based on the Signature Edition or “SE”
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`infusion pump produced by CareFusion’s predecessor company IVAC
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`Corporation. The display of the Signature Edition pump included a “bar graph”
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`display of the pressure in the fluid delivery line, which is disclosed in the Voss
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`patent.
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`CareFusion’s Alaris pump system resulted from the merger of two
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`predecessor companies, IMED and IVAC. Through that merger, various IVAC
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`technology (including the Voss pressure display) was merged with IMED
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`technology, including that disclosed in the Eggers patent. Thus, the combination
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`of Eggers and Voss not only would have been obvious to a person of ordinary skill
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`in the art, it is what actually happened to create CareFusion’s accused product.
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`To the extent that CareFusion’s accused product falls within the challenged
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`claims of the ʼ805 patent, as Baxter contends, those claims are either anticipated by
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`Eggers or at least rendered obvious by Eggers alone or in combination with Voss.
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`Thus, the references relied on herein raise a reasonable likelihood that CareFusion
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`will prevail with respect to at least one challenged claim, and CareFusion’s petition
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`for inter partes review of the ʼ805 patent should be granted.
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`Petition for Inter Partes Review of U.S. Patent No. 5,782,805
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`III. BACKGROUND OF THE ʼ805 PATENT
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`A. Effective Filing and Priority Dates of the ʼ805 Patent
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`The ʼ805 patent issued from U.S. Application No. 08/631,819 (“the ʼ819
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`application”), with a filing date of April 10, 1996. The ʼ805 patent does not claim
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`priority to any earlier application. Furthermore, under the scheduling order in the
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`district court lawsuit (Ex. 1010 at APP0598) and Northern District of Illinois Local
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`Patent Rule 2.1(a)(2) (Ex. 1011 at APP0607), Baxter was required to produce “all
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`documents concerning the conception, reduction to practice, design, and
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`development of each claimed invention” in the ʼ805 patent by June 10, 2016.
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`Baxter’s production does not include documents sufficient to establish either
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`conception or diligent efforts to reduce the ʼ805 claims to practice prior to the ʼ819
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`application’s April 10, 1996, filing date – let alone the Eggers’ application’s March
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`13, 1995, filing date. See generally, e.g., Microsoft Corp. v. SurfCast, Inc.,
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`IPR2013-00292, Paper No. 93, at 15-21 (Oct. 14, 2014). Accordingly, CareFusion
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`states that the priority date for the ʼ805 patent is April 10, 1996.
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`B. Relevant Prosecution History of the ʼ805 Patent
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`The file history for the ʼ805 patent emphasizes that Baxter’s alleged
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`invention centers around using graphics to represent user interface information
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`about the infusion pump. A copy of the file history is attached as Exhibit 1002.
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`Petition for Inter Partes Review of U.S. Patent No. 5,782,805
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`The examiner initially rejected Baxter’s ʼ819 application in light of U.S.
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`Patent Nos. 4,756,706 (“Kerns”) and 4,898,578 (Rubalcaba), which incorporate
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`each other by reference. (See Ex. 1002 at APP0220-28.) The Kerns and
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`Rubalcaba references disclose a modular infusion pump system with multiple
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`pump modules removably attached to a central control unit.
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`In response, Baxter did not dispute that Kerns disclosed a modular pump
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`system with a central user interface. Instead, Baxter argued that the display in
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`Kerns did not include a “pictoral” representation of user interface information:
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`In particular, the Office Action relies on U.S. Patent No. 4,756,706 to
`Kerns, et al., among other things, as teaching the use of “graphical”
`representations of user interface information, citing figure 3, figure 9
`and figure 11. However, figures 3, 9 and 11 depict an alphabetical
`representation and not a pictoral representation as utilized in the
`present invention. In order to clarify that the present invention relates
`to a pictoral representation, claims 5, 6, 7, 8, 55, 57, 62, 63, 64, 68,
`69, 74, 75, 76, 80, 85, 86 and 87 have been amended to specify that
`the graphical representation is a “pictoral graphic” representation.
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`In addition, in contradistinction to Kerns, et al., claim 1 has been
`amended to specify that the invention includes “means for
`generating a pictoral graphic representation as user interface
`information on the main display.” Examples of this include means for
`calculating an infusion profile and for generating pictoral graphic
`representation of the calculated infusion profile (claims 5, 55, 74 and
`85); [and] means for sensing tube restrictions and for generating a
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`Petition for Inter Partes Review of U.S. Patent No. 5,782,805
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`pictoral graphic representation of the degree to which the tube is
`restricted (claims 6, 62, 68 and 86)….
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`(Id. at APP0237 (emphasis added).)
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`Following Baxter’s arguments, the examiner entered an Examiner’s
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`Amendment adding the requirement from claim 1 that the pump modules be
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`“removably secured to the main body portion” to the other independent claims.
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`(See id. at APP0272.) With that amendment, the examiner allowed the ʼ805 patent
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`to issue, citing the following reasons for allowance:
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`[T]he prior art of record does not show the picture graphs, and a
`plurality of sets of configuration parameters that are included as user
`interface information such that a user can select which plurality of sets
`of configuration parameters to configure the infusion pump.
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`(Id. (emphasis added).) Accordingly, the use of “pictoral graphic representations”
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`or “picture graphs” in the pump’s user interface goes to the heart of Baxter’s
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`alleged invention.
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`C.
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`Person of Ordinary Skill in the Art
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`A person of ordinary skill in the art in the field of the ʼ805 patent in the 1996
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`time frame would have been someone with at least a bachelor’s or graduate degree
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`in pharmacy, medicine, biomedical engineering, or a related field, and at least 8
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`years of combined clinical and infusion pump design experience. (See Declaration
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`of Stephen J. Bollish, attached as Exhibit 1003, at ¶ 10.)
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`-8-
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`Petition for Inter Partes Review of U.S. Patent No. 5,782,805
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`IV. CLAIM CONSTRUCTION (37 CFR § 42.104(B)(3))
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`The ʼ805 patent expired on April 10, 2016, twenty years after the ʼ819
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`application was filed. The claims should thus be construed according to their
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`“ordinary and customary meaning as understood by a person of ordinary skill in
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`the art at the time of the invention.” Google Inc. v. CreateAds LLC, IPR2014-
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`00200, Paper No. 19, at 2 (July 16, 2014) (citing Phillips v. AWH Corp., 415 F.3d
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`1303 (Fed. Cir. 2005) (en banc)). For the purposes of this Petition, CareFusion
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`relies on the constructions expressly and implicitly propounded by Baxter in the
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`district court lawsuit. CareFusion does not agree that those constructions are in
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`fact correct. Regardless, Baxter’s contentions are informative for evaluating the
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`validity of the claims. See, e.g., in re Icon Health & Fitness, Inc., 496 F.3d 1374,
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`1379 (Fed. Cir. 2007) (“[A]n infringement or invalidity analysis provides the
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`context for claim construction.”). For example, even if the Board disagrees with
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`Baxter’s constructions and accordingly concludes that an element is not literally
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`present in the prior art, Baxter’s contentions are still highly probative of the
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`obviousness of the alleged invention.
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`Unless stated otherwise below, CareFusion contends that each term in the
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`claims should be given its plain and ordinary English meaning.
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`Petition for Inter Partes Review of U.S. Patent No. 5,782,805
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`A.
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`“Microprocessor Means… for Generating User Interface
`Information”
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`Claim 1 recites the element of “microprocessor means contained in the main
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`body portion for generating user interface information.” Claims 11 and 24
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`likewise recite the element of “microprocessor means for generating user interface
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`information on the display.”
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`This element is a means-plus-function term governed by pre-AIA 35 U.S.C.
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`§ 112 ¶ 6. Baxter’s infringement contentions in the district court lawsuit identify
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`the corresponding structure disclosed in the specification as a generic
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`microprocessor. (See Ex. 1012 at APP0638-40 (citing specification lines 2:67-
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`3:10).)
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`CareFusion agrees that Baxter has cited the only possible disclosure in the
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`specification supporting this element. However, the Federal Circuit has made clear
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`that “[w]hen dealing with a ‘special purpose computer-implemented means-plus-
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`function limitation,’ we require the specification to disclose the algorithm for
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`performing the function.” Function Media, L.L.C., v. Google, Inc., 708 F.3d 1310,
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`1318 (Fed. Cir. 2013); see also, e.g., Ericsson Inc. v. Intellectual Ventures II LLC,
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`Case No. IPR2014-01170, Paper No. 9, at 7-8 (P.T.A.B. Feb. 17, 2015) (citing
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`Function Media for the proposition that “a computer-implemented means-plus-
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`function limitation is indefinite [if] the specification fail[s] to disclose the specific
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`algorithm used by the computer to perform the recited function.”).
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`Petition for Inter Partes Review of U.S. Patent No. 5,782,805
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`The specification passages cited by Baxter do not contain any algorithm for
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`“generating user interface information,” nor is any disclosed elsewhere in the
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`specification. Accordingly, this claim element is indefinite under 35 U.S.C. § 112,
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`and not amenable to claim construction.
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`To the extent that this element is not indefinite, CareFusion agrees with
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`Baxter that the only possible corresponding structure disclosed in the specification
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`is a generic microprocessor.
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`B.
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`“Removably Secured”
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`Claims 1, 11, and 24 all require “at least one pump module removably
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`secured to the main body portion.” The specification explains:
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`It is a particular advantage that the present invention provides the
`flexibility to allow a user to choose a plurality of flow channels
`depending on the user’s requirements. The present invention further
`allows for infusion pumps to be easily modified so that the number of
`flow channels can be changed.
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`(Ex. 1001 at 3:11-16 (emphasis added).) “[T]he specification ‘is always highly
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`relevant to the claim construction analysis. Usually, it is dispositive; it is the single
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`best guide to the meaning of a disputed term.’” Phillips, 415 F.3d at 1315.
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`Accordingly, the proper construction of “removably secured” is “attached in a
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`manner allowing an ordinary user to easily remove the pump module, thereby
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`changing the number of flow channels.”
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`Petition for Inter Partes Review of U.S. Patent No. 5,782,805
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`C.
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`“Means for Applying Pumping Action”
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`Claims 1, 11, and 24 each recite the element of “means for applying
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`pumping action to the tube.” Baxter’s infringement contentions cite the disclosure
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`of “peristaltic-type pumps and valve-type pumps” in the specification. (See Ex.
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`1012 at APP0631 (citing specification lines 1:21-37).) Solely for the purposes of
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`this Petition, CareFusion agrees that this element refers to either a peristaltic-type
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`or valve-type pumping mechanism.
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`D.
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`“Means for Generating a Plurality of Pictoral Graphic
`Representations”
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`Claims 1 recites the element of “means for generating a plurality of pictoral
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`graphic representations as user interface information on the main display.”
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`Baxter’s infringement contentions state that the corresponding structure “is an
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`LCD screen.” (Id. at APP0644 (citing specification lines 2:59-63).) Solely for the
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`purposes of this Petition, CareFusion agrees that this element refers to an LCD
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`screen.
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`E.
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`“Means for Entering Values”
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`Claims 3, 4, 11, 19, 31, and 32 each recite the element of “means for
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`entering values related to a beneficial agent to be infused into a patient.” Baxter’s
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`infringement contentions state that the corresponding structure is a “numeric key
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`pad.” (See id. at APP0650-51 (citing specification lines 3:64-4:5).) Solely for the
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`Petition for Inter Partes Review of U.S. Patent No. 5,782,805
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`purposes of this Petition, CareFusion agrees that this element refers to a numeric
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`key pad.
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`F.
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`“Means Responsive to the Entered Values for Calculating [a
`Dose / an Infusion Profile]”
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`Claims 3, 19, and 31 recite the element of “means responsive to the entered
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`values for calculating a dose of the beneficial agent to be infused into the patient.”
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`Claims 4 and 32 recite the element of “means responsive to the entered values for
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`calculating an infusion profile of the beneficial agent.” These elements are means-
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`plus-function terms governed by pre-AIA 35 U.S.C. § 112 ¶ 6. Baxter’s
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`infringement contentions argue that structure corresponding to these limitations is
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`disclosed by the following passage in the specification:
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`In the optional dose programming subroutines, when two of three
`parameters have been entered, the master microprocessor will
`calculate the final parameter. For example,… if the rate has been
`entered and the concentration of the drug has been entered or
`calculated, the master microprocessor will calculate and display the
`dose.
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`(See Ex. 1012 at APP0652 (citing lines 12:52-64) (emphasis added).)
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`As discussed in Section IV(A), a computer means-plus-function element is
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`indefinite unless the specification discloses not only a processor, but also an
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`algorithm sufficient to perform the recited function. See, e.g., Function Media,
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`708 F.3d at 1318; Ericsson, IPR2014-01170, Paper No. 9, at 7-8. The passage
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`-13-
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`quoted by Baxter provides no details of how the processor allegedly performs the
`
`recited calculation, nor does any other part of the specification. Accordingly, this
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`claim element is indefinite under 35 U.S.C. § 112, and not amenable to claim
`
`construction.
`
`To the extent that this element is not indefinite, CareFusion agrees with
`
`Baxter that the only possible corresponding structure disclosed in the specification
`
`is a generic microprocessor.
`
`G.
`
`“Means for Sensing Tube Restrictions”
`
`Claims 5, 20, and 24 recite the element of “means for sensing tube
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`restrictions.” This element is a means-plus-function term governed by pre-AIA 35
`
`U.S.C. § 112 ¶ 6. Baxter’s infringement contentions argue that the corresponding
`
`structure is a “pressure sensor,” yet the passages Baxter cites do not mention a
`
`sensor or any other structure that actually performs the restriction-sensing function.
`
` (See Ex. 1012 at APP0656-57 (citing lines 11:6-19, 19:16-30).) Accordingly,
`
`there is no structure disclosed in the specification for performing the recited
`
`function, and this element is indefinite.
`
`To the extent that this element is not indefinite, CareFusion agrees with
`
`Baxter that the only possible corresponding structure would be a generic pressure
`
`sensor.
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`Petition for Inter Partes Review of U.S. Patent No. 5,782,805
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`H.
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`“Means for Storing User Interface Information”
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`Claims 9, 12, and 25 require “means for storing user interface information.”
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`Baxter’s infringement contentions state that the corresponding structure is simply
`
`“computer memory.” (Id. at APP0661.) Solely for the purposes of this Petition,
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`CareFusion agrees that this element refers to generic computer memory.
`
`I.
`
`“Means for Clearing the Stored User Interface Information”
`
`Claims 10, 13, and 26 require “means for clearing the stored user interface
`
`information.” Baxter’s infringement contentions state that the corresponding
`
`structure is a “clear settings” key. (See id. at APP0662, APP0664 (citing lines
`
`13:14-17).) Solely for the purposes of this Petition, CareFusion agrees that this
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`element refers to a “clear” key.
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`V.
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`IDENTIFICATION OF SPECIFIC STATUTORY GROUNDS FOR
`CHALLENGE (37 CFR § 42.104(B)(2))
`
`CareFusion respectfully requests the cancellation of claims 1-5, 8-20, 23-26,
`
`28-32, and 35 of the ʼ805 patent. The statutory grounds for the challenge are set
`
`forth below (all citations are to pre-AIA statues):
`
`Ground 35 USC § Claims
`1
`102(e)
`1-4, 8-19, 23
`2
`103(a)
`1-4, 8-19, 23
`3
`103(a)
`5, 20, 24-26,
`28-32, 35
`
`
`
`References
`Eggers (Ex. 1004)
`Eggers (Ex. 1004)
`Eggers (Ex. 1004) in view of Voss (Ex.
`1005)
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`VI. DETAILED EXPLANATION AND EVIDENCE SUPPORTING
`GROUNDS FOR CHALLENGE (37 CFR §§ 42.104(B)(4)-(5))
`
`A. Ground 1: Anticipation of Claims 1-4, 8-19, and 23 Based on
`Eggers
`
`Claims 1-4, 8-19, and 23 are anticipated under 35 U.S.C. § 102(e) by Eggers
`
`as set forth below.
`
`i. Disclosure of Eggers
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`The Eggers patent (U.S. Patent No. 5,713,856, attached as Ex. 1004) is
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`directed to the user interface of the prototype for CareFusion’s modular Alaris
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`infusion pump system – the same products and functionality that Baxter accuses of
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`infringement in the district court lawsuit. (See Ex. 1003 at ¶¶ 4, 6-9,11; Ex. 1012
`
`at APP0618.) The Eggers patent issued from U.S. Patent Application No.
`
`08/403,503, which was filed on March 13, 1995. (Ex. 1004 at APP0292.) As
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`discussed in Section III(A), above, Baxter has not produced any evidence
`
`supporting conception or efforts to reduce the claimed invention to practice prior to
`
`Eggers’ filing date. Accordingly, Eggers is prior art under at least pre-AIA 35
`
`U.S.C. § 102(e).
`
`Eggers teaches “a modular patient care system… comprised of an interface
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`unit and a plurality of patient functional units.” (Ex. 1004 at APP0292.) Eggers
`
`teaches that the interface unit “provides an interface between the system and
`
`external devices, and, except for certain specific information, it provides a majority
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`of the user interface of the system.” (Id. at 3:13-16.) The modular functional units
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`can be a wide variety of devices, including “a standard infusion pumping unit,
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`patient controlled analgesia (PCA) pump, syringe pump, pulse oximeter, [or]
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`invasive or non-invasive blood pressure monitor[.]” (Id. at 4:59-62.)
`
`ii. Comparison of Claims 1-4, 8-19, and 23 to Eggers
`
`The claim chart below specifies where each element of claims 1-4, 8-19, and
`
`23 is found in Eggers.
`
`ʼ805 Claim
`Language
`1[a]. An infusion
`pump comprising:
`
`Citations to Eggers
`
`Eggers teaches an interface unit 100 attached to an infusion
`pump unit 150A. (See, e.g., Ex. 1004 at 2:11-23, 4:27-33,
`4:59-60, 5:23-35, Figs. 1a, 2.)
`
`[1b.] a main body
`portion;
`
`
`Eggers teaches an interface unit 100 attached to an infusion
`pump unit 150A. (See, e.g., Ex. 1004 at 2:11-23, 4:27-33,
`4:59-60, 5:23-35, Figs. 1a, 2.)
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`[1c.] a display
`contained on the
`main body portion
`for displaying user
`interface
`information;
`
`[1d.] at least one
`pump module
`removably secured to
`the main body
`portion and adapted
`to receive a tube, the
`
`For example, Eggers states:
`[I]nterface unit 100 contains an information display
`102, which may be any type of display such as a
`liquid crystal display. Display 102 may be used
`during setup and operating procedures to facilitate
`data entry and editing. Display 102 may also be used
`to display various operating parameters such as
`volume to be infused (VTBI) for individual
`functional units 150 which are pumps and current
`time of day, as well as other prompts, advisories, and
`alarm conditions.
`(Ex. 1004 at 3:16-24.) Eggers further states that “display
`102 of the interface unit is configured so as to act as the
`user interface for the selected functional unit.” (Id. at 5:42-
`47.)
`Eggers states that its “system [is] comprised of an interface
`unit removeably [sic] attached to a plurality of patient
`functional units.” (Ex. 1004 at 2:11-14.) For example,
`Figure 2 illustrates the “interface unit removeably [sic]
`connected to four functional units.” (Id. at 2:41-42.)
`Eggers notes that “any number of functional units 150 may
`be connected using the described connectors in any order to
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`pump module having
`means for applying
`pumping action to
`the tube;
`
`either side of the interface unit 100.” (Id. at 4:50-52.)
`Eggers also explains that the removably attachable
`functional units include infusion pump unit 150A. (See,
`e.g., id. at 4:59-60, 5:23-25, 5:48-53.) Infusion pump unit
`150A includes “typical components of commercially
`available pumps, such as motor controller 364 for
`controlling pump motor 366…. Motor controller 364 and
`pump motor 366 may be comprised of any suitable
`peristaltic pump motor/motor controller combination. Pump
`motor 366 acts to force fluid from a fluid reservoir through
`an infusion set to a vascular access device by peristaltic
`motion[.]” (Id. at 9:23-33.)
`Eggers teaches that the removably attached functional units
`contain auxiliary displays. For example, Eggers states:
`Infusion pump unit 150A contains two displays.
`Rate display 154 may be used to display the actual
`infusion rate at which the pump is operating.
`Channel message display 152 may be used to display
`informational, advisory, alarm, or malfunction
`messages.
`(Ex. 1004 at 5:53-57.)
`As discussed in Section IV(A), to the extent that this
`element is not indefinite, it merely recites a generic
`processor. Eggers teaches that the displays are controlled
`by one or more processors, as illustrated in, e.g., Figures 3
`and 6:
`
`[1e.] an auxiliary
`display contained on
`the pump module for
`displaying
`supplemental user
`interface
`information;
`
`[1f.] microprocessor
`means contained in