Filed on behalf of Patent Owner, Baxter International, Inc.
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________
`
`CAREFUSION CORPORATION,
`Petitioner,
`
`v.
`
`BAXTER INTERNATIONAL INC.,
`Patent Owner.
`__________
`
`Case IPR2016-01456
`Patent 5,782,805
`__________
`
`PRELIMINARY PATENT OWNER RESPONSE
`
`

`
`TABLE OF CONTENTS
`
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`THE ‟805 PATENT ......................................................................................... 3
`
`III. PETITIONER‟S PROPOSED CONSTRUCTIONS ARE INCORRECT AND
`FAIL TO MEET THE REQUIREMENTS OF 37 C.F.R. § 42.104(B)(3). .... 4
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`H.
`
`The Term “Microprocessor Means . . . For Generating User
`Interface Information” Is Not Indefinite. .............................................. 6
`
`The Terms “Means Responsive To The Entered Values For
`Calculating A Dose Of The Beneficial Agent To Be Infused Into
`The Patient” And “Means Responsive To The Entered Values
`For Calculating An Infusion Profile Of The Beneficial Agent”
`Are Not Indefinite. ..............................................................................14
`
`The Term “Means For Sensing Tube Restrictions” Is Not
`Indefinite. ............................................................................................16
`
`Petitioner‟s Proposed Construction For “Removably Secured”
`Reads In Limitations From The Specification And Is
`Unnecessarily Narrow. ........................................................................18
`
`Petitioner‟s Proposed Construction For “Means For Clearing The
`Stored User Interface Information” Ignores The Specification
`And Is Wrong. .....................................................................................20
`
`Petitioner‟s Proposed Construction For “Means For Generating
`A Plurality Of Pictoral Graphic Representations” Is Conclusory
`And Fails To Account For The Claimed Functionality. .....................21
`
`Petitioner Does Not Construe The Term “Configuration
`Parameters,” An Important Element That Petitioner‟s Invalidity
`Theories Fail To Properly Account For. .............................................24
`
`Petitioner Fails To Provide What It Believes Are Proper
`Constructions For The Terms “Means For Applying Pumping
`Action,” “Means For Entering Values,” And “Means For Storing
`User Interface Information.” ...............................................................29
`
`IV. EGGERS DOES NOT ANTICIPATE CLAIMS 1-4, 8-19, AND 23. ..........30
`
`A.
`
`Petitioner Failed To Show That Eggers Discloses A
`“Microprocessor Means Contained In The Main Body Portion
`
`i
`
`

`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`For Generating User Interface Information On The Display
`Areas.” .................................................................................................31
`
`Petitioner Failed To Show That Eggers Discloses A “Means For
`Generating A Plurality Of Pictoral Graphic Representations.” ..........33
`
`Petitioner Failed To Show that Eggers Discloses “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.” ..........................................................34
`
`Petitioner Failed To Show That Eggers Discloses “Wherein A
`Pictoral Graphic Representation Of The Calculated Infusion
`Profile Is Included As User Interface Information, The Pictoral
`Graphic Representation Including The Infusion Remaining.” ...........39
`
`Petitioner Failed To Show That Eggers Discloses “Means For
`Clearing The Stored User Interface Information For A Specific
`Patient.” ...............................................................................................41
`
`Petitioner Failed To Show That Eggers Discloses A “Means For
`Storing User Interface Information Related To A Specific
`Patient.” ...............................................................................................43
`
`Petitioner Failed To Show That Eggers Discloses “Wherein The
`Pictoral Graphic Representation Includes A Ramp Up
`Representation And A Ramp Down Representation.” ........................44
`
`V.
`
`THE PETITION SHOULD BE DENIED BECAUSE PETITIONER HAS
`FAILED TO ESTABLISH A PRIMA FACIE CASE OF OBVIOUSNESS. 46
`
`A.
`
`B.
`
`C.
`
`Petitioner Fails To Acknowledge And Identify The Differences
`Between The Claimed Invention And The Prior Art. .........................47
`
`Petitioner‟s Superficial And Conclusory Analysis Fails To
`Establish That Claims 1-4, 8-19 and 23 Are Obvious Over
`Eggers. .................................................................................................49
`
`Petitioner Fails To Establish That Claims 5, 20, 24-26, 28-32,
`And 35 Are Obvious Over Eggers In View Of Voss. .........................51
`
`1.
`
`2.
`
`Petitioner Has Failed To Show That The Combination Of
`Eggers And Voss Discloses Each And Every Limitation
`Of Claims 5, 20, 24-26, 28-32, And 35. ...................................51
`
`Petitioner Has Failed To Provide A Plausible Rationale
`For Combining Eggers and Voss. .............................................53
`
`ii
`
`

`
`D.
`
`Petitioner‟s Obviousness Theories Cannot Be Sustained By The
`Conclusory Theories Offered By Its Expert........................................62
`
`
`
`
`
`
`iii
`
`

`
`TABLE OF AUTHORITIES
`
`CASES
`
`ActiveVideo Networks, Inc. v. Verizon Comm., Inc.,
`694 F.3d 1312 (Fed. Cir. 2012) ....................................................................... 63, 64
`
`Agilent Techs., Inc. v. Affymetrix, Inc.,
`567 F.3d 1366 (Fed. Cir. 2009) ............................................................................. 45
`
`Apple Inc. v. ContentGuard Holdings, Inc.,
`IPR2015-00444, Paper 9 (P.T.A.B. July 9, 2015) ................................................. 48
`
`Apple Inc. v. Parthenon Unified Memory Architecture LLC,
`IPR2016-00924, Paper 10 (P.T.A.B. Aug. 23, 2016) ............................................ 49
`
`Apple, Inc. v. ContentGuard Holding, Inc.,
`IPR2015-00455, Paper 9 (P.T.A.B. July 6, 2015) ................................................. 30
`
`Arista Networks, Inc. v. Cisco Sys., Inc.,
`IPR2016-00309, Paper 8 (P.T.A.B. June 11, 2016) .............................................. 49
`
`Askeladden LLC v. iSourceLoans LLC,
`IPR2015-00134, Paper 9 (P.T.A.B. April 15, 2015) ............................................. 30
`
`ATD Corp. v. Lydall, Inc.,
`159 F.3d 534 (Fed. Cir. 1998) ............................................................................... 47
`
`Belden Inc. v. Berk-Tek LLC,
`805 F.3d 1064 (Fed. Cir. 2015) ............................................................................. 54
`
`Cadence Pharms., Inc. v. Exela PharmSci Inc.,
`780 F.3d 1364 (Fed. Cir. 2015) ............................................................................. 19
`
`Clickbooth.com LLC v. Essociate, Inc.,
`IPR2015-00464, Paper 9 (P.T.A.B. July 9, 2015) ................................................. 30
`
`Ex parte Gerlach,
`212 U.S.P.Q. 471 (P.T.A.B. 1980) ........................................................................ 54
`
`Front Row Techs. v. MLB Advanced Media, L.P.,
`IPR2015-01932, Paper 7 (P.T.A.B. Mar. 25, 2016) ........................................ 48, 59
`
`iv
`
`

`
`Genband US LLC v. Metaswitch Networks Ltd.,
`IPR2015-01522, Paper 7 (P.T.A.B. January 6, 2016) ........................................... 30
`
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) ............................................................................................. 47, 49
`
`Harris Corp. v. Ericsson Inc.,
`417 F.3d 1241 (Fed. Cir. 2005) ............................................................................... 7
`
`Hughes Network Sys., LLC v. California Inst. of Tech.,
`IPR2015-00061, Paper 18 (P.T.A.B. Apr. 27, 2015) ............................................ 46
`
`I-Blason LLC v. Aevoe Corp.,
`IPR2016-00231, Paper 6 (P.T.A.B. May 18, 2016) .............................................. 46
`
`In re CSB-System Int’l, Inc.,
`832 F.3d 1335, 2016 U.S. App. LEXIS 14561 (Fed. Cir. 2016) ......................... 4, 5
`
`In re Robertson,
`169 F.3d 743 (Fed. Cir. 1999) ............................................................................... 45
`
`K/S HIMPP v. Hear-Wear Techs., LLC,
`751 F.3d 1362 (Fed. Cir. 2014) ............................................................................. 64
`
`Kara Tech. Inc. v. Stamps.com Inc.,
`582 F.3d 1341 (Fed. Cir. 2009) ............................................................................. 19
`
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1343 (Fed. Cir. 2012) ............................................................................. 59
`
`Koito Mfg. Co., LTD v. Turn-Key-Tech, LLC,
`381 F.3d 1142 (Fed. Cir. 2004) ............................................................................. 45
`
`Nautilus, Inc. v. Biosig Instruments, Inc.,
`134 S. Ct. 2120 (2014) ............................................................................................. 8
`
`NJOY, Inc. v. Fontem Holdings 1 B.V.,
`IPR2015-01301, Paper 16 (P.T.A.B. Dec, 8, 2015) .............................................. 62
`
`Norman Int’l, Inc. v. Hunter Douglas Inc.,
`IPR2014-00276, Paper 11 (P.T.A.B. June 20, 2014) ............................................ 59
`
`Old Republic Gen. Ins. Group, Inc. v. Intellectual Ventures I LLC,
`IPR2015-01957, Paper 18 (P.T.A.B. Apr. 18, 2016) ............................................ 49
`
`v
`
`

`
`Outside the Box Innovations, LLC v. Travel Caddy, Inc.,
`695 F.3d 1285 (Fed. Cir. 2012) ............................................................................. 48
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ............................................................... 4
`
`RCA Corp. v. Applied Digital Data Sys., Inc.,
`730 F.2d 1440 (Fed. Cir. 1984) ............................................................................. 50
`
`Rohm and Haas Co. v. Brotech Corp.,
`127 F.3d 1089 (Fed. Cir. 1997) ............................................................................. 64
`
`Runway Safe LLC v. Engineered Arresting Sys.,
`IPR2015-01921, Paper 9 (P.T.A.B. Feb. 29, 2016) ............................................... 59
`
`Samsung Display Co., Ltd. v. Gold Charm Ltd.,
`IPR2015-01499, Paper 12 (P.T.A.B. Dec. 29, 2015) ............................................ 59
`
`SAP America Inc. v. Clouding IP, LLC,
`IPR2014-00299, Paper 8 (P.T.A.B. July 9, 2014) ................................................. 48
`
`Scentair Techs., Inc. v. Prolitec, Inc.,
`IPR2013-00179, Paper 18 at 3 (P.T.A.B. Aug. 23, 2013) ..................................... 49
`
`Shopkick, Inc. v. Novitaz, Inc.,
`IPR2015-00277, Paper 7 (P.T.A.B. May 29, 2015) .............................................. 48
`
`Typhoon Touch Tech., Inc. v. Dell, Inc.,
`659 F.3d 1376 (Fed. Cir. 2011) ............................................................................... 8
`
`Unigene Labs., Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) ............................................................................. 54
`
`Velander v. Garner,
`348 F.3d 1359 (Fed. Cir. 2003) ............................................................................. 64
`
`Verdegaal Bros. v. Union Oil Co. of California,
`814 F.2d 628 (Fed. Cir. 1987) ............................................................................... 30
`
`Vivid Techs., Inc. v. American Science & Eng’g, Inc.,
`200 F.3d 795 (Fed. Cir. 1999) ............................................................................... 14
`
`Wireless Seismic, Inc. v. Fairfield Indus., Inc.,
`IPR2014-1205, Paper 8 (P.T.A.B. Jan. 24, 2015) ................................................. 47
`
`vi
`
`

`
`WMS Gaming Inc. v. Int’l Game Tech.,
`184 F.3d 1339 (Fed. Cir. 1999) ............................................................................. 31
`
`STATUTES
`
`35 U.S.C. § 103 .......................................................................................................... 49
`
`35 U.S.C. § 112 ¶ 6 ................................................................................. 13, 14, 16, 18
`
`35 U.S.C. § 312(a)(3) ................................................................................................... 1
`
`35 U.S.C. § 316(e) ..................................................................................................... 46
`
`OTHER AUTHORITIES
`
`M.P.E.P. § 2141(III)................................................................................................... 62
`
`M.P.E.P. § 2142 ......................................................................................................... 55
`
`RULES
`
`37 C.F.R. § 42.1(d) .................................................................................................... 46
`
`37 C.F.R. § 42.104(b)(3) .................................................................................... passim
`
`37 C.F.R. § 42.104(b)(4) ........................................................................................ 1, 61
`
`37 C.F.R. § 42.65(a) ............................................................................................. 62, 64
`
`
`
`vii
`
`

`
`I.
`
`INTRODUCTION
`
`Patent Owner, Baxter International, Inc. (“Baxter”), respectfully submits this
`
`Preliminary Patent Owner Response to the Petition for Inter Partes Review (“IPR”)
`
`of claims 1-5, 8-20, 23-26, 28-32, and 35 of U.S. Patent No. 5,782,805 (the “‟805
`
`Patent”) filed by Petitioner, CareFusion Corporation (“CareFusion”). Petitioner
`
`alleges that claims 1-4, 8-19, and 23 are anticipated by U.S. Patent No. 5,713,856
`
`(“Eggers”) (Ex. 1004). In the alternative, Petitioner alleges that claims 1-4, 8-19,
`
`and 23 are rendered obvious by Eggers. Petitioner also alleges that claims 5, 20, 24-
`
`26, 28-32, and 35 are rendered obvious by Eggers in view of U.S. Patent No.
`
`5,609,576 (“Voss”).
`
`Under 35 U.S.C. § 312(a)(3), a petition for Inter Partes Review “. . . may
`
`only be considered if . . . the petition identifies, in writing and with particularity,
`
`each claim challenged, the grounds on which the challenge to each claim is based,
`
`and the evidence that supports the grounds for the challenge to each claim . . . .”
`
`Accordingly, a petition must “[p]rovide a statement of the precise relief requested
`
`for each claim challenged,” including “[h]ow the construed claim is unpatentable,”
`
`and it “must specify where each element of the claim is found in the prior art
`
`patents or printed publications relied upon.” 37 C.F.R. § 42.104(b)(4) (emphasis
`
`added.)
`
`1
`
`

`
`Here, Petitioner has utterly failed to meet its burden in a number of ways that
`
`are fatal to its Petition, and the Petition should be denied. As an initial matter,
`
`Petitioner‟s proposed claim constructions are conclusory and incorrect.
`
`Furthermore, Petitioner‟s proposed constructions fail to provide what Petitioner
`
`believes the proper constructions are, and instead rely on unfounded interpretations
`
`of statements made by Patent Owner in related litigation. In fact, Patent Owner has
`
`not proposed claim constructions either in the instant IPR or in any related litigation.
`
`Moreover, the Petition fails to show that each and every element of the
`
`challenged claims is present in the asserted prior art, either expressly or otherwise.
`
`This alone is fatal to Petitioner‟s invalidity arguments. Additionally, Petitioner‟s
`
`obviousness analysis is superficial and conclusory, failing in a number of ways to
`
`follow the required and well-established Graham analysis. For instance, nowhere
`
`does Petitioner identify the differences between the prior art and the claimed
`
`invention, offering only what Petitioner believes each reference discloses in relation
`
`to the challenged claims. This defect is likewise fatal to Petitioner‟s analysis.
`
`Petitioner also fails to provide a motivation for one of ordinary skill in the art to
`
`make the alleged combinations. Rather than provide articulated reasoning with
`
`some rational underpinning to support its obviousness allegations, Petitioner instead
`
`offers only conclusory assertions of what one of ordinary skill in the art could have
`
`done to combine references, based on its hindsight, litigation-induced reasoning.
`
`2
`
`

`
`Petitioner has thus failed to establish a prima facie case of obviousness on any of the
`
`challenged claims.
`
`For at least these reasons, Petitioner has failed to meet its burden of showing
`
`with reasonable likelihood that any of the challenged claims of the ‟805 Patent are
`
`unpatentable, and the Board should deny the Petition.
`
`II. THE ’805 PATENT
`
`The ‟805 Patent (Ex. 1001) is generally directed to a medical infusion pump,
`
`and, in particular, user interfaces for medical infusion pumps. (Ex. 1001 at 1:3-5.)
`
`Medical infusion pumps provide an electro-mechanical way of administering
`
`medical infusion fluids to a patient‟s venous system using a variety of pumping
`
`methods. (Ex. 1001 at 1:8-37.) Prior to the invention of the ‟805 Patent, infusion
`
`pumps were typically designed for a particular clinical application, such as pediatric
`
`use, critical care use, or home care use. (Ex. 1001 at 1:38-43.) Additionally, a
`
`single patient would often require infusion of more than one medical fluid. (Ex.
`
`1001 at 1:48-49.) This required care facilities to buy and maintain a large inventory
`
`of specialized pumps to meet the various needs of its patients. (Ex. 1001 at 1:44-
`
`47.) Needing multiple pumps adds to the expense of care and crowds the limited
`
`space surrounding a patient. (Ex. 1001 at 1:48-52.)
`
`The ‟805 Patent solved this problem by, in one embodiment, providing a
`
`medical infusion pump which was readily adaptable for application in a variety of
`
`3
`
`

`
`use scenarios. (Ex. 1001 at 1:65-2:5.) The ‟805 Patent allowed a user to configure
`
`the pump with a variety of flow channels, and to setup the pump for operation for
`
`different uses without burdening the user and requiring the entry of numerous
`
`programming parameters. (Id.)
`
`Given the circuitry, software, and electro-mechanical components that were
`
`fundamental to infusion pumps at the time of filing of the ‟805 Patent, a person of
`
`ordinary skill in the art of the ‟805 Patent would be an individual having at least a
`
`bachelor‟s degree in engineering who is familiar with mechanical, electronic, and
`
`software engineering as it was practiced for medical devices before or during 1996,
`
`and who had been actively involved in the engineering and design of medical
`
`devices for at least six years using electronics and electro-mechanical components,
`
`including infusion pumps. (Ex. 2001 ¶44.)
`
`III. PETITIONER’S PROPOSED CONSTRUCTIONS ARE
`INCORRECT AND FAIL TO MEET THE REQUIREMENTS OF
`37 C.F.R. § 42.104(B)(3).
`
`Because the claims of an expired patent are not subject to amendment, the
`
`Board‟s review of such claims applies the principles set forth in Phillips v. AWH
`
`Corp., 415 F.3d 1303, 1312-15 (Fed. Cir. 2005) (en banc). In re CSB-System Int’l,
`
`Inc., 832 F.3d 1335, 2016 U.S. App. LEXIS 14561, at *11 (Fed. Cir. 2016).
`
`Therefore, the words of a claim are generally given their ordinary and customary
`
`4
`
`

`
`meaning as understood by a person of ordinary skill in the art at the time of
`
`invention in light of the intrinsic record. Id. at *6-8.
`
`Here, Petitioner allegedly construes nine terms in a mere five and a half
`
`pages. Petitioner‟s half-hearted and conclusory constructions not only fail to
`
`properly apply Phillips, but ignore this Board‟s rules for construing claims under 37
`
`C.F.R. § 42.104(b)(3). For example, under 37 C.F.R. § 42.104(b)(3), the
`
`Petitioner‟s construction for each means-plus-function term “must identify the
`
`specific portions of the specification that describe the structure, material, or acts
`
`corresponding to each claimed function.” But Petitioner admits that it has not
`
`independently construed the claims as it was required to do under 37 C.F.R.
`
`42.104(b)(3), and instead relies on alleged “constructions” by Patent Owner that it
`
`extrapolates from various preliminary infringement contentions that Patent Owner
`
`has offered in a related district court litigation. (Pet. at 9) (“For the purposes of this
`
`Petition, CareFusion relies on the constructions expressly and implicitly
`
`propounded by Baxter in the district court lawsuit. CareFusion does not agree
`
`that those constructions are in fact correct.”) (emphasis added.) Patent Owner
`
`denies that it has offered any such constructions or taken any particular position
`
`with regard to construing any of the claims in that litigation. (Ex. 1015 at 2)
`
`(“These contentions do not indicate Baxter‟s position with regard to the proper
`
`claim construction of any term of the Patents-in-Suit. . . . Baxter’s Initial
`
`5
`
`

`
`Infringement Contentions are not, and should not be construed as, an
`
`endorsement or acceptance by Baxter of any claim interpretations.”) (emphasis
`
`added).)
`
`Nonetheless, Petitioner vaguely and reservedly adopts variations of these
`
`purported constructions by Patent Owner. This includes the means-plus-function
`
`terms Petitioner allegedly construes, the constructions for which are all conclusory
`
`and lacking in any substantive analysis. In other instances, Petitioner dismissively
`
`asserts that some terms are indefinite without conducting an independent analysis of
`
`what is actually disclosed in the specification. Petitioner‟s failure to properly
`
`construe the claims ignores its burden under 37 C.F.R. § 42.104(b)(3), and the
`
`improper constructions it proposes are fatal to the invalidity contentions presented in
`
`the Petition.
`
`A. The Term “Microprocessor Means . . . For Generating User
`Interface Information” Is Not Indefinite.
`
`Petitioner argues that this limitation in independent claims 1, 11 and 24
`
`should be construed as a means-plus-function term. 1 (Pet. at 10-11.) Petitioner also
`
`
`1 Patent Owner does not concede that this or any other term in the ‟805 Patent is
`
`subject to pre-AIA 35 U.S.C. § 112 ¶ 6. In its preliminary infringement contentions
`
`in the related district court litigation (Baxter Int’l, Inc. v. CareFusion Corp., Case
`
`No. 1:15-cv-09986 (N.D. Ill.)) (the “District Court Litigation”), and in anticipation
`
`6
`
`

`
`alleges that the term is indefinite because although the specification discloses a
`
`microprocessor as the structure for accomplishing this function, it fails to disclose
`
`the corresponding algorithm. (Pet. at 10-11.) Petitioner is wrong.
`
`In conducting its analysis of this term, Petitioner relies exclusively on an
`
`alleged “construction” by Patent Owner that it extrapolates from preliminary
`
`infringement contentions Patent Owner has offered in the related District Court
`
`Litigation. To the contrary, and as stated previously, nowhere has Patent Owner yet
`
`construed this or any other term of the ‟805 Patent. And, regardless, it is
`
`Petitioner‟s burden to construe the term, which it has failed to do.
`
`To the extent the Board agrees that this is a means-plus-function term, the
`
`‟805 Patent is very clear about the corresponding structure for accomplishing this
`
`functionality. The corresponding structure for a § 112 ¶ 6 claim for a computer-
`
`implemented function is the algorithm disclosed in the specification.” Harris Corp.
`
`v. Ericsson Inc., 417 F.3d 1241, 1249 (Fed. Cir. 2005). “Precedent and practice
`
`permit a patentee to express that procedural algorithm in any understandable terms
`
`including as a mathematical formula, in prose, or as a flow chart, or in any other
`
`
`of the possibility that the district court might construe this limitation as a means-
`
`plus-function term, Patent Owner cited to a litany of disclosures in the specification
`
`of the ‟805 Patent sufficient to disclose the required corresponding structure and
`
`related algorithms to one of ordinary skill in the art.
`
`7
`
`

`
`manner that provides sufficient structure.” Typhoon Touch Tech., Inc. v. Dell,
`
`Inc., 659 F.3d 1376, 1385 (Fed. Cir. 2011)(emphasis added). Furthermore, a claim
`
`can only be found indefinite “if its claims, read in light of the specification
`
`delineating the patent, and the prosecution history, fail to inform, with reasonable
`
`certainty, those skilled in the art about the scope of the invention.” Nautilus, Inc. v.
`
`Biosig Instruments, Inc., 134 S. Ct. 2120, 2124 (2014).
`
`The specification of the ‟805 Patent includes multiple disclosures of the
`
`required structure for this element. For instance, the specification describes an
`
`architecture having two microprocessors programmed to provide a menu-based user
`
`interface with pop-up windows:
`
`The main body portion 14 includes a slave microprocessor
`
`which is a slave to a master microprocessor. The slave
`
`microprocessor further includes an analog-to-digital converter
`
`(A/D converter). In a preferred embodiment, the master
`
`microprocessor is a 80C186 EB available from Intel
`
`Corporation, Santa Clara, Calif., and the slave microprocessor
`
`is a 80C552 available from Phillips Semiconductors,
`
`Sunnyvale, Calif. All microprocessors include software in read-
`
`only memory (ROM) which drives the user interaction and
`
`pump-monitoring functions described below.
`
`8
`
`

`
`(Ex. 1001 at 2:67-3:10; Ex. 2001 at ¶¶45-47.) In addition, the ‟805 Patent discloses
`
`user navigation flow diagrams in Figures 7a and 7b that depict the overall user
`
`interface navigation:
`
`
`
`
`
`9
`
`

`
`(Ex. 1001 at Figures 7a,7b.) Additionally, the specification provides a multitude of
`
`figures depicting in detail each screen that comprises the user interface, and the
`
`information contained in each. (Ex. 1001 at Figures 8a-8d, 10a-30.) For example,
`
`Figures 10a and 13d show two embodiments of the user interface screens described
`
`in the user interface navigation presented in Figures 7a and 7b:
`
`
`
`
`
`(Ex. 1001 at Figures 10a and 13d.) In addition to these detailed user interface
`
`depictions, the specification further describes each of these embodiments and the
`
`subroutines that produce them. For example, the specification discloses:
`
`Referring now to FIG. 7, a user interface navigation flow
`
`diagram is seen. The figure depicts an overview of the user
`
`10
`
`

`
`interface routine discussed in detail below. Upon power-up, the
`
`infusion pump performs diagnostic tests while the self-
`
`diagnostic routine 300 occurs. After completion of the
`
`diagnostic tests, a power-on screen is displayed. From the
`
`power-on routine 302, the user can access the main display
`
`routine 304 or a select set of configuration parameters routine
`
`306. If the select set of configuration parameters routine 306 is
`
`selected, the user can access a series of view set of
`
`configuration parameters subroutines 308. From the select set
`
`of configuration parameters routine 306 or the view set of
`
`configuration parameters subroutines 308, the main display
`
`routine 304 can be accessed. From the main display routine
`
`304, the user can access a plurality of routines. An options
`
`menu routine 311 provides access to the view set of
`
`configuration parameters series of subroutines 308, a change
`
`occlusion settings routine 313, a battery display routine 315 and
`
`a configuration/service routine 317. From the options menu
`
`routine 311, the series of view set of configuration parameters
`
`subroutines 308, the change occlusion settings routine 313 and
`
`the battery display routine 315, the main display routine 304
`
`and a configuration/service routine 317 can be accessed.
`
`(Ex. 1001 at 6:17-40; see also 6:41-7:11 (providing further details about the user
`
`interface and the component subroutines).) In fact, the majority of the specification
`
`goes on to describe in detail the operation and features of the user interface of the
`
`infusion pump, and in particular the accompanying user interface screens, features,
`
`11
`
`

`
`information, and the subroutines that control their operation. (Ex. 2001 ¶¶48-49.)
`
`Yet, Petitioner ignores these teachings entirely. The ‟805 Patent provides this
`
`information in sufficient detail such that one of ordinary skill in the art at the time
`
`would understand each of the programming routines that comprise the user
`
`interface. (see Ex. 1001 at 7:10-20:3; Ex. 2001 at ¶50.) For example, in one
`
`embodiment, the specification discloses:
`
`When infusing, the display area will show a droplet icon 128 to
`
`indicate that the pump 10 is operational. The programmed rate
`
`of delivery, the volume of fluid remaining to be delivered,
`
`and/or the time remaining to deliver the remaining volume will
`
`be displayed. To stop an infusion before it is completed, the
`
`stop key is pressed. The droplet icon 128 will be replaced with
`
`the stop icon 126 on the main display, and the pump LED will
`
`no longer be illuminated.
`
`(Ex. 1001 at 9:11-19.) In another example, in one embodiment, the specification
`
`discloses:
`
`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 dose has
`
`been entered and the concentration of the drug has been entered
`
`or calculated, as described below, the master microprocessor
`
`will calculate and display the rate. Similarly, if the rate has been
`
`entered and the concentration of the drug has been entered or
`
`calculated, the master microprocessor will calculate and display
`
`12
`
`

`
`the dose. After the necessary parameters have been entered and
`
`the dose or rate calculated, if the dose or rate values are
`
`changed, the master microprocessor will automatically
`
`recalculate and display the new values.
`
`(Ex. 1001 at 12:52-64.) The same is true for all of the user interface screens
`
`depicted in Figures 8 to 30.
`
`Accordingly, should this term be construed as a means-plus-function element,
`
`the specification contains sufficient descriptive text in such understandable terms
`
`that a person of ordinary skill in the art at the time of invention would have known
`
`and understood the procedural algorithm corresponding to the structure. (Ex. 2001
`
`at ¶51-52.) In particular, the specification teaches the algorithm for each subroutine
`
`that the microprocessor could use to generate user interface information. (Ex. 2001
`
`at ¶51-52.) Therefore, in the event this term in claims 1, 11, and 24 is determined to
`
`be a means-plus-function element, it complies with pre-AIA 35 U.S.C. § 112 ¶ 6,
`
`and is not indefinite.2
`
`
`2 Under 37 C.F.R. § 42.104(b)(3), it is Petitioner‟s burden to identify how the
`
`challenged claim is to be construed. Patent Owner has shown why Petitioner‟s
`
`proposed construction, or rather, failure to construe, is clearly erroneous.
`
`Accordingly, while no further construction is necessary to resolve this issue for
`
`purposes of Patent Owner‟s arguments presented herein, Patent Owner reserves the
`
`13
`
`

`
`B.
`
`The Terms “Means Responsive To The Entered Values For
`Calculating A Dose Of The Beneficial Agent To Be Infused
`Into The Patient” And “Means Responsive To The Entered
`Values For Calculating An Infusion Profile Of The Beneficial
`Agent” Are Not Indefinite.
`
`Again, Petitioner does not conduct its own claim construction analysis for
`
`these terms. Rather, Petitioner‟s construction for these terms again relies
`
`exclusively on an alleged “construction” by Baxter that it extrapolates from the
`
`related District Court Litigation. (Pet. at 13-14.) Based on that information alone,
`
`Petitioner summarily concludes with no further analysis that these terms are subject
`
`to pre-AIA 35 U.S.C. § 112 ¶ 6. Petitioner also alleges that the term is indefinite
`
`because although the specification discloses a microprocessor as the structure for
`
`accomplishing this function, it fails to disclose the corresponding algorithm. (Pet. at
`
`13-14.) Here again, Petitioner is wrong.
`
`Presuming for the sake of this argument that a court or this Board were to
`
`construe these terms as means-plus-function, a person of ordinary skill in the art at
`
`the time would recognize and understand the procedural algorithm disclosed in the
`
`specification that corresponds to the structure of