UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`BIO-RAD LABORATORIES, INC.
`Petitioner
`
`v.
`
`GE HEALTHCARE BIO-SCIENCES AB
`Patent Owner
`
`____________
`
`Case: To Be Assigned
`U.S. Patent No. 8,821,718
`____________
`
`PETITION FOR INTER PARTES REVIEW
`PURSUANT TO 37 C.F.R. §42.100 et seq.
`
`
`
`
`
`
`-i-
`
`
`
`
`
`
`
`

`
`
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`MANDATORY NOTICES (37 C.F.R. § 42.8) ............................................... 1
`
`A.
`
`Real Party-in-Interest ............................................................................ 1
`
`B.
`
`C.
`
`Related Matters ...................................................................................... 1
`
`Lead and Back-Up Counsel and Service Information .......................... 1
`
`II.
`
`GROUNDS FOR STANDING 37 C.F.R. § 42.104(A) .................................. 2
`
`III.
`
`IDENTIFICATION OF CHALLENGE (37 C.F.R. § 42.104(B)) .................. 2
`
`A.
`
`Claims for Which Review Is Requested ............................................... 2
`
`B.
`
`C.
`
`Priority Date of the ‘718 Patent............................................................. 2
`
`The Specific Art on Which the Challenge Is Based .............................. 3
`
`D.
`
`The Statutory Grounds on Which the Challenge Is Based.................... 5
`
`E.
`
`Evidence Establishing The Relied Upon References Are Prior
`Art .......................................................................................................... 7
`
`1.
`
`2.
`
`Supporting Facts ......................................................................... 7
`
`Legal Analysis Establishing Printed Publications for the
`Manuals and Brochures Relied On: Exs. 1002, 1003,
`1010, 1011, 1016, and 1017 ...................................................... 13
`
`IV. OVERVIEW OF THE ‘718 PATENT .......................................................... 15
`
`A.
`
`The Specification ................................................................................. 15
`
`B.
`
`The Challenged Claims ....................................................................... 16
`
`V.
`
`LEVEL OF ORDINARY SKILL .................................................................. 19
`
`VI. CLAIM CONSTRUCTION .......................................................................... 19
`
`A.
`
`“Interchangeable Fluid Handling Units” / “Interchangeable
`Modular Components” (All Claims) [A&B] ..................................... 20
`
`
`
`-ii-
`
`

`
`
`
`B.
`
`C.
`
`D.
`
`E.
`
`A Panel Member Separating “the Fluidics Section” from the
`“Non Fluidics Section” (All Claims) [E] ........................................... 21
`
`“Fluidics Sections Are External to the Housing” and “Non
`Fluidic Sections Are Internal to the Housing” (All Claims) [F] ......... 22
`
`“Connected to the Master Control Unit by a System Bus
`Providing Electrical Communication” (Claim 3) ............................... 22
`
`“A Liquid Chromatography System Arranged to Provide
`Controlled Fluid Flow Through a Chromatography Column”
`(Claims 11 and 16-18) ......................................................................... 24
`
`VII. GROUNDS OF UNPATENTABILITY ........................................................ 25
`
`A. Ground 1: ADI 2040 Manual Anticipates Claims 1-3, 5, 11, 14,
`and 16-18 ............................................................................................. 25
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`The ADI 2040 Manual Invalidates Claim 1.............................. 27
`
`Claim 2: The Fluid Handling System of Claim 1,
`Wherein the Interchangeable Modular Components Are
`Sealed Against the Liquid Handling Panel by a Sealing
`Member. .................................................................................... 36
`
`Claim 3: The Fluid Handling System of Claim 1,
`Comprising a Master Control Unit Wherein the
`Interchangeable Modular Components Are Connected to
`the Master Control Unit by a System Bus Providing
`Electrical Communication to Each Interchangeable
`Modular Component. ................................................................ 36
`
`Claim 5: The Fluid Handling System of Claim 1,
`Wherein the Interchangeable Modular Components Are
`of Two or More Sizes. .............................................................. 38
`
`Claim 11: The Fluid Handling System of Claim 1,
`Wherein the System Is a Liquid Chromatography System
`Arranged to Provide a Controlled Fluid Flow Through a
`Chromatography Column. ......................................................... 38
`
`6.
`
`Claim 16 .................................................................................... 41
`
`
`
`-iii-
`
`

`
`
`
`
`
`7.
`
`Claim 17: The Liquid Chromatography System
`According to Claim 16, Wherein the Interchangeable
`Modular Components Include at Least One of: an
`Injection Valve; a Column Valve with Integrated
`Pressure Sensors; a Conductivity Monitor; a UV
`Monitor; a Quaternary Valve; an Inlet Valve with an
`Integrated Air Sensor; a System Pump; a Pump Pressure
`Monitor; an Inlet Valve with Integrated Air Sensor; a
`Rising Valve; a Mixer; a Filter; a Sample Inlet Valve; a
`Flow Restrictor; a pH Valve; an Outlet Valve; and a
`Dummy Component. ................................................................. 41
`
`8.
`
`Claim 18: The Liquid Chromatography System
`According to Claim 17, Wherein Said Modular
`Components Are Interconnected Fluidically on the
`External Side of the Panel. ........................................................ 42
`
`B.
`
`Ground 2: The 2040 Manual Renders Obvious Claims 3, 11, 14,
`and 16-18 ............................................................................................. 43
`
`1.
`
`2.
`
`3.
`
`Claim 3 ...................................................................................... 43
`
`Claim 14 .................................................................................... 43
`
`Claims 11 and 16-18 ................................................................. 44
`
`C.
`
`Ground 3: Combination of the 2040 Manual and the 2040
`Expansion Module and/or 872 Extension Module Renders
`Claim 14 Obvious ................................................................................ 45
`
`D. Ground 4: Combination of the 2040 Manual and ‘164 Patent
`Renders Claims 11 and 16-18 Obvious ............................................... 46
`
`E.
`
`Ground 5: The ‘164 Patent Anticipates Claims 1, 3, 11, 16, and
`17. ........................................................................................................ 46
`
`1.
`
`2.
`
`3.
`
`Claim 1 Preamble ...................................................................... 47
`
`[A] Housing + Two or More Interchangeable Units ................ 47
`
`[B] The Liquid Handling Panel Has More Than Two
`Positions for Receiving Interchangeable Modular Units .......... 49
`
`-iv-
`
`

`
`
`
`
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`[C] Fluidics Section .................................................................. 49
`
`[D] Non Fluidics Section .......................................................... 49
`
`[E] Panel Member for Attaching Module to Liquid
`Handling Panel and Separating Fluidics and Non Fluidics ...... 49
`
`[F] Fluidics Internal and Non Fluidics External ....................... 50
`
`Claim 3 ...................................................................................... 50
`
`Claims 11, 16, and 17: Liquid Chromatography ..................... 51
`
`F.
`
`Grounds 6 and 7: Claims 2, 5, and 18 Are Obvious in Light of
`the ‘164 Patent Alone or in Combination with the 2040 Manual ....... 52
`
`1.
`
`2.
`
`3.
`
`Claim 2 ...................................................................................... 52
`
`Claim 5 ...................................................................................... 52
`
`Claim 18 .................................................................................... 53
`
`G. Ground 8: Claim 14 Expansion Housing is Obvious Over the
`‘164 Patent Alone or in Combination with the 2040 Expansion
`Housing and/or the 872 Extension Module ......................................... 53
`
`H. Ground 9: The Gilson 402 Syringe Pump User’s Guide
`Anticipates Claims 1, 2, and 3............................................................. 54
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`Claim 1 [Pre] Automated Fluid Handling System .................... 54
`
`[A] Housing and Two or More Interchangeable Units ............. 54
`
`[B] Liquid Handling Panel With Two Positions ....................... 55
`
`[C] Fluidics Section .................................................................. 55
`
`[D] Non Fluidics Section .......................................................... 56
`
`[E] Panel Member ..................................................................... 56
`
`[F] Wherein Fluidics Are External and Non Fluidics Are
`Internal ...................................................................................... 56
`
`8.
`
`Claim 2: Sealing Member ........................................................ 57
`
`-v-
`
`

`
`
`
`9.
`
`Claim 3: Modules Connected with System Bus ...................... 57
`
`I.
`
`Ground 10: Obviousness of Claims 11 and 16-18 Based on the
`402 User’s Guide in Light of the Gilson Product Guide ..................... 57
`
`1.
`
`2.
`
`3.
`
`Claims 11 and 16....................................................................... 57
`
`Claim 17 .................................................................................... 58
`
`Claim 18: Modules Fluidically Interconnected ....................... 58
`
`J.
`
`Ground 11: Obviousness of Claims 2 and 5 in Light of the 402
`User’s Guide and 2040 Manual ........................................................... 58
`
`K. Ground 12: Obviousness of Claim 14 Expansion Housing in
`Light of the 402 User’s Guide in Combination with the Gilson
`Product Guide and/or the 2040 Expansion Housing or the 872
`Extension Module................................................................................ 59
`
`VIII. CONCLUSION .............................................................................................. 60
`
`
`
`
`
`
`
`
`
`-vi-
`
`

`
`
`
`
`
`
`EXHIBIT LIST
`
`
`Exhibit No.
`
`Description
`
`Bio-Rad 1001
`
`United States Patent No. 8,821,718, September 2, 2014
`
`Bio-Rad 1002
`
`Bio-Rad 1003
`
`Bio-Rad 1004
`
`“Manual ADI 2040 Process Analyzer” © 1999-2007,
`Applikon Analytical B.V., pages numbered Bio-Rad 00001-
`Bio-Rad 000619 (hereinafter “2040 Manual”); marked as Ex.
`6 Metrohm Deposition of August 10, 2015
`
`“Box Wet Part Module 3X” Applikon Analytical, Drawing
`d50M5-1 dated 11 Feb. 2008 (hereinafter, “2040 Expansion
`Module”); marked as Ex. 8, Metrohm Deposition of August
`10, 2015
`
`Consolidated Sales of Applikon ADI 2040 and 2045 from
`1999-2008, pages numbered Bio-Rad 001323-Bio-Rad
`001326 (hereinafter 2040 Sales Data); marked as Ex. 7,
`Metrohm Deposition of August 10, 2015
`
`Bio-Rad 1005
`
`Deposition Transcript of Metrohm 30(b)(6), Larry Tucker, and
`Thomas Koshy dated August 10, 2015 authenticating the 2040
`Manual, 2040 Expansion Module, and 2040 Sales Data
`
`Bio-Rad 1006
`
`Applikon ADI 2040 Brochure Dated September 2007, pages
`numbered BRGE00001520-BRGE00001527
`
`Bio-Rad 1007
`
`Declaration of Thomas Koshy dated October 30, 2014
`authenticating the “Applikon ADI 2040 Brochure”
`
`Bio-Rad 1008
`
`Metrohm 30(b)(6) Deposition Topics Subpoena; marked as
`Ex. 1, Metrohm Deposition of August 10, 2015
`
`Bio-Rad 1009
`
`United States Patent No. 6,355,164, March 12, 2002, Entitled
`“Collection Apparatus and Method for Multiple Channel High
`Throughput Purification”
`
`Bio-Rad 1010
`
`2007-2008 Gilson Product Guide copyright 2007-2008 and
`archived in the web.archive.org on October 16, 2007
`
`-vii-
`
`

`
`
`
`
`
`
`
`Bio-Rad 1011
`
`Gilson 402 Syringe Pump User’s Guide Dated June 2001 and
`archived in web.archive.org on November 2, 2003
`
`Bio-Rad 1012
`
`Declaration of Christopher Butler dated August 14, 2015
`authenticating the Gilson Product Guide and the Gilson 402
`Syringe Pump User’s Guide
`
`
`
`Bio-Rad 1013
`
`Reply Declaration of Dr. Carl Scandella in support of GE’s
`motion for a preliminary injunction, dated December 19, 2014
`
`Bio-Rad 1014
`
`Hearing Transcript From June 5, 2015 Preliminary Injunction
`Hearing
`
`Bio-Rad 1015
`
`Bio-Rad 1016
`
`Declaration of David Bilsker dated September 2, 2015,
`Authenticating June 5, 2015 Hearing Transcript and Reply
`Declaration of Dr. Carl Scandella dated December 19, 2014
`
`Metrohm 872 Extension Module Manual and Accompanying
`Certified Translation of Selected Portions (hereinafter “872
`Extension Module”); marked as Ex. 3, Metrohm Deposition of
`August 10, 2015
`
`Bio-Rad 1017
`
`Metrohm 850 Professional IC Manual; marked as Ex. 2,
`Metrohm Deposition of August 10, 2015
`
`Bio-Rad 1018
`
`Declaration of Dr. Bruce Gale (hereinafter “Gale Decl.”)
`
`Bio-Rad 1019
`
`CV of Dr. Bruce Gale
`
`Bio-Rad 1020
`
`[Reserved]
`
`Bio-Rad 1021
`
`U.S. Patent No. 5,730,867, March 24, 1998, Entitled “Method
`and Apparatus for Low Pressure Liquid Chromatography”
`
`-viii-
`
`

`
`
`
`Bio-Rad Laboratories, Inc. (“Petitioner” or “Bio-Rad”) petitions the United
`
`States Patent & Trademark Office (“PTO”) to institute an inter partes review of
`
`claims 1-3, 5, 11, 14, and 16-18 (the “challenged claims”) of U.S. Patent No.
`
`8,821,718 to Blomberg et al. (“the ‘718 patent”). According to PTO records, the
`
`‘718 patent is assigned to GE Healthcare Bio-Sciences AB (“GE” or “Patent
`
`Owner”). A copy of the ‘718 patent is provided as Bio-Rad Exhibit 1001.
`
`I. MANDATORY NOTICES (37 C.F.R. § 42.8)
`
`A. Real Party-in-Interest
`
`The real party-in-interest of Petitioner is Bio-Rad Laboratories, Inc.
`
`B. Related Matters
`
`The ‘718 patent is currently involved in the following proceeding: GE
`
`Healthcare Bio-Sciences AB et al v. Bio-Rad Laboratories, Inc., Case No. 1:14-cv-
`
`07080-LTS-SN (S.D.N.Y.).
`
`C. Lead and Back-Up Counsel and Service Information
`
`Lead Counsel
`
`Back-up Counsel
`
`David L. Bilsker,
`Registration No. 39,611
`
`Quinn Emanuel Urquhart & Sullivan
`50 California Street, 22nd Floor
`San Francisco, CA 94111
`Phone: 415.875.6432
`Email:
`davidbilsker@quinnemanuel.com
`copy to:
`BrgeTeam@quinnemanuel.com
`
`Anne Toker,
`Registration No. 53,692
`
`Quinn Emanuel Urquhart & Sullivan
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Phone: 212.849.7440
`Email: annetoker@quinnemanuel.com
`
`
`
`
`-1-
`
`

`
`
`
`
`
`SERVICE INFORMATION: Service information for lead and back-up
`
`counsel is provided in the designation of lead and back-up counsel, above. Petitioner
`
`consents to electronic service by email at the email addresses provided above.
`
`II. GROUNDS FOR STANDING 37 C.F.R. § 42.104(A)
`
`The undersigned and Bio-Rad certify that the ‘718 patent is available for inter
`
`partes review and Petitioner is not barred or estopped from requesting an inter partes
`
`review of the challenged claims of the ‘718 patent. Petitioner has not filed a civil
`
`action challenging the validity of any claim of the ‘718 patent, and no complaint
`
`alleging infringement of the ‘718 patent was served on Petitioner more than a year
`
`before the date of this Petition. The ‘718 patent issued more than nine months prior
`
`to the filing of this Petition.
`
`III.
`
`IDENTIFICATION OF CHALLENGE (37 C.F.R. § 42.104(B))
`
`Petitioner requests an Order canceling the challenged claims of the ‘718 patent
`
`as unpatentable under 35 U.S.C. §§ 102 and/or 103.
`
`A. Claims for Which Review Is Requested
`
`Petitioner requests inter partes review of claims 1-3, 5, 11, 14, and 16-18 of
`
`the ‘718 patent.
`
`B.
`
`Priority Date of the ‘718 Patent
`
`The ‘718 patent issued from U.S. Application No. 13/376,929 filed on
`
`December 8, 2011, an application filed under 35 U.S.C. § 371 and claiming priority
`
`
`
`-2-
`
`

`
`
`
`to international patent application number PCT/SE 2010/050624 filed June 4, 2010,
`
`which claims priority to Swedish Application No. 0950431-7 filed June 9, 2009,
`
`which is the earliest possible effective filing date and earliest possible priority date
`
`for the ‘718 patent. Given that the ‘718 patent appears to have an effective filing
`
`date prior to March 16, 2013, the provisions of pre-AIA 35 U.S.C. §§ 102 & 103
`
`apply.1
`
`C. The Specific Art on Which the Challenge Is Based
`
`Each of the references cited in the Petition is prior art to the ‘718 patent, which
`
`has an effective filing date of June 4, 2010 and an earliest possible priority date of
`
`June 9, 2009. The cited references are as follows:
`
`1.
`
`Ex. 1002, The 2040 Manual, is the manual for the 2040 machine which
`
`is an automated fluid handling machine that uses 20 or more interchangeable
`
`modules. It bears a copyright notice of 1999-2007. Ex. 1002 at 1. The “Hardware
`
`and Installation” chapter of the manual is identified as “Version 1.53” and has a
`
`revision date of “Okt 2007.” Id. at 11. The same is true for the “Basic Maintenance
`
`and Spareparts” chapter. Id. at 571. As detailed in Section E below, the 2040
`
`
`1 This does not constitute an admission by Petitioner with respect to whether the
`
`claims of the ‘718 patent are entitled to the benefit of the earliest possible priority
`
`date.
`
`
`
`-3-
`
`

`
`
`
`Manual was provided to multiple customers of the 2040 in the United States before
`
`the priority date and was also available and provided to those interested in the 2040
`
`machine before the priority date. The 2040 Manual is a printed publication and is
`
`prior art under pre-AIA 35 U.S.C. § 102(a) and (b).
`
`2.
`
`Ex. 1003, The 2040 Expansion Housing This document has a creation
`
`date of February 11, 2008. Ex. 1003. It is a mechanical drawing of an expansion
`
`housing available for use with the 2040 machine. As detailed in Section E below,
`
`this document was available and provided to persons interested in the expansion
`
`housing prior to the priority date. It is prior art under pre-AIA 35 U.S.C. § 102(a)
`
`and (b).
`
`3.
`
`Ex. 1006, The 2040 Brochure. This document has a date of September
`
`2007. As described in Section E below, this document was available on Applikon’s
`
`website before the priority date. It is prior art under pre-AIA 35 U.S.C. § 102(a) and
`
`(b).
`
`4. Ex. 1009, United States Patent No. 6,355,164. This patent issued on
`
`March 12, 2002 and is prior art under pre-AIA 35 U.S.C. § 102(a), (b), and (e). It
`
`covers an automated fluid handling machine.
`
`5.
`
`Ex. 1010, The Gilson Product Guide. As described in Section E
`
`below, this Product Guide was available on the Gilson Website in 2007 more than a
`
`
`
`-4-
`
`

`
`
`
`year before the priority date and is prior art under pre-AIA 35 U.S.C. § 102(a) and
`
`(b).
`
`6.
`
`Ex. 1011, The Gilson 402 Syringe Pump User’s Guide. This
`
`describes an automated pump and valve assembly for use fluid delivery systems such
`
`as HPLC. As described in Section E below, this User’s Guide was available on the
`
`Gilson Website in 2007 more than a year before the priority date and is prior art
`
`under pre-AIA 35 U.S.C. § 102(a) and (b).
`
`7.
`
`Ex. 1016 The 872 Extension Housing. This housing is used to extend
`
`the number of modules in the Metrohm 850 Ion Chromatography Machine. As
`
`described in Section E below, this brochure/manual was on the Metrohm website
`
`more than a year before the priority date and is prior art under pre-AIA 35 U.S.C. §
`
`102(a) and (b).
`
`D. The Statutory Grounds on Which the Challenge Is Based
`
`The Petition identifies twelve grounds of unpatentability:
`
` Ground 1: The ADI 2040 Manual (Ex. 1002) anticipates claims 1-3, 5, 11,
`
`and 16-18 under 35 U.S.C. § 102(b).
`
` Ground 2: The ADI 2040 Manual (Ex. 1002), in light of the knowledge of
`
`one of ordinary skill in the art, renders obvious claims 3, 11, 14, and 16-18
`
`under 35 U.S.C. § 103.
`
`
`
`-5-
`
`

`
`
`
`
`
` Ground 3: The ADI 2040 Manual (Ex. 1002) in view of the 2040 Expansion
`
`Module (Ex. 1003) and/or the 872 Extension Module (Ex. 1016) renders
`
`obvious claim 14 under 35 U.S.C. § 103.
`
` Ground 4: The ADI 2040 Manual (Ex. 1002) in view of the ‘164 Patent (Ex.
`
`1009) renders claims 11 and 16-18 obvious under 35 U.S.C. § 103.
`
` Ground 5: The ‘164 patent (Ex. 1009) anticipates claims 1, 3, 11, 16, and 17
`
`under 35 U.S.C. § 102.
`
` Ground 6: The ‘164 patent (Ex. 1009), in view of the knowledge of one of
`
`ordinary skill in the art, renders obvious claims 2, 5, and 18 under 35 U.S.C.
`
`§ 103.
`
` Ground 7: The ‘164 patent (Ex. 1009), in view of the 2040 Manual (Ex.
`
`1002) renders obvious claims 2, 5, and 18 under 35 U.S.C. § 103.
`
` Ground 8: The ‘164 patent (Ex. 1009) alone or in view of the 872 Extension
`
`Module (Ex. 1016) and/or 2040 Expansion Housing (Ex. 1003) renders
`
`obvious claim 14 under 35 U.S.C. § 103.
`
` Ground 9: The Gilson 402 Syringe Pump User’s Guide (Ex. 1011)
`
`anticipates claims 1, 2 and 3, under 35 U.S.C. § 102.
`
` Ground 10: The Gilson 402 Syringe Pump User’s Guide (Ex. 1011), in view
`
`of the knowledge of one of ordinary skill in the art and/or the Gilson Product
`
`Guide renders obvious claims 11 and 16-18 under 35 U.S.C. § 103.
`
`-6-
`
`

`
`
`
` Ground 11: The Gilson 402 Syringe Pump User’s Guide (Ex. 1011) in view
`
`of the knowledge of one of ordinary skill in the art and/or the 2040 Manual
`
`(Ex. 1002) renders obvious claims 2 and 5 under 35 U.S.C. § 103.
`
` Ground 12: The Gilson 402 Syringe Pump User’s Guide (Ex. 1011) in view
`
`of the knowledge of one of ordinary skill in the art and/or the 2040
`
`Expansion Housing (Ex. 1003) and/or the 872 Extension Module (Ex. 1016)
`
`renders obvious claim 14 under 35 U.S.C. § 103.
`
`E.
`
`Evidence Establishing The Relied Upon References Are Prior Art
`
`1.
`
`Supporting Facts
`
`(a) Ex. 1002: ADI 2040 Manual
`
`Mr. Thomas Koshy received a B.S. in chemistry from Pace University in
`
`1998. Ex. 1005 at 78:7-14.2 He joined Brinkmann Instrument Company in August
`
`2000. Id. at 80:12-18. In 2005 Metrohm purchased Brinkmann and Brinkmann does
`
`business as Metrohm USA. Id. at 9:8-16, 10:12-17. From August 2000-January
`
`2008, Brinkmann sold titration systems manufactured by Metrohm and Mr. Koshy
`
`was responsible for the sales of those systems in the United States. Id. at 80:19-
`
`81:25. Thereafter, for eight months, Mr. Koshy became the product manager of the
`
`ion chromatography line which involved selling Metrohm machines through
`
`
`2 Citations to Ex. 1005 use the court reporter’s pagination and line numbering.
`
`
`
`-7-
`
`

`
`
`
`Brinkmann. Id. at 82:1-83:4. In August 2008 Mr. Koshy left Brinkmann and joined
`
`Applikon Analytical, which was responsible for the Applikon Analyzer product line.
`
`Id. at 83:2-9. He was responsible for sales and marketing of Applikon products such
`
`as the ADI 2040. Id. at 85:21-86:5. He held that position until 2011. Id. at 101:1-
`
`4, 20-22. In 2011 Brinkmann/Metrohm USA purchased Applikon Analytical, Inc.
`
`and Mr. Koshy returned to Brinkmann dba Metrohm USA, where he had worked
`
`from August 2000-August 2008. Id. at 10:12-24. He is currently the Vice President
`
`of Sales for Process Analytical Systems at Brinkmann/Metrohm USA. Ex. 1007
`
`¶ 1. He is responsible for Applikon products, including products such as the ADI
`
`2040 (Ex. 1005 at 13:16-14:23), which was discontinued in 2011 or 2012 (id. at
`
`114:6-8) but is still serviced by Brinkmann/Metrohm USA (id. at 106:1-21).
`
`Mr. Koshy testified regarding the ADI 2040 Manual (Ex. 1002) in both his
`
`personal capacity and as a 30(b)(6) witness for Metrohm USA in response to a
`
`subpoena. Ex. 1008; see Ex. 1005 at 97:5-98:18.
`
`In August 2008 he was given hands on training for the ADI 2040 which
`
`included studying the user manual and product brochures. Id. at 86:6-12. Mr. Koshy
`
`testified that each customer of the 2040 machine received a copy of the user manual
`
`when they purchased a machine. Id. at 99:6-11. The manual was provided in both
`
`print and electronic formats. Id. In the time frame from August 2008 to May 2009,
`
`customers received the manual as a reference for how to operate, service, and
`
`
`
`-8-
`
`

`
`
`
`maintain the machine. Id. at 99:12-19. Further, in that time frame, if a customer lost
`
`their manual, they were provided with one if they asked for a replacement. Id. at
`
`99:20-100:6. Additionally, if a potential customer was thinking about purchasing
`
`an ADI 2040 machine before May 2009 and wanted more information about the
`
`machine and how it operated, they could request a manual from the sales department
`
`at Applikon, and it would be provided to them. Id. at 100:7-17. Mr. Koshy believes
`
`that such inquiries were made before May 2009 and that the policy to provide a 2040
`
`manual to those interested in the machine who asked for it was the same during his
`
`entire time at Applikon from 2008-2011. Id. at 100:18-101:22.
`
`Mr. Koshy testified that the ADI 2040 Manual (Ex. 1002) is Version 1.53 of
`
`the manual that was available in October 2007. Id. 102:16-103:25. He obtained this
`
`document from the server at Metrohm where it was kept in the normal course of
`
`business. Id. at 104:1-14. For the particular manual chapters relied on in this
`
`petition, this is the most recent version of the manual he was aware of. Id. at 104:21-
`
`105:1.3 Mr. Koshy testified that from August 2008 through May 2009, Version 1.53
`
`
`3 Note, Version 1.53 is the most recent version for the two chapters Bio-Rad cites
`
`to in this petition: “The Hardware and Installation Part” beginning at Ex. 1002 p. 11
`
`and “The Basic Maintenance and Spareparts” beginning at Ex. 1002 p. 571. Other
`
`chapters produced by Metrohm USA bear an earlier date.
`
`
`
`-9-
`
`

`
`
`
`(Ex. 1002) is the version that would have been delivered to customers who purchased
`
`a machine or to people interested in the machine if they requested more information
`
`about the machine. Id. Version 1.53 was the only version that he ever used during
`
`his time at Applikon. Id. at 105:2-9. Potential customers would have been aware of
`
`the ADI 2040 machine from seeing, for example, the brochure of the ADI 2040
`
`manual on the internet. Ex. 1006; see Ex. 1007 ¶ 7. Mr. Koshy testified that version
`
`1.0 would have been the first version of the manual and the numbering followed the
`
`software updates. Id. at 105:10-17. Mr. Koshy testified that he was not aware of
`
`any changes made to the hardware of the 2040 from 2002 to 2008. Id. at 105:18-25.
`
`When the machine was first released in 1999, not all the programming for the
`
`analysis packages was complete, so those were pushed at a subsequent time. Id.
`
`154:13-155:2. Mr. Koshy was not aware of any changes to the ADI 2040 manual
`
`over the last five years that it was sold, 2007-2012. Id. at 175:7-14.
`
`Mr. Koshy testified that he had referenced the ADI 2040 manual (Ex. 1002)
`
`at least five to ten times in the last two years. Ex. 1005 at 165:10-21. He also
`
`referenced the document prior to May 2009 for technical specifications when putting
`
`together sales quotations for customers and to provide applications support to the
`
`service team. Id. at 165:22-166:15. Mr. Koshy testified that he was aware of at least
`
`one hundred and sixteen different customers who had purchased or tested an ADI
`
`2040 in the United States between 2002 and 2008. Id. at 107:1-108:20. The
`
`
`
`-10-
`
`

`
`
`
`customers are identified by number in a sales document that Mr. Koshy prepared.
`
`Ex. 1004; see Ex. 1005 at 107:6-10, 108:21-109:3; see also Ex. 1008 at 6 (Deposition
`
`Topic No. 13). Two of the customers identified in the sales document, numbers 32
`
`and 92, were assisted by U.S.-based system integrators to incorporate the ADI 2040
`
`into a larger overall system, and they would have been given access to the ADI 2040
`
`manual (Ex. 1002). Ex. 1005 at 121:11-122:15. All the customers of the ADI 2040
`
`listed in the sales document would have received a copy of the ADI 2040 manual.
`
`Id. at 154:7-12. Mr. Koshy testified that during his entire time working with the
`
`ADI 2040, from August 2008 to the present, he has never seen a machine that did
`
`not function in accordance with what is specified in the ADI 2040 Manual (Ex.
`
`1002). Ex. 1005 at 125:14-17.
`
`(b) Ex. 1003: 2040 Expansion Module
`
`The expansion housing module (Ex. 1003) had the part number ZP 50020010
`
`and was available in February 2008 in the United States as stated by the creation
`
`date on the document. Ex. 1005 at 148:12-149:23, 167:7-168:6. Mr. Koshy testified
`
`that it was an available part when he joined the company in August 2008. Id. at
`
`168:2-6. The drawing depicting the expansion module was available to anyone
`
`interested in expanding the number of modules in the ADI 2040 and it would have
`
`been transmitted to anyone who needed to expand the number of modules. Id. at
`
`245:4-12.
`
`
`
`-11-
`
`

`
`
`
`(c) Ex. 1006: 2040 Brochure
`
`Mr. Koshy’s declaration authenticates that the brochure, which has a date of
`
`September 2007, was available on the Internet by that date. Ex. 1007 at ¶¶ 4, 5, 7.
`
`(d) Ex. 1010: Gilson Product Guide and Ex. 1011: Gilson
`402 Syringe Pump User’s Guide
`
`The Declaration of Mr. Christopher Butler, from the Internet Archive,
`
`authenticates that each of these documents was available on the Internet in 2007.
`
`(Ex. 1012.)
`
`(e) Ex. 1016: 872 Extension Module Manual
`
`Mr. Larry Tucker is the Vice President of Business Development at Metrohm
`
`U.S.A. Ex. 1005 at 7:23-8:2. He has been associated with Metrohm since 2005,
`
`when it acquired Brinkmann where he had been working since 1978. Id. at 8:6-10,
`
`9:6-18. He was responsible for selling the Metrohm 850 ion chromatography
`
`machine. Id. at 15:1-18. He recognized the Manual for the Metrohm 872 Extension
`
`Module Ex. 1016 (Ex. 3 to the deposition). Id. at 20:2-6. The 872 Extension
`
`Module allowed you to add additional modules from the 850 base unit to extend it.
`
`Id. at 23:23-24:8. He testified that the manuals for the Metrohm 850 (Ex. 1017, Ex.
`
`2 in deposition) and 872 (Ex. 1016, Ex. 3 in deposition) were given to customers in
`
`the United States when they purchased the machine from 2007-2009. Id. at 17:6-24,
`
`22:6-8. The manuals for both of these machines were available on the Internet for
`
`download before the priority date. Id. at 17:16-24, 21:5-23. Ex. 1016 was available
`
`
`
`-12-
`
`

`
`
`
`by May 5, 2009, the date stamped on the manual. Id. at 21:2-23. Mr. Tucker testified
`
`that there is nothing different in Ex. 1016 with respect to the mode of operation than
`
`the 872 Extension Modules that were sold in the United States in 2007-2008. Id. at
`
`22:24-25:22.
`
`2.
`
`Legal Analysis Establishing Printed Publications for the
`Manuals and Brochures Relied On: Exs. 1002, 1003, 1010,
`1011, 1016, and 1017
`
`Exs. 1002, 1003, 1010, 1011, 1016, and 1017 are product manuals, brochures,
`
`or mechanical drawings. They are printed publications because they were publicly
`
`available to the interested public before the priority date of the ‘718 patent. The
`
`Federal Circuit held in In re Klopfenstein, 380 F.3d 1345 (Fed. Cir. 2004), that the
`
`touchstone for determining whether a document is a printed publication is whether
`
`it is accessible to the public interested in the art. Id. at 1348. There are a number of
`
`ways that accessibility can be established. One way that conclusively establishes
`
`accessibility is when the document in question was actually disseminated. Id.; see
`
`also id. at 1348 n.3 (noting that prior decisions such as In re Cronyn, 890 F.2d 1158
`
`(Fed. Cir. 1989), had found that dissemination established a document was a printed
`
`publication); see also Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378
`
`(Fed. Cir. 2006) (same).
`
` Here, the Applikon and Metrohm product manuals were widely distributed
`
`before the priority date. The 2040 manual (Ex. 1002) was given to each customer
`
`
`
`-13-
`
`

`
`
`
`who purchased a machine. Ex. 1005 at 99:6-11, 154:7-12. The same is true for the
`
`850 (Ex. 1017) and 872 (Ex. 1016) manuals. Ex. 1005 at 17:16-24, 22:6-8.
`
`All the Applikon manuals, brochures, or drawings were also publicly
`
`accessible to those who were interested in them, regardless of whether they were
`
`disseminated. The 850 (Ex. 1017) and 872 (Ex. 1016) manuals were available on
`
`the Internet before the priority date. Ex. 1005 at 17:16-24, 21:5-23. Someone
`
`searching for machines of the type of the 850 and 872 would have found them.
`
`Similarly, the 2040 brochure (Ex. 1006) was available on the Internet before the
`
`priority date. Ex. 1007 ¶ 7. Someone searching for a modular a