Petition for Inter Partes Review
`of U.S. Patent No. 8,623,291
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________________________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________
`
`
`
`ALERE INC.
`Petitioner
`
`v.
`
`REMBRANDT DIAGNOSTICS, LP
`Patent Owner
`U.S. Patent No. 8,623,291
`
`
`Case No. IPR2016-___
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 8,623,291
`UNDER 35 U.S.C. § 312 AND 37 C.F.R. § 42.104
`
`
`
`
`
`
`
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`

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`Petition for Inter Partes Review
`of U.S. Patent No. 8,623,291
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`TABLE OF CONTENTS
`
`V. 
`
`Page
`TABLE OF AUTHORITIES .................................................................................... iv 
`I. 
`MANDATORY NOTICES ............................................................................. 1 
`A. 
`Real Party-in-Interest ............................................................................ 1 
`B. 
`Related Matters ...................................................................................... 1 
`C. 
`Counsel and Service Information .......................................................... 2 
`CLAIM LISTING ............................................................................................ 2 
`II. 
`III.  GROUNDS FOR STANDING ........................................................................ 4 
`IV.  OVERVIEW OF CHALLENGE AND RELIEF REQUESTED .................... 4 
`A. 
`Prior Art Patents and Printed Publications ............................................ 4 
`B. 
`Grounds for Challenge .......................................................................... 5 
`BACKGROUND ............................................................................................. 6 
`A.  Overview of Technology ....................................................................... 6 
`B. 
`The ’291 Patent And Its Prosecution History ..................................... 10 
`VI.  PERSON OF ORDINARY SKILL IN THE ART ........................................ 14 
`VII.  CLAIM CONSTRUCTION .......................................................................... 14 
`A. 
`“Sample Addition Pad” ....................................................................... 14 
`B. 
`“Transparent Window” ....................................................................... 15 
`C. 
`“A First Transparent Window” ........................................................... 16 
`D. 
`“A Second Transparent Window” ....................................................... 16 
`VIII.  SUMMARY OF SELECT PRIOR ART ....................................................... 17 
`A.  DE ........................................................................................................ 17 
`B.  May ...................................................................................................... 19 
`C. 
`Charm .................................................................................................. 20 
`D. 
`Cipkowski ............................................................................................ 23 
`E. 
`Sun ....................................................................................................... 25 
`IX.  STATEMENT OF NON-REDUNDANCY .................................................. 25 
`X. 
`SPECIFIC GROUNDS FOR PETITION ...................................................... 27 
`
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`3. 
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`B. 
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,623,291
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`A.  Ground I: Claims 1, 2, and 9 Are Obvious Over DE In View of
`May ...................................................................................................... 27 
`1. 
`Claim 1 ...................................................................................... 27 
`2. 
`Claim 2: “…a second transparent window formed within
`the cover through which the test strips can be viewed.”........... 36 
`Claim 9: “A method for detecting a multiplicity of
`analytes which comprises removing the cap from the
`device of claim 1 and inserting the protruding ends of the
`test strips into a sample to be analyzed and observing the
`effect of the sample on the test and control zones of the
`test strips contained in the device.” .......................................... 39 
`Ground II: Claims 1 and 9 Are Obvious Over DE in View of
`Charm and May ’871 ........................................................................... 40 
`1. 
`Claim 1 ...................................................................................... 40 
`2. 
`Claim 9 ...................................................................................... 44 
`Ground III: Claim 2 Is Obvious Over DE In View of May,
`Shuler, and Eisinger ............................................................................ 45 
`D.  Ground IV: Claims 1, 2 and 9 Are Obvious Over Cipkowski In
`View of May ........................................................................................ 48 
`1. 
`Claim 1 ...................................................................................... 48 
`2. 
`Claim 2 ...................................................................................... 56 
`3. 
`Claim 9 ...................................................................................... 58 
`Ground V: Claims 1 and 9 Are Obvious Over Cipkowski in
`View of Charm and May ’871 ............................................................. 59 
`1. 
`Claim 1 ...................................................................................... 59 
`2. 
`Claim 9 ...................................................................................... 62 
`Ground VI: Claim 2 Is Obvious Over Cipkowski in View of
`May, Shuler, and Eisinger ................................................................... 63 
`G.  Ground VII: Claims 1, 2, and 9 Are Obvious Over Sun in View
`of May ................................................................................................. 64 
`1. 
`Claim 1 ...................................................................................... 64 
`2. 
`Claim 2 ...................................................................................... 71 
`3. 
`Claim 9 ...................................................................................... 72 
`
`C. 
`
`E. 
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`F. 
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,623,291
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`H.  Ground VIII: Claims 1 and 9 Are Obvious Over Sun in View of
`Charm and May ’871 ........................................................................... 73 
`1. 
`Claim 1 ...................................................................................... 73 
`2. 
`Claim 9 ...................................................................................... 75 
`Ground IX: Claim 2 Is Obvious Over Sun in View of May,
`Shuler, and Eisinger ............................................................................ 75 
`XI.  CONCLUSION .............................................................................................. 76
`ADDENDUM: LIST OF EXHIBITS…………………………………………….77
`
`
`I. 
`
`iii
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`

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`
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`TABLE OF AUTHORITIES
`
`Petition for Inter Partes Review
`of U.S. Patent No. 8,623,291
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`Page(s)
`
`Cases
`Baldwin Graphic Sys., Inc. v. Siebert, Inc.,
`512 F.3d 1338 (Fed. Cir. 2008) .......................................................................... 16
`
`In re Kuhle,
`526 F.2d 553 (C.C.P.A. 1975) ................................. 36, 42, 44, 55, 56, 60, 61, 68
`
`KSR International Co. v. Teleflex Inc. (“KSR”),
`550 U.S. 398, 417 (2007) .................................................................................passim
`
`Rexnord Indust., LLC v. Kappos,
`705 F.3d 1347 (Fed. Cir. 2013) ............................... 36, 42, 44, 55, 56, 60, 61, 68
`
`SanDisk Corp. v. Kingston Tech. Co., Inc.,
`695 F.3d 1348 (Fed. Cir. 2012) .......................................................................... 16
`
`Statutes
`
`35 U.S.C. § 102 ...................................................................................................... 4, 5
`
`35 U.S.C. § 103 .............................................................................................. 5, 12, 13
`
`35 U.S.C. § 314(a) ..................................................................................................... 6
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`35 U.S.C. § 315(b) ..................................................................................................... 4
`
`Other Authorities
`
`37 C.F.R. § 42.104(b)(4)-(5) .................................................................................... 27
`
`37 C.F.R. § 42.104(b)(1)-(2) ...................................................................................... 4
`
`37 C.F.R. § 42.22(a)(1) .............................................................................................. 4
`
`MPEP § 2141(I)………………………………………………………………passim
`
`
`iv
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`I. MANDATORY NOTICES
`A. Real Party-in-Interest
`Alere Inc. (“Petitioner”) is the real party-in-interest.
`
`Petition for Inter Partes Review
`of U.S. Patent No. 8,623,291
`
`B. Related Matters
`As of the filing date of this petition for inter partes review (“IPR”), U.S.
`
`Patent No. 8,623,291 (“the ’291 patent”) is involved in litigation in the Southern
`
`District of California, captioned Rembrandt Diagnostics, LP v. Alere Inc., et al.,
`
`No. 3:16-cv-698-CAB-NLS (“the district court litigation”).1 Petitioner is not
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`aware of any other judicial or administrative matter that would affect or be affected
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`by a decision in this IPR.2
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`
`
`
`1 In addition to Alere Inc., the following subsidiaries were named as defendants in
`
`the district court litigation: Alere Toxicology Services, Inc., Amedica Biotech,
`
`Inc., Ameditech, Inc., Innovacon, Inc., Instant Technologies, Inc., Instant Tech
`
`Subsidiary Acquisition Inc. d/b/a US Diagnostics, and Branan Medical Corp.
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`2 Petitioner is also filing a Petition for Inter Partes Review of U.S. Patent No.
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`6,548,019, also asserted in the same district court litigation.
`
`1
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`C. Counsel and Service Information
`
`Petition for Inter Partes Review
`of U.S. Patent No. 8,623,291
`
`Backup Counsel
`Julius C. Fister, III
`(Reg. No. 46,702)
`
`
`Jay.fister@alere.com
`
`
`
`Chief IP Counsel
`Alere Inc.
`51 Sawyer Road,
`Suite 200
`Waltham, MA 02453-
`3448
`(781) 314-4066
`
`
`
`Lead Counsel
`Douglas J. Kline
`(Reg. No. 35,574)
`
`Email:
`
`Dkline@goodwinlaw.
`com
`
`Post and
`hand
`delivery:
`
`Goodwin Procter LLP
`100 Northern Avenue
`Boston, Massachusetts
`02210
`
`Tel.:
`
`(617) 570-1000
`
`Counsel consents to electronic service at the email listed above.
`
`
`
`
`
`II. CLAIM LISTING
`Independent Claim 1 of the ’291 patent provides:
`
`1. A device for assaying a fluid for the presence or
`absence of different analytes comprising:
` (A) a base having adjacent slots therein of sufficient
`length for insertion of part of a test strip therein, wherein
`each slot is defined by (a) a floor, (b) raised walls
`depending upwardly from the floor to separate each
`adjacent slot from the next, and (C) at least one open end,
`(B) a multiplicity of test strips having an upstream and a
`downstream end, wherein a single test strip is inserted into
`
`2
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,623,291
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`each slot of the base so the upstream end of each test strip
`protrudes out of the open end of each slot, and wherein
`each test strip has a test zone and a control zone therein,
`and each test zone contains a binder specific for a
`different analyte; the protruding freestanding end of each
`test strip containing a sample addition pad for direct
`contact with the fluid to be analyzed;
`(C) a cover attached to the upwardmost surface of each
`raised wall of the slots of the base and extending to the
`open end of said base, wherein the cover retains the test
`strips within the slots and has a first transparent window
`formed therein through which the test zone and the
`control zone of each of the test strips can be viewed and
`(D) a cap enclosing the protruding ends of the test strips
`and removably attached to the open end of said base.
`Ex. 1001, 11:10-12:2.
`
`Claim 2 depends from Claim 1, and recites: “[t]he device according to claim
`
`1 further comprising a second transparent window formed within the cover through
`
`which the test strips can be viewed.” Id., 12:3-5.
`
`Independent Claim 9 provides:
`
`9. A method for detecting a multiplicity of analytes
`which comprises removing the cap from the device of
`claim 1 and inserting the protruding ends of the test strips
`into a sample to be analyzed and observing the effect of
`
`3
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,623,291
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`the sample on the test and control zones of the test strips
`contained in the device.
`Id., 12:26-30.
`
`III.
`
`
`
`GROUNDS FOR STANDING
`
`Petitioner certifies that the patent for which review is sought is available for
`
`IPR and that Petitioner is not barred or estopped from requesting an IPR on the
`
`grounds in this Petition. This petition is timely under 35 U.S.C. § 315(b) because
`
`it was filed within one year of the March 24, 2017 service of the Complaint on
`
`Alere in the district court litigation.
`
`IV. OVERVIEW OF CHALLENGE AND RELIEF REQUESTED
`Pursuant to Rules 42.22(a)(1) and 42.104(b)(1)-(2), Petitioner challenges
`
`Claims 1, 2, and 9 of the ’291 patent (Ex. 1001).
`
`Prior Art Patents and Printed Publications
`
`A.
`The ’291 Patent was filed Jan. 5, 2007 and claims priority to an application
`
`filed July 14, 1998. The following references are pertinent prior art:
`
`Ex.
`
`Description
`
`Filing, Pub., or
`Issue Date
`
`Prior Art
`
`1004 German Utility Model No. DE 297 02 825
`(“DE”) and certified English translation
`
`May 22, 1997
`
`§ 102(b)
`
`1005 U.S. Patent No. 5,602,040 (“May”)
`
`Feb. 11, 1997
`
`§ 102(b)
`
`4
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`Ex.
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,623,291
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`Description
`
`Filing, Pub., or
`Issue Date
`
`Prior Art
`
`1006 U.S. Patent No. 5,976,895 (“Cipkowski”) March 11, 1996 § 102(e)
`
`1007 U.S. Patent No. 5,962,336 (“Sun”)
`
`March 20, 1997
`
`§ 102(e)
`
`1008 U.S. Patent No. 5,985,675 (“Charm”)
`
`Dec. 31, 1997
`
`§ 102(e)
`
`1009 U.S. Patent No. 4,943,522 (“Eisinger”)
`
`July 24, 1990
`
`§ 102(b)
`
`1010 U.S. Patent No. 5,798,273 (“Shuler”)
`
`Sept. 25, 1996
`
`§ 102(e)
`
`1011 U.S. Patent No. 5,622,871 (“May ’871”)
`
`Apr. 22, 1997
`
`§ 102(b)
`
`
`
`B. Grounds for Challenge
`Petitioner requests cancellation of claims 1, 2, and 9 of the ‘291 patent as
`
`unpatentable under 35 U.S.C. § 103, per the Grounds below.
`
`Ground Claims Description - § 103(a) obviousness combination
`
`I
`
`II
`
`III
`
`IV
`
`V
`
`1, 2, 9 DE in view of May
`
`1, 9
`
`DE in view of Charm and May ’871
`
`2
`
`DE in view of May, Shuler, and Eisinger
`
`1, 2, 9 Cipkowski in view of May
`
`1, 9
`
`Cipkowski in view of Charm and May ’871
`
`5
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`

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`
`VI
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`VII
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`VIII
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`IX
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,623,291
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`Cipkowski in view of May, Shuler, and Eisinger
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`2
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`1, 2, 9 Sun in view of May
`
`1, 9
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`Sun in view of Charm and May ’871
`
`2
`
`Sun in view of May, Shuler, and Eisinger
`
`This petition, supported by Dr. Robert Bohannon’s declaration (Ex.
`
`1003)(“Decl.”), demonstrates a reasonable likelihood that Petitioner will prevail as
`
`to at least one challenged claim, and that each challenged claim is unpatentable.
`
`See 35 U.S.C. §314(a).
`
`V. BACKGROUND
`A. Overview of Technology
`Systems and methods for detecting analytes, such as drugs, in biological
`
`fluid samples, such as urine, have long been known in the art. Decl. ¶¶ 16-43.
`
`Various commercial devices were known in the art long before the earliest
`
`effective filing date to which the ‘291 patent is entitled. Id. ¶¶ 24-25; Ex. 2012.
`
`The ’291 patent discloses that the prior art includes single step assay devices that
`
`produce “visually observable assay results (such as… colored bars on [a] test
`
`strip).” Ex. 1001, 1:11-24. Assays known in the art included “competition”
`
`assays, wherein the absence of a line in a test zone indicates a positive result
`
`(presence of the analyte), and “sandwich” assays, wherein the presence of a line in
`
`a test zone indicates a positive result. See id., 4:41-49 & 4:7-13; Decl. ¶ 18.
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`6
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,623,291
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`The ‘291 patent at 5:16-19 & 5:45-60 acknowledges that the test strips used
`
`in its claimed devices are “conventional in form,” that they are prepared using
`
`“means known in the art,” and use test binders and means for attaching the binders
`
`to porous test strips that are “well-known to those of ordinary skill in the art.” The
`
`’291 patent (Ex. 1001, 5:54-6:3) even refers the reader to prior art patents that
`
`“provide a representative sample of test strip designs known in the art,” including
`
`U.S. Patent No. 5,602,040 (“May,” Ex. 1005), discussed below.
`
`Devices for simultaneously testing a single urine sample for multiple drugs
`
`of abuse were known in the art. Decl. ¶ 26. As discussed in more detail below, the
`
`primary prior art references relied upon in this petition, such as DE 297 02 825
`
`(“DE”)(Ex. 1004), 1-2,3 U.S. Patent No. 5,976,895 (“Cipkowski”)(Ex. 1006), 1:63-
`
`2:10; U.S. Patent No. 5,962,336 (“Sun”)(Ex. 1007), 1:4-22, disclosed dipstick
`
`format multistrip devices for testing urine for drugs of abuse, each with test strips
`
`protruding from a housing, as shown in the following figures from these patents:
`
`
`3 Citations to DE are to Petitioner’s certified English translation.
`
`7
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,623,291
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`Ex. 1004, Fig. 3.
`
` Ex. 1006, Fig. 9.
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`8
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`of U.S. Patent No. 8,623,291
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`Ex. 1007, Fig. 8.
`
`
`
`Such devices typically employed one or more windows/apertures for
`
`viewing parts of a test strip, including test and/or control zones. Decl. ¶¶ 36-39.
`
`
`
`The use of a cap to cover the fluid-contacting open end of a dipstick device
`
`was also disclosed in the prior art. Id. ¶¶ 40-43. For example, U.S. Patent No.
`
`5,602,040 (“May”) (Ex. 1005), which Applicant incorporated by reference in the
`
`‘291 patent (Ex. 1001, 6:2-4), shows a removable cap 503 to cover the sample
`
`receiving end of the test strip contained within a casing.
`
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`9
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,623,291
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`Ex. 1005 at Fig. 8. In addition, U.S. Patent No. 5,985,675 (“Charm”), also
`
`discussed below, discloses capping a multi-strip device to prevent contamination,
`
`and incorporates by reference the capped device of U.S. Patent No. 5,622,871
`
`(“May ’871,” which is in the same family as May)(Ex. 1011).4
`
`The ’291 Patent And Its Prosecution History
`
`B.
`The ’291 patent describes an assay device for testing multiple analytes, such
`
`as drugs, using individual test strips that are “conventional in form” for each
`
`analyte, plus assay methods. Ex. 1001, Abstract; 1:35-40 & 5:16-19; Decl. ¶¶ 56-
`
`61. “Each test strip provides binders and assay reagents for detection of a different
`
`analyte.” Id., 1:54-55. The ’291 patent defines a “binder” as “a ligand for the
`
`analyte” (for “sandwich assay[s]”) or “a ligand for both the analyte and the tracer”
`
`(for “competitive assay[s]”). Id., 3:1-6; see also id., 4:5-57, 5:16-23. A “test
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`zone” is defined as “an area in which a binder or the analyte is attached… to the
`
`test strip.” Id., 3:7-9.
`
`Fig. 2 depicts a top view:
`
`
`4 Other prior art made similar disclosures. Decl. ¶¶ 40-43; U.S. Patent No.
`
`6,808,682 (“Bates”)(Ex. 1013).
`
`10
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`Fig. 1 depicts an exploded view:
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,623,291
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`
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`In dipstick form, the assay device has a housing 100. Id., Fig. 1; 4:61-63.
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`Base 101 has a closed end 104 and an open end 106, with slots (102A-E) separated
`
`by rails (103A-D) for inserting test strips (105A-E), which extend from base 101.
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`Id., 4:67-5:9, 5:10-16, Fig. 2. Test and control zones are viewable through
`11
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`of U.S. Patent No. 8,623,291
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`transparent window portion 111 of cover 110. Id., 6:9-12. The test strips are also
`
`viewable through additional transparent windows (115A-E). Id., 6:20-25. Cap 120
`
`protects protruding strip ends. Id., 6:26-34.
`
`
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`The ’291 patent also discloses a detection method. Id., 8:31-35, 8:43-48. In
`
`dipstick devices, samples are applied to test strips by immersion. Id., 9:59-63.
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`Test results are viewed through window 111. Id., 9:63-66. A color change in test
`
`zone 112 indicates analyte presence. Id., 9:66-10:1.
`
`
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`
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`During prosecution, the Examiner rejected the then-pending claims as
`
`obvious under 35 U.S.C. §103, based on DE (Ex. 1004) in view of U.S. Patent No.
`
`5,770,458 (“Klimov”). Ex. 1002, 94-95; Decl. ¶¶ 62-65. DE’s Figures 1 & 3,
`
`which are discussed in more detail below, show a device for simultaneous testing
`
`of a urine sample for multiple drugs of abuse comprising, inter alia, a base with
`
`slots, with a test strip positioned in each slot, and a cover with transparent windows
`
`for viewing the test results on each strip. Ex. 1004, 1:8-19, 1:23-24, 2:15-25, 3:14-
`
`17, 4:21-5:7, 5:9-13, 7:5-19. Klimov was cited by the examiner as disclosing the
`
`claimed test strips and as teaching use of a seal for sealing or covering the sample
`
`pads. Ex. 1002, 49.5
`
`In its Appeal Brief, Applicant stated as follows about DE:
`
`
`5 Klimov is not relied upon here.
`
`12
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,623,291
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`DE 297 02 825 is a German utility model patent which
`discloses a multiple analyte assay device in which the
`assay test strips extend beyond the housing for the test
`strips which are contained in channels in the housing ...
`The patent does not disclose any kind of cap or cover for
`the exposed parts of the test strips.
`Id., 98:3-7. Thus, the only limitation Applicant identified as missing from DE was
`
`the cap.
`
`In an effort to overcome Klimov, Applicant conceded that: (i) “Appellant
`
`admits that construction of the test strip itself is not novel” (Id., 98:1-2); and (ii)
`
`“appellant does not rely on the construction of the test strip to support the
`
`patentability of the appealed claims” (Id., 101:26-28).
`
`Applicant further acknowledged: “The key feature of the claimed invention
`
`is that it minimizes any contamination of and damage to the various assay strips.
`
`With the cap on, the exposed strips are protected during transport and any contact
`
`between the operator of the test and the sample is further reduced.” Id., 98:27-6:2.
`
`The appeal of the §103 issue turned on whether Klimov disclosed the
`
`claimed cap. The Board reversed the obviousness rejection because “the Examiner
`
`[did] not explain how Klimov [which discloses an assay device with a rubber seal]
`
`would have rendered a removable cap prima facie obvious.” See Ex. 1002, 130-
`
`131. However, neither the Examiner nor the Board considered DE (or other
`
`primary references below) in view of either May (Ex. 1005) or U.S. Patent No.
`13
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,623,291
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`5,985,675 (“Charm” or Ex. 1008), which both clearly disclose the claimed
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`removable cap, as discussed below.
`
`VI. PERSON OF ORDINARY SKILL IN THE ART
`For purposes of this Petition, Petitioner adopts Dr. Bohannon’s opinion that
`
`the field of endeavor is in vitro device engineering, as well as his definition of a
`
`person of ordinary skill in the art (“POSITA”). Id. ¶¶ 52-55. Specifically, a
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`POSITA would have a Bachelor of Science degree (or the equivalent) in a relevant
`
`scientific or engineering field, such as such as mechanical or biomechanical
`
`engineering, biology, biochemistry or immunology, with 3-5 years of experience in
`
`design, testing, and manufacturing of in vitro test devices. Id. ¶ 54.
`
`VII. CLAIM CONSTRUCTION
`A.
` “Sample Addition Pad”
`Claim 1(B) recites: “a multiplicity of test strips… the protruding
`
`freestanding end of each test strip containing a sample addition pad for direct
`
`contact with the fluid to be analyzed.” Id., 11:17-25 (emphasis added). A POSITA
`
`would understand that by July 14, 1998, it was known in the art that liquid samples
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`could be added to a porous member that would absorb the sample, and the sample
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`would then permeate a test strip in a housing. Decl. ¶ 67. For example, May
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`(incorporated by reference in the ‘291 patent) discloses a “porous receiving
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`member to which [a] liquid sample can be applied and from which the sample can
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`permeate the porous solid phase material… [within a] housing.” Ex. 1005,
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`Abstract, 3:56-65, 4:46-5:7, 8:11-12, 12:14-37, 14:42-46, Figs. 8, 10. The porous
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`receiving member provides “the sole route of access… to the strip within the
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`housing, and can deliver the sample to the strip in a controlled manner.” Id.,13:14-
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`20.
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`Applying the broadest reasonable construction, “sample addition pad”
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`should be construed to mean “pad that receives the sample.”
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`“Transparent Window”
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`B.
`Claims 1(C) and 2 both recite “transparent” windows. Ex. 1001, 11:26-31,
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`12:3-5. The ’291 patent discloses that “cover 110 is conveniently constructed of
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`an opaque tape having at least one transparent window 111 formed therein for
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`viewing of test results along test zone 112 and control zone 113” and “cover 110 is
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`also provided with transparent windows 115[A-E] through which labels on test
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`strips 102[A-E] can be viewed.” Id., 6:9-25, Figs. 1-2; see also id., 1:46-48. A
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`transparent window is not an uncovered opening or aperture, but must be made of a
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`solid transparent material; otherwise, the word “transparent” would add no
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`meaning. Decl. ¶ 69. Moreover, a POSITA would understand that constructing a
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`window with a solid transparent material (as opposed to an open aperture) is
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`important in drug testing devices to avoid tampering or contamination of the test
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`results. Id. Applying the broadest reasonable construction, “transparent window”
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`should be construed to mean “window consisting of a solid material that is
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`transparent but whose boundaries may be defined by an opaque material.” Id.
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`“A First Transparent Window”
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`C.
`Claim 1(C) recites a cover attached to the base that “has a first transparent
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`window formed therein through which the test zone and the control zone of the test
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`strips can be viewed…” Ex. 1001, 11:26-31 (emphasis added). In “comprising”
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`claims, “a” commonly means “one or more.” See, e.g., Baldwin Graphic Sys., Inc.
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`v. Siebert, Inc., 512 F.3d 1338, 1342 (Fed. Cir. 2008); SanDisk Corp. v. Kingston
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`Tech. Co., Inc., 695 F.3d 1348, 1360-61 (Fed. Cir. 2012). The ’291 patent teaches
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`that test and control zones may be viewed through “at least one transparent
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`window 111.” Ex. 1001, 6:20-25, Figs. 1-2. Applying the broadest reasonable
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`construction, “a first transparent window” should be construed as “one or more
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`first transparent windows.” Decl. ¶ 70.
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`D.
`“A Second Transparent Window”
`Claim 2 recites: “The device according to claim 1 further comprising a
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`second transparent window formed within the cover through which the test strips
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`can be viewed.” Id., 12:3-5 (emphasis added). The ‘291 patent discloses
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`“transparent windows 115A[-E]” as distinct from the “at least one transparent
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`window 111.” Id., 6:20-25. No specific purpose for the second transparent
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`window, other than viewing the test strips, is recited in Claim 2. Applying the
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`broadest reasonable construction, “a second transparent window” should be
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`construed as “one or more additional transparent windows in the cover through
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`which the test strips can be viewed.” Decl. ¶ 71.
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`VIII. SUMMARY OF SELECT PRIOR ART
`A. DE
`DE is prior art under § 102(b) because it was published in the German Patent
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`and Trade Mark Office’s Patent Gazette on May 22, 1997. Ex. 1004, 11; MPEP §
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`901.5 (IV)(Patent Gazette publication date is the “date published for public”).
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`As discussed briefly above, DE teaches a multiassay dipstick device for use
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`in simultaneously testing a urine sample for multiple drugs of abuse. See Ex. 1004,
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`1:8-19; 2:18-25; Decl. ¶¶ 72-73. DE was considered during prosecution of the
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`ʼ291 patent, but not in combination with the references herein. None of
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`Petitioner’s Grounds relies solely on DE, and Petitioner presents different
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`arguments and evidence not considered by the Patent Office, including Dr.
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`Bohannon’s declaration. See Chimei Innolux Corp. v. Semiconductor Energy
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`Laboratory Co., Ltd., IPR2013-00038, Paper No. 9 at 6 (March 21, 2013)
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`(instituting IPR although certain prior art references were considered during
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`prosecution).
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`DE discloses a holder 1 with multiple strip-like recesses 2. Ex. 1004, 2:15-
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`25, 3:14-17, 4:21-5:7, 7:7-19.
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`Id., Fig. 1. Each test strip detects a different analyte, and is inserted into the recess
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`so that the end to be dipped into the sample protrudes from the holder. Id., 1:23-
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`24, 2:15-25, 7:7-9, Figs. 2-3.
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`Id., Fig. 2.
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`Id., Fig. 3. The test strips are fixed in place with a self-bonding cover film 4 that is
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`glued on the holder and secures the strips in their slots. Id., Figs. 2-3, 5:9-11, 7:5-
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`9. The cover film has transparent windows 5 for viewing test (T) and control (C)
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`zones. Id., Figs. 2, 3, 5:11-13, 7:11-12. The markings 6 on the cover in Figs. 2 &
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`3 indicate that each strip is testing for a different analyte.
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`B. May
`May is prior art under § 102(b) because it issued Feb. 11, 1997. Ex. 1005.
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`May was incorporated by reference into the ‘291 patent (Ex. 1001, 6:3-6), but was
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`not addressed during prosecution of the ‘291 patent. May teaches a test device
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`including a casing (500) with a porous carrier (510) and a sample receiving
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`member (506). Ex. 1005, Abstract; Decl. ¶¶ 74-75.
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`Id., Fig. 8. May also discloses two or more strips arranged in parallel for
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`simultaneously testing different samples or reagents. Id., 6:26-39.
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`As discussed above, May also discloses a removable cap 503 that covers
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`porous member 506. Id., Abstract, 4:8-13; 12:9-15, 12:54-62, 13:27-30. “In
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`operation, the protective cap 503 is removed from the holder and member 506 is
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`exposed to a liquid sample;” then the cap “can be replaced.” Id., 12:54-62. May
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`also discloses apertures 508 and 509 for viewing test and control zones. Id., 12:17-
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`18, 12:62-67, 13:27-30. The apertures can be fitted with transparent inserts to
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`protect against ingress of extraneous moisture from outside the housing. Id.,
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`13:11-14.
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`C. Charm
`Charm is prior art under § 102(e) because it was filed Dec. 31, 1997. Ex.
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`1008
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`Charm teaches a device for testing liquid samples, such as urine, with “one
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`or more test strips.” Id., Abstract, 4:6-12; Decl. ¶ 76. Charm teaches a “protective
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`cap to protect the test device from contamination” before and after use. Ex. 1008,
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`3:44-54. Cap 22 is “adapted to fit over the open application end 16.” Id., 5:4-7.6
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`Charm was not of record during prosecution of the ‘291 patent.
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`Id., Fig. 1. As shown in Fig. 1, each test strip in Charm has “a test and a separate
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`control line … to detect the presence of analytes.” Id., 1:63-67. The housing
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`6 Charm also states that prior art (U.S. Patent No. 5,622,871, which is in the same
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`family as May) describes “a protective, removable cap.” Ex. 1008, 1:17-23; Decl. ¶
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`118.
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`contains “a transparent top cover section” (Id., 1:45-46)— or alternatively, “only a
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`section of the top cover [is] transparent”— for “view[ing] the test results.” Id.,
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`3:38-40. Figures 6 and 13 show results based on control line 40 and reference line
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`38:
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`Id., 4:46-48, 4:56-58, 5:52-56, 6:27-30, 6:48-53, 8:15-17.
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