`
`
`Filed on behalf of:
`Patent Owner Rembrandt Diagnostics, LP
`By:
`Joseph F. Jennings (Reg. No. 40,664)
`Jared C. Bunker (Reg. No. 58,474)
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, Fourteenth Floor
`Irvine, CA 92614
`Tel.: (949) 760-0404
`Fax: (949) 760-9502
`E-mail: BoxREMPIL.001LP2@knobbe.com
`
`
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ALERE, INC.
`Petitioner,
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`v.
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`REMBRANDT DIAGNOSTICS, LP
`Patent Owner.
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`
`Case IPR2016-01498
`Patent 8,623,291
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`PATENT OWNER’S PRELIMINARY RESPONSE TO PETITION
`FOR INTER PARTES REVIEW
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`TABLE OF CONTENTS
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`Page No.
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`I. INTRODUCTION AND SUMMARY OF THE ARGUMENT ............................ 1
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`II. ARGUMENT ........................................................................................................ 2
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`A. Alere’s Declaration Should Be Given No Evidentiary
`Weight ................................................................................................... 2
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`B.
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`C.
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`Response to Alere’s Proposed Construction of
`“Transparent Window,” “A First Transparent Window,”
`and “A Second Transparent Window” .................................................. 3
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`Alere’s Petition Fails to Demonstrate a Reasonable
`Likelihood that Any Challenged Claim is Unpatentable ...................... 7
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`1.
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`2.
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`3.
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`Alere fails to demonstrate in Grounds I–IX a
`reasonable likelihood that the prior art teaches or
`would have suggested the claimed cap ....................................... 8
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`The Board should also decline institution on
`Grounds I–III under 35 U.S.C. § 325(d) because
`the Office already considered Alere’s prior art and
`arguments during prosecution ................................................... 13
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`The Board should also decline institution on
`Grounds IV–IX for two additional reasons............................... 18
`
`i.
`
`ii.
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`Alere’s primary references Cipkowski and Sun are
`substantially the same as DE, justifying dismissal
`under 35 U.S.C. § 325(d) ................................................ 18
`
`Cipkowski and Sun would have discouraged a
`POSITA from modifying a dip holder to include the
`claimed cap ..................................................................... 20
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`III. CONCLUSION .................................................................................................. 24
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`-i-
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`
`
`TABLE OF AUTHORITIES
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`Page No(s).
`
`Cases
`In re Am. Acad. of Sci. Tech. Ctr.,
`367 F.3d 1359 (Fed. Cir. 2004) ............................................................................ 2
`
`CCS Fitness, Inc. v. Brunswick Corp.,
`288 F.3d 1359 (Fed. Cir. 2002) ............................................................................ 4
`
`InfoBionic, Inc. v. Bramer Mfg., LLC,
`IPR2015-01704, Paper 11 (P.T.A.B. Feb. 16, 2016) ............................................ 2
`
`Kinetic Techs., Inc. v. Skyworks Solutions, Inc.,
`IPR2014-00530, Paper 8 (P.T.A.B. Sept. 29, 2014) ............................................. 2
`
`In re Morris,
`127 F.3d 1048 (Fed. Cir. 1997) ............................................................................ 3
`
`Statutes
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`35 U.S.C. § 325(d) ......................................................................................... 1, 13, 18
`
`Other Authorities
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`37 C.F.R. § 42.1(b) .................................................................................................. 20
`
`37 C.F.R. § 42.24(a)(1) .............................................................................................. 3
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`37 C.F.R. § 42.100(b) ................................................................................................ 3
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`IPR2016-01498
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`EXHIBIT LIST
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`Exhibit No.
`
`Description
`
`2001
`
`Annotated Version of Exhibit 1003, Showing in Highlighting the
`Text that Matches the Text In Alere’s Petition
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`Exhibit List, Page 1
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`IPR2016-01498
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`I. INTRODUCTION AND SUMMARY OF THE ARGUMENT
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`The challenged U.S. Patent No. 8,623,291 relates to a multi-strip holder with
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`a removable cap (“the ’291 patent”). Despite asserting multiple prior-art
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`combinations, Alere fails to demonstrate a reasonable likelihood of proving any
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`challenged claim unpatentable. None of Alere’s cited prior art teaches a critical
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`claim limitation: a cap enclosing the ends of multiple test strips.
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`Alere contends that it would have been obvious to a POSITA to modify
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`certain prior-art holders to include the claimed cap. Some of Alere’s cited
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`references, however, undercut Alere’s contention that a POSITA would have been
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`motivated to do so. Moreover, Alere’s main prior art and arguments were
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`thoroughly considered and rejected by the Office during prosecution, justifying
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`rejection under 35 U.S.C. § 325(d). Indeed, the Office addressed Alere’s primary
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`reference DE and Alere’s obviousness argument on appeal to the Board and on
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`remand back to the Examiner. After thoroughly considering the prior art and
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`arguments, the Office concluded the ’291 patent claims were patentable. Alere’s
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`remaining prior art and arguments are substantially the same as those already
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`presented to the Office, and should also be rejected.
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`Rembrandt respectfully submits that the Board should decline institution on
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`all of Alere’s Grounds.
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`IPR2016-01498
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`II. ARGUMENT
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`A. Alere’s Declaration Should Be Given No Evidentiary Weight
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`Conclusory, unsupported opinions by an expert are entitled to little weight.
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`See In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004)
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`(“[T]he Board is entitled to weigh the declarations and conclude that the lack of
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`factual corroboration warrants discounting
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`the opinions expressed
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`in
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`the
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`declarations”). Moreover, “[m]erely repeating an argument from the Petition in the
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`declaration of a proposed expert does not give that argument enhanced probative
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`value.” Kinetic Techs., Inc. v. Skyworks Solutions, Inc., IPR2014-00530, Paper 8
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`at 13 (P.T.A.B. Sept. 29, 2014); see also InfoBionic, Inc. v. Bramer Mfg., LLC,
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`IPR2015-01704, Paper 11 at 6 (P.T.A.B. Feb. 16, 2016) (finding expert declaration
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`unpersuasive when it “repeats the Petitioner’s argument and offers little or no
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`elaboration”).
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`As with its petition challenging Rembrandt’s U.S. Patent No. 6,548,019
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`(IPR2016-01502, Paper 3), Alere submits with its Petition here a declaration
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`signed by Robert C. Bohannon (the “Declaration”). And like the declaration in the
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`companion IPR, Alere’s Declaration here is nearly a word-for-word copy of the
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`Petition’s attorney arguments. Compare Ex. 1003, 59–115 with Pet. 27–76. The
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`major difference seems to be the removal of certain words from the Petition,
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`presumably to satisfy the word-count limits (Alere’s Petition is described as
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`Alere, Inc. v. Rembrandt Diagnostics, LP
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`including 13,990 words). See 37 C.F.R. § 42.24(a)(1). The rest is a slavish copy.
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`Included as Exhibit 2001 is an annotated copy of the Declaration, which shows in
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`highlighting the Declaration’s text that matches the Petition’s text.
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`The evidence indicates that the Declaration is a copy of the Petition, rather
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`than the other way around. Dr. Bohannon acknowledges that he reviewed the
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`Petition before the Declaration was prepared. Ex. 1003 ¶ 4. The Declaration,
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`moreover, even includes Alere’s legal arguments, as well as its citations to case
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`law and the Manual of Patent Examining Procedure. Compare Ex. 1003 ¶ 111
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`with Pet. 39.
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`Because the Declaration parrots the attorney arguments in the Petition, the
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`Board should give the Declaration no evidentiary weight.
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`B. Response to Alere’s Proposed Construction of “Transparent
`Window,” “A First Transparent Window,” and “A Second
`Transparent Window”
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`When construing claims, the Board applies the broadest-reasonable-
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`construction standard. 37 C.F.R. § 42.100(b). This standard requires “the broadest
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`reasonable meaning of the words in their ordinary usage as they would be
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`understood by one of ordinary skill in the art, taking into account whatever
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`enlightenment by way of definitions or otherwise that may be afforded by the
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`written description contained in the applicant’s specification.” In re Morris, 127
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`F.3d 1048, 1054 (Fed. Cir. 1997). There is a heavy presumption that claim terms
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`Alere, Inc. v. Rembrandt Diagnostics, LP
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`should carry their ordinary and customary meaning. CCS Fitness, Inc. v.
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`Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002).
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`Alere proposes that the claim term “transparent window” be construed as a
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`“window consisting of a solid material that is transparent but whose boundaries
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`may be defined by an opaque material.” Pet. 16. According to Alere, “transparent
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`window” must be made of a solid material and cannot be an uncovered opening or
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`aperture. Id. Alere’s support for this position, however, is not the ’291
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`specification. Instead, Alere relies on attorney argument and Alere’s matching
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`Declaration, neither of which is sufficient.
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`Alere’s proposed construction of “transparent window” is not the broadest
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`reasonable in view of the ’291 patent, and it appears aimed at generating a non-
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`infringement argument in the parties’ co-pending district court litigation. The ’291
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`patent does not indicate that the window must be made of a solid material and does
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`not exclude an uncovered opening or aperture. The two references in the patent to
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`“transparent window” simply indicate that portions of the test strips may be viewed
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`through them. Ex. 1001, 6:8–12 (“cover 110 is conveniently constructed of an
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`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.”), 20–24 (“cover
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`110 is also provided with transparent windows . . . through which labels on [the]
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`test strips . . . can be viewed.”). A cover with a window “formed therein” is
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`IPR2016-01498
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`consistent with an opening. There is no description in the specification that
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`compels Alere’s narrow construction.
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`Also unavailing is Alere’s suggestion that “transparent window” should
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`exclude openings and apertures because it “is important in drug testing devices to
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`avoid tampering or contamination of the test results.” Pet. 15. While avoiding
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`tampering and contamination may be important, the ’291 patent does not teach that
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`the windows must therefore be solid. There is no suggestion in the ’291 patent that
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`open windows would lead to tampering and contamination.
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`Alere’s own prior art, in fact, shows several drug test devices with
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`uncovered openings and apertures. May, for example, teaches a test strip holder
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`with “circular hole or window 32” and a separate holder with “square apertures or
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`windows 204 and 205.” Ex. 1005, 10:53, 11:26–27. Likewise, Cipkowski teaches
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`a holder with “opening 42.” Ex. 1006, 5:3. Neither of these references expresses
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`the need for solid coverings to protect from tampering and contamination. Below
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`are figures from May and Cipkowski.
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`IPR2016-01498
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`In sum, Alere’s overly narrow proposed construction of “transparent
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`window” should be rejected. Based on the ’291 patent’s description that the
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`“transparent windows” are for viewing results and labels on the test strips, the
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`proper broadest reasonable construction, which is also a plain and ordinary one,
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`should be “an area through which objects or images can be seen.” The terms “a
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`first transparent window” and “a second transparent window,” for which Alere also
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`proposes constructions (Pet. 16–17), should also be given their plain and ordinary
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`meaning and be similarly construed as “a first area through which objects or
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`images can be seen” and “a second area through which objects or images can be
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`seen.”
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`C. Alere’s Petition Fails to Demonstrate a Reasonable Likelihood
`that Any Challenged Claim is Unpatentable
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`In Grounds I–IX, Alere asserts that Claims 1, 2, and 9 are obvious in view of
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`several prior-art combinations. For these obviousness challenges, Alere relies on
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`three primary references: DE (Grounds I–III) (Pet. 27–47), Cipkowski (Grounds
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`IV–VI) (Pet. 48–63), and Sun (Grounds VII–IX) (Pet. 64–75). For several reasons,
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`Rembrandt respectfully submits that the Board should decline institution on each
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`Ground.
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`IPR2016-01498
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`Alere fails to demonstrate in Grounds I–IX a reasonable
`1.
`likelihood that the prior art teaches or would have
`suggested the claimed cap
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`Alere acknowledges that each of its primary references—DE, Cipkowski,
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`and Sun—fails to teach a “cap enclosing the protruding ends of the test strips,” as
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`required by the challenged claims in the ’291 patent. Pet. 34, 55, 70. To address
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`this deficiency, Alere relies on secondary references: May (Grounds I, III–IV, VI–
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`VII, and IX) (Pet. 34, 45, 55, 63, 70, 75); May ’871 (Grounds II and V) (Pet. 42
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`and 61); and Charm (Grounds II, V, and VIII) (Pet. 42, 61, and 74). The evidence,
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`however, undercuts Alere’s contention that any of the secondary references teaches
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`or would have suggested the claimed cap, and Alere has thus failed to demonstrate
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`a reasonable likelihood of proving any challenged claim unpatentable.
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`May teaches a cap, but the cap encloses the end of only a single test strip.
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`Pet. 34; Ex. 1005, 12:12-14, Figs. 8 and 9. May’s cap 503 is described in the
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`context of May’s “Embodiment 3,” which refers to Figures 8 and 9. Id. Below are
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`May’s Figures 8 and 9.
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`Alere, Inc. v. Rembrandt Diagnostics, LP
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`The challenged claims, on the other hand, require a cap that encloses the
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`protruding ends of multiple strips. Ex. 1001, 12:1–2 (“a cap enclosing the
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`protruding ends of the test strips . . . .”) (emphasis added). Below is Figure 1 from
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`the ’291 patent.
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`IPR2016-01498
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`Alere contends that May discloses a device that includes more than one strip.
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`Pet. 35 (citing Ex. 1005, Abstract, 6:26–39). The cited Abstract says nothing about
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`multiple strips.1 And Alere’s other citation to a single paragraph in May says very
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`little about designing such a device and makes no mention of a cap for the device
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`or its design. See id. at 6:26–39. Thus, while this single paragraph of May
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`suggests multiple strips, it would not have suggested the claimed multiple strips
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`1 The Abstract merely says that the cap may be used for “the protruding bibulous
`member,” which is singular. Ex. 1005, Abstract.
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`IPR2016-01498
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`protruding from an end of the housing, let alone the claimed cap fitted over the
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`multiple protruding ends, as shown in the ’291 patent’s Figures 1 and 3C.
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`More specifically, May’s single disclosure of multiple strips (id. at 6:26–39)
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`refers to two or more bodies of “porous solid phase material.” May identifies the
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`“porous solid phase material” (id. at 6:27–28) as the test strip’s nitrocellulose
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`carrier material (id. at 6:40–41, 7:8–11), which holds the antibodies and labelled
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`reagents used in the tests (id. at 6:40–60, 7:25–39). In May’s “Embodiment 3,”
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`which is the only embodment in May that includes a cap, this carrier material is
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`identified as “strip of porous carrier material 510.” Id. at 12:22. Carrier material
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`510, however, is located inside Embodiment 3’s housing and does not protrude
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`outside the housing and is not enclosed by a cap. Id. at Figure 9, 12:20–27. The
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`only test strip component that is enclosed by a cap is the separate component of
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`“porous member 506.” Id. Below is May’s Figure 9.
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`Thus, in contrast to Alere’s suggestion, May’s reference to two or more
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`bodies of “porous solid phase material,” is not referring to and would not have
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`suggested multiple protruding ends that are enclosed by a cap. Instead, May is
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`Alere, Inc. v. Rembrandt Diagnostics, LP
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`referring to a structure with two or more strips inside a housing that may receive
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`sample from a single application of fluid. Id. at 6:29–32.
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`Alere also attempts to rely on May ’871 to fill the missing cap limitation.
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`But May ’871’s disclosure is identical to May’s. Compare Ex. 1005 with Ex.
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`1011.
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`Charm, Alere’s remaining secondary reference, fails to teach and would not
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`have suggested a cap enclosing any protruding ends. Alere points to Charm’s cap
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`22 as teaching the missing cap limitation. Pet. 43. But Charm’s cap 22 is planar
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`and merely covers the end of the housing—it does not enclose a protruding end of
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`any test strip and would have no reason for doing so because of its design. Ex.
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`1008, Figure 1, 3:49–54, 5:4–7, 5:35–37. Charm’s Figure 1 is reproduced below.
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`Alere, Inc. v. Rembrandt Diagnostics, LP
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`Because none of Alere’s prior art teaches or would have suggested a cap
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`enclosing the protruding ends of multiple test strips, Alere has failed to
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`demonstrate a reasonable likelihood of proving any challenged claim unpatenable.
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`The Board should decline to institute a review based on any of Alere’s Grounds.
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`2.
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`The Board should also decline institution on Grounds I–III
`under 35 U.S.C. § 325(d) because the Office already
`considered Alere’s prior art and arguments during
`prosecution
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`The Board has discretion under 35 U.S.C. § 325(d) to decline institution on
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`grounds that rely on “the same or substantially the same prior art or arguments
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`previously [ ] presented to the Office.” Id.
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`Grounds I–III rely on prior art and arguments that the Office already
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`considered and addressed during prosecution. See Ex. 1002. Each Ground relies
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`on DE as a primary reference and argues that, while DE fails to teach or suggest
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`the claimed cap, modifying DE to add the claimed cap would have been obvious.
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`Pet. 27, 40, 45. In support of its obviousness argument, Alere relies primarily on
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`May and May ’871. Id.
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`DE, however, was previously presented to the Office during prosecution and
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`was used repeatedly to reject the pending ’291 patent claims. Ex. 1002. The
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`Office also repeatedly considered the argument that modifying DE to add the
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`claimed cap would have been obvious. After considering these arguments and
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`Alere, Inc. v. Rembrandt Diagnostics, LP
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`applicant’s responses, the Office recognized that the ’291 patent claims were
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`patentable over DE and other prior art. Id.
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`In particular, DE was identified by the Examiner in the initial April 6, 2009
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`Office Action. Ex. 1002, 49. The Examiner in that action relied on DE as a
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`primary reference, and U.S. Patent No. 5,770,458 to Klimov (“Klimov”) as a
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`secondary reference, to reject the pending ’291 patent claims as obvious. Id. at 49.
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`In response, Dr. Lee argued that DE and Klimov failed to suggest a removable cap
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`enclosing the protruding ends of multiple test strips. Id. at 78.
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`In the second Office Action, mailed June 26, 2009, the Examiner
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`nevertheless maintained the rejection over DE and Klimov. Id. at 89. In response,
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`on November 13, 2009, Dr. Lee appealed the rejection to the Board. Id. at 101–
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`102.
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`On appeal, Dr. Lee argued again that adding a removable cap to enclose
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`DE’s multiple test strips would not have been obvious to a POSITA. Id. at 102.
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`The Examiner maintained that adding a cap to DE’s multi-strip base would have
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`been obvious because caps were well known in the art. Id. at 117. The Examiner
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`also contended that adding the claimed cap would have been obvious in view of
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`Klimov’s teaching of “sealing the ends of the test strips ‘to prevent leakage.’” Id.
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`at 117. On Reply, Dr. Lee maintained that modifying DE to add the claimed cap
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`was patentable and pointed out that the Examiner failed to adequately support the
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`Alere, Inc. v. Rembrandt Diagnostics, LP
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`argument that adding a cap to a multi-strip holder would have been obvious. Id. at
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`122.
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`The Board reversed the Examiner’s rejection over DE in view of Klimov,
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`explaining that the Examiner did not show that the combination rendered the
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`claims unpatentable. Id. at 131.
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`After the Board’s decision, the Examiner updated the search and issued
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`another Office Action. Id. at 159. This time, however, the Examiner dropped the
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`obviousness rejection based on DE. Id. After Dr. Lee addressed an outstanding
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`terminal disclaimer question, the Office allowed the ’291 patent claims to issue.
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`Id. at 165, 172.
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`Thus, during prosecution, the Office repeatedly and thoroughly considered
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`DE and the argument that modifying DE’s multi-strip holder to include the claimed
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`cap would have been obvious. The Office rejected that argument and the
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`Examiner conceded the claims were patentable over DE and the prior art. Because
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`Alere presents the same arguments here in its Petition, the Board should decline to
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`institute on Grounds I–III.
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`Alere’s secondary references in Grounds I–III, May and May ’871, were
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`also presented to the Office. While the Office did not include May or May ’871 in
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`its repeated rejections of the ’291 patent claims, May was identified to the Office
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`in the specification of the ’291 patent and incorporated into the specification by
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`reference. Ex. 1001, 6:2–3. Despite multiple searches and reviews, the Office did
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`not reject the claims over May, but rather allowed the claims over it. Alere’s
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`reliance on May therefore offers nothing beyond what was already presented to the
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`Office. And because May ’871’s disclosure matches that of May, neither does it
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`provide anything beyond what was already presented and considered by the Office.
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`Alere contends that the Office did not consider May. Pet. 13. But the fact
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`that the Examiner did not include May in a rejection does not mean that he did not
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`consider it. The Examiner and Board would have reviewed the specification of the
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`’291 patent, including the May patent, undercutting the suggestion that the Office
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`did not consider it.
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`Alere’s other secondary reference is Charm. While Charm was not included
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`in the ’291 patent specification or otherwise presented to the Office during
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`prosecution, Charm is substantially the same as Klimov. The Office repeatedly
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`said that Klimov taught a seal at the end of the strips to prevent leakage. Ex. 1002,
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`115. Similarly, Charm teaches a cap that is “adapted to fit over the open
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`application end 16 of the housing 12” that “protect[s] the test device . . . after
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`contact with the liquid sample.” Ex. 1008, 3:45–48. The cap 22, moreover, is
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`“adapted to fit over the open application end 16 of the housing 12.” Id. at 5:5–6.
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`Figure 1 from Charm is shown below.
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`Charm’s cap 22, like Klimov’s cap (as described by the Examiner (Ex. 1002,
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`117)), is a seal at the end of the strips to prevent leakage. Charm’s cap 22, again
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`like Klimov’s cap, does not enclose any test strip ends. Ex. 1008, Fig. 1. Alere’s
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`argument based on Charm is therefore substantially the same as the Examiner’s
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`argument based on Klimov. Thus, that argument was previously considered and
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`determined not to render the claimed invention obvious when combined with DE.
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`Ex. 1002, 172.
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`Finally, Alere attempts to distinguish the prosecution arguments and avoid
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`application of 35 U.S.C. § 325(d) by pointing to its Declaration. Pet. 17. But, as
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`explained above in Part II.A, Alere’s Declaration is just a copy of its Petition
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`arguments and provides no reasoning why a POSITA would make the claimed
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`combination absent hindsight. Thus, it should be disregarded.
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`Because the prior art and arguments in Alere’s Grounds I–III are the same or
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`substantially the same as those previously presented to the Office, the Board
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`should exercise its discretion and decline institution on Grounds I–III.
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`3.
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`The Board should also decline institution on Grounds IV–
`IX for two additional reasons
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`i.
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`Alere’s primary references Cipkowski and Sun are
`substantially the same as DE, justifying dismissal
`under 35 U.S.C. § 325(d)
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`Cipkowski and Sun, Alere’s primary references for Grounds IV–IX, are
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`substantially the same as DE, which was already presented to, and thoroughly
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`considered by, the Office during prosecution. Supra Part II.A.2. The Board
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`should therefore decline institution on those Grounds under 35 U.S.C. § 325(d).
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`Alere itself describes that DE, Cipkowski, and Sun are all dipstick-format
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`multi-strip devices, with test strips protruding from a housing. Pet. 7. Alere also
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`explains how all three references describe devices with one or more windows or
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`apertures for viewing different parts of a test strip. Id. at 9. After discussing their
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`similarities, however, Alere then suggests that DE, Cipkowski, and Sun are not
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`redundant in view of one another. Pet. 25–26. In support of this proposition, Alere
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`calls DE a “dipstick device,” Cipkowski a “test card,” and Sun a “panel.” Pet. 26.
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`But Alere fails to explain how these semantic differences equate to any material
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`differences in view of its challenges to the ’291 patent claims. Alere’s Petition, in
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`fact, undercuts the suggestion of non-redundancy. Alere contends that each
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`primary reference includes each limitation of the challenged claims except for the
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`cap. See Pet. 27, 48, 64.
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`Alere points out that, in contrast to DE, the windows in Cipkowski’s cover
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`are open apertures (i.e., no solid cover that can be seen-through). Pet. 53. This
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`difference, however, is immaterial. As outlined above in Part II.B, “transparent
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`window” should be construed as “an area through which objects or images can be
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`seen,” which would cover both a solid, see-through cover, as well as an open
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`aperture. Alere argues that “transparent window,” as claimed, does not include an
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`open aperture. Pet. 15–16. To the extent Alere’s argument is accepted, Cipkowski
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`is less relevant that DE, which Alere contends does disclose a solid or see-through
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`cover, and which was already thoroughly considered by the Office. Pet. 33; supra
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`Part II.A.2. For this additional reason, considering Alere’s argument based on
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`Cipkowski’s less relevant open aperture would not be in the interest of a just,
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`speedy, and inexpensive resolution of a proceeding. 37 C.F.R. § 42.1(b).
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`Similarly, Alere admits that, in contrast to DE, Sun does not expressly teach
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`test strips with a “control zone.” Pet. 66–67. Here again, if Alere’s argument is
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`accepted as true, this difference establishes that the already considered DE is more
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`relevant to the claimed invention than Sun. Thus, Sun’s consideration would not
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`be in the interest of a just, speedy, and inexpensive resolution of a proceeding. 37
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`C.F.R. § 42.1(b).
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`ii.
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`Cipkowski and Sun would have discouraged a
`POSITA from modifying a dip holder to include the
`claimed cap
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`Grounds IV–IX should also be rejected because Alere’s primary references,
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`Cipkowski and Sun, would have discouraged a POSITA from adding the claimed
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`cap.
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`While Alere acknowledges that Cipkowski fails to teach a “cap enclosing the
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`protruding ends of the test strips,” Alere contends that a POSITA would
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`nevertheless be motivated to add a cap to enclose the protruding ends of the test
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`strips shown in Cipkowski’s Figure 9. Pet. 55. Cipkowski’s Figure 9 embodiment
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`differs from the others in that the lower portions of the holder below the max-fill
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`line are removed, allowing the test strips to protrude beyond the end of the card.
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`Ex. 1006, 5:4-8.
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`The other embodiments in Cipkowski, on the other hand, include test strips
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`with ends that are encased by the holder. As shown below, Cipkowski’s Figures 3
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`and 10, for example, depict holders surrounding and encasing the test strips’ ends.
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`Cipkowski thus already teaches a strategy for protecting the test strips’ ends:
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`encasing them as part of the test card holder. According to Cipkowski, protecting
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`the strips can be accomplished by covering the bottom and top faces of the strips
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`with an additional ply. Ex. 1006, 5:12–19 (“The top and bottom faces of the
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`central ply 45 are covered by a bottom ply 46 and a top ply 47”). Alere fails to
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`explain why a POSITA would be motivated to ignore the strategy already taught in
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`Cipkowski and instead enclose the protruding test-strip ends with a cap.
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`Sun, Alere’s other primary reference for Grounds IV–IX, also would have
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`discouraged a POSITA from adding a “cap enclosing the protruding ends of the
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`test strips,” as required by the challenged claims. Sun discloses a multi-strip panel,
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`with each strip housed in a separate holder structure. Ex. 1007, Abstract. Sun’s
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`holders are designed to removably attach together, so a user can select the number
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`and type of strips to join to create a multi-strip device. Ex. 1007, Abstract. Sun’s
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`benefit is that “the user is not confined to a set number” of tests. Ex. 1007, 4:36–
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`38. Shown below are Sun’s Figure 7, which shows a single housing and strip, as
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`well as Sun’s Figure 8, which shows multiple housings attached together.
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`Sun’s expandable housing design undercuts any motivation to modify Sun’s
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`holders to include a cap. Because the purpose of Sun’s designs is to give the user
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`control over the number and arrangement of holders, the manufacturer will not
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`know how large a device the user will end up with. The manufacturer thus will not
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`know how large a cap will be needed to cover the strips. This uncertainty, and the
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`desire to give the user flexibility, undercuts Alere’s suggested motivation to alter
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`Sun. Indeed, Sun would lead a POSITA way from modifying the holders to
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`include a cap.
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`III. CONCLUSION
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`For the foregoing reasons, Alere has failed to meet its burden to show that a
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`review should be instituted on any Ground. Rembrandt therefore respectfully
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`requests that the Board deny the Petition.
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`Respectfully submitted,
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`KNOBBE, MARTENS, OLSON & BEAR, LLP
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`
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`By: /Jared C. Bunker/
`Joseph F. Jennings (Reg. No. 40,664)
`Jared C. Bunker (Reg. No. 58,474)
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`Attorneys for Patent Owner
`REMBRANDT DIAGNOSTICS, LP
` (949) 760-0404
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`Dated: November 15, 2016
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`CERTIFICATE OF TYPE-VOLUME LIMITATIONS
`UNDER 37 C.F.R. § 42.24
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`Pursuant to 37 C.F.R. § 42.24(d), Counsel for Patent Owner Rembrandt
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`
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`Diagnostics, LP hereby certify that this Preliminary Response complies with the
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`type-volume limitation of 37 C.F.R. § 42.24(a)(1)(i). According to Microsoft
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`Office Word 2010’s word count, this Petition contains approximately 4,098 words,
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`including any statement of material facts to be admitted or denied in support of the
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`petition, and excluding the table of contents, table of authorities, grounds for
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`standing under § 42.104, mandatory notices under § 42.8, certificate of service or
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`word count, or appendix of exhibits or claim listing.
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`Respectfully submitted,
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`KNOBBE, MARTENS, OLSON & BEAR, LLP
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`
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`By: /Jared C. Bunker/
`Joseph F. Jennings (Reg. No. 40,664)
`Jared C. Bunker (Reg. No. 58,474)
`Attorneys for Patent Owner
`REMBRANDT DIAGNOSTICS, LP
` (949) 760-0404
`
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`-25-
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`Dated: November 15, 2016
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`IPR2016-01498
`Alere, Inc. v. Rembrandt Diagno