`
`
`
`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
`Email: BoxREMPIL.001LP@knobbe.com
`
`
`
`
`
`Filed: November 1, 2021
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`ALERE, INC.
`
`Petitioner,
`
`v.
`
`REMBRANDT DIAGNOSTICS, LP
`
`Patent Owner
`__________________________________
`
`Case No. IPR2016-01502
`U.S. Patent 6,548,019
`__________________________________
`
`PATENT OWNER’S REQUEST FOR REVIEW BY THE DIRECTOR
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page No.
`
`INTRODUCTION .................................................................................... 1
`I.
`II. BACKGROUND ...................................................................................... 2
`A.
`Procedural History .......................................................................... 2
`B.
`Technical Background .................................................................... 5
`III. ARGUMENT ............................................................................................ 6
`A. Alere’s New Declaration And Reply Went Beyond The
`Proper Scope And Should Have Been Excluded In Their
`Entirety—The Board’s Failure To Do So Justifies Reversal ......... 6
`The Board’s Reliance On Alere’s New Declaration And
`Reply Also Justifies Reversal ......................................................... 7
`The Board Also Erred In Finding That Charm And May
`Each Discloses A Device With Multiple Test Strips In A
`Single Channel ............................................................................... 9
`The Board Also Erred In Finding That One Of Ordinary
`Skill Would Have Been Motivated And Reasonably
`Expected To Successfully Reverse Tydings’s Design ................. 12
`IV. CONCLUSION ....................................................................................... 15
`
`
`
`B.
`
`C.
`
`D.
`
`-i-
`
`
`
`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Alere, Inc. v. Rembrandt Diagnostics, LP,
`791 Fed. Appx. 173 (Fed. Cir. 2019) ......................................................... 3, 4
`Intel. Bioystems, Inc. v. Illumina Cambridge Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) ..................................................................... 6
`In re Stepan,
`868 F.3d 1342 (Fed. Cir. 2017) ................................................................... 12
`TQ Delta v. Cisco Systs.,
`942 F.3d 1352 (Fed. Cir 2019) .............................................................. 10, 13
`OTHER AUTHORITIES
`35 U.S.C. § 312 ............................................................................................... 6, 9
`37 C.F.R. § 42.23 ............................................................................................ 6, 9
`77 Fed. Reg. 48,756 (Aug. 14, 2012).................................................................. 6
`
`
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`-ii-
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`
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`IPR2016-01502
`Alere, Inc. v. Rembrandt Diagnostics, LP
`
`I. INTRODUCTION
`
`The Board originally determined that Alere had failed to show even a
`
`likelihood of proving the unpatentability of claims 3-6 and 10 based on certain
`
`grounds. In doing so, the Board identified several gaps and inconsistencies in
`
`Alere’s petition. Following remand from the Federal Circuit based on SAS Institute,
`
`Alere used the Board’s institution decision as a roadmap in an attempt to fill in those
`
`gaps and correct the inconsistencies. It did so by submitting and relying on new
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`expert testimony and arguments.
`
`Rembrandt informed the Board of these procedural irregularities. In spite of
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`Rembrandt’s objections, the Board, in the Final Written Decision on Remand
`
`(“FWD on Remand”), relied on portions of that new testimony and arguments to
`
`find those claims unpatentable based on the same grounds it had originally rejected
`
`as deficient.
`
`Alere’s new testimony and arguments should have been excluded because
`
`they went beyond responding to Rembrandt’s arguments on remand. The Board
`
`compounded this error by relying on the new testimony and arguments to find claims
`
`3-6 and 10 unpatentable. The additional testimony and arguments, moreover, are
`
`conclusory, conflict with the record, and lack substantial evidentiary support. The
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`Board’s decision should be reversed.
`
`-1-
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`IPR2016-01502
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`II. BACKGROUND
`
`A.
`
`Procedural History
`In 2016, Alere filed an IPR petition challenging claims 1-6 and 9-15 of the
`
`’019 patent. Paper 2, 5. In its petition, Alere asserted thirteen grounds of
`
`unpatentability based on eight prior art references. Id. at i-ii. Alere relied on a
`
`declaration from Dr. Robert Bohannon. Ex. 1003.
`
`In response to Alere’s petition, the Board agreed to institute review of claims
`
`1-5, 9, and 11-15 on certain grounds, but it declined to institute review as to those
`
`same claims on other grounds. Paper 13, 36-37. The Board also denied institution
`
`on any grounds challenging claims 6 and 10. Id. In declining to review claim 10
`
`based on Alere’s Ground IV, the Board found that Alere and Dr. Bohannon failed to
`
`show a likelihood of establishing claim 10 unpatentable based on MacKay in view
`
`of Charm or May:
`
`Petitioner and Dr. Bohannon do not explain sufficiently how the single
`channel device of MacKay would be modified to accept multiple test
`strips within a single flow control channel. Nor do Petitioner and Dr.
`Bohannon explain sufficiently why a person of ordinary skill in the art
`would have concluded from the use of a single test strip within a single
`flow control channel in Charm and May that any additional test strips
`would be placed in the same flow control channel, as opposed to each
`being placed in their own individual flow channels.
`
`Id. at 31. The Board noted that Dr. Bohannon’s testimony on this point was
`
`conclusory and failed to address conflicting statements in the prior art. Id. at 31-32.
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`-2-
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`IPR2016-01502
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`In declining to review claims 3-6 based on Alere’s Ground XII, the Board similarly
`
`found that Alere and Dr. Bohannon had failed to meet the threshold of showing a
`
`likelihood of establishing unpatentability. Id. at 35-36.
`
`The scope of the original proceeding was further reduced after Rembrandt
`
`dedicated to the public claims 1, 9, and 11-15. Ex. 2016. Thus, the only remaining
`
`claims of the ’019 patent subject to the original proceeding were claim 2 (Ground I,
`
`MacKay) and claims 3-5 (Ground II, MacKay in view of Cipkowski).
`
`Rembrandt responded to the petition and submitted a declaration from Dr.
`
`Salvatore Salamone. Paper 15; Ex. 2018. Alere filed a reply and submitted an
`
`additional declaration from Dr. Bohannon. Paper 20; Ex. 1023. The Board held an
`
`oral hearing and issued a final written decision (“original FWD”), in which the Board
`
`held that claim 2 had been shown to be unpatentable but that claims 3-5 had not been
`
`shown to be unpatentable. Paper 39, 26.
`
`Alere appealed the Board’s original FWD to the Federal Circuit, challenging
`
`the Board’s construction of a claim phrase (the “wherein clause”) and the Board’s
`
`decision confirming the patentability of claims 3-5. Alere, Inc. v. Rembrandt
`
`Diagnostics, LP, 791 Fed. Appx. 173, 174 (Fed. Cir. 2019). Alere also asked the
`
`Federal Circuit to remand the proceedings under SAS Institute for the Board to issue
`
`a decision on all non-instituted grounds and claims. Id.
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`-3-
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`IPR2016-01502
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`The Federal Circuit affirmed the Board’s construction of the “wherein
`
`clause,” vacated the remainder of the Board’s original FWD, and, under SAS
`
`Institute, remanded for the Board to address all grounds and claims. Id.
`
`On remand, the PTAB ordered further briefing, and the parties agreed that the
`
`following six grounds remained at issue:
`
`Ground Reference(s)
`II
`MacKay and Cipkowski
`IV
`MacKay, Charm, and May
`V
`Lee-Own
`VI
`Lee-Own and Tydings
`XI
`DE and Cipkowski
`XII
`Tydings, MacKay, and Lee-Own
`
`Basis Claims Challenged
`§ 103
`3–6
`§ 103
`10
`§ 102
`3–6
`§ 103
`3–6
`§ 103
`3–6
`§ 103
`3–6, 10
`
`
`Paper 44. Pursuant to the Board’s Order, Rembrandt filed a patent owner response
`
`addressing these grounds. Rembrandt did not submit new expert testimony but
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`instead pointed out how Alere had failed to satisfy its prima facie burden of proof.
`
`See, e.g., Paper 45, 22, 25-26, 29, 36, 39. In reply, Alere submitted new testimony
`
`from Dr. Bohannon. Paper 46; Ex. 1024. The Board heard oral arguments and
`
`issued the FWD on Remand. In its FWD on Remand, the Board, relying on Dr.
`
`Bohannon’s new testimony, determined that (1) claim 10 had been shown to be
`
`unpatentable based on MacKay in view of Charm or May (Ground IV), and (2)
`
`claims 3-6 had been shown to be unpatentable based on Tydings in view of MacKay
`
`or Lee-Own (Ground XII). Paper 53, 63.
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`-4-
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`IPR2016-01502
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`B.
`
`Technical Background
`The ’019 patent relates to rapid, easy-to-use drug test cups. The claimed cups
`
`include one or more test strips contained in flow control channels. Ex. 1001, 6
`
`(5:57–6:2). These channels include an open end and five closed or liquid impervious
`
`sides and control the volume of sample fluid introduced into the test strips by
`
`creating an air pocket or ambient pressure within the channel equivalent to the
`
`ambient pressure outside the channel. Id. (6:10-11). The ’019 patent also describes
`
`a holder for holding the assembly of test strips and flow control channels inside the
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`cup. Id. at 7 (7:11-12).
`
`The channel openings are oriented toward the container base. Id. at 3 (Fig.
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`6); id. at 7 (7:11-28); id. at 6 (5:53-55); Ex. 2018 ¶ 18. In this arrangement, sample
`
`fluid directly contacts the test strips and moves up the test strip “[a]s assay sample
`
`fluid collects in [the] cup.” Ex. 1001, 1 (Abstract); id. at 6 (6:55-57). There is no
`
`need for a wicking material to deliver fluid to the strips to initiate the test. See id.;
`
`see also id. at 7 (7:54-58). And because of the channel and test strip orientation, as
`
`well as the resulting air pocket created by the flow control channel, flooding is
`
`prevented, even without the wicking material. Id.
`
`Challenged claims 3-6 and 10 include this arrangement of test strips oriented
`
`toward the container base and the absence of an intermediate wicking material. See
`
`id. at 7 (8:57-59). In addition to the preferred embodiment with multiple channels
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`-5-
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`
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`IPR2016-01502
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`and a single test strip disposed in each channel, the ’019 patent also describes an
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`embodiment with multiple strips inside a single flow control channel. Id. at 6 (6:47-
`
`54). Claim 10 is directed to this alternative. Id. at 8 (10:5-6).
`
`III. ARGUMENT
`
`A. Alere’s New Declaration And Reply Went Beyond The Proper Scope And
`Should Have Been Excluded In Their Entirety—The Board’s Failure To
`Do So Justifies Reversal
`Because of the nature of IPR proceedings, “it is of the utmost importance that
`
`petitioners . . . adhere to the requirement that the initial petition identify ‘with
`
`particularity’ the ‘evidence that supports the grounds for the challenge to each
`
`claim.’” Intel. Bioystems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369
`
`(Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)). While a petitioner may reply to
`
`arguments raised in the patent owner response, it may not introduce new evidence
`
`that could have been included in the petition; nor can it present new theories that
`
`could have been included. Id.; see also 37 C.F.R. § 42.23(b). An improper reply
`
`will not be considered and the Board will not “sort proper from improper portions.”
`
`77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012).
`
`Here, Dr. Bohannon’s new declaration and Alere’s reply went beyond
`
`responding to arguments raised in Rembrandt’s patent owner response and presented
`
`new evidence and arguments to fill in gaps identified by Rembrandt and the Board.
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`This is not a situation where Rembrandt opened the door to new evidence and
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`-6-
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`IPR2016-01502
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`arguments by submitting its own new testimony. Instead, Rembrandt relied on
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`pointing out the ways Alere had failed to satisfy its prima facie burden. See, e.g.,
`
`Paper 45, 22, 25-26, 29, 36, 39; see also Paper 49, 1.
`
`For example, Alere presented three new theories regarding its combination of
`
`MacKay and Cipkowski in Ground II. First, Alere newly argued that one of ordinary
`
`skill could have combined MacKay and Cipkowski in an alternative sequence. Paper
`
`46, 5-8; Ex. 1024 ¶¶ 20-31. Second, Alere newly argued that Cipkowski’s inner
`
`closure insert could be modified to include “small open spaces” around the holder
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`to permit fluid delivery using some type of fluid transfer instrument, such as a stent,
`
`catheter, tube, dropper, or pipette. Paper 46, 13-14; Ex. 1024 ¶¶ 20-31. Third, Alere
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`also proposed for the first time that one of ordinary skill could have instead modified
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`Cipkowski’s inner closure insert to include one large opening. Paper 46, 14; Ex.
`
`1024 ¶¶ 20-31.
`
`None of these theories was in Alere’s petition. See Paper 2. Alere’s reply and
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`Dr. Bohannon’s new declaration thus should have been excluded in their entirety.
`
`The Board’s failure to follow the laws and guidelines dictating the proper scope of
`
`reply justifies reversal of the FWD on Remand.
`
`B.
`
`The Board’s Reliance On Alere’s New Declaration And Reply Also
`Justifies Reversal
`Not only did the Board refuse to disregard Alere’s new evidence and
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`-7-
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`IPR2016-01502
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`arguments, it specifically relied on portions of them in finding the challenged claims
`
`unpatentable. For example, regarding Ground IV (claim 10 and MacKay in view of
`
`Charm or May), Alere and Dr. Bohannon attempted to backfill their failure at the
`
`petition stage to present evidence and explain how the single-test-strip holder of
`
`MacKay would be modified to incorporate multiple test strips, and their failure to
`
`present evidence and explain why the ordinary artisan would have made such
`
`changes. They asserted for the first time on reply that one of ordinary skill would
`
`have been motivated to do so to create a test that is cheaper and that uses fewer
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`resources. Paper 46, 22; Ex. 1024 ¶ 47.
`
`Alere and Dr. Bohannon similarly asserted for the first time in reply that
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`modifying MacKay’s holder to incorporate multiple test strips required only
`
`adjusting the device's width. Paper 46, 23-24; Ex. 1024 ¶ 49. In part, the Board
`
`originally declined to institute review based precisely on the absence of these
`
`assertions. Paper 13, 31-32. Thus, there is no doubt that Alere’s reply went beyond
`
`the proper scope by attempting to supply prima facie evidence of unpatentability.
`
`See 35 U.S.C. § 312(a)(3).
`
`Regarding Ground XII (claims 3-6 based on Tydings in view of MacKay and
`
`Lee-Own1), Alere and Dr. Bohannon similarly failed to present evidence and explain
`
`
`1 The ’019 patent is a continuation-in-part of Tydings, and Tydings was the principal
`reference applied by the Examiner during the ’019 patent prosecution. Ex. 1002,
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`-8-
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`IPR2016-01502
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`at the petition stage why one of ordinary skill would have been motivated to
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`eliminate the wicking material in Tydings and reorient the test strips to enable direct
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`contact between the fluid sample and the test strips. Paper 13, 34-36; Paper 45, 36.
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`On reply, Alere and Dr. Bohannon tried to also fill this gap with new evidence and
`
`arguments that one of ordinary skill would have been motivated to do so to reduce
`
`costs and “simplify” Tydings’s devices. Paper 46, 31; Ex. 1024 ¶ 70.
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`These new assertions are part of the prima facie showing Alere was required
`
`to make in its petition. As Rembrant pointed out to the Board, including them for
`
`the first time in a reply declaration responding to an institution decision goes beyond
`
`the proper scope and violates 35 U.S.C. § 312(a)(3) and 37 C.F.R. § 42.23(b). The
`
`Board therefore erred in relying on Alere’s new testimony and arguments. See Paper
`
`53, 21-24 (relying on Dr. Bohannon’s new declaration in determining patentability
`
`of claim 10), 33-35 (relying on Dr. Bohannon’s new declaration in determining
`
`patentability of claims 3-6). The FWD on Remand should be reversed.
`
`C. The Board Also Erred In Finding That Charm And May Each Discloses
`A Device With Multiple Test Strips In A Single Channel
`Alere’s new testimony and arguments, in any event, still fail to adequately
`
`support the Board’s decision in Ground IV that claim 10 is unpatentable. In
`
`
`87-89, 104-108, 143, 150-155. MacKay was also considered by the Examiner during
`prosecution. Id. at 138.
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`-9-
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`IPR2016-01502
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`particular, the Board’s finding that the secondary references, Charm and May,
`
`disclose a device with multiple test strips in a single channel is unsupported and
`
`conflicts with the prior-art teachings as a whole. The general language in these prior-
`
`art references is insufficient to support the Board’s finding, particularly given
`
`MacKay’s and the other prior-art references’ warnings against incorporating
`
`multiple test strips. See TQ Delta v. Cisco Systs., 942 F.3d 1352, 1359-63 (Fed. Cir
`
`2019) (rejecting obviousness determinations based on “conclusory and unsupported
`
`expert testimony” because “crediting such testimony risks allowing the challenger
`
`to use the challenged patent as a roadmap to reconstruct the claimed invention.”).
`
`Regarding Charm, the Board relies on a portion of a single sentence taken out
`
`of context. In particular, Charm includes a paragraph describing how a user can
`
`select a test strip from a variety to target a specific substance or class of substances,
`
`or even select a strip from among those designed to test different fluid types, such
`
`as urine or milk, and then identifies the preferred target substances and test fluid.
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`Ex. 1006, 10 (3:55-4:12). After reciting this preferred embodiment, however, the
`
`paragraph concludes with “however, the test device may employ one or more test
`
`strips directed to a variety of tests.” Id. The Board relied on this final phrase.
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`This phrase merely reflects the common practice of noting that an invention
`
`is not limited to its preferred embodiment—it reinforces the preceding discussion
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`that the housing can accommodate a test strip selected from a variety of options. It
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`-10-
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`IPR2016-01502
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`does not say that the housing accommodates a variety or multiple test strips at the
`
`same time. See Ex. 1006. There is no description of a housing that can accommodate
`
`more than one test strip; there is similarly no figure in Charm showing an
`
`embodiment with multiple test strips in a single flow-control channel. See id.
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`Moreover, the Board’s finding that Charm discloses multiple test strips in a
`
`single flow-control channel is contrary to teachings in the prior art—including
`
`Charm itself—of the risks of cross-contamination. Paper 45, 26; Paper 49, 14; see
`
`also Ex. 1009, 4 (2:59–63) (“isolate each assay strip 12 from each other and prevent
`
`contamination from either the urine or another assay strip 12.”).
`
`Regarding May, the Board points to the general statement that “a device
`
`according to the invention can incorporate two or more discrete bodies of porous
`
`solid phase material, e.g. separate strips or sheets.” Paper 53, 21 (citing Ex. 1012,
`
`10 (6:26-36)). But there are many embodiments described in May, and May does
`
`not connect the general statement about including separate strips to the embodiment
`
`that includes the alleged flow control channel. See Ex. 1012; see also id. at 8 (2:3-
`
`8), 12 (10:45-60). Even within a single reference, combining separate features
`
`requires a showing of motivation and reasonable expectation of success, In re
`
`Stepan, 868 F.3d 1342, 1346 n.1 (Fed. Cir. 2017), which was not done here.
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`As with Charm, there is no description in May of a casing that can
`
`accommodate more than one test strip. There is also no figure in May showing
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`-11-
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`IPR2016-01502
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`multiple test strips in a single flow-control channel or casing. There is similarly no
`
`indication that May is limited to a single housing or casing. Indeed, other prior-art
`
`examples of assay devices with multiple strips show each strip in a separate slot or
`
`channel, undercutting the Board’s finding. See Paper 45, 26.
`
`D. The Board Also Erred In Finding That One Of Ordinary Skill Would
`Have Been Motivated And Reasonably Expected To Successfully Reverse
`Tydings’s Design
`The Board initially determined that Alere’s Ground XII challenge to claims
`
`3-6 based on Tydings in view of MacKay or Lee-Own had no substantial likelihood
`
`of success and refused to institute review. Paper 13, 34-36. Tydings had been
`
`repeatedly addressed and distinguished during the prosecution of claims 3-6 (Ex.
`
`1002, 87-89, 104-108, 143, 150-155), and the Board initially concluded that Dr.
`
`Bohannon’s testimony in this IPR had material gaps and failed to satisfy even the
`
`threshold evidentiary burden to explain why one of ordinary skill would have been
`
`motivated to and reasonably expected to successfully reverse Tydings’s design to
`
`arrive at the challenged claims. Paper 13, 34-36. On remand, however, after Dr.
`
`Bohannon submitted new testimony, the Board determined claims 3-6 were
`
`unpatentable on this ground. Paper 53, 25, 33-37.
`
`Dr. Bohannon’s new testimony is still not supported by substantial evidence.
`
`See TQ Delta, 942 F.3d at 1359-63. In contrast to the devices claimed in the ’019
`
`patent, the devices described in Tydings prevent direct fluid delivery by orienting
`
`-12-
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`IPR2016-01502
`Alere, Inc. v. Rembrandt Diagnostics, LP
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`test strips upward toward the mouth of the container and by relying on an
`
`intermediate wicking material. Ex. 1009, 2 (Fig. 3), 4-5 (2:36-3:9). The
`
`intermediate wicking material is essential to Tydings and is included in each
`
`embodiment described in Tydings. Id. at 1 (Abstract), 4 (1:51, 54, 58-59), 4-5 (2:40-
`
`45, 3:40), 5-6 (4:31-36, 4:52-56, 5:13-18, 6:4-9, 6:23-28)). By relying on an
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`intermediate wicking material, the test strips remain separate from the bulk sample
`
`fluid, in line with federal regulations at the time (Ex. 2017, 13 (1:52-55)), and fluid
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`delivery to the test strips is controlled to avoid flooding. Ex. 1009, 4 (2:59-68).
`
`During prosecution of the application leading to the ’019 patent, the applicant added
`
`claim language to emphasize these significant structural differences from Tydings.
`
`Ex. 1002, 172-73, 175.
`
`To support its finding that an ordinary artisan would have found it obvious to
`
`reverse Tydings’s design to reorient the test strips and eliminate the intermediate
`
`wicking material, the Board relied on Dr. Bohannon’s original declaration (Ex.
`
`1003) at paragraphs 188-190 and his Reply Declaration (Ex. 1024) at paragraphs 69-
`
`71. Paper 53, 33-34. In his original declaration, Dr. Bohannon asserted that
`
`reversing Tydings’s design was “the mere substitution of one known flow control
`
`channel orientation (liquid pervious side up) for another (liquid pervious side
`
`down).” Ex. 1003 ¶ 190. But Dr. Bohannon did not explain why an ordinary artisan
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`-13-
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`IPR2016-01502
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`would have abandoned the test strip orientation and intermediate wicking material
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`that were core to Tydings. See Paper 13, 5-6.
`
`Using the Board’s institution decision as a roadmap, in his new declaration,
`
`Dr. Bohannon offered a new reason why one of ordinary skill would have been
`
`motivated to reorient the test strips in Tydings and to eliminate the wicking material
`
`in each embodiment in Tydings. Ex. 1024 ¶ 70. Without any support, Dr. Bohannon
`
`asserted that one of ordinary skill would have been motivated to do so “to reduce
`
`cost and to simplify the Tydings device.” Id. Dr. Bohannon explains nothing about
`
`the cost of the holder in MacKay or the cost of the multi-layer laminate of Lee-Own
`
`that would lead one to change Tydings’s structure. The Federal Circuit has rejected
`
`such unsupported testimony. TQ Delta, 942 F.3d at 1362.
`
`In his new declaration, Dr. Bohannon also references a statement in Lee-Own
`
`to assert a motivation to modify Tydings to arrive at claims 3-6. Ex. 1024 ¶ 71
`
`(citing Ex. 1008, 7 (3:65-67) (quoting Lee-Own’s statement that, “the assay device
`
`does not require extraneous wicks or pads to augment sample migration, nor are
`
`extra fluids required for sample migration.”). According to Dr. Bohannon, this
`
`statement supports his position that the ordinary artisan would have been motivated
`
`to eliminate Tydings’s wicking material. See id. But again, Dr. Bohannon does not
`
`explain why this statement in Lee-Own, or why a desire to eliminate a wicking
`
`-14-
`
`
`
`IPR2016-01502
`Alere, Inc. v. Rembrandt Diagnostics, LP
`
`material, would outweigh the core teaching in Tydings of incorporating an
`
`intermediate wicking material to control fluid flow.
`
`This asserted motivation to modify Tydings to arrive at the claimed inventions
`
`conflicts with testimony provided by Dr. Salamone (Rembrandt’s technical expert),
`
`as well as statements in the prior art. Dr. Salamone explained that at the time of the
`
`’019 patent, those in the industry wanted to avoid locating test strips such that the
`
`strips would remain soaking in the bulk sample fluid. Ex. 2018 ¶ 52. The industry,
`
`according to Dr. Salamone, was pushing for a test that could separate a portion of
`
`the sample fluid from the remaining bulk sample. Id.; see also Ex. 2017, 13 (1:32-
`
`55). Reversing Tydings’s design to reorient the strips toward the bottom of the
`
`container and to eliminate the wicking material would result in the structure those in
`
`the industry were avoiding. See Ex. 1001, 6 (6:55-60), 7 (8:57-64).
`
`IV. CONCLUSION
`
`Because (1) the Board relied on objected-to evidence and arguments that went
`
`beyond the proper scope of reply, and (2) the relied-on evidence and arguments,
`
`even if proper, do not adequately support the Board’s decision, Rembrandt
`
`respectfully requests the Director reverse the Board’s FWD on Remand and confirm
`
`that Alere failed to satisfy its burden of proving claims 3-6 and 10 of the ’019 patent
`
`unpatentable.
`
`
`
`-15-
`
`
`
`IPR2016-01502
`Alere, Inc. v. Rembrandt Diagnostics, LP
`
`Dated: November 1, 2021
`
`
`
`
`Respectfully submitted,
`
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`
` By: /s/ Jared C. Bunker
`Joseph F. Jennings (Reg. No. 40,664)
`Jared C. Bunker (Reg. No. 58,474)
`Email: BoxREMPIL.001LP@knobbe.com
`Attorneys for Patent Owner
`REMBRANDT DIAGNOSTICS, LP
`
`
`
`-16-
`
`
`
`IPR2016-01502
`Alere, Inc. v. Rembrandt Diagnostics, LP
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that, pursuant to 37 C.F.R. § 42.6(e) and with the agreement
`
`of counsel for Petitioner, a true and correct copy of PATENT OWNER’S
`
`REQUEST FOR REVIEW BY THE DIRECTOR is being served electronically
`
`on November 1, 2021, to the e-mail addresses shown below:
`
`Amanda Hollis (Lead Counsel)
`Amanda.hollis@kirkland.com
`Abbott_Rembrandt_IPR@kirkland.com
`Kourtney Baltzer
`Kourtney.baltzer@kirkland.com
`KIRKLAND & ELLIS LLP
`300 North LaSalle
`Chicago, IL 60654
`Tel: (312) 862-2011
`Fax: (312) 862-2200
`
`
`
`
`Daniel Gross
`Daniel.gross@kirkland.com
`KIRKLAND & ELLIS LLP
`609 Main Street
`Houston, TX 77002
`Tel: (713) 836-3600
`Fax: (713) 836-3601
`
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`
`
`
`/s/ Jared C. Bunker
`Joseph F. Jennings (Reg. No. 40,664)
`Jared C. Bunker (Reg. No. 58,474)
`
`
`Attorneys for Patent Owner
`REMBRANDT DIAGNOSTICS, LP
`
`
`
`Dated: November 1, 2021
`
`
`
`54437465
`
`
`
`
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