Trials@uspto.gov
`571-272-7822
`
`Paper 53
`Entered: February 9, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`ALERE INC.,
`Petitioner,
`
`v.
`
`REMBRANDT DIAGNOSTICS, LP,
`Patent Owner.
`
`
`
`IPR2016-01502
`Patent 6,548,019 B1
`
`
`
`Before CHRISTOPHER L. CRUMBLEY, JON B. TORNQUIST, and
`KIMBERLY McGRAW, Administrative Patent Judges.
`
`TORNQUIST, Administrative Patent Judge.
`
`
`
`JUDGMENT
`Final Written Decision on Remand
`Determining All Challenged Claims Unpatentable
`35 U.S.C. §§ 144, 318(a)
`
`
`
`
`
`

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`IPR2016-01502
`Patent 6,548,019 B1
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`I.
`
`INTRODUCTION
`
`Alere Inc.1 (“Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting
`
`an inter partes review of claims 1–6 and 9–15 of U.S. Patent No.
`
`6,548,019 B1 (Ex. 1001, “the ’019 patent”). Rembrandt Diagnostics, LP
`
`(“Patent Owner”) filed a Preliminary Response to the Petition. Paper 12.
`
`Upon consideration of the Petition and the Preliminary Response, we
`
`determined that Petitioner had demonstrated a reasonable likelihood that it
`
`would prevail with respect to certain challenges to claims 1–5, 9, and 11–15
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`of the ’019 patent. Paper 13, 36–37 (“Inst. Dec.” or “Institution Decision”).
`
`Thus, we instituted inter partes review with respect to whether: (1) claims 1,
`
`9, 12, 14, and 15 are anticipated by Lee-Own;2 (2) claims 9, 11, 12, 14, and
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`15 would have been obvious over Lee-Own and DE ’825; (3) claim 13
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`would have been obvious over Lee-Own, DE ’825, and EP ’701; (4) claims
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`1 and 2 are anticipated by MacKay; (5) claims 3–5, 9, 12, 14, and 15 would
`
`have been obvious over MacKay and Cipkowski; (6) claim 13 would have
`
`been obvious over MacKay, Cipkowski, and EP ’701; and (7) claims 9
`
`and 14 would have been obvious over MacKay and Charm or May. Id. at 6,
`
`36–37.
`
`We did not institute a trial with respect to whether: (1) claims 2–6 are
`
`anticipated by Lee-Own; (2) claims 3–6 would have been obvious over Lee-
`
`Own and Tydings; (3) claim 10 would have been obvious over MacKay and
`
`Charm or May; (4) claims 1–6, 9, 11, 12, 14, and 15 would have been
`
`obvious over DE ’825 or DE ’825 and Cipkowski; (5) claim 13 would have
`
`been obvious over DE ’825, Cipkowski, and EP ’701; (6) claims 1–6, 9–12,
`
`
`1 During the course of this proceeding, Alere Inc. was acquired by Abbott
`Laboratories. Paper 29, 1.
`2 Complete citations for the prior art references are provided in Section II.D.
`
`2
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`Patent 6,548,019 B1
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`14, and 15 would have been obvious over Tydings and MacKay or Lee-
`
`Own; (7) claim 13 would have been obvious over Tydings and Mackay or
`
`Lee-Own and EP ’701; and (8) claim 6 would have been obvious over
`
`MacKay and Cipkowski. Id. at 6, 36; see also infra Section I.D.
`
`Patent Owner subsequently disclaimed claims 1, 9, and 11–15 of the
`
`’019 patent (Ex. 2016, 1), leaving only two of the instituted grounds
`
`remaining for resolution: whether claim 2 is anticipated by McKay and
`
`whether claims 3–5 would have been obvious over the combination of
`
`MacKay and Cipkowski. See Paper 39, 6. Patent Owner filed a response to
`
`the Petition (Paper 15) addressing those remaining grounds on which we
`
`instituted and Petitioner filed a reply to Patent Owner’s response (Paper 20).
`
`An oral hearing was held and a transcript of the hearing is included in the
`
`record (Paper 33).
`
`In our final written decision (Paper 39, “original final written
`
`decision”), issued February 9, 2018, we considered these two grounds and
`
`determined that Petitioner had demonstrated that claim 2 is anticipated by
`
`MacKay, but that Petitioner had failed to demonstrate that the subject matter
`
`of claims 3–5 would have been obvious over the combined disclosures of
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`MacKay and Cipkowski. Paper 39, 19–25. In reaching our decision with
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`respect to the combination of MacKay and Cipkowski, we determined that
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`Petitioner failed to show that these references in combination taught
`
`“a structure that is capable of allowing liquid to enter the container when the
`
`flow control channel is disposed therein,” as required by the first “wherein”
`
`3
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`IPR2016-01502
`Patent 6,548,019 B1
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`clause of claim 1(c),3 and thus by claims 3–5 which depend therefrom. Id. at
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`24.
`
`On April 12, 2018, Petitioner filed a Notice of Appeal with the Court
`
`of Appeals for the Federal Circuit seeking review of our determination that
`
`claims 3–5 of the ’019 patent were not shown to be unpatentable over
`
`MacKay and Cipkowski.4 Paper 40. On April 24, 2018, while the appeal
`
`was pending, the Supreme Court in SAS Institute Inc. v. Iancu, 138 S. Ct.
`
`1348, 1355 (2018), held that in an instituted trial, the Board must decide the
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`patentability of all the claims challenged in a petition.
`
`On October 29, 2019, the Federal Circuit issued a decision affirming
`
`our construction of the first “wherein” clause of claim 1(c). Ex. 3001, 2, 9.
`
`In view of the intervening Supreme Court decision in SAS, and in order to
`
`avoid piecemeal review, however, the Federal Circuit did not review our
`
`determination that claims 3–5 were not shown to be unpatentable, vacated
`
`the remainder of the final written decision, and remanded the case for the
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`Board to review “all claims and grounds included in the petition and issue a
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`complete final written decision.” Id. at 10.
`
`On January 27, 2020, we authorized additional briefing from the
`
`parties “limited to addressing the non-instituted grounds.” Paper 44, 4
`
`(Conduct of the Proceeding and Remand Scheduling Order) (emphasis
`
`added). Subsequently, Patent Owner filed a Response to the Petition (Paper
`
`
`3 Claim 1 of the ’019 patent contains claim elements 1(a), 1(b), and 1(c), and
`two additional “wherein” clauses. Ex. 1001, 8:42–9:2. The Federal Circuit
`identified the two additional “wherein” clauses as part of claim 1(c). Paper
`40, 5, 9. We adopt this nomenclature for purposes of this decision.
`4 On April 27, 2018, Patent Owner filed a Notice of Cross-Appeal.
`Paper 41. This cross-appeal was apparently dismissed. PO Resp. 5 (“Patent
`Owner did not appeal the Board’s decision finding Claim 2 unpatentable.”).
`
`4
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`Patent 6,548,019 B1
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`45, “PO Resp.”), Petitioner filed a Reply (Paper 46, “Pet. Reply”), and
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`Patent Owner filed a Sur-reply (Paper 49, “Sur-reply”). An oral hearing was
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`held on June 22, 2020, and a transcript is included in the record (Paper 52,
`
`“Tr.”).
`
`We have jurisdiction under 35 U.S.C. § 6 and this Final Written
`
`Decision is entered pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`
`II.
`
`BACKGROUND
`
`A.
`
`Related Matters
`
`The parties indicate that the ’019 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.” Pet. 1; see Paper 5, 1.
`
`B.
`
`The ’019 Patent
`
`The ’019 patent is directed to immunoassay devices. Ex. 1001, 1:15.
`
`Figure 2 of the ’019 patent, reproduced below, shows a portion of a prior art
`
`immunoassay device:
`
`
`
`Figure 2 is a cut-away view of one assay means known in the art. Id. at
`
`2:16–17. As shown in Figure 2, in the disclosed prior art device two-sided
`
`solid support backing 8 is covered with wicking material 10 on one side. Id.
`
`at 4:6–8, 4:16–17. One or more assay test strips 12 are provided on
`
`backing 8 and are folded over top edge 15 to bring loading zone 20 of test
`
`5
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`strips 12 into contact with wicking material 10. Id. at 4:6–9, 4:17–20.
`
`The ’019 patent explains that when backing 8 is brought into contact with a
`
`test sample in a collection cup, “the fluid wicks up wicking material 10 to
`
`contact sample loading zone 20 of assay test strip 12.” Id. at 4:23–29.
`
`The ’019 patent reports that the wicking method of the prior art is
`
`undesirable because it is relatively slow to produce results, liquid may not
`
`wick evenly if a small volume of a sample is introduced into the collection
`
`cup, and the need to overlap wicking material 10 and assay test strip 12
`
`results in increased manufacturing costs. Id. at 4:34–53. The ’019 patent
`
`states that, theoretically, the wicking material used to deliver the sample
`
`fluid to assay test strip 12 could be eliminated by simply reversing the
`
`orientation of sample loading zone 20 in cup 2 so that the sample loading is
`
`adjacent to the base of the cup rather than the mouth of the cup, while
`
`retaining “all other features of the device.” Id. at 4:54–58. The ’019 patent
`
`states that in practice this alternative fails because assay test strip 12 rapidly
`
`becomes flooded due to the quantity of assay sample provided in the
`
`collection cup. Id. at 4:61–64.
`
`The ’019 patent discloses, however, that these disadvantages may be
`
`overcome by removing the wicking material and directly introducing a
`
`sample to the sample loading zone of an assay test strip, if a means is
`
`provided to prevent oversaturation of the test strip when a substantial
`
`volume of assay sample fluid is present. Id. at 4:65–5:6. In particular, fluid
`
`flow control is accomplished by placing the assay test strip within a flow
`
`control channel in which the ambient pressure within the flow control
`
`channel is maintained in substantial equilibrium with the ambient pressure
`
`outside the flow control channel. Id. at 1:42–47.
`
`6
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`Patent 6,548,019 B1
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`Figures 3 and 4 of the ’019 patent, reproduced below, show a means
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`for directly contacting the sample loading zone of an assay test strip with a
`
`sample fluid:
`
`
`
`
`
`Figure 3 is a front view of a flow control dipstick assay means and Figure 4
`
`is a cross-section of the assay means of Figure 3 taken along line 4–4. Id. at
`
`2:18–21. As shown in Figures 3 and 4, in the disclosed embodiment “flow
`
`control channel 34 has five liquid impervious walls [35, 35a, 35b, 35c,] and
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`backing 28, and one liquid pervious side consisting of an opening 36 through
`
`which sample loading zone 30 of assay test strip 22 protrudes.” Id. at 6:10–
`
`15. When the flow control channel is oriented in a collection cup with
`
`opening 36 facing the bottom of the cup, fluid within the cup “contacts
`
`sample loading zone 30 and begins migrating upwards through assay test
`
`strip 22.” Id. at 5:53–56, 6:55–57.
`
`The ’019 patent explains that in this orientation, air trapped within
`
`flow control channel 34 prevents the test fluid from flooding the test strip.
`
`Id. at 5:59–64 (“[T]he ambient pressure within the flow control channel is
`
`maintained in substantial equilibrium with the ambient pressure outside of
`
`the flow control channel, even after placement of the flow control channel
`
`into [the] collection container which contains assay sample fluid.”), 6:28–34.
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`7
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`Patent 6,548,019 B1
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`Figure 5 below is a holder for the dipstick assay means depicted in
`
`Figures 3 and 4. Id. at 2:22–23.
`
`
`
`Figure 5 above depicts holder 40 for holding the assay device of Figures 3
`
`and 4 in a collection cup. Id. at 7:11–12. Holder 40 is curved to follow the
`
`inner diameter of cup 2 and has cut-out 44 defining vertical slots 46 and
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`optional horizontal slot 48 for inserting backing 28 of the dipstick assay
`
`means. Id. at 7:12–19. A cap for providing a watertight seal is included to
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`close the collection cup. Id. at 7:38–40.
`
`C.
`
`Illustrative Claims
`
`Claims 1, 3, and 10 are illustrative of the challenged claims and are
`
`reproduced below:
`
`1. A device for collecting and assaying a sample of
`biological fluid, the device comprising:
`
`(a) a flow control channel defined by at least one liquid
`pervious side joined to liquid impervious sides, wherein the
`internal dimensions of the flow control channel are sufficient
`to permit placement therein of an assay test strip;
`
`(b) an assay test strip within the flow control channel, wherein
`the assay test strip has a sample loading zone therein, and
`
`8
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`Patent 6,548,019 B1
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`wherein further the assay test strip is disposed within the
`flow control channel so the sample fluid contacts the sample
`loading zone at a liquid pervious side of the flow control
`channel; and,
`
`(c) a sample fluid container having a base, an open mouth, and
`walls connecting the base to the mouth;
`
`wherein the flow control channel is disposed inside the sample
`fluid container with the liquid pervious side oriented [toward]
`the base of the sample fluid container so that the assay
`sample fluid, when added to the container, is delivered to the
`sample loading zone of the assay test strip by entry through a
`liquid pervious side of the flow control channel without
`migration through an intermediate structure, and wherein
`entry of fluid into the flow control channel creates an
`ambient pressure within the flow control channel equivalent
`to the ambient pressure outside of the flow control channel,
`thereby eliminating a pressure gradient along which excess
`sample fluid could flow into the flow control channel.
`
`Ex. 1001, 8:42–9:2; see also id. at 9 (Certificate of Correction signed
`
`August 12, 2003).
`
`3. A device according to claim 1, wherein one of the
`liquid impervious sides of the flow control channel is formed as
`a portion of a liquid impervious backing; and wherein the
`device [further] comprises a holder fittable inside the fluid
`sample container, the holder having at least one slot formed
`therein to receive the backing.
`
`Id. at 9:6–11; see also id. at 9.
`
`10. A device according to claim 9, wherein all of the
`assay test strips are disposed in a single flow control channel.
`
`Id. at 10:5–6.
`
`D.
`
`Asserted Grounds of Unpatentability
`
`As noted above, subsequent to our Institution Decision, Patent Owner
`
`disclaimed claims 1, 9, and 11–15 of the ’019 patent, and Petitioner did not
`
`appeal our determination finding claim 2 unpatentable. Ex. 2016, 1;
`
`9
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`Patent 6,548,019 B1
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`PO Resp. 5. Thus, of the grounds originally raised in the Petition, the parties
`
`agree that only the following six grounds of unpatentability are at issue
`
`(PO Resp. 1; Pet. Reply 3):
`
`Claim(s) Challenged
`3–6
`10
`3–6
`3–6
`3–6
`3–6, 10
`
`
`35 U.S.C. §
`1035
`103
`102(b)
`103
`103
`103
`
`Reference(s)/Basis
`MacKay6, Cipkowski7
`MacKay, Charm8 or May9
`Lee-Own10
`Lee-Own, Tydings11
`DE ’82512, Cipkowski
`Tydings, MacKay or Lee-Own
`
`E.
`
`Legal Standards
`
`To anticipate a claim under 35 U.S.C. § 102, a reference must
`
`disclose, explicitly or inherently, each and every element of the claimed
`
`invention arranged or combined in the same way as in the claim. In re
`
`Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009).
`
`A patent claim is unpatentable under 35 U.S.C. § 103 if the
`
`differences between the claimed subject matter and the prior art are such that
`
`the subject matter as a whole would have been obvious at the time the
`
`invention was made to a person having ordinary skill in the art to which said
`
`
`5 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011) (“AIA”), included revisions to 35 U.S.C. §§ 102 and 103 that became
`effective after the filing of the application that led to the ’019 Patent.
`Therefore, we apply the pre-AIA versions of 35 U.S.C. §§ 102 and 103.
`6 U.S. Patent No. 5,656,502, issued Aug. 12, 1997 (Ex. 1004).
`7 U.S. Patent No. 5,976,895, issued Nov. 2, 1999 (Ex. 1005).
`8 U.S. Patent No. 5,985,675, issued Nov. 16, 1999 (Ex. 1006).
`9 U.S. Patent No. 5,602,040, issued Feb. 11, 1997 (Ex. 1012).
`10 U.S. Patent No. 5,500,375, issued Mar. 19, 1996 (Ex. 1008).
`11 U.S. Patent No. 6,379,620 B1, issued Apr. 30, 2002 (Ex. 1009).
`12 DE 297 02 825 U1, published May 22, 1997 (Ex. 1010).
`
`10
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`subject matter pertains. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`
`(2007). The question of obviousness is resolved on the basis of underlying
`
`factual determinations, including (1) the scope and content of the prior art;
`
`(2) any differences between the claimed subject matter and the prior art;
`
`(3) the level of ordinary skill in the art; and (4) if in the record, objective
`
`evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18
`
`(1966).
`
`F.
`
`Level of Ordinary Skill in the Art
`
`The parties agree that a person of ordinary skill in the art would have
`
`had “a Bachelor of Science degree (or the equivalent) in a relevant scientific
`
`or engineering field, such as mechanical or biomechanical engineering,
`
`biology, biochemistry or immunology, with 3-5 years of experience in
`
`design, testing, and manufacturing of in vitro devices.” Pet. 10; Ex. 1003
`
`¶ 47 (Declaration of Robert C. Bohannon in support of Petition); Ex. 1024
`
`¶ 14 (Declaration of Robert C. Bohannon in support of Petitioner’s Reply);
`
`PO Resp. 17. As this definition of the ordinarily skilled artisan is both
`
`uncontested and supported by the prior art of record, we adopt it for
`
`purposes of this Decision.
`
`G. Claim Construction
`
`Because the Petition was filed before November 13, 2018, we
`
`previously construed the terms of the ’019 patent “according to their
`
`broadest reasonable interpretation in light of the specification of the patent in
`
`which they appear.” Paper 39, 7; 37 C.F.R. § 42.100(b) (2018). During the
`
`pendency of the appeal, however, the ’019 patent expired. PO Resp. 15.
`
`Thus, we apply the claim construction standard outlined in Phillips v. AWH
`
`Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). See Apple Inc. v. Andrea
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`Elecs. Corp., 949 F.3d 697, 707 (Fed. Cir. 2020) (“When this court reviews
`
`the claim construction of a patent claim term in an IPR appeal after the
`
`patent has expired, such as in this case, we apply the standard established in
`
`Phillips, not the ‘broadest reasonable interpretation.’”). We note, however,
`
`that neither party has argued that the construction of any term of the ’019
`
`patent would change as a result of the change in the applied claim
`
`construction standard.
`
`In our Final Written Decision, we construed the first “wherein” clause
`
`of claim 1(c) (i.e., “wherein the flow control channel is disposed inside the
`
`sample fluid container . . . so that the assay sample fluid, when added to the
`
`container, is delivered to the . . . assay test strip”) to
`
`require a structure that is capable of allowing liquid to enter the
`container when the flow control channel is disposed therein and
`capable of directing this liquid to the sample loading zone of
`the assay test strip without the liquid having to migrate through
`an intermediate structure.
`
`Paper 39, 17. This construction was affirmed by the Federal Circuit under
`
`both the broadest reasonable and Phillips standards of claim construction.
`
`Ex. 3001, 9; see also id. at 7 n.1 (determining that our construction of the
`
`first “wherein” clause is “correct on the point at issue” under either the
`
`broadest reasonable or Phillips standards of claim construction).
`
`The Federal Circuit stated that we correctly construed the “wherein” clause
`
`as creating a functional limitation for structural relationships of the device.
`
`Id. at 9. The Federal Circuit further stated that nothing in the claim language
`
`excludes a container that contains fluid before the flow control channel is
`
`disposed inside, or imports a temporal limitation on when fluid must be
`
`introduced into the container. Id. at 8 (stating, as “the Board pointed out, the
`
`claim recites a device, not a method––an important distinction”).
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`We also determined that the term “device” in the preamble of claim 1
`
`is not limiting and, even if it were, the preamble does not require a single,
`
`unitary structure. Paper 39, 8–15. This construction was not appealed and
`
`neither party argues it can or should be modified on remand. Nor do the
`
`parties assert that any other claim terms of the ’019 patent require
`
`construction for purposes of this Decision. See Nidec Motor Corp. v.
`
`Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)
`
`(quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
`
`(Fed. Cir. 1999) (“[O]nly those terms need be construed that are in
`
`controversy, and only to the extent necessary to resolve the controversy.”)).
`
`III. ANALYSIS
`
`A.
`
`Claim 10 over MacKay and Charm or May
`
`Claim 9 depends from claim 1 and further requires that the device
`
`comprises “additional assay test strips, wherein the additional assay test
`
`strips detect the presence or absence of different analytes in a biological
`
`fluid.” Ex. 1001, 10:1–4. Claim 10 depends from claim 9 and further
`
`requires that “all of the assay test strips are disposed in a single flow control
`
`channel.” Id. at 10:5–6. Petitioner contends the subject matter of claim 10
`
`would have been obvious over the combined disclosures of MacKay and
`
`Charm or May. Pet. 34–37.
`
`In our Institution Decision, we determined Petitioner did not
`
`demonstrate a reasonable likelihood that claim 10 would have been obvious
`
`over MacKay and Charm or May. Inst. Dec. 31–32. We reasoned that
`
`Petitioner did not sufficiently explain how the single channel device of
`
`MacKay would have been modified to accept multiple test strips within a
`
`single flow control channel. Id. Nor was there sufficient explanation why a
`
`person of ordinary skill in the art would have concluded from the use of a
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`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
`
`of MacKay, as opposed to each being placed in their own individual flow
`
`channels. Id. Nevertheless, on the complete record before us, as discussed
`
`in detail below, we determine that Petitioner has shown by a preponderance
`
`of the evidence that claim 10 would have been obvious over the combined
`
`disclosures of MacKay and Charm or May.
`
`1. MacKay
`
`MacKay discloses a test strip holder and a method of using the same.
`
`Ex. 1004, 1:6–7. Figures 4 and 6 of MacKay are reproduced below:
`
`
`
`Figure 4 is a front view of test strip holder 1ˈ of MacKay in “open
`
`condition,” whereas Figure 6 is a front view of test strip holder 1ˈ in “closed
`
`condition.” Id. at 2:56–57, 62–63. In this embodiment, elongated hollow
`
`member 20 is formed from test strip receiving part 21 and test strip covering
`
`part 22, which are connected at hinge 23. Id. at 5:56–60. A test strip is
`
`positioned within test strip receiving part 21 and is “maintained spaced from
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`the sidewalls” by test strip holders 27. Id. at 6:41–55. When test strip
`
`covering part 22 is closed on test strip receiving part 21, peripheral groove
`
`or channel 24 is mated with peripheral protrusion 25 to form an airtight seal.
`
`Id. at 6:4–11. Opening 29 is provided in hollow member 20 to allow for the
`
`entry of liquid into the device, and vent or window 42 is provided to allow
`
`air to exit from the holder when it is immersed in fluid. Id. at 7:1–7, 7:55–
`
`59.
`
`Figures 8A–C of MacKay are reproduced below:
`
`
`
`Figures 8A–C illustrate the insertion of the test strip holder of Figure 4 into a
`
`liquid. Id. at 2:66–67. As shown in Figure 8A–C, as test strip holder 1ˈ is
`
`inserted into liquid L within container C, liquid L enters open end 29 of
`
`elongated hollow member 20 (as shown in Figure 6). Id. at 7:54–57. Air
`
`within elongated hollow member 20 is displaced through vent 42 until liquid
`
`L reaches level L1. At this point, the vent path is no longer open to air,
`
`resulting in increased pressure within elongated member 20 that prevents
`
`liquid L from further entering the holder. Id. at 7:61–67.
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`15
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`2.
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`Charm
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`Charm discloses “an analyte or chemical residue test device and
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`method employing a lateral-flow test strip.” Ex. 1006, 1:34–37. Figure 1 of
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`Charm is reproduced below:
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`Figure 1 is a perspective, exploded view of a molded-housing test device.
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`Id. at 4:40–41. As shown in Figure 1, analyte test device 10 includes
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`molded housing 12, which is “a one-piece, injection-molded, transparent
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`styrene polymer.” Id. at 4:64–66. Housing 12 defines elongate cavity 14
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`with open end 16 and enlarged, rectangular cavity 18. Id. at 4:67–5:2.
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`Protective cap 22 is adapted to fit over open end 16. Id. at 5:4–7. Lateral-
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`flow test strip 28 includes support or backing strip 30, which includes “a
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`treated, mobile-phase, support layer 33 with a visible receptor-probe area 34,
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`a stationary-phase layer 36,” and cellulosic absorbent pad 40 at the distal end
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`of support strip 30 to capture excess liquid sample. Id. at 5:25–30. Charm
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`explains that the disclosed device is particularly useful in detecting
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`antibiotics, toxins, and viruses and that “the test device may employ one or
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`more test strips directed to a variety of tests.” Id. at 4:7–12.
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`In operation, cap 22 is removed prior to use and the open application
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`end of housing 12 is briefly inserted in the liquid to be tested. Id. at 5:38–
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`40. Test device 10 is then removed and pad 32 allowed to expand to fill
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`expansion cavity 18 and start the lateral flow of the sample through test
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`strip 28. Id. at 5:42–45. Cap 22 is preferably “inserted to protect against
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`cross-contamination, and the test device then placed in a horizontal position,
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`with the application cavity 18 extending downwardly in an electric-heated
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`incubator.” Id. at 5:45–49.
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`3. May
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`May discloses a test device that uses reagent-impregnated test strips to
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`detect the presence of an analyte. Ex. 1012, 1:37–59. Figures 3 and 4 of
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`May are reproduced below:
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`Figure 3 is a perspective view of a device utilizing a porous strip and
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`Figure 4 is a perspective view, partially broken away, revealing the porous
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`strip within the device of Figure 3. Id. at 7:66–8:2.
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`May explains that a “typical embodiment of the invention is an
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`analytical test device comprising a hollow casing constructed of
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`moisture-impervious solid material containing a dry porous carrier” that
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`communicates directly or indirectly with the exterior of the casing. Id. at
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`2:3–7. As shown in Figure 3, the device includes flat rectangular body 30
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`having front face 31 that is perforated by circular hole or window 32,
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`revealing porous test strip 10 within the body. Id. at 10:51–54. As shown in
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`Figure 4, test strip 10 extends between the front and back of body 30. Id. at
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`10:57–60. May explains that in operation bottom end 33 of body 30 is
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`immersed in a liquid sample so that the liquid sample can be absorbed by
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`bottom end 11 of test strip 20 and rise by capillary action to top 17 of the test
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`strip. Id. at 11:4–8.
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`Although depicted with only one test strip, May instructs that “a
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`device according to the invention can incorporate two or more discrete
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`bodies of porous solid phase material, e.g., separate strips or sheets, each
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`carrying mobile and immobilized reagents.” Id. at 6:26–30. According to
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`May, “[t]hese discrete bodies can be arranged in parallel, for example, such
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`that a single application of liquid sample to the device initiates sample flow
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`in the discrete bodies simultaneously.” Id. at 6:29–32.
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`4.
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`Analysis
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`a)
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`The Parties’ Arguments
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`Petitioner contends MacKay discloses all of the limitations of claim 1
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`and that May and Charm disclose the use of multiple test strips in a single
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`device, as recited in claim 9. Pet. 21–26, 34–37. Petitioner further contends
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`that one of ordinary skill in the art would have sought to place multiple test
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`strips in the device of MacKay in order to increase the efficiency of
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`MacKay’s device, as disclosed in Charm and May. Pet. 36–38; Ex. 1003
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`¶ 103; Ex. 1024 ¶ 47.
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`With respect to the limitations of claim 10, i.e., placing the multiple
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`test strips in a single flow control channel, Petitioner asserts that “[b]ecause
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`Charm and May . . . disclose only a single flow control channel, a [person of
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`ordinary skill in the art] would have understood the multiple assay test strips
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`of Charm and May” are disposed in a single flow control channel. Pet. 37.
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`And in view of these disclosures, Petitioner contends one of ordinary skill in
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`the art would have also sought to implement multiple test strips, as disclosed
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`in Charm and May, in MacKay’s single flow control channel. Id. (citing
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`Ex. 1003 ¶ 104).
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`Patent Owner contends MacKay’s holder is designed for a single test
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`strip that is “carefully” positioned within MacKay’s enclosure, such that the
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`holder of MacKay supports the test strip away from the walls of the holder,
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`holds the test strip in place through friction, and positions the vent to ensure
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`that the liquid contacts the strip only at predetermined locations. PO Resp.
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`23–24. Patent Owner further contends that “[t]here is no evidence in
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`MacKay that one of ordinary skill would be motivated to modify the careful
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`design of the holder to accommodate variations such as multiple test strips”
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`with a reasonable expectation of success. Id. at 24.
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`Patent Owner further asserts that “[n]either Charm nor May provide
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`the missing motivation or expectation of success.” Id. According to Patent
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`Owner, neither Charm nor May provide a structural description of a device
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`that accommodates more than one test strip, and although May states that a
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`device “can incorporate two or more discrete bodies of porous solid phase
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`material,” “it does not say the two or more bodies are located in the same
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`housing.” Id. at 25–26 (asserting that the mere mention of a device with
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`more than one test strip is “insufficient to establish a motivation” to modify
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`MacKay to arrive at the claimed invention with a reasonable expectation of
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`success). Patent Owner also contends that Petitioner is incorrect to
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`characterize Charm’s device as limited to a single channel, as Charm teaches
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`that the main housing of the device can optionally include an additional,
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`separate housing. Sur-Reply 15 (citing Ex. 1006, 2:59–61). Finally, Patent
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`Owner contends other prior art patents teach locating each test strip in a
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`separate channel and “highlight the risks of cross contamination” in multi-
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`strip assay devices. PO Resp. 26 (citing Ex. 1009, 2:59–63; Ex. 1010, Fig.
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`1).
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`b)
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`Analysis
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`As discussed in the original final written decision, Petitioner
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`persuasively explains where MacKay expressly discloses every limitation of
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`claim 1 of the ’019 patent, including (1) a flow control channel, (2) an assay
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`test strip within the flow control channel, (3) a sample fluid container having
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`a base, an open mouth, and walls connecting the base to the mouth, and
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`(4) disposing the flow control channel inside the sample fluid container with
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`the liquid pervious side oriented towards the base of the sample fluid
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`container, such that liquid added to the container is directed to the flow
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`control channel without having to pass through an intermediate structure.
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`Paper 39, 17–21; Pet. 21–26. Neither party sought additional briefing on
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`this issue or contests this conclusion on remand.13
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`13 Claim 2 depends from claim 1 and further requires “wherein the sides of
`the flow control channel are loosely fitted around the assay test strip.”
`Ex. 1001, 9:3–5. Petitioner demonstrates that the sides of MacKay’s flow
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`With respect to the additional assay test strips requirement of claim 9,
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`Petitioner persuasively argues, with supporting testimony by Dr. Bohannon,
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`that Charm and May both disclose that it is advantageous to use multiple test
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`strips within a single device in order to allow for simultaneous testing of
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`multiple analytes. Pet. 34–37 (citing, inter alia, Ex. 1006, 4:10–12;
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`Ex. 1012, 6:26–36; Ex. 1003 ¶¶ 99–103). Accordingly, we credit
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`Dr. Bohannon’s unrebutted testimony that one of ordinary skill in the art
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`would have sought to incorporate multiple test strips within MacKay’s
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`device in order to detect the presence or absence of different analytes in a
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`singl