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`Trials@uspto.gov
`Tel: 571-272-7822
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`Paper 13
`Entered: February 14, 2017
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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 IPR2016-01498
`Patent 8,623,291 B2
`
`
`Before CHRISTOPHER L. CRUMBLEY, BRIAN P. MURPHY,
`and JON B. TORNQUIST, Administrative Patent Judges.
`
`CRUMBLEY, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
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`IPR2016-01498
`Patent 8,623,291 B2
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`I. INTRODUCTION
`Alere Inc. (“Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting
`an inter partes review of claims 1, 2, and 9 of U.S. Patent No. 8,623,291 B2
`(Ex. 1001, “the ’291 patent”). Rembrandt Diagnostics, LP (“Patent Owner”)
`filed a Preliminary Response to the Petition (Paper 12, “Prelim. Resp.”).
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). The standard for institution is
`set forth in 35 U.S.C. § 314(a), which provides that an inter partes review
`may not be instituted “unless the Director determines . . . there is a
`reasonable likelihood that the petitioner would prevail with respect to at least
`1 of the claims challenged in the petition.”
`After considering the Petition and the Preliminary Response, we
`determine that Petitioner has demonstrated a reasonable likelihood that it
`would prevail with respect to claims 1, 2, and 9 of the ’291 patent.
`Accordingly, we institute inter partes review with respect to those claims.
`
`A. Related Proceeding
`The parties note that the ’291 patent is at issue in Rembrandt
`Diagnostics, LP v. Alere, Inc., Case No. 3:16–cv–00698 (S.D. Cal.). Pet. 1;
`Paper 5, 1.
`
`B. The ’291 Patent
`The ’291 patent is directed to an assay device capable of testing
`multiple analytes, such as drugs. Ex. 1001, Abstract. In one “dipstick
`assay” embodiment of the invention, the test strips are enclosed in a housing,
`with one open end through which the test strips protrude. Id. at 1:38–43. A
`protective cap on the end of the housing encloses the protruding test strips,
`to protect them while not in use. Id. at 1:43–44. A portion of the housing
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`overlying the test strips is transparent, permitting the test and control zones
`of the strips to be viewed. Id. at 1:46–48.
`Figure 2 of the ’291 patent, reproduced below, shows the “dipstick
`assay” embodiment of the claimed device:
`
`
`As shown in Figure 2, the claimed device has multiple test strips extending
`from slots 102A–102E of a housing. Id. at 5:10–11. The test strips have test
`zones 112A–112E and control zones 113A–113E which may be seen
`through transparent window 111. Id. at 5:19–23, 6:8–12. Transparent
`windows 115A–115E permit the labels of the test strips to be viewed. Id. at
`6:20–23.
`
`Figure 1 of the ’291 patent depicts an exploded view of the dipstick
`assay embodiment:
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`Figure 1 shows that the claimed device comprises a housing constructed
`from base 101 and cover 110, and includes test strips 105A–105E and five-
`sided cap 120. Id. at 4:61–63, 5:2–3, 6:26–33. The ’291 patent discloses
`that cap 120 is inserted over open end 106 of base 101, to protect the
`protruding ends of the test strips from contact with other materials, from
`dessication, and from contact with the user. Id. at 6:26–32. “Cap 120 is
`easily secured onto the assay device by a close fit, such as a friction fit or
`snap-fit.” Id. at 6:32–34.
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`C. Challenged Claims
`Claim 1 is illustrative of the challenged claims and is reproduced
`below:
`
`1. A device for assaying a fluid for the presence or absence
`of different analytes comprising:
`(A) a base having adjacent slots therein of sufficient length
`for insertion of part of a test strip therein, wherein each
`slot is defined by (a) a floor, (b) raised walls depending
`upwardly from the floor to separate each adjacent slot
`from the next, and (C) at least one open end,
`(B) a multiplicity of test strips having an upstream and a
`downstream end, wherein a single test strip is inserted into
`each slot of the base so the upstream end of each test strip
`protrudes out of the open end of each slot, and wherein
`each test strip has a test zone and a control zone therein,
`and each test zone contains a binder specific for a different
`analyte; the protruding freestanding end of each test strip
`containing a sample addition pad for direct contact with
`the fluid to be analyzed;
`(C) a cover attached to the upwardmost surface of each raised
`wall of the slots of the base and extending to the open end
`of said base, wherein the cover retains the test strips within
`the slots and has a first transparent window formed therein
`through which the test zone and the control zone of each
`of the test strips can be viewed and
`(D) a cap enclosing the protruding ends of the test strips and
`removably attached to the open end of said base.
`Ex. 1001, 11:10–12:2.
`Claim 2 depends from claim 1 and further requires a “second
`transparent window formed within the cover through which the test strips
`can be viewed.” Id. at 12:3–5. Claim 9 is a method for detecting a
`multiplicity of analytes using the device of claim 1. Id. at 12:26–30.
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`D. The Asserted Grounds of Unpatentability
`Reference(s)
`Basis1 Claim(s) Challenged
`DE ’8252 and May3
`§ 103(a) 1, 2, 9
`DE ’825, Charm,4 and May ’8715
`§ 103(a) 1, 9
`DE ’825, May, Shuler,6 and Eisinger7 § 103(a) 2
`Cipkowski8 and May
`§ 103(a) 1, 2, 9
`Cipkowski, Charm, and May ’871
`§ 103(a) 1, 9
`Cipkowski, May, Shuler, and Eisinger § 103(a) 2
`Sun9 and May
`§ 103(a) 1, 2, 9
`Sun, Charm, and May ’871
`§ 103(a) 1, 9
`Sun, May, Shuler, and Eisinger
`§ 103(a) 2
`
`
`1 The relevant sections of the Leahy-Smith America Invents Act (“AIA”),
`Pub. L. No. 112–29, took effect on March 16, 2013. Because the application
`from which the ’291 patent issued was filed before that date, our citations to
`Title 35 are to its pre-AIA version.
`2 German Patent Application DE 297 02 825 U1, published May 22, 1997
`(Ex. 1004).
`3 U.S. Patent No. 5,602,040 to May et al., issued Feb. 11, 1997 (Ex. 1005).
`4 U.S. Patent No. 5,985,675 to Charm et al., issued Nov. 16, 1999 (Ex.
`1008).
`5 U.S. Patent No. 5,622,871 to May et al., issued Feb. Apr. 22, 1997 (Ex.
`1011).
`6 U.S. Patent No. 5,798,273 to Shuler et al., issued Aug. 25, 1998 (Ex.
`1010).
`7 U.S. Patent No. 4,943,522 to Eisinger et al., issued Jul. 24, 1990 (Ex.
`1009).
`8 U.S. Patent No. 5,976,895 to Cipkowski, issued Nov. 2, 1999 (Ex. 1006).
`9 U.S. Patent No. 5,962,336 to Sun, issued Oct. 5, 1999 (Ex. 1007).
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`Petitioner asserts that DE ’825, May, Eisinger, and May ’871 are prior
`
`art to the ’291 patent under 35 U.S.C. § 102(b), whereas Cipkowski, Sun,
`Charm, and Shuler are prior art under 35 U.S.C. § 102(e). Pet. 4–5. Patent
`Owner does not, at this stage of the proceeding, challenge the prior art status
`of any reference.
`
`II. ANALYSIS
`A. Evidentiary Weight of Declaration Evidence
`In addition to the asserted prior art, the Petition relies upon the
`Declaration of Robert C. Bohannon (Ex. 1003). Patent Owner contends that
`we should accord Dr. Bohannon’s testimony no evidentiary weight. Prelim.
`Resp. 2. Patent Owner asserts that the Declaration is “nearly a word-for-
`word copy of the Petition’s attorney arguments,” and that the Board has
`found such testimony unpersuasive in the past. Id. Patent Owner also
`conjectures that “the Declaration is a copy of the Petition, rather than the
`other way around,” because Dr. Bohannon testifies that he reviewed the
`Petition in forming his opinions. Id. at 3.
`We decline, at this juncture, to disregard the Declaration as Patent
`Owner suggests. While declarations that merely repeat the content of a
`petition may not give an argument “enhanced probative value” (see Kinetic
`Techs., Inc. v. Skyworks Solutions, Inc., Case IPR2014-00530, 13 (PTAB
`Sept. 29, 2014) (Paper 8)), that does not mean the testimony is worthless or
`has no evidentiary value at all. Furthermore, we are not convinced that Dr.
`Bohannon’s statement that he reviewed the Petition in forming his opinions
`necessarily means his Declaration is a copy of an attorney-prepared Petition;
`it is also possible Dr. Bohannon worked with the attorneys to prepare both
`the Petition and Declaration simultaneously.
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`To be clear, the arguments raised by Patent Owner are relevant to the
`proper weight to be accorded Dr. Bohannon’s testimony, a question we will
`decide when weighing the record as a whole. At this stage of the
`proceeding, however, we do not consider Dr. Bohannon’s Declaration to be
`so lacking in credibility as to require its exclusion.
`
`B. Denial of Institution Under 35 U.S.C. § 325(d)
`Patent Owner asks that we exercise our discretionary authority under
`35 U.S.C. § 325(d) to deny one or more grounds on the basis that “the same
`or substantially the same prior art or arguments previously were presented to
`the Office.” Prelim. Resp. 13–20. For the grounds based on DE ’825 as a
`primary reference, Patent Owner notes that DE ’825 was before the
`Examiner during prosecution and was cited in multiple rejections of the
`pending claims. Id. at 13. The application was eventually appealed to the
`Board, which reversed the Examiner’s rejection, and reliance on DE ’825
`was abandoned during subsequent prosecution. See Ex. 1002, 131, 159.
`Patent Owner argues that “the Office repeatedly and thoroughly considered
`DE [’825] and the argument that modifying DE [’825]’s multi-strip holder to
`include the claimed cap would have been obvious.” Prelim. Resp. 15.
`We disagree with Patent Owner’s analysis. In reversing the
`Examiner’s rejection based on a combination of DE ’825 and Klimov,10 the
`Board focused its analysis on Klimov, ultimately concluding that the
`Examiner had failed to establish why Klimov’s integral soft rubber seal
`rendered a removable cap obvious. Ex. 1002, 131. Notably, the panel did
`not address the merits of DE ’825. Id. Three grounds presented in the
`
`
`10 U.S. Patent No. 5,770,458 to Klimov et al., issued Jun. 23, 1998.
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`Petition rely on DE ’825, but cite other secondary references in place of
`Klimov. Though some of these references, such as May and May ’871, were
`before the Office during prosecution, there is no evidence that the Examiner
`considered these references in combination with DE ’825. We do not
`consider these grounds to present “the same or substantially the same” art or
`arguments as that previously presented to the Office during prosecution.
`Patent Owner also argues that the grounds based on Cipkowski or Sun
`as the primary reference should be denied under 35 U.S.C. § 325(d), because
`those primary references are “substantially the same” as DE ’825. Prelim.
`Resp. 18. As we have not found Patent Owner’s arguments regarding DE
`’825—which was cited during prosecution—to be persuasive, there is even
`less justification for denying grounds based on Cipkowski and Sun, which
`were not previously before the Office.
`For these reasons, we decline to exercise our discretion under 35
`U.S.C. § 325(d) to deny institution.
`
`C. Claim Construction
`In an inter partes review, “[a] claim in an unexpired patent shall be
`given its broadest reasonable construction in light of the specification of the
`patent in which it appears.” 37 C.F.R. § 42.100(b); Cuozzo Speed Techs.,
`LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (upholding the use of the broadest
`reasonable interpretation standard). In determining the broadest reasonable
`construction, we presume that claim terms carry their ordinary and
`customary meaning. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257
`(Fed. Cir. 2007). A patentee may define a claim term in a manner that
`differs from its ordinary meaning; however, any special definitions must be
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`set forth in the specification with reasonable clarity, deliberateness, and
`precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`Petitioner asks that we construe “sample addition pad,” “transparent
`window,” “a first transparent window,” and “a second transparent window.”
`Pet. 14–17. Patent Owner proffers constructions for “transparent window,”
`“a first transparent window,” and “a second transparent window.” Prelim.
`Resp. 3–7. Upon review of the parties’ arguments and supporting evidence,
`there appears to be no current dispute that the asserted prior art discloses the
`contested claim limitations under either party’s proffered construction. We,
`therefore, determine that no express constructions are necessary for purposes
`of this Decision. See 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.”).
`
`D. Grounds Based on DE ’825
`Petitioner contends that claims 1, 2, and 9 would have been obvious
`over DE ’825 and May; claims 1 and 9 would have been obvious over DE
`’825, Charm, and May ’871; and claim 2 would have been obvious over DE
`’825, May, Shuler, and Eisinger. Pet. 27–48.
`
`1. DE ’825
`DE ’825 discloses a holder for chromatography test strips.11 Ex.
`1004, 1:8. DE ’825 notes that prior art test strips suffered from several
`disadvantages, including the need to use multiple, individual test strips to
`detect a variety of narcotics in a urine sample and the health risks to workers
`performing such tests. Id. at 1:21–24, 2:9–10. To avoid these problems, DE
`
`
`11 Our citations are to the certified English language translation of DE ’825.
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`’825 discloses a holder capable of simultaneously dipping multiple test strips
`into a sample in a hygienic manner. Id. at 2:18–25.
`Figures 1 and 3 of DE ’825 are reproduced below:
`
`
`As shown in Figure 1, holder 1 is “a flat plastic plate with five recesses in
`strip form.” Id. at 4:21–22. The width and thickness of each recess is
`selected to be approximately equal to the width and thickness of a
`commercially available test strip and the distance between the strips is
`selected to ensure that “the strips do not make contact with each other.” Id.
`at 4:22–5:7.
`
`As shown in Figure 3, self-bonding cover film 4 is adhered to
`holder 1. Id. at 5:9–11. Cover film 4 secures the test strips in position and
`has transparent windows 5 for viewing the indicator fields of the test strips.
`Id. at 5:9–12. DE ’825 reports that cover film 4 serves to protect the
`indicator fields of the test strips “against physical handling and destruction.”
`Id. at 5:12–13.
`
`2. Claims 1, 2, and 9 as Obvious over DE ’825 and May
`Petitioner contends that the combination of DE ’825 and May
`discloses every limitation of claims 1, 2, and 9 of the ’291 patent. Pet. 27–
`40. Petitioner points out that, during the prior appeal of the patent
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`application to the Board, Patent Owner conceded that the construction of the
`test strip was not novel and focused its patentability arguments over DE ’825
`on the presence of a protective cap. Id. at 34; see also id. at 13 (quoting Ex.
`1002, 98:27–99:2) (“The key feature of the claimed invention is that it
`minimizes any contamination of and damage to the various assay strips.
`With the cap on, the exposed strips are protected during transport and any
`contact between the operator of the test and the sample is further reduced.”).
`Petitioner agrees that DE ’825 does not disclose a protective cap, and relies
`on May to supply such a cap. Id. at 34.
`May discloses an analytical test device having a hollow casing
`containing a dry porous carrier and a bibulous sample receiving member that
`protrudes from the casing. Ex. 1005, Abstract. “Preferably, the device
`includes a removable cap for the protruding bibulous member.” Id. Figure 8
`of May is reproduced below:
`
`
`Figure 8 of May depicts a device having housing 500, porous member 506,
`and cap 503. According to May, “[w]hen cap 503 is fitted onto portion 502
`of the housing, it covers porous member 506.” Id. at 12:16–18.
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`Petitioner argues that a person of ordinary skill in the art would have
`had reason to combine the disclosures of DE ’825 and May, as both are
`directed to testing analytes using multiple test strips, and the artisan would
`consider enhancing DE ’825’s test strip holder by adding May’s cap to better
`protect the strips. Pet. 35–36.
`Patent Owner disagrees, and argues that the prior art does not teach or
`suggest the claimed cap. Prelim. Resp. 8–13. According to Patent Owner,
`May discloses a cap that encloses the end of only a single test strip, whereas
`the challenged claims require a cap that encloses the ends of multiple strips.
`Id. at 8–9. Patent Owner disagrees with Petitioner’s characterization of May
`as disclosing multiple test strips, contending that any mention of multiple
`strips is directed to the embodiment of Figure 9, which discloses one internal
`strip and a second protruding strip. Id. at 10–11 (“May’s reference to two or
`more bodies of ‘porous solid phase material,’ is not referring to and would
`not have suggested multiple protruding ends that are enclosed by a cap.”).
`At the outset, we disagree with Patent Owner’s interpretation that the
`disclosure of May is limited to a single protruding test strip. May states that:
`If desired, a device according to the invention can incorporate
`two or more discrete bodies of porous solid phase material, e.g.
`separate strips or sheets, each carrying mobile and immobilised
`reagents. These discrete bodies can be arranged in parallel, for
`example, such that a single application of liquid sample to the
`device
`initiates
`sample
`flow
`in
`the discrete bodies
`simultaneously. The separate analytical results that can be
`determined in this way can be used as control results, or if
`different reagents are used on the different carriers, the
`simultaneous determination of a plurality of analytes in a single
`sample can be made.
`Ex. 1005, 6:26–36 (emphasis added).
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`From this passage, we conclude on this record that May’s disclosure
`
`of multiple test strips is not limited to a single protruding end, as Patent
`Owner asserts. Rather, the reference to arrangement of the strips in parallel
`would suggest a plurality of test strips similar to that disclosed by DE ’825.
`Furthermore, even if the disclosure of May were limited to a single
`test strip, we note that Petitioner’s proposed ground does not rely on May to
`disclose multiple strips; DE ’825 is relied upon for this disclosure. We are
`persuaded that a person of ordinary skill in the art, seeking to protect the
`multiple protruding ends of the test strips of DE ’825, would have looked to
`the cap of May. Even if May were limited to a cap covering a single test
`strip, we consider it within the level of ordinary skill to adapt the cap to
`cover multiple strips. As Petitioner observes, May states that “the general
`shape of the housing and cap, both in terms of their length, cross-section and
`other physical features, can be the subject of considerable variation.” Ex.
`1005, 13:38–41.
`We have reviewed the remainder of Petitioner’s evidence, and on this
`record the combination of DE ’825 and May appear to meet the remaining,
`uncontested limitations of the challenged claims. For example, DE ’825
`discloses a holder that meets the limitations of claim 1’s “base,” as well as a
`cover film with a transparent area that meets claim 1’s requirement of a
`“cover.” See generally Pet. 27–33. With respect to claim 2, Petitioner sets
`forth how May discloses more than one window through which the test
`strips may be viewed. Id. at 36–39. And regarding claim 9, Petitioner sets
`forth why it would have been obvious to use the combination of the DE ’825
`device with May’s cap in the claimed method. Id. at 39–40. We find that
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`these disclosures are sufficient to support a reasonable likelihood of success
`as to these claims.
`
`3. Claims 1 and 9 as Obvious over DE’825, Charm, and May ’871
`Alternatively, Petitioner contends that claims 1 and 9 would have
`been obvious over DE ’825, Charm, and May ’871. Pet. 40–45. Patent
`Owner again focuses its opposition on the disclosure of a cap. Prelim. Resp.
`12–13.
`Petitioner contends that “[t]o the extent DE [’825] does not itself
`disclose a sample addition pad, DE [’825] in view of Charm does.” Pet. 41.
`Charm discloses a test device comprising an elongated plastic housing and a
`lateral-flow test strip in the housing. Ex. 1008, Abstract. The test strip has a
`cellulosic absorbent pad at the distal end, to capture excess liquid sample.
`Id. at 5:25–30. Figure 1 of Charm depicts the disclosed device:
`
`
`Figure 1 of Charm depicts device 10 having housing 12 and test strip 28
`with pad 32. Id. at 4:64–5:37. Charm also discloses removable protective
`cap 22. Id. Petitioner asserts that absorbent pad 32 of Charm discloses the
`sample addition pad of claim 1. Pet. 41.
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`We note that Patent Owner did not dispute, in response to the prior
`ground, that DE ’825 discloses a sample addition pad; nor does it contest
`whether Charm discloses such a pad. Rather, Patent Owner again disputes
`whether Charm and May ’871 disclose the claimed cap. Prelim. Resp. 12–
`13.
`
`We note that Petitioner does not rely on cap 22 of Charm to meet the
`cap limitation of the challenged claims. Rather, Petitioner notes that Charm
`recognizes, in the description of the prior art, that May ’871 discloses “a
`protective, removable cap to protect and enclose the application end of the
`casing.” Ex. 1008, 1:17–23 (quoted by Pet. 42). For this reason, Patent
`Owner’s arguments that Charm does not disclose the claimed cap—because
`its cap 22 does not enclose protruding ends of a test strip—is beside the
`point. See Prelim. Resp. 12. Patent Owner concedes that the disclosure of
`May ’871 is “identical to May’s,” (id.), a disclosure that we found above to
`sufficiently disclose a protective cap enclosing the protruding end of a test
`strip.
`
`We have reviewed the combined disclosures of DE ’825, Charm, and
`May ’871, and are persuaded on this record that they teach or suggest all
`limitations of claims 1 and 9. Furthermore, Petitioner has set forth
`articulated reasoning why a person of ordinary skill in the art would have
`combined the disclosures of the references. See Pet. 41–42. For these
`reasons, we find that Petitioner has established a reasonable likelihood that it
`will prevail as to these claims.
`
`4. Claim 2 as Obvious over DE ’825, May, Shuler, and Eisinger
`Petitioner also contends the subject matter of claim 2 would have been
`obvious over the combined disclosures of DE ’825, May, Shuler, and
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`Eisinger. Pet. 45–48. As discussed above, we are persuaded on this record
`that DE ’825 and May disclose the “second transparent window” of claim 2,
`a point uncontested by Patent Owner at this stage. Petitioner contends that,
`to the extent these two references do not disclose the “second transparent
`window,” Shuler and Eisinger would. Patent Owner does not address the
`disclosures of these references.
`Upon reviewing the record, we are persuaded that—to the extent DE
`’825 and May do not disclose a second transparent window—either Shuler
`or Eisinger contain such a disclosure. See Ex. 1009, Fig 1; Ex. 1010, Fig 1.
`Furthermore, Petitioner has set forth adequate reason why a person of
`ordinary skill in the art would have included the second windows of Shuler
`and Eisinger into the device of DE ’825 as modified by May. Pet. 47–48
`(asserting that a person of ordinary skill would include a second window to
`confirm completion of the assay). For these reasons, we determine that
`Petitioner has adequately established a reasonable likelihood of success on
`this ground of unpatentability.
`
`E. Grounds Based on Cipkowski
`Petitioner contends that claims 1, 2, and 9 would have been obvious
`over Cipkowski and May; claims 1 and 9 would have been obvious over
`Cipkowski, Charm, and May ’871; and claim 2 would have been obvious
`over Cipkowski, May, Shuler, and Eisinger. Id. at 48–63.
`
`1. Cipkowski
`Cipkowski discloses a test kit for the collection and testing of urine.
`Ex. 1006, 1:4–8. Figures 1 and 2 of Cipkowski are reproduced below:
`
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`As shown in Figures 1 and 2, the container of Cipkowski includes
`transparent container or test cup 11, outer cover 22, and insert 15 having slot
`19 shaped to accommodate a test card. Id. at 3:27–54. During a test, test
`cup 11 is provided with a test specimen, insert 15 is placed within the test
`cup, and multiple drug test card 25 is then inserted into slit 19 such that the
`bottom of the test card rests upon the bottom of the test cup. Id. at 4:23–38.
`In an alternate embodiment, Cipkowski discloses a test card from
`which the ends of the test strips protrude, as shown in Figure 9:
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`Figure 9 depicts a modification of the test card 40 having a third ply 41
`which covers test strips 26–30 and has opening 42 through which the test
`strips may be seen. Id. at 4:66–5:8.
`
`2. Claims 1, 2, and 9 as Obvious over Cipkowski and May
`Petitioner contends that the combination of Cipkowski and May
`discloses every limitation of claims 1, 2, and 9 of the ’291 patent. Pet. 48–
`59. Again, Petitioner sets forth how each limitation of the claims is met by
`the references’ disclosures, but focuses its analysis on the removable cap
`limitation. Petitioner argues that Cipkowski discloses a “dip-strip
`embodiment” in Figure 9 in which the protruding ends of the test strips are
`inserted through the slot in the cup lid, into a urine sample. Id. at 55.
`Afterward, the card is removed and the cup sealed for shipment and further
`analysis. Id. Petitioner asserts that a person of ordinary skill in the art
`would have had reason to adapt Cipkowski’s card to include the cap
`
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`Patent 8,623,291 B2
`
`disclosed in May, to better protect the protruding strips before and after
`testing. Id.
`Patent Owner first contends that May does not teach the claimed cap
`(Prelim. Resp. 8–12), an argument we evaluated above and found
`unpersuasive. Patent Owner also argues that Cipkowski would have
`discouraged a person of ordinary skill in the art from making the
`combination with May and adding the claimed cap. Id. at 20–22. This
`argument is based on the fact that although Figure 9 of Cipkowski depicts an
`embodiment having protruding test strips, other embodiments shown in
`Figures 3 and 10 extend the test card over the end of the strips. Id. Patent
`Owner argues that “Cipkowski thus already teaches a strategy for protecting
`the test strips’ ends: encasing them as part of the test card holder,” and that
`Petitioner has not provide a reason why the person of ordinary skill in the art
`would not have simply adopted that strategy. Id. at 22.
`On this record, we are not persuaded by Patent Owner’s arguments.
`The presence of one strategy for protecting the ends of the test strips in
`Cipkowski does not foreclose a person of ordinary skill in the art from
`seeking out alternate strategies, such as the protective cap of May. See KSR
`Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (“When there is a design
`need or market pressure to solve a problem and there are a finite number of
`identified, predictable solutions, a person of ordinary skill has good reason
`to pursue the known options within his or her technical grasp.”). In other
`words, the “mere disclosure of more than one alternative does not constitute
`a teaching away from any of these alternatives” unless the prior art
`“criticize[s], discredit[s], or otherwise discourage[s] the solution claimed.”
`In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).
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`Petitioner has articulated sufficient reasoning why a person of
`ordinary skill in the art would have combined the test card of Cipkowski
`with the cap of May, and shown how the combination discloses all elements
`of claims 1, 2, and 9. For these reasons, we find a reasonable likelihood of
`success on this ground of unpatentability.
`
`3. Claims 1 and 9 as Obvious over Cipkowski, Charm,
`and May ’871
`Petitioner contends claims 1 and 9 would have been obvious over
`Cipkowski, Charm, and May ’871. Pet. 59–62. To the extent that
`Cipkowski does not disclose a “first transparent window” in the cover,
`Petitioner asserts that Charm discloses such a window, and May ’871
`discloses a protective cap as discussed in the similar ground involving DE
`’825. Id. Patent Owner does not address the “first transparent window”
`limitation or contest that Cipkowski or Charm disclose such a window.
`Rather, Patent Owner asserts that Charm and May ’871 do not disclose the
`claimed cap, and that Cipkowski discourages the addition of a cap. Prelim.
`Resp. 12–13, 20–22. For the reasons discussed in the previous grounds, we
`do not find these arguments persuasive on the current record.
`We have reviewed the proposed ground of unpatentability set forth by
`Petitioner and determine that it sufficiently accounts for all limitations of
`claims 1 and 9, and articulates sufficient reason why a person of ordinary
`skill in the art would have combined Cipkowski, Charm, and May ’871. For
`these reasons, we determine that Petitioner has shown a reasonable
`likelihood of prevailing on this ground of unpatentability.
`
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`4. Claim 2 as Obvious over Cipkowski, May, Shuler, and Eisinger
`Petitioner also contends the subject matter of claim 2 would have been
`obvious over the combined disclosures of Cipkowski, May, Shuler, and
`Eisinger. Pet. 63. Petitioner contends that, to the extent Cipkwoski and May
`do not disclose the “second transparent window” of claim 2, Shuler and
`Eisinger would. Id. Patent Owner does not address the disclosures of these
`references.
`As discussed above, we are persuaded that—to the extent Cipkowski
`and May do not disclose a second transparent window—either Shuler or
`Eisinger contain such a disclosure. Petitioner has set forth adequate reason
`why a person of ordinary skill in the art would have included the second
`windows of Shuler and Eisinger into the device of Cipkowski as modified by
`May. Pet. 63. For these reasons, we determine that Petitioner has
`adequately established a reasonable likelihood of success on this ground of
`unpatentability.
`
`F. Grounds Based on Sun
`Petitioner contends that claims 1, 2, and 9 would have been obvious
`over Sun and May; claims 1 and 9 would have been obvious over Sun,
`Charm, and May ’871; and claim 2 would have been obvious over Sun,
`May, Shuler, and Eisinger. Id. at 64–76.
`
`1. Sun
`Sun discloses a multi-test panel with several test strips, wherein each
`strip is housed in a different structure so that the structures may be
`interchangeably joined together. Ex. 1007, Abstract. In one embodiment,
`the device is a “dip strip type test strip,” having an end of the test strip
`extending from the housing. Id. at 4:10–26. The protruding end of the strip
`
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`
`is dipped into a sample, and the result of the test may be seen through a
`window. Id. Figure 8 of Sun depicts such an embodiment:
`
`
`Figure 8 shows a multi-strip device having multiple housings 118a–118d
`enclosing multiple test strips 112a–112d and having windows 128a–128d.
`Id. at 4:27–35. Sun discloses that, by permitting the housings to be
`interchangeably joined together, “the user is not confined to a set number
`and type of tests just because that is the only way the tests are packaged and
`sold. With the present invention a series of tests may be desig
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