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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
`U.S. Patent No. 6,548,019
`
`
`Case No. IPR2016-01502
`
`
`PETITIONER’S REPLY TO PATENT OWNER’S
`RESPONSE TO PETITION
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`TABLE OF AUTHORITIES .................................................................................... ii
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`CLAIM CONSTRUCTION ............................................................................ 3
`
`A.
`
`“A device for collecting and assaying a sample of biological
`fluid” ...................................................................................................... 3
`
`1.
`
`2.
`
`The Preamble Is Not Limiting .................................................... 3
`
`If Construed At All, “A Device” Should Be Construed
`As “One Or More Devices” ........................................................ 9
`
`B.
`
`“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” ......................... 11
`
`III. CLAIMS 2-5 ARE INVALID ....................................................................... 17
`
`A. Anticipation By MacKay (Claim 2) .................................................... 17
`
`B.
`
`Obviousness Based on MacKay in View of Cipkowski (Claims
`3-5) ...................................................................................................... 20
`
`IV. CONCLUSION .............................................................................................. 24
`
`
`
`
`i
`
`
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`01 Communique Lab, Inc. v. LogMeIn, Inc.,
`687 F.3d 1292 (Fed. Cir. 2012) ............................................................................ 9
`
`Page(s)
`
`Aircraft Technical Publishers v. Avantext, Inc.,
`2009 WL 3817944 (N.D. Cal. Nov. 10, 2009) ..................................................... 9
`
`Catalina Marketing Int’l v. Coolsavings.com, Inc.,
`289 F.3d 801 (Fed. Cir. 2002) .................................................................. 3, 4, 5, 8
`
`CreAgri, Inc. v. Pinnaclife Inc.,
`2013 WL 1663611 (N.D. Cal. April 16, 2013) ................................................. 5, 8
`
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) .......................................................................................... 3
`
`Deere & Co. v. Bush Hog, LLC,
`703 F.3d 1349 (Fed. Cir. 2012) ............................................................................ 8
`
`e.Digital Corp. v. Futurewei Tech., Inc.,
`772 F.3d 723 (Fed. Cir. 2014) ............................................................................ 11
`
`Hewlett-Packard Co. v. Bausch & Lomb Inc.,
`909 F.2d 1464 (Fed. Cir. 1990) .......................................................................... 11
`
`IMS Tech. Inc. v. Haas Automation, Inc.,
`206 F.3d 1422 (Fed. Cir. 2000) ............................................................................ 4
`
`Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc.,
`381 F.3d 1111 (Fed. Cir. 2004) .......................................................................... 13
`
`Intel Corp. v. U.S. Int’l Trade Commission,
`946 F.2d 821 (Fed. Cir. 1991) ............................................................................ 15
`
`IPXL Holdings, LLC v. Amazon.com, Inc.,
`430 F.3d 1377 (Fed. Cir. 2005) .......................................................................... 11
`
`ii
`
`
`
`
`
`K-2 Corp. v. Salomon S.A.,
`191 F.3d 1356 (Fed. Cir. 1999) .......................................................................... 16
`
`Laitram Corp. v. Cambridge Wire Cloth Co.,
`863 F.2d 855 (Fed. Cir. 1988) ...................................................................... 16, 17
`
`Liebel-Flarsheim Co. v. Medrad, Inc.,
`358 F.3d 898 (Fed. Cir. 2004) ............................................................................ 12
`
`MBO Labs., Inc. v. Becton, Dickinson & Co.,
`474 F.3d 1323 (Fed. Cir. 2007) ............................................................................ 9
`
`Poly-America, L.P. v GSE Lining Tech., Inc.,
`383 F.3d 1303 (Fed. Cir. 2004) ............................................................................ 9
`
`Revolution Eyewear, Inc. v. Aspex Eyewear, Inc.,
`563 F.3d 1358 (Fed. Cir. 2009) .......................................................................... 16
`
`Shinn Fu Company of America, Inc. v. The Tire Hanger Corp.,
`2017 WL 2838342 (Fed. Cir. July 3, 2017) ........................................................ 21
`
`In re Taylor,
`2012 WL 2149776 (Fed. Cir. 2012) ..................................................................... 3
`
`Unwired Planet LLC v. Google Inc.,
`2015 WL 3378476 (D. Nev. 2015) ....................................................................... 5
`
`Weiland Sliding Doors and Windows, Inc. v. Panda Windows and
`Doors, LLC,
`2011 WL 3490481 (S.D. Cal. Aug. 10, 2011) ...................................................... 8
`
`Other Authorities
`
`U.S. Patent No. 5,403,551 ........................................................................................ 10
`
`U.S. Patent No. 5,656,502 .......................................................................................... 2
`
`U.S. Patent No. 5,976,895 .......................................................................................... 2
`
`U.S. Patent No. 6,548,019 .................................................................................passim
`
`
`
`
`iii
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`
`
`
`
`I.
`
`INTRODUCTION
`
`Underscoring the lack of novelty of its purported invention, Patent Owner
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`disclaimed sole independent claim 1 of U.S. Patent No. 6,548,019 (“the ’019
`
`patent”) (Ex. 1001), along with six dependent claims (9, 11-15) after the Board
`
`instituted an inter partes review of these challenged claims. Only four dependent
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`claims (2-5) remain at issue in this IPR.1
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`Patent Owner’s arguments hinge on challenging the Board’s claim
`
`constructions. But under the broadest reasonable construction standard that must
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`be applied in an IPR, the Board correctly found that the preamble term “a device
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`for collecting and assaying a sample of biological fluid” is not limiting because the
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`body of the claims recite structurally complete invention(s), and nothing in the
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`specification or prosecution history requires a narrower construction. Patent
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`Owner’s preamble arguments rely exclusively on cases that apply a narrower
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`district court claim construction standard that is inapplicable here.2
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`Patent Owner also challenges the Board’s interpretation of the phrase
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`1 Claims 6 and 10, along with the claims from which they depend, are the subject
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`of IPR2017-1130.
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`2 If the preamble were nonetheless found limiting, the broadest reasonable
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`construction of “a device” would be “one or more devices,” consistent with Federal
`
`Circuit precedent.
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`1
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`
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`
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`“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…
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`assay test strip.” But as the Board explained, claim 1 is an apparatus claim that
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`contains only apparatus elements, not method steps or temporal requirements. The
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`Board correctly found that this phrase is a functional limitation, so prior art need
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`only be capable of performing the claimed function to anticipate the claim. Under
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`the broadest reasonable construction, the phrase is not limited to instantly adding
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`fluid to the test strip.
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`Applying the Board’s claim constructions, claims 2-5 are each invalid over
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`the prior art. Claim 2 is anticipated by U.S. Patent No. 5,656,502 (“MacKay”) (Ex.
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`1004). As the Board found in its Institution Decision, MacKay’s holder is capable
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`of both directing a liquid sample to the sample loading zone of the assay test strip
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`and trapping air to form an ambient pressure within the flow control channel.
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`Paper 13 at 26. As Patent Owner’s expert conceded at his deposition, MacKay’s
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`disclosure of putting a dipstick into a cup that already has fluid in it achieves the
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`same function as adding fluid to the cup to reach the bottom of the dipstick. And
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`putting a dipstick into fluid does not modify the structure of the claimed invention.
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`Claims 3-5 are obvious based on MacKay in view of U.S. Patent No.
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`5,976,895 (“Cipkowski”) (Ex. 1005). Patent Owner argues that a person of
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`ordinary skill in the art (“POSA”) would not have been motivated to combine these
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`2
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`
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`prior art references because, allegedly, there would be no reason to literally
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`combine devices disclosed by these two references. However, obviousness does
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`not focus on literal combinability, but on “what the combined teachings of these
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`references would have taught or suggested to one with ordinary skill in the art.”
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`See IPR2017-281, Paper 10 at 20. Here, the Board correctly found that a POSA
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`would be motivated to combine MacKay and Cipkowski, and would have had a
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`reasonable expectation in success in doing so.
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`Accordingly, the Board should confirm its preliminary claim construction
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`determinations, and find claims 2-5 of the ’019 patent invalid.
`
`II. CLAIM CONSTRUCTION
`“A device for collecting and assaying a sample of biological fluid”
`A.
`The Preamble Is Not Limiting
`1.
`In an inter partes review proceeding, claims must be given their broadest
`
`reasonable construction consistent with the specification. Cuozzo Speed Techs.,
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`LLC v. Lee, 136 S. Ct. 2131, 2135 (2016) (standard fair because patent holder
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`“may move to amend at least once in the review process”). The Federal Circuit
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`has recognized that Catalina, which “set forth ‘some guideposts’ for evaluating
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`whether a particular claim’s preamble limits claim scope,” “…arose in the context
`
`of infringement litigation” where courts apply a “narrower interpretive standard.”
`
`In re Taylor, 2012 WL 2149776, *3 (Fed. Cir. 2012) (The “Board correctly
`
`rejected Taylor’s rigid reading of Catalina” and found preambles directed to mix
`
`3
`
`
`
`
`
`for making low-calorie, palatable food or food components “not limiting under the
`
`broadest reasonable interpretation”). Even under district court standards, a
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`preamble is not limiting “where a patentee defines a structurally complete
`
`invention in the claim body and uses the preamble only to state a purpose or
`
`intended use.” Catalina Marketing Int’l v. Coolsavings.com, Inc., 289 F.3d 801,
`
`808 (Fed. Cir. 2002); see also IMS Tech. Inc. v. Haas Automation, Inc., 206 F.3d
`
`1422, 1434 (Fed. Cir. 2000) (“control apparatus” preamble phrase “merely gives a
`
`descriptive name”).
`
`Here, the Board correctly found that the preamble of claim 1 is not limiting
`
`because 1) it merely “recites the intended purpose of the invention, i.e., ‘collecting
`
`and assaying a sample of biological fluid,’” 2) the “claim body defines a
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`structurally complete invention,” and 3) the specification allows other
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`embodiments. See IPR2016-1502, Paper 13 at 8-10. Patent Owner does not
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`identify any particular aspect of the claim body that would not be structurally
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`complete without a limiting preamble. The body of canceled independent claim 1
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`recites (a) “a flow control channel,” (b) “an assay test strip,” and (c) “a sample
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`fluid container,” wherein the flow control channel is disposed inside the sample
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`fluid container with the open end directed toward the base of the container.
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`4
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`
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`
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`Bohannon Decl. ¶ 65.3 Dependent claim 2 specifies that the sides of the flow
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`control channel are loosely fitted around the assay test strip. Id. ¶¶ 65, 100.
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`Dependent claim 3 adds a backing and a holder. Id. ¶¶ 65, 101-108. Dependent
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`claim 4 specifies that the holder and sample fluid container are curved. Id. ¶¶ 65,
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`109. Dependent claim 5 specifies that the container is a cup. Id. ¶¶ 65, 110.
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`Patent Owner contends that antecedent basis makes the preamble limiting.
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`However, antecedent basis is only one “guidepost” in Catalina, and even under
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`that narrower litigation standard, antecedent basis alone is insufficient to find a
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`preamble limiting. See Unwired Planet LLC v. Google Inc., 2015 WL 3378476, *6
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`(D. Nev. 2015) (preambles non-limiting despite body term “the image” having
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`antecedent basis in preambles, because bodies were “structurally complete on their
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`own”), aff’d in relevant part by 2016 WL 6832982, *8-9 (Fed. Cir. 2016). Patent
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`Owner’s antecedent basis argument is based only on claim 3’s recitation of
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`“wherein the device farther [sic] comprises…” and that claims 4 and 5 further
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`depend from claim 3. Paper 15 at 16. But repetition of a preamble term in a
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`dependent claim also does not mandate finding a preamble limiting. See CreAgri,
`
`Inc. v. Pinnaclife Inc., 2013 WL 1663611, at *8 (N.D. Cal. April 16, 2013)
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`(repetition of preamble phrase in dependent claim did not make independent claim
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`3 “Bohannon Decl.” refers to the Reply Declaration of Dr. Robert Bohannon,
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`submitted herewith as Exhibit 1023.
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`5
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`
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`
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`preamble limiting).
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`Patent Owner emphasizes that the word “device” appears in the title and the
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`specification. Paper 15 at 17. But none of these references indicate that “device”
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`is anything other than a generic term like “apparatus” or “system.” And the
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`specification itself uses “device” in a variety of ways, both as a component (along
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`with a container) and as the invention as a whole. See ’019 patent at e.g., 1:30-36
`
`(“One such method is exemplified in U.S. Pat. No. 5,403,551 [Galloway] entitled
`
`“Assaying Device and Container…” This device… requires specialized
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`components (particularly a special fluid collection cup)...”) (emphasis added);
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`1:62-63 (“The invention further provides a combination assaying device and
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`collection chamber…”)(emphasis added); 5:22 (“[t]he dipstick assay device”);
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`5:22-24 (“The dipstick assay device component of the invention 40 consists of
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`assay test strip 22 and a support).” (emphasis added)). Dr. Salamone agreed at his
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`deposition that the holder of claim 3 is a “separate device that fits inside the
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`container,” or in other words a “separate component that is fittable inside the
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`container.” Salamone Tr. (Ex. 1022) at 29:15-20, 30:11-24. A POSA, applying
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`the broadest reasonable construction, would view “device” as a generic term.
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`Bohannon Decl. ¶ 66.
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`Patent Owner takes issue with two of the disclosures in the specification that
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`the Board cited in finding the preamble not limiting. Paper 15 at 19-20; Paper 13
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`6
`
`
`
`
`
`at 9-10. The first disclosure, which appears under the heading “Assay Devices of
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`the Invention,” is that “those of ordinary skill in the art will appreciate that the
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`flow control means of the invention common to each embodiment may be utilized
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`in any test[] strip based immunoassay format.” ’019 patent at 5:12-20. Patent
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`Owner argues that “format” could not refer to multi-part devices, but does not
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`point to any intrinsic evidence giving any special meaning to that word. Paper 15
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`at 19-20. Patent Owner’s expert also provided no evidence that “format” has any
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`special meaning in the field. It does not. A POSA would understand that use in
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`“any test[ -] strip based immunoassay format” would broadly encompass unitary or
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`multi-part devices. Bohannon Decl. ¶ 67.
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`The second disclosure cited by the Board that Patent Owner takes issue with
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`is “the above-described embodiments are merely illustrative of but a few of the
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`embodiments which could be created by one of ordinary skill in the art.” ’019
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`patent at 8:36-40. Patent Owner argues that this disclosure “fails to show” that the
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`’019 patent contemplates a flow control channel and container in kit form or a
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`combination outside of an integrated unitary device. Paper 15 at 20. But Patent
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`Owner’s attempt to escape the applicant’s own catchall language ignores that the
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`broadest reasonable construction—a non-limiting preamble— is fully consistent
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`with that language. A POSA would understand that this catchall language includes
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`embodiments that are not unitary devices. Bohannon Decl. ¶¶ 66- 68.
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`7
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`
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`
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`Patent Owner also contends that the prosecution history supports finding the
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`preamble to be limiting. But for the prosecution history to weigh as a “guidepost”
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`under Catalina, there must be “clear reliance on the preamble during prosecution
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`to distinguish the claimed invention from the prior art.” 289 F.3d at 808 (citation
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`omitted) (emphasis added); cf. Weiland Sliding Doors and Windows, Inc. v. Panda
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`Windows and Doors, LLC, 2011 WL 3490481, *5 (S.D. Cal. Aug. 10, 2011)
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`(applicant’s reliance on portions of preamble to show that prior art reference was
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`nonanalogous art did not rise to level of reliance to make preamble term limiting);
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`CreAgri, 2013 WL 1663611, at *9-10 (amendment to abstract to add term “dietary
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`supplement” and delete non-dietary uses “fail[ed] to demonstrate the sort of clear
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`reliance that would warrant” finding “[a] dietary supplement…” preamble
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`limiting). Nothing in the prosecution history indicates that applicant relied—much
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`less clearly relied— on the preamble to overcome prior art. All Patent Owner
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`points to is repetition of “a device” and “the device” in the file history, but that is a
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`far cry from clear reliance.
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`Each of the cases Patent Owner relies upon regarding limiting preambles
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`were appeals from district court litigations, and thus applied narrow district court
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`claim construction standards, rather than the broadest reasonable construction.
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`Moreover, each involve preamble terms that, on their face, are clearly terms of art
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`rather than generic terms. See Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349,
`
`8
`
`
`
`
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`1357 (Fed. Cir. 2012) (“rotary cutter deck”); Poly-America, L.P. v GSE Lining
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`Tech., Inc., 383 F.3d 1303, 1310 (Fed. Cir. 2004) (“blown film”); MBO Labs., Inc.
`
`v. Becton, Dickinson & Co., 474 F.3d 1323, 1328 (Fed. Cir. 2007) (“method of
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`immediately and positively precluding needlestick injury from a contaminated
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`needle”).
`
`Accordingly, the preamble phrase “[a] device” is not limiting.
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`2.
`
`If Construed At All, “A Device” Should Be Construed As
`“One Or More Devices”
`
`As a “general rule,” even under district court standards, the term “a” is
`
`construed to mean “one or more.” See 01 Communique Lab, Inc. v. LogMeIn, Inc.,
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`687 F.3d 1292, 1297 (Fed. Cir. 2012). “The exceptions to this rule are extremely
`
`limited: a patentee must evince a clear intent to limit ‘a’ or ‘an’ to ‘one.’” Id.; see
`
`also Aircraft Technical Publishers v. Avantext, Inc., 2009 WL 3817944, at *5
`
`(N.D. Cal. Nov. 10, 2009) (finding that even if “a system” were limiting, proposed
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`construction requiring “a single stand alone computer” was “untenable” because
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`there was “no indication” claim was limited to preferred embodiment). The
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`intrinsic evidence here does not show any “clear intent” to limit the invention to a
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`unitary device. As discussed above, the specification does not consistently use the
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`term “device” to refer only to the entire invention, but instead sometimes refers to
`
`a “device” as a component. See ’019 patent at e.g., 1:30-36; 1:62-63; 5:22-24. Dr.
`
`Salamone also testified that a “device” may be a component. See Salamone Tr. at
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`9
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`
`
`
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`17:11-13 (“the kit had a slide component we would normally call the device.”); Ex.
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`1021 at 37 (referencing “ONTRAK slide”). If the Board were to find the preamble
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`limiting, the term “a device” should be construed to mean “one or more devices.”
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`Patent Owner suggests that “device” is a term of art in the field, meaning
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`only a “unitary” device, and that multi-part devices are referred to only as “kits.”
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`Paper 15 at 1, 18-20. POSAs do not understand “device” to necessarily mean a
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`“unitary” device, and would understand that the broadest reasonable construction
`
`would include multi-part devices. Bohannon Decl. ¶¶ 65-68. Patent Owner’s
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`expert testified that he oversaw the development of the first commercial test cup,
`
`known as the OnTrak TesTcup, and he agreed the associated patent (U.S. Patent
`
`No. 5,403,551 (“Galloway”), which issued in 1995 (before the priority date of the
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`’019 patent), describes the invention as an “assaying device” even though it
`
`requires an operator and an extra step to screw on the cap. Salamone Tr. at 7:7-15,
`
`8:18-10:5, 12:7-18. The ’019 patent also refers to the Galloway invention as
`
`“[t]his device.” ’019 patent at 1:30-36.
`
`Patent Owner contends that submissions from an unrelated litigation
`
`involving Petitioner’s predecessor “confirm[ ]” that “device” has a narrow
`
`“customary meaning in the industry.” Paper 15 at 19. But this extrinsic evidence
`
`is not relevant here. The Inverness litigation concerned a different patent, by
`
`different inventors, and involved different claim language. See Ex. 2013, 12 and
`
`10
`
`
`
`
`
`Ex. 2014 ¶ 3 (addressing term “test device”). Because inventors are their own
`
`lexicographers, “a claim of an unrelated patent ‘sheds no light on’” construction of
`
`a different patent. See e.Digital Corp. v. Futurewei Tech., Inc., 772 F.3d 723, 727
`
`(Fed. Cir. 2014). Moreover, Inverness and its expert applied a narrower, district
`
`court claim construction standard rather than the broadest reasonable construction
`
`standard.
`
`
`
`Accordingly, the phrase “a device” – if construed at all— should be
`
`construed as “one or more devices.”
`
`B.
`
`“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”
`
`Patent Owner also challenges the Board’s interpretation of the phrase “when
`
`added to the container.” But as the Board explained, claim 1 is directed to an
`
`apparatus, not a method of using the apparatus. Paper 13 at 25. If claim 1 were
`
`interpreted to include a method step of adding liquid, or a temporal requirement
`
`regarding when the liquid enters the container, it would not inform a POSA
`
`whether the device alone infringes, or whether the fluid must actually be added (at
`
`some particular time) for infringement to occur. Either requirement would render
`
`claim 1 indefinite under Section 112, paragraph 2. See Hewlett-Packard Co. v.
`
`Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990) (“[A]pparatus claims
`
`cover what a device is, not what a device does.”); IPXL Holdings, LLC v.
`
`11
`
`
`
`
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`Amazon.com, Inc., 430 F.3d 1377, 1384 (Fed. Cir. 2005) (apparatus claims that
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`include process limitations or otherwise do not apprise a POSA of their scope are
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`invalid under Section 112, paragraph 2). Thus, the broadest reasonable
`
`construction, and the only way for claim 1 to escape indefiniteness, is to construe
`
`claim 1 as containing only apparatus elements. See Liebel-Flarsheim Co. v.
`
`Medrad, Inc., 358 F.3d 898, 911 (Fed. Cir. 2004) (“claims should be so construed,
`
`if possible, as to sustain their validity.”).
`
`The Board correctly determined that this phrase is a functional limitation,
`
`and therefore prior art need only be “capable of” performing the recited function to
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`anticipate the claim. Paper 13 at 26. The specification itself includes functional
`
`language, describing one embodiment as “capable of easily collecting and testing a
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`biological fluid sample…” See ’019 patent at 1:62-66. The specification also
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`discloses an embodiment where the flow control channel is “immers[ed]” in
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`sample fluid. Id. at 6:22-27. Thus, the goal of the claimed invention is functional:
`
`putting a liquid sample in contact with the sample loading zone of an assay test
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`strip, and trapping air to form an ambient pressure within the flow control channel.
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`Bohannon Decl. ¶ 70. Patent Owner’s expert, Dr. Salamone, agreed this function
`
`could be achieved in multiple ways. Salamone Tr. at 39:15-41:6 (sample could be
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`“[p]oured” or “pipetted” in); 44:22-45:7 (adding liquid to container works same
`
`12
`
`
`
`
`
`way as already having liquid in container); 60:25-62:7 (fluid level moving up to
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`meet dipstick works same way as lowering dipstick into fluid).
`
`Patent Owner’s argument that the flow channel must be previously disposed
`
`inside the container (Paper 15 at 21) ignores the intrinsic evidence, and improperly
`
`limits the claimed invention to a single embodiment. See Innova/Pure Water, Inc.
`
`v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1117 (Fed. Cir. 2004)
`
`(embodiments cannot “limit claim language that has broader effect.”). Moreover,
`
`Dr. Salamone agreed that the claims do not require the flow control channel to be
`
`disposed in a specific way inside the sample fluid container, other than orienting
`
`the liquid pervious side towards the base. Salamone Tr. at 31:8-18; 39:15-41:6.
`
`He testified that adding sample directly to the container is “not required” by the
`
`claim language. Id. at 40:14-41:19. He also agreed that claims 1-5 each address
`
`the claimed structure before any fluid is present. Id. at 32:25-33:24.
`
`To the extent any temporal requirement could be imputed without rendering
`
`the claims indefinite, the term “when” should be construed broadly. The Federal
`
`Circuit has recognized that “common meanings” of “when” include “at or during
`
`the time that; just at the moment that; at any or every time that; at, during, or after
`
`the time that.” See Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243,
`
`1251 (Fed. Cir. 1998). A narrower interpretation is appropriate only if clearly
`
`required by the intrinsic evidence. Cf. id. at 1251-53 (construing “when” narrowly
`
`13
`
`
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`
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`where specification was “replete” with references to “instant” contact between
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`stylus sensing tip and object).
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`
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`Here, the specification does not provide any special, narrow meaning for
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`“when,” and never specifies that fluid be added instantaneously. Nor is “when” a
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`term of art. Bohannon Decl. ¶71. The only timing concern mentioned in the
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`specification is that prior art devices were “relatively slow to produce results… due
`
`to the time necessary for assay sample fluid to wick up” toward the test strip. ’019
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`patent at 4:34-41. In addition to the immersion example above, the specification
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`discloses that fluid sample accumulates after addition and eventually reaches a
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`sufficient volume to reach the test strips. Bohannon Decl. ¶ 73. The specification
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`explains that “[a]s assay sample fluid collects in cup 2, it contacts sample loading
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`zone 30 and begins migrating upwards through assay test strip 22.” ’019 patent at
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`6:55-57. “So long as the volume of fluid introduced into cup 2 is sufficient to
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`contact loading zone 30… any amount of assay fluid up to the maximum volume
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`capacity of cup 2 may be used in performing an assay with the device of the
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`invention. Id. at 6:57-6:63. In other words, the fluid collects until it reaches the
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`sample loading zone; and the volume required may be small or large, depending
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`how far away loading zone 30 is from base 1. Bohannon Decl. ¶ 73. Dr.
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`Salamone agreed there “wouldn’t be any difference in the way the test operates” if
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`it takes “a couple of seconds” for fluid to accumulate. Salamone Tr. at 59:24-
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`14
`
`
`
`
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`60:15. It is not the timing of when the fluid contacts the flow control channel that
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`matters to the invention, but the fact that after contact, the flow control channel
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`operates as claimed and reduces or eliminates potential flooding of the test strip by
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`sample. Bohannon Decl. ¶ 73.
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`Patent Owner argues that Intel, which finds the phrase “when said alternate
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`addressing mode is selected” to be functional, is inapposite because the functional
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`nature of the limitation was attributable to other language (“programmable” or
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`“whereby”). Paper 15 at 25. Patent Owner ignores that the Intel Court italicized
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`not only the word programmable, but also the word “when” in its reasoning:
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`“[b]ecause the language of claim 1 refers to ‘programmable selection means’ and
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`states ‘whereby when said alternate addressing mode is selected’ (emphases
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`added), the accused device, to be infringing, need only be capable of operating in
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`the page mode.” Intel Corp. v. U.S. Int’l Trade Commission, 946 F.2d 821, 832
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`(Fed. Cir. 1991) (emphasis in original). Thus, both words signify capability. And
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`In re Schreiber did not prohibit rearrangement. 128 F.3d 1473, 1478 (Fed. Cir.
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`1997).
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`Patent Owner argues in the alternative that even if the phrase is functional,
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`the “functional language informs structural limitations and is not met simply by a
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`prior art reference that could potentially be rearranged to show the claimed
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`feature.” Paper No. 15 at 22-25. But functional language permits rearrangement
`
`15
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`
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`
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`or movement to achieve a claimed function. See Revolution Eyewear, Inc. v. Aspex
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`Eyewear, Inc., 563 F.3d 1358, 1370 (Fed. Cir. 2009) (claim reciting “said first
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`magnetic members capable of engaging second magnetic members of an auxiliary
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`spectacle frame” infringed because “Revolution’s primary frames, although not
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`specifically designed or sold to be used with top-mounting auxiliary frames, are
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`nevertheless capable of being used in that way… It is irrelevant that Revolution’s
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`auxiliary frames… are not actually used in a top-mounting configuration or cannot
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`be so used.”). In any event, no “rearrangement” is at issue here, because putting a
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`dipstick into fluid does not rearrange any parts of the claimed invention.
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`Bohannon Decl. ¶¶ 94-95.
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`Patent Owner’s cases simply stand for the proposition that different clauses
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`in a claim should be construed in a complementary manner. See K-2 Corp. v.
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`Salomon S.A., 191 F.3d 1356, 1363 (Fed. Cir. 1999) (“the two clauses [are]
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`complementary…” ‘permanently affixed’ requires an unremovable attachment,
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`while the functional language [“for substantially preventing movement
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`therebetween at least in a horizontal plane”] requires that the attachment prevent
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`sliding.”); Laitram Corp. v. Cambridge Wire Cloth Co., 863 F.2d 855, 858 (Fed.
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`Cir. 1988) (claim phrase “so that said module is end-to-end reversible…” provided
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`“definitional parameters” for claim phrase “said link ends being dimensioned and
`
`spaced apart by a distance slightly greater than said width…”). Moreover, Laitram
`
`16
`
`
`
`
`
`confirms that claim terms must be construed consistent with the purpose of the
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`claimed invention. Id. (“the district court properly [interpreted phrase] in terms of
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`its purpose”). The dispute here centers on how “when added” interacts with “the
`
`flow control channel is disposed.” To the extent the former claim phrase informs
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`the latter, it allows for embodiments where fluid does not instantaneously contact
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`the test strips. Bohannon Decl. ¶¶ 69-73. The fluid merely has to be capable of
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`accessing the test strips. Id.
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`Accordingly, the Board should maintain its construction of the disputed
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`phrase as a functional limitation requiring the capability to direct a fluid sample to
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`the loading zone of the assay test strip.
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`III. CLAIMS 2-5 ARE INVALID
`A. Anticipation By MacKay (Claim 2)
`Patent Owner’s arguments focus primarily on overturning the Board’s claim
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`constructions. Paper 15 at 13-25. As discussed above, there is no basis to do so.
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`Claim 2 does not require a unitary device, or instantaneous contact between the
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`fluid sample and the flow control channel. The Board correctly found that “the
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`holder of MacKay is capable of both directing a liquid sample to the sample
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`loading zone of the assay test strip and trapping air to form an ambient pressure
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`within the flow control channel.” Paper 13 at 26; see also Bohannon Decl. ¶¶ 6-7,
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`88-100.
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`17
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`
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`MacKay discloses every limitation of claims 1 and 2. Bohannon Decl. ¶¶ 6-
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`7, 88-100. MacKay discloses a container for collecting a liquid to be tested. Ex.
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`1004, Figs. 3A-3C, Figs. 8A-8C. The liquid is tested using test strips. Id., 7:39-
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`48. The test strip holder includes a “flow control channel” as an elongated hollow
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`member open at one end and air-tightly closed at the other. Id.
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