Trials@uspto.gov
`571-272-7822
`
`Paper No. 47
`
` Entered: February 13, 2019
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`INSTRUMENTATION LABORATORY COMPANY,
`Petitioner,
`
`v.
`
`HEMOSONICS LLC,
`Patent Owner.
`____________
`
`Case IPR2017-00852
`Patent 9,272,280 B2
`____________
`
`
`
`Before JO-ANNE M. KOKOSKI, KRISTINA M. KALAN, and
`JEFFREY W. ABRAHAM, Administrative Patent Judges.
`
`
`ABRAHAM, Administrative Patent Judge.
`
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318 and 37 C.F.R. § 42.73
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`IPR2017-00852
`Patent 9,272,280 B2
`
`
`I.
`
`INTRODUCTION
`
`Instrumentation Laboratory Company (“Petitioner”) filed a Petition
`
`seeking inter partes review of claims 1 and 2 of U.S. Patent No. 9,272,280
`
`B2 (Ex. 1001, “the ’280 patent”). Paper 2 (“Pet.”). HemoSonics LLC
`
`(“Patent Owner”) filed a Patent Owner Preliminary Response to the Petition.
`
`Paper 6 (“Prelim. Resp.”). On September 1, 2017, we instituted an inter
`
`partes review of claims 1 and 2. Paper 14 (“Inst. Dec.”) (instituting trial on
`
`all claims but not all grounds raised in the Petition).
`
`After institution, Patent Owner filed a Patent Owner Response
`
`(Paper 19, “PO Resp.”) and Petitioner filed a Reply (Paper 22, “Reply”). On
`
`April 26, 2018, we issued an order modifying our institution decision to
`
`include all grounds raised in the Petition. Paper 26. After receiving
`
`authorization from the Board, Petitioner filed a Supplemental Reply
`
`(Paper 27, “Suppl. Reply”) addressing the grounds not addressed in its
`
`Reply.
`
`An oral hearing was held on June 12, 2018, and a supplemental
`
`hearing was held on August 14, 2018. A transcript of each hearing has been
`
`entered into the record of the proceeding. Paper 37 (“Hearing Tr.”); Paper
`
`46 (“Suppl. Hearing Tr.”).
`
`On August 28, 2018, the Deputy Chief Administrative Patent Judge
`
`determined that there was good cause to extend the one-year period for
`
`issuing a Final Written Decision in this proceeding, in accordance with 37
`
`C.F.R. § 42.100(c). Paper 44. On the same day, we issued an order
`
`extending the time of pendency in this proceeding by up to six months.
`
`Paper 45.
`
`
`
`2
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`

`

`IPR2017-00852
`Patent 9,272,280 B2
`
`
`We have jurisdiction under 35 U.S.C. § 6. This Final Written
`
`Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`
`For the reasons that follow, we determine that Petitioner has shown by a
`
`preponderance of the evidence that claims 1 and 2 are unpatentable.
`
`II.
`
`BACKGROUND
`
`A. Related Proceedings
`
`The parties identify the petition for inter partes review of related U.S.
`
`Patent No. 9,410,971 B2 (IPR2017-00855) as a related proceeding. Pet. 1;
`
`Paper 3, 1. The parties indicate that U.S. Patent Application No. 15/202,059
`
`may be affected by this inter partes review (Pet. 1, Paper 3, 1), and
`
`Petitioner indicates that U.S. Patent Application No. 15/357,492 may also be
`
`affected by this inter partes review (Pet. 1).
`
`B. The ’280 Patent
`
`The ’280 patent, titled “Device, Systems and Methods for Evaluation
`
`of Hemostasis,” issued on March 1, 2016. Ex. 1001, at [54], [45]. The ’280
`
`patent explains that hemostasis is the physiological control of bleeding, and
`
`is “a complex process incorporating the vasculature, platelets, coagulation
`
`factors (FI-FXIII), fibrinolytic proteins, and coagulation inhibitors.” Id.
`
`at 1:29–32. The ’280 patent indicates that “[d]isruption of hemostasis plays
`
`a central role in the onset of myocardial infarction, stroke, pulmonary
`
`embolism, deep vein thrombosis and excessive bleeding,” and, therefore,
`
`there is a critical need for in vitro diagnostics to “quantify hemostatic
`
`dysfunction and direct appropriate treatment.” Id. at 1:32–37.
`
`Accordingly, the ’280 patent is directed to devices, systems, and
`
`methods for evaluating hemostasis, specifically “sonorheometric devices for
`
`evaluation of hemostasis in a subject by in vitro evaluation of a test sample
`
`
`
`3
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`

`IPR2017-00852
`Patent 9,272,280 B2
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`from the subject.” Id. at 2:22–25. The ’280 patent discloses a device
`
`comprising a cartridge having a plurality of test chambers configured to
`
`receive a test sample of blood and a reagent or combination of reagents that
`
`interact with the blood sample. Id. at 2:25–34. The test chambers are also
`
`configured to be “interrogated with sound to determine a hemostatic
`
`parameter of the test samples” (id. at 2:35–37, 2:43–45), and “[s]ound
`
`reflected from the blood reagent mixture in the test chamber is received and
`
`processed to generate a hemostasis parameter” (id. at 3:3–5).
`
`C. Illustrative Claim
`
`Petitioner challenges claims 1 and 2 of the ’280 patent. Independent
`
`claim 1 is illustrative, and is reproduced below:
`
`1. A device for evaluation of hemostasis, comprising:
`
`a plurality of test chambers each configured to receive blood
`of a test sample, each test chamber comprising a reagent or
`combination of reagents, wherein each chamber is
`configured to be interrogated to determine a hemostatic
`parameter of the blood received therein;
`
`a first chamber of the plurality comprising a first reagent or a
`first combination of reagents that interact with the blood
`received therein, wherein the first reagent, or a reagent
`included in the first combination of reagents, is an activator
`of coagulation; and
`
`a second chamber of the plurality comprising a second
`combination of reagents that interact with blood of the test
`sample received therein, the combination including an
`activator of coagulation and one or both of abciximab and
`cytochalasin D.
`
`Petitioner relies on the following references:
`
`D. References
`
`Baugh et al., U.S. Patent No. 6,221,672 B1, issued Apr. 24, 2001
`(“Baugh,” Ex. 1005).
`
`
`
`4
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`IPR2017-00852
`Patent 9,272,280 B2
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`
`Schubert et al., U.S. Pub. No. 2010/0154520 A1, published June
`24, 2010 (“Schubert,” Ex. 1006).
`
`E. Reviewed Grounds
`
`Reference
`
`Statutory Basis Claims Challenged
`
`Baugh
`
`Schubert
`
`
`
`§ 102
`
`§ 102
`
`1 and 2
`
`1 and 2
`
`F. Level of Ordinary Skill in the Art
`
`Petitioner contends that a person of ordinary skill in the art would
`
`have had “a bachelor’s or advanced degree in chemistry, biochemistry,
`
`mechanical engineering, or a related discipline, with at least four years of
`
`experience in an academic research institution, a hospital research laboratory
`
`or medical device company designing or creating devices for evaluating
`
`hemostasis.” Pet. 7–8; Ex. 1003 ¶¶ 14–16. Patent Owner “agrees that a
`
`person with a bachelor’s degree in a relevant discipline, e.g., biology,
`
`chemical engineering, bioengineering or mechanical engineering related to
`
`medical devices, plus four years of work experience, would qualify as a
`
`person of ordinary skill in the art.” PO Resp. 13. Patent Owner also
`
`contends that a person of ordinary skill would have had “experience in and
`
`an understanding of multiple areas, including hemostasis, blood coagulation
`
`pathway, and bioengineering or mechanical engineering related to medical
`
`devices.” Id. Patent Owner, however, does not agree “that a person with an
`
`advanced degree, e.g., a PhD plus four years of work experience, would
`
`define a person of ordinary skill. That person is one of extraordinary skill.”
`
`Id.
`
`Based on the agreement between the parties, we find that a person of
`
`ordinary skill in the art would have had a bachelor’s degree in a relevant
`
`
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`5
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`IPR2017-00852
`Patent 9,272,280 B2
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`discipline, e.g., biology, chemical engineering, bioengineering, or
`
`mechanical engineering, related to medical devices, plus four years of work
`
`experience in areas relating to hemostasis, the blood coagulation pathway,
`
`and medical devices for evaluating hemostasis. Pet. 7–8; PO Resp. 13. This
`
`level of ordinary skill is reflected by the prior art of record. Okajima v.
`
`Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can
`
`reflect the appropriate level of ordinary skill in the art).
`
`III. ANALYSIS
`
`A. Claim Construction
`
`In an inter partes review, claim terms in an unexpired patent are
`
`interpreted according to their broadest reasonable construction1 in light of
`
`the specification of the patent in which they appear. 37 C.F.R. § 42.100(b)
`
`(2016). Unless a special definition for a claim term is set forth in the
`
`specification, claim terms are given their ordinary and customary meaning as
`
`would be understood by a person of ordinary skill in the art at the time of the
`
`invention and in the context of the entire patent disclosure. In re Translogic
`
`Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007).
`
`Petitioner proposes a specific construction for the following four
`
`claim terms under the broadest reasonable interpretation standard: (1) “test
`
`
`1 The Office recently changed the claim construction standard applicable to
`an inter partes review. See Changes to the Claim Construction Standard for
`Interpreting Claims in Trial Proceedings Before the Patent Trial and Appeal
`Board, 83 Fed. Reg. 51,340 (Oct. 11, 2018) (to be codified at 37 C.F.R. pt.
`42). The rule changing the claim construction standard, however, does not
`apply to this proceeding because Petitioner filed its Petition before the
`effective date of the final rule, i.e., November 13, 2018. Id. at 51,340 (rule
`effective date and applicability date), 51,344 (explaining how the Office will
`implement the rule).
`
`
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`6
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`IPR2017-00852
`Patent 9,272,280 B2
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`chamber configured to receive blood of a test sample,” (2) “configured to be
`
`interrogated to determine a hemostatic parameter of the blood,”
`
`(3) “activator of coagulation,” and (4) “a first chamber of the plurality
`
`comprising a first reagent of a first combination of reagents” and “a second
`
`chamber of the plurality comprising a second combination of reagents.” Pet.
`
`8–11. In the Patent Owner Preliminary Response, Patent Owner proposed
`
`constructions for “configured to be interrogated to determine a hemostatic
`
`parameter of the blood” and “activator of coagulation.” Prelim. Resp. 5–7.
`
`In the Institution Decision, we determined that no express claim construction
`
`was necessary. Inst. Dec. 4–5.
`
`In its Patent Owner Response submitted after the Institution Decision,
`
`Patent Owner again2 disputed Petitioner’s proposed construction of
`
`“configured to be interrogated to determine a hemostatic parameter of the
`
`blood.” PO Resp. 13–23. We, therefore, address the construction of this
`
`term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868
`
`F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are
`
`in controversy, and only to the extent necessary to resolve the
`
`controversy’. . . .”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200
`
`F.3d 795, 803 (Fed. Cir. 1999)).
`
`“configured to be interrogated to determine a hemostatic
`parameter of the blood”
`
`The relevant difference between the parties’ proposed constructions of
`
`this phrase centers on the meaning of the term “hemostatic parameter.” 3
`
`Whereas Petitioner did not expressly construe “hemostatic parameter” in the
`
`
`2 In the Patent Owner Response, Patent Owner offered a different
`construction than the one it proposed in the Preliminary Response. Compare
`PO Resp. 14, with Prelim. Resp. 5.
`
`
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`7
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`IPR2017-00852
`Patent 9,272,280 B2
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`Petition (Pet. 10–11), Patent Owner argues that we should construe the term
`
`to mean “a measurement that relies upon multiple components of
`
`hemostasis” (PO Resp. 14).
`
`Patent Owner argues that a hemostatic parameter “must be a
`
`parameter used in determining a blood sample’s ability to undergo
`
`hemostasis.” Id. at 18. Patent Owner notes that the parties agree that
`
`hemostasis is a multi-component, multi-step process that causes bleeding
`
`from a damaged blood vessel to slow and stop. Id. (citing Ex. 1003 ¶ 18;
`
`Ex. 2005 ¶ 68). Therefore, “[a]s hemostasis is a multi-component,
`
`multi-step process, to evaluate hemostasis in a subject one must model the
`
`combined effects of the multiple components of hemostasis.” Id. at 17–18
`
`(citing Ex. 2005 ¶ 68). Patent Owner thus contends that a “hemostatic
`
`parameter” is “a measurement that relies upon multiple components of
`
`hemostasis.” Id. at 17.
`
`Patent Owner further contends that this construction is consistent with
`
`the disclosure in the ’280 patent Specification. Id. at 18–19. In particular,
`
`Patent Owner argues:
`
`Particular hemostasis parameters disclosed in the ’280 patent
`include TC1, TC2, clot stiffness, clot formation rate (CFR),
`TL1, and TL2. Ex. 1001, 2:56-58. Each of these parameters
`allows for an assessment of the hemostasis process because
`
`
`3 The parties also offer different interpretations of the term “configured to.”
`Petitioner contends the term means “capable of” (Pet. 10 (citing Ex. 1003
`¶¶ 67–68)), whereas Patent Owner contends the term should be construed
`more narrowly as meaning “designed to” (PO Resp. 15–16). In view of
`Patent Owner’s substantive arguments, however, we do not need to resolve
`this controversy for purposes of this Decision. See, e.g., id. at 29–30
`(acknowledging that Baugh is configured to measure platelet activation, but
`arguing that platelet activation is not a hemostatic parameter).
`
`
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`8
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`IPR2017-00852
`Patent 9,272,280 B2
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`each provides an understanding of the combined effect of
`multiple components of hemostasis.
` Ex. 2005, ¶ 70.
`Immediately
`following
`the examples of parameters of
`hemostasis, the patent teaches that the device of the patent may
`generate other measurements stating that “[t]he disclosed
`methods can further include determining” several other factors
`(referred to as hemostatic indices) that provide insight into
`individual components or steps within hemostasis. Ex. 1001,
`3:8-11; Ex. 2005, ¶ 71.
`
`PO Resp. 19. Patent Owner contends that the Specification consistently
`
`distinguishes between hemostatic parameters, which characterize hemostasis
`
`by looking at multiple components of hemostasis, and indices of hemostasis,
`
`which isolate a single component of hemostasis. Id. at 20 (comparing
`
`Ex. 1001, 18:6–11 with 18:27–42); see also id. at 21 (arguing that the
`
`distinction between hemostatic parameters and hemostatic indices is “neither
`
`arbitrary nor without importance”).
`
`Petitioner contends that Patent Owner is impermissibly attempting to
`
`rewrite the claim language, noting that Patent Owner “dispenses with the
`
`central claim terms ‘interrogate’ and ‘parameter’ and introduces new
`
`concepts of ‘multiple components’ and ‘reli[ance]’ on such components.”
`
`Reply 5–6. Petitioner argues that Patent Owner does not show why the
`
`Board should not apply the plain meaning of the claim language as the
`
`broadest reasonable interpretation. Id. at 7. Petitioner further contends that
`
`Patent Owner’s construction is inconsistent with the ’280 patent
`
`Specification. Id. at 8–9.
`
`
`
`Patent Owner’s proposed construction is based on the purported
`
`distinction in the Specification between hemostatic parameters and
`
`hemostatic indices. The Specification, however, does not include explicit
`
`definitions of either term. Further, the use of these terms in the Specification
`
`
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`9
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`IPR2017-00852
`Patent 9,272,280 B2
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`indicates at least some overlap between indices and parameters. For
`
`example, in the section titled “Estimate Indices of Hemostatic Function,” the
`
`Specification discusses how to calculate TC1, TC2, S, CFR, TL1, and TL2,
`
`which are referred to as “parameters.” Ex. 1001, 15:5–40. In fact, Patent
`
`Owner acknowledges that “the specification confuses the terminology by
`
`using the term ‘indices of hemostasis’ when discussing measurement that the
`
`specification repeatedly identifies as hemostatic parameters.” PO Resp. 20,
`
`n.8; Hearing Tr., 38:7–39:23 (counsel for Patent Owner acknowledging that
`
`“the patent isn’t the picture of clarity on this” and “there are some times
`
`where the patent does seem to confuse the two”). Accordingly, the evidence
`
`of record does not support Patent Owner’s assertion that the Specification
`
`draws a distinction between parameters that characterize hemostasis by
`
`looking at multiple components of hemostasis and indices of hemostasis,
`
`which isolate a single component of hemostasis. PO Resp. 20–21.
`
`
`
`In view of this, we decline to adopt Patent Owner’s construction.
`
`Instead, we adopt the plain and ordinary meaning of a “hemostatic
`
`parameter,” which is “a parameter used in measuring a blood sample’s
`
`ability to undergo hemostasis.” PO Resp. 18; see also Reply 7–8 (discussing
`
`the importance of understanding “the effects or shortfalls of particular
`
`processes” and defining “parameter” as “any of a set of physical properties
`
`whose values determine the characteristics or behavior of something”).
`
`
`
`For all of the foregoing reasons, we find that the broadest reasonable
`
`interpretation of the term “configured to be interrogated to determine a
`
`hemostatic parameter of the blood” is “configured to be interrogated to
`
`determine a parameter used in measuring a blood sample’s ability to undergo
`
`hemostasis.”
`
`
`
`
`
`10
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`IPR2017-00852
`Patent 9,272,280 B2
`
`
`B. References
`
`i. Baugh (Ex. 1005)
`
`Baugh is directed to an improved method for measuring the
`
`effectiveness of antiplatelet reagents or platelet inhibitors on the coagulation
`
`of blood. Ex. 1005, 3:47–50. Baugh’s method includes
`
`placing a predetermined amount of heparin in each cell of a
`multicell test cartridge, placing an optimized amount of a
`mechanical platelet and/or clotting activator in each cell, and
`placing a measured amount of platelet inhibitor in each cell, the
`amount of inhibitor in each cell differing from the amount in
`each other cell. An aliquot of a blood sample is added to each
`cell, and the blood sample aliquot, platelet and/or clotting
`activator and platelet inhibitor are mixed. Each cell sample is
`allowed to clot, and the clotting time for each cell is measured.
`The relative clotting times are used to calculate and determine
`the platelet inhibition effect of the platelet inhibitor.
`
`Id. at 4:1–13. Baugh discloses abciximab as an example of a platelet
`
`inhibitor that can be used to evaluate the function of platelets in the
`
`blood sample tested. Id. at 5:26–40.
`
`ii.
`
`Schubert (Ex. 1006)
`
`Schubert is directed to “a cartridge device for a measuring system for
`
`measuring viscoelastic characteristics of a sample liquid, in particular a
`
`blood sample.” Ex. 1006 ¶ 25. Schubert discloses using its cartridge device
`
`and measuring system to measure characteristics such as coagulation or
`
`platelet function of a sample liquid. Id. ¶ 78. Schubert’s cartridge device
`
`includes a receiving cavity for receiving the sample liquid and a reagent
`
`cavity for storing a reagent that is mixed with the sample liquid. Id. ¶¶ 78–
`
`79. Schubert discloses an embodiment of its cartridge device having four
`
`measurement cavities. Id. ¶¶ 81–82. With regard to blood coagulation,
`
`Schubert teaches that
`
`
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`11
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`IPR2017-00852
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`there are different reagents available which activate or suppress
`different parts of the coagulation cascade. Pentapharm GmbH
`(Munich, Germany) for example amongst others provide tests
`for intrinsic and extrinsic activation of a blood sample (INTEM
`or EXTEM respectively), and also a test for extrinsic activation
`in which
`the
`thrombocyte
`function
`is suppressed by
`administration of cytochalasin D (FIBTEM). It is state of the
`art that it is possible by wise combination of such tests to be
`able to determine very precisely at which point within the
`coagulation cascade a problem occurs. . . . It is also possible to
`combine e.g. an INTEM, an EXTEM and a FIBTEM
`coagulation test with a platelet aggregometry test within one
`cartridge.
`
`Id. ¶ 83.
`
`C. Challenges Based on Baugh
`
`Petitioner argues that Baugh anticipates claims 1 and 2 of the ’280
`
`patent. Pet. 12–17. Petitioner provides a claim chart and relies on the
`
`declaration of Patrick Mize, Ph.D. (“the Mize Declaration,” Ex. 1003) to
`
`demonstrate how and where Baugh discloses all of the limitations recited in
`
`claims 1 and 2. Pet. 12–17.
`
`Claim 1 requires “[a] device for evaluation of hemostasis, comprising:
`
`a plurality of test chambers each configured to receive blood of a test
`
`sample.” Petitioner contends Baugh discloses this limitation through its
`
`disclosure of “measuring and determining the effectiveness of antiplatelet
`
`reagents or platelet function inhibitors in the coagulation of blood” using a
`
`cartridge that includes a “plurality of test cells,” wherein “(a)n aliquot of a
`
`blood sample is added to each cell.” Pet. 13–14 (quoting Ex. 1005, 1:14–20,
`
`2:2–7, 4:7–8, 4:42–47).4
`
`
`4 Petitioner acknowledges that the original citations to Baugh in the Petition
`were incorrect, and provides a chart listing the original incorrect citations in
`the Petition and corresponding corrected citations. Ex. 1012. For purposes
`
`
`
`12
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`
`Petitioner further notes that Baugh includes “a reagent chamber which
`
`contains a reagent or reagents” (id. at 14–15 (citing Ex. 1005, 2:2–25, 7:21–
`
`25)), and thus discloses the claim 1 requirement of “each test chamber
`
`comprising a reagent or combination of reagents.”
`
`Claim 1 further recites “a first chamber of the plurality comprising a
`
`first reagent or a first combination of reagents that interact with the blood
`
`received therein, wherein the first reagent, or a reagent included in the first
`
`combination of reagents, is an activator of coagulation.” For this limitation,
`
`Petitioner directs us to the portion of Baugh that teaches using “an activation
`
`reagent to activate coagulation of the blood.” Id. at 15–16 (citing Ex. 1005,
`
`2:2–7).
`
`Petitioner also contends that Baugh discloses using abciximab in
`
`addition to an activator of coagulation in certain test cells, and therefore
`
`satisfies the claim 1 requirement of having “a second chamber of the
`
`plurality comprising a second combination of reagents that interact with
`
`blood of the test sample received therein, the combination including an
`
`activator of coagulation and one or both of abciximab and cytochalasin D.”
`
`Id. at 16–17 (citing Ex. 1005, 5:33–43, 6:34–36).
`
`Claim 2 depends from claim 1 and further requires that the first and
`
`second chambers comprise a combination of reagents including one or more
`
`of kaolin, celite, glass, thrombin, ellagic acid, and tissue factor. Petitioner
`
`asserts that Baugh satisfies this limitation by teaching that suitable activators
`
`include kaolin, powdered glass, and silica. Pet. 17 (citing Ex. 1005, 6:1–17).
`
`
`of this Decision, we refer only to Petitioner’s corrected citations provided in
`Exhibit 1012.
`
`
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`
`Having reviewed the cited evidence, and the record as a whole, we
`
`find that Petitioner has accurately described the above-stated disclosures of
`
`Baugh and, therefore, we agree with, and adopt, Petitioner’s contentions that
`
`Baugh discloses the aforementioned limitations in claims 1 and 2. Patent
`
`Owner does not challenge these contentions. Rather, Patent Owner disputes
`
`only Petitioner’s assertion that Baugh discloses a device “wherein each
`
`chamber is configured to be interrogated to determine a hemostatic
`
`parameter,” which we discuss below.
`
`
`
`Petitioner contends that Baugh’s test cells are “structurally capable of
`
`being interrogated to determine a hemostatic parameter” because Baugh
`
`teaches “mechanical activation of platelets using a plunger assembly 72 in
`
`order to detect coagulation.” Pet. 14 (citing Ex. 1001, 7:21–25). Petitioner
`
`further contends Baugh discloses an “optical sensing system which ‘senses
`
`the physical descent of the plunger assembly 72 through the blood sample
`
`and reagent mixture in the reaction chamber 94 in order to detect
`
`coagulation condition.’” Id. at 15 (citing Ex. 1001, 8:27–31).
`
`
`
`Petitioner contends that Baugh’s measurements of platelet activation
`
`and aggregation, which Patent Owner agrees are components of hemostasis,
`
`constitute the determination of a hemostatic parameter under the broadest
`
`reasonable interpretation of that term. Reply 1–2, 5 (“There is no dispute
`
`that Baugh is adapted to examine the platelet activation and aggregation
`
`aspect of hemostasis process that may be considered a ‘component’ of the
`
`process.”); PO Resp. 2. Petitioner contends that “an important use of blood
`
`coagulation assays like those of Baugh and the ‘280 patent is understanding
`
`of the effects or shortfalls of particular processes.” Reply 7 (citing Ex. 1001,
`
`1:31–32). Petitioner thus argues that Baugh’s interrogation of platelet
`
`
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`14
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`IPR2017-00852
`Patent 9,272,280 B2
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`aggregation constitutes determining a parameter of hemostasis because
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`Baugh “determine[s] a characteristic or behavior of that process, which may
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`be a valuable quantification of ‘dysfunction.’” Id. at 8.
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`Patent Owner argues that Baugh does not disclose a chamber
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`“configured to be interrogated to determine a hemostatic parameter” because
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`[c]onfiguration of the chambers within the device to interrogate
`a sample to determine a hemostatic parameter requires
`designing the chambers to provide measurements that rely upon
`multiple components of hemostasis, e.g., activation and
`adhesion of platelets,
`thrombin production, and
`fibrin
`polymerization. That is not the case with the device of Baugh,
`and this is evident throughout the description in Baugh.
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`PO Resp. 24; see also id. at 2 (“[T]he Baugh device measures one
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`component of hemostasis, but not a hemostatic parameter.”). More
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`specifically, Patent Owner contends Baugh discloses determining platelet
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`activation, which “is a component of hemostasis but does not allow
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`assessment of the overall process of hemostasis.” Id. at 30. As evidence of
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`this, Patent Owner notes that, in order to isolate and assess platelet activity,
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`Baugh includes an anticoagulant (e.g., heparin) in its chambers to inhibit
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`hemostasis. Id. at 26.
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`Patent Owner’s argument that Baugh fails to disclose a chamber
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`“configured to be interrogated to determine a hemostatic parameter” is based
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`on its proposed claim construction of the claim term, which requires
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`measuring multiple components of hemostasis. For the reasons discussed
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`above, we decline to adopt Patent Owner’s proposed construction. Instead,
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`we determined that “configured to be interrogated to determine a hemostatic
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`parameter of the blood” means “configured to be interrogated to determine a
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`parameter used in measuring a blood sample’s ability to undergo
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`IPR2017-00852
`Patent 9,272,280 B2
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`hemostasis.” Patent Owner does not dispute that Baugh discloses chambers
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`“configured to be interrogated to determine a hemostatic parameter of the
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`blood” under the plain and ordinary meaning of the claim language, as
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`proposed by Petitioner.
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`Indeed, Patent Owner acknowledges that platelet activation and
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`aggregation are components of hemostasis. PO Resp. 28, 30; Ex. 2005 ¶ 63
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`(“A person of ordinary skill in the art would understand that hemostasis is a
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`physiologic process during which blood clots and stops bleeding from a
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`damaged vessel through pertinent biology, including platelet activation and
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`aggregation, thrombin production, fibrin formation and polymerization, and
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`fibrin clot formation.”) (emphasis added). Further, Patent Owner states that
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`Baugh assesses platelet activity by “measur[ing] viscosity changes of the
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`sample after the activation of platelets,” noting that, upon activation,
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`platelets aggregate, which leads to an increase in viscosity of the test
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`samples. PO Resp. 28–29. Moreover, the evidence of record demonstrates
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`that platelet aggregation tests were known in the art to be a way of
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`measuring a blood sample’s ability to undergo hemostasis. See, e.g., Ex.
`
`2005 ¶ 42; Ex. 1005, 1:29–2:3. For example, in the background section of
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`the ’280 patent, platelet aggregation assays are listed as an example of
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`existing in vitro diagnostic (IVD) tests, and IVDs are described as being
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`“critically needed to quantify hemostatic dysfunction and direct appropriate
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`treatment.” Ex. 1005, 1:35–42.
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`In view of the foregoing, we find that Baugh’s studies of platelet
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`activity constitute measuring a blood sample’s ability to undergo hemostasis.
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`Accordingly, we find that Baugh’s testing device is “configured to be
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`interrogated to determine a hemostatic parameter of the blood,” as required
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`by claim 1.
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`Based on the information and arguments presented, we find Petitioner
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`explains sufficiently how and where Baugh discloses each limitation of
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`claims 1 and 2. We, therefore, find that Petitioner has demonstrated, by a
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`preponderance of evidence, that Baugh anticipates claims 1 and 2 of the ’280
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`patent.
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`D. Challenges Based on Schubert
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`Petitioner argues that Schubert anticipates claims 1 and 2 of the ’280
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`patent. Pet. 18–24. Petitioner provides a claim chart and relies on the Mize
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`Declaration (Ex. 1003) to demonstrate how and where Schubert discloses all
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`of the limitations recited in claims 1 and 2.
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`Petitioner contends Schubert discloses “a cartridge device for a
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`measuring system for measuring viscoelastic characteristics of a sample
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`liquid, in particular a blood sample.” Id. at 19 (quoting Ex. 1006, Abstract,
`
`¶¶ 2–7, 25). Petitioner notes that Schubert states that its cartridge device has
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`“at least one measurement cavity,” and discloses embodiments wherein the
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`cartridge device has four measurement cavities and the sample liquid is
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`shared among the cavities. Id. at 19–20 (citing Ex. 1006 ¶¶ 19, 8).
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`Petitioner thus argues that Schubert teaches “[a] device for evaluation of
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`hemostasis comprising a plurality of test chambers, each configured to
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`receive blood of a test sample” as required by claim 1. Id.
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`Claim 1 further recites “each test chamber comprising a reagent or
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`combination of reagents.” With regard to this limitation, Petitioner directs
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`us to Schubert’s discussion of certain embodiments wherein “at least one
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`reagent cavity is integrally formed . . . with the at least one measurement
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`cavity,” as well as Schubert’s discussion of reagents that can activate or
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`suppress different parts of the coagulation cascade. Id. at 20 (citing
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`Ex. 1006 ¶¶ 40, 83).
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`Petitioner notes that Schubert teaches each cartridge has “at least one
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`probe element arranged in at least one measurement cavity for performing a
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`test on said sample liquid” to measure a viscoelastic property of the sample
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`liquid. Id. at 21 (citing Ex. 1006 ¶¶ 29, 88 (“FIG. 7c shows the sample
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`liquid 1, which has been pumped into the measurement cavity 20. The probe
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`pin 3 of the probe element 22 is immersed in the sample liquid 1.”)).
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`Petitioner contends this disclosure corresponds to the claim 1 requirement
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`wherein “each chamber is configured to be interrogated to determine a
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`hemostatic parameter of the blood received therein.” Id.
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`Claim 1 further requires “a first chamber of the plurality comprising a
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`first reagent or a first combination of reagents that interact with the blood
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`received therein, wherein the first reagent, or a reagent included in the first
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`combination of reagents, is an activator of coagulation.” Petitioner argues
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`that Schubert “provides examples of different reagents that can be included
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`for performing different assays,” including reagents “which activate . . .
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`different parts of the coagulation cascade.” Id. at 21–22 (citing Ex. 1006
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`¶ 83). Petitioner also directs us to Schubert’s disclosure of “tests for
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`intrinsic and extrinsic activation of a blood sample (INTEMTM or EXTEMTM
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`assays, respectively), and also a test for extrinsic activation