Trials@uspto.gov
`571-272-7822
`
`Paper No. 55
`
` 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 IPR2017-00855
`Patent 9,410,971 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
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`Paper No. 55
`
` 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 IPR2017-00855
`Patent 9,410,971 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
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case IPR2017-00855
`Patent 9,410,971 B2
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`I.
`
`INTRODUCTION
`
`Instrumentation Laboratory Company (“Petitioner”) filed a Petition
`
`seeking inter partes review of claims 1–20 of U.S. Patent No. 9,410,971 B2
`
`(“the ’971 patent,” Ex. 1002). Paper 2 (“Pet.”). HemoSonics LLC (“Patent
`
`Owner”) filed a Patent Owner Preliminary Response to the Petition. Paper 8
`
`(“Prelim. Resp.”). On September 1, 2017, we instituted an inter partes
`
`review of claims 1, 2, 6, 7, 15, and 16. Paper 14 (“Inst. Dec.”) (instituting
`
`trial on a subset of the claims and grounds raised in the Petition).
`
`After institution, Petitioner filed a Request for Rehearing (Paper 16),
`
`which we denied (Paper 20). Patent Owner filed a Response to the Petition
`
`(Paper 21, “PO Response”), and Petitioner filed a Reply (Paper 24, “Reply”)
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`to the Patent Owner Response.
`
`On April 26, 2018, we modified our Institution Decision to include
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`review of “all challenged claims and all of the grounds presented in the
`
`Petition” in view of SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348 (2018).
`
`Paper 28, 2. Patent Owner chose to forego the opportunity to file a
`
`supplemental response, and Petitioner filed a Supplemental Reply addressing
`
`the grounds and claims not addressed in its Reply. Paper 29 (“Suppl.
`
`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 46 (“Hearing Tr.”); Paper
`
`54 (“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
`
`
`
`2
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`Case IPR2017-00855
`Patent 9,410,971 B2
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`C.F.R. § 42.100(c). Paper 52. On the same day, we issued an order
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`extending the time of pendency in this proceeding by up to six months.
`
`Paper 53.
`
`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, 2, 6–8, 15, and 16 of the ’971
`
`patent are unpatentable, and has not shown by a preponderance of the
`
`evidence that claims 3–5, 9–14, and 17–20 are unpatentable.
`
`II. BACKGROUND
`
`A. Related Matters
`
`The parties identify the petition for inter partes review of related U.S.
`
`Patent No. 9,272,280 B2 (IPR2017-00852) as a related matter. Pet. 1; Paper
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`3, 1. The parties indicate that U.S. Patent Application No. 15/202,059 may
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`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 ’971 Patent
`
`The ’971 patent, titled “Devices, Systems and Methods for Evaluation
`
`of Hemostasis,” issued on August 9, 2016. Ex. 1002, at [54], [45]. The ’971
`
`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 1:23–26. The ’971 patent states “[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,
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`there is a critical need for in vitro diagnostics to “quantify hemostatic
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`dysfunction and direct appropriate treatment.” Id. at 1:26–31.
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`Accordingly, the ’971 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
`
`from the subject.” Id. at 2:16–19. The ’971 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 2:19–28. The test chambers are also
`
`configured to be “interrogated with sound to determine a hemostatic
`
`parameter of the test samples” (id. at 2:28–31, 2:37–39), and “[s]ound
`
`reflected from the blood reagent mixture in the test chamber is received and
`
`processed to generate a hemostasis parameter” (id. at 2:64–66).
`
`C. Challenged Claims
`
`Petitioner challenges claims 1–20 of the ’971 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;
`
`a second chamber of the plurality comprising a second
`combination of reagents that interact with blood of the test
`sample received therein, the second combination including
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`an activator of coagulation and one or both of abciximab and
`cytochalasin D; and
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`an interrogation device that measures at least one viscoelastic
`property of the test sample.
`
`Id. at 18:62–19:13. Independent claim 17 recites limitations similar to those
`
`included in claim 1, and further requires the first and second chambers to be
`
`configured to be interrogated with ultrasound, a transducer for transmitting
`
`and receiving ultrasound, and a processor configured to determine
`
`hemostatic parameters from signals transmitted to the transducer. Id.
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`at 20:17–41.
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`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).
`
`Schubert et al., U.S. Pub. No. 2010/0154520 A1, published June
`24, 2010 (“Schubert,” Ex. 1006).
`
`Warden et al., U.S. Patent No. 6,016,712, issued Jan. 25, 2000
`(“Warden,” Ex. 1007).
`
`Lang et al., Different effects of abciximab and cytochalasin D on
`clot strength in thrombelastography, J. THROMB. HAEMOST. 2:147–
`53 (2004) (“Lang,” Ex. 1008).
`
`Viola et al., A novel ultrasound-based method to evaluate
`hemostatic function of whole blood, CLINICAL CHIMICA ACTA. 411
`106–13 (2010) (“Viola,” Ex. 1012).
`
`Gavin et al., U.S. Patent No. 5,504,011, issued Apr. 2, 1996
`(“Gavin,” Ex. 1013).
`
`Braun, Sr. et al., U.S. Patent No. 6,613,286 B2, issued Sept. 2,
`2003 (“Braun,” Ex. 1014)
`
`Ostgaard et al., U.S. Patent No. 5,888,826, issued Mar. 30, 1999
`(“Ostgaard,” Ex. 1015).
`
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`Jina, U.S. Patent No. 6,046,051, issued Apr. 4, 2000 (“Jina,”
`Ex. 1016).
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`Miller et al., U.S. Pub. No. 2003/0199082 A1, published Oct. 23,
`2003 (“Miller,” Ex. 1017).
`
`E. Reviewed Grounds
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`Reference(s)
`
`Statutory
`Basis
`
`Baugh
`
`Schubert
`
`Baugh and Viola
`
`Schubert and Viola
`
`Baugh and Gavin
`
`Schubert and Gavin
`
`Baugh and Braun
`
`Schubert and Braun
`
`Baugh, Gavin, Braun, Ostgaard, Jina, and
`Miller
`
`Claim(s)
`Challenged
`1, 2, 6, 7,
`15, 16
`1, 2, 6, 7, 8,
`15, 16
`
`3, 4
`
`3, 4
`
`5
`
`5
`
`§ 102
`
`§ 102
`
`§ 103
`
`§103
`
`§103
`
`§103
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`§103
`
`8, 12, 13
`
`§103
`
`8, 12, 13
`
`§103
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`9–11
`
`Schubert, Gavin, Braun, Ostgaard, Jina, and
`Miller
`
`§103
`
`9–11
`
`Baugh and Warden
`
`Schubert and Warden
`
`Baugh and Viola
`
`Warden, Lang, and Viola
`
`
`
`§103
`
`§103
`
`§103
`
`§103
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`14
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`14
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`17–20
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`17–20
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`6
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`F. Level of Ordinary Skill in the Art
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`Petitioner contends that a person of ordinary skill in the art at the time
`
`of the ’971 patent 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. 6–7; 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. 16. Patent
`
`Owner also contends that a person of ordinary skill would have had
`
`“experience in and an understanding of multiple areas, including hemostasis,
`
`[the] 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
`
`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. 6–7; PO Resp. 16. This
`
`level of ordinary skill is reflected by the prior art of record. Okajima v.
`
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`7
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`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). Absent a special definition for a claim term being 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
`
`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.”
`
`
`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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`Pet. 7–9. In the Patent Owner Preliminary Response, Patent Owner
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`proposed constructions for “configured to be interrogated to determine a
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`hemostatic parameter of the blood,” “activator of coagulation,” “viscoelastic
`
`property,” and “configured for use with a single test sample.” Prelim.
`
`Resp. 6–12.
`
`In the Institution Decision, we determined that it was only necessary
`
`to construe “configured for use with a single test sample,” and that the
`
`broadest reasonable interpretation of “configured for use with a single test
`
`sample” includes a device that is configured for use with a test sample that is
`
`separated and provided to different chambers of the device. Inst. Dec. 6–7.
`
`Neither party addressed this construction in any subsequent papers. Now,
`
`having considered the full trial record before us, we see no reason to revisit
`
`or change this construction. Additionally, after considering the full record
`
`developed during the trial, we find that it is not necessary to construe any
`
`other terms for purposes of this Decision. 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)).
`
`B. Challenges Based on Schubert
`
`i.
`
`Schubert (Ex. 1006)
`
`Schubert is directed to a “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
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`includes a receiving cavity for receiving the sample liquid and a reagent
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`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. Schubert also teaches that, with regard
`
`to blood coagulation,
`
`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.
`
`ii. Claims 1, 2, 6–8, 15, and 16
`
`Petitioner argues that Schubert anticipates claims 1, 2, 6–8, 15, and 16
`
`of the ’971 patent. Pet. 15–23. To support its argument, Petitioner provides
`
`a claim chart and relies on the Mize Declaration (Ex. 1003) to demonstrate
`
`how and where it asserts that Schubert discloses all the limitations of claims
`
`1, 2, 6–8, 15, and 16 of the ’971 patent. Id.
`
`As to independent claim 1, Petitioner contends Schubert discloses “a
`
`cartridge device for a measuring system for measuring viscoelastic
`
`characteristics of a sample liquid, in particular a blood sample.” Id. at 16
`
`(citing Ex. 1006, Abstract, ¶¶ 2–7, 25). Petitioner notes that Schubert states
`
`that its cartridge device has “at least one measurement cavity,” and discloses
`
`embodiments wherein the cartridge device has four measurement cavities
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`and the sample liquid is shared among the cavities. Id. at 16 (citing
`
`Ex. 1006 ¶¶ 29, 81–82). Petitioner thus argues that Schubert teaches “[a]
`
`device for evaluation of hemostasis comprising: a plurality of test chambers,
`
`each configured to receive blood of a test sample,” as claim 1 requires. Id.;
`
`Ex. 1002, 18:62–64.
`
`Claim 1 further recites “each test chamber comprising a reagent or
`
`combination of reagents.” Ex. 1002, 18:64–65. With regard to this
`
`limitation, Petitioner directs us to Schubert’s discussion of certain
`
`embodiments wherein “at least one reagent cavity is integrally formed . . .
`
`with the at least one measurement cavity,” as well as Schubert’s discussion
`
`of reagents that can activate or suppress different parts of the coagulation
`
`cascade. Pet. 17 (citing Ex. 1006 ¶¶ 40, 83).
`
`Petitioner notes that Schubert is directed to “provid[ing] a cartridge
`
`device for a measuring system for measuring viscoelastic characteristics of a
`
`sample liquid, in particular a blood sample,” and teaches each cartridge of its
`
`device has “at least one probe element arranged in said at least one
`
`measurement cavity for performing a test on said sample liquid” to measure
`
`a viscoelastic property of the sample liquid. Id. at 17–18 (citing Ex. 1006
`
`¶¶ 11, 29, 88 (“FIG. 7c shows the sample liquid 1, which has been pumped
`
`into the measurement cavity 20. The probe pin 3 of the probe element 22 is
`
`immersed in the sample liquid 1.”)), 20 (citing Ex. 1006 ¶¶ 25, 29, 31).
`
`Petitioner contends these disclosures correspond to the limitations in claim 1
`
`requiring “each chamber is configured to be interrogated to determine a
`
`hemostatic parameter of the blood received therein” and “an interrogation
`
`device that measures at least one viscoelastic property of the test sample.”
`
`Id. at 17–18, 20; Ex. 1002, 18:65–67, 19:11–12.
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`Having reviewed the cited evidence, and the record as a whole, we
`
`find that Petitioner has accurately described the disclosures of Schubert, and,
`
`therefore, we agree with, and adopt, Petitioner’s contentions that Schubert
`
`discloses the aforementioned limitations in claim 1.
`
`Claim 1 further requires “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.” Ex. 1002, 19:1–5.
`
`Petitioner argues that Schubert “provides examples of different reagents that
`
`can be included for performing different assays,” including reagents “which
`
`activate . . . different parts of the coagulation cascade.” Pet. 18–19 (citing
`
`Ex. 1006 ¶ 83). Petitioner also directs us to Schubert’s disclosure of “tests
`
`for intrinsic and extrinsic activation of a blood sample (INTEMTM or
`
`EXTEMTM respectively), and also a test for extrinsic activation in which the
`
`thrombocyte function is suppressed by administration of cytochalasin D
`
`(FIBTEMTM).” Id. (citing Ex. 1006 ¶ 83). Petitioner thus contends that
`
`Schubert “includes teachings that a first measurement cavity in a plurality of
`
`measurement cavities can include reagents which ‘activate different parts of
`
`the coagulation cascade’ such as intrinsic or extrinsic activators (as would be
`
`used in the INTEMTM and EXTEMTM assays, respectively).” Id.
`
`Petitioner relies on Schubert’s disclosure of “a test for extrinsic
`
`activation in which the thrombocyte function is suppressed by administration
`
`of cytochalasin D (FIBTEMTM)” to demonstrate that Schubert teaches using
`
`cytochalasin D in addition to an activator in certain test cells. Id. at 19–20
`
`(asserting “a second measurement cavity can include an extrinsic activator in
`
`combination with cytochalasin D reagents (as would be used in the
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`FIBTEMTM assay”)) (citing Ex. 1006 ¶ 83). Petitioner therefore argues that
`
`Schubert discloses the claim 1 requirement of having “a second chamber . . .
`
`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. (citing
`
`Ex. 1006 ¶ 83); Ex. 1002, 19:6–10.
`
`In the Institution Decision, based on arguments presented in Patent
`
`Owner’s Preliminary Response, we determined that Petitioner failed to
`
`demonstrate sufficiently where Schubert discloses the use of activators of
`
`coagulation as a reagent. Specifically, we stated:
`
`Although Schubert does disclose that activators of
`coagulation exist and characterizes the INTEM, EXTEM, and
`FIBTEM tests as tests for intrinsic and extrinsic activation, as
`Patent Owner points out, Schubert never explicitly states that
`these tests use, as a reagent, activators of coagulation. See
`Ex. 1006 ¶ 83.
`Petitioner asserts that intrinsic or extrinsic activators
`would be used in the INTEM, EXTEM and FIBTEM assays,
`but does not provide in the Petition any citation to support those
`assertions. Pet. 19–20.
`
`Inst. Dec. 22.
`
`We, therefore, determined that the record at that time failed to
`
`establish a reasonable likelihood that Petitioner would prevail on its
`
`assertion that Schubert anticipates claim 1 of the ’971 patent, and declined to
`
`include this ground in the inter partes review proceeding. Id. at 23. We
`
`reached the same conclusion regarding dependent claims 2, 6–8, 15, and 16,
`
`based on their dependency from claim 1. Because the question of whether
`
`Schubert anticipates claims 1, 2, 6–8, 15, and 16 was not part of the trial at
`
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`the time Patent Owner’s Response was due, Patent Owner did not address
`
`this challenge in its Patent Owner Response filed December 1, 2017.
`
`On April 26, 2018, after the Supreme Court’s decision in SAS, we
`
`amended our Institution Decision to include this ground. Paper 28.
`
`Subsequently, we offered Patent Owner an opportunity to file a
`
`supplemental Patent Owner Response to address Petitioner’s grounds based
`
`on Schubert, but Patent Owner indicated it did not wish to do so. Ex. 1069,
`
`10:6–12. Petitioner filed a Supplemental Reply addressing our preliminary
`
`determinations in the Institution Decision regarding Schubert. In its
`
`Supplemental Reply, Petitioner argues:
`
`The Petition quotes and cites to paragraph 0083 of
`[Schubert] where consecutive sentences state that (i) “there are
`different reagents available which activate or suppress different
`parts of the coagulation cascade” and (ii) Pentaphar[m] GmbH
`provides tests “for intrinsic and extrinsic activation of a blood
`sample (INTEMTM or EXTEMTM respectively), and also “for
`extrinsic activation in which the thrombocyte function is
`suppressed . . . [cytochalasin D] (FIBTEMTM).”
`
`Suppl. Reply 3. Petitioner again contends that a person of ordinary skill in
`
`the art would have understood these sentences in Schubert to teach that
`
`INTEM and EXTEM include reagents that activate different parts of the
`
`coagulation cascade. Id. Petitioner further argues that Patent Owner did not
`
`contradict Dr. Mize’s testimony that INTEM, EXTEM, and FIBTEM are
`
`assays with known meanings to a person of ordinary skill in the art, and that
`
`the EXTEM assay includes Tissue Factor, the INTEM assay includes ellagic
`
`acid plus phospholipid, and the FIBTEM assay incudes Tissue Factor and
`
`cytochalasin D. Id. at 4–5 (citing Ex. 1003 ¶¶ 19–20, 49, 61).
`
`
`
`On July 11, 2018, we granted Petitioner’s Motion to file Supplemental
`
`Information, allowing three exhibits into the record. Paper 44. These
`
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`14
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`Case IPR2017-00855
`Patent 9,410,971 B2
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`exhibits include U.S. Patent No. 9,915,671 B2 (“the ’671 patent,” Ex. 1072)
`
`and statements by Patent Owner and Patent Owner’s Declarant, Dr.
`
`Diamond, regarding a particular portion of the ’671 patent (Exs. 1070 and
`
`1071, respectively). These statements appear in a petition (Ex. 1070) and
`
`supporting declaration (Ex. 1071) filed in connection with IPR2018-00950
`
`challenging claims of the ’671 patent.
`
`The ’671 patent is a continuation of Schubert and, like Schubert, is
`
`directed to “a cartridge device for a measuring system for measuring
`
`viscoelastic characteristics of a sample liquid.” Ex. 1072, 1:38–40; see also
`
`id. at [63] (claiming priority through continuation applications back to
`
`Application No. 12/640,374, which is the application number listed on
`
`Schubert). The paragraph spanning lines 18 through 55 of column 9 of
`
`the ’671 patent is identical to paragraph 83 of Schubert. Compare Ex. 1072,
`
`9:18–55, with Ex. 1006 ¶ 83. As discussed above, this paragraph includes
`
`the statement that “there are different reagents available which activate or
`
`suppress different parts of the coagulation cascade,” and discusses the
`
`INTEM, EXTEM, and FIBTEM tests. Ex. 1067, 9:18–55; Ex. 1006 ¶ 83.
`
`
`
`In IPR2018-00950, referring to the ’671 patent, Patent Owner states
`
`“[t]he patent discloses incorporating several existing blood coagulation
`
`reagent compositions into the cartridge. [Ex. 1072], 9:18-55. These
`
`reagents include compounds that activate blood coagulation through the
`
`intrinsic pathway (INTEM) and extrinsic pathway (EXTEM), and
`
`compounds that suppress thrombocyte (a.k.a. platelet) function (FIBTEM).
`
`Id., 9:18-55.” Ex. 1070, 9.2 Dr. Diamond states “[t]issue factor is an
`
`
`2 For Exhibits 1070 and 1071, we refer to the page numbers printed at the
`bottom, center of each page.
`
`
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`15
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`Case IPR2017-00855
`Patent 9,410,971 B2
`
`activator of the extrinsic coagulation pathway,” and cites to column 9, lines
`
`18 through 25 of the ’671 patent to support this statement. Ex. 1071, 50–51.
`
`Dr. Diamond also states that the ’671 patent “acknowledg[es] that EXTEM
`
`is an extrinsic activator of coagulation” (id. at 51 (citing Ex. 1072, 9:18–25))
`
`and “acknowledg[es] INTEM as an intrinsic activator of coagulation assay”
`
`(id. at 56 (citing Ex. 1072, 9:20–25)).
`
`
`
`The statements by Patent Owner and Dr. Diamond are consistent with
`
`those made by Petitioner and Dr. Mize, namely, that the language in
`
`paragraph 83 of Schubert (which is identical to the language in column 9,
`
`lines 18 through 55 of the ’671 patent) discloses the use of coagulation
`
`activators among the reagents in the chambers of Schubert’s device. For
`
`example, both Patent Owner and Petitioner state that EXTEM and FIBTEM
`
`tests, disclosed in paragraph 83 of Schubert, include compounds that activate
`
`blood coagulation. Pet. 18; Ex. 1070, 9. Similarly, both Dr. Mize and
`
`Dr. Diamond state that tissue factor is an activator of the extrinsic
`
`coagulation pathway, and conclude that EXTEM includes an extrinsic
`
`activator of coagulation. Ex. 1071, 50–51; Ex. 1003 ¶ 39, n. xxiv (p. 117)
`
`(“The EXTEMTM assay includes an extrinsic activator (Tissue Factor) as a
`
`reagent . . . .”). Thus, although Schubert may not expressly state that
`
`EXTEM, INTEM, and FIBTEM include coagulation activators, it is
`
`undisputed that a person of ordinary skill in the art would have understood
`
`that these tests include coagulation activators. In re Preda, 401 F.2d 825,
`
`826 (CCPA 1968) (“[I]n considering the disclosure of a reference, it is
`
`proper to take into account not only specific teachings of the reference but
`
`also the inferences which one skilled in the art would reasonably be
`
`expected to draw therefrom.”).
`
`
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`16
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`Case IPR2017-00855
`Patent 9,410,971 B2
`
`
`In view of the foregoing, after considering the full record, we agree
`
`with Petitioner that Schubert, through its discussion of EXTEM and
`
`FIBTEM tests in paragraph 83, discloses the use of activators of coagulation
`
`as a reagent in first and second chambers. As noted above, Patent Owner
`
`did not address Petitioner’s arguments regarding Schubert in its Patent
`
`Owner Response, and chose not to file a supplemental response. We,
`
`therefore, find that Petitioner has demonstrated, by a preponderance of
`
`evidence, that Schubert discloses every limitation of claim 1.
`
`Petitioner directs us to its claim chart that identifies portions of
`
`Schubert that disclose the limitations recited in dependent claims 2, 6–8, 15,
`
`and 16. Patent Owner does not dispute that Schubert discloses the
`
`limitations recited in claims 2, 6–8, 15, and 16. Based on our review of the
`
`totality of the record after trial, we agree with, and adopt, Petitioner’s
`
`arguments and evidence that Schubert discloses the limitations of claims 2,
`
`6–8, 15, and 16.
`
`Thus, we determine that the preponderance of evidence supports a
`
`finding that Petitioner has demonstrated that Schubert anticipates claims 1,
`
`2, 6–8, 15, and 16.
`
`iii. Claims 3 and 4
`
`Petitioner contends that the subject matter of claims 3 and 4 would
`
`have been obvious in view of the combined teachings of Schubert and Viola.
`
`Pet. 25.
`
`1. Viola (Ex. 1012)
`
`Viola is directed to “an ultrasound-based technology, named
`
`sonorheometry, which uses the phenomenon of acoustic radiation force to
`
`make repeated viscoelastic measurements of a whole blood sample.”
`
`
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`17
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`Case IPR2017-00855
`Patent 9,410,971 B2
`
`Ex. 1012, 107. Viola explains that sonorheometry is performed using
`
`acoustic radiation force to generate small and localized displacements in a
`
`blood sample, and determines viscoelastic properties by processing returned
`
`echoes from the sample. Id. According to Viola, sonorheometry has been
`
`implemented in a prototype bench-top instrument, and “can measure the
`
`function of plasma coagulation factors (including fibrinogen), platelets, and
`
`fibrinolytic factors from a small sample of whole blood.” Id.
`
`2. Analysis
`
`Claim 3 depends from claim 1, and requires the interrogation device
`
`of claim 1 to be “configured to use acoustic radiation force.” Ex. 1002,
`
`19:24–25. Claim 4 also depends from claim 1, and requires the interrogation
`
`device to be “configured to transmit sound into one or more test chamber.”
`
`Id. at 19:26–27.
`
`In the Petition, Petitioner states that Schubert in combination with
`
`Viola “renders obvious IPR claims 3 and 4, by disclosing each and every
`
`element of the claims, arranged as claimed in a manner enabling to a [person
`
`of ordinary skill in the art], as discussed by Dr. Mize in Ex. 1003, ¶¶ 107-
`
`112.” Pet. 25. Petitioner provides a claim chart describing where Viola
`
`discloses the limitations in claims 3 and 4. Id. at 24–25. According to
`
`Petitioner, this claim chart shows how the prior art “discloses and enables
`
`each and every limitation of claims 3 and 4 of the ’971 patent.” Id. at 25.
`
`“[A] patent composed of several elements is not proved obvious
`
`merely by demonstrating that each of its elements was, independently,
`
`known in the prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418
`
`(2007). Rather, “it can be important to identify a reason that would have
`
`prompted a person of ordinary skill in the relevant field to combine the
`
`
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`18
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`Case IPR2017-00855
`Patent 9,410,971 B2
`
`elements in the way the claimed new invention does.” Id. Furthermore, a
`
`party seeking to demonstrate that a patent would have been obvious must
`
`show that “a skilled artisan would have been motivated to combine the
`
`teachings of the prior art references to achieve the claimed invention, and
`
`that the skilled artisan would have had a reasonable expectation of success in
`
`doing so.” Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342,
`
`1360 (Fed. Cir. 2012) (quoting Procter & Gamble Co. v. Teva Pharm. USA,
`
`Inc., 566 F.3d 989, 994 (Fed. Cir. 2009)).
`
`Furthermore, it is Petitioner’s burden to establish facts supporting its
`
`challenges by a preponderance of the evidence. 35 U.S.C. § 316(e).
`
`“Failure to prove the matter as required by the applicable standards means
`
`that the party with the burden of persuasion loses on that point—thus, if the
`
`fact trier of the issue is left uncertain, the party with the burden loses.”
`
`Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1327 (Fed. Cir.
`
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