UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`INSTRUMENTATION LABORATORY COMPANY
`
`Petitioner
`
`v.
`
`HEMOSONICS LLC
`
`Patent Owner
`
`
`
`Post-Grant Review Case No. Unassigned
`
`Patent 10,031,144
`
`
`
`PETITION FOR POST-GRANT REVIEW OF
`
`U.S. PATENT NO. 10,031,144
`
`
`
`

`

`
`TABLE OF CONTENTS
`
`TABLE OF CONTENTS ............................................................................................ I
`TABLE OF AUTHORITIES ................................................................................... III
`I. INTRODUCTION: .............................................................................................. 1
`II. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(A)(1): .......................... 3
`A. REAL PARTY-IN-INTEREST UNDER 37 C.F.R. § 42.8(B)(1): ................................. 3
`B. RELATED MATTERS UNDER 37 C.F.R. § 42.8(B)(2): ............................................ 3
`C. LEAD AND BACK UP COUNSEL UNDER 37 C.F.R. § 42.8(B)(3): ........................... 5
`D. SERVICE INFORMATION UNDER 37 C.F.R. § 42.8(B)(4): ...................................... 5
`III. ADDITIONAL REQUIREMENTS: .................................................................. 6
`A. PAYMENT OF FEES UNDER 37 C.F.R. § 42.15: ..................................................... 6
`B. TIMING UNDER 37 C.F.R. § 42.202: ..................................................................... 6
`C. GROUNDS FOR STANDING UNDER 37 C.F.R. § 42.204(A): ................................... 6
`IV. THE ‘144 PATENT: ......................................................................................... 6
`A. SPECIFICATION OF THE ‘144 PATENT:................................................................... 6
`B. CHALLENGED CLAIMS OF THE ‘144 PATENT: ..................................................... 13
`C. PROSECUTION HISTORY OF THE ‘144 PATENT: ................................................... 22
`V. 37 C.F.R. § 42.204(B)(1)-(2): IDENTIFICATION OF THE CHALLENGE:
`
`24
`A. STATEMENT OF REQUESTED RELIEF: .................................................................. 24
`B. PERSON OF ORDINARY SKILL IN THE ART (“POSA”): ........................................ 27
`C. BACKGROUND ON THE STATE OF THE ART: ........................................................ 28
`1. Hemostasis: .................................................................................................... 28
`2. Hemostatic Testing: ....................................................................................... 29
`3. Common Features for Hemostatic Testing Devices: ..................................... 33
`VI. 37 C.F.R. § 42.204(B)(3): CLAIM CONSTRUCTION: .............................. 35
`A. CLAIM CONSTRUCTION FOR SPECIFIC TERMS: .................................................... 35
`VII. GROUND 1: IT IS MORE LIKELY THAN NOT THAT THE
`CHALLANGED CLAIMS LACK BOTH ENABLEMENT AND WRITTEN
`DESCRIPTION UNDER 35 U.S.C. § 112(A): ....................................................... 48
`A. AS A MATTER OF POLICY, THE CHALLENGED CLAIMS SHOULD NOT BE ALLOWED
`TO USE FUNCTIONAL RECITALS, UNTETHERED TO ANY DEFINITE STRUCTURE TO
`PREEMPT NON-DISCLOSED AND NON-ENABLED IMPLEMENTATIONS: ...................... 48
`i
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`

`

`B. THE CHALLENGED CLAIMS LACK BOTH ENABLEMENT AND WRITTEN
`DESCRIPTION SUPPORT: ............................................................................................ 50
`C. DEPENDENT CLAIMS 16, 18, 30, 39, 50, 58 AND 63 DECEPTIVELY BROADEN OUT
`CLAIM SCOPE BY RECITING LIMITATION WHICH LACK ENABLEMENT AND WRITTEN
`DESCRIPTION SUPPORT: ............................................................................................ 54
`VIII. GROUND 2: IT IS MORE LIKELY THAN NOT THAT THE
`CHALLENGED CLAIMS ARE UNPATENTABLE AS INDEFINITE UNDER
`35 U.S.C. § 112(B): ................................................................................................... 55
`A. THE CHALLENGED CLAIMS ARE INDEFINITE DUE TO FUNCTIONAL CLAIMING
`UNTETHERED TO ANY CLEAR CORRESPONDING STRUCTURE: .................................. 56
`B. ELEMENT 1.2 OF CLAIM 1 IS INDEFINITE SINCE IT IS UNCLEAR WHETHER
`“SYSTEM” IS A POSITIVELY RECITED ELEMENT OF THE CLAIM: ............................... 59
`IX. GROUND 3: IT IS MORE LIKELY THAN NOT THAT THE
`CHALLENGED CLAIMS ARE UNPATENTABLE AS ANTICIPATED BY
`SCHUBERT UNDER 35 U.S.C. § 102: .................................................................. 60
`A. TEACHINGS IN SCHUBERT: ................................................................................. 60
`1. Viscoelastic Methods in Schubert: ................................................................. 63
`2. Teachings with Respect to Transducers: ....................................................... 66
`3. Teachings With Respect to Computer-Implemented Components Including
`Processors, Memory and Processor Executable Instructions: ............................ 71
`B. APPARATUS CLAIM 1: ........................................................................................ 74
`C. SYSTEM CLAIMS 20, 42 AND 61: ........................................................................ 77
`D. DEPENDENT CLAMS: .......................................................................................... 79
`X. GROUNDS 4 AND 5: IT IS MORE LIKELY THAN NOT THAT THE
`CHALLENGED CLAIMS ARE UNPATENTABLE AS OBVIOUS OVER
`SCHUBERT UNDER 35 U.S.C. § 103: .................................................................. 85
`A. GROUND 4: OBVIOUSNESS OVER SCHUBERT IN VIEW OF THE STATE OF THE ART
`ON TEG AND TEM: .................................................................................................. 85
`B. GROUND 5: OBVIOUSNESS OVER SCHUBERT IN VIEW OF THE STATE OF THE ART
`ON ACOUSTIC-ECHO BASED INTERROGATION AND DATA ANALYSIS: ...................... 89
`XI. CONCLUSION ................................................................................................... 94
`
`
`
`
`
`
`
`
`ii
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`

`

`TABLE OF AUTHORITIES
`
`Statutes
`35 U.S.C. § 102 .......................................................................................... 3, 27, 60, 94
`35 U.S.C. § 103 .......................................................................................... 3, 27, 85, 94
`35 U.S.C. § 112 ................................................................................................... passim
`AIA § 3(n)(1) ................................................................................................................ 1
`AIA § 6(f)(2)(A) ........................................................................................................... 1
`
`Rules
`37 C.F.R. § 42.10 .......................................................................................................... 5
`37 C.F.R. § 42.15 .......................................................................................................... 6
`37 C.F.R. § 42.202........................................................................................................ 6
`37 C.F.R. § 42.204...................................................................................... 6, 24, 35, 47
`37 C.F.R. § 42.8 .................................................................................................... 3, 4, 5
`
`Cases
`35. U.S.C. 112 ............................................................................................................ 55
`Apple Inc. v. Motorola, Inc., 757 F.3d 1286 (Fed. Cir. 2014) ............................. 56, 57
`Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336 (Fed. Cir. 2010) ... 50
`Ex parte Erol, 2011-001143 (Mar. 13, 2013) ............................................................ 57
`Ex parte Lakkala, 2011-001526 12-13 (Mar. 13, 2013) ............................................ 57
`Ex Parte Smith, 2012-007631 15-16 (March 14, 2013) ............................................. 57
`In re Gosteli, 872 F.2d 1008 (Fed. Cir. 1989) ............................................................ 51
`In re Wands, 858 F.2d 731 (Fed. Cir. 1988) ........................................................ 52, 54
`Inguran LLC v. Premium Genetics (UK) Ltd., Case PGR2015-00017, Paper No. 8
`(PTAB Dec. 22, 2015) .............................................................................................. 2
`
`
`
`iii
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`

`

`Instrumentation Laboratory Co. v. HemoSonics LLC, Petition for Post-Grant Review
`of U.S. Patent No. 9,977,039, PGR2019-00033, Paper No. 1 (PTAB filed Feb. 21,
`2019) ....................................................................................................................... 49
`Instrumentation Laboratory Co. v. HemoSonics LLP, IPR2017-00852, Paper No. 47
`(PTAB Feb. 13, 2019) .............................................................................................. 4
`Instrumentation Laboratory Co. v. HemoSonics LLP, IPR2017-00855, Paper No. 55
`(PTAB Feb. 13, 2019) .............................................................................................. 4
`Linear Tech. Corp. v. Impala Linear Corp., 379 F.3d 1311 (Fed.Cir.2004) ............. 57
`LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336 (Fed. Cir. 2005)
` ................................................................................................................ 2, 48, 50, 51
`Minerals Separation Ltd. v. Hyde, 242 U.S. 261 (1916) ........................................... 52
`Nautilus, Inc. v. Biosig Instruments, 134 S. Ct. 2120 (2014) .................................... 55
`O’Reilly v. Morse, 56 U.S. (15 How.) 62, 14 L. Ed. 601 (1853) ......................... 50, 54
`Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) ............................................ 35
`Schul International Company LLC v. EMSEAL Joint Systems Ltd., Case PGR2017-
`00053, Paper No. 10 (PTAB April 9, 2018) ............................................................. 2
`U.S. Endodontics, LLC v. Gold Standard Instruments, LLC, Case PGR2015-00019,
`Paper No. 54 (PTAB Dec. 28, 2016) ........................................................................ 1
`Williamson v. Citrix Online, LLC, 792 F.3d 1339 (Fed. Cir. June 16, 2015) ............ 56
`
` 
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`
`
`
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` 
`
`iv
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`

`

`I.
`
`INTRODUCTION:
`
`Instrumentation Laboratory Company (“Petitioner”) requests post-grant
`
`review (“PGR”) of claims 1-4, 9, 11-14, 16-21, 30, 39, 42, 50, 58, 61 and 63 (the
`
`“Challenged Claims”) of U.S. Patent No. 10,031,144, issued July 24, 2018 (“the
`
`‘144 patent”) (Ex. 1001), which is assigned to HemoSonics LLC (“Patent Owner”;
`
`see Real/Frame No. 040856/0895). The ‘144 patent discloses a single-sample
`
`cartridge having multiple test chambers for evaluating hemostasis in a blood sample
`
`by a specific acoustic-echo interrogation technique. The specification of the ‘144
`
`patent is identical to U.S. Patent Nos. 9,272,280, 9,410,971, 9,977,039 and
`
`10,161,944.
`
`The ‘144 patent claims priority from U.S. Provisional Application No.
`
`61/443,088, which was filed on February 15, 2011 and is a pre-AIA1 provisional
`
`application (Ex. 1004). However, the ‘144 patent issued from a “transitional”
`
`application and the Challenged Claims lack enablement and written description
`
`support by any pre-AIA disclosure (Section VII); consequently, the ‘144 patent is
`
`subject to PGR under AIA §§ 3(n)(1) and 6(f)(2)(A). U.S. Endodontics, LLC v. Gold
`
`Standard Instruments, LLC, Case PGR2015-00019, Paper No. 54, at 7–8 (PTAB
`
`Dec. 28, 2016). Schul International Company LLC v. EMSEAL Joint Systems Ltd.,
`
`
`
`1 Leahy-Smith America Invents Act, Pub. L. 112-29, 125 Stat. 284, Sept. 22, 2011.
`
`
`
`1
`
`

`

`Case PGR2017-00053, Paper No. 10 (PTAB April 9, 2018). Inguran LLC v.
`
`Premium Genetics (UK) Ltd., Case PGR2015-00017, Paper No. 8 (PTAB Dec. 22,
`
`2015).
`
`This Petition shows that, more likely than not, the Challenged Claims lack
`
`both enablement and written description support, as required by 35 U.S.C. § 112(a)
`
`(Ground 1), and are indefinite under 35 U.S.C. § 112(b) (Ground 2). The
`
`independent Challenged Claims 1, 20, 42 and 61 are based on functional limitations
`
`of “interrogation,” “transducers” and “processors,” untethered to any definite
`
`structure, to read on techniques for interrogation and data analysis that far exceed
`
`the scope of the ‘144 patent, which only discloses and enables a specific acoustic-
`
`echo technique. The “genus” claims 1, 20, 42 and 61 should not stand when at best
`
`only a “species” is disclosed. LizardTech, Inc. v. Earth Resource Mapping, Inc., 424
`
`F.3d 1336, 1344 (Fed. Cir. 2005), held redundant and thus invalid a facially broader
`
`claim that was not supported by disclosure beyond the scope of a narrower claims.
`
`On that basis, Challenged Claims 1, 20, 42 and 61 fail under 35 U.S.C. § 112.
`
`Furthermore, various dependent claims recite new matter, which has no basis
`
`in the specification, including (i) premixing of the sample and reagent(s) prior to the
`
`sample being introduced to the test chamber (claims 18, 30 and 50) and (ii) the
`
`transducer(s) comprising an LED emitter (claims 16, 39, 58 and 63), where the
`
`independent claims previously characterize such transducer(s) as being used for
`
`
`
`2
`
`

`

`evaluating hemostasis (i.e., in the interrogation of the sample for determining a
`
`viscoelastic property or hemostatic parameters).2
`
`This Petition also shows that the Challenged Claims (if not limited to the
`
`disclosed acoustic-echo technique), are anticipated (Ground 1) under 35 U.S.C. §
`
`102 by Publication No. 2010/0154520 (“Schubert”) (Ex. 1005) and, under 35 U.S.C.
`
`§ 103, as obvious over Schubert in view of the State of the Art (SoA) for TEM / TEG
`
`(Ground 4). Even if limited to the disclosed acoustic-echo technique, the Challenged
`
`Claims are obvious over Schubert in view of the SoA for acoustic-echo based
`
`interrogation and data analysis. (Ground 5.)
`
`These positions are supported by the Declaration of Dr. Frank LaDuca
`
`(“LaDuca Decl.”) (Ex. 1002).
`
`II. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(a)(1):
`
`A. Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1):
`
`Petitioner, Instrumentation Laboratory Company, is the real party-in-interest.
`
`Related entities, C A Casyso GMBH and Werfen USA, LLC, have interests
`
`represented by Petitioner.
`
`B. Related Matters Under 37 C.F.R. § 42.8(b)(2):
`
`
`
`2 The only disclosure of an LED emitter in the ‘144 patent is for optically monitoring
`
`chamber fluid levels (Ex. 1001, 6:40-45) and not for evaluating hemostasis.
`
`
`
`3
`
`

`

`All claims of related U.S. Patent No. 9,272,280 (“the ‘280 patent”) were held
`
`unpatentable in Instrumentation Laboratory Co. v. HemoSonics LLP, IPR2017-
`
`00852, Paper No. 47 (PTAB Feb. 13, 2019) (“’852 FWD,” Ex. 1028). Additionally,
`
`claims 1, 2, 6–8, 15, and 16 of related U.S. Patent No. 9,410,971 (“the ‘971 patent”)
`
`were held unpatentable in Instrumentation Laboratory Co. v. HemoSonics LLP,
`
`IPR2017-00855, Paper No. 55 (PTAB Feb. 13, 2019) (“’971 FWD,” Ex. 1029).
`
`Specifically, the ‘280 and ‘971 patent claims were held unpatentable as anticipated
`
`by Schubert.
`
`The ‘144 patent issued from U.S. Patent Application No. 15/202,059, which
`
`is a “transitional” patent application filed on July 5, 2016. U.S. Patent Application
`
`No. 15/202,059 (‘144 patent) is a continuation of U.S. Patent Application No.
`
`15/003,325 (‘971 patent), filed January 21, 2016, which is a continuation of U.S.
`
`Patent Application No. 13/397,398 (‘280 patent), filed February 15, 2012.
`
`Additionally, U.S. Application No. 15/991,677 (now issued as U.S. Patent No.
`
`10,161,944), filed May 29, 2018, is a continuation of U.S. Patent Application No.
`
`15/904,984 (pending), filed February 26, 2018, which is a continuation of U.S.
`
`Application No. 15/644,124 (now issued as U.S. Patent No. 9,977,039; currently
`
`petitioned for Post Grant Review under PGR2019-00033), filed July 7, 2017, which
`
`is a continuation of U.S. Patent Application No. 15/202,059 (‘144 patent). Each of
`
`these patents, all owned by Patent Owner, claim combinations of features disclosed
`
`
`
`4
`
`

`

`in their common specification; therefore, they all may be affected by the requested
`
`review. Petitioner’s U.S. Patent No. 9,915,671, based on the same disclosure as
`
`Schubert, but with claims copied in part from those of Patent Owner, is being
`
`reviewed in IPR2018-00950.
`
`C. Lead and Back Up Counsel Under 37 C.F.R. § 42.8(b)(3):
`
`Pursuant to 37 C.F.R. § 42.8(b)(3), lead counsel for this Petition is Stephen
`
`Y. Chow (Reg. No. 31,338) and back-up counsel are Gabriel Goldman (Reg. No.
`
`61,343) and Richard Emmons (Reg. No. 68,216). Pursuant to 37 C.F.R. § 42.10(b),
`
`Petitioner has filed a power of attorney designating the above-identified counsel.
`
`D.
`
`Service Information Under 37 C.F.R. § 42.8(b)(4):
`
`Pursuant to 37 C.F.R. § 42.8(b)(4) service information for the Petition is as
`
`follows:
`
`Lead Counsel
`
`Back-Up Counsel
`
`Stephen Y. Chow (Reg. No. 31,338)
`Hsuanyeh Law Group, PC
`11 Beacon Street
`Boston, MA 02108
`Telephone: (617) 886-9288
`Fax: (617) 886-9188
`Email: stephen.y.chow@hsuanyeh.com
`
`Gabriel Goldman (Reg. No. 61,343)
`Richard Emmons (Reg. No. 68,216)
`Burns & Levinson LLP
`125 Summer Street
`Boston, MA 02110
`Telephone: (617) 345-3304, -3534
`Fax: (617) 345-3299
`Email: ggoldman@burnslev.com;
`rmoore@burnslev.com
`
`Petitioner consents to electronic service at the above-identified email
`
`addresses.
`
`
`
`5
`
`

`

`III. ADDITIONAL REQUIREMENTS:
`
`A.
`
`Payment of Fees Under 37 C.F.R. § 42.15:
`
`The required fees are submitted herewith from Deposit Account No. 03-2410
`
`(Order No. 51310-05007). If any additional fees are due at any time during this
`
`proceeding, the Office is authorized to charge such fees to Deposit Account No. 03-
`
`2410 (Order No. 51310-05007).
`
`B.
`
`Timing Under 37 C.F.R. § 42.202:
`
`The present petition for post-grant review is filed within nine months of
`
`July 24, 2018, the issue date of the ‘144 patent.
`
`C. Grounds for Standing Under 37 C.F.R. § 42.204(a):
`
`Petitioner certifies that: (1) the ‘144 patent is eligible for post-grant review;
`
`and (2) Petitioner is not barred or estopped from requesting post-grant review of any
`
`claims of the ‘144 patent on the grounds identified herein.
`
`IV. THE ‘144 PATENT:
`
`A.
`
`Specification of the ‘144 Patent:
`
`The specification of the ‘144 patent is directed to “devices, systems and
`
`methods for evaluation of hemostasis” as well as “sound focusing assemblies” (Ex.
`
`1001, Title and Abstract). The ‘144 patent discloses a cartridge device (100) and
`
`analysis system (300) for use in evaluation of hemostasis (2:14-15; 2:43-56; 4:18-
`
`19; 13:27-14:3, 18:24-19:10; Tables 2 and 3). LaDuca Decl. ¶ 67.
`
`
`
`6
`
`

`

`Referring to FIGS. 1A-G, 2-5, 8A-8D and 10B (including annotated FIG. 2,
`
`below) of the ‘144 patent, the cartridge device (100) includes a plurality of test
`
`chambers (110, 112, 114, 116) that include a reagent or combination of reagents (Ex.
`
`1001, 2:17-21; 2:37-42, 5:58-63; Table 1) that may be lyophilized (8:47-59). Table
`
`1 provides reagents that can be used in the test wells. LaDuca Decl. ¶ 68.
`
`Table 1 of the ‘144 Patent
`Test Well 1 includes an intrinsic activator (kaolin), Test Well 2 includes an
`
`
`
`intrinsic activator (again kaolin) plus abciximab (which is a platelet inhibitor), Test
`
`Well 3 includes thrombin plus abciximab and Test Well 4 includes an extrinsic
`
`activator (recombinant tissue factor). LaDuca Decl. ¶ 69.
`
`The cartridge device (100) includes a fluid pathway including a plurality of
`
`channels (202, 204, 206, 208, 210, 212, 214) for distributing a blood sample from
`
`an inlet 102 to the plurality of test chambers (Ex. 1001, 4:18-48). LaDuca Decl. ¶
`
`70.
`
`
`
`7
`
`

`

`Annotated Figure 2 of the ‘144 patent
`
`
`
`The cartridge device (100) is designed to be used in a system comprising a
`
`transducer (unidentified part of ultrasonic generating means 502, FIG. 5) that
`
`transmits ultrasound into one or more chamber(s) and receives reflected sound from
`
`the chamber(s) and the test sample therein (Ex. 1001, 2:43-46, 13:27-35). Cartridge
`
`
`
`8
`
`

`

`device (100) is adapted to be positioned into a pocket (302) of an analysis system
`
`(300) to enable acoustic coupling with the test chambers (12:17-25 and 13:29-45).
`
`Each test chamber in the cartridge includes a sound focusing assembly 131 (also
`
`referred to in the ‘144 patent as a lens assembly or lens) that provides dry ultrasonic
`
`coupling both for acoustically exciting the sample and receiving a responsive echo
`
`as in SONAR (17:52-53), rigid substrate (132) and couplant (134) in FIGS. 1D and
`
`1F (11:42-12:6). LaDuca Decl. ¶ 71.
`
`The analysis system (300) and cartridge device (100), as described, are
`
`specifically designed for acoustic-echo interrogation using an ultrasonic transducer
`
`(Ex. 1001, 2:27-29; 2:35-38; 2:43-46; 2:60-65; 12:7-10; 13:19-26, 13:32-45, 15:40-
`
`43). The structure of the ultrasonic transducer is not described, but only referred to
`
`as part of an “[u]ltrasonic generating means 502” pointed at generally in Fig. 5.
`
`(13:31-32.) The system is described to include at least one processor for determining
`
`a hemostasis parameter from the received sound (2:46-48). In particular, an
`
`ensemble of acoustic pulses is transmitted into a blood sample and the returning
`
`echoes are detected and used for time delay estimation (TDE) – an algorithm used
`
`in “RADAR, SONAR and medical ultrasound imaging (Doppler)” (17:53-54) – to
`
`estimate time-displacement curves for the samples in each test chamber throughout
`
`the process of coagulation and fibrinolysis (FIG. 6B; 17:40-50). The time-
`
`displacement curves are used to produce a “relative stiffness” versus time curve
`
`
`
`9
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`

`

`using a “modified Voigt-Kelvin model” (of a dashpot and spring representing
`
`contributions of the viscous and elastic properties of the viscoelastic subject) and
`
`“various parameters relating to the viscoelastic properties of the sample” (including
`
`“relative elasticity, relative viscosity, time constant, and maximum displacement”).
`
`LaDuca Decl. ¶ 72.
`
`“[Hemostatic] parameters3” (Table 2) are generated for each test chamber by
`
`analyzing the “relative stiffness” versus time curve. By generating hemostatic
`
`parameters for the specific combination of tests in Table 1, “indices” (Table 3)
`
`relating to specific aspects of hemostasis (i.e., intrinsic pathway, extrinsic pathway,
`
`platelets, fibrinogen and fibrinolysis) are assigned. LaDuca Decl. ¶ 73.
`
`
`
`3 There is no definition for “hemostatic parameter” in the ‘144 patent, and Table 2 is
`
`not so labeled. It is assumed that the parameters mentioned here may be “hemostatic
`
`parameters.” Nor are “viscoelastic properties” defined, only that they may be
`
`“modeled” using the Voigt-Kelvin model (18:56-59).
`
`
`
`10
`
`

`

`Table 2, of the ‘144 Patent
`
`Table 3, of the ‘144 Patent
`
`
`
`
`
`
`
`
`
`The description of the derivation of the “[hemostatic] parameters” of Table 2
`
`and thus the assigned “indices” of Table 3 is somewhat confused. The description
`
`states, “[i]ndices of hemostasis are calculated by fitting a sigmoidal curve to the
`
`stiffness-time curve (FIG. 6C) and evaluating the first derivative of the curve” (Ex.
`
`1001, 18:30-32). TC1 and TC2 indicate the beginning and ending phases of fibrin
`
`formation, and are “calculated” based on a threshold value (20% of the minimum
`
`
`
`11
`
`

`

`value) of the derivative curve. 32-36). No explanation is provided for this threshold
`
`value choice. A “clotting slope CFR” indicative of the rate of polymerization is
`
`calculated as the maximum of derivative curve (18:36-38). A stiffness parameter S
`
`that “depends [in an unstated way] upon platelet function and the final stiffness of
`
`the fibrin network” is “estimated” 3 minutes after TC2 (18:39-41). “Identical
`
`methods and indices are calculated for the fibrinolytic process” (18:41-43 [emphasis
`
`added]). For example, “TL1 and TL2 can be defined to represent the initial and final
`
`phases of the fibrinolytic process.” (8:42-44 [emphasis added].) These values appear
`
`as “parameters” in Table 2 and the “indices” in Table 3 appear to be derived from
`
`the parameters determined for the specific combination of tests in Table 1. LaDuca
`
`Decl. ¶ 74.
`
`The ‘144 patent teaches that the processing of the disclosed methods, devices
`
`and systems can be performed by software components and that program modules
`
`can be used, for example, to cause the transmission of ultrasound having desired
`
`transmit parameters and to receive and process ultrasound to evaluate hemostasis
`
`indices of a sample from the subject (Ex. 1001, 13:46-14:3). A flow chart of analysis
`
`steps performed by the system is described with respect to FIG. 7 (17:20-38).
`
`Important components (e.g., Time Delay Estimation step 708 and curve-fitting step
`
`710) are expressly drawn from the prior art. It is stated that “TDE is a common signal
`
`processing step in application fields ranging from RADAR, SONAR and medical
`
`
`
`12
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`

`

`ultrasound imaging (Doppler)” and that “[a] variety of ‘off-the-shelf’ algorithms are
`
`available to perform this operation” (17:50-53). In the disclosed interrogation and
`
`processing, “[t]he viscoelastic properties of the blood sample during hemostasis is
`
`modeled using a modified model of the well-known Voigt-Kelvin mechanical
`
`model” (17:56-58 [emphasis added]) also “well validated in the past” (17:61-62).
`
`“Each time-displacement curve is fitted to the modified Voigt-Kelvin model to
`
`estimate a variety of parameters relating to the viscoelastic properties of the sample”
`
`(17:63-66). Other components such as calculating derivatives are common-place
`
`algorithms. Processor/instruction components for “directing” operations, interfacing
`
`with sub-system devices are “routine and conventional” and dependent on the
`
`particular devices. LaDuca Decl. ¶ 75.
`
`The ‘144 patent only discloses and enables using an acoustic-echo technique
`
`for interrogation and data analysis and is completely silent with respect to any non-
`
`acoustic-echo techniques. LaDuca Decl. ¶ 76.
`
`B. Challenged Claims of the ‘144 Patent:
`
`The ‘144 Patent includes 63 total claims, including independent claims 1, 20,
`
`42 and 61. Claim 1 is an apparatus claim while claims 20, 40 and 61 are system
`
`claims. Elements of claims 1, 20, 40 and 61 are specified in Tables A and B below:
`
`
`
`13
`
`

`

`1.2
`
`1.3
`
`1.4
`
`1.5
`
`1.6
`
`Table A: Elements of Apparatus Claim 1
`Element Claim 1
`1.1
`An apparatus for evaluation of hemostasis, comprising (Ex. 1001,
`19:23)
`
`a housing that is configured to couple to a system, (19:24)
`
`wherein the system comprises one or more transducers for each of a
`plurality of test chambers, (19:24-26)
`
`wherein the system comprises at least one processor and memory
`having instructions stored thereon, wherein the instructions when
`executed by the at least one processor cause the at least one processor
`to direct the one or more transducers associated with each of the
`plurality of test chambers in the interrogation of the test sample to
`determine at least one viscoelastic property of the test sample; (19:26-
`34)
`
`the plurality of test chambers, including a first test chamber, a second
`test chamber, and a third test chamber, that are each at least partially
`defined by the housing; and (19:35-38)
`
`a fluid pathway having an inlet, defined by the housing, and from
`which an external vessel establishes fluid communication, to receive a
`test sample, wherein the fluid pathway is in fluid communication with
`the first test chamber, the second test chamber, and the third test
`chamber to deliver the test sample, or a portion thereof, to the first test
`chamber, the second test chamber, and the third test chamber, (19:39-
`46)
`
`wherein each of the plurality of test chambers comprises a reagent or
`combination of reagents, and (19:47-48)
`
`wherein each of the plurality of test chambers, including the first,
`second, and third test chambers, is configured to receive, via the fluid
`pathway, blood of a test sample to be interrogated to determine a
`plurality of hemostatic parameters; (19:48-53)
`
`
`1.7
`
`1.8
`
`
`
`14
`
`

`

`1.10
`
`Element Claim 1
`1.9
`wherein the first test chamber comprises 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 configured to activate coagulation via extrinsic or
`intrinsic pathway; (19:54-59)
`
`wherein the second test chamber comprises a second combination of
`reagents that interact with blood of the test sample received therein,
`wherein the second combination of reagents includes i) a reagent, or a
`combination of reagents, configured to activate coagulation via the
`extrinsic or intrinsic pathway and ii) a reagent, or a combination of
`reagents, configured to inhibit platelet contraction; and (19:60-67)
`
`wherein the third test chambers comprises a third reagent or a third
`combination of reagents that interact with the blood received therein,
`wherein the third reagent, or a reagent included in the third
`combination of reagents, is configured to activate coagulation via the
`extrinsic or intrinsic pathway. (20:1-6)
`
`
`1.11
`
`
`
`Table B: Elements of System Claims 20, 42 and 61:
`Element
`Claim 20
`Claim 42
`2.1
`Same as claim 20
`A system for
`(23:5)
`evaluation of
`hemostasis comprising:
`(Ex. 1001, 21:14)
`
`a plurality of test
`chambers, including a
`first test chamber and a
`second test chamber,
`(21:15-16)
`
`
`2.2
`
`Same as claim 20 (23:
`6-7)
`
`Claim 61
`Same as claim 20
`(24:52)
`
`Same as claim 20
`(24:53-54)
`
`
`
`15
`
`

`

`Claim 42
`Same as claim 20
`(23:7-9)
`
`Claim 61
`Same as claim 20
`(24:54-56)
`
`Same as claim 20
`(23:9-13)
`
`Same as claim 20
`(24:56-59)
`
`Same as claim 20
`(23:14-26)
`
`Same as claim 20
`(24:60-62)
`
`Element
`2.3
`
`2.4
`
`2.5
`
`Claim 20
`wherein each of the
`plurality of test
`chambers comprises a
`reagent or combination
`of reagents, and
`(21:16-18)
`
`wherein each of the
`plurality of test
`chambers is configured
`to receive blood of a
`test sample and to be
`interrogated to
`determine a hemostatic
`parameter of the blood
`received therein;
`(21:18-21)
`
`one or more
`transducers for
`transmitting energy
`into one or more test
`chamber and for
`receiving reflected
`energy from the
`chamber and the
`sample therein; (21:22-
`24)
`
`
`
`
`16
`
`

`

`Element
`2.6
`
`2.7
`
`Claim 20
`at least one processor
`in communication with
`the one or more
`transducers, wherein
`the processor is
`configured to
`determine the
`hemostatic parameters
`from signals
`transmitted to the
`processor from the one
`or more transducers;
`and (21:25-29)
`
`a memory having
`instructions stored
`thereon, wherein the
`instructions when
`executed by the at least
`one processor, cause
`the at least one
`processor to perform at
`least three
`measurements in
`parallel; (21:30-34)
`
`Claim 42
`Same as claim 20
`(23:17-21)
`
`Claim 61
`Same as claim 20
`(24:63-67)
`
`a memory having
`instructions stored
`thereon, wherein
`execution of the
`instructions by the at
`least one processor
`cause the at least one
`processor to determine
`the hemostatic
`parameters in parallel;
`(23:22-25)
`
`a memory having
`instructions stored
`thereon, wherein the
`instructions when
`executed by the at least
`one processor, cause
`the at least one
`processor to determine
`a curve associated with
`a viscoelastic property
`of the blood of each
`test sample, the curve
`being generated from
`the interrogation as a
`function of time;
`(25:1-6)
`
`
`
`
`17
`
`

`

`Claim 20
`wherein the first test
`chamber comprises a
`first reagent or a first
`combination of
`reagents that interact
`with the blood of the
`test sample received
`therein, wherein the
`first reagent, or at least
`one reagent included in
`the first combination of
`reagents, is an activator
`of coagulation; and
`(21:34-39)
`wherein the second test
`chamber comprises a
`second combination of
`reagents that interact
`with blood of the test
`sample received
`therein, the second
`combination of
`reagents including an
`activator of
`coagulation and a
`reagent, or a
`combination of
`reagents, configured to
`cause a reduction in
`measurable changes in
`clot mechanical
`properties of the test
`sample when the test
`sample is interrogated
`by the one or more
`transducers. (21:40-47)
`
`Element
`2.8
`
`2.9
`
`
`
`
`
`Claim 42
`Same as claim 20
`(23:26-30)
`
`Claim 61
`Same as claim 20
`(25:7-12)
`
`wherein the second
`chamber comprises a
`second combination of
`reagents that int