UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`CHARLES RIVER LABORATORIES, INC. and CHARLES RIVER
`LABORATORIES INTERNATIONAL, INC.,
`Petitioners
`
`v.
`
`IDEXX LABORATORIES, INC., and IDEXX DISTRIBUTION, INC.
`Patent Owner
`
`Case No.: To Be Assigned
`
`Patent No.: 8,945,945
`
`For: Sample Collection and Analysis
`
`PETITION FOR INTER PARTES REVIEW
`PURSUANT TO 35 U.S.C. §§ 311–319 AND 37 C.F.R. § 42
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`

`
`TABLE OF CONTENTS
`
`Page
`
`I. 
`
`Introduction ...................................................................................................... 1 
`
`II.  Mandatory Notices Under 37 C.F.R. § 42.8 .................................................... 2 
`
`A. 
`
`B. 
`
`C. 
`
`D. 
`
`E. 
`
`Real Party-in-Interest ............................................................................ 3 
`
`Related Matters ...................................................................................... 3 
`
`Lead and Back-up Counsel and Service Information: .......................... 3 
`
`Service Information ............................................................................... 4 
`
`Fees ........................................................................................................ 4 
`
`III.  Grounds for Standing Under 37 C.F.R. § 42.104(a) ....................................... 4 
`
`IV.  Relief Requested .............................................................................................. 4 
`
`V. 
`
`Identification of Challenge Under 37 C.F.R. § 42.104(b) ............................... 5 
`
`VI.  Threshold Requirement for Inter Partes Review ............................................. 6 
`
`VII.  Overview of the Technology and the ’945 Patent ........................................... 6 
`
`A. 
`
`B. 
`
`C. 
`
`Summary of the Claimed Subject Matter .............................................. 6 
`
`Prosecution History of the ’945 Patent ................................................. 7 
`
`Listing of Challenged Claims ................................................................ 8 
`
`VIII.  Level of Ordinary Skill in the Art ................................................................. 15 
`
`IX.  Construction of Claim Terms ........................................................................ 16 
`
`A. 
`
`“infectious agent indicative of an infectious disease” ........................ 16 
`
`X. 
`
`Summary of the Prior Art .............................................................................. 17 
`
`A. 
`
`B. 
`
`State of the Art .................................................................................... 17 
`
`Ray ....................................................................................................... 21 
`
`
`
`i
`
`

`
`C. 
`
`D. 
`
`E. 
`
`Jenkins ................................................................................................. 22 
`
`Burnett ................................................................................................. 23 
`
`Clark .................................................................................................... 24 
`
`XI.  Detailed Explanation of Grounds for Unpatentability .................................. 24 
`
`A.  Ground 1: Ray Anticipates Claims 1, 4, 6-7 and 9 Under 35
`U.S.C. 102(b) ....................................................................................... 24 
`
`B. 
`
`Ground 2: Jenkins in view of Ray in further view of Clark
`Renders Claims 1-4, 6-9, 11-13, 15-18, 20-21 Unpatentable for
`Obviousness under 35 U.S.C. §103 .................................................... 32 
`
`i. 
`
`ii. 
`
`iii. 
`
`Jenkins, Ray and Clark Teach Or Suggest Every Element
`Of The Challenged Claims ........................................................ 33 
`
`Obvious to Combine Ray, Jenkins and Clark ........................... 49 
`
`Secondary Considerations Do Not Render Claims Non-
`Obvious ..................................................................................... 52 
`
`C. 
`
`Ground 3: Burnett in view of Jenkins Renders Claims 1-4, 6-9,
`11-13, 15-18, and 20-21 Unpatentable for Obviousness under
`35 U.S.C. §103 .................................................................................... 53 
`
`i. 
`
`ii. 
`
`iii. 
`
`Burnett and Jenkins Teach Or Suggest Every Element Of
`The Challenged Claims ............................................................. 53 
`
`Obvious to Combine Burnett and Jenkins ................................ 65 
`
`Secondary Considerations Do Not Render Claims Non-
`Obvious ..................................................................................... 67 
`
`XII.  Conclusion ..................................................................................................... 68 
`
`ii
`
`
`
`
`
`

`
`TABLE OF AUTHORITIES
`
`
`Page(s)
`
`
`Cases 
`Baldwin Graphic Sys., Inc. v. Siebert, Inc.,
`512 F.3d 1338 (Fed. Cir. 2008) ..................................................................... 30, 47
`Cuozzo Speed Techs., LLC v. Lee,
`No. 15-446, 2016 WL 3369425 (Fed. Cir. June 20, 2016) ................................... 16
`Idexx Labs., Inc. et al. v. Charles River Labs., Inc. et al.,
`No. 1:15-cv-00668-RGA (D. Del.) ......................................................................... 3
`In re Peterson,
`315 F.3d 1325 (Fed. Cir. 2003) ............................................................................ 64
`In re Zletz,
`893 F.2d 319 (Fed. Cir. 1989) .............................................................................. 16
`KCJ Corp. v. Kinetic Concepts, Inc.,
`223 F.3d 1351 (Fed. Cir. 2000) ..................................................................... 30, 47
`KSR Int’l Co. v. Teleflex, Inc.,
`127 S. Ct. 1727 (2007) ....................................................................... 49, 52, 65, 67
`Verizon Servs. Corp. v. Cox Fibernet Va., Inc.,
`602 F.3d 1325 (Fed. Cir. 2010) ............................................................................ 32
`Statutes 
`35 U.S.C. § 102 ....................................................................................... 5, 21, 22, 23
`35 U.S.C. § 103 .......................................................................................................... 5
`35 U.S.C. § 311 .......................................................................................................... 1
`35 U.S.C. § 312 .......................................................................................................... 1
`35 U.S.C. § 313 .......................................................................................................... 1
`35 U.S.C. § 314 ......................................................................................................1, 6
`35 U.S.C. § 315 .......................................................................................................... 1
`35 U.S.C. § 316 .......................................................................................................... 1
`35 U.S.C. § 317 .......................................................................................................... 1
`35 U.S.C. § 318 .......................................................................................................... 1
`
`iii
`
`

`
`35 U.S.C. § 319 .......................................................................................................... 1
`Other Authorities 
`MPEP §2131.01 ....................................................................................................... 32
`Rules 
`37 C.F.R. § 42.10 ....................................................................................................... 4
`37 C.F.R. § 42.100 ................................................................................................... 16
`37 C.F.R. § 42.6 ......................................................................................................... 5
`37 C.F.R. §42.104 ............................................................................................... 5, 24
`
`
`
`iv
`
`

`
`
`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`List of Exhibits
`
`Ex. 1001 U.S. Patent No. 8,945,945 (“the ’945 patent”).
`
`Ex. 1002 Declaration of Dr. Susan Compton.
`
`Ex. 1003 Prosecution History of U.S. Patent No. 8,945,945.
`
`Ex. 1004 U.S. Patent Pub. No. 2009/0305899 (“Meegan”).
`
`Ex. 1005 U.S. Patent Pub. No. 2005/0055176 (“Ray”).
`
`Ex. 1006
`
`International Patent Pub. No. WO 2009/152269 (“Pass”).
`
`Ex. 1007 Jenkins et al., Rodent Diagnostic Testing, 17 J. EXOTIC PET MEDICINE
`16, No. 1, 16-25 (2008) (“Jenkins”).
`
`Ex. 1008 GE Healthcare Dried Blood Spot Microvolume Sampling for DMPK
`Package Insert (“FTA”).
`
`Ex. 1009 Clark et al., Utilization of DBS within Drug Discovery: Development
`of a Serial Microsampling Pharmacokinetic Study in Mice, 2
`BIOANALYSIS 1477, No. 8, 1477-88 (2010) (“Clark”).
`
`Ex. 1010 Beaudette et al., Discovery Stage Pharmacokinetics Using Dried
`Blood Spots, J. CHROMATOGRAPHY B, 809, 153-58 (2004).
`
`Ex. 1011 Olfert et al, Humane Endpoints for Infectious Disease Animal Models,
`41 ILAR J. 99, No. 2, 99-104 (2000) (“Olfert”).
`
`Ex. 1012 Li et al., Perforated Dried Blood Spots: A Novel Format for Accurate
`Microsampling, 3 BIOANALYSIS 2321, 2321-2333 (2011) (“Li”).
`
`Ex. 1013
`
`Information Disclosure Statements Submitted by IDEXX (“IDS”).
`
`i
`
`

`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`Ex. 1014 Burnett, Dried Blood Spot Sampling: Practical Considerations and
`Recommendations for use with Pre-Clinical Studies, 3 BIOANALYSIS
`1099, No. 10, 1099-1107 (2011) (“Burnett”).
`
`Ex. 1015 O’Broin et al., Screening of Folate Status with use of Dried Blood
`Spots on Filter Paper, 70 AM. J. CLIN. NUTR. 359, 359-67 (1999)
`(“O’Broin”).
`
`Ex. 1016 Parker et al., The Use of the Dried Blood Spot Sample in
`Epidemiological Studies, 52 J. OF CLINICAL PATHOLOGY, 633-639
`(1999) (“Parker”).
`
`Ex. 1017 Specimen Collection Card and Shipping Instructions (2009) (“Biotek
`Brochure”).
`
`Ex. 1018 Donovan et al., CURRENT PROTOCOLS IN NEUROSCIENCE A.4.G.1-
`A.4.G.9 (John Wiley & Sons, Inc. eds., 2005) (“Donovan”).
`
`Ex. 1019 Engvall, METHODS IN ENZYMOLOGY 419-439 (Academic Press, Inc.
`eds., Vol. 70, 1980) (“Engvall”).
`
`in
`their Applications
`Immunoassay Methods and
`Ex. 1020 Darwish,
`Pharmaceutical Analysis: Basic Methodology and Recent Advances,
`INT’L J. BIOMEDICAL SCIENCE 217, 217-235 (2006) (“Darwish”).
`
`Ex. 1021 Hsu et al., Multiplex Fluorescent Immunoassay for the Simultaneous
`Detection of Serum Antibodies to Multiple Rodent Pathogens, 36
`RESOURCE 36, No. 8, 36-38 (2007) (“Hsu”).
`
`Ex. 1022 Cox et al., IMMUNOASSAY METHODS (2014) (“Cox”).
`
`Ex. 1023 Curriculum Vitae of Dr. Susan Compton.
`
`Ex. 1024 Burtis et al., TIETZ TEXTBOOK OF CLINICAL CHEMISTRY 94-225 (W.B.
`Saunders Co. eds, 3rd ed., 1999) (“Tietz”).
`
`ii
`
`

`
`EXHIBIT
`NO.
`
`DESCRIPTION
`
`Ex. 1025 Henry, CLINICAL DIAGNOSIS AND MANAGEMENT BY LABORATORY
`METHODS 851-876 (W.B. Saunders Co. eds, 19th ed., 1996)
`(“Henry”).
`
`Ex. 1026 Ericsson et al., A Brief History of Animal Modeling, 110 MO. MED.
`201, No. 3, 201-205 (2013) (“Ericsson”).
`
`Ex. 1027 Nicklas et al., Recommendations for the Health Monitoring of Rodent
`and Rabbit Colonies in Breeding and Experimental Units, 36
`LABORATORY ANIMALS 20, 20-42(2002) (“Nicklas”)
`
`Ex. 1028 Khan et al., Simultaneous Serodetection of 10 Highly Prevalent Mouse
`Infectious Pathogens in a Single Reaction by Multiplex Analysis, 12
`CLIN. & DIAG. LAB. IMMUNOLOGY 513, No. 4, 513-519 (2005)
`(“Khan”).
`
`Ex. 1029 Plaintiffs’ Answering Brief in Response to Defendants’ Rule 12(b)(6)
`Motion to Dismiss in Idexx Labs., Inc. et al. v. Charles River Labs.,
`Inc. et al., No. 1:15-cv-00668-RGA (D. Del.).
`
`Ex. 1030 Harlan Laboratories’ Health Monitoring Brochure.
`
`Ex. 1031 Written Opinion of the International Searching Authority (June 13,
`2014).
`
`Ex. 1032 Dainty et al., Dried Blood Spot Bioanalysis: An Evaluation of
`Techniques and Opportunities for Reduction and Refinement in Mouse
`and Juvenile Rat Toxicokinetic Studies, 31 INT’L. J. OF TOXICOLOGY 4,
`No. 1, 4-13 (2012).
`
`Ex. 1033 GE Healthcare “Reliable Extraction of DNA from WhatmanTM FTATM
`cards,” 2010.
`
`
`
`iii
`
`

`
`I.
`
`INTRODUCTION
`
`Pursuant to 35 U.S.C. §§ 311–319 and 37 C.F.R. § 42, Charles River
`
`Laboratories, Inc. and Charles River Laboratories International, Inc. (“Petitioners”
`
`or CRL) respectfully request an inter partes (“IPR”) review of Claims 1-4, 6-9, 11-
`
`13, 15-18, 20-21 of U.S. Patent No. 8,945,945 titled “Sample Collection and
`
`Analysis” (“the ’945 patent,” Ex. 1001), which issued on February 3, 2015 to
`
`Myles and is assigned to IDEXX Laboratories, Inc. (“IDEXX” or “Patent Owner”).
`
`This Petition and supporting exhibits demonstrate that there is a reasonable
`
`likelihood that claims 1-4, 6-9, 11-13, 15-18, 20-21 of the ’945 patent are
`
`unpatentable because each claim was anticipated or would have been obvious to a
`
`person of ordinary skill in the art (“POSA”).
`
`The claims at issue cover methods for detecting infectious disease in rodent
`
`populations that include the general steps of (i) providing basic instructions to a
`
`user on how to use cards on which rodent blood can be placed and dried, (ii)
`
`receiving a plurality of cards as a single unit, (iii) extracting blood from the card,
`
`and (iv) conducting an immunoassay to detect antibodies for infectious disease and
`
`reporting the results. The dependent claims cover using specific immunoassays,
`
`applying the method to specific types of rodents (mice and rats), using a card with
`
`specific features and/or specifying diseases to attempt to detect.
`
`The challenged method claims cover nothing more than an arrangement of
`
`1
`
`

`
`elements, all of which were indisputably in the prior art long before the March 11,
`
`2013 priority date of the ’945 patent. Blood collection cards containing every
`
`feature in the independent and dependent challenged claims (and instructions for
`
`using them) had been in the prior art for at least 50 years before the critical date
`
`and had been used to collect blood from rodents for decades. Likewise, the
`
`claimed immunoassays were well-known, and for at least a decade before the
`
`priority date, many serology laboratories had offered services that included
`
`receiving mouse and rat blood samples and testing them using a multiplex
`
`fluorescence immunoassay to detect antibodies for infectious agents indicative of
`
`infectious disease (including the diseases listed in the challenged dependent
`
`claims).
`
`Claims 1, 4, 6-7 and 9 are anticipated by the prior art. Claims 1-4, 6-9, 11-
`
`13, 15-18, 20-21 also would have been obvious in view of the prior art presented
`
`herein. Each element in the challenged claims performs the same function it has
`
`always been known to perform. The combination of elements in the claims
`
`provides the method for determining whether an infectious disease is present in a
`
`rodent population that a POSA would expect. Accordingly, Petitioners request that
`
`the Board institute an inter partes review.
`
`II. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`
`2
`
`

`
`A. Real Party-in-Interest
`
`The real parties in interest are Charles River Laboratories, Inc. and Charles
`
`River Laboratories International, Inc.
`
`B. Related Matters
`
`The following matters involving the ’945 patent would affect, or be affected,
`
`by a decision in the proceeding: Idexx Labs., Inc. et al. v. Charles River Labs., Inc.
`
`et al., No. 1:15-cv-00668-RGA (D. Del.). Petitioner is also concurrently filing
`
`Petitions for Inter Partes Review of U.S. Patent No. 9,040,308, and U.S. Patent
`
`No. 8,927,298, which are of the same family as the ’945 patent.
`
`C. Lead and Back-up Counsel and Service Information:
`
`LEAD COUNSEL
`Douglas J. Kline
`(Reg. No. 35,574)
`Goodwin Procter LLP
`100 Northern Avenue
`Boston, MA 02210
`(T): 617-570-1209
`(F): 617-523-1231
`dkline@goodwinlaw.com
`
`
`BACK-UP COUNSEL
`Brian T. Drummond
`(Reg. No. 68,414)
`Goodwin Procter LLP
`100 Northern Avenue
`Boston, MA 02210
`(T): 617-570-1551
`(F): 617-523-1231
`bdrummond@goodwinlaw.com
`
`Srikanth K. Reddy
`(to seek pro hac vice admission)
`Goodwin Procter LLP
`100 Northern Avenue
`Boston, MA 02210
`(T): 617-570-1465
`(F): 617-523-1231
`sreddy@goodwinlaw.com
`
`Krupa K. Parikh
`
`3
`
`

`
`(Reg. No. 73,337)
`Goodwin Procter LLP
`901 New York Avenue, NW
`Washington, DC 20001
`(T): 202-346-4059
`(F): 202-346-4444
`kparikh@goodwinlaw.com
`
`Service Information
`
`D.
`Please address all correspondence to the Lead Counsel and Back-Up
`
`Counsel at the above addresses. Counsel consent to electronic service at their
`
`email addresses. Concurrently filed herewith is a Power of Attorney pursuant to
`
`37 C.F.R. § 42.10(b).
`
`Fees
`
`E.
`CRL hereby authorizes the Office to charge the fee set forth in 37 C.F.R.
`
`§42.15(a) for this Petition to Deposit Account No. 506989.
`
`III. GROUNDS FOR STANDING UNDER 37 C.F.R. § 42.104(a)
`
`CRL certifies that the ’945 patent is available for inter partes review and
`
`that CRL is not barred or estopped from requesting this review.
`
`IV. RELIEF REQUESTED
`
`CRL asks that the Patent Trial and Appeal Board (“the Board”) review the
`
`accompanying prior art and analysis, institute a trial for inter partes review of
`
`claims 1-4, 6-9, 11-13, 15-18, 20-21 of the ’945 patent, and cancel those claims as
`
`unpatentable.
`
`4
`
`

`
`V.
`
`IDENTIFICATION OF CHALLENGE UNDER 37 C.F.R. § 42.104(b)
`
`CRL respectfully requests inter partes review of claims 1-4, 6-9, 11-13, 15-
`
`18, 20-21 of the ’945 patent based on the following prior art references:
`
`Ex. 1007
`
` EXHIBIT DESCRIPTION
`Ex. 1005 U.S. Patent Pub. No. 2005/0055176
`(“Ray”).
`Jenkins et al., Rodent Diagnostic Testing,
`17 J. Exotic Pet Medicine 16, No. 1, 16-
`25 (2008) (“Jenkins”).
`Ex. 1009 Clark et al., Utilization of DBS within
`Drug Discovery: Development of a Serial
`Microsampling Pharmacokinetic Study in
`Mice, 2 Bioanalysis 1477, No. 8, 1477-88
`(2010).
`Ex. 1014 Burnett, Dried Blood Spot Sampling:
`Practical Considerations and
`Recommendations for use with Pre-
`Clinical Studies, 3 Bioanalysis 1099, No.
`10, 1099-1107 (2011) (“Burnett”).
`
`PUBL. /
`FILING DATE
`May 9, 2002 /
`Aug. 14, 2001
`Jan. 2008
`
`2010
`
`2011
`
`PRIOR
`ART
`102(a) /
`102(b)
`102(a) /
`102(b)
`
`102(a) /
`102(b)
`
`102(a) /
`102(b)
`
`
`Section XI below sets forth, per 37 C.F.R. §42.104(b)(2), the grounds under
`
`35 U.S.C. §§102 or 103 on which the challenges to the claims are based. In
`
`addition, pursuant to 37 C.F.R. §42.104(b)(4) and (5), explanations of how claims
`
`1-4, 6-9, 11-13, 15-18, 20-21 of the ’945 patent are unpatentable under statutory
`
`grounds are provided in Section XI below, with reference to the supporting
`
`evidence. In accordance with 37 C.F.R. § 42.6(c), copies of the exhibits are filed
`
`herewith. In addition, this Petition is accompanied by the Declaration of Dr. Susan
`
`Compton (Ex. 1002).
`
`5
`
`

`
`VI. THRESHOLD REQUIREMENT FOR INTER PARTES REVIEW
`
`A petition for inter partes review must demonstrate “a reasonable likelihood
`
`that the petitioner would prevail with respect to at least 1 of the claims challenged
`
`in the petition.” 35 U.S.C. § 314(a). This Petition meets this threshold. As
`
`explained below, for each of the grounds of unpatentability proposed below, there
`
`is a reasonable likelihood that Petitioner will prevail with respect to the challenged
`
`claims.
`
`VII. OVERVIEW OF THE TECHNOLOGY AND THE ’945 PATENT
`
`A.
`
`Summary of the Claimed Subject Matter
`
`The ’945 patent claims are invalid. Claims 1-4, 6-9, 11-13, 15-18, 20-21
`
`cover methods of using a known assay to detect known infectious diseases in
`
`rodents using well-known and commercially available collection cards. See, also,
`
`Ex. 1031 (stating that the claimed invention lacks inventive step). The claimed
`
`assay and collection cards are used in their ordinary manner and there are no
`
`unexpected results. The dependent claims cover known, commercially available,
`
`modifications of the elements in the independent claim that were similarly in the
`
`prior art.
`
`The ’945 patent is nominally focused on the concept of determining whether
`
`an infectious disease is present in a rodent colony using specific steps. The claims
`
`describe instructing a user to place blood samples from multiple rodents onto
`
`6
`
`

`
`commercially available blood collection cards (e.g., WHATMAN® FTA® DMPK-
`
`C, WHATMAN® FTA® 31 EFT PK paper, Ex. 1001 at 3:17-29, 3:45-55),
`
`receiving the cards as a single unit, extracting the blood and testing it for
`
`antibodies for agents of infectious disease (id. at 6:11-19; id. at 5:41-67) and
`
`reporting the results to the user.
`
`B.
`
`Prosecution History of the ’945 Patent
`
`The prosecution history of the ’945 patent is not robust. The ’945 patent
`
`issued on February 3, 2015, from Application No. 14/538,381 (the ’381
`
`application) filed on November 11, 2014, itself a continuation of Application No.
`
`14/089,103 (“the ’103 application,” now U.S. Patent No. 8,927,298) filed on
`
`November 25, 2013. The ’103 application claims priority from Provisional
`
`Application No. 61/776,560 (“the ’560 application”) filed March 11, 2013. The
`
`’560 application is also the basis for U.S. Patent No. 9,040,308. The same
`
`Examiner reviewed all three patents.
`
`There were no rejections during prosecution and no references were
`
`considered. See, generally¸ Ex. 1003. Rather, an interview was held on December
`
`3, 2014 at which the Examiner proposed minor amendments to the claims. Ex.
`
`1003 at 80; id. at 77-79. Applicant agreed, and a Notice of Allowance was mailed
`
`on December 10, 2014. Ex. 1003 at 72.
`
`Notably, the Examiner did not consider any of the prior art relied upon in
`
`7
`
`

`
`this Petition.
`
`C. Listing of Challenged Claims
`The challenged claims of the ’945 patent as are follows:
`
`1. A method of determining a presence or absence of an infectious disease in
`
`a population of rodents, the method comprising:
`
`(a) providing instructions to a user responsible for a population of
`
`animals comprising the following:
`
`(i) draw blood from an individual rodent;
`
`(ii) apply the blood to one of a plurality of blood collection
`
`cards;
`
`(iii) allow the blood sample to dry on the collection card;
`
`(iv) repeat steps i, ii, and iii at least once to provide the plurality
`
`of blood collection cards spotted with blood from a plurality of
`
`members from the population of rodents; and
`
`(v) transport the plurality of collection cards to a laboratory as a
`
`single unit;
`
`(b) receiving the plurality of collection cards as a single unit from the
`
`user,
`
`(c) extracting dried blood from the cards;
`
`(d) conducting an immunoassay for analyzing the extracted blood for
`
`8
`
`

`
`a presence or absence of at least one antibody for an infectious agent
`
`indicative of an infectious disease, thereby determining the presence or
`
`absence of the infectious disease in the population; and
`
`(e) reporting the results of the presence or absence of the infectious
`
`disease to the user.
`
`2. The method of claim 1, wherein the immunoassay comprises contacting
`
`the extracted blood with a fluorescently labeled binding partner for the antibody.
`
`3. The method of claim 1, wherein the immunoassay is a multiplex
`
`fluorescence immunoassay.
`
`4. The method of claim 1, wherein the members of the population of rodents
`
`are mice.
`
`6. The method of claim 1, wherein the members of the population of rodents
`
`are rats.
`
`7. The method of claim 1, wherein the instructions further comprise, prior to
`
`instruction (v), the following instruction: identify at least one of the rodent
`
`population and the individual rodent on each of the plurality of blood collection
`
`cards.
`
`8. The method of claim 1, wherein the blood collection cards each have at
`
`least one collection area having an absorbent material suitable for holding about
`
`10-40 μL of whole blood.
`
`9
`
`

`
`9. The method of claim 1, wherein the blood collection cards each have at
`
`least two collection areas.
`
`11. The method of claim 4, wherein the step of analyzing the extracted blood
`
`comprises analyzing for the presence or absence of seven or more diseases selected
`
`from the group consisting of:
`
`a. MHV;
`
`b. MVN (MMV);
`
`c. NS1 (Generic Parvovirus);
`
`d. MPV (MPV1-5);
`
`e. MNV;
`
`f. TMEV;
`
`g. EDIM;
`
`h. Sendai virus;
`
`i. Mycoplasma pulmonis;
`
`j. PVM;
`
`k. REO3;
`
`l. LCMV;
`
`m. Ectromelia virus;
`
`n. MAD1;
`
`o. MAD2;
`
`10
`
`

`
`p. Polyoma virus;
`
`q. Encephalitozoon cuniculi;
`
`r. CARB;
`
`s. Clostridium piliforme;
`
`t. MCMV;
`
`u. K virus;
`
`v. Hantaan virus;
`
`w. Lactate dehydrogenase-elevating virus; and
`
`x. MTV.
`
`12. The method of claim 6, wherein the step of analyzing the extracted blood
`
`comprises analyzing for the presence or absence of seven or more diseases selected
`
`from the group consisting of:
`
`a. RCV;
`
`b. NS1 (Generic Parvovirus);
`
`c. RPV;
`
`d. RMV;
`
`e. KRV;
`
`f. H-1;
`
`g. RTV (Rat theilovirus);
`
`h. Sendai virus;
`
`11
`
`

`
`i. PVM;
`
`j. Mycoplasma pulmonis;
`
`k. REO3;
`
`l. LCMV;
`
`m. CARB;
`
`n. Hantaan virus;
`
`o. Clostridim piliforme;
`
`p. MAD1;
`
`q. MAD2;
`
`r. Encephalitozoom cuniculi; and
`
`s. IDIR.
`
`13. The method of claim 3, wherein the members of the population of
`
`rodents are mice.
`
`15. The method of claim 3, wherein the members of the population of
`
`rodents are rats.
`
`16. The method of claim 3, wherein the instructions further comprise, prior
`
`to instruction (v), the following instruction: identify at least one of the rodent
`
`population and the individual rodent on each of the plurality of blood collection
`
`cards.
`
`17. The method of claim 3, wherein the blood collection cards each have at
`
`12
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`

`
`least one collection area having an absorbent material suitable for holding about
`
`10-40 μL of whole blood.
`
`18. The method of claim 3, wherein the blood collection cards each have at
`
`least two collection areas.
`
`20. The method of claim 13, wherein the step of analyzing the extracted
`
`blood comprises analyzing for the presence or absence of seven or more diseases
`
`selected from the group consisting of:
`
`a. MHV;
`
`b. MVN (MMV);
`
`c. NS1 (Generic Parvovirus);
`
`d. MPV (MPV1-5);
`
`e. MNV;
`
`f. TMEV;
`
`g. EDIM;
`
`h. Sendai virus;
`
`i. Mycoplasma pulmonis;
`
`j. PVM;
`
`k. REO3;
`
`l. LCMV;
`
`m. Ectromelia virus;
`
`13
`
`

`
`n. MAD1;
`
`o. MAD2;
`
`p. Polyoma virus;
`
`q. Encephalitozoon cuniculi;
`
`r. CARB;
`
`s. Clostridium piliforme;
`
`t. MCMV;
`
`u. K virus;
`
`v. Hantaan virus;
`
`w. Lactate dehydrogenase-elevating virus; and
`
`x. MTV.
`
`21. The method of claim 15, wherein the step of analyzing the extracted
`
`blood comprises analyzing for the presence or absence of seven or more diseases
`
`selected from the group consisting of:
`
`a. RCV;
`
`b. NS1 (Generic Parvovirus);
`
`c. RPV;
`
`d. RMV;
`
`e. KRV;
`
`f. H-1;
`
`14
`
`

`
`g. RTV (Rat theilovirus);
`
`h. Sendai virus;
`
`i. PVM;
`
`j. Mycoplasma pulmonis;
`
`k. REO3;
`
`l. LCMV;
`
`m. CARB;
`
`n. Hantaan virus;
`
`o. Clostridim piliforme;
`
`p. MAD1;
`
`q. MAD2;
`
`r. Encephalitozoom cuniculi; and
`
`s. IDIR.
`
`VIII. LEVEL OF ORDINARY SKILL IN THE ART
`As noted above, the claims of the ’945 patent are generally directed to
`
`methods of determining the presence or absence of infectious disease in a
`
`population of rodents. Therefore, a person of ordinary skill in the art would have
`
`had at least a bachelor’s degree in a pertinent discipline, such as biology,
`
`chemistry, chemical engineering, biomolecular engineering, materials science,
`
`toxicology, or a related discipline. Such a person would also have 3-5 years of
`
`15
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`

`
`experience in working with rodent colonies, including experience in maintaining
`
`the health of the colony. Such a person would be aware of and/or have experience
`
`using various immunoassays. To the extent necessary, a POSA may collaborate
`
`with one or more other persons of skill in another art (e.g., one of skill in the art of
`
`immunology) for one or more aspects with which the other person may have
`
`expertise, experience, and/or knowledge that was obtained through his or her
`
`education, industrial, or academic experiences. Ex. 1002 at ¶16.
`
`IX. CONSTRUCTION OF CLAIM TERMS
`A claim in an IPR proceeding is given its “broadest reasonable construction
`
`in light of the specification.” See 37 C.F.R. § 42.100(b). Cuozzo Speed Techs.,
`
`LLC v. Lee, 136 S. Ct. 2131, 2142 (2016). Thus, the words of a claim are given
`
`their plain meaning unless inconsistent with the specification. In re Zletz, 893 F.2d
`
`319, 321 (Fed. Cir. 1989).
`
`A.
`
`“infectious agent indicative of an infectious disease”
`
`The broadest reasonable interpretation of the term “infectious agent
`
`indicative of an infectious disease,” which appears in all claims is “any biological
`
`agent that causes a disease, the presence of which indicates the animal is infected
`
`with the disease.” The ’945 specification states that the claimed method can test
`
`individual rodents for “30 different bacterial and viral agents.” Ex. 1001 at 2:62-
`
`67. This statement would indicate to a POSA that the patentee is using the term
`
`16
`
`

`
`“infectious agent indicative of an infectious disease” broadly to include any type of
`
`agent that would cause disease, including bacteria and viruses. Generally,
`
`infectious agents fall into four groups: viruses, bacteria, fungi, and parasites. Each
`
`of these types of agents cause various diseases in animals. Furthermore, the
`
`specification provides a list of various infectious agents that may be tested
`
`for, Ex. 1001 at 6:15-7:9, again indicating that the patentee intended to define the
`
`term broadly to include any agent that causes infectious disease. Ex. 1002 at ¶¶26-
`
`28.
`
`X.
`
`SUMMARY OF THE PRIOR ART
`A.
`By March 11, 2013, the concept of using dried blood spot (DBS) testing to
`
`State of the Art
`
`detect the presence of antibodies for infectious agents indicative of infectious
`
`diseases in rodent populations was already well known. The two core steps in the
`
`alleged invention – instructing users to use DBS cards to collect rodent blood and
`
`using an immunoassay to detect antibodies for infectious agents indicative of an
`
`infectious disease in the rodent blood – had been practiced for many years.
`
`IDEXX apparently does not dispute this. See, e.g., Ex. 1029 at 16-17 (“blood
`
`collection cards and methods of analyzing blood, including immunoassays, were in
`
`the prior art”); see, also, id. at 21.
`
`17
`
`

`
`Dried blood spots involve “storage of blood as dried samples on paper or
`
`other appropriate media.” Ex. 1009 at 2. The specification recognizes that DBS
`
`collection cards were commercially available at the time of the invention and that
`
`such cards had “multiple collection areas for samples of about 10-40 µL.” Ex.
`
`1001 at 3:16:29 (discussing WHATMAN® FTA® DMPK-C DBS cards sold by
`
`GE Healthcare Biosciences, Piscataway, N.J.); see, also, id, at 3:30-37 (“An
`
`example of a prior art blood collection card is shown in FIGS. 1A and 1B. This
`
`card (Protein Saver™ 903® card by Whatman) has five blood collection spots
`
`arranged on a continuous, non-perforated web of material”).
`
`The datasheet for WHATMAN® FTA® DMPK-C DBS cards that was
`
`publicly available at least in 2011, includes the following basic instructions for
`
`using DBS cards to analyze blood from experimental animals or humans: “[a]pply
`
`blood to card (Fig. 1.) and let dry;” “[s]hip and store as needed at ambient
`
`temperature;” and “[r]emove sample disc (Fig 2.) and elute with solvent.” See,
`
`e.g., Ex. 1008 at 1; Ex. 1002 at ¶¶64, 66. As is self-evident on the datasheet, each
`
`card includes a space above each blood collection area in which the blood sample
`
`can be identified. Ex. 1008 at 1.
`
`Since at least 1963, DBS testing has been used in human neo-natal screening
`
`to detect disorders such as sickle cell anemia, Down’s Syndrome and diabetes.
`
`See, e.g., Ex. 1016 at 1; Ex. 1029 at 8; Ex. 1002 at ¶¶57-58. By at least 1999, it
`
`18
`
`

`
`was well known that DBS testing combined with an assay could be used to detect
`
`the presence of antibodies for an infectious agent indicative of an infectious
`
`disease in blood taken from humans such as HIV, HTLV-1, NCV and toxoplasma
`
`gondii. Ex. 1016 at 1; Ex. 1002 at ¶¶56-58, 68.
`
`Laboratories have offered for sale blood specimen collection “kits” since
`
`long before the ’945 patent was filed, in which a lab provides instructions to a
`
`consumer who creates a DBS sample and sends the sample to the laboratory who
`
`looks for antibodies indicative of an infectious disease, and reports its results to the
`
`consumer. For example, in 2009, US Biotek Labor