Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 1 of 32
`Case 1:17-cv-12194—RGS Document 1-14 Filed 11/07/17 Page 1 of 32
`
`EXHIBIT 14
`EXHIBIT 14
`
`
`Case 1:17-cv-12194—RGS Document 1-14 Filed 11/07/17 Page 1 of 32
`
`EXHIBIT 14
`EXHIBIT 14
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 2 of 32
`
`Exhibit 14 - Infringement of U.S. Patent No. 9,092,392
`
`Defendant Foundation Medicine Inc. makes, uses, offers for sale, and/or sells the subject matter
`claimed in U.S. Patent Number 9,092,392 with its “FoundationOne®” and “FoundationACT®”
`products (collectively referred to as the “Accused Products”).
`The following chart compares the claims of the ’392 patent and the Accused Products solely for
`the purposes of providing the description of Plaintiff’s claim required by Rule 8 of the Federal
`Rule of Civil Procedures, the Local Rules, and any relevant legal precedent. Plaintiff reserves the
`right to modify and/or supplement these charts with additional information as this action
`progresses.
`
`
`
`
`
`
`1
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 3 of 32
`
`’392 Patent, Claim 1
`
`A system for generating
`a report identifying a
`therapeutic agent for an
`individual with
`colorectal cancer
`comprising:
`
`FoundationOne®
`
`To the extent the preamble of claim 1 is a limitation, FoundationOne®
`uses a system for generating a report identifying a therapeutic agent for
`an individual with colorectal cancer. The system for generating these
`reports is described on Defendant’s website, in Defendant’s public
`documents, and in other materials identified herein.
`
`
`
`(https://www.foundationmedicine.com/genomic-testing/foundation-
`one, last accessed Oct. 20, 2017.)
`
`
`
`
`
`2
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 4 of 32
`
`
`
`(FoundationOne® Technical Information and Test Overview, available
`at
`https://assets.contentful.com/vhribv12lmne/6YRrchSINOeSu48Ywues
`oY/0456c20e2b09e08c60793cc4836b9d6c/100316_-
`_F1_Tech_Specs.pdf, last accessed Oct. 20, 2017.)
`
`
`
`
`
`3
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 5 of 32
`
`
`
`
`
`(Sample FoundationOne® Patient Report, available at
`https://assets.contentful.com/vhribv12lmne/IGW77Eols2m8UeUCIocg
`W/5400d5a2c9a21fc616e54c93dd21f067/FoundationOne_Sample_Rep
`ort.pdf, last accessed Oct. 25, 2017.)
`
`
`
`4
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 6 of 32
`
`“Our FoundationOne reports delivered to physicians provide
`information regarding FDA-approved therapies and clinical trials that
`oncologists may use in making treatment decisions for their patients.”
`(Foundation Medicine, Inc. Form S-1, available at
`https://www.sec.gov/Archives/edgar/data/1488613/0001193125133076
`95/d553644ds1.htm, last accessed Oct. 20, 2017, at p. 28.)
`FoundationOne® includes at least one nucleic acid sequencing device
`configured to assay a plurality of molecular targets in a biological
`sample from the individual with colorectal cancer to determine
`molecular profile test values for the plurality of molecular targets.
`Specifically, FoundationOne® includes a next-generation sequencing
`device that identifies genomic alterations within hundreds of molecular
`targets, which currently includes over 300 cancer-related genes. Using
`the next-generation sequencing device, FoundationOne® determines
`individualized molecular profile values for these molecular targets.
`Exemplary Sources:
`
`a. at least one nucleic
`acid sequencing device
`configured to assay a
`plurality of molecular
`targets in a biological
`sample from the
`individual with
`colorectal cancer to
`determine molecular
`profile test values for the
`plurality of molecular
`targets,
`
`
`(Sample FoundationOne® Patient Report, available at
`https://assets.contentful.com/vhribv12lmne/IGW77Eols2m8UeUCIocg
`
`
`
`5
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 7 of 32
`
`W/5400d5a2c9a21fc616e54c93dd21f067/FoundationOne_Sample_Rep
`ort.pdf, last accessed Oct. 25, 2017.)
`
`
`
`
`
`
`
`
`
`
`6
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 8 of 32
`
`
`
`(FoundationOne® Technical Information and Test Overview, available
`at
`https://assets.contentful.com/vhribv12lmne/6YRrchSINOeSu48Ywues
`oY/0456c20e2b09e08c60793cc4836b9d6c/100316_-
`_F1_Tech_Specs.pdf, last accessed Oct. 20, 2017.)
`FoundationOne® assays molecular targets comprising BRAF,
`PIK3CA, EGFR and PTEN.
`Exemplary Sources:
`
`wherein the plurality of
`molecular targets
`comprises BRAF,
`PIK3CA, EGFR and
`PTEN;
`
`
`
`7
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 9 of 32
`
`
`
`
`(FoundationOne® Technical Information and Test Overview, available
`at
`https://assets.contentful.com/vhribv12lmne/6YRrchSINOeSu48Ywues
`oY/0456c20e2b09e08c60793cc4836b9d6c/100316_-
`_F1_Tech_Specs.pdf, last accessed Oct. 20, 2017.)
`FoundationOne® includes at least one computer database comprising:
`i. a reference value for each of the plurality of molecular targets; and
`ii. a listing of available therapeutic agents for each of the plurality of
`molecular targets. FoundationOne®, for example, uses what
`Defendants call a molecular information knowledgebase that stores the
`genomic alteration data along with a database of clinical findings and
`evidence associated with the genomic alteration data.
`Exemplary Sources:
`
`
`b. at least one computer
`database comprising: i. a
`reference value for each
`of the plurality of
`molecular targets; and ii.
`a listing of available
`therapeutic agents for
`each of the plurality of
`molecular targets;
`
`
`
`8
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 10 of 32
`
`
`
`
`
`
`
`(Sample FoundationOne® Patient Report, available at
`https://assets.contentful.com/vhribv12lmne/IGW77Eols2m8UeUCIocg
`
`
`
`9
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 11 of 32
`
`W/5400d5a2c9a21fc616e54c93dd21f067/FoundationOne_Sample_Rep
`ort.pdf, last accessed Oct. 25, 2017.)
`“Our proprietary sample preparation processes and computational
`biology algorithms allow us to utilize small amounts of tumor tissue
`from a wide variety of sample types, including tissue with low tumor
`purity and from liquid (blood) biopsies, so as to allow for routine
`specimen collection. We detect and report the clinically relevant
`genomic alterations, generally within 11 to 14 days for FoundationOne
`and FoundationACT and generally within 15 to 18 days for
`FoundationOne Heme, in each case from the time the specimen is
`received.”
`(Foundation Medicine, Inc. Form 10-K filed 03/02/17, available at
`http://www.getfilings.com/sec-filings/170303/Foundation-Medicine-
`Inc_10-K/, last accessed Oct. 22, 2017, at p. 4.)
`“Our molecular information knowledgebase, FoundationCORE, stores
`this genomic alteration data, along with a highly curated database of
`clinical findings and evidence associated with these genomic results.”
`(Id. at p. 3.)
` FoundationOne® includes a computer-readable program code
`comprising instructions to input the molecular profile test values to
`compare each of the molecular profile test values with a corresponding
`reference value from the at least one computer database in (b)(i).
`Specifically, FoundationOne®, which incorporates what Defendant
`calls computational biology algorithms, includes computer-readable
`program code with instructions to input the individualized molecular
`profile test values and then to compare those values to the reference
`values for the molecular targets stored in the computer database.
`
`c. a computer-readable
`program code
`comprising instructions
`to input the molecular
`profile test values to
`compare each of the
`molecular profile test
`values with a
`corresponding reference
`value from the at least
`one computer database
`in (b)(i);
`
`
`
`10
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 12 of 32
`
`Exemplary Sources:
`
`
`
`
`
`(Sample FoundationOne® Patient Report, available at
`https://assets.contentful.com/vhribv12lmne/IGW77Eols2m8UeUCIocg
`W/5400d5a2c9a21fc616e54c93dd21f067/FoundationOne_Sample_Rep
`ort.pdf, last accessed Oct. 25, 2017.)
`“Our proprietary sample preparation processes and computational
`biology algorithms allow us to utilize small amounts of tumor tissue
`from a wide variety of sample types, including tissue with low tumor
`purity and from liquid (blood) biopsies, so as to allow for routine
`specimen collection. We detect and report the clinically relevant
`genomic alterations, generally within 11 to 14 days for FoundationOne
`and FoundationACT and generally within 15 to 18 days for
`FoundationOne Heme, in each case from the time the specimen is
`received.”
`
`
`
`11
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 13 of 32
`
`(Foundation Medicine, Inc. Form 10-K filed 03/02/17, available at
`http://www.getfilings.com/sec-filings/170303/Foundation-Medicine-
`Inc_10-K/, last accessed Oct. 22, 2017, at p. 4.)
`“Our molecular information knowledgebase, FoundationCORE, stores
`this genomic alteration data, along with a highly curated database of
`clinical findings and evidence associated with these genomic results.”
`(Id. at p. 3.)
`FoundationOne® includes a computer-readable program code
`comprising instructions to access the at least one computer database to
`identify at least one therapeutic agent from the listing of available
`therapeutic agents for the plurality of molecular targets wherein the
`comparison to the reference values in (c) indicates a likely benefit of
`the at least one therapeutic agent.
`Specifically, FoundationOne®, which incorporates what Defendant
`calls computational biology algorithms, includes computer-readable
`program code with instructions to access the computer database to
`identify a therapeutic agent from a list of available therapeutic agents
`for the plurality of molecular targets. FoundationOne® identifies the
`therapeutic agent from the list of available therapeutic agents where
`the comparison to the reference value for the molecular target indicates
`a likely benefit of the therapeutic agent.
`Exemplary Sources:
`
`d. a computer-readable
`program code
`comprising instructions
`to access the at least one
`computer database to
`identify at least one
`therapeutic agent from
`the listing of available
`therapeutic agents for
`the plurality of
`molecular targets
`wherein the comparison
`to the reference values
`in (c) indicates a likely
`benefit of the at least
`one therapeutic agent;
`and
`
`(FoundationOne® Technical Information and Test Overview, available
`at
`https://assets.contentful.com/vhribv12lmne/6YRrchSINOeSu48Ywues
`oY/0456c20e2b09e08c60793cc4836b9d6c/100316_-
`_F1_Tech_Specs.pdf, last accessed Oct. 20, 2017.)
`
`
`
`12
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 14 of 32
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 14 of 32
`
`
`FOUNDATIONONE‘
`mum
`mus-aim
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`minimum-l
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`
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`Emu-pa
`MITTHE TEST:
`rauiidaiinnchie‘is a nan-genera ion sequencing [5435] based assay-ital mmifies genomic aliemiinns wii Iiin hundreds or cancer-relatedgenes.
`
`manned
`mile
`
`PATIENT RESULTS
`
`11mm ‘I'YI'E: lllHG ADEHDCARCIIIDIIA
`
`mmmw
`E12582 amdlflcathn- equivocal'
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`SIX!!! spline site 92 1-152?
`CONNIE [1058'11
`PM! EIIBD“
`mm
`W18 lossemns 6-14
`SPTAI (1.131633, spIce site 353’0-2AH'
`1753 IZSSS
`
`Additional Fildings'
`Tmmn M‘den TMB-th; 3753 NIme
`Additional Bisma-ralmnttienes with Illa
`Reportable Alterations Identified,
`EGFR
`ERAS
`.IIL'C
`EMF
`MET
`1H1"
`ms:
`
`' rota compete list Dill-agencies assayed am perhnuancespecll‘ialnn,
`please re‘le' mmhppemlii
`'SeeAmendhfa-‘mls
`
`
`
`1[I therapies ass-:iciatecl witl’| pc-tential clinical benefit
`
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`
`
`
`
`
`FOUNDAIIQNQHI'
`
`IHTEflPflEI'A'HDN
`
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`
`Gemalflflhieralim: EllBE-ZIflsnIn-nwnas Efl]mamlyl1fiheiimewhfll isinlihe
`amelamiyas mw‘ififinnormpeninnafERBEZnn Haida:WWW“
`Winn-31in!!!
`Fauna-quake”: hmemm Manpifiminnnrmnafimuasm 'I1 6%
`aflulgaflennfintilnmamsfi’J-Ellzmhas hmdnumfllndin ill—aflafmn-smfllcel
`mammal}, alt] ishighu'in “ammsflfllfimhmflllmlm
`haecell{119%]mnmsilhmrmtcymflmrtymflm ”mm pifiemsuiifll
`mehatnringflm mam-um mummh m5.
`mfiemfinamnamdmm mmmflnuwfimamfig
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`mmahUMW-‘mumin mflMWMMJnd aim-um
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`mummy-manna,“ dam-“limit h'paiiulsulill bteastmmmnmmfiflmu'
`P'I'Ell mum muse HEKlfiflmavllairE mmfimrfimmmflnmmsflat
`large! HERZ. inducingllastuzumaband hpalinihmm. PM, malaria havelepnrlied
`mnfl'uigmflsnlithmmflymggmfilgflmrflhufiflmmmamfimk undated lflh
`mmhnfimnm“, an! “Emmamm Hmmm
`inwseddhifil militia mflmfllw.0ifiaflrflsdm a'mai
`“MummmmanfimmflsmmM Wigwam
`
`
`
`13
`13
`
`
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 15 of 32
`
`
`(Sample FoundationOne® Patient Report, available at
`https://assets.contentful.com/vhribv12lmne/IGW77Eols2m8UeUCIocg
`W/5400d5a2c9a21fc616e54c93dd21f067/FoundationOne_Sample_Rep
`ort.pdf, last accessed Oct. 25, 2017.)
`“Our molecular information knowledgebase, FoundationCORE, stores
`this genomic alteration data, along with a highly curated database of
`clinical findings and evidence associated with these genomic results.”
`(Foundation Medicine, Inc. Form 10-K filed 03/02/17, available at
`http://www.getfilings.com/sec‐filings/170303/Foundation‐Medicine‐
`Inc_10‐K/, last accessed Oct. 22, 2017, at p. 3.)
`“Our proprietary sample preparation processes and computational
`biology algorithms allow us to utilize small amounts of tumor tissue
`from a wide variety of sample types, including tissue with low tumor
`purity and from liquid (blood) biopsies, so as to allow for routine
`specimen collection. We detect and report the clinically relevant
`genomic alterations, generally within 11 to 14 days for FoundationOne
`and FoundationACT and generally within 15 to 18 days for
`FoundationOne Heme, in each case from the time the specimen is
`received.”
`(Id. at p. 4.)
`FoundationOne® includes a computer-readable program code
`comprising instructions to generate a report that comprises a listing of
`the molecular targets for which the comparison to the reference value
`indicated a likely benefit of the at least one therapeutic agent in (d) and
`the at least one therapeutic agent identified in (d).
`Exemplary Sources:
`
`
`e. a computer-readable
`program code
`comprising instructions
`to generate a report that
`comprises a listing of
`the molecular targets for
`which the comparison to
`the reference value
`indicated a likely benefit
`of the at least one
`therapeutic agent in (d)
`and the at least one
`therapeutic agent
`identified in (d).
`
`
`
`14
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 16 of 32
`
`
`
`
`(FoundationOne® Technical Information and Test Overview, available
`at
`https://assets.contentful.com/vhribv12lmne/6YRrchSINOeSu48Ywues
`oY/0456c20e2b09e08c60793cc4836b9d6c/100316_-
`_F1_Tech_Specs.pdf, last accessed Oct. 20, 2017.)
`
`
`
`15
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 17 of 32
`
`
`
`(Sample FoundationOne® Patient Report, available at
`https://assets.contentful.com/vhribv12lmne/IGW77Eols2m8UeUCIocg
`W/5400d5a2c9a21fc616e54c93dd21f067/FoundationOne_Sample_Rep
`ort.pdf, last accessed Oct. 25, 2017.)
`“Our proprietary sample preparation processes and computational
`biology algorithms allow us to utilize small amounts of tumor tissue
`from a wide variety of sample types, including tissue with low tumor
`purity and from liquid (blood) biopsies, so as to allow for routine
`specimen collection. We detect and report the clinically relevant
`genomic alterations, generally within 11 to 14 days for FoundationOne
`and FoundationACT and generally within 15 to 18 days for
`FoundationOne Heme, in each case from the time the specimen is
`received.”
`(Foundation Medicine, Inc. Form 10-K filed 03/02/17, available at
`http://www.getfilings.com/sec-filings/170303/Foundation-Medicine-
`Inc_10-K/, last accessed Oct. 22, 2017, at p. 4.)
`
`
`
`
`
`
`
`
`16
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 18 of 32
`
`FoundationOne®
`
`See Claim 1.
`FoundationOne® includes a computer database that also has data
`corresponding to at least one clinical trial of a member of the plurality
`of molecular targets.
`
`’392 Patent, Claim 5
`The system of claim 1,
`wherein the at least one
`computer database
`further comprises data
`corresponding to at least
`one clinical trial of a
`member of the plurality
`of molecular targets.
`
`
`
`
`
`(Sample FoundationOne Patient Report, available at
`https://assets.contentful.com/vhribv12lmne/IGW77Eols2m8UeUCIocg
`W/5400d5a2c9a21fc616e54c93dd21f067/FoundationOne_Sample_Rep
`ort.pdf, last accessed Nov. 3, 2017.)
`
`
`
`
`
`17
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 19 of 32
`
`’392 Patent, Claim 1
`
`A system for generating
`a report identifying a
`therapeutic agent for an
`individual with
`colorectal cancer
`comprising:
`
`FoundationACT®
`
`To the extent the preamble of claim 1 is a limitation,
`FoundationACT® uses a system for generating a report identifying a
`therapeutic agent for an individual with colorectal cancer. The system
`for generating these reports is described on Defendant’s website, in
`Defendant’s public documents, and in other materials identified herein.
`Exemplary Sources:
`
`
`(https://www.foundationmedicine.com/genomic-testing/foundation-act,
`last accessed Oct. 20, 2017.)
`
`
`
`
`18
`
`
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 20 of 32
`
`(FoundationACT® Technical Information, available at
`https://assets.contentful.com/vhribv12lmne/3SPYAcbGdqAeMsOqMy
`KUog/c8ba1e7d5576475684209f449b92956a/FM-
`ACT_TechnicalSpecsOverview_FINAL.pdf, last accessed Oct. 20,
`2017.)
`
`
`(FoundationACT® Sample Report, available at
`https://cdn2.hubspot.net/hubfs/174278/Corporate%20Landing%20Page
`s/031917%20-
`%20FACT%20Momentum%20Campaign%20Landing%20Page/Docu
`ments/FACT%20Sample%20Report_EGFR_T790mF_052516%5B1%
`5D.pdf?t=1493919601061, last accessed Oct. 20, 2017.)
`
`
`a. at least one nucleic
`acid sequencing device
`
`FoundationACT® includes at least one nucleic acid sequencing device
`configured to assay a plurality of molecular targets in a biological
`
`
`
`19
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 21 of 32
`
`configured to assay a
`plurality of molecular
`targets in a biological
`sample from the
`individual with
`colorectal cancer to
`determine molecular
`profile test values for the
`plurality of molecular
`targets,
`
`sample from the individual with colorectal cancer to determine
`molecular profile test values for the plurality of molecular targets.
`Specifically, FoundationACT® includes a next-generation sequencing
`device that identifies genomic alterations within hundreds of molecular
`targets, which currently includes over 300 cancer-related genes. Using
`the next-generation sequencing device, FoundationACT® determines
`individualized molecular profile values for these molecular targets.
`Exemplary Sources:
`
`
`
`(https://www.foundationmedicine.com/genomic-testing/foundation-act,
`last accessed Oct. 20, 2017.)
`
`
`
`20
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 22 of 32
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 22 of 32
`
`Performance
`Spectfications
`
`Base Substitutions
`Insertionsteletinns “-450 hpl
`Rearrangen‘ientsa‘Fusions
`
`Copy Number Variations lCNVI‘
`
`315%
`21%
`21%
`220%
`(20%
`
`:93.9%
`199%
`199%
`95.3%
`\Mll vary depending m CNV
`leuelano tumor lraclinn.
`
`:99.9%
`93.8%
`93.0%
`
`916%
`
`Turn Around Time
`Sample Requirements
`' Coprmmy e B in genes with al leastA largets.
`
`Less than In days
`Two ll] ml tubes of peripheral whole blood
`
`Reporti n g
`Clinically- relevant alterations detected by- FoundationAET are
`matched to targeted therapies and clinical trials and reported
`on the front page of the report.
`Current Gene Llst
`FoundalinnACT idenlifies all clinically relevanl genomic allemlluns in each ul lhe genes listed below.
`
`PTPNII
`
`MYCN
`
`MYDSB
`
`NF]
`
`NPMl
`
`NRAS
`
`PDCDI LG?
`
`PDGFRA
`
`PDGFRB
`
`PIKBCA
`
`PTEN
`
`
`
`CDKL‘:
`
`CDKb
`
`CDKN2A
`
`CRKL
`
`CTNNBI
`
`DDR2
`
`EGFR
`
`ERBBE
`
`ERRFI]
`
`ESRl
`
`E2H2
`
`
`
`
`
`
`
`
`
`21
`21
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 23 of 32
`
`(FoundationACT® Technical Information, available at
`https://assets.contentful.com/vhribv12lmne/3SPYAcbGdqAeMsOqMy
`KUog/c8ba1e7d5576475684209f449b92956a/FM-
`ACT_TechnicalSpecsOverview_FINAL.pdf, last accessed Oct. 20,
`2017.)
`
`(FoundationACT® Sample Report, available at
`https://cdn2.hubspot.net/hubfs/174278/Corporate%20Landing%20Page
`s/031917%20-
`%20FACT%20Momentum%20Campaign%20Landing%20Page/Docu
`ments/FACT%20Sample%20Report_EGFR_T790mF_052516%5B1%
`5D.pdf?t=1493919601061, last accessed Oct. 20, 2017.)
`FoundationACT® assays molecular targets comprising BRAF,
`PIK3CA, EGFR and PTEN.
`Exemplary Sources:
`
`
`wherein the plurality of
`molecular targets
`comprises BRAF,
`PIK3CA, EGFR and
`PTEN;
`
`
`
`22
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 24 of 32
`
`
`
`(FoundationACT® Technical Information, available at
`https://assets.contentful.com/vhribv12lmne/3SPYAcbGdqAeMsOqMy
`KUog/c8ba1e7d5576475684209f449b92956a/FM-
`ACT_TechnicalSpecsOverview_FINAL.pdf, last accessed Oct. 20,
`2017.)
` FoundationACT® includes at least one computer database comprising:
`i. a reference value for each of the plurality of molecular targets; and ii.
`a listing of available therapeutic agents for each of the plurality of
`molecular targets.
`FoundationACT®, for example, uses what Defendants call a molecular
`information knowledgebase that stores the genomic alteration data
`along with a database of clinical findings and evidence associated with
`the genomic alteration data.
`Exemplary Sources:
`
`b. at least one computer
`database comprising: i. a
`reference value for each
`of the plurality of
`molecular targets; and ii.
`a listing of available
`therapeutic agents for
`each of the plurality of
`molecular targets;
`
`
`
`23
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 25 of 32
`
`
`
`(https://www.foundationmedicine.com/genomic-testing/foundation-act,
`last accessed Oct. 20, 2017.)
`
`(FoundationACT® Sample Report, available at
`https://cdn2.hubspot.net/hubfs/174278/Corporate%20Landing%20Page
`s/031917%20-
`%20FACT%20Momentum%20Campaign%20Landing%20Page/Docu
`ments/FACT%20Sample%20Report_EGFR_T790mF_052516%5B1%
`5D.pdf?t=1493919601061, last accessed Oct. 20, 2017.)
`“Our proprietary sample preparation processes and computational
`biology algorithms allow us to utilize small amounts of tumor tissue
`from a wide variety of sample types, including tissue with low tumor
`purity and from liquid (blood) biopsies, so as to allow for routine
`specimen collection. We detect and report the clinically relevant
`genomic alterations, generally within 11 to 14 days for FoundationOne
`and FoundationACT and generally within 15 to 18 days for
`FoundationOne Heme, in each case from the time the specimen is
`received.”
`
`
`
`24
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 26 of 32
`
`(Foundation Medicine, Inc. Form 10-K filed 03/02/17, available at
`http://www.getfilings.com/sec-filings/170303/Foundation-Medicine-
`Inc_10-K/, last accessed Oct. 22, 2017, at p. 4.)
`“Our molecular information knowledgebase, FoundationCORE, stores
`this genomic alteration data, along with a highly curated database of
`clinical findings and evidence associated with these genomic results.”
`(Id. at p. 3.)
`FoundationACT® includes a computer-readable program code
`comprising instructions to input the molecular profile test values to
`compare each of the molecular profile test values with a corresponding
`reference value from the at least one computer database in (b)(i).
`Specifically, FoundationACT®, which incorporates what Defendant
`calls computational biology algorithms, includes computer-readable
`program code with instructions to input the individualized molecular
`profile test values and then to compare those values to the reference
`values for the molecular targets stored in the computer database.
`Exemplary Sources:
`
`
`c. a computer-readable
`program code
`comprising instructions
`to input the molecular
`profile test values to
`compare each of the
`molecular profile test
`values with a
`corresponding reference
`value from the at least
`one computer database
`in (b)(i);
`
`
`
`25
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 27 of 32
`
`Stephens et al., “Analytic Validation of a Clinical Circulating Tumor
`DNA Assay for Patients with Solid Tumors,” available at
`https://cdn2.hubspot.net/hubfs/174278/Corporate%20Landing%20Page
`s/031917%20-
`%20FACT%20Momentum%20Campaign%20Landing%20Page/Docu
`ments/ESMO_2016_Abstract_2197_FMI_FACT_Poster.pdf?t=149911
`0364079, last accessed Oct. 20, 2017.
`
`(FoundationACT® Sample Report, available at
`https://cdn2.hubspot.net/hubfs/174278/Corporate%20Landing%20Page
`s/031917%20-
`%20FACT%20Momentum%20Campaign%20Landing%20Page/Docu
`ments/FACT%20Sample%20Report_EGFR_T790mF_052516%5B1%
`5D.pdf?t=1493919601061, last accessed Oct. 20, 2017.)
`“Our proprietary sample preparation processes and computational
`biology algorithms allow us to utilize small amounts of tumor tissue
`from a wide variety of sample types, including tissue with low tumor
`purity and from liquid (blood) biopsies, so as to allow for routine
`specimen collection. We detect and report the clinically relevant
`genomic alterations, generally within 11 to 14 days for FoundationOne
`and FoundationACT and generally within 15 to 18 days for
`FoundationOne Heme, in each case from the time the specimen is
`received.”
`(Foundation Medicine, Inc. Form 10-K filed 03/02/17, available at
`http://www.getfilings.com/sec-filings/170303/Foundation-Medicine-
`Inc_10-K/, last accessed Oct. 22, 2017, at p. 4.)
`
`
`
`26
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 28 of 32
`
`“Our molecular information knowledgebase, FoundationCORE, stores
`this genomic alteration data, along with a highly curated database of
`clinical findings and evidence associated with these genomic results.”
`(Id. at p. 3.)
`FoundationACT® system includes a computer-readable program code
`comprising instructions to access the at least one computer database to
`identify at least one therapeutic agent from the listing of available
`therapeutic agents for the plurality of molecular targets wherein the
`comparison to the reference values in (c) indicates a likely benefit of
`the at least one therapeutic agent.
`Specifically, FoundationACT®, which incorporates what Defendant
`calls computational biology algorithms, includes computer-readable
`program code with instructions to access the computer database to
`identify a therapeutic agent from a list of available therapeutic agents
`for the plurality of molecular targets. FoundationACT® identifies the
`therapeutic agent from the list of available therapeutic agents where
`the comparison to the reference value for the molecular target indicates
`a likely benefit of the therapeutic agent.
`Exemplary Sources:
`
`d. a computer-readable
`program code
`comprising instructions
`to access the at least one
`computer database to
`identify at least one
`therapeutic agent from
`the listing of available
`therapeutic agents for
`the plurality of
`molecular targets
`wherein the comparison
`to the reference values
`in (c) indicates a likely
`benefit of the at least
`one therapeutic agent;
`and
`
`
`(FoundationACT® Technical Information, available at
`https://assets.contentful.com/vhribv12lmne/3SPYAcbGdqAeMsOqMy
`KUog/c8ba1e7d5576475684209f449b92956a/FM-
`ACT_TechnicalSpecsOverview_FINAL.pdf, last accessed Oct. 20,
`2017.)
`
`
`
`27
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 29 of 32
`
`
`
`(FoundationACT® Sample Report, available at
`https://cdn2.hubspot.net/hubfs/174278/Corporate%20Landing%20Page
`s/031917%20-
`%20FACT%20Momentum%20Campaign%20Landing%20Page/Docu
`ments/FACT%20Sample%20Report_EGFR_T790mF_052516%5B1%
`5D.pdf?t=1493919601061, last accessed Oct. 20, 2017.)
`“Our molecular information knowledgebase, FoundationCORE, stores
`this genomic alteration data, along with a highly curated database of
`clinical findings and evidence associated with these genomic results.”
`(Foundation Medicine, Inc. Form 10-K filed 03/02/17, available at
`http://www.getfilings.com/sec-filings/170303/Foundation-Medicine-
`Inc_10-K/, last accessed Oct. 22, 2017, at p. 3.)
`“Our proprietary sample preparation processes and computational
`biology algorithms allow us to utilize small amounts of tumor tissue
`from a wide variety of sample types, including tissue with low tumor
`purity and from liquid (blood) biopsies, so as to allow for routine
`specimen collection. We detect and report the clinically relevant
`genomic alterations, generally within 11 to 14 days for FoundationOne
`and FoundationACT and generally within 15 to 18 days for
`FoundationOne Heme, in each case from the time the specimen is
`received.”
`(Id. at p. 4.)
`FoundationACT® includes a computer-readable program code
`comprising instructions to generate a report that comprises a listing of
`
`e. a computer-readable
`program code
`
`
`
`28
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 30 of 32
`
`comprising instructions
`to generate a report that
`comprises a listing of
`the molecular targets for
`which the comparison to
`the reference value
`indicated a likely benefit
`of the at least one
`therapeutic agent in (d)
`and the at least one
`therapeutic agent
`identified in (d).
`
`the molecular targets for which the comparison to the reference value
`indicated a likely benefit of the at least one therapeutic agent in (d) and
`the at least one therapeutic agent identified in (d).
`Exemplary Sources:
`
`
`(FoundationACT® Technical Information, available at
`https://assets.contentful.com/vhribv12lmne/3SPYAcbGdqAeMsOqMy
`KUog/c8ba1e7d5576475684209f449b92956a/FM-
`ACT_TechnicalSpecsOverview_FINAL.pdf, last accessed Oct. 20,
`2017.)
`
`
`(FoundationACT® Sample Report, available at
`https://cdn2.hubspot.net/hubfs/174278/Corporate%20Landing%20Page
`s/031917%20-
`%20FACT%20Momentum%20Campaign%20Landing%20Page/Docu
`ments/FACT%20Sample%20Report_EGFR_T790mF_052516%5B1%
`5D.pdf?t=1493919601061, last accessed Oct. 20, 2017.)
`“Our proprietary sample preparation processes and computational
`biology algorithms allow us to utilize small amounts of tumor tissue
`from a wide variety of sample types, including tissue with low tumor
`purity and from liquid (blood) biopsies, so as to allow for routine
`
`
`
`29
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 31 of 32
`
`specimen collection. We detect and report the clinically relevant
`genomic alterations, generally within 11 to 14 days for FoundationOne
`and FoundationACT and generally within 15 to 18 days for
`FoundationOne Heme, in each case from the time the specimen is
`received.”
`(Foundation Medicine, Inc. Form 10-K filed 03/02/17, available at
`http://www.getfilings.com/sec-filings/170303/Foundation-Medicine-
`Inc_10-K/, last accessed Oct. 22, 2017, at p. 4.)
`
`
`FoundationACT®
`
`See Claim 1.
`FoundationACT® includes a computer database that also has data
`corresponding to at least one clinical trial of a member of the plurality
`of the molecular targets.
`
`’392 Patent, Claim 5
`The system of claim 1,
`wherein the at least one
`computer database
`further comprises data
`corresponding to at least
`one clinical trial of a
`member of the plurality
`of the molecular targets.
`
`
`
`
`
`
`
`30
`
`
`
`Case 1:17-cv-12194-RGS Document 1-14 Filed 11/07/17 Page 32 of 32
`
`(FoundationAct Sample Report, available at
`https://cdn2.hubspot.net/hubfs/174278/Corporate%20Landing%20Page
`s/031917%20-
`%20FACT%20Momentum%20Campaign%20Landing%20Page/Docu
`ments/FACT%20Sample%20Report_EGFR_T790mF_052516%5B1%
`5D.pdf?t=1493919601061, last accessed Nov 3, 2017.)
`
`
`
`
`
`
`
`
`
`31
`
`
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