Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 1 of 34
`Case 1:17-cv-12194—RGS Document 1-15 Filed 11/07/17 Page 1 of 34
`
`EXHIBIT 15
`EXHIBIT 15
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 2 of 34
`
`Exhibit 15 - Infringement of U.S. Patent No. 9,292,660
`
`
`Defendant Foundation Medicine Inc. makes, uses, offers for sale, and/or sells the subject matter
`claimed in U.S. Patent Number 9,292,660 with its “FoundationOne®” and “FoundationACT®”
`products (collectively referred to as the “Accused Products”).
`The following chart compares the claims of the ’660 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 1-15 Filed 11/07/17 Page 3 of 34
`
`’660 Patent, Claim 1
`
`A system for generating
`a report identifying a
`therapeutic agent for an
`individual with lung
`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 lung 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 1-15 Filed 11/07/17 Page 4 of 34
`
`
`
`
`
`(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 1-15 Filed 11/07/17 Page 5 of 34
`Case 1:17-cv-12194—RGS Document 1-15 Filed 11/07/17 Page 5 of 34
`
`
`
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`mm: “INS ”Emma“!
`
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`the mummy-swam.
`
` 
`
`4
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 6 of 34
`
`
`(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 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 device configured to assay a
`plurality of molecular targets in a biological sample from the individual
`with lung cancer to determine molecular profile test values for the
`plurality of molecular targets.
`Specifically, FoundationOne® includes a next-generation sequencing
`assay that identifies genomic alterations within hundreds of molecular
`targets, which currently includes over 300 cancer-related genes. Using
`the next-generation sequencing assay, FoundationOne® determines
`individualized molecular profile values for these molecular targets.
`
`
`a. at least one device
`configured to assay a
`plurality of molecular
`targets in a biological
`sample from the
`individual with lung
`cancer to determine
`molecular profile test
`values for the plurality
`of molecular targets,
`
` 
`
`5
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 7 of 34
`
` 
`
`
`
`
` 
`
`(Sample FoundationOne® Patient Report, available at
`https://assets.contentful.com/vhribv12lmne/IGW77Eols2m8UeUCIocg
`W/5400d5a2c9a21fc616e54c93dd21f067/FoundationOne_Sample_Rep
`ort.pdf, last accessed Oct. 25, 2017.)
`
`
`
`(https://www.foundationmedicine.com/genomic-testing/foundation-
`one, last accessed Oct. 20, 2017.)
`
` 
`
`6
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 8 of 34
`Case 1:17-cv-12194—RGS Document 1-15 Filed 11/07/17 Page 8 of 34
`
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`Foundatiorflneé is a oor'rprel'vensiue genomic
`profilefl'a't Eppies neat-generation sequencing
`in a unique mannerto identify all 4 types of
`genomic alterations across all genes known to be
`unambiguous drivers of solid tumors with high
`accuncy. The test sirmIEIneoushr sequences fl've coding nation of 315
`cancer-nelabed genes plus in'lrons from 23 genes often rearmngod or
`altered in cancer to atypical medan dream of omnerage ofgreamr than
`SDOX.Eachcosreredreadreoresa11sa LI'IioueDNAhz-Ignenttoenablethe
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`at low frequencies one to tumor I'velserogeneitjt low ‘IJJI'I‘IDI' purity and smal
`tissue samples FoLl'IdationDne debects all classes of QM altera‘lions.
`inclucing base sLIJstitutions. inserlions and deletqu (indels). copy
`number Ellselations {CHAS} and nearrEl'Igements using a smaI. rout'ne
`FFPE sample {induding cone or like rveecle biopsies).
`
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` 
`
` 
`
`7
`7
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 9 of 34
`
`(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 PTEN,
`CTNNB1, cKIT, BRAF and PIK3CA.
`Exemplary Sources:
`
`wherein the plurality of
`molecular targets
`comprises PTEN,
`CTNNB1, cKIT, BRAF
`and PIK3CA;
`
`
`
`(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
`
`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
`
` 
`
`8
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 10 of 34
`
`therapeutic agents for
`each of the plurality of
`molecular targets;
`
`genomic alteration data along with a database of clinical findings and
`evidence associated with the genomic alteration data.
`Exemplary Sources:
`
`(https://www.foundationmedicine.com/genomic-testing/foundation-
`one, last accessed Oct. 20, 2017.)
` 
`
`
`
`
` 
`
`9
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 11 of 34
`
`
`
`
`(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.)
`“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 and to
`
`10
`
`c. a computer-readable
`program code
`
` 
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 12 of 34
`
`comprising instructions
`to input the molecular
`profile test values and to
`compare each of the
`molecular profile test
`values with a
`corresponding reference
`value from the at least
`one computer database
`in (b)(i);
`
`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.
`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
`
` 
`
`11
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 13 of 34
`
`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 access the at least one computer database in
`(b)(ii) and to identify at least one therapeutic agent if present in the at
`least one computer database for each of the plurality of molecular
`targets wherein said 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.
`
`d. a computer-readable
`program code
`comprising instructions
`to access the at least one
`computer database in
`(b)(ii) and to identify at
`least one therapeutic
`agent if present in the at
`least one computer
`database for each of the
`plurality of molecular
`targets wherein said
`comparison to the
`reference values in (c)
`indicates a likely benefit
`of the at least one
`therapeutic agent; and
`
` 
`
`12
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 14 of 34
`
`Exemplary Sources:
`
`(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.)
`
` 
`
`13
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 15 of 34
`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 15 of 34
`
` 
`
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`
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`
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`
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`
`
`
`14
`14
`
` 
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 16 of 34
`
`
`(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 members of the plurality of 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 members of the
`plurality of 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).
`
` 
`
`15
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 17 of 34
`
`
`
`
`(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.)
`
` 
`
`16
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 18 of 34
`
`
`
`
`
`(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.)
`
`
`
`
`
` 
`
`17
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 19 of 34
`
`’660 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.
`
`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 the molecular targets.
`
`
`
`
`
`
`
`
`
` 
`
`18
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 20 of 34
`
`(Sample FoundationOne® Patient Report, available at
`https://assets.contentful.com/vhribv12lmne/IGW77Eols2m8UeUCIocg
`W/5400d5a2c9a21fc616e54c93dd21f067/FoundationOne_Sample_Rep
`ort.pdf, last accessed Nov. 3, 2017.)
`
`
`
` 
`
` 
`
`19
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 21 of 34
`
`’660 Patent, Claim 1
`
`A system for generating
`a report identifying a
`therapeutic agent for an
`individual with lung
`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 lung 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.)
`
`
`
`
`20
`
` 
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 22 of 34
`
`(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.)
`
`
` 
`
`21
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 23 of 34
`
`a. at least one device
`configured to assay a
`plurality of molecular
`targets in a biological
`sample from the
`individual with lung
`cancer to determine
`molecular profile test
`values for the plurality
`of molecular targets,
`
`FoundationACT® includes at least one device configured to assay a
`plurality of molecular targets in a biological sample from the individual
`with lung cancer to determine molecular profile test values for the
`plurality of molecular targets.
`Specifically, FoundationACT® includes a next-generation sequencing
`assay that identifies genomic alterations within hundreds of molecular
`targets, which currently includes over 300 cancer-related genes. Using
`the next-generation sequencing assay, 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.)
`
`
`
`
`
`
`
` 
`
`22
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 24 of 34
`
`
`
`
`
`(FoundationACT® Technical Information, available at
`https://assets.contentful.com/vhribv12lmne/3SPYAcbGdqAeMsOqMy
`KUog/c8ba1e7d5576475684209f449b92956a/FM-
`ACT_TechnicalSpecsOverview_FINAL.pdf, last accessed Oct. 20,
`2017.)
`
` 
`
` 
`
` 
`
`
`
`
`
` 
`
`23
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 25 of 34
`
`
`
`
`(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 PTEN,
`CTNNB1, cKIT, BRAF and PIK3CA.
`Exemplary Sources:
`
`wherein the plurality of
`molecular targets
`comprises PTEN,
`CTNNB1, cKIT, BRAF
`and PIK3CA;
`
` 
`
`24
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 26 of 34
`
`
`
`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;
`
`(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:
`
`
` 
`
`25
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 27 of 34
`
`
`
`
`(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
`
` 
`
`26
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 28 of 34
`
`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.)
`FoundationACT® includes a computer-readable program code
`comprising instructions to input the molecular profile test values and 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 and to
`compare each of the
`molecular profile test
`values with a
`corresponding reference
`value from the at least
`one computer database
`in (b)(i);
`
`
`
` 
`
`27
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 29 of 34
`
`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.)
`
` 
`
`28
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 30 of 34
`
`“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 access the at least one computer database in
`(b)(ii) and to identify at least one therapeutic agent if present in the at
`least one computer database for each of the plurality of molecular
`targets wherein said 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 in
`(b)(ii) and to identify at
`least one therapeutic
`agent if present in the at
`least one computer
`database for each of the
`plurality of molecular
`targets wherein said
`comparison to the
`reference values in (c)
`indicates a likely benefit
`of the at least one
`therapeutic agent; and
`
` 
`
`29
`
`

`

`Case 1:17-cv-12194-RGS Document 1-15 Filed 11/07/17 Page 31 of 34
`
`(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 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
`
` 
`