Case 1:17-cv-12194-MLW Document 24-1 Filed 01/16/18 Page 1 of 19
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`Exhibit 1
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`Exhibit 1
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`Case 1:17-cv-12194-MLW Document 24-1 Filed 01/16/18 Page 2 of 19
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`Claim 1 of U.S. Patent No. 8,880,350
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`Exhibit 1
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`1
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`Case 1:17-cv-12194-MLW Document 24-1 Filed 01/16/18 Page 3 of 19
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`U.S. Patent No. 8,880,350
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`1. A system for generating a report identifying at least one therapeutic agent for an individual
`with a cancer comprising:
`
`a. at least one device configured to assay a plurality of molecular targets in a biological
`sample to determine individualized molecular profile test values for the plurality of
`molecular targets, wherein the molecular targets comprise EGFR, KIT, TOP1,
`MLH1, PTEN, PDGFRA and ESR1; and
`
`b. at least one computer database comprising:
`
`i.
`
`a reference value for the plurality of molecular targets; and
`
`ii. a listing of available therapeutic agents for said plurality of molecular targets;
`
`c. a computer-readable program code comprising instructions to input the individualized
`molecular profile test values and to compare said test values with a corresponding
`reference value in (b)(i);
`
`d. a computer-readable program code comprising instructions to access the at least one
`computer database and to identify at least one therapeutic agent from the listing of
`available therapeutic agents for the plurality of molecular targets wherein said
`comparison to said reference in (c) indicates a likely benefit of the at least one
`therapeutic agent; and
`
`e. a computer-readable program code comprising instructions to generate a report that
`comprises a listing of the molecular targets wherein said comparison to said reference
`indicated a likely benefit of the at least one therapeutic agent in (d) along with the at
`least one therapeutic agent identified in (d).
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`Exhibit 1
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`2
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`Case 1:17-cv-12194-MLW Document 24-1 Filed 01/16/18 Page 4 of 19
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`Claim 1 of U.S. Patent No. 9,092,392
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`Exhibit 1
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`3
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`Case 1:17-cv-12194-MLW Document 24-1 Filed 01/16/18 Page 5 of 19
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`U.S. Patent No. 9,092,392
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`1. A system for generating a report identifying a therapeutic agent for an individual with
`colorectal cancer comprising:
`
`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, wherein
`the plurality of molecular targets comprises BRAF, PIK3CA, EGFR and PTEN;
`
`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;
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`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);
`
`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
`
`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).
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`Exhibit 1
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`4
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`Case 1:17-cv-12194-MLW Document 24-1 Filed 01/16/18 Page 6 of 19
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`Redline of Claim 1 of U.S. Patent No. 9,092,392
`Over Claim 1 of U.S. Patent No. 8,880,350
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`Exhibit 1
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`5
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`Case 1:17-cv-12194-MLW Document 24-1 Filed 01/16/18 Page 7 of 19
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`U.S. Patent No. 8,880,3509,092,392
`
`1. A system for generating a report identifying at least one a therapeutic agent for an individual
`
`with acolorectal cancer comprising:
`
`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
`
`individualized molecular profile test values for the plurality of molecular targets,
`
`wherein the plurality of molecular targets comprisecomprises BRAF, PIK3CA, EGFR,
`
`KIT, TOP1, MLH1, and PTEN, PDGFRA and ESR1; and
`
`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 saideach of the plurality of
`
`molecular targets;
`
`c. a computer-readable program code comprising instructions to input the individualized
`
`molecular profile test values and to compare saideach of the molecular profile test
`
`values with a corresponding reference value from the at least one computer database in
`
`(b)(i);
`
`d. a computer-readable program code comprising instructions to access the at least one
`
`computer database and to identify at least one therapeutic agent from the listing of
`
`available therapeutic agents for the plurality of molecular targets wherein saidthe
`
`comparison to saidthe reference values in (c) indicates a likely benefit of the at least
`
`one therapeutic agent; and
`
`e. a computer-readable program code comprising instructions to generate a report that
`
`comprises a listing of the molecular targets wherein saidfor which the comparison to
`
`saidthe reference value indicated a likely benefit of the at least one therapeutic agent in
`
`(d) along withand the at least one therapeutic agent identified in (d).
`
`Exhibit 1
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`6
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`Case 1:17-cv-12194-MLW Document 24-1 Filed 01/16/18 Page 8 of 19
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`Claim 1 of U.S. Patent No. 9,292,660
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`Exhibit 1
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`7
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`Case 1:17-cv-12194-MLW Document 24-1 Filed 01/16/18 Page 9 of 19
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`U.S. Patent No. 9,292,660
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`1. A system for generating a report identifying a therapeutic agent for an individual with lung
`cancer comprising:
`
`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, wherein the plurality of molecular targets
`comprises PTEN, CTNNB1, cKIT, BRAF and PIK3CA;
`
`b. at least one computer database comprising:
`
`i.
`
`a reference value for each of the plurality of molecular targets;
`
`ii. a listing of available therapeutic agents for the plurality of molecular targets;
`
`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);
`
`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
`
`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).
`
`Exhibit 1
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`8
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`Case 1:17-cv-12194-MLW Document 24-1 Filed 01/16/18 Page 10 of 19
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`Redline of Claim 1 of U.S. Patent No. 9,292,660
`Over Claim 1 of U.S. Patent No. 8,880,350
`
`Exhibit 1
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`9
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`Case 1:17-cv-12194-MLW Document 24-1 Filed 01/16/18 Page 11 of 19
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`U.S. Patent No. 8,880,3509,292,660
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`1. A system for generating a report identifying at least one a therapeutic agent for an individual
`
`with alung cancer comprising:
`
`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 individualized molecular
`
`profile test values for the plurality of molecular targets, wherein the plurality of
`
`molecular targets comprise EGFR, KIT, TOP1, MLH1, PTEN, PDGFRA and
`
`ESR1comprises PTEN, CTNNB1, cKIT, BRAF and PIK3CA; and
`
`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 saidthe plurality of molecular
`
`targets;
`
`c. a computer-readable program code comprising instructions to input the individualized
`
`molecular profile test values and to compare saideach of the molecular profile test
`
`values with a corresponding reference value from the at least one computer database in
`
`(b)(i);
`
`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 from the
`
`listing of available therapeutic agents for if present in the at least one computer
`
`database for each of the plurality of molecular targets wherein said comparison to
`
`saidthe reference values in (c) indicates a likely benefit of the at least one therapeutic
`
`agent; and
`
`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 wherein saidfor
`
`which the comparison to saidthe reference value indicated a likely benefit of the at
`
`least one therapeutic agent in (d) along withand the at least one therapeutic agent
`
`identified in (d).
`
`Exhibit 1
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`10
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`Case 1:17-cv-12194-MLW Document 24-1 Filed 01/16/18 Page 12 of 19
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`Claim 1 of U.S. Patent No. 9,372,193
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`Exhibit 1
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`11
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`Case 1:17-cv-12194-MLW Document 24-1 Filed 01/16/18 Page 13 of 19
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`U.S. Patent No. 9,372,193
`
`1. A system for generating a report identifying at least one therapeutic agent for an individual
`with a cancer comprising:
`
`a. at least one device configured to assay a plurality of molecular targets in a biological
`sample to determine molecular profile test values for the plurality of molecular
`targets, wherein the plurality of molecular targets comprises AR, EGFR, HER2, KIT,
`MLH1, PTEN, and PDGFRA; and
`
`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;
`
`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);
`
`d. a computer-readable program code comprising instructions to access the at least one
`computer database and 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
`
`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).
`
`Exhibit 1
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`12
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`Case 1:17-cv-12194-MLW Document 24-1 Filed 01/16/18 Page 14 of 19
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`Redline of Claim 1 of U.S. Patent No. 9,372,193
`Over Claim 1 of U.S. Patent No. 8,880,350
`
`Exhibit 1
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`13
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`Case 1:17-cv-12194-MLW Document 24-1 Filed 01/16/18 Page 15 of 19
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`U.S. Patent No. 8,880,3509,372,193
`
`1. A system for generating a report identifying at least one therapeutic agent for an individual
`
`with a cancer comprising:
`
`a. at least one device configured to assay a plurality of molecular targets in a biological
`
`sample to determine individualized molecular profile test values for the plurality of
`
`molecular targets, wherein the plurality of molecular targets comprisecomprises AR,
`
`EGFR, HER2, KIT, TOP1, MLH1, PTEN, and PDGFRA and ESR1; and
`
`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 saideach of the plurality of
`
`molecular targets;
`
`c. a computer-readable program code comprising instructions to input the individualized
`
`molecular profile test values and to compare saideach of the molecular profile test
`
`values with a corresponding reference value from the at least one computer database in
`
`(b)(i);
`
`d. a computer-readable program code comprising instructions to access the at least one
`
`computer database and to identify at least one therapeutic agent from the listing of
`
`available therapeutic agents for the plurality of molecular targets wherein saidthe
`
`comparison to saidthe reference values in (c) indicates a likely benefit of the at least
`
`one therapeutic agent; and
`
`e. a computer-readable program code comprising instructions to generate a report that
`
`comprises a listing of the molecular targets wherein saidfor which the comparison to
`
`saidthe reference value indicated a likely benefit of the at least one therapeutic agent in
`
`(d) along withand the at least one therapeutic agent identified in (d).
`
`Exhibit 1
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`14
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`Case 1:17-cv-12194-MLW Document 24-1 Filed 01/16/18 Page 16 of 19
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`Claim 1 of U.S. Patent No. 9,383,365
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`Exhibit 1
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`15
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`Case 1:17-cv-12194-MLW Document 24-1 Filed 01/16/18 Page 17 of 19
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`U.S. Patent No. 9,383,365
`
`1. A system for generating a report identifying at least one therapeutic agent for an individual
`with a cancer comprising:
`
`a. at least one device configured to assay a plurality of molecular targets in a biological
`sample to determine molecular profile test values for the plurality of molecular
`targets, wherein the plurality of molecular targets comprises EGFR, KIT, TOP1,
`MLH1, PTEN, PDGFRA and ERRB2; and
`
`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;
`
`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);
`
`d. a computer-readable program code comprising instructions to access the at
`least one computer database and 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
`
`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).
`
`Exhibit 1
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`16
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`Case 1:17-cv-12194-MLW Document 24-1 Filed 01/16/18 Page 18 of 19
`
`Redline of Claim 1 of U.S. Patent No. 9,383,365
`Over Claim 1 of U.S. Patent No. 8,880,350
`
`Exhibit 1
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`17
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`
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`Case 1:17-cv-12194-MLW Document 24-1 Filed 01/16/18 Page 19 of 19
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`U.S. Patent No. 8,880,3509,383,365
`
`1. A system for generating a report identifying at least one therapeutic agent for an individual
`
`with a cancer comprising:
`
`a. at least one device configured to assay a plurality of molecular targets in a biological
`
`sample to determine individualized molecular profile test values for the plurality of
`
`molecular targets, wherein the plurality of molecular targets comprisecomprises
`
`EGFR, KIT, TOP1, MLH1, PTEN, PDGFRA and ESR1ERRB2; and
`
`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 saideach of the plurality of
`
`molecular targets;
`
`c. a computer-readable program code comprising instructions to input the individualized
`
`molecular profile test values and to compare saideach of the molecular profile test
`
`values with a corresponding reference value from the at least one computer database in
`
`(b)(i);
`
`d. a computer-readable program code comprising instructions to access the at
`
`least one computer database and to identify at least one therapeutic agent from
`
`the listing of available therapeutic agents for the plurality of molecular targets
`
`wherein saidthe comparison to saidthe reference values in (c) indicates a likely
`
`benefit of the at least one therapeutic agent; and
`
`e. a computer-readable program code comprising instructions to generate a
`
`report that comprises a listing of the molecular targets wherein saidfor which
`
`the comparison to saidthe reference value indicated a likely benefit of the at
`
`least one therapeutic agent in (d) along withand the at least one therapeutic
`
`agent identified in (d).
`
`Exhibit 1
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`18
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