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`Exhibit A
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`Case 1:17-cv-12194-MLW Document 33-1 Filed 03/20/18 Page 2 of 36
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
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`CARIS MPI, INC.,
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`Plaintiff,
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`v.
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`FOUNDATION MEDICINE, INC.
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`Defendant.
`___________________________________
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`C.A. No. 1:17-cv-12194
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`REPLY IN SUPPORT OF FOUNDATION MEDICINE’S MOTION TO DISMISS FOR
`LACK OF PATENTABLE SUBJECT MATTER AND WRITTEN DESCRIPTION
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`Case 1:17-cv-12194-MLW Document 33-1 Filed 03/20/18 Page 3 of 36
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`I.
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`Table of Contents
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`The Allegations in the Complaint Cannot Save the Patents-in-Suit, Which Are
`Drawn to an Unpatentable Abstract Idea. .............................................................................. 1
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`A. Caris’s Description of Its Invention Does Not Adequately Allege that the
`Patents-in-Suit Contain an Inventive Concept. ................................................................ 2
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`B. Caris’s Allegation that the Claimed Inventions Have Provided an Improvement
`to the Field of Cancer Treatment Is Completely Unsupported. ....................................... 5
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`C. The Asserted Patents are Drawn to an Abstract Idea. ...................................................... 7
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`D. The Alleged System for Identifying “Non-Disease Specific” Treatments—
`Which is Divorced from the Actual Claim Language—Does Not Supply an
`Inventive Concept or Significantly More than the Patent Ineligible Abstract
`Idea................................................................................................................................... 8
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`II. This Court Can Dismiss This Case at the Pleading Stage. .................................................. 12
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`III. Claim 1 of the ’350 Patent is Representative. ...................................................................... 15
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`IV. The Patents-in-Suit In Fact Threaten to Preempt the Field of Diagnostic Testing and
`Clinical Reporting for Targeted Cancer Therapeutics. ........................................................ 16
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`V. A Written Description Challenge May Be Decided in This Case Because There is
`No Disputed Question of Fact. ............................................................................................ 18
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`Case 1:17-cv-12194-MLW Document 33-1 Filed 03/20/18 Page 4 of 36
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`TABLE OF AUTHORITIES
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`CASES
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`Page(s)
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`Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121 (Fed. Cir.
`2018) ........................................................................................................................3, 12, 13
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`Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) .....................................5, 19
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`Automated Tracking Sols., LLC v. Coca-Cola Co., No. 2017-1494, 2018 WL
`935455 (Fed. Cir. Feb. 16, 2018) .......................................................................................15
`
`Bancorp Servs., L.L.C. v. Sun Life Assur. Co. of Canada (U.S.), 687 F.3d 1266
`(Fed. Cir. 2012) ..................................................................................................................16
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`Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018) ................................................................13
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`Brookhill-Wilk 1, LLC. v. Intuitive Surgical, Inc., 334 F.3d 1294 (Fed. Cir. 2003) ........................6
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`CMG Fin. Servs., Inc. v. Pac. Tr. Bank, F.S.B., 50 F. Supp. 3d 1306, 1314 (C.D.
`Cal. 2014), aff’d sub nom. CMG Fin. Servs., Inc. v. Pac. Tr. Bank, 616 F.
`App’x 420 (Fed. Cir. 2015)................................................................................................16
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`DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed. Cir. 2014) ...................................17
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`Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1351
`(Fed. Cir. 2014) ...................................................................................................................4
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`Esoterix Genetics Labs. LLC v. Qiagen, Inc. 133 F. Supp. 3d 349 (D. Mass. 2015) ....................14
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`Fujikawa v. Wattanasin, 93 F.3d 1559 (Fed. Cir. 1996) ...............................................................18
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`In re Grams, 888 F.2d 835 (Fed. Cir. 1989) ....................................................................................6
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`In re Ruschig, 379 F.2d 990 (C.C.P.A. 1967) ................................................................................17
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`Intellectual Ventures I LLC v. Symantec Corp., No. 2017-1814, 2018 WL
`1324863 (Fed. Cir. Mar. 15, 2018) ....................................................................................13
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`Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012) ..............................8, 17
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`Return Mail, Inc. v. United States Postal Serv., 868 F.3d 1350 (Fed. Cir. 2017) .........................11
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`Oxford Immunotec Ltd. v. Qiagen, Inc., No. 15-cv-13124-NMG, 2016 WL
`5746639 (D. Mass. Aug. 31, 2016) ....................................................................................15
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`Schatz v. Republican State Leadership Comm., 669 F.3d 50 (1st Cir. 2012) ................................11
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`Case 1:17-cv-12194-MLW Document 33-1 Filed 03/20/18 Page 5 of 36
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`Secure Mail Sols. LLC v. Universal Wilde, Inc., 169 F. Supp. 3d 1039, 1049 (C.D.
`Cal. 2016), aff’d sub nom. Secured Mail Sols. LLC v. Universal Wilde,
`Inc., 873 F.3d 905 (Fed. Cir. 2017) .....................................................................................2
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`Union Oil Co. of Cal. v. Atl. Richfield Co., 208 F.3d 989 .............................................................18
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`Case 1:17-cv-12194-MLW Document 33-1 Filed 03/20/18 Page 6 of 36
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`The Patents-in-Suit do not describe any new cancer therapies. They do not describe any
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`new uses of existing therapies. And they do not describe any new assays or computer
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`technologies for performing molecular profiling relating to cancer. None of the allegations in the
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`Complaint can change those facts. Against this reality, Caris pins the alleged inventiveness of
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`the Patents-in-Suit on the potential for identifying new uses for existing oncology drugs.1 But
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`the use of conventional computer technology and molecular assays—neither of which the named
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`inventors claim to have invented or improved—to identify potential uses for existing drugs is not
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`inventive. Nor does the recitation of a specific gene panel, which is not supported by the
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`specification, make the asserted claims any less abstract. Because the Patents-in-Suit do not
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`describe or claim a concrete application of the alleged invention, the asserted patents are invalid.
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`Moreover, the absence of any basis on which to select the claimed gene panels in the
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`specification of the Patents-in-Suit renders the patents invalid for lack of written description for
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`an additional, independent reason. For these reasons, the Complaint and the patents themselves
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`establish that the Patents-in-Suit are drawn to unpatentable subject matter and do not satisfy the
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`written description requirement. This Court can and should address the legal insufficiency of the
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`Patents-in-Suit at the pleading stage; this case should be dismissed with prejudice.
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`I.
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`The Allegations in the Complaint Cannot Save the Patents-in-Suit, Which Are
`Drawn to an Unpatentable Abstract Idea.
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`Caris complains that FMI’s motion does not cite “one word” of its Complaint. On the
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`contrary, FMI’s motion squarely focuses on the language of the claims, which are repeated and
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`described at length in the Complaint and, indeed, form the basis for the Complaint. Moreover,
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`Caris’s argument that the Complaint cannot be dismissed because it supposedly includes
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`1 Caris has asserted infringement of U.S. Patent Nos. 8,880,350 (the “’350 Patent”); 9,092,392
`(the “’392 Patent”); 9,292,660 (the “’660 Patent”); 9,372,193 (the “’193 Patent”), and 9,383,365
`(the “’365 Patent) (collectively, the “Patents-in-Suit”).
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`Case 1:17-cv-12194-MLW Document 33-1 Filed 03/20/18 Page 7 of 36
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`nineteen paragraphs “describing the claimed inventions” is both without merit and undercuts
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`Caris’s argument that FMI’s motion, which focuses on the claimed invention, does not properly
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`address the Complaint. As a threshold matter, allegations made in a complaint cannot save
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`patents that are facially invalid under Section 101. Moreover, even if considered, the allegations
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`made in the Complaint here do not and cannot rectify the deficiencies in the patents themselves.
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`Despite Caris’s allegation that the claimed invention utilizes a “novel system” for identifying
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`“treatment options” based on sets of “four to seven molecular targets, the combination of which
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`was not traditionally or conventionally associated with a particular type of cancer,” it is
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`indisputable that the Patents-in-Suit provide no examples demonstrating the alleged inventive
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`concept—i.e., the use of molecular profiling based on the claimed gene panels to provide
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`treatment recommendations to patients. Opp. 5, 7 (citing Compl. ¶¶ 12-17). Mere allegations in
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`Caris’s Complaint cannot overcome that deficit in the patents themselves.
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`Although Caris suggests that FMI “rewrites” the claims to support an over-generalized
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`view of the invention, it is in fact Caris that is attempting to use its Complaint and opposition
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`brief to rewrite the actual claims to give them an aura of inventiveness. The claims, however,
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`speak for themselves, and cannot be augmented with artful pleading. Cf. Secure Mail Sols. LLC
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`v. Universal Wilde, Inc., 169 F. Supp. 3d 1039, 1049 (C.D. Cal. 2016), aff’d sub nom. Secured
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`Mail Sols. LLC v. Universal Wilde, Inc., 873 F.3d 905 (Fed. Cir. 2017) (rejecting patentee’s
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`argument about the problem the challenged patent was designed to solve because the problem is
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`not recited in the claims).
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`A.
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`Caris’s Description of Its Invention Does Not Adequately Allege that the
`Patents-in-Suit Contain an Inventive Concept.
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`Caris argues that the Complaint should not be dismissed because the Complaint alleges
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`that the Patents-in-Suit contain an inventive concept and FMI does not cite specific paragraphs
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`Case 1:17-cv-12194-MLW Document 33-1 Filed 03/20/18 Page 8 of 36
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`from the Complaint in its motion. This argument misapplies the law. As an initial matter, no
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`case holds that a citation to the complaint is required for a Section 101 motion to dismiss to be
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`sustained. Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121 (Fed. Cir. 2018),
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`on which Caris relies, instead states that “patentees who adequately allege their claims contain
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`inventive concepts survive a § 101 eligibility analysis under Rule 12(b)(6).” Id. at 1125–27
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`(emphasis added). Only adequate allegations—that is, those that are consistent with the
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`disclosure of the asserted patents—can survive a Section 101 motion. Manufacturing contrived
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`allegations for a complaint that are not supported by the patents themselves cannot save claims
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`drawn to ineligible subject matter.
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`According to Caris, the alleged inventiveness of the Patents-in-Suit lies in the potential
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`for identifying new uses of a known cancer treatment based on a molecular marker (e.g.,
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`overexpression of a particular gene or protein), using a combination of four to seven molecular
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`targets. Opp. 6, 8, 9, 13, 15. However, this supposed “inventiveness,” manufactured by Caris
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`for purposes of its opposition brief, is undermined by the asserted claims themselves because (1)
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`the asserted claims are far broader than the identification of therapeutic agents not associated
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`with a particular cancer and (2) Caris takes the position that the claims are likewise not limited to
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`a set of four to seven molecular targets, which Caris now alleges was a novel feature of the
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`claim.
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`First, despite what position Caris may prefer now for purposes of this motion, the
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`asserted claims do not claim any specific new uses of existing drugs based on molecular
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`information derived from the claimed gene panels, or even require that identified therapies not
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`have been previously associated with a particular target or cancer. Instead, the Patents-in-Suit
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`merely claim identifying “at least one therapeutic agent from the listing of available therapeutic
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`Case 1:17-cv-12194-MLW Document 33-1 Filed 03/20/18 Page 9 of 36
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`agents for the plurality of molecular targets . . . .” Dkt. No. 1-1, ’350 Patent col. 17:17-19
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`(claim 1) (emphasis added). Thus, Plaintiff’s misguided effort to rewrite the claims
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`notwithstanding, the claims on their face describe using known technologies (molecular profiling
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`assays, computer databases, and software) to identify known therapies with known correlations
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`to the listed molecular targets. The correlation of data from a patient’s genetic profile with data
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`regarding known treatments for that particular genetic profile is not patentable. See Digitech
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`Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014) (“Without
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`additional limitations, a process that employs mathematical algorithms to manipulate existing
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`information to generate additional information is not patent eligible.”).
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`Second, Caris’s repeated assertion that the claims are “based on a specific group of four
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`to seven molecular targets” (Opp. 7), ignores the actual claim language and scope. See Opp. 10
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`(the claims “are very specific to the groups of markers used”), id. at 17 (claims are “narrowly
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`drawn” to “a small subset of all targets that are known to play a role in cancer”). Caris has
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`alleged that FMI’s assays infringe the Patents-in-Suit even though FMI’s tests assay hundreds of
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`targets, not merely the four to seven targets in the asserted claims. See Compl. ¶ 41. Thus, Caris
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`appears to be taking the position that the “comprising” language in the asserted claims covers
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`methods that screen a large number of targets, not just the four to seven markers that Caris now
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`focuses on as purportedly being inventive. Therefore, the gene panel limitations do not
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`transform the abstract idea reflected in the claims into a concrete and patentable invention.
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`Plaintiff’s reliance on its Complaint cannot change the fact that the Patents-in-Suit themselves
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`are drawn to an unpatentable abstract idea.
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`Even considering the allegations in Caris’s Complaint separate from the actual claim
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`language, however, those allegations do not “adequately allege” that the claims contain inventive
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`Case 1:17-cv-12194-MLW Document 33-1 Filed 03/20/18 Page 10 of 36
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`concepts: The Complaint merely describes aspirational goals for what the inventors hoped
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`molecular profiling could achieve. E.g., Compl. ¶ 14 (alleging that “molecular profiling can
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`potentially identify treatments for the patient’s tumor”). The paragraphs in question—which
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`purport to describe the claimed inventions (¶¶ 9-18) and relate to a 2010 Pilot Study (¶¶ 19-
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`27)—merely allege the prophetic use of an abstract system to find “new uses of known drugs.”
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`Opp. 8; see also Dkt. No. 1-1, ’350 Patent Fig. 3C (describing a prophetic application of the
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`claimed system based on a genomic screen of 50 genes). Nothing at all in the asserted patents
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`ties the alleged benefits of the invention to the four to seven specific gene panels actually recited
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`in the claims. In any event, aspirational goals—particularly those set forth only in a complaint
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`that asserts claims drawn to facially ineligible subject matter—do not provide an inventive
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`concept sufficient to satisfy Section 101 because “[p]atents are not awarded for academic
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`theories, no matter how groundbreaking or necessary to the later patentable inventions of
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`others.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353 (Fed. Cir. 2010) (explaining
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`that “a patent is not a hunting license”).
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`B.
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`Caris’s Allegation that the Claimed Inventions Have Provided an
`Improvement to the Field of Cancer Treatment Is Completely Unsupported.
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`Caris cites a 2010 study as purported evidence that “the patented system improved the
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`treatment of cancer patients, providing improved progression-free survival over traditional
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`treatments.” Opp. 6, 14 (citing Compl. ¶ 19, 23-26; Daniel D. Von Hoff et al., Pilot Study Using
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`Molecular Profiling of Patients’ Tumors to Find Potential Targets and Select Treatments for
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`Their Refractory Cancers, 28. J. Clinical Oncology 4877 (2010) (the “2010 Study”)). However,
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`the 2010 Study cannot save Caris’s invalid patents for at least three reasons: (1) that study was
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`not published until four years after the filing of the earliest application to which the Patents-in-
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`Suit claim priority; (2) that study describes the results of treatment recommendations based on
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`Case 1:17-cv-12194-MLW Document 33-1 Filed 03/20/18 Page 11 of 36
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`genes that are not claimed in any of the Patents-in-Suit; and (3) that study confirms that Caris’s
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`purported invention is an abstract idea.
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`First, Caris’s argument that a favorable “contemporaneous description of the patented
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`inventions” supports the inventiveness of the patents is both incorrect and misleading. The
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`alleged “contemporaneous description” of the claimed inventions was not in fact
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`contemporaneous with the filing of the earliest priority filing in 2006, but rather, was published
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`four years later.2 A description of the patents published four years after the alleged invention
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`cannot be considered “contemporaneous” and thus does not support Caris’s argument.
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`Brookhill-Wilk 1, LLC. v. Intuitive Surgical, Inc., 334 F.3d 1294, 1299 (Fed. Cir. 2003) (holding
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`that the district court improperly relied on two Internet articles that published years after the
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`relevant timeframe because the articles were “not contemporaneous with the patent”).
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`Second, the 2010 Study indisputably (1) describes the results of treatment
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`recommendations based on genes that are not claimed in any of the Patents-in-Suit and (2)
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`relies on a gene panel does not include the BRAF, PIK3CA, and CTNNB1 genes, which are
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`recited in the ’392 and ’660 patents. The 2010 Study explicitly relied on the molecular profiling
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`of dozens of genes, not just the 4-7 genes recited in the Patents-in-Suit, and most of the treatment
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`recommendations were based on molecular targets that are not recited in any of the asserted
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`patents. See Dkt. No. 1-6 at 4878 (describing arrays of 51 genes and immunohistochemistry
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`analysis of 11 proteins); Ex. 1 at Table A2 (listing targets used to suggest treatment). Despite the
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`breadth of the 2010 Study, the Complaint does not provide allegations establishing any nexus
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`between the 2010 Study and the limitations of the actual asserted claims (including the recited
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`gene panels).
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`2 An example describing the 2010 Pilot Study was added to the specification of the Later Caris
`Patents in U.S. Provisional Patent Application No. 61/229,686 which was filed July 29, 2009.
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`Case 1:17-cv-12194-MLW Document 33-1 Filed 03/20/18 Page 12 of 36
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`Third, the study expressly acknowledges that “the selection of a commercially available
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`agent to suggest for treatment against a particular target was based on an extensive literature
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`review” that “relies on retrospective review of information,” which the authors concede
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`presented an obvious limitation. Dkt. No. 1-6 at 4881. This acknowledgement confirms that
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`the Caris inventors did not invent anything; they merely collected publicly-available
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`information about certain targets and associated treatments and put it into a database. Indeed, the
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`editorial discussing the study that Caris touts in its Complaint and opposition concedes that the
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`purported novelty, if any, is an “algorithm” to perform the matching function that an oncologist
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`would otherwise undertake herself. Dkt. No. 1-7, Ex. 7 at 4869-70 (noting that recommending
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`the most effective treatment based on scientific evidence “is a fundamental goal of oncologic
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`practice”). It is precisely this type of algorithm that courts have found to constitute an
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`unpatentable abstract idea. In re Grams, 888 F.2d 835, 841 (Fed. Cir. 1989) (holding claims
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`unpatentable under Section 101 as drawn to an algorithm where method claim comprised steps
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`that “require[] the performance of clinical laboratory tests on an individual to obtain data for the
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`parameters” with subsequent steps that “analyze that data to ascertain the existence and identity
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`of an abnormality, and possible causes thereof”).
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`In sum, the cited 2010 Study provides no supporting evidence of inventiveness that
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`would rebut the facial invalidity of the Patents-in-Suit.
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`C.
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`The Asserted Patents are Drawn to an Abstract Idea.
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`Caris’s argument that the asserted claims are not directed to an abstract idea under step
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`one of Alice—which is based on a handful of statements in the specifications and the after-the-
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`fact allegations in the Complaint that the asserted claims are drawn to a method by which future
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`cancer treatments could be discovered, sometime in a hypothetical future—is entirely without
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`merit. The Patents-in-Suit are directed to a health care provider’s task of identifying a treatment
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`Case 1:17-cv-12194-MLW Document 33-1 Filed 03/20/18 Page 13 of 36
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`for a particular medical condition but, as articulated above, do not describe or claim any new use
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`of a known therapeutic agent, or any new correlation between a molecular marker and a
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`therapeutic agent associated with a likely benefit. See Sections I.A and I.B supra. A general
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`system for someday potentially identifying a therapeutic agent associated with a likely benefit is
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`the epitome of an abstract idea. Faced with these facts, Caris argues alternatively that the
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`asserted claims are inventive because the claims include a group of four to seven molecular
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`targets that have not traditionally been associated with each other or with any particular cancer
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`type.3 This argument does not salvage the Patents-in-Suit.
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`As described above, the inclusion of a specific gene panel does not render the asserted
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`claims any less abstract because the claims provide no concrete application of the recited gene
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`panel for the identification of any specific drug for the treatment of any specific cancer. See
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`Sections I.A and I.B supra. Moreover, there is no description in the patents themselves
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`supporting the selection of the specifically claimed gene panel (as discussed in FMI’s opening
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`motion, see Mot. 17-19). Finally, Caris’s infringement claim against FMI assumes that the
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`claims are open-ended and not limited to limited to the panel of four to seven genes. There can
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`therefore be nothing inventive about the claimed gene panels.
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`D.
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`The Alleged System for Identifying “Non-Disease Specific” Treatments—
`Which is Divorced from the Actual Claim Language—Does Not Supply an
`Inventive Concept or Significantly More than the Patent Ineligible Abstract
`Idea.
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`3 There is no merit to Caris’s suggestion that FMI “conceded” that the claims do not claim an
`abstract idea because FMI used the term “application” in its motion. Claims drawn to the
`abstract application of a law of nature—that some genetic abnormalities may be associated with
`certain cancer therapies—are still directed to an abstract idea, and the Supreme Court’s statement
`in Mayo does not provide otherwise. In Mayo, the Supreme Court merely stated that an
`application of a law of nature may comprise patentable subject matter, not that an abstract
`application of a law of nature is necessarily patent eligible. Mayo Collaborative Servs. v.
`Prometheus Labs., Inc., 566 U.S. 66, 71 (2012). Use of the term “application” cannot convert an
`abstract idea into an inventive concept.
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`Case 1:17-cv-12194-MLW Document 33-1 Filed 03/20/18 Page 14 of 36
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`Caris does not dispute that well before the filing date of the earliest provisional
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`application to which the Patents-in-Suit claim priority:
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`(1) oncologists were collecting information about patients’ molecular profiles and using
`that information to identify cancer therapies associated with patients’ specific molecular
`profiles (Mot. 8);
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`(2) the molecular mechanisms behind various cancers had been the subject of studies for
`years and treatment regimens had been determined using molecular profiling in
`combination with clinical characterization of patients (Mot. 8; Dkt. No. 1-1, ’350 Patent
`col. 1:42-49);
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`(3) targeted anticancer agents designed to interact with specific receptors or gene
`products had been developed (Mot. 8; Dkt. No. 1-1, ’350 Patent col. 2:14-17); and
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`(4) at least 6 non-disease (i.e., lineage independent) specific treatments were known
`(Mot. 8; Dkt. No. 1-1, ’350 Patent col. 14:5-19 (Table 1)).
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`Caris also does not, and cannot, dispute that the Patents-in-Suit describe the use of generic assays
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`and computer and database technology to perform analyses and comparisons that doctors have
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`performed manually for years. (Mot. 8, 13-14; Dkt. No. 1-1, ’350 Patent cols. 6:63-7:4, 13:21-
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`27, 9:50-10:14, 11:32-52).
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`Caris nevertheless now suggests that the inventive concept in the Patents-in-Suit was the
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`use of molecular profiling “to target specific genes and/or gene expressed proteins with specific
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`drugs or agents that [are] independent of disease lineage diagnosis.” Mot. ¶ 13 (quoting Dkt. No.
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`1-1, ’350 Patent col. 2:28-33). For example, Caris’s alleged inventive concept was the use of a
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`drug like Herceptin® (trastuzumab)—typically used to treat breast cancer—for the treatment of a
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`cancer other than breast cancer, even though Caris does not and cannot allege that it was the first
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`to seek an alternative use for Herceptin. See, e.g., Dkt. No. 1-1, ’350 Patent col. 6:1-19
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`(identifying known non-disease specific agents). The claims, however, are not limited to the
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`identification of a non-disease specific treatment. Accordingly, such allegations in the
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`Complaint are irrelevant to the question of whether the claimed inventions actually set forth in
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`Case 1:17-cv-12194-MLW Document 33-1 Filed 03/20/18 Page 15 of 36
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`the claims themselves comprise significantly more than the abstract idea or provide an inventive
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`concept. And even if the claims were limited to “non-disease specific” treatment—which they
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`are not—the identification of non-disease specific treatments based on the known correlation of
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`genes and known drug therapies is a basic abstract process itself, which is not inventive and
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`instead relies on the clinical research and innovation of others. See, e.g., Dkt. No. 1-1,
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`’350 Patent col. 6:1-19
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`The search for new uses for approved oncology drugs was most assuredly not invented by
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`Caris; to the contrary, that search was indisputably a guiding principle for clinicians and drug
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`companies well before the Patents-in-Suit. For example, the Patents-in-Suit themselves
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`acknowledge and describe prior treatments which were not limited to cancer-specific
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`applications, and Table 1 of the ’350 patent, which describes the work of others, lists six non-
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`disease specific agents that were known before the Patents-in-Suit to interact with specific
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`molecular targets.
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`In the 1990s and early 2000s, many targeted cancer therapies were designed to inhibit the
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`activity of enzymes or growth factors, which were overexpressed in cancer cells. For example,
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`as the Patents-in-Suit themselves acknowledge, inhibitors of the epidermal growth factor
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`receptor (“EGFR”) were developed, and it was common to test these inhibitors against a variety
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`of cancers that overexpressed EGFR.4 Erlotinib (Tarceva®) was an EGFR inhibitor that was
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`tested against a number of different cancer cells based on the overexpression of EGFR and, by
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`2005, erlotinib was approved for the treatment of NSCLC and pancreatic cancer, two of many
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`4 See, e.g., ’392 Patent col. 51:45-51 (“As a non-limiting example, molecular profiling might
`reveal that the EGFR gene is amplified or overexpressed, thus indicating selection of a treatment
`that can block EGFR activity, such as the monoclonal antibody inhibitors cetuximab and
`panitumumab, or small molecule kinase inhibitors effective in patients with activating mutations
`in EGFR such as gefitinib, erlotinib, and lapatinib.”).
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`Case 1:17-cv-12194-MLW Document 33-1 Filed 03/20/18 Page 16 of 36
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`cancers that overexpress EGFR. See, e.g., id. col. 55:25-26 (listing erlotinib as a possible agent
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`for the treatment of a cancer that overexpresses EGFR).5
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`The specific selection of the claimed molecular targets also does not provide the missing
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`inventive concept because there is nothing in the Patents-in-Suit that provides support for the
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`selection of specific targets (and Caris does not cite any such alleged support). The patent
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`specifications do not describe how to select a non-conventional combination of molecular targets
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`and therefore the gene panel cannot form the basis for the inventive aspect of the claim.6
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`Caris’s alternative arguments supposedly supporting an inventive concept in the claims—
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`(1) that the claims recite a non-conventional and non-generic arrangement of molecular assays
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`and computer technology, and (2) the existence of “contemporaneous” praise—are without
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`merit. Caris’s first argument does nothing to rebut the fact that claims that “only recite routine,
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`conventional activities” such as well-known assays or computer components performing their
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`most basic functions are insufficient to transform a patent ineligible abstract idea into something
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`more under Alice and Mayo. Return Mail, Inc. v. United States Postal Serv., 868 F.3d 1350,
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`1368-69 (Fed. Cir. 2017). Caris has not shown—and cannot show—how the claimed computer
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`and diagnostic technology comprises anything more than conventionally known technology. As
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`addressed above, Caris’s second argument should be given no weight because the alleged
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`5 More broadly, this Court can take judicial notice of the common experience that physicians
`frequently pursue new uses of approved medicines. A well-known example is aspirin. Well
`after aspirin had been used to alleviate headache pain, it was discovered that aspirin could also
`be used to prevent and manage heart disease and stroke. See Schatz v. Republican State
`Leadership Comm., 669 F.3d 50, 55-56 (1st Cir. 2012) (affirming dismissal of complaint and
`noting that in reviewing a motion to dismiss the court may “draw on [its] judicial experience and
`common sense” and consider “facts susceptible to judicial notice” and “concessions in plaintiff’s
`response to the motion to dismiss”) (quotations and citation omitted).
`6 The listing of 50 genes in a microarray in Figure 3C of the ’350, ’193, and ’365 patents does
`not provide the necessary “blaze marks” for the selection of the panels of 4-7 genes claimed as
`implied by Caris’s brief. See Opp. 20. Without any specific indication that certain genes were
`noteworthy, the generic list provides no basis at all to select a specific combination of individual
`genes.
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`“contemporaneous” praise arose from a letter to the editor for the 2010 Study, which (1) was not
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`published until four years after the filing of the earliest application to which the Patents-in-Suit
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`claim priority and (2) describes the results of treatment recommendations based on genes that are
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`not claimed in any of the Patents-in-Suit.
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`II.
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`This Court Can Dismiss This Case at the Pleading Stage.
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`In its opposition, Caris’s attempts to fashion a black-letter rule that, so long as a patentee
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`merely alleges that its claims contain an inventive concept, an asserted patent cannot be subject
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`to dismissal at the pleading stage. No such rule exists, however, and nothing in the Aatrix or
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`Berkheimer decisions supports the creation of such a rule.
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`In Aatrix, the Federal Circuit vacated the district