Case 1:17-cv-12194-MLW Document 35-1 Filed 04/03/18 Page 1 of 7
`Case 1:17-cv—12194-MLW Document 35-1 Filed 04/03/18 Page 1 of 7
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`EXHIBIT A
`EXHIBIT A
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`Case 1:17-cv-12194-MLW Document 35-1 Filed 04/03/18 Page 2 of 7
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`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-MLW
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`JURY TRIAL DEMANDED
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`CARIS MPI, INC.’S [PROPOSED] SURREPLY IN OPPOSITION TO
`FOUNDATION MEDICINE INC.’S MOTION TO DISMISS
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`Case 1:17-cv-12194-MLW Document 35-1 Filed 04/03/18 Page 3 of 7
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`Defendant’s Reply Brief misstates the relevant law and wrongly characterizes numerous
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`facts as undisputed. Because these misstatements are central to the parties’ dispute, Caris writes
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`briefly to bring these points to the Court’s attention.
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`Defendant relies on the dissenting opinion from DDR Holdings to claim that the Federal
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`Circuit “invalidated DDR’s patents because their ‘potential scope’ was ‘staggering, arguably
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`covering vast swaths of Internet commerce’…” (ECF No. 33-1 at 17 (emphasis added).) But in
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`fact, the Federal Circuit found those claims patentable. DDR Holdings, LLC v. Hotels.com, L.P.,
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`773 F.3d 1245, 1258 (Fed. Cir. 2014) (“It is also clear that the claims at issue do not attempt to
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`preempt every application of the idea…”). In other words, Defendant represented to this Court
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`that DDR stood for the precise opposite of its holding. Defendant’s assertion is particularly
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`vexing after it quoted from a dissent from a different case in its opening brief, again without ever
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`disclosing to the Court that it was so doing, an inexplicable lapse that Caris noted in its
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`opposition brief. (See ECF No. 31 at 19.)
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`Defendant’s incorrect description of DDR Holdings is representative of a pattern of
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`disregard for the legal standards governing Section 101. Indeed, on each of the key points of law
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`at issue in this motion, Defendant misstates the controlling legal standard:
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`(1) Defendant (at 2) wrongly contends that the Court can ignore the allegations of the Complaint
`for “patents that are facially invalid under Section 101.” The Federal Circuit’s rulings in both
`Aatrix and Berkheimer mandate that disputed factual allegations be considered in a Section
`101 analysis. See Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121, 1125
`(Fed. Cir. 2018) (denying motion to dismiss for invalidity under § 101 because “patentees
`who adequately allege their claims contain inventive concepts survive a § 101 eligibility
`analysis under Rule 12(b)(6)”) (internal citation omitted); Berkheimer v. HP Inc., 881 F.3d
`1360, 1368 (Fed. Cir. 2018) (denying summary judgment of patent ineligibility under § 101
`because, “[t]he question of whether a claim element or combination of elements is well-
`understood, routine and conventional to a skilled artisan in the relevant field is a question of
`fact.”). In short, it defies reason to suggest a court can and should decide a motion to dismiss
`on the pleadings without regard to the pleadings.
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`(2) Defendant’s assertion (at 2) that “[t]he claims, however, speak for themselves” in a Section
`101 analysis, suggesting that the rest of the patent and intrinsic record may be ignored, is also
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`Case 1:17-cv-12194-MLW Document 35-1 Filed 04/03/18 Page 4 of 7
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`contrary to authority. Several cases find that other sources, such as the specification, are
`relevant to determine the scope of the invention. See, e.g., Enfish, LLC v. Microsoft Corp.,
`822 F.3d 1327, 1338 (Fed. Cir. 2015) (“[O]ur conclusion that the claims are directed to an
`improvement of an existing technology is bolstered by the specification’s teachings…”);
`Berkheimer, 881 F.3d at 1370 (noting that “fact questions created by the specification’s
`disclosure” precluded entry of summary judgment under Section 101).
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`(3) Defendant is incorrect (at 6) that evidence after a patent filing (specifically, the 2010 Pilot
`Study showing the “potentially practice-changing” effect of the invention) is irrelevant to a
`Section 101 analysis because it was not “contemporaneous.” Defendant cites Brookhill-Wilk
`1, LLC. v. Intuitive Surgical, Inc., 334 F.3d 1294, 1299, but that case had nothing to do with
`Section 101. Rather, the issue there was whether a reference published long after the patent
`could be used in claim construction to show what the claim terms meant at the time of the
`patent filing. For Section 101, by contrast, a later-published reference is more probative of
`inventiveness than a contemporaneous one because an invention that was deemed novel
`several years after filing was certainly not well-known, routine, or conventional when the
`application was filed.
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`(4) Defendant also misstates the concept of preemption under Section 101 and the use of
`“comprising” in a claim. Because the claims use the “comprising” transition, they cover
`implementations that satisfy all the claim limitations, but also include additional features.
`CIAS, Inc. v. Alliance Gaming Corp., 504 F.3d 1346, 1360 (Fed. Cir. 2007). Thus,
`Defendant’s argument (at 16) that “Caris believes these claims capture any testing that
`includes the recited targets along with potentially hundreds of others, and thereby preempt
`the field” is a non sequitur. Defendant (and anyone else) is free to test for the “potentially
`hundreds” of other genes so long as the test does not include the unique non-lineage specific
`combinations invented by Caris along with all the other system-related requirements of
`Caris’ claims.
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`With respect to the parties’ factual disputes, Defendant (at 13) also inaccurately claims
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`numerous material facts are undisputed when they are, in fact, disputed. These factual disputes
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`demonstrate that Defendant’s invalidity allegations cannot be resolved on a Rule 12(b)(6)
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`motion.
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`(1) Defendant is incorrect (at 8-9) that the claimed invention was well-known at the time of
`filing. The patent specifications, the Examiner’s statements during prosecution, and
`descriptions of the patented inventions in the literature show otherwise. (ECF No. 31 at 11–
`13.)
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`(2) Caris also disputes Defendant’s allegedly “undisputed” assertions (at 9) regarding the state of
`molecular profiling at the time of the invention. The molecular testing available at the time of
`the invention was not the same form of molecular profiling that is claimed in the patents and
`was different than any manual comparisons performed by doctors. (ECF No. 31 at 4–5.) Nor
`is Defendant’s description of the state of molecular profiling consistent with the disclosures
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`2
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`Case 1:17-cv-12194-MLW Document 35-1 Filed 04/03/18 Page 5 of 7
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`in the specification, including those it specifically cites in its reply. (Id. at 12–13.)
`Defendant’s characterization of the inventions (at 9) as simply “generic assays and computer
`and database technology to perform analysis and comparisons that doctors have performed
`manually for years” is also incorrect and, thus, disputed. (See, e.g., ECF No. 31 at 4-5, 8-9,
`11-13.)
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`(3) Defendant (at 14) also selectively quotes the patents to characterize the inventions to suit its
`purpose. For example, Defendant alleges the ’392 patent specification “describ[es] the
`selection of potential treatments based on ‘reviewing the literature for links between
`biological agents and therapeutic agents’” (emphasis added), when the patent instead states
`that “[i]n some embodiments, the mapping [of the claimed database] is created by reviewing
`the literature for links between biological agents and therapeutic agents.” (ECF No. 1-2 at
`53:44-47.) In other words, Defendant omits the key step of performing off-lineage testing
`with unique marker combinations. Defendant (at 13–14) similarly misrepresents the language
`of the ’350 patent specification (compare ECF No. 33-1 at 14 with ECF No. 1-1 at 2:47–53)
`and the claims (compare ECF No. 33-1 at 13–14 with ECF No. 1-1 at 16:64–17:27.)
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`Caris respectfully requests that the Court deny Defendant’s motion with prejudice.
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`3
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`Case 1:17-cv-12194-MLW Document 35-1 Filed 04/03/18 Page 6 of 7
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`Dated: April 3, 2018
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`Respectfully submitted,
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`By:
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`/s/ Adam J. Kessel
`Adam J. Kessel (BBO #661,211)
`FISH & RICHARDSON P.C.
`One Marina Park Drive
`Boston, MA 02210
`Tel: (617) 542-5070
`FAX: (617) 542-8906
`kessel@fr.com
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`Jonathan Singer (admitted pro hac vice)
`FISH & RICHARDSON P.C.
`12390 El Camino Real
`San Diego, CA 92130
`(858) 678-5070
`singer@fr.com
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`Corrin Drakulich (admitted pro hac vice)
`Christina Brown-Marshall (admitted pro hac vice)
`Dexter Whitley (admitted pro hac vice)
`FISH & RICHARDSON P.C.
`1180 Peachtree Street, NE, 21st Floor
`Atlanta, GA 30309
`(404) 892-5005
`drakulich@fr.com
`brown-marshall@fr.com
`whitley@fr.com
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`William R. Woodford (admitted pro hac vice)
`Tasha Francis (admitted pro hac vice)
`FISH & RICHARDSON P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`(612) 335-5070
`woodford@fr.com
`tfrancis@fr.com
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`ATTORNEYS FOR PLAINTIFF
`CARIS MPI, INC.
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`Case 1:17-cv-12194-MLW Document 35-1 Filed 04/03/18 Page 7 of 7
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`CERTIFICATE OF SERVICE
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`I hereby certify that this document filed through the ECF system will be sent electronically to the
`registered participants as identified on the Notice of Electronic Filing (NEF) and paper copies
`will be sent to those indicated as non-registered participants on April 3, 2018.
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`/s/ Adam J. Kessel
`Adam J. Kessel
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