`Case 1:17-cv-00770-JDW Document 299-4 Filed 01/29/24 Page 1 of 38 PagelD #: 29974
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`EXHIBIT 2B
`EXHIBIT 2B
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`Case 1:17-cv-00770-JDW Document 299-4 Filed 01/29/24 Page 2 of 38 PageID #: 29975
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`WIRTGEN AMERICA, INC.,
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`CATERPILLAR INC.,
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`Plaintiff/Counterclaim-Defendant,
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`v.
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`Civil Action No. 1:17-cv-00770-JDW
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`JURY TRIAL DEMANDED
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`Defendant/Counterclaim-Plaintiff.
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`DEFENDANT CATERPILLAR, INC.’S STATEMENT OF
`ISSUES OF LAW THAT REMAIN TO BE LITIGATED
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`Case 1:17-cv-00770-JDW Document 299-4 Filed 01/29/24 Page 3 of 38 PageID #: 29976
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`Pursuant to D. Del. LR 16.3(c)(5), Defendant Caterpillar, Inc. (“Caterpillar”) identifies the
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`following issues of law that remain to be litigated, with citations to authorities relied upon. This
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`statement is based on the arguments Caterpillar expects to make, as well as its understanding of the
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`arguments Plaintiff Wirtgen America, Inc. (“Wirtgen America”) is likely to make, at trial. This
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`statement is based on the current status of the case and the Court’s rulings to date. Caterpillar reserves
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`the right to supplement the instant statement in response to the Court’s subsequent rulings, or if
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`Wirtgen America should seek to introduce different legal arguments than expected. Should the Court
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`determine that any of the issues listed and discussed below are issues of fact, and not law, Caterpillar
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`incorporates such issues by reference into its Statement of Issues of Fact that Remain to be Litigated
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`(Exhibit 1B). To the extent Caterpillar’s Statement of Issues of Fact that Remain to be Litigated
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`contains issues that the Court deems are issues of law, those issues are incorporated herein by
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`reference. The authorities cited herein are exemplary and not exhaustive, and Caterpillar reserves the
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`right to rely on authority not specifically cited in the instant statement, including authority cited by
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`Wirtgen America in its Statement of Issues of Law to be Litigated (Exhibit 2A). Caterpillar further
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`reserves all rights to issues of fact or law disposed of by the Court’s orders at D.I. 272, 273 for purposes
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`of appeal and/or in the event of a relevant remand.
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`I.
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`VALIDITY
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`A.
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`Prior Art
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`i.
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`Issues of Law
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`1.
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`Whether Caterpillar can prove by that the references asserted by Caterpillar are prior
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`art to the ’641, ’268, ’788, ’474, and ’972 Patents.
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`ii.
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`Relevant Authority
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`2.
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`Under the pre-America Invents Act (“AIA”) patent statute, prior art includes any
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`
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`1
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`reference that “was known or used by others in this country, or patented or described in a printed
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`publication in this or a foreign country, before the invention thereof by the applicant for patent (35
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`U.S.C. § 102(a)), and any reference “patented or described in a printed publication in this or a foreign
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`country or in public use or on sale in this country, more than one year prior to the date of application
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`for patent in the United States” (35 U.S.C. § 102(b)).
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`3.
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`To invalidate, the prior use or knowledge of an invention must be public. Woodland
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`Tr., 148 F.3d at 1370. This publicity requirement is met by the absence of affirmative steps by the
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`prior user to conceal the use. See, e.g., W.L. Gore & Assoc. v. Garlock, Inc., 721 F.2d 1540, 1548-49
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`(Fed. Cir. 1983) (citing Elec. Storage Battery Co. v. Shimadzu, 307 U.S. 5, 20 (1939)). It is not
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`necessary that the anticipatory features of the prior use be evident to the public, so long as use is made
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`of those features. See New Railhead Mfg., LLC v. Vermeer Mfg. Co., 298 F.3d 1290, 1297 (Fed. Cir.
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`2002). Efforts to commercialize an invention constitute a public use of the invention for these
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`purposes. See Am. Seating Co. v. USSC Grp., Inc., 514 F.3d 1262, 1267 (Fed. Cir. 2008).
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`4.
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`Under the pre-AIA patent statute, prior art includes any reference that was “ known or
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`used by others in this country, or patented or described in a printed publication in this or a foreign
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`country, before the invention thereof by the applicant for patent” or “patented or described in a printed
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`publication in this or a foreign country or in public use or on sale in this country, more than one year
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`prior to the date of the application for patent in the United States[.]” 35 U.S.C. §§ 102(a), 102(b).
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`Prior art also includes any reference that was “described in a patent granted on an application for patent
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`by another filed in the United States before the invention thereof by the applicant for patent.” 35
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`U.S.C. § 102(e); EmeraChem Holdings, LLC v. Volkswagen Grp. of Am., Inc., 859 F.3d 1341, 1345
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`(Fed. Cir. 2017). Prior art also includes any “invention was described in — (1) an application for
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`patent, published under section 122(b), by another filed in the United States before the invention by
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`-2-
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`the applicant for patent or (2) a patent granted on an application for patent by another filed in the
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`United States before the invention by the applicant for patent, except that an international application
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`filed under the treaty defined in section 351(a) shall have the effects for the purposes of this subsection
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`of an application filed in the United States only if the international application designated the United
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`States and was published under Article 21(2) of such treaty in the English language[.]” 35 U.S.C. §
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`102(e).
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`5.
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`A person is also not entitled to a patent where “(1) during the course of an interference
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`conducted under section 135 or section 291, another inventor involved therein establishes, to the
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`extent permitted in section 104, that before such person’s invention thereof the invention was made
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`by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person’s
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`invention thereof, the invention was made in this country by another inventor who had not abandoned,
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`suppressed, or concealed it. In determining priority of invention under this subsection, there shall be
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`considered not only the respective dates of conception and reduction to practice of the invention, but
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`also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a
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`time prior to conception by the other.” 35 U.S.C. § 102(g).
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`B.
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`Anticipation
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`i.
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`Issues of Law
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`6.
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`Whether Caterpillar can prove by clear and convincing evidence that the following
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`asserted claims are invalid as anticipated by prior art:
`
`a.
`
`b.
`
`c.
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`Claim 11 of the ’641 Patent;
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`Claims 19 and 21 of the ’474 Patent; and
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`Claims 13 and 15 of the ’972 Patent.
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`-3-
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`ii.
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`Relevant Authority
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`7.
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`Under 35 U.S.C. § 102(a), a patent is invalid if “the invention was known or used by
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`others in this country . . . before the invention thereof by the applicant for patent.” 35 U.S.C. § 102(a).
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`In such a circumstance, “the later inventor has not contributed to the store of knowledge, and has no
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`entitlement to a patent.” Woodland Tr. v. Flowertree Nursery, Inc., 148 F.3d 1368, 1370 (Fed. Cir.
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`1998). Under 35 U.S.C. § 102(b), a patent is invalid if “the invention was patented or described in a
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`printed publication in this or a foreign country or in public use or on sale in this country, more than
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`one year prior to the date of the application for patent in the United States[.]” A patent is invalid for
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`anticipation under 35 U.S.C. § 102, if a prior art reference discloses, expressly or inherently, each and
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`every limitation of the claimed invention. Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373,
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`1379 (Fed. Cir. 2003).
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`8.
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`A prior art reference anticipates a claim if the reference enables one of ordinary skill in
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`the art to practice the invention, even if the author or inventor did not actually make or reduce to
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`practice the claimed subject matter. Schering Corp., 339 F.3d. at 1380-81. “A person of ordinary skill
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`in the art” refers to a hypothetical person who is presumed to have knowledge of all of the prior art in
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`the field and analogous fields. In re Gorman, 933 F.2d 982, 986 (Fed. Cir. 1991). Such a person also
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`possesses ordinary creativity, and is not an automaton. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
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`421 (2007).
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`9.
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`To anticipate a patent claim under 35 U.S.C. § 102, “a reference must describe ... each
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`and every claim limitation and enable one of skill in the art to practice an embodiment of the claimed
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`invention without undue experimentation.” ClearValue, Inc. v. Pearl River Polymers, Inc., 668 F.3d
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`1340, 1344 (Fed. Cir. 2012) (citations omitted).
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`-4-
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`C.
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`Obviousness
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`i.
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`Issues of Law
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`10. Whether Caterpillar can prove by clear and convincing evidence that the following
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`asserted claims are invalid as obvious in view of the relevant prior art:
`
`a.
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`b.
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`c.
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`d.
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`e.
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`ii.
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`Claims 11 and 18 of the ’641 Patent;
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`Claims 1, 23, 30, and 32 of the ’268 Patent;
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`Claim 5 of the ’788 Patent;
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`Claims 19 and 21 of the ’474 Patent; and
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`Claims 12 and 15 of the ’972 Patent.
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`Relevant Authority
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`11.
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`Section 103 of Title 35 of the United States Code provides, in relevant part, that:
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`A patent may not be obtained though the invention is not identically disclosed or
`described as set forth in section 102 [of this title], if the differences between the subject
`matter sought to be patented and the prior art are such that the subject matter as a whole
`would have been obvious at the time the invention was made to a person having
`ordinary skill in the art to which said subject matter pertains. Patentability shall not be
`negatived by the manner in which the invention was made.
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`35 U.S.C. § 103(a); see also Wyers v. Master Lock Co., 616 F.3d 1231, 1237 (Fed. Cir. 2010), cert.
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`denied, 131 S. Ct. 1531 (2011). Furthermore, the Supreme Court has opined that:
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`Under § 103, the scope and content of the prior art are to be determined; differences
`between the prior art and the claims at issue are to be ascertained; and the level of
`ordinary skill in the pertinent art resolved. Against this background, the obviousness or
`nonobviousness of the subject matter is determined. Such secondary considerations as
`commercial success, long felt but unsolved needs, failure of others, etc., might be
`utilized to give light to the circumstances surrounding the origin of the subject matter
`sought to be patented.
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`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007) (quoting Graham v. John Deere Co. of Kansas
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`City, 383 U.S. 1, 17-18 (1966)). The determination of whether an invention would have been obvious
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`-5-
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`under § 103 is a legal conclusion based on underlying findings of fact. See In re Sullivan, 498 F.3d
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`1345, 1350 (Fed. Cir. 2007).
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`12.
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`The obviousness determination must be made from the perspective of a person of
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`ordinary skill. The hypothetical person of ordinary skill is “presumed to know all the pertinent prior
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`art, whether or not the applicant is actually aware of its existence.” In re Carlson, 983 F.2d 1032,
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`1038 (Fed. Cir. 1992). The person of ordinary skill is attributed “knowledge of all prior art in the field
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`of the inventor’s endeavor and of prior art solutions for a common problem even if outside that field.”
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`In re Nilssen, 851 F.2d 1401, 1403 (Fed. Cir. 1988). Thus, “the proper way to apply the 103
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`obviousness test . . . is to first picture the inventor as working in his shop with the prior art references
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`– which he is presumed to know – hanging on the walls around him.” In re Winslow, 365 F.2d 1017,
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`1020 (C.C.P.A. 1966). A person of ordinary skill is a person of ordinary creativity, not an automaton.
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`KSR, 550 U.S. at 421.
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`13.
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`“[KSR] directs us to construe the scope of analogous art broadly.” Wyers v. Master
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`Lock Co., 616 F.3d 1231, 1238 (Fed. Cir. 2010). Art is analogous if it is either from the same “field
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`of endeavor” or, even if outside the field of endeavor, “is reasonably pertinent to the [particular]
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`problem with which the inventor [is involved].” In re Kahn, 441 F.3d 977, 986-87 (Fed. Cir. 2006).
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`“[A] reference need not work to qualify as prior art; it qualifies as prior art, regardless, for whatever
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`is disclosed therein. Even if a reference discloses an inoperative device, it is prior art for all that it
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`teaches.” Geo M. Martin Co. v. Alliance Mach. Sys. Int’l LLC, 618 F.3d 1294, 1302–03 (Fed. Cir.
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`2010).
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`14.
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`Rather than applying “rigid preventative rules that deny fact-finders recourse to
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`common sense,” courts must take a more “expansive and flexible approach” to determining whether
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`an invention was obvious. KSR, 550 U.S. at 415, 421. Thus, “the legal determination of obviousness
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`-6-
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`may include recourse to logic, judgment, and common sense[.]” Wyers, 616 F.3d at 1239.
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`“[O]bviousness cannot be avoided simply by a showing of some degree of unpredictability in the art
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`so long as there was a reasonable probability of success.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348,
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`1364 (Fed. Cir. 2007). “[E]xpectation of success need only be reasonable, not absolute.” Id.
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`15.
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`A patent claim is obvious when it does no more than combine familiar elements
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`according to known methods to yield predictable results. KSR, 550 U.S. at 415-17 (“If a person of
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`ordinary skill can implement a predictable variation, § 103 likely bars its patentability.”).
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`Furthermore, when “there are a finite number of identified, predictable solutions, a person of ordinary
`
`skill in the art has good reason to pursue the known options within his or her technical grasp. If this
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`leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and
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`common sense. In that instance, the fact that a combination was obvious to try might show that it was
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`obvious under § 103.” Id. at 421. In making an obviousness determination, “a court must ask whether
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`the improvement is more than the predictable use of prior art elements according to their established
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`functions.” Id. at 417.
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`16.
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`Obviousness may be shown based on a combination of references or based on a single
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`reference. SIBIA Neurosciences, Inc. v. Cadus Pharm. Corp., 225 F.3d 1349, 1356 (Fed. Cir. 2000)
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`(“[A] single prior art reference can render a claim obvious.”); Boston Scientific Scimed, Inc. v. Cordis
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`Corp., 554 F.3d 982, 989–90 (Fed. Cir. 2009). In cases where the invalidity defense is based on a
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`combination of elements known in the prior art, the proper inquiry is a flexible analysis. KSR, 550
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`U.S. at 419–20. “Under the correct analysis, any need or problem known in the field of endeavor at
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`the time of the invention and addressed by the patent [or application at issue] can provide a reason for
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`combining the elements in the manner claimed.” KSR, 550 U.S. at 420. A reason to combine known
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`elements can be found, for example, in the “interrelated teachings of multiple patents; the effects of
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`-7-
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`demands known to the design community or present in the marketplace, and the background
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`knowledge possessed by a person having ordinary skill in the art[.]” KSR, 550 U.S. at 418. “[I]f a
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`technique has been used to improve one device, and a person of ordinary skill in the art would
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`recognize that it would improve similar devices in the same way, using the technique is obvious unless
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`its actual application is beyond his or her skill.” Id.
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`17.
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`A single prior art reference can render a claim obvious. See Comaper Corp. v. Antec,
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`Inc., 596 F.3d 1343, 1351-52 (Fed. Cir. 2010) (“Determining obviousness requires considering
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`whether two or more pieces of prior art could be combined, or a single piece of prior art could be
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`modified, to produce the claimed invention.”); Game and Tech. Co., Ltd. v. Activision Blizzard Inc.,
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`926 F.3d 1370 (Fed. Cir. 2019) (“[A] patent can be obvious in light of a single prior reference if it
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`would have been obvious to modify that reference to arrive at the patented invention.”) (internal
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`quotations and citations omitted). Whether patent claims are obvious in view of a single prior art
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`reference is analyzed in light of the general knowledge of a skilled artisan. See Koninklijke Philips
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`N.V. v. Google LLC, 948 F.3d 1330 (Fed. Cir. 2020); see also Dow Jones & Co. v. Ablaise Ltd., 606
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`F.3d 1338, 1349, 1353 (Fed. Cir. 2010) (affirming the district court’s grant of summary judgment of
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`invalidity on “grounds of obviousness under [a single prior art reference] in view of general knowledge
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`in the field,” in part because the obviousness “analysis requires an assessment of the background
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`knowledge possessed by a person having ordinary skill in the art.”) (internal quotations and citations
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`omitted).
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`18.
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`After the challenger establishes prima facie obviousness, the patentee may come
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`forward with evidence to demonstrate that the invention would not have been obvious such as
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`objective indicia of non-obviousness (“secondary considerations”). Such secondary considerations
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`include commercial success, unexpected results, failure of others to solve the problem, skepticism of
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`-8-
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`others, copying, satisfaction of a long-felt need by the invention, and acclaim for the invention. See
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`Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 1358–59 (Fed. Cir. 2013); Transocean Offshore
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`Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349–54 (Fed. Cir. 2012); Eli
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`Lilly and Co. v. Zenith Goldline Pharms., Inc., 471 F.3d 1369, 1380 (Fed. Cir. 2006). However, the
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`patentee must demonstrate a sufficient nexus between the objective indicia and the claimed invention.
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`See, e.g., J.T. Eaton & Co. v. Atl. Paste & Glue Co., 106 F.3d 1563, 1571 (Fed. Cir. 1997) (stating
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`that a party cannot demonstrate commercial success to show nonobviousness “unless it can show that
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`the commercial success of the product resulted from the claimed invention”); see also Pro-Mold &
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`Tool Co. v. Great Lakes Plastics, Inc., 75 F.3d 1568, 1574 (Fed. Cir. 1996) (describing that a nexus
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`must exist between commercial success and claimed invention to determine the probative value of
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`secondary considerations). “[I]f the feature that creates the commercial success was known in the
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`prior art, the success is not pertinent,” because there is no nexus. Ormco Corp. v. Align Tech., Inc.,
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`463 F.3d 1299, 1312 (Fed. Cir. 2006); see also Tokai Corp. v. Easton Enters., Inc., 632 F. 3d 1358,
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`1369 (Fed. Cir. 2011) (finding lack of nexus to support commercial success where basis for demand
`
`was “due to an element in the prior art”).
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`19.
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`Secondary considerations are circumstantial evidence that shed light on the
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`obviousness determination by drawing inferences from underlying facts. They are found to be
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`probative of whether an invention was obvious or not in that they “inoculate the obviousness inquiry
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`against hindsight.” Mintz v. Dietz & Watson, Inc., 679 F.3d 1372, 1377–79 (Fed. Cir. 2012). But
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`secondary considerations of non-obviousness cannot overcome a strong showing of obviousness. See
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`Tokai Corp. v. Easton Enterprises, 632 F.3d 1358, 1371 (Fed. Cir. 2011). While the overall burden
`
`in respect of obviousness remains on the challenger, the patentee must establish the existence of a
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`secondary consideration supporting non-obviousness. In re Cyclobenzaprine Hydrochloride
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`
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`-9-
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`Case 1:17-cv-00770-JDW Document 299-4 Filed 01/29/24 Page 12 of 38 PageID #: 29985
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`Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1081 n.8 (Fed. Cir. 2012) (burden of
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`establishing nonobviousness does not shift to patentee, but patentee could not rely on unexpected
`
`results because it “failed to offer adequate proof”).
`
`20.
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`The burden is also on the patentee to demonstrate a nexus between the secondary
`
`indicia of non-obviousness relied upon and the claimed invention. See, e.g., Asyst Techs., Inc. v.
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`Emtrak, Inc., 544 F.3d 1310, 1316 (Fed. Cir. 2008) (although embodiments of the invention may have
`
`enjoyed commercial success, patentee failed to link that success to the patented features).
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`D.
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`Enablement
`
`i.
`
`Issues of Law
`
`21. Whether Caterpillar can prove by clear and convincing evidence that the following
`
`asserted claims are invalid due to lack of enablement:
`
`a.
`
`b.
`
`ii.
`
`Claim 5 of the ’788 Patent; and
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`Claims 19 and 21 of the ’474 Patent.
`
`Relevant Authority
`
`22.
`
`To satisfy the enablement requirement, the specifications of the Asserted Patents must
`
`describe the alleged invention and “the manner and process of making and using it, in such full, clear,
`
`concise, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and
`
`use the same.” 35 U.S.C. § 112. A claim lacks enablement, where “undue experimentation” is
`
`required to practice the claimed invention. See In re Wands, 858 F.2d 731, 736-737 (Fed. Cir. 1988).
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`Courts apply the Wands-factors to determine whether “undue experimentation” would be necessary,
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`namely “(1) the quantity of experimentation necessary, (2) the amount of direction or guidance
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`presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the
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`state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability
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`of the art, and (8) the breadth of the claims.” Id. at 737; see, e.g., Enzo Biochem, Inc. v. Calgene, Inc.,
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`188 F.3d 1362, 1370-77 (Fed. Cir. 1999) (upholding the applicability of the Wands-factors). Although
`
`a specification need not disclose what is well known in the art, it “must supply the novel aspects of an
`
`invention in order to constitute adequate enablement.” Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d
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`1361, 1366 (Fed. Cir. 1997). Enablement is a question of law based on underlying factual findings.
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`Wands, 858 F.2d at 1402. To prove that a claim is invalid for non-enablement requires clear and
`
`convincing evidence. See Koito Mfg. Co. v. Turn-Key-Tech, LLC, 381 F.3d 1142, 1156 (Fed. Cir.
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`2004); Cephalon, Inc. v. Watson Pharms., Inc., 707 F.3d 1330, 1336 (Fed. Cir. 2013).
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`23.
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`“To be enabling, the specification of a patent must teach those skilled in the art how to
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`make and use the full scope of the claimed invention without undue experimentation” as of the patent’s
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`effective filing date. MagSil Corp. v. Hitachi Glob. Storage Techs., Inc., 687 F.3d 1377, 1380 (Fed.
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`Cir. 2012). The enablement requirement “serves the dual function in the patent system of ensuring
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`adequate disclosure of the claimed invention and of preventing claims broader than the disclosed
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`invention.” Id. at 1381.
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`“[T]he omission of minor details does not cause a specification to fail to meet the
`enablement requirement. However, when there is no disclosure of any specific
`starting material or of any of the conditions under which a process can be carried out,
`undue experimentation is required; there is a failure to meet the enablement
`requirement that cannot be rectified by asserting that all the disclosure related to the
`process is within the skill of the art. It is the specification, not the knowledge of one
`skilled in the art, that must supply the novel aspects of an invention in order to
`constitute adequate enablement.
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`Genentech, 108 F.3d at 1366.
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`24.
`
`It is not enough to enable a subset of what is claimed, a patent specification “must teach
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`those skilled in the art how to make and use the full scope of the claimed invention without undue
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`experimentation.” Amgen Inc. v. Sanofi, 872 F.3d 1367, 1375 (Fed. Cir. 2017) (Amgen I) (quoting
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`Genentech, Inc., 108 F.3d at 1365). A patentee may choose to claim his invention narrowly or broadly,
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`but “[a] patentee who chooses broad claim language must make sure the broad claims are fully
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`enabled. The scope of the claims must be less than or equal to the scope of the enablement.” Sitrick
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`v. Dreamworks, LLC, 516 F.3d 993, 999 (Fed. Cir. 2008) (internal quotation marks omitted) (holding
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`that the patentee’s claims were broad enough to cover both movies and video games, but patent did
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`not enable movies); see also Trs. of Bos. Univ. v. Everlight Elecs. Co., 896 F.3d 1357, 1364–65 (Fed.
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`Cir. 2018) (invalidating claim to “six permutations” because only five out of the six permutations were
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`enabled); Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1338 (Fed. Cir. 2003)
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`(holding the claim term “plant cell” covered both “monocots” and “dicots,” but that the patent did not
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`enable monocots); Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 1361 (Fed. Cir. 2007) (same);
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`In re Vaeck, 947 F.2d 488, 495 (Fed. Cir. 1991) (“There is no reasonable correlation between the
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`narrow disclosure in appellants’ specification and the broad scope of protection sought in the claims
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`encompassing gene expression in any and all cyanobacteria.”); cf. Genentech, 108 F.3d at 1366
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`(“Patent protection is granted in return for an enabling disclosure of an invention, not for vague
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`intimations of general ideas that may or may not be workable.”).
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`E. Written Description
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`i.
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`Issues of Law
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`25. Whether Caterpillar can prove by clear and convincing evidence that the following
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`asserted claims are invalid due to lack of adequate written description:
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`a.
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`b.
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`ii.
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`Claim 5 of the ’788 Patent; and
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`Claims 19 and 21 of the ’474 Patent.
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`Relevant Authority
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`26.
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`Section 112(a) of Title 35 of the United States Code provides, in relevant part, that:
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`The specification shall contain a written description of the invention, and of the
`manner and process of making and using it, in such full, clear, concise, and exact
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`terms as to enable any person skilled in the art to which it pertains, or with which it
`is most nearly connected, to make and use the same, and shall set forth the best mode
`contemplated by the inventor of carrying out his invention.
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`27.
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`“To fulfill the written description requirement, a patent owner must convey with
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`reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession
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`of the invention, and demonstrate that by disclosure in the specification of the patent.” Idenix Pharms.
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`LLC v. Gilead Scis. Inc., 941 F.3d 1149, 1163 (Fed. Cir. 2019) (internal citations omitted). An
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`adequate written description requires more than “a mere wish or plan for obtaining” the claimed
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`invention. Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927 (Fed. Cir. 2004). The written
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`description requirement is a question of fact. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336,
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`1351 (Fed. Cir. 2010). To invalidate a claim for lack of written description requires clear and
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`convincing evidence. Id. at 1354.
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`28.
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`Determining whether the patent satisfies the written description requirement “requires
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`an objective inquiry into the four corners of the specification.” Centocor Ortho Biotech, Inc. v. Abbott
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`Labs., 636 F.3d 1341, 1348 (Fed. Cir. 2011). Each claim limitation must be described in the
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`specification. See Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997); Centocor,
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`636 F.3d at 1347.
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`29.
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`The written description requirement serves as a quid pro quo “in which the public is
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`given ‘meaningful disclosure in exchange for being excluded from practicing the invention for a
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`limited period of time.’” Univ. of Rochester, 358 F.3d at 920, 922. The written description
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`requirement also “operates as a timing mechanism to ensure fair play in the presentation of claims
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`after the original filing date and to guard against manipulation of that process by the patent applicant.”
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`PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1307 (Fed. Cir. 2008); see Agilent Techs.,
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`Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1379 (Fed. Cir. 2009) (opining that § 112 “prohibits new matter
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`from entering into claim amendments, particularly during the continuation process.”); Amgen Inc. v.
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`Hoechst Marion Roussel Inc., 314 F.3d 1313, 1330, (Fed. Cir. 2003) (“The purpose of the written
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`description requirement is to prevent an applicant from later asserting that he invented that which he
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`did not”); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1561 (Fed Cir. 1991) (“Adequate description of
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`the invention guards against the inventor’s overreaching by insisting that he recount his invention in
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`such detail that his future claims can be determined to be encompassed within his original creation.”).
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`30.
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`To satisfy written description, the specification must “clearly allow persons of ordinary
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`skill in the art to recognize that [the inventor] invented what is claimed.” Ariad Pharms., Inc. v. Eli
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`Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). In other words, the specification itself must show
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`that “the inventor actually invented the invention claimed” by “reasonably convey[ing] to those skilled
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`in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id. The
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`written description does not concern what a person of ordinary skill could do, but rather what the
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`inventors themselves did do – the specification must describe the invention as broadly as it is claimed
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`to demonstrate that the inventors actually invented the full scope of the claimed invention by the time
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`they filed the application. See id. at 1351-52.
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`31.
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`The question is not whether a claimed invention is an obvious variant of an embodiment
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`described in the specification, or whether one skilled in the art might be able to construct the claimed
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`invention. See Ariad Pharms., 598 F.3d at 1352; Regents of Univ. of Cal. v. Eli Lilly & Co., 119 F.3d
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`1559, 1566-67 (Fed. Cir. 1997) (“an applicant complies with the written description requirement ‘by
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`describing the invention, with all its claimed limitations, not that which makes it obvious’”); see also,
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`e.g., ICU Med., Inc. v. Alaris Med. Sys., Inc., 558 F.3d 1368, 1378–79 (Fed. Cir. 2009); Lockwood v.
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`Am. Airlines, 107 F.3d 1565, 1572 (Fed. Cir. 1997). “It is not sufficient for purposes of the written
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`description requirement of § 112 that the disclosure, when combined with the knowledge in the art,
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`would lead one to speculate as to the modifications that the inventor might have envisioned, but failed
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`to disclose.” Id. at 1572. “The knowledge of ordinary artisans may be used to inform what is actually
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`in the specification, but not to teach limitations that are not in the specification, even if those
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`limitations would be rendered obvious by the disclosure in the specification.” Rivera v. ITC, 857 F.3d
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`1315, 1322 (Fed. Cir. 2017) (internal citation omitted).
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`32. Written description support requires more than an “amalgam of disclosures plucked
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`selectively from the [specification].” Novozymes A/S v. Dupont Nutrition BioSciences APS, 723 F.3d
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`1336, 1349 (Fed. Cir. 2013). In assessing written description, “each claim [must be taken] as an
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`integrated whole rather than as a collection of independent limitations.” Id. at 1349. “Working
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`backward from a knowledge of the claims, that is by hindsight” is not permitted because, when doing
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`so, “it is all very clear what route one would travel through the forest of the specification to