Case 1:17-cv-00770-JDW Document 328-4 Filed 02/09/24 Page 1 of 38 PageID #: 30879
`Case 1:17-cv-00770-JDW Document 328-4 Filed 02/09/24 Page 1 of 38 PagelD #: 30879
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`EXHIBIT 2B
`EXHIBIT 2B
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`

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`Case 1:17-cv-00770-JDW Document 328-4 Filed 02/09/24 Page 2 of 38 PageID #: 30880
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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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`Plaintiff/Counterclaim-Defendant,
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`v.
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`Civil Action No. 1:17-cv-00770-JDW
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`CATERPILLAR INC.,
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`JURY TRIAL DEMANDED
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`Defendant/Counterclaim-Plaintiff.
`
`DEFENDANT CATERPILLAR, INC.’S STATEMENT OF
`ISSUES OF LAW THAT REMAIN TO BE LITIGATED
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`

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`Case 1:17-cv-00770-JDW Document 328-4 Filed 02/09/24 Page 3 of 38 PageID #: 30881
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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
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`the 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
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`reserves the right to supplement the instant statement in response to the Court’s subsequent rulings,
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`or if Wirtgen America should seek to introduce different legal arguments than expected. Should
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`the Court determine that any of the issues listed and discussed below are issues of fact, and not
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`law, Caterpillar incorporates such issues by reference into its Statement of Issues of Fact that
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`Remain to be Litigated (Exhibit 1B). To the extent Caterpillar’s Statement of Issues of Fact that
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`Remain to be Litigated contains issues that the Court deems are issues of law, those issues are
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`incorporated herein by reference. The authorities cited herein are exemplary and not exhaustive,
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`and Caterpillar reserves the right to rely on authority not specifically cited in the instant statement,
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`including authority cited by Wirtgen America in its Statement of Issues of Law to be Litigated
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`(Exhibit 2A). Caterpillar further reserves all rights to issues of fact or law disposed of by the
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`Court’s orders at D.I. 272, 273 for purposes 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
`
`i.
`
`Issues of Law
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`1.
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`Whether Caterpillar can prove by that the references asserted by Caterpillar are
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`prior art to the ’641, ’268, ’788, ’474, and ’972 Patents.
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`ii.
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`Relevant Authority
`
`2.
`
`Under the pre-America Invents Act (“AIA”) patent statute, prior art includes any
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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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`1
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`

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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
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`foreign country or in public use or on sale in this country, more than one year prior to the date of
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`application 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-
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`49 (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
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`made of those features. See New Railhead Mfg., LLC v. Vermeer Mfg. Co., 298 F.3d 1290, 1297
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`(Fed. Cir. 2002). Efforts to commercialize an invention constitute a public use of the invention
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`for these purposes. See Am. Seating Co. v. USSC Grp., Inc., 514 F.3d 1262, 1267 (Fed. Cir. 2008).
`
`4.
`
`Under the pre-AIA patent statute, prior art includes any reference that was “ known
`
`or used by others in this country, or patented or described in a printed publication in this or a
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`foreign country, before the invention thereof by the applicant for patent” or “patented or described
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`in a printed publication in this or a foreign country or in public use or on sale in this country, more
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`than one year prior to the date of the application for patent in the United States[.]” 35 U.S.C. §§
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`102(a), 102(b). Prior art also includes any reference that was “described in a patent granted on an
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`application for patent by another filed in the United States before the invention thereof by the
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`applicant for patent.” 35 U.S.C. § 102(e); EmeraChem Holdings, LLC v. Volkswagen Grp. of Am.,
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`Inc., 859 F.3d 1341, 1345 (Fed. Cir. 2017). Prior art also includes any “invention was described
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`in — (1) an application for patent, published under section 122(b), by another filed in the United
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`States before the invention by the applicant for patent or (2) a patent granted on an application for
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`2
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`

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`patent by another filed in the United States before the invention by the applicant for patent, except
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`that an international application filed under the treaty defined in section 351(a) shall have the
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`effects for the purposes of this subsection of an application filed in the United States only if the
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`international application designated the United States and was published under Article 21(2) of
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`such treaty in the English language[.]” 35 U.S.C. § 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
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`interference conducted under section 135 or section 291, another inventor involved therein
`
`establishes, to the extent permitted in section 104, that before such person’s invention thereof the
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`invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2)
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`before such person’s invention thereof, the invention was made in this country by another inventor
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`who had not abandoned, suppressed, or concealed it. In determining priority of invention under
`
`this subsection, there shall be considered not only the respective dates of conception and reduction
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`to practice of the invention, but also the reasonable diligence of one who was first to conceive and
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`last to reduce to practice, from a time prior to conception by the other.” 35 U.S.C. § 102(g).
`
`B.
`
`Anticipation
`
`i.
`
`Issues of Law
`
`6.
`
`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.
`
`ii.
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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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`Relevant Authority
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`7.
`
`Under 35 U.S.C. § 102(a), a patent is invalid if “the invention was known or used
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`by others in this country . . . before the invention thereof by the applicant for patent.” 35 U.S.C. §
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`3
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`

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`102(a). In such a circumstance, “the later inventor has not contributed to the store of knowledge,
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`and has no entitlement to a patent.” Woodland Tr. v. Flowertree Nursery, Inc., 148 F.3d 1368,
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`1370 (Fed. Cir. 1998). Under 35 U.S.C. § 102(b), a patent is invalid if “the invention was patented
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`or described in a printed publication in this or a foreign country or in public use or on sale in this
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`country, more than one year prior to the date of the application for patent in the United States[.]”
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`A patent is invalid for anticipation under 35 U.S.C. § 102, if a prior art reference discloses,
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`expressly or inherently, each and every limitation of the claimed invention. Schering Corp. v.
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`Geneva Pharms., Inc., 339 F.3d 1373, 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 the art to practice the invention, even if the author or inventor did not actually make or
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`reduce to practice the claimed subject matter. Schering Corp., 339 F.3d. at 1380-81. “A person
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`of ordinary skill in the art” refers to a hypothetical person who is presumed to have knowledge of
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`all of the prior art in the field and analogous fields. In re Gorman, 933 F.2d 982, 986 (Fed. Cir.
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`1991). Such a person also possesses ordinary creativity, and is not an automaton. KSR Int’l Co.
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`v. Teleflex Inc., 550 U.S. 398, 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 ...
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`each and every claim limitation and enable one of skill in the art to practice an embodiment of the
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`claimed invention without undue experimentation.” ClearValue, Inc. v. Pearl River Polymers,
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`Inc., 668 F.3d 1340, 1344 (Fed. Cir. 2012) (citations omitted).
`
`C.
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`Obviousness
`
`i.
`
`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.
`
`Claims 11 and 18 of the ’641 Patent;
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`4
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`

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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 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
`
`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.
`
`35 U.S.C. § 103(a); see also Wyers v. Master Lock Co., 616 F.3d 1231, 1237 (Fed. Cir. 2010),
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`cert. 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.
`
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007) (quoting Graham v. John Deere Co. of
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`Kansas City, 383 U.S. 1, 17-18 (1966)). The determination of whether an invention would have
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`been obvious under § 103 is a legal conclusion based on underlying findings of fact. See In re
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`Sullivan, 498 F.3d 1345, 1350 (Fed. Cir. 2007).
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`12.
`
`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
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`prior art, whether or not the applicant is actually aware of its existence.” In re Carlson, 983 F.2d
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`1032, 1038 (Fed. Cir. 1992). The person of ordinary skill is attributed “knowledge of all prior art
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`5
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`

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`in the field of the inventor’s endeavor and of prior art solutions for a common problem even if
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`outside that field.” In re Nilssen, 851 F.2d 1401, 1403 (Fed. Cir. 1988). Thus, “the proper way to
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`apply the 103 obviousness test . . . is to first picture the inventor as working in his shop with the
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`prior art references – which he is presumed to know – hanging on the walls around him.” In re
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`Winslow, 365 F.2d 1017, 1020 (C.C.P.A. 1966). A person of ordinary skill is a person of ordinary
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`creativity, not an automaton. 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
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`“field of endeavor” or, even if outside the field of endeavor, “is reasonably pertinent to the
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`[particular] problem with which the inventor [is involved].” In re Kahn, 441 F.3d 977, 986-87
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`(Fed. Cir. 2006). “[A] reference need not work to qualify as prior art; it qualifies as prior art,
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`regardless, for whatever is disclosed therein. Even if a reference discloses an inoperative device,
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`it is prior art for all that it teaches.” Geo M. Martin Co. v. Alliance Mach. Sys. Int’l LLC, 618 F.3d
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`1294, 1302–03 (Fed. Cir. 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
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`whether an invention was obvious. KSR, 550 U.S. at 415, 421. Thus, “the legal determination of
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`obviousness may include recourse to logic, judgment, and common sense[.]” Wyers, 616 F.3d at
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`1239. “[O]bviousness cannot be avoided simply by a showing of some degree of unpredictability
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`in the art so long as there was a reasonable probability of success.” Pfizer, Inc. v. Apotex, Inc.,
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`480 F.3d 1348, 1364 (Fed. Cir. 2007). “[E]xpectation of success need only be reasonable, not
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`absolute.” Id.
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`6
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`

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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
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`of 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
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`ordinary skill in the art has good reason to pursue the known options within his or her technical
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`grasp. If this leads to the anticipated success, it is likely the product not of innovation but of
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`ordinary skill and common sense. In that instance, the fact that a combination was obvious to try
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`might show that it was obvious under § 103.” Id. at 421. In making an obviousness determination,
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`“a court must ask whether the improvement is more than the predictable use of prior art elements
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`according to their established 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 reference. SIBIA Neurosciences, Inc. v. Cadus Pharm. Corp., 225 F.3d 1349, 1356 (Fed.
`
`Cir. 2000) (“[A] single prior art reference can render a claim obvious.”); Boston Scientific Scimed,
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`Inc. v. Cordis Corp., 554 F.3d 982, 989–90 (Fed. Cir. 2009). In cases where the invalidity defense
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`is based on a combination of elements known in the prior art, the proper inquiry is a flexible
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`analysis. KSR, 550 U.S. at 419–20. “Under the correct analysis, any need or problem known in
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`the field of endeavor at the time of the invention and addressed by the patent [or application at
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`issue] can provide a reason for combining the elements in the manner claimed.” KSR, 550 U.S. at
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`420. A reason to combine known elements can be found, for example, in the “interrelated
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`teachings of multiple patents; the effects of demands known to the design community or present
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`in the marketplace, and the background knowledge possessed by a person having ordinary skill in
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`the art[.]” KSR, 550 U.S. at 418. “[I]f a technique has been used to improve one device, and a
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`person of ordinary skill in the art would recognize that it would improve similar devices in the
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`7
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`

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`same way, using the technique is obvious unless its actual application is beyond his or her skill.”
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`Id.
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`17.
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`A single prior art reference can render a claim obvious. See Comaper Corp. v.
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`Antec, Inc., 596 F.3d 1343, 1351-52 (Fed. Cir. 2010) (“Determining obviousness requires
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`considering whether two or more pieces of prior art could be combined, or a single piece of prior
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`art could be modified, to produce the claimed invention.”); Game and Tech. Co., Ltd. v. Activision
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`Blizzard Inc., 926 F.3d 1370 (Fed. Cir. 2019) (“[A] patent can be obvious in light of a single prior
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`reference if it would have been obvious to modify that reference to arrive at the patented
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`invention.”) (internal quotations and citations omitted). Whether patent claims are obvious in view
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`of a single prior art reference is analyzed in light of the general knowledge of a skilled artisan. See
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`Koninklijke Philips N.V. v. Google LLC, 948 F.3d 1330 (Fed. Cir. 2020); see also Dow Jones &
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`Co. v. Ablaise Ltd., 606 F.3d 1338, 1349, 1353 (Fed. Cir. 2010) (affirming the district court’s grant
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`of summary judgment of invalidity on “grounds of obviousness under [a single prior art reference]
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`in view of general knowledge in the field,” in part because the obviousness “analysis requires an
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`assessment of the background knowledge possessed by a person having ordinary skill in the art.”)
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`(internal quotations and citations 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
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`indicia of non-obviousness
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`(“secondary considerations”).
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` Such secondary
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`considerations include commercial success, unexpected results, failure of others to solve the
`
`problem, skepticism of others, copying, satisfaction of a long-felt need by the invention, and
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`acclaim for the invention. See Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 1358–59 (Fed. Cir.
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`2013); Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340,
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`8
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`

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`Case 1:17-cv-00770-JDW Document 328-4 Filed 02/09/24 Page 11 of 38 PageID #: 30889
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`1349–54 (Fed. Cir. 2012); Eli Lilly and Co. v. Zenith Goldline Pharms., Inc., 471 F.3d 1369, 1380
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`(Fed. Cir. 2006). However, the patentee must demonstrate a sufficient nexus between the objective
`
`indicia and the claimed invention. See, e.g., J.T. Eaton & Co. v. Atl. Paste & Glue Co., 106 F.3d
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`1563, 1571 (Fed. Cir. 1997) (stating that a party cannot demonstrate commercial success to show
`
`nonobviousness “unless it can show that the commercial success of the product resulted from the
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`claimed invention”); see also Pro-Mold & Tool Co. v. Great Lakes Plastics, Inc., 75 F.3d 1568,
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`1574 (Fed. Cir. 1996) (describing that a nexus must exist between commercial success and claimed
`
`invention to determine the probative value of secondary considerations). “[I]f the feature that
`
`creates the commercial success was known in the prior art, the success is not pertinent,” because
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`there is no nexus. Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1312 (Fed. Cir. 2006); see
`
`also Tokai Corp. v. Easton Enters., Inc., 632 F. 3d 1358, 1369 (Fed. Cir. 2011) (finding lack of
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`nexus to support commercial success where basis for demand was “due to an element in the prior
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`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 against hindsight.” Mintz v. Dietz & Watson, Inc., 679 F.3d 1372, 1377–79 (Fed. Cir.
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`2012). But secondary considerations of non-obviousness cannot overcome a strong showing of
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`obviousness. See Tokai Corp. v. Easton Enterprises, 632 F.3d 1358, 1371 (Fed. Cir. 2011). While
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`the overall burden in respect of obviousness remains on the challenger, the patentee must establish
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`the existence of a secondary consideration supporting non-obviousness. In re Cyclobenzaprine
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`Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1081 n.8 (Fed. Cir. 2012)
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`9
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`

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`(burden of establishing nonobviousness does not shift to patentee, but patentee could not rely on
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`unexpected results because it “failed to offer adequate proof”).
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`20.
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`The burden is also on the patentee to demonstrate a nexus between the secondary
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`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).
`
`D.
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`Enablement
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`i.
`
`Issues of Law
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`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
`
`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
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`full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains .
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`. . to make and use the same.” 35 U.S.C. § 112. A claim lacks enablement, where “undue
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`experimentation” is required to practice the claimed invention. See In re Wands, 858 F.2d 731,
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`736-737 (Fed. Cir. 1988). Courts apply the Wands-factors to determine whether “undue
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`experimentation” would be necessary, namely “(1) the quantity of experimentation necessary, (2)
`
`the amount of direction or guidance presented, (3) the presence or absence of working examples,
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`(4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art,
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`(7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” Id. at 737;
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`see, e.g., Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1370-77 (Fed. Cir. 1999) (upholding
`
`10
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`the applicability of the Wands-factors). Although a specification need not disclose what is well
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`known in the art, it “must supply the novel aspects of an invention in order to constitute adequate
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`enablement.” Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997).
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`Enablement is a question of law based on underlying factual findings. Wands, 858 F.2d at 1402.
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`To prove that a claim is invalid for non-enablement requires clear and convincing evidence. See
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`Koito Mfg. Co. v. Turn-Key-Tech, LLC, 381 F.3d 1142, 1156 (Fed. Cir. 2004); Cephalon, Inc. v.
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`Watson Pharms., Inc., 707 F.3d 1330, 1336 (Fed. Cir. 2013).
`
`23.
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`“To be enabling, the specification of a patent must teach those skilled in the art how
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`to make and use the full scope of the claimed invention without undue experimentation” as of the
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`patent’s effective filing date. MagSil Corp. v. Hitachi Glob. Storage Techs., Inc., 687 F.3d 1377,
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`1380 (Fed. Cir. 2012). The enablement requirement “serves the dual function in the patent system
`
`of ensuring adequate disclosure of the claimed invention and of preventing claims broader than
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`the disclosed 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.
`
`Genentech, 108 F.3d at 1366.
`
`24.
`
`It is not enough to enable a subset of what is claimed, a patent specification “must
`
`teach those skilled in the art how to make and use the full scope of the claimed invention without
`
`undue experimentation.” Amgen Inc. v. Sanofi, 872 F.3d 1367, 1375 (Fed. Cir. 2017) (Amgen I)
`
`(quoting Genentech, Inc., 108 F.3d at 1365). A patentee may choose to claim his invention
`
`narrowly or broadly, but “[a] patentee who chooses broad claim language must make sure the
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`broad claims are fully enabled. The scope of the claims must be less than or equal to the scope of
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`the enablement.” Sitrick v. Dreamworks, LLC, 516 F.3d 993, 999 (Fed. Cir. 2008) (internal
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`quotation marks omitted) (holding that the patentee’s claims were broad enough to cover both
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`movies and video games, but patent did not enable movies); see also Trs. of Bos. Univ. v. Everlight
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`Elecs. Co., 896 F.3d 1357, 1364–65 (Fed. Cir. 2018) (invalidating claim to “six permutations”
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`because only five out of the six permutations were enabled); Plant Genetic Sys., N.V. v. DeKalb
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`Genetics Corp., 315 F.3d 1335, 1338 (Fed. Cir. 2003) (holding the claim term “plant cell” covered
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`both “monocots” and “dicots,” but that the patent did not enable monocots); Monsanto Co. v.
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`Syngenta Seeds, Inc., 503 F.3d 1352, 1361 (Fed. Cir. 2007) (same); In re Vaeck, 947 F.2d 488,
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`495 (Fed. Cir. 1991) (“There is no reasonable correlation between the narrow disclosure in
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`appellants’ specification and the broad scope of protection sought in the claims encompassing gene
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`expression in any and all cyanobacteria.”); cf. Genentech, 108 F.3d at 1366 (“Patent protection is
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`granted in return for an enabling disclosure of an invention, not for vague intimations of general
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`ideas that may or may not be workable.”).
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`E.
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`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
`terms as to enable any person skilled in the art to which it pertains, or with which
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`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
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`possession of the invention, and demonstrate that by disclosure in the specification of the patent.”
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`Idenix Pharms. LLC v. Gilead Scis. Inc., 941 F.3d 1149, 1163 (Fed. Cir. 2019) (internal citations
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`omitted). An adequate written description requires more than “a mere wish or plan for obtaining”
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`the claimed invention. Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927 (Fed. Cir.
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`2004). The written description requirement is a question of fact. Ariad Pharms., Inc. v. Eli Lilly
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`& Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). To invalidate a claim for lack of written description
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`requires clear and convincing evidence. Id. at 1354.
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`28.
`
`Determining whether the patent satisfies the written description requirement
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`“requires an objective inquiry into the four corners of the specification.” Centocor Ortho Biotech,
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`Inc. v. Abbott Labs., 636 F.3d 1341, 1348 (Fed. Cir. 2011). Each claim limitation must be
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`described in the specification. See Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir.
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`1997); Centocor, 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
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`is given ‘meaningful disclosure in exchange for being excluded from practicing the invention for
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`a 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
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`applicant.” PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1307 (Fed. Cir. 2008); see
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`Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1379 (Fed. Cir. 2009) (opining that § 112
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`“prohibits new matter from entering into claim amendments, particularly during the continuation
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`process.”); Amgen Inc. v. Hoechst Marion Roussel Inc., 314 F.3d 1313, 1330, (Fed. Cir. 2003)
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`(“The purpose of the written description requirement is to prevent an applicant from later asserting
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`that he invented that which he did not”); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1561 (Fed
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`Cir. 1991) (“Adequate description of the invention guards against the inventor’s overreaching by
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`insisting that he recount his invention in such detail that his future claims can be determined to be
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`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 skill in the art to recognize that [the inventor] invented what is claimed.” Ariad Pharms.,
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`Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). In other words, the specification
`
`itself must show that “the inventor actually invented the invention claimed” by “reasonably
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`convey[ing] to those skilled in the art that the inventor had possession of the claimed subject matter
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`as of the filing date.” Id. The written description does not concern what a person of ordinary skill
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`could do, but rather what the inventors themselves did do – the specification must describe the
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`invention as broadly as it is claimed to demonstrate that the inventors actually invented the full
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`scope of the claimed invention by the time 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
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`embodiment described in the specification, or whether one skilled in the art might be able to
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`construct the claimed invention. See Ariad Pharms., 598 F.3d at 1352; Regents of Univ. of Cal. v.
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`Eli Lilly & Co., 119 F.3d 1559, 1566-67 (Fed. Cir. 1997) (“an applicant complies with the written
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`description requirement ‘by describing the invention, with all its claimed limitations, not that
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`which makes it obvious’”); see also, e.g., ICU Med., Inc. v. Alaris Med. Sys., Inc., 558 F.3d 1368,
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`1378–79 (Fed. Cir. 2009); Lockwood v. Am. Airlines, 107 F.3d 1565, 1572 (Fed. Cir. 1997). “It is
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`not sufficient for purposes of the written description requirement of § 112 that the disclosure, when
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`combined with the knowledge in the art, would lead one to speculate as to the modifications that
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`the inventor might have envisioned, but failed to disclose.” Id. at 1572. “The knowledge of
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`ordinary artisans may be used to inform what is actually in the specification, but not to teach
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`limitations that are not in the specification, even if those limitations would be rendered obvious by
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`the disclosure in the specification.” Rivera v. ITC, 857 F.3d 1315, 1322 (Fed. Cir. 2017) (internal
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`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
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`F.3d 1336, 1349 (Fed. Cir. 2013). In assessing written description, “each claim [must be taken]
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`as an integrated whole rather than as a collection of independent limitations.” Id. at 1349.
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`“Working backward from a knowledge of the claims, that is by hindsight” is not permitted because,
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`when doing so, “it is all very clear what route one would travel through the forest of the
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`specification to arrive at [the claimed invention].” Id.
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`33.
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`Accordingly, § 112 requires the inventor to provide “blaze marks” in the description
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`“to guide a read