`In the Supreme Court of the United States
`
`LABORATORY CORPORATION OF AMERICA HOLDINGS,
`DBA LABCORP, PETITIONER
`v.
`METABOLITE LABORATORIES, INC., ET AL.
`
`ON WRIT OF CERTIORARI
`TO THE UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`BRIEF FOR THE UNITED STATES AS AMICUS CURIAE
`
`PAUL D. CLEMENT
`Solicitor General
`Counsel of Record
`PETER D. KEISLER
`Assistant Attorney General
`THOMAS G. HUNGAR
`Deputy Solicitor General
`DARYL JOSEFFER
`Assistant to the Solicitor
`General
`ANTHONY J. STEINMEYER
`JEFFREY CLAIR
`Attorneys
`Department of Justice
`Washington, D.C. 20530-0001
`(202) 514-2217
`
`JAMES A. TOUPIN
`General Counsel
`JOHN M. WHEALAN
`Deputy General Counsel
`STEPHEN WALSH
`RAYMOND T. CHEN
`Associate Solicitors
`Patent and Trademark Office
`Alexandria, VA 22313
`
`
`
`QUESTION PRESENTED
`
`This Court granted the petition for a writ of certio-
`rari limited to question three as presented in the
`petition, which asks: Whether a method patent setting
`forth an indefinite, undescribed, and non-enabling step
`directing a party simply to “correlat[e]” test results can
`validly claim a monopoly over a basic scientific rela-
`tionship used in medical treatment such that any doctor
`necessarily infringes the patent merely by thinking
`about the relationship after looking at a test result.
`
`(I)
`
`
`
`TABLE OF CONTENTS
`
`Page
`Interest of the United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
`Statement
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
`Summary of Argument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
`Argument:
`A.
`The patent specification satisfies the requirements
`of 35 U.S.C. 112 by describing, enabling, and
`claiming the method . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
`B. Whether the patent claim is invalid because it
`claims a law of nature, natural phenomenon, or
`abstract idea is not fairly included in the question
`presented . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
`The patent claim appears to claim all substantial
`practical applications of the natural relationship
`that are revealed by the limited record before the
`Court . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
`The patent claim is invalid under 35 U.S.C. 102 if it
`claims assay methods that were already included in
`the prior art . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
`Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
`
`D.
`
`C.
`
`TABLE OF AUTHORITIES
`
`Cases:
`Adarand Constructors, Inc. v. Mineta,
`534 U.S. 103 (2001) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
`AK Steel Corp. v. Sollac & Ugine,
`344 F.3d 1234 (Fed. Cir. 2003) . . . . . . . . . . . . . . . . . . . . . . 8
`Albertson’s, Inc. v. Kirkingburg, 527 U.S. 555
`(1999) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
`
`(II)
`
`
`
`IV
`
`
`
`Page
`
`Cases–Continued:
`Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342
`(Fed. Cir. 1999) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
`Aronson v. Quick Point Pencil Co., 440 U.S. 257
`(1979) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
`Bonito Boats, Inc. v. Thunder Craft Boats, Inc.,
`489 U.S. 141 (1989) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
`Carnegie Steel Co. v. Cambria Iron Co.,
`185 U.S. 403 (1902) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
`Diamond v. Chakrabarty, 447 U.S. 303 (1980) . . . . . . . 18, 19
`Diamond v. Diehr, 450 U.S. 175
`(1981) . . . . . . . . . . . . . . . . . . . . . . . . . . . 14, 16, 18, 20, 21, 22
`Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956
`(Fed. Cir. 2002) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
`Evans v. Eaton, 20 U.S. (7 Wheat.) 356 (1822) . . . . . . 8, 9, 11
`Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki
`Co., 535 U.S. 722 (2002) . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
`Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S.
`127 (1948) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18, 19
`General Elec. Co. v. Wabash Appliance Corp.,
`304 U.S. 364 (1938) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
`Gottschalk v. Benson, 409 U.S. 63
`(1972) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6, 16, 18, 20, 21, 27
`Graham v. John Deere Co., 383 U.S. 1 (1966) . . . . . . . . . . . 29
`Graver Tank & Mfg. Co. v. Linde Air Prods. Co.,
`336 U.S. 271 (1949) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
`Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470
`(1974) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
`Le Roy v. Tatham, 55 U.S. (14 How.) 156
`(1852) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18, 19
`
`
`
`V
`
`Page
`
`Cases–Continued:
`LizardTech, Inc. v. Earth Res. Mapping, Inc.,
`424 F.3d 1336 (Fed. Cir. 2005) . . . . . . . . . . . . . . . . . . . 8, 12
`Loom Co. v. Higgins, 105 U.S. 580 (1881) . . . . . . . . . . . . . . . 9
`Mackay Radio & Tel. Co. v. Radio Corp. of Am.,
`306 U.S. 86 (1939) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
`Markman v. Westview Instruments, Inc.,
`517 U.S. 370 (1996) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
`McClain v. Ortmayer, 141 U.S. 419 (1891) . . . . . . . . . . . . 13
`Miles Labs., Inc. v. Shandon Inc., 997 F.2d 870
`(Fed. Cir. 1993), cert. denied, 510 U.S. 1100
`(1994) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
`Moba, B.V. v. Diamond Automation, Inc., 325 F.3d
`1306 (Fed. Cir.), cert. denied, 540 U.S. 982
`(2003) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9, 12
`O’Reilly v. Morse, 56 U.S. (15 How.) 62 (1853)
`. . . . . 18, 19
`Pandrol USA, LP v. Airboss Ry. Prods., Inc.,
` 12
`424 F.3d 1161 (Fed. Cir. 2005) . . . . . . . . . . . . . . . . . . .
`Parker v. Flook, 437 U.S. 584 (1978) . . . . . . 18, 19, 20, 21, 22
`Pfaff v. Wells Elec., 525 U.S. 55 (1998) . . . . . . . . . . . . . . . 9, 28
`Rubber-Tip Pencil Co. v. Howard, 87 U.S. (20 Wall.)
`498 (1874) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
`Schering Corp. v. Geneva Pharm., Inc.,
`339 F.3d 1373 (Fed. Cir. 2003) . . . . . . . . . . . . . . . . . . . . . 29
`Tilghman v. Proctor, 102 U.S. 707 (1880) . . . . . . . . . . . . . . . 9
`Toma, In re, 575 F.2d 872 (C.C.P.A. 1978) . . . . . . . . . . . . . 27
`Tyler v. City of Boston, 74 U.S. (7 Wall.) 327 (1868) . . . . . . 8
`United Carbon Co. v. Binney & Smith Co.,
`317 U.S. 228 (1942)
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
`Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555
`(Fed. Cir. 1991) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
`
`
`
`VI
`
`Cases–Continued:
`Warner-Jenkinson Co. v. Hilton Davis Chem. Co.,
` 13
`520 U.S. 17 (1997) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Yee v. City of Escondido, 503 U.S. 519 (1992) . . . . . . . . . . . 16
`
`Page
`
`Constitution, statutes, and rules:
`U.S. Const.:
`Art. I, § 8, Cl. 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
`Patent Act of 1793, ch. 11, 1 Stat. 318 . . . . . . . . . . . . . . . . . 11
`Patent Act of 1870, ch. 230, 16 Stat. 198 . . . . . . . . . . . . . . . 13
`35 U.S.C. 100(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
`35 U.S.C. 101 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . passim
`35 U.S.C. 102 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7, 28, 29, 30
`35 U.S.C. 102(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
`35 U.S.C. 112 . . . . . . . . . . . . . . . . . . . . 5, 6, 7, 13, 14, 15, 16, 18
`35 U.S.C. 282 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
`Sup. Ct. R.:
`Rule 14.1(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
`Rule 15.2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
`
`Miscellaneous:
`H.R. Rep. No. 1923, 82d Cong., 2d Sess. (1952) . . . . . . . . . 18
`PTO:
`Guidelines for Examination of Patent Applica-
`cations Under the 35 U.S.C. 112 ¶ 1 “Written
`Description” Requirement, 66 Fed. Reg. 1099
`(2001) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8, 9, 12
`
`
`
`
`
`VII
`
`Miscellaneous—Continued:
`Interim Guidelines for Examination of Patent
`Applications for Patent Subject Matter
`Eligibility, 1300 Off. Gaz. Pat. Office 142 (Nov. 22,
`2005)<http://www.uspto.gov/web/patents/patog/week
`47/OG/TOC.htm#ref13>
`. . . . . . . . . . . . . . . . . . . 20, 21
`S. Rep. No. 1979, 82d Cong., 2d Sess. (1952)
`. . . . . . . . . . . 18
`
`Page
`
`
`
`In the Supreme Court of the United States
`
`No. 04-607
`LABORATORY CORPORATION OF AMERICA HOLDINGS,
`DBA LABCORP, PETITIONER
`v.
`METABOLITE LABORATORIES, INC., ET AL.
`
`ON WRIT OF CERTIORARI
`TO THE UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`BRIEF FOR THE UNITED STATES AS AMICUS CURIAE
`
`INTEREST OF THE UNITED STATES
`This case concerns the written description, enable-
`ment, and definiteness requirements of the Patent Act,
`and the question presented might also be construed to
`ask whether claimed inventions that would monopolize
`basic scientific relationships are patentable subject mat-
`ter. The United States Patent and Trademark Office
`(PTO), which is “responsible for the granting and issu-
`ing of patents,” 35 U.S.C. 2(a)(1), has an interest in the
`resolution of such questions. At the invitation of the
`Court, the United States filed a brief as amicus curiae at
`the petition stage of this case.
`STATEMENT
`1. Deficiencies in two B vitamins, cobalamin and fo-
`late, can cause serious illnesses. Once detected, how-
`ever, a deficiency can be treated with vitamin supple-
`ments. Scientific researchers at University Patents
`
`(1)
`
`
`
`2
`
`Inc., the predecessor of respondent Competitive Tech-
`nologies, Inc. (CTI), determined that elevated levels of
`total homocysteine, an amino acid, are closely associated
`with deficiencies in cobalamin or folate. The research-
`ers applied for and received a patent on methods for
`assaying samples of body fluids or tissues to determine
`total homocysteine levels, as well as methods for diag-
`nosing cobalamin or folate deficiency based on elevated
`total homocysteine levels. Pet. App. 2a-3a. The patent
`claim at issue here, claim 13 of United States Patent No.
`4,940,658 (the ’658 patent), identifies:
`A method for detecting a deficiency of cobalamin or
`folate in warm-blooded animals comprising the steps
`of:
`
`assaying a body fluid for an elevated level of total
`homocysteine; and
`correlating an elevated level of total homocy-
`steine in said body fluid with a deficiency of co-
`balamin or folate.
`Pet. App. 3a; Supp. App. (S.A.) 30.
`CTI licensed the ’658 patent to respondent Metabo-
`lite Laboratories, Inc., which in turn sub-licensed the
`patent to the predecessor-in-interest of petitioner Labo-
`ratory Corporation of America Holdings. Physicians
`ordered total homocysteine assays from petitioner,
`which initially performed the assays under its sub-li-
`cense by using an assay method set forth in the patent.
`In 1998, however, petitioner began using a different as-
`say method and stopped paying royalties to Metabolite.
`Respondents then filed suit against petitioner for induc-
`ing patent infringement by the physicians, contributory
`infringement, and breach of contract. Pet. App. 3a-4a.
`
`
`
`3
`
`2. The district court submitted the case to a jury,
`which found claim 13 of the ’658 patent valid; found peti-
`tioner liable for induced infringement, contributory in-
`fringement, and breach of contract; and found that peti-
`tioner’s infringement was willful. The jury assessed
`damages of approximately $1 million for infringement
`and $3.7 million for breach of contract. The district
`court entered judgment based on the jury verdict, de-
`nied petitioner’s motion for judgment as a matter of law,
`and doubled the jury’s infringement award based on the
`finding of willfulness. See Pet. App. 3a-4a, 34a-39a. The
`court permanently enjoined petitioner from performing
`“any homocysteine-only test.” Id . at 36a (citation omit-
`ted).
`3. a. The Federal Circuit affirmed. Pet. App. 1a-
`27a. Noting that the parties focused “solely on * * *
`the correlating step” of claim 13, the court of appeals
`stressed that it did “not address the assaying step.” Id.
`at 13a & n.1. “In essence,” the court held, “‘correlating’
`means to relate the presence of an elevated total
`homocysteine level to either a cobalamin or folate defi-
`ciency, or both * * *, and also to relate the absence of
`an elevated total homocysteine level to a deficiency in
`neither.” Id . at 12a.
`Because “[t]he record shows that physicians order
`assays and correlate the results of those assays,” the
`court of appeals held that physicians who ordered assays
`from petitioner after petitioner stopped making royalty
`payments directly infringed the patent. Pet. App. 13a.
`The court further concluded that substantial evidence
`supports the jury’s finding that petitioner intended to
`induce such infringement because petitioner provided
`total homocysteine assays to physicians and encouraged
`the use of such assays to detect cobalamin and folate
`
`
`
`4
`
`deficiency. Id. at 14a-15a. Because it upheld the finding
`of induced infringement, the court of appeals did not
`review the jury’s finding of contributory infringement.
`Id . at 15a.
`The court of appeals rejected petitioner’s contentions
`that claim 13 is invalid on various grounds—viz, indefi-
`niteness, lack of written description, non-enablement,
`anticipation, and obviousness. Pet. App. 15a-21a. Be-
`cause “[a] patent issued from [PTO] bears the presump-
`tion of validity under 35 U.S.C. § 282,” the court ex-
`plained that “[a]n accused infringer * * * must prove
`patent invalidity under the clear and convincing eviden-
`tiary standard.” Id . at 15a.
`In the Federal Circuit’s view, petitioner did not over-
`come the presumption of validity. Because claim 13 has
`a discernible meaning, the court held that it is not indef-
`inite. Pet. App. 16a. The court concluded that the pat-
`ent specification provides an adequate written descrip-
`tion because “[t]he record is replete with evidentiary
`support that * * * persons of ordinary skill in the art
`* * * understood from the specification that the ’658 pat-
`ent inventors possessed the ‘correlating’ step at the time
`they filed the patent application.” Id . at 17a.
`Similarly, the court determined that the patent speci-
`fication enabled the invention by disclosing all of the
`necessary steps. Pet. App. 17a-18a. The court explained
`that “the correlating step is well within the knowledge
`of one of skill in this art” because it is “a simple conclu-
`sion that a cobalamin/folate deficiency exists vel non
`based on the assaying step.” Id . at 18a. And because
`the prior art in the record did not specifically disclose
`that total homocysteine is correlated with cobalamin or
`folate deficiency, the court further concluded that claim
`13 was neither anticipated by the prior art nor obvious.
`
`
`
`5
`
`Id . at 18a-20a. Finally, the court held that the district
`court’s injunction barring petitioner from performing
`“any homocysteine-only test” is not overbroad because
`it “simply addresses [petitioner’s] specific acts constitut-
`ing indirect infringement.” Id. at 26a-27a (citation omit-
`ted).
`b. Judge Schall concurred in part and dissented in
`part. Pet. App. 28a-33a. He “agree[d] with the major-
`ity’s conclusions with respect to validity” of claim 13, but
`concluded that the claim is infringed only when a test
`reveals elevated levels of total homocysteine, not when
`it reveals normal or low levels. Id . at 28a, 30a.
`SUMMARY OF ARGUMENT
`The patent specification at issue here satisfies the
`enablement, written description, and definiteness re-
`quirements of 35 U.S.C. 112. The specification ade-
`quately enables and describes the claimed method by
`explaining how it works and how to perform it, and by
`including examples demonstrating that the patent appli-
`cants had performed the method. The claim is also suffi-
`ciently definite because its bounds are marked with pre-
`cision, such that a person skilled in the art would under-
`stand whether any given method infringed the claim.
`Although petitioner contends (Pet. 24-25) that the speci-
`fication does not adequately describe the claim’s “corre-
`lating” step, the court of appeals construed that step to
`be “a simple conclusion that a cobalamin/folate defi-
`ciency exists vel non based on the assaying step.” Pet.
`App. 18a.
`Petitioner’s contention (Pet. 23) that holding claim 13
`valid would mean that “parties could claim patent mo-
`nopolies over basic scientific facts” confuses the Section
`112 disclosure and drafting requirements with the Pat-
`
`
`
`6
`
`ent Act’s separate limitations on the subject matter eli-
`gible for patent protection. Although laws of nature,
`natural phenomena, and abstract
`ideas are not
`patentable under 35 U.S.C. 101, petitioner did not con-
`tend in the lower courts that the patent claim is invalid
`under Section 101. Nor does the question presented in
`this Court fairly include that question. Instead, the
`question presented, construed in light of the arguments
`set forth in the body of the petition and in the courts
`below, asserts only that a consequence of affirming the
`jury’s verdict on the Section 112 issues would be to
`grant a monopoly over a scientific relationship. Any
`such consequence, however, would flow from petitioner’s
`failure to raise a Section 101 claim, not from any error
`in applying Section 112.
`If the Court nonetheless concludes that the question
`presented fairly encompasses a Section 101 challenge, a
`remand would be appropriate. The court of appeals’
`claim construction, the jury’s findings, and the relief
`awarded all suggest that any use of a total homocysteine
`assay infringes claim 13, because doctors who review
`such assays can be presumed to perform mental correla-
`tions of the results with cobalamin or folate deficiencies
`or the absence thereof, even if they ordered the assays
`for a different reason. So construed, claim 13 appears
`impermissibly to encompass all “substantial practical
`application[s]” of the natural relationship that can be
`identified by reference to the limited record presently
`before the Court. Gottschalk v. Benson, 409 U.S. 63, 71-
`72 (1972). Because petitioner did not raise a Section 101
`challenge in the lower courts, however, respondents had
`no opportunity to create a full record on that issue. A
`remand for further evidentiary proceedings would
`
`
`
`7
`
`therefore be appropriate if the Court reached the Sec-
`tion 101 issue.
`Claim 13 also appears to be invalid as anticipated by
`the prior art under 35 U.S.C. 102. The court of appeals’
`determination that any use of a total homocysteine assay
`infringes the patent appears to have the effect of imper-
`missibly removing existing assay methods from the pub-
`lic domain. Like the Section 101 issue, however, that
`question is not fairly included in the question presented.
`ARGUMENT
`
`A. THE PATENT SPECIFICATION SATISFIES THE RE-
`QUIREMENTS OF 35 U.S.C. 112 BY DESCRIBING, EN-
`ABLING, AND CLAIMING THE METHOD
`
`The question presented asks (Pet. i) whether a pat-
`ent claim “setting forth an indefinite, undescribed, and
`non-enabling step” is invalid. That question refers to
`Section 112 of the Patent Act, which requires that a pat-
`ent specification 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 make and
`use the same.” 35 U.S.C. 112. Further, “[t]he specifica-
`tion shall conclude with one or more claims particularly
`pointing out and distinctly claiming the subject matter
`which the applicant regards as his invention.” Ibid.
`Section 112 thus imposes three relevant require-
`ments. First, the specification must contain a written
`description of the invention. Second, the specification
`must enable a person skilled in the art to make and use
`the invention. Third, the patent claim must identify with
`definiteness the exact scope of the claimed invention.
`Because the ’658 patent was issued by PTO, it is “pre-
`
`
`
`8
`
`sumed valid.” 35 U.S.C. 282. Petitioner’s arguments
`under Section 112 do not overcome that presumption.
`1. a. The enablement and written description re-
`quirements are related but distinct. “The enablement
`requirement is satisfied when one skilled in the art, af-
`ter reading the specification, could practice the claimed
`invention without undue experimentation.” AK Steel
`Corp. v. Sollac & Ugine, 344 F.3d 1234, 1244 (Fed. Cir.
`2003); accord PTO, Guidelines for Examination of Pat-
`ent Applications Under the 35 U.S.C. 112, ¶ 1 “Written
`Description” Requirement (PTO 112 Guidelines), 66
`Fed. Reg. 1099, 1103 (2001); see Tyler v. City of Boston,
`74 U.S. (7 Wall.) 327, 330 (1868) (construing analogous
`requirement in earlier patent statute to require that a
`patent “state the component parts of the new manufac-
`ture claimed with clearness and precision, and not leave
`the person attempting to use the discovery to find it out
`‘by experiment’”). Enablement is an essential aspect of
`the basic quid pro quo that underlies a patent grant,
`because it ensures that the invention is immediately
`added to the storehouse of public knowledge and that
`the public will receive unlimited use of the invention
`after patent protection expires. See Kewanee Oil Co. v.
`Bicron Corp., 416 U.S. 470, 480-481 (1974); Evans v.
`Eaton, 20 U.S. (7 Wheat.) 356, 433-434 (1822).
`In addition to enabling the invention, the specifica-
`tion must contain a “written description of the inven-
`tion,” 35 U.S.C. 112, that “convey[s] to a person of skill
`in the art that the patentee had possession of the
`claimed invention at the time of the application, i.e., that
`the patentee invented what is claimed.” LizardTech,
`Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336,
`1345 (Fed. Cir. 2005); see Pet. App. 17a; PTO 112 Guide-
`lines, 66 Fed. Reg. at 1104. “An applicant shows posses-
`
`
`
`9
`
`sion of the claimed invention by describing the claimed
`invention with all of its limitations using such descrip-
`tive means as words, structures, figures, diagrams, and
`formulas that fully set forth the claimed invention.”
`PTO 112 Guidelines, 66 Fed. Reg. at 1104. Demonstrat-
`ing that an invention has been reduced to practice is one
`such way of showing possession, id . at 1104, 1107-1108
`n.6, although an invention need not have been reduced
`to practice in order for it to be patentable, Pfaff v. Wells
`Elec., Inc., 525 U.S. 55, 60-61 (1998). In addition to en-
`suring that the claimant has invented and possessed the
`claimed subject matter, the written description require-
`ment helps to prevent inventors from later asserting
`that they invented more than they in fact did. See
`Moba, B.V. v. Diamond Automation, Inc., 325 F.3d
`1306, 1319 (Fed. Cir.), cert. denied, 540 U.S. 982 (2003);
`Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1561, 1563
`(Fed. Cir. 1991); see generally Evans, 20 U.S. (7 Wheat)
`at 434-435.
`As the court of appeals explained, the enablement
`and written description requirements are considered
`from the perspective of one skilled in the art. Pet. App.
`17a, 18a; see, e.g., Tilghman v. Proctor, 102 U.S. 707,
`728 (1880); Loom Co. v. Higgins, 105 U.S. 580, 585-586
`(1881). In this case, the parties agreed, and the jury was
`instructed, that such a person would have “a medical
`degree and experience in researching the amino acid
`homocysteine and its relationship to diseases.” Pet.
`App. 7a (citation omitted).
`b. Especially from the perspective of such a person,
`the patent specification easily satisfies the enablement
`and written description requirements by explaining pre-
`cisely how to perform the claimed method and demon-
`strating that the applicants had in fact performed it.
`
`
`
`10
`
`The specification explains that “[i]t has now been discov-
`ered that an elevated level of total homocysteine in tis-
`sues of warmblooded animals correlates both with
`cobalamin deficiency and with folic acid deficiency; an
`animal with elevated levels of total homocysteine is
`likely to have one or both deficiencies.” S.A. 11. The
`specification goes on to disclose both how to assay for
`total homocysteine and how to correlate elevated levels
`of total homocysteine with deficiencies in the B vitamins.
`See, e.g., S.A. 12-14.
`The specification explains that “[s]uitable assays for
`this purpose include any assays capable of determining
`levels of homocysteine in body tissues, preferably body
`fluids.” S.A. 12. Although petitioner erroneously con-
`tends (Pet. 23) that “[n]either the claim nor the specifi-
`cation says anything about how one is to conduct the
`assay,” the specification describes “several different
`known assays suitable for use in determining levels of
`homocysteine in urine or blood,” S.A. 12, as well as a
`new assay method claimed in the ’658 patent, S.A. 12-14.
`The specification also includes two detailed examples
`that describe how the applicants measured homocy-
`steine using different assay methods. See S.A. 15-20.
`Thus, the specification leaves no doubt that the appli-
`cants had undertaken the assay step, and it simulta-
`neously enables others skilled in the art to undertake
`that step by showing them how to do so.
`The same is true of the correlation step. The specifi-
`cation discloses that “[t]he normal range for homocy-
`steine in human serum is from about 7 to about 22
`:mol/liter, and in human urine is from about 1 to about
`20 :mol/liter. Homocysteine levels above these ranges
`are indicative of cobalamin and/or folate deficiency; the
`higher the level, the stronger the indication.” S.A. 14.
`
`
`
`11
`
`The specification then provides an example of tests con-
`ducted by the applicants in which total homocysteine
`levels were elevated above normal levels for 99% of the
`patients with cobalamin deficiency and 95% of those with
`folate deficiency. S.A. 28.
`Petitioner therefore errs in contending (Pet. 24-25)
`that the specification does not “describe what a practi-
`tioner must do to perform the active ‘correlating’ step.”
`As the court of appeals construed the claim, “[t]he corre-
`lating step is a simple conclusion that a cobalamin/ folate
`deficiency exists vel non based on the assaying step.”
`Pet. App. 18a; see id . at 8a (“The claim only requires
`association of homocysteine levels with vitamin deficien-
`cies. It requires no further correlation to confirm the
`relationship.”).
`Although petitioner protests (Pet. 24) that “[a]ll the
`patent tells a prospective practitioner is that a person
`with an elevated homocysteine level may have a vitamin
`deficiency,” the mere fact that the claimed detecting
`method may not always be accurate does not render it
`invalid under Section 112. The written description and
`enablement inquiries focus on the disclosure and posses-
`sion of the invention, not the extent of its utility. And
`notwithstanding petitioner’s criticisms, moreover, the
`patent claim appears to have substantial utility. The
`court of appeals explained that the claimed method pre-
`dicts cobalamin or folate deficiency “relatively accu-
`rately.” Pet. App. 11a; see S.A. 28.
`c. In any event, the written description and enable-
`ment issues in this case are primarily factual. This
`Court long ago stated that analogous requirements in
`the Patent Act of 1793, ch. 11, 1 Stat. 318, were
`“matter[s] of fact for the jury, and not of law for the de-
`cision of the Court.” Evans, 20 U.S. (7 Wheat.) at 428.
`
`
`
`12
`
`Under the modern patent statutes, the Federal Circuit
`treats the adequacy of a written description as a ques-
`tion of fact and enablement as a question of law based on
`subsidiary findings of fact. Moba, 325 F.3d at 1319,
`1321; Pet. App. 4a-5a.
`Here, the jury found that the specification satisfied
`both the enablement and written description require-
`ments, J.A. 396-397, the district court denied peti-
`tioner’s motion for judgment as a matter of law, Pet.
`App. 34a-35a, and the Federal Circuit affirmed based in
`part on its review of the record, see, e.g., id . at 17a
`(“The record is replete with evidentiary support that
`* * * persons of ordinary skill in the art * * * understood
`from the specification that the ’658 patent inventors pos-
`sessed the ‘correlating’ step.”). This Court does not or-
`dinarily disturb such fact-specific determinations, see
`generally Graver Tank & Mfg. Co. v. Linde Air Prods.
`Co., 336 U.S. 271, 275 (1949), and there is no reason to
`upset the jury’s verdict on the enablement and written
`description questions here.1
`
`1 There is some disagreement among the Federal Circuit’s decisions
`regarding whether the written description requirement is satisfied by
`evidence the inventor possessed the invention, or whether some further
`description of the invention may be required in some circumstances.
`See, e.g., Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 969 (Fed.
`Cir. 2002). PTO has interpreted the written description requirement
`to focus solely on possession, see PTO 112 Guidelines, 66 Fed. Reg. at
`1102, 1104, and the Federal Circuit’s recent cases appear to adopt that
`view, see, e.g., LizardTech, 424 F.3d at 1345; Pandrol USA, LP v.
`Airboss Ry. Prods., Inc., 424 F.3d 1161, 1165 (Fed. Cir. 2005); Pet. App.
`17a. Any disagreement on that point is not relevant here, however,
`because the specification clearly describes the claimed method, its
`allegedly novel aspects, and the extent to which it differs from the prior
`art disclosed in the specification, and thus satisfies either standard. See
`S.A. 10-14; pp. 10-11, supra.
`
`
`
`13
`
`2. While the enablement and written description
`requirements focus on the content of the patent specifi-
`cation, the definiteness requirement directs that the
`patent claim must “particularly point[] out and distinctly
`claim[] the subject matter which the applicant regards
`as his invention.” 35 U.S.C. 112. “It has long been un-
`derstood that a patent must describe the exact scope of
`an invention and its manufacture to ‘secure to [the pat-
`entee] all to which he is entitled, [and] to apprise the
`public of what is still open to them.’” Markman v.
`Westview Instruments, Inc., 517 U.S. 370, 373 (1996)
`(quoting McClain v. Ortmayer, 141 U.S. 419, 424
`(1891)); see Festo Corp. v. Shoketsu Kinzoku Kogyo
`Kabushiki Co., 535 U.S. 722, 731 (2002).
`Because the patent claim defines the scope of the
`patent grant, Markman, 517 U.S. at 373, compliance
`with the definiteness requirement turns on whether the
`claim makes “[t]he limits of the patent” known. General
`Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 369
`(1938); accord United Carbon Co. v. Binney & Smith
`Co., 317 U.S. 228, 232, 236 (1942). In assessing definite-
`ness, a claim must be read in light of the specification
`and the knowledge of a person skilled in the art. Carne-
`gie Steel Co. v. Cambria Iron Co., 185 U.S. 403, 432, 437
`(1902). Thus, “[t]he test for definiteness is whether one
`skilled in the art would understand the bounds of the
`claim when read in light of the specification.” Miles
`Labs., Inc. v. Shandon Inc., 997 F.2d 870, 875 (Fed. Cir.
`1993), cert. denied, 510 U.S. 1100 (1994).2
`
`2 Although General Electric, United Carbon, and Carnegie Steel
`interpreted the definiteness requirement of the Patent Act of 1870, ch.
`230, 16 Stat. 198, the modern version of Section 112 “is not materially
`different from the 1870 Act with regard to claiming.” Warner-Jen-
`kinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 26 (1997). Accord-
`
`
`
`14
`
`Especially when read by a person skilled in the art in
`light of the specification, claim 13 satisfies the definite-
`ness requirement because it marks the boundaries of the
`patent claim with precision. The claim is infringed only
`if a person “assay[s] a body fluid for an elevated level of
`total homocysteine,” and then “correlat[es] an elevated
`level of total homocysteine in said body fluid with a defi-
`ciency of cobalamin or folate.” S.A. 30. Although that
`language is undeniably sweeping, it is not unclear. As
`the court of appeals held, “[t]he claim * * * provides that
`if the assay discloses
`‘an elevated level of total
`homocysteine,’ the physician determines whether there
`is a cobalamin or folate deficiency by ‘correlating,’ i.e.,
`comparing the elevated level with the normal
`homocysteine level.” Pet. App. 12a (quoting S.A. 30);
`see p. 11, supra.
`3. Petitioner argues (Pet. 23) that if claim 13 sati