Laboratory Corp. of Am. Holdings v. Metabolite Amicus - (Merits)

No. 04-607

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 limitedtoquestion three as presented in the petition, which asks: Whether amethodpatent setting forth an indefinite, undescribed, and non-enabling stepdirectinga party simply to "correlat[e]" test results can validly claima monopoly over a basic scientific rela tionship used in medicaltreatmentsuch that any doctor necessarily infringes the patent merely bythinkingabout the relationship after looking at a test result.

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, anddefinitenessrequirements of the Patent Act, and the question presented might alsobeconstrued to ask whether claimed inventions that would monopolize basicscientific relationships are patentable subject mat ter. The UnitedStatesPatent and Trademark Office (PTO), which is "responsible for thegrantingand issu ing of patents," 35 U.S.C. 2(a)(1), has an interest in theresolution of such questions. At the invitation of the Court, theUnitedStates filed a brief as amicus curiae at the petition stage of thiscase.

STATEMENT

1. Deficiencies in two B vitamins, cobalamin and fo late, can causeserious illnesses. Once detected, how ever, a deficiency can be treatedwith vitamin supple ments. Scientific researchers at University PatentsInc., the predecessor of respondent Competitive Tech nologies, Inc.(CTI),determined that elevated levels of total homocysteine, an amino acid,areclosely associated with deficiencies in cobalamin or folate. Theresearchers applied for and received a patent on methods for assaying samplesofbody fluids or tissues to determine total homocysteine levels, as wellasmethods for diag nosing cobalamin or folate deficiency based onelevatedtotal homocysteine levels. Pet. App. 2a-3a. The patent claim at issuehere, claim 13 of United States Patent No. 4,940,658 (the '658 patent),identifies:

A method for detecting a deficiency of cobalamin or folate inwarm-bloodedanimals 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 bodyfluidwith a deficiency of co balamin or folate.

Pet. App. 3a; Supp. App. (S.A.) 30.

CTI licensed the '658 patent to respondent Metabo liteLaboratories,Inc., which in turn sub-licensed the patent to thepredecessor-in-interestof petitioner Labo ratory Corporation of America Holdings. Physiciansorderedtotal homocysteine assays from petitioner, which initially performedtheassays under its sub-li cense by using an assay method set forth in thepatent. In 1998, however, petitioner began using a different as saymethodand stopped paying royalties to Metabolite. Respondents then filed suitagainst petitioner for induc ing patent infringement by the physicians,contributory infringement, and breach of contract. Pet. App. 3a-4a.

2. The district court submitted the case to a jury, which foundclaim13 of the '658 patent valid; found peti tioner liable for inducedinfringement,contributory in fringement, and breach of contract; and found that petitioner's infringement was willful. The jury assessed damages ofapproximately$1 million for infringement and $3.7 million for breach of contract.Thedistrict court entered judgment based on the jury verdict, de niedpetitioner'smotion for judgment as a matter of law, and doubled the jury'sinfringementaward based on the finding of willfulness. See Pet. App. 3a-4a,34a-39a. The court permanently enjoined petitioner from performing "anyhomocysteine-onlytest." Id. at 36a (citation omit ted).

3. a. The Federal Circuit affirmed. Pet. App. 1a- 27a. Noting thatthe parties focused "solely on * * * the correlating step"of claim 13, the court of appeals stressed that it did "not addressthe assaying step." Id. at 13a & n.1. "In essence,"the court held, "'correlating' means to relate the presence of anelevatedtotal homocysteine level to either a cobalamin or folate defi ciency,orboth * * *, and also to relate the absence of an elevated totalhomocysteinelevel to a deficiency in neither." Id. at 12a.

Because "[t]he record shows that physicians order assays andcorrelatethe results of those assays," the court of appeals held that physicianswho ordered assays from petitioner after petitioner stopped makingroyaltypayments directly infringed the patent. Pet. App. 13a. The courtfurtherconcluded that substantial evidence supports the jury's finding thatpetitionerintended to induce such infringement because petitioner provided totalhomocysteineassays to physicians and encouraged the use of such assays to detectcobalaminand folate deficiency. Id. at 14a-15a. Because it upheld the finding ofinduced infringement, the court of appeals did not review the jury'sfindingof contributory infringement. Id. at 15a.

The court of appeals rejected petitioner's contentions that claim13is invalid on various grounds-viz, indefi niteness, lack of writtendescription,non-enablement, anticipation, and obviousness. Pet. App. 15a-21a. Because"[a] patent issued from [PTO] bears the presump tion of validity under35 U.S.C. § 282," the court ex plained that "[a]n accusedinfringer * * * must prove patent invalidity under the clear andconvincingeviden tiary standard." Id. at 15a.

In the Federal Circuit's view, petitioner did not over come thepresumptionof validity. Because claim 13 has a discernible meaning, the court heldthat it is not indef inite. Pet. App. 16a. The court concluded that thepat ent specification provides an adequate written descrip tion because"[t]he record is replete with evidentiary support that * * * personsof ordinary skill in the art * * * understood from the specificationthatthe '658 pat ent inventors possessed the 'correlating' step at the timethey filed the patent application." Id. at 17a.

Similarly, the court determined that the patent speci ficationenabledthe invention by disclosing all of the necessary steps. Pet. App.17a-18a. The court explained that "the correlating step is well withintheknowledge of one of skill in this art" because it is "a simpleconclu sion that a cobalamin/folate deficiency exists vel non based ontheassaying step." Id. at 18a. And because the prior art in the recorddid not specifically disclose that total homocysteine is correlatedwithcobalamin or folate deficiency, the court further concluded that claim13was neither anticipated by the prior art nor obvious. Id. at 18a-20a.Finally, the court held that the district court's injunction barringpetitionerfrom performing "any homocysteine-only test" is not overbroadbecause it "simply addresses [petitioner's] specific acts constituting 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 respectto validity" of claim 13, but concluded that the claim is infringedonly when a test reveals elevated levels of total homocysteine, notwhenit reveals normal or low levels. Id. at 28a, 30a.

SUMMARY OF ARGUMENT

The patent specification at issue here satisfies the enablement,writtendescription, and definiteness re quirements of 35 U.S.C. 112. Thespecificationade quately enables and describes the claimed method by explaining howitworks and how to perform it, and by including examples demonstratingthatthe patent appli cants had performed the method. The claim is alsosufficiently definite because its bounds are marked with pre cision, suchthata person skilled in the art would under stand whether any given methodinfringedthe claim. Although petitioner contends (Pet. 24-25) that the specificationdoes not adequately describe the claim's "corre lating" step,the court of appeals construed that step to be "a simple conclusionthat a cobalamin/folate defi ciency exists vel non based on theassayingstep." Pet. App. 18a.

Petitioner's contention (Pet. 23) that holding claim 13 valid wouldmean that "parties could claim patent mo nopolies over basic scientificfacts" confuses the Section 112 disclosure and drafting requirementswith the Pat ent Act's separate limitations on the subject matter eligiblefor patent protection. Although laws of nature, natural phenomena, andabstract ideas are not patentable under 35 U.S.C. 101, petitioner didnotcon tend in the lower courts that the patent claim is invalid underSection101. Nor does the question presented in this Court fairly include thatquestion. Instead, the question presented, construed in light of theargumentsset forth in the body of the petition and in the courts below, assertsonlythat a consequence of affirming the jury's verdict on the Section 112issueswould be to grant a monopoly over a scientific relationship. Any suchconsequence,however, would flow from petitioner's failure to raise a Section 101claim,not from any error in applying Section 112.

If the Court nonetheless concludes that the question presentedfairlyencompasses a Section 101 challenge, a remand would be appropriate. Thecourt of appeals' claim construction, the jury's findings, and thereliefawarded all suggest that any use of a total homocysteine assayinfringesclaim 13, because doctors who review such assays can be presumed toperformmental correla tions of the results with cobalamin or folatedeficienciesor the absence thereof, even if they ordered the assays for a differentreason. So construed, claim 13 appears impermissibly to encompass all"substantialpractical application[s]" of the natural relationship that can beidentifiedby reference to the limited record presently before the Court.Gottschalkv. Benson, 409 U.S. 63, 71- 72 (1972). Because petitioner did not raisea Section 101 challenge in the lower courts, however, respondents hadnoopportunity to create a full record on that issue. A remand for furtherevidentiary proceedings would therefore be appropriate if the Courtreachedthe Sec tion 101 issue.

Claim 13 also appears to be invalid as anticipated by the prior artunder 35 U.S.C. 102. The court of appeals' determination that any useofa total homocysteine assay infringes the patent appears to have theeffectof imper missibly removing existing assay methods from the pub licdomain. Like the Section 101 issue, however, that question is notfairly includedin 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"settingforth an indefinite, undescribed, and non-enabling step" is invalid.That question refers to Section 112 of the Patent Act, which requiresthata pat ent specification contain "a written description of theinvention,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]hespecifica tion shall conclude with one or more claims particularlypointingout and distinctly claiming the subject matter which the applicantregardsas his invention." Ibid.

Section 112 thus imposes three relevant require ments. First, thespecificationmust contain a written description of the invention. Second, thespecificationmust enable a person skilled in the art to make and use the invention.Third, the patent claim must identify with definiteness the exact scopeof the claimed invention. Because the '658 patent was issued by PTO, itis "pre sumed valid." 35 U.S.C. 282. Petitioner's argumentsunder Section 112 do not overcome that presumption.

1. a. The enablement and written description re quirements arerelatedbut distinct. "The enablement requirement is satisfied when one skilledin the art, af ter reading the specification, could practice theclaimedinvention without undue experimentation." AK Steel Corp. v. Sollac& Ugine, 344 F.3d 1234, 1244 (Fed. Cir. 2003); accord PTO,Guidelinesfor 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 statutetorequire that a patent "state the component parts of the new manufacture claimed with clearness and precision, and not leave the personattemptingto use the discovery to find it out 'by experiment'"). Enablementis an essential aspect of the basic quid pro quo that underlies apatentgrant, because it ensures that the invention is immediately added tothestorehouse of public knowledge and that the public will receiveunlimiteduse of the invention after patent protection expires. See Kewanee OilCo.v. Bicron Corp., 416 U.S. 470, 480-481 (1974); Evans v. Eaton, 20 U.S.(7Wheat.) 356, 433-434 (1822).

In addition to enabling the invention, the specifica tion mustcontaina "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 hadpossessionof the claimed invention at the time of the application, i.e., that thepatentee invented what is claimed." LizardTech, Inc. v. Earth ResourceMapping, 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 possession of the claimed invention by describing the claimed invention withallof its limitations using such descrip tive means as words, structures,figures,diagrams, and formulas that fully set forth the claimed invention." PTO112 Guidelines, 66 Fed. Reg. at 1104. Demonstrat ing that an inventionhas been reduced to practice is one such way of showing possession, id.at 1104, 1107-1108 n.6, although an invention need not have beenreducedto 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 claimanthasinvented and possessed the claimed subject matter, the writtendescriptionrequire ment helps to prevent inventors from later asserting that theyinventedmore 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); seegenerallyEvans, 20 U.S. (7 Wheat) at 434-435.

As the court of appeals explained, the enablement and writtendescriptionrequirements are considered from the perspective of one skilled in theart. 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 thiscase,the parties agreed, and the jury was instructed, that such a personwouldhave "a medical degree and experience in researching the amino acidhomocysteine and its relationship to diseases." Pet. App. 7a (citationomitted).

b. Especially from the perspective of such a person, the patentspecificationeasily satisfies the enablement and written description requirements byexplaining pre cisely how to perform the claimed method and demonstratingthat the applicants had in fact performed it. The specificationexplainsthat "[i]t has now been discov ered that an elevated level of totalhomocysteine in tis sues of warmblooded animals correlates both withcobalamindeficiency and with folic acid deficiency; an animal with elevatedlevelsof total homocysteine is likely to have one or both deficiencies." S.A.11. The specification goes on to disclose both how to assay for totalhomocysteine and how to correlate elevated levels of total homocysteinewith deficiencies in the B vitamins. See, e.g., S.A. 12-14.

The specification explains that "[s]uitable assays for this purposeinclude any assays capable of determining levels of homocysteine inbodytissues, preferably body fluids." S.A. 12. Although petitionererroneouslycon tends (Pet. 23) that "[n]either the claim nor the specifi cationsays anything about how one is to conduct the assay," the specificationdescribes "several different known assays suitable for use indetermininglevels of homocysteine in urine or blood," S.A. 12, as well as a newassay method claimed in the '658 patent, S.A. 12-14. The specificationalso includes two detailed examples that describe how the applicantsmeasuredhomocy steine using different assay methods. See S.A. 15-20. Thus, thespecification leaves no doubt that the appli cants had undertaken theassaystep, and it simulta neously enables others skilled in the art toundertakethat step by showing them how to do so.

The same is true of the correlation step. The specifi cationdisclosesthat "[t]he normal range for homocy steine in human serum is from about7 to about 22 mol/liter, and in human urine is from about 1 to about 20mol/liter. Homocysteine levels above these ranges are indicative ofcobalaminand/or folate deficiency; the higher the level, the stronger theindication." S.A. 14. The specification then provides an example oftests con ductedby the applicants in which total homocysteine levels were elevatedabovenormal 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 thespecificationdoes 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/folatedeficiency exists vel non based on the assaying step." Pet. App. 18a;see id. at 8a ("The claim only requires association of homocysteinelevels with vitamin deficien cies. It requires no further correlationtoconfirm the relationship.").

Although petitioner protests (Pet. 24) that "[a]ll the patent tellsa prospective practitioner is that a person with an elevatedhomocysteinelevel may have a vitamin deficiency," the mere fact that the claimeddetecting method may not always be accurate does not render it invalidunderSection 112. The written description and enablement inquiries focus onthe disclosure and posses sion of the invention, not the extent of itsutility. And notwithstanding petitioner's criticisms, moreover, thepatent claimappears to have substantial utility. The court of appeals explainedthatthe claimed method pre dicts cobalamin or folate deficiency "relativelyaccu rately." Pet. App. 11a; see S.A. 28.

c. In any event, the written description and enable ment issues inthiscase are primarily factual. This Court long ago stated that analogousrequirementsin the Patent Act of 1793, ch. 11, 1 Stat. 318, were "matter[s] offact for the jury, and not of law for the de cision of the Court."Evans, 20 U.S. (7 Wheat.) at 428. Under the modern patent statutes, theFederal Circuit treats the adequacy of a written description as a questionof fact and enablement as a question of law based on subsidiaryfindingsof fact. Moba, 325 F.3d at 1319, 1321; Pet. App. 4a-5a.

Here, the jury found that the specification satisfied both theenablementand written description require ments, J.A. 396-397, the district courtdenied 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 therecord,see, e.g., id. at 17a ("The record is replete with evidentiary supportthat * * * persons of ordinary skill in the art * * * understood fromthespecification that the '658 patent inventors pos sessed the'correlating'step."). This Court does not or dinarily disturb such fact-specificdeterminations, see generally Graver Tank & Mfg. Co. v. Linde AirProds.Co., 336 U.S. 271, 275 (1949), and there is no reason to upset thejury'sverdict on the enablement and written description questions here.1

2. While the enablement and written description requirements focusonthe content of the patent specifi cation, the definiteness requirementdirectsthat the patent claim must "particularly point[] out and distinctlyclaim[] the subject matter which the applicant regards as hisinvention." 35 U.S.C. 112. "It has long been un derstood that a patentmust describethe exact scope of an invention and its manufacture to 'secure to [thepatentee] all to which he is entitled, [and] to apprise the public of whatis still open to them.'" Markman v. Westview Instruments, Inc., 517U.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 onwhetherthe claim makes "[t]he limits of the patent" known. General Elec.Co. v. Wabash Appliance Corp., 304 U.S. 364, 369 (1938); accord UnitedCarbonCo. v. Binney & Smith Co., 317 U.S. 228, 232, 236 (1942). Inassessingdefinite ness, a claim must be read in light of the specification andtheknowledge of a person skilled in the art. Carne gie Steel Co. v.CambriaIron Co., 185 U.S. 403, 432, 437 (1902). Thus, "[t]he test fordefinitenessis whether one skilled in the art would understand the bounds of theclaimwhen read in light of the specification." Miles Labs., Inc. v. ShandonInc., 997 F.2d 870, 875 (Fed. Cir. 1993), cert. denied, 510 U.S. 1100(1994).2

Especially when read by a person skilled in the art in light of thespecification, claim 13 satisfies the definite ness requirement becauseit marks the boundaries of the patent claim with precision. The claimisinfringed only if a person "assay[s] a body fluid for an elevated levelof total homocysteine," and then "correlat[es] an elevated levelof total homocysteine in said body fluid with a defi ciency ofcobalaminor 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 totalhomocysteine,'the physician determines whether there is a cobalamin or folatedeficiencyby 'correlating,' i.e., comparing the elevated level with the normalhomocysteinelevel." Pet. App. 12a (quoting S.A. 30); see p. 11, supra.

3. Petitioner argues (Pet. 23) that if claim 13 satis fied theenablement,written description, and definite ness requirements, "parties couldclaim patent monopo lies over basic scientific facts rather than anynovelin ventions." That argument confuses the Section 112 dis closure anddrafting requirements with the Patent Act's separate limitations on thesubject matter eligible for patent protection. This Court has long heldthat under 35 U.S.C. 101, "laws of nature, natural phenomena, andabstractideas" may not be patented. Diamond v. Diehr, 450 U.S. 175, 185 (1981).But that limitation under Sec tion 101 is entirely separate anddistinctfrom the re quirements of Section 112. Cf. pp. 17-27, infra.

B. WHETHER THE PATENT CLAIM IS INVALID BECAUSE IT CLAIMS A LAW OFNATURE,NATURAL PHENOME NON, OR ABSTRACT IDEA IS NOT FAIRLY INCLUDED IN THEQUESTIONPRESENTED

Although the patent claim as construed by the courts below may beinvalidunder the rule that natural phe nomena may not be patented (see pp.17-27,infra), that issue is not fairly included in the question presented.Underthis Court's Rule 14.1(a), "[o]nly the questions set out in thepetition,or fairly included therein, will be considered by the Court." Thequestion presented here asserts (Pet. i) that the patent claim includesa step that is not sufficiently enabled, described, or definite. Althoughit also asks (ibid.) whether such a patent claim "can validly claima monopoly over a basic scientific rela tionship used in medicaltreatmentsuch that any doctor necessarily infringes the patent merely bythinkingabout the relationship after looking at a test result," that portionof the question is not fairly read as an inde pendent assertion thatclaim13 violates Section 101 by claiming unpatentable subject matter. To thecontrary, that passage appears on its face to be mere argumentregardingthe alleged consequences of upholding the claim against petitioner'sSection112 challenge.

The body of the petition supports that interpretation. The relevantargument heading states that "A Patent That Simply Claims A Scientific'Correlation'-Without More-Is Indefinite, Insufficiently Described, andNon- Enabling." Pet. 23 (emphasis omitted). The heading does notassert that the claim is invalid under the natural-phenomenon doctrineofSection 101. The text of the petition (Pet. 23-26) then focuses on theSection 112 issues. Although it argues (Pet. 25) that "[i]f the FederalCircuit decision is not corrected, [respondent] CTI and others like itwouldimproperly gain monopolies over basic scientific facts," thatcontention,like the cor responding portion of the question presented, appears tobeargument regarding the consequences of uphold ing the court of appeals'Section 112 rulings-not a stand-alone claim of invalidity based onSection101, which is not even cited in the petition.3 Because the pe tition,fairlyread, challenges the patent claim's validity only on grounds other thanfailure to comply with Sec tion 101, the claim's validity under thatSectionis not properly before this Court. See, e.g., Yee v. City of Escondido,503 U.S. 519, 537 (1992); Albertson's, Inc. v. Kirkingburg, 527 U.S.555,563 n.9 (1999); see also Gov't Cert. Br. 16-17.

The absence of any Section 101 challenge from the petition is notsurprising,because petitioner did not raise such a challenge in either of thelowercourts, and neither of those courts addressed the issue. In the courtofappeals, petitioner noted in passing that if its indefi nitenesschallengewere rejected, respondent CTI "would improperly gain a monopoly overa basic scien tific fact rather than any novel invention of its own."Pet. Corr. C.A. Br. 41 (citing Diehr, 450 U.S. at 185). As in thepetition,however, petitioner advanced that cur sory argument solely in supportofits Section 112 chal lenge, not as a separate ground for reversal underSec tion 101. See Gov't Cert. Br. 15-17.

This Court does not ordinarily review questions that were neitherpressednor passed upon below. See, e.g., Adarand Constructors, Inc. v. Mineta,534 U.S. 103, 109 (2001). Although respondents did not call the Court'sattention to the waiver in their brief in opposition, they should notbefaulted for failing to raise a waiver objec tion to an issue that wasnotfairly included in the ques tion presented. Cf. Sup. Ct. R. 15.2 ("Anyobjection to consideration of a question presented * * * may be deemedwaivedunless called to the Court's attention in the brief in opposition.")(emphasis added). Accord ingly, this case does not properly present anyissue re garding the natural phenomenon doctrine.

C. THE PATENT CLAIM APPEARS TO CLAIM ALL SUB STANTIAL PRACTICALAPPLICATIONSOF THE NATU RAL RELATIONSHIP THAT ARE REVEALED BY THE LIMITED RECORDBEFORETHE COURT

If this Court were to conclude that the question pre sented fairlyincludesa challenge to the validity of claim 13 under Section 101, any suchchallengewould neces sarily be limited to the question whether the patentimpermissiblyclaims "a monopoly over a basic scientific relationship," Pet.i, because that is the only potentially relevant language in thequestionpresented. As con strued by the court of appeals, and on the limitedrecordpresently before the Court, claim 13 appears to run afoul of the rulethatone cannot patent every "substan tial practical application" ofa law of nature, natural phe nomenon, or abstract idea. Gottschalk v.Benson,409 U.S. 63, 71-72 (1972). Because petitioner did not raise a Section101challenge in the courts below, however, re spondents had no opportunityor incentive to introduce evidence on that issue in the district court,and accord ingly a remand for further proceedings would be re quired inorder to resolve that issue definitively.

1. a. The scope of patentable subject matter is gen erally quitebroad. "Whoever invents or discovers any new and useful process,machine,manufacture, or com position of matter, or any new and usefulimprovementthereof, may obtain a patent therefor" if the other condi tions forpatentability, such as novelty, non-obviousness, and the Section 112requirementsare satisfied. 35 U.S.C. 101. Thus, this Court has noted that "Congressintended statutory subject matter to 'include anything under the sunthatis made by man.'" Diehr, 450 U.S. at 182 (quoting S. Rep. No. 1979,82d Cong., 2d Sess. 5 (1952), and H.R. Rep. No. 1923, 82d Cong., 2dSess.6 (1952)).

"Excluded from such patent protection," however, are "lawsof nature, natural phenomena, and abstract ideas." Diehr, 450 U.S.at 185; accord, e.g., Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980);Parker v. Flook, 437 U.S. 584, 589 (1978); Benson, 409 U.S. at 67-68;FunkBros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948); MackayRadio& Tel. Co. v. Radio Corp. of Am., 306 U.S. 86, 94 (1939). "Aprinciple,in the ab stract, is a fundamental truth; an original cause; a mo tive;these cannot be patented, as no one can claim in either of them anexclusiveright." Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1852); seeRubber-TipPencil Co. v. Howard, 87 U.S. (20 Wall.) 498, 507 (1874); O'Reilly v.Morse,56 U.S. (15 How.) 62, 116 (1853). In stead, such "manifestations oflaws of nature" are "part of the storehouse of knowledge,""free to all men and reserved exclusively to none." Funk, 333U.S. at 130; see Benson, 409 U.S. at 67 ("Phenomena of nature, thoughjust discovered, mental processes, and abstract intellectual conceptsarenot patentable, as they are the basic tools of scientific andtechnologicalwork.").

Thus, "a new mineral discovered in the earth or a new plant foundin the wild is not patentable subject matter" under Section 101.Chakrabarty,447 U.S. at 309. "Likewise, Einstein could not patent his celebratedlaw that E=mc2; nor could Newton have patented the law of gravity."Ibid. Nor can one patent "a novel and useful mathematical formula,"Flook, 437 U.S. at 585; electromagnetism or steam power, Morse, 56 U.S.(15 How.) at 113-114; or "[t]he qualities of * * * bacteria, * * * theheat of the sun, electricity, or the qualities of metals,"Funk, 333 U.S. at 130; see Le Roy, 55 U.S. (14 How.) at 175.

b. Claim 13 involves such a natural phenomenon, because it assertsandrelies on the existence of a natu rally occurring correlation betweenelevatedlevels of total homocysteine and deficiencies in cobalamin or fo late.The natural relationship between elevated total homocysteine anddeficienciesin the B vitamins is an unpatentable "principle in natural philosophyor physic al science," Morse, 56 U.S. (15 How.) at 116, just as therelationship between energy, mass, and the speed of light discovered byEinstein (E=mc2), and the relation ship between force of attraction,mass,and distance dis covered by Newton (the law of gravity), are unpatentablenatural phenomena. See Chakrabarty, 447 U.S. at 309. Insofar as therelationshipis no more than an ob servable, naturally occurring fact of humanphysiology,it is also analogous to observations of the properties of bacterialstrainsand metals, which this Court has held to be unpatentable. See Funk, 333U.S. at 130.

c. Determining whether claim 13 involves a phe nomenon of nature isonly the beginning of the inquiry, however, because "[i]t is nowcommonplacethat an ap plication of a law of nature or mathematical formula to aknownstructure or process may well be deserving of patent protection."Diehr, 450 U.S. at 187; accord Flook, 437 U.S. at 590 ("[A] processis not unpatentable simply because it contains a law of nature.");Benson, 409 U.S. at 67; Funk, 333 U.S. at 130. "While a scientifictruth, or the mathematical expression of it, is not [a] patentableinvention,a novel and useful structure cre ated with the aid of knowledge ofscientifictruth may be." Diehr, 450 U.S. at 188 (quoting Mackay, 306 U.S. at94).

It is also well established, however, that a patent applicantcannotvalidly patent a process that comprises every "substantial practicalapplication" of a law of na ture, because such a patent "wouldwholly pre-empt the [law of nature] and in practical effect would be apatenton the [law of nature] itself." Benson, 409 U.S. at 71-72; see PTO,Interim Guidelines for Examination of Patent Applications for PatentSubjectMatter Eligibility (In terim Subject Matter Eligibility Guidelines),1300Off. Gaz. Pat. Office 142, 146 (Nov. 22, 2005) <http://www.uspto.gov/web/patents/patog/week47/OG/TOC.htm#ref13>. That "preemption" limitation is important becausewithout it, "a competent draftsman [could] evade the recognizedlimitationson the type of subject matter eligible for patent protection." Diehr,450 U.S. at 192; accord Flook, 437 U.S. at 590, 593.

2. If the question presented raises a Section 101 issue at all, itiswhether claim 13 impermissibly asserts "a monopoly over a basicscientificrelationship," be cause that is the only potentially relevant languagein the text of the question presented. Pet. i. At most, that languagecan be read to raise the question whether claim 13 is invalid under thepreemption rationale set forth in Benson, on the ground that it coversallsubstan tial practical applications of the asserted natural phenomenon. That language cannot plausibly be read to include otherpotential challengesto the validity of the patent claim under Section 101. It does not, forexam ple, ask whether the claim sets forth an invalid but particularizedapplication of the natural phenomenon, as opposed to claiming theentiretyof the natural phenome non.4

a. As construed by the court of appeals, claim 13 is sweeping initsscope. The Federal Circuit determined that "[t]he claim only requiresassociation of homocy steine levels with vitamin deficiencies." Pet.App. 8a. Under that holding, "correlate" means "to relatethe presence of an elevated total homocysteine level to ei ther acobalaminor folate deficiency, or both * * *, and also to relate the absence ofanelevated total homocy steine level to a deficiency in neither." Id.at 12a. Ac cording to the court of appeals, "[t]he claim simply saysnothing about a confirmatory step or a further correla tion beyond thestatedrelationship." Id. at 8a-9a; ac cord id. at 10a. Instead, "[t]hecorrelating step is a sim ple conclusion that a cobalamin/folatedeficiencyexists vel non based on the assaying step." Id. at 18a. In sum, thecourt of appeals held that anyone who thinks about the relationshipbetweenelevated total homocysteine and cobalamin or folate deficiency afterobtainingthe results of a total homocysteine assay infringes the pat ent claim.

The claim's breadth is further underscored by the jury's findingsandthe relief awarded, which suggest that doctors infringe the patentclaimwhenever they review the results of total homocysteine assays, regardlessof the purpose for which they ordered the assays. The district courtinstructedthe jury that it should find petitioner liable for contributoryinfringementif, among other things, the total homocysteine assays performed bypetitionerwere not "capable of substantial nonin fringing use." J.A. 379. Byfinding petitioner liable for contributory infringement, the jurynecessarilycon cluded that no substantial non-infringing uses of the totalhomocysteineassays had been proven on the trial record.

In so concluding, the jury implicitly rejected peti tioner'scontentionthat many of the assays did not in fringe because doctors ordered themforpurposes other than diagnosing cobalamin or folate deficiency. Petitionerhad argued that the assays were used primarily to diagnose otherconditions,especially heart disease. See Pet. C.A. Br. 31-33. Respondents'witnessescoun tered that, whatever the motivation for the assay, it would be"malpractice"for a physician not to perform the correlation upon viewing a totalhomocysteineassay, and that the other conditions associated with elevated totalhomocysteineare treated with supplements of cobalamin or folate in any event. SeeResp.C.A. Br. 32- 33, 41-42, 45. The jury's verdict demonstrates that, likethe court of appeals, it credited that testimony. See Pet. App. 14a(relyingon testimony that "it would be mal practice for a doctor to receivea total homocysteine as say without determining cobalamin/folatedeficiency").

Indeed, the jury evidently awarded damages based on all of theassaysperformed by petitioner, because it awarded the full amount requestedbyrespondents for "all of the assays that were done." J.A. 175-176;see J.A. 396. The district court then permanently enjoined peti tionerfrom performing "any homocysteine-only test, including withoutlimitationhomocysteine-only tests via [petitioner's preferred] method." Pet.App. 36a (empha sis added and citation omitted).

Although the court of appeals did not review the jury'scontributory-infringementfinding or damages award, it affirmed the scope of the district court'sin junction. Pet. App. 15a, 27a. The court specifically re jectedpetitioner'scontention that "the injunction is too broad because it extends beyondthe scope of the claims." Id. at 27a. "To the contrary,"the court con cluded, "the injunction simply addresses [petitioner's]specific acts constituting indirect infringement." Ibid. The courtof appeals thereby appears to have concluded that any assay for totalhomocysteinewould infringe claim 13, regardless of the reason a doctor ordered it,becauseany doctor reviewing a total homocysteine re sult would necessarilyperformthe correlation in his or her head.

b. In light of that broad claim construction and the jury'sfindings,on the record presently before the Court claim 13 appears to cover allsubstantialpractical appli cations of the natural phenomenon. As has been demonstrated,however, the parties did not litigate that issue in the lower courts,andthus respondents had neither reason nor opportunity to introduceevidenceto attempt to defeat a preemption challenge. Moreover, the rele vanceofthe jury's findings on non-infringing uses for purposes of thecontributoryinfringement issue is di luted by the fact that respondents bore theburdenof proof on that issue, whereas petitioner bore the burden of provinginvalidityby clear and convincing evidence. See J.A. 378, 379-380, 390.5

It is unclear, therefore, whether the record would have reflectedtheexistence of one or more substantial practical applications of thecorrelationthat are not cov ered by the patent if the preemption issue had beenfullylitigated below. It is possible, however, to hypothesize potentialnon-infringingapplications that could perhaps be found to be substantial on anappropriaterecord.

i. Because the assay step of claim 13 is limited to assaying a"bodyfluid" (S.A. 30), researchers or physi cians might be able to employthe correlation without infringing the patent merely by determiningtotalhomo cysteine levels through a method other than an assay of bodyfluids. The specification states that "[i]t has now been discoveredthat anelevated level of total homocysteine in tissues of warmblooded animalscorrelates both with cobalamin deficiency and with folic acid deficiency."S.A. 11 (emphasis added). The specification further explains that"[s]uitableassays for this purpose include any assays capable of determininglevelsof homocysteine in body tissues, preferably body fluids." S.A. 12(emphasis added).

It is unclear whether any feasible methods exist for determininghomocysteinelevels without assaying body fluids, or whether any such methods wouldconstitutesubstantial applications of the correlation. The specifi cationdiscloses"several different known assays suitable for use in determining levelsof homocysteine in urine or blood," S.A. 12, but those are body fluids.The patent also claims a series of novel assay methods that are not bytheir terms limited to body fluids (and one of which expressly includesassays of a "body tissue"), see S.A. 30, but the specification'sexamples all involve assays of body fluids, see S.A. 12-20.6

ii. It might also be argued that there are uses of the correlationthatdo not involve any measurements, and therefore are not preempted. Forexample,if a patient had a condition known to be associated with elevated totalhomocysteine and cobalamin or folate deficiency, a doctor mightprescribecobalamin or folate supplements with an eye toward both treating thevitamindeficiency and heading off potential health problems associated withelevatedtotal homocysteine, such as heart disease.

Under the court of appeals' construction of the "cor relating"step, administering cobalamin or folate supple ments in suchcircumstancesmight constitute a use of the correlation that would not involveassayingfor total homocysteine. If so, the question would be whether doc torsengagein that thought process to such an extent that it comprises asubstantialpractical application of the correlation.

c. Thus, it is conceivable that, if a preemption chal lenge underSection101 had been raised in the district court, the record would reflectadditionalinformation concerning the feasibility and relative significance ofthoseor other possible non-infringing applications of the correlationassertedin claim 13. Accordingly, if this Court were to conclude that theSection101 issue is properly presented, it should vacate and remand forfurtherproceedings to determine whether all substan tial practicalapplicationsof the correlation are claimed by the patent.7

3. Regardless of whether claim 13 preempts the nat ural phenomenonatissue here, many medical and diag nostic procedures are unquestionablypatentable. For example, the first 12 claims in the '658 patentidentify assay methodswhose validity has never been chal lenged, in part because they providenovel ways of mea suring substances in bodies. See S.A. 30.

Moreover, many diagnostic procedures that involve correlations maynotmonopolize all of the correlations' substantial practical applications.For example, claim 14 of the patent at issue here is identical to claim13 except that it limits the assay step to assays undertaken ac cordingto a specified and novel method. See S.A. 30. Because that claim doesnot cover all substantial practi cal applications of the naturalrelationship-includingthe assays at issue in this case, which did not make use of the methodidentifiedin claim 14-its validity would not be jeopardized by a holding thatclaim13 impermissibly preempts all substantial practical applica tions ofthenatural correlation.

Other patents that use the term "correlate" might also beconstrued to use that term more narrowly than the court of appealsconstruedit here. All else being equal, the more limits a claim is read toinclude,the more likely it is that the claim covers only some, but not all,substantialpractical applications of any natural phe nomena used in the claimedinvention.

D. THE PATENT CLAIM IS INVALID UNDER 35 U.S.C. 102 IF IT CLAIMSASSAYMETHODS THAT WERE ALREADY INCLUDED IN THE PRIOR ART

The question presented does not ask whether claim 13 is invalidunder35 U.S.C. 102 because it was antici pated by the prior art, and thatquestionis therefore not before this Court. We note, however, that claim 13, asconstrued by the court of appeals, appears to be invalid under Section102because the claim effectively prevents doctors from using previouslyknownassay methods to measure total homocysteine for any purpose, even ifthepurpose was not to diagnose cobalamin or folate defi ciency.

"[T]he stringent requirements for patent protection seek to assurethat ideas in the public domain remain there for the free use of thepublic." Aronson v. Quick Point Pencil Co., 440 U.S. 257, 262 (1979).Thus, "§102 of the Patent Act * * * exclud[es] ideas that are in the publicdomain from patent protection," Pfaff, 525 U.S. at 64, by generallyproviding that no patent may issue on an invention previously known,used,or sold in this country, 35 U.S.C. 102(a), (b). See Bonito Boats, Inc.v. Thunder Craft Boats, Inc., 489 U.S. 141, 148 (1989). Thatfundamentallimitation on patentability is rooted in Article I, Section 8, Clause 8of the Constitution, which this Court has construed to preclude "theissuance of patents whose effects are to remove existent knowledge fromthe public domain, or to restrict free access to ma terials alreadyavailable." Bonito Boats, 489 U.S. at 146 (quoting Graham v. John DeereCo., 383 U.S.1, 6 (1966)).

Although the court of appeals held that the prior art in the recorddid not specifically disclose the correlation between elevated totalhomocysteineand cobalamin or folate deficiency, Pet. App. 18a-20a, the patentspecification acknowledges that methods of assaying for total homocysteine wereknownin the prior art and were used to screen for various medical conditionsother than cobalamin or folate deficiency, see S.A. 12; p. 10, supra.Asexplained above, however, the lower courts enjoined petitioner fromperforming"any homocysteine-only test," Pet. App. 36a, and construed claim13 in such a way that a doctor reviewing a total homocysteine assaycannothelp but infringe the patent regardless of the purpose for which he orsheordered the assay. See pp. 22-24, supra.

So construed, claim 13 appears to remove methods of assaying fortotalhomocysteine from the public domain, in violation of Section 102. "[I]fgranting patent protec tion on the disputed claim would allow thepatenteeto exclude the public from practicing the prior art, then that claim isanticipated, regardless of whether it also covers subject matter not inthe prior art." Atlas Pow der Co. v. Ireco Inc., 190 F.3d 1342, 1346(Fed. Cir. 1999); accord Schering Corp. v. Geneva Pharm., Inc., 339F.3d1373, 1379 (Fed. Cir. 2003). Although claim 13 might not be invalid asanticipated if the correlating step were construed to be less sweeping,or if the assay step were limited to novel assay methods, as construedbythe court of appeals the claim appears to remove the prior art from thepublic domain, in violation of Section 102.8

If the patent claim were held invalid, an anticipation rationalewouldbe more administrable than a preemp tion rationale because it wouldrelyon publicly known inventions, as opposed to requiring an inquiry intopotential alternative applications that may not yet have been disclosedordiscovered.

CONCLUSION

If this Court concludes that the question presented does not fairlyinclude the question whether the patent claims all substantialpracticalapplications of the natu ral correlation, the judgment of the court ofappealsshould be affirmed, or in the alternative the writ of cer tiorarishouldbe dismissed as improvidently granted. If this Court concludes that thequestion presented does include that issue, the judgment of the courtofappeals should be vacated and the case remanded for further proceedings.

Respectfully submitted.

PAUL D. CLEMENT
Solicitor General
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

JAMES A. TOUPIN
General Counsel
JOHN M. WHEALAN
Deputy General Counsel
STEPHEN WALSH
RAYMOND T. CHEN
Associate Solicitors
Patent and Trademark Office

DECEMBER 2005

1 There is some disagreement among the Federal Circuit's decisionsregardingwhether the written description requirement is satisfied by evidencetheinventor possessed the invention, or whether some further descriptionofthe invention may be required in some circumstances. See, e.g., EnzoBiochem,Inc. v. Gen-Probe Inc., 323 F.3d 956, 969 (Fed. Cir. 2002). PTO hasinterpretedthe written description requirement to focus solely on possession, seePTO112 Guidelines, 66 Fed. Reg. at 1102, 1104, and the Federal Circuit'srecentcases appear to adopt that view, see, e.g., LizardTech, 424 F.3d at1345;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 relevanthere,however, because the specification clearly describes the claimedmethod,its allegedly novel aspects, and the extent to which it differs fromtheprior art disclosed in the specification, and thus satisfies eitherstandard. See S.A. 10-14; pp. 10-11, supra.

2 Although General Electric, United Carbon, and Carnegie Steelinterpretedthe definiteness requirement of the Patent Act of 1870, ch. 230, 16Stat.198, the modern version of Section 112 "is not materially differentfrom the 1870 Act with regard to claiming." Warner-Jen kinson Co.v. Hilton Davis Chem. Co., 520 U.S. 17, 26 (1997). Accord ingly, thoseprecedents apply with full force to the current definitenessrequirement.

3 That contention is also wrong for the related reason that nomatterhow the Section 112 issue is resolved, other litigants will retain theright,which petitioner failed to exercise below, to make a non- patentablesubjectmatter argument under Section 101.

4 Under any reading of the question presented, therefore, it doesnotencompass the question whether a process patent that includes a transformativestep satisfies Section 101 when the only "inventive" aspect ofthe patent is a newly discovered law of nature or natural phenomenon.SeeGov't Cert. Br. 11-15 (discussing that issue); see also id. at 7-10. Asthe government explained in its brief at the petition stage (id. at12-14),that question turns on the extent to which this Court's decision inDiehris properly understood to limit the rationale set forth in Flook. Thatissue is not raised by the question on which the Court granted certiorari,because it asks only whether a patentee "can validly claim a monopolyover a basic scientific relationship" (Pet. i (emphasis added)),whereasthe Court emphasized in both Diehr and Flook that those cases did notinvolvemonopolization of a law of nature. Diehr, 450 U.S. at 187 (patentees"donot seek to pre-empt the use of that equation"); Flook, 437 U.S. at589-590 (patentee "does not seek to 'wholly preempt the mathematicalformula'") (quoting Benson, 409 U.S. at 72).

If the issue were before this Court, determining whether claim 13constitutesa valid application of the natural phenomenon would requireconsiderationof the claim "as a whole." Diehr, 450 U.S. at 188; accord Flook,437 U.S. at 594 & n.16. PTO has issued interim guidelines instructingits examiners to determine that if a claim, taken as a whole, "providesa transformation or reduction of an article to a different state orthing,""the claim meets the statutory requirement of 35 U.S.C. Sec. 101."Interim Subject Matter Eligibility Guidelines, 1300 Off. Gaz. Pat.Officeat 146. Claim 13 appears to satisfy that test because the variousmethodsof assaying for total homocysteine that are des cribed in the recordentailsignificant physical or chemical alteration of a sample of blood orotherbodily fluid. See, e.g., S.A. 15-16, Pl. Tr. Exh. 205, Def. Tr. Exhs.JPand BT (describing such methods). PTO's guide lines reflect its (andtheFederal Circuit's) view that Diehr substantially limited the FlookCourt'sholding that a claimed method must contain some inventive aspect otherthana natural phenomenon in order to be patentable under Section 101.CompareDiehr, 450 U.S. at 188-190, with Flook, 437 U.S. at 592-594; see Gov'tCert.Br. 11-14.

5 It is unclear, moreover, whether the inquiry into substantial non-infringing uses in the contributory infringement and damages contextsisthe same as the inquiry into substantial practical applications forpurposesof the preemption issue. It is at least conceivable, for example, thata substantial practical application could exist (and thus preclude afindingof preemption) but be irrelevant for purposes of contributoryinfringementand damages, because it would be a useexclusively by persons other than doctors who order homocysteine assaysfrom petitioner.

6 As noted above, the district court enjoined petitioner fromperforming "any homocysteine-only test," Pet. App. 36a (emphasis addedand citation omitted), and the court of appeals affirmed thatinjunction,id. at 27a. See pp. 23-24, supra. If the only basis for rejecting a preemption challenge to claim 13 were the existence of homocysteine testsoftissues other than body fluids, the injunction would presumably have tobe narrowed to exempt such tests.

7 The Federal Circuit's predecessor held that Benson applies only tomathematical algorithms. See, e.g., In re Toma, 575 F.2d 872, 877(C.C.P.A.1978). Benson's rationale-that one may not patent an "idea,"and that would be the practical effect of patenting all substantialpracticalapplications of the idea, 409 U.S. at 71-refutes any attempt to cabinBenson'sholding to mathematical algorithms. See also id. at 67-69 (relying oncasesinvolving natural phenomena other than mathe matical algorithms).

8 The Patent Act specifies that "a new use of a known process"con stitutes a "process" eligible for patent protection. 35 U.S.C.100(b). Claim 13's apparent invalidity under Section 102 stems from itsbreadth, not from the mere fact that it applies known assay processes.