United States Court of Appeals
`for the Federal Circuit
`______________________
`
`ARIOSA DIAGNOSTICS, INC., NATERA, INC.,
`Plaintiffs-Appellees
`
`DNA DIAGNOSTICS CENTER, INC.,
`Counterclaim Defendant-Appellee
`
`v.
`
`SEQUENOM, INC., SEQUENOM CENTER FOR
`MOLECULAR MEDICINE, LLC,
`Defendants-Appellants
`
`ISIS INNOVATION LIMITED,
`Defendant
`______________________
`
`2014-1139, 2014-1144
`______________________
`
`Appeals from the United States District Court for the
`Northern District of California in Nos. 3:11-cv-06391-SI,
`3:12-cv-00132-SI, Judge Susan Y. Illston.
`______________________
`
`Decided: June 12, 2015
`______________________
`
`DAVID ISAAC GINDLER, Irell & Manella LLP, Los Ange-
`les, CA, argued for plaintiff-appellee Ariosa Diagnostics,
`Inc. Also represented by ANDREI IANCU; AMIR NAINI, Russ
`August & Kabat, Los Angeles, CA.
`
`
`1
`
`SAMSUNG 1041
`Samsung Electronics v. SmartFlash
`CBM2014-00192
`
`

`
`
`
` 2
`
` ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC.
`
`WILLIAM PAUL SCHUCK, Bartko, Zankel, Bunzel & Mil-
`ler, San Francisco, CA, for plaintiff-appellee Natera, Inc.,
`counterclaim defendant-appellee DNA Diagnostics Cen-
`ter, Inc.
`
`
`MICHAEL J. MALECEK, Kaye Scholer LLP, Palo Alto,
`CA, argued for defendants-appellants. Also represented
`by PETER E. ROOT, Menlo Park, CA; ATON ARBISSER, Los
`Angeles, CA.
`
`RICHARD L. BLAYLOCK, Pillsbury Winthrop Shaw
`Pittman LLP, San Diego, CA, for amicus curiae Invitae
`Corporation. Also represented by KIRKE M. HASSON,
`COLIN TRAVERS KEMP, San Francisco, CA.
`
`KEVIN EDWARD NOONAN, McDonnell, Boehnen Hul-
`bert & Berghoff, LLP, Chicago, IL, for amicus curiae
`Biotechnology Industry Organization.
`
`WILLIAM LARRY RESPESS, I, Sheppard, Mullin, Richter,
`& Hampton LLP, San Diego, CA, for amicus curiae The
`San Diego Intellectual Property Law Association.
`______________________
`
`Before REYNA, LINN, and WALLACH, Circuit Judges.
`Opinion for the court filed by Circuit Judge REYNA.
`Concurring Opinion filed by Circuit Judge LINN.
`REYNA, Circuit Judge.
`This appeal is from a grant of summary judgment of
`invalidity of the asserted claims of U.S. Patent No.
`6,258,540 (“the ’540 patent”). The United States District
`Court for the Northern District of California found that
`the asserted claims of the ’540 patent are not directed to
`patent eligible subject matter and are therefore invalid
`under 35 U.S.C. § 101. For the reasons explained below,
`we affirm.
`
`2
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`

`
`ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC.
`
`3
`
`I
`In 1996, Drs. Dennis Lo and James Wainscoat discov-
`ered cell-free fetal DNA (“cffDNA”) in maternal plasma
`and serum, the portion of maternal blood samples that
`other researchers had previously discarded as medical
`waste. cffDNA is non-cellular fetal DNA that circulates
`freely in the blood stream of a pregnant woman. Applying
`a combination of known laboratory techniques to their
`discovery, Drs. Lo and Wainscoat implemented a method
`for detecting the small fraction of paternally inherited
`cffDNA in maternal plasma or serum to determine fetal
`characteristics, such as gender. The invention, commer-
`cialized by Sequenom as its MaterniT21 test, created an
`alternative for prenatal diagnosis of fetal DNA that
`avoids the risks of widely-used techniques that took
`samples from the fetus or placenta. In 2001, Drs. Lo and
`Wainscoat obtained the ’540 patent, which relates to this
`discovery.
`The parties agree that the patent does not claim
`cffDNA or paternally inherited cffDNA. Instead, the ’540
`patent claims certain methods of using cffDNA. The steps
`of the method of claim 1 of the ’540 patent include ampli-
`fying the cffDNA contained in a sample of a plasma or
`serum from a pregnant female and detecting the paternal-
`ly inherited cffDNA. Amplifying cffDNA results in a
`single copy, or a few copies, of a piece of cffDNA being
`multiplied across several orders of magnitude, generating
`thousands to millions of copies of that particular DNA
`sequence. In the amplification step, DNA is extracted
`from the serum or plasma samples and amplified by
`polymerase chain reaction (“PCR”) or another method.
`PCR exponentially amplifies the cffDNA sample to de-
`tectable levels.
`In the detecting step, the lab technician adds the am-
`plified cffDNA to an agarose gel containing ethidium
`
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` 4
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` ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC.
`
`bromide to stain and visualize the paternally inherited
`cffDNA.
`The ’540 patent also provides for making a diagnosis
`of certain fetal characteristics based on the detection of
`paternally inherited cffDNA. The specification explains
`that analysis of cffDNA permits more efficient determina-
`tion of genetic defects and that a pregnant woman carry-
`ing a fetus with certain genetic defects will have more
`cffDNA in her blood than will a woman with a normal
`fetus. ’540 patent col. 3 ll. 30-43.
`Claims 1, 2, 4, 5, 8, 19-22, 24, and 25 of the ’540 pa-
`tent are at issue in this appeal.1 Independent claim 1
`requires:
`1. A method for detecting a paternally inherited
`nucleic acid of fetal origin performed on a mater-
`nal serum or plasma sample from a pregnant fe-
`male, which method comprises
`amplifying a paternally inherited nucleic acid
`from the serum or plasma sample and
`detecting the presence of a paternally inherited
`nucleic acid of fetal origin in the sample.
`’540 patent col. 23 l. 61-67.
`For comparison, independent claims 24 and 25 re-
`quire:
`24. A method for detecting a paternally inherited
`nucleic acid on a maternal blood sample, which
`method comprises:
`
`1 The parties have stipulated that for the purposes
`of this appeal claims 1, 2, 4, 5, 8, 9-22, 24 and 25 are
`representative of claims 6, 7, 12, 13, 15, and 18 of the ‘540
`patent. J.A. 24-25, 30-31.
`
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`ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC.
`
`5
`
`removing all or substantially all nucleated and
`anucleated cell populations from the blood sample,
`amplifying a paternally inherited nucleic acid
`from the remaining fluid and subjecting the am-
`plified nucleic acid to a test for the Paternally [sic]
`inherited fetal nucleic acid.
`
`25. A method for performing a prenatal diagnosis
`on a maternal blood sample, which method com-
`prises
`obtaining a non-cellular fraction of the blood sam-
`ple
`amplifying a paternally inherited nucleic acid
`from the non-cellular fraction
`and performing nucleic acid analysis on the ampli-
`fied nucleic acid to detect paternally inherited fe-
`tal nucleic acid.
`Id. at 26 ll. 20-36.
`The remaining claims explain how the method of de-
`tection occurs or how it can be used. For example, claim 2
`depends from claim 1 and claims amplification by poly-
`merase chain reaction. Id. at col. 24 ll. 60-61. Claim 4
`similarly depends from claim 1 and claims detection via a
`sequence specific probe. Id. col. 24 ll. 65-67. Claim 21
`also depends from claim 1, but instead of focusing solely
`on a method for detecting, it focuses on a method for
`performing a prenatal diagnosis, using claim 1’s method
`for detecting. Id. col. 26 ll. 4-14.
`II
`Appellee Ariosa Diagnostics, Inc. (formerly known as
`“Aria Diagnostics, Inc.”) makes and sells the Harmony
`Test, a non-invasive test used for prenatal diagnosis of
`certain fetal characteristics. Natera, Inc. makes and sells
`
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` 6
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` ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC.
`
`the Non-Invasive Paternity Test, which is intended to
`confirm the paternity or non-paternity of a gestating fetus
`from genetic information in fetal DNA available in the
`blood of the pregnant female. Diagnostics Center, Inc. is
`a licensee of Natera.
`In response to letters threatening claims of infringe-
`ment, Ariosa Diagnostics, Inc., Natera, Inc. and Diagnos-
`tics Center, Inc. each filed separate declaratory judgment
`actions from December 2011 through early 2012 against
`Sequenom alleging that they did not infringe the ’540
`patent. Sequenom counterclaimed alleging infringement
`in each case. The district court related the three actions
`for pretrial purposes.
`
`In the Ariosa action, Sequenom filed a motion seeking
`to preliminarily enjoin Ariosa from selling the accused
`Harmony Prenatal Test. In July 2012, the district court
`issued an order denying Sequenom’s motion for a prelimi-
`nary injunction. In the context of doing so, the district
`court found that there was a substantial question over
`whether the subject matter of the asserted claims was
`directed to eligible subject matter. Sequenom appealed to
`this court.
`On August 9, 2013, this court vacated and remanded
`the case, holding that the district court erred in certain
`respects not relevant to this appeal. Aria Diagnostics,
`Inc., 726 F.3d 1296, 1305
`Inc. v. Sequenom,
`(Fed. Cir. 2013). In addition, this Court noted that it
`offered no opinion “as to whether there is or is not a
`substantial question regarding the subject matter eligibil-
`ity of the asserted claims” of the ’540 patent, but remand-
`ed “for the district court to examine subject matter
`eligibility . . . . in light of [Ass’n for Molecular Pathology v.
`Myriad Genetics, Inc., 569 U.S. ___, 133 S. Ct. 2107, 2117
`(2013)].” Id. at 1304.
`
`After remand, the parties filed cross motions for
`summary judgment regarding invalidity under 35 U.S.C.
`
`6
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`

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`ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC.
`
`7
`
`§ 101. The district court agreed with Ariosa’s argument
`that the claims of the ’540 patent were directed to the
`natural phenomenon of paternally inherited cffDNA and
`that the claims did not add enough to the natural phe-
`nomenon to make the claims patent eligible under § 101.
`The district court determined that the steps of amplifying
`and detecting were well-understood, routine, or conven-
`tional activity in 1997, when the application for the ’540
`patent was filed. The district court concluded that the
`’540 patent was not directed to patentable subject matter
`because “the only inventive component of the processes of
`the ’540 patent is to apply those well-understood, routine
`processes to paternally inherited cffDNA, a natural phe-
`nomenon.” J.A. 18. The district court also found that the
`claimed processes posed a risk of preempting a natural
`phenomenon. Sequenom appeals.
`We have jurisdiction under 28 U.S.C. § 1295(a)(1).
`III
` We review the grant of summary judgment under the
`law of the regional circuit, in this case the Ninth Circuit.
`Charles Mach. Works, Inc. v. Vermeer Mfg. Co., 723 F.3d
`1376, 1378 (Fed. Cir. 2013). The Ninth Circuit reviews
`the grant or denial of summary judgment de novo. Leever
`v. Carson City, 360 F.3d 1014, 1017 (9th Cir. 2004). We
`also review de novo the question of whether a claim is
`invalid under section 101. In re BRCA1- and BRCA2-
`Based Hereditary Cancer Test Patent Litig., 774 F.3d. 755,
`759 (Fed. Cir. 2014).
`
`Section 101 of the Patent Act defines patent eligible
`subject matter:
`Whoever invents or discovers any new and useful
`process, machine, manufacture, or composition of
`matter, or any new and useful improvement
`thereof, may obtain a patent therefor, subject to
`the conditions and requirements of this title.
`
`7
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`

`
`
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` 8
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` ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC.
`
`35 U.S.C. § 101. The Supreme Court has long held that
`there are certain exceptions to this provision: laws of
`nature, natural phenomena, and abstract ideas. Alice
`Corp. v. CLS Bank Int’l, ___ U.S. ___, 134 S. Ct. 2347,
`2354 (2014) (collecting cases).
`In Mayo Collaborative Services v. Prometheus Labora-
`tories, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012), the
`Supreme Court set forth a framework for distinguishing
`patents that claim laws of nature, natural phenomena,
`and abstract ideas from those that claim patent-eligible
`applications of those concepts. First, we determine
`whether the claims at issue are directed to a patent-
`ineligible concept. Id. at 1297. If the answer is yes, then
`we next consider the elements of each claim both individ-
`ually and “as an ordered combination” to determine
`whether additional elements “transform the nature of the
`claim” into a patent-eligible application. Id. at 1298. The
`Supreme Court has described the second step of this
`analysis as a search for an “inventive concept”—i.e., an
`element or combination of elements that is “sufficient to
`ensure that the patent in practice amounts to significant-
`ly more than a patent upon the [ineligible concept] itself.”
`Id. at 1294; see also Digitech Image Techs., LLC v. Elecs.
`For Imaging, Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014)
`(“Without additional limitations, a process that employs
`mathematical algorithms to manipulate existing infor-
`mation to generate additional information is not patent
`eligible.”).
`The claims of the ’540 patent that are at issue in this
`appeal are method claims. Methods are generally eligible
`subject matter. In this case, the asserted claims of the
`’540 patent are directed to a multistep method that starts
`with cffDNA taken from a sample of maternal plasma or
`serum—a naturally occurring non-cellular fetal DNA that
`circulates freely in the blood stream of a pregnant woman.
`See, e.g., ’540 patent claims 1, 24, 25. It is undisputed
`that the existence of cffDNA in maternal blood is a natu-
`
`8
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`ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC.
`
`9
`
`ral phenomenon. Sequenom does not contend that Drs.
`Lo and Wainscoat created or altered any of the genetic
`information encoded in the cffDNA, and it is undisputed
`that the location of the nucleic acids existed in nature
`before Drs. Lo and Wainscoat found them. The method
`ends with paternally inherited cffDNA, which is also a
`natural phenomenon. The method therefore begins and
`ends with a natural phenomenon. Thus, the claims are
`directed to matter that is naturally occurring.
`
`The written description supports the conclusion that
`the claims of the ’540 patent are directed to a naturally
`occurring thing or natural phenomenon. In the Summary
`and Objects of the Invention section of the ’540 patent, the
`patent states that “[i]t has now been discovered that
`foetal DNA is detectable in maternal serum or plasma
`samples.”2 ’540 patent col. 1 ll. 50-51. The patent goes on
`to state that “[t]his is a surprising and unexpected find-
`ing; maternal plasma is the very material that is routine-
`ly discarded by
`investigators studying noninvasive
`prenatal diagnosis using foetal cells in maternal blood.”
`Id. col. 1 ll. 51-55. In the discussion, the patent notes:
`In this study we have demonstrated the feasibility
`of performing non-invasive foetal RhD genotyping
`from maternal plasma. This represents the first
`description of single gene diagnosis from maternal
`plasma.
`Id. col. 10 ll. 53-58. Further, the description of the inven-
`tion notes: “[w]e have demonstrated that foetal DNA is
`present in maternal plasma and serum,” id. col. 13 ll. 6-7,
`and “[t]hese observations indicate that maternal plas-
`ma/serum DNA may be a useful source of material for the
`
`
`2 The term “fetal” and “foetal” are used inter-
`changeably in the ’540 patent and by the parties.
`
`9
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` ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC.
`
`non-invasive prenatal diagnosis of certain genetic disor-
`ders,” id. col. 13 ll. 11-13. The patent also states: “[t]he
`most important observation in this study is the very high
`concentration of foetal DNA in maternal plasma and
`serum.” Id. col. 16 ll. 12-14. Thus, the claims at issue, as
`informed by the specification, are generally directed to
`detecting the presence of a naturally occurring thing or a
`natural phenomenon, cffDNA in maternal plasma or
`serum. As we noted above, the claimed method begins
`and ends with a naturally occurring phenomenon.
`Because the claims at issue are directed to naturally
`occurring phenomena, we turn to the second step of
`Mayo’s framework. In the second step, we examine the
`elements of the claim to determine whether the claim
`contains an inventive concept sufficient to “transform” the
`claimed naturally occurring phenomenon into a patent-
`eligible application. 132 S. Ct. at 1294. We conclude that
`the practice of the method claims does not result in an
`inventive concept that transforms the natural phenome-
`non of cffDNA into a patentable invention.
`Mayo made clear that transformation into a patent-
`eligible application requires “more than simply stat[ing]
`the law of nature while adding the words ‘apply it.’” Id. at
`1294. A claim that recites an abstract idea, law of nature,
`or natural phenomenon must include “additional fea-
`tures” to ensure “that the [claim] is more than a drafting
`effort designed to monopolize the [abstract idea, law of
`nature, or natural phenomenon].” Id. at 1297. For pro-
`cess claims that encompass natural phenomenon, the
`process steps are the additional features that must be
`new and useful. See Parker v. Flook, 437 U.S. 584, 591
`(1978) (“The process itself, not merely the mathematical
`algorithm, must be new and useful.”).
`In Mayo, the patents at issue claimed a method for
`measuring metabolites in the bloodstream in order to
`calibrate the appropriate dosage of thiopurine drugs in
`
`10
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`ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC.
`
`11
`
`the treatment of autoimmune diseases. 132 S. Ct. at
`1294. The respondent contended that the claimed method
`was a patent eligible application of a natural law that
`described the relationship between the concentration of
`certain metabolites and the likelihood that the drug
`dosage will be harmful or ineffective. Methods for deter-
`mining metabolite levels, however, were already “well
`known in the art.” Id. at 1298. Further, the process at
`issue amounted to “nothing significantly more than an
`instruction to doctors to apply the applicable laws when
`treating their patients.” Id. In that case, “[s]imply ap-
`pending conventional steps, specified at a high level of
`generality,” was not enough to supply an inventive con-
`cept. Id. at 1300.
`Like the patentee in Mayo, Sequenom contends that
`the claimed methods are patent eligible applications of a
`natural phenomenon, specifically a method for detecting
`paternally inherited cffDNA. Using methods like PCR to
`amplify and detect cffDNA was well-understood, routine,
`and conventional activity in 1997. The method at issue
`here amounts to a general instruction to doctors to apply
`routine, conventional techniques when seeking to detect
`cffDNA. Because the method steps were well-understood,
`conventional and routine, the method of detecting pater-
`nally inherited cffDNA is not new and useful. The only
`subject matter new and useful as of the date of the appli-
`cation was the discovery of the presence of cffDNA in
`maternal plasma or serum.
`The specification of the ’540 patent confirms that the
`preparation and amplification of DNA sequences in plas-
`ma or serum were well-understood, routine, conventional
`activities performed by doctors in 1997. The ’540 patent
`provides that “[t]he preparation of serum or plasma from
`the maternal blood sample is carried out by standard
`techniques.” ’540 patent col. 2 ll. 27-28. It also provides
`that “[s]tandard nucleic acid amplification systems can be
`used, including PCR, the ligase chain reaction, nucleic
`
`11
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`
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` 12
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` ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC.
`
`acid sequence based amplification (NASBA), branched
`DNA methods, and so on.” Id. col. 2 ll. 44-47.
`Other evidence supports this conclusion. For exam-
`ple, Sequenom’s expert, Dr. Evans, testified at deposition
`that PCR and other methodologies for amplifying DNA
`were “already well known in science [in 1997].” J.A. 1092-
`93, 1995-96. Similarly, in a declaration filed during
`prosecution of the ’540 patent, Dr. Lo testified that
`“[s]uitable amplification techniques can be ordinary PCR
`or more sophisticated developments thereof, but these
`techniques were all known in the literature before the
`date of my invention.” J.A. 1109.
`The detecting step was similarly well-understood,
`routine, and conventional. During prosecution of the
`application that became the ’540 patent, the applicant
`stated:
`[O]ne skilled in the art is aware of a variety of
`techniques which might be used to detect different
`nucleic acid species. For example, there are nu-
`merous techniques which might be used to detect
`repeat expansions, single gene mutations, dele-
`tions or translocations. These techniques are a
`matter of routine for one skilled in the art for the
`analysis of DNA.
`J.A. 1052. The applicant went on to note:
`[O]ne skilled in the art is readily able to apply the
`teachings of the present application to any one of
`the well-known techniques for detection of DNA
`with a view to analysis of foetal DNA in paternal
`[sic] plasma or serum.
`J.A. 1055. Similarly, the applicant later added that “[t]he
`person skilled in the art has a broad range of techniques
`available for the detection of DNA in a sample.”
`J.A. 1057.
`
`12
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`ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC.
`
`13
`
`The dependent claims are broad examples of how to
`
`detect cffDNA in maternal plasma. The dependent claims
`are focused on the use of the natural phenomenon in
`combination with well-understood, routine, and conven-
`tional activity. For example, claim 2 identifies the poly-
`merase chain reaction as the amplification technique to be
`used in the detection method of claim 1. As noted above,
`this technique was well-understood, routine, and conven-
`tional in 1997, as specified by the patent itself. Like
`claim 1, claims 5 and 8 focus on detecting a specific chro-
`mosome within the cffDNA—a natural phenomenon—
`again, adding no inventive concept to the limitations of
`claim 1. None of the remaining asserted dependent or
`independent claims differ substantially from these claims.
`Thus, in this case, appending routine, conventional steps
`to a natural phenomenon, specified at a high level of
`generality, is not enough to supply an inventive concept.
`Where claims of a method patent are directed to an appli-
`cation that starts and ends with a naturally occurring
`phenomenon, the patent fails to disclose patent eligible
`subject matter if the methods themselves are convention-
`al, routine and well understood applications in the art.
`The claims of the ’540 patent at issue in this appeal are
`not directed to patent eligible subject matter and are,
`therefore, invalid.
`
`IV
`In its opinion, the district court addressed the princi-
`ple of preemption. The district court noted:
`It is important to note that the ’540 patent does
`not merely claim uses or applications of cffDNA, it
`claims methods for detecting the natural phenom-
`enon. Because generally one must be able to find
`a natural phenomenon to use it and apply it,
`claims covering the only commercially viable way
`of detecting that phenomenon do carry a substan-
`tial risk of preempting all practical uses of it.
`
`13
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` ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC.
`
`J.A. 19.
`Sequenom argues that there are numerous other uses
`of cffDNA aside from those claimed in the ’540 patent,
`and thus, the ’540 patent does not preempt all uses of
`cffDNA, as shown by evidence in the record before the
`district court. Sequenom also argues that “a method
`applying or using a natural phenomenon in a manner that
`does not preclude alternative methods in the same field is
`non-preemptive, and, by definition, patent-eligible under
`Section 101.” Appellants’ Br. 30. Similarly, Sequenom
`and amici argue that because the particular application of
`the natural phenomena that the ’540 patent claims em-
`body are narrow and specific, the claims should be upheld.
`Ariosa argues that the principle of preemption does not
`alter the analysis. Ariosa argues that the claimed meth-
`ods are not, as Sequenom asserts, limited and specific.
`The Supreme Court has made clear that the principle
`of preemption is the basis for the judicial exceptions to
`patentability. Alice, 134 S. Ct at 2354 (“We have de-
`scribed the concern that drives this exclusionary principal
`as one of pre-emption”). For this reason, questions on
`preemption are inherent in and resolved by the § 101
`analysis. The concern is that “patent law not inhibit
`further discovery by improperly tying up the future use of
`these building blocks of human ingenuity.” Id. (internal
`quotations omitted). In other words, patent claims should
`not prevent the use of the basic building blocks of technol-
`ogy—abstract ideas, naturally occurring phenomena, and
`natural laws. While preemption may signal patent ineli-
`gible subject matter, the absence of complete preemption
`does not demonstrate patent eligibility. In this case,
`Sequenom’s attempt to limit the breadth of the claims by
`showing alternative uses of cffDNA outside of the scope of
`the claims does not change the conclusion that the claims
`are directed to patent ineligible subject matter. Where a
`patent’s claims are deemed only to disclose patent ineligi-
`ble subject matter under the Mayo framework, as they are
`
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`ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC.
`
`15
`
`in this case, preemption concerns are fully addressed and
`made moot.
`Sequenom and amici encourage us to draw distinc-
`tions among natural phenomena based on whether or not
`they will interfere significantly with innovation in other
`fields now or in the future. The Supreme Court cases,
`however, have not distinguished among different laws of
`nature or natural phenomenon according to whether or
`not the principles they embody are sufficiently narrow.
`See, e.g., Parker v. Flook, 437 U.S. 584 (1978) (holding
`narrow mathematical formula unpatentable). In Parker
`v. Flook, the Supreme Court stated the issue in the case
`as follows: “The question in this case is whether the
`identification of a limited category of useful, though
`conventional, post-solution applications of such a formula
`makes respondent’s method eligible for patent protection.”
`Id. at 585. The answer to that question was “no” because
`granting exclusive rights to the mathematical formula
`would be exempting it from any future use.
`V
`For completeness, we address Sequenom’s remaining
`arguments. Sequenom argues that “before the ’540 pa-
`tent, no one was using the plasma or serum of pregnant
`mothers to amplify and detect paternally-inherited
`cffDNA.” Appellants’ Br. 49 (emphasis original). This
`argument implies that the inventive concept lies in the
`discovery of cffDNA in plasma or serum. Even if so, this
`is not the invention claimed by the ’540 patent.
` Sequenom further argues that “[o]ne simple measure
`of [Drs.] Lo and Wainscoat’s contribution is that their
`1997 Lancet publication has been cited over a thousand
`times.” Appellants’ Br. 25. Sequenom also notes that “the
`method reflects a significant human contribution in that
`[Drs.] Lo and Wainscoat combined and utilized man-made
`tools of biotechnology in a new way that revolutionized
`prenatal care.” Id. We agree but note that the Supreme
`
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` ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC.
`
`Court instructs that “[g]roundbreaking, innovative, or
`even brilliant discovery does not by itself satisfy the § 101
`inquiry.” Myriad Genetics, Inc., 133 S. Ct. at 2117. The
`discovery of the BRCA1 and BRCA2 genes was a signifi-
`cant contribution to the medical field, but it was not
`patentable. Id. at 2117. While Drs. Lo and Wainscoat’s
`discovery regarding cffDNA may have been a significant
`contribution to the medical field, that alone does not make
`it patentable. We do not disagree that detecting cffDNA
`in maternal plasma or serum that before was discarded as
`waste material is a positive and valuable contribution to
`science. But even such valuable contributions can fall
`short of statutory patentable subject matter, as it does
`here.
`
`VI
`For each of the reasons stated above, we affirm the
`district court’s summary judgment ruling.
`AFFIRMED
`COSTS
`
`No costs.
`
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`
`United States Court of Appeals
`for the Federal Circuit
`______________________
`
`ARIOSA DIAGNOSTICS, INC., NATERA, INC.,
`Plaintiffs-Appellees
`
`DNA DIAGNOSTICS CENTER, INC.,
`Counterclaim Defendant-Appellee
`
`v.
`
`SEQUENOM, INC., SEQUENOM CENTER FOR
`MOLECULAR MEDICINE, LLC,
`Defendants-Appellants
`
`ISIS INNOVATION LIMITED,
`Defendant
`______________________
`
`2014-1139, 2014-1144
`______________________
`
`Appeals from the United States District Court for the
`Northern District of California in Nos. 3:11-cv-06391-SI,
`3:12-cv-00132-SI, Judge Susan Y. Illston.
`______________________
`
`LINN, Circuit Judge, concurring.
`I join the court’s opinion invalidating the claims of
`the ’540 patent only because I am bound by the sweeping
`language of the test set out in Mayo Collaborative Ser-
`vices v. Prometheus Laboratories, Inc., 566 U.S. ___, 132
`S. Ct. 1289 (2012). In my view, the breadth of the second
`part of the test was unnecessary to the decision reached
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` ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC.
`
`in Mayo. This case represents the consequence—perhaps
`unintended—of that broad language in excluding a meri-
`torious invention from the patent protection it deserves
`and should have been entitled to retain.
`It has long been established that “[l]aws of nature,
`natural phenomena, and abstract ideas are not patenta-
`ble.” Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354
`(2014) (citations omitted). In Mayo, the Supreme Court
`set forth a two-step framework for distinguishing patents
`that claim laws of nature, natural phenomena, and ab-
`stract ideas from those that claim patent-eligible applica-
`tions of those concepts. The first step looks to determine
`whether claims are directed to a patent-ineligible concept.
`Mayo, 132 S. Ct. at 1297. If they are, the second step is to
`consider whether the additional elements recited in the
`claim “transform the nature of the claim” into a patent-
`eligible application by reciting an “inventive concept” that
`is “sufficient to ensure that the patent in practice
`amounts to significantly more than a patent upon the
`[ineligible concept] itself.” Id. at 1294.
`In applying the second part of the test, the Supreme
`Court in Mayo discounted, seemingly without qualifica-
`tion, any “[p]ost-solution activity that is purely conven-
`tional or obvious,” id. at 1299 (original alterations
`omitted). This was unnecessary in Mayo, because doctors
`were already performing in combination all of the claimed
`steps of administering the drug at issue, measuring
`metabolite levels, and adjusting dosing based on the
`metabolite levels, id.
`In Diamond v. Diehr, the Supreme Court held that “a
`new combination of steps in a process may be patentable
`even though all the constituents of the combination were
`well-known and in common use before the combination
`was made.” 450 U.S. 175, 188 (1981). As Mayo explained:
`Diehr “pointed out that the basic mathematical equation,
`like a law of nature, was not patentable. But [Diehr]
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`ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC.
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`3
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`found the overall process patent eligible because of the
`way the additional steps of the process integrated the
`equation into the process as a whole.” Mayo 132 S. Ct. at
`1298. Despite that recognition, Mayo discounted entirely
`the “conventional activity” recited in the claims in that
`case because the steps “add nothing specific to the laws of
`nature other than what is well-understood, routine,
`conventional activity, previously engaged in by those in
`the field.” Id. at 1299. While that conclusion might have
`been warranted in that case, given the fact that the
`“conventional activities” in Mayo were the very steps that
`doctors were already doing—administering the drug at
`issue, measuring metabolite levels, and adjusting dosing
`based on the metabolite levels—the Supreme Court did
`not limit its ruling to those particular facts and circum-
`stances.
`The Supreme Court’s blanket dismissal of conven-
`tional post-solution steps leaves no room to distinguish
`Mayo from this case, even though here no one was ampli-
`fying and detecting paternally-inherited cffDNA using the
`plasma or serum of pregnant mothers. Indeed, the ma-
`ternal plasma used to be “routinely discarded,” ’540
`patent col.1 ll.50–53, because, as Dr. Evans testified,
`“nobody thought that fetal cell-free DNA would be pre-
`sent.”
`It is hard to deny that Sequenom’s invention is truly
`meritorious. Prior to the ’540 patent, prenatal diagnoses
`required invasive methods, which “present[ed] a degree of
`risk to the mother and to t