Ariosa Diagnostics, Inc v. Sequenom, Inc. , 809 F.3d 1282 ( 2015 )

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.
______________________
ON PETITION FOR REHEARING EN BANC
______________________
MICHAEL J. MALECEK, Kaye Scholer LLP, Palo Alto,
CA, filed a petition for rehearing en banc for defendants-
appellants. Also represented by PETER E. ROOT; ATON
ARBISSER, Los Angeles, CA; THOMAS GOLDSTEIN, ERIC F.
CITRON, Goldstein & Russell, P.C., Bethesda, MD.
2 ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC.
DAVID ISAAC GINDLER, Irell & Manella LLP, Los Ange-
les, CA, filed a response to the petition for plaintiff-
appellee Ariosa Diagnostics, Inc. Also represented by
ANDREI IANCU, JOSHUA GORDON; AMIR NAINI, Russ August
& Kabat, Los Angeles, CA.
MARK ANDREW PERRY, Gibson, Dunn & Crutcher LLP,
Washington, DC, filed a response to the petition for
plaintiff-appellee Natera, Inc. Also represented by TRACEY
B. DAVIES, BRETT ROSENTHAL, MICHAEL A. VALEK, Dallas,
TX.
WILLIAM PAUL SCHUCK, Bartko, Zankel, Bunzel & Mil-
ler, San Francisco, CA, for counterclaim defendant-
appellee DNA Diagnostics Center, Inc.
GIDEON A. SCHOR, Wilson Sonsini Goodrich & Rosati,
PC, New York, NY, for amici curiae Amarantus Biosci-
ence Holdings, Inc., Personalis, Inc., Population Diagnos-
tics, Inc. Also represented by MAYA SKUBATCH, Palo Alto,
CA; RICHARD TORCZON, CHARLES J. ANDRES, JR., Washing-
ton, DC.
LANA GLADSTEIN, Nutter McClennen & Fish LLP,
Boston, MA, for amicus curiae Bioindustry Association.
Also represented by KONSTANTIN M. LINNIK, ISAAC A.
HUBNER.
CHRISTOPHER MICHAEL HOLMAN, University of Mis-
souri-Kansas City, Kansas City, MO, for amici curiae
Biotechnology Industry Organization, Pharmaceutical
Research and Manufacturers of America. Biotechnology
Industry Organization also represented by BRIAN P.
BARRETT, Eli Lilly and Company, Indianapolis, IN; LI
WESTERLUND, Bavarian Nordic, Inc., Redwood City, CA.
ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC. 3
BENJAMIN JACKSON, Myriad Genetics, Inc., Salt Lake
City, UT, for amicus curiae The Coalition for 21st Century
Medicine. Also represented by DAVID CARTER HOFFMAN,
Genomic Health, Inc., Redwood City, CA.
DONALD LOUIS ZUHN, JR., McDonnell Boehnen Hul-
bert & Berghoff LLP, Chicago, IL, for amicus curiae Paul
Gilbert Cole.
TEIGE P. SHEEHAN, Heslin, Rothenberg, Farley & Me-
siti, P.C., Albany, NY, for amicus curiae Intellectual
Property Owners Association. Also represented by PHILIP
STATON JOHNSON, Johnson & Johnson, New Brunswick,
NJ; KEVIN H. RHODES, 3M Innovative Properties Compa-
ny, St. Paul, MN; HERBERT CLARE WAMSLEY, JR., Intellec-
tual Property Owners Association, Washington, DC.
MATTHEW JAMES DOWD, Andrews Kurth LLP, Wash-
ington, DC, for amicus curiae JYANT Technologies, Inc.
Also represented by ROBERT A. GUTKIN, SUSHILA
CHANANA.
JEFFREY LEFSTIN, University of California Hastings
College of Law, San Francisco, CA, for amici curiae Jef-
frey Lefstin, Peter S. Menell.
JOHN D. MURNANE, Fitzpatrick, Cella, Harper & Scin-
to, New York, NY, for amicus curiae New York Intellectu-
al Property Law Association. Also represented by ALICIA
ALEXANDRA ROSE RUSSO, ERIN AUSTIN; DOROTHY R. AUTH,
Cadwalader, Wickersham & Taft LLP, New York, NY;
IRENA ROYZMAN, Patterson Belknap Webb & Tyler LLP,
New York, NY; DAVID F. RYAN, Croton-on-Hudson, NY.
COREY A. SALSBERG, Novartis International AG, Ba-
sel, Switzerland, for amicus curiae Novartis AG.
4 ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC.
KEVIN EDWARD NOONAN, McDonnell Boehnen Hulbert
& Berghoff LLP, Chicago, IL, for amici curiae Twenty-
Three Law Professors.
DAN L. BAGATELL, Perkins Coie LLP, Phoenix, AZ, for
amici curiae Wisconsin Alumni Research Foundation,
Marshfield Clinic, MCIS, Inc. Also represented by
MICHELLE MARIE UMBERGER, Madison, WI; MICHAEL
ROBERT OSTERHOFF, Chicago, IL.
Before PROST, Chief Judge, NEWMAN, LOURIE, DYK,
MOORE, O’MALLEY, REYNA, WALLACH, TARANTO, CHEN,
HUGHES, and STOLL, Circuit Judges.
LOURIE, Circuit Judge, with whom MOORE, Circuit
Judge, joins, concurs with the denial of the petition for
rehearing en banc.
DYK, Circuit Judge, concurs with the denial of the pe-
tition for rehearing en banc.
NEWMAN, Circuit Judge, dissents from the denial of
the petition for rehearing en banc.
PER CURIAM.
ORDER
A petition for rehearing en banc was filed by defend-
ants-appellants Sequenom, Inc. and Sequenom Center for
Molecular Medicine, LLC. The petition for rehearing was
first referred to the panel that heard the appeal, and
thereafter, to the circuit judges who are in regular active
service. A response was invited by the court and filed by
plaintiffs-appellees Ariosa Diagnostics, Inc. and Natera,
Inc. A poll was requested, taken, and failed.
Upon consideration thereof,
IT IS ORDERED THAT:
ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC. 5
(1) The petition for rehearing en banc is denied.
(2) The mandate of the court will issue on December
9, 2015.
FOR THE COURT
December 2, 2015 /s/ Daniel E. O’Toole
Date Daniel E. O’Toole
Clerk of Court
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.
______________________
LOURIE, Circuit Judge, with whom MOORE, Circuit Judge,
joins, concurring in the denial of the petition for rehearing
en banc.
I concur in the court’s denial of rehearing en banc in
this case, based on the precedent of Mayo Collaborative
Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132
S. Ct. 1289 (2012). I do so because I find no principled
2 ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC.
basis to distinguish this case from Mayo, by which we are
bound. I write separately to express some thoughts
concerning laws of nature and abstract ideas, which seem
to be at the heart of patent-eligibility issues in the medi-
cal sciences.
Since the Supreme Court’s decision in Bilski v. Kap-
pos, 561 U.S. __, 130 S. Ct. 3218 (2010), the issue of
patent eligibility under § 101 has been of key importance
in the adjudication of patent cases, particularly in the
field of software. The Court’s decisions in Mayo, Associa-
tion for Molecular Pathology v. Myriad Genetics, Inc., 569
U.S. __, 133 S. Ct. 2107 (2013), and Alice Corp. v. CLS
Bank International, 573 U.S. __, 134 S. Ct. 2347 (2014),
have further brought the focus onto the field of medical
diagnostics.
The Supreme Court in Mayo determined that the
claims in that patent “set forth laws of nature.” It further
held in Mayo that steps additional to those setting forth
laws of nature in a claimed process must add something
“that in terms of patent law’s objectives ha[ve] signifi-
cance” to the natural laws, such that those steps trans-
form the process into an inventive application of those
laws. Mayo, 132 S. Ct. at 1299. Moreover, the Court
rejected “post-solution activity that is purely conventional
or obvious” as not significant enough to bring a claimed
invention within the realm of patent-eligible subject
matter. Id. (internal quotation marks and alteration
omitted).
Alice relates to the third specific exception to eligibil-
ity—abstract ideas—and its discussion also incorporates
the requirement of an “inventive concept” beyond “con-
ventional steps.” It held that claims that amount to
nothing more than instruction to apply an abstract idea
are not patent eligible, although application of the ab-
stract idea may be. In my view, neither of the traditional
ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC. 3
preclusions of laws of nature or of abstract ideas ought to
prohibit patenting of the subject matter in this case.
Laws of nature are exact statements of physical rela-
tionships, deduced from scientific observations of natural
phenomena. They are often represented by equations,
and include such laws as the relationship between energy
and mass (E=mc2), the relationship between current and
resistance (Ohm’s Law), that between force, mass, and
acceleration (F=ma), Maxwell’s equations, Newton’s laws
of motion, and many more. Those laws, all agree, are not
and should not be patent-eligible subject matter. But
methods that utilize laws of nature do not set forth or
claim laws of nature. All physical steps of human ingenu-
ity utilize natural laws or involve natural phenomena.
Thus, those steps cannot be patent-ineligible solely on
that basis because, under that reasoning, nothing in the
physical universe would be patent-eligible.
Abstract steps are, axiomatically, the opposite of tan-
gible steps; that which is not tangible is abstract. But
steps that involve machines, which are tangible, steps
that involve transformation of tangible subject matter, or
tangible implementations of ideas or abstractions should
not be considered to be abstract ideas. In Bilski, the
Supreme Court supported this proposition when it de-
scribed our earlier machine-or-transformation test as a
useful clue, albeit not the only test, for eligibility.
Conversely, abstract ideas are essentially mental
steps; they are not tangible even if they are written down
or programmed into a physical machine. Alice, in affirm-
ing this court, held that claims that amount to nothing
significantly more than instruction to apply an abstract
idea are not patent eligible. But the fact that steps are
well-known, although relevant to other statutory sections
of the patent law, does not necessarily make them ab-
stract.
4 ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC.
The claims at issue in Sequenom’s patent are directed
to methods for detecting paternally-inherited fetal DNA
in maternal blood samples, and performing a prenatal
diagnosis based on such DNA. Following Mayo, which
held that certain steps merely recite natural laws and
that the remaining steps must be sufficiently innovative
apart from the natural laws, the panel in this case held
that the claims do not involve patent-eligible subject
matter. Appellants and amici have argued before us in
briefs that a broad range of claims of this sort appear to
be in serious jeopardy. It is said that the whole category
of diagnostic claims is at risk. It is also said that a crisis
of patent law and medical innovation may be upon us, and
there seems to be some truth in that concern.
The claims in this case perhaps should be in jeopardy,
not because they recite natural laws or abstract ideas, but
because they may be indefinite or too broad. But they
should not be patent-ineligible on the ground that they set
forth natural laws or are abstractions.
Claim 1 is directed to a method for detecting a pater-
nally inherited nucleic acid of fetal origin from a pregnant
female comprising amplifying a paternally inherited
nucleic acid and detecting the presence of a paternally
inherited nucleic acid. Claim 21 is directed to a method of
performing a prenatal diagnosis comprising providing a
maternal blood sample, separating the sample into a
cellular and non-cellular fraction, detecting the presence
of a nucleic acid, and providing a diagnosis. Both of these
claims contain the nucleus of patent-eligible subject
matter.
As the panel noted, the natural phenomenon here is
the presence of cell-free fetal DNA (“cffDNA”) in maternal
plasma, which, when subjected to certain conventional
steps, has led to an important new development: diagno-
sis of possible birth defects without using highly intrusive
means. Applications of natural phenomena or laws to a
ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC. 5
known process “may well be deserving of patent protec-
tion.” Diehr, 450 U.S. at 187. And it is not disputed that
this scientific work on its own seems like an important
discovery and a valuable contribution to the medical field,
although no one asserts that a claim directed to the mere
existence of cffDNA is patent-eligible. But neither of the
representative claims here merely recites a law of nature,
a natural phenomenon, or an abstract idea. The claims
rely on or operate by, but do not recite, a natural phenom-
enon or law. The claimed invention involves taking
maternal serum, separating it, amplifying the genetic
material to detect cffDNA, and running tests to identify
certain genes or genetic defects; these are all physical,
and not insignificant, steps requiring human intervention.
The claims might be indefinite or too broad in that
they do not specify how to amplify and detect, or how to
separate, detect, and diagnose. Or they perhaps attempt
to claim all known methods of carrying out those steps.
But the finer filter of § 112 might be better suited to
treating these as questions of patentability, rather than
reviewing them under the less-defined eligibility rules.
It is not disputed that fractionating blood, amplifying
DNA, and analyzing DNA to detect specific gene sequenc-
es are known techniques in the art. As all other steps in
the claims are individually well-known, the innovative
aspect of the claims appears to be the improvement in the
method of determining fetal genetic characteristics or
diagnosing abnormalities of fetal DNA, consisting of use of
the non-cellular fraction of fetal DNA obtained from a
maternal blood sample.
The claim to this invention, then, might have been
better drafted as a so-called Jepson claim, which recites
what is in the prior art and what is the improvement.
Such a claim might read, perhaps with more details
added: “In a method of performing a prenatal diagnosis
using techniques of fractionation and amplification, the
6 ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC.
improvement consisting of using the non-cellular fraction
of a maternal blood sample.”
Regardless, we are not experts in drafting claims to
protect new biological procedures and we are not in a
position to rewrite claims or review a hypothetical claim.
But against the accusation that such a claim to the inven-
tion might be considered mere draftsmanship and thus
still ineligible under the seemingly expansive holding of
Mayo, it must be said that a process, composition of
matter, article of manufacture, and machine are different
implementations of ideas, and differentiating among them
in claim drafting is a laudable professional skill, not
necessarily a devious device for avoiding prohibitions.
This is true despite the Supreme Court’s affirmance of
this court in Alice, where we had held, by a 7–3 vote, that
method and media claims in inventions of the type
claimed there were essentially the same.
But focusing on the claims we have rather than those
we might have had, the claims here are directed to an
actual use of the natural material of cffDNA. They recite
innovative and practical uses for it, particularly for diag-
nostic testing: blood typing, sex typing, and screening for
genetic abnormalities. And it is undisputed that before
this invention, the amplification and detection of cffDNA
from maternal blood, and use of these methods for prena-
tal diagnoses, were not routine and conventional. But
applying Mayo, we are unfortunately obliged to divorce
the additional steps from the asserted natural phenome-
non to arrive at a conclusion that they add nothing inno-
vative to the process.
Moreover, the claims here are not abstract. There is
nothing abstract about performing actual physical steps
on a physical material. And if the concern is preemption
of a natural phenomenon, this is, apparently, a novel
process and that is what patents are intended to incentiv-
ize and be awarded for. The panel here also noted that
ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC. 7
there were other uses for cffDNA and other methods of
prenatal diagnostic testing using cffDNA that do not
involve the steps recited in the various claims. That fact
should sufficiently address the concern of improperly
tying up future use of natural phenomena and laws.
In sum, it is unsound to have a rule that takes inven-
tions of this nature out of the realm of patent-eligibility
on grounds that they only claim a natural phenomenon
plus conventional steps, or that they claim abstract con-
cepts. But I agree that the panel did not err in its conclu-
sion that under Supreme Court precedent it had no option
other than to affirm the district court.
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.
______________________
DYK, Circuit Judge, concurring in the denial of the peti-
tion for rehearing en banc.
I concur in the court’s denial of rehearing en banc. In
my view the framework of Mayo and Alice is an essential
ingredient of a healthy patent system, allowing the inval-
2 ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC.
idation of improperly issued and highly anticompetitive
patents without the need for protracted and expensive
litigation. Yet I share the concerns of some of my col-
leagues that a too restrictive test for patent eligibility
under 35 U.S.C. § 101 with respect to laws of nature
(reflected in some of the language in Mayo) may discour-
age development and disclosure of new diagnostic and
therapeutic methods in the life sciences, which are often
driven by discovery of new natural laws and phenomena.
This leads me to think that some further illumination as
to the scope of Mayo would be beneficial in one limited
aspect. At the same time I think that we are bound by
the language of Mayo, and any further guidance must
come from the Supreme Court, not this court.
I
The language of Mayo is clear. The Mayo Court found
that prior Supreme Court decisions “insist that a process
that focuses upon the use of a natural law also contain
other elements or a combination of elements, sometimes
referred to as an ‘inventive concept,’ sufficient to ensure
that the patent in practice amounts to significantly more
than a patent upon the natural law itself.” Mayo Collabo-
rative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289,
1294 (2012) (quoting Parker v. Flook, 437 U.S. 584, 594
(1978)). Patent claims directed to laws of nature are
ineligible under 35 U.S.C. § 101 when, “(apart from the
natural laws themselves) [they] involve well-understood,
routine, conventional activity previously engaged in by
researchers in the field.” Id. (emphasis added). Review-
ing the Court’s earlier Flook decision, the Mayo Court
determined that Flook’s claim to a chemical process
applying an “apparently novel mathematical algorithm,”
id. at 1298, was ineligible under § 101 because the steps
of the process “were all ‘well known,’ to the point where,
putting the formula to the side, there was no ‘inventive
concept’ in the claimed application of the formula,” id. at
ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC. 3
1299 (quoting Flook, 437 U.S. at 594) (emphasis added).
“[S]imply appending conventional steps, specified at a
high level of generality, to laws of nature, natural phe-
nomena, and abstract ideas cannot make those laws,
phenomena, and ideas patentable.” Id. at 1300. In other
words, Mayo states that the inventive concept necessary
for eligibility must come in the application analyzed at
step two, rather than from the discovery of the law of
nature itself.
Alice subsequently confirmed that the two-step
framework articulated in Mayo is a unitary rule that
applies equally “for distinguishing patents that claim
laws of nature, natural phenomena, and abstract ideas
from those that claim patent-eligible applications of those
concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S.
Ct. 2347, 2355 (2014) (citing Mayo). Alice explained,
First, we determine whether the claims at issue
are directed to one of those patent-ineligible con-
cepts. If so, we then ask, what else is there in the
claims before us? . . . We have described step two 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 significantly more than a patent upon
the ineligible concept itself.
Id. (emphasis added) (alterations, citations, and quotation
marks omitted). “At Mayo step two, we must examine the
elements of the claim to determine whether it contains an
‘inventive concept’ sufficient to ‘transform’ the claimed
abstract idea into a patent-eligible application.” Id. at
2357 (emphasis added) (quotation marks omitted). Thus
Alice also holds that inventive concept must be found at
step two of the framework.
Mayo has unambiguously announced a generally ap-
plicable test for determining subject-matter eligibility
4 ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC.
under § 101 with respect to laws of nature, and we are
bound to follow it. We cannot confine Mayo to its facts or
otherwise cabin a clear statement from the Supreme
Court. “[O]nce the Court has spoken, it is the duty of
other courts to respect that understanding of the govern-
ing rule of law.” Rivers v. Roadway Express, Inc., 511
U.S. 298, 312 (1994). A court of appeals must not “con-
fus[e] the factual contours of [a Supreme Court decision]
for its unmistakable holding” to arrive at a “novel inter-
pretation” of that decision. Thurston Motor Lines, Inc. v.
Jordan K. Rand, Ltd., 460 U.S. 533, 534–35 (1983) (per
curiam). As we have recognized, “[a]s a subordinate
federal court, we may not so easily dismiss [the Supreme
Court’s] statements as dicta but are bound to follow
them.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d
1336, 1347 (Fed. Cir. 2010) (en banc) (citing Stone Con-
tainer Corp. v. United States, 229 F.3d 1345, 1349–50
(Fed. Cir. 2000)).
The panel thus held correctly that Mayo is controlling
precedent that governs the outcome here. The panel’s
opinion aptly states and applies the two-step framework
of Mayo. “First, we determine whether the claims at issue
are directed to a patent-ineligible concept.” Ariosa Diag-
nostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1375 (Fed.
Cir. 2015) (citing Mayo, 566 U.S. at 1292). “[T]he 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. . . . [T]he claimed method begins and
ends with a naturally occurring phenomenon.” Id. at
1376. At the second step of the Mayo framework, the
panel determined that “[t]he method at issue here
amounts to a general instruction to doctors to apply
routine, conventional techniques when seeking to detect
cffDNA.” Id. at 1377. The panel therefore found that the
claims were not patent eligible under § 101. Id. at 1378.
ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC. 5
II
The Mayo/Alice framework works well when the ab-
stract idea or law of nature in question is well known and
longstanding, as was the situation in Mayo itself (as
discussed below), earlier Supreme Court cases, 1 and in
many of our own recent cases where we have found claims
patent ineligible under § 101. 2 Where the abstract idea or
1 See, e.g., Bilski v. Kappos, 561 U.S. 593, 611
(2010) (“Hedging is a fundamental economic practice long
prevalent in our system of commerce and taught in any
introductory finance class.”) (quoting In re Bilski, 545
F.3d 943, 1013 (Fed. Cir. 2008) (Rader, J., dissenting))
(emphasis added); Diamond v. Diehr, 450 U.S. 175, 177
n.2 (1981) (noting that the Arrhenius equation “has long
been used to calculate the cure time in rubber-molding
processes”) (emphasis added); Funk Bros. Seed Co. v. Kalo
Inoculant Co., 333 U.S. 127, 129 (1948) (“Methods of
selecting the strong strains [of nitrogen-fixing root-nodule
bacteria] and of producing a bacterial culture from them
have long been known.”) (emphasis added); see also the
influential English patent case discussed in Mayo, 132 S.
Ct. at 1300, Neilson v. Harford, Webster’s Patent Cases
295, 371 (1841) (“We think the case must be considered as
if the principle [that hot air promotes ignition better than
cold air is] well known . . . .”) (emphasis added).
2 See, e.g., Intellectual Ventures I LLC v. Capital
One Bank, 792 F.3d 1363, 1369 (Fed. Cir. 2015) (invali-
dating claims that applied an abstract idea—tailoring of
advertising to individual customers—which “had often
been” used before); OIP Techs., Inc. v. Amazon.com, Inc.,
788 F.3d 1359, 1362, 1364 (Fed. Cir. 2015) (invalidating
claims to computerized methods of offer-based price
optimization and noting that the abstract idea implicated
was a “fundamental economic concept[]”); Ultramercial,
6 ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC.
law of nature is well known and longstanding, there is no
basis for attributing novelty to that aspect of the claimed
invention.
Also, it seems to me that the Mayo/Alice framework
works well with respect to abstract ideas. In my view,
claims to business methods and other processes that
merely organize human activity should not be patent
eligible under any circumstances. See Alice, 134 S. Ct. at
2360 (Sotomayor, J., concurring); In re Bilski, 545 F.3d
943, 972 (Fed. Cir. 2008) (en banc) (Dyk, J., concurring).
In any event, departing from the Mayo/Alice framework
with respect to abstract ideas (as opposed to discoveries of
natural laws and phenomena) would create serious risks
of undue preemption because of the difficulty in distin-
guishing between new and established abstract ideas.
But, as I see it, there is a problem with Mayo insofar
as it concludes that inventive concept cannot come from
discovering something new in nature—e.g., identification
of a previously unknown natural relationship or property.
In my view, Mayo did not fully take into account the fact
that an inventive concept can come not just from creative,
Inc. v. Hulu, LLC, 772 F3d 709, 715 (Fed. Cir. 2014)
(invalidating a claim to routine, conventional application
of the abstract idea of “using advertising as an exchange
or currency” and rejecting the patentee’s argument that
the idea was new); buySAFE, Inc. v. Google, Inc., 765 F.3d
1350, 1351, 1355 (Fed. Cir. 2014) (invalidating a claim to
a method of guaranteeing a party’s performance in an
online transaction and finding that the abstract idea
implicated was “beyond question of ancient lineage”);
SmartGene, Inc. v. Advanced Biological Labs., SA, 555 F.
App’x 950 (Fed. Cir. 2014) (invalidating a claim to com-
puterized application of a mental process for treating
medical patients that “doctors do routinely”).
ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC. 7
unconventional application of a natural law, but also from
the creativity and novelty of the discovery of the law
itself. This is especially true in the life sciences, where
development of useful new diagnostic and therapeutic
methods is driven by investigation of complex biological
systems. I worry that method claims that apply newly
discovered natural laws and phenomena in somewhat
conventional ways are screened out by the Mayo test. In
this regard I think that Mayo may not be entirely con-
sistent with the Supreme Court’s decision in Myriad. 3
In Myriad the patent applicant discovered a previous-
ly unknown natural phenomenon: the sequences of the
BRCA1 and BRCA2 genes and their connection with
cancer. Ass’n for Molecular Pathology v. Myriad Genetics,
Inc., 133 S. Ct. 2107, 2112–13 (2013). While the Court
found ineligible Myriad’s claims to naturally occurring
gDNA sequences, it suggested that “new applications of
knowledge about the BRCA1 and BRCA2 genes” could
generally be eligible, with reference to claim 21 of U.S.
Patent No. 5,753,441 (discussed further below). 4 Id. at
2120. Myriad thus appeared to recognize that an in-
ventive concept can sometimes come from discovery of an
3 Any tension between Mayo and Myriad does not,
of course, change our obligation to respect the sweeping
precedent of Mayo, as the panel did. Supreme Court
“decisions remain binding precedent until [the Court]
see[s] fit to reconsider them, regardless of whether subse-
quent cases have raised doubts about their continuing
vitality.” Hohn v. United States, 524 U.S. 236, 252–53
(1998) (citation omitted).
4 The “new applications” referred to by the Court
must have meant applications of the newly discovered
genes rather than inventive concepts at step two of the
Mayo/Alice framework.
8 ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC.
unknown natural phenomenon, not just from unconven-
tional application of a phenomenon. As Myriad empha-
sized, the first party with knowledge of a law of nature,
natural phenomenon, or abstract idea should be “in an
excellent position to claim applications of that
knowledge.” Id. (quoting Ass’n. for Molecular Pathology v.
USPTO, 689 F.3d 1303, 1349 (Fed. Cir. 2012) (Bryson, J.,
concurring in part and dissenting in part)).
III
Of course, I do not suggest that a newly discovered
law of nature should be patent eligible in its entirety.
Laws of nature are never patentable as such, even when
first discovered by the patent applicant. As Mayo recog-
nized, “Einstein could not patent his celebrated law that
E=mc2.” 132 U.S. at 1293 (quoting Diamond v.
Chakrabarty, 447 U.S. 303, 309 (1980)); see also Flook,
437 U.S. at 591; Gottschalk v. Benson, 409 U.S. 63, 72
(1972) (holding that claims to methods of using a new
mathematical algorithm were unpatentable because they
“in practical effect would be a patent on the algorithm
itself”). Myriad itself reminded us that
“[g]roundbreaking, innovative, or even brilliant discovery
does not by itself satisfy the § 101 inquiry.” Myriad, 133
S. Ct. at 2117; see also Ariosa, 788 F.3d at 1379.
The primary concern with a patent on a law of nature
is undue preemption—the fear that others’ innovative
future applications of the law will be foreclosed. See
O’Reilly v. Morse, 56 U.S. 62, 113 (1853); Mayo, 132 S. Ct.
at 1301. As Mayo emphasized, “there is a danger that the
grant of patents that tie up the[] use [of laws of nature]
will inhibit future innovation premised upon them . . . .”
132 S. Ct. at 1301; see also id. at 1304 (highlighting “the
kind of risk that underlies the law of nature exception,
namely the risk that a patent on the law would signifi-
cantly impede future innovation”).
ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC. 9
As far back as O’Reilly v. Morse, the Supreme Court
found unpatentable Morse’s sweeping claim to all “mark-
ing or printing [of] intelligible characters, signs, or letters,
at any distances” via “the use of the motive power of the
electric or galvanic current, which I call electro-
magnetism,” holding that “the claim is too broad, and not
warranted by law.” 56 U.S. at 112, 113. Morse, like
Mayo, was concerned with undue preemption of the
building blocks of human ingenuity. “[W]hile he shuts the
door against inventions of other persons, the patentee
would be able to avail himself of new discoveries in the
properties and powers of electro-magnetism which scien-
tific men might bring to light.” Id. at 113.
Similarly, in an aspect of our original Myriad decision
that was not reversed by the Supreme Court, Ass’n for
Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct.
694 (2012), and again in our court’s recent In re BRCA1-
& BRCA2-Based Hereditary Cancer Test decision, we
found genetic testing claims that sought to capture “all
comparisons between the patient’s BRCA genes and the
wild-type BRCA genes” to be overbroad and thus ineligi-
ble under § 101, noting that “[t]he covered comparisons
are not restricted by the purpose of the comparison or the
alteration being detected.” 774 F.3d 755, 763, 765 (Fed.
Cir. 2014).
However, if the breadth of the claim is sufficiently
limited to a specific application of the new law of nature
discovered by the patent applicant and reduced to prac-
tice, I think that the novelty of the discovery should be
enough to supply the necessary inventive concept. My
proposed approach would require that the claimed appli-
cation be both narrow in scope and actually reduced to
practice, not merely “constructively” reduced to practice
by filing of a patent application replete with prophetic
examples.
10 ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC.
In my view, the breadth of the claim should be criti-
cal. Even when a patent applicant has demonstrated
some particular utility for a newly discovered law of
nature and reduced it to practice, the claim should be
invalid unless narrowly tailored to the particular applica-
tion of the law that has been developed. Claims that
extend far beyond the utility demonstrated by the patent
applicant and reduced to practice should be invalid, as
they “too broadly preempt the use” of the underlying idea
by others. Mayo, 132 S. Ct. at 1294; see also Diamond v.
Diehr, 450 U.S. 175, 191–92 (1981). But, so long as a
claim is narrowly tailored to what the patent applicant
has actually invented and reduced to practice, there is
limited risk of undue preemption of the underlying idea.
In Myriad the Court noted, 133 S. Ct. at 2120, that an
example of a meritorious claim might be claim 21 of
Myriad’s U.S. Patent No. 5,753,441 (“the ’441 patent”),
which was not at issue in the case and which Judge
Bryson discussed in his concurring opinion on our court’s
decision below, Ass’n for Molecular Pathology, 689 F.3d at
1348 (Bryson, J., concurring). Claim 21 of the ’441 patent
covers a method of detecting any of several specific muta-
tions in the BRCA1 gene, newly discovered by the patent
applicant and shown to increase a person’s risk of devel-
oping particular cancers, using conventional methods.
See In re BRCA1 & BRCA2, 774 F.3d at 765.
This approach appears also to be supported by Morse.
The Supreme Court established in Morse that the extent
to which a patentee can claim is the extent to which he
has actually made some concrete use of the discovery and
reduced it to practice. “The specification of this patentee
describes his invention or discovery, and the manner and
process of constructing and using it; and his pa-
tent . . . covers nothing more.” Morse, 56 U.S. at 119.
Limiting patentees to narrow applications they have
actually developed and reduced to practice would be in
ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC. 11
keeping with Mayo’s commandment that “simply append-
ing conventional steps, specified at a high level of general-
ity, to laws of nature, natural phenomena, and abstract
ideas cannot make those laws, phenomena, and ideas
patentable.” Mayo, 132 S. Ct. at 1300 (emphasis added).
This proposed approach, limiting the scope of patents
based on new discoveries to narrow claims covering
applications actually reduced to practice, would allow the
inventor to enjoy an exclusive right to what he himself
has invented and put into practice, but not to prevent new
applications of the natural law by others. 5 This would
ensure that the scope of the patent claims would not
“foreclose[] more future invention than the underlying
5 It has been suggested that the requirements of
enablement and written description will guard against
the dangers of overclaiming a law of nature. Those doc-
trines, important as they are, generally require only that
one or a handful of representative embodiments be de-
scribed by the patentee. See, e.g., Donald S. Chisum,
Chisum on Patents, § 7.03 at 7-15 (2015) (“An enabling
disclosure is all that is required [for enablement]. The
applicant need not describe actual embodiments or exam-
ples. Indeed, an applicant need not have reduced the
invention to practice prior to filing.”); Id. § 7.04[1][e] at
7-309–7-310.1 (“In Ariad Pharmaceuticals, Inc. v. Eli Lilly
& Co. (2010), the Federal Circuit, sitting en banc, reaf-
firmed that written description of the invention is a
requirement distinct from enablement . . . . [The court]
declined to set forth ‘bright-line rules,’ including rules on
the number of species needed to support a generic claim.”)
(citing and quoting Ariad, 598 F.3d at 1351–52). There-
fore, the doctrines of enablement and written description
would not entirely prevent claims that preempt future
applications of the law of nature by others.
12 ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC.
discovery could reasonably justify.” Id. at 1301. Limiting
the scope of the patent also would avoid the problem that
“the more abstractly [a process patent’s] claims are stat-
ed, the more difficult it is to determine precisely what
they cover.” Mayo, 132 S. Ct. at 1302 (quoting Christina
Bohannan & Herbert Hovenkamp, Creation without
Restraint: Promoting Liberty and Rivalry in Innovation
112 (2012)).
To be sure, determination of whether a claim applying
a new law of nature is overbroad could present difficulties
of definition and line drawing. But allowing narrow
claims that have been actually reduced to practice when
those claims embody an inventive, newly discovered law
of nature would promote the fundamental policies under-
lying § 101. Requiring narrow claims and actual reduc-
tion to practice would be a reasonable accommodation in
return for a more permissive inventive concept require-
ment. The approach would, I think, ensure that only
diagnostic and therapeutic method patents limited in
their claim scope would survive. These patents would
provide the world with disclosure and useful applications
of previously unknown natural laws, and the opportunity
to obtain such patents would help to restore the incentive
to make those discoveries that the patent system has
historically provided.
IV
To be clear, I do not suggest that Mayo was incorrect-
ly decided on its particular facts. The claims at issue in
Mayo contributed only routine application to a law of
nature that was already well known. “At the time the
discoveries embodied in the patents were made, scientists
already understood that the levels in a patient’s blood of
certain metabolites, including, in particular, [the individ-
ual metabolites measured in the claimed methods], were
correlated with the likelihood that a particular dosage of a
ARIOSA DIAGNOSTICS, INC v. SEQUENOM, INC. 13
thiopurine drug could cause harm or prove ineffective.”
132 S. Ct. at 1295 (emphasis added). While “those in the
field did not know the precise correlations between me-
tabolite levels and likely harm or ineffectiveness,” id.,
“scientists routinely measured metabolites as part of their
investigations into the relationships between metabolite
levels and efficacy and toxicity of thiopurine compounds,”
id. at 1298 (emphasis added). In Mayo, the application of
the natural law was merely routine optimization of drug
dosage to maximize therapeutic effect. 6 As discussed
above, Mayo thus forms part of a long line of Supreme
Court decisions invalidating patent claims to conventional
applications of well-known laws of nature.
V
Finally, it seems to me that the approach I suggest
would not change the result in this case. Sequenom’s
challenged claims embody a newly discovered natural
phenomenon, the presence of paternally inherited cell-free
fetal DNA (cffDNA) in a mother’s bloodstream. Judge
Linn’s concurrence notes that “the amplification and
detection of cffDNA had never before been done.” Ariosa,
788 F.3d at 1381 (Linn, J., concurring). But the major
defect is not that the claims lack inventive concept but
rather that they are overbroad. See Mayo, 132 S. Ct. at
1294.
6 Cf. Pfizer, Inc., v. Apotex, Inc., 480 F.3d 1348,
1368 (Fed. Cir. 2007) (“[D]iscovery of an optimum value of
a variable in a known process is usually obvious.”); In re
Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (noting that
generally, in the context of obviousness, “it is not in-
ventive to discover the optimum or workable ranges by
routine experimentation”) (quoting In re Aller, 220 F.2d
454, 456 (CCPA 1955)).
14 ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC.
For example, claim 1 of the ’540 patent broadly covers
any method of detecting paternally inherited cffDNA from
maternal serum or plasma via amplification and detection
of that cffDNA. ’540 patent, col. 23, ll. 61–67. Even the
somewhat narrower claim 21 of the ’540 patent, which
recites a method of performing a prenatal diagnosis based
on the presence, quantity, or sequence of paternally
inherited cffDNA detected by the method of claim 1, still
broadly encompasses any diagnosis of any disease, disor-
der, or condition. ’540 patent, col. 26, ll. 4–14. Such
claims appear to be impermissible attempts to capture the
entire natural phenomenon of cffDNA rather than any
particular applications thereof developed and actually
reduced to practice by the inventors.
A future case is likely to present a patent claim where
the inventive concept resides in a newly discovered law of
nature or natural phenomenon, but the claim is narrowly
drawn and actually reduced to practice. That case will, I
hope, provide the Supreme Court with an opportunity to
revisit the Mayo/Alice framework in this one limited
aspect.
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.
______________________
NEWMAN, Circuit Judge, dissenting from denial of the
petition for rehearing en banc.
I agree with my colleagues that this case is wrongly
decided. However, I do not share their view that this
incorrect decision is required by Supreme Court prece-
dent. The facts of this case diverge significantly from the
2 ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC.
facts and rulings in Mayo Collaborative Services v. Prome-
theus Laboratories, Inc., 132 S. Ct. 1289 (2012), and in
Association for Molecular Pathology v. Myriad Genetics,
133 S. Ct. 2107 (2013).
In Mayo, both the medicinal product and its metabo-
lites were previously known, leaving sparse room for
innovative advance in using this information as a diag-
nostic dosage tool. Nonetheless, the Court recognized the
principle that patent eligibility is not disabled when
science is put to practical use, stating that “a new way of
using an existing drug” is patent-eligible under Section
101. 132 S. Ct. at 1302.
Whether or not Mayo drew an appropriate line in that
case, particularly in view of the specificity of the diagnos-
tic method that was developed, this decision does not
require the drawing of a different line on quite different
facts. In the case now before us, the claimed method was
not previously known, nor the diagnostic knowledge and
benefit implemented by the method.
Similar caveats accompanied the Court’s decision in
Association for Molecular Pathology v. Myriad Genetics,
with the Court stating that “this case does not involve
patents on new applications of knowledge about the
BRCA1 and BRCA2 genes.” 133 S. Ct. at 2120 (emphasis
original). The Court further explained its holding, stating
that: “We merely hold that genes and the information
they encode are not patent eligible under § 101 simply
because they have been isolated from the surrounding
genetic material.” Id.
In the case at bar, the inventors are not claiming the
scientific fact of the discovery of paternal DNA in the
blood of a pregnant woman; they are claiming the discov-
ery and development of a new diagnostic method of using
this information. As the panel recognized, this is a
“breakthrough,” for this information can now be learned
not only earlier in the gestation period than was previous-
ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC. 3
ly available, but without the risks of the previously re-
quired invasive procedures of penetrating the amniotic
sac.
Precedent does not require that all discoveries of nat-
ural phenomena or their application in new ways or for
new uses are ineligible for patenting; the Court has
cautioned against such generalizations. Such caution
takes hold for the case at bar. The new diagnostic method
here is novel and unforeseen, and is of profound public
benefit—“a significant contribution to the medical field,”
Panel Maj. Op. at 16—a “breakthrough,” Panel Conc. Op.
at 5. The panel’s decision to withhold access to patenting,
now endorsed by the en banc court’s refusal to rehear the
case, is devoid of support.
Nor does patenting of this new diagnostic method pre-
empt further study of this science, nor the development of
additional applications. Patenting does, however, facili-
tate the public benefit of provision of this method through
medical diagnostic commerce, rather than remaining a
laboratory curiosity.
This subject matter is not ineligible under Section
101, but warrants standard legal analysis for compliance
with the requirements of patentability, that is, novelty,
unobviousness, specificity of written description, enable-
ment, etc., and whether the claims are appropriately
limited, as discussed many years ago in O’Reilly v. Morse,
56 U.S. 62, 112 (1853) (“We perceive no well-founded
objection to the description which is given of the whole
invention and its separate parts, nor to his right to a
patent for the first seven inventions set forth in the
specification of his claims.”).
I respectfully dissent from my colleagues’ conclusion
that Supreme Court precedent on Section 101 excludes
this invention from eligibility for patenting. The subject
matter should be reviewed for compliance with Sections
4 ARIOSA DIAGNOSTICS, INC. v. SEQUENOM, INC.
102, 103, and 112, and any other relevant provisions of
the patent law.