*1 authority is broad enforcement Board’s restoration, facilitate such with
enough to policies, valid agency’s
in the limits of the Army, 458 F.3d Dep’t Smith v.
see (Fed.Cir.2006). addition, powers under 5
Board’s enforcement 1204(a)(2)may appropriate cir
U.S.C. to award power
cumstances include the pay Lary “and other relief.” v.
both back Serv., 493 F.3d 1356-57
U.S. Postal
(Fed.Cir.2007) (clarifying original opinion remand, rehearing). petition
on for On whether
the Board determine presents
case such circumstances.
CONCLUSION reasons, vacate those we
Board’s decision and remand for further opinion. consistent with this
proceedings
No costs. AND REMANDED
VACATED DIAGNOSTICS, INC., Natera,
ARIOSA
Inc., Plaintiffs-Appellees Diagnostics Center, Inc., Defendant-
Counterclaim
Appellee
SEQUENOM, INC., Sequenom Center Medicine, LLC, Molecular
Defendants-Appellants Limited, Defendant.
Isis Innovation 2014-1139,
Nos. 2014-1144. Appeals, States Court of
United
Federal Circuit.
June *2 Gindler,
David Isaac Irell & Manella LLP, CA, Angeles, argued Los plain- for tiff-appellee Ariosa Diagnostics, Inc. Also Iancu; Naini, represented by Amir Andrei Rabat, August Angeles, Russ & Los CA. Schuck, Bartko, Zankel, William Paul Miller, Francisco, CA, Bunzel & San for Natera, Inc., plaintiff-appellee counter- claim defendant-appellee Diagnostics Center, Inc. Malecek, Kaye LLP,
Michael J. Scholer Altо, CA, Palo argued for defendants-ap- pellants. represented by Also Peter E. Root, Park, CA; Arbisser, Menlo Aton Los Angeles, CA. Blaylock,
Richard L. Pillsbury Winthrop LLP, CA, Shaw Pittman Diego, San Corporation. amicus curiae Invitae Also represented by Hasson, Kirke M. Colin Francisco, Travers Kemp, San CA. Noonan, McDonnell, Kevin Edward LLP, Boehnen Berghoff, Hulbert & Chica- IL, go, for amicus Biotechnology curiae Industry Organization. I, Larry Respess, Sheppard,
William Mullin, Richter, LLP, & Hampton San Di- CA, ego, Diego for amicus curiae The San Property Intellectual Law Association. REYNA, LINN, Before WALLACH, Judges. Circuit steps the court filed Circuit of the method of claim 1 of the Opinion for Concurring Opinion REYNA. file Judge amplifying include the cffDNA con- Judge LINN. by Circuit in a sample tained of a or serum pregnant from a female and REYNA, Judge. Circuit *3 paternally inherited Amplifying cffDNA. appeal grant summary is from a This single copy, cffDNA results in a or a few invalidity of the asserted judgment copies, piece being of a of cffDNA multi- (“the 6,258,540 Patent No. claims U.S. plied magnitude, across several orders of The States District patent”). '540 United generating thousands to of copies millions District of Court for the Northern Califor- particular sequence. of that DNA In the nia that the asserted claims of the found amplification step, DNA is extracted from patent patent eligi- '540 are not directed to serum or plasma samples ampli- and subject matter and are therefore inval- ble (“PCR”) 101. For the reasons by polymerase id under U.S.C. fied chain reaction below, explained we or another method. exponentially PCR affirm.' amplifies sample the cffDNA to detectable
I levels. In Drs. Dennis Lo and James detecting step, In the the lab technician cell-free fetal DNA Wainscoat discovered amplified adds the agarose cffDNA to an (“cffDNA”) serum, plasma in maternal gél containing ethidium bromide to stain portion samples of maternal blood paternally аnd visualize the inherited previously other researchers had discarded cffDNA. as medical waste. cffDNA is non-cellular freely fetal DNA that circulates in the patent The '540 provides also for mak- pregnant Ap- stream of a woman. blood a ing diagnosis of certain fetal characteris- laboratory a of known plying combination tics based on the of paternally detection techniques discovery, to their Drs. Lo and specification inherited cffDNA. The ex- implemented a method for de-
Wainscoat plains analysis permits of cffDNA tecting paternally the small fraction of in- genetic more efficient determination of de- cffDNA in maternal or se- herited pregnant fects that a carrying woman characteristics, rum to determine fetal genetic fetus with certain defects will a invention, gender. as The commer- such have more cffDNA in her blood than will a by Sequenom cialized its MaterniT21 a normal woman with fetus. '540 test, prenatal created an alternative col. 3 11.30-43. diagnosis of fetal DNA that avoids the widely-used techniques risks of that took 1, 2, 4, 5, 8, 19-22, 24, Claims and 25 of samples placenta. from the fetus or in this appeal.1 the '540 are issue 2001, Drs. Lo and obtained the Wainscoat Independent requires: claim patent, which relates tо discov- ery. detecting paternally 1. A method for a origin per- inherited nucleic acid of fetal parties agree that the does formed on a maternal serum or paternally not claim cffDNA or inherited female, sample pregnant from a which Instead, cffDNA. claims using comprises certain methods of cffDNA. The method 12, 13, 15, parties stipulated pur- patent. 1. The have that for the and 18 of the '540 J.A. 1, 2, 4, 5, 8, 9-22, poses appeal 24-25, of this 30-31. representative 24 and 25 are of claims paternally inherited nucleic II amplifying plasma sample serum or acid from the (for- Appellee Diagnostics, Ariosa Inc. Inc.”) merly known as “Aria Diagnostics, Test, Harmony makes and sells the a non- presence paternally of a prenatal diagnosis invasive test used for origin inherited nucleic acid of fetal Natera, certain fetal characteristics. Inc. sample. makes and sells the Non-Invasive Paterni- col. 23 1.61-67. Test, ty which is intended to confirm the comparison, independent claims 24 paternity non-paternity of a gestating require: and 25 genetic fetus from information in fetal detecting paternally 24. A method for preg- available the blood of the inherited nucleic acid on a maternal *4 Center, nant Diagnostics female. Inc. is a сomprises: blood which method sample, licensee of Natera.
removing substantially all or all nucleat- In response threatening to letters claims populations ed and anucleated cell from infringement, Inc., Diagnostics, Ariosa sample, the blood Natera, Diagnostics Center, Inc. and Inc. amplifying paternally a inherited nucleic each separate declaratory filed judgment remaining acid from the fluid and sub- actions from through early December 2011 amplified jecting the nucleic acid to a 2012 against Sequenom alleging they Paternally test for the inherited [sic] infringe did not patent. Seque- fetal nuсleic acid. nom alleging counterclaimed infringement in each case. The district court related A for performing prena- 25. method a pretrial the three actions for purposes. diagnosis tal on maternal blood sam- ple, comprises which method action, In the Sequenom Ariosa filed a motion seeking preliminarily enjoin Ari- obtaining a non-cellular fraction of the selling osa from Harmony accused sample blood 2012, July Prenatal Test. In the district amplifying paternally inherited nucleic court issued an order denying Sequenom’s acid from the non-cellular fraction motion for a preliminary injunction. In рerforming nucleic acid analysis on so, doing the context of the district court amplified nucleic pa- acid to detect found there was a question substantial ternally inherited fetal nucleic acid. subject over whether the matter of the Id. at 26 11.20-36. eligible asserted claims was directed to subject Sequenom matter. appealed to The remaining explain claims how the this court. method of detection occurs or how it can be used. 2 example, claim depends 9, 2013, August On this court vacated from claim 1 and amplification by claims holding remanded the that the polymerase chain reaction. Id. аt col. 24 district court respects erred certain ll. 60-61. 4 similarly depends Claim from appeal. relevant to this Diagnostics, Aria claim 1 and claims sequence detection via a Inc., Sequenom, 1296, Inc. v. 726 F.3d specific probe. Id. col. 24 11.65-67. (Fed.Cir.2013). Claim addition, 1305 1, 21 depends also from claim but instead Court noted opinion that it offered no “as of focusing solely on a method for detect to whether there is or is not a substantial ing, it focuses on a method for performing question regarding subject matter eli- a prenatal diagnosis, using claim gibility l’s meth of the asserted claims” of the '540 detecting. od for patent, Id. col. 26 ll. 4-14. but remanded “for the distriсt
1375 755, (Fed. subject eligibili- Litig., matter Test Patent 774 court to examine F.3d Cir.2014). ty.... light Molecular [Ass’n for Genetics, Inc., 569
Pathology Myriad Section 101 of the Patent Act defines -, U.S. 133 S.Ct. patent eligible subject matter: (2013) L.Ed.2d 124 Id. ].” Whoever invents any or discovers new remand, parties filed cross machine, After process, and useful manufac- summary regarding ture, judgment matter, motions for composition § invalidity thereof, under 35 U.S.C. 101. The dis- new improvement and useful therefor, agreed argument trict court with Ariosa’s obtain a patent subject to the claims of the '540 were the conditions and requirements of this phenomenon pa- directed to the natural title.
ternally
cffDNA and that
inheritеd
§
35 U.S.C.
101. The
Court has
enough
did not add
to the natural
claims
long
exceptions
held
there are certain
make the
phenomenon
provision:
nature,
to this
laws of
eligible under
101. The district court phenomena, and abstract
ideas. Alice
, —
steps
amplifying
determined that
Corp.
-,
v. CLS Bank
U.S.
Int’l
welhunderstood,
were
rou-
L.Ed.2d
tine,
activity in
or conventional
when
(2014)
cases).
(collecting
*5
application
patent
thé
for the '540
Collaborative Services v.
filed. The district court concluded that
Laboratories,
Inc.,
Prometheus
patent
patent-
the '540
was not directed to
-,
1289,
Ill
pat
form the nature of the claim” into a
grant
summary
review the
ent-eligible application.
We
Id. at 1298. The
judgment
regional Supreme
under the law of the
has
Court
described the second
circuit,
in
step
analysis
this case the Ninth Circuit.
of this
aas
search for an
Works,
Mach.
Inc.
concept” i.e.,
Charles
v. Vermeer
“inventive
an element or
—
(Fed.Cir.
Co.,
Mfg.
723 F.3d
combination of elements that is “sufficient
2013).
practice
The Ninth Circuit reviews the
to ensure that
in
grant or
summary judgment
significantly
pat
denial of
de
amounts to
more than a
novo.
City,
upon
[ineligible concept]
Leever v. Carson
360 F.3d
ent
itself.”
(9th Cir.2004).
1294;
Digitech Image
We also review Id. at
see also
Techs.,
Inc.,
de
question
Imaging,
novo the
of whether a claim is
LLC v. Elecs. For
(Fed.Cir.2014) (“With
101. In
invalid under section
re BRCA1- 758 F.3d
limitations,
and
Hereditary
process
BRCA2-Based
Cancer
out additional
a
algorithms to ma- nal
col. 1 11.
mathematical
blood.” Id.
51-55.
In the
employs
existing
generate
discussion,
information to
nipulate
notes:
information
patent eligi-
is not
additional
study
In this
we have demonstrated the
ble”).
feasibility of performing non-invasive
RhD genotyрing
foetal
from maternal
The claims of
plasma. This represents the first de-
appeal
are at issue in this
are method
scription
single gene diagnosis
from
generally eligible
are
claims. Methods
maternal plasma.
In this
subject matter.
asserted
patent are directed to a
claims of the '540
Further,
Id. col. 10 11.
descrip-
53-58.
that starts with cffDNA
multistep method
tion of the
notes:
have
“[w]e
invention
sample
a
of maternal
taken from
present
demonstrated that foetal DNA is
naturally occurring
serum —a
non-cellular
serum,”
maternal
and
id. col. 13
freely
that circulates
in the
fetal DNA
“[tjhese
6-7,
11.
observations indicate
See,
pregnant
of a
woman.
blood stream
plasma/serum
that maternal
be
It is
e.g.,
a useful
source material for the non-
undisputed that the existence of cffDNA
prenatal
invasive
diagnosis
ge-
of certain
phenomenon.
a natural
maternal blood .is
disorders,”
netic
id. col. 13 11.11-13. The
not contend that
Lo
Sequenom does
Drs.
patent also
important
states:
most
“[t]he
created
altered
Wainscoat
study
very high
observation
is the
genetic
information encoded
of foetal DNA in
concentration
maternal
cffDNA,
undisputed
it
loca
plasma and serum.” Id. col. 16 11.12-14.
tion of the nucleic acids existed
nature
Thus,
issue,
the claims at
as informed
before Drs. Lo and Wainscoat found them.
specification,
generally
are
directed to
paternally
The method ends with
inherited
detecting the
presence
naturally
oc-
cffDNA,
phenome
which is also natural
curring thing or a natural phenomenon,
non. The method therefore begins and
*6
cffDNA in
plasma
maternal
or serum. As
Thus,
phenomenon.
ends with
natural
abovej
we noted
the claimed method be-
the
are
to
that is
directed matter
gins
naturally occurring
and ends with a
naturally occurring.
phenomenon.
description supports
The written
Because the claims at issue are directed
pat-
conclusion that the claims of the '540
naturally
to
occurring phenomena, we turn
naturally occurring
ent are directed to a
to the
step Mayo’s
second
framework.
thing
phenomenon.
or natural
In the
In
step,
the second
we examine the ele-
Summary
Objects
and
of the Invention
ments of the claim to determine whether
section of the '540 patent,
the claim contains an
concept
inventive
states that
has now been discovered
“[i]t
sufficient to “transform” the claimed natu-
that foetal DNA is
in maternal
detectable
rally occurring phenomenon
patent-
into a
samples.”2
or plasma
serum
eligible application.
2. The term "fetal” and "foetal” are used in-
terchangeably
in the '540
ing methods like
amplify
made clear that transfor
PCR to
and de-
application
well-understood, routine,
re
patent-eligible
mation into a
tect cffDNA was
simply stat[ing]
than
the law
quires “more
activity
and conventional
in 1997. The
adding
‘apply
the words
of nature while
general
method
issue here amounts to a
”
an
1294. A claim that recites
it.’
Id. at
routine,
apply
instruction to doctors to
nature,
idea,
natural
law of
abstract
techniques
seeking
conventional
when
fea
must include “additional
phenomenon
detect cffDNA. Because the
steps
method
“that the
is more
[claim]
tures” to ensure
well-understood,
were
conventional and
drafting
designed monopo
than a
effort
routine,
detecting paternally
the method of
idea,
nature,
law of
[abstract
lize the
inherited cffDNA not
new and useful.
phenomenon].” Id. at 1297. For
natural
only subject
The
matter new and useful.as
encompass
claims that
process
application
of the date of the
phenomenon,
process steps
are the
discovery
presence
of cffDNA in
additional features that must -be new and
plasma
maternal
or serum.
Flook,
useful. See Parker v.
specification
con-
(1978)
[0]ne techniques which variety might of be occurring phenomenon, fails to spe different nucleic acid used to detect patent eligiblе subject disclose matter if there are numerous example, cies. For conventional, the methods themselves are might techniques be used to de which applications routine and well understood single gene mu repeat expansions, tect in the art. The of the tations, translocations. deletions in appeal issue this are not directed to are a techniques These matter of routine patent eligible subject are, matter and analysis in the art for the for one skilled therefore, invalid. DNA. of applicant J.A. 1052. The went on to note: IV readily in the art is skilled able [0]ne opinion, In its the district court ad- teaсhings present appli- apply principle preemption. dressed the The cation to one of the well-known tech- court district noted: niques detection of DNA with a view important It to note that the '540 foetal in analysis paternal claim merely does uses or plasma or serum. [sic] cffDNA, applications of it claims meth- Similarly, the applicant J.A. 1055. later detecting ods for phenome- the natural person added that skilled the art “[t]he generally non. Because one must be range techniques has a broad available able to find a natural phenomenon to use for the detection of DNA in a sаmple.” it, apply it and claims covering only JA. 1057. commercially way viable of detecting The dependent claims are broad that phenomenon carry do a substantial examples of how to detect in ma cffDNA of preempting practical risk all uses plasma. dependent ternal claims are it. focused on the the natural phenom use of J.A. 19. well-understood, enon in combination with Sequenom argues that there are numer- routine, activity. and conventional ous other uses of cffDNA aside from those example, poly-mer- claim identifies the thus, patent, claimed ase chain amplificatiоn reaction as the preempt does not all uses technique to be used in the detection cffDNA, as shown evidence the rec- above, method of claim 1. As noted ord Sequenom before the district court. well-understood, routine, technique was argues also that “a applying method specified by conventional using phenomenon a natural in a manner itself. Like claim claims 5 preclude that does not alternative methods and 8 focus on a specific chro and, non-preemptive, the same field is mosome .within the cffDNA—a natural definition, patent-eligible under Section phenomenon agаin, adding no inventive *8 — Appellants’ Similarly, 101.” Br. 30. Se- concept to the limitations of claim 1. None quenom amici argue that because the of the remaining dependent asserted particular application phe- of the natural independent substantially claims differ nomena that the '540 claims em- Thus, case, from these in claims. routine, body specific, are narrow and the claims appending conventional a steps to phenomenon, upheld. argues natural should be Ariosa that the specified high at a level generality, of enough supply principle preemption is not to of not alter does
1379 unpatentable). matical formula Parker that the claimed argues Ariosa analysis. asserts, Flook, not, Sequenom Supreme as Court stated the are methods specific. question limited and issue in the case as follows: “The is whether the this case identification of has made Supreme Court The category useful, a though limited con- preemption principle that clear ventional, post-solution applications of such judicial exceptions to for the the basis respondent’s a formula makes method eli- Alice, S.Ct. at 2354 patentability. gible patent protection.” Id. at (“We that the concern hаve described question 2522. The answer to that S.Ct. one of exclusionary principal as drives this granting rights “no” was because exclusive reason, questions For this pre-emption”). mathematical formula would be ex- to the re are inherent preemption on it future empting from use. The concern by analysis. § 101 solved further dis law not inhibit “patent is that V the future
covery by improperly tying up
inge
of human
building
of these
blocks
use
completeness,
Seque-
we address
omitted).
(internal
nuity.”
quotations
Id.
remaining arguments.
Sequenom
nom’s
words,
claims should not
In other
argues
patent,
that
the '540
no one
“before
-building
the basic
the use of
prevent
preg-
оr serum of
using
was
ideas, natu
technology-
blocks of
—abstract
amplify
pater-
and detect
nant mothers
natural
rally occurring phenomena,
nally-inherited
Appellants’
cffDNA.”
Br.
may
preemption
signal
laws. While
original).
argument
This
im-
(emphasis
matter,
the absence of
ineligible subject
plies
concept
that the inventive
lies in the
not
complete preemption does
demonstrate
or serum.
discovery of cffDNA
case, Seque-
In this
patent eligibility.
so,
claimed
Even if
this is not the invention
to limit the breadth of
attempt
nom’s
patent.
alternative uses of
by showing
claims
argues
further
Sequenom
“[o]ne
scope
the claims
cffDNA outside of the
Lo and
simple measure of
Wains-
[Drs.]
change
not
the conclusion
does
Lan-
is that their 1997
coat’s contribution
ineligible
are
claims
directed
has
cited over a
publication
cet
been
subject
patent’s
matter.
Where
Appellants’ Br. 25. Se-
thousand times.”
ineligi
only
are
to disclose
deemed
also notes that “the method re-
quenom
subject
matter under the
frame
ble
human
significant
flects a
contribution
work,
they
preemption
are in this
combined
Lo and Wainscoat
fully
[Drs.]
and made
are
addressed
concerns
and utilized man-made tools
biotechnol-
moot.
pre-
way
in a new
that revolutiоnized
ogy
encourage us to
Sequenom and amici
note that
agree
natal care.” Id. We
but
among
phenome-
natural
draw distinctions
Supreme Court
instructs
inter-
they
na
on whether or not
will
based
innovative, or even
“[groundbreaking,
with innovation
other
significantly
fere
discovery
does not
itself satis-
brilliant
fields now or in the future.
Genetics,
Myriad
fy
inquiry.”
however,
cases,
have not distin-
Court
Inc.,
discovery at 2117. The
133 S.Ct.
among different laws of nature
guished
genes
sig-
was a
and BRCA2
BRCA1
according to whether
phenomenon
field,
the medical
nificant contribution to
they embody are suf-
principles
or not the
at 2117.
patentable.
it
Id.
See,
but
ficiently
e.g.,
narrоw.
Parker v.
discovery
Flook,
Drs. Lo and Wainscoat’s
57 While
(1978)
sig-
cffDNA
have been
regarding
narrow mathe-
(holding
L.Ed.2d 451
*9
field,
to the medical
concept. Mayo,
nificant contribution
claims of the '540
because I
Diehr,
In
Diamond
the Supreme
am
sweeping
bound
the
language of the Court held that “a new combination of
Mayo
test set out in
Collaborative Services
steps
process
in a
patentable
be
even
Laboratories, Inc.,
v. Prometheus
though all the constituents of the combina-
-,
132 S.Ct.
It has been established that “[l]aws whole.” nature, Mayo 132 Despite S.Ct. phenomena, natural and ab that recognition, Mayo entirely stract ideas are not discounted patentable.” Alice — Corp. Int’l, activity” “conventional -, v. CLS Bank recited in the U.S. claims in steps 13 S.Ct. that case because the “add L.Ed.2d 296 (2014) (citations omitted). nothing specific to the laws of nature Mayo, other well-understood, than routine, Court set what is two-step forth a con- frame for distinguishing patents activity, previously work ventional engaged that claim nature, phenomena, laws those in the field.” Id. at 1299. While ideas abstract from those that claim pat might conclusion have been warranted ent-eligible applications concepts. given those the fact that the “con- step first looks to determine whether ventional activities” in were very claims are directed to a patent-ineligible steps already doing— that doctors were
1381
issue, measuring
structions in the claims at
drug
at
issue
administering the
levels,
adjusting dosing
widely
they
had been
used
and
metabolite
doctors—
measuring
Su- had been
and
the metabolite levels—the
metabolites
recal-
based on
culating
ruling
dosages
toxicity/ineffica-
not limit its
based on
Court did
preme
cy
years here,
amplification
circumstances.
limits for
particular facts and
those
—
and detection of сffDNA had never before
Supreme Court’s blanket dismissal
been done. The
use of the previously
new
steps leaves
post-solution
of conventional
plasma
discarded maternal
to achieve such
Mayo from this
distinguish
room to
no
advantageous
deserving
pat-
an
result is
of
though
ampli
here no one was
even
protection.
Eisenberg,
ent
Rebecca S.
Cf.
fying
detecting paternally-inherited
Diagnostics,
Prometheus Rebound:
Na-
using
or serum of
cffDNA
ture,
122
Algorithms,
and Mathematical
Indeed, the maternal
pregnant mothers.
(2013)
341,
(noting
Yale L.J.
343-44
Online
discarded,”
“routinely
used to be
that despite Mayo’s declaration that a
ll.50-53, beсause,
1
as Dr.
col.
way
using
claim to “a new
an existing
testified, “nobody thought that fetal
Evans
drug”
patentable, Mayo,
is
132 S.Ct. at
present.”
cell-free DNA would be
1302, it
unclear
a claim to
how
new uses
deny
Sequenom’s in
It is hard to
existing drugs
Mayo’s
would survive
meritorious. Prior to the
truly
vention is
test).
sweeping
required
prenatal diagnoses
patent,
short, Sequenom’s
invention is noth
methods,
“presented]
which
a de
invasive
Mayo.
at
ing like the invention
issue
mother and to the
gree of risk to the
Sequenom
practical
result
“effectuate[d]
1 ll.16-17. The
pregnancy.”
Id.
col.
attained,”
previously
and benefit not
so its
“techniques
available
time-consum
[we]re
traditiоnally
would
have been valid.
expensive equipment.”
ing
require[d]
Tatham,
132, 135-36, 22
Roy
Le
v.
1
Dr. Mark Evans
Id. at col.
ll.17-37.
(1859)
132,
(quoting
How.
tection than other tests. Unlike claims a new method in- patent eligible. While the
should be