Court Opinion

ID: 812230
Source: CourtListenerOpinion
Date Created: 2012-11-20 16:28:41+00
Date Added: 2024-06-11T18:00:44.154439
License: Public Domain

NOTE: This opinion is nonprecedential.

  United States Court of Appeals
      for the Federal Circuit
              __________________________

 PERKINELMER, INC. AND NTD LABORATORIES,
                   INC.,
            Plaintiffs-Appellees,
                           v.
                 INTEMA LIMITED,
                 Defendant-Appellant.
              __________________________

                      2011-1577
              __________________________

    Appeal from the United States District Court for the
District of Massachusetts in case no. 09-CV-10176, United
States District Judge F. Dennis Saylor, IV.
                __________________________

              Decided: November 20, 2012
              __________________________

    BRADFORD J. BADKE, Ropes & Gray LLP, of New York,
New York, argued for plaintiffs-appellees. With him on
the brief were NICOLE M. JANTZI, of Washington, DC, and
DALILA ARGAEZ WENDLANDT, of Boston, Massachusetts.

   LAWRENCE ROSENTHAL, Stroock & Stroock & Lavan
LLP, of New York, New York, argued for defendant-
PERKINELMER   v. INTEMA                                  2

appellant. With him on the brief were ANGIE M. HANKINS,
MATTHEW W. SIEGAL, and IAN G. DIBERNARDO.
               __________________________

Before BRYSON, O’MALLEY, and WALLACH, Circuit Judges.
O’MALLEY, Circuit Judge.
     Intema Limited (“Intema”) appeals from a decision of
the United States District Court for the District of Massa-
chusetts granting summary judgment to PerkinElmer,
Inc. and NTD Laboratories, Inc. (collectively, “PerkinEl-
mer”). The district court determined that U.S. Patent No.
6,573,103 (“the ’103 patent”) was drawn to patent-eligible
subject matter under 35 U.S.C. § 101, but held that the
asserted claims were anticipated and obvious. On appeal,
we consider only the issue of patent eligibility under
section 101, reverse the district court on this point, and
affirm summary judgment to PerkinElmer.
                     I.   BACKGROUND
    Doctors perform prenatal non-invasive screening to
determine the risk that a fetus has Down’s syndrome. If
the risk is high enough, the doctor will order invasive
diagnostic testing to determine definitively whether the
fetus has Down’s syndrome. These test, however, carry a
significant risk of miscarriage and doctors seek to avoid
them if possible. Accordingly, accurate non-invasive
screening methods are desirable to avoid performing
unnecessary diagnostic testing.
    The ’103 patent discloses specific screening methods
to estimate the risk of fetal Down’s syndrome. The proc-
esses use markers from both the first and second trimes-
ters of pregnancy to determine the risk. Claims 1 and 20
are representative. Claim 1 reads:
3                                 PERKINELMER   v. INTEMA

    A method of determining whether a preg-
    nant woman is at an increased risk of hav-
    ing a fetus with Down’s syndrome, the
    method comprising the steps of:
    measuring the level of at least one screen-
    ing marker from a first trimester of preg-
    nancy by:
    (i) assaying a sample . . . ; and/or
    (ii) measuring at least one first ultrasound
    screening marker from an ultrasound scan
    . . .;
    measuring the level of at least one second
    screening marker from a second trimester
    of pregnancy, the at least one second
    screening marker from the second trimes-
    ter of pregnancy being different from the
    at least one first screening marker from
    the first trimester of pregnancy, by:
    (i) assaying a sample . . .; and/or
    (ii) measuring at least one second ultra-
    sound screening marker from an ultra-
    sound scan . . .;
    and determining the risk of Down’s syn-
    drome by comparing the measured levels
    of both the at least one first screening
    marker from the first trimester of preg-
    nancy and the at least one second screen-
    ing marker from the second trimester of
    pregnancy with observed relative fre-
    quency distributions of marker levels in
    Down’s syndrome pregnancies and in un-
    affected pregnancies.
PERKINELMER   v. INTEMA                               4

Claim 20 states:
       A method of determining whether a preg-
       nant woman is at an increased risk of hav-
       ing a fetus with Down’s syndrome, the
       method comprising the steps of:
       measuring the level of at least one first
       screening marker from a first trimester of
       pregnancy by:
       (I) assaying a sample . . .; and/or
       (ii) measuring at least one first ultrasound
       screening marker from an ultrasound scan
       ...;
       determining a first risk estimate of
       Down’s syndrome by comparing the meas-
       ured level of the at least one first screen-
       ing marker level from the first trimester of
       pregnancy with observed relative fre-
       quency distributions of marker levels in
       Down’s syndrome pregnancies and in un-
       affected pregnancies;
       comparing the first risk estimate with a
       predetermined cut-off level to initially
       classify the pregnant woman as screen-
       positive or screen-negative based on the
       comparison;
       and if the pregnant woman is initially
       classified as screen-negative; measuring
       the level of at least one second screening
       marker from a second trimester of preg-
       nancy, the at least one second screening
       marker from the second trimester of preg-
       nancy being different from the at least one
5                                    PERKINELMER   v. INTEMA

       first screening marker from the first tri-
       mester of pregnancy, by:
       (I) assaying a sample . . .; and/or
       (ii) measuring at least one second ultra-
       sound screening marker from an ultra-
       sound scan . . .
       and determining the risk of Down’s syn-
       drome by comparing the measured level of
       both the at least one first screening
       marker from the first trimester of preg-
       nancy and the at least one second screen-
       ing marker from second trimester of
       pregnancy with observed relative fre-
       quency distributions of marker levels in
       Down’s syndrome pregnancies and in un-
       affected pregnancies.
The key difference between claims 1 and 20 is that, in
claim 20, patients are screened into “screen positive” or
“screen negative” groups, with only the latter undergoing
testing in the second trimester. The “determining” step at
the end of claims 1 and 20 is the key limitation. It was
construed by the district court as follows:
       (1) determining the risk of Down’s syn-
       drome by comparing distributions of
       marker levels in Down’s syndrome preg-
       nancies, and in unaffected pregnancies,
       and
       (2) combining screening markers from the
       first and second trimesters into a single
       risk calculation.
   Among other motions, Intema filed a motion for sum-
mary judgment of patent eligibility under section 101;
PerkinElmer filed a corresponding cross-motion of ineligi-
PERKINELMER   v. INTEMA                                   6

bility under section 101. The district court granted In-
tema’s motion and denied PerkinElmer’s cross-motion.
The district court held that the claims cover patent-
eligible subject matter because, even though they recite
an ineligible algorithm, they focus on a data-gathering
method. PerkinElmer, Inc. v. Intema, Limited, Case No.
09-cv-10176, slip op. at 21 (D. Mass. Aug. 12, 2011) [here-
inafter “Slip op.”]. And “the process of gathering data by
taking blood samples and measuring ultrasounds is
manifestly statutory subject matter. . . .” Id. The district
court found that the machine-or-transformation test
confirmed its outcome because the data-gathering steps
satisfy the test. The step of “assaying a blood sample”
was transformative, according to the district court, be-
cause it changes the composition of the sample. Id. at 24.
And the district court found that “measuring” an ultra-
sound scan necessarily was tied to use of an ultra-sound
machine. Id. at 25.
                      II. DISCUSSION
    Patent-eligible subject matter is defined in 35 U.S.C. §
101: “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 require-
ments of this Title.” The Supreme Court has long held
that section 101, although broad, is subject to important
limitations. “Laws of nature, natural phenomena, and
abstract ideas are not patentable.” Mayo Collaborative
Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293
(2012) (internal quotation marks omitted). These excep-
tions make ineligible, for example, mental processes, see
Gottschalk v. Benson, 409 U.S. 63, 67 (1972), and products
of nature, cf. Diamond v. Chakrabarty, 477 U.S. 303, 313
(1980). But these exceptions are not boundless, “[f]or all
inventions at some level embody, use, reflect, rest upon,
7                                   PERKINELMER   v. INTEMA

or apply laws of nature, natural phenomena, or abstract
ideas.” Mayo, 132 S. Ct. at 1293. The key distinction,
which bears on our decision today, is between claims that
recite ineligible subject matter, and no more, and claims
to specific inventive applications of that subject matter.
See Diamond v. Diehr, 450 U.S. 175, 187 (1981); see also
Mayo, 132 S. Ct. at 1294. Unlike the former, the latter
do not risk the broad preemption of “the basic tools of
scientific and technological work,” Benson, 409 U.S. at 67,
and therefore clear the threshold of section 101.
    For a process claim to cover a patentable application
of, for example, a natural law, it must “contain other
elements or a combination of elements, sometimes re-
ferred 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, 132 S.
Ct. at 1294. Process claims fail this requirement if, apart
from the ineligible concept, they contain nothing more
than “well-understood, routine, conventional activity
previously engaged in by researchers in the field.” Id.
Because they merely describe the ineligible concept,
amounting to a claim on the concept, such claims run
afoul of section 101. That is the case here.
    PerkinElmer argues that the claims are directed to an
ineligible mathematical algorithm and fail the machine-
or-transformation test. According to PerkinElmer, pre-
solution data-gathering steps, even if transformative or
tied to a machine, do not render the algorithm patentable.
PerkinElmer contends that the claimed process fails the
machine-or-transformation test because the “determining”
step is not tied to a machine and, since the “determina-
tion” is a calculation of risk based on data, nothing is
physically transformed. Nor does PerkinElmer think the
“measuring” step satisfies the test since measuring the
results of an ultrasound scan requires no transformation
PERKINELMER   v. INTEMA                                   8

and it is not the ultrasound machine which does the
“measuring” described in the claims.
     Intema responds that the claims are directed to a spe-
cific medical test, not to an abstract method. Intema
contends that the machine-or-transformation test is
satisfied by the “assaying” measurement because the
sample is chemically transformed. Intema also believes
that the measurement of an ultrasound scan involves the
transformation of data into a visual depiction, and thus
relies on In re Abele, 684 F.2d 902 (C.C.P.A. 1982), to
argue that this transformation satisfies the test.
    The Supreme Court’s decision in Mayo and this
court’s recent decision in Ass’n for Molecular Pathology v.
PTO, 689 F.3d 1303 (Fed. Cir. 2012) [hereinafter Myriad],
dictate the result we reach today. Those two cases dealt
with process claims similar to those at issue here and, in
both, the process claims were held ineligible under section
101. In Mayo, the claimed method was a diagnostic assay
involving                     two                     steps:
“administering” a thiopurine compound to a patient and
“determining the level of 6-thioguanine,” a metabolite of
thiopurine, in the patient. The claims contained two
“wherein” clauses which did not dictate any step in the
process, but disclosed the metabolite concentration range
necessary for effective treatment—the purported discov-
ery embodied in the claims. This correlation, i.e., that an
effective dose of thiopurine produces a certain range of
metabolite concentrations, was the result of the natural
metabolic process. The claims in dispute thus were
drawn to a law of nature and needed to “add enough to
their statement of the correlation[] to allow the processes
they describe to qualify as a patent-eligible processes that
apply the natural laws.” Mayo,132 S. Ct. at at 1297
(emphasis in original). This they failed to do:
9                                    PERKINELMER   v. INTEMA

        [T]he claims inform a relevant audience
        about certain laws of nature; any addi-
        tional steps consist of well-understood,
        routine, conventional activity already en-
        gaged in by the scientific community; and
        those steps, when viewed as a whole, add
        nothing significant beyond the sum of
        their parts taken separately. For these
        reasons we believe that the steps are not
        sufficient to transform unpatentable natu-
        ral correlations into patentable applica-
        tions of those regularities.
Mayo, 132 S. Ct. at 1298.
    The Supreme Court emphasized the “inventive con-
cept” requirement of section 101, stating that “simply
appending conventional steps, specified at a high level of
generality, to laws of nature, natural phenomena, and
abstract ideas cannot make those laws, phenomena, and
ideas patentable.” Id. at 1300; see also id. at 1298
(“Purely conventional or obvious pre-solution activity is
normally not sufficient to transform an unpatentable law
of nature into a patent-eligible application of such a law.”)
(internal quotation marks omitted); id. at 1299 (explain-
ing that in Parker v. Flook, 437 U.S. 584 (1978), “putting
the [ineligible] formula to the side, there was no ‘inventive
concept’ in the claimed application of the formula,” mak-
ing the claims there ineligible since “‘[p]ost-solution
activity’ that is purely ‘conventional or obvious’” “‘cannot
transform an unpatentable principle into a patentable
process.’”) (quoting Flook, 437 U.S. at 589); id. (“These
instructions 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.”); cf.
id. at 1299 (explaining that the claims in Diehr were
patent-eligible “because of the way the additional steps of
PERKINELMER   v. INTEMA                                 10

the process integrated the [ineligible] equation into the
process as a whole,” and the Diehr court “nowhere sug-
gested that all these steps, or at least the combination of
those steps, were in context obvious, already in use, or
purely conventional.”).
     In Myriad, a panel of this court found certain process
claims ineligible because they were drawn to abstract
mental processes.1 The stricken claims there are indis-
tinguishable from those before us. The Myriad claims
covered screening methods for cancer-predisposing muta-
tions in human gene sequences. Myriad, 689 F.3d at
1309-10. One claim, for example, contained the sole step
of “analyzing” a human gene sequence to identify a cer-
tain mutation. Id. at 1309. Another required the single
step of “comparing” a gene sequence from a sample of a
tumor with a sequence from a non-tumor sample to iden-
tify a certain mutation; the claim contained a “wherein”
clause stating that a specific difference between the two
sequences identifies the mutation of concern. Id. at 1310.
This second claim, the panel held, “recites nothing more
than the abstract mental steps necessary to compare two
different nucleotide sequences.” Id. at 1334. The claims
were not over an application of the mental process of
comparing. “Rather, the step of comparing two DNA
sequences [was] the entire process that [was] claimed.”
Id. at 1335.
    Here, Intema claims analytical methods to determine
the risk of fetal Down’s syndrome. Claim 10, for example,
requires two “measuring” steps; a screening marker from
the first trimester of pregnancy is observed; then, a

   1    The panel found patent-eligible a claim drawn to
the method of screening potential cancer treatments by
comparing cellular growth rates or treated and untreated
cells, as well as composition claims over isolated DNA
molecules.
11                                   PERKINELMER   v. INTEMA

marker from the second trimester is observed. The claim
then contains a “determining” step in which the risk of
Down’s syndrome is calculated by comparing both screen-
ing marker measurements with known statistical infor-
mation. Claim 20 adds a “determining” step in between
the two “measuring” steps, in which the risk of Down’s
syndrome is calculated based on the first measurement.
The second measurement is taken only if this first risk is
below a predetermined level. The claims thus recite the
mental process of comparing data to determine a risk
level: data are gathered in the first trimester of preg-
nancy; data are gathered in the second trimester of preg-
nancy; those data are compared to known statistical
information. No action beyond the comparison is re-
quired.
     Intema also claims a law of nature: the relationship
between screening marker levels and the risk of fetal
Down’s syndrome. That an increased risk of fetal Down’s
syndrome produces certain analytical results is a natural
process, an eternal truth that “exists in principle apart
from any human action.” Mayo,132 S. Ct. at 1297. Since
Intema’s claims recite mental processes and natural laws,
we must decide if Intema added enough to the statements
of ineligible subject matter to direct the claims, not to the
ineligible concepts themselves, but to applications of those
concepts. We think not.
     The “measuring” steps are insufficient to make the
claims patent-eligible. They merely tell the users of the
process to measure the screening markers through what-
ever known method they wish. In fact, the patent states:
“The individual measurements are obtained through
known methods. . . . Any markers which are effective at
each particular stage may be selected.” ’103 patent, col.5
ll.31-35. These steps tell the user “to engage in well-
understood, routine, conventional activity previously
PERKINELMER   v. INTEMA                                   12

engaged in by scientists who work in the field. Purely
‘conventional or obvious’ ‘presolution activity’ is normally
not sufficient to transform an ineligible law of nature into
a patent-eligible application of such a law.” Mayo, 132 S.
Ct. at 1298.
     Nor is the “determining” step sufficient. This step re-
quires the ineligible mental step of “comparing” the
measured markers “with observed relative frequency
distributions of marker levels in Down’s syndrome preg-
nancies and in unaffected pregnancies” to determine the
risk of fetal Down’s syndrome. See, e.g., ’103 patent,
col.17 ll.13-19. The statistical information mentioned in
this step is insufficient to make the claim patent-eligible
because it is well-understood, conventional information.
Id. at col.6 ll.45-50 (“[T]he necessary statistical distribu-
tion parameters which specify the Gaussian distribution
are the mean, standard deviation and correlations for the
two distributions. These are known, being derivable from
observed distributions . . . .”). And the unspecified and
unclaimed statistical calculation for determining the risk
is also known and conventional. Id. at col.6 ll.23-26 (“Any
of the known statistical techniques may be used. Prefera-
bly the multivariate Gaussian model is used, which is
appropriate where the observed distributions are rea-
sonably Gaussian. Such multivariate Gaussian analysis
is in itself known . . . .”).
    Looking to the claims as a whole, the steps in combi-
nation do not make the ineligible mental step and natural
law patent-eligible. As the Court in Mayo reasoned,
anyone who wants to use this mental step or natural law
must follow the claimed process. Mayo, 132 S. Ct. at
1298. And, as in Mayo, there is no requirement that a
doctor act on the calculated risk. There is at most “a
suggestion” that the doctor take the mental determination
13                                   PERKINELMER   v. INTEMA

into account when assessing the patient. Id. at 1297. The
claims are thus ineligible under section 101.2
    The claims held patent-eligible in Myriad, and the
reasoning underlying that decision, bolster our decision
here. The panel in Myriad found eligible claims to a
screening method for cancer treatments. 689 F.3d at
1337. The claimed method consisted of “comparing” the
growth rates of two sets of host cells that had been altered
with a cancer-causing human gene—one set was treated
with the potential therapeutic and the other was un-
treated. Id. at 1336. If the growth rate of the treated
cells was slower than the untreated cells, the treatment
was effective. Id. The comparison was an ineligible
mental step. But the host cells did not occur naturally;
they were man-made and, thus, were themselves patent-
eligible subject matter. So, according to the panel, their
inclusion in the process made the claims patent-eligible
despite the reference to an otherwise ineligible mental
step. Id. Here, the challenged claims include no patent-
eligible subject matter along with the ineligible concepts.
They include only “conventional steps, specified at a high

     2  This court’s decision in Classen Immunotherapies,
Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011)
makes clear that, for this reason, Intema’s claims are not
drawn to patent-eligible applications of ineligible con-
cepts. In Classen, the court found one set of claims di-
rected to eligible applications of an abstract idea, while
another set claimed only the abstract principle. Id. at
1067-68 (“The ’283 claims do not include putting this
knowledge to practical use, but are directed to the ab-
stract principle that variation in immunization schedules
may have consequences for certain diseases. In contrast,
the claims of the ’139 and ’739 patents require the further
act of immunization in accordance with a lower-risk
schedule, thus moving from abstract scientific principle to
specific application.”). Here, no “further act” moves the
recited concepts to a specific application.
PERKINELMER   v. INTEMA                                    14

level of generality,” which are insufficient. Mayo, 132 S.
Ct. at 1300.
    The reasoning in Myriad also undercuts the main
premise on which the district court relied. The district
court distinguished In re Grams, 888 F.2d 835 (Fed. Cir.
1989). That case held that “[t]he presence of a physical
step in the claim to derive data for the algorithm will not
render the claim statutory.” Grams, 888 F.2d at 840. In
other words, physical data-gathering steps, which may
cover patent-eligible subject matter, are insufficient to
make claims reciting abstract ideas patent-eligible appli-
cations of the ineligible concepts. The district court
reasoned that Grams was of no moment because it con-
cluded that the data gathering in the claims at issue here
is “a focus of the claimed method, not a mere antecedent
step.” Slip op. at 21. Specifically, the brunt of the claims,
according to the district court, is the use of data from both
the first and second trimesters of pregnancy in combina-
tion; according to Intema, only one marker was previously
used. Even assuming it is new or even inventive, this
“two markers are better than one” concept is still a men-
tal step or abstract idea, i.e., it is ineligible subject mat-
ter. Unlike the patent-eligible host cells in Myriad, the
data-gathering step of Intema’s claims are no saving
grace.
    The machine-or-transformation test confirms our con-
clusion.    As a threshold matter, the machine-or-
transformation test does not trump the section 101 exclu-
sions created by case law. Mayo, 132 S. Ct. at 1303 (“[W]e
have neither said nor implied that the [machine-or-
transformation] test trumps the ‘law of nature’ exclu-
sion.”). Thus, even if the test were satisfied, these claims
would remain unpatentable. But the claims fail the test.
The purported transformation resulting from “assaying a
sample” is insufficient since it could be performed “with-
15                                   PERKINELMER   v. INTEMA

out transforming the [sample], should science develop a
totally different system for [assaying for a biochemical
screening marker] that did not involve such a transforma-
tion.” Id. And the “measuring” of an ultrasound scan at
most transforms data derived from the scan into data
regarding the risk of fetal Down’s syndrome. No tangible
output or visual depiction of the risk is required.3 The
claims do not require that an ultrasound be taken, only
that data from previous ultrasounds be assessed. Even if
required as part of the claimed processes, the data-
gathering steps are conventional and obvious extra-
solution activity that cannot save the claims. See Flook,
437 U.S. at 590 (“The notion that post-solution activity, no
matter how conventional or obvious in itself, can trans-
form an unpatentable principle into a patentable process
exalts form over substance.”). It is the “two data points

    3    Intema argues that this transformation is suffi-
cient, relying on In re Abele, 684 F.2d 902, 909 (C.C.P.A.
1982) abrogated by In re Bilski, 545 F.3d 943 (Fed. Cir.
2008). In Bilski, this court stated that “the transforma-
tion [in Abele] of [] raw data into a particular visual
depiction of a physical object on a display was sufficient to
render that more narrowly-claimed process patent-
eligible.” 545 F.3d at 963. Here, however, no physical
depiction of the risk data is claimed. More importantly, in
Abele, the claims reciting the ineligible algorithm were
found eligible because they claimed an “improved CAT-
scan process.” Abele, 684 F.2d at 909. That is, the claims
were drawn to a patent-eligible application of the algo-
rithm, not to the algorithm itself. See id. (“What appel-
lants have done is to discover an application of an
algorithm to process steps which are themselves part of
an overall process which is statutory.”) Here, the claims
cover at most an improved mental process—i.e., use two
data points to make a decision instead of one. Unlike the
one involved in Abele, this overall process is not statutory
subject matter.
PERKINELMER   v. INTEMA                                 16

are better than one” concept which is the focus of the
claims; that concept simply does not depend on the
method by which the data points are obtained.
                     III. CONCLUSION
     Because the asserted claims recite an ineligible men-
tal step and natural law, and no aspect of the method
converts these ineligible concepts into patentable applica-
tions of those concepts, the claims cannot stand. Accord-
ingly, we find the claims ineligible under section 101 and
affirm the judgment for PerkinElmer.
                          AFFIRMED
                            COSTS
No costs.