Exergen Corporation v. Brooklands Inc.
Filing
124
Judge Douglas P. Woodlock: MEMORANDUM AND ORDER entered granting 46 Motion for Summary Judgment under sec. 101; finding as moot 73 Motion to Compel; finding as moot 86 Motion to Compel; denying 88 Motion for Summary Judgment as to secs. 102 and 103; denying 106 Motion for Sanctions; finding as moot 118 Motion for Order; granting 122 Motion for Leave to File Document. (Woodlock, Douglas)
UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
EXERGEN CORPORATION,
Plaintiff,
v.
BROOKLANDS INC.,
Defendant.
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CIVIL ACTION NO.
12-12243-DPW
MEMORANDUM AND ORDER
August 28, 2015
In this action, Exergen Corporation alleges that
Brooklands, Inc. has infringed United States Patent No.
7,787,938 (“’938 patent”) by selling infrared thermometers.
Brooklands moves for summary judgment on the affirmative
defenses that the ‘938 patent is invalid under 35 U.S.C. § 101
(unpatentable subject matter), § 102 (anticipation), and § 103
(obviousness).
Brooklands also moves for Rule 11 sanctions
against Exergen and its counsel, Sunstein Kann Murphy & Timbers
LLP (“Sunstein”).
I. BACKGROUND
Exergen asserts that Brooklands has infringed two method
claims of the ‘938 patent, which is entitled “Temporal Artery
Temperature Detector.” These are claims 51 and 54.
Claim 51 of the ‘938 patent claims: “A method of detecting
human body temperature comprising: measuring temperature of a
1
region of skin of the forehead; and processing the measured
temperature to provide a body temperature approximation based on
heat flow from an internal body temperature to ambient
temperature.”
Claim 54 of the ‘938 patent claims: “A method of detecting
human body temperature comprising: measuring radiation as target
skin surface of the forehead is viewed, and processing the
measured radiation to provide a body temperature approximation
based on heat flow from an internal body temperature to ambient
temperature.”
Exergen’s CEO, Dr. Francesco Pompei, is the named inventor
of the ‘938 patent as well as of numerous other patents held by
Exergen related to thermometry.
The ‘938 patent, which issued
on January 25, 2008, is a continuation of an application
previously filed on September 11, 1998, and it references
twenty-five of Dr. Pompei’s own patents.
Two of these patents
are Patent No. 5,012,813 (‘813), issued May 7, 1991, and Patent
No. 5,653,238 (‘238), issued August 5, 1997, which include
claims directed to a radiation-detecting machine designed
primarily to take measurements at the ear’s tympanic membrane
and convert it to internal body temperature.
As discussed
below, however, those two patents also included broader claims
about measuring a target of biological surface tissue.
2
Exergen previously brought suit against manufacturers of
forehead thermometers in Exergen Corp. v. Wal-Mart Stores, Inc.,
No. 01-cv-11306-RCL (D. Mass.), consolidated with Exergen Corp.
v. CVS Corp., No. 02-cv-10436-RCL (D. Mass.), which included
allegations that the defendants were manufacturing forehead
thermometers that infringed certain Exergen patents — including
the ‘813 and ‘238 patents, as well as Patent No. 6,319,206
(“‘206 patent”) — claiming a method and various devices for
measuring temperature at the forehead.
See Exergen Corp. v.
Wal-Mart Stores, Inc., 575 F.3d 1312 (Fed. Cir. 2009)(reversing
jury finding of infringement of ‘813 patent).
Exergen brought a
similar claim in Exergen Corp v. Kidz-Med, Inc., No. 1:08-cv11416-DPW (D. Mass.)
During the prior litigation, Exergen and
Dr. Pompei made a number of statements about the language of
these prior patents, which will be discussed below.
In this case, Brooklands filed a motion before claim
construction for summary judgment of invalidity due to
unpatentable subject matter under 35 U.S.C. § 101.
This case
thereafter was consolidated with two other pending matters for
claim construction before Judge Stearns, who issued a claim
construction decision on August 15, 2014.
Exergen v.
Brooklands, Inc., 2014 WL 4049879 (D. Mass. August 15, 2014).1
1
Exergen v. Kaz USA, Inc., No. 1:13-cv-10628, remains pending
before Judge Stearns. Judge Stearns recently issued a
3
The claim construction provided by Judge Stearns largely tracks
the plain language of the claims themselves.
The parties agreed
that the term “human body temperature” should be constructed as
“the core temperature of a human being,” and Judge Stearns
construed “body temperature approximation” to mean “a
temperature approximating human body temperature encompassing
all such possible temperatures.”
Id. at *9.
After the claim construction, Brooklands filed additional
motions for summary judgment on the issues of patent validity
under 35 U.S.C. §§ 102 and 103.
Partial discovery, specifically
document production, had already occurred prior to the filing of
these motions.
Brooklands moved, however, for a stay of further
discovery, which I have granted, pending resolution of these
motions.
II. ANALYSIS
A.
Standard of Review
Summary judgment is proper only when the movant shows that
there is “no genuine dispute as to any material fact and the
Memorandum and Order denying Kaz’s motion for summary judgment
of invalidity because of obviousness, and allowing Kaz’s motion
for summary judgment of no willful infringement. See Exergen
Corp. v. Kaz USA, Inc., 2015 WL 4974167 (D. Mass. Aug. 20,
2015). The other consolidated case, Exergen v. Thermomedics,
Inc., No. 1:13-cv-11243, remains pending before Judge Casper.
As of this date, motions for summary judgment on the bases of
invalidity under 25 U.S.C. §§ 101, 102, and 103 are under
consideration before her.
4
movant is entitled to judgment as a matter of law.”
Civ. P. 56.
Fed. R.
All reasonable inferences must be drawn in favor of
the nonmovant, Exergen.
All patents are entitled to a presumption of validity.
35
U.S.C. § 282; see also Minnesota Min. & Mfg. Co. v. Chemque,
Inc., 303 F.3d 1294, 1301 (Fed. Cir. 2002) (“An issued patent is
presumed valid and the burden is on the party challenging the
validity of a patent to show that it is invalid by clear and
convincing evidence.”)
Whether an inquiry into patentable
subject matter under § 101 is subject to the same presumption of
validity has recently become a matter of debate.
Historically,
§ 101 analysis for patentable subject matter has been assessed
with a presumption of validity.
See CLS Bank Intern. v. Alice
Corp. Pty. Ltd., 717 F.3d 1269, 1284 (Fed. Cir. 2013), aff’d 134
S.Ct. 2347 (2014) (“as with obviousness and enablement, that
presumption applies when § 101 is raised as a basis for
invalidity in district court proceedings.”).
In a concurring opinion in Ultramercial, Inc. v. Hulu, LLC,
772 F.3d 709 (Fed. Cir. 2014)(Mayer, J. concurring), Judge Mayer
noted that because recent Supreme Court decisions make clear
that the Patent and Trademark Office has “for many years applied
an insufficiently rigorous subject matter eligibility standard,
no presumption of eligibility should attach when assessing
whether claims meet the demands of section 101.”
5
Id. at 720.
He further observed that the Supreme Court has not mentioned or
applied any presumption of eligibility in § 101 cases in recent
years. Id. at 720-21.
In Microsoft Corp. v. i4i Ltd.
Partnership, 131 S.Ct. 2238, 2242-43 (2011), the Supreme Court
discussed the requirement that patent invalidity be shown by
clear and convincing evidence due to the presumption of
validity.
In its discussion, the court did not distinguish
§ 101 from §§ 102 and 103, which are plainly covered by the
presumption.
Id.
Justice Breyer suggested in his concurring
opinion that the “clear and convincing” standard arising from
the presumption of validity applies only when a court is
considering questions of fact, not questions of law.
2253.
Id. at
Whether the claims at issue here contain patentable
subject matter is a question of law, see In re Roslin Institute,
750 F.3d 1333, 1335 (Fed. Cir. 2014), albeit one that may build
on factual determinations.
Given the plain language of 35
U.S.C. § 282 which codifies a general presumption of validity
and the fact that no Supreme Court or Federal Circuit majority
has disavowed the presumption of validity for § 101, I will
apply the heightened standard to all three validity sections,
although I agree with Justice Breyer that the presumption has
less significance in the context of a largely legal
determination.
6
In evaluating this motion for summary judgment, I must view
the record “through the prism of the evidentiary standard of
proof that would pertain at a trial on the merits . . . Thus, a
moving party seeking to invalidate a patent at summary judgment
must submit such clear and convincing evidence of invalidity so
that no reasonable jury could find otherwise.”
Eli Lilly Co. v.
Barr Labs., Inc., 251 F.3d 955, 962 (Fed. Cir. 2001)(citations
omitted).
B.
Unpatentable Subject Matter under Section 101
The statute outlining patentable subject matter, 35 U.S.C.
§ 101, contains broad language.
It provides: “Whoever invents
or discovers any new and useful process, machine, manufacture,
or composition of matter, or any new and useful improvement
thereof, may obtain a patent therefor, subject to the conditions
and requirements of this title.”
The Supreme Court has held
that based on the use of the term “any” in the statute,
“Congress plainly contemplated that the patent laws would be
given wide scope.”
Bilski v. Kappos, 130 S. Ct. 3218, 3225
(2010)(quoting Diamond v. Chakrabarty, 447 U.S. 303, 308
(1980)).
The term “process” is defined by the Patent Act to
mean “process, art, or method, and includes a new use of a known
process, machine, manufacture, composition of matter, or
material.”
35 U.S.C. § 100(b).
Claims 51 and 54 in the ‘938
patent are method claims.
7
Courts have long held that § 101 “contains an important
implicit exception: Laws of nature, natural phenomena, and
abstract ideas are not patentable.”
Alice Corp. Pty. Ltd. v.
CLS Bank Int'l, 134 S.Ct. 2347, 2354 (2014).
An experienced
Federal Circuit panel member thereafter criticized the Federal
Circuit’s own prior interpretation of § 101 as a “coarse filter”
not designed to limit significantly what is eligible for a
patent, and suggested instead that courts have a significant and
active role to play at the § 101 analysis stage.
2014 WL 5904902 at *10 (Mayer J., concurring).
Ultramercial,
Such a
realignment of approach has been prompted by a number of Supreme
Court decisions in recent years requiring courts to conduct a
more probing and demanding § 101 subject matter eligibility
analysis than before.
See, e.g., Alice Corp., 134 S.Ct. at
2354–55; Ass'n for Molecular Pathology v. Myriad Genetics, Inc.,
133 S.Ct. 2107, 2116 (2013); Mayo Collaborative Servs. v.
Prometheus Labs., Inc., 132 S.Ct. 1289, 1293–94 (2012).
Nevertheless, at the same time the concept of rigorous § 101
analysis has been expanding, the Supreme Court has reaffirmed
that exceptions to patentability cannot be read too broadly
because “all inventions at some level embody, use, reflect, rest
upon, or apply laws of nature, natural phenomena, or abstract
ideas.”
Mayo, 132 S. Ct. at 1293.
8
The Supreme Court reaffirmed in Alice Corp, 134 S.Ct. at
2355, that the two-part framework for § 101, drawn from its
earlier decision in Mayo, 132 S. Ct. at 1296-97, controls the
analysis of whether the subject matter of a particular claim is
eligible to be patented.2
Under this framework, a court must
first “determine whether the claims at issue are directed to one
of those patent-ineligible concepts” and, if so, whether the
claims include “an element or combination of elements that are
‘sufficient to ensure that the patent in practice amounts to
significantly more than a patent upon the [ineligible concept]
itself.’”
Alice, 132 S.Ct. at 2355 (quoting Mayo, 132 S. Ct. at
1294).
The first part of the inquiry is easily resolved and
essentially undisputed here.
The claims in the ‘938 patent
clearly are directed to a law of nature.
The language of the
2
The Federal Circuit’s “machine or transformation test” is one
tool for evaluating, but is not the definitive test for, patent
eligibility.
This test certainly does not trump the law of
nature exclusion. Mayo, 132 S.Ct. at 1303. Particularly
following Alice, which held that performing a conventional task
on a computer is not patentable, courts have relied even less on
this tool. I therefore note briefly, though without giving it
much weight, that Exergen’s ‘938 patent fails the machine-ortransformation test. Exergen claims that the surface
temperature is “transformed” into an internal body temperature.
Simply running an input through a mathematical equation or other
law of nature, however, does not “transform” that input into the
output.
9
“processing” step of claims 51 and 54 states that they process
“the measured temperature [/radiation] to provide a body
temperature approximation based on heat flow from an internal
body temperature to ambient temperature.”
The claim
construction did not change this language.
Exergen
acknowledges, as it must based on the language of the claim,
that the “process” step of the claims involves the application
of mathematical formulas that model heat transfer principles.
Mathematical formulas are quintessential laws of nature that,
standing alone, may not be patented.
Mayo 132 S. Ct. at 1303
(“the cases have endorsed a bright-line prohibition against
patenting laws of nature, mathematical formulas and the like . .
.”).
As the Supreme Court held in Mayo, “if a law of nature is
not patentable, then neither is a process reciting a law of
nature, unless that process has additional features” that make
it patentable under the second part of the framework.
132 S.
Ct. at 1297.
Under the second part of the framework laid out in Mayo, I
must ask whether “the patent claims add enough to their
statements of the correlations to allow the processes they
describe to qualify as patent-eligible processes that apply
natural laws”.
Mayo, 132 S. Ct. at 1297.
I must consider
whether the claims include “additional elements,” other than the
patent-ineligible concept, Alice 132 S.Ct. at 2355, that are
10
sufficient to transform the claim into patent-eligible subject
matter.
Id. at 2357.
concept.”
This second step requires an “inventive
Id.
At this step, I must look to the elements of the claims
both individually and in combination within the claim.
When
examining the individual elements, I consider whether they are
“well-understood, routine, [or] conventional,” because such
activity is “normally not sufficient to transform an
unpatentable law of nature into a patent-eligible application of
such a law.”
Mayo 132 S.Ct. at 1298.
When considering the
claim as a whole, I must consider the steps as an ordered
combination to determine whether the claims add something to the
law of nature that is not present when the steps are considered
separately.
While looking at the claim in its entirety, I may
not disregard an element of a claim as simply being conventional
or well-understood because “a new combination of steps in a
process may be patentable even though all the constituents of
the combination were well known and in common use before the
combination was made.” Diamond v. Diehr, 450 U.S. 175, 188
(1981).
The two steps in these claims are the “measuring” step,
which involves measuring temperature or radiation at the skin of
the forehead, and the “processing” step, which involves taking
the data from the “measuring” step and a mathematical formula
11
that uses heat transfer principles to result in an output, an
approximate core body temperature.
Exergen directs its argument
to the claim as a whole, not arguing that the step of measuring
the temperature or radiation of forehead skin is sufficiently
novel and unconventional on its own but rather that the notion
that body temperature can be determined from surface skin
temperature measured at the exposed site of the forehead is what
transforms the claim into patent-eligible subject matter.
In
support of this argument, Exergen points to a statement by the
American Society for Testing and Materials that “skin
temperature can not [sic] be independently correlated with the
internal body temperature” as evidence of the state of the art
at the time that Dr. Pompeii made his discoveries and of the
novelty of using an exposed skin surface to calculate internal
body temperature.3
The Supreme Court has decided a number of cases concerning
the patentability of a claim involving a natural law in the form
of a mathematical formula.
Exergen contends that its claim is
similar to that in Diamond v. Diehr, 450 U.S. at 177-79.
The
3
Brooklands challenges the American Society for Testing and
Materials statement as hearsay, but it is not being proffered
for the truth of the matter asserted — indeed, Exergen argues
that it is an inaccurate statement. It is offered only as
evidence of the state of the art to show that this was not a
“well-understood, routine, conventional activity previously
engaged in by scientists who work in the field.” Mayo, 132 S.
Ct. at 1298.
12
claim in Diehr involved a method for determining when a rubbercuring process was complete.
The claimed steps included
continuously monitoring the temperature of rubber in a mold,
feeding the numbers to a computer, which used a mathematical
equation to recalculate the curing time, and sending a signal
from the computer to open the molds at the proper time.
Id.
The Diehr court found the process to be patent eligible although
the equation itself was not, because the additional steps
integrated the equation into the process as a whole. Id. at 187.
The process itself was patent-eligible, and the court held that
it did not become unpatentable simply because it involved an
algorithm.
Id.
By contrast, in Parker v. Flook, 437 U.S. 584 (1978), the
Supreme Court found the claim not to be patent eligible.
The
claim in Flook concerned an improved method of adjusting alarm
limits to signal danger or inefficiency in the catalytic
conversion of hydrocarbons.
The claim involved measuring the
current level of a variable, such as the temperature, then using
a mathematical algorithm to calculate the alarm limits and
adjusting the system to reflect new alarm limit values.
The
Supreme Court assumed that the mathematical equation used in the
process was novel but held that the additional steps other than
the mathematical equation were not patentable because they were
conventional and contained no “inventive concept.”
13
Id. at 594.
Thereafter, in the 2012 case of Mayo, the Supreme Court
considered a claim for a process that helped calibrate the
amount of a drug provided to a particular patient by providing
the drug to the patient, measuring the amount of a compound from
that drug in the patient’s blood, and increasing or decreasing
the dosage going forward based on whether it appeared in the
blood in an amount greater or less than a concentration
specified in the claim.
132 S.Ct. at 1295.
Mayo held that the
correlation between the concentration of this compound in the
blood and the likelihood that dosage would need to be increased
or decreased was a law of nature.
Id. at 1296.
The Court
concluded that the additional step, primarily that of measuring
the level of the compound in the blood, was a step that was
necessary to apply the law of nature and found that the other
steps were merely well-understood, routine, conventional
activity, previously engaged in by those in the field.
Id. at
1299.
The claims before me are closer to those in Mayo and in
Flook than those in Diehr.
The law of nature in the “process”
step is the conversion of the skin temperature of the forehead
into the internal body temperature.
This step takes into
account heat transfer principles, as well as variables
specifically chosen to capture heat transfer, perfusion rate,
and blood-specific heat at the forehead artery.
14
‘938 Patent,
3:32-35.
Unlike in Diehr, the formula is not used to affect a
physical transformation.
It is also part of a much more simple
and straightforward process.
The only additional step added to
this law of nature is taking a measurement of temperature or
radiation at the forehead.
The question is whether this one
additional step is sufficient to establish patent eligibility.
In order to convert the skin surface temperature of the
forehead into the internal body temperature, one must first
collect the data to input into this formula.
As the Federal
Circuit held in In re Grams, “Given that the method of solving a
mathematical equation may not be the subject of patent
protection, it follows that the addition of the old and
necessary antecedent steps of establishing values for the
variables in the equation cannot convert the unpatentable method
to patentable subject matter.”
888 F.2d 835, 839 (Fed. Cir.
1989). See also In re Richman, 563 F.2d 1026, 1030 (C.C.P.A.
1977) (“notwithstanding that the antecedent steps are novel and
unobvious, they merely determine values for the variables used
in the mathematical formulae used in making the calculations.
[They] do not suffice to render the claimed methods, considered
as a whole, statutory subject matter.”).
Aside from the
processing step, which is the mathematical formula used to
convert the forehead surface skin temperature or radiation into
internal body temperature, the sole additional step in this
15
claim involves collecting the data through measurement, a
necessary step for determining the proper input for the
mathematical formula.
Exergen insists that Dr. Pompei’s invention of forehead
thermometry in general so defied conventional wisdom that it
cannot be considered to be routine or conventional.
In
Ameritox, Ltd. v. Millenium Health, LLC., 2015 WL 728501, at *19
(W.D. Wis. Feb. 19, 2015), Judge Conley considered a urine drug
screening protocol that was based on the idea of comparing a
person’s metabolite/creatinine ratio to the same ratio in a
known population.
Judge Conley held that whereas the Supreme
Court in Mayo held that steps were conventional because they
were “already engaged in by the scientific community,” 132 S.Ct.
at 1298, the inverse is also true: “if inventors engage in
activities that run counter to scientific thought, those
activities can hardly be considered conventional under § 101”
and that “[w]hen invention is based on the combination of
elements that cuts against the grain of scientific thought, this
heightens the novelty of invention itself.”
Id.
He concluded
that the patent as a whole was addressed to patent-eligible
subject matter because of processing steps that were found to be
unconventional in part because the state of the art at the time
of the invention suggested that such a screening could not be
done.
Id. at 27 (“Because the inventors cut against scientific
16
thought at the time of the invention, and because the invention
targeted a specific problem in the field of urine testing, the
court finds that there is sufficient inventive concept in the
[patent] for the purposes of meeting the threshold test of
section 101.”).
Similarly, Exergen claims that Dr. Pompei’s
invention of forehead thermometry solved a problem in health
care through a method that, at the time, defied the conventional
wisdom as to whether the forehead could be a suitable site for
determining internal body temperature.
Without addressing whether I believe that Ameritox was
correctly decided, I note that the process steps held
unconventional in Ameritox were significantly more specific than
those at issue here.
The additional steps in Ameritox involved
identifying and applying techniques that scientists were not
using in the field at the time to solve the problem addressed by
the patent — in fact, the existing art taught against being able
to use the techniques applied to the urine sample in Ameritox.
In contrast, here, the only step in the patent aside from the
law of nature: identified in the formula for converting the
surface forehead temperature into internal temperature is the
step of measuring the forehead temperature or detecting
radiation — a step that can hardly be considered unconventional
in the field of thermometry, particularly once the conversion
for forehead temperature was identified.
17
The patent in this case is more similar to that in Celsis
in Vitro, Inc. v. CellzDirect, Inc., 2015 WL 1523818 (N.D. Ill.
Mar. 13, 2015), in which Judge Shadur held that a patent
protecting processes for freezing liver cells was not directed
to patent-eligible subject matter.
In Celsis, the patent
identified a law of nature: that certain liver cells were
capable of being frozen and thawed more than once, although the
prevailing thought was that they could only be frozen once.
at *7.
Id.
Aside from the discovery that double freezing was
feasible, the steps used to freeze and unfreeze the cells twice
were the same as those that would be used to freeze and unfreeze
the cells once, a practice that was already in wide usage.
Id.
Judge Shadur addressed the decision in Ameritox, noting both
that he was not bound by its reasoning and also distinguishing
that case from the one before him by noting that in Celsis, as
in the case before me, “the combination of steps in the [patent]
directly follows from the discovery of a law of nature.”
Id. at
*7, n.7.
The Federal Circuit recently addressed similar facts in
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed.
Cir. 2015).
In Ariosa, the patent claimed methods for detecting
fetal DNA circulating in the blood of a pregnant woman.
The
Federal Circuit did not doubt that before the patent at issue,
“no one was using the plasma or serum of pregnant mothers to
18
amplify and detect” fetal DNA, or that the method “reflects a
significant human contribution.”
Id. at 1379.
The discovery of
a law of nature, such as the method for non-invasive fetal
testing in Ariosa or the discovery of the BRCA1 and BRCA2 genes
in Myriad, no matter how novel, cannot on their own amount to
patentable subject matter, id. at 1379; see also Myriad
Genetics, 133 S.Ct. at 2117.
“Groundbreaking, innovative, or
even brilliant discovery does not by itself satisfy the § 101
inquiry.”
Id.
Exergen may well be correct that Dr. Pompei’s discovery
that surface skin measurements taken at the forehead reliably
can be converted to accurate body temperature is novel and
valuable.
However, the additional step of measuring the surface
skin of the forehead is a necessary, conventional step involving
collecting the data needed to be plugged into the mathematical
equations in the processing step.
Measuring temperature or
radiation is simply not an inventive or unconventional step in
the field of thermometry.
As the Supreme Court held in Mayo,
132 S.Ct. at 1294, “to transform an unpatentable law of nature
into a patent-eligible application of such a law, one must do
more than simply state the law of nature while adding the words
‘apply it.’”
The process step of measuring temperature or
radiation at the forehead does nothing more than direct a party
to apply a law of nature, the heat flow conversion calculation
19
for the forehead.
The claim lacks an inventive concept outside
of the laws of nature and therefore is not eligible for a
patent.
While my conclusion that the subject matter of the two
method claims of the ‘938 patent at issue in this litigation are
unpatentable under § 101 is sufficient to ground my grant of the
motion for summary judgment, in the interests of completeness
and because they are the predicates for the defendant’s Rule 11
initiative, I turn to the alternative grounds — anticipation and
obviousness — also urged by grounds for summary judgment.
C.
Anticipation under Section 102
Brooklands argues that the ‘938 patent is invalid because
it was anticipated by Exergen’s own prior patents ‘813 and ‘238.
Under 35 U.S.C. § 102, a person is not entitled to a patent if
“the claimed invention was patented, described in a printed
publication, or in public use, on sale, or otherwise available
to the public before the effective filing date of the claimed
invention.”
A claim is considered anticipated “if each and
every limitation is found either expressly or inherently in a
single prior art reference.”
King Pharm., Inc. v. Elan Pharm.,
Inc., 616 F.3d 1267, 1274 (Fed. Cir. 2010).
Inherent
anticipation occurs when a missing characteristic is not
disclosed but is necessarily present in a prior reference.
Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed.
20
Cir. 2003).
With respect to § 102, a patent is presumed valid
under 25 U.S.C. § 282.
This presumption, however, can be
rebutted by clear and convincing evidence, a standard that
reflects the presumption of validity.
Allergan, Inc. v. Apotex
Inc., 754 F.3d 952, 958 (Fed. Cir. 2014).
The ‘813 patent, filed in 1991, and the ‘238 patent, filed
in 1997, each concern improved radiation detectors and
components of radiation detectors.
Both are primarily directed
to conducting measurements at the tympanic membrane in the ear,
but both also contain broader references to tissue beyond the
tympanic membrane itself.
The ‘813 patent references, for
example, that the heat balance approach may be used “in other
applications,” 11:15-16, and refers to a radiation detector that
“view[s] a target of biological surface tissue,” Claim 7, 14:5052 and also “a radiation detector as claimed in claim 7 wherein
the biological surface tissue is tympanic membrane,”
14:64-66.
Claim 8,
Similarly, the ‘238 patent is primarily directed to a
device for detecting readings from the ear, but claims 34 and 36
of the patent each reference a sensor viewing “a target,”
whereas claim 37 specifies a detector adapted to sense radiation
from an ear.
24:1-22.
The ‘831 and ‘238 patents primarily
disclose devices, whereas the ‘938 patent discloses methods.
This distinction between machine and method, however, is not
material because “a method claim will be anticipated by an
21
earlier device performing all of the operative steps of the
method.”
Schumer v. Laboratory Computer Systems, Inc., 308 F.3d
1304, 1309 n.3 (Fed. Cir. 2002).
Exergen argues that the ‘813 and ‘238 patents do not
disclose “measuring temperature of a region of skin of the
forehead” or “measuring radiation as target skin surface of the
forehead is viewed” and that this “undisputed fact” — as
evidenced by the lack of the word “forehead” in the prior art
patents — “destroys Brooklands’ anticipation argument.”4
While
Exergen is correct that the word “forehead” is missing from the
express language of the patents, this does not resolve whether
the broader references in the early patents, such as to
“biological surface tissue” or a “target” other than the
tympanic membrane or ear, are properly read to disclose the
concept of measuring skin at the forehead.
The question, then,
is whether there is clear and convincing evidence that the broad
terms of the early patents disclose the use of forehead skin as
a source of measurement such that the devices of the earlier
4
Exergen does not explicitly concede that each of the other
elements of the claims at issue in the ‘938 patent are
anticipated, but does not challenge Brooklands assertion that
they are. The ‘938 patent itself states that using the arterial
heat balance is disclosed in the ‘813 patent and that the prior
thermometers use the same function to determine internal core
temperature using skin and ambient temperatures. ‘938, 1:48-52
and 3:15-23.
22
patents can be considered to perform the methods described in
the ‘938 patent.5
Determining internal temperature from the forehead is
plainly a narrower focus than determining internal temperature
from “biological surface tissue” or a “target.”
The Federal
Circuit has held that whether a generic disclosure necessarily
anticipates everything within the genus is a factual
determination that depends on “the specific disclosure and the
particular products at issue.”
Sanofi-Synthelabo v. Apotex,
Inc., 550 F.3d 1075, 1083 (Fed. Cir. 2008).
In Atofina v. Great Lakes Chemical Corp., 441 F.3d 991
(Fed. Cir. 2006), the Federal Circuit reversed a district
court’s ruling after a bench trial that certain claims had been
anticipated.
The Federal Circuit held that “the disclosure of a
genus in the prior art is not necessarily a disclosure of every
species that is a member of that genus.”
Id. at 999.
A prior
patent disclosed a temperature range of 100-500 degrees Celsius
5
This same question undergirds what Brooklands presents as its
inherent anticipation argument, which focuses on the contention
that because forehead skin is a surface tissue, the earlier
patents “necessarily” include forehead skin measurement.
Inherent anticipation is invoked when a prior claim is silent
about a characteristic that is necessarily part of the claim.
Continental Can Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264,
1268 (Fed. Cir. 1991). In contrast, Brooklands’ argument relies
on the language of the prior patents themselves, and is more
accurately considered a regular, not inherent, anticipation
claim.
23
as necessary for a claimed method for synthesizing a compound,
and the patent at issue involved a process for synthesizing the
same compound but with a narrow subset of the temperature range,
330-450 degrees Celsius.
Id.
The court held that the claimed
range was significantly different from the range in the prior
art, such that no reasonable fact finder could conclude that the
prior art described the claimed range with sufficient
specificity to anticipate the subsequent patent.
Id.
By contrast, in ClearValue, Inc. v. Pearl River Polymers,
Inc., 668 F.3d 1340 (Fed. Cir. 2012), the Federal Circuit
reversed a district court’s denial of judgment as a matter of
law after a jury verdict in favor of the patent-holder, finding
that a patent was invalid as anticipated where the prior art
patent concerned clarifying water of raw alkalinity less than
150 parts per million and the patent at issue in the suit
concerned water with alkalinity less than 50 parts per million.
Id. at 1345.
The Federal Circuit contrasted Atofina, noting
that the patent-holder had not argued that the lower alkalinity
limit was “critical” or that the claimed method somehow worked
differently at different points within the prior art’s larger
range.
The court also noted that the patent-holder did not
argue that the prior patent “fails to teach one of ordinary
skill in the art how to use the claimed invention.”
Id.
The
Federal Circuit held that “unlike Atofina where there was a
24
broad genus and evidence that different portions of the broad
range would work differently, here, there is no allegation of
criticality or any evidence demonstrating any difference across
the range.”
Id.
I cannot resolve this issue as a matter of law unless all
reasonable fact finders would find that there is clear and
convincing evidence that variation within a genus would make no
difference for the claims at issue here and that a person of
ordinary skill would have recognized measuring forehead
temperature as a specific application of the broader categories
in the prior patents.
OSRAM Sylvania, Inc. v. American
Induction Technologies, Inc., 701 F.3d 698, 706 (Fed. Cir.
2012).
“How one of ordinary skill in the art would understand
the scope of the disclosure or, stated differently, how one of
ordinary skill in the art would understand the relative size of
a genus or species in a particular technology is of critical
importance.”
Id.
If there is not clear and convincing evidence
as a matter of law, then this case could proceed to further fact
finding on the § 102 anticipation defense.
Brooklands states that disclosure of external tissue
surface is a “definite and limited set of locations that can be
used to take measurements,” and that “[u]pon reading the ‘813
and ‘238 patents, one of ordinary skill in the art, indeed, a
layperson, would immediately envision that forehead skin is a
25
skin or external tissue surface.”
Brooklands does not have
specific support for these broad assertions, but does cite
Exergen’s statements in response to requests for admissions and
in prior litigation.
For example, Brooklands refers to numerous
statements that confirm the breadth of the ‘813 and ‘238 patents
as applying to all human tissue, not only tissue in the ear,
see, e.g., Brooklands SOF 35, 36, 59, 62.
While these
statements do show that the prior patents apply not simply to
tissue in the ear, using those statements to establish that the
claims encompass all surface tissue of the human body cuts
against Brookland’s claim that the disclosure of the genus is
limited.
Brooklands also cites statements about the broad
applicability of the heat balance equation disclosed in the
earlier patents to other parts of the body, see, e.g.,
Brooklands SOF 41, 42, 58, and “interest” in the forehead as a
location for assessing human body temperature.
In addition, it
cites studies showing that while numerous variables would need
to be controlled for the forehead to give an accurate
temperature reading, “the forehead could provide a reasonably
accurate indication of internal temperature.”
Id. at 107.
Many of the “facts” referenced in Brooklands’ Rule 56.1
Statement of Material Facts in support of its allegation that
the ‘938 patent was anticipated or previously disclosed through
26
Dr. Pompei’s prior patents come from Dr. Pompei’s depositions in
prior litigation.
As Brooklands noted in its Response to
Exergen’s Rule 56.1 Statement of Material Facts, the opinions
and skills of Dr. Pompei as the inventor of the ‘938 patent are
irrelevant to a validity analysis.
The question of what a
person of ordinary skill would believe is determined “with
reference to a hypothetical ‘person having ordinary skill in the
art,’” not with reference to the skill of an inventor.
Standard
Oil Co. v. American Cyanamid Co., 774 F.2d 448, 454 (1985).6
In
addition, all statements in the prior litigation occurred after
Dr. Pompei had secured initial patents related to a forehead
thermometer, some of which are parent patents to the ‘938
patent.
Dr. Pompei’s statement, for example, that one reading the
‘238 patent “could make a, you know, a poor forehead
thermometer, yes,” SOF 112, is not definitive evidence that a
person of ordinary skill would consider a forehead thermometer
to be included in the disclosures of the ‘813 and ‘238 patents
concerning a general “target” or “biological surface tissue,”
6
A person having ordinary skill in the art is most commonly
referenced in patent eligibility analysis as the touchstone for
an obviousness analysis, as discussed in Standard Oil, 774 F.2d
at 454, and as conducted below. It is also the touchstone for
part of an anticipation analysis, particularly where, as here,
there is a factual question whether the disclosure of a genus
discloses the particular species that is the subject of a
subsequent patent.
27
particularly given Dr. Pompei’s role as the inventor of these
products and the benefit of hindsight. Cf. Scientific Plastic
Products, Inc. v. Biotage AB, 766 F.3d 1355, 1359 (Fed. Cir.
2014) (a person of ordinary skill analysis is conducted “with
the foresight of a person of ordinary skill, not with the
hindsight of the inventor's successful achievement”).
Exergen
argues that any of the statements made in prior litigation must
be understood in their contexts.
Exergen admits that the ‘813
and ‘238 patents contain claims that can be used with forehead
thermometers, but contends that the disclosures of the ‘813 and
‘238 patents would not have been perceived as disclosing
forehead thermometry to a person of ordinary skill, at least not
until after Dr. Pompei invented the forehead thermometer.
Exergen has submitted a statement of disputed material
facts that it claims warrants my denying summary judgment.
These concern the fact that there existed significant skepticism
in the medical community regarding the possibility of accurately
determining body temperature at the forehead, and that “exposed
body sites, such as the forehead, were not considered
appropriate sites for measurement” because of variations in
temperature and because of exposure to ambient temperature.
Many of the statements in Exergen’s statement of facts, however,
are conclusory, for example that “[t]he mere existence of the
heat flow models disclosed in the ‘813 and ‘238 patents would
28
not have led one of ordinary skill in the art to apply the
measurement techniques disclosed in those patents to the
forehead.”
Brooklands has presented significant, and undisputed,
evidence that the ‘831 and ‘238 patents reach beyond ear tissue
and claim application to human surface tissue more broadly.
The
undisputed facts show that these patents also disclose the heat
flow models that underpin the processing step of the ‘938
patent.
The question for me, however, is whether Brooklands has
presented such clear and convincing evidence that it would be
unreasonable for a fact finder to find that the ‘938 patent was
not anticipated by the prior art at the time it was issued.
I conclude that there remain factual disputes about whether
disclosure of the broad terms such as “target” or “biological
surface tissue,” particularly in the context of a patent that
otherwise focuses primarily on the tympanic membrane,
necessarily also discloses the significantly more narrow concept
of measuring forehead skin.
While forehead skin is certainly
biological surface tissue, claiming application to the entirety
of human biological surface tissue is “not a small genus,” and
there is a “considerable difference between” claiming biological
surface tissue generally and claiming the exposed skin of the
forehead, see Atofina, 441 F.3d at 999, such that it could be
reasonable for a fact finder to conclude that the disclosures in
29
the prior art did not anticipate those in the ‘938 patent.
Exergen argues that Brooklands has not presented any evidence
that it would have been reasonable for a person of ordinary
skill in the art to read the prior art patents to disclose
measuring literally any surface tissue (would a person of
ordinary skill think to measure at the nose? The sole of the
feet?).
While Brooklands contends that the forehead would have
been a particularly obvious entry within the genus of
“biological surface tissue,” there is at least one significant
difference between forehead skin and the other tissue discussed
in the prior patents that make the forehead a less likely
candidate.
Whereas the specific surface tissue discussed in the
earlier patents was physically protected, the forehead is an
area subject to significant variations in temperature due its
location and general exposure to ambient temperature.
There are outstanding questions of fact surrounding whether
a person with “ordinary skill in the art” would have thought
that forehead skin fell within the scope of the prior art or
that the prior art would operate differently at the forehead
skin relative to biological surface tissue generally due to its
exposure to ambient temperature.
Dr. Pompei’s affidavit states
that it would not have been obvious, while Dr. Lipson’s
affidavit states that it would have been.
The Federal Circuit
has made clear that where any question remains as to whether
30
there is a difference between a broad genus and a particular
species, here that difference is at the heart of what a person
of ordinary skill would have understood the disclosures of the
‘813 and ‘238 patents to be.
I may not find the ‘938 patent
invalid as a matter of law in summary judgment practice; the
issue would have to be resolved through fact finding.
See
OSRAM, 701 F.3d at 706.
D.
Obviousness under Section 103
A patent claim is invalid as obvious when “the differences
between the subject matter sought to be patented and the prior
art are such that the subject matter as a whole would have been
obvious at the time the invention was made by a person having
ordinary skill in the art.”
35 U.S.C. § 103(a).
In determining
obviousness, I engage in an “expansive and flexible” inquiry,
considering: (1) the scope and content of the prior art; (2) the
differences between the prior art and the asserted claims; (3)
the level of ordinary skill in the art; and (4) any secondary
considerations of obviousness.
550 U.S. 398, 406 (2007).
KSR Int’l Co. v. Teleflex Inc.,
As with other validity-based
defenses, the patent is presumed non-obvious and valid until
invalidity is demonstrated by clear and convincing evidence.
35
U.S.C. § 282; see also Procter & Gamble Co. v. Teva Pharm. USA,
Inc., 566 F.3d 989, 994 (Fed. Cir. 2009).
31
As discussed above, Exergen concedes that the limitations
of the prior art include all aspects of the ‘938 claims except
for that of conducting the measurements at the forehead.
The
factual record does not permit me to resolve as a legal matter
whether the broad references to a “target” or “biological
surface tissue” in the ‘813 and ‘238 patents would have made the
process of measuring forehead skin and processing it to
determine internal temperature obvious to a person of ordinary
skill in the art.7
Brooklands next argues that other prior art references that
involve measuring skin surface temperature or radiation at the
forehead would have made this one remaining limitation obvious.
The motivation to combine prior art references can arise from
(1) the references themselves, (2) the knowledge of a person of
ordinary skill in the art, or (3) from the type of problem to be
solved.
Wyers v. Master-Lock, Co. 616 F.3d 1231, 1238 (Fed.
Cir. 2010).
Brooklands contends that a person with ordinary
skill in the art would consider other patents involving
measurement of the forehead and would be motivated to combine
7
Judge Stearns’ decision in Exergen Corp. v. Kaz USA, 2010 WL
4974167 (Aug. 20, 2015), denying a motion for summary judgment
for obviousness under § 103 did not consider the same patents as
those raised by the defendant in this case. However, he
similarly concluded in that case that there remain factual
question whether a person skilled in the art would have been
motivated to combine the teachings of prior art references
including ‘813.
32
them with the ‘813 and ‘238 patents.
Specifically, Brooklands
focuses on four patents: Kitado, Wortz, Luk, and Smith.
I
conclude, however, that there is insufficient support in the
record to conclude that the Kitado, Wortz, Luk, and Smith
patents together or individually would motivate a person with
ordinary skill in the art to combine measuring the forehead with
the ‘813 or ‘238 patents.
I note, before addressing them
specifically, that the patent examiner allowed the ‘938 patent
over each of those patents.
The Kitado patent concerns a sleep regulation system for
heating and cooling the body during sleep.
While the patent
does disclose measuring the forehead, the forehead is measured
solely to determine surface skin temperature.
In fact, the
Kitado “teaches away” from using the forehead as a source for
core body temperature because it describes the significant
variability of measurements at the forehead at various stages of
sleep.
ClearValue, Inc., 668 F.3d at 1344 (“alleged teaching
away would be relevant to an obviousness analysis”).
The Wortz patent is focused not on detecting body
temperature, but on measuring involuntary responses to external
stimuli.
The patent similarly teaches away from using the
temporal artery as a source for body temperature because the
patent teaches that measurements at the forehead vary based on
responses to external stimuli.
33
The Luk patent concerns a liquid crystal temperature
adhesive sheet attached to the surface of the body, such as the
forehead.
The patent concerns covering part of the forehead to
try to get a reading of body temperature.
In contrast, the
claim in ‘938 is directed to sensing temperature at the exposed
forehead.
The product claimed in the Luk patent was also
subject to numerous inaccuracies, such as only providing a two
degree range for a result, that could teach against using the
forehead as a source of accurate measurement.
The Smith patent presents a closer question.
That patent
was for a thermometer that primarily takes measurements in the
ear, but also specifically states, “Temperature readings can be
taken at pulse points such as the wrist, under the arm, behind
the knee, in the exterior ear, on the forehead . . .” Smith at
6:58-62 (emphasis supplied).
The patent examiner initially
rejected the ‘938 patent over the Smith patent, but ultimately
allowed the claims after Exergen explained significant
differences.
Specifically, the Smith patent does not measure
temperature or radiation, but rather electrical resistance at
pulse points.
It also does not explain the processing step and
nowhere explains the heat flow principles on which ‘938 relies.
These explanations would be sufficient to defeat a claim of
anticipation, but they do not clearly defeat an argument of
obviousness when combined with ‘813 and ‘238.
34
The burden, however, is not on Exergen but on Brooklands to
prove obviousness by clear and convincing evidence.
The Smith
patent clearly claims the forehead as a feasible location for a
measurement that could be converted to core body temperature.
That claim combined with the concepts of measuring temperature
or radiation and using heat transfer principles from the ‘813
and ‘238 patents may be sufficient to render the ‘938 patent
obvious.
However, I have not been provided with clear and
convincing evidence that this is so as a matter of law.
Brooklands presents Dr. Lipson’s conclusory statement that he
believes a person of ordinary skill in the art would combine the
Kitado, Wortz, Luk and Smith patents with the ‘813 and ‘238
patents.
I have not been presented with any evidence
specifically about how the differences between the Smith
patent’s claim of measuring electrical resistance at pulse
points, including the one on the forehead, and the concept of
measuring temperature and radiation at the forehead skin, would
be perceived by a person of ordinary skill in the art and
whether such a person would think to combine these concepts.
Given the lack of clear and convincing evidence on this record,
I must deny the motion for invalidity on the ground of
obviousness.
E.
Rule 11 Sanctions
Brooklands moves for Rule 11 Sanctions against Exergen and
35
its counsel, Sunstein.8
Brooklands argues that Exergen’s claims
in this case are plainly frivolous and could not have been the
product of a reasonable pre-litigation inquiry given admissions
and statements by Exergen and Dr. Pompei in the prior Walmart
and KidzMed litigations.
Rule 11(b)(2) of the Federal Rules of
Civil Procedure requires an attorney to certify that a
reasonable inquiry was conducted to determine that “the claims,
defenses, and other legal contentions are warranted by existing
law or by a nonfrivolous argument for extending, modifying, or
reversing existing law or for establishing new law.”
Where a
party or lawyer advocates a frivolous claim with “culpable
carelessness,” that can amount to a violation of Rule 11.
CQ
Int’l Co. v. Rochem Int’l, Inc., 659 F.3d 53, 60 (1st Cir.
2011).
If a plaintiff brings suit on a claim without a good
faith belief in the validity of a patent, Rule 11 sanctions may
be appropriate.
The primary substance of the Rule 11 motion is that the
claims at issue in the ‘938 patent are so clearly invalid under
§§ 102 and 103 that it was frivolous to file an infringement
suit because an invalid patent cannot be infringed.
Commil USA,
8
Rule 11 contains significant procedural hurdles involving
notice. It appears that Brooklands has surmounted those hurdles
by following the proper steps in providing notice to Exergen and
allowing a 21-day “safe harbor” period before filing for
sanctions. Fed R. Civ. P. 11(c)(2). Exergen does not challenge
the request for sanctions on procedural grounds.
36
LLC v. Cisco Systems, Inc., 720 F.3d 1361 (Fed. Cir. 2013).
Brooklands points to the admissions made by Exergen and Dr.
Pompei as well as arguments made by Sunstein in prior litigation
as evidence that the disputed claims are obviously invalid.
Exergen and Sunstein have maintained a narrow and focused
legal argument related to Brooklands’ claims of patent
invalidity, specifically acknowledging that the prior art ‘813
and ‘238 patents disclose the “processing” step of the ‘938
patent but arguing that they do not disclose taking measurements
at the forehead.
Brooklands attacks this position as legally
untenable by repeatedly contending that Exergen has made
conclusory admissions that it has not made.9
When discussing the
prior litigation, Brooklands consistently emphasizes the
applicability of prior patents to forehead thermometry while
omitting the fact that at least one of Exergen’s existing
patents at that earlier time directly claimed devices and
9
For example, Brooklands’ repeated statements that Exergen
admits that the ‘813 and ‘238 patents disclose “measuring
temperature of a region of skin of the forehead/measuring
radiation as target skin surface of the forehead is viewed” in
the Rule 11 motion and in the §§ 102 and 103 motion clearly
overstate the purported admissions by Exergen. Another example
of misleading quotation by Brooklands of Exergen’s “admissions”
may be found on page five of Exergen’s sur-reply, in which
Brooklands altered a quote to reference the ‘813 and ‘238
patents in the context of a discussion of features of a forehead
thermometer, when the original suit mentioned the “patents in
suit” which included ‘813 and ‘238 but also included at least
one patent that claimed a forehead thermometer device.
37
methods related to forehead thermometry.
Brooklands then
presents admissions about the heat balance approach in the ‘238
and ‘813 patents and that electronics disclosed in those patents
may be used in a forehead thermometer as if they are admissions
that the prior art patents disclose conducting measurements at
the forehead.
However, given the preexisting forehead-related
patent, the fact that these prior art patents were included in
an earlier action concerning forehead thermometers does not do
as much work as Brooklands claims it does.
I find that, while Exergen made significant admissions,
Exergen’s prior statements do not foreclose a reasonable
argument that the prior art patents do not disclose or render
obvious conducting measurements at the skin of the forehead.
As
indicated, I do not find sufficiently clear and convincing
evidence that this argument is incorrect.
Brooklands’ position
that disclosing the “genus” of biological surface tissue
necessarily discloses the “species” of forehead skin may, at the
end of the day, have proven successful, but this is a complex
area of law with conflicting Federal Circuit precedent, as
discussed above, and would have had to await fact finding.
Exergen has consistently conceded that the ‘813 and ‘238 patents
have relevance to forehead thermometers, but that the full
relevance was not apparent until after Dr. Pompei’s invention of
38
the forehead thermometer.
Exergen’s numerous admissions that
the concepts and some of the electronics ultimately were useful
in creating a forehead thermometer are not admissions that
forehead thermometry was disclosed or obvious in the prior art
no matter how many times Brooklands states in its memoranda that
they are.
As discussed above, Brooklands is correct that the ‘938
patent is invalid.
That ruling, however, is rooted in § 101,
ineligible subject matter, and not §§ 102 and 103.
Brooklands
does not contend that Exergen committed sanctionable conduct for
maintaining the suit in light of subject matter eligibility
concerns.
Exergen’s position that the prior art patents do not
anticipate or render obvious the single step of measuring at the
forehead for purposes of determining internal body temperature
was not frivolous.
Sanctions are not warranted.
III. CONCLUSION
For the reasons set forth more fully above, it is hereby
ORDERED that:
1. The Motion for Summary Judgment of Invalidity Under 35
U.S.C. § 101 (Docket No. 46) is GRANTED;
2. The Motion for Summary Judgment of Invalidity Under 35
U.S.C. §§ 102 and 103 (Docket No. 88) is DENIED;
39
3.
The Motion for Sanctions against Exergen (Docket No. 106)
is DENIED.
/s/ Douglas P. Woodlock______
DOUGLAS P. WOODLOCK
UNITED STATES DISTRICT JUDGE
40
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