Exergen Corporation v. KAZ USA, Inc.

Filing 395

Judge Richard G. Stearns: ORDER entered denying 381 Motion for Judgment of Invalidity under 35 U.S.C. § 101. "For the foregoing reasons, Kaz's motion for judgment of invalidity under 35 U.S.C. § 101 is DENIED. The Clerk will now enter judgment for Exergen." (RGS, int2)

UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
CIVIL ACTION NO. 13-10628-RGS
EXERGEN CORPORATION
v.
KAZ USA, INC.
MEMORANDUM AND ORDER ON DEFENDANT’S MOTION
FOR JUDGMENT OF INVALIDITY UNDER 35 U.S.C. § 101
March 25, 2016
STEARNS, D.J.
The court is again confronted 1 with Kaz USA, Inc.’s subject matter
patentability challenge to the viability of Exergen Corporation’s asserted
claims. In addition to the parties’ exhaustive briefing, I now have the benefit
of the evidence presented at the well-litigated jury trial. Guided by the jury’s
verdict, and by the pleadings specific to this case, I will affirm the validity of
the challenged claims for the reasons that will be explained. See Internet

Applying the doctrinal precepts of issue preclusion, the court
previously ruled that claims 27, 29, 37, and 56 of the ’938 patent were invalid
in light of Judge Casper’s order granting defendant’s motion for summary
judgment on the issue of § 101 invalidity as to claims 51, 52, and 54 of the
’938 patent in Exergen’s infringement suit against Thermomedics, Inc., and
Sanomedics International Holdings, Inc. See Exergen Corp. v. Kaz USA,
Inc., 2015 WL 8082402 (D. Mass. Dec. 7, 2015); Exergen Corp. v.
Thermomedics, Inc., 2015 WL 5579800 (D. Mass. Sep. 15, 2015).
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Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1347 (Fed. Cir. 2015)
(noting that a “pragmatic analysis of § 101 is facilitated by considerations
analogous to those of §§ 102 and 103 as applied to the particular case.”);
Accenture Global Servs., GmbH v. Guidewire Software, Inc., 728 F.3d 1336,
1341 (Fed. Cir. 2013) (the legal determination under § 101 may depend on
“underlying factual issues”).
Exergen’s ’685 and ’938 patents are directed to non-invasive methods
and devices for accurately determining a person’s deep body temperature by
taking measurements of the skin temperature over an artery, preferably, the
temporal artery.
[P]rior to inventions of the patents-in-suit, persons skilled in the
art were skeptical that accurate internal temperatures could be
determined from external measurements taken at exposed
locations, such as the forehead. There existed an unmet need in
the field, particularly in pediatric medicine, for accurate
temperature measurements taken by less intrusive instruments
than ear thermometers.
Exergen Corp. v. Kaz USA, Inc., 2015 WL 4974167, at *4 (D. Mass. Aug. 20,
2015). Claim 49 of the ’938 patent, a device claim, is representative.
49. [A body temperature detector comprising:
a radiation detector; and
electronics that measure radiation from at least three
readings per second of the radiation detector as a target
skin surface over an artery is viewed, the artery having
a relatively constant blood flow, and that process the
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measured radiation to provide a body temperature
approximation, distinct from skin surface temperature,
based on detected radiation;]
wherein the artery is a temporal artery.
The other asserted claims – claims 17, 24, 33, 39, 40, 46, 60, and 66 of the
’938 patent, and claims 7, 14, and 17 of the ’685 patent – are examined in
detail in one of the court’s earlier opinions. See Exergen, 2015 WL 8082402,
at *6-9.
Section

101

serves

to

promote

scientific

and

technological

advancement by excluding laws of nature, natural phenomena, and abstract
ideas from the realm of patentable subject matter, thus preventing patentees
from monopolizing “the basic tools of scientific and technological work.”
Mayo Collaborative Servs. v. Prometheus Labs., 132 S. Ct. 1289, 1293
(2012).

“[H]owever, too broad an interpretation of this exclusionary

principle could eviscerate patent law. For all inventions at some level
embody, use, reflect, rest upon, or apply laws of nature, natural phenomena,
or abstract ideas.” Id. In balancing these often competing desirables, the
Supreme Court has adopted a two-step inquiry into subject matter eligibility.
First, we determine whether the claims at issue are directed to
[a] patent-ineligible concept[]. [Mayo], 132 S. Ct., at 1296-1297.
If so, we then ask, “[w]hat else is there in the claims before us?”
Id., [] at 1297. To answer that question, we consider the elements
of each claim both individually and “as an ordered combination”
to determine whether the additional elements “transform the
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nature of the claim” into a patent-eligible application. Id., [] at
1298, 1297. We have described step two of this analysis as a
search for an “‘inventive concept’”— i.e., an element or
combination of elements that is “sufficient to ensure that the
patent in practice amounts to significantly more than a patent
upon the [ineligible concept] itself.” Id., [] at 1294.
Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2355 (2014).
Guided by Alice, the parties focus on whether Exergen’s asserted
claims, when stripped of those elements that simply reflect laws of nature,
were “well-understood, routine, conventional activity previously engaged in
by scientists who work in the field,” and whether singly or in combination,
they truly illuminate an “inventive concept.” Mayo, 132 S. Ct. at 1298, 1294.
The relevant laws of nature, however, do not drop out of the analysis
altogether. Rather, they require a nuanced appreciation in the context of the
claims taken as a whole.
The evidence received at trial established that Exergen’s “body
temperature detector” built on two previously known but unrelated natural
laws or phenomena – the absence of arteriovenous anastomoses (AVAs)2
that would create a relatively constant blood flow in certain arteries close to
the skin surface, including the temporal artery, see Tr. Day 2 at 86-89; and
the principles of thermodynamics embodied by the heat transfer equations

AVAs function like valves, adjusting blood flow to the skin to regulate
the body’s temperature. Tr. Day 2 at 87.
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2

disclosed in the patents, see id. at 104. As asserted, the claims do not attempt
to appropriate or cordon off the development by others of ideas based on
either or both of these principles. See Alice, 134 S. Ct. at 2354-2355 (while
allowing patents on building blocks “would risk disproportionately tying up
the use of the underlying ideas, . . . [inventions incorporating these
fundamental laws] pose no comparable risk of pre-emption, and therefore
remain eligible for the monopoly granted under our patent laws.”) (internal
quotation marks and citation omitted). An artery’s lack of AVAs may prove
useful in medical applications other than temperature measurement, and the
heat transfer equations at issue have already been used in ways that are not
covered by the patents-in-suit. See Tr. Day 2 at 68-70.
Nor do Exergen’s claims succumb to the fatal sin of “simply stat[ing]
[a] law of nature while adding the words ‘apply it.’” Mayo, 132 S. Ct. at 1294.
In Mayo, the Supreme Court found ineligible for patentability claims that
recited the correlation between thiopurine metabolite levels and the toxicity
and efficacy of thiopurine drugs and then added a generic instruction to
adjust dosages accordingly.

Similarly, in Ariosa Diagnostics, Inc. v.

Sequenom, Inc., 788 F.3d 1371, 1377-1378 (Fed. Cir. 2015), the Federal
Circuit found claims that applied “well-known” sequencing techniques to the
discovery of fetal DNA in maternal blood to be unacceptable subject matter.
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In contrast, the trial evidence presented in this case established that
the invention defined in the asserted claims was not a mere appropriation of
the laws of nature on which it was based. That certain arteries lacked AVAs
was no mystery to the medical community prior to Dr. Pompei’s patents, but
that knowledge had not been exploited in measuring human body
temperature. See Tr. Day 2 at 86-87. The heat transfer approach was known
and incorporated in Dr. Pompei’s own prior art devices measuring body
temperature at a protected site (the ear canal), but Dr. Pompei was himself
unsure that the approach could be made to work at a location as exposed as
the forehead. Id. at 68-69. The jury found that combining the two natural
phenomena to achieve an accurate noninvasive measurement of human body
temperature was not obvious to a person of ordinary skill in the art at the
time of the invention. See Verdict at 4-5. Indeed, at its unveiling, Dr.
Pompei’s device received a lukewarm reception among practitioners whose
skepticism took some years to overcome. See, e.g., Tr. Day 4 at 68-71.
In applying step one of Mayo, the court is persuaded that, while the
asserted claims are based in natural phenomena, they do not simply identify
some previously unremarked upon natural law, or recite a perfunctory
intersection of a couple of previously perceived phenomena; rather, they
reveal a novel combination of two previously known but uncorrelated
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scientific principles. This is a salient distinction. “[I]n applying the § 101
exception, we must distinguish between patents that claim the buildin[g]
block[s] of human ingenuity and those that integrate the building blocks into
something more.” Alice, 134 S. Ct. at 2354 (quotation marks and citations
omitted). “Even though a phenomenon of nature or mathematical formula
may be well known, an inventive application of the principle may be
patented.” Parker v. Flook, 437 U.S. 584, 594 (1978).3
The teaching in this case, it should be emphasized, is not that novel
combinations of natural phenomena are patentable without more, although
they might possibly be in some circumstances. Rather Mayo requires that a
second question be asked: What else is there in the claims besides the
recitation of laws of nature? Kaz notes that the asserted claims each recite a
subset of three additional steps – moving while (laterally) scanning (’685
patent claims 7, 14, and 17; ’938 patent claims 17, 24, 33, 60, and 66),
obtaining a peak temperature reading (’685 patent claim 7; ’938 patent
claims 60 and 66), and obtaining at least three readings per second (’938

Many of the most useful human innovations are based on a
combination of previously known but unconnected natural phenomena. The
relatively modern greenhouse, for example, exploits the transparency and
insulating properties of glass to capture and retain the sun’s energy to grow
plants outside of their natural season or habitat, while the more ancient
water wheel converts the force of gravity’s pull on the fluid dynamics of water
to produce usable mechanical power.
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3

patent claims 17, 24, 39, 40, 46, and 49) – but no claim recites the three
additional steps ensemble. Pointing to prior art elicited at trial, such as
Wortz, Barnes, Hood, Walsall, Exergen’s ’091 patent, and the Exergram and
Dermatemp devices, Kaz asserts that these additional elements were familiar
accoutrements in the field of thermometry.
As previously noted, that additional claim elements were known in the
art does not necessarily defeat subject matter eligibility.

“[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).
Here again, the evidence at trial informs the analysis. The additional steps
were previously utilized to detect hot spots indicating injury or tumors, or
surface temperature differentials. See, e.g., Tr. Day 3 at 62-63 (detecting
injury in horses); Tr. Day 4 at 17 (use of motion to scan differential surface
temperatures). In the asserted claims, the additional steps solve a different
problem. In order to make use of the temporal artery as a suitable location
for body temperature measurement, a method or device must accurately
locate the artery, which is under the skin surface and invisible to the eye. The
temporal artery is small and its exact location varies from person to person.
Tr. Day 2 at 101-102. Dr. Pompei devised a method to “cross the T” – by
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taking multiple measurements and detecting the highest temperature while
scanning laterally across the forehead over the location of the temporal
artery. Id. at 102. The additional steps of the asserted claims are directed to
aspects of this method. There is no evidence in the record that these steps
were “well-understood, routine, [or] conventional[ly]” used to detect arterial
temperature beneath the skin before the introduction of Exergen’s
invention.4
As the Supreme Court has said (more than once), “[w]hile a scientific
truth, or the mathematical expression of it, is not a patentable invention, a
novel and useful structure created with the aid of knowledge of scientific
truth may be.” Mayo, 132 S. Ct. at 1294, quoting Diehr, 450 U.S. at 188,
quoting Mackay Radio & Tel. Co. v. Radio Corp. of Am., 306 U.S. 86, 94
(1939). In Diehr, the Court found patent-eligible a claim for a rubber curing
process that incorporated a well-known mathematical formula.

Why?

Because the additional steps “transformed the process into an inventive
application of the formula.” Mayo, 132 S. Ct. at 1299. Here, in similar
fashion, the asserted claims transformed the underlying natural laws into

4 Wortz is the only prior art reference directed to detecting temperature

above the temporal artery. It discloses detecting the location of the artery by
locating its pulse.
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inventive methods and useful devices that noninvasively and accurately
detect human body temperature. Ad susceptum perficiendum.
ORDER
For the foregoing reasons, Kaz’s motion for judgment of invalidity
under 35 U.S.C. § 101 is DENIED. The Clerk will now enter judgment for
Exergen.
SO ORDERED.
/s/ Richard G. Stearns
__________________________
UNITED STATES DISTRICT JUDGE

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