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In This Issue
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Federal
Circuit Affirms District Court Ruling of Patent Invalidity Under 35 U.S.C. §
101 Where Claims are Directed to a Natural Law
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Hulu
Patent Bid Opens Doors for New Prior Art Precedent
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Federal Circuit Affirms District Court
Ruling of Patent Invalidity Under 35 U.S.C. § 101 Where Claims are Directed
to a Natural Law
The Federal Circuit recently affirmed the ruling of
the United States District Court for the Eastern District of Virginia, in Cleveland Clinic Foundation, Cleveland
Heartlab, Inc., v. True Health Diagnostics LLC, dismissing Cleveland
Clinic’s infringement claims under U.S. Patent No. 9,575,065 (“the ‘065
patent”) and U.S. Patent No. 9,581,597 (“the ‘597 patent”) on the grounds
that the asserted claims were invalid, under 35 U.S.C. § 101, as directed to
an ineligible natural law.
By way of background, the ‘065 patent and ‘597
patent are directed to diagnostic tests which can be used to determine
whether an individual is at a lower risk or higher risk of developing or
having cardiovascular disease. These diagnostic tests are based on the
discovery that patients with coronary artery disease (“CAD”) have
significantly greater levels of leukocyte and blood myeloperoxidase (“MPO”)
levels. MPO is a naturally-occurring heme protein
associated with some types of white blood cells. The patents disclose several
methods of measuring a patient’s blood MPO level. The Federal Circuit had previously
addressed the subject matter eligibility of a parent patent, U.S. Patent
7,223,552 (“the ‘552 patent”), in Cleveland
Clinic Foundation v. True Health Diagnostics LLC, 859 F.3d 1352 (Fed.
Cir. 2017), cert. denied, 138 S.
Ct. 2621, (2018) (“Cleveland Clinic I”).
In Cleveland
Clinic I, the Federal Circuit held the claimed methods of the ‘552 patent
invalid under Section 101 as directed to the ineligible natural law that
blood MPO levels correlate with atherosclerotic CVD, holding that the claimed
method “starts and ends” with observation of “naturally occurring phenomena,”
based upon Ariosa Diagnostics, Inc. v.
Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015). The Federal Circuit
further held that, because Clevland did not assert the
‘552 patent to claim any of the biological techniques used to detect MPO or
the statistical methods used to compare a patient’s MPO levels to the control
group, the claims recited no further inventive concept sufficient
to transform the nature of the claims into a patent-eligible application of
the natural law, based upon Mayo
Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 78 (2012).
On appeal, Cleveland Clinic argued that the claims
were not directed to a natural law, but to the technique of using an
immunoassay to measure the blood MPO levels of patients with atherosclerotic
CVD. Cleveland Clinic further asserted that, in any case, the correlation
between blood MPO levels and atherosclerotic CVD is not a natural law because
it can only be detected using certain techniques. Cleveland Clinic further
argued that, while performing an immunoassay on blood samples was known,
using the immunoassay to detect the correlation between blood MPO levels and
atherosclerotic CVD supplies an inventive concept sufficient
to transform the claims into patent-eligible subject matter.
True Health responded that the correlation between
atherosclerotic CVD and blood MPO levels is a natural law because the
correlation exists in nature apart from human intervention, regardless of the
technique used to observe it. True Health further argued that using known
techniques in a standard way to observe a natural law, neither renders the
claims directed to something other than this natural law nor supplies an
additional inventive concept.
The Federal Circuit agreed with True Health and
held, as in Cleveland Clinic I,
that the claims were directed to the natural law that blood MPO levels
correlate with atherosclerotic CVD, and not new techniques for performing an
immunoassay to detect a patient’s blood MPO levels. That is, the claims only
recite applying known methods to detect MPO levels in plasma, comparing the
levels to standard MPO levels, and reaching a conclusion: that the patient’s
blood MPO levels are elevated in comparison to a control group. The Federal
Circuit concluded that this was simply another articulation of the natural
law that blood MPO levels correlate with atherosclerotic CVD,
and held that the claims were directed to the patent-ineligible
natural law that blood MPO levels correlate with risk of atherosclerotic
CVD. The Federal Circuit noted that:
(i) rephrasing the claims does not make them less directed to a natural law,
nor is the fact that blood MPO levels correlate with atherosclerotic CVD any
less a natural law because it can only be observed by use of certain
techniques; and (ii) Cleveland Clinic’s argument that using a known technique
in a standard way to observe a natural law can confer an inventive concept
has been consistently rejected in circumstances nearly identical to this
case. Athena Diagnostics, Inc. v. Mayo
Collaborative Servs., LLC, 915 F.3d 743, 753–54 (Fed. Cir. 2019) (holding
that there is no inventive concept in “applying standard techniques in a
standard way to observe a natural law”); see
also Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377 (Fed. Cir. 2015) (“For
process claims that encompass natural phenomenon, the process steps are the
additional features that must be new and useful.”).
Cleveland Clinic also argued that the District
Court failed to give the appropriate deference to the subject matter
eligibility guidance published by the PTO in 2016 as required by Skidmore v. Swift & Co., 323 U.S.
134 (1944), which “requires courts to give some deference to informal agency
interpretations of ambiguous statutory dictates, with the degree of deference
depending on the circumstances.”
The Federal Circuit agreed with True Health that
the District Court did not err in finding the instant claims ineligible
stating that “[w]hile we greatly respect the PTO’s expertise on all matters
relating to patentability, including patent eligibility, we are not bound by
its guidance. And, especially regarding the issue of patent eligibility and
the efforts of the courts to determine the distinction between claims
directed to natural laws and those directed to patent-eligible applications
of those laws, we are mindful of the need for consistent application of our
case law.”
Hulu Patent
Bid Opens Doors for New Prior Art Precedent
The Presidential Opinion Panel (“POP”), which was
created last year, has announced that it will review and reconsider the
previous decision by the Patent Trial and Appeal Board (“PTAB”) denying
Hulu’s request for administrative review of a Sound View Innovations, LLC
patent involving data processing. Hulu
had argued that Sound View Innovation’s patented method was obvious due to
information in a textbook and therefore unpatentable. The PTAB had tossed
Hulu’s challenge after finding that the textbook’s copyright date was
insufficient to qualify it as prior art.
Hulu, in asking the POP to reconsider the denial, argued
that the PTAB’s finding “conflicts with numerous other Board decisions,” and
that the PTAB “misapprehended or overlooked prior decisions” finding copyrights
sufficient to establish a date of publication for
prior art purposes. The decision by the POP could set new precedent for when
printed publications constitute prior art, as copyright dates, internet
information and a document’s accessibility can complicate determining whether
content existed prior to a patent application filing. The decision could also affect proceedings
where patents are challenged based upon prior art.
Documents in Inter
Partes Review(s) (“IPR(s)”) must qualify as prior art. Some documents, such as earlier patents and
published applications, clearly show dates for comparisons. But dates for
other documents, such as those obtained from the internet or a conference
presentation, can be harder to establish.
Petitioners often submit non-patent literature in IPR proceedings
because patent examiners have typically already reviewed previous patents
when considering a patent application.
As noted below, the Federal Circuit issued several
rulings last year dealing with qualifying printed materials as prior
art. In GoPro, Inc. v. Contour IP Holding LLC, the Federal Circuit
vacated a PTAB finding that a brochure distributed at a widely-attended trade
show did not qualify
as prior art. In Acceleration Bay, LLC v. Activision Blizzard Inc., the Federal
Circuit agreed with the PTAB that a reference uploaded to a technical reports website did not qualify as prior art because the
reference was not easily accessible.
In Jazz Pharm., Inc. v. Amneal
Pharm., LLC, the Federal Circuit affirmed the PTAB’s invalidating patent
claims based upon information published in the Federal Register.
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