from the United States District Court for the Southern
District of California in No. 3:16-cv-02146-H-AGS, Judge
Marilyn L. Huff.
M. Bell, Porzio, Bromberg & Newman, PC, Washington, DC,
argued for plaintiff-appellant. Also represented by Scott A.
M. Chambers, Billy Dell Chism, Caroline Cook Maxwell, Richard
J. Oparil; Matthew Zapadka, Bass, Berry & Sims, PLC,
John O'Shea, O'Shea Law LLC, Jackson, MO, argued for
Melissa A. Brand, Biotechnology Innovation Organization,
Washington, DC, for amicus curiae Biotechnology Innovation
Organization. Also represented by Hansjorg Sauer; Brian Paul
Barrett, Eli Lilly and Company, Indianapolis, IN.
Edward Noonan, McDonnell, Boehnen, Hulbert & Berghoff,
LLP, Chicago, IL, for amici curiae Christopher Michael
Holman, David Lund, Adam Mossoff, Kristen J. Osenga, David O.
Taylor. Also represented by Aaron Vincent Gin.
Moore, Reyna, and Wallach, Circuit Judges.
concurring-in-part and dissenting-in-part filed by
Circuit Judge Reyna. Moore, Circuit Judge.
Alternatives International, Inc., appeals a decision of the
U.S. District Court for the Southern District of California
granting Creative Compounds, LLC's motion for judgment on
the pleadings that the asserted claims of U.S. Patent Nos. 5,
965, 596, 7, 825, 084, 7, 504, 376, 8, 993, 610, 8, 470, 865,
and RE45, 947 are not patent eligible. Because Creative
Compounds has failed to demonstrate under Natural
Alternatives' proposed claim constructions that the
claims are not patent eligible, we reverse and remand.
Alternatives owns a number of patents that relate to dietary
supplements containing beta-alanine and have substantially
similar specifications. Beta-alanine is an amino acid.
Together with histidine, another amino acid, it can form
dipeptides that are found in muscles. E.g., '596
patent 1:59-64. The dipeptides are involved in the regulation
of intra-cellular pH during muscle contraction and
development of fatigue, and variations in dipeptide
concentrations affect the anaerobic work capacity of
individual athletes. Id. at 4:58-62, 5:1-3. One of
these dipep-tides is carnosine, which contributes to
hydronium ion buffering. Id. at 2:11-13. During
certain sustained exercise, hydronium ions and lactate can
accumulate and severely reduce intracellular pH. Id.
at 1:50-54. The reduced pH interferes with the
creatine-phosphorylcrea-tine system, a part of the process by
which energy is generated in cells, particularly muscle
cells. Id. at 1:31-43, 1:54-55. The claimed patents
generally relate to the use of beta-alanine in a dietary
supplement to "increas[e] the anaerobic working capacity
of muscle and other tissue." Id. at 2:16-18.
Alternatives has asserted its patents in multiple suits in
the Southern District of California. Creative Compounds moved
for judgment on the pleadings, which the district court
granted. Applying the two-part test from Alice Corp.
Party Ltd. v. CLS Bank International, 573 U.S. 208, 217
(2014), it held all of the asserted claims were directed to
patent ineligible subject matter under 35 U.S.C. § 101
and lacked an inventive concept sufficient to render them
patent eligible. The district court granted judgment in favor
of Creative Compounds, and Natural Alternatives timely
appealed. We have jurisdiction under 28 U.S.C. §
101 of the Patent Act provides that "[w]hoever 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." 35
U.S.C. § 101. The term "process"
"includes a new use of a known process, machine,
manufacture, composition of matter, or material." 35
U.S.C. § 100(b). The Supreme Court has explained that
under § 101, patent protection does not extend to the
patent ineligible concepts of laws of nature, natural
phenomena, and abstract ideas, which are "building
blocks of human ingenuity." Alice, 573 U.S. at
216-17. We must therefore distinguish between claims to
patent ineligible subject matter and those that
"integrate the building blocks into something
more." Id. at 217.
doing so, we first determine whether the claims at issue are
"directed to" a patent ineligible concept.
Id. As the Supreme Court has cautioned, we must be
careful in this analysis as "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." Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 71 (2012). If we determine
that the claims are directed to a patent ineligible concept,
"we consider the elements of each claim both
individually and 'as an ordered combination' to
determine whether additional elements 'transform the
nature of the claim' into a patent-eligible
application," i.e., whether there is an "inventive
concept." Alice, 573 U.S. at 217 (quoting
Mayo, 566 U.S. at 78-79).
under § 101 is a question of law based on underlying
facts that, ultimately, we review de novo. SAP Am. v.
InvestPic, LLC, 898 F.3d 1161, 1166 (Fed. Cir. 2018). It
may be resolved on a motion to dismiss where "there are
no factual allegations that, taken as true, prevent resolving
the eligibility question as a matter of law." Aatrix
Software, Inc. v. Green Shades Software, Inc., 882 F.3d
1121, 1125 (Fed. Cir. 2018).
district court held that the claims at issue are not patent
eligible and dismissed. We review a district court's Rule
12(c) dismissal for judgment on the pleadings under the law
of the regional circuit. Amdocs (Isr.) Ltd. v. Openet
Telecom, Inc., 841 F.3d 1288, 1293 (Fed. Cir. 2016). The
Ninth Circuit reviews a court's grant of judgment on the
pleadings de novo. Newton v. Parker Drilling Mgmt.
Servs., Ltd., 881 F.3d 1078, 1083 (9th Cir. 2018). This
analysis is "functionally identical" to the
standard for deciding a motion to dismiss. Cafasso v.
Gen. Dynamics C4 Sys., Inc., 637 F.3d 1047, 1055 n.4
(9th Cir. 2011) (quoting Dworkin v. Hustler Magazine
Inc., 867 F.2d 1188, 1192 (9th Cir. 1989)). In doing so,
the court "inquire[s] whether the complaint's
factual allegations, together with all reasonable inferences,
state a plausible claim for relief." Id. at
1055. In the Ninth Circuit, a court deciding a motion under
Rule 12 may consider "material which is properly
submitted as part of the complaint," including documents
that are not physically attached to the complaint, if their
authenticity is not contested and the complaint necessarily
relies on them, and it may take judicial notice of matters of
public record. See Lee v. City of L.A., 250 F.3d
668, 688-89 (9th Cir. 2001).
district court stated that in performing its eligibility
analysis, it accepted Natural Alternatives' proposed
claim constructions. J.A. 7 n.3. This was proper given the
stage of the litigation. Applying the proposed claim
constructions, we hold that the complaint's factual
allegations, together with all reasonable inferences,
plausibly establish the eligibility of the representative
of the asserted patents claim methods of treatment using
beta-alanine ("the Method Claims"). Claim 1 of the
'596 patent and claim 1 of the '865 patent have been
treated as representative of the claims in those patents.
Claim 1 of the '596 patent recites:
1. A method of regulating hydronium ion concentrations in a
human tissue comprising:
providing an amount of beta-alanine to blood or blood plasma
effective to increase beta-alanylhisti-dine dipeptide
synthesis in the human tissue; and
exposing the tissue to the blood or blood plasma, whereby the
concentration of beta-alanylhistidine is increased in the
Claim 1 of the '865 patent recites:
1. A method of increasing anaerobic working capacity in a
human subject, the method comprising:
a)providing to the human subject an amount of an amino acid
to blood or blood plasma effective to increase
beta-alanylhistidine dipeptide synthesis in the tissue,
wherein said amino acid is at least one of:
i) beta-alanine that is not part of a dipep-tide, polypeptide
ii) an ester of beta-alanine that is not part of a dipeptide,
polypeptide or oligopeptide; or
iii) an amide of beta-alanine that is not part of a
dipeptide, polypeptide or oligopeptide; and
the tissue to the blood or blood plasma, whereby the
concentration of beta-alanylhistidine is increased in the
tissue, wherein the amino acid is provided through a
Alternatives' proposed construction of the
"effective" limitations is to "elevates
beta-alanine above natural levels to cause an increase in the
synthesis of beta-alanyl-histidine dipeptide in the
tissue." J.A. 579-81. It defines "dietary
supplement" as "an addition to the human diet,
which is not a natural or conventional food, which
effectively increases athletic performance when administered
to the human over a period of time." J.A. 581. It also
defines "increasing anaerobic working capacity" as
"increasing the amount of work performed by a muscle
under lactate producing conditions." J.A. 580.
district court held both claims are directed to natural laws.
It held claim 1 of the '865 patent is directed to the
natural law that "ingesting certain levels of
beta-ala-nine, a natural substance, will increase the
carnosine concentration in human tissue and, thereby,
increase the anaerobic working capacity in a human."
J.A. 22. It held claim 1 of the '596 patent is directed
to the natural law that "ingesting certain levels of
beta-alanine, a natural substance, will increase the
carnosine concentration in human tissue and, thereby, aid in
regulating hydronium ion concentration in the tissue."
J.A. 21. We do not agree.
certain quantities of beta-alanine to a human subject alters
that subject's natural state. Specifically, homeostasis
is overcome, and the subject's body will produce greater
levels of creatine. See '596 patent 5:27-35.
This, in turn, results in specific physiological benefits for
athletes engaged in certain intensive exercise. See
'596 patent 5:21-23. The claims not only embody this
discovery, they require that an infringer actually administer
the dosage form claimed in the manner claimed, ...