United States Court of Appeals
for the Federal Circuit
__________________________
BILLUPS-ROTHENBERG, INC.,
Plaintiff-Appellant,
v.
ASSOCIATED REGIONAL AND UNIVERSITY
PATHOLOGISTS, INC.
(DOING BUSINESS AS ARUP LABORATORIES) AND
BIO-RAD LABORATORIES, INC.,
Defendants-Appellees,
and
DOES 2-20,
Defendants.
__________________________
2010-1401
__________________________
Appeal from the United States District Court for the
Central District of California in case no. 08-CV-1349,
Senior Judge Mariana R. Pfaelzer.
_____________________
Decided: April 29, 2011
_____________________
ROBERT D. FISH, Fish & Associates, P.C., of Irvine,
California, argued for plaintiff-appellant.
BILLUPS-ROTHENBERG v. ASSOC REGIONAL 2
BRIAN C. CANNON, Quinn Emanuel Urquhart & Sulli-
van, LLP, of Redwood Shore, California, argued for defen-
dants-appellees. With him on the brief were KEVIN P.B.
JOHNSON; and RORY S. MILLER and KRISTIN J. MADIGAN, of
Los Angeles, California.
__________________________
Before GAJARSA, LINN, and MOORE, Circuit Judges.
GAJARSA, Circuit Judge.
This is an appeal from a patent infringement action
involving a genetic test for Type I hereditary hemochro-
matosis. Billups-Rothenberg, Inc. (“Billups”) sued Associ-
ated Regional and University Pathologists, Inc. (“ARUP”)
and Bio-Rad Laboratories, Inc. (“Bio-Rad”) alleging in-
fringement of U.S. Patent Nos. 5,674,681 (“’681 patent”)
and 6,355,425 (“’425 patent”) (collectively, “patents-in-
suit”). The parties filed cross-motions for summary
judgment. The district court denied Billups’s motion for
summary judgment of infringement and granted ARUP
and Bio-Rad’s motion for invalidity. In its order, the
district court concluded that (1) the asserted claims of the
’681 patent were invalid for lack of written description
and (2) the asserted claims of the ’425 patent were invalid
as anticipated because U.S. Patent No. 6,025,130 (“’130
patent”) disclosed the claimed genetic test for a specific
mutation implicated in Type I hereditary hemochromato-
sis. Order at 2, Billups-Rothenberg, Inc. v. Associated
Reg’l & Univ. Pathologists, Inc., No. 08-CV-21349 (C.D.
Cal. May 26, 2010), ECF No. 248 (“Summ. J. Order”).
Because the district court properly granted summary
judgment on both asserted patents, we affirm.
BACKGROUND
Deoxyribonucleic acid (“DNA”) is the chemical name
for the genetic material that forms the basis of heredity in
3 BILLUPS-ROTHENBERG v. ASSOC REGIONAL
humans. DNA is composed of sequences of four nucleo-
tides: adenine, thymine, guanine, and cytosine (abbrevi-
ated A, T, G, and C, respectively) arranged in functional
units known as genes. Each gene codes for a sequence of
amino acids that make up peptides and proteins. The
relationship between a nucleotide sequence and the
corresponding amino acid sequence is known as the
genetic code. Mutations that alter a sequence of nucleo-
tides may change the corresponding amino acid sequence,
which in turn may affect the structure or function of the
protein encoded by the gene.
DNA is packaged into structures known as chromo-
somes. In somatic cells, humans have one pair of sex
chromosomes and twenty-two pairs of autosomal chromo-
somes, which are numbered according to size from the
largest to the smallest. One chromosome per pair is
inherited from each parent. Each chromosome is com-
posed of two arms, known as the short arm and long arm.
The patents-in-suit describe genetic tests for Type I
hereditary hemochromatosis, an iron disorder character-
ized by excessive iron absorption by the body. Hereditary
hemochromatosis is caused by specific mutations in a
gene involved in regulating iron absorption. The gene in
question, the High Fe (“HFE”) gene (“Fe” is the chemical
symbol for iron), is located on the short arm of chromo-
some six in humans. The HFE gene codes for the HFE
protein, also known as the human hemochromatosis
protein. When certain mutations occur in the HFE gene,
the resulting mutated HFE protein results in increased
iron absorption from the gut. Hereditary hemochromato-
sis is an autosomal recessive condition, meaning that a
person must inherit one mutated form of the HFE gene
from each parent to develop the disease. Not everyone
with two mutated HFE genes becomes clinically ill and, in
some cases, inheriting only one mutated gene in combina-
BILLUPS-ROTHENBERG v. ASSOC REGIONAL 4
tion with mutations in other genes may lead to some
increased iron absorption. The claims of the patents-in-
suit are directed to the detection of one or both of two
distinct mutations in the HFE gene, known as C282Y and
S65C. The prior art ’130 patent describes three muta-
tions in the HFE gene: C282Y, S65C, and H63D.
In 1994, Billups filed the application for the ’681 pat-
ent, entitled “Methods to Identify Hemochromatosis.” Dr.
Barry E. Rothenberg, the founder of Billups, was named
as the inventor. The ’681 patent explains that Type I
hereditary hemochromatosis (“hemochromatosis”) is a
disease caused by a gene linked to the major histocom-
patibility complex (“MHC”). ’681 patent col.17 ll.51-54.
The genes associated with the MHC code for a variety of
products, many of which defend the body against patho-
gens. The ’681 patent identifies human chromosome six
as the location of the gene responsible for hemochromato-
sis. Id. col.17 ll.53-54. The specification of the ’681
patent addresses how to detect a mutation:
A mutation in a nucleic acid sequence can be de-
tected by various methods to analyze nucleic acids
such as by nucleic acid sequencing, polymerase
chain reaction or hybridization. Such methods are
well known to those in the art (see, for example,
Sambrook et al, supra, 1989; Hames and Higgins
Nucleic Acid Hybridisation: a practical approach
(IRL Press, New York, 1985), both of which are
incorporated herein by reference).
Id. col.23 ll.26-33.
Although some of the ’681 patent’s claims also cover
testing for hemochromatosis by detecting defective pro-
teins in a patient’s blood, only claims covering the genetic
test for what is now known as the C282Y mutation are
5 BILLUPS-ROTHENBERG v. ASSOC REGIONAL
asserted in this case. Claim 2, which is representative of
the asserted claims, reads:
2. A method to identify an individual having or
predisposed to having hemochromatosis, compris-
ing the steps of:
a) providing from the individual a sample contain-
ing a gene encoding a nonclassical MHC class I
heavy chain
and
b) detecting a mutation in said gene, which muta-
tion results in the reduced ability of said heavy
chain to associate with said β2 microglobulin,
wherein the presence of said mutation identi-
fies said individual as having or predisposed to
having hemochromatosis.
Id. col.31 ll.19-24.
Although Billups claimed methods of detecting muta-
tions responsible for hemochromatosis in the ’681 patent,
it had not yet identified any disease-causing mutations.
In August of 1995, Dr. Rothenberg employed Dr. Ritsuko
Sawada-Hirai to help him identify the mutations respon-
sible for hemochromatosis. They were unable to isolate
the hemochromatosis gene or any mutations of the gene.
Others, however, had more success. In 1996, Dr. John
N. Feder and a group of scientists unaffiliated with
Billups isolated and sequenced the hemochromatosis gene
and published their results. John N. Feder et. al., A
Novel MHC Class I-like Gene is Mutated in Patients with
Hereditary Haemochromatosis, 13(4) Nature Genetics 399
(1996). This group of researchers specifically noted that
“further refinement of the location of this gene has been
difficult.” Id. at 399. This research resulted in numerous
U.S. and foreign patents, including the ’130 patent, enti-
BILLUPS-ROTHENBERG v. ASSOC REGIONAL 6
tled “Hereditary Hemochromatosis Gene.” The ’130
patent discloses the exact genetic sequences for the three
mutations at issue in this case: C282Y, H63D, and S65C.
See, e.g., fig.4A (genetic code for the H63D and S65C
mutations identified as 24d2 and 24d7, respectively);
fig.4C (genetic code for the C282Y mutation identified as
24d1).
Fig. 4A
Fig. 4C
Also, the ’130 patent describes genetic tests for hemo-
chromatosis utilizing the mutations and sequence vari-
ants identified within the patent. Id. col.23 ll.10-67. Bio-
Rad is the assignee of the ’130 patent and licenses it to
ARUP, a laboratory at the University of Utah that pro-
vides genetic testing services.
Dr. Feder and his team published their discovery
while ARUP was continuing to search for the hemochro-
matosis gene and its mutations. In October 1998, a
medical director at ARUP published a paper describing
how the genetic probes for the H63D mutation also acci-
dentally identified the nucleotide sequence A193T, which
corresponds to the S65C mutation. ARUP developed this
7 BILLUPS-ROTHENBERG v. ASSOC REGIONAL
assay into the genetic test presently accused of infringing
the patents-in-suit. The assay detected the C282Y, H63D,
and S65C mutations in samples from patients.
At the same time, the Billups researchers also used
the genetic sequences discovered by Dr. Feder and his
team to refine their own experiments. On March 26,
1999, Dr. Rothenberg, Dr. Sawada-Hirai, and collaborator
Dr. James Barton filed the application that matured into
the ’425 patent. The ’425 patent claims a method for
diagnosing an iron disorder by testing for genetic muta-
tions including S65C.
Claim 1 of the ’425 patent appears below:
1. A method of diagnosing an iron disorder or a
genetic susceptibility to developing said disor-
der in a mammal, comprising determining the
presence of a mutation in exon 2 of an HFE
nucleic acid in a biological sample from said
mammal, wherein said mutation is not a C G
substitution at nucleotide 187 of SEQ ID NO:
1 and wherein the presence of said mutation is
indicative of said disorder or a genetic suscep-
tibility to developing said disorder.
’425 patent col.59 ll.19-26.
Table 1 of the ’425 patent labels a genetic sequence
identical to the genetic sequence in Figure 4A of the ’130
patent as “S65C.” Cf. ’425 patent col.1-2 Table 1 (“ga-
gagtcgcc”); ’130 patent fig.4A (“gagagtcgcc”). Additionally,
the ’425 patent explains that two of the twenty hemo-
chromatosis patients had the S65C mutation. ’425 patent
col.31 ll.20-37 table 6, col.32 l.8 (“Probands 3 and 4 had a
S65C mutation.”) The inventors of the ’425 patent con-
cluded that the S65C mutation could be used to diagnose
hemochromatosis. Id. col.32 ll.8-13.
BILLUPS-ROTHENBERG v. ASSOC REGIONAL 8
In 2009, Billups sued ARUP and Bio-Rad for in-
fringement of the patents-in-suit. Billups amended its
complaint and alleged that ARUP and Bio-Rad infringe
the patents-in-suit by “providing and/or using diagnostic
assays or kits for detecting hemochromatosis” associated
with one or both of the C282Y and S65C mutations. Am.
Compl. ¶ 14. After completion of discovery, a Markman
hearing, and claim construction by the court, the parties
filed cross-motions for summary judgment. The district
court granted summary judgment of invalidity for lack of
a written description to ARUP and Bio-Rad. The district
court found it undisputed that: “The DNA sequence of the
hemochromatosis gene and/or sequence of the C282Y
mutation were not expressly specified in the ’681 patent.”
Summ. J. Order 3. Further, the district court noted that
it is “undisputed by the parties that no species of the
genus of DNA mutations, the presence of which would
identify an individual as having or being predisposed to
having hemochromatosis, were disclosed in the ’681
patent specification.” Id. at 6. The district court further
stated that “[d]escribing the structure of the resulting
protein is not the same as describing the structure of the
DNA and its mutations. The invention claimed in the
’681 patent is a method to test for a DNA mutation, not a
test for a defective protein.” Id. Additionally, the district
court explained that the “patentee has merely directed
the person of ordinary skill in the art to a general location
of a mutation on a chromosome and suggested that the
mutation may be found in that vicinity.” Id. at 8. The
district court held the asserted claims of the ’681 patent
invalid for lack of written description. The district court
concluded that ARUP and Bio-Rad’s enablement argu-
ments were “persuasive,” but declined to rule on them in
light of its ruling that the claims failed the written de-
scription requirement. Id. at 9.
9 BILLUPS-ROTHENBERG v. ASSOC REGIONAL
The district court also granted summary judgment of
invalidity of the ’425 patent. First, it held that Bio-Rad’s
’130 patent was prior art under 35 U.S.C. § 102(e) because
it was filed on May 23, 1996, which is before the March
1999 filing date of the ’425 patent. Id. at 3-4, 10. Then,
the district court determined that the asserted claims of
the ’425 patent are anticipated because they claim “the
same genetic test for S65C as is disclosed in the ’130
patent.” Id. at 10. The district court entered final judg-
ment in favor of ARUP and Bio-Rad dismissing the case.
This court has jurisdiction over Billups’s timely filed
appeal pursuant to 28 U.S.C. § 1295(a)(1).
DISCUSSION
This court reviews an order of summary judgment de
novo. See, e.g., Amgen, lnc. v. Hoechst Marion Roussel,
Inc., 314 F.3d 1313, 1339 (Fed. Cir. 2003). Summary
judgment must be granted when, drawing all reasonable
inferences in favor of the non-movant, there is no genuine
issue as to any material fact. Anderson v. Liberty Lobby,
Inc., 477 U.S. 242, 248 (1986); Fed. R. Civ. P. 56(c). We
first examine whether the asserted claims of the ’681
patent are invalid for lack of written description. Then,
we determine whether the asserted claims of the ’425
patent are invalid as anticipated.
I
Written description is a statutory requirement set
forth in 35 U.S.C. § 112. The written description re-
quirement requires the inventor to disclose the claimed
invention so as to “allow persons of ordinary skill in the
art to recognize that [the inventor] invented what is
claimed.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d
1336, 1351 (Fed. Cir. 2010) (en banc) (internal quotations
omitted). “Requiring a written description of the inven-
tion limits patent protection to those who actually per-
BILLUPS-ROTHENBERG v. ASSOC REGIONAL 10
form the difficult work of ‘invention’—that is, conceive of
and complete the final invention.” Id. The written de-
scription requirement exists to ensure that inventors do
not “attempt to preempt the future before it has arrived.”
Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993). In
Fiers, a party’s priority application failed to provide an
adequate written description as it purported to cover all
DNAs coding for a specific protein but did not describe the
DNA. The party only provided a generic reference that
the DNA could be obtained by reverse transcription and
this court held that “[c]laiming all DNA’s that achieve a
result without defining what means will do so is not in
compliance with the description requirement.” Id.
The “level of detail required to satisfy the written de-
scription requirement varies depending on the nature and
scope of the claims and on the complexity and predictabil-
ity of the relevant technology.” Ariad, 598 F.3d at 1351
(citing Capon v. Eshhar, 418 F.3d 1349, 1357-58 (Fed. Cir.
2005)). “[A]n adequate description of a DNA requires
more than a mere statement that it is part of the inven-
tion and reference to a potential method for isolating it;
what is required is a description of the DNA itself.”
Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d
1559, 1566-67 (Fed. Cir. 1997) (internal quotations omit-
ted). Complementary DNA (“cDNA”) is a form of DNA
that only contains exons, stretches of DNA that code for
genes. In Regents, a claim to a cDNA invention was held
invalid as lacking written description because such a
claim “requires a specificity usually achieved by means of
the recitation of the sequence of nucleotides that make up
the cDNA.” Id. at 1569.
Billups claims that its disclosure of the mutation’s
general location somewhere “within less than a 300 base
pair region of a defined exon of a well studied multi-gene
family,” combined with the knowledge that existed at the
11 BILLUPS-ROTHENBERG v. ASSOC REGIONAL
time of filing the ’681 patent, established that Dr. Roth-
enberg possessed the claimed invention. Appellant’s Br.
9. The ’681 patent claims a test for mutations, yet it is
undisputed that the specification and originally filed
claims of the ’681 patent disclose neither the hemochro-
matosis gene sequence nor any specific mutations within
that gene. Although the ’681 patent states that the
hemochromatosis mutations are in a gene encoding the α3
domain of a nonclassical MHC class I heavy chain located
on the short arm of chromosome six, that does not disclose
the exact location or sequence of the mutation. ’681
patent col.32 ll.13-14. Billups did not possess a genetic
mutation useful for diagnosing hemochromatosis when it
filed its patent application in December of 1994. The ’681
patent merely represents Billups’s research plan. See
Ariad, 598 F.3d at 1351.
Billups maintains that based on knowledge outside
the patent, including the subsequent discovery of C282Y,
the ’681 patent adequately described the envisioned, but
then unknown, mutations. Given the lack of knowledge of
sequences for the hemochromatosis gene and its muta-
tions in the field, the limited extent and content of the
prior art, and the immaturity and unpredictability of the
science when the ’681 patent was filed, Billups cannot
satisfy the written description requirement merely
through references to later-acquired knowledge. This
case is like Regents and Fiers, in which the DNA se-
quences at issue were unknown in the art. Regents, 119
F.3d at 1567-69; Fiers, 984 F.2d at 1171.
The ’681 patent claims methods covering the identifi-
cation of a genus of unknown genetic mutations. ’681
patent col.31 ll.19-24. A claim encompassing two or more
disclosed embodiments within its scope is a genus claim.
For genus claims, “an adequate written description of a
claimed genus requires more than a generic statement of
BILLUPS-ROTHENBERG v. ASSOC REGIONAL 12
an invention’s boundaries.” Ariad, 598 F.3d at 1349
(citing Regents, 119 F.3d at 1568). Under Ariad, a patent
must set forth “either a representative number of species
falling within the scope of the genus or structural features
common to the members of the genus.” Id. at 1350. The
’681 patent does not identify even a single species that
satisfies the claims. In this case, the eventual discovery
of only one species—the C282Y mutation—within the
claimed genus does not constitute adequate written
description of that genus.
Ariad also explained that “[f]unctional claim language
can meet the written description requirement when the
art has established a correlation between structure and
function.” Id. Billups maintains that the ’681 patent
satisfies the written description requirement because it
contains functional claim language. Billups contends that
the ’681 patent taught structure, i.e., that hemochromato-
sis has a genetic basis, and function, namely, its adverse
effect upon the binding of β2 microglobulin with a non-
classical MHC class I heavy chain. Specifically, Billups
argues that the ’681 patent’s correlation of function with
the general location of the C282Y mutation, combined
with the knowledge of a person of ordinary skill in the art
in the field at the time of filing, satisfied the written
description requirement by localizing the mutation to a
300 base pair region.
The district court, however, found that the art did not
establish a correlation between structure and function
because the “[p]atentee’s general location disclosure is too
imprecise to constitute structural features necessary to
meet the written description requirement.” Summ. J.
Order 6-9. As explained in the district court’s order, the
“specification for the ’681 patent contains only functional,
not structural, characteristics of the predicted mutations.”
Id. at 7. The district court properly granted summary
13 BILLUPS-ROTHENBERG v. ASSOC REGIONAL
judgment to Appellees that there is no genuine issue of
material fact that the asserted claims of the ’681 patent
are invalid for lack of written description requirement.
Finally, Billups argues that the district court erred in
failing to rule upon whether the ’681 patent satisfied the
enablement requirement of 35 U.S.C. § 112. Because the
district court properly granted summary judgment that
the ’681 patent does not satisfy the written description
requirement, it was not erroneous for it to decline to rule
upon whether the ’681 patent satisfied the enablement
requirement of 35 U.S.C. § 112.
II
A patent claim is anticipated if each and every limita-
tion is found either expressly or inherently in a single
prior art reference. 35 U.S.C. § 102. The asserted claims
of the ’425 patent are invalid because they are anticipated
by the ’130 patent. The ’130 patent was filed nearly three
years before the ’425 patent and is prior art under
§ 102(e). The district court correctly ruled that the ’130
patent discloses use of the S65C mutation as a “HH
[(hereditary hemochromatosis)] diagnostic,” and, thus,
Billups was not the first to disclose diagnosis of hemo-
chromatosis using the S65C mutation. Summ. J. Order
11.
The ’130 patent discloses the genetic sequence of the
S65C mutation and describes a genetic assay for detecting
one or more of the C282Y, H63D, and S65C mutations. In
an example entitled “HH Diagnostic: Other Nucleotide
Based Assays,” the specification of the ’130 patent states
that
any combination of such techniques [for conduct-
ing a genetic assay] can be used in accordance
with the invention for the design of a diagnostic
BILLUPS-ROTHENBERG v. ASSOC REGIONAL 14
device and method for the screening of samples of
DNA or RNA for HH gene mutations in accor-
dance with the invention, such as the mutations
and sequence variants identified herein (24d1,
24d2, and 24d7).
’130 patent col.38 l.64-col.39 l.8. The variants correspond
to the C282Y, H63D, and S65C mutations, respectively.
Billups contests whether the ’130 patent discloses the
subject of the ’425 patent, namely, the diagnosis of an iron
disorder using the S65C mutation. It is undisputed that
the S65C mutation falls within claim 1 of the ’425 patent.
Billups argues that the ’425 patent claims a genetic
predisposition to an iron disorder or the diagnosis of such
a predisposition, but the ’130 patent merely correlates the
S65C mutation and hemochromatosis. Billups interprets
the ’130 patent as concluding that the S65C mutation was
only a clinically insignificant polymorphism unrelated to
disease state. Thus, Billups contends that the ’130 patent
did not teach using the S65C mutation to diagnose hemo-
chromatosis.
Billups’s argument is based on the portion of the ’130
patent stating:
In Table 4, the 24d7(T) allele was observed in only
one chromosome present in the patient sample
(HC43) (0.4%) and present in four chromosomes
from the unaffected individuals (3%). The pres-
ence of the 24d7(T) allele shows no increase in
risk of acquiring HH and thus may only be a po-
lymorphic variant within the population.
Id. col.19 ll.22-27.
Despite the inventors’ uncertainty regarding the util-
ity of the S65C mutation because of their small sample
size, the ’130 patent describes two genetic tests for hemo-
15 BILLUPS-ROTHENBERG v. ASSOC REGIONAL
chromatosis that involve detection of the S65C mutation
as an input for the diagnosis of hemochromatosis. The
patent describes one genetic test as “HH diagnostic,”
meaning that it could be used in the diagnosis of hemo-
chromatosis. Id. col.38 l.65-col.39 l.40. The patent also
describes a test kit for hemochromatosis mutations,
including S65C. Id. col.38 ll.49-52.
Although the ’130 patent discounts the utility of the
S65C mutation in diagnosing hemochromatosis, we have
held that a “reference is no less anticipatory if, after
disclosing the invention, the reference then disparages it.”
Celeritas Techs., Ltd. v. Rockwell Int’l Corp., 150 F.3d
1354, 1361 (Fed. Cir. 1998). Indeed, in Celeritas, this
court explained that “whether a reference ‘teaches away’
from the invention is inapplicable to an anticipation
analysis.” Id. (quoting Kalman v. Kimberly-Clark Corp.,
713 F.2d 760, 772 (Fed. Cir. 1983)). In Celeritas, this
court considered prior art stating that “de-emphasis
would cause severe inter-symbol interference in a single-
carrier data signal; it may be feasible only for multicarrier
signals.” Id. (emphasis added). This court held that the
disclosure was sufficient to anticipate and invalidate the
claims of the asserted patent, as “[t]he fact that a modem
with a single carrier data signal is shown to be less than
optimal does not vitiate the fact that it is disclosed. The
modem in the article is not disclosed to be inoperative.”
ld.
Like the prior art reference in Celeritas, the ’130 pat-
ent discloses using the S65C mutation when diagnosing
hemochromatosis, but qualifies that disclosure with the
observation that the mutation “may only be a polymorphic
variant.” ’130 patent col.19 ll.25-27 (emphasis added). In
both cases, the prior art questioned the utility of an
application of the disclosed invention but, nevertheless,
disclosed the invention. Likewise, the Kalman case states
BILLUPS-ROTHENBERG v. ASSOC REGIONAL 16
that “it is only necessary that the claims under attack, as
construed by the court, read on something disclosed in the
reference.” 713 F.2d at 772, overruled in part on other
grounds, SRI Int’l v. Matsushita Elec. Corp. of Am., 775
F.2d 1107, 1125 (Fed. Cir. 1985) (en banc) (internal quota-
tions omitted). In the present case, the district court
correctly recognized that the ’130 patent discloses a
diagnostic test for hemochromatosis that included identi-
fication of the S65C mutation, and, therefore, anticipated
the ’425 patent’s claims.
At oral argument, Billups conceded that it waived its
argument that the ’130 patent cannot be used to antici-
pate because the relevant teachings were not enabled.
Oral Arg. at 25:23-25:50; 29:23-29:56, available at
http://www.cafc.uscourts.gov/oral-argument-
recordings/all/billups.html. Even if this argument had
not been waived, the district court presumes the enable-
ment of the material in a prior art patent, and Billups
failed to present evidence of nonenablement that the
district court found persuasive. The ’130 patent may be
used to anticipate the ’425 patent. Even though the
inventors of the ’425 patent performed experiments
revealing greater diagnostic utility of the S65C mutation
than initially suspected, the use of the S65C mutation as
a diagnostic tool was already contemplated by the ’130
patent. Accordingly, there is no genuine issue of material
fact that the asserted claims of the ’425 patent are invalid
because they are anticipated by the ’130 patent.
CONCLUSION
Because the district court properly granted summary
judgment to Appellees that the asserted claims of the ’681
patent are invalid for lack of written description and the
asserted claims of the ’425 patent are invalid as antici-
pated, we affirm the judgment of the district court.
17 BILLUPS-ROTHENBERG v. ASSOC REGIONAL
AFFIRMED
COSTS
No costs.