United States District Court, D. Delaware
B. Graham, Esq., MORRIS NICHOLS ARSHT & TUNNELL LLP,
Wilmington, DE; Rodger D. Smith II, Esq., MORRIS NICHOLS
ARSHT & TUNNELL LLP, Wilmington, DE; Stephen J.
Kraftschik, Esq., MORRIS NICHOLS ARSHT & TUNNELL LLP,
Wilmington, DE; Chad J. Peterman, Esq., PAUL HASTINGS LLP,
New York, NY; Bruce M. Wexler, Esq., PAUL HASTINGS LLP, New
York, NY; Simon F. Kung, Esq., PAUL HASTINGS LLP, New York,
NY; Michael F. Werno, Esq., PAUL HASTINGS LLP, New York, NY.
Attorneys for Plaintiff.
Melanie K. Sharp, Esq., YOUNG CONAWAY STARGATT & TAYLOR
LLP, Wilmington, DE; James L. Higgins, Esq., YOUNG CONAWAY
STARGATT & TAYLOR LLP, Wilmington, DE; Robert M. Vrana,
Esq., YOUNG CONAWAY STARGATT & TAYLOR LLP, Wilmington,
DE; Scott J. Bornstein, Esq., GREENBERG TRAURIG, LLP, New
York, NY; Richard C. Pettus, Esq., GREENBERG TRAURIG, LLP,
New York, NY; Jonathan D. Ball, Esq., GREENBERG TRAURIG, LLP,
New York, NY; Justin A. MacLean, Esq., GREENBERG TRAURIG,
LLP, New York, NY. Attorneys for Defendant.
ANDREWS, U.S. DISTRICT JUDGE.
brought this patent infringement action on June 3, 2015,
alleging that Defendant had infringed seven of Plaintiff s
patents by filing Abbreviated New Drug Application
("ANDA") No. 208043 seeking to enter the market
with a generic version of Plaintiff s Contrave product. (D.I.
1). On April 15, 2016, Plaintiff filed a First Amended
Complaint alleging infringement of four patents. (D.I. 47).
Prior to trial, Plaintiff withdrew one of the four patents
(see D.I. 182), leaving three patents-in-suit: U.S.
Patent Nos. 7, 462, 626 ("the '626 patent"), 7,
375, 111 ("the '111 patent"), and 8, 916, 195
("the '195 patent"). The Court held a three day
bench trial on June 5-7, 2017. (D.I. 178, 179, 180)
Contrave product is approved by the Food and Drug
Administration ("FDA") for "chronic weight
management in adults" who are obese or overweight and
who have "at least one weight-related comorbidity,
" such as type 2 diabetes or hypertension. (D.I. 117-1
at 5, ¶ 4). Contrave is formulated as extended-release
tablets with the active ingredients naltrexone hydrochloride
and bupropion hydrochloride. (Id. ¶ 3).
was first approved by the FDA in 1996 for use as an
antidepressant and in 1997 for use in smoking cessation
treatment. (Tr. 422:11-13). Bupropion was known to have
weight loss effects as early as 1995. (Tr. 422:18-424:11).
The efficacy and safety of bupropion for weight loss had been
studied extensively prior to 2003, the priority date for the
invention claimed in the patents-in-suit. (Tr.
425:10-431:23). Naltrexone is an opioid agonist that is FDA
approved for treating drug addiction. (Tr. 432:112-433:10).
At least as early as 2002, naltrexone was known to reduce
carbohydrate cravings in patients with diabetes. (Tr.
'626 patent is directed to methods of treating overweight
or obesity using a combination of naltrexone and bupropion.
Plaintiff asserts that Defendant induces infringement of
dependent claims 2, 15, 26, and 31 of the '626 patent.
Claims 2 and 15 depend from independent claim 1, which reads:
1. A method of treating overweight or obesity, comprising
diagnosing an individual as suffering from overweight or
obesity by determining said individual has a body mass index
of at least 25 kg/m2, and treating said overweight or obesity
by administering to said individual a first compound and a
second compound in order to treat said overweight or obesity,
wherein said second compound is bupropion or a
pharmaceutically acceptable salt thereof in an amount
effective to induce weight loss in said individual, and said
first compound is naltrexone or a pharmaceutically acceptable
salt thereof in an amount effective to enhance weight loss
activity of said bupropion or a pharmaceutically acceptable
('626 patent, claim 1). Dependent claim 2 adds the
limitation that the naltrexone and bupropion "are
administered together." Dependent claim 15 adds the
limitation that the naltrexone and bupropion "are
administered in a single oral dosage form."
26 depends from independent claim 25, which reads:
25. A method of treating overweight or obesity, comprising
administering a weight loss effective amount of a first and
second compound to an individual who has been diagnosed as
suffering from overweight or obesity in order to treat said
overweight or obesity, wherein said first compound is
bupropion, or a pharmaceutically acceptable salt thereof, and
said second compound is naltrexone, or a pharmaceutically
acceptable salt thereof, and wherein the weight loss activity
of said first and second compounds is enhanced compared to
the administration of the same amount of either compound
('626 patent, claim 25). Claim 26 adds the limitation
that the naltrexone and bupropion "are administered
together." Asserted claim 31 depends from claim 30,
which is not asserted and which depends from claim 25. Claim
30 adds the limitation that the naltrexone and bupropion
"are in a sustained-release formulation." Asserted
claim 31 adds the limitation that the naltrexone and
bupropion "are administered in a single oral dosage
'111 patent is directed to compositions for use in weight
loss treatments comprising a combination of sustained release
formulations of bupropion and naltrexone. Plaintiff asserts
that Defendant directly infringes claim 1 of the '111
patent. Claim 1 reads:
1. A composition for affecting weight loss comprising:
(a) a sustained release formulation of bupropion or a
pharmaceutically acceptable salt thereof in an amount
effective to induce weight loss in an individual; and
(b) a sustained release formulation of naltrexone or a
pharmaceutically acceptable salt thereof in an amount
effective to enhance the weight loss effect of the bupropion
or salt thereof; wherein said composition is in a single oral
dosage form fixed combination.
('111 patent, claim 1).
'195 patent is directed to methods of treating overweight
or obesity using a combination of naltrexone and bupropion.
Plaintiff asserts that Defendant directly infringes claim 11
of the '195 patent. Claim 11 reads:
11. A method of treating overweight or obesity having reduced
adverse effects comprising orally administering daily about
32 mg of naltrexone and about 360 mg of bupropion, or
pharmaceutically acceptable salts thereof, to a person in
need thereof, wherein the bupropion or pharmaceutically
acceptable salt thereof is administered as a
sustained-release formulation, wherein the naltrexone or
pharmaceutically acceptable salt thereof is administered as a
sustained-release formulation, and wherein said
sustained-release formulation of naltrexone has an in vitro
naltrexone dissolution profile in a dissolution test of USP
Apparatus 2 Paddle Method at 100 rpm in a dissolution medium
of water at 37° C. of:
a) between 39% and 70% of naltrexone released in one hour;
b) between 62% and 90% of naltrexone released in two hours;
c) at least 99% in 8 hours;
wherein about 16 mg of said sustained-release formulation of
naltrexone or a pharmaceutically acceptable salt thereof is
administered twice daily, and about 180 mg of said
sustained-release formulation of bupropion or a
pharmaceutically acceptable salt thereof is administered
('195 patent, claim 11).
contends that it does not infringe any of the asserted
claims. Defendant also argues that claim 11 of the '195
patent is invalid for lack of written description and all
asserted claims of the '111 and '626 patents are
invalid as obvious in view of the prior art.
MOTION TO STRIKE THE GADDE FAX
moves to strike Defendant's exhibits DTX-48 and DTX-180,
a fax sent by Dr. Kishore Gadde to Orexigen on November 19,
2003 ("Gadde Fax" or "Fax"), as
inadmissible hearsay. (D.I. 155 at 2). The Fax consists of a
table which contains brief descriptions of patients Dr. Gadde
treated for obesity in 1997 and 2000. (DTX-180 at
GADDE0000010). According to the table, Dr. Gadde treated four
patients in 1997 with a combination of fluoxetine and
naltrexone and two patients in 2000 with a combination of
bupropion and naltrexone. (Id.). Dr. Gadde testified
at trial that he prepared the table in 2003 "by
reviewing the patient charts." (Tr. 715:16-18,
768:19-21). The original patient charts were not produced as
evidence in this case. (D.I. 155 at 3).
argues that the Gadde Fax is not hearsay because it qualifies
as an adoptive admission under Federal Rule of Evidence
801(d)(2)(B). (D.I. 159 at 2; Tr. 722:10-12). According
to Defendant, Plaintiff shared the data in the Gadde Fax with
the FDA to help demonstrate safety and efficacy of the
combination of bupropion and naltrexone. (D.I. 159 at 2; Tr.
722:12-19). As support for this contention, Defendant
produced a clinical study report submitted to the FDA as part
of Orexigen's Investigational New Drug ("IND")
Application for fluoxetine or bupropion SR in combination
with naltrexone. (DTX-154). In relevant part, the report
stated, "When naltrexone was added to fluoxetine or
bupropion SR therapy, additional weight loss was observed in
2 of 6 patients; no adverse events other than nausea were
reported (K Gadde, personal communication)." (DTX-154 at
trial I found the Gadde Fax to be admissible as an adoptive
admission, but allowed the parties to present additional
arguments about its admissibility in post-trial briefing.
(Tr. 731:1-4). I found that, while "not an absolute
certainty, " it was "a fair inference" that
the paragraph Defendant pointed to was referring to the chart
in the Gadde Fax. (Tr. 730:11-14). I also stated that it
seemed clear that the paragraph's reference to additional
weight loss referred to patients 2 and 3 on the fax, which
are patients who received the fluoxetine/naltrexone
combination therapy. (Tr. 728:15-729:2).
opinion that the Gadde Fax is admissible as an adoptive
admission has not changed. I think there is sufficient detail
in the FDA report to support the inference that the
"personal communication" referred to was the Fax. I
disagree with Plaintiffs contention that this paragraph was
merely a reference to the Fax and a repetition of the hearsay
contained in the Fax. (D.I. 155 at 5-6). Orexigen presented
this information to the FDA in support of its IND
Application. I find it difficult to believe Orexigen would
have done so if it did not believe in the trustworthiness of
the contents of the communication. As to Plaintiffs argument
that Defendant must show that each statement in the Fax was
separately adopted (D.I. 155 at 7), I think this is satisfied
by the statement that "additional weight loss was
observed in 2 of 6 patients." It seems to me that this
refers to the six patients reported in the Fax and I think
the only reasonable interpretation is that the Fax was
adopted in its entirety.
does not mean, however, that the Gadde Fax is admissible as
substantive evidence of anything that Dr. Gadde did in 1997
or 2000. The parties agreed that any allegations of public
use by Dr. Gadde in 2000 would be subject to the
corroboration requirement for inventor testimony. (Tr.
950:17-23). Defendant stated at trial that the purpose of Dr.
Gadde's testimony and the Gadde Fax was not to prove
prior use, but to prove secondary considerations, such as
motivation to combine. (Tr. 951:13-17). Defendant argued that
motivation to combine was not subject to the corroboration
requirement. (Tr. 954:17-955:5). As I discuss below, I
disagree. The Gadde Fax is not admissible to show that Dr.
Gadde treated patients with the combinations of drugs
reported in the Fax in 1997 and 2000, or as evidence of
anything that occurred prior to the date the Fax was
foregoing reasons, Plaintiffs Motion to Strike (D.I. 155) is
denied. The Gadde Fax is admissible for the limited purpose
of showing that Dr. Gadde shared the data reported in the Fax
with Orexigen in 2003.
written description requirement contained in 35 U.S.C. §
112, ¶ 1 requires that the specification "clearly
allow persons of ordinary skill in the art to recognize that
[the inventor] invented what is claimed." Ariad
Pharm., Inc., v. Eli Lilly & Co., 598 F.3d 1336,
1351 (Fed. Cir. 2010) (en banc) (alteration in original).
"In other words, the test for sufficiency is whether the
disclosure of the application relied upon reasonably conveys
to those skilled in the art that the inventor had possession
of the claimed subject matter as of the filing date."
Id. "A party must prove invalidity for lack of
written description by clear and convincing evidence."
Vasudevan Software, Inc. v. MicroStrategy, Inc., 782
F.3d 671, 682 (Fed. Cir. 2015).
argues that claim 11 of the '195 patent is invalid for
lack of written description because the ranges given for the
claimed dissolution profile "were improperly cobbled
together" and were measured using a different method
than that required by the claim. (D.I. 162 at 10).
Specifically, Defendant argues that the lower bounds of the
dissolution ranges at one and two hours recited in the claim
were not obtained using the USP Apparatus 2 Paddle Method
required by the claim. (Id. at 10). Defendant
further argues that there is no evidence in the specification
as to which method was used to obtain the 99% dissolution
profile stated in the claim for the eight hour range.
(Id.). Finally, Defendant argues that the upper
bounds of the one and two hour ranges were picked from
"a boilerplate paragraph without any sensible reason or
industry custom/practice for their random selection."
responds that simply because the claims draw support from
different parts of the specification does not mean that a
person of ordinary skill would not believe that the inventor
was in possession of the invention. (D.I. 164 at 30).
Plaintiff also argues that there is no legal requirement that
all claim limitations be set out in a single place in the
specification. (Id. at 31). Plaintiff points to the
prosecution history, which shows the applicant cited to
specific portions of the specification as support for claim
11, resulting in a notice of allowance for this claim.
11 of the '195 patent claims a method of treating
overweight or obesity using a sustained released formulation
of bupropion and naltrexone. Claim 11 includes the limitation
that the naltrexone have a specific dissolution profile
measured "in a dissolution test of USP Apparatus 2
Paddle Method at 100 rpm in a dissolution medium of water at
37°C." The dissolution profile recited requires
"a) between 39% and 70% of naltrexone released in one
hour; b) between 62% and 90% of naltrexone released in two
hours; and c) at least 99% in 8 hours."
support for the claimed dissolution profile, Plaintiff points
to Table 10 in the specification. (Id. at 32). Table
10 provides dissolution data for naltrexone in one embodiment
described in the specification. ('195 patent at
19:60-67). Table 10 indicates that, after one hour, 67%) of
naltrexone was released, after two hours, 85% of naltrexone
was released, and after 8 hours, 99% of naltrexone was
released. ('195 patent at 20:1-10). These values fall
squarely within the ranges in claim 11. Defendant argues that
this data is not relevant as it was not obtained using the
USP Apparatus 2 method. (D.I. 162 at 11). In response,
Plaintiff points to a portion of the specification that it
argues constitutes a definition of a "standard
dissolution test." (D.I. 164 at 32; '195 patent at
with Plaintiff that the specification would indicate to a
person of ordinary skill that all of the dissolution data
reported in the patent was obtained "using Apparatus 2
... at a spindle rotation speed of 100 rpm and a dissolution
medium of water, at 37° C, or other test conditions
substantially equivalent thereto." ('195 patent at
6:52-55). Plaintiffs expert, Dr. Treacy, testified that a
person of ordinary skill would recognize that the inventors
had possession of an embodiment representative of the
invention, as described in Table 10. (Tr. 660:21-661:1). Dr.
Treacy further testified that a person of ordinary skill
"would find reasonable support for the claim limitations
in the written description, " specifically the upper and
lower limits for each of the ranges. (Tr. 660:12-20). Dr.
Treacy also opined that, in the context of the patent, a
person of ordinary skill would understand that the inventors
had possession of the claimed invention regardless of whether
the USP Apparatus 2 method or a "substantially
equivalent" method were used. (Tr. 663:3-9).
expert, Dr. Mayersohn, testified at trial that the paddle
method and the USP Apparatus 1 basket method were different
in that the hydrodynamics were different and that a person of
ordinary skill would expect the two methods to yield
different results. (Tr. 602:23-604:20). Dr. Mayersohn did
not, however, perform any actual tests on the tablets claimed
in this patent. (Tr. 640:19-22). Furthermore, in his expert
report, Dr. Mayersohn provided an opinion on obviousness for
this claim in which he relied on a prior art reference that
used the USP Apparatus 1 basket method. (Tr. 637:8-640:13).
It seems to me that Dr. Mayersohn's theoretical opinion
that the methods would yield different results is at odds
with his reliance on a prior art reference using the basket
method to argue that claim 11, which specifies the paddle
method, was obvious.
not think it matters whether the two methods would yield
exactly the same results. I find credible Dr. Treacy's
testimony that a person of ordinary skill would understand,
in the context of the patent, that the inventors possessed
the claimed invention. The embodiments disclosed in a patent
are intended to be exemplary and it is clear to me that the
inventors possessed at least one embodiment that falls
squarely within the claimed ranges, as evidenced by Table 10.
Furthermore, Defendant's emphasis on the purported
differences between the two methods of measuring dissolution
profiles seems to me to be misplaced as even its own expert
was willing to favorably compare the two methods when it was
to Defendant's benefit to do so. Therefore, whether the
dissolution data reported in the specification was obtained
using the basket method or the paddle method is not relevant
to whether the inventors had possession of the invention.
also argues that the lower bounds of the one and two hour
ranges lack written description support because they were
pulled from Table 5, which reports data on specific
embodiments which includes different amounts of the polymer
excipient hydroxypropylmethyl cellulose ("HPMC").
(D.I. 162 at 12). Defendant contends that the data from the
15% HPMC formulation was "randomly selected" and
"improperly picked from amongst a plethora of other
possible options." (Id. at 12-13). I disagree.
As Plaintiff points out, claim 11 calls for a
"sustained-release formulation." (D.I. 164 at 34).
Both Dr. Mayersohn and Dr. Treacy testified that the data
from the 5% and 10% HPMC formulations indicated that both
were "essentially immediate release" and the 15%
formulation was "the first one . . . where you see a
sustained release profile." (Tr. 615:6-19, 655:10-17).
For this reason, it seems clear that these are appropriate
data points to support the claimed lower bounds for the one
and two hour ranges.
Mayersohn's main criticism of using the data in Table 5
was that there was no eight-hour value and, in his opinion,
the data provided indicated that the dissolution profile
would plateau and never reach the claimed 99% at eight hours.
(Tr. 615:20-616:3). I am not convinced. There is no data
provided at all in Table 5 for the dissolution at eight
hours. I do not think there is sufficient evidence to support
Dr. Mayersohn's plateau theory to a clear and convincing
standard for invalidating this patent claim. In contrast, as
Plaintiff notes, there is an embodiment reported in Table 10
that has a dissolution profile falling squarely within the
claimed ranges. (D.I. 164 at 32).
also argues that the inventor did not possess the eight-hour
limitation by attempting to characterize this limitation as a
range, wherein "at least 99%" necessarily
"extends up to and includes 100%." (D.I. 162 at
13). Defendant suggests that to show the inventor possessed
the invention, Plaintiff must establish written description
support "for the upper end of the claimed range above
99%." (Id. at 15). I disagree. Dr. Treacy
opined that "at least 99%" would be understood by a
person of ordinary skill to mean "essentially complete
dissolution." (Tr. 653:5-12). I find this testimony
credible. It seems clear to me that "at least 99%"
means "at least 99%" rather than "between 99%
and 100%." I think it is sufficient that the inventors
showed possession by disclosing an embodiment that falls
squarely within all of the claimed ranges, including "at
least 99%" at eight hours.
also criticizes the upper bounds of the one and two hour
ranges as lacking written description support because these
bounds come from "a boilerplate paragraph containing
multiple theoretical ranges." (D.I. 162 at 14). As an
initial matter, there is no definitive evidence that these
ranges were "theoretical." More importantly, I see
nothing odd or invalidating about the inventors looking to
different tables of dissolution data and other places in the
specification to determine the ranges for the claimed
dissolution profile. A single test on a single tablet could
provide only a single data point at each time; rather,
multiple tests are necessarily required to establish a range.
suggests that all of the purported shortcomings it has
identified in the disclosure of the claimed ranges
necessarily lead to the conclusion that the patent fails to
provide "blazemarks" that would direct a person of
ordinary skill to select those specific bounds. (D.I. 162 at
15). The cases Defendant cites to support for this failure do
not support its position. (Id. at 9). Most of
Defendant's cases dealt with situations where an inventor
had disclosed a large genus of possible compounds.
Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed.
Cir. 1996) ("simply describing a large genus of
compounds is not sufficient to satisfy the written
description requirement as to particular species or
sub-genuses"); Boston Sci. Corp. v. Johnson &
Johnson, 647 F.3d 1353, 1367 (Fed. Cir. 2011) (finding
lack of written description where patent claimed
"rapamycin or a macrocyclic triene analog thereof but
specification "fail[ed] to disclose even a single member
of either the genus of 'analogs' of rapamycin, or the
more specific genus of 'macrocyclic triene analogs'
of rapamycin"); In re Ruschig, 379 F.2d 990,
994 (C.C.P.A. 1967) (finding lack of written description
where disclosure of genus encompassed "half million
compounds within the scope of the broadest claim"). The
instant case is not one of an inventor disclosing a large
genus without any disclosure that certain of the species
within the genus are preferred. I hold that Defendant has not
proven by clear and convincing evidence that claim 11 of the
'195 patent is invalid for lack of written description.
argues that claims 26 and 31 of the '626 patent and claim
1 of the '111 patent are invalid as obvious over the
prior art. (D.I. 162 at 22, 27-28). Specifically,
Defendant argues that a person of ordinary skill in the art
would have been motivated to combine the teachings of the
Jain and O'Malley references to administer the
combination of naltrexone and bupropion for treating
overweight and obesity with a reasonable expectation of
success. (Id. at 28).
patent claim is invalid as obvious "if 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 to a
person having ordinary skill in the art to which said subject
matter pertains." 35 U.S.C. § 103; see also KSR
Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406-07
(2007). The determination of obviousness is a question of law
with underlying factual findings. See Kinetic Concepts,
Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1359-60
(Fed. Cir. 2012). "The underlying factual inquiries
include (1) the scope and content of the prior art; (2) the
differences between the prior art and the claims at issue;
(3) the level of ordinary skill in the art; and (4) any
relevant secondary considerations .. . ." Western
Union Co. v. MoneyGram Payment Sys., Inc., 626 F.3d
1361, 1370 (Fed. Cir. 2010) (citing Graham v. John Deere
Co., 383 U.S. 1, 17-18 (1966)).
is required to consider secondary considerations, or
objective indicia of nonobviousness, before reaching an
obviousness determination, as a "check against hindsight
bias." See In re Cyclobenzaprine Hydrochloride
Extended-Release Capsule Patent Litig., 676 F.3d 1063,
1078-79 (Fed. Cir. 2012). Relevant secondary considerations
include commercial success, long felt but unsolved needs,
failure of others, praise, unexpected results, and copying,
among others. Graham, 383 U.S. at 17-18; Ruiz v.
A.B. Chance Co., 234 F.3d 654, 662-63 (Fed. Cir. 2000);
Tex. Instruments, Inc. v. U.S. Int'l Trade
Comm'n, 988 F.2d 1165, 1178 (Fed. Cir. 1993).
Secondary considerations of nonobviousness are important
because they "serve as insurance against the insidious
attraction of the siren hindsight...." W.L. Gore
& Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540,
1553 (Fed. Cir. 1983).
patentee is not required to present evidence of secondary
considerations. See Prometheus Labs., Inc. v. Roxane
Labs., Inc., 805 F.3d 1092, 1101 (Fed. Cir. 2015). That
said, if the patent challenger establishes a prima facie case
of obviousness, "the patentee would be well advised to
introduce evidence sufficient to rebut that of the
challenger." Id. (quoting Pfizer, Inc. v.
Apotex, Inc., 480 F.3d 1348, 1360 (Fed. Cir. 2007)).
There must be enough evidence, however, for a finding that a
given secondary consideration exists by a preponderance of
the evidence. See Apple, Inc. v. Samsung Elec. Co.,
Ltd., 839 F.3d 1034, 1053 (Fed. Cir. 2016) (en banc). If
there is, then the probative value of each secondary
consideration will be considered in light of the evidence
produced. That does not mean, though, that the burden of
persuasion on the ultimate question of obviousness transfers
to the proponent of the secondary consideration. Pfizer,
Inc., 480 F.3d at 1359. That burden stays always with
the patent challenger. Id. at 1359- 60.
asserting that a patent is invalid as obvious must "show
by clear and convincing evidence that a skilled artisan would
have been motivated to combine the teachings of the prior art
references to achieve the claimed invention, and that the
skilled artisan would have had a reasonable expectation of
success in doing so." Pfizer, Inc. v. Apotex,
Inc.,480 F.3d 1348, 1361 (Fed. Cir. 2007). That
"expectation of success need only be reasonable, not
absolute." Id. at 1364. "Whether an
ordinarily skilled artisan would have reasonably expected
success .... is ...