Ex Parte Arduini

Board of Patent Appeals and Interferences

Jun 15, 2011

10343626 (B.P.A.I. Jun. 15, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ARDUINO ARDUINI
__________

Appeal 2011-001512
Application 10/343,626
Technology Center 1600
__________

Before TONI R. SCHEINER, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of using a fibrate for the treatment of congestive heart failure. The
Examiner rejected the claims as anticipated. We have jurisdiction under 35
U.S.C. § 6(b). We affirm.

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Application 10/343,626

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Statement of the Case
The Claims
Claims 1 and 3-6 are on appeal.
1
Claim 1 is representative
2
and reads
as follows:
1. A method of using a fibrate for the treatment of
congestive heart failure comprising administering an
effective amount of a fibrate.

The issue
The Examiner rejected claims 1 and 3-6 under 35 U.S.C. § 102(b) as
anticipated by The Coronary Drug Project Research Group
3
(Ans. 4-5).
The Examiner finds that the “Coronary Drug Project Research Group
teaches the administration of clofibrate to subjects with CHF (p. 351, Table
1)” (Ans. 4). The Examiner finds that the Coronary Drug Project Research
Group “does not explicitly teach that this method is a treatment of . . .
however the method comprises the same active step of administering
clofibrate, to the same patient population, subjects with CHF. Therefore
these effects are inherently accomplished” (Ans. 4).
Appellant contends that the “solely asserted reference simply would
not have enabled a skilled person in the art to make and use the as-claimed
invention” (App. Br. 9). Appellant contends that “the claimed method –

1
The Examiner required a species election of a particular fibrate
and in the response filed July 19, 2006, Appellant elected
clofibrate.
2
“The rejections should be treated as a single group, and the Board
may select claim 1 as representative of the group” (App. Br. 9).
3
The Coronary Drug Project Research Group, Clofibrate and
Niacin in Coronary Heart Disease, 231 JAMA 360-381 (1975).
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which relates to the method of treating congestive heart failure through the
administration of an effective amount of a fibrate – was not inherently or
expressly discussed or mentioned in Coronary Drug Project Research
Group” (App. Br. 9).
Appellant contends that the
prior art discloses an unsuccessful method of treatment of
myocardially infarcted (MI) patients with clofibrate (a
fibrate). Although some patients of the prior art study also
had CHF in addition to MI (as noted in Table 1), but the
unsuccessful outcome is the same and no investigations are
made specifically on CHF.

(App. Br. 12). Appellant contends that “the cited reference clearly
discourages one from using clofibrate (namely a fibrate) in heart disease”
(App. Br. 14). Appellant contends that the “cited reference does not record
such an improvement in cardiac function. The enormous abundance of data
brings the authors of the Coronary Project to exclude any beneficial effect of
clofibrate” (App. Br. 15).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s finding that the Coronary Drug Project Research
Group anticipates claim 1?
Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
1. The Coronary Drug Project Research Group teaches that the
“project clinical centers recruited 8,341 patients, who were randomly
assigned to the six treatment groups . . . clofibrate, 1.8 gm/day” (The
Coronary Drug Project Research Group 360, col. 2).
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2. The Coronary Drug Project Research Group teaches that “[r]isk
group 2 comprised patients with . . . one MI [myocardial infarction] with one
or more of the following acute complications . . . congestive heart failure”
(The Coronary Drug Project Research Group 360, col. 3).
3. Table 1 of the Coronary Drug Project Research Group is
reproduced in part below:

Table 1 discusses the percentages of patients with various findings including
medical history at entry into the study. (The Coronary Drug Project
Research Group 361, col. 2).
4. Table 14 of the Coronary Drug Project Research Group is
reproduced in part below:

Table 14 discusses the five year percentages of deaths based on findings at
entry (The Coronary Drug Project Research Group 371).

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5. The Coronary Drug Project Research Group teaches that “there
is no evidence of significant efficacy of clofibrate with regard to total
mortality or cause-specific mortality” (The Coronary Drug Project Research
Group 379, col. 1).
6. The Coronary Drug Project Research Group teaches that “[a]ll
of the surviving patients were in the study for at least 54 months” (The
Coronary Drug Project Research Group 361, col. 1).
Principles of Law
“A single prior art reference that discloses, either expressly or
inherently, each limitation of a claim invalidates that claim by anticipation.”
Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1375 (Fed. Cir.
2005). In Cruciferous Sprout, the court stated “[i]t is well settled that a prior
art reference may anticipate when the claim limitations not expressly found
in that reference are nonetheless inherent in it.” In re Cruciferous Sprout
Litigation, 301 F.3d 1343, 1349 (Fed. Cir. 2002).
Inherent anticipation requires that the missing descriptive material is
„necessarily present,‟ not merely probably or possibly present in the prior
art. See In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999).
Analysis
The Coronary Drug Project Research Group teaches that 17.1% of
patients treated with clofibrate had a suspected or definite history of
congestive heart failure (FF 3). The Coronary Drug Project Research Group
teaches that 1,103 patients were treated with clofibrate, of whom 189
patients had suspected or definite congestive heart failure (FF 4). Thus, this
is not a Robertson situation, since it is not merely possible that some patients
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with congestive heart failure were treated with clofibrate. In fact, the
Coronary Drug Project Research Group expressly teaches that 189 patients
with suspected or definite congestive heart failure were treated with
clofibrate for at least 54 months (FF 4, 6).
The dispute therefore centers over whether treatment of these 189
patients by the Coronary Drug Project Research Group inherently satisfies
the requirements of claim 1.
Appellant contends that the “solely asserted reference simply would
not have enabled a skilled person in the art to make and use the as-claimed
invention” (App. Br. 9).
We are not persuaded. In Cruciferous Sprout, the Federal Circuit was
faced with a similar issue where “Brassica argues that only specific cultivars
of these plant species are rich in glucosinolates and high in Phase 2 enzyme-
inducing activity. Thus, according to Brassica, the prior art fails to meet the
„identifying‟ steps of the claims because it does not specify which cultivars
should be sprouted.” Cruciferous Sprout, 301 F.3d at 1351. This argument is
similar to the instant case, since the Coronary Drug Project Research Group
does not state that clofibrate is a treatment for congestive heart failure.
The court responded “Brassica cannot credibly maintain that no one
has heretofore grown and eaten one of the many suitable cultivars identified
by its patents. It is unnecessary for purposes of anticipation for the persons
sprouting these particular cultivars to have realized that they were sprouting
something rich in glucosinolates and high in Phase 2 enzyme-inducing
potential.” Cruciferous Sprout, 301 F.3d at 1351 (Fed. Cir. 2002).
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Similarly, Appellant cannot credibly maintain that the Coronary Drug
Project Research Group did not actually treat patients with congestive heart
failure with clofibrate (FF 1-4, 6).
Appellant contends that “the claimed method – which relates to the
method of treating congestive heart failure through the administration of an
effective amount of a fibrate – was not inherently or expressly discussed or
mentioned in Coronary Drug Project Research Group” (App. Br. 9).
We are not persuaded. It is unnecessary for anticipation whether the
Coronary Drug Project Research Group appreciated that treatment of
patients with congestive heart failure with clofibrate would be beneficial or
not, since the Coronary Drug Project Research Group actually performed
such a treatment on CHF patients for at least 54 months (FF 1-4, 6).
Mehl mandates this result, noting “[i]t is not a question of
probabilities as to whether a person of ordinary skill following the teachings
of the article will align the laser light applicator over a hair follicle.”
MEHL/Biophile Intern. Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir.
1999). The radiation in Mehl was not focused on hair follicles, but was
applied to the backs of guinea pigs. Id. at 1366. While much of the radiation
would not impact any hair follicle, the fraction which did was sufficient for
the court to conclude that “[w]here, as here, the result is a necessary
consequence of what was deliberately intended, it is of no import that the
article's authors did not appreciate the results.” Id. at 1366. The instant
facts are far more certain that Mehl, since there can be no reasonable dispute
that 189 patients with suspected or definite congestive heart failure were
treated with clofibrate for at least 54 months (FF 1-4, 6).
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Appellant contends that the
prior art discloses an unsuccessful method of treatment of
myocardially infarcted (MI) patients with clofibrate (a
fibrate). Although some patients of the prior art study also
had CHF in addition to MI (as noted in Table 1), but the
unsuccessful outcome is the same and no investigations are
made specifically on CHF.

(App. Br. 12). Appellant contends that “the cited reference clearly
discourages one from using clofibrate (namely a fibrate) in heart disease”
(App. Br. 14). Appellant contends that the “cited reference does not record
such an improvement in cardiac function. The enormous abundance of data
brings the authors of the Coronary Project to exclude any beneficial effect of
clofibrate” (App. Br. 15).
We note that the Court of Appeals for the Federal Circuit has
determined that “[t]eaching away is irrelevant to anticipation.” Seachange
Int’l, Inc., v. C-Cor, Inc., 413 F.3d 1361, 1380 (Fed. Cir. 2005) (citing
Celeritas Tech., Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354, 1361 (Fed. Cir.
1998). Insofar as Appellant may intend to argue that the Coronary Drug
Project Research Group teaches away from the use of clofibrate, this
argument is irrelevant. As already noted, the Coronary Drug Project
Research Group actually performed clofibrate treatment on 189 patients with
suspected or definite congestive heart failure for at least 54 months (FF 1-4,
6).
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C. §
102(b) as anticipated by the Coronary Drug Project Research Group.
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Pursuant to 37 C.F.R. § 41.37(c)(1)(vii)(2006), we also affirm the rejection
of claims 3-6, as these claims were not argued separately.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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