Ex Parte Davis

Board of Patent Appeals and Interferences

Dec 18, 2009

10247032 (B.P.A.I. Dec. 18, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte HARRY R. DAVIS
__________

Appeal1 2010-000409
Application 10/247,032
Technology Center 1600
__________

Decided: December 21, 2009
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s final rejection of claims 1-3, 10, 12, 13, 17, 19, 20, and 30-36.
We have jurisdiction under 35 U.S.C. § 6(b).

1 This appeal is related to Appeal No. 2006-2368, decided September 22,
2006.

Appeal 2010-000409
Application 10/247,032

STATEMENT OF THE CASE
Claim 1 is representative of the claims on appeal, and reads as
follows:
1. A method for treating vascular inflammation in a subject comprising
the step of administering
(1) at least one sterol absorption inhibitor or at least one 5α-stanol
absorption inhibitor and
(2) at least one cholesterol biosynthesis inhibitor
to a subject in need of such treatment for vascular inflammation and having
a blood level of c-reactive protein of greater than about 0.4 mg/dL for the
purpose of treating vascular inflammation.

The Examiner relies on the following evidence:
Rosenblum US 5,846,966 Dec. 8, 1998

Jane Y. Yeun and George A. Kaysen, C-Reactive protein, oxidative stress,
homocysteine, and troponin as inflammatory and metabolic predictors of
atherosclerosis in ESRD, 9 CURRENT OPINION IN NEPHROLOGY AND
HYPERTENSION 621-630 (2000).

Erren et al., Systemic Inflammatory Parameters in Patients With
Atherosclerosis of the Coronary and Peripheral Arteries, 19
ATHEROSCLEROSIS, THROMBOSIS, AND VASCULAR BIOLOGY 2355-2363
(1999).

Luis Gruberg, Inflammatory Markers in Acute Coronary Syndromes: C-
reactive Protein (CRP) and Chlamydia, American Heat Association
Scientific Sessions (2000).

Appellant relies on the following evidence:
Sager et al., Effect of Coadministration of Ezetimibe and Simvastatin on
High-Sensitivity C-Reactive Protein, 92 THE AMERICAN JOURNAL OF
CARDIOLOGY 1414-1418 (2003).

We affirm.
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ISSUE
The Examiner finds that claim 1 is anticipated by Rosenblum as
evidenced by Erren.
Appellant contends that the Examiner has failed to set forth a prima
facie case that Rosenblum anticipates all of the limitations of claim 1.
Thus, the issue on appeal is: Has Appellant demonstrated that the
Examiner erred in finding that Rosenblum as evidenced by Erren anticipates
all of the limitations of claim 1?

FINDINGS OF FACT
FF1 According to the Specification, the “present invention relates to
methods of treating or preventing vascular inflammation in a subject
comprising administering to the subject a composition comprising at least
one sterol absorption inhibitor and/or 5α-stanol absorption inhibitor.” (Spec.
1.)
FF2 The Specification teaches that “[v]ascular inflammation is an
etiological event that often precedes the development and the continual
process of atherosclerotic coronary heart disease.” (Id.)
FF3 Thus, the Specification teaches that “[v]ascular inflammation,
beginning with an injury or change in the endothelial wall of the artery, may
cause an alteration in the intimal layer that increases platelet adhesion to the
endothelium.” (Id.)
FF4 The Specification teaches further that “[c]holesteryl esters are a major
are a major component of atherosclerotic lesions which can result in vascular
inflammation and an increase in plasma c-reactive protein levels.” (Id. at 4.)
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FF5 The Specification defines “inflammation” as “injury or the bodily
response to an injury.” (Id. at 5.)
FF6 The Specification defines “vascular inflammation” as “to arterial
damage and bodily responses thereto that can lead to atherosclerosis or
coronary heart disease.” (Id.)
FF7 The Examiner rejects claims 1-3, 10, 12, 13, 19, 20, and 30-35 under
35 U.S.C. § 102(b) as being anticipated by Rosenblum as anticipated by
Erren (Ans. 3). As Appellant did not argue the claims separately, we focus
our analysis on claim 1, and claims 2, 3, 10, 12, 13, 19, 20, and 30-35 stand
or fall with that claim. 37 C.F.R. § 41.37(c)(1)(vii).
FF8 The Examiner finds:
Rosenblum [ ] teaches a method of treating or preventing
atherosclerosis in [a, sic] mammal comprising administering to
the mammal a combination of the compounds herein elected.
See, particularly, claims 6-10. The method is particularly
effective in human. See, particularly, column 20, lines 39-48.
Note the recitation of the level of C-reactive protein is not
see[n, sic] to further limit the claims because patient[s, sic] with
vascular condition[s, sic], such as atherosclerosis, . . . inherently
hav[e, sic] elevated c-reactive protein levels.

(Id. at 3-4.)
FF9 The Examiner cites Erren for teaching that “it is known in the art that
patients with atherosclerosis are associated with inflammation.” (Id. at 4.)
FF10 Specifically, Erren teaches that “[p]lasma concentration of markers of
inflammation are increased in patients with atherosclerosis.” (Erren,
Abstract.)
FF11 Erren teaches further that “evidence has been accumulating that
inflammation plays an important role in both the initiation and progression
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of atherosclerosis of the coronary, carotid, and peripheral arteries.” (Id. at
2355, first column.)
FF12 Thus, the Examiner finds that atherosclerotic patients “would meet the
limitation of ‘a subject in need of such treatment for vascular
inflammation.’” (Ans. 4.)
FF13 The Examiner finds further that the “limitation ‘for the purpose of
treating vascular inflammation’” is intended use, and not a patentable
limitation (id.).
FF14 The Examiner notes further that “the claiming of a new use, new
function or unknown property which is inherently present in the prior art
does not necessarily make the claim patentable.” (Id.)
FF15 Sager, relied upon by Appellant, “assessed the effect of ezetimibe
coadministration with simvastatin on high-sensitivity C-reactive protein (hs-
CRP) in patients with primary hypercholesterolemia.” (Sager, Abstract.)
FF16 Sager teaches that “[c]ompared with placebo, the reduction in hs-CRP
by ezetimibe monotherapy was not statistically significant.” (Id. at 1416,
first column.)
FF17 Sager notes “that in patients with primary hypercholesterolemia,
ezetimibe coadministered with simvastatin significantly reduced hs-CRP
almost twice as much as simvastatin monotherapy, possibly potentiating the
vascular protective effects of simvastatin monotherapy.” (Id. at 1417, first
column.)
FF18 As to the results found with ezetimibe alone, Sager teaches that a
“significant effect on hs-CRP may not have been observed in the ezetimibe
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monotherapy group because of the small sample size (n=54) or a threshold
effect on lipid profile modification.” (Id. at 1417, second column.)
FF19 The Examiner also rejects claims 1-3, 10, 12, 13, 17, 19, 20, and 30-
36 under 35 U.S.C. § 103(a) as being obvious over the combination of
Rosenblum and Erren or Yeun (Ans. 5). Appellant only argues claims 1 and
32 separately, thus we focus our analysis on those claims, and claims 2, 3,
10, 12, 13, 17, 19, 20, and 30-36 stand or fall with those claims.
FF20 The Examiner further rejects claims 1-3, 10, 12, 13, 17, 19, 20, and
30-36 under 35 U.S.C. § 103(a) as being obvious over the combination of
Rosenblum and Erren or Yeun as further combined with Gruberg (id. at 6).
Appellant did not argue the claims separately; we thus focus our analysis on
claim 1, and claims 2, 3, 10, 12, 13, 17, 19, 20, and 30-36 stand or fall with
that claim.

PRINCIPLES OF LAW
We recognize that in order for a prior art reference to serve as an
anticipatory reference, it must disclose every limitation of the claimed
invention, either explicitly or inherently. In re Schreiber, 128 F.3d 1473,
1477 (Fed. Cir. 1997).
A single prior art reference that discloses, either
expressly or inherently, each limitation of a claim invalidates
that claim by anticipation. Thus, a prior art reference without
express reference to a claim limitation may nonetheless
anticipate by inherency. “Under the principles of inherency, if
the prior art necessarily functions in accordance with, or
includes, the claims limitations, it anticipates.” Moreover,
“[i]nherency is not necessarily coterminous with knowledge of
those ordinary skill in the art. Artisans of ordinary skill may
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not recognize the inherent characteristics or functioning of the
prior art.”

Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1375-76 (Fed.
Cir. 2005) (citations omitted). In addition, “[i]t is a general rule that merely
discovering and claiming a new benefit of an old process cannot render the
process again patentable.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir.
1990); see also Perricone, 432 F.3d at 1377-78 (noting that the realization of
a new benefit of an old process does not render that process patentable);
Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368,
1376 (Fed. Cir. 2001) (stating in the context of a claimed process that was
drawn to the same use comprising the same steps of the prior art, “[n]ewly
discovered results of known processes directed to the same purpose are not
patentable because such results are inherent.”).

ANALYSIS
Appellant argues that the Examiner erred in not giving any patentable
weight to “the limitation ‘for the purpose of treating vascular inflammation’
any patentable weight.” (App. Br. 12.) Appellant asserts, citing Jansen v.
Rexall Sundown, Inc., 342 F.3d 1329 (Fed. Cir. 2003) and Rapoport v.
Dement, 254 F.3d 1053 (Fed. Cir. 2001), that “limitation should be
construed to require that the claimed method steps be performed with the
intent of treating vascular inflammation.” (App. Br. 12.) According to
Appellant, “[b]ecause the Examiner has failed to point out any discussion in
Rosenblum [ ] which teaches, discloses or suggests administering the recited
combination of compounds to a patient with the intent of treating vascular
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inflammation, the rejection of claims 1-3, 10, 12, 13, 19-20 and 30-35 under
35 U.S.C. § 102(b) should be reversed.” (Id.)
We disagree. The Examiner made a finding that atherosclerotic
patients “would meet the limitation ‘a subject in need of such treatment for
vascular inflammation.’” (FF12.) Thus, the Examiner did make findings as
to the limitation of treating vascular inflammation, and relied on Erren for
demonstrating that treating atherosclerosis would be inherently treating
vascular inflammation.
Appellant argues further that “[i]t is also incorrect to classify vascular
inflammation as a genus of which atherosclerosis is a species,” as they are in
fact “very distinct disorders with different physiological conditions and
diagnosis.” (App. Br. 15.) Appellant asserts that at most they are “similar
disorders which are experienced concurrently in some patients.” (Id.)
Appellant argues, citing Rapoport, that such “an overlap in patient
population is not determinative of patentability,” as in that case “there was
[a] clear overlap between the patient population in the prior art and the
patient population of the claimed method.” (Id.) Appellant asserts, citing
Jansen, that the limitation “‘for the purpose of treating vascular
inflammation’ . . . . is not met unless the claimed method was previously
performed ‘with the intent to achieve the objective stated in the preamble.’”
(Id.)
Thus, Appellant argues, as Rosenblum “does not expressly or
inherently disclose that a combination of ezetimibe and simvastatin could be
used for the purpose of treating vascular inflammation,” and that “nowhere
is it mentioned or inferred that one should or could also take the claimed
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combination for the purpose of treating vascular inflammation.” (Id. at 17.)
Appellant argues, citing the Sager reference, that “ezetimibe alone is
effective in treating atherosclerosis but is not effective in lowering c-reactive
protein levels or in treating vascular inflammation,” but it is “[o]nly when
ezetimibe is used in combination with a cholesterol biosynthesis inhibitor
will an effective treatment of vascular inflammation occur.” (Id. at 18.)
Thus, Appellant asserts, the Examiner has not established that Rosenblum
anticipates the rejected claims.
All of Appellant’s arguments have been considered, but are not
deemed to be persuasive. First, “vascular inflammation” covers a wide
range of conditions. As defined by the Specification, “inflammation” refers
to “injury or the bodily response to an injury” (FF5), and “vascular
inflammation” as “arterial damage and bodily responses thereto that can lead
to atherosclerosis or coronary heart disease” (FF6). Thus, as defined by the
Specification, vascular inflammation is a component of atherosclerosis.
Erren provides further evidence that vascular inflammation is a component
of atherosclerosis by teaching that “[p]lasma concentration of markers of
inflammation are increased in patients with atherosclerosis” (FF10), and that
that “evidence has been accumulating that inflammation plays an important
role in both the initiation and progression of the carotid, and peripheral
arteries” (FF11). Thus, as found by the Examiner, one who is treating
atherosclerosis by administering ezetimibe and simvastatin, compounds
which meet the limitations of claim 1, is inherently treating vascular
inflammation.
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The Jansen and Rapport cases do not convince us otherwise. Jansen
was an infringement case, with claims drawn “to methods of ‘treating or
preventing macrocytic-megaloblastic anemia’ by administering a
combination of folic acid and vitamin B12 ‘to a human in need thereof.’”
Jansen, 342 F.3d at 1330. The court looked at the prosecution history, and
noted that the patent was allowed after a submission of finding unexpected
results—that is, the applicants had demonstrated that “the medical
community had come to realize the effectiveness of folic acid-vitamin B12
combination therapy to treat pernicious anemia only after Jansen’s invention
date.” Jansen, 342 F.3d at 1331. The court therefore found that the claims
were not infringed unless the combination of folic acid and vitamin B12 were
administered with specific intent to treat macrocytic-megaloblastic anemia.
Jansen is thus distinguishable because it is an infringement case, where the
claims were narrowly construed against the patentee in view of the
prosecution history so as to sustain its validity. See Whittaker Corp. by
Technibilt Div. v. UNR Indus., Inc., 911 F.2d 709, 712 (Fed. Cir. 1990).
Rapoport, an interference case, involved the issue of whether a
reference that taught treatment of anxiety in patients suffering from sleep
apnea with buspirone anticipated a claim drawn to treatment of sleep apnea
per se. Rapoport, 254 F.3d at 1060. Specifically, the court noted that the
prior art did not disclose the administration of buspirone for treating sleep
apnea, but only for anxiety, in patients suffering from sleep apnea. Id. at
1061. Thus, Rapoport is also not controlling as the prior art in that case
taught treatment of anxiety, and not sleep apnea. There was no evidence of
record demonstrating that anxiety is a component of sleep apnea, or that
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treatment of anxiety inherently treated sleep apnea. As discussed above, the
evidence in the instant record demonstrates that vascular inflammation is a
component of atherosclerosis, and thus treatment of atherosclerosis would
inherently treat vascular inflammation.
We find that the facts in this case are more similar to the facts in
Perricone. At issue in that case was a claim drawn to
[a] method for the treatment of skin damaged or aged by
oxygen-containing free radicals or oxidative generation of
biologically active metabolites which comprises topically
applying to affected skin areas a composition containing an
effective amount of an ascorbyl fatty acid ester in a
dermatologically acceptable, fat-penetrating carrier such that
the ester is percutaneously delivered to lipid-rich layers of the
skin.

432 F.3d at 1373. The prior art taught a cosmetic composition for topical
application that included ascorbyl palmitate, among many other ingredients.
Id. at 1376.
The Federal Circuit found that the prior art anticipated the above
referenced claim, along with other claims to particular skin benefits achieved
by applying the composition to the skin. Id. at 1378-79. Specifically, the
court found that all skin is subject to damage or aging by oxygen-containing
free radicals or oxidative generation of biologically active metabolites, thus
applying the composition to the skin would have inherently had treated skin
damage or aging. Id. at 1379-80.
Moreover, as set forth in Perricone, the ordinary artisan need not
recognize the inherent characteristics or functioning of the prior art. As
discussed above, vascular inflammation is a component of atherosclerosis.
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Thus the benefit stated in the preamble of the claims, treating vascular
inflammation, would flow from the recited method of administering
ezetimibe and simvastatin, see, e.g., Perricone, 432 F.3d at 1378, and thus
Rosenblum inherently anticipates the subject matter of claim 1.
We have also considered the Sager reference cited by Appellant.
Sager did note that ezetimibe monotherapy did not result in a statistically
significant reduction in hs-CRP (FF16). Sager, however, did not conclude
that vascular inflammation was not a component of atherosclerosis, but
stated that a “significant effect on hs-CRP may not have been observed in
the ezetimibe monotherapy group because of the small sample size (n=54) or
a threshold effect on lipid profile modification.” (FF18.) Thus, Sager does
not support Appellant’s assertion that vascular inflammation and
atherosclerosis are very distinct disorders with different physiological
conditions and diagnosis.

CONCLUSION OF LAW
We find that the Appellant has not demonstrated that the Examiner
erred in finding that Rosenblum as evidenced by Erren anticipates all of the
limitations of claim 1. We thus affirm the rejection of claim 1 under 35
U.S.C. § 102(b) as being anticipated by Rosenblum as evidenced by Erren.
As Appellant did not argue the claims separately, we also affirm the
rejection as to claims 2, 3, 10, 12, 13, 19, 20, and 30-35.
As to the rejections of claims 1-3, 10, 12, 13, 17, 19, 20, and 30-36
under 35 U.S.C. § 103(a) as being obvious over the combination of
Rosenblum and Erren or Yeun, and claims 1-3, 10, 12, 13, 17, 19, 20, and
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30-36 under 35 U.S.C. § 103(a) as being obvious over the combination of
Rosenblum and Erren or Yeun as further combined with Gruberg, as we
have found that claims 1 and 32 are anticipated by Rosenblum as evidenced
by Erren, and as anticipation is the epitome of obviousness, In re McDaniel,
293 F.3d 1379, 1385 (Fed. Cir. 2002), we affirm these rejections as well.

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).

AFFIRMED

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