Ex Parte Kosoglou et al

Board of Patent Appeals and Interferences

Jun 24, 2009

10057339 (B.P.A.I. Jun. 24, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/057,339 01/25/2002 Teddy Kosoglou CV01490K 1512
24265 7590 06/25/2009
SCHERING-PLOUGH CORPORATION
PATENT DEPARTMENT (K-6-1, 1990)
2000 GALLOPING HILL ROAD
KENILWORTH, NJ 07033-0530
EXAMINER
KANTAMNENI, SHOBHA
ART UNIT PAPER NUMBER
1617
MAIL DATE DELIVERY MODE
06/25/2009 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte TEDDY KOSOGLOU, RUDYARD J. RESS, JOHN T. STRONY,
ENRICO P. VELTRI, and WILLIAM HAUER
__________

Appeal 2009-0026551
Application 10/057,339
Technology Center 1600
__________

Decided:2 June 24, 2009
__________

Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
MELANIE L. MCCOLLUM, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

1 Schering Corporation is the real party in interest.
2 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

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DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
composition that contains at least one sterol inhibitor and at least one
cardiovascular agent. The Examiner has rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Claims 1, 3, 22, 23, 33, 34, 43-46, and 49 stand finally rejected and
are on appeal (App. Br. 1). Claim 1 is representative and reads as follows:
1. A composition comprising:
(a) at least one sterol absorption inhibitor represented
by Formula (I):

or isomers thereof, or pharmaceutically acceptable salts or
solvates of the compounds of Formula (I) or of the isomers
thereof, wherein:
Ar1 and Ar2 are independently selected from the group
consisting of aryl and R4-substituted aryl;
Ar3 is aryl or R5-substituted aryl;
X, Y and Z are independently selected from the group
consisting of -CH2-, -CH(lower alkyl)- and -C(dilower alkyl)-;
R and R2 are independently selected from the group
consisting of -OR6, -O(CO)R6, -O(CO)OR9 and -O(CO)NR6R7;
R1 and R3 are independently selected from the group
consisting of hydrogen, lower alkyl and aryl;
q is 0 or 1;
r is 0 or 1;
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m, n and p are independently selected from 0, 1, 2, 3 or 4;
provided that at least one of q and r is 1, and the sum of m, n, p,
q and r is 1, 2, 3, 4, 5 or 6; and provided that when p is 0 and r
is 1, the sum of m, q and n is 1, 2, 3, 4 or 5;
R4 is 1-5 substituents independently selected from the
group consisting of lower alkyl, -OR6, -O(CO)R6, -O(CO)OR9,
-O(CH2)1-5OR6, -O(CO)NR6R7, -NR6R7, -NR6(CO)R7, -
NR6(CO)OR9, -NR6(CO)NR7R8, -NR6SO2R9, -COOR6, -
CONR6R7, -COR6, -SO2NR6R7, S(O)0-2R9,
-O(CH2)1-10-COOR6, -O(CH2)1-10CONR6R7, -(lower
alkylene)COOR6, -CH=CH-COOR6, -CF3, -CN, -NO2 and
halogen;
R5 is 1-5 substituents independently selected from the
group consisting of
-OR6, -O(CO)R6, -O(CO)OR9, -O(CH2)1-5OR6, -O(CO)NR6R7, -
NR6R7, -NR6(CO)R7, -NR6(CO)OR9, -NR6(CO)NR7R8,
-NR6SO2R9, -COOR6, -CONR6R7, -COR6, -SO2NR6R7, S(O)0-
2R9, -O(CH2)1-10-COOR6 , -O(CH2)1-10CONR6R7,
-(lower alkylene)COOR6 and -CH=CH-COOR6;
R6, R7 and R8 are independently selected from the group
consisting of hydrogen, lower alkyl, aryl and aryl-substituted
lower alkyl; and
R9 is lower alkyl, aryl or aryl-substituted lower alkyl; and
(b) at least one cardiovascular agent for treating vascular
conditions selected from the group consisting of channel
blockers, adrenergic blockers, adrenergic stimulants,
angiotensin-converting enzyme (ACE) inhibitors,
antihypertensive agents, angiotensin II receptor antagonists,
anti-anginal agents, coronary vasodilators, diuretics and
combinations thereof.

The Examiner cites the following documents as evidence of
unpatentability:
Rosenblum US 5,846,966 Dec. 8, 1998

Aram V. Chobanian et al., Antiatherogenic Effect of Captopril in the
Watanabe Heritable Hyperlipidemic Rabbit, 15 HYPERTENSION 327-331
(March 1990).
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Grit Schaarmann et al., Influence of Soluble Dietary Fibre on the
Faecal Excretion of Tocopherol and Blood Lipids in Women, 19 NUTRITION
RESEARCH 689-695 (1999)

A. L. Myasnikov, The Effect of Some Vitamins on Cholesterol Level
and the Development of Experimental Atherosclerosis, 28 KLIN. MED.
U.S.S.R. 3-10 (1950) (abstract only).

Istvan Lelek et al., The Effect of Essential Fatty Acids on the Plasma
Lipoprotein Fractions in Experimentally Induced Atherosclerosis, 49
ORVOSI HETILAP 1735-1738 (1960) (abstract only).

The following rejections are before us for review:
Claims 1, 3, 22, 23, 33, 34, and 49 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Rosenblum and Chobanian (Ans. 3-5).3
Claims 43-46 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Rosenblum, Chobanian, Lelek, Myasnikov, and
Schaarmann (Ans. 5-7).
OBVIOUSNESS -- ROSENBLUM AND CHOBANIAN
ISSUE
The Examiner cites Rosenblum as disclosing the “claimed compounds
of Formula (I), such as ezetimibe compound as old and well known in
combination with another therapeutic cardiovascular agent such as [a]
cholesterol biosynthesis inhibitor” (Ans. 4). According to the Examiner, the
compounds of Appellants’ formula (I) are “taught as useful for reducing
cholesterol and for treating vascular condition such as arteriosclerosis” (id.).
The Examiner notes that “Rosenblum further teaches that the risk factors

3 Examiner’s Answer mailed March 1, 2006.
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associated for atherosclerotic coronary heart disease, include hypertension,
serum cholesterol etc.” (id.).
The Examiner cites Chobanian as teaching “the claimed
cardiovascular agent, captopril as old and well known in combination with
various pharmaceutical carriers and excipients, in a dosage form (see
abstract). This medicament is taught as useful for treating hypertension, and
arteriosclerosis, at those levels herein envisioned” (id.).
The Examiner notes that
It is generally considered prima facie obvious to combine
two, or more, compounds each of which is taught by the prior
art to be useful for the same purpose, in order to form a
composition which is to be used for the very same purpose. The
idea for combining them flows logically from their having been
used individually in the prior art.

(Id. at 5.) Thus, the Examiner concludes, “[a]s shown by the recited
teachings, the instant claims define nothing more than the concomitant use
of conventional anti-arteriosclerosis agents. It would follow that the recited
claims define prima facie obvious subject matter” (id.).
Appellants contend that the Examiner failed to make a prima facie
case of obviousness because “the desirability of combining the two agents
claimed . . . is nowhere shown in the prior art” (App. Br. 9). Appellants urge
that “[t]he mere fact that the prior art could be modified does not make the
modification obvious unless the prior art suggests the desirability of the
modification” (id.).
Appellants argue that, rather than combining compounds of
Appellants’ formula (I) with the claimed antihypertensive agents,
Rosenblum only discloses combining its compounds with “a cholesterol
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biosynthesis inhibitor, specifically a HMG CoA reductase inhibitor” (id. at
10). With respect to Chobanian, Appellants argue that the data supporting
captopril’s use in treating atherosclerosis is equivocal, and that therefore
“the use of captopril alone for treating atherosclerosis in humans is not even
strongly suggested in the Chobanian et al. study; further study of the drug is
recommended” (id.).
Moreover, Appellants urge, even if an ordinary artisan accepted
Chobanian’s disclosure as suggesting use of captopril for treatment of
atherosclerosis, “which Applicants do not concede, it can also be said to
teach away from the concept of use of two separate compounds (a
compound of formula (I) and a separate cardiovascular agent as claimed)
because captopril would serve both functions as an antihypertensive and a
treatment for atherosclerosis” (id.).
Appellants further contend that “it is never obvious to combine two
drugs into one dosage form” (id.). Rather, Appellants argue, “[s]afety and
efficacy studies of the combined compounds must always be undertaken.
There is no way of knowing, prior to such testing, that the compounds, when
administered in combination, will have the same profile as the compounds
administered separately” (id.).
Thus, Appellants contend, combining Rosenblum and Chobanian as
posited by the Examiner “renders the present claims at best ‘obvious to try’,
which is not the standard for patentability” and applies improper hindsight
reasoning (id. at 11). Appellants conclude that an ordinary artisan would
therefore “not be motivated by the teachings of Rosenblum et al. and
Chobanian et al., . . . to provide a compound of formula (I) and a separate
cardiovascular agent as presently claimed” (id.).
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Appellants do not argue any of the claims subject to this ground of
rejection separately. We select claim 1 as representative of the rejected
claims. See 37 C.F.R. § 41.37(c)(1)(vii).
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether the Examiner erred in
concluding claim 1 would have been obvious to an ordinary artisan where
Rosenblum advised the artisan that compounds encompassed by formula (I)
of claim 1 were useful for reducing cholesterol and for treating vascular
conditions such as arteriosclerosis, where Rosenblum also advised that those
compounds were suitably combined with other agents useful in treating
vascular disorders, where Rosenblum further advised that risk factors for
atherosclerotic coronary heart disease include hypertension and serum
cholesterol, and where Chobanian advised the artisan that the ACE inhibitor
captopril was useful for treating hypertension, and potentially useful for
treating arteriosclerosis.
FINDINGS OF FACT (“FF”)
1. Claim 1 recites a composition that has two ingredients, (a) a
compound of formula (I), and (b) at least one cardiovascular agent for
treating vascular conditions. Claim 1 states that the cardiovascular agent can
be an angiotensin-converting enzyme (ACE) inhibitor or an antihypertensive
agent.
2. Rosenblum discloses that “[a]therosclerotic coronary heart disease
(CHD) represents the major cause for death and cardiovascular morbidity in
the western world. Risk factors for atherosclerotic coronary heart disease
include hypertension, diabetes mellitus, family history, male gender,
cigarette smoke and serum cholesterol” (Rosenblum, col. 1, ll. 26-30).
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3. Rosenblum discloses “a method of lowering the serum cholesterol
level in a mammal in need of such treatment comprising administering an
effective amount of a compound of formula I. That is, the use of a
compound of the present invention as an hypocholesterolemic agent is also
claimed” (Rosenblum, col. 3, ll. 44-49).
4. Appellants do not dispute that the compounds of Rosenblum’s
formula I are encompassed by formula (I) recited in appealed claim 1.
5. Rosenblum also discloses “a method of reducing plasma cholesterol
levels, and to a method of treating or preventing atherosclerosis, comprising
administering to a mammal in need of such treatment an effective amount of
a combination of a hydroxy-substituted azetidinone cholesterol absorption
inhibitor of formula I and a cholesterol biosynthesis inhibitor” (Rosenblum,
col. 3, ll. 54-60).
6. Thus, Rosenblum’s invention also “relates to a pharmaceutical
composition comprising an effective amount of a hydroxy-substituted
azetidinone cholesterol absorption inhibitor of formula I, a cholesterol
biosynthesis inhibitor, and a pharmaceutically acceptable carrier”
(Rosenblum, col. 4, ll. 1-5).
7. Rosenblum discloses:
Cholesterol biosynthesis inhibitors for use in the
combination of the present invention include HMG CoA
reductase inhibitors such as lovastatin, pravastatin, fluvastatin,
simvastatin, and Cl-981; HMG CoA synthetase inhibitors, for
example L-659,699 ((E,E)-11-[3'R-(hydroxy-methyl)-4'-oxo-
2'R-oxetanyl]-3,5,7R-trimethyl-2,4-undecadienoic acid);
squalene synthesis inhibitors, for example squalestatin 1; and
squalene epoxidase inhibitors, for example, NB-598 ((E)-N-
ethyl-N-(6,6-dimethyl-2-hepten-4-ynyl)-3-[(3,3'-bithiophen-5-
yl)methoxy]benzene-methanamine hydrochloride) and other
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cholesterol biosynthesis inhibitors such as DMP-565. Preferred
HMG CoA reductase inhibitors are lovastatin, pravastatin and
simvastatin.

(Rosenblum, col. 6, ll. 37-39.)
8. Chobanian discloses that the “effects of 9 months of orally
administered captopril (25-50 mg/kg body wt/day) on aortic atherosclerosis
was examined in normotensive Watanabe heritable hyperlipidemic rabbits.
Captopril caused a significant decrease in aortic atherosclerosis” (Chobanian
327 (abstract)).
9. Chobanian discloses that “[t]hese studies indicate that captopril has a
potent antiatherosclerotic action in the Watanabe heritable hyperlipidemic
rabbit” (Chobanian 327 (abstract)).
10. Chobanian states that “[t]he clinical significance of these findings is
unknown” (Chobanian 331). However, Chobanian states, given the
“widespread use of captopril and other ACE inhibitors in the treatment of
hypertension, further studies need to be performed to determine the
mechanism far the antiatherosclerotic effect of captopril in the WHHL rabbit
and to examine the influence of the drug on the course of arterial disease in
humans” (id.).
PRINCIPLES OF LAW
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme
Court reaffirmed that “when a patent ‘simply arranges old elements with
each performing the same function it had been known to perform’ and yields
no more than one would expect from such an arrangement, the combination
is obvious.” Id. at 417 (quoting Sakraida v. AG Pro, Inc., 425 U.S. 273
(1976)).
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Thus, “when the question is whether a patent claiming the
combination of elements of prior art is obvious” the relevant inquiry is
“whether the improvement is more than the predictable use of prior art
elements according to their established functions.” Id. The Court reasoned
that:
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that it was obvious under § 103.

Id. at 421.
As our reviewing court has stated, “[o]bviousness does not require
absolute predictability of success. . . . For obviousness under § 103, all that
is required is a reasonable expectation of success.” In re O’Farrell, 853
F.2d 894, 903-04 (Fed. Cir. 1988).
[T]o have a reasonable expectation of success, one must be
motivated to do more than merely to “vary all parameters or try
each of numerous possible choices until one possibly arrived at
a successful result, where the prior art gave either no indication
of which parameters were critical or no direction as to which of
many possible choices is likely to be successful.” Similarly,
prior art fails to provide the requisite “reasonable expectation”
of success where it teaches merely to pursue a “general
approach that seemed to be a promising field of
experimentation, where the prior art gave only general guidance
as to the particular form of the claimed invention or how to
achieve it.”
Medichem S.A. v. Rolabo S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006)
(quoting O’Farrell, 853 F.2d at 903-04).
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As to motivation, while the Supreme Court held that some rationale
must be supplied for a conclusion of obviousness, the Court explicitly
rejected a “rigid approach” to the obviousness question, and instead
emphasized that “[t]hroughout this Court’s engagement with the question of
obviousness, our cases have set forth an expansive and flexible approach . . .
.” KSR, 550 U.S. at 415. The Court also rejected the use of “rigid and
mandatory formulas” as being “incompatible with our precedents.” Id. at
419; see also id. at 421 (“Rigid preventative rules that deny factfinders
recourse to common sense, however, are neither necessary under our case
law nor consistent with it.”).
The Court thus reasoned that the analysis under 35 U.S.C. § 103 “need
not seek out precise teachings directed to the specific subject matter of the
challenged claim, for a court can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ.” Id. at 418; see
also id. at 421 (“A person of ordinary skill is . . . a person of ordinary
creativity, not an automaton.”).
ANALYSIS
Appellants’ arguments do not persuade us that the Examiner erred in
concluding that claim 1 would have been obvious to an ordinary artisan in
view of the teachings of Rosenblum and Chobanian.
It may be true that neither reference explicitly teaches combining its
disclosed medicament with therapeutic agents of the type disclosed in the
other reference. However, Rosenblum does, in fact, disclose that its
compounds of formula I are amenable to combination with any of a number
of different cholesterol biosynthesis inhibitors that affect different steps in
the cholesterol biosynthesis pathway (see FF 5-7). Rosenblum also discloses
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that, in addition to the high serum cholesterol treatable by compounds of
formula I, hypertension is a risk factor atherosclerotic coronary heart disease
(FF 2).
In view of these teachings, we agree with the Examiner that a person
of ordinary skill in the art, being a person of ordinary creativity and common
sense, KSR, 550 U.S. at 418, 421, would have been prompted to combine the
high cholesterol-treating compounds of Rosenblum’s formula I with
Chobanian’s widely used hypertension-treating captopril (FF 10), in order to
treat two of the risk factors of coronary heart disease. We therefore also
agree with the Examiner that a person of ordinary skill in the art would have
considered claim 1 prima facie obvious.
We are not persuaded, as Appellants argue (App. Br. 10), that a
person of ordinary skill in the art would have been dissuaded from
combining the drugs of Rosenblum and Chobanian because the drugs might
interact in a deleterious way, or that the drugs might not function together in
the same way that they do separately. While Appellants assert that “[t]here
is no way of knowing, prior to . . . testing, that the compounds, when
administered in combination, will have the same profile as the compounds
administered separately,” Appellants have provided no evidence to support
that assertion.
More importantly, Appellants have not provided any specific evidence
suggesting that a person of ordinary skill in the art would have expected the
drugs of Rosenblum and Chobanian to interact unacceptably or lack their
expected efficacy when combined. It is well settled that argument by
counsel cannot take the place of evidence. In re Cole, 326 F.2d 769, 773,
(CCPA 1964); In re Geisler, 116 F.3d 1465, 1471 (Fed. Cir. 1997).
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The evidence currently of record is contrary to Appellants’ assertions.
Specifically, by disclosing that the compounds of formula I can be combined
with a variety of different agents that act on different steps in the cholesterol
biosynthesis pathway, Rosenblum would have suggested to an ordinary
artisan that its compounds were amenable to combination with other agents
useful in treating risk factors for atherosclerotic coronary heart disease, such
as hypertension. Thus, while a person of ordinary skill may have had some
pause when combining certain therapeutic agents, Rosenblum suggests that
its drug can be suitably combined with other medicaments.
Moreover, as noted above, “[o]bviousness does not require absolute
predictability of success. . . . For obviousness under § 103, all that is
required is a reasonable expectation of success.” O’Farrell, 853 F.2d at
903-04. In the instant case, given the explicit disclosures in Rosenblum and
Chobanian that their respective drugs are suitable in treating conditions that
are risk factors for atherosclerotic coronary heart disease, a person of
ordinary skill would not have had to excessively vary parameters, try
numerous possible choices, or explore treatment options with only general
guidance, in order to combine the two references’ drugs and treat the
disease.
We are therefore not persuaded that the claimed combination of
ingredients would only have been obvious to try. Moreover, because the
Examiner’s conclusion of prima facie obviousness is based solely on the
disclosures in the prior art, we are not persuaded that the Examiner
improperly used hindsight reasoning.
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We therefore affirm the Examiner’s rejection of claim 1 as obvious
over Rosenblum and Chobanian. Claims 3, 22, 23, 33, 34, and 49 fall with
claim 1. See 37 C.F.R. § 41.37(c)(1)(vii).
OBVIOUSNESS -- ROSENBLUM, CHOBANIAN, LELEK,
MYASNIKOV, AND SCHAARMANN
ISSUE
Claims 43-46 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Rosenblum, Chobanian, Lelek, Myasnikov, and
Schaarmann (Ans. 5-7).
Claims 43-46 read as follows:
43. The composition according to claim 1, further comprising at
least one Omega 3 fatty acid.

44. The composition according to claim 1, further comprising at
least one natural water soluble fiber.

45. The composition according to claim 1, further comprising at
least one antioxidant or vitamin.

46. A pharmaceutical composition for the treatment or
prevention of vascular conditions, obesity, diabetes or lowering a
concentration of a sterol in plasma of a mammal, comprising a
therapeutically effective amount of the composition of claim 1 and a
pharmaceutically acceptable carrier.

The Examiner cites Lelek as teaching linolenic acid (an omega-3 fatty
acid), Schaarmann as teaching soluble fiber, and Myasnikov as teaching
vitamin C, as being “useful for reducing cholesterol and treating
arteriosclerosis” (Ans. 5-6). The Examiner concludes that, “[a]s shown by
the recited teachings, the instant claims define nothing more than the
concomitant use of conventional anti-arteriosclerosis agents. It would
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follow that the recited claims define prima facie obvious subject matter” (id.
at 6).
Appellants again contend that a person of ordinary skill in the art
would have lacked motivation to combine Rosenblum and Chobanian (App.
Br. 14-15). Moreover, Appellants urge, Schaarmann’s disclosure is only
tenuously relevant to treating atherosclerosis, and Lelek and Myasnikov do
not suggest combining their disclosed compounds with other therapeutic
agents, “nor the combination of compounds specifically claimed in Claim 1”
(id. at 16).
Appellants contend that following “the reasoning presented in the
Office Action, one skilled in the art would combine every compound that
may have some minor activity in treating some aspect of
hyp[er]cholesterolemia, which can encompass thousands of compounds.
Yet no guidance is provided as to the selection of particular combinations of
classes of compound” (id.).
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether the Examiner erred in
concluding that claims 43-46 would have been obvious to an ordinary artisan
where, as discussed above, Rosenblum and Chobanian would have rendered
compositions including compounds of formula (I) and captopril prima facie
obvious due to their capacity to treat risk factors for atherosclerotic coronary
art disease, and where Lelek, Schaarmann, Myasnikov, respectively, further
teach omega-3 fatty acids, soluble fiber, and vitamin C, as being useful for
reducing cholesterol and treating arteriosclerosis.

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FINDINGS OF FACT
11. Lelek discloses a study in which Leghorn roosters rendered
atherosclerotic by administration of cholesterol were co-administered
Linacidin, a product containing equal amounts of linoleic and linolenic acids
(Lelek, abstract).
12. Lelek states that atherosclerosis was prevented when Linacidin was
administered together with the cholesterol. Pyridoxine increased Linacidin’s
therapeutic effect (Lelek, abstract).
13. Schaarmann discloses that a “human experiment with 9 women was
carried out to measure the interrelationship between the intake of soluble
dietary fibre and the faecal excretion of tocopherol. The volunteers
consumed additionally 40 g oats bran per day after a control period without
bran supplement” (Schaarmann 689).
14. Schaarmann discloses that “the apparent absorption of tocopherol
increased by 6 %. The concentration of the total cholesterol did not change,
however, the ratio of HDL- to LDL-cholesterol was positively influenced”
(Schaarmann 689). Specifically, “the ratio of LDL-/HDL-cholesterol was
significantly improved by about 1.0 units (from 3.3 to 2.3 p<0.05)” (id. at
694).
15. Myasnikov discloses a study on the influence of vitamins on elevated
cholesterol and experimentally induced atherosclerosis (Myasnikov,
abstract).
16. Myasnikov found that continued use of vitamin C by patients with
hypertension and atherosclerosis lowered their elevated cholesterol levels,
and that vitamin C reduced blood cholesterol in rabbits having
experimentally induced atherosclerosis (Myasnikov, abstract).
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ANALYSIS
Appellants’ arguments do not persuade us that the Examiner erred in
concluding that claims 43-46 would have been obvious to an ordinary artisan
in view of the cited references’ teachings. While it is true that Schaarmann’s
study focuses on the effect of soluble fiber on tocopherol absorption,
Schaarmann also discloses that fiber had a significant positive effect on the
patients’ HDL/LDL balance (FF 14). Similarly, both Lelek and Myasnikov
disclose that linolenic acid and vitamin C have positive effects on
atherosclerosis and elevated cholesterol, respectively (FF 12, 16).
Given these teachings that the disclosed agents exerted positive
effects on factors involved in atherosclerotic coronary heart disease, we
agree with the Examiner that a person of ordinary skill in the art would have
been prompted to include each of the agents in a composition containing
Rosenblum’s compound and Chobanian’s captopril. We therefore also agree
with the Examiner that a person of ordinary skill in the art would have
considered claims 43-45 obvious in view of the cited references. Moreover,
in view of Rosenblum’s disclosure of the suitability of pharmaceutical
carriers in such compositions (FF 6), we also agree with the Examiner that
claim 46 would have been prima facie obvious.
We do not agree with Appellants that the issue is whether a person of
ordinary skill in the art to would have combined every possible
anti-atherosclerotic active agent into a single composition. Rather, the issue
is whether a person of ordinary skill in the art would have considered it
obvious to combine any one of the three ingredients recited in claims 43-45
into an anti-atherosclerotic composition that also contained a compound
disclosed by Rosenblum and captopril.
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As discussed above, because each of the ingredients is disclosed in the
art as having a beneficial effect on a factor affecting atherosclerotic coronary
heart disease, we agree with the Examiner that a person of ordinary skill in
the art would have been prompted to combine any one of the three agents
recited in claims 43-45 into a composition that also contained a compound
disclosed by Rosenblum and captopril so as to treat or prevent the disorder.
Appellants do not point to any evidence suggesting that the agents function
in an unexpected manner. We therefore affirm the Examiner’s rejection of
claims 43-45, as well as claim 46.
SUMMARY
We affirm the Examiner’s rejection of claims 1, 3, 22, 23, 33, 34, and
49 under 35 U.S.C. § 103(a) as being unpatentable over Rosenblum and
Chobanian.
We also affirm the Examiner’s rejection of claims 43-46 under 35
U.S.C. § 103(a) as being unpatentable over Rosenblum, Chobanian, Lelek,
Myasnikov, and Schaarmann.
TIME PERIOD
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

lp

Appeal 2009-002655
Application 10/057,339

19

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