Ex Parte Wald et al

Patent Trial and Appeal Board

Dec 11, 2018

13799682 (P.T.A.B. Dec. 11, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/799,682 03/13/2013
23377 7590 12/13/2018
BAKER & HOSTETLER LLP
CIRA CENTRE 12TH FLOOR
2929 ARCH STREET
PHILADELPHIA, PA 19104-2891
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Nicholas J. Wald
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
106262. 000003 1054
EXAMINER
SOROUSH, LAYLA
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
12/13/2018 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
eofficemonitor@bakerlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NICHOLAS J. WALD and MALCOLM R. LA W 1
Appeal2017-001041
Application 13/799,682
Technology Center 1600
Before TONI R. SCHEINER, DEMETRA J. MILLS, and JOHN G. NEW,
Administrative Patent Judges.
SCHEINER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the final rejection of
claims directed to a pharmaceutical formulation. The claims have been
rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
We reverse.
1 Appellants identify the Real Parties in Interest as Nicholas J. Wald and
Malcolm R. Law. Appeal Br. 1.
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Application 13/799,682
BACKGROUND
According to the Specification, current clinical practice concerning
drug treatment for reducing the incidence of cardiovascular disease in the
general population is inefficient. Spec. ,r,r 5, 8.
Under current clinical practice ... , individuals found to
have high values of the risk factors of cardiovascular disease
are treated to reduce the risk factors ( e.g. blood pressure or lipid
level) to the so-called normal value, but no lower, by the
application of one of many active principals known in the art.
These high values may come to light as a result of routine
health screening ... [or] a cardiovascular insult such as a heart
attack or stroke .. .
However,
The present inventors have demonstrated ... reducing the level
of a risk factor below the accepted normal value gives rise to a
concomitant reduction in the risk of cardiovascular disease ....
Even within the population "normal" range, further reduction of
the risk factor continues to provide further reduction in the risk
of cardiovascular disease .... [T]he present inventors have
shown that there is no effective lower threshold of the risk of
cardiovascular disease in relation to the level of a particular risk
factor in economically developed populations, below which
there is no further reduction in risk for further reductions in the
risk factor.
Id. ,I 13.
[T]hus ... there are considerable advantages in reducing the
level of risk factors such as blood pressure, serum lipid levels,
platelet function levels and serum homocysteine levels below
the normal levels exhibited in a given population, even where
none of these levels exceeds the normal level in an individual.
Id. ,I 15.
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"The basis of the present invention is therefore that individuals should
be treated irrespective of whether they exhibit particularly high values of any
of the risk factors associated with cardiovascular disease or have a clinical
history of cardiovascular disease, and that all risk factors should be
changed." Id. ,r 17.
According to the Specification, "[t]he physiological effects of blood
pressure lowering agents, lipid-regulating agents, platelet function altering
agents and serum homocysteine lowering agents in reducing the risk of
cardiovascular disease have been found to be independent of each other."
Id. ,r 31. The Specification thus discloses formulations for prevention of
cardiovascular disease comprising at least two blood pressure lowering
agents, each selected from a different physiological mode of action (e.g.,
diuretics, beta blockers, angiotensin converting enzyme (ACE) inhibitors,
angiotensin II receptor antagonists, and calcium channel blockers), and
drugs from at least two of the following categories: lipid-regulating agents,
platelet function altering agents, and serum homocysteine lowering agents.
Spec. ,r,r 26-29.
Further according to the Specification, however, at conventional
"preferred dosages of these drugs, the prevalence of the ratio of benefit to
hazard, i.e., the ratio of the reduction in the incidence of cardiovascular
disease to the prevalence of adverse effects of the drugs, is high." Id. at
,r 31. Accordingly, the Specification discloses formulations comprising
dosage levels below "the commonly used dose in clinical practice for the
treatment of high levels of the risk factor or for the treatment of
cardiovascular disease by the separate active principal." Id. ,r 39. For
instance, "[ f]or drugs used to lower blood pressure, the dose of an active
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principal is below the lower therapeutic dosage[2J for the indication of the
active principal." Id. ,r 39.
STATEMENT OF THE CASE
Claims 41, 42, 44--46, 51, 52, and 54--56 are on appeal; claims 1--40,
43, 47-50, and 53 have been canceled. Claims 41, 42, and 44 are
representative and read as follows:
41. A formulation comprising:
(a) at least two drugs from the category of blood pressure
lowering agents, each selected from a different physiological
mode of action selected from a diuretic, a beta blocker, an
angiotensin converting enzyme (ACE) inhibitor, an angiotensin
II receptor antagonist, and a calcium channel blocker; and
(b) drugs from at least two of the following three
categories:
i) at least one lipid-regulating agent,
ii) at least one platelet function altering agent, and
iii) at least one serum homocysteine lowering agent;
wherein said formulation reduces the risk of
cardiovascular disease.
42. A formulation according to claim 41, wherein the
dose of each blood pressure lowering agent is below a
recommended lower therapeutic dosage for the blood pressure
lowering agent.
44. A formulation comprising:
(a) at least two drugs from the category of blood pressure
lowering agents independently selected from a diuretic, a beta
blocker, an angiotensin converting enzyme (ACE) inhibitor, an
2 According to the Specification, "the term 'therapeutic dosage' is intended
to refer to the commonly used dose in clinical practice for the treatment of
high levels of the risk factor or for the treatment of cardiovascular disease by
the separate active principal." Spec. ,r 39.
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angiotensin II receptor antagonist, and a calcium channel
blocker;
(b) at least one lipid-regulating agent, and
( c) optionally, drugs from at least one of the following
two categories:
i) at least one platelet function altering agent, and
ii) at least one serum homocysteine lowering agent,
wherein the dose of the blood pressure lowering agent is
below a recommended lower therapeutic dosage for the blood
pressure lowering agent, and wherein said formulation reduces
the risk of cardiovascular disease.
In rejecting the claims, the Examiner relies on the following evidence:
Baldwin et al. us 4,677,102 June 30, 1987
Joshi et al. us 4,808,413 Feb.28, 1989
Nelson et al. us 5,663,186 Sept. 2, 1997
Defelice us 5,962,020 Oct. 5, 1999
Tobert US 6,673,831 Bl Jan. 6, 2004
Appellants rely, in relevant part, on the following additional evidence:
Lawrence Green et al., Combination Pharmacotherapy for
Cardiovascular Disease, 143 ANNALS OF INTERNAL MEDICINE
593---600 (2005) ("Annals of Int. Med.").
Letter of Dr. Roderick J. Flower, dated May 12, 2000
(Evidence Appendix at A31 in parent application 10/257 ,429).
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I
II
III
IV
The claims stand rejected under 35 U.S.C. § 103(a) as follows 3:
CLAIMS
41, 42, 44, 51,
52, and 544
45,46,55,and
56
41, 42, 44, 51,
52, and 54
45,46,55,and
56
REFERENCES
Baldwin and Tobert
Baldwin, Joshi, and Tobert
Baldwin, Nelson, and
Defelice
Baldwin, Joshi, Nelson, and
Defelice
THE PRIOR ART
Baldwin
PAGES
Ans. 3-5
Ans. 6-8
Ans. 9-11
Ans. 11-14
Baldwin discloses substituted diazapine compounds "useful in the
treatment of cardiovascular disorders." Baldwin, 4: 18-19. According to
Baldwin:
[These compounds] have broad pharmacological utility in that
they exhibit (i) pronounced and long-lasting vasodilating effect
accompanied by an energy-sparing effect on cardiac
metabolism; (ii) antiarrythmic and antianginal action on cardiac
muscle; (iii) vascular spasmolytic action; (iv) antihypertensive
action; (v) spasmolytic action on the smooth muscle of the
gastrointestinal and urogenital tracts and the cerebrovascular
and respiratory system; (vi) useful antihypercholesterolemic
and antilipidemic action; (vii) protection of the ischemic
3 In the Answer, the Examiner maintained a rejection of claims 41, 42, 44--
46, 51, 52, and 54--56 under the doctrine of obviousness-type double
patenting (Ans. 14--16), but this rejection was resolved by terminal
disclaimer on October 19, 2015, prior to entry of the Examiner's Answer on
August 24, 2016.
4 The Examiner's statement of this rejection includes claim 47, but claim 47
has been canceled.
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myocardium; ( viii) inhibition of irritable bowel syndrome and
esophageal spasm; and, (ix) inhibition of migraine.
Id. at 4:20-31.
Further according to Baldwin, the compounds can be administered "in
combination with angiotensin converting enzyme inhibitors and/or
antihypertensives and/or diuretics and/or B-blocking agents, and/or
cardiotonic agents." Id. at 5:1-5. "For example, the compounds ... can be
given in combination with such compounds as enalapril, hydralazine
hydrochloride, hydrochlorothiazide, methyldopa, timolol, digitalis and the
like, as well as admixtures and combinations thereof." Id. at 5:5-9. Finally,
Baldwin teaches that "the individual daily dosages for these combinations
can range from about one-fifth of the minimally recommended clinical
dosages to the maximum recommended levels for the entities when they are
given singly." Id. at 5:10-14.
Tobert
Tobert discloses a "combination therapy comprising the
administration of a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA)
reductase inhibitor (or HMG-CoA RI) and folic acid ... for preventing,
halting or slowing the progression of atherosclerotic cardiovascular diseases
and related conditions and disease events." Tobert, 1:13-19.
Joshi
Joshi discloses:
[A] pharmaceutical composition ... which acts as a controlled
release formulation in the form of beadlets of medicament, for
example, ACE inhibitor, such as captopril, zofenopril or
fosinopril, beta-blocker, such as nadolol, propranolol or
atenolol, calcium channel blocker such as diltiazem or
nifedipine, or any of the pharmaceuticals as set out hereinafter
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or combinations thereof, capable of being filled into
pharmaceutical hard shell capsules or compressed into a tablet.
Joshi, 5:15-24.
Joshi identifies hundreds of additional pharmaceutical agents
appropriate for its formulations, including antispasmodic agents,
tranquilizers, muscle relaxants, antidepressants, hypotensive agents,
bronchodialators, antibacterial agent, antimalarial agents, antibiotics,
vitamins, etc., and combinations thereof. Id. at 8:40-9:19.
Nelson
Nelson discloses a "method of using an angiotensin II antagonist ...
for the treatment of atherosclerosis and/or reducing cholesterol, alone or in
conjunction with the treatment of hypertension" (Nelson, 1:3-7) and also
teaches "using an angiotensin II antagonist in combination with ... an
HMG-Co A reductase inhibitor and an angiotensin converting enzyme
inhibitor" (id. at 1:10-13). Suitable HMG-Co A reductase inhibitors include
lovastatin and simvastatin, and suitable angiotensin converting enzyme
inhibitors include Lisinopril and enalapril. Id., Tables 7, 8, claims 1, 2.
DeFelice
Defelice discloses a "composition and method for preventing and/or
treating microalbuminuria," where the composition includes "vitamin E,
folic acid, a magnesium-containing compound, a chromium-containing
compound and vitamin B-12." Defelice, 1:6-12. Defelice further teaches
"[i]n addition to being an independent cardiovascular risk factor,
microalbuminuria has been associated with increases in other known risk
factors such as hypertension, abnormal lipid levels, blood coagulation
disorders and possibly insulin resistance." Id. at 1 :43--47.
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DISCUSSION
We begin by construing the claim term "formulation," as it is central
to the principal issue raised by this appeal.
According to the Specification, "[a]lthough the active principals may
be administered simultaneously, separately or sequentially, preferably the
active principals are administered simultaneously in a single dosage form"
(id. ,r 37), "preferably in the form of a tablet, a capsule, a pill, a powder,
granules, a solution, or a suspension" (id. ,r 133). The claim term
"formulation" is not explicitly defined in the Specification, but the
Specification repeatedly identifies certain "critical distinctions" between the
prior art and the present invention-including distinguishing several
conventional combination therapies from the present invention as "not
specified as a single preparation formulation." Spec. ,r 20. Reading the term
in light of the Specification, we determine that the broadest reasonable
interpretation of "formulation" is a single dosage form-in other words, the
claim requires that all the active principals specified in the claim are
combined in a single dosage form. 5
Issue
The dispositive issue raised by each of Rejections I-IV, then, is
whether the Examiner has established by a preponderance of the evidence
that it would have been obvious for one of ordinary skill in the art to
5 While not needed for the purpose of deciding this appeal, we further note
that this interpretation is consistent with the U.S. Food and Drug
Administration's definition of "pharmaceutical formulation" as "the process
in which different chemical substances, including the active drug, are
combined to produce a final medicinal product."
See https://www.registrarcorn.com/fda-d1ugs/definitions/
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combine all of the specific active principals required by the claims in a
formulation, i.e., single dosage form.
Rejection I
Claims 41, 42, 44, 51, 52, and 54 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Baldwin and Tobert (Ans. 3-5).
The Examiner finds, in relevant part, that Baldwin discloses "a novel
diazapine (taught to have (vi) anti-lipidemic activity (limitation (b) of claims
41 and 44)) formulation which are advantageously used in combination with
angiotensin converting enzyme inhibitors and/or antihypertensives and/or
diuretics and/or B-blocking agents, and/or cardiotonic agents (limitation (a)
of claims 41 and 44)." Ans. 19 (citing Baldwin, 5:1-18, and claims 11, 12);
see also Ans. 6 ( citing same).
The Examiner acknowledges that Baldwin "fails to specify a second
drug from the said three categories of claim 41," but finds that Tobert
"teaches a combination therapy comprising the administration of a 3-
hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor ( or
HMG-CoA RI) and folic acid ... for preventing, halting or slowing the
progression of atherosclerotic cardiovascular diseases." Ans. 4. According
to the Examiner, folic acid "reduce[s] the plasma level ofhomocysteine."
Id. at 5.
Essentially, the Examiner relies on Baldwin as teaching that two or
more blood pressure lowering agents (category (a) of claims 41 and 44) can
be administered in combination with a lipid-regulating agent ( category (b) of
claims 41 and 44), and on Tobert as teaching that a homocysteine lowering
agent ( category (b )(iii) of claim 41; category ( c )(ii) of claim 44) can be used
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in combination with a lipid-regulating agent ( category (b) of claims 41 and
44).
The Examiner, citing In re Kerkhoven, 626 F.2d 846, 850 (CCPA
1980), concludes it would have been obvious to combine the various active
agents disclosed by Baldwin and Tobert because "[i]t is prima facie obvious
to combine two compositions each of which is taught by the prior art to be
useful for the same purpose, in order to form a third composition to be used
for the very same purpose." Ans. 5. We understand the Examiner to
consider the "same purpose" to be preventing or treating cardiovascular
disease.
Appellants acknowledge that "Baldwin mentions using diazepines in
combination with ACE inhibitors," but contend that "Baldwin does not
identify the use of more than one blood pressure lowering agent ... [or]
suggest that use of a single blood pressure lowering is somehow deficient or
ineffective." Appeal Br. 25. Appellants argue "[ w ]ithout any such
suggestion, one of skill in the art would have no motivation to select a
second blood pressure lowering agent to use together with the ACE
inhibitor." Id.
Similarly, Appellants acknowledge that "Tobert teaches statins, and
... that statins operate in a way that differs from ACE inhibitors," but
contend that
neither Baldwin nor Tobert teach ( 1) use of a statin ( or other
lipid regulating agent) with two or more other blood pressure
lowering agents specified in appellants' independent claims and
then (2) combining those blood pressure lowering agents with
still two more additional agents from the other three categories
mentioned in claims 41 and 44.
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Id. Appellants contend essentially that the Examiner "did not identify any
disclosure in any reference that suggests these selections and combinations."
Id.
Appellants further argue:
[E]ven if the Examiner had identified some broad suggestion in
the prior art to combine agents that are expected to reduce
cardiovascular disease ( a point not conceded), that mere general
suggestion would not be sufficient. For example as mentioned
above, the drug rosiglitazone lowers blood sugar, and hence
would be expected to prevent cardiovascular disease but this
drug has been shown not to do so because of its effects in
raising blood pressure and causing weight gain. Similarly, the
drug torcetrapib raises HDL cholesterol (a protective effect) but
also raises blood pressure, thus failing to reduce the overall risk
of cardiovascular disease. The choice of risk factors and the
choice of agent needed to safely modify those risk factors, as
set forth in the instant claims, was not obvious when the
application was filed in 2000.
Appeal Br. 25-26.
Moreover, Appellants contend, "[a]lthough the Examiner's quotation
of Kerkhoven is correct, her application of that decision is not" (id. at 26), at
least in part because "Kerkhoven concerned a composition which combined
two well-known detergents that shared a common mode of action" (id. at
27). Appellants argue that "combining conventional compounds that share a
predictable mode of action is entirely different from the claimed therapeutic
compositions, which compositions combine different medical agents that
have different metabolic and physiological actions." Id. at 27-28.
Finally, Appellants contend that the Examiner "did not ... at all
address appellants' objective evidence [of secondary consideration], which
failure is contrary to blackletter law on obviousness." Id. at 28 (citing W.L.
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Gore &Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 1555 (Fed. Cir.
1983)).
We agree with Appellants that the Examiner's reliance on Kerkhoven
is overly simplistic and inapposite. As discussed above, and not disputed by
the Examiner, the Specification teaches that "[t]he physiological effects of
[the claimed] blood pressure lowering agents, lipid-regulating agents,
platelet function altering agents and serum homocysteine lowering agents in
reducing the risk of cardiovascular disease have been found to be
independent of each other." Spec. ,r 31. The claims are consistent with the
Specification in requiring at least two blood pressure lowering agents with
different physiological modes of action. Nor do any of the other drugs in the
formulation use a "common mode of action," as in Kerkhoven. The drugs
specified by the claims, therefore, are not individually useful for the same
purpose-by design. Nor would they form a third composition useful for the
very same purpose-unless the "purpose" is so generalized ( e.g., preventing
cardiovascular disease) as to be essentially meaningless.
Moreover, even assuming the cited art would have given one of
ordinary skill in the art a reason to give all of the claimed drugs in
combination, the Examiner has not explained or otherwise addressed how or
why the cited references would have led one of ordinary skill in the art to
combine all of the claimed drugs into a single formulation (i.e., a single
dosage form).
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Finally, the Examiner disregards Appellants' evidence of secondary
indicia of nonobviousness, arguing that "the letter by Dr. Flower May, 6
Declaration in view of Wald and Law, Annals of Internal Medicine, and Dr.
Aronson relate to the method claims." Ans. 18. Nevertheless, merely by
way of example, we note that Dr. Flower, in his letter of May 12, 2000,
discusses the method claims in parent application 10/257 ,429 (now US
8,470,868, issued June 25, 2013), and also discusses the drug formulation
itself: "Neither, to my mind would it be obvious to the average worker in
the field to prepare this combined dosage tablet." Evidence Appendix at
A31 in parent application 10/257 ,429 ( emphasis added). Similarly,
Appellants provided an article entitled "Combination Pharmacotherapy for
Cardiovascular Disease," which discusses both the formulation of the instant
invention and the method of using it:
The strategy proposed by Wald and Law has at least 2
unique aspects: simultaneous intervention on 4 potentially
causal risk factors for CVD (lipids, blood pressure, platelet
aggregation, and homocysteine) with a single pill and
intervention in the entire population at high risk on the basis of
age, history of CVD, or diabetes.
Annals of Int. Med., 594 (emphasis added; internal citations omitted).
At a bare minimum, the Examiner should have addressed Appellants'
evidence bearing on the obviousness of the formulation itself, explaining
whether and why ( or why not) the evidence was persuasive.
We find that the Examiner's initial burden of establishing that
independent claims 41 and 44, as well as dependent claims 42, 51, and 52
6 We understand the Examiner to refer to the May 12, 2000 letter of Dr.
Roderick J. Flower (Evidence Appendix at A31 in parent application
10/257 ,429).
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would have been prima facie obvious over Baldwin and Tobert has not been
met. Accordingly, the rejection is reversed.
Rejection II
Claims 45, 46, 55, and 56 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Baldwin, Joshi, and Tobert (Ans. 6-8).
Claim 45 is directed to a formulation comprising specific dosages of
hydrochlorothiazide, atenolol, enalapril, atorvastatin, aspirin, and folic acid.
Claim 46 specifies simvastatin, rather than atorvastatin, but is otherwise the
same as claim 45. Claim 55 is directed to a formulation comprising specific
dosages ofhydrochlorothiazide, atenolol, enalapril, atorvastatin, and folic
acid. Finally, claim 56 specifies simvastatin, rather than atorvastatin, but is
otherwise the same as claim 46.
The Examiner relies on Baldwin and Tobert as discussed above, but
acknowledges that the references "fail[] to specify specifically atenolol,
atorvastatin, aspirin, [ and] folic acid." Ans. 7. The Examiner cites Joshi as
teaching "a pharmaceutical composition comprising an ACE inhibitor, for
example captopril, a beta-blocker such as nadolol, propranolol or atenolol, a
calcium channel blocker such as diltiazem of nifedipine or other
pharmaceuticals including combinations thereof," and notes that additional
agents "can include aspirin." Id. (citing Joshi, Abstract).
As in the previous rejection, the Examiner, citing In re Kerkhoven,
concludes it would have been obvious to combine the various active agents
disclosed by Baldwin, Joshi, and Tobert because "[i]t is prima facie obvious
to combine two compositions each of which is taught by the prior art to be
useful for the same purpose, in order to form a third composition to be used
for the very same purpose." Ans. 8.
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Appellants rely on the same arguments discussed above in connection
with Rejection I in addressing this rejection, and we find Appellants'
arguments persuasive for the same reasons discussed above.
We find that the Examiner's initial burden of establishing that
independent claims 45, 46, 55, and 56 would have been prima facie obvious
over Baldwin, Joshi, and Tobert has not been met. Accordingly, the
rejection is reversed.
Rejection III
Claims 41, 42, 44, 51, 52, and 54 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Baldwin, Nelson, and Defelice (Ans. 9--11).
The Examiner relies on Baldwin as discussed above. Ans. 9-10.
Similarly, the Examiner cites Nelson as teaching "a method of treatment of
atherosclerosis, reducing cholesterol and/or in conjunction with the
treatment of hypertension using a[n] angiotensin II antagonist, HMG-CoA
reductase inhibitor, [in this case] simvastatin ... and an angiotensin
converting enzyme inhibitor, enalapril." Id. at 10 (citing Nelson, Tables 7,
8, and claim 1 ). The Examiner acknowledges that "a second drug from the
said three categories of claim 41" is not taught. Id.
Thus, in this rejection, the Examiner relies on both Baldwin and
Nelson as teaching that two or more blood pressure lowering agents
( category (a) of claims 41 and 44) can be administered in combination with a
lipid-regulating agent ( category (b) of claims 41 and 44).
The Examiner relies on DeF elice as teaching a composition
comprising folic acid (i.e., category (b )(iii) of claim 41; category ( c )(ii) of
claim 44) "in the treatment of microalbuminuria" (id.), and also as teaching
that microalbuminuria is "an independent cardiovascular risk factor," and
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"has been associated with increases in other known risk factors such as
hypertension, abnormal lipid levels, blood coagulation disorders and
possibly insulin resistance" (id.).
Again, the Examiner, citing In re Kerkhoven, concludes it would have
been obvious to combine the various active agents disclosed by Baldwin,
Nelson, and Defelice because "[i]t is prima facie obvious to combine two
compositions each of which is taught by the prior art to be useful for the
same purpose, in order to form a third composition to be used for the very
same purpose." Ans. 8.
Appellants rely on the same arguments discussed above in connection
with Rejection I in addressing this rejection, and we find Appellants'
arguments persuasive for the same reasons discussed above.
We find that the Examiner's initial burden of establishing that
independent claims 41, 42, 44, 51, 52, and 54 would have been prima facie
obvious over Baldwin, Nelson, and Defelice has not been met.
Accordingly, the rejection is reversed.
Rejection IV
Claims 45, 46, 55, and 56 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Baldwin, Joshi, Nelson, and Defelice (Ans. 11-14).
The Examiner relies on Baldwin, Nelson, and Defelice as discussed
above, but acknowledges that the references "fail[] to specify specifically
atenolol, atorvastatin, aspirin, [and] folic acid." Ans. 12. The Examiner
cites Joshi as teaching "a pharmaceutical composition comprising an ACE
inhibitor, for example captopril, a beta-blocker such as nadolol, propranolol
or atenolol, a calcium channel blocker such as diltiazem of nifedipine or
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other pharmaceuticals including combinations thereof," and notes that
additional agents "can include aspirin." Id. (citing Joshi, Abstract).
Again, the Examiner, citing In re Kerkhoven, concludes it would have
been obvious to combine the various active agents disclosed by Baldwin,
Joshi, Nelson, and Defelice because "[i]t is prima facie obvious to combine
two compositions each of which is taught by the prior art to be useful for the
same purpose, in order to form a third composition to be used for the very
same purpose." Ans. 13.
Appellants rely on the same arguments discussed above in connection
with Rejection I in addressing this rejection, and we find Appellants'
arguments persuasive for the same reasons discussed above.
We find that the Examiner's initial burden of establishing that
independent claims 45, 46, 55, and 56 would have been prima facie obvious
over Baldwin, Joshi, Nelson, and Defelice has not been met. Accordingly,
the rejection is reversed.
SUMMARY
Rejections I-IV of claims 41, 42, 44--46, 51, 52, and 54--56 under
35 U.S.C. § 103(a) are reversed.
REVERSED
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