Ex Parte Grossman et al

Patent Trial and Appeal Board

Aug 22, 2013

10939737 (P.T.A.B. Aug. 22, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte TERRY GROSSMAN and RAYMOND C. KURZWEIL
____________

Appeal 2012-000326
Application 10/939,737
Technology Center 1600
____________

Before DEMETRA J. MILLS, JOHN A. EVANS, and ULRIKE W. JENKS,
Administrative Patent Judges.

JENKS, Administrative Patent Judge

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims directed to
a method of treating arthrosclerosis by administering EDTA in conjunction
with piperine or by administering an enterically coated EDTA. The Patent
Examiner has rejected the claims for lacking enablement, for indefiniteness,

1 Appellants state that the real party in interest is Ray and Terry's Health
Products, Inc. (App. Br. 2.)
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Application 10/939,737

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and for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm-in-part.

STATEMENT OF THE CASE
Claims 14-27 are on appeal, and can be found in the Claims Appendix
of the Appeal Brief (App. Br. 26-28). Claims 14-17, 21 and 24 are
representative of the claims on appeal, and read as follows:
14. A method for the treatment of atherosclerosis, the method
comprising; identifying a patient having atherosclerosis or at
risk of having atherosclerosis, and orally administering to the
patient a composition comprising EDTA or a pharmaceutically
acceptable prodrug or derivative thereof and piperine.
15. The method of claim 14, wherein the EDTA is enteric
coated.
16. The method of claim 14, further comprising
administering to the patient an additional therapeutic agent.
17. The method of claim 16, wherein the additional
therapeutic agent is an ACE inhibitor, a calcium channel
blocker, a beta-blocker, or a diuretic.
21. A method for the treatment of atherosclerosis, the method
comprising identifying a patient having atherosclerosis or at
risk for having atherosclerosis, and orally administering to the
patient a composition comprising enteric coated EDTA or a
pharmaceutically acceptable prodrug or derivative thereof.
24. The method of claim 23, wherein the additional
therapeutic agent is an ACE inhibitor, a calcium channel
blocker, a beta-blocker, or a diuretic.

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The Examiner has rejected the claims as follows:
I. claims 14-27 stand rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the enablement
requirement;
II. claims 14-27 stand rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite;
III. claims 14 and 19-20 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Mercer2 in view of Majeed;3
IV. claims 16-18 stand rejected under 35 U.S.C. 103(a) as being
unpatentable over Mercer in view of Majeed and further in view
of Hayward;4
V. claims 15, 21-22, and 26-27 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Mercer in view of Majeed,
as set forth above and further in view of Glynn;5
VI. claims 23-25 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Mercer in view of Majeed and Glynn as set
forth above and further in view of Hayward.

The Examiner made both a restriction requirement and election of
species requirement in the office action dated June 24, 2008. In response to
this requirement, Appellants elected Group II corresponding to claims 14-27,
with the additional species election requirement, Applicants elected the ACE
inhibitor. (Response to Restriction Requirement dated Sept. 23, 2008.)

2 James B. Mercer et al., US 3,838,196, issued Sept. 24, 1974.
3 Muhammed Majeed et al., US 5,536,506, issued Jul. 16, 1996.
4 Cheryl M. Hayward et al., US 2002/0169192 Al, published Nov. 14, 2002.
5 Peter Glynn et al., US 2004/0009896 Al, published Jan. 15, 2004.
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When the Examiner has required the Applicant to elect a species for
examination, the issue on appeal is the patentability of the elected species.
We thus limit discussion to that single issue and take no position respecting
the patentability of the broader generic claims, including the remaining, non-
elected species. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987).

I. The Issue: Enablement
The Examiner takes the position that the Specification is not enabled
for the administration and use of pharmaceutically acceptable prodrug or
derivatives of EDTA (Ans. 6-8). The Examiner cites Testa6 to support the
position that “in-vitro and in-vivo pharmacokinetics varies for prodrugs from
parent compound in way that goes beyond the original pharmaceutical,
pharmacokinetic or pharmacodynamic objective pursued.” (Id. at 6-7.) The
Examiner’s position is that there is unpredictability in the production of a
prodrug or derivative and there is unpredictability in the in vivo use due to
pharmacokinetic issues as disclosed in Testa (id. at 7).
The issue is: Does the evidence of record support the Examiner’s
conclusion that the claims are not enabled?

FF 1. The Specification provides that “[a] ‘pharmaceutically
acceptable derivative or prodrug’ means any pharmaceutically acceptable
salt, ester, salt of an ester, or other derivative of a compound of this

6 Bernard Testa, Prodrug research: futile or fertile? 68 BIOCHEMICAL
PHARMACOLOGY 2097-2106 (2004).
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invention, which, upon administration to a recipient, is capable of providing
(directly or indirectly) a compound of this invention.” (Spec. 8.)

Analysis
Appellants contend that the Examiner reliance on Testa is misplaced.
“Appellant describes that ‘pharmaceutically acceptable derivative or
prodrug’ means any pharmaceutically acceptable salt, ester, salt of an ester,
or other derivative of a compound of this invention [EDTA], which, upon
administration to a recipient, is capable of providing (directly or indirectly) a
compound of this invention [EDTA].” (App. Br. 9.)
We find that Appellants have the better position. The Examiner’s
rejection is predicated on the understanding that “[p]rodrugs are chemicals
with little or no pharmacological activity, undergoing biotransformation to a
therapeutically active metabolite.” (Testa 2097; Ans. 6.)
“During examination, ‘claims … are to be given their broadest
reasonable interpretation consistent with the specification, and … claim
language should be read in light of the specification as it would be
interpreted by one of ordinary skill in the art.”’ In re Am. Acad. of Sci. Tech.
Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004) (quoting In re Bond, 910 F.2d.
831, 833 (Fed. Cir. 1990)). With respect to the present claims the
Specification defines a prodrug or derivative as any acceptable salt, ester, or
salt of an ester (FF 1) of EDTA for the administration to a patient. Here, the
Specification defines the prodrug or derivate as a salt or ester of the active
compound (EDTA) and salts of EDTA are known in the art (see Mercer, col.
1, ll. 47-48; col. 4, ll. 44-50). We find that the Examiner has not adequately
explained why in light of the definition found in the Specification the
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present claims are not enabled. Accordingly, we reverse the rejection of
claims 14-27 as lacking enablement.

II. The Issue: Indefiniteness
The Examiner takes the position that the metes and bounds of the term
“prodrug” or “derivative” is not defined (Ans. 8-9).
We find that Appellants have the better position. The Specification
defines a prodrug or derivative as any acceptable salt, ester, or salt of an
ester of the active ingredient, in this case EDTA, for the administration to a
patient (FF 1). The test for definiteness under 35 U.S.C. § 112, second
paragraph, is whether “those skilled in the art would understand what is
claimed when the claim is read in light of the specification.” Orthokinetics,
Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986)
(citations omitted). However, the fact that a claim is broad does not mean
that it is indefinite, and even undue breadth is not indefiniteness. In re
Johnson, 558 F.2d 1008, 1016 n.17 (CCPA 1977).
Here, the Specification has provided a definition for the term prodrug
or derivative thereof (FF 1), even if this definition differs from the ordinary
use of the term, the definition provided in the Specification controls the
interpretation of the claims. Accordingly, we reverse the Examiner’s
rejection of claims 14-27 as being indefinite.

III. The Issue: Obviousness over Mercer and Majeed
The Examiner takes the position with respect to claims 14 and 19-20
that Mercer teaches the use of administering EDTA on an empty stomach in
order to promote permeation of “EDTA to [the] blood stream and
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permeation to body tissues in therapeutic quantity” (Ans. 9). “Majeed
teaches [that] piperine has been used and added in multi-drug formulations
and for most drugs concentration of drugs in the presence of piperine was
higher, such bioavailability enhancement of drugs helps lower drug dosage
amount and shorten treatment course.” (Id. at 10.) The Examiner concludes
that the ordinary artisan would have been motivated to “utilize piperine
along with the drug such as EDTA for higher plasma concentration of the
drug EDTA which acts as a bioavailability enhancer . . . and Majeed teaches
utilization of piperine to increase levels of drug in plasma and for longer stay
of drugs in the body.” (Id.)
The issue is: Does the preponderance of the evidence of record
support the Examiner’s conclusion of obviousness?

Findings of Fact
FF 2. Mercer disclosed that “EDTA, especially the calcium di-sodium
salt (Na2[CaEDTA]) . . . has been investigated as a treatment for the removal
of metastatic calcium deposits in various internal body tissues including the
kidneys, pancreas and blood vessels, the latter for the removal of
atherosclerotic plaques associated with occlusive vascula[r] disease.”
(Mercer, col. 1, ll. 47-55; Ans. 9.)
FF 3. Mercer disclosed that “by administering the drug orally on an
empty stomach, suitably adjusted for pH, for example, by mixing with an
edible agent such as fruit juice, citric acid, etc., movement into the blood
stream and permeation into body tissues in therapeutic quantities appears to
be reasonably assured.” (Mercer, col. 2, ll. 29-34; Ans. 9.)
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FF 4. Mercer disclosed that “[v]asodilating drugs, where indicated,
may help the absorbed EDTA reach otherwise blocked sites where the
therapy is needed. (Mercer, col. 4, ll. 58-60; Ans. 9.)
FF 5. Majeed disclosed that “[p]iperine, or mixtures containing
piperine, have been shown to increase the efficacy, blood levels, and
bioavailability of a number of drugs.” (Majeed, col. 1, ll. 61-63; Ans. 10.)
FF 6. Majeed disclosed that “[p]iperine has also been added in multi-
drug formulations for the treatment of tuberculosis and leprosy. A
formulation containing rifampicin, pyrazinamide and isoniazid has been
tested in human volunteers.” (Majeed, col. 2, ll. 7-10; Ans. 10.)
FF 7. Majeed disclosed that “all of these examples clearly illustrate
the role of piperine as a drug bioavailability enhancer. The combination of
piperine with tested drugs is effective primarily due to higher plasma
concentration and a longer stay of the drugs in the body.” (Majeed, col. 2, ll.
30-35; Ans. 10.)
FF 8. Majeed disclosed that piperine “[w]hen used in a preparation
for oral administration, the piperine is used at a daily dose of 0.04-0.08
mg/kg of body weight, or, alternatively, a dose of about 4 mg piperine per
500 mg of nutrient, biological compound, or nutritional supplement for an
average adult.” (Majeed, col. 4, ll. 31-35; Ans. 20.)

Principle of Law
The test for obviousness is what the combined teachings of the
references as a whole would have suggested to those of ordinary skill in the
art. In re Keller, 642 F.2d 413, 425 (CCPA 1981).

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Analysis
Appellants contend that “Mercer and Majeed teach away from the
claimed invention of combining EDTA and piperine. Mercer notes that
EDTA can be rendered therapeutically inactive when combined with food.”
(App. Br. 19.) Appellants contend:
a person reading Majeed would be led to believe that piperine
increases the absorption of metals, which according to Mercer
would decrease the efficacy of EDTA. Therefore, the
secondary reference would motivate the person of ordinary skill
to avoid the combination of EDTA and piperine in an oral
administration for treatment of atherosclerosis.
(App. Br. 20; see also Reply Br. 4-5.)
We are not persuaded by Appellants’ contentions. We agree with the
Examiner’s fact finding, statement of the rejection and responses to
Appellants’ arguments as set forth in the Answer. We find that the
Examiner has provided evidence to support a prima facie case of
obviousness. Specifically, we agree with the Examiner that in addition to
pointing out the problems of administering EDTA with food “Mercer also
emphasizes the importance of consuming EDTA [on an] empty stomach
orally for the same purpose as claimed that is to treat atherosclerosis.”
(Ans. 20; FFs 2, 3; see also Mercer claim 1.) Therefore, Mercer teaches one
of ordinary skill in the art how to avoid a decrease in efficacy of EDTA, by
administering it on an empty stomach. Appellants have not pointed to any
persuasive evidence in Mercer that would dissuade the ordinary artisan from
orally administering EDTA for the treatment of arthrosclerosis, especially if
given on an empty stomach so any problems with food is avoided.
We agree with the Examiner that “Majeed teaches use of piperine to
increase gastrointestinal absorption of water soluble actives that is [sic]
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increases bioavailability of drugs once consumed orally and also teaches oral
administration of piperine for increased absorption in adults.” (Ans. 20; FFs
5-8.) We agree with the Examiner’s conclusion that the ordinary artisan
would have been motivated to utilize “piperine along with the drug such as
EDTA for higher plasma concentration of the drug EDTA which acts as a
bioavailability enhancer . . . . Majeed teaches utilization of piperine to
increase levels of drug in plasma and for longer stay of drugs in the body.”
(Ans. 10.)
Even though piperine increases the absorption of metals if present,
this would not motivate a person of ordinary skill to avoid the combination
of EDTA and piperine in an oral administration for treatment of
atherosclerosis as suggested by Appellants (App. Br. 20; see also Reply
Br. 4-5).
[O]bviousness must be determined in light of all the facts, and
there is no rule that a single reference that teaches away will
mandate a finding of nonobviousness. Likewise, a given course
of action often has simultaneous advantages and disadvantages,
and this does not necessarily obviate motivation to
combine. See [Winner Int'l Royalty Corp. v. Wang, 202 F.3d
1340, 1349 n. 8 (Fed.Cir.2000)] (“The fact that the motivating
benefit comes at the expense of another benefit, however,
should not nullify its use as a basis to modify the disclosure of
one reference with the teachings of another. Instead, the
benefits, both lost and gained, should be weighed against one
another.”). Where the prior art contains “apparently
conflicting” teachings (i.e., where some references teach the
combination and others teach away from it) each reference must
be considered “for its power to suggest solutions to an artisan of
ordinary skill.... consider[ing] the degree to which one reference
might accurately discredit another.” In re Young, 927 F.2d 588,
591 (Fed.Cir.1991).
Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006).
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The Examiner is relying on Majeed to teach the use of piperine as a
bioavailability enhancer (Ans. 10). We agree with the Examiner’s finding
that piperine acts as a bioavailability enhancer to promote the absorption of
drugs across the gastrointestinal membrane (FFs 4-8). Although Majeed’s
exemplified compositions are directed to using piperine in combination with
botanical extracts, as well combinations with vitamins and minerals
(Majeed, col. 6, l. 15 to col. 8, l. 32) the teaching of Majeed is not limited to
piperine and trace minerals or vitamins only. As recognized by the
Examiner Majeed teaches that piperine has been used in a multidrug
“formulation containing rifampicin, pyrazinamide and isoniazid [that] has
been tested in human volunteers” (Ans. 10; FF 6). Majeed also disclosed the
use of piperine with propranolol to increase plasma levels of propranolol
(Majeed, col. 2, ll. 17-28). We agree with the Examiner’s conclusion that
the totality of the teaching of Majeed provides that “[m]any drugs have
shown enhanced bioavailability with piperine and thus the reference teaches
role of piperine as a drug bioavailability enhancer.” (Ans. 10; FFs 4-8.) We
agree with the Examiner’s conclusion that one of ordinary skill in the art
would have utilized piperine with the “teachings of Mercer which teaches
using chelating agent EDTA for atherosclerosis or for reducing calcium
(plaque) in blood vessels.” (Ans. 10.)
We conclude that the evidence cited by the Examiner supports a prima
facie case of obviousness with respect to claim 14. As Appellants do not
argue the claims separately, claims 19 and 20 fall with claim 14. 37 C.F.R.
§ 41.37 (c)(1)(vii).

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12
IV. The Issue: Obviousness over Mercer, Majeed, and Hayward
The Examiner acknowledges that neither Mercer nor Majeed disclose
the use of statins (Ans. 11). The Examiner looks to Hayward for a teaching
of using statins to treat arthrosclerosis (id.). The Examiner concludes that it
would have been obvious to “utilize statin as additional agent in treating
atherosclerosis along with EDTA which also helps in reducing plaque in
blood vessels as taught by Mercer et al.” (Id.) “One of ordinary [skill]
would have expected added effect by adding additional active that treats
atherosclerosis by utilizing statins as taught by Hayward.” (Id. at 24.)
The issue is: Does the preponderance of the evidence of record
support the Examiner’s conclusion of obviousness?

Findings of Fact
FF 9. The Specification provides that “[t]he term ‘statin’ refers
to of pharmaceutical agent that acts by competitively inhibiting 3-hydroxy-
3-methylglutaryl coenzyme A (HMG CoA) reductase, an enzyme involved
in the liver cholesterol synthesis.” (Spec. 8.)
FF 10. The Specification provides that “[t]he term ‘ACE
inhibitor’ refers to an antihypertensive drug that blocks the formation of
angiotensin in the kidney, leading to relaxation of the arteries and promotes
the excretion of salt and water by inhibiting the activity of the angiotensin
converting enzyme.” (Spec. 8.)
FF 11. Hayward disclosed a method of treating arthrosclerosis
by administering a peroxisome proliferator activator receptor (PPAR)
agonist of formula I, reproduced below:
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14
With respect to claims 16 and 18, we are not persuaded by
Appellants’ contention. As discussed above (III), we find no error in the
Examiner’s prima facie case of obviousness with regard to independent
claim 14 based on Mercer and Majeed. The Examiner finds that Hayward
disclosed the use of statins for the treatment of arthrosclerosis (Ans. 11; FF
12).
It 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 which is to be
used for the very same purpose.... [T]he idea of combining
them flows logically from their having been individually taught
in the prior art.
In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980)(citations omitted). The
Examiner concludes that the ordinary artisan “would have expected added
effect by adding additional active that treats atherosclerosis by utilizing
statins as taught by Hayward.” (Ans. 24.) We agree with the Examiner’s
conclusion that it would be prima facie obvious to add an additional
compound, known to be effective at treating arthrosclerosis, in order to
arrive at a third composition that can also be used to treat arthrosclerosis.
We conclude that the preponderance of the evidence of record
supports the Examiner’s conclusion that the combination of Mercer, Majeed
and Hayward renders obvious the method of treating arthrosclerosis of
claims 16 and 18.
With respect to claim 17, and specifically the elected species of “ACE
inhibitor,” we find that the Appellants have the better position. The
Examiner has not pointed to any persuasive evidence in the record with
regard to using an ACE inhibitor (FF 10) for the treatment of arthrosclerosis.
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See Ex parte Ohsaka, 2 USPQ2d at 1461. Accordingly, we reverse the
rejection of claim 17 as it reads on the elected species of “ACE inhibitor.”

V. The Issue: Obviousness over Mercer, Majeed, and Glynn
The Examiner acknowledges that neither Mercer nor Majeed disclose
the use of enteric coatings (Ans. 12). The Examiner looks to Glynn for the
“enteric coated tablet and teaches that enteric coatings prevent denaturation
of the composition in the stomach or upper bowel where pH is acidic and the
reference teaches that enteric coatings permit intestinal absorption.” (Id.)
The Examiner concludes that it would have been obvious to “make
enterically coated formulation comprising EDTA and piperine in order to
delay the release of drug and permit intestinal absorption with a reasonable
expectation of success.” (Id.)
The issue is: Does the preponderance of the evidence of record
support the Examiner’s conclusion of obviousness?

Findings of Fact
FF 13. Glynn disclosed that lactoferrin is a single chain metal
binding glycoprotein that can be dispersed in a pharmaceutically acceptable
carrier comprising the metal chelator EDTA (Glynn, p. 1, ¶ 0005 and
¶ 0012).
FF 14. Glynn disclosed that the composition of lactoferrin and
EDTA can be formulated into “hard or soft shell gelatin capsules, tablets, or
pills. More preferably, gelatin capsules, tablets, or pills are enterically
coated. Enteric coatings prevent denaturation of the composition
in the stomach or upper bowel where the pH is acidic.” (Glynn, p. 4, ¶ 0055;
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see also ¶ 0049 and ¶ 0051; Ans. 25.)

Analysis
Appellants contend that the combination of Mercer and Glynn would:
teach away from combining EDTA with an enteric coating.
Mercer describes combining EDTA with an acid. . . . In
contrast, Glynn describes that enteric coatings are used to
protect the composition from acid. . . . a person reading Mercer
would conclude that oral administration of EDTA is facilitated
by exposure to an acid and would therefore avoid combining
EDTA with an enteric coating, as described in Glynn.
(App. Br. 22-23.) In addition, Appellants assert that “there would be no
reason for a person to believe that an enteric coating on the EDTA would
increase the bioavailability of the EDTA.” (Id. at 22.)
We are not persuaded by Appellants’ contention. The Examiner’s
position is that “[e]nteric coatings are taught by Glynn for intestinal
absorption, no novelty is found with respect to enteric coatings.” (Ans. 25.)
We agree with the Examiner that Glynn teaches the administration of
lactoferrin including the administration of lactoferrin in combination with
EDTA (FF 13). In addition, Glynn specifically disclosed that the
combination can be enterically coated (FF 14).
We note that claim 21 does not require the limitation that the
composition comprising the enteric coating increases the bioavailability of
EDTA. We find that the Examiner has provided a reasonable basis for
combining the references. Specifically, Mercer teaches a method of treating
arthrosclerosis by administering EDTA, while Glynn also teaches
administering an EDTA containing composition to a patient even though it is
for a different ailment. Here, Glynn disclosed that the EDTA containing
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composition can be enterically coated to “prevent denaturation of the
composition in the stomach or upper bowel where the pH is acidic.”
(FF 14.) “The combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). We agree
with the Examiner’s conclusion that it would have been obvious to use
“enterically coated formulation comprising EDTA and piperine in order to
delay the release of drug and permit intestinal absorption with a reasonable
expectation of success.” (Ans. 12.)
We conclude that the preponderance of the evidence of record
supports the Examiner’s conclusion that the combination of Mercer, Majeed
and Glynn renders obvious the method of treating arthrosclerosis of claim 21
under 35 U.S.C. § 103(a). As claims 15, 22, 26 and 27 have not been argued
separately, they fall together with claim 21. 37 C.F.R. § 41.37 (c)(1)(vii).

VI. The Issue: Obviousness over Mercer, Majeed, Glynn, and Hayward
The Examiner finds that it would have been obvious to include statins
in combination with EDTA as disclosed in Mercer for the treatment of
arthrosclerosis (Ans. 13).
Appellants’ contentions with respect to claims 23-25 are similar to
those discussed above (IV) with respect to claims 16-18.
As discussed above (V), we have found no error in the Examiner’s
prima facie case with regard to independent claim 21 based on Mercer,
Majeed and Glynn. For the same reasons as discussed above (IV) we agree
with the Examiner’s conclusion that it would be prima facie obvious to add
an additional compound, known to be effective at treating arthrosclerosis, in
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order to arrive at a third composition that can also be used to treat
arthrosclerosis. See In re Kerkhoven, 626 F.2d at 850.
We conclude that the preponderance of the evidence of record
supports the Examiner’s conclusion that the combination of Mercer, Majeed,
Glynn and Hayward renders obvious the method of treating arthrosclerosis
of claims 23 and 25 utilizing an enterically coated composition.
With respect to claim 24, and specifically the elected species of “ACE
inhibitor,” we find that the Appellants have the better position. The
Examiner has not pointed to any persuasive evidence in the record with
regard to using an ACE inhibitor (FF 10) for the treatment of arthrosclerosis.
See Ex parte Ohsaka, 2 USPQ2d at 1461. Accordingly, we reverse the
rejection of claim 17 as it reads on the elected species of “ACE inhibitor.”

SUMMARY
We reverse the rejection of claims 14-27 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the enablement requirement.
We reverse the rejection of claims 14-27 under 35 U.S.C. § 112,
second paragraph, as being indefinite.
We affirm the rejection of claims 14 and 19-20 under 35 U.S.C.
§ 103(a) as being unpatentable over Mercer in view of Majeed.
We affirm the rejection of claims 16 and 18 under 35 U.S.C. 103(a) as
being unpatentable over Mercer in view of Majeed and further in view of
Hayward.
We reverse the rejection of claim 17, directed to the elected species of
ACE inhibitor, under 35 U.S.C. 103(a) as being unpatentable over Mercer in
view of Majeed and further in view of Hayward.
Appeal 2012-000326
Application 10/939,737

19
We affirm the rejection of claims 15, 21-22, and 26-27 under 35
U.S.C. § 103(a) as being unpatentable over Mercer in view of Majeed, as set
forth above and further in view of Glynn.
We affirm the rejection of claims 23 and 25 under 35 U.S.C. § 103(a)
as being unpatentable over Mercer in view of Majeed and Glynn as set forth
above and further in view of Hayward.
We reverse the rejection of claim 24, directed to the elected species of
ACE inhibitor, under 35 U.S.C. § 103(a) as being unpatentable over Mercer
in view of Majeed and Glynn as set forth above and further in view of
Hayward.

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).

AFFIRMED-IN-PART

cdc