Ex Parte Kuczynski et al

Board of Patent Appeals and Interferences

Sep 21, 2010

10131916 (B.P.A.I. Sep. 21, 2010)

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.
10/131,916 04/25/2002 Anthony L. Kuczynski ALZA-0005 2081
7590 09/22/2010
Joseph Lucci
Woodcock Washburn LLP
One Liberty Place
46th Floor
Philadelphia, PA 19103
EXAMINER
HAGHIGHATIAN, MINA
ART UNIT PAPER NUMBER
1616
MAIL DATE DELIVERY MODE
09/22/2010 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 ANTHONY L. KUCZYNSKI, ATUL D. AYER, and
PATRICK S.L. WONG
__________

Appeal 2010-003055
Application 10/131,916
Patent 6,361,795 B1
Technology Center 1600
__________

Before ERIC GRIMES, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 in an application seeking
reissue of claims to a method of lowering blood sugar levels using extended

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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release forms of glipizide. The Examiner has rejected the claims for
obviousness and obviousness-type double patenting. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Claims 1-9 are on appeal. Claims 1, 5, and 9 are representative and
read as follows:
1. A method for treating hyperglycemia in a patient, wherein the
method comprises administering to the patient a once-a-day dosage form
comprising 2.0 mg to 750 mg of a glipizide composition and wherein the
method is characterized by administering the glipizide from an osmotic
dosage form comprising a semipermeable polymer permeable to the passage
of fluid.

5. A method for treating hyperglycemia in a patient, wherein the
method comprises administering to the patient a once-a-day dosage form
comprising 2.0 mg to 750 mg of a glipizide composition and wherein the
method is characterized by administering the glipizide from a diffusion
dosage form comprising a polymer that permits diffusion of glipizide
through the polymer.

9. A method for lowering blood sugar in the treatment of a diabetic
patient, which method comprises orally administering to the patient an
effective blood sugar lowering dose of a composition comprising glipizide
and a pharmaceutically acceptable carrier, which blood sugar lowering dose
is administered by ion-exchange to produce the intended lowering of the
blood sugar in the patient.

The claims stand rejected as follows:
• Claims 1-8 under 35 U.S.C. § 103(a) based on Ranade2 (Answer 4);
• Claims 1-8 under 35 U.S.C. § 103(a) based on Curatolo3 (Answer 5);

2 Ranade, US 4,792,448, issued Dec. 20, 1988
3 Curatolo, US 5,030,452, issued July 9, 1991
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• Claim 9 under 35 U.S.C. § 103(a) based on Raghunathan4 and
Curatolo (Answer 7);
• Claims 1-9 for obviousness-type double patenting based on claims
1-4, 7, 8, 10-13, and 15 of U.S. Patent 5,591,454 (Answer 9);
• Claims 1-8 for obviousness-type double patenting based on claims
1-7 of U.S. Patent 5,545,413 (Answer 10); and
• Claims 1-9 for obviousness-type double patenting based on claims 1
and 2 of U.S. Patent 5,024,843 (Answer 10).
I.
The Examiner has rejected claims 1-8 under 35 U.S.C. § 103(a) as
obvious in view of Ranade (Answer 4). The Examiner acknowledges that
Ranade does not teach treating hyperglycemia with a once-a-day dosage
form of glipizide that comprises a semi-permeable membrane, but concludes
that “it would have been obvious to one of ordinary skill in the art at the
time the invention was made to have modified the teachings of Ranade to
include a method of treating hyperglycemia and to have implemented known
dosage forms and doses for the treatment” (id. at 5).
Appellants argue that the Examiner has not established prima facie
obviousness because, among other things, “the Examiner does not account
for the subject [matter] of claim 1 as a whole and does not cite to prior art in
support of the assertions regarding known dosage forms and dosages”
(Appeal Br. 8).

4 Raghunathan, US 4,221,778, issued Sept. 9, 1980
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We agree with Appellants that the Examiner has not adequately
shown that Ranade, by itself, would have made obvious the claimed
methods. The Examiner has not shown that Ranade provides evidence that
“known dosage forms and doses for the treatment” of hyperglycemia
(Answer 5) include the dosage forms and doses recited in the claims on
appeal. The Examiner therefore has not shown that the claimed methods
would have been obvious based on the teachings of Ranade.
II.
Issue
The Examiner has rejected claims 1-8 under 35 U.S.C. § 103(a) as
obvious in view of Curatolo (Answer 5) and claim 9 as obvious in view of
Raghunathan and Curatolo (Answer 7). Since the same issue is dispositive
with respect to both rejections, we will consider them together.
The Examiner finds that “Curatolo teaches dosage forms that control
release rates, comprise[d] of glipizide and an osmotic solute and/or a coating
that comprises one water permeable polymer. The said dosage forms are
shown to have release rates of over 21 hours.” (Answer 6-7.) The Examiner
concludes that “it would have been obvious to one of ordinary skill in the art
at the time the invention was made to have employed the teachings provided
by Curatolo to prepare the dosage form claimed for a method of treating
hyperglycemia comprising administration of glipizide” (id. at 7).
Appellants contend that Curatolo does not disclose a once-a-day
dosage form of glipizide, as claimed (Appeal Br. 18-19). Appellants also
contend that the Lebovitz Declaration rebuts any prima facie case of
obviousness, because it shows that those of skill in the art doubted that
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sustained-release glipizide would effectively treat hyperglycemia without
causing hypoglycemia (Appeal Br. 10-13, 20).
The issues with respect to this rejection are:
Does Curatolo’s disclosure show that the method of claim 1 would
have been obvious to a person of ordinary skill in the art? and, if so,
Does the Lebovitz Declaration provide evidence that, when weighed
with the evidence provided by Curatolo, shows that the method of claim 1
would not have been obvious?
Findings of Fact
1. Curatolo discloses “devices for the controlled delivery of one or
more beneficial agents to an environment of use which devices comprise a
mixture of one or more beneficial agents and lyotropic liquid crystals
surrounded by a coating of a material that is permeable to water . . . and
which coating contains one or more holes” (Curatolo, col. 2, ll. 24-30).
2. Curatolo discloses that the devices can be used for oral
administration of a drug (id. at col. 8, ll. 31-35), including hypoglycemics
(id. col. 6, l. 31) such as glipizide (id. at col. 10, ll. 43-47).
3. Curatolo discloses that its devices
also comprise a coating (3) which surrounds the mixture (6) of
one or more beneficial agents (4) and lyotropic liquid crystals
(5). . . . The coating (3) comprises at least one water permeable
polymer but, significantly and in contrast to many prior art
devices, the coating need not be semi-permeable. Therefore,
the coating (3) can be freely permeable to low molecular weight
compounds.
(Id. at col. 7, ll. 3-12.)
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4. Curatolo discloses that the “amount of coating (3) to be applied can
be varied to affect the release rate of the devices” (id. at col. 9, ll. 59-61).
5. Curatolo discloses that its devices “may optionally contain an
osmotically effective solute for the purpose of providing a colloidal osmotic
pressure which is additive with the swelling pressure of the lyotropic liquid
crystals” (id. at col. 5, ll. 52-56).
6. Curatolo exemplifies 500 mg tablets containing 5 weight percent
glipizide (id. at col. 11, ll. 29-36) and 500 mg bilayer tablets in which one
250 mg layer contained 10 weight percent glipizide (id. at col. 12, ll. 18-33).
7. Five percent of 500 mg is 25 mg (500 x 0.05 = 25). Ten percent of
250 mg is 25 mg (250 x 0.1 = 25).
8. Curatolo measured the rate of release of glipizide from its
exemplary tablets over the course of 21.25 hours (id. at col. 13, ll. 1-20) or
23.16 hours (id. at col. 13, ll. 26-48).
9. Appellants have submitted a declaration under 37 C.F.R. § 1.132
by Harold E. Lebovitz (“Lebovitz Declaration,” dated April 30, 2003).
10. Dr. Lebovitz declared that, in his opinion, “it could not have been
reasonably expected before the filing date of the 795 Patent that the delivery
of glipizide in a sustained manner would result in an effective treatment for
NIDDM [non-insulin dependent diabetes mellitus]” (Lebovitz Declaration,
¶ 14).
11. Dr. Lebovitz declared that the immediate release (IR) form of
glipizide that was available before Jan. 11, 1994 (the filing date of the patent
on reissue) was taken before meals, stimulating secretion of insulin and
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thereby mimicking the normal, meal-induced production of insulin (id. at
¶¶ 6, 10).
12. Dr. Lebovitz declared that it could not have been predicted that “a
once a day administration delivering a constant amount of glipizide over 12
to 24 hours would be able to effectively modulate the changing (i.e., rising
and falling) levels of blood glucose over that time frame” (id. at ¶ 17).
13. Dr. Lebovitz declared that “there was a concern” that sustained
release glipizide would not provide an adequate dose of the drug to control
blood glucose levels after a meal (id. at ¶ 18) and “there was an equal and
competing concern” that sustained release glipizide would cause insulin
secretion between meals, resulting in hypoglycemia (id. at ¶ 19).
14. Dr. Lebovitz declared that he and other endocrinologists advised
Pfizer in the late 1980’s that pursuing a sustained release glipizide
formulation was not scientifically reasonable because it was likely to cause
hypoglycemia in patients (id. at ¶ 22).
15. Dr. Lebovitz declared that “[n]evertheless, Pfizer apparently
proceeded [with] research and development for a sustained release glipizide
product,” and that its “Glucotrol® XL was approved by the FDA in April of
1994 for the safe and effective treatment of NIDDM” (id. at ¶ 23).
Principles of Law
“Reasonable expectation of success is assessed from the perspective
of the person of ordinary skill in the art.” Life Technologies, Inc. v.
Clontech Labs., Inc., 224 F.3d 1320, 1326 (Fed. Cir. 2000).
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Analysis
Claim 1 is directed to a method of treating hyperglycemia by
administering glipizide in a once-a-day osmotic dosage form comprising 2-
750 mg of glipizide and a semipermeable membrane.
Curatolo discloses a dosage form for controlled delivery of beneficial
agents and expressly suggests using its device to deliver hypoglycemic
agents, including glipizide. Curatolo discloses that its device comprises a
coating that “need not be semi-permeable” (FF 3); in other words, the
coating can be semipermeable but does not have to be. Curatolo also
discloses that the amount of coating can be varied to change the release rate
of the active agent, and measured the release rate of exemplary devices,
which contained 25 mg of glipizide, over 21-23 hours.
We agree with the Examiner that Curatolo’s disclosure would have
made obvious the method of claim 1. Curatolo discloses an osmotic dosage
form comprising 25 mg glipizide, a drug which was known to be useful for
treating hyperglycemia (as evidenced by Appellants’ own Specification; col.
1, ll. 27-30). Curatolo suggests that the dosage form can include a
semipermeable coating and that the amount of coating can be varied to
adjust the release rate of the active agent. Curatolo discloses that its devices
release glipizide for at least 23 hours. In view of these disclosures, it would
have been obvious to administer Curatolo’s glipizide-containing formulation
to a patient in need of treatment for hyperglycemia, and Curatolo’s
disclosure of glipizide release for 23 hours and its suggestion to modify the
coating to adjust the release rate would have suggested modifying the
exemplified devices, if necessary, to allow once-a-day administration.
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Appellants argue that Curatolo does not suggest a once-a-day dosage
form of glipizide because its exemplified dosage forms do not “perform in
such a manner as to release all or nearly all of their drug during the 21-23
hour measurement period, which suggests that longer periods of release than
24 hours are contemplated for the disclosed dosage forms” (Appeal Br. 19).
This argument is not persuasive. Claim 1 itself provides evidence that
a “once-a-day” dosage form need not contain more than 2 mg of glipizide.
All of Curatolo’s exemplified tablets contained 25 mg of glipizide and
released between 34.25% and 75.5% of the glipizide over the 21-23 hour
measurement period (Curatolo, col. 13, l. 1 to col. 15, l. 10). Appellants
have provided no evidence to show that the amount of glipizide released by
Curatolo’s tablets would not effectively treat hyperglycemia in a once-a-day
dosage. In any event, Curatolo directs the skilled worker to adjust the
amount of coating to achieve the desired release rate, and a once-a-day
dosage form would have been obvious in view of Curatolo’s disclosure of
forms that release glipizide over the course of 23 hours.
Appellants also argue that the Lebovitz declaration provides evidence
that those of skill in the art would not have reasonably expected a sustained
release dosage form of glipizide to effectively treat hyperglycemia without
causing hypoglycemia (Appeal Br. 20-21).
We have considered the evidence provided by Dr. Lebovitz but
conclude that, weighed together with the evidence provided by Curatolo, it
does not establish the nonobviousness of the claimed method. Dr. Lebovitz
discusses the normal secretion of insulin and the peak-and-trough pattern of
insulin secretion caused by immediate release insulin. Dr. Lebovitz states
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that a sustained release dosage for of glipizide would not produce this peak-
and-trough pattern and that there were concerns that sustained release
glipizide would provide either too little insulin to control blood glucose after
meals or too much insulin between meals, causing hypoglycemia. Dr.
Lebovitz states that, in his opinion, sustained release glipizide would not
reasonably have been expected to effectively treat diabetes as of the filing
date of the patent on reissue.
Whether the prior art would have provided a reasonable expectation of
success is determined from the point of view of the hypothetical person of
ordinary skill in the art. Life Technologies, 224 F.3d at 1326. Here, the
evidence shows that, while Dr. Lebovitz may have doubted the prospects of
sustained release glipizide, that view was not shared by others in the field.
Dr. Lebovitz states that, despite his concerns that sustained release glipizide
would cause hypoglycemia, researchers at Pfizer “apparently proceeded
[with] research and development for a sustained release glipizide product”
(FF 15), which was approved by the FDA in April 1994, only a few months
after the filing date of the patent on reissue. The evidence that Pfizer’s
researchers developed a sustained release dosage form of glipizide, which
was on the verge of regulatory approval when the patent on reissue was
filed, is persuasive evidence that a person of ordinary skill in the art would
not have reasonably doubted the likelihood of success for a once-a-day
dosage form of glipizide.
Appellants argue that claims 2 and 7, while they do not require once-
a-day dosage, are “patentable because of the uncertainty surrounding
whether administering glipizide over a sustained period would likely have
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the net result of causing hypoglycemia” (Appeal Br. 21). This argument has
been addressed above.
Regarding claim 9, Appellants argue that Raghunathan does not
remedy the shortcomings of Curatolo and that the Lebovitz Declaration
shows that the effectiveness of a sustained release glipizide formulation
would be unpredictable (Appeal Br. 22-23). For the reasons discussed
above, however, we conclude that Curatolo supports a conclusion of
obviousness and that the Lebovitz Declaration does not cast doubt on the
ordinary artisan’s reasonable expectation of success.
Conclusion of Law
Curatolo’s disclosure shows that the method of claim 1 would have
been obvious to a person of ordinary skill in the art. The Lebovitz
Declaration does not provide evidence that, when weighed with the evidence
provided by Curatolo, shows that the method of claim 1 would not have
been obvious. Claims 3-6 and 8 were not argued separately and therefore
fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). Appellants’ arguments
regarding claims 2, 7, and 9 are not persuasive of their separate patentability.
III.
The Examiner has rejected claims 1-8 for obviousness-type double
patenting on the basis that they are not patentably distinct from claims 1-7 of
U.S. Patent 5,545,413 (Answer 10), because “instant claims are drawn to a
method of treating hyperglycemia by administering a dosage form
comprising [2.0 to 750 mg] glipizide and a semi-permeable polymer,” while
the ‘413 patent’s “claims are drawn to a method for controlling
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hyperglycemia by administering a dosage comprising from 2 to 50 mg
glipizide and a polymer and comprising a wall permeable to the passage of
fluid” (Answer 10).
Appellants contend that the “claims of the ‘413 patent do not set forth
the presence of an osmotic dosage form or administration of glipizide by
osmosis,” nor do they include a diffusion dosage form as required by claims
5-8 of the patent on reissue (Appeal Br. 24).
Additional Findings of Fact
16. Claim 1 of the ‘413 patent reads as follows:
1. A method for controlling hyperglycemia and its associated
symptomatology in a patient in need of glipizide therapy for controlling
same, wherein the method comprises:
(a) admitting orally into the patient a dosage form comprising:
(1) a wall comprising at least at part a composition
permeable to the passage of fluid, which wall surrounds;
(2) a compartment;
(3) a lamina in the compartment comprising about 2.0 mg to 50
mg of glipizide and a polyethylene oxide comprising an 80,000
to 350,000 molecular weight;
(4) a displacement lamina in the compartment comprising a
polyethylene oxide comprising a 4,000,000 to 8,000,000
molecular weight, which displacement lamina imbides [sic]
fluid, expands and displaces the lamina comprising the glipizide
from the compartment;
(5) at least one exit means in the wall for delivering
glipizide from the dosage form;
(b) imbibing fluid into the dosage form for contacting the
displacement lamina comprising the polyethylene oxide causing it to
expand and displace the lamina comprising the glipizide; thereby,
(c) delivering a therapeutically effective amount of glipizide to
the patient to produce the intended effects.

(‘413 patent, col. 8, l. 42 to col. 9, l. 2.)
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17. The “wall comprising . . . a composition permeable to the passage
of fluid” recited in part (a)(1) of the ‘413 patent’s claim 1 can comprise
“cellulose acylate, cellulose diacylate, cellulose triacylate, cellulose acetate,
cellulose diacetate, [or] cellulose triacetate” (‘413 patent, claim 4).
18. The application on reissue states that the “composition
comprising wall 12 is semipermeable” (‘795 patent, col. 3, ll.48-49) and that
[w]all 12, in a present embodiment, comprises 60 weight
percent (wt %) to 100 weight percent of a composition
comprising a cellulose polymer. The cellulose polymer
comprises a member selected from the group consisting of . . .
cellulose acylate, cellulose diacylate, cellulose triacylate,
cellulose acetate, cellulose diacetate, and cellulose triacetate.
(Id. at col. 3, ll. 55-61.)
Analysis
Claim 1 on appeal and claim 1 of the ‘413 patent are both directed to
methods of controlling hyperglycemia by administering a dosage form
comprising glipizide, in amounts that overlap. Claim 1 on appeal requires
an “osmotic dosage form comprising a semipermeable polymer permeable to
the passage of fluid,” while claim 1 of the ‘413 patent requires a dosage
form comprising a “wall comprising . . . a composition permeable to the
passage of fluid” (FF 16). The wall of the ‘413 patent’s dosage form can be
made of the same polymers as the semipermeable polymer of the instant
claims (FFs 17, 18). In addition, the ‘413 patent’s claim 1 states that its
dosage form works by “imbibing fluid into the dosage form for contacting
the displacement lamina . . . causing it to expand and displace the lamina
comprising the glipizide; thereby, . . . delivering a therapeutically effective
amount of glipizide to the patient” (FF 16).
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This limitation is reasonably interpreted to describe sustained release
of glipizide based on osmosis; i.e., an osmotic dosage form. We therefore
agree with the Examiner that claim 1 on appeal and the ‘413 patent’s claim 1
are directed to methods that are not patentably distinct, even though the ‘413
patent does not expressly state that its dosage form is an “osmotic dosage
form.”
However, we agree with Appellants that the Examiner has not
explained why claims 5-8 on appeal are not patentably distinct from the
claims of the ‘413 patent. We therefore reverse the rejection of claims 5-8.
IV.
The Examiner has rejected claims 1-9 for obviousness-type double
patenting on the basis that they are not patentably distinct from claims 1-4,
7, 8, 10-13, and 15 of U.S. Patent 5,591,4545 (Answer 9), because the ‘454
patent’s “claims are drawn to a method of treating hyperglycemia by
administering a dosage form comprising from 2 to 22 mg glipizide and a
polymer. . . . The said polymers can be both osmotic and ion exchange
resins.” (Answer 9.)
Appellants contend that the claims of the ‘454 patent “do not teach or
suggest the administration of a dosage form comprising a semipermeable
polymer permeable to the passage of fluid as recited in appealed claim 1,” or
the diffusion dosage form or ion-exchange dosage form required by claims
5-9 (Appeal Br. 23).

5 The ‘454 patent originally issued with three claims; claims 4-15 were
added during reexamination. Ex Parte Reexamination Certificate, issued
Nov. 4, 2003.
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Additional Findings of Fact
19. Claim 1 of the ‘454 patent reads as follows:
1. A method for treating hyperglycemia in a patient, wherein the
method comprises administering to the patient a dosage form comprising 2
mg to 22 mg glipizide that is administered at a therapeutically effective dose
of 2 mg to 22 mg over 24 hours from the dosage form comprising 20 mg to
70 mg osmagent and a hydrogel selected from the group consisting of
poly(ethylene oxide) having a 4,000,000 to 8,000,000 molecular weight and
a carboxymethylcellulose having a 200,000 to 1,000,000 molecular weight
to the patient to produce the intended effect in the patient.

20. The ‘454 patent discloses that a composition of glipizide and an
osmagent “exhibits an osmotic pressure gradient across semipermeable wall
12 against an external aqueous or biological fluid. The osmagents are
known also as osmotically effective solute and as osmotically effective
compound.” (‘454 patent, col. 4, 41-44.)
Analysis
Claim 1 on appeal and claim 1 of the ‘454 patent are both directed to
methods of controlling hyperglycemia by administering a dosage form
comprising glipizide, in amounts that overlap. Claim 1 on appeal requires
“osmotic dosage form comprising a semipermeable polymer permeable to
the passage of fluid.” Claim 1 of the ‘454 patent requires an osmagent that,
in a composition with glipizide, “exhibits an osmotic pressure gradient
across semipermeable wall 12 against an external aqueous or biological
fluid” (FF 20). Based on the ‘454 patent’s definition of the osmagent in its
claimed dosage form, the semipermeable polymer recited in claim 1 on
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appeal would have been either inherent in the ‘454 patent’s dosage form
(because it is required to allow the osmagent to carry out its function) or a
variation that would have been obvious to those of ordinary skill in the art.
However, we agree with Appellants that the Examiner has not
explained why claims 5-9 on appeal are not patentably distinct from the
claims of the ‘454 patent. We therefore reverse the rejection of claims 5-9.
V.
The Examiner has rejected claims 1-9 for obviousness-type double
patenting on the basis that they are not patentably distinct from claims 1 and
2 of U.S. Patent 5,024,843 (Answer 10), because the ‘843 patent’s claims
“are drawn to a pharmaceutical granulation comprising granules of 2 mg to
50 mg of substantially aqueous insoluble glipizide and polymers
manufactured as an osmotic dosage form for dispensing the glipizide for up
to 22 hours” (Answer 10-11).
Appellants contend that the claims on appeal are patentably distinct
from the claims of the ‘843 patent because the patented claims are directed
to a pharmaceutical granulation that includes glipizide, not a method of
administering an osmotic dosage form that includes a semipermeable
membrane, a diffusion dosage form, or an ion-exchange dosage form, as
required by the claims on appeal (Appeal Br. 25).
We agree with Appellants that the Examiner has not adequately
explained why methods of treating hyperglycemia using the particular
dosage forms recited in the claims on appeal would have been considered to
be obvious variants of the claims of the ‘843 patent, which are directed to a
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pharmaceutical granulation comprising glipizide, polyethylene oxide, and
hydroxypropylmethylcellulose.
SUMMARY
We reverse the rejection of claims 1-8 as obvious in view of Ranade
and the rejection of claims 1-9 for obviousness-type double patenting based
on U.S. Patent 5,024,843. We also reverse the obviousness-type double
patenting rejections of claims 5-9 based on the claims of U.S. Patent
5,591,454 or U.S. Patent 5,545,413.
We affirm the rejection of claims 1-8 as obvious in view of Curatolo,
and the rejection of claim 9 as obvious in view of Raghunathan and
Curatolo. We also affirm the rejection of claims 1-4 for obviousness-type
double patenting based on the claims of U.S. Patent 5,591,454 or U.S. Patent
5,545,413.

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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

alw

JOSEPH LUCCI
WOODCOCK WASHBURN LLP
ONE LIBERTY PLACE
46TH FLOOR
PHILADELPHIA, PA 19103