Ex Parte Zerbe et al

Board of Patent Appeals and Interferences

Sep 8, 2010

10542983 (B.P.A.I. Sep. 8, 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.
10/542,983 07/21/2005 Horst G. Zerbe AML/13131.19 7824
61114 7590 09/08/2010
BCF LLP
1100 RENE'-LE'VESQUE BLVD. WEST
25TH FLOOR
MONTREAL, QC H3B-5C9
CANADA
EXAMINER
AHMED, HASAN SYED
ART UNIT PAPER NUMBER
1615
MAIL DATE DELIVERY MODE
09/08/2010 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 HORST G. ZERBE and POMPILIA SZABO
__________

Appeal 2010-005034
Application 10/542,983
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 involving claims to a multi-
layer oral dosage form. The Examiner has rejected the claims as anticipated.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

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.
Appeal 2010-005034
Application 10/542,983

2
STATEMENT OF THE CASE
Claim 1 is on appeal,2 and reads as follows:
1. A multi-layer oral dosage form, comprising:
(a) a matrix core comprising a therapeutically effective amount of a
first drug, wherein the matrix core allows sustained release of the first drug;
(b) a first layer, which is in contact with said matrix core, comprising
a first portion of a pharmaceutically effective amount of a second drug,
wherein the first layer allows sustained release of the second drug; and
(c) a second layer, which is also in contact with said matrix core,
comprising a second portion of the second drug, wherein the second layer
allows immediate release of the second drug.

Issue
The Examiner has rejected claim 1 under 35 U.S.C. § 102(b) as
anticipated by Edgren.3 The Examiner finds that Figure 3 of Edgren
discloses the claimed multilayer oral dosage form (Answer 3). The
Examiner finds that the claim’s sustained release matrix core (a) corresponds
to Edgren’s element 13, the claim’s first layer in contact with the matrix core
(b) corresponds to Edgren’s element 12, and the claim’s second layer in
contact with the matrix core (c) corresponds to Edgren’s element 15 (id.).
Appellants contend that the Examiner erred in finding that Edgren
discloses an oral dosage form having two sustained release layers because
Edgren’s “laminate layer 13 … does not allow ‘sustained release of the first
drug.’ Instead laminate layer 13 of Edgren appears to be an instant release
layer” (Appeal Br. 4).

2 Although claims 2-15, 17-19, 28, and 30 are reproduced in the Appeal
Brief’s Claims Appendix, they have been withdrawn from consideration by
the Examiner (Office Action mailed Dec. 23, 2008, page 1).
3 Edgren et al., US 4,946,685, issued Aug. 7, 1990
Appeal 2010-005034
Application 10/542,983

3
The issue presented is: Does the evidence of record support the
Examiner’s finding that Edgren discloses an oral dosage form having two
sustained release layers?
Findings of Fact
1. Edgren discloses a “bilaminate dosage form … comprising a first
lamina and a second lamina …, and wherein a drug is present in at least one
of the lamina. An optional coat is disclosed that surrounds the bilaminate
form” (Edgren, abstract).
2. Figure 3 of Edgren is shown below:

Figure 3 shows
a dosage form 10 … in opened view and it comprises body 11,
first lamina 12, a drug 14 in first lamina 12, second lamina 13
and a drug 14 in second lamina 13. Drug 14 present in first
lamina 12 and in second lamina 13 may be the same or
different. In FIG. 3, dosage form 10 additionally comprises an
external coat 15. Coat 15 surrounds internal lamina 12 and
internal lamina 13.
(Id. at col. 6, l. 55-63.)
3. Edgren discloses that “dosage form 10 comprises optional drug 16
in coat 15. The presence of drug 16 provides instant drug release when
Appeal 2010-005034
Application 10/542,983

4
dosage form 10 is introduced into an aqueous environment of use” (id. at
col. 7, ll. 32-37).
4. Edgren discloses that
the bilaminated structure of dosage form 10 comprises a fast
drug releasing lamina 13, and a slower drug releasing lamina
12. The fast drug releasing lamina 13 begins to dispense drug
14 immediately for producing an initial plasma concentration of
drug 14.… The slower drug releasing lamina 13 [sic, 12]
releases drug 14 continuously and over time for producing a
steady-state drug 14 concentration. The expression, “fast drug
14 releasing lamina 13 and slower drug 14 releasing lamina
12,” as used for the purpose of this invention, denotes that
lamina 13 releases drug 14 at a faster rate per unit time than
does lamina 12.
(Id. at col. 14, ll. 54-67.)
5. Edgren discloses that one exemplary dosage form comprises
(a) a drug delivery lamina comprising a cellulose ether
composition means and a drug for continuously and slowly
delivering the drug at a rate controlled by the lamina over an
extended period up to 21 hours; and (b) a drug releasing lamina
comprising a cellulosic ether composition means for delivering
the drug immediately and over an unextended period up to 3
hours at a rate controlled by the lamina.
(Id. at col. 15, ll. 25-32.)
6. Appellants concede that Edgren’s “[c]oat 15 may provide ‘instant
drug release’ when a drug is included in the coat” (Appeal Br. 5).
7. Appellants do not point to any definition of “sustained release” in
the Specification that requires drug release over a specific length of time.
Principles of Law
“[A]s an initial matter, the PTO applies to the verbiage of the
proposed claims the broadest reasonable meaning of the words in their
Appeal 2010-005034
Application 10/542,983

5
ordinary usage as they would be understood by one of ordinary skill in the
art, taking into account whatever enlightenment by way of definitions or
otherwise that may be afforded by the written description contained in the
applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir.
1997).
Analysis
Claim 1 is directed to a multi-layer oral dosage form comprising two
sustained release portions (the matrix core and the first layer) and an
immediate release layer (the second layer).
Appellants argue that Edgren’s dosage form “includes two instant
release layers and a sustained release layer” (Appeal Br. 6) rather than two
sustained release layers and one instant release layer, as required by the
claims (id.).
Appellants’ arguments are not persuasive. Edgren’s Example 31,
which Appellants cite as disclosing that one of Edgren’s two lamina layers is
an instant release layer rather than a sustained release layer, describes the
two lamina layers respectively as (i) “delivering the drug at a rate controlled
by the lamina over an extended period up to 21 hours” and (ii) “delivering
the drug immediately and over an unextended period up to 3 hours at a rate
controlled by the lamina.” The term “sustained release” is not defined in the
Specification and, in accord with In re Morris, we give the term its broadest
reasonable interpretation in view of the Specification. The broadest
reasonable interpretation of “sustained release” reasonably encompasses
release of a drug over the course of three hours, as specified for the fast
release layer of Edgren. Appellants have not pointed to any disclosure in the
Appeal 2010-005034
Application 10/542,983

6
Specification that is inconsistent with this interpretation of the claim
language.
Conclusion of Law
The evidence of record supports the Examiner’s finding that Edgren
discloses an oral dosage form having two sustained release layers.
SUMMARY
We affirm the rejection of claim 1 under 35 U.S.C. § 102(b).
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

lp

BCF LLP
1100 RENE'-LE'VESQUE BLVD. WEST
25TH FLOOR
MONTREAL QC H3B-5C9 CA CANADA