Ex Parte Fergione et al

Board of Patent Appeals and Interferences

May 1, 2007

10327383 (B.P.A.I. May. 1, 2007)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte MICHAEL FERGIONE and BARBARA A. JOHNSON
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Appeal 2007-1082
Application 10/327,383
Technology Center 1600
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Oral Argument: None
Decided: 01 May 2007
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Before: FRED E. McKELVEY, Senior Administrative Patent Judge,
and ROMULO H. DELMENDO and SALLY GARDNER LANE ,
Administrative Patent Judges.

McKELVEY, Senior Administrative Patent Judge.

DECISION ON APPEAL

A. Statement of the case 1
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This ex parte appeal under 35 U.S.C. § 134(a) is from a rejection of
claims 1, 3-4, 7-9, 11, 13-23, 25-26 and 28, the only claims remaining in the
application on appeal.
We have jurisdiction under 35 U.S.C. § 6(b).
The application on appeal was filed on 20 December 2002.

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Appellants claim benefit of an earlier filing date based on Provisional
Application 60/343,469, filed 21 December 2001.
The real party in interest is Pfizer Inc.
The Examiner rejected claims 1, 3-4, 7-9, 11, 13-23, 25-26 and 28 (all
of the claims) under 35 U.S.C. § 103(a) as being unpatentable over
Tenengauzer. (The reader should know that no references to et al. are made
in this opinion.)
The Examiner has also rejected claims 1, 3-4, 7-9, 11, 13-23, 25-26
and 28 under 35 U.S.C. § 103(a) as being unpatentable over Singer and
Curatolo.
The following prior art was relied upon by the Examiner.

Name Patent Number Issue Date13
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Curatolo US 5,605,889 25 Feb 1997
Singer US 6,365,574 B2 02 Apr 2002
Tenengauzer US 6,764,997 20 Jul 2004

Curatolo is prior art vis-à-vis appellants under 35 U.S.C. § 102(b).
Singer is prior art vis-à-vis appellants under 35 U.S.C. § 102(e) based
on Singer’s filing date of 30 November 1999.
Tenengauzer is prior art vis-à-vis appellants under 35 U.S.C. § 102(e)
based on Tenengauzer’s filing date of 18 October 2002, appellants’ filing
date being 20 December 2002. Appellants claim priority of a Provisional
Application filed 21 December 2001 and Tenengauzer claims priority based
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on Provisional Applications filed (1) 17 December 2001, (2) 21 November
2001 and (3) 18 October 2001.
In this appeal, appellants have not attempted to antedate Singer or
Tenengauzer. Accordingly, for the purpose of this appeal, Singer and
Tenengauzer are prior art.

B. Record on appeal
In deciding this appeal, we have considered only the following
documents:
1. Specification, including original claims.
2. Final Rejection entered 30 March 2006
3. The Appeal Brief filed 4 October 2006
4. The Examiner’s Answer filed 17 October 2006
5. Tenengauzer
6. Curatolo
7. Singer
8. PTO bibliographic data sheet for the application on appeal
9. Rouhi, The Right Stuff, 18 Chemical and Engineering News
26-33 (Feb. 23, 2003), a copy of which appears in the Evidence Appendix of
the Appeal Brief.
10. Claims 1, 3-4, 7-9, 11, 13-23, 25-26 and 28 on appeal.
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C. Issues
There are two principal issues on appeal.
The first issue is whether appellants have sustained their burden of
showing that the Examiner erred in rejecting the claims on appeal as being
unpatentable under 35 U.S.C. § 103(a) over Tenengauzer
The second issue is whether appellants have sustained their burden of
showing that the Examiner erred in rejecting the claims on appeal as being
unpatentable under 35 U.S.C. § 103(a) over Singer and Curatolo.

D. Findings of fact
The following findings of fact are believed to be supported by a
preponderance of the evidence. To the extent that a finding of fact is a
conclusion of law, it may be treated as such. Additional findings as
necessary may appear in the Discussion portion of the opinion.
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The invention
The invention relates to a method of forming non-dihydrate
azithromycin granules. Specification, page 2:18-19.
The method involves mixing “non-dihydrate azithromycin” particles
with a “granulating amount” of a “granulating liquid” to form wet granules
of non-dihydrate azithromycin and then drying to remove any granulating
liquid to form azithromycin “granules.” Specification, page 2:20-25.
“Granules” are particles of azithromycin which are adhered together
or agglomerated. Specification, page 3:20-23. Good granules typically have
few fines, uniform size and stay intact after drying and sizing. Specification,
page 11:15-16.
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“Non-dihydrate azithromycin” means all amorphous and crystalline
forms of azithromycin, other than the dihydrate form of azithromycin
(Form A). Specification, page 3:29-33.
The “granulating liquid” may be non-aqueous or aqueous.
Specification, page 7:27-28. A preferred non-aqueous granulating liquid
includes ethanol. Specification, page 8:16-17.
A “granulating amount” is an amount of liquid sufficient to permit
particle adherence or agglomeration without significant dissolution of the
azithromycin. Specification, page 7:23-26.
The method of the invention is said to result in particles, i.e., granules,
which are free flowing and have good characteristics for tableting.
Specification, page 22:7-9.
According to appellants, flow properties of a formulation may be
evaluated by a number of methods known in the art. Specification,
page 22:16-17.
One way of characterizing formulation properties of a powdered
material is by bulk density measurements. Specification, page 22:17-19.
A simple method to provide a description of flow characteristics by
bulk density measurement is Carr’s Compressibility Index. Specification,
page 22:19-22.
Carr’s Compressibility Index is said to be a simple test to evaluate
flowability by comparing both the initial and final (tapped) bulk volumes
and the rate of packing down. Specification, page 22:22-25.
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A useful empirical guide to flow is given by Carr’s Compressibility
Index: Compressibility Index (%) = [(tapped density – initial density)
divided by tapped density] x 100. Specification, page 22:25-29.
Appellants tell us that it is preferred that the granules have a Carr’s
Compressibility Index of less than about 34%, more preferably less than
about 31%, and even more preferably less than about 28%. Specification,
page 22:31 through 23:2.
Example 6 describes a process of wet granulation of formulation of
Azithromycin Form F according to the invention. Specification, page 47:1
through end of page 48.
Azithromycin Form F has the empirical formula:
C38H72N2O12·H2O·0.5C2H5OH
in the single crystal structure and is referred to by appellants as being
azithromycin monohydrate hemi-ethanol solvate. Specification, page 7:1-3.
The structural formula of azithromycin is shown in Singer.
Col. 1:20-30.
Tapped density data is presented in the specification of bulk
azithromycin and various granulated azithromycins. Specification, page 48,
Table 6.
We will assume for the purpose of deciding the appeal that the data is
based on actual experimentation.
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The Table 6 data shows, inter alia, the following, where “Bulk drug”
is taken as being bulk azithromycin:
Sample Type Tapped Density3
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(g/cc)

Bulk drug 0.439

Granulated with 0.563
EtOH (which is
ethanol)

Granulated with 0.429
H2O

Granulated with 0.474
EtOH:H20
(50:50)

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Claims on appeal
Claim 1 on appeal is representative of the claimed method.
Claim 1 reads:
A method of forming non-dihydrate azithromycin granules,
comprising:
a) mixing
(i) a granulating amount of a non-aqueous granulating
liquid,
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(ii) optionally particles of one or more
pharmaceutically acceptable excipients,1 and
(iii) non-dihydrate azithromycin particles
to form wet granules, wherein the wet granules comprise non-
dihydrate azithromycin and the non-aqueous granulating liquid;
and
b) drying the wet granules to remove the non-aqueous
granulating liquid and thereby form non-dihydrate azithromycin
granules;
wherein said non-dihydrate azithromycin is selected from
the group consisting of substantially pure azithromycin
monohydrate hemi-ethanol solvate and azithromycin
sesquihydrate.

Claim 15 is representative of the composition claims on appeal.
Claim 15 reads:
A granule comprising non-dihydrate azithromycin and
optionally, one or more excipients2 wherein said granule is

1 Normally in assessing the scope of a claim, every limitation in a claim
should be given some meaning. However, limitation a) (ii) adds absolutely
nothing to define the scope of the claim. A method “comprising” (1) steps
a) (i) and a) (iii) and (2) b) has precisely the same scope as a method
including step a) (ii) due to the language “optionally” in step a) (ii) and the
transition phrase “comprising” which appears after the preamble. We would
recommend that step a) (ii) be deleted from claim 1 and be made the subject
of a claim depending from claim 1 in which limitation a) (ii) appears in the
dependent claim.
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formed by a wet granulation process using non-aqueous
granulating liquid; wherein said granule has a Carr’s
Compressibility Index of less than 34%; wherein said non-
dihydrate azithromycin is selected from the group consisting of
substantially pure azithromycin monohydrate hemi-ethanol
solvate and azithromycin sesquihydrate.

Tenengauzer 8
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Tenengauzer relates to stabilized azithromycin compositions.
Col. 1:13-14; col. 3:1-2.
One suitable particular azithromycin is azithromycin ethanolate
monohydrate. Col. 3:2-6.
Pharmaceutical compositions comprising the stabilized azithromycins
include dosage forms such as granulates. Col. 4:35-37.
While other dosage forms are described, according to Tenengauzer
among the methods for forming preferred tablet dosage forms are wet
granulation and dry granulation. Col. 4:41-43.
Tenengauzer describes numerous formulations using azithromycin.
See, e.g., the formulations described in Table 2 (beginning at the bottom of
columns 9 and 10 and ending at the top of columns 11 and 12).
Preparation 7 is described in Table 2 as being azithromycin granulated
with an ethanolic solution of antioxidant.
A further description of Preparation 7 is: “Technical grade
azithromycin was recrystallized from ethanol. BHT [butylated
2 With respect to the italicized portion of claim 15, see n. 1, supra.
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hydroxytoluene—col. 2:41-42] ... was dissolved in ethanol and the solution
was sprayed onto the azithromycin with thorough mixing.” Col. 10:4-8.
According to Formulation 1, “[s]tabilized azithromycin resulting
from Preparation 7 was formulated into a wet granulated tablet ....”
Col. 11:51-53.
The process of making Formulation 1 is described as mixing
Preparation 7 with denatured alcohol to form granules and then drying the
granules. See steps 2-5 in col. 12:35-40.
The description of making Formulation 1 from Preparation 7 is
consistent with the Examiner’s finding that “Tenengauzer ... teach[es] that
formulation containing azithromycin can be formed into granules ... by wet
granulation ....” Examiner’s Answer, page 4.
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Singer
The Examiner found that Singer describes “azithromycin ethanolate
which can be formed into tablets ... but do[es] not disclose a method of
forming azithromycin ethanolate into granules by wet granulation.”
Examiner’s Answer, page 5:1-3.
A review of Singer will confirm the Examiner’s finding.
For example, Singer teaches that oral forms of administering
azithromycin includes “tablets.” Col. 3:24-25.
An Example in Singer describes preparation of azithromycin
ethanolate. Col. 3:54.
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Curatolo
The Examiner found that Curatolo describes preparation of
azithromycin tablets and that granulation is a preferred step in the process of
formulating tablets. Examiner’s Answer, page 5.
The Examiner also found that Curatolo describes the use of
“excipients” in combination with azithromycin. Id.
Curatolo tells us that azithromycin is a broad spectrum antimicrobial
compound. Col. 1:11-13.
Curatolo, which predates Singer, describes an oral dosage form of
azithromycin. Col. 2:36-37.
Excipients may be combined with azithromycin. Col. 6:54-57.
Curatolo, which is said to be owned by appellants’ assignee Pfizer
Inc., tells one the following about the level of skill in the art more than one
year prior to the filing date of the application on appeal:
As known in the art, tablet blends may be dry-granulated
or wet granulated before tableting. Alternatively, tablet blends
may be directly compressed. The choice of processing
approach depends upon the properties of the drug and chosen
excipients, for example particle size, blending compatibility,
density and flowability. For azithromycin tablets, granulation
is preferred, with wet granulation being most preferred.
Azithromycin may be wet-granulated and then other excipients
may be added extragranularly. Alternatively, azithromycin and
one or more excipients may be wet-granulated.

Col. 7:51-61.

Curatolo confirms that wet granulating was a known technique for use
in the overall process of making azithromycin tablets.
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Curatolo further confirms that the choice of processing approach
depends on the properties sought to be obtained.
One of those properties is “density” which is a property of interest to
appellants. See Specification, page 48, Table 6 (density and tapped density).
Curatolo still further confirms that wet granulation is preferred as a
step in making azithromycin tablets.
Many of the examples of Curatolo describe products with
azithromycin dihydrate—which, of course, is outside the scope of the claims
on appeal.
However, nothing in Curatolo limits the applicability of the Curatolo
invention to azithromycin dihydrate.

E. Principles of law
A claimed invention is not patentable if the subject matter of the
claimed invention would have been obvious to a person having ordinary skill
in the art. 35 U.S.C. § 103(a); Graham v. John Deere Co. of Kansas City,
383 U.S. 1 (1966).
Facts relevant to a determination of obviousness include (1) the scope
and content of the prior art, (2) any differences between the claimed
invention and the prior art, (3) the level of skill in the art and (4) any
relevant objective evidence of obviousness or non-obviousness. Graham,
383 U.S. at 17-18.
A person having ordinary skill in the art uses known elements and
process steps for their intended purpose. Anderson's-Black Rock, Inc. v.
Pavement Salvage Co., 396 U.S. 57 (1969) (radiant-heat burner used for its
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intended purpose in combination with a spreader and a tamper and screed);
Sakraida v. AG Pro, Inc., 425 U.S. 273, 282 (1976) (the involved patent
simply arranges old elements with each performing the same function it had
been known to perform); Dunbar v. Myers, 4 Otto (94 U.S.) 187, 195 (1876)
(ordinary mechanics know how to use bolts, rivets and screws and it is
obvious that any one knowing how to use such devices would know how to
arranged a deflecting plate at one side of a circular saw which had such a
device properly arranged on the other side).
An inventor must show that the results the inventor says the inventor
achieves with the invention are actually obtained with the invention and it is
not enough to show results are obtained which differ from those obtained in
the prior art—any difference must be shown to be an unexpected difference.
In re Klosak, 455 F.2d 1077, 1080, 173 USPQ 14, 16 (CCPA 1972). See
also In re Geisler, 116 F.3d 1465, 1469-70, 43 USPQ2d 1362, 1365 (Fed.
Cir. 1997) (party asserting unexpected results has the burden of proving that
the results are unexpected).
A showing of unexpected results generally must be commensurate in
scope with the breadth of the claimed invention. In re Greenfield, 571 F.2d
1185, 1189, 197 USPQ 227, 230 (CCPA 1978). See also In re Harris, 409
F.3d 1339, 1344, 74 USPQ2d 1951, 1955 (Fed. Cir. 2005).
Where, as here, the claimed and prior art products are identical or
substantially identical, or are produced by identical or substantially identical
processes, the PTO can require an applicant to prove that the prior art
products do not necessarily or inherently possess the characteristics of his
claimed product. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433
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(CCPA 1977). See also In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655,
1657-1658 (Fed. Cir. 1990).

F. Discussion
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Examiner’s § 103 rejection based on Tenengauzer
The findings support the Examiner’s holding of obviousness.
The process described by Tenengauzer for making Formulation 1
from Preparation 7 facially appears to involve all of the steps set out in
appellants’ method claim 1: (1) mixing an azithromycin with a granulating
amount of a non-aqueous granulating liquid to form wet granules and (2)
drying the wet granules. See Steps 2 to 5 mentioned in our findings.
One azithromycin described as useful by Tenengauzer is azithromycin
ethanolate monohydrate.
We, like the Examiner, find it difficult to distinguish the product made
by the process described by Tenengauzer from that claimed by appellants.
In re Best, supra.
Appellants’ principal argument seems to be that Tenengauzer does not
describe granules with a Carr’s Compression Index of less that 34%. Appeal
Brief, page 14 (answering the Examiner’s § 102 rejection) and page 15
(answering the Examiner’s § 103 rejection).
A review of claims 1, 3-4, 7-11 and 13-14 will reveal that no Carr’s
Compression Index is recited. Accordingly, appellants’ argument cannot
control the obviousness and patentability determination of those claims.
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Furthermore, appellants have not shown that use of the Tenengauzer
process would not result in granules having a Carr’s Compression Index of
less than 34%. In re Best, supra.
Appellants also argue: “In addition, the claimed method uses ‘a
granulating amount’ of ‘a non-aqueous granulating liquid.’ One of ordinary
skill in the art would not interpret such terms as involving adding enough
liquid to fully dissolve azithromycin.”
The terms “a granulating amount” and “granulating liquid” are
defined in the specification (page 7) to permit particle adherence or
agglomeration, without significant dissolution of azithromycin.
According to Step 2 of Tenengauzer, Preparation 7 is “mixed” with a
liquid and granulated.
Insofar as we can tell, Tenengauzer does not say, and appellants have
not established, that significant dissolution of azithromycin takes place in the
Tenengauzer process.
Moreover, with respect to the composition claims, appellants have not
told us where the record establishes that dissolution makes any difference as
to a composition.
Appellants’ argument is an argument of counsel not supported by any
reference to objective evidence in the record. We decline to search the
record to determine if there might be evidence which might support
counsel’s argument. 37 C.F.R. § 41.67(a)(1)(vii) (2006) (appellant’s brief is
to set out the contentions of appellant with respect to each issue and “the
basis therefore, with citations of the … parts of the record relied on.”). See
also Bamberger v. Cheruvu, 55 USPQ2d 1523, 1537 (Bd. Pat. App. & Int.
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1998) (we decline to search the record in the first instance to determine
whether there is evidence which might support a holding of obviousness)
and the Federal Circuit’s observation in Rexnord Corp. v. Laitram Corp.,
274 F.3d 1336, 1343, 60 USPQ2d 1851, 1855 (Fed. Cir. 2001) (the parties
have the responsibility to provide all relevant arguments and point out with
specificity the relevant support of their arguments).
With respect to the claims which recite a Carr’s Compression Index of
less that 34%, appellants’ argument is not convincing for a variety of
reasons.
First, based on the evidence called to our attention in the Appeal
Brief, at best appellants have established that they can obtain a Carr’s
Compression Index of less than 34% only for azithromycin Form 4, which is
azithromycin monohydrate hemi-ethanol solvate. Specification, page 7:1-3.
Except for claims 8 and 17-22, the remaining claims cover a process of
using and compositions made from another azithromycin.
Second, we have not been told where the record would support
findings to demonstrate that the 34% is an unexpected result. Merely
because appellants achieve a Carr’s Compression Index of less than 34%
does not per se establish an unexpected result—at best a Carr’s Compression
Index of 34% is a “different” result. In any event, we cannot overlook the
fact that we are told by Curatolo that wet granulation is the method of choice
for making azithromycin tablets and that one skilled in the art looking for
density properties would take into account the choice of processing. When
the objective evidence of non-obviousness is balanced against the prior art
and the objective evidence of obviousness which appears in this record, we
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have no trouble declining to credit appellants’ “showing” of non-
obviousness.

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Examiner’s § 103 rejection based on Singer and Curatolo
The Examiner found that a person having ordinary skill in the art
seeking to make the tablets of Singer would have found it obvious to use the
process of Curatolo to do so.
The evidence supports the Examiner’s finding.
As the Examiner noted, Singer describes tablets made from
azithromycin ethanolate.
To be sure, Singer does not describe precisely how one would go
about making a tablet from its azithromycin—nor need Singer do so given
that the prior art already describes how a tablet is to be made. Cf. Webster
Loom Co. v. Higgins, 15 Otto (105 U.S.) 580 (1881) ((1) "The loom itself
was old. Every part of it was familiar to every loom manufacturer and to
every weaver."; (2) an inventor may begin a description of an invention at
the point where his invention begins, and describe what he has made that is
new, and what it replaces of the old and that which is common and known is
as if it were written out in the patent and delineated in the drawings).
Curatolo is a primer on what one skilled in the art knows about
making tablets.
Curatolo tells us that one skilled in the art seeking to make a tablet
containing azithromycin first granualates using preferably a wet-granulating
method and that depending on the precise properties sought knows how to
make processing choices.
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On the basis of the evidence before us, we have no difficulty
concluding that appellants have done nothing more than make granulated
azithromycin using known techniques to get exactly what one skilled in the
art would expect.
Appellants disagree maintaining that the art must, in appellants’
words, have “some suggestion or motivation” to combine the teachings of
Singer and Curatolo. Appeal Brief, page 17.
We have no trouble finding that the teachings of Singer and Curatolo
can be combined—the Curatolo glove fits right on the Singer hand.
Singer is said to fail to describe all the limitations of the claims. The
argument is a side show apart from the main event. If Singer described all
the limitations, then the Examiner would have made an anticipation
rejection. What appellants’ argument amounts to is a “divide and conquer”
approach—since Singer does not show it all, then the combination of Singer
and Curatolo is “no good”. Sometime ago, however, binding precedent
made clear that an obviousness rejection cannot be overcome by attacking
references individually—which is precisely what appellants are doing. In re
Young, 403 F.2d 754, 757, 159 USPQ 725, 728 (CCPA 1968).
Appellants go on to say that Singer does not describe any
azithromycin having a Carr’s Compression Index of less that 34%. Appeal
Brief, page 18. Appellants are correct that there is no explicit description of
a Carr’s Compression Index in Singer. However, making a tablet is
described by Singer and Curatolo tells anyone skilled in the art precisely
how to make the tablet. Not only that, but based on Curatolo, any one
skilled in the art would know that through process choices, properties—
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including density—can be controlled. On this record, for all we know,
anyone making a tablet using Singer’s azithromycin via the Curatolo
preferred wet granulating process would get results similar to those of
appellants. Even if not so, one skilled in the art making a granule to make
the Singer tablet would obtain a granule having a Carr’s Compression Index
of some value. On this record we have no idea what that Index number
might be.
Appellants, of course, maintain that the Carr’s Compression Index of
less that 34% is unexpected. We have already addressed why appellants’
proofs fall short of those required by law to establish the “unexpected”
nature of the results.
Appellants also maintain that the Examiner has engaged in hindsight.
We totally disagree and appellants have failed to explain why one skilled in
the art would not have used the Curatolo process choices to make the Singer
tablet. Binding precedent tells us that obviousness judgments are necessarily
based on hindsight, but so long as judgment takes into account only
knowledge known in the art, there is no hindsight error. In re McLaughlin,
443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). The Examiner’s
rejections are based squarely on the prior art. There is no impermissible
hindsight in this case.
Appellants rely on Rouhi in an attempt to “catch” the Examiner
contradicting herself. The Examiner initially had held that the claimed
invention was based on a non-enabling description because, according to
appellants, the Examiner initially felt that there was some question whether
azithromycin (presumably Form F) would maintain its crystalline structure
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when granulated. Basically, what the Examiner was investigating was
whether appellants on the one hand had an enabling description and if so on
the other hand whether the invention would have been obvious. The
Examiner’s technique is a proper and often used technique to accomplish the
examination required by 35 U.S.C. § 131 and 37 C.F.R. § 1.104 (2006) in
pharmaceutical and organic chemistry cases. In support of a first blush non-
enabling rejection, the Examiner mentioned Rouhi—as she should have to
support the rejection. Upon consideration of appellants’ arguments,
ultimately the Examiner became convinced that there was an enabling
description and so the lack of enablement rejection was withdrawn. But,
what appellants seek to do is create an “estoppel” against the Examiner from
forever changing her mind when becoming convinced an applicant has a
point with respect to one of numerous rejections. If the Examiner, at the
Examiner’s Answer stage, had harbored any doubt about enablement, we
would have had both an enablement and obviousness rejection before us.
Moreover, on the merits of the rejections before us, Rouhi seems to be a
“generic” discussion about numerous problems and concerns in the
pharmaceutical field. While paroxetine hydrochloride and cefadroxil are
mentioned (see page 30), neither are azithromycins—a fact which
immediately can be confirmed by reference to the 2001 Physicians’ Desk
Reference at pages 1003 and 3114. Appellants’ reliance on Rouhi is not
persuasive when weighed against the explicit azithromycin teachings of
Curatolo—a patent said to be owned by appellants’ assignee. Curatolo
convincingly shows that one skilled in the art uses wet granulating
techniques to make azithromycin tablets. Rouhi does not appear to mention
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azithromycin. For the reasons given, as applied to the facts of this case we
credit the more relevant teachings of Curatolo over the less relevant
“teachings” of Rouhi.

G. Conclusions of law
Appellants have not sustained their burden on appeal of showing that
the Examiner erred in rejecting the claims on appeal as being unpatentable
under 35 U.S.C. § 103(a) over Tenengauzer.
Appellants have not sustained their burden on appeal of showing that
the Examiner erred in rejecting claims on appeal as being unpatentable under
35 U.S.C. § 103 over Singer and Curatolo.
On the record before us, appellants are not entitled to a patent
containing claims 1, 3-4, 7-9, 11, 13-23, 25-26 or 28.

H. Decision
ORDERED that the decision of the Examiner rejecting
claims 1, 3-4, 7-9, 11, 13-23, 25-26 and 28 over Tenengauzer is affirmed.
FURTHER ORDERED that the decision of the Examiner
rejecting claims 1, 3-4, 7-9, 11, 13-23, 25-26 and 28 over Singer and
Curatolo is affirmed.
FURTHER ORDERED that no time period for taking any
subsequent action in connection with this appeal may be extended under 37
C.F.R. § 1.136(a)(1)(iv) (2006).

AFFIRMED
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mv

cc (via First Class mail)
Lance Y. Liu, Esq.
Pfizer Inc.
Patent Department, MS 8260-1611
Eastern Point Road
Groton, CT 06340

Tel: 860-868-1652
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