Ex Parte Murphy et al

Board of Patent Appeals and Interferences

May 1, 2007

10327459 (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for publication and is not binding precedent of the Board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 BRENDAN MURPHY, STEVEN W. COLLIER,
ERNEST QUAN and BARBARA A. JOHNSON
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Appeal 2007-1378
Application 10/327,459
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 rejections of
claims 1, 5, 7-9, 11-14, 16-23, 25-27, 29, 31, 33-37, 39-45, 48-51, 56-58,
60-62, 64-82 (hereafter “claims 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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The real party in interest is Pfizer Inc.
The Examiner rejected the claims on appeal 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 also rejected the claims on appeal under 35 U.S.C.
§ 103(a) as being unpatentable over Singer and Curatolo.
The following prior art relied was relied upon by the Examiner.

Name Patent Number Issue Date9
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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, appellants’ filing date being
20 December 2002.
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.
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.
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B. Record on appeal
In deciding this appeal, we have considered only the following
documents:
1. Specification, including original claims.
2. Drawing
3. Office action entered 26 October 2005.
4. Office action entered 04 April 2006
5. Corrected Appeal Brief on appeal filed 02 August 2006
6. Examiner’s Answer entered 31 August 2006
7. Tenengauzer
8. Curatolo
9. Singer
10. PTO bibliographic data sheet
11. 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.
12. Claims on appeal.

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.
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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 dry blend of non-dihydrate azithromycin
which can be used to make tablets containing the azithromycin.
Specification, page 3:11-14.
“Dry blend” means a generally homogeneous mixture of two or more
materials in particle form. Specification, page 4:34-36.
“Non-dihydrate azithromycin” means all amorphous and crystalline
forms of azithromycin, other than the dihydrate form of azithromycin
(Form A). Specification, page 5:15-19.
According to appellants, flow properties of a formulation may be
evaluated by a number of methods known in the art. Specification,
page 13:6-7.
One way of characterizing formulation properties of a powdered
material is by bulk density measurements. Specification, page 13:7-9.
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A simple method to provide a description of flow characteristics by
bulk density measurement is Carr’s Compressibility Index. Specification,
page 13:9-12.
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 13:13-15.
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 13:16-20.
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 14:1-5.

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Claims on appeal
Since appellants do not single out any particular claim for special
consideration, we will treat claim 1 on appeal as representative of the
claimed invention. 37 C.F.R. § 41.37(c)(1)(vii) (2006).
Claim 1 reads:
A dry blend, used for forming azithromycin tablets by direct
compression, comprising:
(a) about 1-80%, by weight, non-dihydrate azithromycin;
(b) at least one pharmaceutically acceptable excipient; and
(c) from about 0.25-10%, by weight, of a lubricant;
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wherein the Carr’s Compressibility Index, of the dry blend, is
less than about 34%;
wherein said non-dihydrate azithromycin is azithromycin
monohydrate hemi-ethanol solvate.

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Tenengauzer
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 tablets. Col. 4:35-37.
While other dosage forms are described, according to Tenengauzer
among the methods for forming preferred tablet dosage forms are dry
granulation (compaction and slugging) and direct compression.
Col. 4:41-43.

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Singer
Singer describes azithromycin ethanolate which can be formed into
tablets and compressed or coated pills. Col. 3:24-27
An Example in Singer describes preparation of azithromycin
ethanolate. Col. 3:54.
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Curatolo
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 and lubricants 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 granulation was a known technique for use in
the overall process of making azithromycin tablets.
Curatolo further confirms that the choice of processing approach
depends on the properties sought to be obtained.
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One of those properties is “density” which is a property of interest to
appellants. See the various references to Carr’s Compression Index in the
specification generally and in the various examples.
Curatolo still further confirms that granulation is preferred as a step in
making azithromycin tablets, although Curatolo expresses a preference for
wet-granulation. Col. 7:56-58.
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.

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Level of skill in the art
In addition from what we learn from Curatolo, we also learn from
background of the invention as described in appellants’ specification that a
person having ordinary skill in the art knows that direct compression is a
tableting process in which tablets are compressed directly from powder
blends containing an active ingredient. Specification, page 1:5-7.
In direct compression, all the ingredients required for tableting,
including the active ingredient and processing aids, are incorporated into a
free flowing blend which is then tableted. Specification, page 1:7-11.
The active ingredient, excipients, and other substances are blended
and then compressed into tablets. Specification, page 1:11-12.
Tablets are typically formed by pressure being applied to a material in
a tablet press. Specification, page 1:13-14.
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According to appellants, pharmaceutical manufacturers now prefer
the use of direct compression, over wet and dry granulation processes,
because of its shorter processing times and cost advantages. Specification,
page 1:20-23.
What appellants tell us about the preference for direct compression, at
least as of the date the application on appeal was filed (20 December 2002),
is not precisely the same as what appellants’ assignee said about forming
tablets in Curatolo, which was filed on 29 April 1994. Apparently the art
has evolved between 1994 and 2002, as is often the case.
Appellants note, in this respect, that direct compression is generally
limited to those situations in which the active ingredient has physical
characteristics suitable for forming pharmaceutically acceptable tablets via
direct compression. Specification, page 1:23-26.
Some active ingredients, which are generally unsuitable for direct
compression per se, can be formed into a directly compressible formulation
by incorporating one or more excipients before compression. Specification,
page 1:27-30.
It is known that, to form a tablet from a given formulation, the
formulation must have good flow properties for precise volumetic feeding of
the material [i.e., formulation,] to a die cavity and suitable compressibility,
compactability, and ejection properties to form a tablet. Specification,
page 2: 18-23.
The flow properties of powders are said to be critical for “efficient
tableting operation.” Specification, page 2:23-24.
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Azithromycin A is not considered to be amenable to the production of
directly compressible tablets of azithromycin formulation. Specification,
page 3:1-4.
However, as Tenengauzer reveals, azithromycin ethanolate
monohydrate is a suitable candidate for dry granulation tablet formation
involving (1) roller compaction (Example 4; col. 15:21) and pressing
(Example 4; col. 15:32) and (2) milling (Example 5; col. 18:14) and pressing
(Example 5; col. 18:19).
Curatolo also tells us that azithromycin dihydrate is a suitable
candidate for dry granulation or direct compression. Col. 7:51-53.

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
intended purpose in combination with a spreader and a tamper and screed);
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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).
A prior art reference is not limited to its preferred embodiments or
specific working examples. In re Burckel, 592 F.2d 1175, 1179, 201 USPQ
67, 70 (CCPA 1979). See also In re Mills, 470 F.2d 649, 651, 176 USPQ
196, 198 (CCPA 1972).
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).
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,
1657-58 (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.
One azithromycin described as useful by Tenengauzer is azithromycin
ethanolate monohydrate—which is not a hydrate of azithromycin.
Lubricants said to be useful in making the Tenengauzer product are
magnesium stearate and talc. Col. 5:38-39. In Example 4, magnesium
stearate and talc are present in an amount of 7.6% [(32.0 + 2.0 {from Part II}
+ 13.6 + 15 {from Part III})/824 = 7.6%], which falls within the scope of
appellants’ claimed range of 0.25-10% lubricant.
Tenengauzer also describes addition of excipients. Col. 4:30.
We, like the Examiner, find it difficult to distinguish the product made
by Tenengauzer from that claimed by appellants. In re Best, supra.
Appellants argue that Tenengauzer does not describe all the
limitations of claim 1. However, Tenengauzer plainly reveals that a dry
blend may have a non-dihydrate azithromycin, an excipient and a lubricant
in an amount mentioned in claim 1.
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 12.
With respect to the Carr’s Compression Index of less than 34%,
appellants’ argument is not convincing.
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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 granulation and direct compression are suitable
methods 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 have no trouble declining to credit appellants’
“showing” of non-obviousness.
The Examiner made a point in the Examiner’s Answer to the effect
that according to the specification (page 13:30 to page 14:1), appellants
indicate that formulations with a Carr’s Compression Index greater than
34% “resulted in poor flow and inability to form suitable tablets on an
F-press.” Examiner’s Answer, page 5.
In effect, what the Examiner found was that a blend has to be
formulated in such a manner as to be suitable for making tablets.
Apparently that means a Carr’s Compression Index of less than 34%.
What appellants have determined is precisely what we learn from
Curatolo—choice of processing conditions depends on the properties of the
drug and chose excipients. Col. 7:52-64.
A person skilled in the art, attempting to make a dry blend, from the
ingredients set out in Tenengauzer would use ingredients and amounts to
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succeed. The level of skill in the art, as revealed by this record, shows that
one skilled in the art manifestly would be able to do so. To the extent that
appellants limit the claims to blends which are “operable” is not surprising
and reflects, we believe, nothing more than a realization of what one having
ordinary skill in the art would do. Once a person sets out to follow
Tenengauzer to make a tablet, one skilled in the art would be expected to use
proper techniques, as shown by the level of skill on the record, to succeed—
not to fail.
Appellants argue that Tenengauzer described the use of an anti-
oxidant to prevent chemical degradation of azithromycin. Appeal Brief,
page 13.
Appellants’ argument is foreclosed by the Examiner’s observation that
appellants use the transition language “comprising.” Examiner’s Answer,
page 5. See Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948).

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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 dry
granulation or direct compression as described by Curatolo.
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
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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. See also the background of the invention as described in the
specification.
Curatolo tells us that one skilled in the art seeking to make a tablet
containing azithromycin may dry granulation or direct compression and that
depending on the precise properties sought knows how to make processing
choices.
On the basis of the evidence before us, we have no difficulty
concluding that appellants have done nothing more than make an
azithromycin dry blend 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 16.
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
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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 16. Appellants are correct that there is no explicit description of
Carr’s Compression Index in Singer. However, making a tablet is described
by Singer and any one skilled in the art would know from Curatolo 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—
including density—can be controlled. On this record, for all we know,
anyone successfully making a tablet using Singer’s azithromycin via the
Curatolo dry granulation or direct compression 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.
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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
when granulated. Basically, what the Examiner was investigating was
whether appellants on the one hand had an enabling description and if so
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
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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 dry granulating or direct compression techniques to make azithromycin
tablets. Rouhi does not appear to mention 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.
Appellants maintain that the Examiner has used an “obvious to try”
standard. According to appellants an “obvious to try” standard is not an
appropriate standard. Appeal Brief, pages 12-13 and 16-17. This argument
goes nowhere. The Examiner did not make an obviousness holding based on
“obvious to try.” Moreover, an “obvious to try” argument is often made
when there is an issue of whether the evidence supports a finding that there
is a reasonable chance of success. In re O’Farrell, 853 F.2d 894, 7 USPQ2d
1673 (Fed. Cir. 1988). See also (1) In re Eli Lilly & Co., 902 F.2d 943, 945,
14 USPQ2d 1741, 1743 (Fed. Cir. 1990) (an "obvious-to-try" situation exists
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Appeal 2007-1378
Application 10/327,459

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when a general [prior art] disclosure may pique the scientist's curiosity, such
that further investigation might be done as a result of the [prior art]
disclosure, but the [prior art] disclosure itself does not contain a sufficient
teaching of how to obtain the desired result, or that the claimed result would
be obtained if certain directions were pursued) and (2) Pfizer, Inc. v. Apotex,
Inc., 480 F.3d 1348, 1365, 82 USPQ2d 1321, ____ (Fed. Cir. 2007). There
is no legitimate “obvious to try” issue in this case since the prior art tells one
skilled in the art precisely how to make “operable” tablets. Not only is there
a reasonable chance of success in this case—there is no doubt a skilled
artisan would be successful.

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 over (1) Tenengauzer or (2) the combination of
Singer and Curatolo.
On the record before us, appellants are not entitled to a patent
containing the claims on appeal.

H. Decision
ORDERED that the decision of the Examiner rejecting the
claims on appeal under 35 U.S.C. § 103(a) over Tenengauzer is affirmed.
FURTHER ORDERED that the decision of the Examiner
rejecting the claims on appeal under 35 U.S.C. § 103(a) over the
combination of Singer and Curatolo is affirmed.
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Appeal 2007-1378
Application 10/327,459

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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).

5 AFFIRMED

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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