Ex Parte LI et al

Board of Patent Appeals and Interferences

May 1, 2007

10650253 (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for publication and is not binding precedent of the Board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 ZHENG J. LI and ANDREW V. TRASK
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Appeal 2007-1348
Application 10/650,253
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 125 and 128-144.
We have jurisdiction under 35 U.S.C. § 6(b).
The application on appeal was filed on 27 August 2003.

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The application on appeal is said to be a continuation of application
10/152,106, filed 21 May 2002, which claims benefit of (1) provisional
application 60/343,041, filed 21 December 2001, (2) provisional application
60/297,741, filed 12 June 2001, and (3) provisional application 60/292,565,
filed 22 May 2001.
The real party in interest is Pfizer Inc.
The Examiner rejected claims 125 and 128-144 for failure to comply
with the enablement requirement of the first paragraph of 35 U.S.C. § 112.
The Examiner further rejected claims 125 and 128-144 as being
anticipated under 35 U.S.C. § 102(b), alternatively as being unpatentable
under 35 U.S.C. § 103(a), over Bright.
The Examiner still further rejected claims 125 and 128-144 as being
unpatentable under 35 U.S.C. § 103(a) over Singer and Curatolo. (The
reader should know that no references to et al. are made in this opinion.)
The following references were relied upon by the Examiner.
Name Patent Number Issue Date16
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Bright US 4,474,768 02 Oct. 1984
Curatolo US 5,605,889 25 Feb. 1997
Singer US 6,365,574 B2 02 Apr. 2002

Bright and Curatolo are prior art vis-à-vis appellants under 35 U.S.C.
§ 102(b).
Singer is facially prior art vis-à-vis appellants under 35 U.S.C.
§ 102(e). Appellants have abandoned any attempt to antedate Singer.
Supplemental Reply Brief, filed 16 October 2006.
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B. Record on appeal
1. Specification, including original claims and a preliminary
amendment to the specification setting out the claimed priority.
2. Drawings
3. Final Rejection entered 16 March 2006
4. Brief on Appeal filed 03 August 2006
5. Examiner’s Answer entered 31 August 2006
6. Reply Brief filed 13 September 2006
7. Examiner’s notation of Reply Brief entered 03 October 2006
8. Supplemental Reply Brief filed 16 October 2006 (in which
appellants explicitly withdraw reliance on a Rule 131 declaration of
Dr. Richard Todd Darrington seeking to antedate Singer)
9. Bright
10. Curatolo
11. Singer
12. Memorandum Opinion and Order (Decision on Motions) entered
in Li v. Singer, Interference 105,366, Paper 71 (Bd. Pat. App. & Int. Nov. 8,
2006)—a copy of the Memorandum Opinion and Order appears in the
evidence appendix of the Appeal Brief.

C. Issues
There are three 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 under
35 U.S.C. § 112, first paragraph, for lack of an enabling description.
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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
anticipated under 35 U.S.C. § 102(b) by Bright, alternatively that the
claimed subject matter is unpatentable under 35 U.S.C. § 103(a) over Bright.
The third 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.
Involved in the resolution of all three issues is the scope of claim 125.

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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Claim 125
Claim 125 is representative of the claims on appeal.
According to the claims appendix accompanying the Appeal Brief,
claim 125 reads [matter in brackets added]:
A pharmaceutical dosage form comprising said [sic “a”]
[1] substantially pure crystalline azithromycin monohydrate
hemi-ethanol solvate and [2] a pharmaceutically acceptable
carrier or diluent; wherein said crystalline azithromycin
monohydrate hemi-ethanol solvate is characterized as having a
13C solid state NMR spectrum comprising at least one peak with
chemical shift of about 179.5 ppm.
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The invention
A review of the specification will reveal that the crystalline
azithromycin to which appellants make reference in claim 125 is what we
believe appellants call “substantially pure” azithromycin “Form F.”
According to the specification, the invention relates to a crystal form
of azithromycin where the crystal form is selected from forms C, D, E, F, G,
H, J, M, N, O, P, Q and R. Specification, page 2:7-8.
A reference to Form F per se needs to be distinguished from a
reference to “substantially pure” Form F vis-à-vis other possible Form F’s.
See specification, page 2:28 and page 5:22-29.
The empirical formula of Form F is:
C38H72N2O12·H2O·0.5C2H5OH
in the single crystal structure and is referred to by appellants as being
azithromycin monohydrate hemi-ethanol solvate.
The structural formula of azithromycin itself is shown in the
specification at page 1:8.
Form F has a 13C solid state NMR spectrum comprising at least one
peak with chemical shift at about 179.5 ppm ± 0.2 ppm. Specification,
page 2:19 and Fig. 23 (mentioned in the specification, page 9:6).
Crystallographic data of Form F is set out in a table on page 11 of the
specification.
For further information concerning substantially pure azithromycin
Form F we refer the reader to a MEMORANDUM OPINION and ORDER
(Decision on Motions) entered in Li v. Singer, Interference 105,366,
Paper 71 (Bd. Pat. App. & Int. Nov. 8, 2006).
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Claim 125 requires two ingredients: (1) substantially pure crystalline
azithromycin Form F and (2) a carrier or diluent.
With respect to carriers and diluents, the following appears in the
specification (page 32:25-33; emphasis added):
The active compound may be administered alone or in
combination with pharmaceutically acceptable carriers or
diluents … and such administration may be carried out in single
or multiple doses. More particularly, the active compound may
be administered in a wide variety of different dosage forms, i.e.,
they may be combined with various pharmaceutically
acceptable insert carriers in the form of tablets, capsules,
lozenges, trouches, hard candies, powders, sprays, creams,
salves, suppositories, jellies, gels, pastes, lotions, ointments,
sachets, powders for oral suspension, aqueous suspensions,
injectable solutions, elixirs, syrups, and the like. Such carriers
include solid diluents or fillers, sterile aqueous media and
various non-toxic organic solvents, etc.

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Bright
Bright describes azithromycin. Col. 1, lines 16-17 and col. 2,
lines 1-15.
Bright does not describe azithromycin Form F or substantially pure
Form F.
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Singer
Singer describes an azithromycin which Singer characterizes as an
ethanolate of azithromycin having an ethanol content of about 1.5% to
about 3%. Col. 4, lines 16-17 (claim 1).
Li has previously sustained its burden of establishing that a Singer
ethanolate of azithromycin having an ethanol content of about 1.5% to about
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3% is not the same as substantially pure azithromycin Form F. Li v. Singer,
Interference 105,366, Paper 71 (Bd. Pat. App. & Int. Nov. 8, 2007).
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Curatolo
We find it unnecessary to discuss what is described by Curatolo.

E. Principles of law
Claims undergoing examination are given their broadest reasonable
construction consistent with the specification. Burlington Industries v.
Quigg, 822 F.2d 1581, 1583, 3 USPQ2d 1436, 1438 (Fed. Cir. 1987);
In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-51 (CCPA
1969).
During the examination of a patent application, an examiner has an
initial burden of establishing some objective basis for questioning
enablement of a specification. In re Marzocchi, 439 F.2d 220, 169 USPQ
367 (CCPA 1971). On appeal from a lack of enablement rejection, the
appellant bears the burden of showing that the examiner did not have a
sufficient objective basis to legally support the rejection.
The fact that a claim may include inoperative embodiments does not
per se render the claim unpatentable under the first paragraph of 35 U.S.C.
§ 112. In re Angstadt, 537 F.2d 498, 190 USPQ 214 (CCPA 1976).
An anticipation under 35 U.S.C. § 102(b) or 102(e) requires a prior art
reference to describe every limitation in a claim—either explicitly or
inherently. In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431
(Fed. Cir. 1997).
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A claimed invention is patentable if the subject matter of the claimed
invention would not 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.

F. Discussion
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Lack of enablement and anticipation based on Bright
In this particular appeal, the lack of enablement rejection and the
anticipation rejection based on Bright may be considered together.
Resolution of both rejections turns on a proper interpretation of
claim 125.
The Examiner determined that there was a lack of enablement and an
anticipation by Bright based on her finding that a crystalline compound
cannot maintain its crystalline structure in an aqueous media. Examiner’s
Answer, page 3.
The Examiner also determined that appellants’ “carrier” or “diluent”
could be “sterile aqueous media.” Examiner’s Answer, page 3.
Since a crystalline compound cannot maintain its crystalline structure
in water, the Examiner reasoned that appellants’ disclosure is insufficient to
enable one to make a combination of substantially pure Form F and water
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because on placing the substantially pure Form F in water there no longer
would be any Form F. Examiner’s Answer, page 3.
Using similar reasoning, the Examiner found that when substantially
pure Form F is placed in water, a mixture of the azithromycin and water of
appellants would be the same as a mixture of the azithromycin of Bright and
water. Examiner’s Answer, pages 4-5.
We agree with appellants, however, that claim 125 requires the
presence of substantially pure azithromycin Form F.
To the extent that a mixture does not contain substantially pure
Form F, it cannot fall within the scope of claim 125.
We can assume, as did the Examiner, that substantially pure Form F
would not maintain its crystalline structure in water.
A mixture of (1) azithromycin, resulting from de-crystallization of
Form F when placed in water, and (2) water are not covered by, and do not
fall within the scope of claim 125.
Even if we assume that some embodiments within the scope of
claim 125 might be non-enabled, the composition defined by claim 125
would still be useful and the specification otherwise advises one skilled in
the art how to make and use substantially pure azithromycin Form F mixed
with other carriers and diluents. In re Angstadt, supra.
Bright does not describe a mixture containing substantially pure
azithromycin Form F.
Accordingly, Bright cannot describe a mixture within the scope of
claim 125.

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Obviousness based on Singer
Singer, like Bright, does not describe or render obvious substantially
pure azithromycin Form F.
Appellants and the Examiner agree that Curatolo likewise does not
describe substantially pure azithromycin Form F.
Based on Li v. Singer, what surfaces in this case is that an essential
element of appellants’ mixture does not appear in the prior art relied upon by
the Examiner.
Accordingly, the scope and content of the prior art is such that the
prior art, as a whole, cannot render obvious the subject matter of claim 125.

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Additional observations
1. In fairness to the Examiner, we wish to point out that the Examiner’s
Answer was entered on 31 August 2006, but our decision in Li v. Singer was
not entered until 08 November 2006.
When the Examiner’s Answer was written in August, the Examiner
could not have known what we might hold in November in an inter partes
case involving Li (one appellant here) and Singer (the reference relied upon
by the Examiner here).
In Li v. Singer, Li was able to sustain its burden of showing that
Singer did not anticipate or render obvious subject matter which is
somewhat broader than the subject matter of claim 125.
Had the Examiner been aware of Li v. Singer, we are confident the
rejection based on obviousness would not have been maintained.
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2. In the appeal brief an elaborate argument is made to the effect that the
Examiner failed to follow PTO standards for claim construction. Appeal
Brief, pages 10-12.
In particular, it is said that the Examiner’s claim interpretation in this
case is inconsistent with claim interpretation by (1) the Examiner in other
cases and (2) other examiners in other cases.
The Examiner did not address appellants’ argument and we think
correctly so. The argument simply is irrelevant.
Our appellate reviewing court, as well as other earlier reviewing
courts, has made it clear for a long time that the issue in a case is whether an
examiner and the board erred in the case under consideration. In re Phillips,
315 F.2d 943, 137 USPQ 369 (CCPA 1963) (issuance of patent to third
party is irrelevant to patentability on direct appeal in other case even if
references are the same); In re Riddle, 438 F.2d 618, 169 USPQ 45 (CCPA
1971) (an examiner's allowance of claim in patent does not bar rejection of
claim in application to substantially same invention on substantially same art
considered in patent prosecution). See also Fessenden v. Coe, 99 F.2d 426,
38 USPQ 516 (D.C. Cir. 1938).
We have given no consideration to appellants’ argument concerning
alleged different interpretation by the Examiner or other examiners in other
cases.
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G. Conclusions of law
Appellants have sustained their burden on appeal of showing that the
Examiner erred in rejecting claims 125 and 128-144 as being based on a lack
of enablement under the first paragraph of 35 U.S.C. § 112.
Appellants have sustained their burden on appeal of showing that the
Examiner erred in rejecting claims 125 and 128-144 as being anticipated
under 35 U.S.C. § 102(b) by Bright.
Appellants have sustained their burden on appeal of showing that the
Examiner erred in rejecting claims 125 and 128-144 as being unpatentable
under 35 U.S.C. § 103(a) over Singer and Curatolo.

H. Decision
ORDERED that the decisions of the Examiner rejecting
claims 125 and 128-144 (1) for lack of enablement, (2) as being anticipated
by Bright, alternatively unpatentable under 35 U.S.C. § 103(a), and (3) as
being unpatentable over Singer and Curatolo are reversed.
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).

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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: 860-686-1652
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