Ex parte Kosley Jr. et al.

Board of Patent Appeals and Interferences

Sep 28, 2000

08137444 (B.P.A.I. Sep. 28, 2000)

Application for patent filed October 15, 1993. 1
1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered
today (1) was not written for publication in a law
journal and (2) is not binding precedent of the
Board.
Paper No. 18
UNITED STATES PATENT AND TRADEMARK OFFICE
________________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
________________
Ex parte RAYMOND W. KOSLEY JR., LARRY DAVIS
and VERONICA TABERNA
________________
Appeal No. 1997-2167
Application 08/137,4441
________________
ON BRIEF
________________
Before WINTERS, W. SMITH and METZ, Administrative Patent
Judges.
METZ, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal from the examiner's refusal to allow
claims 1 through 52, all the claims remaining in this
application.
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Application 08/137,444
2
THE INVENTION
The appealed subject matter is directed to a genus of
compounds which may be broadly characterized as galanthamine
derivatives, pharmaceutical compositions comprising a
pharmaceutically acceptable carrier and an
acetylcholinesterase (AChE) inhibiting amount of the
galanthamine derivative, methods of treating memory
dysfunction characterized by decreased cholinergic function by
administering to a mammal an AChE inhibiting amount of the
galanthamine derivative and methods of treating memory
dysfunction characterized by decreased cholingeric function by
administering to a mammal an AChE inhibiting amount of the
galanthamine derivative which metabolizes in situ to form 6-O-
demethylgalanthamine. According to appellants, the claimed
family of galanthamine derivatives possesses the ability to
inhibit the enzyme AchE. The enzyme AChE lowers acetylcholine
levels in the brain. Inhibition of AChE therefore increases
brain levels of acetylcholine.
Claims 1, 2, 48, 49 and 50 are believed to be adequately
representative of the appealed subject matter and are
reproduced below for a more facile understanding of
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Application 08/137,444
3
appellants' invention.
Claim 1. A compound of the formula
wherein
R is hydrogen, (C -C )alkylcarbonyl,1 1 I2
(C -C )alkoxycarbonyl, aryl(C -C )alkylaminocarbonyl,1 I2 1 I2
mono(C -C )alkylaminocarbonyl or1 18
di(C -C )alkylaminocarbonyl; 1 18
R is (C -C )alkylcarbonyloxy,2 1 I2
aryl(C C )alkylcarbonyloxy, (C -C )alkoxycarbonyloxy,l- 4 1 12
arylcarbonyloxy, hydroxy,
(C -C )alkoxycarbonyl(C -C )alkoxy or1 6 1 6
hydroxy(C -C )alkoxy;l 10

R is hydrogen or halo; and pharmaceutically3
acce ptable
addi tion salts;
with the proviso
that when R is2
hydr oxy, R and1
R are not3
both hydrogen or
when R is2
hydr oxy and R3
is hydrogen, R1
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Application 08/137,444
4
is not methylcarbonyl.
Claim 2. The compound of Claim 1 wherein

R is hydrogen, (C -C )alkylcarbonyl or (C -1 1 12 1
C )alkoxycarbonyl; 12
R is (C -C )alkylcarbonyloxy, arylcarbonyloxy, 2 1 12
(C -C )alkoxycarbonyloxy, hydroxy, (C -C )1 12 1 6
alkoxycarbonyl(C -C )alkoxy or hydroxy(C -C )1 6 1 6
alkoxy; and
R is hydrogen or halogen; with the proviso that when3
R is hydroxy, R and R are not both hydrogen or R2 1 3 2
is hydroxy and R is hydrogen, R is not3 1
methylcarbonyl.

Claim 48. A pharmaceutical composition which
comprises a pharmaceutically acceptable carrier and
an acetylcholinesterase inhibiting amount of the
compound of Claim 1.

Claim 49. A method of treating memory dysfunction
characterized by decreased cholinergic function
which comprises administering to a mammal an
acetylcholine-sterase inhibiting amount of the
compound of Claim 1.
Claim 50. A method of
treating memory dysfunction characterized by
decreased cholinergic function with
6-O-demethylgalanthamine which comprises
administering to a mammal an acetylcholinesterase
inhibiting amount of the compound of Claim 2 when R3
is hydrogen.
RELATED APPEALS
On page 2, lines 1 through 9 of their brief, appellants
direct our attention to two, related appeals which, according
Appeal No. 1997-2167
Application 08/137,444
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to appellants, relate to the same issues as herein involved.
The related appeals involve U.S. Application Serial Number
08/137,440, filed on October 15, 1993 (Appeal Number 1997-
2188); and U.S. Application Serial Number 08/137,443, filed on
October 15, 1993 (Appeal Number 1997-2182).
The claims in this application differ from the claims in
the two related applications chiefly in the description of the
substituent R . Decisions in the two related appeals were2
mailed on even date with this opinion.
THE REJECTIONS
Claims 1 through 52 are rejected under 35 U.S.C. § 112,
first paragraph, on the grounds the specification fails to
adequately teach how to use the claimed invention. Claims 50
and 51 are rejected under 35 U.S.C. § 112, second paragraph,
on the grounds that the claims do not distinctly claim the
subject matter which appellants regard as their invention.
Claims 1 through 4 are rejected under 35 U.S.C. § 112, first
paragraph, on the grounds that the subject matter now claimed
by appellants is not described in appellants' original
disclosure.
OPINION
We have carefully considered the entire record before us,
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Application 08/137,444
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including the well-argued positions taken by both the examiner
and the appellants. We find, however, that the examiner has
failed to make out a prima facie case of unpatentability under
the relevant statutes as the statutes have been interpreted by
our reviewing courts. Accordingly, for reasons expressed
fully below, we shall reverse each of the examiner's stated
rejections.
THE CLAIMS
Our analysis of the issues before us begins with a
determination of the scope and content of what appellants
claim as their invention. As claims pending in a yet to be
patented application, we must give the claims their broadest,
reasonable interpretation, consistent with appellants'
disclosure as said disclosure would have been understood by a
person of ordinary skill in the art at the time appellants
made their invention, but without importing limitations from
the specification into the claims for the purpose of narrowing
the scope of the claims.
The compound claims (claims 1 through 46 and 52) are
directed solely to a specific group of compounds. The
specific group of compounds is defined solely by the
substitutents R , R and R located at the various positions1 2 3
Appeal No. 1997-2167
Application 08/137,444
7
found on the compound depicted by formula (II) in claim 1 and
also includes the "pharmaceutically acceptable addition salts"
thereof. The terminology "pharmaceutically acceptable
addition salts" is conventional language used to describe
well-known groups of compounds (salts) prepared from various
acids and the claimed compounds. The salts are usually
prepared for purposes of solubility and bioavailability. See
appellants' disclosure at page 8, lines 9 through 12 for acids
useful for preparing the claimed salts.
Appellants' composition claims are so-called "comprising"
claims and, as such, are directed to compositions including
the recited carrier and an acetylcholinesterase inhibiting
amount of the compounds defined by claim 1. The compositions
are open to the inclusion of compounds such as those described
by appellants in their specification at page 8, line 13
through page 9, line 27. The compositions do not exclude any
other materials, including materials disclosed but not claimed
and materials neither disclosed nor even contemplated.
Appellants' method claims are directed to two separate
embodiments: one where memory dysfunction characterized by
decreased cholinergic function is treated by administering the
compounds of claim 1 to a mammal in an amount effective to
Appeal No. 1997-2167
Application 08/137,444
8
inhibit AChE; and, a second where memory dysfunction
characterized by decreased cholinergic function is treated
with 6-O-demethylgalanthamine, a known AChE inhibiting
compound, by administering to a mammal in an amount sufficient
to inhibit AChE the compound of Claim 2 where R is hydrogen. 3
Thus, both methods are limited to treating memory dysfunction
characterized by decreased cholinergic function.
The first method requires administering to a mammal with
memory dysfunction characterized by decreased cholinergic
function an amount of the compound of claim 1 sufficient to
inhibit the formation in the mammal of the enzyme AchE. As a
"comprising" claim the first method does not exclude any other
step or ingredient, including steps or ingredients disclosed
but not claimed and even steps or ingredients neither
disclosed or even contemplated. The second method requires
administering to a mammal with memory dysfunction
characterized by decreased cholinergic function the compound
6-O-demethylgalanthamine by administering to said mammal in an
amount sufficient to inhibit the formation in the mammal of
AChE the compound of Claim 2 or 31 which metabolizes to 6-O-
demethylgalanthamine. Like the first method, the second
method is open to other steps and ingredients, both disclosed
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Application 08/137,444
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but not claimed ones and steps and ingredients neither
disclosed nor even contemplated.
THE "HOW TO USE" REJECTION UNDER § 112
The examiner's rejection of the claims as being based on
a specification which fails to adequately teach "how to use"
the claimed invention is a rejection under the so-called
"enablement" requirement of the first paragraph of 35 U.S.C. §
112. It is incumbent upon the examiner in rejecting claims
under the first paragraph of 35 U.S.C. § 112, to establish a
prima facie case of lack of enablement. In re Strahilevitz,
668 F.2d 1229, 1232, 212 USPQ 561, 563 (CCPA 1982); In re
Wertheim, 541 F.2d 257, 263, 191 USPQ 90, 97 (CCPA 1976); In
re Armbruster, 512 F.2d 676, 677, 678, 185 USPQ 152, 153 (CCPA
1975); In re Marzocchi, 439 F.2d 220, 224, 169 USPQ 367, 370
(CCPA 1971). Moreover, in determining whether or not a
disclosure is enabling, it has been consistently held that the
enablement requirement of the first paragraph of 35 U.S.C. §
112 requires nothing more than objective enablement. In re
Marzocchi, 439 F.2d at 223, 169 USPQ at 369. In meeting the
enablement requirement, an application need not teach, and
preferably omits, that which is well-known in the art.
Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367,
Appeal No. 1997-2167
Application 08/137,444
10
1384, 231 USPQ 81, 94 (Fed. Cir. 1986).
How such a teaching is set forth, whether by the use of
illustrative examples or by broad descriptive terminology, is
of no importance since a specification which teaches how to
make and use the invention in terms which correspond in scope
to the claims must be taken as complying with the first
paragraph of 35 U.S.C. § 112 unless there is reason to doubt
the objective truth of the statements relied upon therein for
enabling support. Marzocchi, at 439 F.2d 223, 169 USPQ 369. A
specification is considered to be enabling if a person of
ordinary skill in the art could "make and use" the claimed
invention without resort to "undue experimentation". In re
Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970).
"Whether making and using an invention would have
required undue experimentation, and thus, whether a disclosure
is enabling under 35 U.S.C. § 112, ¶ 1 (1994), is a legal
conclusion based upon underlying factual inquiries." Johns
Hopkins University v. CellPro Inc., 152 F.3d 1342, 1354, 47
USPQ2d 1705, 1713 (Fed. Cir. 1998). Nevertheless, there must
be a reasonable correlation between the scope of what is
claimed and the scope of enablement provided by appellants'
specification to the person of ordinary skill in the art. In
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Application 08/137,444
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re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir.
1991); In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA
1970).
Factors to be considered in determining whether a
disclosure would require "undue" experimentation include (1)
the quantity of experimentation necessary, (2) the amount of
direction or guidance presented, (3) the presence or absence
of working examples, (4) the nature of the invention, (5) the
state of the prior art, (6) the relative skill of the
routineer in the art, (7) the predictability or lack thereof
in the art, and (8) the breadth of the claims. In re Wands,
858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The examiner's position as stated in his Answer is that
he considers appellants' claims to be directed to the
treatment of Alzheimer's disease, the only disease mentioned
in their specification as including as a symptom thereof
memory loss due to decreased cholinergic function. The
examiner explains that appellants have failed to present
adequately reliable information
in their disclosure for effectively treating Alzheimer's
disease. Specifically, the examiner questions the reliability
Appeal No. 1997-2167
Application 08/137,444
See page 6, line 27 through page 7, line 15 of the 2
specification for an explanation of the Dark Avoidance Test.
12
of appellants' screening method for screening prospective drug
candidates for treatment of memory dysfunction characterized
by decreased cholinergic function. The examiner also
questions whether appellants use of the Dark Avoidance Test2
can reliably predict efficacy in humans of the claimed
compounds.
At page 2 of his Answer, the examiner has listed various
prior art references which serve as the evidence which
supports his rejection. Of all the listed prior art the
examiner has proffered as evidence in support of his
rejection, we find the article by Han et al. in the European
Journal of Medical Chemistry to be the most relevant reference
to the issues presented for our determination. Han et al.
acknowledges on page 673 that:
One of the more promising palliative approaches relates
to potentiating the activity of the central cholinergic
system. A decrease in central nervous system cholinergic
markers is the most consistent and well-documented
neurochemical change in Alzheimer's disease. Accordingly,
several pharmacological strategies to enhance central
cholinergic function are being explored: muscarinic
agonists, acetylcholine releasing agents and
cholinesterase inhibitors. [cites to the bibliography
omitted]
Appeal No. 1997-2167
Application 08/137,444
Whether or not the results of the clinical trial have3
been published and whether, if published, the results are
prior art having a bearing on the patentability of the
appealed claims is an issue the examiner and appellants should
investigate upon return of this application to the examining
group.
13
Thereafter in the paragraph bridging pages 673 and 674, the
authors observe that:
Galanthamine (1, scheme 1), a long-acting, centrally-
active competitive cholinesterase inhibitor, has shown
considerable promise. This natural product, an alkaloid
of the Amaryllidaceae family, is hydrolysis-resistant,
only moderately toxic, and more readily absorbed than
physostigmine. The animal data suggest that this compound
might be effective in treating the central cholinergic
deficits in Alzheimer's disease. A recent clinical trial
found that 1 was a well-tolerated drug during long term
treatment. [cites to the bibliography omitted] 3
On page 674 the parent compound 1 and nine other galanthamine
derivatives are set forth. On page 679 in Table III, the
IC 's for seven galanthamine derivatives is set forth and in50
vivo studies were conducted on galanthamine n-butyl carbamate
in mice and yielded "promising results".
Additionally, the examiner has cited several other
references in support of his rejection which acknowledge the
role of AChE inhibitors in treating Alzheimer's disease. See
for example, Robinson et al. at page 1127 wherein the authors
Appeal No. 1997-2167
Application 08/137,444
1,2,3,4 -tetrahydro-9-aminoacridine, also known as THA.4
14
acknowledge the therapeutic effect of AChE inhibitors for
treating Alzheimer's disease. The examiner has also cited
Sarter et al. as evidence that there was a recognition in the
art at the time appellants made their invention that the high
number of failures in clinical trials for drugs ("recognition
enhancers") screened and then tested on an animal model was
directly correlated to the lack of sufficient attention to the
specific psychological mechanisms underlying behavioral
enhancement. Nevertheless, Sarter et al. do recognize at page
154 that, "[a]rguably the strongest case for positive effects
can be made for the AChE inhibitors," and Sarter et al. also
observe at page 149 that:
AChE inhibitors and muscarinic agonists can reverse
behavioral deficits caused by lesions to the cholinergic
basal forebrain nuclei or drug induced ACh depletion in a
wide variety of learning and memory tasks. (citation
omitted)
Further, both Nordberg et al. and Liston et al. recognize the
mechanism by which Tacrine functions is believed to be due to4
AChE inhibition. Indeed, Liston et al. comment that they:
conclude that the inhibition of brain AChE by THA is
sufficient to explain its therapeutic action in
Alzheimer's disease. (emphasis ours)
Appeal No. 1997-2167
Application 08/137,444
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Simply stated, the examiner has failed to present
objective evidence sufficient to cast doubt on the objective
truthfulness of appellants' assertions made in their
specification and on which they rely for enablement. It is
only after the examiner presents evidence which establishes
that one of ordinary skill in the art would reasonably doubt
the assertions made by appellants in their specification in
support of the enablement requirement of the statute that
appellants must rebut the position taken by the examiner.
As we have noted above, on balance, the evidence on which
the examiner has relied gives credence to the objective
truthfulness of appellants' representations rather than casts
doubt on them. Moreover, the examiner has improperly narrowly
construed appellants' claims as limited to the treatment of
Alzheimer's disease. Both the claims and appellants'
disclosure are directed generally to treating a type of memory
dysfunction in mammals characterized by decreased cholinergic
function. The very art on which the examiner relies suggests
that at the time appellants made their invention, AChE
inhibitors were generally recognized as a class of compounds
suitable for treating illness attributable to decreased
acetylcholine function, including Alzheimer's disease.
Appeal No. 1997-2167
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16
The examiner also expresses his belief that the prior art
on which he has relied establishes that there was, at the time
of appellants' invention, no known cure or even treatment for
Alzheimer's disease. In the first instance, as we have stated
above, appellants do not claim either a cure of or even
treatment for Alzheimer's disease but claim a method for
treating a specific type of memory dysfunction. Secondly, the
operative claim term used is "treating" by administration of
the claimed compounds to a mammal. We consider the term
"treatment" to encompass a method which results in the
mitigation of any symptom of the condition being treated but
not to encompass "curing" the condition. We also disagree
with the examiner's position that a method of treating a
disease or medical condition must address the underlying
disease or condition. Persons who suffer from allergies such
as hayfever, for example, "treat" their symptoms with
antihistamines and, yet, still have the underlying allergy.
Appellants' specification describes how to synthesize the
claimed galanthamine compounds (see page 3, line 27 through
page 6, line 2 of the specification), including forty-one
examples of the synthesis of compounds within the claims
(pages 10 through 40 of the specification). Appellants
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Application 08/137,444
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disclose how the claimed compounds may be administered, what
constitutes effective quantities for administration and the
form in which the compounds may be administered (page 8, lines
1 through page 9, line 28 of the specification). Possessed of
this disclosure, we have no doubt but that the skilled
routineer would be able to prepare and use the claimed
compounds in the manner disclosed above.
The examiner's criticism of the claims as set forth in
the statement of his rationale for rejecting the claims
appears to be an expression of his concern that the claimed
compounds and method of using the same may not be efficacious
or even work at all. While the examiner's concern is
laudable, it is misplaced here. As the court observed in In
re Brana, 51 F.3d 1560, 1567, 34 USPQ2d 1436, 1442 (Fed. Cir.
1995):
The Commissioner, as did the Board, confuses the
requirements under the law for obtaining a patent
with the requirements for obtaining government
approval to
market a particular drug for human consumption. See Scott v.
Finney, 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120 (Fed. Cir.
1994)
Simply stated, approval of the Food and Drug Administration is
not a prerequisite for finding a compound useful within the
Appeal No. 1997-2167
Application 08/137,444
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meaning of 35 U.S.C. § 112, first paragraph. Only objective
enablement is required.
To the extent the position taken by the examiner is that
appellants' claims may include inoperative embodiments we
observe that it has been held that, even assuming it could be
established that the claims do embrace some inoperative
embodiments, it is not the function of the claims to
specifically exclude all possible inoperative substances or
ineffective amounts and proportions. See, Atlas Powder Co. v.
E.I. Du Pont de Nemours & Co, 750 F.2d 1569, 1576, 224 USPQ
409, 414 (Fed. Cir. 1984) citing In re Dinh-Nguyen, 492 F.2d
856, 858, 859, 181 USPQ 46, 48 (CCPA 1974). Accordingly, for
all the above reasons, we reverse the rejection of claims 1
through 52 under 35 U.S.C. § 112, first paragraph.
THE "WRITTEN DESCRIPTION' REJECTION UNDER § 112
The examiner has rejected claims 1 through 4 under the
first paragraph of 35 U.S.C. § 112. It is the examiner's
position that the newly added "provisos" to claims 1 through 4
which limit the definition of certain substitutents when R is2
hydroxy or when R is hydroxy and R is hydrogen are not2 3
"described" in the sense of the statute in appellants'
Appeal No. 1997-2167
Application 08/137,444
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original disclosure. The examiner relies on Ex parte
Grasselli, 231 USPQ 393 (Bd. App. 1983), aff'd mem 738 F.2d
453 (Fed. Cir. 1984) in support of his position. Appellants
urge that the "provisos" were added to specifically exclude
from the claims a known compound which known compound is
disclosed in the specification in Example 7.
The examiner's reliance on Grasselli, a case decided on
different facts than the facts in this case, does not support
the position taken by the examiner here. Here, appellants
discovered, apparently after filing the instant application,
that the broad claim terminology included compounds which were
known, that is, unpatentable to appellants because, based on
appellants' own admission, they are described in the prior
art.
Appellants' compound claims are so-called closed claims,
that is, they do not include any of the well-known open-ended
terms which leave the claims open to the inclusion of other
components. Thus, the compound claims include only the
compounds defined by the various substituents R , R and R in1 2 3
the formula depicting the compounds. Thus, the claims include
every compound defined by the various permutations for the
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Application 08/137,444
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various substituents and the compounds could also have been
claimed by listing by name each compound embraced by the
formula in claim 1. We see appellants' addition of the
"provisos" as the equivalent of deleting from the claim
particular compounds in the list of compounds for which
appellants originally sought protection. Manifestly, every
compound defined by the formula in claim 1 is "described" in
the sense of the statute. Logically, compounds which remain
after excluding the compounds according to the "provisos" are
part of the originally defined group and are, therefore, also
described.
The action taken by the examiner, if upheld, would be
tantamount to requiring appellants to maintain the scope of
their originally filed claims, even though said claims would
be unpatentable to appellants. Such a requirement does not
reflect the law. See In re Johnson, 558 F.2d 1008, 1019, 194
USPQ 187, 196 (CCPA 1977), wherein the court noted that:
The notion that one who fully discloses, and teaches
those skilled in the art how to make and use, a
genus and numerous species therewithin, has somehow
failed to disclose, and teach those skilled in the
art how to make and use, that genus minus two of
those species, and has failed to satisfy the
requirements of § 112, first paragraph, appears to
result from a hypertechnical application of
legalistic prose relating to that provision of the
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Application 08/137,444
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statute. All that happened here is that appellants
narrowed their claims to avoid having them read on a
lost interference count.
Here, appellants have merely retreated from the full scope of
their originally disclosed invention in light of appellants'
recognition that their original claims included unpatentable
compounds. Accordingly, we reverse the rejection of claims 1
through 4 under 35 U.S.C. § 112, first paragraph.
THE REJECTION UNDER 35 U.S.C. § 112, SECOND PARAGRAPH
The examiner has rejected claims 50 and 51 because the
examiner believes appellants' expressed intention of what they
intended to claim in claims 50 and 51 does not comport with
the language of claims 50 and 51. Appellants direct our
attention to the specification at page 6, lines 6 through 8
wherein it is disclosed that certain galanthamine derivatives
cleave to form in situ the compound 6-O-demethylgalanthamine
which is admitted by appellants to be a known AChE inhibitor.
Appellants urge that the claims, therefor, are directed to
administering the compounds of either claims 2 or 31,
respectively, to form, in situ, the admittedly known AChE
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Application 08/137,444
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inhibitor 6-O-demethylgalanthamine.
While we agree with the examiner's conclusion that claims
50 and 51 are not models of clarity, we find the claims
adequately define the metes and bounds of what appellants
intend to claim by the claim language. We find the claims are
directed to administering the compounds of either claim 2 or
31, respectively, for the purpose of being converted in situ
in the mammal to whom the compounds are administered to the
known AChE inhibitor 6-O-demethylgalanthamine. Accordingly,
the rejection is reversed.
SUMMARY
The rejection of claims 1 through 52 under 35 U.S.C. §
112, first paragraph, is reversed. The rejection of claims 1
through 4 under 35 U.S.C. § 112, first paragraph, is reversed.
The rejection of claims 50 and 51 under 35 U.S.C. § 112,
second paragraph, is reversed.
The decision of the examiner is reversed.
REVERSED.
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SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
)
)
WILLIAM F. SMITH )BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
)INTERFERENCES
)
)
)
ANDREW H. METZ )
Administrative Patent Judge )
AHM/gjh
Carolyn Moon
Adventist Pharmecuticals
Patent Department/Mail Stop EMC 1028
Route#202-206/P.O. Box 6800
Bridgewater, NJ 08807-0800