Ex Parte Van Dyke

Board of Patent Appeals and Interferences

Jul 26, 2002

08475791 (B.P.A.I. Jul. 26, 2002)

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for publication and is not binding precedent of the Board.

Paper No. 27

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte KNOX VAN DYKE
__________

Appeal No. 1999-2523
Application No. 08/475,791
__________

ON BRIEF
__________

Before WILLIAM F. SMITH, ADAMS and MILLS, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL

This is a decision on the appeal under 35 U.S.C. § 134 from the
examiner’s final rejection of claims 57-62 and 64-67, which are all the claims
pending in the application.
Claim 57 is illustrative of the subject matter on appeal and is reproduced
below:
57. One of a pharmaceutical composition and kit comprising:
(i) an agent in an amount effective to cause blood glutathione
levels to increase, selected from the group consisting of
glutathione, N-acetyl cysteine, 2-oxo-4 thiazolidine
carboxylic acid, ebselen, oltipraz, L-cysteine, N-acetyl
cysteine ethyl ester, N-acetyl cysteine methyl ester,
cystamine, cysteamine, penicillamine, 2,3 dimercapto-1-
propanol, L-2-oxothiazolidone-4-carboxylate, dimethyl
maleate, glutathione ethyl ester, glutathione methyl ester,
Appeal No. 1999-2523 Page 2
Application No. 08/475,791

glutathione isopropyl ester, oxazolidone, and combinations
thereof;
(ii) an amount of one or more additional antioxidants at a dose
higher than the recommended daily minimum requirement;
and
(iii) an NFKB induction inhibitor in an amount effective to inhibit
nuclear factor kappa B, said NFKB induction inhibitor being
selected from the group consisting of anti-inflammatory
steroids and nonglucocorticoid lazaroids.

The references relied upon by the examiner are:
Malfroy-Camine et al. (Malfroy-Camine) 5,403,834 Apr. 4, 1995
Muller 5,463,063 Oct. 31, 1995
GROUND OF REJECTION

Claims 57-62 and 64-67 stand rejected under 35 U.S.C. § 103 as being
unpatentable over Malfroy-Camine alone or in combination with Muller.
We reverse.
DISCUSSION
According to the specification (page 7), “NFKB is a gene transcription
factor that switches on the production of the HIV virus of a virally infected cell.”
Appellant discloses (Specification, pages 7-8), that the oxidant peroxynitrite,
produced from lipopolysaccharide or interferon activated hybridoma
macrophages, activates NFKB and causes the HIV virus and other latent viruses
in an infected cell to replicate. Appellant suggests (Specification, page 8), “the
inhibition of the oxidation mechanism could stop the replication of the virus.” In
addition, appellant discloses (id.), “[r]educed glutathione reacts with peroxynitrite
to reduce it to NO2+.” Accordingly, appellant discloses (page 5), “[t]he present
invention provides methods and pharmaceutical compositions for repressing
reproduction of latent viruses, such as HIV, in humans and animals, by generally
Appeal No. 1999-2523 Page 3
Application No. 08/475,791

concurrent administration of 1) a glutathione agent; 2) at least one additional
antioxidant; and 3) at least one NFKB induction inhibitor.” Appellant discloses
(specification, page 6), “by using this combination of ingredients, the
reproduction of latent viruses in animals can be repressed.”
THE REJECTION UNDER 35 U.S.C. § 103:
According to the examiner (Answer, page 3) Malfroy-Camine teaches “a
composition containing N-acetylcysteine[1], tocopherol (fat soluble vitamine),
ascorbate (water soluble vitamine), 21 aminosteroids (lazaroids) and cortisone
(note col. 26, lines 45-51).” However, the examiner finds (id.), that while Malfroy-
Camine does not exemplify the claimed composition, the reference “teaches the
functions of lazaroids, steroids and various antioxidants and the rationale for
preparing compositions containing these ingredients for the treatment of various
diseases including AIDS[ ]([]note columns 1-7, and 26-27).” Therefore, the
examiner concludes (Answer, bridging sentence, pages 3-4) that it would have
been obvious “to one of ordinary skill in the art [at the time the invention was
made] to prepare compositions containing [the] instant components” based on
the teachings of Malfroy-Camine alone.
Notwithstanding the above conclusion, the examiner finds (Answer, page
4) that “Malfroy-Camine does not use the term, NFKB inhibitors.” However, the
examiner finds (id.) Muller discloses “that TNF is inflammatory and activates
NFKB and a potential activator for HIV and other retroviruses.” The examiner
also finds (id.) Muller discloses “that the suppression of TNF effects was

1 We note the specification discloses (page 8) that “N-acetyl cysteine, L-cysteine or 2-oxo-4-
thiazolidene carboxylic acid, as well as other substances, can act as glutathione precursors.”
Appeal No. 1999-2523 Page 4
Application No. 08/475,791

attempted in the art by steroids such as dexamethasone and prednisolone and
then advocates the use of cyclic imides in combination with steroids.” Based on
this evidence the examiner concludes (id.) that the “inclusion of NFKB inhibitors
such as dexamethasone and prednisolone in the teachings of Malfroy-Camine,
with the expectation of obtaining at least an additional effect, … would have
been obvious to an artisan [at the time the invention was made], if the disease to
be treated is a retro[-]viral infection.”
In response, appellant argues (Brief, page 6) that Malfroy-Camine “merely
provide a list of ingredients, any of which may or may not be administered in
combination, with at least one species of antioxidant salen-metal complex.”
Appellant finds (Brief, pages 6-7) that following the disclosure of Malfroy-Camine
“one may try” eight different categories of compositions of which only two:
may contain one of the recited agents for raising blood glutathione
levels, an additional antioxidant, and an NFKB induction inhibitor,
but only if the selected one or more free radical scavengers include
an agent selected from the group of compounds listed under (i) of
[appellant’s] claim 57 and only if the selected one or more
oxyradical inhibitors includes an anti-inflammatory steroid or a
nonglucocorticoid lazaroid.

Appellant finds (Brief, page 8), that since Malfroy-Camine’s specification
provides no guidance in the selection of appropriate or suitable active ingredients
for compositions useful in the treatment of disease, “it would only be by chance
that one having ordinary skill in the art would select a composition containing a
free radical scavenger which increases blood glutathione levels and an
oxyradical inhibitor which is an anti-inflammatory steroid or a nonglucocoirticoid
Appeal No. 1999-2523 Page 5
Application No. 08/475,791

lazaroid.” Therefore, appellant finds (Answer, page 10) “that the Malfroy-
Camine et al. patent does not suggest the subject matter of claim 57.”
With regard to Muller, appellant finds (Answer, page 11) the disclosure of
attempts “to use steroids to suppress the effects of TNFα, and that steroids can
be co-administered with cyclic imides to suppress the effects of TNFα do not
suggest that steroids should be used in combination with the salen-metal
complexes described by Malfroy-Camine et al. for treating free radical-
associated diseases[2].” Therefore, appellant concludes (id.), “Muller does not
provide the guidance which Malfroy-Camine et al. lack, and therefore, is of little,
if any, relevance with respect to claim 57.”
Appellant argues (Reply Brief, page 3) “[t]he question is always whether
the prior art teaches or suggests the claimed combination, not whether a
reference lists all of the ingredients. Without disclosure of specific combinations
or guidance as to how one selects specific ingredients, a listing of ingredients is
merely a suggestion to try various combinations.” With reference to In re Deuel,
51 F.3d, 1552, 1558-59, 34 USPQ2d 1210, 1215, appellant finds (Reply Brief,
page 6) that “[m]otivation to select the claimed combinations must be taught by
the prior art.”
In response, the examiner argues (Answer, page 4), “motivation for one to
arrive at a specific combination need not be the same as applicants’.” According
to the examiner (Answer, page 5) “selecting compounds from the combinations

2 We note the abstract of Malfroy-Camine discloses that “[t]he invention provides antioxidant
salen-metal complexes … to treat or prevent a disease associated with cell or tissue damage
produced by free radicals such as superoxide.”
Appeal No. 1999-2523 Page 6
Application No. 08/475,791

taught by the reference and finding that the combination is effective against
certain viruses … is to be expected and not unexpected in nature.” With regard
to Muller, the examiner agrees with appellant (id.) that “Muller does not teach or
suggest that steroids would be expected to provide a beneficial effect when used
in combination with antioxidants generally or in combination with specific
antioxidant salen-metal complexes described by Malfroy-Camine.” However, the
examiner argues (id.):
Muller is relied upon for its teachings of the knowledge in the art of
TNF’s inflammatory nature and its activation of NFKB and thus, a
potential activator for HIV and other retro[-]viruses inhibition, and
for its’ teachings of the knowledge in the art of the suppression []of
the effects of TNF by the steroids, dexamethasone and
prednisolone.

As set forth in In re Kotzab, 217 F.3d 1365, 1369-70, 55 USPQ2d 1313,
1316 (Fed. Cir. 2000):
A critical step in analyzing the patentability of claims pursuant to
section 103(a) is casting the mind back to the time of invention, to
consider the thinking of one of ordinary skill in the art, guided only
by the prior art references and the then-accepted wisdom in the
field. … Close adherence to this methodology is especially
important in cases where the very ease with which the invention
can be understood may prompt one “to fall victim to the insidious
effect of a hindsight syndrome wherein that which only the
invention taught is used against its teacher.” …

Most if not all inventions arise from a combination of old elements.
… Thus, every element of a claimed invention may often be found
in the prior art. … However, identification in the prior art of each
individual part claimed is insufficient to defeat patentability of the
whole claimed invention. … Rather, to establish obviousness based
on a combination of the elements disclosed in the prior art, there
must be some motivation, suggestion or teaching of the desirability
of making the specific combination that was made by the applicant.
[citations omitted]

Appeal No. 1999-2523 Page 7
Application No. 08/475,791

In other words, “there still must be evidence that ‘a skilled artisan, ... with
no knowledge of the claimed invention, would select the elements from the cited
prior art references for combination in the manner claimed.’” Ecolochem Inc. v.
Southern California Edison, 227 F.3d 1361, 1375, 56 USPQ2d 1065, 1075-76
(Fed. Cir. 2000).
At best, the statement of the rejection establishes that individual parts of
the claimed invention were known in the prior art, however, as appellant points
out (Reply Brief, page 3) “[t]he question is always whether the prior art teaches
or suggest the claimed combination, not whether a reference [or combination of
references] lists all of the ingredients.” On this record, we agree with appellant
that the prior art relied upon by the examiner fails to suggest appellant’s claimed
invention. Accordingly, we reverse the rejection of claims 57-62 and 64-67 under
35 U.S.C. § 103 as being unpatentable over Malfroy-Camine alone or in
combination with Muller.
Appeal No. 1999-2523 Page 8
Application No. 08/475,791

Having determined that the examiner has not established a prima facie
case of obviousness, we find it unnecessary to discuss the unexpected results
relied on by appellants (Brief, page 12) to rebut any such prima facie case.
REVERSED

William F. Smith )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Donald E. Adams )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Demetra J. Mills )
Administrative Patent Judge )

Appeal No. 1999-2523 Page 9
Application No. 08/475,791

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