Ex Parte Kossler et al

Board of Patent Appeals and Interferences

Sep 1, 2010

10297533 (B.P.A.I. Sep. 1, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PETER KOSSLER, NORBERT FUCHS, BODO KUKLINSKI,
and RAIMUND SCHIEFER
__________

Appeal 2009-009602
Application 10/297,533
Technology Center 1600
__________

Before ERIC GRIMES, JEFFREY N. FREDMAN, and STEPHEN
WALSH, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating herpes infections or pigmental moles (age spots). The Examiner

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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has rejected the claims as anticipated or obvious. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The Specification discloses “a method for increasing the antioxidant
potential of selenium-containing aqueous solutions, which is characterized in
that a selenium-containing aqueous solution is supplemented with
pharmaceutically acceptable or food compatible acids” (Spec. 3). The
Specification states that “a decrease of the pH of selenium-containing
solutions, in particular sodium selenite and selenate solutions, exhibit a
strongly increased antioxidant potential as compared to non-pH-reduced
solutions” (id. at 4).
Claims 42 and 45-67 are on appeal. Claims 42 and 67 are
representative and read as follows:
42. A method of treating a herpes infection or a pigmental mole in
a patient comprising topically administering to the patient a preparation
comprising a selenite having an increased antioxidant potential as compared
to elemental selenium and one or more pharmaceutically-acceptable or food-
compatible acids, wherein the herpes infection or the pigmental mole is
treated in the patient.

67. A method for increasing an antioxidant potential of a selenite in
a pharmaceutical composition for treatment of a herpes infection or
pigmental mole comprising adding a pharmaceutically acceptable or food-
compatible acid to the pharmaceutical composition, wherein the antioxidant
potential of the selenite is increased.

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The claims stand rejected as follows:
• Claim 67 under 35 U.S.C. § 102(b) as anticipated by Bankit2 (Ans.
4);
• Claims 42, 46, 47, and 51-55 under 35 U.S.C. § 103(a) as obvious
in view of Murad,3 Lundy,4 and Garcia5 (Ans. 5); and
• Claims 42, 45, and 47-66 under 35 U.S.C. § 103(a) as obvious in
view of Natterer,6 Levitt,7 and Richardson8 (Ans. 8).
I.
Issue
The Examiner finds that Bankit anticipates the method of claim 67
because it “teaches a process for preparing an aqueous solution of sodium
selenite in combination with an edible acid, particularly citric and ascorbic
acid . . . , in amounts which do not impair the effectiveness of sodium
selenite” (Ans. 4).
Appellants contend that Bankit’s composition would not contain
selenite because “those of ordinary skill in the art at the time the present
application was filed would have known that a composition acidified with
ascorbic acid would contain elemental selenium rather than selenite”
(Appeal Br. 4).

2 Bankit et al., US 4,668,515, May 26, 1987
3 Murad, US 6, 800,292 B1, Oct. 5, 2004
4 Lundy, US 4,512,977, Apr. 23, 1985
5 Garcia, US 5,512,200, Apr. 30, 1996
6 Natterer, US 5,079,010, Jan. 7, 1992
7 Levitt, US 4,340,590, July 20, 1982
8 Richardson et al., US 6,231,889 B1, May 15, 2001
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The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s finding that Bankit discloses all of the
limitations of claim 67?
Findings of Fact
1. Bankit discloses making a composition by blending, among other
things, sodium selenite, citric acid, and citrus fruit products containing
ascorbic acid (Bankit, col. 2, ll. 57-63; col. 2, l. 64; col. 3, ll. 8 and 56-63).
2. The Specification discloses that “[a]cidifying agents for the
selenium-containing solution comprise, in particular, acidifying agents that
are generally recognized as safe to both man and animal, such as, e.g., citric
acid, acetic acid, malic acid, carbonic acid, various fruit acids, and mixtures
thereof” (Spec. 4).
3. Bankit discloses that its final product contains 1-3 x 10-4 % by
weight, or 1.8 to 2.5 µg/ml, sodium selenite (Bankit, col. 3, l. 46; col. 4, ll.
28-29) and 0.3-0.6 % by weight citric acid and ascorbic acid (id. at col. 3,
l. 48; col. 4, ll. 29-31).
4. Ganther states that “[s]elenite is rapidly reduced to elemental
selenium by ascorbic acid, whereas selenate is not so readily reduced and
remains in solution. Precipitation of selenite with ascorbic acid, followed by
oxidation . . . is a good procedure for obtaining labeled selenite of high
purity.” (Ganther, 109).
Principles of Law
In patent prosecution, the examiner is entitled to reject
application claims as anticipated by a prior art patent without
conducting an inquiry into whether or not that patent is enabled
or whether or not it is the claimed material (as opposed to the
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unclaimed disclosures) in that patent that are at issue. . . . The
applicant, however, can then overcome that rejection by
proving that the relevant disclosures of the prior art patent are
not enabled.
Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir.
2003).
“[A] presumption arises that both the claimed and unclaimed
disclosures in a prior art patent are enabled.” Id.
Analysis
Bankit discloses making a composition by mixing citric acid and
sodium selenite, among other ingredients. We agree with the Examiner that
Bankit’s method meets the limitations of claim 67. We also agree with the
Examiner (Ans. 4) that claim 67’s preamble is merely a statement of the
intended use of the composition and not a limitation on the claimed method
and (Ans. 5) that increasing the antioxidant potential of the selenite in
Bankit’s composition would be the inherent result of mixing it with citric
acid.
Bankit discloses that its final composition contains sodium selenite,
not elemental selenium, and is entitled to a presumption that it enables a
method of making the disclosed composition. Amgen, 314 F.3d at 1355.
Appellants have the burden of proving that Bankit does not enable a skilled
worker to make its sodium selenite-containing composition. Id.
Appellants argue that Bankit’s composition would contain elemental
selenium rather than sodium selenite, because the ascorbic acid in Bankit’s
composition would reduce the selenite to selenium (Appeal Br. 4). In
support of their position, Appellants cite the Specification at page 7, lines
13-18 (Appeal Br. 4-5). Page 7 of the Specification, however, consists of
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two tables reporting the results of various herpes virus treatments; it does not
support Appellants’ argument regarding ascorbic acid and selenite. We have
reviewed the rest of the Specification but find no support therein for the
assertion that ascorbic acid reduces selenite to selenium.
Appellants also cite Ganther’s statement that “[s]elenite is rapidly
reduced to elemental selenium by ascorbic acid” (FF 4) as evidence that
Bankit’s composition would not contain selenite (Appeal Br. 5). Ganther
provides evidence that, under some circumstances, ascorbic acid will reduce
selenite to selenium, but it does not disclose the conditions under which that
will happen. In particular, Ganther does not state that, at the concentrations
and conditions of Bankit’s composition, all of the sodium selenite would be
reduced by ascorbic acid to elemental selenium. Notably, Ganther states that
when selenite is reduced to elemental selenium, it precipitates out of solution
(FF 4), but Bankit does not mention a precipitate forming in its composition.
In sum, Appellants have not provided sufficient evidence that,
contrary to its express disclosure, Bankit does not enable a method of
making a composition that contains sodium selenite rather than elemental
selenium.
Conclusion of Law
The evidence of record supports the Examiner’s finding that Bankit
discloses all of the limitations of claim 67.
II.
Issue
The Examiner has rejected claims 42, 46, 47, and 51-55 as obvious
based on Murad, Lundy, and Garcia (Ans. 5). The Examiner finds that
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Murad discloses topical pharmaceutical compositions for treating age spots,
comprising citric acid and a selenium compound or salt thereof (Ans. 5-6)
and that Lundy discloses sodium or potassium selenite salts for
pharmaceutical use (id. at 6).9 The Examiner concludes it would have been
obvious “in light of the teaching of using a pharmaceutically acceptable
selenium salt by Murad, to employ a selenite salt (such as that disclosed by
Lundy) in the composition disclosed by the reference” (id.).
Appellants contend that the claimed method would not have been
obvious in view of the “enormous number of combinations disclosed in
Murad” (Appeal Br. 6), that a skilled worker would not substitute a selenite
salt for Murad’s selenium because the selenite would not have been expected
to retain the same activity as selenium (id. at 8), and that the Specification
provides evidence of surprising results in treating pigmental moles (id.).
The issues with respect to this rejection are:
Does the evidence of record support the Examiner’s conclusion that a
person of ordinary skill in the art would have considered it obvious to
include a selenite in Murad’s composition for treating age spots? and, if so,
Have Appellants provided evidence of unexpected results that, when
weighed with the evidence of obviousness, shows that the claimed method
would not have been obvious?

9 The Examiner finds that Garcia teaches the pharmaceutical use of malic
acid but that is not limitation of claim 42.
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Additional Findings of Fact
5. The Specification discloses that “[p]igment moles (so-called age
spots) . . . appear[ ] as locally delimited light- to dark-brown discolorations”
(Spec. 8).
6. Murad discloses “compositions for managing dermatological
conditions that contain at least one fruit extract from pomegranate . . . , a
moisturizing agent . . . , and a pharmaceutically acceptable carrier” (Murad,
col. 6, ll. 24-29).
7. Murad discloses that “[d]ermatological conditions include . . . age
spots” (id. at col. 8, ll. 8-10).
8. Murad discloses that “[s]uitable moisturizing agents include, but
are not limited to, acidic components, hydrophobic agents, and hydrophilic
agents” (id. at col. 9, ll. 19-21).
9. Murad discloses that “[m]oisturizing agents that are acidic
components include mono- or poly-hydroxy acids, tannic acid, and mixtures
thereof” (id. at col. 9, ll. 26-28).
10. Murad discloses that the “hydroxy acids are preferably selected
from one or more alpha-hydroxy or beta-hydroxy acids, . . . most preferably
from citric and salicylic acids” (id. at col. 10, ll. 11-14).
11. Murad discloses that “a source of selenium may also be
optionally added to the pharmaceutical composition. A selenium compound,
or a pharmaceutically acceptable salt thereof, may be used.” (Id. at col. 11,
ll. 56-59.)
12. Lundy discloses “therapeutic compositions for treating mammals,
including humans, comprising a therapeutically effective but non-toxic
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amount of a water soluble organic or inorganic selenium compound”
(Lundy, col. 2, ll. 14-17).
13. Lundy discloses that “selenium compounds in which the selenium
has a +4 or a +6 valence, usually as the selenite and selenate ions, may be
utilized” (id. at col. 3, ll. 64-67) and that sodium and potassium selenite and
selenate are particularly preferred (id. at col. 4, ll. 3-4).
14. Lundy discloses that the compositions “may be applied topically
to the specifically affected areas of the skin” (id. at col. 2, ll. 57-59).
Analysis
Murad discloses a composition for treating dermatological conditions,
including age spots, and containing a pomegranate extract and a
moisturizing agent, of which citric acid is a preferred species. Murad also
suggests including a “selenium compound, or a pharmaceutically acceptable
salt thereof” in its composition (FF 11). Lundy discloses topical
compositions containing a selenium compound, preferably sodium or
potassium selenite. We agree with the Examiner that, based on these
teachings, it would have been obvious to use a selenite compound (e.g.,
sodium selenite) in Murad’s composition, because Murad suggests including
a pharmaceutically acceptable selenium salt in its composition and Lundy
discloses that sodium selenite is one such selenite salt. It would also have
been obvious to use the selenite-containing composition to treat age spots
because Murad expressly suggests using its composition to do so.
Appellants argue that Murad discloses such a large number of
potential combinations that “it would not have been obvious to one of skill
in the art to select the specified ingredients, and then further modify the
combination to use selenite as the selenium compound, and then additionally
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incorporate acetic, malic, or carbonic acid” (Appeal Br. 7). This argument is
not persuasive because, as discussed above, Murad discloses that citric acid
is one of its most preferred moisturizing agents and expressly suggests
including a pharmaceutically acceptable selenium salt, and Lundy shows
that sodium selenite was a known, pharmaceutically acceptable selenium
salt, and therefore obvious to use in view of Murad’s suggestion. Citric acid
is a pharmaceutically acceptable or food compatible acid, as required by
claim 42 (see FF 2), and therefore the claimed method does not require the
further addition of acetic, malic, or carbonic acid.
Appellants also argue that those skilled in the art would not have
considered it obvious to use selenite in place of selenium because the two
compounds would not have been expected to have the same activity (Appeal
Br. 8). This argument is also unpersuasive because Murad expressly
suggests using either a selenium compound or a pharmaceutically acceptable
salt thereof; in view of this teaching, a skilled worker would reasonably have
expected Lundy’s selenite salt to have the activity required by Murad’s
composition.
Finally, Appellants argue that “Example 3 in the present specification
provides surprising results regarding the effectiveness of an acidified sodium
selenite solution in treating pigmental moles” (Appeal Br. 8). This argument
is unpersuasive because unexpected results must be shown by comparison to
the closest prior art. In re Baxter-Travenol Labs., 952 F.2d 388, 392 (Fed.
Cir. 1991) (“[W]hen unexpected results are used as evidence of
nonobviousness, the results must be shown to be unexpected compared with
the closest prior art.”). The Specification, however, does not show a
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comparison of the inventive composition to any prior art composition, and
therefore cannot be relied on as persuasive evidence of nonobviousness.
Conclusions of Law
The evidence supports the Examiner’s conclusion that a person of
ordinary skill in the art would have considered it obvious to include a
selenite in Murad’s composition for treating age spots. Appellants have not
provided evidence of unexpected results that, when weighed with the
evidence of obviousness, shows that the method of claim 42 would not have
been obvious. Claims 46, 47, and 51-55 have not been argued separately
and therefore fall with claim 42. 37 C.F.R. § 41.37(c)(1)(vii).
III.
Issue
The Examiner has rejected claims 42, 45, and 47-66 as obvious based
on Natterer, Levitt, and Richardson (Ans. 8). The Examiner finds that
Natterer discloses a composition for treating skin conditions, comprising
metallic trace elements (including selenium) and acid (including acetic acid
or citric acid) (id.). The Examiner finds that Levitt discloses topical
compositions comprising sodium or potassium selenite (id. at 8-9) and that
Richardson discloses selenium-containing compositions for treating herpes
simplex virus infections (id. at 9-10). The Examiner concludes that, based
on Levitt, it would have been obvious to use a selenite salt in Natterer’s
composition, and to use the composition to treat herpes simplex virus
infection in view of Richardson’s disclosure that selenium has antiviral
activities (id. at 10).
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Appellants contend that it would not have been obvious to treat a
herpes virus infection with a selenite-containing composition based on the
cited references, because “only Richardson mentions the treatment of herpes
infections” and Richardson discloses the use of selenium, not selenite
(Appeal Br. 9).
The issue with respect to this rejection is: Do the cited references
support the Examiner’s conclusion that a person of ordinary skill in the art
would have considered it obvious to include a selenite in Natterer’s
composition and to use the composition to treat a herpes virus infection?
Additional Findings of Fact
15. Natterer discloses “a pharmaceutical preparation . . . which
assure[s] increased bio-availability, upon both transdermal and oral use”
(Natterer, col. 1, ll. 15-18).
16. Natterer discloses that the preparation
can be produced in the manner that at least one metal forming
an essential metallic trace element, in particular from the group
consisting of iron, zinc, manganese, chromium, copper, cobalt,
molybdenum, tin, vanadium, nickel and selenium, is brought,
preferably in comminuted or powdered form, with acid and
water into solution, the pH of the solution then being adjusted.
(Id. at col. 3, ll. 36-43.)
17. Natterer discloses that “it is also possible to produce the
preparation of the invention in the manner that at least one water-soluble
metal compound of an essential metallic trace element . . . is dissolved in
water with the addition of the physiological acid” (id. at col. 3, ll. 45-50).
18. Natterer discloses that the pH of its preparation should be
between 4.5 and 1.0, and that the “pH can be adjusted by the addition of a
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corresponding amount of physiological acid (for instance hydrochloric acid,
sulfuric acid, silicic acid, acetic acid, and/or ascorbic acid)” (id. at col. 3, ll.
10-15).
19. Natterer discloses that its preparation “may also be [used] to treat
animals including humans, suffering from a virus, comprising administering
to the sufferer an anti-viral effective amount of the preparation” (id. at col. 4,
ll. 56-59).
20. Lundy is a divisional application based on Levitt (Lundy, cover
page). Levitt therefore provides the same disclosure as Lundy (see FFs 12-
14, above).
21. Richardson discloses a composition for treating herpes simplex
virus-1 (HSV-1) and herpes simplex virus-2 (HSV-2) infections
(Richardson, col. 6, ll. 43-45).
22. Richardson discloses that its composition contains a selenium
compound, which “[i]mprov[es] host-cell defenses by increasing
endogenous reduced-GSH levels” and “[i]mprov[es] local host-cell antiviral
antioxidative effectiveness by reducing local levels of hydroxyl radicals
involved in the pathogenesis of ophthalmic herpes” (id. at col. 7, ll. 26-33).
Analysis
Natterer discloses a composition for transdermal or oral use,
containing a metallic trace element and a physiological acid. Natterer
suggests including selenium in its composition and suggests that the
composition can be made by dissolving a water-soluble salt of the metallic
trace element in water with addition of a physiological acid (e.g., acetic
acid). Natterer also discloses that its compositions have anti-viral activity.
Levitt discloses that sodium and potassium selenite are water soluble
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selenium salts used in pharmaceutical compositions (FFs 12, 13, 20).
Richardson discloses that selenium compounds are useful in compositions
for treating herpes virus infections.
In view of these disclosures, we agree with the Examiner that it would
have been obvious to use Levitt’s selenite compound as the metallic trace
element in Natterer’s composition, because Natterer suggests using selenium
and a water-soluble salt of the metallic element, and to use the resulting
composition to treat herpes virus infections, because Natterer discloses that
its composition has anti-viral activity and Richardson discloses that selenium
aids in treating herpes virus infections.
Appellants argue that those of skill in the art would not have expected
Levitt’s selenite to be useful in treating herpes virus infections because
“Richardson teaches the use of selenium (Se2+) in its role as a cofactor in the
glutathione (GSH) system” and “selenite, the oxidized selenium species
SeO3–2, is not a cofactor for the GSH system” (Appeal Br. 9).
This argument is not persuasive. Natterer discloses that compositions
containing a physiological acid and a metallic trace element, including
selenium or a water-soluble salt thereof, have anti-viral activity. A skilled
worker would therefore reasonably expect that Natterer’s composition would
have anti-viral activity if it contained, for example, sodium selenite.
Appellants have provided no evidence, or sound reasoning based on science
or logic, to support their position that a skilled worker would not have
expected a selenite-containing composition to have anti-viral activity similar
to an otherwise identical composition containing selenium.
Appellants also argue that “Example 2 in the present specification
provide[s] surprising results regarding the effectiveness of an acidified
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sodium selenite solution in treating herpes infection” (Appeal Br. 9). This
argument is not persuasive because the Specification does not provide any
comparison to the prior art; the evidence provided in the Specification
therefore does not outweigh the evidence supporting the rejection.
Claims 45 and 47-66 have not been argued separately and therefore
fall with claim 42. 37 C.F.R. § 41.37(c)(1)(vii).
Conclusion of Law
The cited references support the Examiner’s conclusion that a person
of ordinary skill in the art would have considered it obvious to include a
selenite in Natterer’s composition and to use the composition to treat a
herpes virus infection.
SUMMARY
We affirm the rejection of claim 67 under 35 U.S.C. § 102(b) as
anticipated by Bankit, the rejection of claims 42, 46, 47, and 51-55 under 35
U.S.C. § 103(a) as obvious based on Murad, Lundy, and Garcia; and the
rejection of claims 42, 45, and 47-66 under 35 U.S.C. § 103(a) as obvious
based on Natterer, Levitt, and Richardson.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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