Ex Parte Kleiman et al

Board of Patent Appeals and Interferences

Jul 22, 2009

09899432 (B.P.A.I. Jul. 22, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte ROBERT KLEIMAN and JAMES H. BROWN

Appellants
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Appeal 2009-005006
Application 09/899,432
Technology Center 1600
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Decided1: July 22, 2009
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Before RICHARD TORCZON, SALLY GARDNER LANE, MICHAEL P.
TIERNEY, Administrative Patent Judges.

LANE, Administrative Patent Judge.

DECISION ON APPEAL

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

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I. STATEMENT OF THE CASE
The appeal, under 35 U.S.C. § 134(a), is from a Final Rejection of
Appellants’ claims 91-102. Claims 1, 3, 4, 6-13, 15, 16, 18, 19, 21, 22, 24,
25, 27, 28, 30, 31, 33, 34, 36-85, 87, 88, and 90 have been cancelled, while
claims 2, 5, 14, 17, 20, 23, 26, 29, 32, 35, 86, and 89 have been withdrawn.
(App. Br. 4). We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Appellants’ claims are directed to methods of treating virus-induced
or inflammatory diseases.
The Examiner relied upon the following references.
Name Number Date
Katz ‘794 4,874,794 October 17, 1989
Katz ‘107 5,070,107 December 3, 1991
Katz ‘392 5,952,392 September 14, 1999
Sintov WO 96/02244 February 1, 1996
Arquette WO 99/20224 April 29, 1999

The Examiner rejected claims 91 and 92 under 35 U.S.C.
§ 103(a) over Katz ‘392, Sintov, and Arquette. Appellants did not argue
separately for the patentability of any of the rejected claims. We focus on
claim 91 as a representative claim. See 37 C.F.R. § 41.37(c)(1)(vii).
The Examiner rejected claims 93-102 under 35 U.S.C.
§ 103(a) over Katz ‘392, Sintov, Arquette, and Katz ‘794 or Katz ‘107.
Appellants did not argue separately for the patentability of any of the
rejected claims. We focus on claim 93 as a representative claim. See 37
C.F.R. § 41.37(c)(1)(vii).
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II. PRINCIPLES OF LAW
“[S]tructural similarity between claimed and prior art subject matter,
proved by combining references or otherwise, where the prior art gives
reason or motivation to make the claimed compositions, creates a prima
facie case of obviousness, and . . . the burden (and opportunity) then falls on
an applicant to rebut that prima facie case. Such rebuttal or argument can
consist of a comparison of test data showing that the claimed compositions
possess unexpectedly improved properties or properties that the prior art
does not have . . . that the prior art is so deficient that there is no motivation
to make what might otherwise appear to be obvious changes . . . , or any
other argument or presentation of evidence that is pertinent." In re Dillon,
919 F.2d 688, 692-93 (Fed. Cir. 1990) (en banc).
“[W]hen unexpected results are used as evidence of nonobviousness,
the results must be shown to be unexpected compared with the closest prior
art.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991).
III. ISSUE
Would those of skill in the art have had reason to administer the
claimed combination of long chain monounsaturated alcohols, long chain
fatty acid salts, and long chain esters to treat virus-induced diseases?
IV. CLAIM 91
Findings of Fact
1. Appellants’ claim 91 recites:
A method for treating at least one of virus-induced and
inflammatory diseases, said method comprising the step of
providing a topical composition consisting essentially of:
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at least one of
octadecenol,
eicosenol,
docosenol,
tetracosenol and
hexacosenol
in a concentration of from 0.1 to 25 percent by weight of
an admixed physiologically active carrier;
at least one salt of a jojoba-derived trans-free fatty acid
according to the formula R1-COO-M+, wherein:
R1 comprises CH3(CH2)7CH=CHCH2(CH2)x;
x is at least one of 8, 10, and 12; and
M+ is a monovalent alkali metal ion; and
at least one mixed ester according to the formula R2-
COO-R3, wherein:
R2 comprises CH3(CH2)7CH=CHCH2(CH2)y;
y is at least one of 6, 8, 10 and 12; and
R3 is at least one of an alkyl group and an aliphatic
group comprising between 1 to 12 carbon atoms.

(App. Br. 26; Claims Appx.).
2. Katz ‘392 teaches that inactivation of viruses can be achieved
with unsaturated long chain alcohols having from 14 to 20 carbons. (Katz
‘392 col. 2, ll. 5-7).
3. Katz ‘392 teaches the specific unsaturated long chain alcohol
“γ-linolenyl alcohol,” which is a C18 alcohol with three cis double bonds
and is significantly more effective than “a C18 alcohol with one cis double
bond . . . .” (Katz ‘392 col. 2, ll. 7-11).
4. The claimed compound octadecenol is a C18 alcohol with one
cis double bond.
5. Appellants do not dispute that the monounsaturated C18
alcohol taught in Katz ‘392 falls within the scope of the claimed method.
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6. Katz ‘392 teaches administering the long chain alcohol antiviral
ingredients at between 1% and 10% by weight of the final composition.
(Katz ‘392 col. 6, ll. 50-52).
7. Katz ‘392 teaches applying the long chain antiviral ingredients
topically, in a physiologically active carrier. (Katz ‘392 col. 20, ll. 26-42).
8. Katz ‘392 does not teach combining the monounsaturated long
chain alcohols with the long chain fatty acid salts and fatty acid esters
claimed.
9. Sintov teaches topical compositions “containing a carboxylic or
dicarboxylic acid or a salt thereof as active ingredient therein, in [a]
pharmaceutically or cosmetically acceptable carrier” for the prevention and
treatment of lesions and sores associated with herpes virus. (Sintov 1).
10. Sintov does not teach C20 or greater fatty acid salts.
11. Arquette teaches that fatty alcohols and waxes can be obtained
from the oil in the seeds of the jojoba plant. (Arquette 3, ll. 1-2).
12. Arquette teaches fatty acid esters from jojoba oil that have the
formula CH3-(CH2)7-CH=CH-CH2-(CH2)x-COO-CH-(CH3)2, wherein X is 6,
8, 10 and/or 12. (Arquette 4, ll. 12-14).
13. Arquette teaches that these fatty acid esters are effective
emollients for pharmaceutical compositions. (Arquette 2, l. 28, through 3,
l. 2).
14. Appellants provide two affidavits under 37 C.F.R. § 1.132, one
by Robert Kleiman and one by David Ashley, which both report the same
experiments and data. (Exhibits 5 and 6).
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15. The Kleiman and Ashley affidavits report data comparing the
antiviral activity of a compound “K100” with docosanol, a saturated C22
alcohol. (Exhibits 5 and 6).
16. The Kleiman and Ashley affidavits identify “K100” only as
“the combination of monounsaturated long chain alcohols, jojoba-derived
fatty acid salts, and fatty acid esters (specifically, jojoba esters) . . . .”
(Exhibits 5 and 6).
17. The Kleiman and Ashley affidavits state that “[w]hen
comparing the kill concentrations of the combination of the present
invention [K100] and n-docosanol alone, it is shown that the combination of
the present invention is approximately 100 times more effective than n-
docosanol alone in killing the HSV-1 Strain 6143.” (Exhibits 5 and 6).
Analysis
Appellants claim a method of treating a viral or inflammatory disease
with a topical composition that consists essentially of (1) at least one of a
named long chain alcohol, (2) a salt of a jojoba-derived trans-free fatty acid,
and (3) at least one mixed ester. (FF2 1). In claim 1, the long chain alcohol
is chosen from octadecenol, eicosenol, docosenol, tetracosenol, and
hexacosenol.
Katz ‘392 teaches that monounsaturated long chain alcohols,
including the monounsaturated C18 alcohol (FF 3), which Appellants do not
dispute falls within the scope of the claimed monounsaturated long chain
alcohols (FFs 4 and 5), treat viral infections (FF 2). Katz ‘392 teaches that

2 Finding of Fact.
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the long chain alcohol antivirals can be administered topically at between
1% and 10% final weight composition (FF 6) and combined with a
physiologically active carrier (FF 7).
Katz ‘392 does not teach combining a long chain alcohol with other
components. (FF 8). Sintov teaches that carboxylic acid salts, which include
fatty acid salts, are effective for treating virus-associated diseases. (FF 9),
though Sintov does not expressly recite carboxylic acid salts of C20 or
greater. In the absence of unexpected results, those of skill in the art would
have considered it obvious to use long chain fatty acid salts having the
claimed number of carbons to treat viral diseases because Katz ‘392 teaches
that similar C20 carbon compounds are useful for that purpose (FF 2).
Given the common utility, those of skill in the art would have had reason to
look to C20 or greater fatty acid salts for combination with the
monounsaturated long chain alcohols of Katz ‘392 to treat viral diseases.
See KSR Int’l Co. v. Teleflex, Inc., 550 US 398, 417 (2007) (“When a work
is available in one field of endeavor, design incentives and other market
forces can prompt variations of it, either in the same field or a different one.
If a person of ordinary skill implement a predictable variation, § 103 likely
bars its patentability.”); see also Dillon, 919 F.2d at 692-93.
In addition, those of skill in the art would have found it obvious to
combine these long chain alcohols and fatty acid salts with the claimed
jojoba-derived esters because Arquette teaches that the esters are useful as
emollients in pharmaceuticals (FF 11-13).
Appellants argue that neither Katz ‘392, Sintov, or Arquette teaches
the combination of the claimed monounsaturated long chain alcohols and
claimed mixed esters with the claimed salts of fatty acids. (App. Br. 15-17
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and 21). “Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references.” In re Merck & Co., Inc., 800 F.2d 1091, 1097
(Fed. Cir. 1986). Therefore, Appellants’ argument about the deficiencies of
each separate reference is not persuasive.
Appellants also argue that Sintov teaches away from combining
carboxylic acid salts with other compounds because it states that the
disclosed compositions do not require the presence of “any other antiviral
agent.” (App. Br. 16, quoting Sintov 2). “A reference may be said to teach
away when a person of ordinary skill, upon reading the reference, would be
discouraged from following the path set out in the reference, or would be led
in a direction divergent from the path that was taken by the applicant.” In re
Gurley, 27 F3d 551, 553 (Fed. Cir. 1994). Sintov does not discourage those
in the art from using other antiviral agents, it merely states the advantage of
not requiring other antiviral agents. Thus, Sintov does not teach away from
the claimed method.
Appellants argue that Sintov teaches away from the claimed method
because long chain fatty acid salts with less than 20 carbons have a different
solubility in water than the claimed long chain fatty acid salts. (App. Br. 17).
Appellants rely on the affidavit of David Ashley (Exhibit 7) as evidence of
the difference in solubility between fatty acids of different lengths. We are
not persuaded that a difference in water solubility indicates those of skill in
the art would not choose C20 or greater long chain fatty acid salts to treat
viral infections, as claimed. The claim method is not limited to water as a
carrier and Appellants have not persuaded us that an ordinarily skilled
artisan would not have been able to find a carrier or solute to deliver the
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claimed C20 or greater long chain fatty acid salts. Appellants do not point to
characteristics that differ between the long chain carbon compounds of Katz
‘392 and Sintov that would have discouraged those in the art from using the
claimed fatty acid esters in the claimed method.
Appellants argue further that the teaching of Sintov is restricted to a
limited number of fatty acid salts, and, thus, excludes the claimed fatty acid
salts. (App. Br. 18-19). Appellants point to the use of “consisting of” in
Sintov when reciting specific salts. (Id.). Sintov, though, expressly provides
for topical compositions “containing a carboxylic or dicarboxylic acid or a
salt thereof as active ingredient therein, in [a] pharmaceutically or
cosmetically acceptable carrier” for the prevention and treatment of lesions
and sores associated with herpes virus. (FF 9). That Sintov exemplifies
specific carboxylic and dicarboxylic acid salts does not limit what it teaches
as prior art. See In re Mills, 470 F.2d 649, 651 (CCPA 1972) (“All the
disclosures in a reference must be evaluated, including nonpreferred
embodiments . . . and a reference is not limited to the disclosure of specific
working examples.” (citation omitted)).
Finally, Appellants assert that the results of the claimed method are
unexpected. (App. Br. 20 and 21-22). Appellants relied on the affidavits of
Robert Kleiman and David Ashley as evidence of unexpected results. (FF
14). According to their affidavits, “K100,” exhibits a 100 fold increase in
antiviral activity over that of docosanol alone. (FF 17). Appellants assert
that this increased activity is “surprising” and “synergistic.” (App. Br. 21).
“It is well settled ‘that objective evidence or non-obviousness must be
commensurate in scope with the claims which the evidence is offered to
support.’” In re Grasselli, 713 F.2d 731, 743 (Fed. Cir. 1983) (quoting In re
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Tiffin, 448 F.2d 791 (CCPA 1971)). Appellants and declarants Kleiman and
Ashley indicate only that “K100” is “the combination of monounsaturated
long chain alcohols, jojoba-derived fatty acid salts and fatty acid esters
(specifically, jojoba esters)” (FF 16; App. Br. 22). Without knowing the
specific components of “K100” we cannot know if it is commensurate with
the scope of claim 1, or even if it falls within the scope of claim 1. In
addition, “when unexpected results are used as evidence of nonobviousness,
the results must be shown to be unexpected compared with the closest prior
art.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991).
Appellants compared the antiviral activity of “K100” with docosanol alone,
but docosanol is not a claimed compound. (See FF 1). It is not closer to the
composition than, for instance, the C18 unsaturated alcohols provided in
Katz ‘392. (See FF 3). Thus, we are not persuaded that Appellants have
shown unexpected results for the claimed method.
Moreover, Appellants have not provided persuasive evidence that the
results with “K100” are “synergistic.” The affidavits compare the activity of
“K100” to only one compound, docosanol. (FF 15). They do not report the
antiviral activity of each component, or other long chain alcohols, recited in
claim 91, alone, so that the additive effect can be determined. Without
knowing the additive effect, the skilled artisan would not be able to
determine if the antiviral activity of “K100” is synergistic.
Appellants have not shown that the Examiner erred in rejection claim
91 under 35 U.S.C. § 103(a) over Katz ‘392, Sintov, and Arquette.
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V. CLAIMS 93-102
Findings of Fact
18. Appellants’ claim 93 recites:
A method for treating viral infections, said method
comprising the step of intravenous delivery of a composition
consisting essentially of an effective amount of from about 0.1
mg to about 2 gm per 50 kg of body weight of a compound
comprising at least one C18 to C24 monounsaturated alcohol in
a physiologically active carrier;
at least one salt of a jojoba-derived trans-free fatty acid
according to the formula R1-COO-M+, wherein:
R1 comprises CH3(CH2)7CH=CHCH2(CH2)x;
x is at least one of 8, 10, and 12; and
M+ is a monovalent alkali metal ion; and
at least one mixed ester according to the formula R2-
COO-R3, wherein:
R2 comprises CH3(CH2)7CH=CHCH2(CH2)y;
y is at least one of 6, 8, 10 and 12; and
R3 is at least one of an alkyl group and an aliphatic
group comprising between 1 to 12 carbon atoms.

(App. Br. 27, Claims App’x).

19. Katz ‘794 teaches that C20 to C26 aliphatic alcohols are useful
in treating viral infections and inflammatory diseases. (Katz ‘794 col. 1, ll.
5-7 and col. 3, ll. 63-68).
20. Katz ‘107 teaches intravenous delivery of C27-C30 aliphatic
alcohols to treat viral disease. (Katz ‘107 col. 3, ll. 57-64).
21. Katz ‘107 teaches that the aliphatic alcohols can be
administered at from 0.1mg/50 kg body weight to 2 gm/50 kg body weight.
(Katz ‘107 col. 4, ll. 45-47).
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Analysis
Appellants’ claim 93 is similar to claim 91, but instead of reciting
specific long chain alcohols, claim 93 recites a C18 to C24 monounsaturated
alcohol. (FF 18). In addition, claim 93 requires that the composition be
delivered intravenously at between about 0.1 mg to about 2 gm per 50 kg of
body weight. (FF 18).
Katz ‘794 teaches C20 to C26 alcohols that are used to treat viral
infections (FF 19), while Katz ‘107 teaches that long chain alcohols can be
used to treat viral disease when delivered intravenously (FF 20) at the
claimed dosing ranges (FF 21). We agree with the Examiner that it would
have been obvious to those of skill in the art to use C20 to C24
monounsaturated alcohols to treat viral infections by administering them
intravenously.
Appellants argue the claimed method produces unexpected results, as
evidenced by the Kleiman and Ashley affidavits discussed above. (See FFs
14-17). As explained above, these affidavits are not persuasive because they
do not show a comparison to the closest prior art and because it is not known
if they show results that are synergistic or are commensurate with the scope
of the claimed method. Accordingly, we are not persuaded that the claimed
method produces unexpected results.
VI. CONCLUSION
Those of skill in the art would have considered it to be obvious to
administer the claimed combination of long chain monounsaturated alcohols,
long chain fatty acid salts, and long chain esters to treat virus-induced
diseases, as claimed.
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VII. ORDER
Upon consideration of the record and for the reasons given,
the rejection of claims 91 and 92 under 35 U.S.C. § 103(a) over Katz
‘392, Sintov, and Arquette is AFFIRMED; and
the rejection of claims 93-102 under 35 U.S.C. § 103(a) over Katz
‘392, Sintov, Arquette, and Katz ‘794 or Katz ‘107 is AFFIRMED.
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).
AFFIRMED

MAT

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