Ex Parte Brilman

Board of Patent Appeals and Interferences

Oct 23, 2008

10742527 (B.P.A.I. Oct. 23, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
_________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_________________

Ex parte YAKOV YEVSEYEVICH BRILMAN
Appellant
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Appeal 2008-4971
Application 10/742,527
Application Publication 2005/0074503
Technology Center 1600
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Decided: October 23, 2008
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Before RICHARD E. SCHAFER, SALLY GARDNER LANE, and JAMES
T. MOORE, Administrative Patent Judges.

LANE, Administrative Patent Judge.
DECISION ON APPEAL

Appeal 2008-4971
Application 10/742,527

I. STATEMENT OF THE CASE
The appeal is from a Final Rejection of claims 2, 4-9, which are all of
the pending claims. 35 U.S.C. § 134. Claims 10-13 have been withdrawn as
being drawn to a non-elected species and claims 1 and 3 have been canceled.
(see Amendment of September 17, 2007). Appellant did not file a Reply
Brief. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
The application was filed October 5, 2003. It was published as
Application Publication 2005/0074503 on April 7, 2005. The real party in
interest is said to be Appellant, Yakov Brilman. (App. Br. 1).
The Examiner relied on
• Brilman, Voenno-Meditsinkski Journal, vol. 10, p. 71 (1962)
(translation filed Feb. 18, 2004) (“Brilman”).
• U.S. Patent 5,900,412, May 4, 1999 (“Traue”).
• U.S. Patent Application Publication 2005/0004084, Jan. 6, 2005
(“Dardai”).
• Goodman & Gilman’s The Pharmacological Basis of
Therapeutics 8 (2001) (“Goodman”).
Appellant did not argue against the prior art status of these references.
Appellant appeals the rejection of claims 2, 4-6 and 8-9 under 35
U.S.C. § 103(a) over the combination of the teachings of Brilman, Traue,
and Dardai. Appellant did not argue separately for the patentability of any
of the rejected claims. We review claim 2 as a representative claim. See Bd.
R. 37(c)(1)(vii). Appellant also appeals the rejection of claim 7 under 35
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U.S.C. § 103(a) over the combination of the teachings of Brilman, Traue,
Dardai, and Goodman.1
II. FINDINGS OF FACT
The record supports the following findings of fact as well as any other
findings of fact set forth in this opinion, by at least a preponderance of the
evidence.
1. Appellant’s claim 2 recites:
A method for treating a disease of the musculoskeletal
system, comprising:
applying a composition comprising porcine bile, solvent,
acetylsalicylic acid, thymol and sodium chloride to an external
surface of a patient to be treated, wherein the composition
comprises 77.5 to 78.5 percent by weight of the porcine bile,
0.5 to 10 percent by weight thymol, 0.5 to 1.0 percent by
weight acetylsalicylic acid and 0.5 weight percent sodium
chloride, with the balance being solvent.

(App. Br. 11).
2. Brilman provides a treatment for “neuromyositis arthritis and
radiculitis,” comprising “89.5 ml of healthy swine bladder gall . . . 10 ml
96% alcohol, 0.5 spiritus metilici, 0.85g natrium chloridii.” (Brilman,
translation).
3. We understand, and Appellant does not dispute, that “swine
bladder gall” contains porcine bile.

1 In addition, Appellant also appealed the rejection of claim 6 under
35 U.S.C. § 112, first paragraph. (App. Br. 3). This rejection has since been
withdrawn by the Examiner. (See Ans. 6).
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4. We understand, and Appellant does not dispute that
neuromyositis arthritis and radiculitis are diseases of the musculoskeletal
system.
5. We understand, and Appellant does not dispute, that natrium
chloridii is sodium chloride.
6. Brilman does not teach that the composition used in the method
recited comprises acetylsalicylic acid or thymol.
7. Brilman does not teach using the exact percentages of the
components recited in Appellant’s claim 2.
8. Traue relates to the use of acetylsalicylic acid (referred to as
“ASA”) in “eliciting anti-inflammatory, analgesic and antipyretic effects.”
(Traue col. 1, ll. 14-18).
9. Traue teaches “alcoholic solutions for the percutaneous
administration of ASA, comprising acetylsalicylic acid or salts thereof as the
active compound . . . .” (Traue col. 2, ll. 43-46).
10. We understand “percutaneous administration” to mean
administration by means of the skin.
11. Traue teaches “[w]here appropriate, penetration enhancers of
the cyclic terpene type, preferably L-menthol or thymol, may be present in
the subject alcoholic solutions.” (Traue col. 3, ll. 40-42).
12. Traue teaches that “[f]or administration, the alcoholic ASA
solutions may be formulated into a suitable vehicle, diluent or carrier
therefore, or else topically applied directly to the skin.” (Traue col. 3, ll. 55-
57).
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13. Dardai teaches compositions that “include active agents utilized
in conventional formulations for the topical treatment of joint and rheumatic
pains . . . .” (Dardai ¶ [0010]).
14. The composition of Dardai is a “transdermal pharmaceutical
composition comprising acetylsalicylic acid, together with a carrier, a
diluent and/or other auxiliary agent suitable for transdermal application.”
(Dardai ¶ [0005]).
15. Appellant’s specification does not include examples or results
of any tests conducted with the claimed method.
16. Appellant’s claim 7 recites:
The method according to claim 2, further comprising applying
the composition to an area wherein a patient to be treated is
experiencing pain from the disease by use of a compress.

(App. Br. 11).

17. Goodman discloses different ways to achieve topical
application of a drug, teaching that “[b]ecause hydrated skin is more
permeable than dry skin, the dosage form may be modified or an occlusive
dressing may be used to facilitate absorption.” (Goodman 8).
III. LEGAL PRINCIPLES
The Supreme Court has recently noted that “[w]hen 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 can implement a predictable variation, § 103 likely
bars its patentability.” KSR Int’l v. Teleflex Inc., 127 S.Ct. 1727, 1740
(2007).
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For claims relying on ranges of components, “discovery of an
optimum value of a result effective variable in a known process is ordinarily
within the skill of the art,” unless the results of such optimization are
unexpectedly good. In re Boesch, 617 F.2d 272, 276 (CCPA 1980).
IV. ANALYSIS
Claims 2-6 and 8-9
Appellant’s claim 2 recites
A method for treating a disease of the musculoskeletal
system, comprising:
applying a composition comprising porcine bile, solvent,
acetylsalicylic acid, thymol and sodium chloride to an external
surface of a patient to be treated, wherein the composition
comprises 77.5 to 78.5 percent by weight of the porcine bile,
0.5 to 10 percent by weight thymol, 0.5 to 1.0 percent by
weight acetylsalicylic acid and 0.5 weight percent sodium
chloride, with the balance being solvent.

(FF2 1). Brilman teaches a treatment for “neuromyositis arthritis and
radiculitis,” diseases of the musculoskeletal system (FFs 2 and 4),
comprising “89.5 ml of healthy swine bladder gall . . . 10 ml 96% alcohol,
0.5 spiritus metilici, 0.85g natrium chloridii.” (FF 2). We understand, and
Appellant did not dispute, that “swine bladder gall” contains porcine bile.
(FF 3). We understand, and Appellant does not dispute, that natrium
chloridii is sodium chloride. (FF 5). While Brilman teaches the use of
swine gall bladder and sodium chloride in ethanol as a treatment for
musculoskeletal diseases, Brilman does not teach combining these

2 Finding of Fact.
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components with acetylsalicylic acid and thymol (FF 6) or the exact
percentages of the components recited in Appellant’s claim 2. (FF 7).
Traue relates to the use of acetylsalicylic acid (referred to as “ASA”)
in “eliciting anti-inflammatory, analgesic and antipyretic effects.” (FF 8).
Specifically, Traue teaches “alcoholic solutions for the percutaneous
administration of ASA, comprising acetylsalicylic acid or salts thereof as the
active compound . . . .” (FF 9). Traue also teaches “[w]hen appropriate,
penetration enhancers . . . preferably . . . thymol, may be present in the
subject alcoholic solutions.” (FF 11). According to Traue, “the alcoholic
ASA solutions may be formulated into a suitable vehicle, diluent or carrier
therefore, or else topically applied directly to the skin.” (FF 12). Thus,
Traue teaches administration of ASA to the skin, along with thymol to
increase penetration.
Dardai discloses compositions that “include active agents utilized in
conventional formulations for the topical treatment of joint and rheumatic
pains . . . .” (FF 13). The composition taught by Dardai are “transdermal
pharmaceutical composition comprising acetylsalicylic acid, together with a
carrier, a diluent and/or other agent suitable for transdermal application.”
(FF 14). Thus, like Traue, Dardai teaches acetylsalicylic acid in a solvent
and that this composition can be used topically to treat musculoskeletal
diseases, such as arthritis.
Those in the art would have found it obvious to modify the porcine
bile and sodium chloride in solvent, as taught by Brilman, by adding
acetylsalicylic acid and thymol, as taught in Traue, to achieve the anti-
inflammatory, analgesic, and antipyretic effects taught in Traue. See KSR,
supra. Furthermore, those of skill in the art would have expected this
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modification to “yield a predictable result,” KSR, supra, because Brilman
teaches that the porcine gall bladder treats musculoskeletal conditions,
including arthritis, and Dardai teaches that acetylsalicylic acid also treats
conditions such as arthritis. We consider determination of specific
concentrations of a therapeutic to be optimization of a result effective
variable, see Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 809
(Fed. Cir. 1989) (determining that optimization of a dosage range was
obvious when the procedures to do so were known to those in the art), and
Appellant has not shown that the claimed concentrations of the components
recited in claim 2 are unexpectedly good. See Boesch, supra. Thus,
Appellant has not shown that the specific parameters claimed would not
have been obvious to those of skill in the art. Id. Accordingly, the
Examiner presented a prima facie case for the obviousness of the method
claimed by Appellant.
Appellant argued that “no apparent reason exists to combine Brilman,
Traue and Dardai to obtain the claim invention.” (App. Br. 5). According to
Appellant, “the central aspect of Traue is directed to antithrombotic therapy,
which is not directed to the same problems addressed by the claimed
invention” (App. Br. 6), and “the alcohol and penetration solution (e.g.,
thymol) of the present invention are not equivalent or in any way directed to
the same purpose as the ‘component’ in Dardai.” (Id.).
Traue teaches that the combination of acetylsalicylic acid and thymol
has “anti-inflammatory, analgesic and antipyretic effects” (FF 8), which
those of skill in the art would have known to be useful for treating
musculoskeletal diseases, e.g., arthritis. In fact, Dardai teaches that
transdermal pharmaceutical compositions comprising acetylsalicylic acid are
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used to treat “joint and rheumatic pains.” (FFs 13 and 14). Whether Traue
also teaches other uses of acetylsalicylic acid and thymol does not render the
claimed method patentable. See In re Lemelson, 397 F.2d 1006, 1009
(CCPA 1968) (“The use of patents as references is not limited to what the
patentees describe as their own inventions or to the problems with which
they are concerned. They are part of the literature of the art, relevant for all
they contain.”).
Appellant also argued that “Brilman includes a higher concentration
porcine bile formulation including alcohol and sodium chloride. As noted by
the Appellant in providing his own prior formulation, it was problematic in
that it was not as efficiently delivered and was odorous.” (App. Br. 5). We
assume that Appellant is referring to the letter attached to the copy of
Brilman submitted by Appellant, which states: “I have found that my sample
of writing was complemented by a preservative (Formalini, Furacillini) and
odorous substances. . . . the composition proposed by me has different
components in ‘Bilious Balsam’ from the prototype, and is a more efficient
medical treatment.” (Letter submitted Feb. 18, 2004). Appellant did not
direct us to evidence that would support this statement. Appellant has not
directed us to evidence of the odor level of the composition used in the
claimed method compared to that in Brilman, or to any other comparative
data between the claimed method and that in Brilman. If Appellant is
arguing that the claimed method demonstrates unexpected results,
comparative data is required as support. In re De Blauwe, 736 F.2d 699, 705
(Fed. Cir. 1984) (“It is well settled that unexpected results must be
established by factual evidence. Mere argument or conclusory statements in
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the specification does not suffice.”). Thus, we are not convinced by
Appellant’s argument.
Appellant argued further that “all of the references, including Dardai
and Traue, have specific formulation ranges illustrating that the component
ranges are important to the compositions as claimed. They thus teach away
from changing their particular formulations.” (App. Br. 6). “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 F.3d 551, 553 (Fed. Cir. 1994).
Even though the references include express ranges, Appellant has not
directed us to, and we do not find, portions of the references that teach other
ranges should not be used.3 Thus, we do not consider the ranges provided in
the references to be a teaching away of the claimed ranges. As explained
above, the determination of therapeutic concentrations of ingredients is
optimization of result effective variables. Without a showing that the
specific concentrations presented unexpectedly good results, Appellant has
not provided us with sufficient evidence for us to conclude that these ranges
are patentable over those disclosed in Traue and Dardai. See Boesch, supra.
Appellant also argued that

[t]he combined references fail to provide a reasonable
expectation of success. . . . Dardai and Traue have specific

3 Dardai even notes, after providing specific amounts of acetylsalicyclic acid,
that “[h]owever, as well known to one skilled in pharmacotechnology, the
active agent content may also vary with this type of composition.” (Dardai
¶ [0006]).
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formulation ranges illustrating that the component ranges are
important to the claimed compositions. Thus, modification of
the cited art does not provide a reasonable expectation of
success and is contrary to the reasoning and teaching in both
Dardai and Traue.

(App. Br. 8). The components taught in Brilman, Traue, and Dardai can
each be used to treat musculoskeletal diseases, thus, those in the art would
expect that their combination would also be useful in treating these diseases.
Appellant has not provided us with any evidence that the claimed
components, combined at the claimed ranges, does “more than yield a
predictable result.” KSR, supra. Thus, we are not convinced that those in
the art would not have had a reasonable expectation of success using the
claimed combination.
Finally, Appellant argued that “[t]he formulation in Brilman was
published in 1961, and yet no one to the Appellants knowledge has done
further successful work or provided a modified formulation until the
Appellant many years after Brilman's initial publication.” (App. Br. 8).
“Absent a showing of long-felt need or the failure of others, the mere
passage of time without the claimed invention is not evidence of
nonobviousness.” Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317,
1325 (Fed. Cir. 2004). To show that there was a long-felt need, Appellant
must present affidavits or other factual evidence of “a failure of others to
provide a feasible solution to [a] long-standing problem” and evidence “that
experts did not forsee” the solution claimed. See In re Piasecki, 745 F.2d
1468, 1475 (Fed. Cir. 1984). Because Appellant has not directed us to such
affidavits or evidence, we do not find this argument convincing.
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Appellant has not persuaded us that the claimed invention would not
have been obvious over the cited references. Thus, Appellant has not
convinced us that the Examiner erred in rejecting claim 2 under 35 U.S.C.
§ 103(a) over the combination of Brilman, Traue, and Dardai.
Claim 7
Appellant’s claim 7 recites:
The method according to claim 2, further comprising applying
the composition to an area wherein a patient to be treated is
experiencing pain from the disease by use of a compress.

(FF 16). Goodman discloses different ways to achieve topical
administration of a drug, including by “an occlusive dressing[,which] may
be used to facilitate absorption.” (FF 17). The Examiner asserted, and
Appellant did not dispute,4 that “an occlusive dressing is also a pad that is
held into place on the skin for topical administration.” We agree that those
of skill in the art would have had reason to use the dressings of Goodman,
with an expectation of success, to facilitate absorption of the composition
recited in the method of Appellant’s claim 2. Appellant has not provided
any convincing reason to the contrary.
Appellant has not convinced us that the claimed invention would not
have been obvious over the cited references. Thus, Appellant has not
convinced us that the Examiner erred in rejecting claim 7 under 35 U.S.C.
§ 103(a) over the combination of Brilman, Traue, Dardai, and Goodman.
V. ORDER
Upon consideration of the record and for the reasons given,

4 Appellant agreed that “Goodman teaches the use of compresses that include
various compositions for therapeutic use.” (App. Br. 9).
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the Examiner’s rejection of claims 2, 4-6 and 8-9 under 35 U.S.C.
§ 103(a) over the combination of the teachings of Brilman, Traue, and
Dardai is AFFIRMED; and
the Examiner’s rejection of claim 7 under 35 U.S.C. § 103(a) over the
combination of the teachings of Brilman, Traue, Dardai, and Goodman is
AFFIRMED, and
FURTHER ORDERED that no time period for taking any subsequent
action in connection with the appeal may be extended under 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED

MAT

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