Ex Parte Cook et al

Board of Patent Appeals and Interferences

Dec 22, 2009

10756719 (B.P.A.I. Dec. 22, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MARK E. COOK and DAN E. BUTZ
__________

Appeal 2009-0053471
Application 10/756,719
Technology Center 1600
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Decided: December 22, 2009
__________

Before TONI R. SCHEINER, DEMETRA J. MILLS, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a method of
treating rheumatoid arthritis with conjugated linoleic acid. The Examiner
rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 The Wisconsin Alumni Research Foundation is the real party in interest.
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STATEMENT OF THE CASE
“Conjugated linoleic acid (‘CLA’) is a group of positional and
geometrical isomers of linoleic acid. . . . These naturally occurring fatty
acids are found in beef and dairy products due to ruminal isomerization of
linoleic acid” (Spec. [0003] (citations omitted)). According to the
Specification, “CLA has been shown to modulate immune response” in prior
art studies (id. at [0006] (citations omitted)).
The Specification discloses that, in a mouse model for human
rheumatoid arthritis, “mice fed CLA had significantly lower arthritis severity
scores as compared to mice fed corn oil” (id. at [00025]), the scores being
based on redness and swelling of the ankle or wrist (id. at [00023]).
Claims 3 and 5-16 stand rejected and appealed (App. Br. 2). Claim 3,
the only independent claim, and claim 5 are representative and read as
follows:
3. A method for treating rheumatoid arthritis in a
human or non-human animal in need thereof, the method
comprising the steps of:
administering to the human or non-human animal a
composition that consists of a conjugated linoleic acid (CLA)
and one or more carriers wherein the CLA is in an amount
effective to reduce joint inflammation in the human or non-
human animal; and
observing an improvement in joint redness and
swelling in the human or non-human animal.

5. The method of claim 3, wherein the CLA is
selected from a free conjugated linoleic acid, an ester of a
conjugated linoleic acid, a non-toxic salt of a conjugated
linoleic acid, an active isomer of a conjugated linoleic acid, an
active metabolite of a conjugated linoleic acid, and a mixture
thereof.

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The Examiner cites the following documents as evidence of
unpatentability:
Horrobin US 6,245,811 B1 Jun. 12, 2001
Cook US 6,395,782 B1 May 28, 2002

The sole rejection before us for review is the Examiner’s rejection of
claims 3 and 5-16 as being unpatentable under 35 U.S.C. § 103(a) over Cook
and Horrobin (Ans. 3-6).
OBVIOUSNESS
ISSUE
The Examiner cites Cook as disclosing administration of conjugated
linoleic acid to treat autoimmune disorders, including rheumatoid arthritis
(Ans. 3-4). The Examiner cites Horrobin as disclosing administration of
esters of conjugated linoleic acid, also for treating rheumatoid arthritis (id. at
4).
Based on these teachings the Examiner concludes that an ordinary
artisan would have considered it obvious “to use an ester of conjugated
linoleic acid, as suggested by Horrobin et al., in the method of treating
rheumatoid arthritis as taught by Cook et al. and produce the instant
invention” (id. at 5).
Appellants contend that the Examiner erred in interpreting the
teachings in the prior art because neither Cook nor Horrobin “teach the
element of ‘improvement in joint redness and swelling’ recited in
independent claim 3” (App. Br. 4; see also App. Br. 6, 10). Thus,
Appellants argue, if the Examiner meant that “conjugated linoleic acid
would inherently reduce joint redness and swelling, this is a legal mistake in
that what is inherent in the prior art, if not known at the time of the
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invention, cannot form a proper basis for rejecting the claimed invention as
obvious under § 103” (id. at 5 (citing In re Shetty, 566 F.2d 81, 86 (CCPA
1977)); see also App. Br. 8).
Appellants argue that “the evidence on the record supports that an
ester of conjugated linoleic acid is unlikely to reduce joint redness and
swelling even assuming it can extend the survival time and reduce body
weight wasting” as taught by Cook (App. Br. 6). Specifically, Appellants
urge,
it is not uncommon that a treatment of a condition reduces some
but not all symptoms of the condition. For example, a patient
suffering from a common cold may experience fever, pain,
nasal congestion, excess cough and other symptoms.
Acetaminophen can reduce fever and pain but not other
symptoms. Similarly, decongestants will reli[e]ve congestion
but not other symptoms.

(Id. at 7.) Therefore, Appellants argue, “just because Cook et al. taught that
conjugated linoleic acid can extend the survival time and reduce body
weight wasting does not mean that it can also reduce joint redness and
swelling” (id.).
Appellants further argue, as evidenced by Yang’s2 disclosure of
conjugated linoleic acid promoting the early onset of proteinuria in the same
mouse model used by Cook, that the claimed therapeutic agent was known
to promote rather than reduce certain symptoms of lupus erythematosus (id.
at 8-9). Moreover, Appellants argue, given that rheumatoid arthritis

2 Mingder Yang et al., Dietary Conjugated Linoleic Acid Protects Against
End Stage Disease of Systemic Lupus Erythematosus in the NZB/W F1
Mouse, 22 IMMUNOPHARMACOLOGY AND IMMUNOTOXICOLOGY 433-449
(2000).
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involves deposition of antibody/antigen immune complexes, an ordinary
artisan viewing the disclosures by Sugano3 and Yamasaki4 that conjugated
linoleic acid increases antibody production “would not conclude with a
reasonable likelihood of success based on the teachings of Cook et al. that
conjugated linoleic acid can reduce joint redness and swelling in rheumatoid
arthritis” (id. at 10 (citing Cook et al., U.S. Patent No. 5,428,072, issued Jun.
27, 1995) (hereinafter “Cook ‘072”)).
Appellants further contend that the Examiner erred in interpreting
Horrobin as teaching or suggesting administering conjugated linoleic acid
for treating rheumatoid arthritis, because Horrobin teaches numerous fatty
acids as being useful treating a number of different disorders (App. Br. 11-
12). Appellants therefore conclude that, when all of the relevant prior art is
considered, “it would not have been obvious to one of ordinary skill in the
art that conjugated linoleic acid can be used to reduce joint redness and
swelling in rheumatoid arthritis” (id. at 15).
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether Appellants have shown that
the Examiner erred in concluding that an ordinary artisan viewing the
teachings of Cook and Horrobin, as well as the other relevant prior art
teachings, would have considered it obvious to treat rheumatoid arthritis

3 Michihiro Sugano et al., Conjugated Linoleic Acid Modulates Tissue
Levels of Chemical Mediators and Immunoglobulins in Rats, 33 LIPIDS 521-
27 (1998).
4 Masao Yamasaki et al., Immunoglobulin and Cytokine Production from
Spleen Lymphocytes Is Modulated in C57BL/6J Mice by Dietary Cis-9,
Trans-11 and Trans-10, Cis-12 Conjugated Linoleic Acid, 133 J. NUTR. 784-
88 (2003).
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with conjugated linoleic acid, or esters of conjugated linoleic acid, as recited
in the claims.
FINDINGS OF FACT (“FF”)
1. Cook discloses a “method for extending the survival time of a human
or non-human animal having an autoimmune complex disease [which]
includes the step of administering to the animal after diagnosis of the
autoimmune complex disease an amount of CLA [(conjugated linoleic acid)]
effective to extend the life span of the animal” (Cook, col. 2, ll. 34-39).
2. Cook discloses that its methods “are not limited to use in human SLE
[(systemic lupus erythematosus)] patients (or equivalent diseases in non-
human animals)” (id. at col. 3, ll. 37-39). Rather,
[t]he methods are of particular use in other autoimmune
diseases and conditions including but not limited to arthritis,
multiple sclerosis, Addison’s disease, Goodpastures’s
syndrome, Graves’ disease, Hashimoto’s thyroiditis, insulin-
dependent diabetes mellitus, myasthenia gravis, myocardial
infarction, poststreptococcal glomerulonephritis, spontaneous
infertility, ankylosing spondylitis, rheumatoid arthritis,
scleroderma, and Sjogren’s syndrome.

(Id. at col. 3, ll. 43-50 (emphases added).)
3. Cook acknowledges the disclosure in Yang that “dietary CLA fed
from weaning onward accelerates the onset of proteinuria but does not
significantly affect anti-DNA antibody production in those same mice. In
the same study, the CLA-fed mice lived longer from the onset of proteinuria
and lost less body weight than control mice” (Cook, col. 2, ll. 17-20).
4. Horrobin discloses preparing therapeutically active molecules by
covalently binding together two individual compounds known to have
desirable biological activities, using ester linkages (Horrobin, col. 1, ll. 18-
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20). “For example, a bioactive alcohol may be coupled to an unsaturated
fatty acid as an ester/ether via a geminal dioxo linkage” (id. at col. 2, ll. 23-
25).
5. Horrobin discloses that fatty acids useful in its methods include GLA
(gamma linoleic acid), DGLA (dihomo gamma linoleic acid), and
conjugated linoleic acid (id. at col. 5, l. 54, through col. 6, l. 39).
6. According to Horrobin:
In their own right GLA and DGLA have been shown to
have anti-inflammatory effects, to lower blood pressure, to
inhibit platelet aggregation, to lower cholesterol levels, to
inhibit cancer cell growth, to reduce dyskinetic movements, to
relieve brea[s]t pain, to improve calcium absorption and
enhance its deposition in bone, to reduce the adverse effects of
ionising radiation, to treat various psychiatric disorders, to
cause vasodilation, to improve renal function, to treat the
complications of diabetes, to dilate blood vessels and so on.
Actives linked to GLA and DGLA will therefore not only
become more lipophilic, enhancing penetration across all
membranes, the skin and the blood brain barrier, but are also
likely to exhibit new additional therapeutic effects.

(Id. at col. 6, ll. 15-27 (emphasis added).)
7. Horrobin discloses that the anti-inflammatory effects of GLA and
DLA render them suitable for the treatment of various disorders, including
“osteoarthritis and rheumatoid arthritis” (id. at col. 13, ll. 30-31; see also col.
13, ll. 60-64)
8. Horrobin discloses that conjugated linoleic acid is also a fatty acid “of
particular interest” in the disclosed methods, given its “effects in treating
and preventing cancer, in promoting growth particularly of protein-
containing tissues, in preventing and treating cardiovascular disease and as
an antioxidant” (id. at col. 6, ll. 34-39).
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9. One passage at issue in Horrobin reads as follows:
It is thus apparent that various specific fatty acids are
likely to be able to add to the efficacy of drugs and other
bioactive substances of almost any class, in both the treatment
and prevention of disease, in skin care and in nutrition, as well
as having valuable therapeutic effects when given in the form as
now proposed by the present invention as a single fatty acid or
as two different fatty acids in the same molecule. Of particular
value in therapy is that under most circumstances the fatty acids
are remarkably non-toxic and can be administered safely in
large doses without the risk of important side effects.

Specific Uses of Compounds Containing Geminal Dioxo
or Geminal Amino Oxo Linkage(s)

1. Geminal dioxo or geminal amino oxo moiety-
containing compounds containing: two fatty acids in which one
fatty acid is GLA or DGLA and the other is GLA, DGLA, SA,
EPA, DHA, cLA (conjugated linoleic acid) or CA (columbinic
acid) for the treatment of:
(a) complications of diabetes, particularly neuropathy and
retinopathy; and improvement of responses to insulin in
diabetes and pre-diabetes;
(b) cancers;
(c) osteoarthritis;
(d) rheumatoid arthritis;
(e) other inflammatory and auto-immune diseases
including Sjogren’s syndrome, systemic lupus, ulcerative
colitis, Crohn’s disease and uveitis; respiratory diseases
including asthma;
(g) neurological disorders including multiple sclerosis,
Parkinson’s disease and Huntington’s chorea;
(h) renal and urinary tract disorders;
(i) cardiovascular disorders;
(j) degenerative diseases of the eye including retinitis
pigmentosa and
senile macular degeneration;
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(k) psychiatric disorders including schizophrenia,
Alzheimer’s disease, attention deficit disorder,
alcoholism and depression;
(l) prostatic hypertrophy and prostatitis;
(m) impotence and male infertility;
(n) mastalgia;
(o) male pattern baldness;
(p) osteoporosis;
(q) dermatological disorders, including atopic eczema,
hand eczema, psoriasis, urticaria and allergic disorders;
(r) dyslexia and other learning disabilities;
(s) cancer cachexia.

(Id. at col. 14, l. 44, through col. 15, l. 25 (emphasis added).)
10. Yang investigated “the influence of dietary CLA on immune disorders
in the SLE-prone NZB/W F1 mice” (Yang 435).
11. Yang found that dietary CLA “accelerated the onset of proteinuria in
autoimmune-prone NZB/W F1 mice but did not affect anti-DNA antibody
production” (id. at 433 (abstract)). Yang ultimately concluded that its data
“suggested that dietary CLA may accelerate the autoimmune symptoms of
NZB/W F1 mice, however, CLA protected against the disease related body
weight loss and prolonged survival after proteinuria” (id.).
12. Yamasaki “evaluated the effect of cis-9, trans-11 (9c, 11 t) and trans-
10, cis-12 (10t, 12c) conjugated linoleic acid (CLA) on the immune system
in C57BL/6J mice” (Yamasaki 784 (abstract)).
13. Yamasaki discloses that relative spleen weights “of all CLA fed mice
were greater than the controls. Spleen lymphocytes isolated from the mice
fed 10t, 12c-CLA produced more immunoglobulin (Ig)A and IgM but not
IgG when stimulated with concanavalin A (ConA) compared with controls”
(id.).
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14. Yamasaki states that its results suggest that “9c, 11t and 10t, 12c-CLA
can stimulate different immunological effects and that the simultaneous
intake of the two isomers can change the T cell population” (id.).
15. Sugano examined the “effects of conjugated linoleic acid (CLA) on
the levels of chemical mediators in peritoneal exudate cells, spleen and lung,
and the concentration of immunoglobulins in mesenteric lymph node and
splenic lymphocytes and in serum” in rats (Sugano 521).
16. Sugano discloses:
Splenic levels of immunoglobulin A (IgA), IgG, and IgM
increased while those of IgE decreased significantly in animals
fed the 1.0% CLA diet. This was reflected in the serum levels
of immunoglobulins. The levels of IgA, IgG, and IgM in
mesenteric lymph node lymphocytes increased in a dose
dependent manner, while IgE was reduced in those fed the
higher CLA intake. However, no differences were seen in the
proportion of T-lymphocyte subsets of mesenteric lymph node.
These results support the view that CLA mitigates the food-
induced allergic reaction.

(Id.)
17. Cook ‘072 discloses a “method of enhancing weight gain and feed
efficiency in an animal which comprises administering to the animal a safe
and effective amount of a conjugated linoleic acid” (Cook ‘072, abstract).
PRINCIPLES OF LAW
In KSR Int' l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme
Court rejected a rigid approach to the question of obviousness, and
ultimately reaffirmed that “when a patent ‘simply arranges old elements with
each performing the same function it had been known to perform’ and yields
no more than one would expect from such an arrangement, the combination
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is obvious.” Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273
(1976)).
The Court also cautioned that, “[i]n determining whether the subject
matter of a patent claim is obvious, neither the particular motivation nor the
avowed purpose of the patentee controls. What matters is the objective
reach of the claim. If the claim extends to what is obvious, it is invalid
under § 103.” Id. at 419.
Ultimately, therefore, as our reviewing court has stated, “[i]n
determining whether obviousness is established by combining the teachings
of the prior art, the test is what the combined teachings of the references
would have suggested to those of ordinary skill in the art.” In re GPAC Inc.,
57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal quotations omitted).
Nonetheless, a prima facie case of obvious cannot be based on a fact
not disclosed in the prior art. See In re Rijckaert, 9 F.3d 1531, 1534 (Fed.
Cir. 1993) (“‘That which may be inherent is not necessarily known.
Obviousness cannot be predicated on what is unknown.’ Such a
retrospective view of inherency is not a substitute for some teaching or
suggestion supporting an obviousness rejection.”) (quoting In re Spormann,
363 F.2d 444, 448 (CCPA 1966)).
On the other hand, the inherent properties of prior art elements need
not be disclosed in the prior art. See In re Woodruff, 919 F.2d 1575, 1577-
78 (Fed. Cir. 1990) (obviousness rejection affirmed where using claimed
elements in the manner suggested by the prior art necessarily resulted in
claim-recited effect); see also MEHL/Biophile Int'l Corp. v. Milgraum, 192
F.3d 1362, 1365 (Fed. Cir. 1999) (“Inherency is not necessarily coterminous
with knowledge of those of ordinary skill in the art. Artisans of ordinary
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skill may not recognize the inherent characteristics or functioning of the
prior art.”); In re Baxter-Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991)
(“Mere recognition of latent properties in the prior art does not render
nonobvious an otherwise known invention.”).
ANALYSIS
Appellants’ arguments do not persuade us that the Examiner erred in
concluding that an ordinary artisan viewing the teachings of Cook and
Horrobin, as well as the other relevant prior art teachings, would have
considered it obvious to treat rheumatoid arthritis with conjugated linoleic
acid, or esters of conjugated linoleic acid, as recited in the claims.
As the Examiner points out, Cook discloses that conjugated linoleic
acid was known to be useful for treating rheumatoid arthritis (FF 2). The
Examiner does not, however, appear to dispute Appellants’ contention that
Cook fails to explicitly disclose that its treatment improves the disorder’s
swelling and redness.
Thus, it might be true that Appellants’ stated rationale for treating
rheumatoid arthritis with CLA, reducing swelling and redness, is different
than the prior art’s reason. That fact, however, does not render the claimed
process any less obvious, given Cook’s direct and explicit disclosure that
CLA is useful for treating rheumatoid arthritis. See KSR, 550 U.S. at 419
(“In determining whether the subject matter of a patent claim is obvious,
neither the particular motivation nor the avowed purpose of the patentee
controls.”).
Moreover, we are not persuaded that Horrobin fails to suggest
administering esters of CLA for treating rheumatoid arthritis. Horrobin
discloses that compounds in which GLA or DGLA is esterified to another
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fatty acid, which can be CLA, are useful in the treatment of, among other
diseases, rheumatoid arthritis (see FF 9). While it might be true that CLA is
not among the fatty acids disclosed by Horrobin as being useful for treating
rheumatoid arthritis, both GLA and DGLA are disclosed as being useful in
such a treatment method (see FF 7).
Thus, because GLA and DGLA are disclosed as being useful for
treating rheumatoid arthritis, we agree with the Examiner that an ordinary
artisan viewing Horrobin’s disclosure would have reasoned that GLA and/or
DGLA esterified with CLA would also be useful in treating rheumatoid
arthritis, particularly given Horrobin’s listing of that disorder among the
treatable diseases, and further given Cook’s disclosure of using CLA to treat
rheumatoid arthritis.
Thus, the rationale for practicing the administering and observing
steps recited in claim 3 is the express disclosure in both of the cited
references that the claimed therapeutic agents are useful for treating the
claimed disorder. We are therefore not persuaded that the Examiner has
improperly used any undisclosed inherent properties of CLA or CLA esters
in finding that an ordinary artisan would have been prompted to treat
rheumatoid arthritis with those agents.
Moreover, with respect to the claimed effect of improvement in joint
redness and swelling, “[m]ere recognition of latent properties in the prior art
does not render nonobvious an otherwise known invention.” In re Baxter-
Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991); cf. In re Woodruff, 919
F.2d at 1577-78 (Fed. Cir. 1990) (obviousness rejection affirmed where
using claimed elements in the manner suggested by the prior art necessarily
resulted in claim-recited effect).
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We acknowledge the disclosures in Yang, Sugano, Yamasaki, and
Cook ‘072 (see FF 10-17). While it might be true that Sugano and
Yamasaki disclose that CLA increases certain populations of
immunoglobulins, Appellants do not point to any disclosure in either of
these references, or Cook ‘072, specifically mentioning, much less
disparaging, the treatment of rheumatoid arthritis with CLA.
We are therefore not persuaded that these references’ disclosures are
sufficient to refute the direct disclosures in both Cook and Horrobin of the
desirability of treating rheumatoid arthritis with conjugated linoleic acid
and/or its esters. To the contrary, Cook teaches the usefulness of CLA in
treating rheumatoid arthritis despite explicitly acknowledging Yang’s
disclosure of the increase in proteinuria caused by CLA administration (FF
3).
We are therefore not persuaded that any of the Yang, Sugano,
Yamasaki, or Cook ‘072 references, alone or in combination, would have
dissuaded an ordinary artisan from treating rheumatoid arthritis with
conjugated linoleic acid and/or its esters, as explicitly taught by Cook and
Horrobin. We accordingly affirm the Examiner’s rejection of claims 3 and 5
as being obvious over Cook and Horrobin.
Because they were not argued separately, claims 6-16 fall with claims
3 and 5. See 37 C.F.R. § 41.37(c)(1)(vii).

SUMMARY
We affirm the Examiner’s rejection of the Examiner’s rejection of
claims 3 and 5-16 as being unpatentable under 35 U.S.C. § 103(a) over Cook
and Horrobin.
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TIME PERIOD
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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