Ex Parte 5,569,676 et al

Patent Trial and Appeal Board

Aug 16, 2013

90011742 (P.T.A.B. Aug. 16, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
90/011,742 06/15/2011 5,569,676 11-24912 4922
81008 7590 08/16/2013
TechLaw LLP
10755 Scripps Poway Parkway, Suite 465
San Diego, CA 92131
EXAMINER
HUANG, EVELYN MEI
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
08/16/2013 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

IMAGENETIX, INC.
Patent Owner and Appellant
____________

Appeal 2013-002637
Ex Partes Reexamination Control 90/011,742
Patent U.S. 5,569,676
Technology Center 3900
____________

Before TONI R. SCHEINER, RICHARD M. LEBOVITZ, and
JEFFREY B. ROBERTSON, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on the appeal by the Patent Owner, Imagenetix, Inc.,
from the Patent Examiner‟s rejections of claims 1-5 in the ex parte
reexamination of US 5,569,676, issued October 29, 1996. The Board‟s
jurisdiction for this appeal is under 35 U.S.C. §§ 6 and 134. We reverse.

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I. STATEMENT OF THE CASE
A request for ex parte reexamination of claims 1-5 of U.S. Patent
5,569,676 (hereinafter, “the „676 patent) was made by Third Party
Requester, Nikken, Inc., on June 15, 2011, pursuant to 35 U.S.C. §§ 302-307
and 37 C.F.R. § 1.510. The sole inventor of the „676 patent is Harry
W. Diehl. A final rejection, rejecting claims 1-5, was mailed by the
Examiner on January 13, 2012. Patent Owner appeals the Examiner‟s
adverse decision on patentability to the Patent Trial and Appeal Board. An
oral hearing was held on April 24, 2013. A transcript of the hearing was
entered into the record on July 9, 2013.
The claims are directed to a method of treating osteoarthritis in
mammals comprising a step of “administering a therapeutically effective
amount of cetyl myristoleate to a mammal having osteoarthritis.” (Claim 1.)
Osteoarthritis (hereinafter, “OA”) is “a degenerative joint disease which
primarily affects cartilage that covers and cushions the ends of the bones
causing [the cartilage] to fray, wear, ulcerate, and in extreme cases, to
disappear entirely leaving a bone on bone joint.” („676 patent, col. 1, ll. 45-
48.) The „676 patent teaches that cetyl myristoleate (hereinafter, “CM”)
alleviated pain in patients afflicted with OA. For instance, Example V
describes a patient diagnosed with OA who took “three capsules, each
containing 1 cc of cetyl myristoleate, followed five months latter [sic, later]
by four more of the same capsules.” („676 patent, col. 3, ll. 11-14).
According to the example, the patient‟s osteoarthritis “was alleviated
sufficiently that he was able to discontinue other arthritis medication and
resume playing the guitar.” („676 patent, col. 3, ll. 14-16.)
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Claims 1-5 are pending. Claim 1 is the only independent claim;
claims 2-5 depend from claim 1. The claims stand rejected by the Examiner
as follows:
Rejection 1. Claims 1-5 under 35 U.S.C. § 103(a) as obvious in view
of US 4,113,881 (Diehl I), in view of US 3,683,076 (Rovati), US 4,628,052
(Peat), US 4,721,712 (Kadin), US 4,927,814 (Gall), US 5,246,964 (Ueno),
US 5,391,743 (Ebetino), US 5,603,959 (Horrobin), US 5,763,611 (Kaas), EP
0251408 Al (Loomans), or EP 0265238 A2 (Stephan).
Rejection 2. Claims 1-5 as unpatentable on the ground of the
judicially-created non-statutory obviousness-type double patenting over
claims 1-8 of U.S. Patent 4,113,881 (Diehl I), in view of US 3,683,076
(Rovati), US 4,628,052 (Peat), US 4,721,712 (Kadin), US 4,927,814 (Gall),
US 5,246,964 (Ueno), US 5,391,743 (Ebetino), US 5,603,959 (Horrobin),
US 5,763,611 (Kaas), EP 0251408 Al (Loomans), or EP 0265238 A2
(Stephan).

II. REPRESENTATIVE CLAIM
Independent claim 1 is representative and reads as follows:
A method for treating osteoarthritis arthritis in mammals which
comprises administering a therapeutically effective amount of
cetyl myristoleate to a mammal having osteoarthritis arthritis.

III. ISSUE
The primary prior art publication cited in both rejections is Diehl I.
The inventor of Diehl I is Harry W. Diehl, who is the same inventor of the
„676 patent. Diehl I describes administering CM to treat rheumatoid arthritis
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(hereinafter,”RA”). The issue in Rejections 1 and 2 is whether it would have
been obvious to one of ordinary skill in the art to treat OA with CM, based
on the teachings in Diehl I that RA could be treated with CM.

V. ANALYSIS
Independent claim 1 is directed to a method of treating osteoarthritis
arthritis in mammals comprising “administering a therapeutically effective
amount of cetyl myristoleate to a mammal having osteoarthritis arthritis.”
Based on description that appears in the „676 patent, the Examiner
interpreted “treating osteoarthritis arthritis in mammals” to include treating
symptoms of osteoarthritis, including treating pain (Answer 3). The
Examiner found that Diehl I teaches that “CM relieves and inhibits the
symptoms of inflammatory RA, which include pain and inflammation (col.
4, lines 29-30), indicating that CM possesses anti-inflammatory and
analgesic properties.” (Id. at 6.) Citing a number of different secondary
publications as evidence (see Rejections 1 and 2 supra.), the Examiner found
that “RA and OA have common symptoms, such as joint swelling and pain,
which are treated by the same drugs, such as NSAIDs” (id. at 4). The
Examiner concluded:
Since cetyl myristoleate (CM) alleviates or inhibits these
symptoms in RA as shown in Diehl I, it would have been
obvious for one of ordinary skill in the art to use CM to treat
the same symptoms found in OA, and with a reasonable
expectation of success.
(Id.)
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The Examiner also stated:
[T]he effectiveness of CM in treating RA symptoms as shown
by Diehl I would have motivated one of ordinary skill in the art
to use CM for treating the same symptoms found in OA, and
with a reasonable expectation of success, especially in view of
the prior art teaching that drugs for treating the symptoms of
RA are also effective for treating the same symptoms of OA, as
detailed in the rejection and as discussed supra.
(Id. at 7.)
The rejections are thus primarily based on the Examiner‟s finding that
CM treats joint pain in RA, and that since patients with OA experience joint
pain, it would have been obvious to have used CM to treat joint pain in OA.
However, as explained below, while Diehl I teaches that CM alleviates and
inhibits pain and other symptoms of RA (Diehl I, col. 3, ll. 21-25), the
treatment is a result of protecting against and preventing RA. CM was not
shown by Diehl I to have separate analgesic or anti-inflammatory properties
that would have made it useful in treating OA.
Diehl I, as the Examiner found, teaches that CM treats symptoms of
RA:
An object of the present invention is to provide a method
for relieving and inhibiting the symptoms of inflammatory
rheumatoid arthritis in mammals.
Another object of the invention is to inhibit the
symptoms, such as pain, fever and inflammation associated
with inflammatory rheumatoid arthritis in mammals by
administering orally, topically or parenterally cetyl myristoleate
extracted from the tissues of mice.
(Diehl I, col. 1, ll. 22-29.)
However, when Diehl I is read in its entirety, it is evident that the
alleviation of symptoms in RA by administering CM is a result of CM‟s
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efficacy in preventing the disease. Diehl I began its experiments with CM
by observing that it was “well known that Freund‟s adjuvant will induce
poly-arthritis in rats but not in mice.” (Diehl I, col. 1, ll. 32-33.) Poly-
arthritis is an inflammatory arthritis of the same type as RA (Day Decl.
1
¶¶
4-5.) Diehl I considered poly-arthritis to be an animal model for RA since
Diehl I extrapolated its findings for poly-arthritis in rats to RA in humans:
It has been common practice to test various compounds and
compositions in laboratories to determine their effectiveness in
relieving the symptoms of inflammatory rheumatoid arthritis by
administering test compounds or compositions to rats having
poly-arthritis induced previously by administering Freund‟s
adjuvant.
(Diehl I, col. 1, ll. 33-39.)
Diehl I describes isolating a substance from mice “which, when
administered to rats, essentially prevents the formation of poly-arthritis
and the resultant symptoms when the rats are subsequently injected with
Freund‟s adjuvant.” (Diehl I, col. 1, ll. 44-47; emphasis added.) When
purified, the substance was identified as CM (id. at col. 1, ll. 49-50). Diehl I
describes experiments in which CM was administered to rats in combination
with an agent, Bacto m. Butyricum (“Butyricum”). Butyricum, when
administered alone causes poly-arthritis. However, when given in
combination with CM, the CM was shown to prevent poly-arthritis:
In accordance with the present invention a substance has been
isolated from mice which, when administered to rats,

1
Declaration by Heather Marie Day, M.D., filed on October 19, 2011. Dr.
Day is an American Board certified rheumatologist who has been in practice
since 1996 (Day Decl. ¶ 2) and therefore has the requisite knowledge and
experience to testify as one of ordinary skill in the art pertinent to the
claimed invention.
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essentially prevents the formation of poly-arthritis and the
resultant symptoms when the rats are subsequently injected
with Freund‟s adjuvant.
(Diehl I, col. 1, ll. 43-47; emphasis added.)
Rats injected with “Butyricum” developed “severe poly-arthritis.”
(Diehl I, col. 4, ll. 1-12). CM protected against it:
About 70% of the first group (those treated with the material
extracted from mice [comprising CM] plus Butyricum) were
completely protected from the poly-arthritis. They showed
no swelling or other symptoms. The other 30% were partially
protected during the 32-day period.
(Diehl I, col. 4, ll. 13-17; emphasis added.)
All of the second group (those treated with synthetically
produced cetyl myristoleate plus Butyricum) were protected
from the poly-arthritis and showed a steady gain in weight.
It was found that the purer the cetyl myristoleate the
more dramatic were the results in protecting the rats from
poly-arthritis.
(Diehl I, col. 4, ll. 18-25; emphasis added.)
CM was not targeted at treating symptoms of RA, alone, but rather at
protecting against the disease in order that the resultant disease symptoms
did not occur. Thus, the Examiner‟s finding that it would have been obvious
to administer CM to OA patients because CM treats the same symptoms
observed in both diseases is not supported by a preponderance of the
evidence.
Diehl I teaches that CM protects against the onset of RA. The
underlying cause of RA is different from that of OA. The Examiner
acknowledged this:
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[R]heumatoid arthritis (RA) and osteoarthritis (OA) have
different underlying causes and are different diseases, as
declared by Dr. Silverman (Silverman Decl. ¶¶ 8-12, citing
Palmoski & Brant, Hochberg I & II, and the textbook
references, Kelley, Klippel and Weisman).
(Answer 4.)
Because the mechanisms are different, one of ordinary skill in the art
would not have had reason to believe that CM would be effective in
preventing OA. Patent Owner provided testimony on this fact by Stuart L.
Silverman, M.D. Dr. Silverman, at the time of filing of the application
resulting in the „676 patent, was an Adjunct Professor of Medicine and
Rheumatology at UCLA and has treated numerous patients with both
rheumatoid arthritis and osteoarthritis (Silverman Decl. § 3, filed March 13,
2010). Based on his experience with both RA and OA, we find that the Dr.
Silverman is qualified to testify on matters relating to the obviousness of the
claimed invention.
Dr. Silverman testified:
Textbooks of rheumatology written in 1990 to 1995 in both the
U.S. and the U.K. suggested that OA was largely
biomechanical in pathogenesis. Therefore, in 1995,
rheumatologists did not believe that OA had an inflammatory
pathogenesis. Instead, they believed in the importance of
biomechanical forces in the pathogenesis of the disease.
(Silverman Decl. ¶ 10, emphasis added.)
As discussed above, rheumatologists knew that OA was a
biomechanical disease with little to no local inflammatory
component. Rheumatologists, including myself, would have
known that the term "inflammatory disease" was applied to
diseases, such as rheumatoid arthritis, that exhibited a systemic
inflammatory response. OA was not known to be an
inflammatory disease.
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(Silverman Decl. ¶ 15, emphasis added.)
Dr. Day also testified that, unlike RA, OA was not an inflammatory
disease:
While rheumatoid arthritis is fundamentally an inflammatory
disease with a systemic presentation that leads to structural
damage in the joints, osteoarthritis is localized structural
damage of the joint leading to mild inflammatory response.
(Day Decl. ¶ 6.)
Drs. Silverman‟s and Day‟s testimony is supported by the evidence of
record. For example:
[R]heumatoid arthritis (RA) is a chronic, systemic, inflammatory
disorder of unknown etiology, affecting approximately 1% of the
world‟s population.
(Appeal Br., Exhibit C, Weisman et al., p. 31.)
[O]steoarthritis emanates from a degeneration of the articular
cartilage.
(Appeal Br., Exhibit C, Weisman et al., p. 287.)
Because the diseases are different, Dr. Silverman testified in his
written declaration:
. . . rheumatologists would not have expected a medication or
therapy which was useful in an inflammatory arthritis to be
effective in an arthritis such as OA, which was thought to have
a biomechanical pathogenesis. Nor would they be motivated to
use a medication effective in an inflammatory arthritis such as
RA for treatment of an arthritis such as OA thought to have a
biomechanical pathogenesis.
(Silverman Decl. ¶ 11.)
Thus, because the mechanisms are different, contrary to the
Examiner‟s conclusion that “Diehl I would have motivated one of ordinary
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skill in the art to use CM for treating the same symptoms found in OA”
because “drugs for treating the symptoms of RA are also effective for
treating the same symptoms of OA” (Answer 7), the skilled worker would
not reasonably expected the CM would be effective in treating OA.
The Examiner also premised the rejection on the finding, based on
Diehl‟s alleged teaching, that “CM possesses anti-inflammatory and
analgesic properties” (Answer 6). Diehl I, as explained above, describes
preventing the onset of RA. As already discussed, there is no evidence in
Diehl I that CM‟s efficacy was a result of analgesic properties of CM. To
the contrary, Diehl I teaches that its efficacy was related to its ability to
prevent disease.
Consistently, Dr. Day testified:
Cetyl myristoleate is not known to have analgesic properties
and therefore unlike NSAIDs would not be expected to reduce
symptoms of osteoarthritis (a predominantly noninflammatory
condition). Therefore, I find it very surprising that cetyl
myristoleate has been shown to be effective in the treatment of
both OA and RA.
(Day Decl. ¶ 15.)
As to CM as an “anti-inflammatory,” to the extent this activity was
associated with the prevention of RA, as already discussed, OA was not
believed at the time of the invention to be caused by inflammation. RA, on
the other hand, was known to be an inflammatory disease and CM was used
by Diehl I to treat the underlying inflammatory response responsible for RA
(Silverman Decl. ¶ 5). Inflammation observed with RA was therefore of a
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different cause than any subsequent inflammation observed with OA.
2

Consequently, it would not have been reasonably expected that CM would
be useful in treating OA since inflammation in RA is the cause of the
disease, while with OA it may occur as the disease progresses.
In sum, we conclude that the Examiner did not provide sufficient
evidence to establish that it would have been obvious at the time of the
invention to treat OA with CM. Accordingly, we reverse Rejections 1 and 2
of claim 1, and dependent claims 2-5.

REVERSED

alw

2
Answer 4 (“Both Klippel and Kelley thus indicate that there is an
inflammatory component in OA. Indeed, as OA progresses, the surface of
the articular cartilage is disrupted and wear particles gain access into the
synovial fluid, thereby stimulating phagocytosis by macrophage cells (Kaas,
col. 2, lines 33-43 and 59-62; col. 3, lines 1-15).”)
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PATENT OWNER:

TECHLAW LLP
10755 SCRIPPS POWAY PARKWAY
SUITE 465
SAN DIEGO, CA 92131

THIRD PARTY REQUESTER:

CISLO & THOMAS LLP
1333 2
nd
STREET
SUITE 500
SANTA MONICA, CA 90401-4110