Ex Parte Prather et al

Patent Trial and Appeal Board

Jan 30, 2013

11867689 (P.T.A.B. Jan. 30, 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.
11/867,689 10/05/2007 Paul L. Prather 110 030US1 9512
66981 7590 01/30/2013
HUGH MCTAVISH
MCTAVISH PATENT FIRM
429 BIRCHWOOD COURTS
BIRCHWOOD, MN 55110
EXAMINER
BAEK, BONG-SOOK
ART UNIT PAPER NUMBER
1629
MAIL DATE DELIVERY MODE
01/30/2013 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
____________

Ex parte PAUL L. PRATHER and JOHN P. CROW
____________

Appeal 2012-002091
Application 11/867,689
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, JACQUELINE WRIGHT BONILLA,
and ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
cannabinoid receptor modulator to treat a neurodegenerative disease,
specifically, amyotrophic lateral sclerosis. The Examiner has rejected the
claims for containing new matter and anticipation. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.

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STATEMENT OF THE CASE
“There are two known cannabinoid receptor sub-types, CB1 and CB2.
CB1 receptors are expressed throughout the central nervous system (CNS),
while CB2 receptors are expressed predominantly in immune cells and
nonneuronal tissues.” (Spec. ¶ 0003.) The Specification describes
“selective CB2 modulators [that] act as efficacious pharmacological agents
with several distinct advantages for the management of neurodegenerative
diseases. One benefit of potential selective CB2 modulation therapy for
neurodegenerative diseases is that significant therapeutic effects are
observed even when selective CB2 modulators are initiated at symptom
onset.” (Spec. ¶ 0030.)
Claims 1, 5, 6, and 26 are on appeal, and can be found in Appendix I
of the Appeal Brief (App. Br. 8, 9). Independent claim 1 is representative:
l. A pharmaceutical composition for the treatment of a
neurodegenerative disease in a human, the composition comprising (i)
a selective CB2 receptor modulator in a unit dosage form in a dosage
effective to treat the neurodegenerative disease in a human and (ii) a
pharmaceutically acceptable excipient; wherein the neurodegenerative
disease is amyotrophic lateral sclerosis.
The Examiner has rejected the claims as follows:
I. claims 1, 5, 6, and 26 under 35 U.S.C. § 112 first paragraph, as
containing new matter; and
II. claims 1, 5, 6, and 26 under 35 U.S.C. § 102(b) as unpatentable
over Ibrahim.
1

1
Ibrahim, Activation of CB2 cannabinoid receptors by AM1241 inhibits
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As Appellants do not argue the claims separately, we focus our
analysis on claim 1, and claims 5, 6, and 26 stand or fall with that claim. 37
C.F.R. § 41.37 (c)(1)(iv).
I.
The Issue
The Examiner takes the position that “[t]he specification only
mentions about vehicles such as olive oil for injectable compositions in the
examples (p17, [0058]). The newly added limitation, „a pharmaceutically
acceptable excipient‟ is broader than the original „vehicle‟ disclosure.”
(Ans. 5.)
Appellants contend:
A pharmaceutical composition implicitly and inherently
comprises a pharmaceutically acceptable excipient. In addition,
paragraph 58 discloses that the drugs “have poor water
solubility and require a vehicle which is both capable of
dissolving the drug and is biocompatible." Several specific
vehicles are listed in paragraph 58, including ethanol/water,
glycerol and high purity olive oil. A pharmaceutical "vehicle"
has the same meaning as "a pharmaceutically acceptable
excipient." Webster's New World Dictionary, second college
edition, 1979, defines "excipient" as "any of various inert
substance added to a prescription to give the desired
consistency or form" That seems to have the same meaning as a
pharmaceutical vehicle.
(App. Br. 5.)
Does the evidence of record support the Examiner's conclusion that

experimental neuropathic pain: Pain inhibition by receptors not present in
the CNS, 100 PNAS 10529-10533 (2003).
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the disclosure of the Specification failed to provide descriptive support for a
“pharmaceutically acceptable excipient”?
Finding of Fact
The following finding of fact (FF) is supported by a preponderance of
the evidence of record.
1. The Specification disclosed:
All drugs and vehicle were administered once daily by
the i.p. route beginning the first day of symptom onset. AM-
1241, AM630, JTE-907 and WIN- 55,212-2 have very poor
water solubility and require a vehicle which is both capable of
dissolving the drug and is biocompatible (with chronic dosing).
Other groups have used complex vehicles composed of
polyethoxylated vegetable oils and/or ethanol/glycerol/water
mixtures. We tested a number of traditional vehicles such as
ethanol/water, glycerol, polyethylene glycol, and high purity
olive oil. Stable dissolution of AM-1241, AM630, JTE-907
and WIN-55,212-2 was achieved only with olive oil, thus it was
selected as the vehicle for these studies. Two different
concentrations of AM-1241 (1 mg/ml and 0.1 mg/ml) and one
WIN-55,212-2 concentration (1 mg/ml) were prepared in order
to minimize the volume of olive oil that was injected IP.
(Spec. ¶ 0058.)
Principle of Law
“[T]he written description requirement does not demand either
examples or an actual reduction to practice; a constructive reduction to
practice that in a definite way identifies the claimed invention can satisfy the
written description requirement.” Ariad Pharmaceuticals, Inc. v. Eli Lilly
and Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010).
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Analysis
The Examiner position is that the newly added limitation of a
“pharmaceutically acceptable excipient” is new matter (Ans. 5.) The
Examiner argues that Appellants‟ points are unpersuasive (id. at 7-8).
The standard to be applied is “whether the disclosure of the
application as originally filed reasonably conveys to the artisan that the
inventor had possession at that time of the later claimed subject matter,
rather than the presence or absence of literal support in the specification for
the claim language.” In re Kaslow, 707 F.2d 1366, 1375 (Fed. Cir. 1983).
Applying that standard, we find that the evidence (FF1) supports Appellants
position, for the reason provided in the Appeal Brief (App. Br. 4-5). The
new matter rejection of claims 1, 5, 6, and 26 is reversed.
II.
The Issue
The Examiner takes the position that “Ibrahim et al. teach an
injectable composition (a pharmaceutical composition) comprising AM1241
in a unit dosage (0.1, 0.3, 1.0, and 3 mg/kg) with a pharmaceutically
acceptable excipient such as dimethyl sulfoxide as recited in the instant
invention, thus it would be capable of performing the intended use as
claimed.” (Ans. 6.)
Appellants contend that “Ibrahim does not disclose or suggest that
AM124l is effective to treat ALS.” (App. Br. 6.) “The structural differences
defined by these functional limitations - a pharmaceutical composition
comprising a pharmaceutically acceptable excipient and comprising a
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selective CB2 receptor modulator in a unit dosage form effective to treat
ALS - are not disclosed or suggested by Ibrahim” (App. Br. 6), and that
“[t]he claims recite „a unit dosage form‟ for a human” (id. at 7). Finally,
Appellants assert that “[n]onsterile or nonpharmaceutical grade DMSO
would not be a pharmaceutically acceptable excipient.” (Id. at 6-7.)
Does the Examiner establish by a preponderance of the evidence
(either expressly or inherently) that Ibrahim anticipates the claims?
Further Findings of Fact
The following findings of fact (FF) are supported by a preponderance
of the evidence of record.
2. Ibrahim disclosed “AM1241, a selective CB2 cannabinoid
receptor agonist, and used it to test the hypothesis that CB2 receptor
activation would reverse the sensory hypersensitivity observed in
neuropathic pain states. AM1241 exhibits high affinity and selectivity for
CB2 receptors. It also exhibits high potency in vivo.” (Ibrahim Abstract;
Ans. 5.)
3. Ibrahim disclosed that “[c]annabinoid drugs were dissolved in
dimethyl sulfoxide [DMSO]. AM630 is a CB2 receptor-selective antagonist
with 70- to 165-fold selectivity for binding to the CB2 receptor in vitro (18,
19). AM251 is a 300-fold selective CBl receptor antagonist (20, 21). Drugs
were administered i.p. 15 min before behavioral testing.” (Ibrahim 10530;
Ans. 6.)
4. Ibrahim disclosed that:
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Our data demonstrate that activity of CBl cannabinoid
receptors is not required for the inhibition of neuropathic pain
by AM1241. They do not, however, fully exclude the
involvement of other receptors. For example, a putative
receptor has recently been described in brain that is modulated
by the cannabinoid receptor agonist WIN55,212-2 but has
different pharmacological properties from the CBl receptor and
is not inhibited by the CBl receptor-selective antagonist AM251
(34). To date, this receptor has not been cloned, and its
interactions with cannabinoid ligands have not been
characterized.
(Ibrahim 10533.)
5. Ibrahim disclosed intraperitoneal (i.p.) administration of
AM1241 in mice and rats at dosages of 0.1 mg/kg (100 μg/kg), 0.3 mg/kg
(300 μg/kg) (Ibrahim 10531, see Fig. 2; Ans. 5), 1 mg/kg (Ibrahim 10532,
see Fig. 4; Ans. 5), and 3 mg/kg (Ibrahim 10532, see Fig. 5; Ans. 5).
6. The Specification disclosed that “[m]ice were administered
daily i.p. injections, beginning at onset of symptoms, with one of four
treatments; vehicle (Fig. 4A-C, n=9), the relatively non-selective CBl/CB2
agonist WIN-55,212-2 (5 mg/kg, Fig. 4A, N=6), the selective CB2 partial
agonist AM-1241 (0.3 mg/kg, Fig. 4B, N=14) or AM-1241 (3 mg/kg, Fig.
4C, N=14).” (Spec. ¶ 0079.)
Principle of Law
“[T]he discovery of a previously unappreciated property of a prior art
composition, or of a scientific explanation for the prior art‟s functioning,
does not render the old composition patentably new to the discoverer.” Atlas
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Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999). Thus, the
claiming of a new use, new function or unknown property which is
inherently present in the prior art does not necessarily make the claim
patentable. In re Best, 562 F.2d 1252, 1254 (CCPA 1977).
Analysis
We are not persuaded by Appellants‟ argument that there are
structural differences defined by functional limitations in claim 1. The
claim 1 requires the following limitations: “treatment of a neurodegenerative
disease in a human” and “wherein the neurodegenerative disease is
amyotrophic lateral sclerosis.” These limitations are interpreted by the
Examiner to be intended use limitations (Ans. 6). “[T]he patentability of
apparatus or composition claims depends on the claimed structure, not on
the use or purpose of that structure.” Catalina Mktg. Int’l, Inc. v.
Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). We agree with
the Examiner‟s conclusion that the claim is directed to a composition,
specifically, a selective CB2 receptor modulator, for example such as
AM1241, specifically recited in dependent claim 26. The recited use of the
composition does not impart any structural features onto the CB2 receptor
modulator that would distinguish it from any other CB2 receptor modulator
of the prior art.
We agree with the Examiner‟s finding that Ibrahim disclosed the use
of AM1241 in animals. Specifically, Ibrahim injected rats or mice i.p. with
AM1241 (FFs 2,3) at dosages of 0.1, 0.3, 1 and 3 mg/kg (FF5), where the
compound was mixed with DMSO (FF3). The administration of “AM124l
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reversed SNL-induced tactile and thermal hypersensitivity in rats and in
mice.” (Ibrahim 10531.) The Specification disclosed the i.p. administration
of AM1241 in mice at dosages of 0.3 mg/kg and 3 mg/kg (FF6), where the
compound was mixed with olive oil (FF1). Thus, the experimental
conditions in Ibrahim and the Specification use the same route of
administration, i.p., to provide the same drug AM1241 at the same
concentration, albeit with a different pharmaceutical vehicle, to either rats or
mice. The discovery of the previously unappreciated property of AM1241
on halting the disease progression in amyotrophic lateral sclerosis, even after
the onset of symptoms in a mouse model, does not change the structure of
the old composition, in this case AM1241. See Atlas Powder, 190 F.3d at
1347.
Appellants acknowledge that “[s]terile, pharmaceutical grade
dimethyl sulfoxide (DMSO) is a pharmaceutically acceptable excipient.”
(App. Br. 6.) However, Appellants contend that “there is no evidence that
this [sterile DMSO] was what was used in Ibrahim for experiments with
rats.” (Id.) We are not persuaded by Appellants‟ argument that
“pharmaceutically acceptable excipient,” as recited in claim 1, does not
encompass the DMSO vehicle used in Ibrahim, i.e., an acceptable excipient
in animals. “Attorneys‟ argument is no substitute for evidence.” Johnston v.
IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989). Moreover, there is no
evidence, in this record, that the ordinary artisan would have understood that
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it was routine procedure in the pharmaceutical art to use non-sterile DMSO
2

when administering composition to an animal.
We conclude that the preponderance of the evidence of record
supports the Examiner‟s conclusion that Ibrahim anticipates the composition
of claim 1. We thus affirm the anticipation rejection of claim 1 under 35
U.S.C. § 102(b). As claims 5, 6, and 26 stand or fall with claim 1, we affirm
the rejection as to those claims as well.

SUMMARY
We reverse the rejection of claims 1, 5, 6, and 26 under 35 U.S.C.
§ 112, first paragraph.
We affirm the rejection of claims 1, 5, 6, and 26 under 35 U.S.C.
§ 102(b) as being anticipated by Ibrahim.

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

cdc

2
The FDA lists DMSO as an inactive ingredient for approved drugs, and
this includes infusion products, injection suspensions, as well as topical drug
applications; http://www.accessdata.fda.gov/scripts/cder/iig/getiigWEB.cfm
(last accessed January 28, 2013).