Ex Parte Ahmad et al

Patent Trial and Appeal Board

Sep 22, 2016

12513654 (P.T.A.B. Sep. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/513,654 02/02/2010
72960 7590 09/26/2016
Casimir Jones, S.C.
2275 DEMING WAY, SUITE 310
MIDDLETON, WI 53562
FIRST NAMED INVENTOR
Moghis U. Ahmad
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
JINA-13426/US-l/PCT 4505
EXAMINER
POPA, ILEANA
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
09/26/2016 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
docketing@casimirjones.com
pto .correspondence@casimirjones.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MOGHIS U. AHMAD, SHOUKATH M. ALI, ATEEQ AHMAD,
SAIFUDDIN SHEIKH, and IMRAN AHMAD 1
Appeal2014-006924
Application 12/513,654
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and JOHN E.
SCHNEIDER, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
composition, which have been rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The Specification states that "[i]n the 1960s the oleogum resin (gum
guggul), isolated from a small tree Commiphora wighitii ... was studied for
1 Appellants identify the Real Party in Interest as Jina Pharmaceuticals, Inc.
(Appeal Br. 3.)
Appeal2014-006924
Application 12/513,654
its potential use in the treatment of elevated blood cholesterol or
hyperlipidemia." (Spec. i-f 2.)
[I]t was determined that the soluble portion of the gum in ethyl
acetate, and specifically its neutral portion, contained most of the
hypolipidemic properties. The neutral fraction was found to be
source of sterol compounds known as Z- and E-guggulsterone,
present in an amount minimum of 2.5% and responsible for
lowering of blood cholesterol.
(Id.) The Specification discloses "guggul derivatives having general
structures III-XII." (Id. i-f 9.) For example, "guggulsulfate of Formula VII
is synthesized by reacting guggulsterol IIA with chlorosulfonic acid in
presence of base ... in a suitable solvent." (Id. i-f 116.)
Claims 42, 44--4 7, 50, 52, and 53 are on appeal. Claim 42 is the only
independent claim and reads, in relevant part,2 as follows:
42. A composition comprising a guggul-based lipid molecule having a
general structure selected from the group consisting of structures IV-XII[,]
vu
wherein:
0
O--M.-ox
H
0
v) in structures IV-X, Xis hydrogen, methyl, ammonium, sodium,
potassium, calcium, barium ion or any non-toxic ion;
and wherein:
xi) structures IV-XII are in the form selected from the group consisting
of £-isomer, Z-isomer, or a mixture of E- and Z- isomers[,]
2 The Examiner states that, as a result of an election of species requirement,
"the instant claims are examined to the extent that they read on the elected
species of guggulsteryl sulfate set forth by structure VII." (Ans. 4.)
2
Appeal2014-006924
Application 12/513,654
xii) structures IV-XII are optically pure, or one or more of structures
IV[-]XII are mixtures of optical isomers[.]
The claims stand rejected as follows:
Claims 42 and 45--47 under 35 U.S.C. § 103(a) as obvious based on
Weitkemper3 and Kang4 (Ans. 4);
Claims 42, 44--47, 50, 52, and 53 under 35 U.S.C. § 103(a) as obvious
based on Weitkemper, Kang, Ostlund, 5 and Barchfeld6 (Ans. 5); and
Claims 42, 44--47, 50, 52, and 53, provisionally, for obviousness-type
double patenting based on application 13/120,127 (Ans. 3).
I
The Examiner has rejected claims 42 and 45--47 as obvious based on
Weitkemper and Kang. The Examiner has also rejected all of the claims as
obvious based on W eitkemper, Kang, Ostlund, and Barchfeld. The same
issue is dispositive for both rejections.
The Examiner finds that W eitkemper teaches "a composition for
reducing cholesterol levels, the composition comprising a phytosterol fatty
acid ester as an anti-cholesterol agent and a phytosterol sulfate as a
potentiating agent." (Ans. 4.) The Examiner finds that Kang teaches "that
guggulsterone (having the ... structure I) is useful as an anti-cholesterol
agent." (Id. at 4--5.)
3 US 6,383,514 Bl, issued May 7, 2002.
4 WO 2004/094450 Al, published Nov. 4, 2004.
5 US 6,063,776, issued May 16, 2000.
6 US 5,709,879, issued Jan. 20, 1998.
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Appeal2014-006924
Application 12/513,654
The Examiner concludes that "[b ]ased on these teachings, one of skill
in the art would have known that guggulsterone is a functional equivalent of
the phytosterol fatty acid esters of W eitkemper et al. with respect to the
capacity of reducing cholesterol levels." (Id. at 5.) Therefore, he concludes
that it would have been obvious to modify W eitkemper' s composition "by
replacing their phytosterol fatty acid ester with the guggulsterone of Kang"
and "to sulfate the C-16 hydroxyl group of this guggulsterol and further use
the resulting guggulsteryl sulfate to potentiate the anti-cholesterolemic
activity of guggulsterone," because guggulsterol was known to be a
phytosterol. (Id.)
Appellants argue that "compound VII of claim 42 can be described as
comprising an oxo-group at C-3 and a sulfate group at C-16" (Appeal Br. 9),
but W eitkemper defines phytosterols as "vegetable steroids which only
contain a hydroxyl group but no other functional groups at C-3" (id. at 10-
11 ). Appellants argue that the guggulsterone and guggulsterol disclosed by
Kang have an oxo group at C-3, not a hydroxyl group as specified by
Weitkemper. (Id. at 12-13.) Appellants conclude that
there is no reason provided to modify W eitkemper to use the
expressly excluded guggulsterone and guggulsterol of Kang as a
starting material for the disclosed sulfate modification, and there
is no reason provided to modify Kang to add a sulfate group to
the guggulsterone or guggulsterol, where none is taught.
(Id. at 18.)
We agree with Appellants that the Examiner has not established that it
would have been obvious to modify Weitkemper's composition to contain
the guggulsteryl sulfate (structure VII) recited in claim 42. Weitkemper
discloses compositions for lowering cholesterol comprising phytostanol
4
Appeal2014-006924
Application 12/513,654
esters and tocopherols. (Weitkemper 1 :48-53.) Weitkemper states that
"[p ]hytostanol (also known as phytosterols) are vegetable steroids which
only contain a hydroxyl group but no other functional groups at C-3." (Id. at
1 :62---64.) The phytostanols form phytostanol esters when esterified with a
fatty acid. (Id. at 1:66 to 2: 1.) "The phytostanol component can be derived
from the hydrogenation products of ergosterols, campesterols, stigmasterols,
brassicasterols, preferably sitosterols." (Id. at 2:2-5.)
W eitkemper discloses that its compositions can also "contain
phytosterol sulfates as further potentiating agents (component c2).
Phytosterol sulfates are known substances which may be obtained, for
example, by sulfation of phytosterols .... Typical examples are the sulfates
o[ fJ ergosterols, campesterols, stigmasterols and sitosterols." (Id. at 3 :42-
48.)
Kang discloses that guggulsterone "ha[ s] an effect of lowering the
elevated low density lipoprotein (LDL) and high levels of the cholesterol
effectively." (Kang 1:7-9.) The Examiner has not pointed to disclosure of
any activity for guggulsterol in Kang. Guggulsterone' s two isomers have
the following structures:
0
(Id. at 3:19-20, 4:5.)
We agree with Appellants that the Examiner has not shown that a
person of ordinary skill in the art would have found it obvious to modify
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Appeal2014-006924
Application 12/513,654
W eitkemper' s composition by substituting guggulsterone for the phytosterol
in its phytostanol ester component, and to substitute guggulsteryl sulfate for
the phytosterol sulfate component. As Appellants point out (Appeal Br. 10-
13), Weitkemper expressly defines the phytosterols that are useful in its
composition as having a hydroxyl group at C-3, where guggulsterone has an
oxo group.7
While Kang discloses that guggulsterone has a cholesterol-lowering
effect, the Examiner has not pointed to evidence showing that a skilled
worker would expect it to retain that activity after esterification, as disclosed
for phytosterols (having a hydroxyl group at C-3) in Weitkemper. More
importantly for the claimed composition, the Examiner has not pointed to
evidence that guggulsteryl sulfate (structure VII) would have been expected
to potentiate the cholesterol-lowering activity of guggulsterone or an ester
derived from it.
In view of Weitkemper's focus on the C-3 hydroxyl group, and its use
of phytosterols having that group in both its ester and sulfate components,
the evidence does not support the Examiner's conclusion that a skilled
worker would expect compounds lacking that group (even assuming they
would be considered phytosterols) would give the same results if combined
in the manner described by W eitkemper.
Thus, the Examiner's conclusion that the composition of claim 42
would have been obvious based on W eitkemper and Kang is not supported
by a preponderance of the evidence. Both rejections under 35 U.S.C.
7 C-3 is the ring carbon at the bottom left of each structure. (Appeal Br. 9.)
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Appeal2014-006924
Application 12/513,654
§ 103(a) rely on the same reasoning. We therefore reverse both rejections
based on 35 U.S.C. § 103(a).
II
The Examiner has provisionally rejected all of the claims for
obviousness-type double patenting. (Ans. 3.) We do not reach the
provisional rejection.
If a "provisional" nonstatutory obviousness-type double
patenting (ODP) rejection is the only rejection remaining in the
earlier filed of the two pending applications, while the later-filed
application is rejectable on other grounds, the examiner should
withdraw that rejection and permit the earlier-filed application to
issue as a patent without a terminal disclaimer.
MPEP § 804(I)(B)(l ).
On return of this application, the Examiner should follow the
guidance in the MPEP regarding the provisional obviousness-type double
patenting rejection.
SUMMARY
We reverse both of the rejections based on 35 U.S.C. § 103(a).
We do not reach the rejection based on obviousness-type double
patenting.
REVERSED
7