Ex parte Kunin

Board of Patent Appeals and Interferences

Aug 28, 1997

07939990 (B.P.A.I. Aug. 28, 1997)

Application for patent filed September 3, 1992. 1
According to applicant, this application is a continuation-in-part
of Application 07/737,705, filed July 30, 1991, now abandoned.
1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today
(1) was not written for publication in a law journal and
(2) is not binding precedent of the Board.
Paper No. 11
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte ROBERT KUNIN
____________
Appeal No. 94-1545
Application 07/939,9901
____________
ON BRIEF
____________
Before WINTERS, WILLIAM F. SMITH and GRON, Administrative Patent
Judges.
GRON, Administrative Patent Judge.
DECISION ON APPEAL UNDER 35 U.S.C. § 134
This is an appeal of an examiner's final rejections of
Claims 1-7, all claims pending in this application.
Appeal No. 94-1545
Application 07/939,990
2
Claim 2 stands rejected under 35 U.S.C. § 112, fourth
paragraph. Appellant concedes that this rejection is proper
(Appeal Brief, page 4). Therefore, we affirm the examiner's
rejection of Claim 2 under § 112.
Claims 1-7 stand rejected under 35 U.S.C. § 102 as
anticipated by Ghebre-Sellassie et al. (Ghebre-Sellassie),
U.S. 4,814,354, patented March 21, 1989. For the rejection under
this section, all claims stand or fall together (Appeal Brief,
page 4). We reverse the examiner's rejection of Claims 1-7 under
§ 102.
Discussion
Claim 1 is representative of the claimed subject matter and
reads:
1. A salt comprising the reaction product of
nicotinic acid and a basic anion exchange resin
having a degree of crosslinking with
divinylbenzene of less than about 4%, a maximum
degree of crosslinking corresponding to a minimum
moisture content of 50%, and a particle size in
water in a swollen, chloride form ranging from
about 0.03 to about 0.84 mm.
To sustain an examiner's rejection under 35 U.S.C. § 102,
a prior art reference must itself sufficiently describe the
claimed invention to have placed a person having ordinary skill
in the art in possession of it. In re Spada, 911 F.2d 705, 708,
15 USPQ2d 1655, 1657 (Fed. Cir. 1990). We hold that the examiner
clearly erred in finding that Ghebre-Sellassie placed the
Appeal No. 94-1545
Application 07/939,990
3
invention appellant claims in the possession of the public.
Appellant claims a salt, i.e., a reaction product of an acid
with a base. The acid is nicotinic acid. The base is a basic
anion exchange resin crosslinked to a specified degree with
divinylbenzene. While the crosslinking limitations of the basic
anion exchange resin reactant are not apparent from Ghebre-
Sellassie's general description of cholestyramine, i.e., a
pharmaceutically important anionic-exchange resin including
"basic quaternary ammonium-exchange functionalities . . .
attached to a styrene divinylbenzene copolymer skeleton"
(col. 2, lines 63-66) having the structure depicted at column 3,
lines 1-10, appellant does not challenge the examiner's inference
that the basic anion exchange resin reactant described by Ghebre-
Sellassie is either identical to or substantially the same as the
basic anion exchange resin reactant of appellant's salt.
Nor does the appellant deny that Ghebre-Sellassie teaches
that cholestyramine and nicotinic acid are both known lipid
lowering/regulating agents (col. 3, lines 12-25 and 40-50) and
contemplates formulations comprising cholestyramine and other
lipid modifiers, one of which may be nicotinic acid (col. 3,
lines 33-50). Rather appellant argues that Ghebre-Sellassie's
invention is directed to pharmaceutical compositions comprising
(1) a basic anion exchange resin lipid regulator which is coated
Appeal No. 94-1545
Application 07/939,990
4
with a pharmaceutically acceptable acid resistant enteric
phthalate soluble in intestinal juice of the small intestine,
and (2) an acidic lipid regulator, e.g., gemfibrozil (Ghebre-
Sellassie, col. 6, Claim 1).
We find that the inventive compositions Ghebre-Sellassie
describes are not reaction products at all. In fact, Ghebre-
Sellassie coats the basic anion exchange resin lipid regulator
for the express purpose of preventing a salt-forming reaction
between the basic anion exchange resin lipid regulator and other
known acidic lipid regulators, e.g., gemfibrozil and nicotinic
acid. Ghebre-Sellassie teaches that salt-forming reactions
reduce the pharmaceutical efficacy of the individual regulators
(col. 1, lines 61 to 65):
Furthermore, the coating process used in the
pretreatment virtually assures that the
cholestyramine or other ionic component will not
react to any significant extent before it reaches
the proper location in the gastrointestinal tract
so that its efficacy is maximized (emphasis
added).
Thus, Ghebre-Sellassie actually teaches away from the salt
appellant claims. However, teaching away from the claimed
invention is pertinent to determinations of patentability under
35 U.S.C. § 103, not findings of anticipation under § 102.
Nevertheless, why the examiner cannot understand that a salt
is the reaction product of an acid and a base escapes us. While
Appeal No. 94-1545
Application 07/939,990
5
we find that Ghebre-Sellassie compares the amount of gemfibrozil
which binds to treated cholestyramine at pH 4.5-7.5 (Table II) to
amount of gemfibrozil which binds to untreated cholestyramine at
the same pH (Table I), we find that Ghebre-Sellassie does not
sufficiently describe a salt of nicotinic acid and untreated
cholestyramine to have placed it in the possession of the public.
Conclusion
1. The rejection of Claim 2 under 35 U.S.C. § 112, fourth
paragraph, is affirmed.
2. The rejection of Claims 1-7 under 35 U.S.C. § 102 is
reversed.
No time period for taking any subsequent action in
connection with this appeal may be extended under 37 CFR
§ 1.136(a).
AFFIRMED-IN-PART
Sherman D. Winters )
Administrative Patent Judge )
)
)
)
William F. Smith ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
Appeal No. 94-1545
Application 07/939,990
6
)
)
Teddy S. Gron )
Administrative Patent Judge )

Appeal No. 94-1545
Application 07/939,990
7
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