Ex Parte Lipari et al

Board of Patent Appeals and Interferences

Apr 30, 2004

09215831 (B.P.A.I. Apr. 30, 2004)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

Paper No. 43

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JOHN M. LIPARI, DAWN M. RAYMOND,
TOM REILAND, and YESHWANT D. SANZGIRI
__________

Appeal No. 2004-0494
Application No. 09/215,831
__________

ON BRIEF1
__________

Before WINTERS, SCHEINER, and ADAMS, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on the appeal under 35 U.S.C. § 134 from the
examiner’s final rejection of claims 1, 3-5, 12, 14, 16 and 18, which are all the
claims pending in the application.
Claim 1 is illustrative of the subject matter on appeal and is reproduced
below:
1. A composition consisting of a fibrate dissolved in at least one
monoglyceride.

The examiner relies on the following reference:

1 Appellants waived (Paper No. 42, received April 8, 2004) their request for oral hearing,
therefore we considered this appeal on Brief.
Appeal No. 2004-0494 Page 2
Application No. 09/215,831

Lacy et al. (Lacy) 5,645,856 Jul. 8, 1997
GROUND OF REJECTION
Claims 1, 3-5, 12, 14, 16 and 18 stand rejected under 35 U.S.C. § 103 as
being unpatentable over Lacy.
We reverse.
DISCUSSION
Appellants’ claims are drawn to a composition and method of using the
composition. As set forth above, claim 1 is drawn to a composition consisting of
(1) a fibrate, which can be fenofibrate (see e.g., appellants’ claim 3 and
appellants’ specification page 3, lines 28-31), and (2) at least one monoglyceride,
which can be glyceryl caprylate, glyceryl oleate, or glyceryl caprylate/caprate
(see e.g., appellants’ claim 4 and appellants’ specification page 3, lines 33-36).
According to the examiner (Answer, page 3), “Lacy discloses
compositions containing fenofibrate. … Although Lacy does not teach
compositions containing only monoglycerides, it is deemed obvious to one of
ordinary skill in the art [at the time the invention was made] to remove any
component of Lacy if that compound is deemed unnecessary….” In response
appellants assert (Brief, page 3), “an essential element of the Lacy carrier

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Application No. 09/215,831

system or composition is a surfactant system….” In this regard, appellants point
out (id.),
Lacy discloses a carrier system for a hydrophobic drug which
comprises a digestible oil and a surfactant comprising 1) a
hydrophilic surfactant that does not substantially inhibit the lipolysis
of the digestible oil, or 2) a hydrophilic surfactant which
substantially inhibits the in vivo lipolysis of the digestible oil and a
lipophilic surfactant capable of at least substantially reducing the
inhibitory effect of the hydrophilic surfactant.

Accordingly, appellants assert (Brief, page 4), Lacy teaches away from the
present invention at column 1, lines 21-23 by disclosing “the administration of a
drug in oil alone is not advantageous because of the poor miscibility of the oil
with the aqueous environment of the gastrointestinal tract.” According to
appellants (Brief, page 4), contrary to the disclosure of Lacy, their claimed
composition “specifically exclude[s] a surfactant.” In addition, appellants argue
(id.), to the extent that the examiner relies on example 6 of Lacy, “[w]hile this
example does purport to disclose a solution of fenofibrate, there are four other
components, none of which is a monoglyceride as is required by each [of
appellants’] claim[s].”
Appellants are correct in that Lacy discloses in the background of the
specification (column 1, lines 21-23), “the administration of drug in oil alone is not
advantageous because of the poor miscibility of the oil with the aqueous
environment of the gastrointestinal tract.” Upon review of Lacy, we find that Lacy
discloses (column 3, lines 39-45), the invention “in its broadest aspect provides a
carrier system for a hydrophobic drug which comprises: (a) a digestible oil, and
(b) a pharmaceutically acceptable surfactant for dispersing the oil in vivo upon
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Application No. 09/215,831

administration of the carrier system, said surfactant comprising a hydrophilic
surfactant component….” As we understand Lacy’s disclosure, Lacy overcomes
the disadvantages of using drug in oil alone by including a hydrophilic surfactant
to the drug in oil composition.
However, as Lacy points out (column 3, lines 50-52), the majority of
hydrophilic surfactants “will inhibit the lipolysis of the digestible oil component.”
Therefore, to overcome the inhibitory effect of the hydrophilic surfactant, Lacy’s
composition must also include a lipophilic co-surfactant. Lacy, column 3, lines
52-55. Accordingly, as we understand Lacy’s disclosure, Lacy’s composition
includes four components, (1) a hydrophobic drug, (2) a digestible oil, (3) a
hydrophilic surfactant, and (4) a lipophilic surfactant. See e.g., Lacy, column 3,
lines 56-67. In contrast, appellants’ claimed invention includes only (1) a
hydrophobic drug (a fibrate), and (2) at least one monoglyceride. Therefore, as
we understand the issue on appeal, the question is whether Lacy suggests
removing two of the four components of the disclosed composition and if so, are
the two remaining components (1) a fibrate and (2) at least one monoglyceride?
We note that Lacy carves out an exception to the use of digestable oils.
Specifically, Lacy discloses (column 4, lines 1-5), “[i]f the lipophilic surfactant is
itself a digestible oil, or can serve as the source of lipolytic products, then in a
modification of the preferred carrier system a separate digestible oil component
may be omitted….” In this regard, we note that Lacy discloses (column 4, lines
36-56), “examples of lipophilic surfactants which can be used for the purposes of
the present invention are as follows: … 2. Mono- and/or di-glycerides of fatty
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Application No. 09/215,831

acids e.g. … Imwitor 308 (glyceryl mono-caprylate), …Capmul MCM (glyceryl
caprylate/caprate), Capmul GMO (glyceryl mono-oleate), … Maisine (glyceryl
mono-oleate); and Peceol (glyceryl mono-oleate)….” According to Lacy (column
6, lines 14-16), these lipophilic surfactants “are capable of serving as the
digestible oil component in this invention, or serving as the source of lipolytic
products.
Taking the foregoing teachings of Lacy together, the monoglycerides
Imwitor 308 (glyceryl mono-caprylate), Capmul MCM (glyceryl caprylate/caprate),
Capmul GMO (glyceryl mono-oleate), Maisine (glyceryl mono-oleate); and
Peceol (glyceryl mono-oleate) are capable of serving as the digestible oil
component in this invention, or serving as the source of lipolytic products and
therefore in a modification of Lacy’s preferred carrier system a separate
digestible oil component may be omitted. Accordingly, such a composition would
include (1) a hydrophobic drug, (2) a hydrophilic surfactant, and (3) a lipophilic
surfactant. While Lacy’s hydrophobic drug and lipophilic surfactant are within the
scope of appellants’ claimed invention, Lacy’s composition includes an additional
component, a hydrophilic surfactant, which is specifically excluded from
appellants’ claimed invention. Accordingly, this embodiment of Lacy’s disclosure
does not support the examiner’s position.
Lacy also carves out an exception to the use of lipophilic surfactants, we
note that Lacy discloses (column 8, lines 14-18), this applies to “one class of
hydrophilic surfactants, namely the transesterification products of
polyoxyethylene glycol with glycerol esters of capric and caprylic acids … [which
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Application No. 09/215,831

do] not substantially inhibit the in vivo lipolysis of digestible oils.” According to
Lacy (column 8, lines 19-23), “with this class of hydrophilic surfactants there is no
necessity to include any lipophilic surfactant component at all….” Accordingly,
Lacy discloses (column 8, lines 24-30):
[I]n a further aspect, the present invention provides a carrier
system for a hydrophobic drug which comprises:

(a) a digestible oil,
(b) a transesterification product of polyoxy-ethylene glycol
with glycerol esters of capric and/or caprylic acids as
hydrophilic surfactant, and
(c) optionally a lipophilic surfactant.

Lacy discloses that Labrasol (glyceryl caprylate/caprate and PEG-8
caprylate/caprate) and Softigen 767 (PEG-6 caprylic/capric glycerides) as
examples of this type of hydrophilic surfactant. See Lacy, column 8, lines 31-37.
Since this composition includes (1) a hydrophobic drug, (2) a digestible oil, and
(3) a hydrophilic surfactant, this embodiment of Lacy’s disclosure also does not
support the examiner’s position.
Therefore, while it may be true that Lacy suggests, under certain
circumstances, that a digestible oil or a lipophilic surfactant are not necessary,
and may be removed from Lacy’s composition, for the foregoing reasons we find
nothing in Lacy to suggest that even if these components were removed they
would lead to appellants’ claimed composition or the claimed method of using the
composition. In this regard, we remind the examiner that “[t]he Patent Office has
the initial duty of supplying the factual basis for its rejection. It may not, because
it may doubt that the invention is patentable, resort to speculation, unfounded
assumptions or hindsight reconstruction to supply deficiencies in its factual
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Application No. 09/215,831

basis.” In re Warner, 379 F.2d 1011, 1017, 154 USPQ 173, 178 (CCPA 1967).
For the foregoing reasons, it is our opinion that the examiner has fallen “victim to
the insidious effect of hindsight syndrome wherein that which only the inventor
taught is used against its teacher.” W.L. Gore & Associates, Inc. v. Garlock, Inc.,
721 F.2d 1540, 1553, 220 USPQ 303, 312-13 (Fed. Cir. 1983).
Accordingly, we reverse the rejection of claims 1, 3-5, 12, 14, 16 and 18
under 35 U.S.C. § 103 as being unpatentable over Lacy.
REVERSED

)
Sherman D. Winters )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Toni R. Scheiner )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Donald E. Adams )
Administrative Patent Judge )

Appeal No. 2004-0494 Page 8
Application No. 09/215,831

STEVEN F. WEINSTOCK
ABBOTT LABORATORIES
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