Ex Parte Jansen et al

Patent Trial and Appeal Board

Oct 23, 2012

10469391 (P.T.A.B. Oct. 23, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte THEODORUS JANSEN,
VIRGIL ELISABETH SCHIJNS, and ERIK HERMKENS
__________

Appeal 2011-010974
Application 10/469,391
Technology Center 1600
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1-9 and 17-20. We have jurisdiction under
35 U.S.C. § 6(b).
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Application 10/469,391

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STATEMENT OF THE CASE
Claim 1 is representative of the claims on appeal, and reads as
follows:
1. An injectable, imununogenic adjuvant composition comprising a
water-in-oil emulsion, wherein said emulsion comprises an antigen and a
polymeric emulsifier which is a block copolymer having a general formula
A-COO-B-OOC-A, in which component B is the divalent residue of a water-
soluble polyalkylene glycol and components A are the residue of an oil-
soluble complex monocarboxylic acid, said emulsion having a viscosity
below 450 mPas.

The claims have been examined to the extent they read on the elected
emulsifier, ARLACEL® P135 (Ans. 5).

The following grounds of rejection are before us for review:
I. Claims 1-7, 9, and 17-20 stand rejected under 35 U.S.C. § 103(a)
as being rendered obvious by the combination of Hunter
1
and
Allard
2
(Ans. 4).
II. Claim 8 stands rejected under 35 U.S.C. § 103(a) as being rendered
obvious by the combination of Hunter and Allard as further
combined with Mitani
3
(Ans. 7).

We reverse.

1
Hunter et al., US 5,622,649, issued Apr. 22, 1997.
2
Allard, US 6,174,518 B1, issued Jan. 16, 2001.
3
Mitani, US 4,963,656, issued Oct. 16, 1990.
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ANALYSIS
The Specification teaches that water-in-oil (w/o) emulsions are often
used as adjuvants, and are generally injected (Spec. 1). The Specification
teaches, however, that w/o emulsions are “are often relatively viscous which
makes injection of these emulsions very difficult” (id.). According to the
Specification, “when certain specific emulsifiers are used w/o emulsions can
be made that are stable, and provide excellent adjuvant activity, even when
based on non-mineral, metabolisable oils,” and that the “emulsions have a
very low viscosity and thus suitable for injection” (id. at 2).
The Examiner rejects claims 1-7, 9, and 17-20 as being rendered
obvious by the combination of Hunter and Allard (Ans. 4-7). The Examiner
finds that Hunter teaches w/o preparations for numerous applications,
including as vaccine adjuvants, pharmaceutical uses, and cosmetic uses (id.
at 4). The Examiner finds that the emulsions of Hunter “can incorporate
antigens and oil phase surfactants such as A[RLACEL®] 186 in an amount
of 10 wt. % (see Figure 8; columns 33-34; column 13, lines 22-24)” (id. at
5).
Hunter “relates to compositions and methods for preparing stable
water-in-oil multiple emulsions which are useful for many different
applications, including, but not limited to, adjuvants; vaccines, including
oral and p[a]rental immunization; oral, topical and parental drug delivery,
and cosmetics” (Hunter, col. 1, ll. 20-25). According to Hunter, the “major
problems impeding the increased use of water-in-oil emulsions are difficulty
in preparation, high viscosity, and poor stability” (id. at col. 4, ll. 26-28).
Hunter specifically teaches the use of ARLACEL® 186, which is a nonionic
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surfactant mixture of mono and diglycerides (id. at col. 14, ll. 48-49), and
presents a Figure, Figure 8 (id. at cols. 33 and 34) in which ARLACEL®
186 was used as the surfactant in the oil phase of a water-in-oil emulsion,
which was then used in a water-in-oil-in-water [w-o-w] multiple emulsion.
The Examiner notes that Hunter “do[es] not teach the elected
emulsifier, A[RLACEL®] P135,” (Ans. 5).
The Examiner finds that Allard teaches “a cosmetic or dermatological
emulsion of the water/oil/water type wherein the fatty phase comprises a
lipophilic emulsifier which is preferably A[RLACEL®] P135 in an amount
of 0.5-10 wt.% and more preferably 2-5 wt.% (column 5, lines 45-50;
abstract)” (id.). The Examiner finds that Allard teaches that the above
emulsifier allows the composition to remain stable in storage, as well as
“exhibit a better persistence toward water than conventional O/W
emulsions” (id.).
Allard teaches “cosmetic or dermatological triple emulsions of the
water/oil/water type comprising a non-continuous fatty phase comprising, as
water/oil emulsifier, at least one block copolymer composed of a polymer
block derived from a monohydroxycarboxylic acid and of a polymer block
derived from an alkylglycol or from a polyalkylene glycol and a
photoprotective system capable of screening out UV (UV-A and/or UV-B)
radiation” (Allard, col. 1, ll. 8-15). Allard teaches that ARLACEL® P135 is
a block copolymer, that is, PEG-30 dipolyhydroxystearate (id. at col. 5, ll.
45-47). Allard teaches further that the compositions may also contain a
thickener (id. at col. 7, ll. 53-54).
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The Examiner concludes that it would have been obvious to the
ordinary artisan to use the ARLACEL® P135 emulsifier as taught by Allard
in the oily phase of Hunter’s emulsion rather than ARLACEL® 186 because
Allard teaches that the use of the emulsifier “is beneficial in making
water/oil/water emulsions remain stable in storage, which Hunter [ ]
recognize[s] is a major problem impeding the increased use of water-in-oil
emulsions (see column 4, lines 26-28)” (Ans. 5).
As to the requirement that the emulsion have a viscosity below 450
mPAS, the Examiner finds that viscosity would “be an intrinsic property of
Hunter’s emulsions modified by Allard” (id. at 6). The Examiner finds
further that as Hunter teaches “that its emulsions are an improvement upon
water-in-oil emulsions with high viscosity and poor stability in the past
(column 4, lines 26-28), it is the examiner's position that the viscosity of
Hunter et al modified by Allard would be low, particularly since Hunter et al
teach that its emulsions are suitable for injection” (id.).
Appellants argue that the Examiner has provided no evidence that
ARLACEL® P135 may be substituted for ARLACEL® 186 (App. Br. 10).
According to Appellants, “ARLACEL 186 is a combination of glycerol
monooleate and propylene glycol,” whereas “ARLACEL P135 is a block
copolymer comprising polyethylene glycol and dipolyhydroxystearate in a
formula A-COO-B-OOC-A, wherein A is the dihydroxystearate residue and
B is the polyethylene glycol residue” (id.).
Appellants further assert that the claims require that the composition
be injectable and have a viscosity below 450 mPas (id. at 11). Appellants
cite Villa as evidence that “at the time of the invention that ARLACEL P135
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was used to increase viscosity in cosmetic and dermatological compositions”
(id. (citing Villa, col. 13, ll. 44-48)).
The Examiner finds Villa unpersuasive “because its compositions are
very different compared to the instant composition as well as Hunter’s and
Allard’s compositions” (Ans. 9). According to the Examiner
Villa does not teach water-in-oil emulsions like the instant
invention and the prior art of Hunter and Allard relied upon.
Thus, since the compositions of Villa are not an appropriate
comparison to the instant invention and prior art, Appellant’s
conclusion that A[RLACEL®] P135 was known to increase
viscosity is not supported. An ordinary skilled artisan would
not come to Appellant’s conclusion given Villa’s composition
comprises base, oil, A[RLACEL®] P135, and isostearic acid
and no water (see Example 1; column 12 of Villa).

(Id. at 9-10.)
Appellants respond that Villa’s compositions do in fact contain water,
and ARLACEL® P135 is used to achieve the required viscosity (Reply Br. 2
(citing Villa, col. 13, Example 4)). According to Appellants, the
“compositions of Hunter and Villa are sufficiently similar to suggest to the
ordinary practitioner, reading the disclosure of Villa, that substituting
ARLACEL® P135 (PEG-30 Dipolyhydroxystearate) for the ARLACEL®
186 (glyceryl oleate) emulsifier used by Hunter would result in the
extremely high viscosities reported by Villa, that a viscosity below 450
mPas could not possibly be achieved” (id. at 3).
Villa is drawn to “liquid cleansing compositions of the type typically
used in skin cleansing or shower gel compositions which compositions are
lamellar phase compositions …. [that] are characterized by high zero shear
viscosity (good for suspending) while simultaneously being very shear
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thinning such that they readily dispense in pouring” (Villa, col. 1, ll. 6-12).
Villa teaches that “certain polymeric emulsifiers, particularly hydrophilic
groups modified on one or both ends, preferably both ends, by polyhydroxy
fatty acid ester hydrophobic chains (e.g., dipolyhydroxystearate), can be
used at small levels to enhance both initial viscosity and low temperature
viscosity, thereby providing much more stable compositions” (id. at col. 2,
ll. 59-65). Villa teaches that an example of such an emulsifier is
ARLACEL® P135 (PEG-30 Dipolyhydroxystearate) (id. at col. 9, ll. 38-44).
According to Villa:
When isostearic acid alone, for example, is used as
lamellar inducing structurant, the initial viscosity is about
40,000 cps, but when subjected to freeze-thaw tests when
temperature is lowered (i.e., to be about 15°F.) and raised (i.e.,
to room temperature), the viscosity remains same or lower.
When even small amounts of emulsifier are used,
however (e.g., 0.25%), both initial viscosity and freeze-thaw
viscosity are enhanced.

(Id. at col. 9, ll. 49-57.)
We conclude that the Examiner has not established by a
preponderance of the evidence that the combination of Hunter and Allard
renders the claimed injectable, imununogenic adjuvant compositions, which
have a viscosity below 450 mPas, obvious.
Hunter teaches w/o emulsions that may be used in adjuvants and
cosmetics. Hunter teaches the use of ARLACEL 186, which is a nonionic
surfactant mixture of mono and diglycerides in the oil phase. Hunter teaches
that a problem in using w/o emulsions is increased viscosity.
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Allard is drawn to w/o/w emulsions for use in photoprotective
systems. While Allard teaches that block copolymers, such as ARLACEL®
P135, increase the stability of the emulsion, Allard is not concerned with
obtaining a composition having a viscosity below 450 mPas, and in fact
teaches that a thickener may be added to the system. Villa, as noted by
Appellants, teaches that when emulsifiers such as ARLACEL® P135 are
used in emulsions, the initial viscosity is enhanced. Thus, we agree with
Appellants that the ordinary artisan would not replace ARLACEL 186, (a
nonionic surfactant mixture of mono and diglycerides in the oil phase) with
ARLACEL® P135 (PEG-30 Dipolyhydroxystearate) in order to obtain
adjuvants with decreased viscosity.
We therefore reverse the rejection as to independent claim 1, as well
as the claims dependent thereon. As independent claim 9 also requires a
viscosity below 450 mPas, we also reverse the rejection as to that claim.
As to the rejection of claim 8 as being rendered obvious by the
combination of Hunter and Allard as further combined with Mitani, as
Mitani was not cited to remedy the above deficiency of the combination of
Hunter and Allard (see Ans. 7), we reverse that rejection as well.

REVERSED

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