Ex Parte Bott et al

Patent Trial and Appeal Board

Dec 22, 2014

10576356 (P.T.A.B. Dec. 22, 2014)

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.
10/576,356 12/11/2006 Richard R. Bott DOG 0101 PA/35319.68 9374
23368 7590 12/22/2014
DINSMORE & SHOHL LLP
FIFTH THIRD CENTER, ONE SOUTH MAIN STREET
SUITE 1300
DAYTON, OH 45402-2023
EXAMINER
PARK, HAEJIN S
ART UNIT PAPER NUMBER
1615
MAIL DATE DELIVERY MODE
12/22/2014 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 RICHARD R. BOTT, KURT FRIEDRICH BRANDSTADT,
CSILLA KOLLAR, THOMAS HOWARD LANE,
DONALD TAYLOR LILES, MAE SALDJENO, and
XAVIER JEAN-PAUL THOMAS
__________

Appeal 2012-006143
Application 10/576,356
Technology Center 1600
__________

Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

PAULRAJ, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a
controlled-release composition. The Examiner rejected the claims on
obviousness grounds. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.

1 Appellants identify the Real Parties in Interest as Danisco US, Inc., and
Dow Corning Corporation (see App. Br. 1).
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STATEMENT OF THE CASE
Background
According to the Specification:
The subject invention generally relates to a multi-layer dressing and a
controlled-release composition for topical application to a substrate. The
subject invention also generally relates to a method of delivering an active
agent to the substrate. More specifically, the dressing, the controlled-release
composition, and the method of this invention relate are used for topical
application to skin and, more particularly, to controlled release dressings
comprising emulsions of protein-containing active agents and silicone that,
when applied to the skin for therapeutic purposes, provide controlled-release
of the active agents from the dressing.
(Spec. 1).
The Claims
Claims 72 and 74–91 are on appeal. Independent claim 72 is
representative, and reads as follows:
72. A controlled-release composition for topical application to a
substrate, said composition comprising: an oil-in-water emulsion
substantially free of lipophilic solvent wherein the oil-in-water emulsion has
a hydrophilic phase comprising a protein as an active agent, water, and a
carrier, and a hydrophobic phase comprising a silicone component.

The Rejection

The Examiner rejected the claims under 35 U.S.C. § 103(a) as obvious
over the combination of Kosal,2 Bott,3 and Woodard.4

2 Kosal, US 6,545,086 B1, issued Apr. 8, 2003.
3 Bott et al., US 2003/0180281 A1, issued Sep. 25, 2003.
4 Woodard et al., US 4,655,767, issued Apr. 7, 1987.
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FINDINGS OF FACT
FF1. Kosal is directed to oil-in-water (O/W) emulsions for “medical
applications such as transdermal drug delivery patches, ... or to
hold an active material such as a fungicide to the skin surface”
(Kosal, col. 5 ll. 24–26), wherein “[t]he O/W emulsions comprise
an oil or silicone phase with pressure sensitive adhesives (PSAs),
in a continuous water phase, and a surfactant (Title; abstract; claim
1)” (Ans. 5).
FF2. Kosal teaches “the inclusion of a thickener in the aqueous phase
prior to the mixing of the aqueous phase with the siloxane
composition when using the dispersion process, produces a more
uniform, stable emulsion than without the inclusion of the
thickener” (Kosal, col. 5 ll. 4–8).
FF3. Kosal teaches that “[t]he avoidance of hydrocarbon based solvents
is generally desirable in medical and personal care applications”
(id., col. 5 ll. 26–28).
FF4. Kosal teaches
A preferred process for the production of the pressure sensitive
adhesive emulsion is an inversion process comprising mixing the
silicone pressure sensitive adhesive and the volatile silicone fluid
with the surfactant and adding water while shearing to form an
emulsion. . . . We have found that the best way to make an
inversion emulsion of the pressure sensitive adhesive is to have an
oleophilic/more hydrophobic surfactant mixed into the oil phase
blend of silicone pressure sensitive adhesive and volatile silicone
fluid before adding the water, which has the more hydrophilic
surfactant premixed into it, to the oil phase.

(Id., col. 4 ll. 24–24).
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FF5. Example 5 of Kosal teaches the preparation of an O/W emulsion
wherein “the emulsion was diluted with 1464 g water containing
6 g Kathon® CG biocide” (id., col. 7 ll. 15–18).
FF6. Bott teaches “topical preparations for release of an active agent”
wherein: “The preparations may have an internal phase dispersed
within an external phase. The internal phase may be a hydrophilic
carrier and an active agent. The external phase may be a silicone
matrix.” (Bott, Abstract). “The active agents may be proteins,
particularly enzymes such as hydrolases and glucose oxidase”
(Bott, ¶ 6). The topical preparations of Bott “are effective in
providing controlled release of active agents to the skin” (id., ¶ 9).
ANALYSIS
Claims 72, 74–86, 90, and 91
With regard to independent claim 72, the Examiner finds that “Kosal
is directed to oil-in-water (O/W) emulsions for ‘medical applications such as
transdermal drug delivery patches, ... , or to hold an active agent such as a
fungicide to the skin surface’, or for formulating mascaras and sunscreens
(col.1 ll.20-23; col.5 ll.23-24)” (Ans. 5), wherein “[t]he O/W emulsions
comprise an oil or silicone phase with pressure sensitive adhesives (PSAs),
in a continuous water phase, and a surfactant (Title; abstract; claim 1)”
(FF1). The Examiner further finds that Kosal teaches the avoidance of
lipophilic (i.e., hydrocarbon based) solvents in medical applications, and that
the aqueous (hydrophilic) phase of the emulsion includes a “thickener,” i.e.,
a carrier (FF2–3).
The Examiner acknowledges that “Kosal does not expressly teach
incorporating a protein active agent in the hydrophilic phase of the O/W
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emulsion,” but relies upon Bott’s teaching of “water-in-oil (W/O) emulsions
comprising a protein active agent in an aqueous phase and a carrier such as
polyvinyl alcohol, wherein the external, i.e., hydrophobic phase may be a
silicone PSA (title; abstract; paras.0002, 0008, 0041)” (Ans. 5). The
Examiner concludes that “[i]t would have been obvious to one of ordinary
skill in the art at the time the invention was made to combine the teachings
of Kosal and Bott et al. and prepare O/W emulsions of Kosal comprising the
protein active agent of Bott et al. in the hydrophilic phase and a silicone PSA
in the hydrophobic phase as taught by Kosal and Bott et al.” (id. at 6).
Based on the cited teachings of the prior art (FF1–6) and the rationale
supplied by the Examiner (Ans. 6), we determine that a prima facie showing
of obviousness has been made. We have considered Appellants’ arguments
but do not find them persuasive.
We are not convinced by Appellants’ argument that Kosal does not
“describe a controlled release composition containing a protein active
agent,” but rather “[i]n those embodiments [of Kosal] in which there is an
active agent, the agent is either separate from the PSA and held to the
substrate in a conventional manner with the pressure sensitive adhesive, or
the active agent is physically mixed with the PSA and adhered to the
substrate,” and “[a]s to the latter, Kosal is silent concerning whether the
active agent resides in the oil phase or the aqueous phase of the PSA” (App.
Br. 5). Appellants also argue that “[t]here is a material difference between
locating an active agent in an oil-in-water emulsion to control the release of
that agent (claimed invention) versus simply holding an active agent against
a patient’s skin (Kosal)” (App. Br. at 9). We disagree as we find that
Kosal’s teaching that the PSA emulsion may be used for “medical
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applications such as transdermal delivery patches, . . . or to hold an active
material such as a fungicide to the skin surface” would be understood by the
skilled artisan to refer to a controlled release composition (FF1). This is
consistent with the statement in Appellants’ own Specification that
“[t]ransdermal delivery systems allow controlled-release of active molecules
with biologically appropriate kinetics to a targeted area” (Spec. 1 ll. 26–28).
Moreover, contrary to Appellants’ assertion, we agree with the Examiner’s
finding that Example 5 of Kosal teaches an active agent (biocide) dispersed
in the hydrophilic/aqueous phase of the emulsion (FF5; Ans. 9). With
regard to this teaching, Appellants argue that the “extremely minor amount
of biocide” used in Example 5 “is intended for use as a preservative for the
adhesive, not as a blended active agent for any health, medical, or personal
care use” (Reply Br. 2). However, Appellants do not cite to any teaching in
Kosal to support that assumption. See In re Geisler, 116 F.3d 1465, 1470
(Fed. Cir. 1997) (“An assertion of what seems to follow from common
experience is just attorney argument and not the kind of factual evidence that
is required to rebut a prima facie case of obviousness.”). In any event,
Kosal’s example shows incorporation of a water-soluble biocide in the
aqueous phase of its emulsion, which would have suggested the inclusion of
other water-soluble biocides (e.g., fungicides) as active materials in the
aqueous phase.
Appellants further argue that “[u]nlike Kosal, Bott teaches the use of a
continuous silicone phase (‘silicone matrix’) and a discontinuous aqueous
phase which would be understood by persons skilled in the art to be a water-
in-oil composition in which the hydrophilic carrier containing the active
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agent is dispersed throughout a silicone matrix (see, e.g., para. [0008])”
(App. Br. 6). Appellants assert that
Bott suggests that several mechanisms could be involved in
controlling the release of the active agent from the preparation
including the addition of hydrophilic agents to the silicone
phase or choosing a silicone having a low cross-link density
such that the active agent can be released through cracks, pores,
or fissures in the silicone phase. See, e.g., paras. [0035] and
[0058].

(App. Br. 6).
We are not convinced that any difference in the mechanism of
controlling the release of an active agent in the W/O emulsion of Bott would
have dissuaded a skilled artisan from utilizing the O/W emulsion taught by
Kosal as a controlled release composition for the release of a protein from
the hydrophilic phase. The claims do not require any particular mechanism
of release of the active agent from the hydrophilic phase, nor does the
Examiner’s obviousness rationale rely upon utilization of Bott’s mechanism
of release in Kosal’s O/W emulsion. Moreover, Kosal teaches that the O/W
emulsion disclosed therein is prepared by the phase inversion of a W/O
emulsion (FF4). This is consistent with the teaching in Appellants’ own
Specification that the O/W emulsion may be prepared by the mechanical
inversion of a W/O emulsion (Spec. p. 6, ll. 7–12, p. 16 ll. 9–3). We
therefore do not find that the skilled artisan would have looked away from
Bott’s teachings merely because it involved a different mechanism of
release. In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (A
reference must be “read, not in isolation, but for what it fairly teaches in
combination with the prior art as a whole”).
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Appellants further argue that the Examiner has not established a
motivation to combine the reference teachings as none of the advantageous
properties of Kosal’s composition identified by the Examiner “relate to the
controlled release of an active agent from the composition” (App. Br. 11).
Appellants assert that “[t]he rejection is based on speculation and prohibited
hindsight” (id. at 12). We are not persuaded by Appellants’ contentions. In
particular, Appellants argue that the Examiner’s asserted motivation to
utilize Kosal’s composition for purposes of “controlled tack and lubrication”
only “relates to the use of Kosal’s pressure sensitive adhesive in paper
coatings for adhesive labels and envelope sealing strips” and “[t]hese
properties have nothing to do with the controlled release of any active agent”
(App. Br. 11). We find nothing of record, however, to suggest that
“controlled tack and lubrication” properties taught by Kosal would not be
desirable for a controlled release composition, such as in the transdermal
drug delivery patch application identified in the very same sentence (FF1).
Indeed, that would be contrary to Appellant’s own Specification teaching
that “[t]he controlled-release composition according to this invention is
capable of delivering performance properties such as adhesion, controlled
tack, controlled lubrication, [etc.]” (Spec. 18 ll. 7–9 (emphasis added)). Nor
is there any support for Appellants’ assertion that the “greater durability”
taught by Kosal for its composition would not be considered a desirable
feature for a controlled release composition, such as that utilized in a
transdermal drug delivery patch (App. Br. 11). As such, we find sufficient
motivation to use Kosal’s O/W emulsion as a controlled release composition
for the release of a protein as the active agent.
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We accordingly affirm the obviousness rejection of claim 72.
Appellants do not present separate arguments for dependent claims 74–86,
90, and 91, and therefore those claims fall with claim 72. 37 C.F.R.
§ 41.37(c)(1)(vii).

Claims 87 and 88
With respect to claims 87 and 88, Appellants argue that “[i]t is
apparent that Kosal’s adhesive could be used as adhesive layer 22 in
Woodard, but that substitution does not meet the claims” (App. Br. 13). In
particular, Appellants assert that modifying the prior art teachings to
“include the active agent of Bott in the pressure sensitive adhesive of Kosal
. . . would render layer 20 in Woodard superfluous” (id.). We are not
persuaded. For the reasons discussed above, we find that a skilled artisan
would understand that the O/W emulsion of Kosal could be used as the
controlled release composition for the drug layer 20 in the transdermal drug
delivery device taught by Woodard.
Claim 89
With respect to claim 89, Appellants argue that “Kosal does not teach
or suggest a controlled release layer free of water,” and that “while Bott
teaches an embodiment using a dry patch, again, Bott teaches a water-in-oil
emulsion, not an oil-in-water emulsion” (App. Br. 13). For the reasons
discussed above, we disagree with Appellants’ assertion that Kosal fails to
suggest an O/W composition that can control the release of an active agent.
In addition, as the Examiner found (Ans. 8), Bott provides examples in
which an enzyme-containing emulsion is spread on a substrate and dried.
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Bott states that the enzyme remained stable during storage (see, e.g., Bott,
¶ 85).

SUMMARY
We affirm the claim rejection under 35 U.S.C. §103(a).
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
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