Ex Parte Gueret

Board of Patent Appeals and Interferences

Nov 10, 2003

09418825 (B.P.A.I. Nov. 10, 2003)

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for publication and is not binding precedent of the Board.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. 31
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte JEAN-LOUIS GUERET
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Appeal No. 2003-0984
Application No. 09/418,825
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HEARD: October 9, 2003
__________
Before WINTERS, LORIN and SCHEINER, Administrative Patent Judges.
SCHEINER, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the final rejection of
claims 1-3, 5, 7-21, 23-26 and 28-30. Claims 22 and 27 are also pending in the
application, but claim 27 has been allowed, and claim 22 is merely objected to as
dependent on a rejected base claim.
Claims 1, 18 and 20 are representative of the subject matter on appeal:
1. A patch comprising:
a matrix having adhesive properties in a dry state and containing at least one
active substance;
said matrix being attached via one face to a porous backing and being for
application via its other face to the skin;
wherein said backing is capable of containing a liquid suitable for dissolving, at
least in part, said at least one active substance;
wherein said matrix is permeable to the liquid; and
wherein said at least one active substance is not suitable for migrating through
the matrix, toward the other face for application to the skin, without addition of said
liquid to the patch.
18. A kit constituted by a patch as defined in claim 1, and a receptacle
containing a liquid for impregnating said backing.
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20. A method comprising:
supplying a patch as defined in claim 1; and
impregnating said patch with said liquid before or after applying the patch to the
skin.
The references relied on by the examiner are:
Katz et al. (Katz) 5,028,435 Jul. 2, 1991
Petersen et al. (Petersen) 5,156,846 Oct. 20, 1992
Claims 1-3, 5, 7-21, 23-26 and 28-30 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Katz and Petersen.
We reverse this rejection.
DISCUSSION
The claims on appeal are directed to transdermal delivery patches and methods
of using them. Each of the claims requires, at a minimum, a patch comprising a liquid
permeable matrix having dry adhesive properties and containing at least one active
agent unsuitable for migrating through the matrix without the addition of liquid to the
patch, wherein the matrix is attached on one face to a porous backing capable of
containing a liquid.
Katz describes systems (devices) and methods for rate-controlled drug delivery.
The systems include transdermal patches comprising “a matrix layer having a backing”
and a “means for securing the system to the skin, such as a tape or adhesive layer;” the
matrix layer contains the drug and “a chemical penetration enhancer which promotes
transport of the drug across [the] skin” (column 2, lines 44-55). “[A]t least a portion of
either the drug or the chemical penetration enhancer (or both) will be contained within a
plurality of polymeric particles dispersed within the matrix layer . . . which entrap and
release the drug and/or enhancer into the matrix at a preselected rate” (column 2, lines
58-65). Katz’s “suitable backing materials will generally be thin, flexible films or fabrics
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such as woven and non-woven fabrics and polymeric films, such as polyethylene,
polypropylene, and silicone rubber; metal films and foils; and the like” (column 4, lines
17-21). “[I]t is the view of the examiner that the non-woven fabrics disclosed by Katz [ ]
as suitable backing material can be porous.” Answer, page 3.
Petersen describes “a method of delivering a drug, a drug delivery system and a
drug delivery kit” (Answer, page 4). According to the examiner, “the drug delivery kit
includes a first patch containing one or more [proteolytic] enzymes and a second patch
containing one or more drugs,” and “a typical patch . . . includes a backing, a reservoir
to contain the enzyme or the drug preparations, a membrane to contain and release the
contents of the reservoir and a protective strip” (id.), and Petersen “teaches that the
enzyme and the drug are admixed with a liquid, such as water or ethanol” and “the
reservoir can be divided into two compartments, one containing the active ingredient in
a dry, stable form, and the other containing the solvent to be mixed with the active
ingredient” (id.). Turning to the Petersen reference, we note that the backing is
described as an “occlusion means” (column 6, lines 18-20), and may be aluminized
plastic, plastic film or Bioclusive™ tape (column 6, lines 20-22).
“The PTO has the burden under section 103 to establish a prima facie case of
obviousness. It can satisfy this burden only by showing some objective teaching in the
prior art or that knowledge generally available to one of ordinary skill in the art would
lead that individual to combine the relevant teachings of the references.” In re Fine,
837 F.2d 1071, 1074, 5 USPQ2d 1596, 1598 (Fed. Cir. 1988) (citations omitted). An
adequate showing of motivation to combine requires “evidence that ‘a skilled artisan,
confronted with the same problems as the inventor and with no knowledge of the
claimed invention, would select the elements from the cited prior art references for
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combination in the manner claimed.’” Ecolochem, Inc. v. Southern Calif. Edison Co.,
227 F.3d 1361, 1375, 56 USPQ2d 1065, 1075 (Fed. Cir. 2000)
Here, the examiner’s statement of the rejection leaves a great deal to conjecture.
All of the claims on appeal stand rejected as unpatentable over the combined teachings
of Katz and Petersen, but it appears that the examiner believes that Katz anticipates
the limitations of all of the claims with the exception of those claims drawn to methods
of use or kits. According to the examiner, Katz is only “deficient in the fact[ ] that it does
not include a kit and method of application in the invention” (Answer, page 4), and “[i]t
would have been obvious to one having ordinary skill in the art . . . to modify the
transdermal drug delivery system disclosed by Katz [ ] by including the patch and the
solvent in a kit and devising a method of administration according to the teachings of
Petersen . . . to prevent loss of the active substance and facilitate penetration into the
skin” (Answer, page 5).
Nevertheless, appellant argues that, unlike the drug in the claimed patches, the
drug in Katz’s patch “is always suitable for migrating through the matrix without the
addition of liquid to the patch” because the enhancer, which “dissolves the drug for
transport of the drug from the patch to the skin,” “is part of the patch . . . upon
manufacture” (Brief, page 7). In addition, appellant argues that “Katz does not suggest
that [the patch’s] backing material[ ] should be porous or capable of containing a liquid
suitable for dissolving an active substance, as in the patches of all of the rejected
claims” (Brief, page 7).
It may or may not be that Katz’s active substance is contained in the matrix in
such a way that it is not suitable for migrating (unless and until it is contacted by the
enhancer). We need not resolve this issue, however, because all of the claims on
appeal also require a porous backing “capable of containing a liquid suitable for
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dissolving . . . [the] active substance,” and we agree with appellant that Katz does not
suggest such a limitation. In the portion of Katz that deals with transdermal patches,
Katz specifically teaches that “the backing will usually be impermeable to the drug and
enhancer,” and it is this “impermeability [that] inhibits the loss of the drug and enhancer
and allows the user to rub the patch in order to promote release of the enhancer or drug
from the polymeric particles.” Katz, column 4, lines 10-21.
Moreover, the examiner has not explained how adding a solvent (which Petersen
uses to dissolve the active agent) to Katz’s completely self-contained transdermal patch
would “prevent loss of the active substance and facilitate penetration into the skin”
(Answer, page 5). The matrix of Katz’s patch already contains both a drug and a
“chemical penetration enhancer” which dissolves the drug and “promotes transport of
the drug across [the] skin” (column 2, lines 44-55); any additional solvent or liquid would
seem to be superfluous.
In this case, we agree with Appellants that the examiner has not adequately
explained how the references, taken individually or in combination, would have
suggested transdermal patches of the particular configuration required by the claims,
much less the claimed methods and kits.
For the reasons discussed above, we reverse the rejection of claims 1-3, 5, 7-21,
23-26 and 28-30 under 35 U.S.C. § 103(a) as unpatentable over Katz and Petersen.
REVERSED
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)
Sherman D. Winters )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
)
Hubert C. Lorin ) APPEALS AND
Administrative Patent Judge )
) INTERFERENCES
)
)
)
Toni R. Scheiner )
Administrative Patent Judge )
Appeal No. 2003-0984
Application No. 09/418,825
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