Ex Parte Foreman et al

Patent Trial and Appeal Board

Aug 15, 2017

11238277 (P.T.A.B. Aug. 15, 2017)

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.
11/238,277 09/29/2005 Paul B. Foreman N-3157.TDM-US 1757
79525 7590
Henkel Corporation
One Henkel Way
Rocky Hill, CT 06067
EXAMINER
LOVE, TREVOR M
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
08/17/2017 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
rhpatentmail @henkel. com
trish.russo@henkel.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PAUL B. FOREMAN and ALLISON LUCIANO
Appeal 2017-0035661
Application 11/238,277
Technology Center 1600
Before RICHARD M. LEBOVITZ, ERIC B. GRIMES, and
RICHARD J. SMITH, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims relating to a solution acrylic pressure
sensitive adhesive comprising a solvent with specific solvent solubility
parameters and an at least partially dispersed active ingredient. The
Examiner rejected the claims under 35 U.S.C. § 103 as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). The rejection is affirmed.
STATEMENT OF THE CASE
Claims 4, 13, 22, 24, 25, 29, 30, 43, 44, 48—51, and 53 stand rejected
under 35 U.S.C. § 103 as obvious in view of US 2002/0077437 Al, iss. Jun.
1 The Appeal Brief (“Br.”) 2 (dated Dec. 16, 2015) identifies Henkel AG &
Co., KGaA, as real-party-in-interest.
Appeal 2017-003566
Application 11/238,277
20, 2002 (“Silverberg”) andU.S. Pat. No. 5,686,099, iss. Nov. 11, 1997
(“Sablotsky”). Final Action (“Final Act.”) 4. Appellants included claim 52
in their statement of the rejection (Br. 3), but claim 52 is withdrawn from
consideration. Final Act., cover page.
Claim 49, which is representative of the rejected claims, is reproduced
below:
49. A transdermal delivery system consisting of:
(1) a backing substrate;
(2) a release liner; and
(3) an active ingredient at least partially dispersed in a
homogeneous solution acrylic pressure sensitive adhesive;
wherein the solution acrylic pressure sensitive
adhesive comprises:
(a) an acrylic polymer prepared from (al) alkyl
(meth)acrylate monomer and (a2) at least one monomer selected
from the group consisting of vinyl ester monomer, N-substituted
acrylamide and N-substituted methacrylamide; and
(b) a solvent or mixture of solvents that has a
solubility parameter of 12 to 17.1 or 21.1 to 40 MPa1/2.
OBVIOUSNESS REJECTION
There are three independent claims on appeal, claims 4, 49, and 50.
Each of the claims comprises a “solution acrylic pressure sensitive adhesive”
(also referred to as a “PSA”) which is utilized as a transdermal delivery
system. The solution acrylic pressure sensitive adhesive comprises:
(1) specifically recited monomers (al) and (a2),
(2) an active ingredient, and
(3) “a solvent or mixture of solvents that has a solubility parameter
of 12 to 17.1 or 21.1 to 40 MPaC” The term “MPa/2” is a unit of solubility.
2
Appeal 2017-003566
Application 11/238,277
The active ingredient is “at least partially dispersed in the solution.”
The Specification explains that, when solvents of the recited solubility
range are utilized, the active ingredient is at least partially dispersed in the
solution and that the ingredient (a drug) “remain dispersed during the drying
process, thus avoiding supersaturation” which has negative consequences for
drug delivery. Spec. 2:8—10; 3:11—15; 1:14—2:4.
The term “partially dispersed” is not defined in the Specification.
However, the Specification discloses that the “invention provides an acrylic
PSA in an organic solution in which the active ingredient (e.g., drugs) are
dispersed rather than fully dissolved.” Id. at 2:8—9. Consequently, we
interpret “dispersed” to mean that the active ingredient is present in the
solution in a form other than dissolved in it.
REJECTION
The Examiner found the Silverberg describes an adhesive composition
for drug delivery comprising a drug, solvent, and the same monomers (al)
and (a2) which are claimed. Final Act. 4. The Examiner found that
Silverberg exemplifies a solvent comprising ethyl acetate. Id.
The Examiner acknowledged that Silverberg does not teach a solvent
having the recited solubility parameters. Id. However, the Examiner found
that Sablotsky describes a transdermal drug delivery device comprising a
drug, a pressure sensitive adhesive, and solvent. Id. The Examiner found
that Sablotsky discloses a list of useful solvents that includes ethyl acetate,
as well as other solvents which exhibit solubility parameters that fall within
the claimed range. Id. at 5—6. The Examiner further found that Sablotsky
also teaches acrylic polymers of the same type which are claimed. Id. at 5.
3
Appeal 2017-003566
Application 11/238,277
The Examiner determined it would have been obvious to one of
ordinary skill in the art to have utilized a solvent taught by Sablotsky in
place of the ethyl acetate of Silverberg because Sablotsky teaches the
functional equivalence of the solvents. Id. at 6. The Examiner cited legal
principles to establish the obviousness of the claimed choice:
It is noted that MPEP 2144.07 states “[t]he selection of a known
material based on its suitability for its intended use supported a
prima facie obviousness determination in Sinclair & Carroll Co.
v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) [. . .]
‘[rjeading a list and selecting a known compound to meet known
requirements is no more ingenious than selecting the last piece
to put in the last opening in a jig-saw puzzle.’ 325 U.S. at 335,
65 USPQ at 301.)”. Further, MPEP 2144.06(11) states “[a]n
express suggestion to substitute one equivalent component or
process for another is not necessary to render such substitution
obvious. In re Font, 675 F.2d 297, 213 USPQ 532 (CCPA
1982)”. Finally, it is noted that the art is not required to teach the
same reasoning for adding components as Applicant, MPEP
2144 (IV) states “the reason or motivation to modify the
reference may often suggest what the inventor has done, but for
a different purpose or to solve a different problem. It is not
necessary that the prior art suggest the combination to achieve
the same advantage or result discovered by Applicant. See, e.g.,
In re Kahn, 411 F.3d 977, 987, 78 USPQ2d 1329,1336 (Fed. Cir.
2006).”
Id.
Appellants contend that the Examiner erred in finding that Silverberg
teaches a drug at least partially dispersed in the adhesive as claimed. Br. 6.
Appellants also contend that Silverberg “fails to provide a reason for a
skilled artisan to select a solution that has a solubility parameter within the
specific claimed ranges, let alone, teach or suggest dispersing an active
ingredient in a solution acrylic pressure sensitive adhesive instead of fully
dissolving it.” Id. Appellants also contend that Sablotsky teaches
4
Appeal 2017-003566
Application 11/238,277
“increasing the solubility of the drug in a solvent increases the drug
availability in the dermis. Id., col. 4, lines 14-15.” Id. at 7. Appellants
argue that Sablotsky lists solvents that fall outside the claimed solubility
range and “fails to specify that a specific range of solubility parameter is
required for the solution.” Id. at 7—8.
Appellants provided a declaration by Paul Foreman, Ph.D., said to
show that the clay utilized by Sablotsky “negatively affects the adhesion of
the instant adhesive.” Id. at 8. Appellants concluded:
Moreover, as noted above, Appellants] recognized that
there are several problems presented by the supersaturation of a
drug in an adhesive composition, and further discovered that
these problems can be overcome by providing an acrylic PSA in
which the drug is at least partially dispersed in the solvent, rather
than fully dissolved.
Id. at 9.
Discussion
Appellants’ arguments and evidence do not persuade us that the
Examiner erred in making the rejection.
First, contrary to Appellants’ arguments, both Silverberg and
Sablotsky teach that the drug can be dispersed in the solvent of the adhesive.
Silverberg at paragraph 67 (cited in the Answer on page 2 and in Final
Action on page 4) discloses (emphasis added):
A drug delivery device of the invention can be prepared by using
conventional methods to apply an appropriate carrier to the
backing. For example, a matrix device can be manufactured by
preparing a coating formulation by mixing a solution of the
adhesive in a solvent with the drug and any excipients to form
a homogeneous solution or suspension; applying the
formulation to a substrate (a backing or a release liner) using well
known knife or bar or extrusion die coating methods; drying the
5
Appeal 2017-003566
Application 11/238,277
coated substrate to remove the solvent; and laminating the
exposed surface to a release liner or backing.
The Examiner found that a drug “suspension” indicates that the drug
is dispersed in the solvent as required by the claim (Ans. 2) because the drug
is not dissolved in the solvent, but rather is suspended in it. Appellants did
not identify an error in the Examiner’s findings.
Sablotsky also teaches a drug dispersed in a solvent:
The term “solvent,” when used to refer to one or more of
the components of the composition, means a substance added to
minimize the lack of solubility or dispersibility of one or more
of the components in the dermal composition. The solubilities
of the components in polar and non-polar solvents of the
composition are either known or can easily be determined by
known methods.
When a lipophilic drug is used, such as 17-beta estradiol,
a fat soluble steroid, the drug has a limited solubility in various
polymers used for pressure sensitive adhesives. The addition of
a glycol improves the dispersibility of the steroid such as 17-
beta estradiol, while maintaining the even distribution of the drug
throughout the adhesive. However the addition of glycol and
various other liquids to the composition often results in
plasticization and thus a reduction in the adhesiveness of the
composition.
Sablotsky, col. 6,11. 23—38.
Thus, the disclosure reproduced above establishes that
Sablotsky expressly acknowledges that drugs can be present in the
adhesive in a dispersed form, and teaches that solvents can be utilized
to improve dispersibility, i.e., to minimize the lack of dispersibility.
Appellants identified column 4, lines 14 to 15 and column 7, lines 1 to
12, of Sablotsky as teaching the benefits of increasing solubility with
6
Appeal 2017-003566
Application 11/238,277
respect to drug release. Br. 7. However, such teaching does not
negate the other teachings in Sablotsky about dispersibility.
Moreover, column 7, lines 1—12, of Sablotsky does not teach
that the drug must be dissolved. In fact, Sablotsky gives an example
of a steroid, which at column 6, lines 23—38, Sablotsky teaches is
dispersed in the solvent (see above).
Column 4, lines 14—15 of Sablotsky also does not refer to the
drug dissolved in the solvent or adhesive.
In sum, Appellants’ statements regarding the lack of teaching of
dispersibility is contrary to the express disclosure in the cited
Silverberg and Sablotsky publications.
Appellants contend that there is no reason to have picked a solvent
with the recited solubility characteristics. Br. 6. However, as established
by the Examiner, Sablotsky teaches a list of solvents that includes solvents
that fall within the recited range of solubility parameters. Final Act. 6.
Appellants did not dispute this finding. Silverberg did not limit its
disclosure to a particular solvent. See, e.g., Silverberg | 60. Accordingly,
the choice of any solvent from Sablotsky would have been obvious since
they appear in a list which includes ethyl acetate, the same solvent
exemplified in Silverberg, reasonably suggesting each solvent’s usefulness
for the same purpose. Thus, it is not necessary, as argued by Appellants,
that Sablotsky teach the claimed solubility parameters (Br. 7—8), because
each solvent in the list would have been obvious to pick, and picking one
with the claimed solubility characteristics would meet all the limitations
recited in the claim.
7
Appeal 2017-003566
Application 11/238,277
With respect to the arguments and declaration regarding clay (Br. 8—
9), the Examiner’s rejection is based on utilizing a solvent from Sablotsky in
Silverberg’s adhesive. Thus, the presence of clay (and rubber) in Sablotsky
is not pertinent because Sablotsky’s system is not the basis for the rejection.
Consequently, the declaration evidence and arguments are not persuasive.
SUMMARY
For the foregoing reasons, the obviousness rejection of claims 4, 49,
and 50 is affirmed. To the extent that claims 13, 22, 24, 25, 29, 30, 43, 44,
48, 51, and 53 were not argued separately, they fall with the independent
claims. 37 C.F.R. § 41.37(c)(l)(iv).
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
8