Ex Parte Meconi et al

Patent Trial and Appeal Board

Aug 29, 2017

11885716 (P.T.A.B. Aug. 29, 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.
05/077 LTS 9020
EXAMINER
LAZARO, DOMINIC
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
11/885,716 04/11/2008
759038263
ProPat, LLC
1794 Deer Park Lake Road
Spruce Pine, NC 28777
Reinhold Meconi
08/30/2017 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 REINHOLD MECONI and KLAUS SCHUMANN1
Appeal 2017-001994
Application 11/885,716
Technology Center 1600
Before RICHARD J. SMITH, JOHN E. SCHNEIDER,
and TIMOTHY G. MAJORS, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to
transdermal therapeutic systems which have been rejected for failing to
satisfy the written description requirement and as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
We also enter new grounds of rejection under 37 C.F.R. § 41.50(b).
STATEMENT OF THE CASE
Transdermal delivery systems are used to administer pharmaceutically
active substances through the skin. Spec. 14. The backing layer of the
1 Appellants identify the Real Party in Interest as LTS Lohmann Therapie-
Systeme AG. Appeal Br. 3.
Appeal 2017-001994
Application 11/885,716
transdermal system must be impermeable to the active substance and often
comprises a metal film or special plastic film. Spec. 17. One disadvantage
of the films used as the backing layer is that they are conspicuous. Spec. 1
8. The Specification describes a transdermal therapeutic system having a
backing that is light permeable. Spec. 116.
Claims 13, 19—21, 24, and 29-31 are on appeal. Claims 13, 29, and
31 are the independent claims and read as follow:
13. A three-layered transdermal therapeutic system
(TTS) consisting of an active substance-impermeable backing
layer, a pressure-sensitive adhesive layer onto which an active
substance-containing preparation has been applied, and a
detachable protective layer, wherein said transdermal
therapeutic system is free of fibrous constituents and is
permeable to light, and the active substance-containing
preparation comprises a polymer which is also a constituent of
said pressure-sensitive adhesive layer;
wherein said backing layer is free of fibers and is
permeable to light;
wherein said pressure-sensitive adhesive layer is free of
fibers and is permeable to light; and
wherein three-layered transdermal therapeutic system
comprises a thickness of at least 300 pm.
29, A four-layered transdermal therapeutic system (TTS)
consisting of:
an active substance-impermeable backing layer, said
active substance-impermeable backing layer being free of fibers
and being permeable to light;
a pressure-sensitive adhesive layer onto which an active
substance-containing preparation has been applied, said
pressure-sensitive adhesive layer being free of fibers and being
permeable to light;
a detachable protective layer, wherein said transdermal
therapeutic system is free of fibrous constituents and is
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Application 11/885,716
permeable to light, and the active substance-containing
preparation comprises a polymer which is also a constituent of
said pressure-sensitive adhesive layer; and
a further reservoir layer or matrix layer, said further
reservoir layer or matrix layer being free of fibres and
comprising a material which is selected from the group
consisting of polyacrylates, isobutylene, polyvinyl acetate,
ethylene-vinyl acetate, hot-melt adhesives and at least one of
natural or synthetic rubbers.
31. A fiber-free, light permeable three-layered
transdermal therapeutic system (TTS) consisting of:
a fiber-free, light permeable active substance-
impermeable backing layer having a thickness of about 15 um;
a fiber-free, light permeable pressure-sensitive adhesive
layer directly adjacent to said backing layer, having a flowable
active substance-containing preparation between said pressure-
sensitive adhesive layer and said backing layer, wherein said
pressure-sensitive adhesive layer comprises a weight per unit
area of about 300 g/m2; and
a detachable protective layer directly adjacent to said
pressure-sensitive adhesive layer on the side opposite that
adjacent to said backing layer:
wherein said transdermal therapeutic system is free of
fibrous constituents and is permeable to light, and wherein the
active substance-containing preparation comprises a polymer,
said polymer also being a constituent of said pressure-sensitive
adhesive layer.
The claims stand rejected as follows:
Claims 13, 19—21, and 24 have been rejected under 35U.S.C. § 112,
first paragraph, for failing to comply with the written description
requirement.
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Application 11/885,716
Claims 13, 19, 20, 24, 29, and 31 have been rejected under 35 U.S.C.
§ 103(a) as unpatentable over Hoffmann2 in view of Gale.3
Claims 29 and 30 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Bracht4 in view of Gale.
WRITTEN DESCRIPTION
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that claims 13, 19-21, and
24 do not comply with the written description requirement.
The Examiner finds that the limitation calling for the TTS to have a
thickness of at least 300pm is not supported by the Specification. Final Act.
3. The Examiner finds that nothing in the Specification would lead one
skilled in the art to conclude that the TTS disclosed in the Specification
would have a thickness of at least 300pm. Id. at 4—5
Appellants contend that one skilled in the art would understand from
the Specification that the TTS disclosed in the example would have a
thickness of about 368pm and that this supports the claim limitation.
Appeal Br. 31—32.
Principles of Law
“Adequate written description means that, in the specification, the
applicant must ‘convey with reasonable clarity to those skilled in the art that,
2 Hoffmann et al., US 4,769,028, issued Sept. 6, 1988 (“Hoffmann”).
3 Gale, WO 00/37058, published June 29, 2000 (“Gale”).
4 Bracht et al., US 2004/0096490 Al, published May 20, 2004 (“Bracht”).
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Application 11/885,716
as of the filing date sought, he or she was in possession of the [claimed]
invention.’ Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563—64 (Fed. Cir.
1991). “When no such description can be found in the specification, the
only thing the PTO can reasonably be expected to do is to point out its
nonexistence.” Hyatt v. Dudas, 492 F.3d 1365, 1370 (Fed. Cir. 2007).
“Attorneys’ argument is no substitute for evidence.” Johnston v.
IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989).
Analysis
We agree with the Examiner that the limitation calling for the TTS to
have a thickness of at least 300pm is not supported by the Specification.
Ans. 26. As the Examiner noted, the only disclosure of thicknesses supports
a thickness of about 255pm for the film and active substance layers. Ans.
26—27. We agree with the Examiner that there in nothing in the
Specification with regards to the thickness of the pressure sensitive adhesive
(“PSA”) layer. Thus, there is no support to the limitation calling for the TTS
to have a thickness of 300pm.
Appellants contend that the Specification would lead one skilled in the
art to understand that the PSA layer alone would have a thickness of 300pm.
Appeal Br. 31—32. Appellants base this measurement on the proposition that
the PSA and the active substance preparation would have a density of
lg/cm2. Id. We are not persuaded. Appellants offer no basis for the density
for the PSA and active substance layers other than attorney argument.
Attorney argument is insufficient. In addition, even if Appellants’ assertion
were correct, Appellants have not shown how that value yields a thickness
for the PSA of 300pm.
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Application 11/885,716
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claims 13, 19—21, and 24 do not comply with the
written description requirement.
HOFFMANN COMBINED WITH GAFE
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that claims 13, 19, 20, 24,
29, and 31 would have been obvious over Hoffmann combined with Gale.
The Examiner finds that Hoffmann discloses a TTS comprising an
impermeable backing layer, a reservoir layer, an adhesive layer and a cover
layer. Final Act. 7. The Examiner finds that while Hoffmann discloses that
reservoir layer may contain two or more individual layers, those layers can
comprise the same polymer thus creating an active substance preparation.
Id. The Examiner finds that while Hoffmann does not teach a TTS which is
light permeable, Gale teaches a TTS which is transparent. Final Act. 12—13.
The Examiner concludes that
it would have been prima facie obvious to one of ordinary skill
in the art at the time of the invention to prepare Hoffmann's
transdermal therapeutic system as either a transparent patch or
one having a skin-colored backing layer, as taught by Gale. One
would have been motivated to do so with a high expectation of
success since both Hoffmann and Gale are concerned with
similar problems in the art, namely the transdermal delivery of
active ingredient. Hoffman, abstract; Gale title and abstract.
Further, it is well within the skill of the ordinary artisan to
select an appropriate visual configuration. Doing so amounts to
no more than combining prior art elements according to known
methods to yield predictable results, namely the preparation of a
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Application 11/885,716
transdermal therapeutic system for delivering active ingredient
that are made to appear inconspicuous (Gale, p. 2, In. 20-22).
Final Act. 13.
Appellants contend that Hoffmann teaches TTS that comprises five or
more layers and that there is nothing in the references to teach or suggest
using less than five layers. Appeal Br. 12. Appellants argue that Hoffmann
teaches an active substance reservoir that comprises two or more layers and
one skilled in the art would not have been motivated to use a single layer for
the reservoir. Id. at 13—14. Appellants contend that Gale does not address
the deficiencies of Hoffmann. Id. at 19.
Appellants go on to argue that Hoffmann and Gale do not suggest
forming an active substance loading gradient in the PSA layer. Appeal Br.
21. With respect to claim 31, Appellants also argue that Hoffmann and Gale
do not teach or suggest a concentration profile resulting from the active
substance preparation disposed between the PSA and the backing layer.
Appeal Br. 25. Finally, Appellants argue that the references do not teach or
suggest a flowable active substance containing preparation as called for in
claim 31. Appeal Br. 27.
Findings of Fact
We adopt the Examiner’s findings as our own, including with regard
to the scope and content of, and motivation to modify or combine, the prior
art. The following findings are included for emphasis and reference
purposes.
FF1. Hoffmann discloses a TTS comprising
(a) an impermeable backing layer,
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Application 11/885,716
(b) a reservoir layer adjacent to and in close contact with, this
backing layer and supersaturated with the therapeutically
active agent or agents said reservoir layer comprising a
polymer matrix wherein the therapeutically active agent or
agents are soluble and which is permeable to said agent or
agents,
(c) an adhesive layer adjacent to and in close contact with, said
reservoir layer and permeable to said therapeutically active
agent or agents and
(d) a cover layer covering and adhering to said adhesive layer
and removable therefrom for the use of said pharmaceutical
product as a transdermal therapeutic system.
Hoffmann col. 2,11. 8—21.
FF2. Hoffmann teaches that the reservoir layer can comprise two or
more layers of an active agent containing polymer matrix. Hoffmann col. 6,
11. 13-19.
FF3. Hoffmann teaches that the polymer layer of the reservoir layer
can comprise the same polymer. Hoffmann col. 2,11. 57—61.
FF4. Gale discloses a TTS that is transparent. Gale. 2 and 4.
Principles of Law
“The factual predicates underlying an obviousness determination
include the scope and content of the prior art, the differences between the
prior art and the claimed invention, and the level of ordinary skill in the art.”
In reRouffet, 149 F.3d 1350, 1355 (Fed. Cir. 1998).
“[Djuring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification.” In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000).
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Application 11/885,716
“[T]he claims define the invention. . . . [Limitations from the
specification are not to be read into the claims.” Sjolund v. Musland, 847
F.2d 1573, 1582 (Fed. Cir. 1988).
Analysis
Claim 13 is representative of the rejected claims and is reproduced
above.
The preponderance of the evidence supports the Examiner’s
conclusion that the device recited in claim 13 would have been obvious to an
ordinary artisan in view of Hoffmann and Gale. Appellants do not persuade
us otherwise. To the contrary, we agree with the Examiner’s findings of
fact, and conclusion of obviousness derived therefrom, and adopt them as
our own. We include the discussion below for emphasis.
Appellants contend that the present invention is directed to a three or
four layer TTS whereas Hoffmann is directed to a TTS comprising five or
more layers. Appeal Br. 12—13. Appellants argue that the instant claims
only call for one reservoir layer whereas Hoffmann requires at least two
reservoir layers. Id. We are unpersuaded. Hoffmann discloses a single
reservoir layer which is the same as the active substance preparation recited
in the claims. FF1. While Appellants have not labeled the active substance-
containing preparation as a separate layer, claim 13 calls for applying the
preparation to the PSA, thus creating a layer of substance containing
preparation.
We note that the term active substance-containing preparation is not
specifically defined in the Specification and there is nothing in the claims or
Specification which limits the preparation to a single layer. Thus, using the
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Application 11/885,716
broadest reasonable interpretation, we conclude that the active substance-
containing preparation embraces one or more layers of an active substance
and polymer combination.
Appellants argue that Gale does not cure the deficiencies of
Hoffmann. We are not persuaded. As noted above, with the exception of
the TTS being light permeable, Hoffmann teaches the elements of claim 13.
Gale teaches the preparation of transparent TTS. FF4.
Appellants next argue that Hoffmann and Gale do not teach or suggest
an active substance loading gradient within the PSA layer. Appeal Br. 21.
This argument is unpersuasive as claim 13 does not include a limitation
calling for an active substance loading gradient.
Appellants next argue that the subject matter of claim 31 is not
obvious as the references do not teach a concentration profile which results
from the active substance preparation being placed between the PSA and the
backing layer. Appeal Br. 25. This argument is unpersuasive as claim 31
does not include a limitation call for a concentration profile.
Finally, Appellants argue that the subject matter of claim 31 would
not be obvious as the references do not teach a flowable active substance
preparation. Appeal Br. 27. Appellants point to the teachings of Hoffmann
which call for removal of the solvent as teaching that the preparation is not
flowable. Id. The Examiner finds that the active substance preparation is
flowable since the active substance can flow through the different layers to
reach the skin. Here we believe Appellants have the better argument.
Claim 31 calls for the active substance preparation not just the active
substance itself. Appeal Br. 44 (Claims App’x). Claim 31 also makes it
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Application 11/885,716
clear that the active substance preparation comprises the active substance
and a polymer. Id. at 45. Thus it is the combination of the active substance
and the polymer which must be flowable. The Examiner has stated a
rationale in which the active substance may be flowable but has not shown
that the combination of the active substance and polymer disclosed in
Hoffmann would be flowable after solvent extraction.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claim 13 would have been obvious over
Hoffmann combined with Gale. However, the evidence does not support the
Examiner’s conclusion that claim 31 would have been obvious over this
combination. Claims 19, 20, 24, and 29 fall with claim 13.
BRACHT COMBINED WITH GALE
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that claims 29 and 30
would have been obvious over Bracht combined with Gale.
The Examiner finds that Bracht discloses a TTS comprising an
impermeable backing layer, a reservoir layer in contact with an active
ingredient PSA layer and a peelable protective film wherein all the layers are
comprised of a methacrylate copolymer. Final Act. 21. The Examiner finds
that while Bracht does not teach a TTS that is light permeable, Gale teaches
a transparent TTS. Final Act. 23—24. The Examiner concludes that
it would have been prima facie obvious to one of ordinary skill
in the art at the time of the invention to prepare Bracht's
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Application 11/885,716
transdermal therapeutic system either as a transparent patch or
one having a skin-colored backing layer. One would have been
motivated to do so with a high expectation of success since both
Bracht and Gale are concerned with similar problems in the art,
namely the transdermal delivery of active ingredients.
Final Act. 24.
Appellants contend that Bracht does not teach a PSA layer onto which
an active substance-containing preparation has been applied along with a
separate reservoir layer. Appeal Br. 29.
Principles of Law
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citation omitted).
Analysis
We agree with Appellants that the Examiner has failed to establish a
prima facie case of obviousness with respect to claims 29 and 30. Bracht
discloses only a single layer of an active substance containing material, not a
layer applied to the PSA and a separate active substance reservoir recited in
claim 29. Appeal Br. 29. Bracht teaches a PSA layer which contains
nicotine as well as a separate nicotine containing layer. Bracht H 13 and 17.
We agree that this is different from the TTS claimed in claims 29 and 30
which call for a separate active substance containing preparation which is
applied to the PSA and a separate active substance reservoir.
Gale does not remedy the deficiencies of Bracht. The Examiner only
points to Bracht for the teaching of a transparent TTS. Ans. 23. The
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Application 11/885,716
Examiner points to nothing in Gale to support a teaching of both an active
substance containing preparation applied to the PSA and a separate active
substance reservoir.
Conclusion of Law
We conclude that a preponderance of the evidence does not support
the Examiner’s conclusion that claims 29 and 30 would have been obvious
over Bracht combined with Gale.
NEW GROUNDS FOR REJECTION
Claims 21 and 30
As discussed above, Hoffmann teaches a TTS having an active
substance reservoir. FF1. The reservoir of Hoffmann can consist of two or
more layers of polymer containing the active substance. FF2. Gale teaches
a TTS that is transparent. FF4. Thus, the references teach the TTS
described in independent claims 13 and 29. Neither Hoffmann nor Gale
teach the use of methacrylate copolymers as required by claims 21 and 30.
However, Bracht teaches the use of methacrylate copolymers in a
TTS. Bracht H 14 and 16. A person of ordinary skill in the art would have
been motivated to use methacrylate as the polymer of claims 13 and 29, with
a reasonable expectation of success, because Bracht teaches that acrylate
copolymers have very good nicotine release properties. Accordingly, claims
21 and 30 are rejected under 35 U.S.C. § 103(a) as obvious over Hoffmann
combined with Bracht and Gale.
Claim 31.
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Application 11/885,716
With respect to claim 31, while Hoffmann does not teach a flowable
active substance preparation, Bracht teaches the use of such a preparation.
For example, Bracht teaches that the nicotine containing layer can be
introduced using printing technology. Bracht 125. In addition, Bracht
teaches application of a nicotine containing solution to the backing followed
by application of the PSA. Bracht || 42-44.
It would have been obvious to one of ordinary skill in the art to use
the flowable nicotine containing composition of Bracht to make the TTS
disclosed in Hoffmann. As taught by Bracht, one skilled in the art would
have been motivated to do so to simplify the coating process. Bracht | 8.
Accordingly, claims 31 is rejected under 35 U.S.C. § 103(a) as obvious over
Hoffmann combined with Bracht and Gale.
These are new grounds of rejection under 37 C.F.R. § 41.50(b)
SUMMARY
We affirm the rejection of claims 13, 19-21, and 24 under 35 U.S.C.
§112, first paragraph for failing to comply with the written description
requirement.
We affirm the rejection of Claims 13, 19, 20, 24, and 29 under 35
U.S.C. § 103(a) as unpatentable over Hoffmann in view of Gale.
We reverse the rejection of claim 31 under 35 U.S.C. § 103(a) as
unpatenable over Hoffmann in view of Gale.
We reverse the rejection of claims 29 and 30 under 35 U.S.C. § 103(a)
as unpatentable over Bracht in view of Gale.
We enter new rejections of claims 21, 30, and 31 under 35 U.S.C.
§ 103(a) as unpatentable over Hoffmann in view of Bracht and Gale.
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TIME PERIOD FOR RESPONSE
This Decision contains a new grounds of rejection pursuant to
37 C.F.R. § 41.50(b). Section 41.50 provides “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
Section 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate amendment of
the claims so rejected or new Evidence relating to the claims so
rejected, or both, and have the matter reconsidered by the
examiner, in which event the prosecution will be remanded to
the examiner. The new ground of rejection is binding upon the
examiner unless an amendment or new Evidence not previously
of Record is made which, in the opinion of the examiner,
overcomes the new ground of rejection designated in the
decision. Should the examiner reject the claims, appellant may
again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
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Further guidance on responding to a new ground of rejection can be
found in the MPEP § 1214.01.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
37 C.F.R $ 41.50(b)
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