Ex Parte Asmussen et al

Patent Trials and Appeals Board

Mar 27, 2019

12525888 - (D) (P.T.A.B. Mar. 27, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/525,888 08/05/2009
20999 7590 03/29/2019
HAUG PARTNERS LLP
745 FIFTH A VENUE - 10th FLOOR
NEW YORK, NY 10151
FIRST NAMED INVENTOR
Bodo Asmussen
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
512100-2072 2273
EXAMINER
GHALI, ISIS AD
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
03/29/2019 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):
docket@haugpartners.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BODO ASMUSSEN, MICHAEL HORSTMANN,
CHRISTOPH SCHMITZ, MOHAMMAD SAMET!,
YVES-THORSTEN PRZYBYLLA, and ROLF PRACHT
Appeal2018-000391
Application 12/525,888 1
Technology Center 1600
Before ERIC B. GRIMES, TA WEN CHANG, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
transdermal therapeutic system, which have been rejected as obvious. We
have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
STATEMENT OF THE CASE
According to Appellants' Specification: "Transdermal therapeutic
systems have been established on the market for numerous active substances
for a number of years." (Spec. 1.) "In general, pharmaceutical active-
1 Appellants identify the real party in interest as L TS Lohmann Therapie-
Systeme AG. (Appeal Br. 1.)
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Application 12/525,888
substance patches of this kind are based on what are known as matrix
patches or reservoir/membrane patches." (Id.) The transdermal therapeutic
system of the invention is composed of two phases: "the stationary solid
phase being formed from a solid, which may be flexible and which has a
fibrous or open-pore fleece- or spongelike structure, and the liquid phase
being composed of an aqueous solution, emulsion or suspension that
comprises the pharmaceutically active substance." (Id. at 4.)
Claims 1, 2, 4, and 6-10 are on appeal. Claim 1 is representative and
reads as follows:
1. A transdermal therapeutic system for controlled delivery of a
water-soluble, active pharmaceutical substance from an
aqueous phase, comprising:
an occlusive backing layer;
a central device facing the skin and intended for delivery of the
active pharmaceutical substance, said central device
compnsmg:
a stationary solid phase; and
a liquid phase;
wherein said liquid phase comprises the active substance
in aqueous solution;
wherein the solid phase has a fibrous, open-pore, fleece-
like structure, and is made from at least one material
selected from cellulose, viscose, polyester, polyurethane,
and silicone;
wherein the fibrous, open-pore, fleece-like structure has
open space in which the liquid phase is arranged;
an adhesive layer margin concentrically surrounding the central
delivery device; and
a redetachable protective foil;
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wherein the water-soluble active pharmaceutical substance is a
peptide or polypeptide.
(Appeal Br. 19.)
The following grounds of rejection by the Examiner are before us on
review:
1. Claims 1, 2, 4, and 6-10 under 35 U.S.C. § 103 as
unpatentable over Kreckel, 2 Muller, 3 Brooke, 4 and Gertner. 5
2. Claims 1, 2, 4, and 6-10 under 35 U.S.C. § 103 as
unpatentable over Gertner, Brooke, and Muller.
DISCUSSION
Obviousness Rejection 1
The Examiner finds that Kreckel teaches a transdermal drug delivery
device that has a reservoir surrounded by a carrier material adhered to the
skin by skin compatible adhesive. (Final Action 4.) The Examiner further
finds the reservoir contains a liquid formulation of a drug absorbed into a
carrier of polyurethane foam or nonwoven fleece. (Id.) The Examiner also
finds that the reservoir is covered by a peelable protective covering. (Id.)
The Examiner notes that "Kreckel does not explicitly teach the drug
formulation is contained in the open spaces of the fleece." (Id. at 5.) The
Examiner finds, however, that the prior art teaches foam like carrier fleece
and polyurethane foam or sponge used in transdermal products that have a
reservoir and in which active agent is carried in the pores of the fleece or
2 Kreckel et al., US 5,244,677, issued Sept. 14, 1993.
3 Muller et al., US 4,719,239, issued Jan. 12, 1988.
4 Brooke et al., US 6,328,992, issued Dec. 11, 2001.
5 Gertner et al., US 5,707,641, issued Jan. 13, 1998.
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sponge. (Id. (citing Muller and Brooke).) The Examiner finds that Brooke
teaches that such a structure provides for controlled release of the active
agent "such that plasma levels of it may be controlled in a safe convenient
and effective manner for the patient." (Id.) The Examiner concludes that it
would have been obvious to one having ordinary skill in the art to "use
porous fleece material to absorb the drug solution as taught by Muller or use
polyurethane porous material as a reservoir material wherein the active agent
is contained within the pores of the porous structure as taught by Brooke," in
order to provide for plasma levels of the active agent to be controlled in a
safe, convenient, and effective manner. (Id. at 6-7.)
The Examiner also notes that Kreckel does not teach the drug is a
peptide or polypeptide. (Id. at 5.) The Examiner, however, finds that
Gertner teaches that it was known to use transdermal administration of
peptides or polypeptides, such as insulin, which is water soluble, where the
insulin is absorbed into a flexible porous solid support. (Id. at 6.) The
Examiner concludes that it would have been obvious to one of ordinary skill
in the art to use the transdermal delivery system of Kreckel as modified by
Muller and Brooke to deliver water soluble insulin in light of Gertner
teaching that such an agent can be delivered via an aqueous emulsion
absorbed into a flexible porous support. (Id. at 7.)
We agree with the Examiner that the claims would have been obvious
from Kreckel, Muller, Brooke, and Gertner.
Appellants contend that the cited art does not render obvious a solid
phase that is a fibrous, open-pore, fleece-like structure as required by claim
1. (Appeal Br. 9-13.) Appellants contend that the non-woven fleece of
Kreckel, which the Examiner refers to as being the absorbent material, is not
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the material to which the low-viscous solution is absorbed but is, instead, a
tape that serves as a carrier element. (Appeal Br. 10.) According to
Appellants, Kreckel's transdermal delivery device for low-viscous solutions
or low-viscous microemulsions employs an absorbent material that has
closed cells like the polyethylene foam used to surround the holes of the
punched out laminate. (Id.) We disagree on both points.
While it is certainly true that Kreckel teaches that non-woven fleece is
a tape that holds an absorbent material in place (see, e.g., Kreckel 6:5-10,
3: 1-10), Kreckel does not teach that the absorbent material that is saturated
with the low-viscosity drug solution is a closed cell foam. In fact, Kreckel
describes clearly, in Example 3, a device to be used with low-viscosity
micro-emulsions where the absorbent material that is saturated with the
micro-emulsion containing the active ingredient is "non-woven fleece" of
viscose-rayon. (Kreckel 8: 11-17.)
Although less clear in Example 2-which describes the preparation of
"[a] device according to the invention for administering low-viscous
solutions"-we conclude the absorbent material there is also non-woven
fleece of viscose-rayon. In particular, Kreckel describes "[a] piece of a non-
woven fleece of viscose rayon, about 1 mm thick" that is placed on the
pressure-sensitive adhesive side of the aluminum vapor-coated polyethylene
film and that is smaller than the diameter of the barrier layer film. (Id. 6:
41--42, 50-55.) This non-woven fleece is a second piece of non-woven
fleece used in the device and is not the piece of non-woven fleece material
that is coated with a skin compatible adhesive that is employed in making
the laminated carrier layer described in Example 2. (Id. at 6:43--49). The
description of this device parallels the description in Example 3 except it
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does not specifically state that the non-woven fleece that was placed into the
punched out opening was saturated with a liquid containing active
ingredient. (Compare id. at 8:5-22 with id. at 6:43-55.) In light of the
parallel disclosures, we conclude that the non-woven fleece that is about 1
mm thick in Example 2 is the absorbent material that is to be saturated with
the drug solution, just as in Example 3.
Although we disagree with the Examiner that the non-woven fleece
and open-cell polyurethane foams 6 "all read on each other" so as to meet the
requirement of a fleece-like structure of Appellants' claim (Ans. 3),7 we,
nevertheless, agree with the Examiner that Kreckel teaches a fibrous fleece-
like material as the solid phase in which the low-viscosity liquid phase with
the active ingredient therein is absorbed.
According to Appellants, something is "fibrous" when it "consists of
individual fibers" rather than being "formed by trapping pockets of gas, such
as the open-cellfoam pieces of Kreckel." (Appeal Br. 12, emphasis added.)
Appellants, however, do not point to evidence that Kreckel' s fleece made of
non-woven viscose rayon is not made of fibers. Thus, we do not find
6 Kreckel teaches open-cell polyurethanes are used in the devices with high
viscous active agent formulations. (Id. at 5 (Example 1).)
7 The Examiner arrives at this conclusion because Appellants' Specification
equates fleece-like with sponge-like "in terms of fibrous open-pore
materials." (Final Action 12 (citing Spec. 5:1-5); Ans. 3 (citing same).)
While it may be true that sponge-like and fleece-like were both noted to be
capable of being fibrous and having open-pores by Appellants in their
Specification, this does not lead to the conclusion that sponge-like and
fleece-like are one and the same. Although the Specification does not make
clear what a fibrous open-porous sponge-like structure is, it is identified as
something different from a fibrous open-porous fleece-like structure. And,
Appellants' claim is directed at a fleece-like structure.
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persuasive Appellants' argument (Reply Br. 10-12) that Kreckel is silent
about using fibrous fleece-like material for a low viscosity drug formulation.
As to whether Kreckel' s fleece has pores, we note that Appellants'
Specification indicates that "materials referred to as nonwovens" are
materials that can have a fibrous, open-pore, fleece-like structure. (Spec. 5:
1-9.) Moreover, Muller teaches fleece material is foam-like with pores.
(Muller 6:48-50.) That Muller does not describe the carrier fleece to which
the liquid formulation is absorbed as "fibrous" fleece (Appeal Br. 12) does
not preclude the fleece so described as being fibrous. Appellants provide no
evidence that the fleece of Muller is not made with fibers. Instead,
Appellants assert without evidence that the fact that Muller teaches the
active-containing liquid is absorbed by pores of a foam-like fleece "like [ the
teaching] of Kreckel, appears to describe open-cell-structured foams." (Id.)
"Attorney argument is not evidence." Icon Health & Fitness v. Strava, 849
F.3d 1034, 1043 (Fed. Cir. 2017) (citing Gemtron Corp. v. Saint-Gobain
Corp., 572 F.3d 1371, 1380 (Fed. Cir. 2009)). We conclude that Muller's
description of its fleece as a foam-like carrier does not change the material
from which it was made, which is fleece and not foam. And, we conclude
that this fibrous absorbent fleece structure that is described by Muller as
being "a foam-like carrier" is what has "pores." (Muller 6:48-50.)
In the absence of any evidence to the contrary, we conclude that
Kreckel's non-woven fleece made of viscose rayon that is used as the
absorbent for a low viscosity formulation in a transdermal delivery system
that includes a reservoir meets the requirements of claim 1 of a solid phase
that has a fibrous, open-pore, fleece-like structure. "[W]here the Patent
Office has reason to believe that a functional limitation asserted to be critical
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for establishing novelty in the claimed subject matter may, in fact, be an
inherent characteristic of the prior art, it possesses the authority to require
the applicant to prove that the subject matter shown to be in the prior art
does not possess the characteristic relied on.'" In re Best, 562 F.2d 1252,
1254--55, (CCPA 1977) (quoting In re Swinehart, 439 F.2d 210, 212-13
(CCPA 1971)).
Appellants' argument that Muller's foam-like fleece does not teach or
suggest a "fibrous" open-pore, fleece-like structure (Appeal Br. 12, Reply
Br. 13) is not persuasive for the reasons discussed above.
Appellants argue that Brooke does not cure the deficiencies of
Kreckel and Muller, "even if Brooke did disclose a structure that was
fibrous, open-pore, and fleece-like," because it is concerned with delivering
a non-water soluble active, namely THC, and Kreckel teaches "that the
delivery system must be designed differently depending on whether you are
delivering a highly-viscous substance, a low-viscosity solution ( e.g., and
aqueous solution), or a microemulsion." (Reply Br. 13.)
We do not find this argument persuasive. As the Examiner explains,
"Brooke is relied upon for emphasizing the teaching of Kreckel that [a] drug
formulation can be contained in [a] porous material in the reservoir of [a]
delivery device." (Final Action 15.) Moreover, for the reasons discussed
above, we understand Kreckel to teach that both low-viscous solutions and
low-viscous microemulsions that contain an active agent are contained in a
fibrous fleece structure.
Brooke explains that, where the transdermal device includes a
reservoir with a matrix material that is impregnated with the active
ingredient, that material should be porous so that the active can sit in the
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pores, and that using such a structure is useful for controlling the delivery
rate of the active. (Brooke 5:37-51; see also id. at 9 (Example C).) Brooke
explains that the porous matrix material can be "an open pore structure."
(Id. at 5 :45-51.) It describes as examples of such a structure, a foamed
polyurethane, sponge, or an open weave fabric. (Id.) We do not find
Brooke to be limited to only these open pore structures in light of the fact
that it lists these as examples only: "The porous matrix material 34 may
comprise an open pore structure such as a foamed polyurethane or sponge."
(Id. ( emphasis added).) What is important with respect to the porous matrix
disclosure is that the active ingredient is held in the pores ( called interstices
between the fibers when discussing woven fabrics). (Id. ("Alternatively, the
material may include a pad of an open weave fabric such as gauze. In such
case, the cannabis preparation would be held within the interstices between
the fabric fibers.").)
We agree with the Examiner that Brooke reinforces that it would have
been obvious to one of ordinary skill in the art that the non-woven viscose
rayon fleece absorbent of Kreckel, when impregnated with an active, would
hold the active in the pores of that structure, which would assist in controlled
release of the active. That THC is water insoluble is therefore immaterial
for what one of ordinary skill in the art would take away from the teaching
of Brooke regarding controlling delivery of actives in a transdermal delivery
device that includes a reservoir.
Appellants argue that Gertner does not cure the deficiency with
respect to Kreckel, particularly because Gertner does not teach or suggest a
fleece-like structure. (Appeal Br. 14.) Appellants argue that Gertner teaches
in Example 3 that the solid support can be absorbent paper towel, does not
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describe a central delivery device, and the formulation used included an oil.
(Appeal Br. 14.) Appellants further argue that Gertner is concerned with
improving the therapeutic effect of the insulin by a pretreatment of the
insulin prior to its use. (Id.) We agree with the Examiner (Ans. 17-19) that
these arguments are not persuasive. As the Examiner explains (Final Action
17; Ans. 13-14), Example 3, which describes the use of a paper towel as the
absorbent, is not the only relevant disclosure in Gertner. A reference is
available for all that it teaches to a person of ordinary skill in the art. See
Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir.
1989). Gertner is relied upon by the Examiner for teaching that insulin was
known to be used in a transdermal delivery device where it was provided on
and "absorbed into flexible porous solid support." (Final Action 6.) We
agree this is taught by Gertner. (See Gertner 4:26-36 (explaining the matrix
for transdermal administration "comprises a porous, absorbent, perforate and
flexible monolaminar or polylaminar solid support.").) 8
Furthermore, as the Examiner noted (Final Action 18; Ans. 14), claim
1 is open-ended and does not preclude the use of insulin that has been
pretreated or a composition that also includes an oil phase. "'Comprising' is
a term of art used in claim language which means that the named elements
are essential, but other elements may be added and still form a construct
8 Furthermore, in light of Appellants' argument that fibrous is a material
that is made of fibers (Appeal Br. 12), we conclude that a paper towel, which
is made of cellulose, is fibrous. Moreover, given the broader description of
absorbent materials discussed for use by Gertner as including materials that
are "porous," we further concluded that the fibrous paper towel absorbent is
also porous.
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within the scope of the claim." Genentech, Inc. v. Chiron Corp., 112 F.3d
495, 501 (Fed. Cir. 1997).
For the foregoing reasons, we do not find the Examiner erred in
rejecting claim 1 as being obvious over Kreckel, Muller, Brooke, and
Gertner.
Claims 2, 4, and 6-10 have not been argued separately and therefore
fall with claim 1. 37 C.F.R. § 4I.37(c)(l)(iv).
Obviousness Rejection 2
The Examiner's position regarding the teachings of Gertner, Muller,
and Brooke is set forth above. The Examiner notes that while Gertner "does
not explicitly teach the porous support is fibrous, open-pore, fleece-like
structure, and is made from at least one or more materials selected from
cellulose, viscose, polyester, polyurethane, and silicone," the use of such a
material would have been obvious to one of ordinary skill in the art in light
of Muller. (Final Action 9, 11 ("one having ordinary skill in the art would
have used porous fleece material taught by Muller based on suitability of
such porous fleece material to absorb drug solution").) The Examiner notes
further that
applicants failed to show unexpected results obtained from
using porous fleece over foam or sponge in term of absorbing
the active agent in the reservoir, especially in view of the term
"fleece like" of the claims. Porous fleece was known at the
time of the invention for that purpose as taught by Kreckel and
Muller.
(Id. at 11) In short, the Examiner's position, just as in the first rejection, is
that porous fleece was known to be used as an absorbent material in a
transdermal active agent delivery device, and thus would have been obvious
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to substitute into the reservoir device of Gertner. This rejection is, thus, no
different than what the Examiner has asserted in rejection 1.
Moreover, Appellants' focus on the alleged failure of the Examiner's
position is the same as that noted above for rejection 1, i.e., none of the cited
references disclose, teach, or suggest a fibrous, open-pore, fleece-like
structure having open space in which an active-substance-containing
aqueous solution is arranged. (Compare Appeal Br. 16-18 with id. at 12-14;
see also Reply Br. 18:
[T]his rejection also hinges on overlooking the "fibrous"
recitation, as well as the assertion that the term "fleece-like"
means that any fleece, sponge, or foam reads on the solid phase
in the claims. See Examiner's Answer, p.3, 4 (first paragraph),
7, 8 (penultimate paragraph), 9 (second paragraph), 10 (third
paragraph), 11 (last paragraph), 13 (first full paragraph). But,
as explained above in section VII.B.2., none of the references
teaches a fibrous, open-pore, and fleece-like material that is
used to deliver an active contained in an aqueous solution.
Thus, none of the cited reference disclose, teach, or suggest the
solid phase of claim 1.
We disagree with Appellants' argument incorporating the discussion
above. Moreover, we note that Appellants do not define the term fleece-like,
much less what structure it imparts. We note that paper towel is made of
cellulose fibers and Appellants' claim encompasses a fleece-like structure
made of cellulose. Thus, we find that Gertner' s exemplification of a paper
towel meets the fleece-like structural limitations.
And in any event, as discussed above, Gertner is not limited by the
specific examples provided. In re Inland Steel Co., 265 F.3d at 1360.
Gertner teaches that the matrix for the use in the transdermal administration
of active "comprises a porous, absorbent, perforate and flexible
monolaminar or polylaminar solid support, having absorbed thereon [the]
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pharmaceutical formulation." (Gertner 4:26-30.) This teaching
encompasses fleece and fleece- like material required by Appellants' claim.
And as discussed above, and pointed out by the Examiner, Muller
specifically teaches liquid formulations can be absorbed onto fleece that has
pores and is thus foam-like, and Kreckel also teaches fleece may be used to
absorb liquid formulations on and to be used for transdermal delivery of the
formulation. We agree with the Examiner that one of ordinary skill in the art
would have found it obvious to substitute such known fleece or fleece-like
structures into the Gertner device.
Appellants also argue that Brooke is nonanalogous art because (1) it
"teaches a non-water soluble cannabis preparation that is contained in a
reservoir which may comprise a porous material" and thus "does not relate
to the delivery of an active agent in an aqueous solution" and (2) it "relates
to addressing problems associated with transdermally administering a highly
lipophilic active agent in general ... [and] THC in particular." (Appeal Br.
16 (emphasis in original).) We do not find this argument persuasive.
Brooke is analogous art as it is from the same filed of endeavor irrespective
of the specific problem it is addressing. In re Clay, 966 F.2d 656, 658-59
(Fed. Cir. 1992) ("Two criteria have evolved for determining whether prior
art is analogous: (1) whether the art is from the same field of endeavor,
regardless of the problem addressed, and (2) if the reference is not within the
field of the inventor's endeavor, whether the reference still is reasonably
pertinent to the particular problem with which the inventor is involved.")
As the Examiner explained (Final Action 9; Ans. 11, 13), Brooke
teaches that drug formulations can be contained in "porous matrix material"
(Brooke 5 :45--46) in a reservoir of a transdermal drug delivery device, and
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Gertner teaches that insulin as an aqueous emulsion can be provided on an
absorbent porous matrix for transdermal drug delivery. That Brooke
identifies foamed polyurethane specifically as an example of an open pore
structure that may be used as the porous matrix material (Brooke 5 :45-51 ),
is not limiting. This is but one example, and the Examiner has shown that
other porous materials besides sponges were known to be used for the same
purpose, e.g., Muller, Kreckel.
In light of the foregoing, we affirm the Examiner's rejection of claims
1, 2, 4, and 6-10 under 35 U.S.C. § 103 as unpatentable over Gertner,
Brooke, and Muller.
SUMMARY
We affirm the rejection of claims 1, 2, 4, and 6-10 under 35 U.S.C.
§ 103 as unpatentable over Kreckel, Muller, Brooke, and Gertner.
We affirm the rejection of claims 1, 2, 4, and 6-10 under 35 U.S.C.
§ 103 as unpatentable over Gertner, Brooke, and Muller as evidenced by
Kreckel.
TIME PERIOD FOR RESPONSE
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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