Bj¿rn Schurad et al.

Patent Trials and Appeals Board

Apr 2, 2020

14359676 - (D) (P.T.A.B. Apr. 2, 2020)

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.
14/359,676 05/21/2014 Björn Schurad LAK.P12-073314 6238
23575 7590 04/02/2020
CURATOLO SIDOTI CO., LPA
24500 CENTER RIDGE ROAD, SUITE 280
CLEVELAND, OH 44145
EXAMINER
AHMED, HASAN SYED
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
04/02/2020 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@patentandtm.com
pair@patentandtm.com
sidoti@patentandtm.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BJÖRN SCHURAD and SONJA RAK
Appeal 2018-004531
Application 14/359,676
Technology Center 1600
Before JOHN G. NEW, TAWEN CHANG, and JAMIE T. WISZ,
Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 17–20. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as Luye Pharma
AG. Appeal Br. 3.
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BACKGROUND
“Fentanyl and its analogues . . . are potent synthetic opiates” that are
“highly efficacious and . . . rapidly metabolized.” Spec. 1. However, these
compounds have a “relatively narrow therapeutic index” wherein
undesirable side effects occur when threshold values are exceeded, and are
also relatively expensive and pose a high risk of abuse. Id. The
Specification states that, accordingly, desired properties for fentanyl patches
include “a sufficient active ingredient release over the entire duration of
use,” “a sufficient adhesive capacity and cutaneous tolerance in order that
the usual duration of use . . . of typically three days is ensured,” “no
appreciable cold flow,” “easy and cost-effective . . . prepar[ation],” “an
active ingredient load [that] is as little as possible,” and “a content of
residual active ingredient after use [that] is as low as possible.” Id. at 4.
The Specification states that prior art polyisobutylene-based patches
have part but not all of the desired properties described above and that,
“[t]hus, there is [a] further need for a patch based on polyisobutylenes for
administering fentanyl or an analogue thereof that has the aforementioned
advantageous combination of properties.” Spec. 5. The Specification
further states that “the inventors of the present application surprisingly have
found that the temperature dependency of the viscoelastic behavior of the
polyisobutylenes of the matrix layer of a transdermal therapeutic system is
of decisive importance for the relevant properties of the transdermal
therapeutic system.” Id. at 5–6.
CLAIMED SUBJECT MATTER
The claims are directed to a method of utilizing a pressure-sensitive
adhesive matrix layer in the preparation of a transdermal therapeutic system
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for the administration of an active ingredient through the skin. Claim 17 is
illustrative:
17. A method of utilizing a pressure-sensitive adhesive matrix layer
in the preparation of a transdermal therapeutic system for the
administration of an active ingredient through the skin alleviating pain
during an intended wearing time of optionally 3 to 7 days, wherein the
matrix layer of the transdermal therapeutic system after application to
the skin for the intended wearing time has a residual content of the
active ingredient below 35 % of the initial content of the active
ingredient, wherein the transdermal therapeutic system comprises:
a) a back layer,
b) the pressure-sensitive adhesive matrix layer containing the
active ingredient; and
c) a stripping layer (release liner),
wherein the active ingredient is fentanyl or an analogue of the
fentanyl selected from alfentanil, carfentanil, lofentanil, remifentanil,
and trefentanil or a salt of one of these active ingredients and
wherein the matrix layer as a pressure-sensitive adhesive
polymer contains a mixture of a polyisobutylene A and a
polyisobutylene B,
wherein the polyisobutylene A has a storage modulus G’ the
value of which is substantially constant in the temperature range of
from 10°C to 40°C and
wherein the polyisobutylene B has a storage modulus G’ the
value of which continuously decreases with increasing temperature in
the temperature range of from 10°C to 40°C,
wherein the storage modulus G’ is measured in the linear
viscoelastic range at a frequency of 10 rad/sec using a rheometer with
parallel plate geometry and parallel plates; and
wherein the pressure-sensitive adhesive matrix layer contains
undissolved active ingredient in the form of active ingredient
particles.
Appeal Br. 13 (Claims App.).
REJECTION(S)
A. Claims 17–20 are rejected under 35 U.S.C. § 112(b) or 35 U.S.C.
§ 112 (pre-AIA), second paragraph, as being indefinite for failing to
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particularly point out and distinctly claim the subject matter which the
inventor or a joint inventor (for 35 U.S.C. § 112(b)), or the applicant
(for 35 U.S.C. § 112 (pre-AIA), second paragraph), regards as the
invention. Final Act. 2.
B. Claims 17–20 are rejected under 35 U.S.C. § 112(a) or 35 U.S.C.
§ 112 (pre-AIA), first paragraph, as failing to comply with the written
description requirement. Final Act. 3.

OPINION
A. Rejection for indefiniteness (claims 17–20)
1. Issue
The Examiner concludes that claim 17, the only independent claim on
appeal, “recites both a method of utilizing a pressure sensitive layer and a
transdermal therapeutic system.” Final Act. 2. The Examiner states that “[a]
single claim which claims both an apparatus and the method steps of using
the apparatus is indefinite under 35 U.S.C. § 112(b) or pre-AIA 35 U.S.C.
§ 112, second paragraph. ” Id.
Appellant contends that the authorities the Examiner cites in support
of the rejection “address the situation where an apparatus claim recited
method steps to be performed by a user, and not merely the capability of the
apparatus,” whereas “the present claims are directed to a method involving
the use of an apparatus.” Appeal Br. 6.
Appellant does not separately argue the claims; we therefore limit our
analysis to claim 17 as representative. The issue with respect to this
rejection is whether claim 17 impermissibly combines two separate statutory
classes of invention such that it fails to particularly point out and distinctly
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claim the subject matter that the inventor or joint inventor, or the applicant
(pre-AIA), regards as the invention.
2. Analysis
The Federal Circuit has held that “[a] single patent may include
claims directed to one or more of the classes of patentable subject matter,
but no single claim may cover more than one subject matter class.”
Microprocessor Enhancement Corp. v. Texas Instruments Inc., 520 F.3d
1367, 1374 (Fed. Cir. 2008). This holding is premised on “the lack of clarity
as to when the mixed subject matter claim would be infringed.” Id. For the
reasons discussed below, we agree with the Examiner that claim 17 is
indefinite.
“A method or process . . . is an act or a series of acts and from the
standpoint of patentability must distinguish over the prior art in terms of
steps, whereas a claim drawn to apparatus must distinguish in terms of
structure.” Ex parte Lyell, 17 USPQ2d 1548, 1552 (BPAI 1990) (quoting Ex
parte Forsyth, 151 USPQ 55, 56 (Bd. App. 1965)) (internal quotation marks
omitted). In this case, although claim 17 recites in its preamble “[a] method
of utilizing a pressure-sensitive adhesive matrix layer in the preparation of a
transdermal therapeutic system for the administration of an active ingredient
through the skin alleviating pain during an intended wearing time of optional
3 to 7 days,” the claim does not recite any steps of a method. Appeal Br. 13
(Claims App.) (emphasis added). Instead, the remainder of claim 17 recites
only structural limitations relating to the matrix layer and/or the transdermal
therapeutic system. There is thus a lack of clarity as to whether the claim is
infringed by any transdermal therapeutic system comprising the structural
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limitations set forth in the claims, or whether an infringement requires the
performance of one or more (unspecified) steps.
Appellant contends that, unlike the cases cited in the MPEP section
relied upon by the Examiner, which “address the situation where an
apparatus claim recited method steps to be performed by a user, and not
merely the capability of the apparatus,” “the present claims are directed to a
method involving the use of an apparatus (i.e., a pressure sensitive adhesive
matrix layer).” Appeal Br. 6. Instead, Appellant analogizes the instant
claims to those in Microprocessor Enhancement, which the Federal Circuit
found were not indefinite.
We are not persuaded. We acknowledge that “[m]ethod claim
preambles often recite the physical structures of a system in which the
claimed method is practiced,” and that such claims are not necessarily
indefinite. Microprocessor Enhancement, 520 F.3d at 1374–1375. As the
Court explained in Microprocessor Enhancement, however, the claim(s) at
issue in that case had the following general structure:
1. A method of executing instructions in a pipelined processor
comprising:
[structural limitations of the pipelined processor];
the method further comprising:
[method steps implemented in the pipelined processor].
Id. at 1374. The Court thus found that there is no ambiguity regarding when
the claim would be infringed, because “[d]irect infringement of [the above
claim] is clearly limited to practicing the claimed method in a pipelined
processor possessing the requisite structure.” Id. at 1375.
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Unlike the claims in Microprocessor Enhancement, claim 17
does not recite any method steps. Thus, it is unclear what is involved
in practicing the claimed method of “utilizing a pressure-sensitive
adhesive matrix layer in the preparation of a transdermal therapeutic
system” possessing the requisite structure.2
Accordingly, we affirm the Examiner’s rejection of claim 17 as
indefinite. Claims 18–20, which are not separately argued, fall with
claim 17. 37 C.F.R. § 41.37(c)(1)(iv).
B. Rejection for lack of written description (claims 17–20)
1. Issue
The claims recite “a pressure-sensitive adhesive polymer contains a
mixture of a polyisobutylene A and a polyisobutylene B.” The Examiner
finds that, while Appellant “provide[s] a storage modulus G’ of
‘polyisobutylene A’ and ‘polyisobutylene B’,” the Specification does not
provide sufficient structural description of polyisobutylene A and

2 We note that claim 17 further requires that “the matrix layer . . . after
application to the skin for the intended wearing time as a residual content of
the active ingredient below 35% of the initial content of the active
ingredient,” where the intended wearing time is “optionally 3 to 7 days.”
Appeal Br. 13 (Claims App.). We conclude that this limitation also renders
the claim indefinite, because, although the Specification describes an
“intended wearing time of typically 1 to 7 days, preferably 3 to 7 days, in
particular 3 days,” see, e.g., Spec. 22, the time set forth in the claim (i.e., 3
to 7 days) is specified to be optional, and it is not otherwise clear from
whose perspective the “intended wearing time” is to be determined. Cf.
Datamize, LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350 (Fed. Cir.
2005), abrogated on other grounds by Nautilus, Inc. v. Biosig Instruments,
Inc., 572 U.S. 898 (2014) (holding the phrase “aesthetically pleasing” to be
indefinite because “[s]ome objective standard must be provided in order to
allow the public to determine the scope of the claimed invention”).
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polyisobutylene B to reasonably convey to a skilled artisan that the inventor
had possession of the invention. Final Act. 3–4.
Appellant contends that, “[b]ased on the common knowledge in the
field and the supporting disclosure in the present application, one of ordinary
skill in the art would readily be able to obtain the claimed polyisobutylene A
and B based on their corresponding storage modulus, as defined in the
claims.” Appeal Br. 7. Appellant contends that the Specification mentions,
as examples of suitable polyisobutylene A and/or B, Durotak 87-625A and
87-626A, which are widely known in the art to contain certain
polyisobutylenes. Id. at 8.
Appellant does not argue the claims separately. We therefore limit
our analysis to claim 17 as representative. The issue with respect to this
rejection is whether the Specification sufficiently describes the claimed
polyisobutylene A and polyisobutylene B so as to reasonably convey to a
skilled artisan that the inventor and/or joint inventor had possession of the
claimed invention at the time of the application.
2. Analysis
We agree with the Examiner that the claim terms “polyisobutylene A”
and “polyisobutylene B” are not adequately described in the Specification.
Our reviewing court has held that
a sufficient description of a genus . . . requires the disclosure of
either a representative number of species falling within the
scope of the genus or structural features common to the
members of the genus so that one of skill in the art can
‘visualize or recognize’ the members of the genus.
Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010).
The court further explained that “an adequate written description requires a
precise definition, such as by structure, formula, chemical name, physical
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properties, or other properties, of species falling within the genus sufficient
to distinguish the genus from other materials” and that “functional claim
language can meet the written description requirement when the art has
established a correlation between structure and function.” Id. However, the
court explained that “merely drawing a fence around the outer limits of a
purported genus is not an adequate substitute for describing a variety of
materials constituting the genus and showing that one has invented
a genus and not just a species.”
Claim 17 recites “polyisobutylene A [having] a storage modulus G’
the value of which is substantially constant in the temperature range of from
10ºC to 40ºC” and “polyisobutylene B [having] a storage modulus G’ the
value of which continuously decreases with increasing temperature in the
temperature range of from 10ºC to 40ºC.” Appeal Br. 13 (Claims App.).
Both of these limitations recite a genus of polymer molecules,
specifically polymers (or mixtures of polymers) of isobutylene having the
recited relationship between storage modulus and temperature. Spec. 14, 16
(stating that polyisobutylenes A and B may be prepared “by mixing two or
more polyisobutylenes,” even though they are preferably “an individual
polyisobutylene”). We find, however, that for neither limitation does the
Specification disclose “either a representative number of species falling
within the scope of the genus or structural features common to the members
of the genus so that one of skill in the art can ‘visualize or recognize’ the
members of the genus.” Ariad, 598 F.3d at 1350.
In particular, the Specification provides only a single example of a
polyisobutylene meeting the storage modulus limitation of polyisobutylene
A (Durotak 87-625A) and a polyisobutylene meeting the storage modulus
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limitation of polyisobutylene B (Durotak 87-626A). The Specification
provides no evidence, however, that these example polymers are in fact
representative of the genera of polymer molecules claimed (i.e.,
polyisobutylenes or mixtures of polyisobutylenes exhibiting the recited
relationship between storage modulus and temperature). Likewise,
Appellant provides no persuasive evidence that the disclosure of Durotak
87-625A and 87-626A allows a skilled artisan to “‘visualize or recognize’
the members of the genus.”
Appellant argues that Durotak 87-625A and 87-626A, including their
technical specification, “are well-known to those of ordinary skill in the art,
and the Specification informs the skilled person where to obtain such
products.” Appeal Br. 8–9. We are not persuaded: Assuming, for the sake
of argument, that the Specification adequately describes Durotak 87-625A
and 87-626A, the disclosures of these species do not adequately describe the
genera of polymer/polymer mixtures claimed (i.e., polyisobutylene A and
polyisobutylene B) for the reasons discussed above.
Appellant further argues that “it would be readily apparent to one of
ordinary skill in the art that the technical feature ‘storage modulus’
(corresponding to the claimed storage modulus G’) is a commonly employed
parameter for characterizing polyisobutylenes and allows for the production
of specific polyisobutylenes based on their corresponding storage modulus.”
Appeal Br. 7. Appellant cites in particular to the statement in the
Specification that “[t]he indication of the desired characteristic of the storage
modulus is sufficient for the manufacturer of the polyisobutylenes to provide
a corresponding polyisobutylene,” as well as the disclosure in the
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Specification regarding “how the storage modulus G’ was determined.”
Appeal Br. 7 (citing Spec. 12–13).
We are not persuaded. As an initial matter, the fact that a
manufacturer can provide a polyisobutylene having the recited storage
modulus does not necessarily mean that such polyisobutylene is described in
the Specification. In Eli Lilly, for example, our reviewing court affirmed a
district court holding that a claim to a microorganism containing a human
insulin cDNA lacks adequate written description, even though the
Specification provided “a process for obtaining human insulin-encoding
cDNA.” Regents of the University of California v. Eli Lilly & Co., 119 F.3d
1559, 1567 (Fed. Cir. 1997). In this case, the Specification has not even
described the process that a manufacturer would use to provide a claimed
polyisobutylene. Furthermore, Appellant cites no evidence that a
manufacturer would be able to provide a range of polyisobutylenes that are
“representative” of the apparently broad genera claimed, and also does not
persuasively explain how a skilled artisan would be able to otherwise
“visualize or recognize” polyisobutylenes that possess the recited storage
modulus.
Similarly, the fact that the Specification teaches how to determine
storage modulus Gʹ of a polyisobutylene polymer does not suggest that a
skilled artisan would be able to visualize or recognize, based on the
description in the Specification, polyisobutylene or polyisobutylene mixture
that will fall within the claimed genera when its storage modulus is
determined according to the method described in the Specification.
In short, the Specification does not show that the inventors possessed
pressure-sensitive adhesive matrix layers containing the broad genera of
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claimed polyisobutylene A and polyisobutylene B. Accordingly, we affirm
the Examiner’s rejection of claim 17 as failing to comply with the written
description requirement. Claims 18–20, which are not separately argued,
fall with claim 17. 37 C.F.R. § 41.37(c)(1)(iv).

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/
Basis 
Affirmed Reversed
17–20 112(b) or 112 (pre-
AIA), second paragraph
Indefiniteness

17–20
17–20 112(a) or 112 (pre-
AIA), first paragraph
Written
Description

17–20
Overall
Outcome
17–20

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED