Ex Parte Southam et al

Board of Patent Appeals and Interferences

Jan 30, 2012

11456952 (B.P.A.I. Jan. 30, 2012)

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.
11/456,952 07/12/2006 Mary Southam 40068-702.302 /6407
/AR02
6407
99094 7590 01/30/2012
Incline / Wilson Sonsini Goodrich & Rosati
650 page mill road
pal alto, CA 94304
EXAMINER
VU, QUYNH-NHU HOANG
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
01/30/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte MARY SOUTHAM, KEITH J. BERNSTEIN, and
HENK NOORDUIN
____________

Appeal 2010-001070
Application 11/456,952
Technology Center 3700
____________

Before JENNIFER D. BAHR, LINDA E. HORNER, and
KEN B. BARRETT, Administrative Patent Judges.

HORNER, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Mary Southam et al. (Appellants) seek our review under 35 U.S.C.
§ 134 of the Examiner’s decision rejecting claims 25-30. We have
jurisdiction under 35 U.S.C. § 6(b). We REVERSE.
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THE INVENTION
Appellants’ claimed invention relates to a device for “electrotransport
delivery of analgesic drugs, particularly fentanyl and analogs of fentanyl.”
Spec. 1, para. [0002]. Claim 25, reproduced below, is representative of the
subject matter on appeal.
25. A patient-worn device for transdermally delivering
fentanyl solely by electrically induced or electrically enhanced
electrotransport to a human patient suffering from pain,
comprising:
a donor reservoir formulation comprised of a fentanyl
salt solution being the sole source of fentanyl in the device;
a counter reservoir;
a source of electrical power electrically connected to said
reservoirs; and
a control circuit for controlling electrotransport current,
said control circuit including a switch which activates said
device and wherein said reservoirs, said power source and said
control circuit deliver solely by electrotransport a dose of about
20 µg to about 60 µg of fentanyl over a predetermined delivery
period of up to about 20 minutes and terminate said delivery at
the end of said delivery period, and wherein said control circuit
allows up to 143 additional of said doses over a period of about
24 hours.
THE REJECTIONS
Appellants seek review of the following rejections:
1. Claims 25 and 28 under 35 U.S.C. § 112, first paragraph, as failing to
comply with the written description requirement.
2. Claims 25-30 under 35 U.S.C. § 102(b) as anticipated by, or in the
alternative under 35 U.S.C. § 103(a) as unpatentable over, Haak
(US 5,203,768, iss. Apr. 20, 1993).
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ISSUES
The issues presented by this appeal are:
Does Appellants’ original disclosure reasonably convey to those
skilled in the art that the inventors had possession of the subject matter of
claims 25 and 28 as of the filing date?
Does Haak disclose “a donor reservoir formulation comprised of a
fentanyl salt solution being the sole source of fentanyl in the device” as
called for in claim 25?
Does Haak disclose “a donor reservoir formulation comprised of a
sufentanil salt solution being the sole source of sufentanil in the device” as
called for in claim 28?
PRINCIPLES OF LAW
To satisfy the written description requirement, “the [original]
specification must describe an invention understandable to that skilled
artisan and show that the inventor actually invented the invention claimed.”
Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
(en banc). “[T]he test for sufficiency is whether the disclosure of the
application relied upon reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as of the filing date.”
Id. (citations omitted). The claimed invention need not be recited in haec
verba in the original specification to satisfy the written description
requirement. Id. at 1352. “[T]he written description requirement is satisfied
by the patentee’s disclosure of ‘such descriptive means as words, structures,
figures, diagrams, formulas, etc., that fully set forth the claimed invention.’”
Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 969 (Fed. Cir. 2002)
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(quoting Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir.
1997)).
ANALYSIS
Claim Construction
Claims 25 and 28 recite a device comprising “a donor reservoir
formulation comprised of a fentanyl [sufentanil] salt solution being the sole
source of fentanyl [sufentanil] in the device.” These claims also recite that
the reservoir(s), power source, and control circuit “deliver solely by
electrotransport” a specific dosage range of fentanyl or sufentanil over a
predetermined delivery period.
The Specification describes an electrotransport device 10 having an
anode reservoir 26 that contains a formulation comprised of fentanyl or
sufentanil salts and a cathode reservoir 28 that contains a biocompatible
electrolyte. Spec. 12-13, paras. [0032] – [0035]. The Specification
describes:
The fentanyl/sufentanil salt-containing anodic reservoir
formulation for transdermally delivering the above mentioned
doses of fentanyl/sufentanil by electrotransport is preferably
comprised of an aqueous solution of a water soluble
fentanyl/sufentanil salt such as HCl or citrate salts. Most
preferably, the aqueous solution is contained within a
hydrophilic polymer matrix such as a hydrogel matrix.
Spec. 10, para. [0028]. See also Spec. 12, para. [0031] (“the donor reservoir
is preferably a hydrogel formulation.”). The Specification describes that
“[a] preferred hydrogel formulation contains a suitable hydrophilic polymer,
a buffer, a humectant, a thickener, water and a water soluble fentanyl or
sufentanil salt (e.g., HCl salt).” Spec. 10-11, para. [0029]. The
Specification does not disclose that device 10 contains any source of
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fentanyl or sufentanil other than the donor reservoir hydrogel formulation
contained in the anode reservoir 26 and comprised of a water soluble
fentanyl or sufentanil salt. Id. The Specification describes:
Upon depression of push button switch 12, the electronic
circuitry on circuit board assembly 18 delivers a predetermined
DC current to the electrodes/reservoirs 22, 26 and 24, 28 for a
delivery interval of predetermined length, e.g., about 10
minutes. . . . Analgesic drug, e.g. fentanyl, is then delivered
through the patient’s skin, e.g., on the arm, for the
predetermined (e.g., 10 minute) delivery interval.
Spec. 13, para. [0034].
In light of the Specification, which describes a device in which the
sole disclosed source of fentanyl or sufentanil is a donor reservoir hydrogel
formulation contained in the anode reservoir 26 and is comprised of a water
soluble fentanyl or sufentanil salt, one skilled in the art would understand the
donor reservoir formulation limitation to call for this formulation to include
a fentanyl or sufentanil salt solution, where this donor reservoir formulation
is the sole source of fentanyl or sufentanil in the device. Because the claims
recite each formulation as being “comprised of” a fentanyl or sufentanil salt
solution, the claims are broad enough to encompass other components within
each formulation, such as hydrophilic polymer, buffer, humectant, thickener,
and water. See Spec. 10-11, para. [0029]. The claims do not encompass,
however, a device having formulations other than a donor reservoir
formulation comprised of a fentanyl or sufentanil salt solution as a source of
fentanyl or sufentanil in the device.
The claims further call for the combination of the reservoir(s), power
source, and control circuit to “deliver solely by electrotransport” the claimed
dose of fentanyl or sufentanil. In light of the Specification, which describes
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a device in which a donor reservoir, power source, and control circuit are
used to deliver a specified dose of fentanyl/sufentanil only via
electrotransport, one skilled in the art would understand this claim limitation
to mean that the claims do not encompass a device in which the reservoir(s),
power source, and control circuit deliver the claimed dose by
electrotransport in combination with another mode of delivery.
Written Description Rejection
The Specification does not describe a device that delivers fentanyl or
sufentanil by a mechanism other than electrotransport, nor does it describe a
device containing a donor reservoir formulation comprising a fentanyl or
sufentanil salt solution in combination with another fentanyl or sufentanil
formulation. The original method claims filed with the application were
directed to a method of using fentanyl [sufentanil] comprising
“transdermally delivering fentanyl [sufentanil] using a transdermal system
that delivers fentanyl [sufentanil] solely by electrotransport.” See, e.g.,
original claims 1, 6, 11, and 16. The original disclosure describes in
Example 1 the testing of two devices, both of which use electrotransport
current to deliver a particular fentanyl dose over a delivery interval, and in
which patients could self-administer a prescribed number of doses per hour
up to a maximum number of doses. Spec. 17, paras. [0043] – [0044]. Each
drug unit contained an anodic fentanyl HCl-containing donor gel. Spec. 17,
para. [0045]. The testing was to determine whether the electrotransport
fentanyl delivery regimen was sufficient to control pain or whether patients
sought to be re-titrated with supplemental fentanyl through intravenous
administration. Spec. 18-19, paras. [0046] – [0047].
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While the Specification does not contain an explicit statement that no
other sources of fentanyl or sufentanil aside from the donor reservoir
formulation comprised of a fentanyl or sufentanil salt solution were present
in the device, or an explicit statement that the reservoirs, power source and
control circuit delivered the dose “solely” by electrotransport, we find
conspicuously absent disclosure of any other source of fentanyl or sufentanil
or any means other than electrotransport for delivering the prescribed dose
throughout the Specification, which would seem to cry out for discussion of
such additional sources or means if such were used. See Ex Parte Parks,
30 USPQ2d 1234, 1236 (BPAI 1993). In the case before us, the originally
filed disclosure would have conveyed to one skilled in the art that the
inventors had possession of a device as called for in claims 25 and 28. Thus,
we cannot sustain the rejection of claims 25 and 28 under 35 U.S.C. § 112,
first paragraph.
Rejections based on Haak
The Examiner’s anticipation rejection and alternative obviousness
rejection are based on the finding that Haak’s donor reservoir “can contain
the sole source of fentanyl/sufentanil or any agents, such as for intended
use.” Ans. 4. For the reasons provided supra, we do not agree with the
Examiner that the fentanyl or sufentanil salt solution “being the sole source
of fentanyl [sufentanil] in the device” is a statement of intended use. Rather,
the claims are directed to a device comprising a donor reservoir formulation
comprising a fentanyl or sufentanil salt solution and specifically exclude any
other fentanyl or sufentanil formulation as a source in the device.
Haak does not disclose a device comprising “a donor reservoir
formulation comprised of a fentanyl [sufentanil] salt solution being the sole
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source of fentanyl [sufentanil] in the device” as called for in independent
claims 25 and 28. Haak discloses two embodiments of a delivery device
both of which deliver an agent both passively (i.e., by diffusion) and actively
using electrical power. Col. 1, ll. 7-9; fig. 1 and 2. In the first embodiment,
the device 10 includes an active agent reservoir 24, an electrolyte reservoir
25, and a reservoir 26 for the passive agent. Col. 5, ll. 58-62; col. 6, ll. 26-
27; fig. 1. See also col. 13, ll. 50-52; col. 13, l. 65 – col. 14, l. 3; col. 14,
ll. 35-39 (describing a therapeutic system designed to transdermally deliver
fentanyl using the configuration of the first embodiment, in which the active
agent reservoir 24 contains a fentanyl salt solution and the passive reservoir
26 contains a fentanyl base in the form of neutral, uncharged molecules).
In the device 20 of the second embodiment, both the active agent and
the passive agent are contained within agent reservoir 34. Col. 11, ll. 40-42;
fig. 2. Haak describes that in this second embodiment, “the active agent is in
the form of charged ions which are actively delivered by the electric field
generated by the power source in layer 21” and “[t]he passive agent
contained in reservoir 34 is non-ionizable (ie, the passive agent is in the
form of uncharged molecules) and is passively delivered through the body
surface due to the concentration gradient between the high concentration of
the passive agent in reservoir 24 [sic, 34] and the low concentration of the
passive agent within the body.” Col. 11, ll. 42-51. See also col. 15, ll. 13-16
and 28-32 (describing a therapeutic system designed to transdermally deliver
via reservoir 34 sufentanil base in the form of neutral uncharged molecules
by passive delivery and sufentanil HCl by active delivery using the
configuration of the second embodiment.).
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In both examples, the device includes a passive formulation of
fentanyl or sufentanil, which is not comprised of a fentanyl or sufentanil salt
solution, and thus the donor reservoir formulation comprised of a fentanyl or
sufentanil salt solution is not the sole source of fentanyl or sufentanil in the
device. For this reason, we do not sustain the Examiner’s rejection of
independent claims 25 and 28 or their dependent claims 26, 27, 29, and 30.
CONCLUSIONS
Appellants’ original disclosure reasonably conveys to those skilled in
the art that the inventor had possession of the subject matter of claims 25
and 28 as of the filing date.
Haak does not disclose “a donor reservoir formulation comprised of a
fentanyl salt solution being the sole source of fentanyl in the device” as
called for in claim 25.
Haak does not disclose “a donor reservoir formulation comprised of a
sufentanil salt solution being the sole source of sufentanil in the device” as
called for in claim 28.
DECISION
The decision of the Examiner to reject claims 25-30 is REVERSED.

REVERSED

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