Ex Parte Pickup et al

Board of Patent Appeals and Interferences

Nov 3, 2010

10791974 (B.P.A.I. Nov. 3, 2010)

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.
10/791,974 03/03/2004 Ray L. Pickup 10004227-9 4848
7590 11/03/2010
HEWLETT-PACKARD COMPANY
Intellectual Property Administration
P.O. Box 272400
Fort Collins, CO 80527-2400
EXAMINER
HAND, MELANIE JO
ART UNIT PAPER NUMBER
3761
MAIL DATE DELIVERY MODE
11/03/2010 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 RAY L. PICKUP, CLEMENT C. LO, and
WILLIAM D. NOONAN
____________

Appeal 2009-008532
Application 10/791,974
Technology Center 3700
____________

Before LINDA E. HORNER, MICHAEL W. O’NEILL, and
FRED A. SILVERBERG, Administrative Patent Judges.

HORNER, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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STATEMENT OF THE CASE
Ray L. Pickup et al. (Appellants) seek our review under 35 U.S.C.
§ 134 of the Examiner’s decision rejecting claims 83-100, 102-109, 118-120,
123-128, 131-133, 136, 140, 141, 148-150, and 183-185, which are all of the
pending claims. We have jurisdiction under 35 U.S.C. § 6(b).
SUMMARY OF DECISION
We REVERSE.
THE INVENTION
Appellants’ claimed invention is directed to “cutaneous delivery of a
bioactive composition using a jet dispenser, such as a piezoelectric or
thermal jet dispenser, for instance of a construction used in the inkjet
printing arts.” Spec. 4, para. [21]. Claims 83 and 91, reproduced below, are
representative of the subject matter on appeal.
83. A method of administering a bioactive composition to a
subject, the method comprising:
applying to a cutaneous surface of the subject a jet
dispenser comprising a container holding the bioactive
composition;
dispensing the bioactive composition in droplets from the
dispenser through at least one orifice toward the cutaneous
surface such that the bioactive composition becomes airborne
upon leaving the at least one orifice and remains airborne until
coming into contact with the cutaneous surface or a dermal
patch thereon; and
retaining the bioactive composition in prolonged contact
with the cutaneous surface.

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91. A method of administering a bioactive composition to a
subject, the method comprising:
applying a cutaneous patch to skin of the subject; and
dispensing the bioactive composition from an inkjet
dispenser by ejection through an orifice spaced from and
directly above a face of the patch.
THE EVIDENCE
The Examiner relies upon the following evidence:
Meyerson US 5,179,947 Jan. 19, 1993
Rogers US 5,480,062 Jan. 2, 1996
Jacobsen US 5,860,957 Jan. 19, 1999
Svedman US 6,048,337 Apr. 11, 2000
Hayes US 6,325,475 B1 Dec. 4, 2001
THE REJECTIONS
Appellants seek review of the following rejections:
1. The Examiner rejected claims 83-85, 87-89, 91-95, 98, 99, 102, 105-
107, 118, 123, 126, 131, 136, 140, 141, and 183-185 under 35 U.S.C.
§ 102(b) as being anticipated by Svedman.
2. The Examiner rejected claims 86, 96, 97, 119, 120, 127, 128, and 148-
150 under 35 U.S.C. § 103(a) as being unpatentable over Svedman.
3. The Examiner rejected claims 90 and 100 under 35 U.S.C. § 103(a) as
being unpatentable over Svedman and Rogers.
4. The Examiner rejected claims 103 and 104 under 35 U.S.C. § 103(a)
as being unpatentable over Svedman and Hayes.
5. The Examiner rejected claims 108 and 109 under 35 U.S.C. § 103(a)
as being unpatentable over Svedman and Jacobsen.
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6. The Examiner rejected claims 124, 125, 132, and 133 under 35 U.S.C.
§ 103(a) as being unpatentable over Svedman and Meyerson.
ISSUES
The issues presented by this appeal are:
Does the embodiment of Figure 79 of Svedman disclose dispensing a
bioactive composition in droplets through an orifice in a dispenser “such that
the bioactive composition becomes airborne upon leaving the at least one
orifice and remains airborne until coming into contact with the cutaneous
surface or a dermal patch thereon” as called for in claim 83?
Does the embodiment of Figure 63 of Svedman disclose “dispensing
the bioactive composition from an inkjet dispenser by ejection through an
orifice spaced from and directly above a face of [a cutaneous] patch” as
called for in claim 91?
ANALYSIS
Rejections of claims 83-90, 102-104, 108, 118-120, 123-125, 136, 140, 148,
149, and 183
Appellants contend that the rejection of independent claim 83 and the
rejections of all of the claims depending from claim 83 are in error because
Svedman does not teach or suggest the airborne dispensing called for in
claim 83. Br. 11-20.
The Examiner found that Svedman discloses airborne dispensing in
column 35, lines 51-63. Ans. 4. In particular, the Examiner found that “the
pump 177 of Figure 79 is a thermal droplet generator with an array of
nozzles (at least one orifice) that dispenses a drug (bioactive composition) in
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droplets … toward drug cell 175 where the drug will subsequently be
administered to the cutaneous surface.” Ans. 21. The Examiner found that
“when droplets are formed, air is also necessarily present, especially since
the droplets are conveyed toward the drug cell 175, thus they are airborne, as
air is necessarily present in the conduit.” Id.
Figure 79 of Svedman is “a schematic sectioned elevation of an
arrangement in which two separate implementing devices are utilized for
sampling and drug delivery.” Svedman, col. 13, ll. 59-61; see also
Svedman, col. 35, ll. 43-45. Svedman describes that enclosures 172 and 173
provide sampling and drug delivery cells 174 and 175, respectively,
arranged in registration with skin sites 170 and 171, respectively. Svedman,
col. 35, ll. 43-48. Svedman describes that a control unit 169 actuates a
pump 177 to deliver metered quantities of drug to drug delivery cell 175
from a reservoir 159. Svedman, col. 35, ll. 51-53. Svedman further
describes the pump 177 as follows:
The pump 177 may for example be a micro pump of the
type normally used in bubble jet ink printers and relying upon
the pulsed application of heat to expel discrete quantities of
liquid within capillaries by the formation of vapour bubbles.
Such a micro pump, in this case typically referred to as a
thermal droplet generator, an array of nozzles is provided, each
having an associated liquid channel of nanolitre volume with a
heating element associated with each channel, the nozzle outlet
dimensions being of the order of 40 microns diameter.
Svedman, col. 35, ll. 54-63. Svedman does not appear to disclose that the
nozzles of pump 177 are positioned in or contiguous to drug delivery cell
175. Rather, Figure 79 of Svedman appears to disclose a conduit disposed
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between micro pump 177 and drug delivery cell 175. As shown in Figure
79, the conduit has a first leg that extends downwardly from the exit of
micro pump 177, and a second leg disposed at 90 degrees to the first leg and
that extends to a right side entry port in enclosure 173 of drug delivery
cell 175. Enclosure 173 appears to have an opening at the center of its
bottom side directly above the skin site 171. Svedman, fig. 79.
Claim 83 calls for the dispensed droplets to become airborne upon
leaving the orifice and remain airborne until coming into contact with the
cutaneous surface or dermal patch thereon. We fail to see how the droplets
dispensed from Svedman’s pump 177 remain airborne from the point at
which they leave the pump 177 until they come into contact with the
patient’s skin. Because the pump 177 dispenses the droplets into a conduit
and the droplets must travel through a bend in the conduit to reach the drug
delivery cell 175, it seems probable that the droplets touch the sides of the
conduit as they travel from the pump 177 to the drug delivery cell 175. The
Examiner’s finding that Svedman’s apparatus depicted in Figure 79
anticipates the airborne dispensing step of claim 83 is based on speculation.
As such, we cannot find by a preponderance of the evidence that Svedman
anticipates claim 83.
The rejections of the remaining claims that depend from claim 83
likewise rely on this same finding of fact. Accordingly, we will not sustain
the rejection of claim 83 as anticipated by Svedman, or the rejections of
dependent claims 84-90, 102-104, 108, 118-120, 123-125, 136, 140, 148,
149, and 183.
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Rejections of claims 91-100, 105-107, 109, 126-128, 131-133, 141, 150,
184, and 185
Appellants contend that the rejection of independent claim 91 and the
rejections of all of the claims depending from claim 91 are in error because
Svedman does not disclose use of an inkjet dispenser for dispensing a
bioactive composition above a patch, and does not disclose ejection of a
bioactive composition through an inkjet dispenser orifice that is spaced from
and directly above the face of a patch, as called for in claim 91. Br. 21-24.
The Examiner found that Svedman discloses dispensing a bioactive
composition from an inkjet dispenser by ejection through an orifice spaced
from and directly above a face of site 8 or the patch 121 in the form of
aperture 6. Ans. 6 (citing Svedman, figs. 63, 65, and 66 and col. 31, ll. 12-
15). In particular, the Examiner found that the embodiment of Figure 63 is
identical to the device 1 shown in Figures 34 through 37 except for the
application of a patch 121 after de-epithelialisation. Ans. 22. Thus, the
Examiner found that “the patch 121 must be present over the site prior to
delivery of the drug, and therefore the drug is necessarily delivered from
device 1 to the patch 121.” Id. The Examiner further found that “the orifice
for delivery, aperture 6, is necessarily spaced from a face of the patch 121 in
order for the drug to be able to be administered to the patch 121, rather than
being trapped and or pooling at the orifice 6.” Id.
We fail to see in the embodiments of Figures 34-37 or Figures 63-69
of Svedman any disclosure of dispensing the bioactive composition through
the orifice of an inkjet dispenser. Svedman discloses that “[t]he device 1 is
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modified in FIG. 63 to include a patch applicator 120 which is operable to
apply a patch 121 to the area of skin 8 following de-epithelialisation while
the device 1 remains in situ.” Svedman, col. 31, ll. 12-15. The device 1 is
shown schematically in Figures 34-37 of Svedman and described in column
23, line 37 – column 25, line 5. As described with respect to Figures 34-37,
in use, suction is applied to a suction cup 9 of device 1 to form a suction
blister 17 on the patient’s skin 4. Svedman, col. 24, ll. 1-7; fig. 34. A blade
18 is then moved arcuately so as to cut through the suction cup 9, wherein
the roof of the suction blister 17 remains adhered to a removable portion 20
of the suction cup 9. Svedman, col. 24, ll. 16-23; fig. 35. Following
severing of the suction cup 9, the removable portion 20 is removed and a
rotatable portion 5 of device 1 is rotated into a second position so that an
outlet port 22 of reservoir 11 is brought into registration with an aperture 6
in base 3 of device 1. Svedman, col. 24, ll. 24-25 and ll. 39-42; fig. 36.
Drug 12 within the reservoir 11 then enters a chamber 16 and comes into
contact with the de-epithelialised area of skin 8. Svedman, col. 24, ll. 48-51.
On completion of the drug delivery phase, the rotatable portion 5 is rotated
to a third position so that outlet port 22 of the reservoir 11 is closed.
Svedman, col. 24, ll. 55-59; fig. 37.
In the embodiment of Figures 63-69, the device 1 is modified to
include a patch applicator 120 in lieu of the reservoir 11. The patch
applicator 120 is operable to apply a patch 121 to the area of skin 8
following de-epithelialisation. Svedman, col. 31, ll. 12-15; fig. 63.
Svedman discloses that once the patch 121 is applied to the patient’s skin via
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modified device 1, then the adhesive tape 133 is dissociated from the skin 4
and the base 3 is dissociated from the skin so that the device 1 can be lifted
clear. Svedman, col. 32, ll. 43-48. Svedman discloses that patch 121 may
be a self-contained means for administering a supply of drug (e.g., a porous
pad impregnated with a liquid for diffusion out of the pad and onto the de-
epithelialised area of dermis), or the patch 121 may comprise a permeable
membrane through which a liquid drug can be diffused from a conventional
skin patch applied over patch 121. Svedman, col. 32, ll. 51-61.
It does not appear from the description provided in Svedman of the
modified device 1 of Figure 63, that this modified device is used to
administer the drug to patch 121. Nor does it appear from the disclosure in
Svedman that an inkjet dispenser is used to administer the drug to patch 121.
Rather, the patch 121 may either be impregnated with the drug or receive the
drug from a conventional skin patch applied over patch 121. Thus, the
Examiner’s finding that Svedman’s Figure 63 discloses the step of
dispensing the bioactive composition from an inkjet dispenser by ejection
through an orifice spaced from and directly above a face of the patch, as
called for in claim 91, is in error.
The rejections of the remaining claims that depend from claim 91
likewise rely on this same erroneous finding of fact. Accordingly, we will
not sustain the rejection of claim 91 as anticipated by Svedman, or the
rejections of dependent claims 92-100, 105-107, 109, 126-128, 131-133,
141, 150, 184, and 185.
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CONCLUSIONS
The embodiment of Figure 79 of Svedman does not disclose
dispensing a bioactive composition in droplets through an orifice in a
dispenser “such that the bioactive composition becomes airborne upon
leaving the at least one orifice and remains airborne until coming into
contact with the cutaneous surface or a dermal patch thereon” as called for in
claim 83.
Thee embodiment of Figure 63 of Svedman does not disclose
“dispensing the bioactive composition from an inkjet dispenser by ejection
through an orifice spaced from and directly above a face of [a cutaneous]
patch” as called for in claim 91.
DECISION
The decision of the Examiner to reject claims 83-100, 102-109, 118-
120, 123-128, 131-133, 136, 140, 141, 148-150, and 183-185 is reversed.

REVERSED

nlk

HEWLETT-PACKARD COMPANY
Intellectual Property Administration
P.O. Box 272400
Fort Collins CO 80527-2400