Ex Parte FARONE et al

Patent Trial and Appeal Board

Dec 11, 2018

12245615 (P.T.A.B. Dec. 11, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/245,615 10/03/2008
26359 7590 12/13/2018
Maynard Cooper & Gale, PC (Birmingham)
1901 Sixth Avenue North
2400 Regions/Harbert Plaza
BIRMINGHAM, AL 35203-2618
FIRST NAMED INVENTOR
WILLIAM A. FARONE
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.
P2102 4404
EXAMINER
CARPENTER, WILLIAM R
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
12/13/2018 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):
ipdocket@maynardcooper.com
tebbert@maynardcooper.com
JThomas@maynardcooper.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WILLIAM A. FARONE and W. BRADLEY WORTHINGTON
Appeal2017-002296 1
Application 12/245,615 2
Technology Center 3700
Before NINA L. MEDLOCK, KENNETH G. SCHOPPER, and
ALYSSA A. FINAMORE, Administrative Patent Judges.
SCHOPPER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the rejection of
claims 7, 10, 12, 13, 15, 17, 18, 39--41, 43, and 44. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.
1 Our decision references the Appeal Brief ("Appeal Br.," filed July 25,
2016), the Reply Brief ("Reply Br.," filed Nov. 28, 2016), the Examiner's
Answer ("Ans.," mailed Sept. 28, 2016), and the Final Office Action ("Final
Act.," mailed Oct. 14, 2015).
2 According to Appellants, the real party in interest is Gradient
Technologies. Appeal Br. 3.
Appeal2017-002296
Application 12/245,615
BACKGROUND
According to Appellants, "[t]he present invention relates to a method
of utilizing magnetic devices and electrical fields for transdermal delivery of
drugs with therapeutic application for mammals and more particularly to the
method of use of a static magnetic field including the use of a quadrapolar
magnetic transdermal drug delivery device." Spec. 1, 11. 23-26.
ILLUSTRATIVE CLAIM
Claim 7 is the only independent claim on appeal and recites:
7. A method for administering a drug through a dermal
layer, comprising the following steps:
a. providing a static magnetic device alone in a
magnet array of two (2) or four ( 4) magnets of alternating
polarity in which the magnetic poles are separated by a
predetermined distance to provide an effective magnetic field
creating a magnetic sphere of influence at a desired site of
action from the magnetic fields of all adjacent poles;
b. providing the drug in a tissue permeable drug
formulation which is positioned on the site of action; and
c. positioning the magnetic device adjacent to the
tissue permeable drug formulation wherein the magnetic sphere
of influence alone exerts a force on the drug sufficient to move
the drug through the dermal layer,
wherein the magnetic array produces a magnetic field
gradient at the site of action of adjacent poles of at least
1.5 mT/mm in the direction perpendicular to the axis from the
magnetic poles.
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Application 12/245,615
REJECTION
The Examiner rejects claims 7, 10, 12, 13, 15, 17, 18, 39--41, 43, and
44 under 35 U.S.C. § I03(a) as unpatentable over Ostrow 4243 in view of
Holcomb. 4
DISCUSSION
Claims 7, 10, 12, 15, 17, 18, 39-41, 43, and 44
With respect to claim 7, the Examiner finds that Ostrow 424 discloses
the method substantially as claimed. Final Act. 2-3. The Examiner relies
on Holcomb as disclosing a magnet array as claimed, and the Examiner
concludes that it would have been obvious to include such an array in
Ostrow 424 "in order to improve the magnetic flux and gradient of the
supplied field to better move drugs through the magnetic field, focusing and
concentrating the delivery of the drug to the active site." Id. at 4. The
Examiner also specifically finds that Ostrow 424 contemplates the use of
magnetophoresis alone for affecting transdermal drug delivery and that
magnetic field gradient is a result-effective variable. See Final Act. 3, 5---6.
As discussed below, we are not persuaded of error in the Examiner's
findings or conclusions by Appellants' arguments.
Appellants first argue that Ostrow 424 does not teach the use of
magnetic fields alone to enhance drug delivery. Appeal Br. 18-22.
Appellants assert that Ostrow 424 teaches a drug delivery system that
employs magnetic fields only in combination with a novel electrode design
and "not in the absence of electrophoresis, as alleged by the Examiner." Id.
at 19. We disagree. Rather, we agree with the Examiner that the plain
3 Ostrow et al., US 2002/0147424 Al, pub. Oct. 10, 2002 ("Ostrow 424").
4 Holcomb, US 2007/0208209 Al, pub. Sept. 6, 2007.
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Application 12/245,615
language in Ostrow 424 suggests that pads 24 may be used for drug delivery
using magnetophoresis alone. For example, although the pads may include
electrodes, Ostrow 424 teaches that "[ e Jach pad 24 may provide delivery of
a different substance and may use different methods of active transport
delivery, including magnetophoresis, electrophoresis, sonophoresis, light, or
laser in singular or in combination." Ostrow 424 ,r 140. Ostrow 424 teaches
that this flexible design "enables multi-channel drug delivery providing
integrated modes of delivery and therapeutic [regimes]." Id. Thus, although
Ostrow 424 discloses a pad with electrodes and the use of magnetophoresis
in combination with electrophoresis (see, e.g., id. ,r 146), we agree with the
Examiner that Ostrow 424 contemplates the use of pads 24 in which the only
force exerted on a drug is provided via a magnetic device, which may be
accomplished without activating the electrodes.
Appellants also argue that Ostrow 424 and a provisional application
from which it claims priority, Ostrow 2, 5 teach away from the use of
magnetic force alone to deliver a drug. Appeal Br. 22-23. In particular,
Appellants argue that Ostrow 2 provides experimental data and conclude
that Ostrow 2 "specifically teaches that magnetic force alone is insufficient
to increase drug delivery over simple diffusion in an experimental model
employing human stratum comeum" and that Ostrow 424 "offers no data
that would lead a person of skill in the art to reach a different conclusion."
Id. We are not persuaded of error. First, we note that, as found above,
Ostrow 424 specifically contemplates the use of magnetic force alone for
drug delivery. Further, we agree with the Examiner's assessment of
5 Ostrow, US Provisional Application No. 60/317,163, filed Sept. 6, 2001
(hereinafter Ostrow 2).
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Application 12/245,615
Ostrow 2. See Ans. 7-11. For example, experimental results indicate an
increase in permeability with the use of permanent magnets over passive
diffusion alone. See Ostrow 2, 19 (second table), 21 (second table), 23
("Coefficient permeability results"). Further, Ostrow 2 concludes that
permanent magnets provide a decrease in propagation time over passive
diffusion alone. Id. at 24; see also id. at 32 ("The potential exists to increase
or enhance drug delivery via the skin by the creation of this technique
[ magnetoporation] over other existing techniques that are more harmful and
damaging to the skin such as the electric fields employed in
electroporation. "). In light of this evidence, we are not persuaded that either
Ostrow 424 or Ostrow 2 teaches away, i.e., we do not find that one of
ordinary skill in the art would be discouraged from following the path set out
in the reference or would be led in a direction divergent from the path taken
by Appellants. See In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).
Next, Appellants argue that the combination proposed would not have
been obvious because there was not a reasonable expectation of success.
Appeal Br. 23. However, this argument primarily relies on Appellants'
previous argument that Ostrow 424 does not teach the use of magnetic fields
alone to enhance drug delivery. See id. at 24--25. We are not persuaded by
this argument here for the reasons provided above.
Further, to the extent Appellants argue that the Examiner cannot rely
on an "obvious to try" rationale to support the proposed combination, we are
not persuaded of error. See Appeal Br. 25-27. The Examiner indicates that
Ostrow 424 "provides clear, irrefutable obviousness to try motivation to an
ordinary artisan by EXPRESSLY and EXPLICITLY suggesting and
contemplating the use of permanent, static magnets ALONE to [ e ]ffect
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Application 12/245,615
transport." Final Act. 11-12. Because we agree that Ostrow 424 suggests a
method of administering drugs with static magnets alone, we see no error in
the Examiner's additional rationale that such a method would have been
obvious to try.
Finally, Appellants argue that magnetic field gradient has not been
established as a result-effective variable. Appeal Br. 27-29. We disagree
for the reasons provided by the Examiner. See Ans. 32-35. Ostrow 424
expressly provides that the size and strength of the permanent magnet is a
variable that requires "research and examination to produce
magnetophoresis." Ostrow 424 ,r,r 68, 71. Further, as discussed above,
Ostrow 424 suggests the use of permanent magnets alone to provide
magnetophoresis. Finally, we agree with the Examiner that Ostrow 424
discloses the use of magnets with a field gradient meeting the claim
requirements and Ostrow 424 discloses that the required magnet field may
be provided by a permanent magnet by itself. See id. ,r,r 54, 14 7. Thus, we
find that Ostrow 424 discloses that magnetic field gradient is a result-
effective variable, and we find that Ostrow 424 expressly discloses the use
of a magnet with a field gradient within the claimed range.
Based on the foregoing, we are not persuaded of reversible error in the
rejection of claim 7. Accordingly, we sustain the rejection of claim 7. We
also sustain the rejection of claims 10, 12, 15, 17, 18, 39-41, 43, and 44, for
which Appellants do not provide separate arguments.
Claim 13
Claim 13 depends from claim 7 and further requires that "the
magnetic field at the center of the North Pole of the magnets is about
530 mT." Appeal Br. 34, Claims App. Appellants separately argue here that
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Application 12/245,615
magnetic field intensity has not been shown to be a result-effective variable.
Id. at 29--32. For the reasons discussed above with respect to claim 7, we
are also unpersuaded of error by this argument. Accordingly, we sustain the
rejection of claim 13.
CONCLUSION
We AFFIRM the rejection of clams 7, 10, 12, 13, 15, 17, 18, 39--41,
43, and 44.
No time period for taking any subsequent action in connection with
this appeal may be extended under 3 7 C.F .R. § 1.13 6( a )(1 )(iv).
AFFIRMED
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