Ex Parte Wallace et al

Board of Patent Appeals and Interferences

May 27, 2011

10744853 (B.P.A.I. May. 27, 2011)

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.
10/744,853 12/22/2003 Michael P. Wallace 03-0519 US01 1672
71422 7590 05/27/2011
VISTA IP LAW GROUP LLP/BSC - NEUROMODULATION
2040 MAIN STREET, Suite 710
IRVINE, CA 92614
EXAMINER
BERTRAM, ERIC D
ART UNIT PAPER NUMBER
3766
MAIL DATE DELIVERY MODE
05/27/2011 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 MICHAEL P. WALLACE, KAMAL RAMZIPOOR,
ROBERT J. GARABEDIAN, and ROBERT M. ABRAMS
____________________

Appeal 2009-012181
Application 10/744,853
Technology Center 3700
____________________

Before: JENNIFER D. BAHR, STEVEN D. A. MCCARTHY, and
STEFAN STAICOVICI, Administrative Patent Judges.

BAHR, Administrative Patent Judge.

DECISION ON APPEAL

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STATEMENT OF CASE
Michael P. Wallace et al. (Appellants) appeal under 35 U.S.C. § 134
from the Examiner’s rejections under 35 U.S.C. § 103(a) of claims 1-3, 6, 7,
15, 19, 20, 22, 23, 50-52, and 54 as being unpatentable over Methods of
Placement of Neurostimulation Lead, Infusion Catheter, and/or Sensor via
the Vasculature to the Brain, IP.com IPCOM000012135D (Apr. 10, 2003)
(found at http://www.ip.com/pubview/IPCOM000012135D) (hereinafter
“Reference A”) and Clemens (US 2002/0077684 A1, pub. Jun. 20, 2002);
claims 24, 25, 27, 35, 39-43, and 49 as being unpatentable over Reference A
and Purdy (US 2003/0014016 A1, pub. Jan. 16, 2003); and claims 45-48 as
being unpatentable over Reference A, Purdy, and Baudino (US
2002/0062143 A1, pub. May 23, 2002). The Examiner has withdrawn the
rejections of claims 53 and 55-68. Ans. 3. We have jurisdiction under 35
U.S.C. § 6(b).
We REVERSE.
The Invention
Appellants’ invention is directed to therapeutic treatment of tissue
using electrical stimulation. Spec. 1:9-10. Claim 1, reproduced below, is
illustrative of the claimed subject matter:
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1. A method of treating a disorder in a patient, comprising:
delivering a stimulation lead within a cerebral blood
vessel;
occluding the flow of blood through the blood vessel by
selectively actuating an occlusive device;
intralumenally puncturing a wall of the blood vessel to
create an exit point downstream from the actuated occlusive
device, wherein blood is prevented from flowing through the
exit point; and
introducing the stimulation lead through the exit point
into contact with brain tissue the stimulation of which treats
the neurological disorder.

OPINION
Reference A and Clemens
Issue
The issue presented in the appeal of this rejection is whether
Reference A and Clemens render obvious the method of claim 1, including
occluding blood flow through the blood vessel by selectively actuating an
occlusive device and puncturing a wall of the blood vessel to create an exit
point downstream from the actuated occlusive device, wherein blood is
prevented from flowing through the exit point. Performance of these steps
as called for in claim 1 requires that the occlusive device be actuated to
occlude blood flow at the time the wall is punctured to create the exit.
Findings
Reference A teaches delivering a stimulation lead within a cerebral
blood vessel, or vasculature (p. 3); puncturing a wall of the vessel to create
an exit and introducing the lead through the exit to implant it in target brain
tissue (p. 9); and anchoring the lead in the vasculature near the target site
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using devices similar to those used to anchor cardiac leads (p. 10). The
Examiner finds that Reference A does not disclose occluding blood flow by
selectively actuating an occlusive device upstream of the exit (Ans. 7).
Clemens is directed to cardiac pacing, and teaches inflating a balloon
for either of two purposes: (1) temporarily occluding blood backflow into
the vein, so that a venogram can be taken (paras. 10, 11) and (2) anchoring
the lead after it has been implanted (paras. 55 and 56). In the first use, the
balloon is deflated before the pacing lead is advanced over the guidewire for
placement at the implant site (paras. 10, 11). The second use is directed to
inflation for anchoring the lead after the lead is located at the desired implant
site (paras. 24, 25, 55, 56).
Discussion
In the rejection, the Examiner concluded it would have been obvious
to modify Reference A by including and actuating the balloon assembly “in
order to retain the lead in a desired position while the rest of the method is
carried out, as taught by Clemens.” Ans. 7-8. However, as pointed out by
Appellants on page 6 of the Appeal Brief, and as noted in our findings
above, both Clemens and Reference A discuss anchoring the lead after the
implantation procedure is completed. Consequently, any occlusion of blood
flow would be after the exit point has already been created, such that blood
would not be prevented from flowing through the exit at the time of
puncturing, as required in claim 1.
In response to Appellants’ arguments, the Examiner appears to
propose modifying the method of Reference A by actuating a balloon to
occlude the blood vessel for venograms, pointing out that this would be done
prior to the puncturing. See Ans. 8. The problem with this line of reasoning
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is that, as noted in our findings above, Clemens teaches deflating the balloon
prior to advancing the lead over the guidewire. Reference A teaches
creating the exit by pushing a lead through the wall or using a mechanical
device to drive the lead sideways from the main lead (p. 9). Thus, it appears
that the puncturing would take place after the balloon has been deflated.
Consequently, any occlusion for the purpose of venograms, in accordance
with the teachings of Clemens, would not prevent blood flow through the
exit, as required by claim 1.
Finally, in further response to Appellants’ arguments, the Examiner
intimates that it would have been obvious to inflate the balloon to occlude
flow of blood in order to prevent edemas and hematomas in the brain. See
Ans. 8-9. The Examiner alleges that “[t]he Examiner has provided
supporting references in the past that show the desire to avoid such issues”
(Ans. 9), but has not specified what those references are, much less included
them in the rejection. If the Examiner believes these references support the
Examiner’s conclusion of obviousness, the Examiner might consider
applying them in a new ground of rejection.
For the above reasons, we conclude that the Examiner has not
established a prima facie case that Reference A and Clemens render obvious
the method of claim 1, including occluding blood flow through the blood
vessel by selectively actuating an occlusive device and puncturing a wall of
the blood vessel to create an exit point downstream from the occlusive
device, wherein blood is prevented from flowing through the exit point. We
do not sustain the rejection of claim 1, or of dependent claims 2, 3, 6, 7, 15,
19, 20, 22, 23, 50-52, and 54.

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Reference A and Purdy (and Reference A, Purdy, and Baudino)
Issue
The issue raised in the appeal of this rejection is whether Reference A
and Purdy render obvious the method of claim 24, including the step of
“advancing the stimulation lead from the exit point [of a cerebral blood
vessel] in a plane of a sub-arachnoid space of the patient’s head, the plane
extending along a surface of the cortex of the patient’s brain.” See Reply Br.
5. After considering the Examiner’s findings and reasoning on pages 4-6
and 9-10 of the Answer, and the disclosures of Reference A and Purdy, as
discussed below, we conclude that the Examiner has not established a prima
facie case that the subject matter of claim 24, and the claims depending from
claim 24, would have been obvious.
Findings
Reference A (p. 5) teaches that the superior thalamostriate vein 200
provides relatively easy access to portions of the thalamus, caudate nucleus,
and choroids plexus; internal cerebral veins 210 run along the
interventricular foramen (of Monro) along the roof of the third ventricle,
adjacent the thalamus; the basal vein (Rosenthal’s vein) 220 offers relatively
easy access to portions of the brainstem, thalamus, and inferior cortex for
electrical stimulation; and electrical stimulation of portions of the thalamus
may provide effective therapy to patients with chronic pain, movement
disorders, and/or epilepsy.
Reference A (p. 9) also teaches that the exit through the wall of the
vasculature to implant the lead in an adjacent target may be accomplished

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by, for example, pushing or forcing a lead with a stiffening member through
the wall, or by using a mechanical device to drive the lead sideways from the
main lead.
Purdy discusses navigating the sub-arachnoid space, starting in the
spinal sub-arachnoid space and including the intracranial sub-arachnoid
space in some cases. Paras. 50-51. Purdy also discusses implanting
detector(s) in brain tissue or in the sub-arachnoid space, and illustrates a
detector 112 implanted in the corpus callosum. Para. 106; fig. 17.
Discussion
While Reference A and Purdy, in combination, may render obvious a
method of stimulating brain tissue to treat a disorder in a patient, comprising
the step of navigating from a cerebral blood vessel into, and through, the
sub-arachnoid cavity for implantation in brain tissue for stimulation, there is
nothing in the cited prior art pointing to the particular path called for in
claim 24 (i.e., from the exit point of the cerebral blood vessel in a plane of
the sub-arachnoid space extending along a surface of the cortex). Neither
has the Examiner provided any evidence showing that a technique including
advancing a lead along such a path was known in the art or even within the
level of ordinary skill in the art. Therefore, the Examiner has failed to make
the necessary factual findings to support the conclusion of obviousness of
the subject matter of claim 24.1
We reverse the rejection of claim 24, and of dependent claims 25, 27,
35, 39-43, and 49, as being unpatentable over Reference A and Purdy.

1 A conclusion of obviousness must be supported by explicit findings and
analysis establishing an apparent reason to combine the known elements in
the manner required in the claim at issue. KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 418 (2007).
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In rejecting claims 45-48, which depend from claim 24, as being
unpatentable over Reference A, Purdy, and Baudino, the Examiner does not
point to any teaching in Baudino that would make up for the deficiency in
the rejection of claim 24. Thus, we also reverse the rejection of claims 45-
48.

DECISION
For the above reasons, the Examiner’s decision is reversed.

REVERSED

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