Ex Parte Shafer

Board of Patent Appeals and Interferences

Jun 10, 2011

11000856 (B.P.A.I. Jun. 10, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte LISA L. SHAFER
__________

Appeal 2010-008771
Application 11/000,856
Technology Center 1600
__________

Before DONALD E. ADAMS, ERIC GRIMES, and STEPHEN WALSH,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
of treating a stroke in a subject. The Examiner has rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The Specification discloses methods “to promote recovery o[f]
damaged CNS tissue by making use of the endogenous (not-implanted) stem
cell[] populations” (Spec. 5, ¶ 14) by “combining electrical and chemical
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therapies to optimize the proliferation, differentiation, migration, and
integration of endogenous stem cells” (id.).
Claims 4-10, 18, 19, 33, 36-38, 41, 46, 47, and 55 are on appeal.
Claim 4 is representative and is directed to a method of treating stroke that
comprises, among other steps, implanting a “first therapy delivery element”
(either a catheter or a lead) in the subject and “positioning the therapy
delivery region of the first therapy delivery element in a first CNS region
containing endogenous stem cells selected from the group consisting of a
subventricular zone of a lateral ventricle, a central canal of a spinal cord,
[and] a subgranular zone of the hippocamupus [sic],” then applying a first
therapy that is either an electrical signal or one of several specified
therapeutic agents, where the delivered signal or agent “promote[s] the
endogenous stem cells to proliferate, migrate, or differentiate.” The full text
of claim 4 is reproduced in Appellant’s Claims Appendix (Appeal Br. 18-
19).
All of the claims on appeal stand rejected under 35 U.S.C. § 103(a)
both in view of John,1 Finklestein,2 Wiessner,3 and Gliner,4 and in view of
John, Hartlaub,5 and Gliner.

1 John, US 6,066,163, issued May 23, 2000.
2 Finklestein et al., WO 01/12236 A3, published Feb. 22, 2001.
3 Wiessner et al., Anti-Nogo-A Antibody Infusion 24 Hours After
Experimental Stroke Improved Behavioral Outcome and Corticospinal
Plasticity in Normotensive and Spontaneously Hypertensive Rats, 23 J.
CEREBRAL BLOOD FLOW & METABOLISM 154-165 (2003).
4 Gliner et al., US 2003/0088274 A1, issued May 8, 2003.
5 Hartlaub, US 2002/0042597 A1, issued Apr. 11, 2002.
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I.
Issue
The Examiner has rejected all of the claims on appeal as being
obvious in view of John, Finklestein, Wiessner, and Gliner. The Examiner
finds that John discloses a method of treating, e.g., stroke “by a first therapy
that is an electrode to generate a[n] electric signal and a second therapy that
is [an] infusion of [a] neurotrophic or therapeutic agent” (Answer 5). With
regard to the limitation of claim 4 requiring positioning a therapy delivery
element in one of three specific CNS regions, the Examiner finds that John
discloses the infusion of “pharmacological agonists/antagonists or
neurotrophic factors … through [the] lateral ventricle…. The lateral
ventricle encompasses the subventricular zone.” (Id. at 6-7.)
Appellant contends that it would not have been obvious to position a
therapy delivery element in the recited CNS regions because the cited
references do not discuss providing therapy to endogenous stem cells or
suggest positioning a therapy delivery element in any of the recited regions
that contain endogenous stem cells (Appeal Br. 10-12).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that it would have been obvious to
one of ordinary skill in the art, in view of the cited references, to position a
catheter portion or an electrode lead in a subventricular zone of a lateral
ventricle?
Findings of Fact
1. The Specification discloses that a “subventricular zone includes a
mediolateral wall of a lateral ventricle” (Spec.16, ¶ 64).
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2. Figure 5 of the Specification is shown below:

The figure shows
a catheter with an electrode 5 may be positioned in a region
containing endogenous stem cells. The catheter with an
electrode 5 is positioned at the lateral walls of the ventricles. At
step 1, a stem cell enhancing agent may be delivered via the
catheter with the electrode 5 to the lateral walls of the
ventricles. At step 2, an electrical signal may also be applied to
the lateral walls of the ventricles.
(Spec. 20, ¶ 82.)
3. John discloses a “brain stimulation system and method … which
aids in the rehabilitation of patients from traumatic brain injury, coma, or
other brain dysfunction. After a direct brain stimulator is implanted in a
brain region of a patient, the patient is stimulated according to a set of
stimulation parameters.” (John, abstract.)
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4. John discloses that “a second area of the brain is stimulated when
stimulation of the first brain area produces a desired effect, thereby
reinforcing the prior response of the brain” (id.).
5. John discloses that “instead of electrical stimulation, stimulation
can utilize pharmacological means such as systemic injection or local
microinjection of psychostimulants (amphetamine) or other and functional
agonists or antagonists which can be routed directly into a specific brain area
or into a lateral ventricle” (id. at col. 12, ll. 58-63).
6. John discloses that an infusion apparatus
can provide a supply of pharmacological antagonists, or
agonists such as psycho stimulants which can move the brain or
an area of the brain into a more active state, or provide a supply
of therapeutic agents such as neurotropic substances that will
work either independently or in conjunction with the electrical
stimulation to produce beneficial results.
(Id. at col. 10, ll. 60-66.)
Analysis
We agree with Appellant that the Examiner has not adequately shown
that the cited references would have made obvious to position a therapy
delivery element in any of the regions that are recited in claim 4 (Appeal Br.
10-12). As discussed above (FFs 3-6), John only discloses administering
therapeutic agents to a lateral ventricle itself. A ventricle, as shown in the
Specification’s Figure 5 (FF 2) is a (fluid-filled) empty space. Claim 4, by
contrast, requires positioning the therapy delivery element in the
subventricular zone of the ventricle, which, as described in the Specification
(FFs 1, 2), is the wall of the ventricle; i.e., the tissue that defines the
boundary of the ventricle.
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The Examiner reasons that therapeutic agents “delivered into a lateral
ventricle would diffuse and reach the SVZ [subventricular zone] of the
lateral ventricle. Thus intraventricular delivery of neurogenesis-enhancing
agents into the lateral ventricle as taught by [John] does equate to delivery of
the agents to the SVZ of a lateral ventricle.” (Answer 16.)
We do not agree that this adequately supports the rejection. Claim 4
does not recite “delivery of the agents” to the subventricular zone of the
lateral ventricle, as the Examiner states. Claim 4 expressly recites
“positioning the therapy delivery region of the first therapy delivery
element” in a subventricular zone of a lateral ventricle. Although the
Specification discloses that this step can be met by a “catheter with an
electrode 5 … positioned at the lateral walls of the ventricles” (FF 2), the
broadest reasonable interpretation of the claims does not read on simply
delivering an agent to the lateral ventricle itself, whether or not an agent so
delivered would also reach the subventricular zone.
The Examiner also reasons that John discloses electric stimulation of
the hippocampus and the cortex, which contain endogenous stem cells in the
“subgranular zone of the hippocampus” and the “subventricular zone of a
lateral ventricle,” respectively (Answer 17).
This reasoning is not persuasive because it impermissibly ignores
claim limitations: positioning a therapy delivery element in the
hippocampus or the cortex is not the same as positioning it in the
subgranular zone of the hippocampus or in a subventricular zone of a lateral
ventricle.
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Independent claims 41 and 55, like claim 4, require positioning the
infusion section of a catheter (claim 41) or an electrode lead (claim 55) in a
subventricular zone of a lateral ventricle, a central canal of a spinal cord, or
a subgranular zone of the hippocampus. Thus, the rejection of claims 4, 41,
and 55, and dependent claims 5-10, 18, 19, 46 and 47, is reversed for the
reasons discussed above
Independent claim 33 is similar to claim 4 in requiring the positioning
of both an electrode lead and an infusion section of a catheter “in
communication with a … subventricular zone of a lateral ventricle, a central
canal of a spinal cord, a subgranular zone of the hippocamupus [sic].”
Claim 33 also requires that the electrical stimulation and therapeutic agent
promote proliferation, migration, or differentiation of the endogenous stem
cells. Since none of the cited references disclose or suggest an electrode
lead or an infusion element in any of the recited regions, the Examiner has
not adequately explained why one of skill in the art would expect that the
application of electric stimulation or therapeutic agents to portions of the
brain, other than those recited in the claim, would result in the proliferation,
migration, or differentiation of the endogenous stem cells from the claimed
regions. Thus, the rejection of claim 33, and dependent claims 34-36, is
reversed.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that it would have been obvious to position a catheter portion or an electrode
lead in a subventricular zone of a lateral ventricle.
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II.
The Examiner has rejected all of the claims on appeal under 35 U.S.C.
§ 103(a) as being obvious in view of John, Hartlaub and Gliner. The
Examiner finds that Hartlaub discloses treating a stroke patient by
“implanting an infusion system in the patient to deliver a medicament
composition” (Answer 11). The Examiner relies on John and Gliner as for
the rejection discussed above. The Examiner concludes that it would have
been obvious to one of ordinary skill in the art to combine the teachings of
John, Hartlaub and Gliner “to apply neurotrophic factors to the CNS to
rescue neuronal death and simultaneously to apply an electric signal by an
implantable electrode to the CNS to treat … stroke … since neurotrophic
factors and electric stimulation have been shown to stimulate neurogenesis
of neural stem cells” (id. at 14).
As with the previously discussed rejection, Appellant argues that it
would not have been obvious to position a therapy delivery element in any
of the recited regions because none of the cited references disclose or
suggest providing therapy to endogenous stem cells or suggest positioning a
therapy delivery element in the specified regions (Appeal Br. 16).
We agree with Appellant that the Examiner has not adequately shown
that the cited references would have made obvious the claims on appeal.
The Examiner reasons that John discloses the treatment or stimulation
of the hippocampus and the cortex and the “hippocampus and cortex are
known … regions that contain endogenous stem cells,” i.e. in the
subgranular zone of the hippocampus and in the subventricular zone of a
lateral ventricle, respectively (Answer 22). The Examiner further reasons
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that in Gliner the “brain regions to be treated or stimulated by electrodes
include regions containing endogenous stem cells, such as the hippocampus,
which is the damaged brain region of Alzheimer's disease” (id. at 21). The
Examiner does not cite Hartlaub for any disclosure relating to the brain areas
specified in the claims (see id. at 11, 21).
As discussed above, however, the Examiner has not adequately
explained why the disclosure of treating a larger brain portion such as the
cortex or the hippocampus would have made obvious positioning a catheter
portion or an electrode lead in a smaller part of those areas, specifically, the
subventricular zone of a lateral ventricle or the subgranular zone of the
hippocampus. Thus, the rejection of independent claims 4, 41 and 55, and
their associated dependent claims is reversed.
Further, as discussed above for claim 33, the Examiner has not
adequately explained why one of skill in the art would expect that the
application of electric stimulation or therapeutic agents to portions of the
brain, other than those recited in the claims, would result in the proliferation,
migration, or differentiation of the endogenous stem cells from the claimed
regions. Thus, the rejection of independent claim 33, and its dependent
claims, is reversed.
SUMMARY
We reverse the rejection of claims 4-10, 18, 19, 33, 36-38, 41, 46, 47
and 55 under 35 U.S.C. § 103(a).

REVERSED

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EG
SW
DEA

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