Ex Parte Elborno

Patent Trial and Appeal Board

Sep 4, 2014

12258317 (P.T.A.B. Sep. 4, 2014)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
12/258,317 10/24/2008 Ahmed A. Elborno 1362009-2103.1 8790
50638 7590 09/04/2014
Boston Scientific Neuromodulation Corp.
c/o Lowe Graham Jones
701 Fifth Avenue
Suite 4800
Seattle, WA 98104
EXAMINER
DIETRICH, JOSEPH M
ART UNIT PAPER NUMBER
3762
MAIL DATE DELIVERY MODE
09/04/2014 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte AHMED A. ELBORNO
__________

Appeal 2012-005245
Application 12/258,317
Technology Center 3700
__________

Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

Opinion for the Board filed by Administrative Patent Judge PAULRAJ.

Opinion Dissenting-in-Part filed by Administrative Patent Judge GRIMES.

PAULRAJ, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to methods
for treating essential tremor and restless leg syndrome using spinal cord
stimulation. The Examiner rejected the claims on obviousness grounds. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.2

1 Appellant identifies the Real Party in Interest as Boston Scientific
Neuromodulation Corporation (see App. Br. 3).
2 We also decide a related appeal, Appeal 2012-005243 (Application No.
12/180,924), concurrently with this decision.
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STATEMENT OF THE CASE
Background
“The present invention is directed to the area of implantable spinal
cord stimulation systems and methods of making and using the systems,”
and “is also directed to the use of implantable spinal cord stimulation
systems for treating Parkinsonism, essential tremor, or restless leg
syndrome” (Spec. 1:9-13). According to the Specification, essential tremor
and restless leg syndrome are progressive neurological diseases with no
known cures (id. at 2-3). The Specification states that a method for treating
essential tremor or restless leg syndrome includes “implanting a lead near a
spinal cord of a patient,” and providing electrical signals “from a control
module coupled to the lead to stimulate a portion of the spinal cord of the
patient using at least one of the electrodes” in order to “reduce, alleviate, or
eliminate at least one adverse effect” of the disease (id. at 4).
The Claims
Claims 1, 3-6, 9, 12, 14-17, 20, and 23-32 are on appeal. Independent
claim 1 is representative, and reads as follows:
1. A method for treating essential tremor using spinal
cord stimulation, the method comprising:
implanting a lead near a spinal cord of a patient, the lead
comprising a plurality of electrodes disposed on a distal end of
the lead and electrically coupled to at least one contact terminal
disposed on a proximal end of the lead, wherein the lead is
implanted near the patient’s spinal cord such that at least one of
the plurality of electrodes is disposed near at least one of the
patient’s C4-coccygeal spinal cord segments, wherein the at
least one spinal cord segment that the at least one of the
plurality of electrodes is implanted near is selected such that at
least one peripheral nerve attaches to the at least one spinal cord
segment; and
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providing electrical signals, from a control module
coupled to the lead, to stimulate a portion of the spinal cord of
the patient at the spinal cord segment that the at least one of the
plurality of electrodes is implanted near using at least one of the
plurality of electrodes, wherein the electrical signals reduce,
alleviate, or eliminate at least one adverse effect of essential
tremor.
Independent claim 12 is similar to claim 1, except it is directed to the
treatment of restless leg syndrome using the same spinal cord stimulation
method (Cl. 12).
The Issues
The Examiner has rejected the claims as follows:
I. Claims 1, 3-6, 9, and 23-27 under 35 U.S.C. § 103(a) as being
unpatentable over Cameron.3
II. Claims 12, 14-17, 20, and 28-32 under 35 U.S.C. § 103(a) as
being unpatentable over the combination of Cameron and Kim.4
FINDINGS OF FACT
FF1. Cameron is directed to a “method of using spinal cord stimulation
to treat neurological disorders or conditions,” comprising
“surgically implanting an electrical stimulation lead that is in
communication with spinal nervous tissue associated with a first,
second, or third cervical vertebral segment to result in spinal
nervous tissue stimulation” (Cameron, Title, Abstract).
FF2. Cameron discloses that “[t]he use of electrical stimulation for
treating neurological disease, including . . . essential tremor . . . has
been widely discussed in the literature” (Cameron ¶ 5).

3 Cameron et al., US 2007/0060954 A1, published Mar. 15, 2007.
4 Kim et al., US 2006/0052856 A1, published Mar. 9, 2006.
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FF3. Cameron discloses:
According to one aspect of the invention, a
neurological stimulation system is provided for
electrically stimulating a subject’s spinal nervous tissue
associated with a C1, C2, or C3 cervical vertebral
segment to treat one or more neurological disorders. The
system includes an electrode or stimulation portion
adapted for implantation into a subcutaneous area in
communication with the spinal nervous tissue associated
with a C1, C2, or C3 cervical vertebral segment. The
stimulation portion includes one or more stimulation
electrodes adapted to be positioned in the subcutaneous
area associated with a C1, C2, or C3 vertebral segment to
deliver electrical stimulation pulses to the neuronal
tissue. The system also includes a pulse generation
source to stimulate the one or more electrodes.
(Id. ¶ 10).
FF4. Cameron discloses:
[a]s another example, in certain embodiments, electrical
stimulation of the spinal nervous tissue associated with a
C1, C2, or C3 cervical vertebral segment may be
delivered to treat localized, diffuse, or other pain in any
one or more regions of the body below the head, such as
pain in the neck, shoulders, upper extremities, torso,
abdomen, hips, and lower extremities.
(Id. ¶ 13). Cameron further discloses: “in certain embodiments,
electrical stimulation of the spinal nervous tissue associated with a
C1, C2, or C3 cervical vertebral segment may be provided to
effectively treat lack of coordination in the upper or lower
extremities (e.g., gait problems).” (Id. ¶ 14).
FF5. Cameron discloses:
Those of skill in the art are aware that the spinal cord and
tissue associated therewith are associated with cervical,
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thoracic, and lumbar vertebrae. In the present invention,
the spinal cord or spinal tissue that is stimulated is
associated with at least one or more of the cervical
vertebra. See also FIGS. 3A and 3B. As used herein, C1
refers to cervical vertebral segment 1 or the first vertebral
segment, C2 refers to cervical vertebral segment 2 or the
second vertebral segment, C3 refers to cervical vertebral
segment 3 or the third vertebral segment, C4 refers to
cervical vertebral segment 4 or the fourth vertebral
segment, C5 refers to cervical vertebral segment 5 or the
fifth vertebral segment, C6 refers to cervical vertebral
segment 6 or the sixth vertebral segment, and C7 refers to
cervical vertebral segment 7 or the seventh vertebral
segment, unless otherwise specifically noted.
(Id. ¶ 47).
FF6. Cameron discloses that
[i]n general terms, stimulation system 10 includes an
implantable pulse generation portion (e.g., electrical
stimulation source) 12 and an implantable stimulation
portion (e.g., electrical stimulation lead, or electrode) 14
for applying the stimulation signal to the target the spinal
cord. In operation, both of these primary components are
implanted in the person’s body.
(Id. ¶ 52).
FF7. Cameron teaches that “[i]n a preferred embodiment, two or more
laminotomy leads are positioned within the epidural space of C1,
C2, or C3, or both. The leads may assume any relative position to
one another” (id. ¶ 69).
FF8. Kim is directed to “stimulation systems and components for
selective stimulation and/or neuromodulation of one or more dorsal
root ganglia through implantation of an electrode on, in or around a
dorsal root ganglia” (Kim, Abstract).
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FF9. Kim discloses essential tremor and restless leg syndrome (RLS) as
neuromuscular disorders that may be treated using
pharmacological agents alone or in combination with electrical
stimulation (id. ¶ 148, Fig. 24).
FF10. Figure 3B of Kim is reproduced below:

“FIG. 3B relates the spinal nerve roots to their respective vertebral
spinal levels.” (Id. ¶ 87). “The letter C designates nerves and
vertebrae in the cervical levels. The letter T designates vertebrae
and nerves in the thoracic levels. The letter L designates vertebrae
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and nerves in the lumbar levels. The letter S designates vertebrae
and nerves in the sacral levels.” (Id.).
FF11. Figure 3C of Kim is reproduced below:

“FIG. 3C illustrates the various dermatomes of the body related to
their respective nerve roots using the designations in FIG. 3B.”
(Id. ¶ 87).
FF12. The Specification states that the “spinal cord 302 is typically
divided into thirty-one different segments. . . . There are typically
eight cervical segments (C1-C8) 304, twelve thoracic segments
(T1-T12) 306, five lumbar segments (L1-L5) 308, five sacral
segments (S1-S5) 310, and a coccygeal segment 312.” (Spec.
10:6-11).
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FF13. The Specification states:
Each segment of the spinal cord 302 sends and
receives signals corresponding to muscle movement,
such as skeletal muscle movement at different locations
of a patient’s body. For example, muscles used to
control movement of the head and neck typically connect
to the spinal cord 302 at C1-C3; muscles used to control
movement of the hands typically connect to the spinal
cord 302 at T1; muscles used to control movement of the
wrists and elbows typically connect to the spinal cord
302 at C6-C7; muscles used to control movement of the
hips typically connect to the spinal cord 302 at L2;
muscles used to control movement of the quadriceps
typically connect to the spinal cord 302 at L3; muscles
used to control movement of the hamstrings and knees
typically connect to the spinal cord 302 at L4-L5; and
muscles used to control movement of the feet and knees
typically connect to the spinal cord 302 at L4-S1.
(Spec. 10:12-22).
PRINCIPLES OF LAW
“Section 103(a) forbids issuance of a patent when ‘the differences
between the subject matter sought to be patented and the prior art are such
that the subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said
subject matter pertains.”’ KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
(2007) (quoting 35 U.S.C. § 103(a)). “[W]hen a patent claims a structure
already known in the prior art that is altered by the mere substitution of one
element for another known in the field, the combination must do more than
yield a predictable result.” Id. at 416. “[I]f a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize
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that it would improve similar devices in the same way, using the technique is
obvious unless its actual application is beyond his or her skill.” Id. at 417.
“Obviousness [under 35 U.S.C. § 103] does not require absolute
predictability of success . . . all that is required is a reasonable expectation of
success.” In re O’Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988) (citations
omitted).
ANALYSIS
Claims 1 and 12
Claim 1 is directed to a method of treating essential tremor
comprising implanting a lead so that an electrode “is disposed near at least
one of the patient’s C4-coccygeal spinal cord segments” (Cl. 1). Based on
the Specification’s description of cervical (C1-C8) and coccygeal segments
of the spinal cord (FF12), we interpret claim 1’s reference to “C4-coccygeal
spinal cord segments” to mean any spinal cord segment between and
including the C4 cervical segment and the coccygeal segment.
The Examiner finds that Cameron renders claim 1 obvious based on
its teaching of a method for treating neurological disorders by “implanting
electrodes [ ] and stimulating the C1, C2, and/or C3 vertebral segments,”
which the Examiner considers to be “near” the C4 spinal cord segment (Ans.
4; see FF1-3). The Examiner further takes official notice that “essential
tremor is a well known movement disorder,” and thus concludes:
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[i]t would have been obvious to one having ordinary skill in the art at
the time the invention was made to modify the treated movement
disorders (i.e., Parkinson’s and tremor) as taught by Cameron with
treating essential tremor as is known in the art, since such a
modification would provide the predictable results of improving the
well being of a patient suffering from movement disorders.

(Ans. 4).
The Examiner alternatively finds that “Cameron mentions that any of
the cervical vertebra, including the C4 segment can be stimulated,” and
concludes:
[i]t would have been obvious to modify the embodiment that
stimulates the C1, C2, and/or C3 segments as taught in paragraph 14
of Cameron with stimulating the C4 segment as taught in paragraph
47 of Cameron, since all patients react differently to different
stimulations, and such a modification would provide the predictable
results of determining the best location for optimum therapy.

(Id. at 4-5; see FF5).
With respect to claim 12, although Cameron does not disclose treating
restless leg syndrome, the Examiner finds that “Kim teaches it is well known
to treat restless leg syndrome through stimulation of the spinal cord,” and
concludes that
[i]t would have been obvious to one having ordinary skill in the art at
the time the invention was made to modify the treated movement
disorders (i.e. Parkinson’s and tremor) as taught by Cameron with
treating restless leg syndrome as taught by Kim, since such a
modification would provide the predictable results of improving the
well being of a patient suffering from a large number of movement
disorders.

(Id. at 6; see FF8-9).
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We agree with the Examiner that a prima facie case of obviousness
has been established based on the cited prior art. We have considered
Appellant’s arguments, but are not persuaded otherwise.
Appellant’s primary argument is that “Cameron does not teach or
suggest implanting a lead near at least one of the patient’s C4-coccygeal
spinal cord segments and stimulating the patient’s spinal cord at that at least
one spinal cord segment (i.e., at the selected C4-coccygeal spinal cord
segment)” (App. Br. 12). Appellant asserts that “Cameron does not teach
surgically implanting an electrical stimulation lead in proximity to any other
spinal cord segments, other than C1, C2, and C3,” and “there is no teaching
in Cameron that the disclosed stimulation method could be applied to any
other spinal cord segments” (id.). Citing MPEP § 2112(IV), Appellant
contends that “[s]timulation of the C1, C2, and/or C3 spinal cord segments
does not necessarily stimulate the C4-coccygeal spinal cord segments” (App.
Br. 13).
We disagree with Appellant’s characterization of the Cameron
reference. Cameron explicitly teaches that “[i]n the present invention, the
spinal cord or spinal tissue that is stimulated is associated with at least one
or more of the cervical vertebra,” which it then defines to include the C1-C7
cervical vertebral segments (FF5). Although the embodiments disclosed in
Cameron focus on the C1-C3 segments, “[a]ll the disclosures in a reference
must be evaluated, including nonpreferred embodiments . . ., and a reference
is not limited to the disclosure of specific working examples.” In re Mills,
470 F.2d 649, 651 (CCPA 1972) (citations omitted). As such, we find that
Cameron teaches that spinal cord or spinal tissue associated with other
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cervical vertebral segments (C4-C7) may also be stimulated according to the
“invention” disclosed therein.
Moreover, even if one were to focus on the specific embodiments of
Cameron, the problem with Appellant’s arguments is that there is nothing in
the claims that requires the purposeful stimulation of the C4-coccygeal
spinal cord segments. While the claims require “stimulat[ing] a portion of
the spinal cord of the patient at the spinal cord segment . . . ,” that does not
necessarily require stimulating one of the C4-coccygeal segments itself, as
opposed to stimulating any other spinal cord segment that is also “near” the
implanted electrodes. We therefore determine that the broadest reasonable
interpretation of the claims would encompass stimulating other nearby spinal
cord segments. In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000)
(“[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification.”). Regardless of
what other spinal cord segments might qualify as “near,” we find that
requirement satisfied by Cameron’s disclosure of stimulating the C3
segment, which is directly adjacent to the C4 segment (see FF5; Cameron,
Fig. 3).
Appellant asserts that “the Specification describes ‘near’ as being in
the epidural space and close enough to a nerve of interest to contact that
nerve with stimulation pulses equal to or above a minimum therapeutic
stimulation level” (App. Br. 15, citing Spec. ¶ 66). The cited portions of the
Specification are described only for “at least some embodiments” relating to
the treatment of Parkinsonism, and therefore do not clearly define the term
“near” to preclude stimulation of other spinal cord segments adjacent to the
C4 segment for the claimed methods of treating essential tremor or restless
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leg syndrome. The claims do not require the C4-coccygeal segments to be
stimulated at or above any particular level; rather, they only require that “the
electrical signals reduce, alleviate, or eliminate at least one adverse effect”
of essential tremor or restless leg syndrome. Furthermore, we find nothing
in the Specification identifying any unexpected results or criticality
associated with stimulating the C4-coccygeal spinal cord segments for the
treatment of essential tremor or restless leg syndrome. Indeed, other than a
general statement that “[t]here are typically eight cervical segments (C1-
C8),” the Specification does not mention the C4 spinal cord segment at all
(Spec. 10).
As such, we find that Cameron’s general disclosure that “the spinal
cord or spinal tissue that is stimulated is associated with at least one or more
of the cervical vertebra” (FF5), in combination with the specific embodiment
wherein electrical leads may be implanted in the epidural space of the C3
segment (i.e., “near” the C4 segment) (FF6-7), renders the method of claim
1 obvious. We therefore affirm the rejection of claim 1. We also
accordingly conclude that Cameron’s disclosure, in combination with Kim’s
disclosure that restless leg syndrome can be treated using pharmacological
agents in combination with electrical stimulation (FF9), renders obvious the
method of claim 12. Appellant does not make separate arguments for
dependent claims 3, 4, 6, 9, 14, 15, 17, 20, 23, 24, 26, 28, and 29; therefore,
those claims fall with their respective independent claims. 37 C.F.R.
§ 41.37(c)(1)(vii).
Claims 5 and 16
Dependent claims 5 and 16 require that “at least one of the plurality of
electrodes is disposed near a portion of the spinal cord with at least one
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peripheral nerve extending to a lower extremity” (Cls. 5, 16). With respect
to these claims, Appellant additionally argues that “[o]ne of skill in the art
would recognize that peripheral nerves do not extend between the C1-C3
spinal cord segments and the lower extremities,” and that “the portions of
the spinal cord with at least one peripheral nerve extending to a lower
extremity include the lumbar and sacral spinal cord segments” (App. Br. 17-
18).
As noted by the Examiner, Cameron specifically teaches that the
electrical stimulation disclosed therein may affect lower extremities (Ans. 7;
FF4). With regard to this teaching, Appellant argues that “[o]ne of skill in
the art would recognize that C1-C3 have nerve roots that extend to the head
and the neck, and that none of C1-C3 have nerve roots that extend to lower
extremities” (App. Br. 19). Appellant also argues that
were a medical practitioner to contact the lumbar and sacral
spinal cord segments with stimulation pulses equal to or above
a minimum therapeutic stimulation level while being located in
communication with the C1-C3 spinal cord segments (as
suggested by the Final Office Action), the stimulation
amplitude may need to be at a level that is sufficiently high
enough to be detrimental to patient tissue on or around the C1-
C3 spinal cord segments.
(Id.).
As discussed above, Cameron generally discloses that spinal nervous
tissue associated with any of the cervical vertebral segments (C1-C7) may be
stimulated (FF5). Although we recognize that the cervical spinal cord
segments are not typically associated with peripheral nerves extending to a
lower extremity, the reference nonetheless states that lower extremities may
be affected as a result of the stimulation (FF4). Furthermore, there is
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nothing in the claim language or the Specification that requires any
particular degree of proximity between the implanted electrode and the
portion of the spinal cord with the peripheral nerve extending to the lower
extremity, other than simply being “near” one another. Other than the broad
requirement in the independent claims that “the electrical signals reduce,
alleviate, or eliminate at least one adverse effect” of essential tremor or
restless leg syndrome, claims 5 and 16 do not further require that the
peripheral nerve extending to the lower extremity be stimulated with the
nearby electrode at any particular level.
As with the independent claims, the term “near” is broad enough to
encompass disposing an electrode directly adjacent to other spinal cord
segments even if those portions of the spinal cord do not themselves have a
peripheral nerve extending to a lower extremity. The dissent states that the
term “near” is “reasonably interpreted to encompass a spinal cord segment
adjacent to one of the specific spinal cord segments required by the claims,”
but finds that “interpreting segment C7 to be ‘near’ segment L1 requires an
unreasonably broad interpretation of the claim language” (Dissent 2-3).
Certainly, the C7 segment is closer than other cervical segments to the L1
segment (FF10). Given that we give claims “their broadest reasonable
interpretation consistent with the specification,” Hyatt, 211 F.3d at 1372,
and the fact that Appellant’s Specification does not clearly suggest
otherwise, we find no basis to draw an arbitrary line as to which segments
can qualify as “near a portion of the spinal cord with at least one peripheral
nerve extending to a lower extremity.”5 We find that interpretation to be

5 The term “near” is a relative term. Because Appellant is in the best
position to bring clarity to the scope of his claims, we find it reasonable to
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consistent with the language of the independent claim requiring that “at least
one of the plurality of electrodes is disposed near at least one of the patient’s
C4-coccygeal spinal cord segments.”
Claims 5 and 16 therefore encompass electrodes disposed “near” the
C4-C7 cervical vertebral segments that are also “near” a portion of the spinal
cord with at least one peripheral nerve extending to a lower extremity.
Appellant does not explain why the stimulation would be detrimental to
tissue around the C1-C3 segments but not the other cervical segments within
the scope of the claim. Indeed, Cameron’s disclosure also encompasses the
stimulation of spinal cord or tissue associated with the C4, C5, C6, and C7
segments, which are even closer to the lumbar and sacral spinal cord
segments that have peripheral nerves extending to a lower extremity.
We therefore affirm the obviousness rejections of claim 5 and 16.
Claims 25, 27, and 30-32
Claim 25 requires “providing electrical signals to the T1 spinal cord
segment . . . to reduce, alleviate, or eliminate at least one adverse effect of
essential tremor in the patient’s hands” (Cl. 25). Claims 27 and 32 require
“providing electrical signals to at least one of the L4, L5, or S1 spinal cord
segment . . . to reduce, alleviate, or eliminate at least one adverse effect of

broadly interpret the claims to encompass the stimulation of non-adjacent
spinal cord segments. See In re Zletz, 893 F.2d 319, 321-22 (Fed. Cir. 1989)
(“During patent examination the pending claims must be interpreted as
broadly as their terms reasonably allow.... The reason is simply that during
patent prosecution when claims can be amended, ambiguities should be
recognized, scope and breadth of language explored, and clarification
imposed.... An essential purpose of patent examination is to fashion claims
that are precise, clear, correct, and unambiguous. Only in this way can
uncertainties of claim scope be removed, as much as possible, during the
administrative process.”).
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[essential tremor or restless leg syndrome] in at least one of the patient’s feet
or knees” (Cls. 27, 32). Likewise, claims 30 and 31 require “providing
electrical signals to the L3 spinal cord segment” (claim 30) or “at least one
of the L4 or L5 spinal cord segment” (claim 31) “to reduce, alleviate, or
eliminate at least one adverse effect of restless leg syndrome” in the
patient’s quadriceps, hamstrings, or knees (Cls. 30, 31).
With respect to these dependent claims, the Examiner takes official
notice that “it is well known that muscles used to control the hands typically
connect to the T1 spinal cord segment, . . . muscles used to control feet and
knees typically connect to the L4, L5, or S1 spinal cord segments,” “that
muscles used to control the quadriceps typically connect to the L3 spinal
cord segment, and muscles used to control the hamstrings or knees typically
connect to the L4 or L5 spinal cord segments” (Ans. 5-6). Appellant does
not dispute those facts, which are corroborated by both Appellant’s
Specification (FF13) and the disclosure in Kim (FF10-11). In making a
rejection, . . . an examiner may “take notice of facts beyond the record
which, while not generally notorious, are capable of such instant and
unquestionable demonstration as to defy dispute.’” In re Ahlert, 424 F.2d
1088, 1091 (CCPA 1970). Because Appellant does not dispute those facts,
we assume them to be true in our consideration of the obviousness rejection
of these dependent claims. See In re Fox, 471 F.2d 1405, 1407 (CCPA
1973) (affirming rejection based on official notice where “appellant has not
denied the existence of the facts on which the examiner rested his
obviousness rejection nor the added facts of which the board took judicial
notice”).
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Appellant argues that “there is no suggestion in Cameron to stimulate
other regions of the spinal cord to treat lack of coordination in the upper or
lower extremities when Cameron already teaches that the upper and lower
extremities are treatable by stimulation of C1, C2, and C3” (App. Br. 23).
However, given Cameron’s disclosure that “[t]hose of skill in the art are
aware that the spinal cord and tissue associated therewith are associated with
cervical, thoracic, and lumbar vertebrae” (FF5), and the undisputed known
correlation between spinal cord segments and the affected portions of the
body (dermatomes) (FF11, FF13), we find that one skilled in the art would
have a reasonable expectation of success in treating nervous disorders
associated with the upper or lower extremities (e.g., essential tremor or
restless leg syndrome) by providing electrical signals to the spinal cord
segments that contain peripheral nerves extending to those specific portions
of the body.
Appellant argues that “were a medical practitioner to contact the Tl,
L3, L4, L5, or S1 spinal cord segments with stimulation pulses equal to or
above a minimum therapeutic stimulation level while being located in
communication with the C1-C3 spinal cord segments (as suggested by the
Final Office Action), the stimulation amplitude may need to be at a level that
is sufficiently high enough to be detrimental to patient tissue on or around
the C1-C3 spinal cord segments” (App. Br. 22). Appellant further argues
that “the T1, L3, L4, L5, and/or S1 spinal cord segments are located too far
away from the C1-C3 spinal cord segments to be reachable during an
implantation procedure at the C1-C3 spinal cord segments” (Reply Br. 18).
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Contrary to the premise of Appellant’s arguments, the rejection is not
based only on Cameron’s embodiments wherein the C1-C3 spinal cord
segments are stimulated. Rather, the Examiner finds
it would have been obvious to modify stimulating the cervical
segments [as taught by Cameron] with stimulating the T1, L4,
L5, and/or S1 segments as are well known in the art, since such
a modification would stimulate the part of the spinal cord that is
related to the patient's extremities that are affected by essential
tremor and/or restless leg syndrome.
(Ans. 8). At least the T1 spinal cord segment is directly adjacent to the
spinal cord tissue associated with the C7 vertebral segment, which as stated
above, is within the scope of Cameron’s disclosure (FF4; Cameron, Fig. 3).
Other than unsupported attorney argument, Appellant presents no evidence
that stimulation of the T1, L3, L4, L5, or S1 spinal cord segments would
necessarily be detrimental to tissue around the cervical vertebral segments.
See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s
argument in a brief cannot take the place of evidence.”). Nor do the claims
suggest that electrodes could not be disposed near both areas of the spinal
cord. 6
We therefore affirm the obviousness rejection of claims 25 and 27
based on Cameron, and the rejection of claims 30-32 based on the
combination of Cameron and Kim.

6 The dissent notes that claims 25, 27, and 30–32 require providing electrical
signals specifically “to,” not “near,” one of the T1, L3, L4, L5, or S1 spinal
cord segments (Dissent 3). While true, these claims do not require providing
electrical signals to only those particular spinal cord segments, nor do they
further limit the placement of the electrodes beyond the requirements of the
independent claims.
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SUMMARY
We affirm the claim rejections under 35 U.S.C. § 103(a).
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
bar

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte AHMED A. ELBORNO
__________

Appeal 2012-005245
Application 12/258,317
Technology Center 3700
__________

Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

GRIMES, Administrative Patent Judge, dissenting-in-part.

I agree with the majority that claims 1 and 12—which recite
implanting an electrode near, for example, the C4 spinal cord segment—
encompass implanting an electrode at the C3 spinal cord segment, and
therefore read on the methods made obvious by Cameron alone or by
Cameron and Kim. I part ways with the majority, however, with respect to
claims 5, 16, 25, 27, and 30-32.
Claims 5 and 16 require implanting a lead so that an electrode is
“disposed near a portion of the spinal cord with at least one peripheral nerve
extending to a lower extremity” (Appeal Br. 25, 27 (Claims App’x)). Kim’s
Figure 3C shows that the peripheral nerves extending to the legs and feet
originate at spinal cord segments L1–L5, S1, and S2 (FF11). Thus, claims 5
and 16 require implanting an electrode near one of spinal cord segments L1–
L5, S1, and S2.
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Application 12/258,317

2
Cameron’s disclosed method is limited to providing electrical
stimulation to one of the C1–C3 cervical vertebral segments (see FF3, FF4).
Although Cameron states broadly that, “[i]n the present invention, the spinal
cord or spinal tissue that is stimulated is associated with at least one or more
of the cervical vertebra” (FF5), it does not describe any actual method that
provides electrical stimulation at a vertebral segment other than C1–C3. The
majority notes that Cameron states that its method can affect the lower
extremities (ante at 14), but that statement at best would have led a skilled
artisan to stimulate one of the C1–C3 vertebral segments in order to affect
the legs or feet. That disclosure does not address the structural requirement
of claims 5 and 16 of implanting an electrode near a portion of the spinal
cord with a peripheral nerve extending to a lower extremity; i.e., one of
spinal cord segments L1–L5, S1, and S2.
The majority also reasons that claims 5 and 16 read on the method
made obvious by the prior art because the Specification does not define the
term “near,” and thus “the term ‘near’ is broad enough to encompass
disposing an electrode directly adjacent to other spinal cord segments even if
those portions of the spinal cord do not themselves have a peripheral nerve
extending to a lower extremity” (ante at 15). I agree that “near” is
reasonably interpreted to encompass a spinal cord segment adjacent to one
of the specific spinal cord segments required by the claims. I do not agree
with the majority’s conclusion that Cameron discloses stimulating any of
cervical segments C1–C7, but even assuming it does, claims 5 and 16
require stimulating a spinal cord segment near one of L1–L5, S1, and S2.
Segment C7 is separated from segment L1 by all twelve of the thoracic
spinal cord segments (see FF10). In my opinion, interpreting segment C7 to
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Application 12/258,317

3
be “near” segment L1 requires an unreasonably broad interpretation of the
claim language, and effectively reads the term “near” out of the claims
entirely.
For the above reasons, I respectfully dissent from the majority’s
conclusion that the cited references would have made obvious the methods
defined by claims 5 and 16.
Claims 25, 27, and 30–32 require providing electrical signals
specifically “to,” not “near,” one of the T1, L3, L4, L5, or S1 spinal cord
segments (Appeal Br. 28-29 (Claims App’x)). The majority concludes that
it would have been obvious to modify Cameron’s method to include
stimulation of those spinal cord segments because it was known that they
connect to nerves in the hands and the lower extremities (ante at 16-17).
I respectfully disagree with this conclusion. In my view, Cameron’s
disclosed method is limited to providing stimulation to the C1–C3 segments,
but even assuming it would have suggested providing stimulation to any of
the C1–C7 cervical segments, the majority points to no suggestion in the
cited references that would lead a skilled artisan to provide stimulation to
any of the thoracic, lumbar, or sacral spinal cord segments. The knowledge
that peripheral nerves controlling the hands and legs connect to the T1, L3,
L4, L5, and S1 spinal cord segments does not, in my mind, provide the
required reason to modify the prior art as required by the claims. As
Appellant has pointed out (Appeal Br. 23), Cameron discloses that
stimulation of the C1–C3 spinal cord segments can effectively treat the
upper and lower extremities (FF4). Cameron also expressly states that “[i]n
the present invention, the spinal cord or spinal tissue that is stimulated is
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4
associated with at least one or more of the cervical vertebra” (FF5, emphasis
added).
In my view, the majority’s conclusion that a skilled artisan would
have considered it obvious to modify Cameron’s method as required by
claims 25, 27, and 30-32, in order to accomplish what Cameron describes as
a result of stimulating the C1–C3 spinal cord segments, is based on
hindsight rather than on the teachings of the prior art.
In summary, I agree with the majority’s analysis with regard to claims
1, 3, 4, 6, 9, 12, 14, 15, 17, 20, 23, 24, 26, 28, and 29, but dissent with
respect to the analysis of claims 5, 16, 25, 27, and 30–32.