Ex Parte Howard et al

Patent Trial and Appeal Board

Aug 29, 2017

13900889 (P.T.A.B. Aug. 29, 2017)

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.
13/900,889 05/23/2013 Joshua Dale Howard BSNC-1-260.1 3437
50638 7590 08/29/2017
Boston Scientific Neuromodulation Corp.
c/o Lowe Graham Jones
701 Fifth Avenue
Suite 4800
Seattle, WA 98104
EXAMINER
ALTER MORSCHAUSER, ALYSSA MARGO
ART UNIT PAPER NUMBER
3762
MAIL DATE DELIVERY MODE
08/29/2017 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 JOSHUA DALE HOWARD and JACOB B. LEVEN1
(Applicant: Boston Scientific Neuromodulation Corporation)
____________

Appeal 2016-006134
Application 13/900,889
Technology Center 3700
____________

Before JEFFREY N. FREDMAN, RICHARD J. SMITH, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

SMITH, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 involving claims to an
implantable electrical stimulation lead and method of implanting a lead. We
have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.

1 According to Appellants, the real party in interest is Boston Scientific
Neuromodulation Corporation. (Appeal Br. 2.)
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STATEMENT OF THE CASE
Claims on Appeal
Claims 9 and 11–20 are on appeal.2 (Appeal Br. 14–16, Claims
Appendix.) Claims 9 and 14 are illustrative and read as follows (emphases
added):
9. An implantable electrical stimulation lead,
comprising:
a lead body having a distal end, a proximal end, and a
longitudinal length;
a plurality of electrodes disposed along the distal end of
the lead body;
a plurality of terminals disposed on the proximal end of
the lead body;
a plurality of conductors, each conductor electrically
coupling at least one of the electrodes to at least one of the
terminals; and
a bendable shaping member permanently disposed within
at least the distal end of the lead body, wherein the bendable
shaping member is a metal or plastic wire that is not electrically
coupled to any of the plurality of electrodes and plurality of
terminals and is reversibly bendable and permits formation of a
hook or coil shape in the distal end of the lead body in absence
of a stylet disposed within the lead body by bending of the
distal end of the lead body into the hook or coil shape, wherein
the bendable shaping member is configured and arranged to
retain the distal end of the lead body in the hook or coil shape
without external force being applied.

14. A method of implanting a lead, the method
comprising:
providing a lead comprising a lead body having a distal
end, a proximal end, and a longitudinal length, a plurality of
electrodes disposed along the distal end of the lead body, a

2 Claims 1–8 are withdrawn as directed to a non-elected invention. (Non-
Final Act. 3–4, dated Sept. 24, 2015.)
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plurality of terminals disposed on the proximal end of the lead
body, and a plurality of conductors, each conductor electrically
coupling at least one of the electrodes to at least one of the
terminals;
inserting a guidewire or stylet into the lead; and
implanting the lead into the patient and around at least a
portion or dorsal root ganglion of the patient using the
guidewire or stylet to shape the distal end of the lead body into
a coil of at least one complete turn around the portion of the
dorsal root ganglion.

Examiner’s Rejections
1. Claims 9 and 11–20 stand rejected under pre-AIA 35 U.S.C. § 103(a)
as unpatentable over Kishawi.3 (Ans. 4–8.)
2. Claims 9 and 11–13 stand rejected under 35 U.S.C. § 112(a) or
35 U.S.C. § 112 (pre-AIA), first paragraph, as failing to comply with the
written description requirement. (Id. at 2–3.)
3. Claims 9 and 11–13 stand rejected under 35 U.S.C. § 112(b) or 35
U.S.C. § 112 (pre-AIA), second paragraph, as indefinite. (Id. at 3.)
DISCUSSION
Rejection No. 1
Issue
Whether a preponderance of evidence of record supports the
Examiner’s rejection under 35 U.S.C. § 103(a).
Analysis
The Examiner’s obviousness rejection is based on the teachings of
Kishawi. (Ans. 4–8.) The Examiner’s findings regarding Kishawi include
references to Figures 10A, 10C, and 12 of Kishawi, illustrated below:

3 Kishawi et al., US 2010/0249875 A1, pub. Sept. 30, 2010 (“Kishawi”).
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Figure 10A above illustrates a lead 100, Figure 10C above illustrates a
stylet 124, and Figure 12 above illustrates a sheath 122.
The Examiner finds that Kishawi “discloses an implantable electrical
stimulation lead with a lead body having a distal end, a proximal end, a
longitudinal length . . . and a plurality of electrodes [102] disposed at the
distal end of the lead body.” (Ans. 4, citing Kishawi ¶¶ 49, 51, and Figs. 3,
10A, 12.) The Examiner further finds that Kishawi discloses a bendable
shaping member or stylet 124 inserted into lead 100 to shape the distal end
of the lead body into a hook or coil. (Id. at 5, citing Kishawi ¶ 51, Fig. 10C.)
Referring to Figures 10A, 10C, and 12, Kishawi states that:
The stylet 124 has a distal end 130 which is pre-curved . . . .
The stylet 124 is sized and configured to be advanced within
the stylet lumen 104 of the lead 100. Typically the stylet 124
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extends therethrough so that its distal end 130 aligns with the
distal end 101 of the lead 100. Passage of the stylet 124 through
the lead 100 causes the lead 100 to bend in accordance with the
precurvature of the stylet 124. Typically, the stylet 124 has a
smaller radius of curvature, or a tighter bend, than the sheath
122. Therefore, as shown in FIG. 12, when the stylet 124 is
disposed within the lead 100, extension of the lead 100 and
stylet 124 through the sheath 122 bends or directs the lead 100
through a first curvature 123. Further extension of the lead 100
and stylet 124 beyond the distal end 128 of the sheath 122
allows the lead 100 to bend further along a second curvature
125. This allows the laterally directed lead 100 to now curve
around toward the target [dorsal root ganglion] along the nerve
root angulation.
(Kishawi ¶ 51.)

Claim 9
We adopt as our own the Examiner’s findings, analysis, and
conclusions regarding the rejection of claim 9 under Section 103, as set forth
in the Answer (see, e.g., Ans. 4–6, 9–10). We discern no error in the
Examiner’s rejection of claim 9 as obvious. We address Appellants’
arguments below.
We first address the construction of claim 9. Claim 9 is to an
apparatus or device; namely, an implantable electrical stimulation lead.
(Appeal Br. 14.) As such, the patentability of claim 9 depends on its
claimed structure, not on its use or purpose. See Catalina Mktg. Int’l, Inc. v.
Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002) (“the
patentability of apparatus . . . claims depends on the claimed structure, not
on the use or purpose of that structure.”) Here, that structure includes a lead
body, electrodes, terminals, and conductors, as well as a bendable shaping
member. (Appeal Br. 14.) The bendable shaping member (i.e., a shaping
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member capable of being bent) is a metal or plastic wire that is permanently
disposed within at least the distal end of the lead body and is reversibly
bendable. (Id.)
Bendable shaping member
Appellants argue that:
Because stylet 124 is a stylet, it cannot correspond to the recited
bendable shaping member that “permits formation of a hook or
coil shape in the distal end of the lead body in absence of a
stylet disposed within the lead body”, according to claim 9.
The presence of stylet 124 for bending the lead of Kishawi is
clearly in contradiction to the recitations of claim 9.
(Appeal Br. 8–9; see also Reply Br. 5.)
We are not persuaded. Claim 9 can reasonably be construed as
reciting a bendable shaping member in accordance with the structure
discussed above. Moreover, the fact that stylet 124 is called a “stylet” in
Kishawi rather than a bendable shaping member does not mean it does not
have the structure of a bendable shaping member. Thus, as discussed
further below, we agree with the Examiner’s finding that the stylet 124 of
Kishawi is a bendable shaping member permanently disposed within at least
the distal end of the lead body. (Ans. 5–6.)
As described by Kishawi and illustrated in Figures 10A, 10C, and 12,
the stylet 124 is advanced within the stylet lumen 104 of lead 100. (Kishawi
¶ 51.) Furthermore, when the stylet is disposed within the lead, extension of
the lead and stylet through the sheath 122 bends or directs the lead 100
through a first curvature 123. (Id.) Further extension of the lead and stylet
beyond the distal end 128 of the sheath 122 allows the lead to bend further
along a second curvature 125. (Id.) Thus, because the stylet 124 is disposed
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within the lead and the lead bends as it passes through the sheath 122, the
stylet 124 also bends, indicating that it is a bendable shaping member.
The Examiner also points to Kishawi’s teaching that “the lead may
have a pre-curved shape,” and the lead may have a curved hook in the
absence of a stylet disposed within the lead body. (Ans. 5, citing Kishawi ¶¶
51, 55.) As the Examiner states, Kishawi discloses a bendable shaping
member 124 inserted into the lead that may cause the lead to have a “pre-
curved shape.” (Id. at 9.) Appellants argue, however, that “Kishawi does
not explicitly teach how the ‘pre-curved shape’ can be achieved,” and that
“Kishawi does not inherently teach or suggest the recited bendable shaping
member.” (Appeal Br. 9.)
We are not persuaded. Appellants’ argument appears premised on the
incorrect position that the structure described in Kishawi, and referred to in
Kishawi as a stylet, is not a bendable shaping member. That bendable
shaping member may be used to cause the lead to have a pre-curved shape.
Moreover, the argument that Kishawi “does not explicitly teach how the
‘pre-curved shape’ can be achieved” is not persuasive because ‘“a reference
[e.g. Kishawi] must be considered not only for what it expressly teaches, but
also for what it fairly suggests.’” In re Baird, 16 F.3d 380, 383 (Fed. Cir.
1994) (quoting In re Burckel, 592 F.2d 1175, 1179 (CCPA 1979)). Again,
we agree with the Examiner’s finding that Kishawi teaches and suggests a
bendable shaping member as claimed.
Reversibly bendable
Appellants argue that claim 9 recites “that the bendable shaping
member ‘is reversibly bendable’” but that Kishawi “does not teach or
suggest a lead with a pre-curved shape is reversibly bendable.” (Appeal Br.
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9; Reply Br. 6.) We are not persuaded. A bendable shaping member as
taught by Kishawi is necessarily “reversibly bendable,” as evidenced by
Kishawi’s statement that “[a]dvancement of the [pre-curved] lead out of the
sheath [122] allows the lead to recoil toward its pre-curved shape” (i.e.,
reverse its bend). (Kishawi ¶ 55.)
Metal or plastic wire
Claim 9 recites that the bendable shaping member is a metal or plastic
wire. (Appeal Br. 14.) Appellants contend that modification of the material
of the shaping member, asserted as obvious by the Examiner, “is a
conclusory argument that has no basis in Kishawi and is merely
speculative.” (Id. at 9; see also Reply Br. 6.)
We are not persuaded. As the Examiner states, “it has been held to be
within the general skill of a worker in the art to select a known material on
the basis of its suitability for the intended use as a matter of obvious design
choice.” (Ans. 6, 9–10.) See In re Leshin, 277 F.2d 197, 199 (CCPA 1960).
Appellants do not rebut the Examiner’s position with evidence that claim 9
requires materials different than those ordinarily employed by the ordinary
artisan in surgical devices.
Accordingly, for the reasons of record and as set forth above, we
affirm the rejection of claim 9. Claims 11–13 were not argued separately
and fall with claim 9.

Claim 14
Claim 14 recites a method of implanting a lead in which a guidewire
or stylet is used “to shape the distal end of the lead body into a coil of at
least one complete turn around the portion of the dorsal root ganglion.”
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(Appeal Br. 15.) The Examiner acknowledges that, while Kishawi discloses
that the severity of the turn of the lead may vary based on individual patient
anatomy, Kishawi does not explicitly disclose that the lead creates “at least
one complete turn around a portion of the dorsal root ganglion.” (Ans. 7.)
However, the Examiner concludes that:
It would have been obvious to one having ordinary skill in the
art at the time the invention was made to modify the curvature
of the distal portion of the lead to be a “complete turn” of a coil
to ensure sufficient contact with the target stimulation site in a
patient that has angulation or anatomy that differs from normal
anatomy in order to provide the predictable results of ensuring
sufficient contact with the stimulation target site for delivery of
appropriate therapy.
(Id., citing Kishawi ¶ 48.)
Appellants argue that “Kishawi does not teach or suggest forming a
coil of at least one complete turn around a portion of the dorsal root
ganglion. At best, Kishawi teaches forming a bend, but that bend does not
form a complete turn.” (Appeal Br. 10.) Appellants argue further that:
None of the leads of Kishawi illustrates any curve that even
approaches a full turn. Moreover, Kishawi provides no
discussion as to how one of skill in the art would place a full
turn of the lead around the dorsal root ganglion. Kishawi is
simply directed to implanting the curved lead next to the patient
tissue.
(Id.)
We find that Appellants have the better position. The Examiner bears
the initial burden of establishing a prima facie case of obviousness and has
not done so as to claim 14. See In re Oetiker, 977 F.2d 1443, 1445 (Fed.
Cir. 1992). In particular, the Examiner does not establish a teaching or
suggestion in Kishawi of a coil of at least one complete turn of the distal end
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of the lead body, or how one complete turn of an electrical stimulation lead
would be necessary or desirable “to provide the predictable results of
ensuring sufficient contact with the stimulation target site for delivery of
appropriate therapy.” (Ans. 7.)
The rejection of claim 14 for obviousness is reversed. Claims 15–20
depend, directly or indirectly, on claim 14 and are likewise nonobvious.

Conclusions of Law
A preponderance of evidence of record supports the Examiner’s
rejection of claim 9 under 35 U.S.C. § 103(a). Claims 11–13 were not
argued separately and fall with claim 9.
A preponderance of evidence of record fails to support the Examiner’s
rejection of claim 14 under 35 U.S.C. § 103(a). Dependent claims 15–20
stand with claim 14.

Rejection No. 2
Issue
Whether a preponderance of evidence of record supports the
Examiner’s written description rejection under 35 U.S.C. § 112.
Analysis
The Examiner rejects claims 9 and 11–134 as failing to comply with
the written description requirement. (Ans. 2–3.) The Examiner states that
claim 9 recites a “bendable shaping member” and “absence of a stylet

4 Claims 11 and 12 depend on claim 9, and claim 13 recites a method of
implanting an electrical stimulation lead that includes the step of providing
the electrical stimulation lead of claim 9.
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disposed within the lead body,” but “a ‘stylet’ is [a] ‘bendable shaping
member.’” (Id. at 3.) According to the Examiner, “[w]hile there are
embodiments recited [in the Specification] that do not require a stylet, there
is no support or description for any embodiments to exclude a stylet or
guidewire and include a ‘bendable shaping member.’” (Id.)
Appellants argue that the Specification discloses a ‘“bendable shaping
member’ with respect to the embodiments of Figures 6A and 6B that is not a
stylet.” (Appeal Br. 6.) Appellants argue further that the Specification
“discloses using a stylet with other embodiments including those illustrated
in Figures 7A, 7B, 8A, and 8B.” (Id.)
We find that Appellants have the better position. In evaluating
compliance with the written description requirement, “the test for
sufficiency is whether the disclosure of the application relied upon
reasonably conveys to those skilled in the art that the inventor had
possession of the claimed subject matter as of the filing date.” Ariad
Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
(citing cases).
Here, while lacking the clarity required for claims under examination
(see Rejection 3 below), claim 9 reasonably has descriptive support for
reciting a bendable shaping member that is not a stylet. Moreover,
Appellants persuasively argue that the Specification describes embodiments
(Figures 6A and 6B) that include a bendable shaping member that is not a
stylet, and embodiments that describe a stylet (Figures 7A, 7B, 8A, and 8B).
(Appeal Br. 6.) Thus, we find that the Specification reasonably conveys that
Appellants had possession, as of the filing date, of an embodiment having a
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bendable shaping member that is not a stylet (i.e. not every bendable shaping
member is a stylet).

Conclusion
A preponderance of evidence fails to support the Examiner’s rejection
of claim 9 for failing to comply with the written description requirement.
Claims 11–13 stand with claim 9.

Rejection No. 3
Issue
Whether a preponderance of evidence of record supports the
Examiner’s rejection under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-
AIA), second paragraph, as indefinite.
Analysis
The Examiner rejects claims 9 and 11–13 as being indefinite. (Ans.
3.) The Examiner states that “it is unclear how the lead body can have both
a ‘bendable shaping member permanently disposed within . . . the lead’ and
an ‘absence of a stylet disposed within the lead body.’” (Id.) Appellants
repeat essentially the same arguments advanced in connection with the
written description rejection, including the statement that “claim 9 clearly
distinguishes the bendable shaping member from a stylet by referring to
both.” (Appeal Br. 7; see also Reply Br. 4: “[c]laim 9 . . . uses different
names for these components.”)
We find that the Examiner has the better position. “[A] claim is
indefinite when it contains words or phrases whose meaning is unclear,” that
is, “ambiguous, vague, incoherent, opaque, or otherwise unclear in
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describing and defining the claimed invention.” In re Packard, 751 F.3d
1307, 1310–13 (Fed. Cir. 2014). Furthermore, “during patent prosecution
when claims can be amended, ambiguities should be recognized, scope and
breadth of language explored, and clarification imposed.” In re Zletz, 893
F.2d 319, 321 (Fed. Cir. 1989).
The Specification does not define “bendable shaping member” or
“stylet.” Moreover, claim 9 recites that the bendable shaping member is
“permanently disposed within at least the distal end of the lead body” and “is
configured and arranged to retain the distal end of the lead body in the hook
or coil shape without external force being applied.” (Appeal Br. 14.)
However, the Specification illustrates a stylet within the distal end of the
lead body (see 704 in Figs. 7B, 8A, and 8B), and also indicates that the stylet
“may remain in the lead after implantation to retain the bent or coiled shape
of the distal end of the lead.” (Spec. 15, ll. 21–22.) Thus, while Appellants’
Specification may contemplate usage of the bendable shaping member and
stylet in different ways, they have the same or essentially the same structure
as described in the Specification and recited in claim 9.5 See Catalina
Mktg., Int’l, 289 F.3d at 809 (“the patentability of apparatus . . . claims
depends on the claimed structure, not on the use or purpose of that
structure.”). Accordingly, we find that the recitation in claim 9 of both a
bendable shaping member permanently disposed within the lead body and

5 While we reverse the written description rejection based on the
Specification’s usage of “bendable shaping member” and “stylet” in
different embodiments, we will not incorporate limitations from the
Specification into claim 9.
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“absence of a stylet disposed within the lead body” lacks the clarity required
of claims undergoing prosecution. See In re Zletz, 893 F.2d at 321.

Conclusion of Law
A preponderance of evidence supports the Examiner’s rejection of
claim 9 under 35 U.S.C. § 112 as indefinite. Claims 11–13 fall with claim 9.

SUMMARY
We AFFIRM:
the rejection of claims 9 and 11–13 under 35 U.S.C. § 103(a); and
the rejection of claims 9 and 11–13 under 35 U.S.C. § 112 as
indefinite.
We REVERSE:
the rejection of claims 14–20 under 35 U.S.C. § 103(a); and
the rejection of claims 9 and 11–13 under 35 U.S.C. § 112 as failing
to comply with the written description requirement.

TIME PERIOD FOR RESPONSE
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-IN-PART