Ex Parte Wechter

Patent Trials and Appeals Board

May 1, 2019

14263933 - (D) (P.T.A.B. May. 1, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/263,933 04/28/2014
50638 7590 05/03/2019
Boston Scientific Neuromodulation Corp.
c/o Lowe Graham Jones
701 Fifth Avenue
Suite 4800
Seattle, WA 98104
FIRST NAMED INVENTOR
David Ernest Wechter
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.
BSNC-1-336.1 5781
EXAMINER
MARLEN, TAMMIE K
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
05/03/2019 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):
patentdocketing@lowegrahamjones.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID ERNEST WECHTER
Appeal2017-007141
Application 14/263,933
Technology Center 3700
Before CHRISTOPHER G. PAULRAJ, RICHARD J. SMITH, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
Appellant1 submits this appeal under 35 U.S.C. § 134(a) involving
claims to an electrical stimulation lead, and to systems including the lead.
The Examiner rejected the claims as obvious. We have jurisdiction under 35
U.S.C. § 6(b).
We REVERSE.
1 Appellant identifies the Real Party in Interest as Boston Scientific
Neuromodulation Corporation. App. Br. 2.
Appeal2017-007141
Application 14/263,933
STATEMENT OF THE CASE
Appellant's "invention is directed to the area of implantable electrical
stimulation systems ... , and in particular implantable electrical stimulation
leads having anchoring units interspersed with electrodes and methods of
making and using the leads." Spec. 1 :9-12.
Claims 1-20 are on appeal. Claim 1 is illustrative, and reads:
1. An electrical stimulation lead, comprising:
a lead body having a distal end portion, a proximal end
portion, and a longitudinal length;
a plurality of electrodes disposed along the distal end
portion of the lead body, wherein the plurality of electrodes
comprises at least six electrodes, wherein all of the electrodes of
the lead are divided into a first set of electrodes and a second set
of electrodes adjacent to the first set of electrodes, wherein the
first set of electrodes comprises at least four of the electrodes and
the second set of electrodes comprises at least two of the
electrodes, wherein adjacent electrodes of the first set are
longitudinally spaced apart from each other by a first distance
and adjacent electrodes of the second set are longitudinally
spaced apart from each other by a second distance that is greater
than the first distance and the first set is longitudinally spaced
apart from the second set by a third distance, defined as a distance
between one electrode of each of the first and second sets that are
closest to each other, that is greater than or equal to the second
distance;
a plurality of terminals disposed along the proximal end
portion of the lead body;
a plurality of conductors electrically coupling the
terminals to the electrodes; and
a plurality of anchoring units disposed along the distal end
portion of the lead body and proximal to all of the electrodes of
the first set of electrodes, wherein at least two of the anchoring
units are disposed between the first set of electrodes and the
second set of electrodes and longitudinally spaced apart from
each other.
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Appeal2017-007141
Application 14/263,933
App. Br. 11 (Claims App'x).
Independent claim 14 recites an electrical stimulation lead with
similar features to those recited in claim 1, but claim 14 requires, inter alia,
"a first set of anchoring units disposed between the first set of electrodes and
the second set of electrodes and a second set of anchoring units disposed
between the electrodes of the second set of electrodes." App. Br. 13-14
( emphasis added). Like claim 1, claim 14 requires anchoring units that are
"longitudinally spaced apart from each other" in certain regions on the lead
body. Id. Claims 12 and 19 recite systems that include, respectively, the
electrical stimulation leads of claims 1 and 14. Id. at 13-15.
The claims stand rejected as follows:
Claims 1-9 and 11-20 under 35 U.S.C. § 103 as obvious over
Schleicher '095. 2 Final Act. 2-8.
Claim 10 under 35 U.S.C. § 103 as obvious over Schleicher '095 in
view of Schleicher '696. 3
DISCUSSION
Issue
The issue on appeal is whether a preponderance of the evidence
supports the Examiner's conclusion of obviousness. More specifically, the
decisive question here is whether the Examiner has established, based on the
evidence cited and reasons given, that an electrical lead with the particular
arrangement of electrodes and anchoring units required in independent
2 Schleicher et al., US 2009/0248095 Al, published Oct. 1, 2009.
3 Schleicher et al., US 2010/0256696 Al, published Oct. 7, 2010.
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Appeal2017-007141
Application 14/263,933
claims 1 and 14 would have been obvious over Schleicher '096? 4 The
answer on this record is "no." We explain below.
Analysis
The Specification's figures are helpful to understanding the claimed
subject matter. Relevant portions of Figs. 6A and 6B are shown below.
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Spec., Figs. 6A-B (partial). Figs. 6A (left) and 6B (right) are schematic side
views of the distal portions of embodiments of the electrical lead. Id. at 4: 1-
4. As depicted, each lead includes a first set (660) and a second set (662) of
electrodes (634). Id. at 16:21-19:26 (describing Figs. 6A-B). Electrodes in
4 The Examiner's reliance on Schleicher '696 is limited to addressing
elements in dependent claim 10 and, in particular, Schleicher '696' s
disclosure of allegedly cone-shaped anchoring members and their placement
relative to electrodes on a lead body. Final Act. 8-9.
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Appeal2017-007141
Application 14/263,933
the first set ( 660) are spaced apart from each other by a "first distance"
( 670), electrodes in the second set ( 662) are spaced apart from each other by
a "second distance" (672), and a "third distance" (674) is the distance
between the first and second sets of electrodes. Id. As further shown in the
figures above, anchoring units ( 650) are disposed on the lead: "one or more
anchoring units 650 are mounted between electrodes 634 of the second set
662," and "one or more of the anchoring units are mounted in the space
(identified by distance 674) between the first set 660 and the second set
662." Id. at 19:8-12.
Turning to the claims, claim 1 requires, among other elements, that
adjacent electrodes of the first set are longitudinally spaced apart from each
other by a first distance, and that adjacent electrodes of the second set are
spaced apart by a second distance that is greater than the first distance. And
claim 1 requires that the third distance-----the distance between the respective
electrodes of the first and second sets that are closest to each other-be
greater than or equal to the second distance. Put differently, the distances in
claim 1 can be represented as follows: distance 1 < distance 2 :S distance 3.
This same relation between electrodes and distances appears in claim 14.
Other claims recite narrower distance requirements ( e.g., dependent claim 4,
which requires "the third distance is at least twice the second distance").
App. Br. 12. The claims also require, similar to the figures reproduced
above, longitudinally spaced apart "anchoring units." For example, claim 1
requires "a plurality of anchoring units ... proximal to all of the electrodes
of the first set of electrodes, wherein at least two of the anchoring units are
disposed between the first set of electrodes and the second set of electrodes
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Appeal2017-007141
Application 14/263,933
[i.e., in the region defined by the third distance] and longitudinally spaced
apart from each other."
The Examiner, relying primarily on Fig. 5B of Schleicher '095,
concludes that an electrical lead with the arrangement of electrode sets,
distances, and anchoring units recited in claims 1 and 14 would have been
obvious. Final Act. 2-3, 6-7; Ans. 2-3. We include below the Examiner's
annotation of Fig. 5B, modified to improve its legibility compared to the
version appearing in the Final Office Action and Answer.
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l:::H·.:ond_ :~:t':\r:,f_e!t::d,-c:;c.!e~ J508 ' "' 502
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Schleicher '095, Fig. 5B (annotated).
The Examiner finds that "Schleicher '095 discloses the claimed
invention except for electrode 512 included on the lead shown in the figure
above." Final Act. 3. According to the Examiner, however, "[i]t would
have been obvious ... to omit electrode 512, since it has been held that
omission of an element and its function in a combination where the
remaining elements perform the same functions as before involves only
routine skill in the art. In re Karlson, 136 USPQ 184." Id. In other words,
the Examiner contends it would have been obvious to omit electrode (512),
as shown within the region defined by the hashed lines from the annotation
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Appeal2017-007141
Application 14/263,933
above, while apparently maintaining the sets of tines (508) in that region,
thus, allegedly arriving at an electrical lead with all the features claimed.
The Examiner has not, on this record, met the threshold burden of
showing that claim 1 ( or 14) would have been prima facie obvious over
Schleicher '095. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992) (The
Examiner "bears the initial burden ... of presenting a prima facie case of
unpatentability."). We reach this conclusion for at least three reasons, which
we discuss in detail below.
First, the Examiner provides neither evidence nor persuasive technical
reasoning to demonstrate that the first, second, and third distance elements
of the claims (e.g., distance 1 < distance 2 :S distance 3, as in claims 1 and
14) are disclosed in, or obvious in view of, Schleicher '095. The Examiner,
for example, cites to no disclosure in Schleicher '095 specifying any of the
distances between individual electrodes, much less between sets of
electrodes, or suggesting that relative distances between electrodes is a
variable of significance. 5 The drawings, which are not indicated as being
drawn to scale, do not make up for this deficiency. Indeed, patent drawings
are not necessarily intended to show accurate relative dimensions and
arguments based on measurement of such drawings or, as apparently here,
5 For dependent claims 3-5, 15, and 16, the Examiner asserts that the
distances are merely result effective variables. Final Act. 4. But, as
Appellant points out, the Examiner provides no evidence and gives no
rationale sufficient to support this assertion. App. Br. 7-8. The Examiner's
only support, cited for the first time in the Answer, is to Appellant's
Specification. Ans. 5. Hindsight reconstruction of the claims, using the
Specification as a blueprint, is impermissible; and so too, the Examiner's
reliance on the Specification as the sole proof of the claimed relative
distances being alleged result effective variables is improper on this record.
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Appeal2017-007141
Application 14/263,933
"eyeballing" of an annotated patent drawing are of little value. Hockerson-
Halberstadt, Inc. v. Avia Group Int'!, Inc., 222 F.3d 951,956 (Fed. Cir.
2000) (holding that "it is well established that patent drawings do not define
the precise proportions of the elements and may not be relied on to show
particular sizes if the specification is completely silent on the issue"). Here,
the Examiner has not pointed to any teaching in the specification of
Schleicher '095 to suggest that we may rely on a measurement of the
drawings to determine distances between individual electrodes.
Second, as argued by Appellant, the Examiner provides no actual
reasoning to support the modification of Schleicher '095 's drawing and
electrical lead. App. Br. 7; Reply Br. 3--4 ("the linchpin in the argument in
the Examiner's Answer is that electrode 512 of Schleicher must be removed,
but the Examiner provides no rationale for the removal other than the
support the rejection of the claims over Schleicher."). Merely citing a legal
principle, without sufficient reasoning or application of such a principle to
the facts, is not enough. Cf In re Cofer, 354 F.2d 664,667 (CCPA 1966)
("[I]t is facts appearing in the record, rather than prior decision in and of
themselves, which must support the legal conclusion of obviousness."). The
Examiner cites In re Karlson as though it set forth a per se rule that omission
of an element in the prior art is always obvious when the remaining elements
perform the same functions. Final Act. 3. It did not, and per se rules are
generally inconsistent with the analysis required under § 103. In re Ochiai,
71 F.3d 1565, 1572 (Fed. Cir. 1995) ("The use of per se rules, while
undoubtedly less laborious than a searching comparison of the claimed
invention-including all its limitations-with the teachings of the prior art,
flouts section 103 and the fundamental case law applying it."). In fact, in
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Appeal2017-007141
Application 14/263,933
Karlson the court cited numerous reasons given in the record for modifying
the prior art that went beyond the simple notion that omission of an element
is always obvious. See In re Karlson, 311 F.2d 581,583 (CCPA 1963)
( agreeing with the Examiner's reasoning that eliminating a screen and filler
tube in the prior art feeding tank would, for example, allow a solution to be
introduced into that tank in a different manner). That is what is lacking here.
The record is wanting for any reason why the ordinarily skilled person would
have omitted electrode 512 in the manner proposed by the Examiner.
Third, in the Answer, the Examiner asserts for the first time that
"Schleicher '095 satisfies the independent claim with or without
modification (i.e., whether or not electrode 512 is omitted)." Ans. 4--5. We
remain unpersuaded. The Examiner still fails, on this record, to make a
sufficient showing that the distance limitations in the claims are disclosed or
otherwise obvious in view of an unmodified version of Schleicher '095 for
the reasons explained above. Moreover, claims 1 and 14 require at least two
anchoring units disposed, and longitudinally spaced apart from each other,
between the first set and second set of electrodes (i.e., within the claimed
third distance region). The Examiner does not explain persuasively how this
element is satisfied in an unmodified version of the lead shown in, for
example, Schleicher '095's Fig. 5B. In the region between the alleged first
set and second set of electrodes in unmodified Fig. 5B there appear to be
only two tines on opposing sides of the lead body-"at the same longitudinal
position" as argued by Appellant. See Ans. 4 ( alternative annotation of Fig.
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Appeal2017-007141
Application 14/263,933
5B); Reply Br. 3. 6 Those two tines would, thus, not be longitudinally spaced
apart from each other as required by the claims.
Conclusion of Law
For the reasons above, we are unpersuaded the preponderance of the
evidence on this record supports the Examiner's conclusion that the leads
recited in claims 1 and 14 ( as well as the systems requiring such leads in
claims 12 and 19) would have been obvious over Schleicher '095. For the
same reasons, we are unpersuaded the rejected dependent claims would have
been obvious over Schleicher '095. In re Fritch, 972 F.2d 1260, 1266 (Fed.
Cir. 1992) ("[D]ependent claims are nonobvious if the independent claims
from which they depend are nonobvious."). As to dependent claim 10, 7 the
Examiner has not asserted or shown that Schleicher '696 makes up for the
deficiencies discussed above.
6 Although we agree with Appellant as to Fig. 5B and the Examiner's
annotations of it, Appellant's argument that Schleicher '095 "only discloses
placing one pair of tines between each pair of electrodes" is not correct.
App. Br. 7; Reply Br. 3. To the contrary, Schleicher '095 discloses that "any
number of tines can be disposed between adjacent electrodes," and further
that "one or more rings of tines may be disposed between adjacent
electrodes," implying a longitudinal arrangement of such tines and/or rings
of tines between electrodes. Schleicher '095 ,r 67.
7 We observe that the element "the at least one anchoring element" in claim
10 (and also in claim 11) lacks antecedent basis. App. Br. 12. Claim 1,
from which claim 10 and 11 depend, uses the term "anchoring units."
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Application 14/263,933
SUMMARY
We reverse the rejections for obviousness on appeal.
REVERSED
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