Ex Parte Leven

Patent Trial and Appeal Board

Jul 31, 2018

14091863 (P.T.A.B. Jul. 31, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/091,863 11/27/2013
50638 7590 07/31/2018
Boston Scientific Neuromodulation Corp.
c/o Lowe Graham Jones
701 Fifth Avenue
Suite 4800
Seattle, WA 98104
FIRST NAMED INVENTOR
Jacob B. Leven
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-1-269.1 7482
EXAMINER
EDWARDS, PHILIP CHARLES
ART UNIT PAPER NUMBER
3762
MAIL DATE DELIVERY MODE
07/31/2018 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 JACOB B. LEVEN
Appeal2017-004548
Application 14/091,863
Technology Center 3700
Before JEFFREY N. FREDMAN, JOHN E. SCHNEIDER, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
Appellant1 submits this appeal under 35 U.S.C. § 134 involving
claims to an electrical stimulation lead. The Examiner rejected the claims as
non-enabled and for obviousness. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We REVERSE. A new ground of rejection is, however, entered for
claim 13 based on obviousness.
1 Appellant identifies the Real Party in Interest as Boston Scientific
Neuromodulation Corporation. App. Br. 2.
Appeal2017-004548
Application 14/091,863
STATEMENT OF THE CASE
Appellant's "invention is ... directed to implantable electrical
stimulation leads having one or more distal reinforcing elements, as well as
methods of making and using the leads." Spec. 1: 10-12.
The Specification explains that "[i]nvasive electrical stimulation
systems have proven therapeutic in a variety of diseases and disorders," such
as treating chronic pain syndromes via systems implanted in the spinal cord
or brain. Id. at 1: 15-18. According to the Specification, "[t]o provide
effective stimulation, the electrodes should face the desired body part or
tissue to be stimulated." Id. at 2: 1-2. "During deployment, however, the
lead may twist or tum such that it may not be deployed in the desired
orientation" potentially resulting in "ineffective stimulation" and the need
for subsequent surgery/re-implantation. Id. at 2:4--9.
Claims 1-3, 5-8, and 11-18 are on appeal. Claims 1 and 13, the
independent claims, are illustrative and are reproduced below:
1. An electrical stimulation lead. comprising:
a lead body having a distal end, a proximal end, and a
longitudinal length, the lead body defining a central lumen
extending along the longitudinal length of the lead body:
a plurality of electrodes disposed along the distal end of
the lead body.
a plurality of terminals disposed along 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:
a tubular reinforcing member disposed in the central
lumen of the lead body entirely within the distal end of the lead
body. the reinforcing member extending proximal of the plurality
of electrodes and extending beneath no more than half of the
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Application 14/091,863
electrodes, wherein the reinforcing member is configured and
arranged to stiffen a portion of the distal end of the lead body in
which the reinforcing member resides: and
a stylet configured and arranged for insertion within the
central lumen and passing through the tubular reinforcing
member, wherein the stylet comprises a curved distal end that is
configured and arranged, when inserted into the lead, to cause at
least a portion of the distal end of the lead body, distal to the
tubular reinforcing member, to curve, wherein the stylet is
further configured and arranged so that the curved distal end is
temporarily straightened when the stylet is retracted so that the
curved distal end resides within the tubular reinforcing member.
13. an electrical stimulation lead comprising:
a lead body having a distal end, a proximal end, an
exterior, and a longitudinal length:
a plurality of electrodes disposed along the distal end of
the lead body,
a plurality of terminals disposed along 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
at least one reinforcing member disposed upon the exterior
of the distal end of the lead body proximal to the plurality of
electrodes, wherein the at least one reinforcing member is
configured and arranged to stiffen a portion of the distal end upon
which at least one reinforcing member is disposed.
App. Br. 11-13 (Claims App.).
The claims stand rejected as follows:
Claim 1 is rejected under 35 U.S.C. § 112(a) for failure to satisfy the
enablement requirement. Non-Final Act. 2-3. 2
2 Non-Final Office Action dated July 11, 2016.
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Claims 1-3, 5-8, and 11-18 under 35 U.S.C. § 103 for obviousness
over Paspa3 and Houser. 4 Non-Final Act. 3---6.
ENABLEMENT
The Examiner rejected claim 1 for lack of enablement because,
according to the Examiner, "the claim mixes limitations from embodiments
in figures 4A-C ... with limitations from the embodiments in figure 6A."
Non-Final Act. 3. The Examiner asserts that "[i]t is not clear to the
examiner how these embodiments are usable together." Id.
The issue with respect to this rejection is: has the Examiner
established by a preponderance of the evidence that the Specification does
not enable the claimed invention?
"[T]o be enabling, the specification of a patent must teach those
skilled in the art how to make and use the full scope of the claimed invention
without 'undue experimentation."' In re Wright, 999 F.2d 1557, 1561 (Fed.
Cir. 1993) ( citation omitted).
Factors to be considered in determining whether a disclosure
would require undue experimentation ... include (1) the quantity
of experimentation necessary, (2) the amount of direction or
guidance presented, (3) the presence or absence of working
examples, ( 4) the nature of the invention, ( 5) the state of the prior
art, ( 6) the relative skill of those in the art, (7) the predictability
or unpredictability of the art, and (8) the breadth of the claims.
In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
3 Paspa et al., US 6,606,521 B2, issued Aug. 12, 2003.
4 Houser et al., US 5,833,604, issued Nov. 10, 1998.
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Application 14/091,863
The Examiner has not met the burden to establish that claim 1 is non-
enabled. The Examiner provides no substantive findings and analysis ( such
as findings and analysis according to the Wands factors) sufficient to explain
why claim 1 fails the enablement requirement. And the Examiner fails to
state, much less explain, why it would require undue experimentation to
make or use the stimulation lead recited in claim 1.
Appellant argues that the Specification's use of the "same reference
number[ s ]" and a "continuous narrative" across the embodiments and figures
cited by the Examiner provide a clear linking disclosure sufficient to enable
claim 1. App. Br. 6; Reply Br. 2-3. On this record, we agree. Figures 4A,
4B, and 4C show, respectively, a tubular reinforcing member (450) beneath
half, none, or all of the electrodes (108) disposed on the distal portion of the
lead body (410). Spec. Figs. 4A---C. The Specification discloses that, "[f]or
example, the reinforcing member 450 may extend beneath one of the
electrodes or less than half of the electrodes, or half the electrodes, or more
than half of the electrodes." Spec. 11: 12-16. The Specification's very next
paragraph describes Figure 5, which shows reinforcing member ( 450)
beneath half the electrodes (108), and explains that a stylet ( 452) may be
disposed in the lead's central lumen. Spec. 11 :24--26 and Fig. 5. The
Specification continues, further explaining Figure 5, and disclosing that
"[a]ny suitable stylet can be used including straight stylets or stylets that are
curved along part or all of the length of the stylet." Id. at 12:16-18. The
Specification then immediately describes Figures 6A and 6B, expressly
indicating that the "electrodes are not illustrated in these two Figures for
clarity in illustrating operations with the stylet." Id. at 12:21-23. Yet the
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Application 14/091,863
Specification explains how, as shown in Figures 6A and 6B, the sty let ( 452)
may include a curved distal end that causes a portion of the lead body
beyond tubular reinforcing member ( 450) to curve when the stylet is moved
distally, and how withdrawal of the sty let into the tubular reinforcing
member will temporarily straighten the stylet. Id. at 12:23-28. We are
persuaded the skilled artisan could, based on these disclosures, make and use
the subject matter of claim 1 without undue experimentation.
In response to the Appellant's arguments, the Examiner states that
"[ t ]he examiner is neither persuaded nor not persuaded." Ans. 3. What does
that mean? The Board cannot sustain a rejection for lack of enablement
based on a record where the evidence is in equipoise ( even if that was the
case here, which it is not). The Examiner concedes that the described
embodiments "may be usable together," but maintains the rejection because
"the applicant appears to be mixing embodiments." Id. Critically missing,
however, is any evidence or analysis showing why this alleged "mixing"
would require undue experimentation.
OBVIOUSNESS
Claim 1
The Examiner finds that Paspa discloses the subject matter of claim 1,
except for ( 1) "the reinforcing member extending beneath no more than half
of the electrodes," and (2) the "sty let" having a "curved distal end" that is
configured: (i) when inserted, to cause a portion of the lead distal to the
reinforcing member to curve and; (ii) when the stylet is retracted within the
reinforcing member, to temporarily straighten. Non-Final Act. 4. So, the
Examiner turns to Houser, finding "Houser teaches that it is known to use
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Application 14/091,863
such a modification as set forth in [Rouser's] abstract, figures 2 and 3,
element 61, column 4 lines 3-24 to provide more precise steering of the
distal end of the lead body." Id. at 4--5. The Examiner concludes it would
have been obvious to modify Paspa's system "with such a modification as
taught by Houser, since such a modification would provide the predictable
results of more precise steering of the distal end of the lead body." Id. at 5.
It is not clear, on this record, how specifically the Examiner is
proposing Paspa's system be modified and how such a modification would
meet all the structural limitations of claim 1. Structure 61 of Houser is a
rigid curve adjusting tube, which moves axially along a distal portion of a
catheter body with the aid of a mandrel. Houser Figs. 2-3; see also id. 4:3-
24. It is not, however, curved and therefore cannot be a curved stylet with
the features required in claim 1. Insofar as the Examiner suggests the
bendable support wire (34) of Houser is a stylet ( a position not set forth in
the Non-Final Act.), that wire cannot be inserted or withdrawn relative to
Rouser's catheter or lead. Ans. 3. Rather, as Appellant points out, Rouser's
support wire is permanently disposed within the catheter and affixed to a
steering assembly. App. Br. 8. To the extent support wire (34) bends or
straightens in Houser, it appears to do so based on manipulation of steering
wires in Rouser's handle in combination with axial movement of the curve
adjusting tube ( 61) over portions of the support wire (34). Houser 3 :42-
4:23; Reply Br. 4--6. In short, we agree with Appellant here that Rouser's
steering mechanism operates by a different mechanism than recited in claim
1 (App. Br. 7-8), and the Examiner has not explained sufficiently how
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Application 14/091,863
Paspa's implantable lead would be modified based on Rouser's mechanism
to produce the device recited in claim 1.
For these reasons, we reverse the rejection of claim 1 over Paspa and
Houser. We also reverse the rejection of claims 2, 3, 5-8, and 12, which
depend from claim 1. 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.").
Claim 13
Citing the same disclosures in Paspa (particularly Figs. 2 and 3), the
Examiner finds that Paspa teaches the subject matter of claim 13 "except for
the at least one reinforcing member disposed upon the exterior of the distal
end of the lead body proximal of the plurality of electrodes." Non-Final Act.
6. Figure 3 of Paspa is reproduced below.
116 104 · .. · · ·
114- ~
1 100 ,,
Figure 3
~~-116· I ..
'
Figure 3 is a cross-sectional view of a distal end (104) of lead body (100),
having a longitudinal lumen (120), within which reinforcing tube (118) is
beneath all the outwardly facing electrodes (108) at the lead's distal end.
See Paspa, 5:36-47. The Examiner concludes that it would have been
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Application 14/091,863
obvious to change Paspa's design (in Fig. 3) "to dispose the reinforcing
member upon the exterior of the distal end of the lead body proximal to the
plurality of electrodes" because merely "rearranging parts of a prior art
structure involves only routing [sic] skill in the art." Non-Final Act. 6.
We are unpersuaded on this record that merely an obvious
rearrangement of parts shown in Paspa's Figure 3 is required to arrive at the
subject matter of claim 13. As Appellant notes, "reinforcing tube 118 of
Paspa is disposed beneath [all] the electrodes, not proximal to the
electrodes." App. Br. 9. At minimum, the skilled person would need to
redesign Paspa's Figure 3 to place reinforcing tube 118 on the exterior of the
lead's distal end (104) and to shorten or move the reinforcing tube away
from the lead's distal tip so that it is located proximal to the plurality of
electrodes. As Appellant notes, such a modification would reduce rigidity at
lead's distal end contrary to Paspa's teachings. App. Br. 9-10. Apart from
asserting that the proposed modification is simply an obvious rearrangement
of parts, the Examiner has not provided sufficient evidence or technical
reasoning to show why this modification of Paspa would have been made. 5
For the reasons above, we reverse the rejection of claim 13 (and
dependent claims 14--18) over Paspa and Houser.
5 The Examiner, for example, offers no reasoning to explain whether other
features in Paspa (e.g., a stylet or a helical conductor set) could or would
provide longitudinal resilience to mitigate the decrease in distal resilience
and rigidity arising from the modification proposed. See Paspa, 5:26-30,
5 :44--4 7. The Examiner's assertion that the modified "reinforcing tube will
still provide rigidness to the distal portion of the lead body until the tube
stops analogous to what applicant is claiming" relies on hindsight. Ans. 5.
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NEW GROUNDS OF REJECTION
As explained further below, we enter a New Ground of Rejection of
claim 13 under 35 U.S.C. § 103(a) as obvious over Paspa. 6
We agree with the Examiner's findings that Paspa teaches the "lead
body," "plurality of electrodes," "plurality of terminals," and "plurality of
conductors" with the features recited in claim 13. Non-Final Act. 3--4;
Paspa, Fig. 2 (e.g., structures 100, 101, 104, 106, 108, 116); see also id. 4:9--
23. Appellant did not argue to the contrary. App. Br. 9--10.
The only remaining limitation of claim 13 recites "at least one
reinforcing member disposed upon the exterior of the distal end of the lead
body proximal to the plurality of electrodes, wherein the at least one
reinforcing member is configured and arranged to stiffen a portion of the
distal end upon which the at least one reinforcing member is disposed."
App. Br. 13. As broadly recited, Paspa teaches or suggests this limitation.
Paspa, for example, teaches a cannula (134) disposed upon the exterior of
lead (100) during a lead placement procedure. Paspa, 5:60-6:39. Paspa
teaches the cannula is generally constructed of stainless steel. Id. at 6: 12-
6 Should there be further prosecution, we leave to the Examiner to determine
whether to make a new ground of rejection of other claims dependent on
claim 13. See 37 C.F.R. § 4I.50(b); see also Manual of Patent Examining
Procedure (MPEP) § 1213.02. Under 37 C.F.R. § 4I.50(b), the Board may,
in its decision, make a new rejection of one or more of any of the claims
pending in the case. Because the exercise of authority under 37 C.F.R. §
41.50(b) is discretionary, no inference should be drawn from the decision to
exercise that discretion with respect to some but not all of the claims on
appeal.
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13. And Paspa's Figure 4a further shows the cannula's distal end (138)
disposed near, yet proximal to the lead's distal electrodes. Id. Fig. 4a; see
also id. Figs. 1 a-1 d ( showing a traditional lead placement technique), 1: 54--
2 :4 (describing a traditional lead placement technique disclosing that
"cannula 14" is "a rigid tunneling and positioning tool capable of sliding
over the brain lead"). Given the cannula's position on the lead and the
cannula' s material ( e.g., made of stainless steel or other rigid material), the
cannula would stiffen a portion of the lead's distal end as required by claim
13. Accordingly, for the above reasons, we conclude that claim 13 would
have been obvious over Paspa.
SUMMARY
We reverse the rejection of claim 1 for lack of enablement, and further
reverse the rejection of claims 1-3, 5-8, and 11-18 as obvious over Paspa
and Houser. We enter a New Ground of Rejection of claim 13 under 35
U.S.C. § 103 over Paspa.
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 4I.50(b). Section 4I.50(b) provides "[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review."
Section 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
( 1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
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Application 14/091,863
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under §41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the MANUAL OF PATENT EXAMINING PROCEDURE§ 1214.01 (9th
Ed., Rev. 07.2015, Nov. 2015).
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
REVERSED; 37 C.F.R. § 4I.50(b)
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