Ex Parte True et al

Patent Trial and Appeal Board

Sep 26, 2017

13721923 (P.T.A.B. Sep. 26, 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.
13/721,923 12/20/2012 Kyle True 432469 000083 9881
42074 7590 09/28/2017
Faegre Baker Daniels LLP
PATENT DOCKETING - INTELLECTUAL PROPERTY (32469)
2200 WELLS FARGO CENTER
90 SOUTH SEVENTH STREET
MINNEAPOLIS, MN 55402-3901
EXAMINER
FLORY, CHRISTOPHER A
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
09/28/2017 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 @ F aegreB D .com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KYLE TRUE and BRIAN SOLTIS1
Appeal 2016-008106
Application 13/721,923
Technology Center 3700
Before JEFFREY N. FREDMAN, RYAN H. FLAX, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to an implantable medical lead. Claims 1—16,21, and 22 are
on appeal as rejected under 35 U.S.C. § 103(a). We have jurisdiction under
35 U.S.C. § 6(b).
We affirm-in-part.
1 The Real Party in Interest is identified as “Cardiac Pacemakers, Inc. ... a
wholly owned subsidiary of Boston Scientific Corporation.” App. Br. 3.
Appeal 2016-008106
Application 13/721,923
STATEMENT OF THE CASE
Claims 1,11, and 21 are the independent claims. We find claim 1
representative and it is reproduced below (emphasis highlighting Appellants’
argued limitations added):
1. An implantable medical lead for stimulating or sensing
a target tissue and minimizing stimulation of a surrounding
tissue, the implantable medical lead comprising:
a lead body including a proximal end portion and a distal
end portion, the lead body formed from a flexible and electrically
insulative material that defines an outer periphery of the lead
body, the lead body further comprising at least one electrode
extending circumferentially along the outer periphery of the lead
body, the at least one electrode located on the distal end portion
of the lead body;
an insulating sheath disposed over at least a portion of the
distal end portion of the lead body and the at least one electrode,
the insulating sheath formed from an electrically insulative
polymer material and configured to rotate about the lead body
and the at least one electrode, the insulating sheath having at
least one window adapted to electrically expose at least one
portion of the at least one electrode to the target tissue while
the electrically insulative polymer material of the sheath
simultaneously covers at least one other portion of the at least
one electrode to electrically insulate the at least one other
portion, wherein the window is formed from a solid, electrically
permeable material that allows stimulation energy to pass
through the electrically permeable material, and
at least one protmsion extending radially outward from a
portion of the insulating sheath at a location generally opposed
to the at least one window the protrusion adapted to urge the
electrically exposed at least one portion of the at least one
electrode toward the target tissue upon rotation of the insulating
sheath with respect to the lead body to shorten a distance between
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Application 13/721,923
the electrically exposed at least one portion of the at least one
electrode and the target tissue.
App. Br. 15 (Claims App’x).
The following rejection is on appeal:2
Claims 1—16, 21, and 22 stand rejected under 35 U.S.C. § 103(a) over
Sommer,3 Soltis,4 and Knapp.5 Ans. 2.
FINDINGS OF FACT
Except where otherwise indicated in this decision, we agree with and
adopt the Examiner’s findings of fact and determinations as to the scope and
content of the prior art. We identify the following facts to highlight certain
evidence of record.
FF1. Sommer is directed to and discloses:
An implantable lead including a lead body including an outer
surface, a proximal end, a distal end, and at least one electrode;
an electrically insulating member that extends axially over a first
portion of the outer surface of the lead body between the
proximal end and distal end, the electrically insulating member
defining at least one aperture that exposes a first portion of the at
least one electrode when in a first position over the lead body.
Sommer abstract; see also Final Action 2—8, and Ans. 2, 3, 8
(discussing Sommer).
2 Rejection of claims 1—8, 10-12, and 14—16 under 35 U.S.C. § 103(a) over
“Sommer,” “Soltis,” and “Hall,” “Harrington,” or “Krall,” has been
withdrawn by the Examiner. Ans. 2.
3 US 2010/0331938 A1 (published Dec. 30, 2010) (“Sommer”).
4 US 2007/0293923 A1 (published Dec. 20, 2007) (“Soltis”).
5 US 2008/0161871 A1 (published July 3, 2008) (“Knapp”).
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Application 13/721,923
FF2. Sommer illustrates such a device at Fig. 2A, which is
reproduced below:
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“FIGS. 2A [is a] conceptual diagram[] illustrating an example lead
including an example reinforcement member and example insulating
member.” Sommer 113; see also Final Action 2—8, and Ans. 2, 3, 8
(discussing Sommer). Fig. 2A shows a lead 38 with a lead body 40
and an insulating member 36 thereover. Sommer 145; see also Final
Action 2—8, and Ans. 2, 3, 8 (discussing Sommer). The lead body 14
includes electrodes 46 and the insulating member 36 includes
apertures 42A, 42B that are “sized and shaped to expose portions of
electrodes 46.” Sommer H 48-49; see also Final Action 2—8, and
Ans. 2, 3, 8 (discussing Sommer).
FF3. Sommer discloses the “insulating member 36 . . . rotates
. . . over lead body 40 ... to selectively expose and cover portions of
electrodes 46 and 48 via apertures 42.” Sommer 1 54; see also Final
Action 2—8, and Ans. 2, 3, 8 (discussing Sommer).
FF4. Knapp is directed to and discloses “a lead assembly
including a lead body, at least one conductor extending through the
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Application 13/721,923
lead body, and a covering having varied material properties.” Knapp
abstract; see also Final Action 2, 4, 7—9, and Ans. 2, 4—8 (discussing
Knapp).
FF5. Knapp illustrates such a device at Fig. 2B, which is
reproduced below:
FIG. 2B shows a lead assembly 215 having:
a covering 260 [that] includes separate covers 265, 270, 275
having different material properties. In an example, the covers
265, 270, 275 are made from different forms (e.g. varying
porosity) of the same polymer. In an example, the covers 265,
270, 275 are joined together, for example by heat bonding,
adhesive bonding, welding, solvent bonding, or laser sintering.
Covers 265, 275 extend over defibrillation electrodes 230, 235
and a portion of a lead body 205. In an example, at least a portion
of the covers 265, 275 extending over the electrodes 230, 235 are
conductive.
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Application 13/721,923
Knapp 126; see also Final Action 2, 4, 7—9, and Ans. 2, 4—8
(discussing Knapp). Knapp further explains that the lead assembly
covering can be “polytetrafluoroethylene (PTFE) and expanded
polytetrafluoroethylene (ePTFE). . . . Fully dense PTFE provides
good abrasion resistance, dielectric integrity, and lubricity. In an
example, portions of a covering near or over an electrode, such as a
defibrillation electrode, are formed from ePTFE to provide electrical
conductivity through the covering.” Knapp 125; see also Final
Action 2, 4, 7—9, and Ans. 2, 4—8 (discussing Knapp).
FF6. Knapp explains that:
[f]orming a cover from a single polymer having varying material
properties can provide a number of advantages. In an example,
a covering having varying material properties provides desirable
handling characteristics, such as flexibility, pushability, and/or
abrasion resistance. Varying forms (e.g. expanded and non-
expanded polytetrafluoroethylene (PTFE)) of a single polymer
tend to bond well, while bonds between dissimilar materials (e.g.
polyethylene and PTFE) can provide weak points in a lead
assembly. In an example, varying the properties in lead assembly
covering limits fibrotic adhesion and tissue ingrowth and
supports extractability of a lead.
Knapp 118; see also Final Action 2, 4, 7—9, and Ans. 2, 4—8
(discussing Knapp).
DISCUSSION
Only those arguments made by Appellants in the Briefs have been
considered in this Decision. Arguments not presented in the Briefs are
waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015).
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Application 13/721,923
“[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,” and
“[t]he combination of familiar elements according to known methods is
likely to be obvious when it does no more than yield predictable results.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (citing U.S. v.
Adams, 383 U.S. 39, 50-51 (1966)). As to motivation to combine separately
disclosed subject matter, ‘“the question is whether there is something in the
prior art as a whole to suggest the desirability, and thus the obviousness, of
making the combination.’” In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir.
2004) (citation omitted).
Claims 1, 11, and 21
We find that, under the above-cited precedent and in view of the
evidence of record, the Examiner has established a prima facie case that
claim 1 would have been obvious over Sommer, Soltis, and Knapp.
Appellants have not produced persuasive evidence showing, or persuasively
argued, that the Examiner’s determinations are incorrect. We address
Appellants’ arguments below.
Appellants argue:
Independent claims 1, 11, and 21 recite, in part, an insulating
sheath having at least one window formed from a solid,
electrically permeable polymeric material and is adapted to
electrically expose at least one portion of the at least one
electrode by permitting stimulation energy emitted from the at
least one portion of the at least one electrode to pass through the
electrically permeable polymeric material to the target tissue
while another portion of the at least one electrode is covered and
electrically insulated by the electrically insulative polymer
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Application 13/721,923
material of the insulating sheath. The Examiner asserts that this
limitation is met by the polymer cover disclosed in Knapp
(Advisory Action, p. 2). The Appellant respectfully disagrees.
App. Br. 9. Appellants also argue that Sommer and Knapp fail to teach a
polymer covering that is rotatable with respect to the underlying lead /
electrode. Id. at 11. These arguments are not persuasive.
We find the Examiner’s position on Sommer and Knapp is supported
by the weight of evidence. Sommer discloses apertures (windows) on a
rotatable sheath, where the apertures (windows) correspond to electrodes of
an underlying lead. FF1—FF3. Knapp teaches that such apertures (windows)
can be solid material that is similar to, but structurally and/or functionally
modified with respect to other parts of the sheath material so that the
apertures are, e.g., electrically conductive at electrode sites. FF4—FF5. The
Examiner identifies compelling rationale for motivation to make this prior
art combination and modification. FF6.
For the reasons above, we affirm this rejection as to claims 1, 2, 4—15,
21, and 22.
Claims 3 and 16
Appellants separately argue the patentability of claims 3 and 16. App.
Br. 12. These claims each recite, “wherein the insulating sheath comprises
an inner insulating member and an outer insulating member having a
compartment, and further wherein the protrusion is disposed on the inner
insulating member and is configured to extend at least partially through the
compartment.” Id. at 16, 18.
Appellants argue “[dependent claims 3 and 16 recite wherein the
insulating sheath comprises an inner insulating member and an outer
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Application 13/721,923
insulating member having a compartment, and further wherein the
protrusion is disposed on the inner insulating member and is configured to
extend at least partially through the compartment.” Id. at 12. Appellants
argue that the Examiner has not established a prima facie case of
obviousness because Soltis discloses a protrusion on an outer sheath (i.e.,
sheath 40), but not on an inner sheath (i.e., sheath 42), and also fails to
disclose a compartment through which a protrusion extends. Id. We find
these arguments persuasive.
In support of the determination of obviousness regarding the claim
term “compartment” and the associated protrusions, the Examiner makes,
essentially, an indefmiteness argument, contending that the generalness with
which Appellants’ Specification describes “compartment” opens the term to
the disclosure of Soltis. Ans. 8—9. We do not agree with the Examiner’s
determinations.
The Specification does not expressly define “compartment.”
Merriam-Webster, however, defines “compartment” as: “1 : a separate
division or section[;] 2 : one of the parts into which an enclosed space is
divided.” Merriam-Webster Dictionary, compartment,
https://www.merriam-webster.com/dictionary/compartment (last visited
Sept. 18, 2017). No matter how broadly one interprets “compartment,” here,
the Examiner has not demonstrated that Soltis teaches the inner and outer
sheaths have a compartment where a protrusion from the inner sheath
extends there-into.
For this reason, we reverse the rejection as to claims 3 and 16.
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SUMMARY
The rejection under 35 U.S.C. § 103(a) over Sommer, Soltis, and
Knapp is affirmed with respect to claims 1, 2, 4—15, 21, and 22 and is
reversed with respect to claims 3 and 16.
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
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