Ex Parte Gerber et al

Patent Trial and Appeal Board

Feb 8, 2017

13011106 (P.T.A.B. Feb. 8, 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.
13/011,106 01/21/2011 Martin T. GERBER 134.07170101 4006
64619 7590 02/10/2017
MEDTRONIC, INC. (NEURO/MRG)
710 MEDTRONIC PARKWAY NE
MS-LC340
MINNEAPOLIS, MN 55432-5604
EXAMINER
HOUSTON, ELIZABETH
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
02/10/2017 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):
medtronic_neuro_docketing @ cardinal-ip.com
ptodocketing @ mrgs .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARTIN T. GERBER and MICHAEL D. BAUDINO
Appeal 2015-002663
Application 13/011,106
Technology Center 3700
Before WILLIAM A. CAPP, MICHAEL L. WOODS, and
ARTHUR M. PESLAK, Administrative Patent Judges.
CAPP, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants seek our review under 35 U.S.C. § 134 of the final
rejection of claims 14—19 as unpatentable under 35 U.S.C. § 103(a) over
Yang (US 5,824,030, iss. Oct. 20, 1998), Silipo (US 2010/0082087 Al, pub.
Apr. 1, 2010), and Bonde (US 2007/0255368 Al, pub. Nov. 1, 2007). We
have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
Appeal 2015-002663
Application 13/011,106
THE INVENTION
Appellants’ invention relates to medical leads that can be introduced
into patients. Spec. 1. Claim 14, reproduced below with language central to
the dispute highlighted in italics, illustrates the subject matter on appeal.
A system comprising:
a lead having a fixation element and a first electrode for
delivering an electrical signal to a patient,
wherein the fixation element is located on the lead distally
relative to the first electrode; and
an introducer having (i) a body member defining a lumen
extending from a proximal end of the body member to a distal
end of the body member, and (ii) a first conductive member
located between the proximal and distal ends of the body
member and extending into the lumen,
wherein the lead is slidably disposable in the lumen of the
body member and positionable in the lumen such that the first
electrode of the lead contacts and electrically couples to the
conductive member of the introducer, wherein the conductive
member is configured to be in communication with tissue of the
patient such that a test electrical signal applied through the first
electrode of the lead is applied to the tissue of the patient via
the first conductive member while the introducer is in the
patient’s body and the fixation element is retained in a
retracted configuration by a portion of the body member distal
the conductive member.
OPINION
Claim 14
The Examiner finds that Yang discloses all of the elements of
claim 14 except for retaining the fixation element in a retracted
configuration within the body of the introducer. Final Action 3^4. The
Examiner relies on Silipo as teaching an implantable lead there the fixation
element is retained in a retracted configuration. Id. at 4. The Examiner
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Application 13/011,106
further relies on Bonde as demonstrating that it was known to retain a
fixation element in a retracted configuration within an introducer and that
deploys to an expanded configuration after the fixation element exits the
body of the introducer. Id. at 4—5. The Examiner concludes that it would
have been obvious to a person of ordinary skill in the art at the time of the
invention to have the fixation element retained in a retracted configuration
when the lead is slidably disposed in the lumen of body member. Id. at 4.
According to the Examiner, a person of ordinary skill in the art would have
viewed this as a beneficial modification to Yang as Yang’s fixation elements
are always deployed to an expanded configuration with an attendant
disadvantage that they may inadvertently engage with undesired body tissue.
Id. at 6.
Appellants traverse the Examiner’s rejection by arguing against the
Examiner’s proposed combination. Appeal Br. 5—8. Among other things,
Appellants point out that Yang’s sheath 25 is affixed to the lead, making it
an integral part of the lead and, therefore, not an “introducer” within the
meaning of the claim. Id. at 7. Appellants also point out that Yang requires
a fixed, fluid tight seal between the lead and sheath at the distal end of 29 of
sheath 25. Id. at 8. Appellants argue that it is unclear how Yang’s sheath 25
could be modified such that fixation element 21 could be retained in a
retracted configuration by a portion of a body member distal to conductive
members 36, 37. Id. Appellants fault the Examiner’s rejection as failing to
explain how Yang’s sheath 25 could accommodate fixation element 21 in a
retracted position while maintaining its fluid tight seal and while otherwise
retaining its operability. Id. at 9. Appellants characterize the Examiner’s
proposed combination as rendering Yang unsatisfactory for its intended
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Application 13/011,106
purpose. Id. at 10 (“Modifying the alleged introducer 25 of Yang et al. such
that it extends over the alleged fixation element 21 would eliminate this fluid
seal”).
In response, the Examiner essentially concedes Appellants’ position
that eliminating Yang’s fluid tight seal would render Yang unsatisfactory for
its intended purpose. Ans. 5—8. Nevertheless, the Examiner states that Yang
could be modified so as to retain its fluid tight seal. Id. at 6. According to
the Examiner, the fluid tight seal of Yang could be extended past fixation
elements 21. Id. The Examiner takes the position that such a modification
would be both desirable and necessary as it would permit Yang’s tines 21 to
reside within the sheath in a contracted position. Id.
In our opinion, Appellants have successfully traversed the Examiner’s
rejection. We are not persuaded that extending Yang’s sheath beyond
tines 21, as proposed by the Examiner in the Answer, would result in an
operable device. The Examiner’s proposed modification does not account
for deformation of the sheath material which would take either or both of
two forms: (1) deformation of the sheath material surrounding the tines
during deployment from a retracted to a deployed configuration; and/or (2)
deformation of the sheath material along the axial length of the lead body
attendant upon axial contraction and extension before and after extension of
lead body 16 to deploy the tines. See e.g., Yang, Fig. 2. The obviousness
inquiry requires a determination that a skilled artisan would have been
motivated to combine the teachings of the prior art references to achieve the
claimed invention, and that the skilled artisan would have had a reasonable
expectation of success in doing so. See Kinetic Concepts, Inc. v. Smith &
Nephew, Inc., 688 F.3d 1342, 1360 (Fed. Cir. 2012). Given that the
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Application 13/011,106
Examiner’s proposed combination retains the fluid tight seal around the
distal end of Yang’s outer sheath 25 (Yang, col.. 5,11. 10—33, Fig. 2), we are
not persuaded that a person of ordinary skill in the art would have been
motivated to modify Yang in the manner proposed by the Examiner or that
such person would have untaken such a modification with a reasonable
expectation of success in achieving the claimed invention.
In view of the foregoing discussion, we do not sustain the Examiner’s
unpatentability rejection of claim 14.
Claims 15—19.
Claims 16 and 19 are independent claims. Claims App. Claim 15
depends from claim 14 and claims 17 and 18 depend from claim 16. Id.
The Examiner’s rejection of these claims suffers from essentially the same
infirmity with respect to modifying Yang that we have identified with
respect to claim 14 above. Thus, for essentially the same reasons discussed
above with respect to claim 14, we do not sustain the Examiner’s rejection
of claims 15—19.
DECISION
The decision of the Examiner to reject claims 14—19 is REVERSED.
REVERSED
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