Ex Parte Gerber

Patent Trial and Appeal Board

Jun 21, 2016

11606774 (P.T.A.B. Jun. 21, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/606,774 11130/2006
71996 7590 06/23/2016
SHUMAKER & SIEFFERT, P.A
1625 RADIO DRIVE, SUITE 100
WOODBURY, MN 55125
FIRST NAMED INVENTOR
Martin T. Gerber
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.
1023-597US01 6760
EXAMINER
LEVICKY, WILLIAM J
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
06/23/2016 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):
pairdocketing@ssiplaw.com
medtronic _neuro _ docketing@cardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte MARTIN T. GERBER
Appeal2014-002160
Application 11/606,7741
Technology Center 3700
Before JENNIFER D. BAHR, STEFAN STAICOVICI, and
LEE L. STEPINA, Administrative Patent Judges.
ST AI CO VICI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Martin T. Gerber (Appellant) appeals under 35 U.S.C. § 134(a) from
the Examiner's final decision rejecting claims 1-14 and 16-31. We have
jurisdiction over this appeal under 35 U.S.C. § 6(b ).
SUMMARY OF DECISION
We REVERSE.
According to Appellant, the real party in interest is Medtronic, Inc.
Appeal Br. 3 (filed July 18, 2013).
Appeal2014-002160
Application 11/606,774
INVENTION
Appellant's invention relates to "techniques for fixation of
implantable medical devices within a body of a patient." Spec. i-f 1.
Claims 1, 17, and 19 are independent. Claim 1 is illustrative of the
claimed invention and reads as follows:
1. A method comprising:
introducing an implantable medical device into
subcutaneous tissue below a scalp of a patient, the implantable
medical device defining an outer surface and comprising a
stimulation electrode extending at least partially around the
outer surface, the implantable medical device being configured
to deliver electrical stimulation therapy to the patient;
guiding the implantable medical device to a target tissue
site within the subcutaneous tissue proximate to at least one of
an occipital nerve or a trigeminal nerve of the patient, wherein
the target tissue site is selected such that delivery of electrical
stimulation therapy by the implantable medical device to the
target tissue site results in delivery of electrical stimulation
therapy to the at least one of the occipital nerve or the
trigeminal nerve; and
actively deploying a fixation element attached to the
implantable medical device, wherein the fixation element is
actively deployable from a first shape to a second shape that is
configured to engage with tissue at the target tissue site in order
to resist substantial movement of the implantable medical
device from the target tissue site, wherein the fixation element
extends from the outer surface of the implantable medical
device when the fixation element is in the second shape, and
wherein the fixation element comprises wire formed from at
least one of an elastic material or a shape memory material.
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Appeal2014-002160
Application 11/606,774
REJECTIONS
The following rejections are before us for review2 :
I. The Examiner rejected claims 1, 2, 4, 7-10, 13, 14, 16-19, 21-
24, 26, and 29-31under35 U.S.C. § 102(b) as being
anticipated by Mische (US 2005/0015129 Al pub. Jan. 20,
2005). 3
II. The Examiner rejected claims 3 and 20 under 35 U.S.C.
§ 103(a) as being unpatentable over Mische and Duysens (US
6,308,105 Bl, iss. Oct. 23, 2001).
III. The Examiner rejected claims 5 and 6 under 35 U.S.C. § 103(a)
as being unpatentable over Mische and Leopold (US 6,352,561
B 1, iss. Mar. 5, 2002).
IV. The Examiner rejected claim 11 under 35 U.S.C. § 103(a) as
being unpatentable over Mische and Zabara (US 5,540, 734, iss.
July 30, 1996).
V. The Examiner rejected claims 12 and 25 under 35 U.S.C.
§ 103(a) as being unpatentable over Mische and Tadlock (US
2004/0243206 Al, pub. Dec. 2, 2004).
2 The rejection of claim 12 under 35 U.S.C. § 112, second paragraph, as
being indefinite, has been withdrawn by the Examiner. See Ans. 3.
3 In the heading of Rejection I, Appellant includes claims 27 and 28,
but does not include claims 29-31. As claims 27 and 28 are not included in
the body of Rejection I, but are rejected under Rejection VI, we consider the
Examiner's inclusion of claims 27 and 28 as a typographical error. We also
consider the Examiner's omission of claims 29-31 from the heading of
Rejection I to be a typographical error because they are included in the body
of Rejection I.
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Application 11/606,774
VI. The Examiner rejected claims 27 and 28 under 35 U.S.C.
§ 103(a) as being unpatentable over Mische and Weiner (US
2002/0198572 Al, pub. Dec. 26, 2002).
ANALYSIS
Rejection I
Each of independent claims 1 and 17 requires, inter alia, a "fixation
element ... that is configured to engage with tissue at the target tissue site in
order to resist substantial movement of the implantable medical device from
the target tissue site." See Appeal Br. 25, 30. In a similar vein, independent
claim 19 recites "a "fixation element ... that is configured to engage with
tissue at the target tissue site in order to resist substantial movement of the
lead from the target tissue site." See id. at 31.
The Examiner finds that Mische teaches, inter alia, introducing an
implantable medical device (delivery catheter 32, 44) into tissue of a patient
and deploying a fixation element (tubular mesh mechanical stress device
(MSD) 34, 42, 52) "that is configured to engage with the tissue site in order
to resist substantial movement of the implantable medical device from the
tissue target site." Final Act. 3, 10 (transmitted Feb. 14, 2013); see also
Mische, i-fi-136-38; Figs. 3-5.
Appellant argues that Mische fails to teach that its MSD "is
configured to engage with the tissue site in order to resist substantial
movement of the delivery catheter . . . from the tissue target site." Appeal
Br. 10. According to Appellant, Mische's "catheter delivers the tubular
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Appeal2014-002160
Application 11/606,774
mesh MSD[] and does not disclose that the tubular mesh MSD 34 functions
in any manner as a fixation mechanism for the catheter." Id.
In response, the Examiner takes the position that "the MSD in an
expanded configuration clearly anchors the stimulation catheter/lead body as
the catheter/lead body is attached to the MSD." Ans. 6 (emphasis added).
According to the Examiner, when the MSD is connected directly to an
electric generator, "the MSD is indeed attached to the catheter by way of the
conductor." Id. at 5.
We do not agree with the Examiner's position because, although
Mische's MSD 34, 42, 52 includes hooks or other protruding elements that
may restrict movement of the MSD at the tissue site, this does not mean that
the MSD is also configured to resist movement of delivery catheter 32, 44.
See Mische i-f 30. In other words, Mische teaches at most that the hooks or
other protruding elements on the MSD are configured to restrict movement
of the MSD, but not the delivery catheter. The Examiner has not pointed to
any portion of Mische and we have not found any portion that teaches
restricting movement of the delivery catheter from the tissue site. To the
contrary, as Mische's claim 1 teaches placing an MSD at a tissue site with a
"placement device," i.e., a delivery catheter, and then removing the
placement device after placing the MSD, movement of the delivery catheter
is not restricted at the tissue site. Furthermore, even if the MSD is
connected directly to an electrical generator, as the Examiner opines, this
does not mean that movement of the delivery catheter is restricted by the
MSD. See Ans. 4--5; see also Mische i-f 49. At most, the MSD restricts
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Appeal2014-002160
Application 11/606,774
movement of the wire or cable connecting the MSD to the electrical
generator.
Accordingly, the Examiner's finding that Mische's MSD is
configured "to resist substantial movement" of the delivery catheter is
speculation and conjecture based on an unfounded assumption that the hooks
or other protruding elements of the MSD are configured to "to resist
substantial movement" of both the MSD and the delivery catheter. The
Examiner has not provided an adequate basis in fact and/ or technical
reasoning that would support the Examiner's finding that Mische's MSD
"anchors," that is, restricts substantial movement of the delivery catheter at
the tissue site.
In conclusion, for the foregoing reasons, we do not sustain the
rejection under 35 U.S.C. § 102(b) of claims 1, 2, 4, 7-10, 13, 14, 16-19,
21-24, 26, and 29-31 as being anticipated by Mische.
Rejections II-VI
The Examiner's use of the disclosures of Duysens, Leopold, Zabara,
Tadlock, and Weiner do not remedy the deficiencies of Mische as described
supra. See Final Act. 6-9. Therefore, for the same reasons as discussed
above, we also do not sustain the rejections under 35 U.S.C. § 103(a) of
claims 3 and 20 as unpatentable over Mische and Duysens; claims 5 and 6 as
unpatentable over Mische and Leopold; of claim 11 as unpatentable over
Mische and Zabara; of claims 12 and 25 as unpatentable over Mische and
Tadlock; and of claims 27 and 28 as unpatentable over Mische and Weiner.
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Application 11/606,774
SUMMARY
The Examiner's decision to reject claims 1-14 and 16-31 is reversed.
REVERSED
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