Ex Parte Wahlstrand et al

Patent Trial and Appeal Board

Jan 22, 2019

15366349 (P.T.A.B. Jan. 22, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
15/366,349 12/01/2016
64619 7590 01/24/2019
MEDTRONIC, INC. (NEURO/MRG)
710 MEDTRONIC PARKWAY NE
MS-LC340
MINNEAPOLIS, MN 55432-5604
FIRST NAMED INVENTOR
Carl D. Wahlstrand
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.
134.05590102 1617
EXAMINER
WEISBERG, AMY REGINA
ART UNIT PAPER NUMBER
3649
NOTIFICATION DATE DELIVERY MODE
01/24/2019 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):
ptodocketing@mrgs.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte CARL D. WAHLSTRAND, JOHN E. KAST,
GABRIELA C. MOLNAR, GLENNA L. CASE, LISA M. JOHANEK, and
PHILLIP C. FALKNER
Appeal2018-001987
Application 15/3 66,349
Technology Center 3700
Before STEVEN D.A. McCARTHY, JEREMY M. PLENZLER, and
ALYSSA A. FINAMORE, Administrative Patent Judges.
PLENZLER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant seeks our review under 35 U.S.C. § 134(a) of the
Examiner's Decision rejecting claims 21--45. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.
Appeal2018-001987
Application 15/366,349
CLAIMED SUBJECT MATTER
Claims 21, 32, and 41 are independent, with claims 22-31, 33--40, and
42--45 depending from claim 21, 32, or 41. Claim 21 is reproduced below:
21. An introducer for introducing a medical lead into a
patient, the introducer comprising:
a shaft;
a lumen configured to receive the medical lead;
a radial component; and
an arcuate component having a proximal end and a distal
end, the arcuate component connected to the radial component
and the radial component connected to the shaft, wherein the
distal end defines a distal opening in communication with the
lumen,
wherein the arcuate component extends along a closed
path at least 90 degrees and less than 360 degrees and is
configured to tunnel a path through subcutaneous tissue,
wherein the introducer is configured such that rotating
the shaft results in rotation of the arcuate component to create
an arcuate path through subcutaneous tissue, and
wherein projecting the introducer onto a plane with a
longitudinal axis of the shaft normal to the plane produces an
arcuate shape defined by the arcuate component.
REJECTIONS
1. Claims 21-30, 32-39, and 41--44 are rejected under 35 U.S.C.
§ 102(b) as anticipated by Wijayarthna (US 4,694,838, issued Sept. 22,
1987).
2. Claims 31, 40, and 45 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Wijayarthna and Pohndorf (US 4,512,351, issued
Apr. 23, 1985).
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Application 15/366,349
OPINION
Claims 21, 32, and 41 are each directed to "[a]n introducer for
introducing a medical lead into a patient" with a "lumen configured to
receive the medical lead." The introducer of claims 21 and 32 includes an
"arcuate component configured to tunnel a path through subcutaneous tissue,
the introducer [being] configured such that rotating the shaft results in
rotation of the arcuate component to create an arcuate path through
subcutaneous tissue." Claim 41 similarly recites that the arcuate component
"is configured to tunnel through subcutaneous tissue." Claim 44, which
depends from claim 41, recites "wherein the introducer is configured such
that twisting the shaft results in rotation of the arcuate component to create
an arcuate path through subcutaneous tissue."
The Examiner finds that "Wijayarthna teaches an introducer (see
figure 1) capable of being used for introducing the medical lead into a
patient" and "the introducer is configured such that rotating the shaft results
in rotation of the arcuate component to create an arcuate path through
subcutaneous tissue, see figure 1." Final Act. 3--4 ( addressing claim 21 ); see
also id. at 6, 8 (addressing claims 32 and 41 in same manner). In the
Answer, the Examiner explains that Wijayarthna's device is "configured
such that rotating the shaft results in rotation of the arcuate component to
create an arcuate path through subcutaneous tissue," as recited in claims 21
and 32, because "Wijayarthna does not provide any disclosure of a reason
the device is not fully capable of being used to tunnel through tissue without
the use of a sheath or guidewire." Ans. 5 (explaining that the "configured
to" limitations recited in the claims are simply an intended use). The
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Application 15/366,349
Examiner additionally determines that the "tunnel[ling]" recited in the
claims does not require the introducer to create any passage. Id. at 4.
Appellant disputes these findings. Appeal Br. 7-12. We agree that
the Examiner erred in finding these elements are disclosed by Wijayarthna.
One problem with the rejection is that the Examiner misapprehends
the requirements of the "configured to" limitations recited in the claims.
Those limitations do not simply recite an intended use, as the Examiner
asserts. Rather, those limitations require that the apparatus "is designed or
constructed to be used" in the manner recited. In re Giannelli, 739 F.3d
1375, 1379 (Fed. Cir. 2014). As Appellant explains, this is clear from the
Specification. Appeal Br. 10 ( citing Spec. ,r,r 31, 46, 58). The Specification
explains, for example, that the distal end of the introducer "may be blunt or
have a sharp end to facilitate advancement of arcuate component 24 through
tissue of a patient" (Spec. ,r 33), and "the introducers or components thereof
are formed from metal, alloy, or hard plastic material" (id. ,r 58) so that "the
distal end 29 of the arcuate component 24 [ of the introducer can be] inserted
through or past the skin" and "the shaft 22 [ of the introducer can] be twisted
about its axis ... to cause arcuate component 24 to tunnel a semi-circular
path beneath the skin 60 of the patient" (id. ,r 46).
Appellant explains that "the device of Wijayarthna ... is a device that
is introduced into a patient through the use of an introducer (guidewire or
sheath) and is not an introducer in the parlance of the present claims when
read in light of the present specification." Appeal Br. 9 (citing Wijayarthna,
5:47-50). Appellant further explains that when describing its structure,
Wijayarthna states that "[t]he tip portion forming the loop is made of a soft
flexible material ... so as to be inserted over the guidewire or positioned
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Appeal2018-001987
Application 15/366,349
within the sheath." Id. at 11-12 (citing Wijayarthna, 5:18-25). Appellant is
correct.
The Examiner responds that "[t]he act of tunneling through tissue
does not require the device to cut tissue but simply to form a passageway
through the tissue, which the device ofWijayarthna would do when
extended through an opening in the tissue due to its hollow cylindrical
shape." Ans. 4. That is, the Examiner determines that passing
Wijayarthna's catheter through an existing opening is tunneling. The
Examiner, however, provides no explanation as to why that reading of the
claims is consistent with Appellant's Specification. Appellant responds that
it is not. Reply Br. 3--4. We agree with Appellant. As explained above,
Appellant's Specification clearly describes the introducer as forming the
opening (i.e., tunneling) and having the structure necessary to perform the
tunneling. See Spec. ,r,r 33, 46, 58. Reading the claims in the manner
proposed by the Examiner would not be consistent with the Specification.
Under the proper reading of the claims, the Examiner has not
established that Wijayarthna's catheter is capable of "tunnel[ling] ...
through subcutaneous tissue," let alone that it is designed or constructed to
be used in that manner as required by the claims. The Examiner fails to
explain sufficiently, for example, why the soft flexible catheter of
Wijayarthna is designed or constructed to perform the recited tunneling.
Accordingly, we do not sustain the Examiner's decision to reject
claims 21--45.
DECISION
We REVERSE the Examiner's decision to reject claims 21--45.
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Appeal2018-001987
Application 15/366,349
REVERSED
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