Ex Parte Wu et al

Patent Trial and Appeal Board

Oct 10, 2018

12495691 (P.T.A.B. Oct. 10, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/495,691 06/30/2009 Andrew Wu
28390 7590 10/12/2018
MEDTRONIC VASCULAR, INC.
IP LEGAL DEPARTMENT
3576 UNOCAL PLACE
SANTA ROSA, CA 95403
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.
P0041110.0l US 3208
EXAMINER
VAHDAT, KHADIJEHA
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
10/12/2018 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):
rs.vasciplegal@medtronic.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANDREW WU, BENJAMIN J. CLARK, DENISE ZARINS, and
ERIK THAI
Appeal2017-005808
Application 12/495,691 1
Technology Center 3700
Before FRANCISCO C. PRATS, TA WEN CHANG and
DAVID COTTA, Administrative Patent Judges.
COTT A, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
catheter apparatus. The Examiner rejected the claims on appeal under 35
U.S.C. §§ 102(b) and (e) as anticipated and under 35 U.S.C. § 103(a) as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the real party in interest is Medtronic Ardian
Luxembourg S.a.r.l., which is a subsidiary of Medtronic, Inc., a wholly-
owned subsidiary of Medtronic plc. App. Br. 1.
Appeal2017-005808
Application 12/495,691
STATEMENT OF THE CASE
Claims 15-18, 20-22, 24, 25, 28, and 33--41 are on appeal.
Claim 15 and 36 are illustrative and read as follows:
15. A catheter apparatus, comprising:
an elongated shaft extending along an axis;
a distal tip of the catheter apparatus consisting of a single
electrode configured to apply treatment to tissue using at least
one of radiofrequency energy and microwave energy; and
a distal flexure zone separating the electrode and the
elongated shaft by a fixed length, wherein the distal flexure
zone is configured to carry the electrode, and further wherein
the distal flexure zone comprises a flexible structure more
flexible than the elongated shaft and having an outermost
surface extending between the electrode and the elongated shaft
and composed of a non-conductive polymer coating or sheath,
and
wherein, in response to a force applied to the electrode
via contact with the tissue surface, the flexible structure
accommodates passive flexure in any plane through the axis
and forms an angle between the electrode and a distal end of the
elongated shaft.
36. A catheter comprising:
an elongated shaft extending along an axis to a shaft
distal end;
a single, non-expandable electrode disposed on the axis
at a fixed length distal from the shaft distal end, wherein the
electrode is configured to apply treatment to tissue using at
least one of radiofrequency energy and microwave energy; and
a distal flexure zone attaching the electrode to the shaft
distal end;
wherein the distal flexure zone is configured to facilitate
stable contact between the electrode and a tissue surface of a
patient;
wherein the distal flexure zone comprises a flexible
structure more flexible than the elongated shaft and having an
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Appeal2017-005808
Application 12/495,691
outermost surface composed of an electrically insulating
polymer coating or sheath, and
wherein, in response to a force applied to the electrode
via contact with the tissue surface, the flexible structure
accommodates passive flexure in any plane through the axis
and forms an angle between the electrode and the distal end of
the elongated shaft.
App. Br. 13, 15 ( emphasis added to highlight limitations at issue).
The claims stand rejected as follows.
1. Claims 15-18, 28, 33, 34, and 36 were rejected under 35 U.S.C.
§ 102( e) as anticipated by Govari. 2
2. Claim 36 was rejected under 35 U.S.C. § I02(b) as anticipated
by Kaplan. 3
3. Claims 20-22, 24, and 25 were rejected under 35 U.S.C. §
I03(a) as obvious over Govari.
4. Claim 35 was rejected under 35 U.S.C. § I03(a) as obvious
over the combination of Govari and Tu. 4
5. Claim 35 was rejected under 35 U.S.C. § I03(a) as obvious
over the combination of Govari and Panescu. 5
6. Claims 37--41 were rejected under 35 U.S.C. § I03(a) as
obvious over the combination of Govari and Zarins. 6
2 Govari et al., US Patent Publication No. 2009/0093806 Al, published Apr.
9, 2009 ("Govari").
3 Kaplan et al., US Patent Publication No. 2006/0247619 Al, published Nov.
2, 2006 ("Kaplan").
4 Tu et al., US Patent No. 5,891,027, issued Apr. 6, 1999 ("Tu").
5 Panescu et al., US Patent No. 5,810,802, issued Sept. 22, 1998
("Panescu").
6 Zarins et al., US Patent Publication No. 2008/0255642 Al, published Oct.
16, 2008 ("Zarins").
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Appeal2017-005808
Application 12/495,691
GROUND 1: ANTICIPATION BY GOV ARI
Appellants argue claims 15-18, 28, 33, 34, and 36 together. We
designate claim 15 as representative.
Govari discloses "methods and devices for sensing pressure exerted
against a probe, such as a catheter, inside the body of a patient." Govari ,r 1.
The Examiner found that Govari disclosed a catheter apparatus comprising
all of the elements recited in claim 15. Non-Final Act. 4--5. 7 With respect to
the requirement of claim 15 that the catheter apparatus include "a distal
flexure zone separating the electrode and the elongated shaft by a fixed
length," the Examiner found that Govari disclosed "a distal flexure zone (the
area shown by a cut-view in Fig. 2 including a resilient member 58)
separating the electrode and the elongated shaft by a fixed length." Id. at 4.
Figure 2 of Govari is reproduced below.
30~
FIG. 2
\
60
s 64 58 62 50
j
/ i
( ________________________________________________________________ .i:+:i(, ~W--J.Jt::::+==:L __________________________________ _
54
Figure 2 is a "cutaway view showing details of the distal end of a catheter, in
accordance with an embodiment of [Govari's] invention." Govari ,r 43. As
shown in Figure 2, the catheter comprises "a flexible insertion tube 54, with
a distal tip 52 connected to the distal end of tube 54 at a joint 56. The
insertion tube is covered by a flexible, insulating material 60, such as
Celcon® or Teflon®." Id. ,r 50. The distal tip may be "covered, at least in
part, by an electrode 50." Id. The "[d]istal tip 52 is connected to the distal
7 Non-Final Office Action mailed June 14, 2016 ("Non-Final Act").
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Appeal2017-005808
Application 12/495,691
end of insertion tube 54 by a resilient member 58" which may be in the form
of a "coil spring" or "other ... resilient component[]." Id. ,r 51.
Appellants argue that Govari does not teach "a distal flexure zone
separating the electrode and the elongated shaft by a fixed length" because
Govari teaches that the resilient member 58 (a coil spring) is configured "to
permit axial displacement (i.e., lateral movement along the axis of catheter
28)." App. Br. 8. (Emphasis omitted). According to Appellants, this
violates the requirement that the flexure zone separate the electrode and the
elongated shaft by a "fixed length." Id. We are not persuaded.
We acknowledge that Govari includes a coil spring that permits axial
displacement. Govani ,r 51 ("The spring serving as the resilient member in
this embodiment may be configured, for example, to permit axial
displacement (i.e., lateral movement along the axis of catheter 28) of the
distal tip by about 1-2 mm and angular deflection of the distal tip by up to
about 30°"). However, the Examiner does not rely on Govari's spring itself
as corresponding to the claimed "distal flexure zone." Rather, the Examiner
identifies the distal flexure zone as an area within which the spring rests.
Non-Final Act. 4 (identifying the distal flexure zone as "the area shown by a
cut-view in Fig. 2 including a resilient member 58") (emphasis added); Ans.
3 (interpreting the flexure zone as "the section of the catheter having its
cover removed in Fig. 2 distal to the distal end of shaft 54 including the
spring section 58") ( emphasis added).
The fact that the area of Govari that corresponds to the claimed distal
flexure zone includes a coil spring or other resilient component does not
prevent it from meeting the claim requirement for a distal flexure zone.
Indeed, claim 15 expressly recites that "the distal flexure zone comprises a
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Application 12/495,691
flexible structure." This is also consistent with the Specification, which
contemplates that the distal flexure zone may include a flexible metal coil-
i.e. a spring. Spec. ,r 172 ("In alternative embodiments for the distal flexure
zone 44, the flexible structure 7 4 can take the form of a tubular metal coil,
cable, braid or polymer, as Fig. 15H shows.").
The Specification also repeatedly emphasizes that the distal flexure
zone is configured to accommodate flexure or bending. Id. ,r 128 ("the distal
flexure zone 44 is sized, configured, and has the mechanical properties that
accommodate additional flexure or bending"); id. ,r 129 ("the distal flexure
zone effectively reduces the contact force between the thermal heating
element 24 and the vessel wall"); id. ,r 131 ("The mechanical properties of
distal flexure zone 44 and the intermediate flexure zone 34 in terms of axial
stiffness, torsional stiffness, and flexibility can be comparable. However,
the distal flexure zone 44 can be sized and configured to be less stiff and,
importantly, to possess greater flexibility than the intermediate flexure zone
34."). As the Examiner points out, even when the flexure zone bends
laterally- as opposed to axially by compression - "one side will become
shorter and the other side longer and the space between the electrode and the
shaft would change and therefore, not remain at a fixed length during the
usage of the device." Ans. 4.
Our reviewing court has explained that, during examination, the PTO
must interpret terms in a claim using "the broadest reasonable meaning of
the words in their ordinary usage as they would be understood by one of
ordinary skill in the art, taking into account whatever enlightenment by way
of definitions or otherwise that may be afforded by the written description
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Application 12/495,691
contained in the applicant's specification." In re Morris, 127 F.3d 1048,
1054 (Fed. Cir. 1997).
As explained further in In re Zletz, 893 F.2d 319, 321-22 (Fed. Cir.
1989), the reason for this rule of interpretation is that "during patent
prosecution when claims can be amended, ambiguities should be recognized,
scope and breadth of language explored, and clarification imposed." Here,
when the language of the claim is viewed as a whole, and interpreted in view
of the Specification, we see no basis for interpreting the limitation requiring
"a distal flexure zone separating the electrode and the elongated shaft by a
fixed length" to exclude an area that accommodates a coil spring or other
resilient component.
Accordingly, we affirm the Examiner's rejection of claim 15.
Because they were not argued separately, claims 15-18, 28, 33, 34, and 36
fall with claim 15.
GROUND 2: ANTICIPATION BY KAPLAN
Kaplan discloses "devices configured to treat the airways or other
anatomical structures ... with uniform or predictable contact ( or near
contact) between an active element and tissue." Kaplan ,r 10. The Examiner
found that Kaplan disclosed a catheter comprising all of the elements recited
in claim 36. Non-Final Act. 7-8. With respect to the requirement of claim
36 that the catheter include "a single, non-expandable electrode disposed on
the axis at a flexed length distal from the shaft distal end," the Examiner
found that, in Kaplan's catheter, "one of electrodes 134 of structure 122 or
one of the electrodes of an arm 124 as explained in [0070], which is
disposed on the axis at a flexed length distal from the shaft distal end is
interpreted to be a single, non-expandable electrode." Id. at 7.
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Appeal2017-005808
Application 12/495,691
Figure 5B of Kaplan is reproduced below.
Figure 5B shows a "side sectional view[] of a device of [Kaplan's] invention
being advance[d] in an airway." Kaplan ,r 40. The device of Figure 5B
includes a plurality of electrodes 134 as part of a basket of adjustable size.
Id. ,r 70 (identifying corresponding structure in Figure 5A).
Appellants argue that
the Examiner's attempt to correlate Kaplan's expandable basket
122 having a plurality of arms 124 with multiple electrodes 134
arranged thereon to the claimed catheter having a "single, non-
expandable electrode" that is "disposed on the axis [ of the
elongated shaft]" is ... not consistent with how one of ordinary
skill in the art would interpret or understand the language of
claim 36.
Reply Br. 3.
As discussed above, during prosecution, we interpret the scope of the
claims in patent applications giving claims their broadest reasonable
interpretation consistent with the specification. In re Morris, 127 F.3d 1048
(Fed. Cir. 1997). Here, we agree with Appellants that the broadest
reasonable interpretation of "a single, non-expandable electrode" in light of
the Specification does not encompass a plurality of electrodes. We
acknowledge that claim 36 uses the term "comprising" as a transitional
phrase, indicating that the claim allows for additional elements beyond those
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Application 12/495,691
recited in the claim. Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364,
1368 (Fed. Cir. 2003) ("The transition 'comprising' in a method claim
indicates that the claim is open-ended and allows for additional steps.").
However, claim 36 also uses the term "single." The ordinary meaning of
"single," as reflected in the Oxford English Dictionary is "[o]nly one; not
one of several.'' https://en.oxford dictionaries.com/definition/single
(accessed Sept. 27, 2018). The language of the claim, considered by itself,
thus leaves some ambiguity as to whether additional electrodes may be
present.
However, when this claim language is viewed in the context of the
Specification, we think Appellants have the better position. In particular, we
note that all of the embodiments disclosed in the Specification employ only
one electrode. Moreover, the Examiner does not identify, and we do not
find, anything in the Specification that suggests employing more than one
electrode. In the context of the present Specification, we thus agree with
Appellants that the claim term "single, non-expandable electrode" is limited
to one, and only one electrode. Accordingly, because the structure in Kaplan
relied upon by the Examiner as anticipating claim 3 6 includes two
electrodes, we reverse the Examiner's rejection of claim 36.
GROUNDS 3-6: OBVIOUSNESS OVER COMBINATIONS OF PRIOR
ART INCLUDING GOV ARI
Appellants argue that Grounds 3-6 should be reversed for the same
reasons Ground 1 should be reversed. Appellants do not advance any
independent bases for reversing the rejections of Grounds 3---6. Accordingly,
we affirm the Examiner's rejection of claims 20-22, 24, 25, 35, and 37--41
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as obvious over the cited art for the reasons discussed in connection with
Ground 1.
SUMMARY
In summary, we affirm the Examiner's rejection of claims 15-18, 28,
33, 34, and 36 under 35 U.S.C. § 102(e) as anticipated by Govari.
We reverse the Examiner's rejection of claim 36 under 35 U.S.C.
§ 102(b) as anticipated by Kaplan.
We affirm the Examiner's rejection of claims 20-22, 24, and 25 under
35 U.S.C. § 103(a) as obvious over Govari.
We affirm the Examiner's rejection of claim 35 under 35 U.S.C.
§ 103 (a) as obvious over the combination of Govari and Tu.
We affirm the Examiner's rejection of claim 35 under 35 U.S.C.
§ 103 (a) as obvious over the combination of Govari and Panescu.
We affirm the Examiner's rejection of claims 37--41 under 35 U.S.C.
§ 103 (a) as obvious over the combination of Govari and Zarins.
AFFIRMED
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