Ex Parte Paul et al

Patent Trial and Appeal Board

Nov 17, 2016

11966576 (P.T.A.B. Nov. 17, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111966,576 12/28/2007
67337 7590 11/21/2016
DYKEMA GOSSETT PLLC (STJ)
4000 Wells Fargo Center
90 South Seventh Street
Minneapolis, MN 55402
FIRST NAMED INVENTOR
Saurav Paul
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.
OB-056100US(065513-0058) 5376
EXAMINER
MEHTA, PARIKHA SOLANKI
ART UNIT PAPER NUMBER
OPQA
NOTIFICATION DATE DELIVERY MODE
11/21/2016 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):
MN_IPMail@dykema.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SA URA VP AUL, TROY T. TEGG,
CHOU THAO, and HARRY PURYEAR
Appeal2015-001139
Application 11/966,57 6
Technology Center 3700
Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and
ANNETTE R. REIMERS, Administrative Patent Judges.
HOELTER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
This is a decision on appeal, under 35 U.S.C. § 134(a), from a final
rejection of claims 1, 3, 4, 6, 8, 9, 11-13, 17-24, and 27-30. App. Br. 16-
19, Claims App. Claims 2, 5, 7, 10, 14--16, 25, and 26 have been canceled.
Appeal Br. 16-19, Claims App. We have jurisdiction under 35 U.S.C.
§ 6(b ). We AFFIRM.
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Application 11/966,57 6
THE CLAIMED SUBJECT MATTER
The disclosed subject matter "is directed toward a flexible polymer
electrode, including a flexible polymer electrode for MRI-guided positioning
and RF ablation." Spec. i-f 1. Independent claims 1 and 19 are illustrative of
the claims on appeal and are reproduced below:
1. An electrode for use on a medical device comprising:
a main body of electrically conductive material extending
along an axis and comprising a proximal end, a distal end, and a
wall disposed about and defining a lumen extending along said
axis; and
a magnetic resonance imaging (MRI) tracking coil
comprising electrically insulated wire that is wound in a plurality
of turns that each extend circumferentially around said axis,
wherein said MRI tracking coil further comprises an opening
configured to receive a portion of the medical device that extends
along said axis, wherein said MRI tracking coil is one of:
embedded directly within said wall; and
disposed directly within said lumen,
further wherein said MRI tracking coil is electrically
coupled \~1ith t\~10 \~1ires that are configured to transmit an induced
electromotive force to an MRI system when the MRI system is
activated, said induced electromotive force being indicative of a
location of said MRI tracking coil.
19. A catheter, comprising:
a shaft comprising an outer wall, said outer wall
comprising a distalmost end; and
an electrode disposed on said distalmost end of said outer
wall of said shaft, said electrode comprising:
a main body extending along an axis and
comprising a proximal end and a distal end, and a wall
disposed about and defining a lumen extending along said
axis;
an electrical conductor, disposed in and electrically
coupled with said main body, configured to provide
ablation energy to said electrode; and
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Application 11/966,57 6
a magnetic resonance imaging (MRI) tracking coil
disposed in said main body, said tracking coil comprising
electrically insulated wire that is wound in a plurality of
turns that each extend circumferentially around said axis
of said main body, said coil further comprising an opening
configured to receive a portion of said shaft that extends
along said axis, wherein said MRI tracking coil is distal to
said distalmost end of said outer wall of said shaft.
REFERENCES RELIED ON BY THE EXAMINER
Tulley US 2003/0028095 Al Feb. 6, 2003
Ormsby US 2007 /0066972 Al Mar. 22, 2007
Sven Zuehlsdorff et al., MR Coil Design for Simultaneous
Tip Tracking and Curvature Delineation of a Catheter,
Magnetic Resonance in Medicine 52:214--218 (2004)
(hereinafter "Zuehlsdorff').
THE REJECTIONS ON APPEAL
Claims 1, 3, 4, 6, 8, 9, 11-13, 17, 18, and 20-24 are rejected under 35
U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
Claims 1, 3, 4, 6, 9, 11, 12, 17, 18, 20-24, and 27 are rejected under
35 U.S.C. § 103(a) as unpatentable over Ormsby, Tulley, and Zuehlsdorff.
Claim 8 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Ormsby, Tulley, Zuehlsdorff, and Howson.
Claim 13 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Ormsby, Tulley, Zuehlsdorff, and Dumoulin.
Claims 19 and 27-30 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Ormsby and Tulley.
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Application 11/966,57 6
Claims 1, 3, 4, 6, 8, 9, 11-13, 17-24, and 27-30 are rejected on the
ground of nonstatutory obviousness-type double patenting as being
unpatentable over claims 1-21 and 23-25 of U.S. Patent No. 8,175,679. 1
ANALYSIS
The rejection of claims 1, 3, 4, 6, 8, 9, 11-13, 17, 18, and 20-24 under 35
US. C. § 112, first paragraph, as failing to comply with the written
description requirement
Regarding the written description requirement, the test for sufficiency
is whether the disclosure of the application relied upon reasonably conveys
to those skilled in the art that the inventor had possession of the claimed
subject matter as of the filing date. See Ariad Pharms., Inc. v. Eli Lilly &
Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (citations omitted). In the matter
before us, the Examiner finds that both independent claims 1 and 20
"include a new recitation for two wires electrically coupled to both the
tracking coil and MR system." Final Act. 2. In particular, the Examiner
finds:
The specification is only found to generally describe a single
"electrical conductor" capable of transmitting an EMF to the MR
system (specification p. 8, paragraph 25). The original disclosure
provided no detail to support and/or enable the express
configuration of a single wire, let alone two wires, which would
reasonably render them capable of transmitting a location -
specific EMF from the tracking coil to the MRI system.
Final Act. 2; However, the Examiner further finds "Figure 1 supports, at
best, a first wire 36 and an additional wire of unspecified arrangement, the
1 Appellants have not filed a Terminal Disclaimer nor have they provided
argument and/or amendment sufficient to overcome the double patenting
rejection. See App. Br. 15; Ans. 5. Accordingly, we summarily sustain the
Examiner's double patenting rejection.
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Application 11/966,57 6
two wires transmitting some kind of arbitrary signal to the MR system by
way of the drawn arrows." Ans. 6.
In rebuttal, Appellants contend that "Fig. 1 of the instant application []
clearly illustrates a two-wire connection (item 36) between an MRI tracking
coil (item 32) and an MRI system (item 34)." App. Br. 13; see also Reply.
Br. 2-3. Based on this, Appellants contend that "[ t ]he disclosure of figures
contributes to compliance with the written description requirement." App.
Br. 13; see also Reply Br. 3.
On this point regarding the use of figures, we agree with Appellants
because our reviewing court has indicated that drawings may be used to
provide support under 35 U.S.C. § 112, first paragraph. See Vas-Cath Inc. v.
Mahurkar, 935 F. 2d 1555, 1565 (Fed. Cir. 1991).
Additionally, Appellants reference Paragraph 24 of Appellants'
Specification as providing written support for this limitation. App. Br. 14.
Paragraph 24 states, "MRI tracking coil 32 may comprise an electrically
insulated wire" and that "MRI system 34 may be responsive to the signal
from MRI tracking coil 32." This same paragraph also states, "another
electrical conductor 36 may carry the signal (e.g., EMF) from MRI tracking
coil 32 to MRI system 34." Hence, whether the limitation to "two wires" is
understood to refer to Appellants' "each 'end' of the MRI tracking coil
[being] coupled to a respective wire" (App. Br. 8; Reply Br. 2) or whether
this limitation is understood to refer to the Examiner's two distinct
conductors and not "a single 'electrical conductor"' (Final Act. 2; Ans. 5---6),
Appellants' Paragraph 24 provides support for either. Accordingly, because
the Specification and drawings convey that Appellants were in possession of
the presently claimed system, including "two wires" electrically coupled to
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both the tracking coil and MR system, as of the filing date of the application,
the Examiner's rejection for lack of descriptive support under 35 U.S.C.
§ 112, first paragraph, cannot be sustained.
The rejection of claims 1, 3, 4, 6, 9, 11, 12, 17, 18, 20--24, and 27 under
35US.C. § 103(a) as unpatentable over Ormsby, Tulley, and Zuehlsdorff
Claims 1, 3, 4, 6, 9, 11, 12, 17, 18, 20--22, and 27
Appellants argue the rejection of claims 1, 3, 4, 6, 9, 11, 12, 17, 18,
20-22, and 27 as a group. App. Br. 6-11. We select independent claim 1
for review with claims 3, 4, 6, 9, 11, 12, 17, 18, 20-22, and 27 standing or
falling with claim 1. 37 C.F.R. § 41.37(c)(l)(iv). Claims 23 and 24 are
argued separately and are addressed separately below.
Regarding claim 1, the Examiner primarily relies on Ormsby but
relies on Tulley for teaching "an MRI tracking coil 208 comprising insulated
wire (i-f l 09) wound in a" helix and embedded within a cylindrical body.
Final Act. 3. The Examiner concludes: "[i]t would have been obvious to a
skilled artisan to have included the tracking coil of Tulley ('095) within the
body wall of Ormsby ('972), in order to facilitate MR tracking of the
ablation catheter within the patient during use." Final Act. 3.
The Examiner further relies on Zuehlsdorff for teaching a catheter
tracking coil L 1 "coupled to the MR system via two wires" and that this coil
is "capable of transmitting an EMF-induced signal from the coil to the
system as some arbitrary indication of the general location of the coil."
Final Act. 4. The Examiner concludes that it would have been obvious in
view of Ormsby and Tulley "to include the coupling wires of Zuehlsdorff'
and that "such a modification amounts to the combination of known prior art
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parts to yield predictable results (i.e., direct connection between the coil and
system to facilitate direct inter-element communication)." Final Act. 4.
Appellants address Tully's single-wire antenna, not Zuehlsdorffs two
wire arrangement (which the Examiner relied upon), contending that
Tulley's "antenna cannot form a complete circuit with an MRI system" and
that by "not forming a complete circuit, the antenna of Tulley is not capable
of providing an induced EMF signal that is indicative of the position of the
antenna." App. Br. 9; see also Reply Br. 4--5. As for Zuehlsdorff,
Appellants contend: "[ u ]nder a reasonable interpretation, Zuehlsdorff does
not teach transmitting an induced EMF indicative of a location of an MRI
tracking coil." App. Br. 10.
Appellants' arguments are not persuasive. As indicated supra, the
Examiner relies on Zuehlsdorff for disclosing two wires (that can be used to
complete a circuit) and also for an indication of coil location. See Figure 1
at page 215 of Zuehlsdorff, and associated text, which address MRI tracking
coil "L 1" connected by two wires that are capable of transmitting an EMF-
induced signal from the coil to the MRI system; see also Zuehlsdorff
Abstract and subsequent discussion at page 214 of "using inductively
coupled RF coils as positive markers" for visualization and location
purposes. Furthermore, regarding coil location, Tulley's antenna not only
operates as an antenna but also provides signals indicative of the location or
position of the antenna. See e.g., Tulley i-fi-f 11, 12, 22, and 23. According to
Tulley: "[i]t is therefore desired in the art to produce a probe that has an
antenna suitable to receive and enhance MR images, that antenna providing
signal that renders it visible on an MR image and suitable for use as an
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Application 11/966,57 6
imaging probe or guidewire." Tulley il I 1 (emphasis added); see also Tulley
iii! 12, 22, 23, 87' 88.
Further, we agree with the Examiner that modification of Ormsby and
Tulley by Zuehlsdorff results in an assemblage of known parts whose
combination produces predictable results. Final Act. 4. "The combination
of familiar elements according to known methods is likely to be obvious
when it does no more than yield predictable results." KSR Int'! Co. v.
Teleflex Inc., 550 U.S. 398, 416 (2007).
Appellants also contend that "Tulley teaches away from using
magnetically-induced signals. See Tulley,~~ [0103]-[0104]." App. Br. 9.
However, the paragraphs referenced discuss the ability to add shielding "in
the form of a balun circuit as is understood in the art" and that "[ t ]his tuned
balun circuit could help to increase the SNR performance and reduce the
induced currents on the wire during an RF pulse." Tulley iii! 103, 104.
Appellants do not indicate where either paragraph actually "criticize,
discredit, or otherwise discourage the solution claimed" as required. In re
Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Appellant's contention is not
persuasive.
Accordingly, based on the record presented, and for the foregoing
reasons, we sustain the Examiner's rejection of claims 1, 3, 4, 6, 9, 11, 12,
17, 18, 20-22, and 27 as obvious over Ormsby, Tulley, and Zuehlsdorff.
Claims 23 and 24
Claim 23 depends from claim 11 and further recites "wherein said
uninsulated portion of said electrically conductive wire is disposed in said
lumen and wherein at least part of said uninsulated portion of said
electrically conductive wire is configured to engage said wall." App. Br. 19,
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Claims App. Claim 24 depends from claim 11 and further recites "wherein
one of said screen, said mesh, said braid, or said fabric of electrically
conductive material is disposed in said lumen and wherein at least part of
one of said screen, said mesh, said braid, or said fabric of electrically
conductive material is configured to engage said wall." App. Br. 19, Claims
App.
In addressing claims 23 and 24, the Examiner finds "embedding the
coil in the body as taught by Tulley ('095) constitutes 'engaging' as
claimed." Final Act. 4. However, Appellants contend that the Examiner's
rejection is incomplete in that "[t]he Office Action does not address the
feature of 'disposed in the lumen."' App. Br. 12.
We agree. The Examiner has failed to address this limitation, and as
such, has failed to establish a prima facie case of obviousness with respect to
claims 23 and 24. Accordingly, based on the record presented, and for the
foregoing reason, we do not sustain the Examiner's rejection of claims 23
and 24 as obvious over Ormsby, Tulley, and Zuehlsdorff.
The rejection of claims 19 and 27-30 under 35 USC§ 103(a) as
unpatentable over Ormsby and Tulley
Claims 19, 27, 28, and 30
Appellants argue the rejection of claims 19, 27, 28, and 30 under 35
U.S.C. § 103(a) as unpatentable over Ormsby and Tulley as a group. App.
Br. 11. We select independent claim 19 for review with claims 27, 28, and
30 standing or falling with claim 19. 37 C.F.R. § 41.37(c)(l)(iv). Claim 29
is argued separately and is separately addressed below.
Independent claim 19 is directed to an electrode and to an electrical
conductor that is "configured to provide ablation energy to said electrode."
The Examiner relies on Ormsby and Tulley for disclosing the limitations of
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Application 11/966,57 6
claim 19 (Final Act. 5) and further concludes that it would have been
obvious to include Tulley's tracking coil "within the body wall of Ormsby
('972), in order to facilitate MR tracking of the ablation catheter within the
patient during use." Final Act. 3.
Appellants contend that, alone or in combination, Ormsby and Tulley
"do not teach an electrical conductor for the provision of ablation energy and
an MRI coil in the same electrode body." App. Br. 11. In particular,
Appellants assert: "[i]n Tulley, no ablation electrode is disclosed. In
Ormsby, the 'electrodes' cited in the Office Action (elements 314 and 330)
are disclosed as ECG electrodes, not as ablation electrodes. Ormsby,~~
[0031 ]-[0032]." App. Br. 11. Lastly, Appellants contend: "the Office
Action does not identify (or even acknowledge the recitation in claim 19 of)
how 'said MRI tracking coil is distal to said distalmost end of said outer wall
of said shaft' in either Ormsby or Tulley." App. Br. 11.
Regarding providing ablation energy, the Examiner relies on Ormsby
for teaching an RF energy source as specifically "being configured for
transmitting ablation energy." Ans. 8 (referencing Ormsby Title, Abstract
and i-f 21 ). Appellants do not explain how this transmission of ablation
energy source cannot be "configured to provide ablation energy to" an
electrode as claimed. See also Ans. 8. Further, it is noted that the coils
disclosed in the references and in Appellants' device are all similarly placed,
i.e., distally, and hence Appellants do not explain how the prior art coils fail
to be "distal to said distalmost end of said outer wall of said shaft" as
claimed. See, e.g., Ormsby, Figure 4 and Tulley, Figure 7.
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Application 11/966,57 6
Accordingly, based on the record presented, and for the foregoing
reasons, we sustain the Examiner's rejection of claims 19, 27, 28, and 30 as
obvious over Ormsby and Tulley.
Claim 29
Claim 29 depends from claim 19 and further recites "wherein said
electrical conductor is wound in a plurality of turns that each extend
circumferentially around said axis of said main body, said electrical
conductor further comprising an opening configured to receive a portion of
said shaft that extends along said axis." App. Br. 19, Claims App.
The Examiner finds that "Ormsby further teaches an RF antenna coil
250 wound in a plurality of turns extending circumferentially around the axis
of the main body (Figs. 4-5)." Final Act. 5.
Appellants contend that "the Office Action does not identify any
reason that a person having skill in the art would be motivated to include
both a MRI tracking coil and an electrical conductor configured to provide
ablation energy wound within the same electrode." App. Br. 12.
Appellants' argument is not persuasive. The Examiner offers a well-
founded reason for doing so, namely, "to facilitate MR tracking of the
ablation catheter within the patient during use." Final Act. 3. The Examiner
has provided evidence of the coils of claim 29 being found in Ormsby and
Tulley and has articulated a logical reason for their combination in a single
electrode. Appellants do not explain how this reason to combine fails to
provide sufficient articulated reasoning with rational underpinning to
support the legal conclusion of obviousness as discussed in KSR Int'! Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007) (citing In re Kahn, 441 F.3d 977,
988 (Fed. Cir. 2006)). Accordingly, we do not find Appellants' contentions
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persuasive of Examiner error. We sustain the Examiner's rejection of claim
29 as obvious over Ormsby and Tulley.
The rejection of claim 8 as unpatentable over Ormsby, Tulley,
Zuehlsdorff, and Howson and the rejection of claim 13 as unpatentable over
Ormsby, Tulley, Zuehlsdorff, and Dumoulin
Given that Appellants make no arguments in support of the
patentability of either claim 8 or claim 13, we sustain the rejections of those
claims. Ex Parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential)
(the Board may treat arguments appellant failed to make as waived).
DECISION
We affirm the Examiner's rejection of claims 1, 3, 4, 6, 8, 9, 11-13,
17-24, and 27-30 on the ground of nonstatutory obviousness-type double
patenting as set forth by the Examiner.
We reverse the Examiner's rejection of claims 1, 3, 4, 6, 8, 9, 11-13,
17, 18, and 20-24 under 35 U.S.C. § 112, first paragraph.
We affirm the Examiner's rejection of claims 1, 3, 4, 6, 9, 11, 12, 17,
18, 20-22, and 27 under 35 U.S.C. § 103(a) as unpatentable over Ormsby,
Tulley, and Zuehlsdorff.
We reverse the Examiner's rejection of claims 23 and 24 under 35
U.S.C. § 103(a) as unpatentable over Ormsby, Tulley, and Zuehlsdorff.
We affirm the Examiner's rejection of claims 19 and 27-30 under 35
U.S.C. § 103(a) as unpatentable over Ormsby and Tulley.
We affirm the Examiner's rejection of claim 8 under 35 U.S.C.
§ 103(a) as unpatentable over Ormsby, Tulley, Zuehlsdorff, and Howson.
We affirm the Examiner's rejection of claim 13 under 35 U.S.C.
§ 103(a) as unpatentable over Ormsby, Tulley, Zuehlsdorff, and Dumoulin.
No time period for taking any subsequent action in connection with
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this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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