Ex Parte Christian et al

Patent Trial and Appeal Board

Jun 12, 2017

12597840 (P.T.A.B. Jun. 12, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/597,840 04/13/2010 Steven C. Christian 0B-053703US 3145
55962 7590
Wiley Rein LLP
Patent Administration
1776 K Street, NW
Washington, DC 20006
06/14/2017 EXAMINER
CARDINAL, ERIN M
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
06/14/2017 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEVEN C. CHRISTIAN, HARRY A. PURYEAR,
JAMES V. KAUPHUSMAN, and WILLIAM M. SUTTON
Appeal 2016-000035
Application 12/597,8401
Technology Center 3700
Before STEFAN STAICOVICI, LEE L. STEPINA, and
ARTHUR M. PESLAK, Administrative Patent Judges.
STAICOVICI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Steven C. Christian et al. (Appellants) appeal under 35 U.S.C.
§ 134(a) from the Examiner’s final decision rejecting claims 17—21, 24—27,
30-33, and 37.2 We have jurisdiction over this appeal under 35 U.S.C.
§ 6(b).
1 According to Appellants, St. Jude Medical, Atrial Fibrillation Division,
Inc. is the real party in interest. Br. 2 (filed Jan. 20, 2015).
2 Claims 1—6, 22, 23, 28, and 29 are canceled and claims 34—36 are
withdrawn. Appellants’ Amendment 2-4 (filed July 2, 2014); Br. 4.
Appeal 2016-000035
Application 12/597,840
SUMMARY OF DECISION
We AFFIRM.
INVENTION
Appellants’ invention relates “to positioning and retaining a reference
electrode of a localization system employed in navigating a medical device
through a patient.” Spec., para. 2.
Claims 17, 21, and 25 are independent. Claim 17 is illustrative of the
claimed invention and reads as follows:
17. A catheter for anchoring an electrode in a lumen, the
catheter comprising:
an elongate catheter body configured for introduction
over a guidewire and including a central axis and a flexible
anchor segment,
the flexible anchor segment configured to be movable
between a deployed configuration, wherein the flexible anchor
segment is deviated from the central axis of the catheter body
into a uniform corkscrew shape to engage a tissue surface of the
lumen such that relative movement between the catheter body
and the lumen is inhibited without completely occluding the
lumen, and an undeployed configuration, wherein the flexible
anchor segment is generally collinear with the central axis of
the catheter body to introduce the catheter into the lumen; and
an ablation electrode on the catheter body within the
flexible anchor segment,
wherein the flexible anchor segment is biased into the
deployed configuration.
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Application 12/597,840
REJECTIONS
The following rejections are before us for review:
(I) The Examiner rejected claims 17—20, 25—27, and 32 under
35 U.S.C. § 102(b) as anticipated by Scheiner et al. (US
2003/0195603 Al, pub. Oct. 16, 2003) (“Scheiner”).
(II) The Examiner rejected claims 17—21, 24—26, 31, and 37 under
35 U.S.C. § 102(b) as anticipated by Deem et al. (US
2005/0288730 Al, pub. Dec. 29, 2005) (“Deem”).
(III) The Examiner rejected claims 21, 24, 30, 31, 33, and 37 under
35 U.S.C. § 103(a) as unpatentable over Scheiner and Deem.
(IV) The Examiner rejected claims 27, 30, and 32 under 35 U.S.C.
§ 103(a) as unpatentable over Deem.
ANALYSIS
The Anticipation Rejection Based Upon Scheiner
The Examiner finds that Scheiner discloses all of the limitations of
independent claims 17 and 25 including ablation electrodes, because
Schemer’s sensing and pacing electrodes “are capable of being used for
[both] mapping and ablation.” Final Act. 2—3 (citing Scheiner, paras. 51—55,
61, 69 and Fig. 1A).
Appellants argue that the Examiner “does not offer any evidentiary
support” that Schemer’s electrodes are capable of being used for ablation.
Br. 9. According to Appellants, ablation and non-ablation electrodes are not
interchangeable because “there are structural differences, both in the
electrode itself and in the surrounding device, between a pacing and/or
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Application 12/597,840
sensing electrode as disclosed in Schemer and an ablation electrode as
claimed.” Id. (citing the Declaration of Jeff Schweitzer submitted on July 2,
2014 (“Schweitzer Declaration”)).
The Examiner responds that even though the Scheiner electrode is for
sensing or pacing, it “is also inherently capable of being used for delivering
ablation energy, as evidenced by Deem.” Ans. 2 (emphasis added).
According to the Examiner, because Deem teaches that an electrode is
equally capable of modulating, blocking, and ablating, Deem evidences “that
the Scheiner electrode is inherently capable of being used for ablating.”
Ans. 4 (citing Deem, paras. 40-42) (emphasis added). The Examiner thus,
takes the position that as the electrodes of Scheiner are capable of providing
a stimulating current, they are also “inherently capable of providing current
for ablation.” Id (emphasis added).
“It is well settled that a prior art reference may anticipate when the
claim limitations not expressly found in that reference are nonetheless
inherent in it. Under the principles of inherency, if the prior art necessarily
functions in accordance with, or includes, the claimed limitations, it
anticipates.” In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir.
2002) (citations and internal quotation marks omitted). “Inherency,
however, may not be established by probabilities or possibilities. The mere
fact that a certain thing may result from a given set of circumstances is not
sufficient.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (quoting In
re Oelrich, 666 F.2d 578, 581 (Fed. Cir. 1991)). In this case, the Examiner’s
rejection relies on Deem for the proposition that Schemer’s electrodes are
inherently capable of ablation. See Ans. 4 (citing Deem, paras. 40-42).
Although the Examiner correctly points out that the electrodes of Scheiner
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Application 12/597,840
can provide a stimulating current, this in no way demonstrates that
Sacheiner’s electrodes are capable of providing a current for ablation, as the
Examiner contends. Just because the electrodes of Scheiner are
sensing/pacing electrodes, it does not necessarily mean that they can also
ablate tissue. Even though we appreciate Deem’s electrodes could be used
so that structures could be “modulated, blocked or ablated,” Deem’s
conductive coil or slotted tube is not the pacing electrode disclosed by
Scheiner, and the Examiner does not proffer any evidence to show that
Deem’s electrode is the same as the electrode described by Scheiner. See
Deem, para. 85; Scheiner, paras. 57, 69 and Figs. 4C, 6D. For example, we
note that the pacing system of Scheiner uses a battery powered pulse
generator that is implanted in the patient, whereas the pulsed electric field
generator 100 of Deem is located external to the patient. Compare Scheiner,
para. 4 with Deem, para. 85, Fig. 4.
Hence, just because Deem’s electrodes are configured to perform
modulation or ablation does not mean that the electrodes of Scheiner are
necessarily capable of ablation, as the Examiner contends. The Examiner’s
finding that Schemer’s electrode is necessarily capable of being used as an
ablation electrode is mere speculation based on an unfounded assumption
that the electrode of the Scheiner would necessarily provide an ablation
current and hence, function as an ablation electrode.
Therefore, for the foregoing reasons, we do not sustain the rejection of
claims 17—20, 25—27, and 32 as anticipated by Scheiner.
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The Anticipation Rejection Based Upon Deem
Claims 17, 19—21, 24^26, 31, and 37
The Examiner finds that Deem discloses each of the limitations of
independent claims 17, 21, and 25. Final Act. 3 (citing Deem, paras. 38, 40,
41, and 87; Figs. 4, 5).
Appellants argue that the anchor segment of Deem is not configured
for “inhibiting relative movement between the catheter and the vessel,”
because the Deem catheter is “brought into contact with an interior wall of
the artery (Deem at | [0087]), which is not the same as inhibiting relative
movement.” Br. 9.
The Examiner responds that the anchor of Deem inhibits relative
motion, because Deem discloses “that the device is ‘stabilized within the
vessel’ before energy delivery [] by pressing the catheter in contact with the
lumen.” Ans. 5 (citing Deem, paras. 40 and 87).
We do not find Appellants’ arguments to be persuasive, because as the
Examiner correctly finds, Deem discloses that the catheter “is stabilized
within the vessel (e.g., braced against the vessel wall).” Deem, para. 40.
Appellants do not explain adequately why a catheter that is “stabilized” and
“braced” within the vessel would not inhibit movement relative to the vessel,
as well.
Accordingly, Appellants do not apprise us of error in the Examiner’s
findings. We thus, sustain the rejection of claims 17, 19—21, 24—26, 31, and
37 as anticipated by Deem.
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Claim 18
Appellants assert that Deem does not disclose “a guidewire
configured to cause the flexible anchor segment to assume the undeployed
configuration when the elongate catheter body is introduced thereover,” as
recited in claim 18, because “Deem merely discloses a catheter that can be
advanced over a guidewire.” Br. 9-10 (citing Deem, para. 38).
The Examiner responds that Deem discloses that “guidewire delivery
is used instead of or in conjunction with sheath delivery ... to achieve the
deployed configuration . . . and the delivery mechanism (the guidewire
and/or sheath) holds the device in the undeployed configuration for
delivery.” Ans. 5 (citing Deem, paras. 38, 43, 87, and 88).
We agree with the Examiner that Deem discloses that a guidewire is
used to achieve the deployed configuration and holds the device in the
undeployed configuration. Specifically, Deem discloses that the catheter
may be positioned “in a low profile configuration within sheath 150” and
then be expanded via a pull wire to contact the interior of a vessel wall.
Deem, para. 87. Appellants do not explain adequately why a guidewire that
causes the catheter to be in a low profile configuration before being
deployed is not a guidewire configured as required by claim 18. Thus,
Appellants’ arguments do not apprise us of Examiner error.
Accordingly, for the foregoing reasons, we also sustain the rejection
of claim 18 as anticipated by Deem.
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Application 12/597,840
The Obviousness Rejection Based Upon Scheiner and Deem
Claims 21, 24, 30, 31, and 33
Claim 21 recites, in relevant part, “conducting an ablation procedure
using the electrode on the catheter as an ablation electrode.” Br. 13 (Claims
App.).
The Examiner finds that although Scheiner fails to disclose an
ablation step, nonetheless Deem discloses an anchored helix catheter
including electrodes that provide both stimulation to modulate or block
activity and to ablate tissue. Final Act. 4 (citing Scheiner, para. 51; Deem,
paras, 40, 41, Fig. 4). The Examiner concludes that it would have been
obvious for a person of ordinary skill in the art “to use the Scheiner device
[with the electrodes of Deem] for ablation in addition to the disclosed
pacing, as predictable results would ensue.” Id.
Appellants reiterate that Scheiner does not use ablation electrodes, and
that the structural differences discussed in the Schweitzer Declaration,
“would defeat any motivation to modify the device of Scheiner as suggested
by the Examiner to utilize ablating electrodes as disclosed in Deem.” Br. 10.
The Examiner responds that because Deem discloses that electrodes
of a device can be used for pacing (neuromodulation) and ablation, “Deem
provide(s) the necessary motivation to use the device [of Scheiner] for
ablation procedures, including any necessary device modifications (such as
larger wire alleged to be required, or a connection to a source of ablation
energy).” Ans. 6 (citing Deem, paras. 40-42).
We do not find Appellants’ arguments to be persuasive, because
although the electrodes of Scheiner are not inherently ablation electrodes,
nor inherently capable of conducting an ablation procedure, for the reasons
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discussed, supra, Appellants do not explain adequately why the electrodes of
Scheiner could not be modified, according to the disclosure of Deem, to
conduct an ablation procedure in addition to the pacing procedure. We
appreciate that there are structural differences in the electrodes of Scheiner
and Deem, but the Examiner’s modification of Schemer’s electrodes,
according to Deem, takes these differences into account. See Ans. 6. Thus,
we agree with the Examiner that based on the disclosure of Deem, a person
of ordinary skill in the art would know what size electrode and what amount
of energy to use to conduct an ablation procedure, using an electrode that is
configured to conduct ablation. See Deem, paras. 40 and 41.
In conclusion, for the foregoing reasons, Appellants do not apprise us
of error in the Examiner’s conclusion of obviousness. Accordingly, we
sustain the rejection of claims 21, 24, 30, 31, and 33 as unpatentable over
Scheiner and Deem.
Claim 3 7
Claim 37 recites, in relevant part, “wherein the ablation electrode is
electrically coupled to a wire configured to transmit ablative energy
therethrough.” Br. 15 (Claims App.).
Appellants argue that because the electrodes of Scheiner are not
ablation electrodes, and due to the structural differences between the
electrodes of Scheiner and Deem, “one skilled in the art would not have
modified the device of Scheiner to couple the electrodes to wire configured
to transmit ablative energy.” Br. 11.
As discussed, supra, the Examiner’s modification of Schemer’s
electrodes, according to Deem, takes the structural differences into account,
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including the size of the wire and “a connection to a source of ablation
energy.” Ans. 6. Furthermore, because the electrode of Deem is configured
to perform both modulation (pacing) and ablation, the Examiner has a solid
basis for concluding that a modification to the Scheiner electrode and wire
would predictably work in the same manner. See Final Act. 4.
As such, Appellants’ arguments that the device of Scheiner would not
have been modified based on the teachings of Deem to couple the electrodes
to a wire configured to transmit ablative energy are unpersuasive.
Accordingly, for the foregoing reasons, we likewise sustain the rejection of
claim 37 as unpatentable over Scheiner and Deem.
The Obviousness Rejection Based Upon Deem
Appellants do not present separate arguments for the patentability of
claims 27, 30, and 32 other than those presented for the rejection of claims
17, 21, and 25 in Rejection II. Br. 11.
Accordingly, for the reasons discussed supra, we do not find
Appellants’ arguments persuasive. Thus, for the same reasons, we sustain
the rejection of claims 27, 30, and 32, as unpatentable over Deem.
SUMMARY
The Examiner’s decision to reject under 35 U.S.C. § 102(b) claims
17—20, 25—27, and 32 as anticipated by Scheiner is reversed.
The Examiner’s decision to reject under 35 U.S.C. § 102(b) claims
17—21, 24—26, 31, and 37 as anticipated by Deem is affirmed.
The Examiner’s decision to reject under 35 U.S.C. § 103(a) claims 21,
24, 30, 31, 33, and 37 as unpatentable over Scheiner and Deem is affirmed.
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The Examiner’s decision to reject under 35 U.S.C. § 103(a) claims 27,
30, and 32 as unpatentable over Deem is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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