Ex Parte Kauphusman et al

Patent Trial and Appeal Board

Nov 16, 2018

12982675 (P.T.A.B. Nov. 16, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/982,675 12/30/2010
67337 7590 11/20/2018
DYKEMA GOSSETT PLLC (STJ)
4000 Wells Fargo Center
90 South Seventh Street
Minneapolis, MN 55402
FIRST NAMED INVENTOR
James V. Kauphusman
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-140301US/065513-000677 8830
EXAMINER
ANTISKA Y, BRIAN MICHAEL
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
11/20/2018 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):
ASJM_Patents@abbott.com
MN-IPMail@dykema.com
Patents@dykema.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAMES V. KAUPHUSMAN, MARTIN M. GRASSE,
ALLAN M. FUENTES, and SALOME A. GONZALEZ 1
Appeal2017-010025
Application 12/982,675
Technology Center 3700
Before JEFFREY N. FREDMAN, RYAN H. FLAX, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision under 35 U.S.C. § 134(a) involving claims directed
to an electrophysiological medical device and a system with such a device.
Claims 1-26 are on appeal as rejected under 35 U.S.C. § 103. We have
jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 Appellants identify the Real Party in Interest as "St. Jude Medical, Atrial
Fibrillation Division, Inc." Appeal Br. 1. Herein we reference the
Specification of Dec. 30, 2012 ("Spec."); Final Office Action of Sept. 27,
2016 ("Final Action"); Appeal Brief of Mar. 27, 2017 ("Appeal Br.");
Examiner's Answer of May 18, 2017 ("Answer"); and Reply Brief of July
18, 2017 ("Reply Br.").
Appeal2017-010025
Application 12/982,675
STATEMENT OF THE CASE
Independent claim 1 is representative and is reproduced below:
1. An electrophysiological medical device comprising:
an electrophysiological catheter-introducer comprising a
tubular inner liner defining an inner surface and an outer surface,
said inner surface defining an unobstructed central major lumen
which extends along a longitudinal axis;
a tubular outer layer around said inner liner and in contact
with said outer surface of said inner liner, wherein said tubular
outer layer has an outer diameter sized to pass through human
cardiac vasculature to a human heart,
a plurality of circumferentially separated minor lumens
extending axially through said outer layer and in contact with
said inner liner;
a braid extending through said outer layer and surrounding
said unobstructed central major lumen, wherein said braid
extends through a majority of the longitudinal axis of the
electrophysiological catheter-introducer, and wherein each wire
of said braid comprises a rectangular cross-section, and wherein
the braid is configured to maintain a structural integrity of the
shaft along the length of the braid and is further configured to
transfer a torque along the longitudinal axis;
an electroanatomical system imaging element coupled to
a distal portion of said electrophysiological catheter-introducer;
an electrical wire coupled to said electroanatomical system
imaging element and extending through one of said plurality of
minor lumens;
a plurality of pull wires respectively extending through
other ones of said plurality of minor lumens; and
an actuator coupled to said plurality of pull wires and
capable of deflecting a distal end of the electrophysiological
catheter-introducer,
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Application 12/982,675
said electrical wire and said plurality of pull wires
extending through a separate minor lumens, and the minor lumen
through which said electrical wire extends being
circumferentially located between minor lumens through which
pull wires extend,
wherein the actuator and the unobstructed central major
lumen are configured to allow a catheter to extend from a
proximal end of the actuator through the unobstructed central
major lumen and exit the distal end of the electrophysiological
catheter-introducer.
Appeal Br. 30-31 (Claims Appendix). Independent claim 12 is directed to a
system and is substantially similar to claim 1, but also recites "an
electroanatomical navigation system." Id. at 33-34. Claim 17 is directed to
a medical device and is also substantially similar to claim 1, but recites "a
torque transfer member" rather than specifically a braid. Id. at 35-36.
Appellants do not argue these different elements to be patentable distinctions
over the prior art.
The following rejections are appealed:
Claims 1, 5, 6, 10-14, 16-22, and 24--26 stand rejected under
35 U.S.C. § I03(a) over Wendlandt, 2 Gibson, 3 Cimino, 4 Cumming, 5 and
Zhou. 6 Final Action 2.
Claims 2, 3, 7, and 23 stand rejected under 35 U.S.C. § I03(a) over
Wendlandt, Gibson, Cimino, Cumming, Zhou, and Kampa. 7 Id. at 16.
2 US 6,517,477 Bl (issued Feb. 11, 2003) ("Wendlandt").
3 US 2008/0139999 Al (published June 12, 2008) ("Gibson").
4 US 5,364,352 (issued Nov. 15, 1994) ("Cimino").
5 US 2007 /0299424 Al (published Dec. 27, 2007) ("Cumming").
6 US 2005/0043713 Al (published Feb. 24, 2005) ("Zhou").
7 US 7,824,517 B2 (issued Nov. 2, 2010) ("Kampa").
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Application 12/982,675
Claim 4 stands rejected under 35 U.S.C. § I03(a) over Wendlandt,
Gibson, Cimino, Cumming, Zhou, Kampa, and Barbut. 8 Id. at 18.
Claims 8 and 9 stand rejected under 35 U.S.C. § I03(a) over
Wendlandt, Gibson, Cimino, Cumming, Zhou, and Devens. 9 Id. at 18.
Claim 15 stands rejected under 35 U.S.C. § I03(a) over Wendlandt,
Gibson, Cimino, Cumming, Zhou, and Beatty. 10 Id. at 19.
DISCUSSION
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting aprimafacie case ofunpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Arguments made by Appellants in the Appeal Brief and properly presented
in the Reply Brief have been considered in this Decision; arguments not so-
presented in the Briefs are waived. See 37 C.F.R. § 4I.37(c)(l)(iv) (2015);
see also Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010)
(informative) ("Any bases for asserting error, whether factual or legal, that
are not raised in the principal brief are waived.").
"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 'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "[W]hen a patent
claims a structure already known in the prior art that is altered by the mere
substitution of one element for another known in the field, the combination
must do more than yield a predictable result." Id. at 416 (citing US. v.
8 US 7,468,027 B2 (issued Dec. 23, 2008) ("Barbut").
9 US 2009/0228092 Al (published Sept. 10, 2009) ("Devens").
10 US 7,826,881 Bl (issued Nov. 2, 2010) ("Beatty").
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Application 12/982,675
Adams, 383 U.S. 39, 50-51 (1966)). "In determining whether the subject
matter of a patent claim is obvious, neither the particular motivation nor the
avowed purpose of the patentee controls. What matters is the objective
reach of the claim. If the claim extends to what is obvious, it is invalid
under§ 103." Id. at 419.
The Examiner determined that claims 1, 5, 6, 10-14, 16-22, and 24--
26 would have been obvious over the combination of Wendlandt, Gibson,
Cimino, Cumming, and Zhou; that claims 2, 3, 7, and 23 would have been
obvious over this same prior art combination also adding Kampa; further,
that claim 4 would have been obvious over the initial prior art combination
adding Kampa and Barbut; further that claims 8 and 9 would have been
obvious over the initial prior art combination adding Devens; and finally that
claim 15 would have been obvious over the initial prior art combination
adding Beatty. See Final Action 2-22 and Answer 2-24; see also the prior
art as cited and discussed therein, e.g., Wendlandt Abstract, 1:40-45, 4:26-
36, 5:1-10, 7:7: 7:52---64, 8:5-7, 15:1-7, figures 1, 2; Gibson ,r,r 5, 7, 15, 18,
41, 43, 46, 47, 59, 67, 69, 76, figures 2A, 2B, 4, 7, 11; Cimino Abstract,
1:6-11, 1:32--48, 7:1-16, 8:29-35, figure 7; Cumming ,r,r 5, 8, 10, 57,
figures 3, 8; Zhou ,r,r 4, 29, 30; Kampa Abstract, 1:22-37, 2:18-26, 7:13-21,
7:61---62, 8:18-21, 8:33--40, 8:45--48, 10:47--49, figure lB; Barbut figure 6A;
Devens Abstract; Beatty Abstract, figure 1. We discern no error in the
Examiner's determinations and adopt the Examiner's findings of fact and
rationale. Final Action 2-22; Answer 2-24.
Appellants focus their arguments on the individual teachings and
alleged shortcomings of the Wendlandt reference, for example, that it
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Application 12/982,675
teaches away from its combination with the other cited prior art, that its
disclosed catheter system is not sized correctly for cardiac use, and that
modifying its catheter system for such a use would render it inoperable. See
Appeal Br. 12-28. Such arguments overlook that the obviousness rejections
are over combinations of prior art where Wendlandt is but one reference.
"Non-obviousness cannot be established by attacking references individually
where the rejection is based upon the teachings of a combination of
references. . . . [The reference] must be read, not in isolation, but for what it
fairly teaches in combination with the prior art as a whole." In re Merck &
Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). For this reason, Appellants
arguments are not persuasive. However, we address Appellants' arguments
below.
Appellants argue "Wendlandt teaches away from an unobstructed
central major lumen as adding additional components to the introducer
system would increase the thickness of the tubular catheter and lessen the
diameter of the working channel." Appeal Br. 13. Appellants cite
Wendlandt's discussion of the disadvantages of the art's small working
channels at column 1, lines 53-58, as support for this contention. Id. at 13-
14.
Appellants argument is not persuasive. Wendlandt very clearly shows
and teaches "an unobstructed central major lumen" as claimed. See, e.g.,
Wendlandt Figs. 1 and 2 (element 10). Furthermore, Wendlandt notes, in
the portion of its specification just after that referenced by Appellants, that,
in addition to the drawback of a working channel being small as compared to
the overall diameter of the endoscope, additional disadvantages are caused
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Application 12/982,675
by "space [in the lumen being] taken up by ... mechanisms," leaving a
"very small area ... for other tools to be introduced through the endoscope."
Id. at 1 :53---60. Thus, besides being concerned with ameliorating the small
working channel problem of the prior art, Wendlandt discloses, as an
objective, an endoscope lumen that is unobstructed, as claimed.
Furthermore, even were Appellants' position regarding Wendlandt's central
lumen correct, which it is not, the other cited prior art references, e.g.,
Gibson (Fig. 2B), Cumming (Fig. 3), Zhou (Fig. 2), Kampa (Fig. lB),
Barbut (Fig. 6A), and Devens (Figs. 3, 4), disclose such "an unobstructed
central major lumen" as claimed.
Appellants also argue that adding additional components outside the
central lumen of Wendlandt's catheter would directly impede Wendlandt's
objective of having a large lumen within the endoscope, and that Wendlandt
"is specifically placing the components within the working channel to
maximize the size of the working channel." Appeal Br. 14--15. Appellants
contend adding components outside the central lumen would "negate the
stated purpose of Wendlandt." Id. at 15-16.
Appellants' arguments are not persuasive. Wendlandt discloses
having components around the perimeter of its relatively large, central
lumen, for example, a coil to maintain its cross sectional shape, a vision chip
(12), a light source (14), an accessory (14) such as an irrigator, a flexible
braid or mesh (37), propulsion mechanization, and several wires (30, 38).
See Wendlandt Figure 1 and portions cited supra. Thus, it is apparent that
having components around the perimeter of its central lumen would not be
contrary to the Wendlandt's objectives. Moreover, the other cited prior art
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references, e.g., Gibson (Figs. 2B, 11 ), Cimino (Fig. 7), Cumming (Figs. 3,
4), and Kampa (Fig. lB), disclose a main, central lumen surrounded by
secondary lumens carrying various things such as wires and electrodes,
demonstrating that this arrangement is a known, even common, option in the
prior art.
Appellants argue that "modifying Wendlandt as discussed within the
Office action ... would render the endoscope of Wendlandt inoperable for
its intended purpose." Id. at 16. Here, Appellants' argument's focus is that
"[n]othing within Wendlandt discloses how a combined wall thickness of 12
mm (36 French) and an equally large central lumen can be reduced to the
size discussed herein to allow the endoscope to still operate as intended."
Appeal Br. 16. In a somewhat similar vein, Appellants argue that the claims
require "said tubular outer layer has an outer diameter sized to pass through
human cardiac vasculature to a human heart," and Wendlandt's disclosed
device having a diameter of 14 mm or 20 mm is too large. Appeal Br. 17-
21.
These arguments are not persuasive. Wendlandt expressly invites the
skilled artisan to scale its endoscope/catheter device to fit within blood
vessels, as follows:
As indicated, the-catheter introducer system of the present
invention could be used to navigate within body cavities other
than the GI tract. For example, air passages or blood vessels
could be explored using this system. For blood vessels, it would
be necessary to reduce the size of the apparatus, and preferably
to only use the steering section, to avoid interference with blood
flow through the vessel. For example, an outer diameter of the
device would have to be less than about 2 mm.
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Application 12/982,675
Wendlandt 14:66-15:7. Moreover, the other cited prior art references
disclose using their catheters for cardiac vasculature navigation. See cited
portions supra. Thus, we conclude that Wendlandt and the other cited prior
art references teach and suggest an operable catheter device, sized as
claimed, would have been obvious and within the level of skill in the art.
For the reasons set forth above, we are unpersuaded that the Examiner
erred in presenting a case for obviousness. Appellants present the same
arguments for all rejections and claims, contending that no other cited prior
art makes up for the alleged shortcomings of Wendlandt; an argument we
have found unpersuasive. See Appeal Br. 22-28. Thus, all claims fall with
claim 1 for the reasons set forth above. The balance of evidence on appeal
favors the Examiner's position.
SUMMARY
The obviousness rejections under 35 U.S.C. § 103 are each affirmed.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 3 7 C.F .R. § 1.13 6( a )(1 )(iv).
AFFIRMED
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