Ex Parte Weber et al

Board of Patent Appeals and Interferences

Mar 29, 2012

11280120 (B.P.A.I. Mar. 29, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/280,120 11/16/2005 Jan Weber 1001.1925101 7250
11050 7590 03/30/2012
SEAGER, TUFTE & WICKHEM, LLC
1221 Nicollet Avenue
Suite 800
Minneapolis, MN 55403
EXAMINER
SHUMATE, VICTORIA PEARL
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
03/30/2012 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JAN WEBER and TRACEE E.J. EIDENSCHINK
__________

Appeal 2011-000883
Application 11/280,120
Technology Center 3700
__________

Before TONI R. SCHEINER, FRANCISCO C. PRATS, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

BONILLA, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
medical device comprising a hypotube comprising a plurality of slots and a
strength altering means. The Examiner has rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Appeal 2011-000883
Application 11/280,120

2
STATEMENT OF THE CASE
Claims 1-3, 8, 9, 18-20, and 29-34 are on appeal. Claims 1, 18, 29,
31, and 34 are independent. Appellants argue claims 1-3, 8, 9 and 19 as a
group, and therefore these claims stand or fall together. 37 C.F.R.
§ 41.37(c)(1)(vii). Appellants also argue claims 29-34 as a group, and
therefore these claims likewise stand or fall together.
Claims 1, 18 and 29 are representative. Independent claim 1 recites:
1. A medical device comprising:
a hypotube comprising a plurality of slots passing transversely
through a longitudinal side wall of the hypotube; and
strength altering means for changing compressive strength of
the hypotube.
Independent claim 18 recites:
18. A medical device comprising:
a hypotube comprising a plurality of slots passing transversely
through a longitudinal sidewall of the hypotube at an angle with
respect to the axial axis and each comprising a first wall and an
opposing second wall; and
an electroactive polymer disposed on at least one of the first
wall and the opposing second wall of the plurality of slots.
Claim 20 depends on claim 18, and further recites that the electroactive
polymer comprises polypyrrole doped with sodium dodecyl benzene
sulfonate.
Independent claim 29 recites:
29. A medical device comprising:
Appeal 2011-000883
Application 11/280,120

3
a hypotube comprising a slot passing transversely through a
longitudinal sidewall of the hypotube, the slot comprising a first wall
and an opposing second wall;
an electroactive polymer disposed on at least one of the first
wall and the second wall;
an insulating layer disposed about the hypotube; and
a conductive pattern disposed about the insulating layer.
The claims stand rejected as follows:
• Claims 1-3, 8, 9, 18, and 19 under 35 U.S.C. § 103(a) as obvious
over Swanson, U.S. Pat. No. 5,605,543 (issued Feb. 25, 1997), in view of
Lovett et al., U.S. Publ. Pat. Application No. 2003/0065373 A1 (Apr. 3,
2003).
• Claim 20 under 35 U.S.C. § 103(a) as obvious over Swanson in
view of Lovett, and further in view of Jasne, U.S. Pat. No. 5,130,054 (Jul.
14, 1992).
• Claims 29-34 under 35 U.S.C. § 103(a) as obvious over Swanson, in
view of Lovett, and further in view of Couvillon, Jr., U.S. Publ. Pat.
Application No. 2004/0143160 A1 (issued Jul. 22, 2004).
I.
Issue
Does Swanson in view of Lovett render obvious a medical device
comprising a hypotube comprising a plurality of slots at an angle with
respect to the axial axis, and a strength altering means, such as an
electroactive polymer disposed on at least one wall of the slots, as recited in
claims 1 and 18?
App
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Appeal 2011-000883
Application 11/280,120

6
Figure 12 depicts a guide catheter 600 comprising a lumen 610 that includes
a first lumen 614 and a second lumen 616 that are disposed on opposite sides
of the passage 612. (Id. at 7, [0073], [0076].)
7. As stated in Lovett, “[d]isposed within the first lumen 614 and the
second lumen 616 is a rheometric material 618, such as a magnoactive
material or an electroactive material.” (Id. at 7, [0076]; [0075].)
8. Lovett also states that “that the cross-sectional shape, geometry,
number, length, and configurations of the lumens which receive the
rheometric material therein are modifiable in several configurations, as
shown by way of example, in FIGS. 11-21.” (Id. at [0075].)
9. Lovett also teaches that “in one option, applying electric current
includes pulsing the electric current and alternately stiffening and relaxing
the first portion of the device body.” (Id. at 2, [0018].)
10. In the same paragraph, Lovett also teaches that “[i]n yet another
option, the device body includes one or more lumens therein, and associating
includes disposing rheometric material in at least one lumen of the device
body, or in at least two or more lumens of the device body.” (Id.)
11. Lovett also describes an embodiment having one or more assemblies
420 serially disposed along a lead body 410, which allow the assemblies to
be selectively activated. (Id. at 5, [0059]; see also Figures 5 and 6.) In this
capacity, Lovett teaches that the one or more assemblies 420 include
rheometric material, such as an electroactive polymer, where the rheometric
material “stiffens the body upon application of energy thereto.” (Id. at
Appeal 2011-000883
Application 11/280,120

7
[0060]; see also [0062] (describing selective expansion of the electroactive
polymer in one or more assemblies to cause bending in the hypotube.)
12. Lovett discloses that “[e]xamples of suitable electrically active
polymers include, but are not limited to, … ionic polymer metallic
composite (IPMC), and ionic polymers such as polypyrole ….” (Id. at 4,
[0050].)
Principles of Law
The ultimate question of obviousness is one of law, based upon
factual inquiries set forth in the Graham case: (1) the scope and content of
the prior art; (2) the differences between the prior art and the claims at issue;
(3) the level of ordinary skill in the pertinent art; and (4) objective evidence
of non-obviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17-18
(1966). “An examiner bears the initial burden of presenting a prima facie
case of obviousness.” In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir.
2011). “Once the examiner establishes a prima facie case of obviousness,
the burden shifts to the applicant to rebut that case.” Id. If the applicant
presents rebuttal evidence, such as unexpected results or that the prior art
teaches away from the claimed invention, the Examiner “must consider the
totality of the evidence to determine whether the obviousness rejection
should stand.” Id.
Analysis
We first address whether claims 1 and 18 are obvious over Swanson
in view of Lovett. Swanson teaches a hypotube comprising “a plurality of
slots passing transversely through a longitudinal side wall of the hypotube”
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Application 11/280,120

8
as recited in claims 1 and 18, and that the slots are “at an angle with respect
to the axial axis and each comprising a first wall and an opposing second
wall” as recited in claim 18. (FF 1-3). As noted by the Examiner, Figure 10
in Swanson clearly discloses these elements. (Ans. 3-4.)
While Swanson does not expressly teach a “strength altering means”
as recited in claim 1, such as an electroactive polymer as recited in claim 18,
Lovett provides such teachings in the context of contracting and expanding,
and consequently stiffening, i.e., strengthening, a relevant hypotube catheter.
(Ans. 3-4; FF 4-10.) Both Swanson and Lovett teach medical devices
comprising catheters, i.e., hypotubes. (FF 1, 4.) As such, medical
practitioners using or studying catheters would have had reason to read these
two references together.
We agree with the Examiner that Figure 12 of Lovett shows a
hypotube having multiple lumens 610 (lumens 614 and 616) containing an
electroactive polymer that acts as a “strength altering means for changing the
compressive strength of the hypotube” as recited in claims 1 and/or 18.
(Ans. 3-4.; see also FF 4-10.) Thus, the Examiner has advanced evidence
supporting a prima facie case that it would have been obvious to dispose the
same electroactive polymer inside the slots of the hypotube in Swanson for
the same purpose taught in Lovett, i.e., to allow expansion of the
electroactive polymer, thereby causing the hypotube to become “stiff as
compressive forces ... are increased” (FF 5), and consequently change
compressive strength of the hypotube.
Alternatively, it would have been obvious to modify the lumens in
Lovett into slots, such as those taught in Swanson, in light of the teachings
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Application 11/280,120

9
in Lovett that “that the cross-sectional shape, geometry, number, length, and
configurations of the lumens which receive the rheometric material therein
are modifiable ….” (FF 8.)
Appellants assert that “[a]ny modification of the catheter of Swanson
which results in a catheter having the ability to stiffen a region of the
fabricated catheter would impermissibly alter the principle of operation of
Swanson.” (App. Br. 11.) Appellants also state “[o]ne of ordinary skill in
the art would not be motivated to alter the operating principle of Swanson by
the addition of the materials of Lovett in the absence of an indication that the
desired flexibility might be obtained.” (Id. at 12, see also 15-16; Reply Br.
2-3.)
Such statements ignore teachings in Lovett, however, which describe
the benefit of being able to alternately stiffen and relax a hypotube (Ans. 7-
8; FF 9). Such benefits exist even assuming one wished to start with a
particular stiff or flexible hypotube initially, such as the one shown in Figure
10 of Swanson. Additionally, Lovett describes advantages of being able to
selectively stiffen certain parts of a hypotube at certain locations, to affect a
curve or bending in the hypotube. (FF 11.) Appellants have pointed to
nothing in Swanson or Lovett that actually teaches away from such benefits
and advantages as they might relate to a hypotube having slots, such as those
shown in Figure 10 of Swanson, comprising electroactive polymer material.
Appellants also argue that “Lovett appears to teach stiffening a
catheter in flexure without altering its column strength.” (App. Br. 12-14;
Reply Br. 3-6.) We disagree. As noted by the Examiner (Ans. 4, 8), Lovett
teaches that upon applying a voltage, the electroactive polymer contracts,
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Application 11/280,120

10
forcing it to expand in different directions, causing the device body to
become stiff as compressive forces increase. (FF 5.) Skilled artisans would
have understood that expanding and stiffening “as the compressive forces …
are increased” (Lovett, 4, [0054]; FF 5) necessarily, i.e., inherently, involved
“changing compressive strength,” as recited in claim 1. Appellants cite no
evidence that persuades us otherwise.
Appellants also assert that “the material present in the longitudinal
lumen of Lovett is not the electroactive polymer of Lovett, but rather the
rheometric material.” (App. Br. 14; Reply Br. 3-4.) We find this assertion
to be without basis. Lovett clearly states that “[d]isposed within the first
lumen 614 and the second lumen 616 is a rheometric material 618, such as
… an electroactive material.” (FF 7.)
We also disagree with Appellants’ suggestion that Lovett only teaches
a rheometric fluid or gel, thereby requiring the use of a lumen. (App. Br. 12-
13; Reply Br. 4-5.) We first note that claim 1 does not exclude a fluid-
containing lumen from the hypotube. Further, in the same paragraph [0050]
of Lovett cited by Appellants (App. Br. 12), Lovett states that “[e]xamples
of suitable electrically active polymers include, but are not limited to, …
ionic polymer metallic composite (IPMC), and ionic polymers such as
polypyrole….” (FF 12.) Lovett does not indicate that the electroactive
polymer must be a fluid or gel, even assuming certain examples of fluid and
gel electroactive polymers (also discussed in [0050] of Lovett, as cited by
Appellants) can be used in certain disclosed embodiments.
Regarding claim 18 in particular, Appellants also argue that:
To provide the electrical stimulation employed by Lovett in the
configuration of the perforations of Swanson would require
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Application 11/280,120

11
supplying transverse electrodes passing current through each
perforation to cause the material to contract radially within the
perforation, as opposed to between simple planar electrodes, as
taught by Lovett, thereby adding undue complexity without
providing an identified benefit.
(App. Br. 15.)
We disagree with Appellants that passing a current over the slots of
Swanson would add “undue complexity” without “an identified benefit.” As
discussed above, Lovett indicates benefits and advantages of using a
hypotube having lumens or slots, such as those shown in Figure 10 of
Swanson, comprising electroactive polymer material. Moreover, it would
have been prima facie obvious to those skilled in the art to provide at least
one electrode, such as multiple electrodes, as a way to pass a current over
the slots of Swanson, especially in light of the fact that Lovett teaches one or
more assemblies 420 serially disposed along a lead body 410, which allow
assemblies to be selectively activated, as shown in Figures 5 and 6 of Lovett.
(FF 11.)
Thus, we find that the references cited by the Examiner establish a
prima facie case of obviousness of both claims 1 and 18. Appellants have
not presented sufficient rebuttal evidence, such as unexpected results or an
actual teaching away in the prior art, to overcome the prima facie case.
Conclusion of Law
We conclude that Swanson in view of Lovett render obvious a
medical device comprising a hypotube comprising a plurality of slots at an
angle with respect to the axial axis, and a strength altering means, such as an
electroactive polymer on at least one wall of the slots. Thus, we agree with
Appeal 2011-000883
Application 11/280,120

12
the Examiner that it would have been prima facie obvious to combine the
teachings of Swanson and Lovett to prepare the medical devices recited in
claims 1 and 18. We further conclude that the record before us does not
provide sufficient evidence of secondary considerations, when weighed with
the evidence of obviousness, to rebut the prima facie case. Because they are
not separately argued, claims 2-3, 8, 9, and 19 fall together with claims 1
and 18.
II.
Issue
Does Swanson in view of Lovett and Jasne render obvious the
medical device of claim 20, where the electroactive polymer comprises
polypyrrole doped with sodium dodecyl benzene sulfonate?
Additional Findings of Fact
13. Jasne teaches methods for making electrically conductive polymers.
(Jasne, col. 1, ll. 35-41.) As stated in Jasne, the “utilization of a polymeric
counteranion, in affiliation with the cationic charges of an
electropolymerized polymer, confers plasticizing and flexibilizing.” (Id. at
ll. 42-45.)
14. Jasne teaches that pyrrole, such as polypyrrole, is useful in methods
for making such polymers. (Id. at col. 2, ll. 19-20; col. 3, ll. 44-61.)
15. Jasne also discloses that preparation of the polymer can be “be
accomplished by polymerization of an ethylenically unsaturated monomer
(or mixture of comonomers) in the presence of a surfactant,” such as sodium
dodecyl benzene sulfonate. (Id. at col. 4, l. 57 – col. 5, l.1.)
Appeal 2011-000883
Application 11/280,120

13
Analysis
For the reasons already discussed above, we find that Swanson in
view of Lovett render obvious the medical device recited in independent
claim 18. Claim 20 depends on claim 18, but further recites that the
electroactive polymer comprises polypyrrole doped with sodium dodecyl
benzene sulfonate (“SDBS”).
Although we find that Lovett suggests the use of polypyrrole (FF 12),
neither Swanson nor Lovett expressly teaches polypyrrole doped with
sodium dodecyl benzene sulfonate. As noted above, Jasne teaches methods
for making electroactive polymers using polymers such as polypyrrole as
starting material. (FF 13-14.)
We find that the Examiner establishes a prima facie case of
obviousness when pointing to citations in Jasne that teach that a conductive
polypyrrole polymer can be made in the presence of a surfactant such as
SDBS. (FF 15.) Lovett expressly teaches the use of electroactive polymers,
and provides examples that “include, but are not limited” to certain disclosed
“ionic polymers, such as polypyrole.” (FF 12.) One reading Lovett would
have looked to a reference such as Jasne to find other appropriate
electroactive polymers, including those comprising polypyrrole.
In response to the Examiner’s position, Appellants assert that
“[f]ollowing the polymerization step, Jasne teaches washing the polymer
which would appear to remove the sodium dodecyl benzene sulfonate.
(Solubility: 20 g/ml at 25°C)” (App. Br. 17 (emphasis added); Reply Br. 9.)
Thus, according to Appellants, “it is not clear that sodium dodecyl benzene
sulfonate would be present at a useful level in the polymer of Jasne. (Id.; see
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Application 11/280,120

14
also Reply Br. 9, (stating that “the process of Jasne appears to wash the
sodium dodecyl benzene sulfonate from the polymer produced by the
production process”) (emphasis added).)
Appellants provide no citation to Jasne or elsewhere in the record in
support, however, and do not provide any evidence as to why the alleged
washing away, rather than at least some doping, would “appear” to be the
case. In the absence of any evidence in support, we find that Appellants’
attorney argument is insufficient to rebut the prima facie case of obviousness
established by the Examiner.
Conclusion of Law
We conclude that Swanson in view of Lovett and Jasne render
obvious the medical device of claim 20, where the electroactive polymer
comprises polypyrrole doped with sodium dodecyl benzene sulfonate. We
further find that the record before us does not provide sufficient evidence of
secondary considerations, when weighed with the evidence of obviousness,
to rebut the prima facie case established by the Examiner.
III.
Issue
Does Swanson in view of Lovett and Couvillon render obvious the
medical device of claim 29, which comprises a hypotube comprising a slot,
an electroactive polymer disposed on at least one wall of the slot, an
insulating layer disposed about the hypotube, and a conductive pattern
disposed about the insulating layer?
App
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Appeal 2011-000883
Application 11/280,120

16
20. In one embodiment, active member 12 (or 612) “is a polypyrrole
film,” or any other “conducting polymer that exhibits contractile or
expansile properties.” (Id. at 3, [0041]; 1, [0014]; 5, [0069].)
21. As taught in Couvillon, counter-electrode 18 (i.e., counter-electrode
618 in Figures 6D and 6E) may be any electrical conductor. (Id. at 3,
[0043]; 5, [0069].)
22. As also taught in Couvillon, the intervening electrolyte-containing
layer 14 (i.e., 614 in Figures 6D and 6E) can act to prevent contact between
active members 612 and counter-electrode 618, and thereby prevent short-
circuiting, if one provides “the electrolyte within a flexible porous layer of
insulating polymer material.” (Id. at 5, [0069].) Couvillon describes
“[b]eneficial insulating polymers for this purpose.” (Id.)
Analysis
Independent claim 29 is similar to independent claim 1, except that
claim 29 further recites an insulating layer disposed about the hypotube, and
a conductive pattern disposed about the insulating layer.
Like Swanson and Lovett, Couvillon teaches a guide catheter.
(Swanson, col. 1, ll. 17; Lovett, 1, [0003]; Couvillon, 1, [0002].) Because
all three references teach medical devices comprising catheters (FF 1, 4, 16),
i.e., hypotubes, medical practitioners using or studying catheters would have
had reason to read these references together.
Couvillon teaches a guide catheter comprising a plurality of
electroactive polymer actuators disposed along its axial length. (FF 16.)
Each electroactive polymer comprises (a) an active member portion that
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Application 11/280,120

17
comprises an electroactive polymer, such as a polypyrrole film, that
contracts or expands depending on ion flow (FF 17, 19, 20), (b) a counter-
electrode portion that may be any electrical conductor (FF 21), and (c) a
region comprising an electrolyte disposed between the active member
portion and the counter-electrode portion (FF 17). As taught in Couvillon,
the electrolyte-containing layer 614 can comprise “the electrolyte within a
flexible porous layer of insulating polymer material.” (FF 22; see also
Figures 6D and 6E; FF 18.) In other words, as found by the Examiner (Ans.
6), Couvillon expressly teaches an insulating layer.
Appellants appear to suggest that layer 614 cannot be “an insulator
layer” as claimed because “[e]lement 614 contains both an insulator and a
conductor, but acts as a conductor.” (Reply Br. 11; see also App. Br. 19.)
This argument does not establish, however, that layer 614 fails to act as an
insulating layer as recited in claim 29. We note that Couvillon expressly
refers to having the electrolyte in layer 614 “within a flexible porous layer of
insulating polymer material.” In other words, even assuming layer 614 acts
as a conductor, it also acts as an insulating layer in that it prevents contact
between active members 612 and counter-electrode 618, and thereby
prevents short-circuiting. (FF 22.)
Moreover, Figure 6D shows counter-electrode 618, i.e., a conductive
pattern, “disposed about the insulating layer,” i.e., layer 614, which is
“disposed about the hypotube,” as recited in claim 29. Thus, to one reading
Swanson in view of Lovett and Couvillon, as stated by the Examiner (Ans.
6-7), it would have been prima facie obvious to dispose at least one active
member 612 (comprising an electroactive polymer) inside a slot of the
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Application 11/280,120

18
hypotube of Swanson, and dispose the insulating layer 614 about the
hypotube, and then dispose counter-electrode 618 (a conductive pattern)
about the insulating layer, as shown in Figure 6D, or via a modified version
of what is shown in Figure 6E in Couvillon.
Conclusion of Law
We conclude that Swanson in view of Lovett and Couvillon render
prima facie obvious the medical device of claim 29, which comprises a
hypotube comprising a slot, an electroactive polymer disposed on at least
one wall of the slot, an insulating layer disposed about the hypotube, and a
conductive pattern disposed about the insulating layer. We further conclude
that the record before us does not provide sufficient evidence of secondary
considerations, when weighed with the evidence of obviousness, to rebut the
prima facie case. Because they are not separately argued, claims 30-34 fall
together with claim 29.
SUMMARY
We affirm the rejection of claims 1-3, 8, 9, 18, and 19 under 35
U.S.C. § 103(a) as obvious over Swanson in view of Lovett. We also affirm
the rejection of claim 20 as obvious over Swanson in view of Lovett, and
further in view of Jasne. In addition, we affirm the rejection of claims 29-
34 as obvious over Swanson, in view of Lovett, and further in view of
Couvillon.

Appeal 2011-000883
Application 11/280,120

19
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

cdc