Ex Parte Jones et al

Patent Trial and Appeal Board

Jul 22, 2013

11724578 (P.T.A.B. Jul. 22, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte MICHAEL L. JONES and FRANK R. LOUW
1

__________

Appeal 2011-012037
Application 11/724,578
Technology Center 3700
__________

Before TONI R. SCHEINER, DONALD E. ADAMS, and ERIC GRIMES,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a medical
device, which have been rejected for obviousness. We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse and enter new grounds of rejection.

1
Appellants identify the Real Party in Interest as SenoRx, Inc. (Appeal Br.
3.)
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Application 11/724,578

2
STATEMENT OF THE CASE
The Specification states that irradiation treatment can be directed to
the tissue surrounding a cavity created by removal of cancerous tissue by
delivery of a radiation source through the lumen of an implantable device
(Spec. 1-2, ¶¶ 3-4). The catheter shaft of such a device “is formed of low
durometer polymeric material in order to improve flexibility but low
durometer polymeric materials have high friction surfaces, making
advancing a radiation source through a lumen of the catheter shaft difficult”
(id. at 3, ¶ 7).
The Specification discloses coating the radiation delivery lumen with a
lining of higher durometer polymeric material . . . preferably
applied by dissolving the higher durometer polymeric material
in a suitable non-aqueous solvent, e.g. tetrahydrofuran,
applying the solution to the surface of the inner lumen and then
evaporating the solvent to leave the higher durometer material
on the surface of the lumen,

(Id. at 4-5, ¶ 10.) The Specification also discloses that pigments “may be
suspended in the polymer solution to be deposited with the polymeric
material. The pigment particles provide an undulating or uneven surface
which reduces contact with the brachytherapy seed and the friction between
the seed and the coating.” (Id. at 9-10, ¶ 25.)
Claims 1-7, 9-12, 16-18, and 37-44 are on appeal. Claims 1 and 37
are representative and read as follows:
1. An elongated catheter device for irradiating tissue surrounding a
body cavity within a patient, comprising:
a. a treatment location on a distal portion of the catheter device;
b. an elongated flexible shaft which has a longitudinal axis, which
is formed at least in part of a low durometer polymeric material
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and which has a plurality of radiation delivery lumens
extending about the longitudinal axis having surfaces formed of
the low durometer polymeric material and configured to receive
a radiation source; and
c. each of said radiation delivery lumens having a particulate
coating that includes a polymeric solute material with a
durometer substantially higher than the low durometer
polymeric material of the flexible shaft that is deposited from a
solution thereof onto the surfaces of said lumens so as to line
said radiation delivery lumens and to provide improved
frictional characteristics thereto.

37. The elongated catheter device of claim 1 wherein the particulate
comprises pigment particles to provide an undulating or uneven coating
surface which reduces contact with the radiation source and the friction
between the radiation source and the coating.

The claims stand rejected under 35 U.S.C. § 103(a) as follows:
• Claims 1, 37, and 38 based on Lubock,
2
White,
3
Cohen,
4
Sutton,
5

and Hudgin
6
(Answer 4);
• Claims 1-7, 9-12, 16-18, and 39 based on Lubock, White, Cohen,
and Engelson
7
(Answer 6);
• Claims 37 and 38 based on Lubock, White, Cohen, Engelson, and
Finley
8
(Answer 8-9);

2
Lubock, US 6,923,754 B2, issued Aug. 2, 2005.
3
White et al., US 2006/0100475 A1, published May 11, 2006.
4
Cohen, US 6,217,565 B1, issued Apr. 17, 2001.
5
Sutton, US 5,704,926, issued Jan. 6, 1998.
6
Hudgin et al., US 3,975,350, issued Aug. 17, 1976.
7
Engelson et al., US 5,312,356, issued May 17, 1994.
8
Finley, US 2008/0057298 A1, published Mar. 6, 2008.
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• Claims 39-42 based on Lubock, White, Cohen, Engelson, and Ren
9

(Answer 9);
• Claims 39-41 and 43 based on Lubock, White, Cohen, Engelson,
and Furst
10
(Answer 10); and
• Claim 44 based on Lubock, White, Cohen, Engelson, Ren, and
Hassan
11
(Answer 10).
I.
All of the rejections on appeal rely on the combination of Lubock,
White, and Cohen. The Examiner finds that Lubock discloses a device
similar to that of claim 1 except that Lubock‟s device does not have multiple
radiation lumens or a high durometer inner lining (Answer 4-5). The
Examiner finds that White discloses a similar device with multiple lumens
and Cohen discloses a catheter with a shaft made of low durometer material
lined with a high durometer inner liner, and teaches that “[s]uch construction
is used to provide desired flexibility and kink resistance” (id. at 5). The
Examiner concludes that it would have been obvious “to use a low
durometer shaft with a high durometer inner liner and further to line the
lumen with a polymeric solute in the device of Lubock as taught by Cohen
since such construction can be used to provide adequate flexibility and kink
resistance” (id.).
Appellants argue that “the liner of Cohen is not akin to a coating. As
disclosed in Cohen, the „liner‟ is formed first, and then is covered with a

9
Ren, US 6,086,970, issued Jul. 11, 2000.
10
Furst et al., US 2006/0136051 A1, issued Jun. 22, 2006.
11
Hassan et al., US 6,378,137 B1, issued Apr. 30, 2002.
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variable pitch braid 14 which then is „encapsulated within an interior co-
taper 16 and an exterior cotaper 18 that form the tube wall 20‟” (Appeal Br.
16). Appellants also argue that “considering the multiple lumen
configuration disclosed in Lubock, one skilled in the art would not be
motivated to attempt to form the Lubock shaft 18 having the multiple
lumens by the technique described in Cohen that begins with the forming of
the inner liner 12” (id.).
We agree with Appellants that the Examiner has not persuasively
shown that it would have been obvious to modify the radiation lumen of
Lubock‟s device to include an inner layer (liner or coating) of higher
durometer material, as disclosed by Cohen. Lubock discloses a device for
delivering therapy, such as radiation therapy, to tissue adjacent a body cavity
(Lubock, col. 2, ll. 39-40, 51). Lubock‟s Fig. 2 is reproduced below:

Figure 2 shows a longitudinal cross-section of an embodiment of
Lubock‟s device (id. at col. 4, ll. 44-50). The device includes a treatment
location (26) at the distal end and an elongated shaft (18) that includes a
radiation delivery lumen (28) (id. at col. 5, ll. 38-64).
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Cohen discloses “reinforced co-tapered, variable stiffness tubing”
(Cohen, col. 1, ll. 14-15) that is “constructed by forming an interior liner 12
as the inner most layer. The liner 12 is then covered with a variable pitch
braid 14 and then encapsulated within an interior co-taper 16 and exterior
co-taper 18 that form the tube wall 20.” (Id. at col. 4, ll. 45-48.) Cohen
discloses that the “liner 12 is manufactured from a resin having suitable
properties to provide minimal friction between a guide wire/device or fluid
and the interior surface of the liner 12” (id. at col. 4, ll. 48-51).
Cohen discloses that the braid in its tubing “increase[s] the resistance
to kinking while maintaining the desired flexibility. The braid further
increases the burst pressures and pushability of the catheter. Possibly the
most valuable improvement is the increased torque control of the distal tip.”
(Id. at col. 4, ll. 17-21.)
The Examiner concludes that it would have been obvious to use
Cohen‟s reinforced, variable stiffness tubing to make the radiation delivery
lumen of Lubock‟s device “since such construction can be used to provide
adequate flexibility and kink resistance, having a low durometer shaft helps
reduce trauma to the body and the harder inner liner allows for proper
maneuverability” (Answer 5). However, Cohen discloses that the properties
that the Examiner relies on – flexibility and kink resistance – are the result
of the braid in Cohen‟s device, not the liner. In addition, the radiation
delivery lumen of Lubock‟s device is not only an integral part of the device,
but the central-most lumen of the device. The Examiner has not provided a
persuasive reason for concluding that flexibility and kink resistance would
be considered advantages for a tube that is an integral, interior part of a
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larger device, and therefore not capable of being advanced by itself in a
patient.
In summary, the Examiner has not provided a persuasive reason for
combining Cohen‟s tubing with Lubock‟s device. Since all of the rejections
on appeal depend on the combination of Lubock and Cohen, we reverse all
of the rejections on appeal.
II.
Under the provisions of 37 C.F.R. § 41.50(b), we enter the following
new grounds of rejection: (1) Claims 1-7, 9-12, 16-18, and 39-44 are
rejected under 35 U.S.C. § 112(b) as indefinite; and (2) Claims 1-7, 9-12,
16-18, and 39-44 are rejected under 35 U.S.C. § 112(a) for lack of adequate
written description in the Specification.
(1) Indefiniteness
Claim 1 is directed to a device comprising “radiation delivery lumens
having a particulate coating that includes a polymeric solute material” (claim
1). Claim 37 depends on claim 1 and adds the limitation that “the particulate
comprises pigment particles to provide an undulating or uneven coating
surface which reduces contact with the radiation source and the friction
between the radiation source and the coating” (claim 37).
A dependent claim must further limit the claim from which it depends.
35 U.S.C. § 112(d). Thus, the particulate coating recited in claim 1 is not
limited to one comprising pigment particles, as recited in claim 37.
However, the Specification does not define what properties are required of a
coating in order for it to be a “particulate coating” as required by claim 1.
The Specification, in fact, does not contain the phrase “particulate coating.”
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The only discussion of particles in the Specification is provided in the
following passage:
Pigments such as Reactive Blue, Prussian Blue, iron oxide,
titanium dioxide, manganese violet, ultramarine blue and others
may be suspended in the polymer solution to be deposited with
the polymeric material. The pigment particles provide an
undulating or uneven surface which reduces contact with the
brachytherapy seed and the friction between the seed and the
coating.
(Id. at 9-10, ¶ 25.)
The Specification provides no further details on what the particles of
the “particulate coating” of claim 1 can be made from, what sizes the
particles can be, or what density of particles in a coating is required for the
coating to be a “particulate coating” within the scope of the claims.
35 U.S.C. § 112(b) states that claims must “particularly point[ ] out
and distinctly claim[ ] the subject matter which the inventor . . . regards as
the invention.” Because the Specification does not define or otherwise make
clear the boundaries of the “particulate coating” required by claim 1, the
scope of claim 1, even when read in light of the Specification, is unclear.
Claim 1 therefore fails to comply with 35 U.S.C. § 112(b). Claims 2-7,
9-12, 16-18, and 39-44 depend on claim 1 and therefore are indefinite for the
same reason. Claims 37 and 38, which are limited to particulates that are
pigment particles, do not suffer from the same lack of clarity.
(2) Written Description
As discussed above, the only coating comprising particles that is
described in the Specification is one that includes pigment particles. The
Specification therefore does not show that Appellants had possession, as of
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the filing date of the instant application, of particulate coatings that comprise
particles other than pigment particles. See 35 U.S.C. § 112(a); Ariad
Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
(“[T]he 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.”). The
Specification therefore does not provide a written description that supports
claim 1, or dependent claims 2-7, 9-12, 16-18, and 39-44.
SUMMARY
We reverse the rejections based on 35 U.S.C. § 103(a) but enter new
rejections of claims 1-7, 9-12, 16-18, and 39-44 under 35 U.S.C. § 112(a)
and (b).
Time Period for Response
This decision contains new grounds of rejection pursuant to 37 CFR
§ 41.50(b) (revised, 76 Fed. Reg. 72270, effective Jan. 23, 2012). 37 CFR
§ 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph
shall not be considered final for judicial review.”
37 CFR § 41.50(b) also provides that the appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
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(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the prosecution
will be remanded to the examiner. . . .
(2) Request rehearing. Request that the proceeding be reheard
under § 41.52 by the Board upon the same Record. . . .

REVERSED, 37 C.F.R. § 41.50(b)

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