Ex Parte Brodersen

Patent Trial and Appeal Board

Nov 14, 2012

10936674 (P.T.A.B. Nov. 14, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
10/936,674 09/09/2004 Jens P. Brodersen 7383 8502
39196 7590 11/15/2012
SHLESINGER, ARKWRIGHT & GARVEY LLP
5845 Richmond Highway, Suite 415
ALEXANDRIA, VA 22303
EXAMINER
VU, QUYNH-NHU HOANG
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
11/15/2012 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 JENS P. BRODERSEN
__________

Appeal 2011-003038
Application 10/936,674
Technology Center 1600
__________

Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for anticipation. We have jurisdiction under 35 U.S.C. § 6(b).
Appeal 2011-003038
Application 10/936,674

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STATEMENT OF CASE
Claim 1 is present for examination. Claims 2-21 are withdrawn.

1. Sclerotherapy catheter for sclerotherapy of blood vessels,
comprising:
a) at least two lumina, a first lumen of the at least two
lumina having a first balloon-like element which can be filled
with air and inflated to block the blood vessel;
b) a second lumen of the at least two lumina having an
interior wall and at least one outlet opening fixed in location
relative to the first balloon-like element and configured for
the application of a sclerosant; and
c) the second lumen being sufficiently rigid along its
entire length, so that upon generation of a negative pressure in
the second lumen required for the evacuation of excess
sclerosant from a blood vessel into the second lumen, closure of
the second lumen by elastic deformation of the interior wall of
the second lumen is prevented.

Cited References

Simpson et al. US 5,462, 529 Oct. 31, 1995
Constantz US 6,712,798 B2 Mar. 30, 2004

Grounds of Rejection
Claim 1 is rejected under 35 U.S.C. § 102(b) as being anticipated by
Simpson.

Claim 1 is alternatively rejected under 35 U.S.C. §102(e) as being
anticipated by Constantz.

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 3-
7.

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Application 10/936,674

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Discussion
ISSUE
The Examiner concludes that Simpson and Constantz teach each
element claimed. More particularly
Simpson et al discloses, in Figs. 1-10, a catheter
comprising: at least two luminas/lumens (lumens 52,54 (Fig. 1);
lumens 128,138,140,126,136 of Figs. 8-9); a first lumen 54
(Fig. 1) or 128 and 140 (Fig. 8) having a first balloon 48 (Fig.
1) or 114/116 (Fig. 8) which can be filled with air and inflated
to block a blood vessel; a second lumen 52 (Fig. 1) or 126 (Fig.
8) having an interior wall and at least an outlet opening (at the
distal end portion 44 as shown in Fig. 1, or distal end portion
112 shown in Fig. 8) fixed in location relative to the first
balloon element 48 (Fig. 1) or 114 (Fig. 8) and configured for
the application of a sclerosant.

(Ans. 3.)

Constantz discloses a catheter comprising: at least two
lumens 17,19, a first lumen having a first balloon element 13
which can be filled with air and inflated to block the blood
vessel (see Figs, 1A-b markup below), a second lumen 17
having an interior wall and at least an outlet opening (at the
distal end of catheter 16) fixed in location relative to the first
balloon element 13 and configured for the application of a
sclerosant, wherein the second lumen is sufficiently rigid along
its entire length upon generation of negative pressure in a
second lumen require excess sclerosant will be evacuated from
a blood vessel into the second lumen (and note that the device
is capable of preventing of elastic deformation). With regard to
the limitation "the second lumen being sufficiently rigid along
its entire length", it is noted that applicant does not clearly
disclose that the second lumen is made of a specific material
(for example, plastic, polymer, etc) to support that the second
lumen is rigid along entire length of the second lumen.
Applicant only states that the second lumen may be constructed
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substantially rigid along its entire length, the walls of the
second cavity lumen can in principle consist of a highly elastic
material, see paragraphs [0015, 0020-0021, 0028] of the present
specification. Therefore, using the test of broadest reasonable
interpretation, the examiner interprets the second lumen of
Constantz as being constructed sufficiently rigid along its entire
length. For example, upon generation of a negative pressure (by
spirating/suctioning/vacuuming), the aspiration lumen (the
claimed "second lumen") will be sufficiently rigid so that it will
not collapse or be deformed so that an evacuation of a friable
material and fluid can exit through the aspiration lumen 17.

(Ans. 4.)

Appellant argues neither Simpson nor Constantz teach a second lumen
which is sufficiently rigid along its entire length as claimed. (Br. 7.)
Appellant further argues that, “Appellant submits, and case law supports,
that “sufficiently rigid” is a structural limitation which must be
given patentable weight. Contrary to the Examiner's position, "sufficiently
rigid" is not a mere recitation of "intended use" for which no weight
need be given.” (Br. 5.)
The issue is: Does the cited prior art teach a second lumen which is
sufficiently rigid along its entire length as claimed?

PRINCIPLES OF LAW
In order for a prior art reference to serve as an anticipatory reference,
it must disclose every limitation of the claimed invention, either explicitly or
inherently. See In re Schreiber, 128 F.3d 1473, 1477(Fed. Cir. 1997). To
anticipate, every element and limitation of the claimed invention must be
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found in a single prior art reference, arranged as in the claim. Karsten Mfg.
Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001). ]
Moreover:
Where . . . the claimed and prior art products are
identical or substantially identical, or are produced by identical
or substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed
product…. Whether the rejection is based on “inherency” under
35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C.
§ 103, jointly or alternatively, the burden of proof is the same,
and its fairness is evidenced by the PTO’s inability to
manufacture products or to obtain and compare prior art
products.

In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (emphasis added.)

Inherency …. 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. If, however, the
disclosure is sufficient to show that the natural result flowing from the
operation as taught would result in the performance of the questioned
function, it seems to be well settled that the disclosure should be
regarded as sufficient. In re Oelrich, 666 F.2d 578, 581, (CCPA
1981)(quoting Hansgirg v. Kemmer, 102 F.2d 212, 214, (CCPA
1939).

ANALYSIS
We agree with the Examiner’s fact finding, statement of the rejection
and responses to Appellant’s argument as set forth in the Answer. While we
differ somewhat from the Examiner’s claim interpretation, we find that the
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Examiner has provided evidence to support a prima facie case of
anticipation. We provide the following additional comment.
Appellant argues that the Examiner has improperly interpreted the
language “sufficiently rigid” in the claim as intended use, which has no
patentable weight. ( Br. 5.) However, the Examiner provides another
alternative claim interpretation on the record with which we agree, that
the examiner interprets the second lumen of Constantz as being
constructed sufficiently rigid along its entire length. For
example, upon generation of a negative pressure (by
aspirating/suctioning/vacuuming), the aspiration lumen (the
claimed "second lumen") will be sufficiently rigid so that it will
not collapse or be deformed so that an evacuation of a friable
material and fluid can exit through the aspiration lumen 17. As
indicated therein, if elastic deformation of the interior wall of
the second lumen occurs, it will not function to suction/aspirate
the fluid out of the lumen (it will not occur in the device of
Constantz because the friable material and excess fluid are
removed from the target site back through the aspiration lumen,
see col. 5, lines 1-49). Therefore, the second lumen 17 of
Constantz meets the claimed limitation of being "sufficiently
rigid along its entire length."
…
In this case, the devices of both Simpson and Constantz are
capable of performing the function of aspirating/suctioning the
fluid escapes through the second lumen (i.e., the aspiration
lumen). Moreover, the aspiration lumen of these references
will inherently be rigid (not deformed or collapsed) so that the
fluid is able to escape when a negative pressure is applied. For
example, upon generation of a negative pressure (by
aspirating/suctioning/vacuuming), the second lumen as
aspiration lumen will be rigid enough so that it will not collapse
or be deformed so that an evacuation of fluid can exit through
the second lumen. And if elastic deformation of the interior
wall of the second lumen occurs, the device cannot perform the
function of aspirating/suctioning the fluid out of the aspiration
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lumen. Such will not happen in the devices of Simpson and
Constantz because the fluids are removed from the vascular site
through the second lumen (aspiration lumen), see col. 6, lines
63-66 of Simpson and col. 5, lines 1-49 of Constantz.
Therefore, the second lumen of both Simpson and Constantz
will inherently be sufficiently rigid along its entire length so
that upon generation of a negative pressure (by operating a
suction/vacuum/-aspiration) in the second lumen, the closure of
the second lumen (aspiration lumen) by elastic deformed will
not occur so that the unwanted fluid is able to escape through
second lumen (aspiration lumen).

(Ans. 4-6.)
Appellant notes that the claimed catheter may be made of
polyurethane for example. (Br. 6.) Constantz discloses that,
Another common feature of all of the multilumen
catheters of the subject invention is that the elongated
multilumen tube is typically a polymeric extruded element,
which is made up of one or more biocompatible polymers that
have been extruded to produce the non-coaxial multilumen
tube. Biocompatible polymers of interest include, but are not
limited to: polyimide, polyamide, PBAXTM, polyethylene,
polyisoprene, nylon and the like. (Col. 4, ll. 13-20.)

Constantz further defines that its catheter has lumens for aspiration
and flushing. (Col. 4, ll. 29-33.) This disclosure that the catheter of
Constantz is capable of aspiration is sufficient to shift the burden to
Appellant to show that the catheter of Constantz is not sufficiently rigid to
support aspiration.
Appellant has not provided evidence that the materials of the
Constantz catheter would not result in a product which is “sufficiently
rigid,” as claimed.
Furthermore, Simpson discloses a catheter with two lumens.
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The second catheter lumen is connected to an infusion port at
its proximal end. The port is used to introduce a flushing fluid
or liquid medication or the like into the treatment chamber.
In another preferred embodiment, the diameter of the
aspiration lumen is substantially greater than the diameter of
the enclosed second catheter member. The aspiration lumen 60
is used for access by other catheter type devices to the
treatment chamber and to extract excess fluid and biological
debris. The infusion and aspiration lumens are connected to
infusion and aspiration ports at their proximal ends. (Col. 3, ll.
54-64.)

This disclosure that the catheter of Simpson is capable of aspiration is
sufficient to shift the burden to Appellant to show that the catheter of
Simpson is not “sufficiently rigid” to support aspiration.
Appellant has not provided evidence that the Simpson catheter is not
capable of aspiration or is not “sufficiently rigid,” to support aspiration, as
claimed.
In other words, because both catheters of the prior art are capable of
performing flushing and aspiration functions, this disclosure is sufficient to
show that the natural result flowing from the operation of aspiration, as
taught, would result in the performance of the “sufficient rigidity” for
aspiration “so that upon generation of a negative pressure in the second
lumen required for the evacuation of excess sclerosant from a blood vessel
into the second lumen, closure of the second lumen by elastic deformation of
the interior wall of the second lumen is prevented,” as claimed.

CONCLUSION OF LAW
The cited references support the Examiner’s anticipation rejections,
which are affirmed for the reasons of record.
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Application 10/936,674

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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

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