Ex Parte Kleshinski et al

Patent Trial and Appeal Board

Nov 21, 2013

11184069 (P.T.A.B. Nov. 21, 2013)

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.
11/184,069 07/19/2005 Stephen J. Kleshinski 7999
7590 11/21/2013
SCOTT RUSSELL, PRESIDENT & CEO
SEPTRX, INC
47533 WESTINGHOUSE DRIVE
SUITE C
FREMONT, CA 94536
EXAMINER
ORKIN, ALEXANDER J
ART UNIT PAPER NUMBER
3773
MAIL DATE DELIVERY MODE
11/21/2013 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte STEPHEN J. KLESHINSKI and SCOTT M. RUSSELL
__________

Appeal 2012-003257
Application 11/184,069
Technology Center 3700
__________

Before DEMETRA J. MILLS, ERICA A. FRANKLIN, and
ULRIKE W. JENKS, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134(a) involving claims to
methods of treating a defect in a septum, occluding a septal defect, and
occluding a lumen of a septal defect. The Patent Examiner rejected the
claims as failing to comply with the written description requirement (new
matter), as anticipated and as obvious. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm-in-part.

1 Appellants identify the Real Party in Interest as SeptRx, Inc. (See App. Br.
2.)
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Application 11/184,069

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STATEMENT OF THE CASE
The Specification explains:
Studies have shown that adults with strokes of unknown
origin, i.e., cryptogenic strokes, have about twice the normal
rate of patent foramen ovales than the normal population.
Although there is a correlation between strokes and patent
foramen ovales, it is currently unknown why this correlation
exists. It is theorized that blood clots and plaque that have
formed in the peripheral venous circulation (in the legs for
example) break off and travel to the heart. Normally, the clots
and plaque get delivered to the lungs where it is trapped and
usually cause no harm to the patient. Patients with a patent
foramen ovale, however, have a potential opening that the clots
or plaque can pass through the venous circulation and into the
arterial circulation and then into the brain or other tissues to
cause a thromboembolic event like a stroke.

(Spec. [0008].) The claimed invention concerns methods for treating “septal
defects through the use of an embolic filtering device capable of
instantaneously deterring the passage of emboli from the moment of
implantation.” (Id. at [0002].)
Claims 78-81, 83, and 86-115 are on appeal. Claims 78 and 104 are
representative and read as follows:
78. A method of treating a defect in a septum, wherein the defect is
defined by a tissue wall, comprising:
delivering a treatment device into the defect, wherein the device
comprises a frame comprising first and second arms disposed in a first plane,
an internal element attached to the frame, there being no frame element
disposed outside of the first plane and supporting the internal element, a first
anchor and a second anchor extending from a first end of the frame, a third
anchor and a fourth anchor extending from a second end of the frame,
wherein the internal element has interstitial spaces;
securing the device in the defect, wherein securing comprises
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Application 11/184,069

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positioning the first anchor and the second anchor on a first side of the tissue
wall defining the defect, and positioning the third anchor and the fourth
anchor on a second side of the tissue wall defining the defect; and
wherein securing comprises expanding the frame in the first plane
within the defect to distend the tissue wall outward in the first plane, and
pulling the first anchor and the second anchor toward the third anchor and
the fourth anchor along the first plane.

104. A method for occluding a lumen of a septal defect of a heart
comprising:
delivering a treatment device into the defect lumen in a collapsed
configuration, wherein the device comprises a frame disposed in a frame
plane, occlusion promoting material supported by the frame, a first anchor
extending from a first end of the device, and a second anchor extending from
a second end of the device;
moving the first anchor to engage first side of a tissue wall defining
the defect;
expanding the frame in the frame plane within the defect lumen,
distending septal defect lumen tissue outward in the frame plane and
pressing septal defect lumen tissue in contact with occlusion promoting
material; and
moving the second anchor plane to engage a second side of the tissue
wall defining the defect.

The Examiner rejected the claims as follows:2
• claims 78-81, 83, and 86-115 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement
(new matter);
• claims 78, 79, 81, 86-92, 97-100, 104-106, and 111-115 under
35 U.S.C. § 102(b) as anticipated by Thill;3

2 The Examiner withdrew the rejection of claims 78, 79, 81, 86-90, 92-96,
98-104, 107, 108, and 110-115 as unpatentable over Deem (Patent
Application Publication No. US 2007/0044811 A1 by Mark E. Deem,
published Mar. 1, 2007) and Ryan. (Ans. 4.)
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Application 11/184,069

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• claims 80 and 83 under 35 U.S.C. § 103(a) as unpatentable over
Thill and VanTassel;4 and
• claims 93-96, 101-103, and 107-110 under 35 U.S.C. § 103(a) as
unpatentable over Thill and Ryan.5

NEW MATTER
The Examiner found that the claim recitation “no frame element is
disposed outside of the first plane” is new matter. (Ans. 5.) The Examiner
found that the Specification states that “the arms are connected to the first
and second bases and are in line with longitudinal axis of the frame
(paragraph 36).” However, the Examiner found that “[t]he arms can be in
line with the longitudinal axis of the bases and be in a different plane.” (Id.)
According to the Examiner, even though the Specification includes Figure
2D showing a device wherein no frame element is outside of the first plane,
the Specification does not provide a statement teaching that no frame
element may be outside the plane. (Id.)
Appellants contend that that independent claim 104 does not recite
“‘no frame element is disposed outside of the first plane,’” which the
Examiner deemed to be new matter. (App. Br. 4.) We agree with
Appellants and reverse the rejection of claim 104 and its dependent claims
105-115.

3Patent Application Publication No. US 2001/0037129 A1 by Gary A. Thill,
published Nov. 1, 2001.
4 Patent No. US 6,652,555 B1 issued to Robert A. VanTassel et al., Nov. 25,
2003.
5 Patent Application Publication No. US 2003/0191495 A1 by Carol A.
Ryan et al., published Oct. 9, 2003.
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Regarding independent claims 78 and 98, Appellants assert that the
disputed limitation was “fully supported by the specification at the time of
filing ….” (Id. at 5.) Appellants assert that “[e]ven if the written description
of the pending application does not explicitly recite the language, ‘there
being no frame element disposed outside of the first plane’, the drawings
clearly do show an embodiment where there is no frame element not in the
plane.” (Id. at 5-6)(citing Spec. Figs. 2A, 2C and 2D). According to
Appellants, “[t]he Examiner appears to ignore the fact that drawings alone
are sufficient to comply with the written description requirement ….” (Id. at
5.)
While it is true that “under proper circumstances, drawings alone may
provide a ‘written description’ of an invention as required by § 112,” Vas-
Cath Inc. v. Mahurkar, 935 F.2d 1555, 1565 (Fed. Cir. 1991),
“[c]onsideration of what the drawings conveyed to persons of ordinary skill
is essential,” id. at 1566, citing Ralston Purina Co. v. Far-Mar-Co, Inc. 772
F.2d 1570, 1575 (Fed. Cir. 1985). To satisfy the written description
requirement, the disclosure must reasonably convey to skilled artisans that
Appellants possessed the claimed invention as of the filing date. Ariad
Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en
banc).
Here, Appellants rely on Figures 2A, 2C, and 2D as providing this
disclosure. While the figures may show the frame elements in a first plane,
there is no description that no frame element may be disposed outside of the
first plane, or even that the figures represent the only embodiments of the
invention. Rather, the Specification teaches that “[t]he invention has been
described through a preferred embodiment. However, those of ordinary skill
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will recognize that various modifications can be made without departing
from the scope of the invention as defined by the claims.” (Spec. [0053].)
Thus, we find that Appellants’ exclusion of any frame element being
disposed outside of the first plane introduces a new concept that is not
reasonably supported by the original disclosure. See, e.g., Omega Eng'g,
Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed. Cir. 2003) (finding no
express disclaimer or independent lexicography in the written description to
justify adding negative limitation).
Accordingly, we affirm the new matter rejection of claims 78-81, 83,
and 86-103.
ANTICIPATION/OBVIOUSNESS
For both the anticipation and obviousness rejections, the Examiner
found that Thill disclosed a method of treating a defect in a septum by
delivering a treatment device 20 into the defect, wherein the device
comprises a frame 40 comprising first and second arms disposed in a first
plane, an internal element 42 attached to the frame, and there being no frame
element disposed outside of the first plane and supporting the internal
element. (Ans. 5-6.)
Appellants contend that “Thill cannot anticipate claims 78 and 98
because Thill has frame elements that are not all within a single plane.”
(App. Br. 6.) Appellants assert that the Thill device includes first and
second occluder panels 30 and 60, each being generally round and having
frame elements in more than one plane. (Id.) Further, Appellants assert that
“[s]ince the Thill frame does not describe a frame disposed in a single frame
plane, Thill cannot teach the method step of expanding the frame in the
frame plane, as recited in claim 104.” (Id.)
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The Examiner responds that the occluder panels “could be called
tissue support structures that are separate from the frame.” (Ans. 10.)
According to the Examiner, the frame is considered to be “just reference
number 40, as seen in figure 1.” (Id. at 9-10.) The Examiner explains that
“the frame (40) will expand in one plane, will support the attached [] internal
element in a given manner, and have the anchors generally extending from
ends of the frame.” (Id. at 10.)
We agree with Appellants that the Examiner has not established that
Thill disclosed each and every element as set forth in the claim. See
Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631 (Fed. Cir.
1987). The Examiner relies on Thill Figure 1, set forth below:

Figure 1 is a “side elevational view of the septal defect occluder of the
present invention deployed in a septal defect.” (Thill [0023].) The
Examiner identifies element 40 as the frame. However, Thill describes
element 40 as the internal eyelets, stating:
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[0045] The conjoined points within the fabric support
structures 32, 62, which responsively link the opposing
structures, comprise loops formed in the traversing segments 38
thereof, these loops defining internal eyelets 40 for the
structures 32, 62. The internal eyelets 40 of each of the
structures 32, 62 are shown as being joined by suture (e.g.,
polyester, non-absorbable or other suitable material), and to
some extent delimit the defect conforming region 80, and serve
to center the occluder 20 within the defect.

(Thill [0045].) Regarding claims 78 and 98, the Examiner has not explained
how internal eyelets 40 meet the claims limitations for the frame. In
particular, the Examiner has not identified the first and second arms of
element 40, shown how those arms are disposed in a first plane, or where
and how the internal element 42 is attached to element 40. Similarly,
regarding claim 104, the Examiner has not explained how the element 40
functions as a frame and supports occlusive promoting material. (See Ans.
5-6 and 9-10.) Without these descriptions, supported by the evidence, we
find that the Examiner has not established that Thill anticipates independent
claims 78, 98, and 104.
Accordingly, we reverse the anticipation rejection of these
independent claims and their dependent claims.
Further, because the Examiner’s obviousness rejection relies on Thill
disclosing each of the elements of independent claims 78 and 104 (see Ans.
8), we also reverse this rejection.

SUMMARY
We affirm the rejection of claims 78-81, 83, and 86-103 under
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Application 11/184,069

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35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement (new matter);
we reverse the rejection of claims 104-115 under 35 U.S.C. § 112,
first paragraph, as failing to comply with the written description requirement
(new matter);
we reverse the rejection of claims 78, 79, 81, 86-92, 97-100, 104-106,
and 111-115 under 35 U.S.C. §102(b) as anticipated by Thill;
we reverse the rejection of claims 80 and 83 under 35 U.S.C. § 103(a)
as unpatentable over Thill and VanTassel; and
we reverse the rejection of claims 93-96, 101-103, and 107-110 under
35 U.S.C. § 103(a) as unpatentable over Thill and Ryan.

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-IN-PART

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