Ex Parte McKinsey et al

Patent Trial and Appeal Board

May 7, 2013

12195762 (P.T.A.B. May. 7, 2013)

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.
12/195,762 08/21/2008 James F. McKinsey 12730/407
(PA-5967-RFB)
9086
48003 7590 05/07/2013
BRINKS HOFER GILSON & LIONE/CHICAGO/COOK
PO BOX 10395
CHICAGO, IL 60610
EXAMINER
SCHALL, MATTHEWWAYNE
ART UNIT PAPER NUMBER
3738
MAIL DATE DELIVERY MODE
05/07/2013 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 JAMES F. MCKINSEY,
SHYAM SV KUPPURATHANAM, and
MATTHEW S. WANINGER
__________

Appeal 2012-001030
Application 12/195,762
Technology Center 3700
__________

Before DEMETRA J. MILLS, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
implantable graft. The Examiner rejected the claims as failing the written
description requirement, as anticipated and as obvious. We have jurisdiction
under 35 U.S.C. § 6(b). We reverse.

Appeal 2012-001030
Application 12/195,762

2
Statement of the Case
Background
The Specification teaches that “[a]neurysms occur in blood vessels in
locations where, due to age, disease or genetic predisposition, the blood
vessel strength or resiliency is insufficient” (Spec. 1, ll. 11-13). “The
present disclosure provides for a variable yarn density textile graft for
bridging a defect in a main vessel near one or more branch vessels” (Spec. 4,
ll. 19-20).
The Claims
Claims 1-20 are on appeal. Claim 1 is representative and reads as
follows:
1. An implantable graft comprising:
a main graft body forming a lumen with a proximal
end and a distal end;
where at least a portion of the lumen is defined by a
woven fabric comprising yarns aligned in a first direction
interwoven with yarns aligned in a second direction;
where the woven fabric further comprises a main
portion and at least one reduced yarn density region
disposed between the proximal and distal end;
where, although at least some yarns traverse the
reduced yarn density region, the reduced yarn density region
is defined by having a lower yarn density than the main
portion; and
where both the main portion and the reduced yarn
density region are substantially impermeable to fluid flow.

The issues
A. The Examiner rejected claims 1-20 under 35 U.S.C. § 112, first
paragraph as failing to comply with the written description requirement
(Ans. 4).
Appeal 2012-001030
Application 12/195,762

3
B. The Examiner rejected claims 1, 2, 5-8, 14-17, and 19 under 35
U.S.C. § 102(b) as anticipated by Greenhalgh1 (Ans. 5-8).
C. The Examiner rejected claims 3, 4, and 9-11 under 35 U.S.C. § 103(a)
as obvious over Greenhalgh (Ans. 8-11).
D. The Examiner rejected claims 12, 13, and 18 under 35 U.S.C. § 103(a)
as obvious over Greenhalgh and Rakos2 (Ans. 11-12).
E. The Examiner rejected claim 20 under 35 U.S.C. § 103(a) as obvious
over Greenhalgh and Quadri3 (Ans. 12-13).
A. 35 U.S.C. § 112, first paragraph - written description
The Examiner finds that “[t]here is no support in the disclosure for the
additional claim limitation of ‘the main portion and the reduced yarn density
region are substantially impermeable to fluid flow’” (Ans. 4). The Examiner
finds that “[s]imply stating holes may be created in the region to provide
blood flow does not require the region to be substantially impermeable and
this does not support the newly added claim limitation. The material could
be semi-permeable or permeable and the added holes are used to increase the
blood flow” (id. at 13).
Appellants contend that “key to whether a claim limitation has
adequate support is not whether the specification provides a literal basis for
the claim, but what the specification demonstrated to those of ordinary skill
in the art” (App. Br. 11). Appellants contend that “the device must be

1 Greenhalgh, E., US 2002/0052649 A1, published May 2, 2002.
2 Rakos et al., US 2005/0240261 A1, published Oct. 27, 2005.
3 Quadri, A., US 2005/0154444 A1, published Jul. 14, 2005.
Appeal 2012-001030
Application 12/195,762

4
substantially impermeable to fluid flow to work for its intended purpose and
one of ordinary skill in the art would know this” (App. Br. 11).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that the claims lack descriptive
support for the limitation “where both the main portion and the reduced yarn
density region are substantially impermeable to fluid flow”?
Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
1. The Specification teaches “[v]ariable yarn density textile grafts
include any prosthesis that is introduced temporarily or permanently into the
body for the prophylaxis or therapy of a medical condition” (Spec. 6, ll. 25-
27).
2. The Specification teaches that the “reduced yarn density regions
may be perforated, preferably in situ, to establish fenestrations providing
blood flow to the real arteries 222, 223” (Spec. 7, ll. 13-15).
3. The Specification teaches that “[f]ollowing proper positioning
of the graft, the guide wire may be used to poke through and perforate the
reduced yarn density region. In some examples, an inflatable balloon may be
used to enhance perforation of the reduced yarn density region to further
enable blood flow through the fenestration” (Spec. 7, ll. 21-25).
4. The Specification teaches that a “reduced yarn density region
variable weave the may permit a tighter fit between a bridge stent and a
fenestration, thereby decreasing any fluid leakage about the circumference
of the fenestration” (Spec. 9, ll. 26-28).
Appeal 2012-001030
Application 12/195,762

5
Principles of Law
“[I]t is the specification itself that must demonstrate possession. And
while the description requirement does not demand any particular form of
disclosure, ... or that the specification recite the claimed invention in haec
verba, a description that merely renders the invention obvious does not
satisfy the requirement” Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co.,
598 F.3d 1336, 1352 (Fed. Cir. 2010).
Analysis
While the Examiner is correct that the specific language of the claims
was not disclosed ipsis verbis in the Specification, ipsis verbis support is not
required. Fujikawa v. Wattanasin, 93 F.3d 1559, 1570 (Fed. Cir. 1996).
Here, the Specification clearly requires fenestrations (i.e. added perforations)
in order to permit fluid flow through the weave (FF 2-4). That is, the weave
is not permeable to fluid until fenestrations are established, such as by
perforating the reduced yarn density section (FF2). We therefore agree with
Appellants that the Specification inherently provides descriptive support for
the concept of an “impermeable” weave.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that the claims lack descriptive support for the limitation “where both the
main portion and the reduced yarn density region are substantially
impermeable to fluid flow.”
B. 35 U.S.C. § 102(b) over Greenhalgh
The Examiner finds that:
Greenhalgh discloses an implantable graft comprising: a
main graft body forming a lumen with a proximal end and a
Appeal 2012-001030
Application 12/195,762

6
distal end; where at least a portion of the lumen is defined
by a woven fabric comprising yarns aligned in a first
direction interwoven with yarns aligned in a second
direction; where the woven fabric further comprises a main
portion and at least one reduced yarn density region
disposed between the proximal and distal end; and where,
although at least some yarns traverse the reduced yarn
density region, the reduced yarn density region is defined by
having a lower yarn density than the main portion

(Ans. 5). The Examiner finds that “the main portion and the reduced yarn
density region will be substantially impermeable to fluid flow after tissue
ingrowth has occurred. Additionally and/or alternatively, Figures 4-5
disclose alternative embodiments of the graft material that contains regions
of higher and lower yarn density and also do not have any fluid permeable
regions” (id.).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion Greenhalgh anticipates claim 1?
Findings of Fact
5. Figure 1 of Greenhalgh is reproduced below:

“FIG. 1 shows a vascular stent graft 10 typically used to treat a vascular
aneurysm 12 in an artery 14. . . . At each end of substrate 18 are attachment
Appeal 2012-001030
Application 12/195,762

7
regions 22 engage able with the living tissue of the artery” (Greenhalgh 2 ¶¶
0023-0025).
6. Greenhalgh teaches that because “the substrate 18 between the
attachment regions 22 must remain substantially hemostatic, however, the
attachment regions 22 of higher permeability are confined to relatively
narrow bands . . . . This length should provide adequate attachment and
sealing of the graft to the artery without resulting in unacceptable levels of
leakage” (Greenhalgh 2 ¶ 0026).
7. Greenhalgh teaches that “the regions 22 of higher permeability
may be formed by changing the density of the weave in these regions, i.e.,
weaving fewer filamentary members per unit area” (Greenhalgh 2 ¶ 0028).
8. Figure 4 is reproduced below:

“As shown in FIG. 4, a means for promoting growth of living animal tissue
across attachment regions 22 to attach and seal the graft to the vessel also
includes creating a textured surface 23 having increased surface area”
(Greenhalgh 3 ¶ 0032).
9. Greenhalgh teaches that:
Appeal 2012-001030
Application 12/195,762

8
the textured surface 23 having increased surface area may
also be formed over region 22 by weaving or knitting
textured filamentary members 31 under varying tension,
using low tension where the fabric is to be bulkier and have
a higher surface area and high tension to stretch the yarns
and remove the bulk and reduce the surface area available
for attachment to the living animal tissue.

(Greenhalgh 3 ¶ 0033.)
10. Greenhalgh teaches that an advantage in “using increased
surface area to form the regions to promote living animal tissue ingrowth is
that the hemostatic properties of the graft are maintained throughout the
entire length of the graft, i.e., there are no regions of high permeability
which may leak initially after the graft is implanted” (Greenhalgh 3 ¶ 0035).
Principles of Law
“A single prior art reference that discloses, either expressly or
inherently, each limitation of a claim invalidates that claim by anticipation.”
Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1375 (Fed. Cir.
2005).
Analysis
The Examiner’s rejection identifies two different embodiments which
the Examiner finds anticipate claim 1, the graft of figure 1 and the graft of
figure 4.
Regarding the figure 1 embodiment, Appellants contend that the
“reference numerals 22 designate these porous high permeability regions at
the ends of the graft, and not between the ends of the graft as clearly recited
by the claims” (App. Br. 15). Appellants also contend that “although
Greenhalgh discloses other regions of the graft are substantially
Appeal 2012-001030
Application 12/195,762

9
impermeable, the areas of reduced density are, to the absolute contrary,
porous and have a ‘substantially higher permeability’” (App. Br. 15).
While we are not persuaded by Appellants’ argument regarding the
location of the reduced density regions, we agree with Appellants that
Greenhalgh clearly discloses that the regions in the graft in figure 1 are
permeable, specifically Greenhalgh teaches that “attachment regions 22 of
higher permeability are confined to relatively narrow bands . . . . This length
should provide adequate attachment and sealing of the graft to the artery
without resulting in unacceptable levels of leakage” (Greenhalgh 2 ¶ 0026;
FF 6). For this reason, the embodiment in figure 1 does not anticipate the
claimed invention.
Appellants contend that with “regard to Figure 4 of this embodiment,
Greenhalgh does not discuss whether this region 22 has a greater or lesser
yarn density, but only that it has increased surface area, for example by
creating loops on the surface. The Examiner has not shown that the
increased surface are of Greenhalgh equates with increased or decreased
density.” (App. Br. 16.)
The Examiner responds that “Greenhalgh very clearly discloses
altering the density of portions of the device in paragraph [0033]. Increasing
the number of threads and/or loops increases the density” (Ans. 14). The
Examiner also finds that “‘the main portion’ and the ‘reduced yarn density
region’ are vague and can be located at any portion between the ends of the
prior art invention” (id.).
We find that Appellants have the better position. Claim 1 requires a
woven fabric which “comprises a main portion and at least one reduced yarn
Appeal 2012-001030
Application 12/195,762

10
density region.” The claim requires that the reduced density must be in the
woven fabric, and does not address the surface area requirement.
Greenhalgh teaches that
the textured surface 23 having increased surface area may
also be formed over region 22 by weaving or knitting
textured filamentary members 31 under varying tension,
using low tension where the fabric is to be bulkier and have
a higher surface area and high tension to stretch the yarns
and remove the bulk and reduce the surface area available
for attachment to the living animal tissue.

(Greenhalgh 3 ¶ 0033; FF 9.) While Greenhalgh teaches that textured
surface 23 may include additional weaving, the Examiner has not established
that the region 23 necessarily has a higher yarn density than region 18 in
figure 4. That is, increased surface area of the yarn is not necessarily
equivalent to increased density, but rather describes how the yarn is woven,
not the amount of yarn incorporated per unit area. “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.”
MEHL/Biophile Int’l. Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir.
1999).
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
Greenhalgh anticipates claim 1.
C-E. 35 U.S.C. § 103(a) rejections
Each of these rejections relies upon the underlying anticipation
rejection over Greenhalgh. Having reversed the rejection of claim 1 over
Appeal 2012-001030
Application 12/195,762

11
Greenhalgh above, we necessarily reverse these obviousness rejections,
which do not suggest the reduced yarn densities as required by claim 1.
SUMMARY
In summary, we reverse the rejection of claims 1-20 under 35 U.S.C.
§ 112, first paragraph as failing to comply with the written description
requirement.
We reverse the rejection of claims 1, 2, 5-8, 14-17, and 19 under 35
U.S.C. § 102(b) as anticipated by Greenhalgh.
We reverse the rejection of claims 3, 4, and 9-11 under 35 U.S.C. §
103(a) as obvious over Greenhalgh.
We reverse the rejection of claims 12, 13, and 18 under 35 U.S.C. §
103(a) as obvious over Greenhalgh and Rakos.
We reverse the rejection of claim 20 under 35 U.S.C. § 103(a) as
obvious over Greenhalgh and Quadri.

REVERSED

cdc