Ex Parte Braginsky et al

Board of Patent Appeals and Interferences

Jan 23, 2009

10335680 (B.P.A.I. Jan. 23, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte SIDNEY BRAGINSKY and RUSSELL A. HOUSER
____________

Appeal 2008-4495
Application 10/335,680
Technology Center 3700
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Decided: January 23, 2009
____________

Before DONALD. E. ADAMS, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL

This appeal under 35 U.S.C. § 134 involves claims 1-4, 7-11, 13-16,
and 20-27. “Claims 5, 6, 12, 17-19, 28, 29, and 53-168 have been
withdrawn” from consideration (App. Br. 1). We have jurisdiction under 35
U.S.C. § 6(b).
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Application 10/335,680

STATEMENT OF THE CASE
The claims are directed to an exterior stent. Claim 1 is representative:
1. An exterior stent comprising:
a support layer having inner and outer surfaces, and
a securing element on said inner surface of said support layer
designed to contact an exterior of a body lumen to secure said support
layer to said exterior of said body lumen.

The Examiner relies on the following evidence:
Roy et al. (Roy I) US 6,743,243 B1 Jun. 1, 2004
Roy et al. (Roy II) WO 99/48427 Sep. 30, 1999

The rejections as presented by the Examiner are as follows:
1. Claims 1-4, 7-11, 13-16, 22-24, 26, and 27 stand rejected under 35 U.S.C.
§ 102(a) as unpatentable over Roy II.
2. Claims 20, 21, and 25 stand rejected under 35 U.S.C § 103(a) as
unpatentable over Roy II.
We affirm.

Anticipation:
ISSUE

Does Roy II teach every element of the claimed invention?

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FINDINGS OF FACT
FF 1. The Examiner’s rejection is based on Roy II, but refers to the
disclosure of Roy I. Appellants do not dispute and therefore concede to the
Examiner’s finding that Roy I’s disclosure is the same as Roy II (Ans. 3).
FF 2. The Examiner finds that Roy II teaches a stent that comprises “an
adhesive layer ([Roy I,] col. 5, lines 22-25) as a securing element for
securing the device to a tubular body organ such as a blood vessel” (Ans. 3-
4).
FF 3. The Examiner finds that Roy I and II’s “device meets all [the]
structural limitations of the claimed invention” (Ans. 4).
FF 4. The Examiner finds that Roy I “(Figs. 1, 14, 15A, 15B, 15C;
Example I, line 40[,] col. 5 to line 12, col. 6) clearly discloses an adhesive
layer as a securement element between the inner surface of Roy [I’s] . . .
device and an exterior surface of a blood vessel to secure the inner surface of
Roy [I’s] . . . device to the exterior surface of the blood vessel” (Ans. 5
(emphasis removed)). Specifically, the Examiner finds that Roy I
discloses a left IMA (internal mammary artery) is inserted into
an inner surface having an adhesive . . . [a] balloon . . . inside
the left IMA is inflated to provide a positive contact between
the exterior surface of the left IMA and the inner surface
(with an adhesive layer) of the device so that a securement
between the inner surface of the Roy . . . [I]’s device and
exterior surface of the left IMA is formed.

(Ans. 5-6.) The Examiner finds that a “two-component adhesive requires
both components for curing” (id. at 6).
FF 5. Roy II teaches an anastomosis device and its use (see e.g., Roy II 7:
7 – 11: 13). For clarity, we reproduce Roy II’s Figures 1 and 16 below:

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Fig. 1 shows a first embodiment of the invention to be used if
circumferential dissection of the outflow vessel is not possible
(e.g. in coronary artery bypass). This embodiment of the
invention shows a first tubular member 1 and a second tubular
member 2, where the first tubular member 1 is provided with a
longitudinal split 3. The split 3 is wide and the edges are not in
contact. This characteristic allows use of this embodiment of
the invention in cases where the outflow vessel cannot be
circumferentially dissected, by placing the first tubular member
as a “cap” on the vessel. The second tubular member 2 is
attached on the side of the first tubular member 1 opposite the
split. In this embodiment of the invention, the second tubular
member does not show a split.

(Roy II 4: 19-29.) Fig. 16 illustrates “an externally stented end-to-side
anastomosis by means of the device according to the invention for outflow
vessels that cannot be circumferentially dissected” (Roy II 4: 5-7).
FF 6. Roy II’s Example I assumes
[T]hat the device is precoated with an [sic] single component
adhesive or the substrate of a two component adhesive. If the
device is not precoated with a single component adhesive/
substrate of two-component adhesive, it is applied to the inner
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surface of the anastomosis device before it is introduced into
the operative field.

(Roy II 7: 11-15.) Step 8 of Roy II’s Example I requires that a portion of the
IMA to be “drawn into the side arm of type I Y-shaped anastomosis device
. . . (Modification : If a two component adhesive is being used, the
appropriate activator is sprayed on the stump of left IMA.)” (Roy II 7: 31-
34). Step 9 of Roy II’s Example I requires that “[t]he balloon is inflated
apposing the wall of left IMA to the inner surface of the anastomosis device”
(Roy II 8: 1-2). Roy II’s figures 15A-15C illustrate this procedure and are
reproduced below:

Figs. 15A-15C illustrate “an externally stented end-to-side anastomosis by
means of the device according to the invention for outflow vessels that
cannot be circumferentially dissected” (Roy II 4: 5-7; see also Roy II 7: 25 –
8: 2). The remaining part of the device (e.g., elements 2 and 3 of Fig. 1) is
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then attached to a second artery through the use of an adhesive (Roy II 8: 11-
29).
FF 7. The Examiner finds that Roy II teaches “a support device/stent of a
polymeric material or nitinol . . . having a pharmacologic layer (col. 5, lines
27-29) for treatment purpose” (Ans. 3-4). The Examiner finds that Roy II
“teaches the inner surface of the device is lined with appropriate
pharmacologic agents, which inherently are bioactive and re-sorbable
materials” (id. at 6).
FF 8. The Examiner finds that Roy II teaches “a support device/stent of a .
. . braided material (Fig. 11)” (id. at 3-4). For clarity we reproduce Roy II’s
figure 11 below:

Fig. 11 shows an alternative embodiment of the fixation sleeve.
The cylindrical segment of the fixation sleeve is reinforced with
a cylindrical mesh of a thermodynamic shape-memory metal . .
. with transitional temperature range (TTR) slightly above
normal body temperature. Below the TTR, the mesh is in
martensitic state and its diameter [is] greater than that of the
inner sleeve to simplify placement. Above TTR the metal
moves into austenitic state and the cylinder shrinks in diameter
to match the inner sleeve.

(Roy II 6: 1-8.) Example 4 of Roy II teaches the use of a fixation sleeve and
specifically states that
[i]t is assumed that the components of the kit are precoated with
an single component adhesive or the substrate of a two
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component adhesive. If they are not pre-coated with a single
component adhesive/substrate of two component adhesive, it is
applied before the various components of the anatomosis kit are
introduced into the operative field.

(Roy II 12: 13-17.)

FF 9. The Examiner finds that Roy II teaches a device that “comprises
shape memory material” and a “shape memory braid material” (Ans. 6).
FF 10. The Examiner finds that Roy II teaches a device wherein the support
comprises two members joined through a hinge (id.). For clarity, we
reproduce Roy II’s figures 3 and 9 below:

Fig. 3 shows a third embodiment of the invention to be used if
circumferential dissection of the outflow vessel is possible.
This embodiment of the invention is similar to the embodiment
in Fig. 1 except that the second tubular member 2 is split too
and it is attached to the first tubular member 1 in such a way
that both splits are in contact. The whole device is “hinged”
round a longitudinal line in tubular member 1 lying opposite to
the split 3. The term “hinged” in this case is to be understood
as a minimum separation of the splits’ 3 edges, that otherwise
are in contact.

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(Roy II 4: 31 – 5: 2.)

Fig. 9 shows another possibility for connection of the splits
edges. This possibility consists in extending the splits edges to
form overlapping flaps. The surfaces of the flaps facing each
other can be provided with a fastening material, e.g., Velcro
strips.

(Roy II 5: 32-35.)

PRINCIPLES OF LAW
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros., Inc. v. Union Oil Co. of California, 814
F.2d 628, 631 (Fed. Cir. 1987). Analysis of whether a claim is patentable
over the prior art under 35 U.S.C. § 102 begins with a determination of the
scope of the claim. We determine the scope of the claims in patent
applications not solely on the basis of the claim language, but upon giving
claims their broadest reasonable construction in light of the specification as
it would be interpreted by one of ordinary skill in the art. In re Am. Acad. Of
Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). The properly
interpreted claim must then be compared with the prior art.
“It is well settled that a prior art reference may anticipate when the
claim limitations not expressly found in that reference are nonetheless
inherent in it. Under the principles of inherency, if the prior art necessarily
functions in accordance with, or includes, the claimed limitations, it
anticipates.” In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir.
2002) (citations and internal quotation marks omitted). “Inherency,
however, may not be established by probabilities or possibilities. The mere
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fact that a certain thing may result from a given set of circumstances is not
sufficient.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citations
and internal quotation marks omitted).
“[A] prima facie case of anticipation [may be] based on inherency.”
In re King, 801 F.2d 1324, 1327 (Fed. Cir. 1986). Once a prima facie case
of anticipation has been established, the burden shifts to the Appellant to
prove that the prior art product does not necessarily or inherently possess the
characteristics of the claimed product. In re Best, 562 F.2d 1252, 1255
(CCPA 1977) (“Where, as here, 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.”). See also In re Spada, 911 F.2d
705, 708-09 (Fed. Cir. 1990).
“A patent applicant is free to recite features of an apparatus either
structurally or functionally.” In re Schreiber, 128 F.3d 1473, 1478 (Fed.
Cir. 1997). However, “‘[f]unctional’ terminology may render a claim quite
broad . . .[;] a claim employing such language covers any and all
embodiments which perform the recited function.” In re Swinehart, 439
F.2d 210, 213 (CCPA 1971) (emphasis added).
Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii)
(“Any arguments or authorities not included in the brief or a reply brief ...
will be refused consideration by the Board, unless good cause is shown.”).

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ANALYSIS
Claims 1-4, 7-11, 13-16, 22-24, 26, and 27 stand rejected under 35
U.S.C § 103(a) as unpatentable over Roy II. Appellants provide separate
arguments for the following groups of claims: (I) claim 1; (II) claim 2; (III)
claims 3 and 4; (IV) claim 7; (V) claim 8; (VI) claim 9; (VII) claims 10 and
11; (VIII) claim 13; (IX) claim 14; (X) claims 15 and 16; (XI) claim 22;
(XII) claims 23 and 24; (XIII) claim 26; and (XIV) claim 27. We take each
group in turn.

Claim 1:
Appellants contend that Roy II discloses “that the walls of vessels are
in apposition to the inner surface of [Roy II’s] anastomosis device” (App.
Br. 10). Appellants contend that “[a]pposition does not mean that the
surfaces are in contact with each other” (id.). In this regard, Appellants
contend that Roy II does not teach a device that has “a securing element on
the inner surface that secures the inner surface of the tubular member(s) to
the exterior of the body lumen” (App. Br. 10). We are not persuaded.
Roy II teaches a device (e.g., a stent) that comprises a support layer
having inner and outer surfaces (e.g., element 1 of Roy II’s Fig. 1) (FF 5).
Roy II teaches that the anastomosis device is precoated with a single
component adhesive; or in the case of a two component adhesive the device
is either precoated with the substrate or that the adhesive substrate is applied
to the inner surface of the anastomosis device before it is introduced into the
operative field (FF 5 and 6). We note that the securing element of
Appellants’ claim 1 can be an adhesive (Cf. Appellants’ claim 22 which
depends from claim 1).
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Roy II teaches that in practice an artery can be inserted into the
anastomosis device (FF 6). Roy II teaches that if a two component adhesive
is used, the second component of the adhesive is applied to the artery at the
time it is inserted into the device (e.g., at element 2 of Fig. 1) (FF 5 and 6).
Roy II teaches that a balloon in the artery is then inflated to appose the wall
of the artery to the inner surface of the anastomosis device (id.). In this
regard, a person of ordinary skill in the art would understand that the Roy
II’s adhesive (e.g., securing element located on the inner surface of the
support layers) contacts and secures the exterior surface of the arterial lumen
to the inner surface of the device. Therefore, we are not persuaded by
Appellants’ contention that Roy II teaches “two members, edges, or pieces
of the anastomosis device that attach to each other and are positioned about
the vessels by an adhesive that surrounds both the exterior surface of the
device and the vessels” (App. Br. 7 (emphasis removed)). For the same
reason we are not persuaded by Appellants’ contention that Roy II fails to
teach “a securing element on an interior surface of a support layer that
contacts the lumen’s exterior to secure the support layer to the exterior of the
body lumen” (App. Br. 8 (emphasis removed)). Further, for the same reason
we are not persuaded by Appellants’ intimation that since Roy II does not
refer to the adhesive as a securing element it does not function as a securing
element (App. Br. 10 (“Roy et al. do not disclose that the device’s tubular
member(s) has/have a securing element on the inner surface that secures the
inner surface of the tubular member(s) to the exterior of the body lumen”);
see also Reply Br. 5-6 (“while Roy et al. may disclose that ‘the device is
precoated with an [sic] single component adhesive…,’ (5:46-47), there is
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absolutely no disclosure that the adhesive is a securing element that secures
the support layer to the exterior of the body lumen”) (alteration original)).
To be complete, we note that Appellants’ claim 1 does not exclude the
attachment of the device to a second body lumen as taught by Roy II (FF 5-
6). In addition, Appellants’ claim 1 does not exclude the use of adhesive on
both the inner and exterior surface of the device.

Claim 2:
Claim 2 depends from and further limits the support layer of the stent
of claim 1 to one which has an inner diameter greater than an exterior
diameter of the lumen.
Appellants contend that Roy II fails to teach “a support layer that has
an inner diameter that is greater than the exterior diameter of the lumen”
(App. Br. 11). We disagree. Roy II teaches that the artery is placed inside
of Roy II’s device (FF 5-6). Accordingly, absent evidence to the contrary,
which there is none, a person of ordinary skill in this art would interpret Roy
II as teaching a stent that comprises a support layer that has an inner
diameter that is greater than the exterior diameter of the lumen of the artery
being inserted into the stent.

Claim 3:
Claim 3 depends from and further limits the support layer of claim 1
to one which comprises a biologically inert material.
Appellants do not dispute and therefore concede to the Examiner’s
finding that Roy II teaches a stent with a support layer comprising a
polymeric material or nitinol (FF 7). Arguments not made are waived. See
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37 C.F.R. § 41.37(c)(1)(vii). However, Appellants contend that Roy II fails
to teach all the embodiments of claim 1 from which claim 3 depends (App.
Br. 12). For the reasons set forth with regard to claim 1, we disagree.
Because it is not argued separately claim 4 falls together with claim 3.
37 C.F.R. § 41.37(c)(1)(vii).

Claim 7:
Claim 7 depends from and further limits the support layer of claim 3
to one which comprises a biologically active material.
Appellants contend that the “Examiner has not pointed to any specific
disclosure in Roy et al. of a support layer that further comprises a
biologically active material” (App. Br. 12). We are not persuaded (FF 7).
Appellants also contend that Roy II fails to teach all the embodiments of
claim 1 from which claim 7 ultimately depends (App. Br. 12). For the
reasons set forth with regard to claim 1, we disagree.

Claim 8:
Claim 8 depends from and further limits the active material of claim 7
to one which is drug-releasing coating on one of said surfaces of the support
layer that permits timed or prolonged pharmacological activity.
Appellants contend that
Roy et al. fail to disclose a securing element on the inner
surface of the support layer that secures the support layer to the
exterior of the body lumen, any disclosure with regard to a
pharmacological agent on the inner surface of the anastomosis
device of Roy et al. fails to ameliorate the deficiencies thereof
as an anticipatory reference.

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(App. Br. 12.) As discussed with regard to claim 1, Roy II teaches a
securing element (e.g., adhesive) on the inner surface of the support layer.
Accordingly, we are not persuaded by Appellants’ contention to the
contrary. Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii).

Claim 9:
Claim 9 depends from and further limits the support layer of claim 1
to one that comprises resorbable material.
Appellants contend that Roy II fails to teach a “support layer
comprising a resorbable material” (App. Br. 12). The Examiner finds that
Roy II “teaches the inner surface of the device is lined with appropriate
pharmacologic agents, which inherently are bioactive and re-sorbable
materials” (FF 7). Appellants do not contest and therefore concede that Roy
II teaches a stent comprising pharmacological agents or the Examiner’s
finding that pharmacological agents are resorbable materials. Accordingly,
we are not persuaded by Appellants’ contention. Arguments not made are
waived. See 37 C.F.R. § 41.37(c)(1)(vii).
Appellants also contend that Roy II fails to teach all the embodiments
of claim 1 from which claim 9 depends (App. Br. 12). For the reasons set
forth with regard to claim 1, we disagree.

Claims 10 and 11:
Claim 10 depends from and further limits the support layer of claim 9
to further comprise a biologically active material. Claim 11 depends from
and further limits the support layer of claim 10 to be a shape-memory
material.
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The Examiner finds that Roy II teaches a support layer comprising a
biologically active material and a shape-memory material (FF 7-8).
Appellants contend that
any alleged disclosure in Roy et al. with respect to a support
layer that further comprises a biologically active material or a
[sic] wherein the support layer is shape-memory material fails
to ameliorate the deficiencies of Roy, et al. because Roy et al.
do not disclose each and every element of Applicants’ claimed
invention and particularly a securing element on the interior of
a support layer that secures the support layer to the exterior of
the body lumen.

(App. Br. 13.) We are not persuaded.
As discussed with regard to claim 1, Roy II teaches a securing
element (e.g., adhesive) on the inner surface of the support layer.
Accordingly, we are not persuaded by Appellants’ contention to the
contrary. Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii).

Claim 13:
Claim 13 depends from and further limits the support layer of claim 1
to one that comprises a braided material.
The Examiner finds that Roy II teaches a device that “comprises
shape memory material” and a “shape memory braid material” (FF 9).
Appellants also contend that Roy II fails to teach all the embodiments
of claim 1 from which claim 13 depends and any disclosure in Roy of a
braided material “does not ameliorate the deficiencies thereof as an
anticipatory reference” (App. Br. 13). We disagree, for the reasons set forth
above.

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Claim 14:
Claim 14 depends from and further limits the support layer of claim 1
to a single unified member.
Appellants contend that the “Examiner has not pointed to any specific
disclosure in Roy et al. of a support layer that is a single unified member”
(App. Br. 13). We disagree (see e.g., FF 5 and 6 (Figs. 1 and 15A-15C)).
Appellants also contend that Roy II fails to teach all the embodiments
of claim 1 from which claim 14 depends (App. Br. 13-14). For the reasons
set forth with regard to claim 1, we disagree.

Claims 15 and 16:
Claim 15 depends from and further limits the support layer of claim 1
to comprise at least two members flexibly joined together. Claim 16
depends from and further limits the members of claim 15 to be joined by a
hinge.
Appellants contend that the “Examiner has not pointed to any specific
disclosures in Roy et al. of either a support layer that comprises at least two
members flexibly joined together, or of members being joined by a hinge”
(App. Br. 14). We are not persuaded.
Roy II teaches a device wherein the support layer comprises at least
two members flexibly joined together through a hinge (FF 10). Appellants
recognize that “[f]igure 3 of Roy et al. actually shows a device that Roy et
al. describe as ‘hinged’” (App. Br. 14). Nevertheless, Appellants contend
that it is important to note that “the slits of first and second members contact
each other” (id.). Appellants do not, however, explain why their claimed
invention is distinct from this feature of Roy II’s device.
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Appellants also contend that Roy II fails to teach all the embodiments
of claim 1 from which claim 15 depends (App. Br. 14). We disagree, for the
reasons set forth with regard to claim 1.

Claim 22:
Claim 22 depends from and further limits the securing element of
claim 1 to an adhesive.
Appellants contend that Roy II’s figures 20, 24, 32, 37, 39, and 44-46
illustrate the use of “an adhesive that surrounds both the external surfaces of
the members of the device and the vessel itself” (App. Br. 15). We agree,
but find that the application of an adhesive in the manner illustrated by Roy
II is not excluded from Appellants’ claimed invention.
Appellants contend that Roy II does “not disclose a securing element
on the interior surface of a support layer that secures the support layer to the
lumen’s exterior surface” (id.). We disagree, for the reasons set forth above
with respect to claim 1.

Claims 23 and 24:
Claim 23 depends from and further limits the adhesive of claim 22 to
one that is biologically inert. Claim 24 depends from and further limits the
adhesive of claim 22 to one that requires curing.
Appellants assert that Roy II fails to teach a securing element that is a
biologically inert adhesive or an adhesive that requires curing and even if it
did it “would not ameliorate the deficiencies thereof as an anticipatory
reference” (App. Br. 15). We disagree.
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We find no error in the Examiner’s finding that a two-component
adhesive required both components for curing (FF 4). Roy II describes a
device coated with the first component of a two component adhesive,
wherein the second component is added to the device to activate and cure the
adhesive (FF 4-6). In addition, we find no evidence on this record to suggest
that Roy II’s adhesive is not biologically inert.
Further, for the reasons set forth with regard to claim 1, we disagree
with Appellants’ contention that Roy II fails to teach all the embodiments of
claim 1 from which claims 23 and 24 ultimately depends.

Claim 26:
Claim 26 depends from and further limits the securing element of
claim 1 to be locks that close said support layer tightly onto the lumen to
prevent it from slipping but not to restrict the lumen.
Appellants contend that Roy II fails to teach “a securing element that
locks or closes the support layer tightly onto the lumen to prevent it from
slipping but not to restrict the lumen” (App. Br. 16). We disagree.
Roy II teaches a device that utilizes a fastening material (e.g., Velcro
strips) that serves to lock or close the support layer around the lumen (FF
10). There is no evidence on this record that would suggest that Roy II’s
fastening material would not lock the support layer tightly onto the lumen to
prevent it from slipping but not to restrict the lumen.
Further, for the reasons set forth with regard to claim 1, we disagree
with Appellants’ contention that Roy II fails to teach all the embodiments of
claim 1 from which claim 26 depends.

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Claim 27:
Claim 27 depends from and further limits the support layer of claim 1
to cover less than the entire circumference of the lumen.
Appellants contend that Roy II fails to teach “a support layer that
covers less than the entire circumference of the lumen” (App. Br. 16). We
disagree (see FF 5 and 6 (Figs. 1, 15A-15C, and 16)).
Further, for the reasons set forth with regard to claim 1, we disagree
with Appellants’ contention that Roy II fails to teach all the embodiments of
claim 1 from which claim 27 depends.

CONCLUSION OF LAW
Roy II teaches every element of the claimed invention. Accordingly,
the rejection of claims 1-4, 7-11, 13-16, 22-24, 26, and 27 under 35 U.S.C
§ 102(a) as unpatentable over Roy II is affirmed.

OBVIOUSNESS:
ISSUE
Would a person of ordinary skill in the art at the time the invention
was made recognize that a barb, hook, or suture can be used to secure Roy
II’s device to a lumen.

PRINCIPLES OF LAW
“In proceedings before the Patent and Trademark Office, the
Examiner bears the burden of establishing a prima facie case of obviousness
based upon the prior art.” In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir.
1992). On appeal to this Board, Appellants must show that the Examiner
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has not sustained the required burden. See (1) Ex parte Yamaguchi,
http://www.uspto.gov/web/offices/dcom/bpai/ prec/fd074412.pdf, slip op. at
5 and 23 (BPAI Aug. 29, 2008) (precedential); (2) Ex parte Fu,
http://www.uspto.gov/web/offices/ dcom/bpai/prec/fd080601.pdf, slip op. at
5 and 20 (BPAI Mar. 31, 2008) (precedential); (3) Ex parte Catan,
http://www.uspto.gov/web/ offices/dcom/bpai/prec/fd070820.pdf, slip op. at
3 and 21 (BPAI Jul. 3, 2007) (precedential), and (4) Ex parte Smith,
http://www.uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf, slip op. at
4, 9 and 23 (BPAI Jun. 25, 2007).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, ___, 127 S. Ct. 1727, 1739
(2007).
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that is was obvious under § 103.

Id. at 1742. It is proper to “take account of the inferences and creative steps
that a person of ordinary skill in the art would employ.” Id. at 1741. See
also id. at 1742 (“A person of ordinary skill is also a person of ordinary
creativity, not an automaton.”). “In determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir.
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1995) (internal quotations omitted). “[W]hen a patent claims a structure
already known in the prior art that is altered by the mere substitution of one
element for another known in the field, the combination must do more than
yield a predictable result.” KSR, 127 S. Ct. at 1740.
A reference is said to “teach away” from a claimed invention when it
“suggests that the line of development flowing from the reference's
disclosure is unlikely to be productive of the result sought by the applicant”
In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). See In re Beattie, 974 F.2d
1309, 1312-13 (Fed. Cir. 1992) (“Moreover, Guilford’s endorsement of a
dodecatonic twelve tone notation over the traditional twelve tone notation
does not establish a teaching away from the older system such that Guilford
cannot be combined with Eschemann. Guilford merely presents an
alternative to a well-entrenched musical theory . . . . The recommendation of
a new musical notation system, however, does not require obliteration of
another; coexistence of the teachings of Guilford and traditional musical
notation for nearly a century bears this out.”).
“Express suggestion to substitute one equivalent for another need not
be present to render such substitution obvious.” In re Fout, 675 F.2d 297,
301 (CCPA 1982); see also In re Mayne, 104 F.3d 1339, 1340 (Fed. Cir.
1997) (“Because the applicants merely substituted one element known in the
art for a known equivalent, this court affirms [the rejection for
obviousness].”).

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FINDINGS OF FACT
FF 11. The Examiner finds that Roy II “does not disclose using a
barb/hook/suture for a securing element in his device” (Ans. 4).
FF 12. The Examiner finds that “barbs or sutures are well known securing
elements in the art ([Roy I,] col. 1, line 38 to col. 3, line 21)” (id.).
FF 13. Roy II teaches that the prior art recognizes a variety of means for
securing a device to a lumen, including barbs, sutures, and clips (Roy II 2: 9-
11; 1: 35-36; and 2: 1-5). With regard to barbs, Roy II teaches that the
barbed device can “be wrapped round the blood vessel so that the barbs
pierce and anchor to the outer wall of the blood vessel” (Roy II 2: 15-17).
FF 14. With regard to the prior art barbed device, Roy II teaches that
“penetration of the vessel wall by the barbs on the device can cause
separation of the layers of the vessel wall, which in turn can lead to
thrombus formation or dissection at the site” (Roy II 2: 21-23).
FF 15. Roy II teaches a device that does not require the use of sutures or
clips (Roy II Abstract).

ANALYSIS
Claims 20, 21, and 25 stand rejected under 35 U.S.C § 103(a) as
unpatentable over Roy II.
Claims 20, 21, and 25 each depend from and further limit the securing
element of claim 1 to one that is a barb, hook, or suture.
We agree with Appellants’ contention that Roy II teaches that the barb
and sutures used with prior art devices can damage a lumen (App. Br. 19;
see also FF 14). However, we disagree with Appellants’ contention that
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Roy II teaches away from the use of a device that utilizes a barb, hook, or
suture securing element (App. Br. 19).
Barbs, hooks, loops, clips, sutures, adhesives are all means for
securing two materials (FF 12). “Express suggestion to substitute one
equivalent for another need not be present to render such substitution
obvious.” In re Fout, 675 F.2d at 301.
A person of ordinary skill in the art reading Roy II would recognize
that a variety of securing elements are available for use with Roy II’s device.
Here, Appellants recognized that a variety of securing elements are available
for use with Roy II’s device. “[W]hen a patent claims a structure already
known in the prior art that is altered by the mere substitution of one element
for another known in the field, the combination must do more than yield a
predictable result.” KSR, 127 S. Ct. at 1740.
While Roy II teaches that a particular securing element (e.g.,
adhesive) may be preferred over barbs, clips, and sutures (FF 13-14), this
does not mean that Roy II teaches away from the use of these art recognized
securing elements. In re Gurley, 27 F.3d at 553; In re Beattie, 974 F.2d at
1312-13.
Accordingly, we are not persuaded by Appellants’ contentions to the
contrary. Instead, we agree with the Examiner’s conclusion that “[i]t would
have been obvious to one of ordinary skill in the art at the time of the
invention to provide a barb/hook/suture for a securing element in . . . [Roy
II’s] device as these elements are well known for securing an implant to a
body organ” or lumen (Ans. 4).
We are also not persuaded by Appellants’ contention that the prior art
devices and securing elements are not used “to secure the inner surface of a
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stent to the exterior of the body lumen” (Reply Br. 6). Roy II expressly
teaches a prior art device which utilizes barbs to secure a device to the outer
wall of a blood vessel (FF 13).
We are not persuaded by Appellants’ contention that “[t]here is
absolutely no teaching or suggestion in Roy et al. that such [prior art]
mechanisms could be used as a securing element that secures the support
layer to the exterior of the body lumen to open and enlarge the body lumen
from the exterior” (Reply Br. 7). There is no requirement in Appellants’
claimed invention that a body lumen be opened and enlarged from the
exterior.

CONCLUSION OF LAW
A person of ordinary skill in the art at the time the invention was
made would recognize that a barb, hook, or suture can be used to secure Roy
II’s device to a lumen. Accordingly, the rejection of claims 20, 21, and 25
under 35 U.S.C § 103(a) as unpatentable over Roy II is affirmed.

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

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cdc
COHEN & GRIGSBY, P.C.
625 LIBERTY AVENUE
PITTSBURGH PA 15222-3152
25