Ex Parte Lansac

Board of Patent Appeals and Interferences

Feb 1, 2010

10912570 (B.P.A.I. Feb. 1, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte EMMANUEL LANSAC1
____________

Appeal 2009-003865
Application 10/912,570
Technology Center 3700
____________

Decided: February 2, 2010
____________

Before JAMES T. MOORE, Vice Chief Administrative Patent Judge, and
MICHAEL W. O’NEILL and DANIEL S. SONG, Administrative Patent
Judges.

SONG, Administrative Patent Judge.

DECISION ON APPEAL

1 The real party in interest is Assistance Publique – Hopitaux de Paris of
Paris, France (Br. 1).
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The Appellant appeals under 35 U.S.C. § 134 from a Final Rejection
of claims 17-36. Claims 1-16 have been previously canceled (Br. 2). We
have jurisdiction over this appeal under 35 U.S.C. § 6(b) (2002).
The claimed invention is directed to a medical device for surgically
repairing an aortic valve. The device includes an aortic ring that forms a
closed-perimeter structure around an external segment of an aortic root of a
patient. In use, the closed-perimeter structure of the aortic ring strengthens
the aortic root by providing external reinforcement thereto (Spec. p. 9, ll. 20-
25).
The Appellant’s Figure 2 is reproduced below:

Figure 2 reproduced above shows a perspective view of the aortic ring
in the open position and in the form of a band 2 made of flexible
DACRON® (Spec. p. 7, ll. 31-35; see also Spec. p. 7, ll. 19-21). The aortic
ring has two threads 3, 4 that pass through the band and emerge at both ends
thereof in order to permit closure of the aortic ring (Spec. p. 7, ll. 31-37).
Independent claims 17 and 23 read as follows (Br. 14, 16-17, Claims
App’x.; emphasis added):

17. A device for implantation in proximity to an aortic
valve of a patient, comprising:
an aortic ring having a flexible construction and being
configured and sized for placement externally around an aortic
root of the patient, the aortic root being generally tubular and
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containing therewithin the aortic valve having a plurality of
valve leaflets, the leaflets cooperating with one another to
control blood flow through the aortic root, said aortic ring
being elastically expandable in annular perimeter between a
first ring configuration in which the aortic root is exposed to a
diastolic phase of a cardiac cycle and a second ring
configuration of larger annular perimeter than said first ring
configuration in which the aortic root is exposed to a systolic
phase of the cardiac cycle, in said first ring configuration the
aortic ring having an appropriately sized first perimeter length
so as to urge the valve leaflets to coapt under the constraining
effect of the aortic ring and restrict blood flow through the
aortic valve, and in said second ring configuration the aortic
ring expands to a second perimeter length greater than said
first perimeter length whereby said aortic ring allows the aortic
root to expand a controlled predetermined amount allowing the
valve leaflets to open and allow blood flow therethrough.

23. A device for surgical repair of an aortic valve of a
patient, the aortic valve being exposed to alternating diastolic
and systolic phases of a cardiac cycle, the aortic valve having a
valve axis and contained within a generally tubular aortic root,
the aortic valve including a plurality of valve leaflets, the valve
leaflets attached to a sigmoid-shaped valve annulus and each
having a leaflet free margin, the sigmoid-shaped valve annulus
extending circumferentially around the valve axis, the sigmoid-
shaped valve annulus extending in height along the valve axis
between a nadir portion at a base of the aortic root and a spaced
away commissure portion generally at a sinotubular junction of
the aortic root, the aortic root also having a subvalvular region
located below the nadir portion and a supravalvular region
located above the commissure portion, the aortic root having
coronary arteries attached thereto between the subvalvular and
supravalvular regions, the aortic root and the valve annulus
expanding outwardly away from the valve axis during a cardiac
cycle transition from the diastolic phase to the systolic phase
and retracting inwardly toward said valve axis during a
transition from the systolic phase to the diastolic phase, the
valve leaflets movable between a closed configuration in which
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the leaflet free margins are in an approximated spatial
relationship during the diastolic phase and an open
configuration in which the leaflet free margins are spaced away
from one another during the systolic phase to allow blood flow
through the aortic valve generally along a direction parallel to
the valve axis, the device comprising:
an aortic ring configured and sized for placement
externally around the aortic root to form a closed-perimeter
flexible structure therearound, whereby the closed-perimeter
structure serves to constrain the aortic root to an anatomically
representative geometry that improves coaptation of the leaflet
free margins in the diastolic phase of the cardiac cycle.

Independent claim 20 is similar to independent 17 in that claim 20
recites that the aortic ring is elastically expandable between a first ring
configuration and a second ring configuration in which the aortic ring
elastically expands a predetermined desired amount under the influence of
the systolic phase (Br. 15-16, Claims App’x.).

The prior relied upon by the Examiner in rejecting the claims is:
Chevillon US 6,248,116 B1 Jun. 19, 2001

The Examiner rejected claims 17-36 under 35 U.S.C. § 102(b) as
anticipated by Chevillon.

We AFFIRM-IN-PART.

ISSUE
Whether the Appellant has shown that the Examiner erred in finding
that Chevillon inherently describes the aortic ring recited in the rejected
claims, including an aortic ring capable of elastically expanding to a second
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ring configuration of larger annular perimeter as a function of the phases of
the cardiac cycle.
FINDINGS OF FACT
The record supports the following findings of fact (FF) by a
preponderance of the evidence.
1. Chevillon describes a medical device for treating an aneurysm
of the aorta (col. 3, ll. 38-42). The device includes an implant 100
placed within an aorta V, and a collar 140a, 140b placed around the
outside of the aorta to secure the two free ends 100a and 100b of the
implant (col. 3, ll. 43-48, 51-54, and 62-64; col. 4, ll. 14-16 and 25-
31; col. 7, ll. 10-23; fig. 1).
2. Figure 11 of Chevillon shows an enlarged perspective view of
the collar 140a. Figure 11 is reproduced below:

Figure 11 of Chevillon reproduced above shows the collar 140a in the
open position. The collar includes two adjustable bloodtight straps
365, 367 (made of fabric, such as DACRON®) that extend beyond a
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central area of the collar which includes an elastic, radially distortable
reinforcing core 369 (col. 7, ll. 10-19; fig. 11). The straps 365 and
367 are fastened together to insure a bloodtight closure around the
outside of the aorta (col. 4, ll. 18-22; col. 7, ll. 10-19; fig. 11), thereby
forming a closed-perimeter structure.
3. In Chevillon, collar 140a is elastic, and radially distortable (i.e.,
flexible) in order to allow a medical practitioner to place and shape
the collar around the outside of the aorta V during the surgical
procedure (col. 5, l. 59 – col. 6, l. 2; col. 7, ll. 10-19; figs. 1 and 11).

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., 814 F.2d 628, 631
(Fed. Cir. 1987). “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).
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); see also In re Spada, 911 F.2d 705,
708-09 (Fed. Cir. 1990). “Inherency, however, may not be established by
probabilities or possibilities. The mere fact that a certain thing may result
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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).
In addition, “[i]t is well settled that the recitation of a new intended
use for an old product does not make a claim to that old product patentable.”
In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (citations omitted). In
this regard, with respect to functional limitations, “[a] patent applicant is free
to recite features of an apparatus either structurally or functionally.” Id. at
1478 (citing In re Swinehart, 439 F.2d 210, 212 (CCPA 1971) (“[T]here is
nothing intrinsically wrong with [defining something by what it does rather
than what it is] in drafting patent claims.”). “Yet, choosing to define an
element functionally, i.e., by what it does, carries with it a risk.” Id.
In particular,
where the Patent Office has reason to believe that a
functional limitation asserted to be critical for
establishing novelty in the claimed subject matter
may, in fact, be an inherent characteristic of the
prior art, it possesses the authority to require the
applicant to prove that the subject matter shown to
be in the prior art does not possess the
characteristic relied on.
Swinehart, 439 F.2d at 213.

ANALYSIS
The Examiner rejects claims 17-36 as anticipated by Chevillon,
finding that Chevillon describes all of the claimed structural elements
thereof, and that the device of Chevillon is “inherently capable for use as
claimed.” (Ans. 3-5). In support of the latter, the Examiner contends that
Chevillon discloses improvements “may be used for other vessels to treat
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different affections.” (Ans. 4). The Examiner additionally finds that
“[i]ndependent claims 17, 20, and 23 each recite a multitude of intended use
or functional recitations” and “the anatomical structure of the aortic root
does not structurally define the invention.” (Ans. 4).
In the present appeal, the Appellant initially submit arguments
directed to all of the rejected claims (Br. 10-12). In addition, the Appellant
sets forth additional arguments for the patentability of independent claims 17
and 20, and dependent claim 24 (which depends from independent claim 23)
(Br. 12). We address the Appellant’s various arguments infra, slightly out of
order for clarity.
We first dispense with the Appellant’s argument that Chevillon does
not teach “us[ing] the strap 140'a without also using the implant 100....” (Br.
11). This argument is not persuasive because the rejected independent
claims each utilize the open-ended transitional term “comprising” which
does not exclude additional, unrecited elements. See Genentech, Inc. v.
Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 2005).
The Appellant also argues that because Chevillon “teaches a lining or
strap member 140'a placed around the outside of an anatomical duct ‘V’ and
used in conjunction with an endoluminal implant 100 placed within the duct
‘V’,” Chevillon “teaches away” from the recited aortic ring that is placed
externally around the aortic root (Br. 11). This argument is misdirected
because “teaching away” is irrelevant to anticipation. See Seachange
Intern., Inc. v. C-COR, Inc. 413 F.3d 1361, 1380 (Fed. Cir. 2005).
The Appellant further disputes the Examiner’s finding of inherency
and argues that Chevillon “fails to teach or suggest an aortic annuloplasty
ring or device at all, let alone one that is specifically configured and sized to
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be placed around the aortic root to restore leaflet coaptation.” (Br. 10). The
Appellant also asserts that “[t]here is no evidence provided in the Chevillon
reference indicating, expressly or implicitly, that vascular ring (140) would
properly or effectively operate as claimed . . .,” or that collar 140a can
perform the specific functions recited in the rejected claims (Br. 10-11).
Turning to these arguments, we first observe that Chevillon discloses
the basic structure of the device described by the rejected independent
claims (FF 2-3). We also note that all of the rejected claims are device
claims, not method claims. As such, statements directed to the manner in
which the device is used are mere statements of intended use and are not
given patentable weight. In re Schreiber, 128 F.3d at 1477. Hence,
statements of intended use present in all of the rejected claims which are
directed to specific placement of the device, structure and operation of the
aortic root, and effect on the valve leaflets and blood flow, are not given
patentable weight.
However, functional limitations are given patentable weight. In re
Swinehart, 439 F.2d 212. In the present appeal, the functional limitations
recited in the various claims differ. Hence, the disposition of the appealed
claims depends on whether the functional limitations recited in the various
claims are inherently satisfied by Chevillon. We discuss the functional
limitations relative to each of the independent claims infra.
Turning first to claim 23 which is arguably the broadest claim, the
functional recitation “whereby the closed-perimeter structure serves to
constrain....” does not distinguish over the art. The structure described in
Chevillon functions to constrain the aorta when placed and fastened around
the external perimeter thereof (FF 2), and thus, appears to be inherently
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capable of performing the recited constraining function. As such, it is the
Appellant’s burden to show that the prior art device is not capable of
performing the constraining function recited in claim 23. In re Schreiber,
128 F.3d at 1478; In re Swinehart, 439 F.2d at 213; In re Best, 562 F.2d
1258. The Appellant has not provided any persuasive evidence in the record
in satisfaction of that burden. Therefore, in view of the above, the evidence
of record supports a finding that Chevillon inherently is capable of
performing the recited function, and the Appellant has not shown that the
Examiner erred in rejecting independent claim 23 as anticipated by
Chevillon.
The Appellant does not present separate arguments with respect to the
patentability of dependent claims 33, 35, and 36, which depend from claim
23. Thus, the Appellant has failed to show the Examiner erred in rejecting
these claims as well. See 37 C.F.R. § 41.37(c)(1)(vii)(2007).
Turning to independent claims 17 and 20, and dependent claim 24
(which depends from independent claim 23), the Appellant argues that
“Chevillon fails to teach an elastically expandable ring which can increase
its annular perimeter, or equivalent diameter, in the transition between the
diastolic and systolic phases of a cardiac cycle to achieve the claimed
function.” (Br. 12). In this regard, the Appellant asserts that “the Chevillon
reference does not express any ability to perform this function and one of
ordinary skill in the art would not view the passage [at] columns 5 through 6
of the Chevillon reference as evidencing such an ability.” Id.
Independent claims 17 and 20 are similar to independent claim 23, but
further recite that the aortic ring is elastically expandable between a first ring
configuration and second ring configuration of larger annular perimeter than
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the first ring configuration. Claim 17 includes the functional recitation that
“the aortic ring expands to a second perimeter length greater than said first
perimeter length,” the second ring configuration being the configuration in
which the aortic ring is subject to a systolic phase of the cardiac cycle.
Similarly, claim 20 includes the functional recitation that “the aortic ring
elastically expands a predetermined amount under the influence of the
systolic phase” of the cardiac cycle. Likewise, dependent claim 24 recites
that the aortic ring is elastic and expandable between a first and second ring
configuration as a function of the phases of the cardiac cycle.
We agree with the Appellant that the Examiner has not sufficiently
established that the prior art collar of Chevillon is capable of elastically
expanding to a second ring configuration of larger annular perimeter than the
first ring configuration as a function of the phases of the cardiac cycle, as
required by claims 17, 20, and 24. While the Examiner is correct in
contending that Chevillon describes an elastically expandable ring because
“the materials of the device 140a may include elastic or flexible materials,”
(Ans. 5) Chevillon merely describes that the collar 140a is elastic and
radially distortable for placement and shaping purposes during the surgical
procedure (FF 3). The Examiner fails to establish how the disclosure that
the collar 140a is elastically expandable inherently describes elastically
expanding to a second ring configuration in response to the systolic phase of
the cardiac cycle. It is speculative as to whether the collar 140a is
sufficiently elastic to expand to a second ring configuration based on the
systolic phase of the cardiac cycle, especially in view of the presence of the
reinforcing core 369 (FF 2), and the fact that elasticity does not only depend
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on the material used, but also on the dimension thereof (e.g., thickness of the
material). See In re Robertson, 169 F.3d at 745.
Therefore, in view of the above, the Examiner’s anticipation rejection
of claims 17, 20, and 24 as set forth in the Answer is not sustained. In
addition, the Examiner’s rejection of dependent claims 18 and 19 (which
depend from claim 17), dependent claims 21 and 22 (which depend from
claim 20), and dependent claims 25-32 and 34 (which depend from claim
24) is also not sustained for the same reasons.

CONCLUSIONS
1. The Appellant has not shown that the Examiner erred in finding
that Chevillon inherently describes the aortic ring recited in independent
claim 23.
2. The Appellant has shown that the Examiner erred in rejecting
independent claims 17 and 20 and dependent claim 24 because Chevillon
does not inherently describe an aortic ring capable of elastically expanding
to a second ring configuration of larger annular perimeter as a function of
the phases of the cardiac cycle.

DECISION
1. The Examiner’s rejection of claims 23, 33, 35, and 36 as being
anticipated by Chevillon is AFFIRMED.
2. The Examiner’s rejection of claims 17-22, 24-32, and 34 as
being anticipated by Chevillon is REVERSED.
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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). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2007).

AFFIRMED-IN-PART

ack

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