Ex Parte Loubens et al

Board of Patent Appeals and Interferences

Apr 20, 2009

10181953 (B.P.A.I. Apr. 20, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte THIERRY LOUBENS,
ANTOINE WATRELOT, and LIONEL RIOU
__________

Appeal 2008-5148
Application 10/181,953
Technology Center 3700
__________

Decided:1 April 21, 2009
__________

Before ERIC GRIMES, RICHARD M. LEBOVITZ, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).
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This is an appeal under 35 U.S.C. § 134 involving claims to a surgical
needle. The Examiner has rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.
STATEMENT OF THE CASE
Claims 12 and 17-34 are pending and on appeal. We will focus on
claim 12, which reads as follows:
12. A surgical needle comprising:
a crimping zone for securing a suture to the needle;
the needle being made of a hyper-elastic alloy which, after treatment,
has two distinct states;
one of the two distinct states allowing the needle to be forced into a
roughly elongated position when the needle is housed in an internal bore of a
cannula or an applicator;
another of the two distinct states allowing the needle to adopt, after
extraction from the cannula or the applicator, a curved profile as a result of
superelasticity or hyper-elasticity of the needle, the curved profile having the
shape of an arc of a circle; and
the needle having a free end comprising a tapered point which
includes an inclined heel portion,
wherein the inclined heel portion is arranged on an inside portion of
the curved profile and is structured and arranged to bear against an interior
wall of the internal bore of the cannula or the applicator when the needle
slides within the internal bore, whereby a profile of the tapered point is
protected.
Claims 12 and 17-34 stand rejected under 35 U.S.C. § 103(a) as
obvious over Bendel (US 5,219,358, Jun. 15, 1993) or Middleman
(US 5,904,690, May 18, 1999) in view of Kurtz (US 4,128,351, Dec. 5,
1978) (Ans. 3).
The Examiner relies on Bendel or Middleman for disclosing a
superelastic needle, noting that the Specification uses the terms
“superelastic” and “hyper-elastic” interchangeably (Ans. 3).
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The Examiner relies on Kurtz for suggesting that “a needle can have
an inclined heel on an inner curved portion of the needle” (id.). In
particular, the Examiner finds that “figure 4 of Kurtz . . . shows an inclined
portion 58” (id. at 3-4).
The Examiner concludes that it would have been obvious “to modify
Bendel et al or Middleman et al so as to have an incline[d] heel portion . . .
as shown in figures 3 and 4 of Kurtz et al. Such modification of Bendel and
Middleman would provide the references with multiple cutting surfaces.”
(Id. at 3.)
ISSUES
Did the Examiner err in concluding that Bendel and/or Middleman
disclose a needle made of a hyper-elastic alloy?
Did the Examiner err in concluding that Kurtz teaches or suggests a
surgical needle having the claimed inclined heel portion?
Did the Examiner err in concluding that it would have been obvious to
modify the tip of the needles disclosed in Bendel and/or Middleman to
include the tip configuration disclosed in Kurtz?
Did the Examiner set forth a prima facie case that dependent
claims 18-23 and 25-27 would have been obvious?
FINDINGS OF FACT
1. The Specification discloses a surgical needle
made of a hyper-elastic alloy which, after treatment, has two
distinct states making it possible, on the one hand, to force the
needle into a roughly elongate position when it is housed in the
internal bore of a cannula or of an applicator and, on the other
hand, when it is extracted from the cannula or from the
applicator, to adopt a curved profile in the shape of an arc of a
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circle because of its own characteristics of superelasticity or
hyper-elasticity, and in that the needle comprises . . . a tapered
point provided with an inclined heel which is arranged inside
the curvature of the needle and which bears against the interior
wall of the bore of the cannula or of the applicator to protect the
profile of the tapered point as said needle slides inside the
internal bore.
(Spec. 2: 17-33.)
2. The Specification discloses that the hyper-elastic alloy
“contains about 54% to 58% of nickel and about 42% to 46% of titanium”
(id. at 2: 35-37).
3. The Specification also discloses that the hyper-elastic alloy
“undergoes a heat treatment under stress, the temperature of which is
between 400°C and 600°C for 15 to 60 minutes, followed by a sudden
quenching in air or water at between 0°C and 3°C” (id. at 3: 8-13).
4. In addition, the Specification discloses that the “switch from the
first state to the second is inherent in the characteristics of the alloy which is
treated so that it has characteristics of superelasticity or hyper-elasticity” (id.
at 5: 7-10).
5. Specification Figure 2 is reproduced below:

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This Figure depicts the tapered point 6 of the needle 1, the tapered point
comprising a heel 7 “inclined by an angle α with respect to a horizontal
tangent which depends on the internal diameter of the cannula or of the
applicator 2, [and] on the diameter and . . . the length of the needle 1” (id. at
4: 19-20 & 6: 1-8.)
6. The Specification also discloses that “only the heel 7, and more
particularly, the point where it meets the curved part of the needle 1, is in
contact with the internal wall of the bore 11 of the sleeve 10, thus protecting
the tapered point 6 against any damage due to rubbing” (id. at 8: 33-37).
7. It is not disputed that the terms “superelasticity” and “hyper-
elasticity” are interchangeable (Ans. 3).
8. Bendel discloses surgical needles “fabricated from a shape
memory alloy . . . [that] has a low temperature state, in which the needle is
formable into an elongated shape to pass through an elongated tube, and a
high temperature state, in which the needle forms an arc” (Bendel, Abstract).
9. Bendel also discloses that “superelasticity” is an inherent
property of shape memory alloys, “[s]uperelasticity (or ‘pseudoelasticity’)
[being] the property of shape memory alloys that they return to their original
shape upon unloading after a substantial deformation” (id. at col. 1, ll. 50-
56).
10. In addition, Bendel discloses that, “[i]n order to induce in the
alloy a shape that will be remembered, the alloy must be trained by
constraining it in the desired shape and heating it to a temperature well
above Af,” which is the temperature at which the phase change to the high
temperature state is complete (id. at col. 4, ll. 1-9).
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11. As the shape memory alloy, Bendel discloses “Nitinol alloys,
which are primarily nickel and titanium (generally about 50% each)” (id. at
col. 5, ll. 40-42).
12. Middleman discloses “an apparatus for inserting, through
organic tissue, an elastic needle member . . . , said needle having a first
shape when not subject to mechanical stress and a second shape when
subject to mechanical stress, said needle returning toward said first shape
upon at least partial relief of said mechanical stress” (Middleman, col. 7,
ll. 26-33).
13. Middleman also discloses that “the elastic member is most
preferably a pseudoelastic material, preferably a superelastic material” (id. at
col. 7, ll. 51-53).
14. As the pseudoelastic material, Middleman discloses “a shape
memory alloy that exhibits pseudoelasticity. Alloys which exhibit
superelasticity . . . are especially preferred, eg shape memory alloys which
exhibit superelasticity.” (Id. at col. 4, ll. 50-54.)
15. Middleman also discloses a needle member in the shape of an
arc (id. at Figure 35).
16. Kurtz discloses a surgical needle “having a simple main cutting
edge extending across the needle and formed by the intersection of two
planar surfaces for use in cutting through hard body tissue material” (Kurtz,
Abstract).
17. Kurtz also discloses that the “surgical needle is preferably
curved in the reference plane defined by the main cutting edge and the axis
of the needle” (id.).
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18. Kurtz Figure 4 is reproduced below:

This Figure depicts a “surgical needle 50 . . . ha[ving] a curved axis 56. . . .
A main cutting edge 58 is formed . . . by the intersection of a first
substantially planar surface 60 and a second substantially planar surface 62”
(not shown in the Figure). (Id. at col. 4, ll. 24-30.)
19. Kurtz also discloses that “a blunt cutting edge portion 70
(FIG. 6) . . . is formed by the intersection of a third substantially planar
surface 72 (FIG. 3) with the first and second surfaces 60 and 62, thereby
forming secondary cutting edges 74 and 76” (id. at col. 4, ll. 35-39).
PRINCIPLES OF LAW
“It is axiomatic that, in proceedings before the PTO, claims in an
application are to be given their broadest reasonable interpretation consistent
with the specification.” In re Sneed, 710 F.2d 1544, 1548 (Fed. Cir. 1983).
“An intended use or purpose usually will not limit the scope of the claim
because such statements usually do no more than define a context in which
the invention operates.” Boehringer Ingelheim Vetmedica v. Schering-
Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003).
“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
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GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal quotations
omitted). “[A]ny need or problem known in the field of endeavor at the time
of invention and addressed by the patent can provide a reason for combining
the elements in the manner claimed.” KSR Int’l v. Teleflex Inc., 550 U.S.
398, ___, 127 S. Ct. 1727, 1742 (2007).
[I]t is elementary that the mere recitation of a newly discovered
function or property, inherently possessed by things in the prior
art, does not cause a claim drawn to those things to distinguish
over the prior art. Additionally, 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.
In re Best, 562 F.2d 1252, 1254-55 (CCPA 1977).
“A reference may be said to teach away when a person of ordinary
skill, upon reading the reference, would be discouraged from following the
path set out in the reference, or would be led in a direction divergent from
the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553
(Fed. Cir. 1994). “Attorney’s argument in a brief cannot take the place of
evidence.” In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974).
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citation omitted).
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ANALYSIS
Bendel and Middleman each discloses a needle made of a superelastic
alloy allowing the needle to be forced into a roughly elongated position
when the needle is housed in an internal bore of a cannula or an applicator
and allowing the needle to adopt, after extraction from the cannula or the
applicator, a curved profile having the shape of an arc of a circle (Findings
of Fact (FF) 8-15). Kurtz discloses a needle having a curved profile, having
a main cutting edge 58 arranged on the inside portion of the curved profile,
and having secondary cutting edges (FF 16-19) We agree with the Examiner
that it would have been prima facie obvious to modify Bendel’s and
Middleman’s needles to include Kurtz’s tip configuration in order to provide
multiple cutting surfaces (Ans. 3).
Appellants argue, however, that Bendel “is entirely silent with regard
to the needle being made of a hyper-elastic alloy as recited in claim 12.
Appellant[s] submit[] that a shape memory alloy is not per se a hyper-elastic
alloy.” (App. Br. 7.) Appellants also argue:
It is also apparent that BENDEL is entirely silent, and indeed
entirely unconcerned, with providing the needle with
characteristics that would allow it to either assume a roughly
elongate position or which would allow it to be slid into a
cannula or an applicator. As is apparent from Fig. 5 of
BENDEL, the needle 10 does not assume a roughly elongated
position when slid into the cannula 14. To the contrary, Fig. 2
of BENDEL shows that the needle assumes such a position
only when it is maintained at a specific temperature.
(Id. at 8.)
We are not persuaded. As the hyper-elastic alloys, the Specification
discloses nickel-titanium alloys that have been heat treated under stress
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(FF 2-3). Similarly, Bendel discloses a nickel-titanium alloy that has been
trained to return to a desired shape “by constraining it in the desired shape
and heating it to a temperature well above the Af” (FF 10-11). In addition,
Bendel discloses that “superelasticity” is an inherent property of shape
memory alloys (FF 9). It is not disputed that the terms “superelasticity” and
“hyper-elasticity” are interchangeable (FF 7). Thus, even if not all shape
memory alloys are hyper-elastic, we agree that there is a prima facie case
that the shape memory alloys disclosed in Bendel are hyper-elastic.
With regard to “allowing the needle to be forced into a roughly
elongated position,” we understand from the Specification that this is an
inherent characteristic of the hyper-elastic alloy (FF 1 & 4). Thus, whether
or not Bendel is concerned with providing its needle with this characteristic,
we agree that there is a prima facie case that Bendel discloses a needle
having this characteristic.
Appellants “acknowledge[] that MIDDLEMAN discloses a surgical
suture needle 10 which is disclosed as having ‘the property of
pseudoelasticity, preferably superelasticity’ . . . and that is capable of sliding
into a cannula 11 (see e.g., Fig. 33)” (App. Br. 8). However, Appellants
argue:
MIDDLEMAN clarifies what is meant by superelasticity by
explaining on, col. 19, lines 44-47, that the “superelasticity [is]
at the temperature to be encountered within the body”. Thus,
while it is apparent that MIDDLEMAN discloses a shape-
memory alloy, it is not apparent that such an alloy can be
properly characterized as a hyper-elastic alloy as recited in at
least claim 12.
(Id.)
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We are not persuaded. Claim 12 recites a hyper-elastic alloy.
Middleman discloses a shape memory alloy that exhibits superelasticity
(FF 14). It is undisputed that the terms “superelasticity” and “hyper-
elasticity” are interchangeable (FF 7). Specifically, Appellants have not
shown that the term “hyper-elastic” requires that the alloy be hyper-elastic at
any particular temperature.
Appellants also argue:
KURTZ make[s] clear that portion 58 is a “main cutting edge”
and not a[n] inclined heel portion, much less, one that is
arranged on an inside portion of the curved profile and that is
structured and arranged to bear against an interior wall of the
internal bore of the cannula or the applicator when the needle
slides within the internal bore, whereby a profile of the tapered
point is protected.
(App. Br. 9.) In particular, Appellants argue:
the Examiner has provided no documentary evidence to support
an assertion that one ordinarily skilled in the art would
understand or refer to a cutting edge as a “heel” nor has the
Examiner attempted to explain why one ordinarily skilled in the
art would understand or refer to the cutting edge as a “heel.”
(Reply Br.2 2.)
We are not persuaded. We understand that Kurtz element 58 is a main
cutting edge. However, it is also an inclined portion (FF 18). In addition, it
is arranged on an inside portion of the curved profile (FF 17-18). In fact, it
is in the same basic location as Appellants’ inclined heel (FF 5 & 18). Thus,
we are not aware of any reason Kurtz’s element 58 cannot be considered an
inclined heel portion.

2 Reply Brief dated December 12, 2006.
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Although the Examiner has not provided any “documentary evidence
to support an assertion that one ordinarily skilled in the art would understand
or refer to a cutting edge as a ‘heel,’” the Specification does not set forth a
definition of this term. Thus, giving the term its broadest reasonable
interpretation, we agree that it was proper, in the absence of evidence to the
contrary, to interpret the term to refer to any region on the tapered point that
can be considered the heel. As discussed above, Kurtz’s edge 58 is in the
same basic location as Appellants’ inclined heel (FF 5 & 18). Thus, we
agree that it was reasonable for the Examiner to consider this region to be
the heel.
With regard to the recitation in claim 12 that the inclined heel portion
“is structured and arranged to bear against an interior wall of the internal
bore of the cannula or the applicator when the needle slides within the
internal bore, whereby a profile of the tapered point is protected,” as noted
by the Examiner (Ans. 3), the claim is directed to a needle, not to a needle
inside an internal bore. Thus, to satisfy claim 12, the inclined heel portion
need only be capable of bearing against an interior wall of an internal bore
and protecting a profile of the tapered point when the needle slides within
the internal bore. Based on the disclosure in the present Specification
(FF 6), we agree that there is a prima facie case that edge 58 would be
capable of this function.
In addition, Appellants argue that “it would not have been obvious to
combine the teachings of” Bendel or Middleman with Kurtz (App. Br. 9). In
particular, Appellants argue that “sharp edge 58 of KURTZ would more
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likely cause damage to the cannula 10 or to the edge 58 itself” (id. at 10).
Thus, Appellants argue:
KURTZ teaches away from such a combination by not
disclosing a protective heel portion and by instead specifically
utilizing a sharp edge which would offer no protection to the tip
and which simply cannot protect the tapered point of the needle
by bearing against an interior wall of the internal bore of the
cannula or the applicator when the needle slides within the
internal bore.
(Id.)
We are not persuaded. First, we are aware of no reason Kurtz’s sharp
edge 58 could not protect the tapered point by bearing against the interior
wall of an internal bore when the needle slides within the internal bore, even
if this might damage the wall and/or the edge. In addition, as discussed
above, claim 12 only requires that the inclined heel portion be capable of
bearing against an interior wall of an internal bore when the needle slides
within the internal bore, whereby the tapered point is protected. Thus, it is
not necessary for the applied references to teach or suggest using the
inclined portion 58 to protect the needle’s point, or even to teach or suggest
a conformation where the inclined portion 58 bears on the wall of the bore.
However, assuming that the Examiner’s combination would result in a
device in which at least a portion of edge 58 bears against the wall of a bore,
we do not agree that the argument that this edge may damage the bore or the
edge itself is sufficient to demonstrate that Kurtz teaches away from
combining its disclosure with Bendel or Middleman. “Attorney’s argument
in a brief cannot take the place of evidence.” In re Pearson, 494 F.2d 1399,
1405 (CCPA 1974).
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Appellants also argue:
[A]s KURTZ discloses a cutting edge for[] cutting hard tissue,
the art of record fails to provide any teaching or suggestion for
forming such a cutting device with an elastic or memory metal
material. That is, the art fails to provide any teaching or
suggestion that a cutting device formed in the materials
disclosed by BENDE[L] or MIDDLEMAN would allow the
cutting device of KURTZ to operate in its intended manner.
(Reply Br. 5-6.)
We are not persuaded. The Examiner does not argue that it would
have been obvious to form Kurtz’s needle, which is “for use in cutting
through hard body tissue material” (FF 16), with the materials of Bendel or
Middleman. Instead, the Examiner finds that it would have been obvious to
use Kurtz’s tip configuration on the needles disclosed in Bendel and
Middleman. As discussed above, we agree that this would have been
obvious in order to provide multiple cutting surfaces (Ans. 3).
In addition, Appellants traverse the rejection of independent claims 33
and 34 for substantially the same reasons as for claim 12 (App. Br. 12-22).
We are not persuaded by these arguments for the reasons discussed above.
Appellants also argue that, with regard to dependent claims 18-23 and
25-27, “the Examiner has failed to establish a prima facie case of
unpatentability. . . . [T]he Examiner has not even bothered to identify any
language in any of the applied documents which discloses or suggests” the
features of claims 18-23 and 25-27. (App. Br. 22-30.) While making no
comment on whether there is basis for rejecting claims 18-23 and 25-27 as
obvious over Bendel or Middleman in view of Kurtz, we agree with
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Appellants that the Examiner has not set forth a prima facie case that these
claims are obvious.
We therefore vacate the Examiner’s rejection of claims 18-23 and 25-
27. If, on return of this application, the Examiner concludes that claims 18-
23 and 25-27 would have been obvious in view of the prior art, the basis for
that conclusion should be clearly stated on the record and Appellants must
be provided an opportunity to respond to any rejection.
CONCLUSION
Appellants have not shown that the Examiner erred in concluding that
Bendel and/or Middleman disclose a needle made of a hyper-elastic alloy,
that Kurtz teaches or suggests a surgical needle having the claimed inclined
heel portion, or that it would have been obvious to modify the tip of the
needles disclosed in Bendel and/or Middleman to include the tip
configuration disclosed in Kurtz. We therefore affirm the obviousness
rejection of claims 12, 33, and 34. Claims 17, 24, and 28-32 have not been
argued separately and therefore fall with claim 12. 37 C.F.R.
§ 41.37(c)(1)(vii).
However, we agree with Appellants that the Examiner did not set
forth a prima facie case that dependent claims 18-23 and 25-27 would have
been obvious. We therefore vacate the obviousness rejection of these
claims.
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, VACATED-IN-PART
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LP

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