Ex Parte Grandfield

Board of Patent Appeals and Interferences

Apr 30, 2012

10931746 (B.P.A.I. Apr. 30, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte RYAN GRANDFIELD
____________

Appeal 2010-005741
Application 10/931,746
Technology Center 3700
____________

Before STEFAN STAICOVICI, EDWARD A. BROWN and
JAMES P. CALVE, Administrative Patent Judges.

STAICOVICI, Administrative Patent Judge.

DECISION ON APPEAL

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STATEMENT OF THE CASE
Ryan Grandfield (Appellant) appeals under 35 U.S.C. § 134 from the
Examiner’s decision rejecting claims 1-15, 19 and 20. Claims 16-18 have
been withdrawn by the Examiner. We have jurisdiction over this appeal
under 35 U.S.C. § 6.

THE INVENTION
Appellant’s invention relates to guide wire for use in cardiovascular,
peripheral or carotid procedures. Spec. 4, para. [0009] and figs. 1 and 2.
Claim 1 is illustrative of the claimed invention and reads as follows:
11. A guide wire for applications related to chronic total occlusions
in a patient's vasculature, comprising:
a distal section having a coiled structure wherein a distal
portion is steeply tapered over a short distance, wherein an outer
surface has a rippled shape;
a first polymer having high conformance properties applied to a
distal portion of said coiled structure [wherein] such that an outer
surface thereof substantially assumes the rippled shape of the outer
surface of the underlying coiled structure; and
a second polymer having relatively low conformance properties
applied to a substantially straight portion of said coiled structure
proximal to said distal portion such that an outer surface thereof does
not assume the rippled shape of the underlying coiled structure so as
to be substantially smooth.

THE REJECTIONS
The Examiner relies upon the following as evidence of
unpatentability:

Gold US 4,534,363 Aug. 13, 1985
Davidson US 5,107,852 Apr. 28, 1992
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Sutton US 5,472,435 Dec. 5, 19951
Samson US 5,827,201 Oct. 27, 1998
Deem US 6,042,876 Mar. 28, 2000
Anderson US 2002/0082524 A1 Jun. 27, 2002

The following rejections are before us for review:
I. The Examiner rejected claims 1, 2, 5-15, 19, and 20 under 35 U.S.C.
§ 103(a) as unpatentable over Anderson and Samson.
II. The Examiner rejected claims 3 and 4 under 35 U.S.C. § 103(a) as
unpatentable over Anderson, Samson, and Davidson.
III. The Examiner rejected claim 1, 2, 5-15, 19, and 20 under 35 U.S.C.
§ 103(a) as unpatentable over Samson and Anderson.
IV. The Examiner rejected claims 3 and 4 under 35 U.S.C. § 103(a) as
unpatentable over Samson, Anderson and Davidson.
V. The Examiner rejected claims 1, 2, and 11 under 35 U.S.C. § 103(a)
as unpatentable over Anderson, Gold and Deem.
VI. The Examiner rejected claims 3 and 4 under 35 U.S.C. § 103(a) as
unpatentable over Anderson, Gold, Deem, and Davidson.

SUMMARY OF DECISION
We AFFIRM-IN-PART.

1 On pages 27-28 of the Examiner’s Answer, the Examiner relies on the
disclosure of Sutton to show that it is known in the art to apply a polymer
layer 22 onto a flat coil (i.e., a braid 24 of rectangular cross-section) such
that the outer surface of the polymer layer substantially assumes the rippled
or contoured shape of the outer surface of the underlying coiled structure 24.
See Sutton, figs. 8A and 8B.

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ANALYSIS
Rejection I
The Examiner found that Anderson discloses all the limitations
of independent claims 1 and 19 with the exception of “a high and a low
conformance polymer disposed over the distal section [13]” of guide wire
10. Ans. 3-4. The Examiner further found that Samson discloses a guide
wire 170 including (1) a first polymer having high conformance properties
applied to a distal portion of coiled structure 178, 188, wherein the
polymer’s outer surface substantially assumes the rippled shape of the
outer surface of the underlying coiled structure 178, 188; and (2) a second
polymer having relatively low conformance properties applied to a portion
of the coiled structure 178, 188 proximal to the distal portion wherein the
polymer’s outer surface does not assume the rippled shape of the underlying
coiled structure 178, 188 so as to have a substantially smooth/straight
profile. Ans. 4 and 6-7. See also Samson, col. 4, ll. 41-44; col. 5, ll. 53-56;
col. 8, ll. 21-25; col. 11, ll. 49-50; and fig. 6B.
Appellant argues that Samson fails to teach or suggest that the
different surface textures of the polymer covering the braided and the coiled
sections of the guide wire of Figure 6B are the result of differences in
conformance2 properties of the polymer, as called for by each of
independent claims 1 and 19. App. Br. 9. Specifically, Appellant argues
that a braid would provide a different degree of support than a coil for an
overlying polymer. Id. According to Appellant, the gaps between the

2 Appellant describes the term “conformance” as “a material’s ability for
its outer surface to assume the shape of an underlying surface.” App. Br. 7.
See also Spec. 4, para. [00010].
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peripheries of adjacent round coils and adjacent square braids of Figure 6B
of Samson is different, in that the braided structure would provide support of
a polymer coating on all four sides of each gap; whereas, a coil would only
provide support of a polymer coating on two sides of each gap. Reply Br. 5.
Consequently, according to Appellant, a polymer extending across adjacent
round coils would droop (i.e., hang downward) more than a polymer
extending across adjacent square braids. App. Br. 9. See also Reply Br. 5.
As such, Appellant contends that the surface texture differentiation of the
polymer of Figure 6B of Samson is due to the difference in the underlying
structure of the braid and the coil rather than a difference in the polymer’s
conformance properties. Reply Br. 3.
In response, the Examiner notes that Samson discloses that the
polymers along the length of the guide wire can have different hardnesses
(i.e., durometer values). Ans. 24. See also Samson, col. 14, ll. 59-67. Thus,
according to the Examiner, a proximally disposed polymer of low
conformance (i.e., high durometer) is layered over the braided section 178 of
guide wire 170 to form a smooth shape and a distally disposed polymer of
high conformance (i.e., low durometer) is layered over the coiled section
188 of guide wire 170 to form a rippled shape. Ans. 4, 7, and 22. See also,
Samson, fig. 6B. Hence, the Examiner appears to take the position that
because Samson discloses a first polymer that assumes a rippled shape and a
second polymer that assumes a smooth shape, the rippled and smooth shapes
of the polymers over the coiled structure 178, 188 of the guide wire 170 of
Figure 6B of Samson are due to the polymers’ conformance properties. Ans.
24. We disagree with the Examiner’s position for the following reasons.
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Samson discloses that (1) different sections of the guide wire may be
coated with different polymers (See Ans. 4 and 6-7. See also Samson, col.
4, ll. 41-44, col. 5, ll. 53-56, col. 8, ll. 21-25 and col. 11, ll. 49-50 and fig.
6B); and (2) the polymer overlying the braided section may have a different
hardness (i.e., durometer value) than the polymer overlying the coiled
section (See Ans. 24. See also Samson, col. 14, ll. 59-67). Hence, Samson
specifically discloses that polymers having a different hardness overlying a
coiled structure result in different surface textures, i.e., smooth and rippled
shapes. However, the different surface textures of Samson are not
necessarily the result of the characteristics of the underlying structure, i.e.
coiled or braided, as Appellant suggests. Likewise, it does not mean that
it is the conformance characteristics of the polymers, as the Examiner
proposes. Hence, in a first instance, we find that both situations are possible.
However, inherency may not be established by probabilities or possibilities.
In re Oelrich, 666 F.2d 578, 581 (CCPA 1981) (quoting Hansgirg v.
Kemmer, 102 F.2d 212, 214 (CCPA 1939). Although we appreciate that the
durometer value may be indicative of a polymer’s tendency to conform to a
substrate, nonetheless, we note that the Examiner has failed to provide
factual evidence of a direct correlation between the durometer values (i.e.,
hardness) of the polymers and the conformance of the polymers to show that
the surface texture of the polymers of the guide wire of Figure 6B of Samson
is in fact due to differences in conformance properties of the polymers as
opposed to differences in the underlying structure of the braid and the coil of
the guide wire of Samson, as proposed by Appellant. We agree with
Appellant that other factors such as viscosity and thickness may also affect
the conformance characteristic of a polymer. App. Br. 11.
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In conclusion, we find that the Examiner has not provided sufficient
evidence to support the finding that the different surface textures of Samson
are necessarily the result of the different conformance characteristics of the
polymers overlying the braided and coiled sections. Thus, the Examiner has
not made the initial factual findings required to demonstrate a prima facie
case of obviousness of independent claims 1 and 19. See In re Warner, 379
F.2d 1011, 1017 (CCPA 1967).
Accordingly, the rejection of independent claims 1 and 19, and their
respective dependent claims 2, 5-15 and 20 under 35 U.S.C. § 103(a) as
unpatentable over Anderson and Samson, cannot be sustained. See In re
Fine, 837 F.2d 1071, 1076 (Fed. Cir. 1988).

Rejection II
The addition of Davidson does not remedy the deficiencies of
Anderson and Samson as described above. Accordingly, we shall also
reverse the rejection of claims 3 and 4 under 35 U.S.C. § 103(a) as
unpatentable over Anderson, Samson, and Davidson.

Rejections III and IV
In rejections III and IV, the Examiner has merely switched the order
of the teachings of Anderson and Samson so that Samson is now a primary
reference and Anderson is a secondary reference. Unlike the Examiner, we
do not consider the order in which prior art is applied in a rejection to be
significant. See, e.g., In re Bush, 296 F.2d 491, 496 (CCPA 1961).
Furthermore, Appellant’s arguments with respect to rejections III and IV,
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merely incorporate the arguments presented with respect to rejections I and
II, respectively. See App. Br. 12-18.
In conclusion, for the reasons set forth above, the rejections under
35 U.S.C. § 103(a) of claims 1, 2, 5-15, 19 and 20 as unpatentable over
Samson and Anderson and of claims 3 and 4 as unpatentable over Samson,
Anderson, and Davidson, likewise cannot be sustained.

Rejection V
The Examiner found that Anderson discloses all the limitations of
independent claim 1 with the exception of “a first polymer having high
conformance and a second polymer having a low conformance.” Ans. 17-
18. The Examiner further found that (1) Gold discloses a guide wire with a
polymer 20 having high conformance properties applied to coiled structure
18 forming a rippled shape; and (2) Deem discloses a guide wire with a
polymer 30 having low conformance properties applied to straight portion
of a coiled structure forming a smooth shape. Ans. 18-19.
Appellant argues that (1) Gold fails to teach or suggest a guide wire
including a polymer having high conformance properties; and (2) Deem fails
to teach or suggest a guide wire including a polymer having relatively low
conformance properties, as required by independent claim 1. App. Br. 18-
20.
In response, the Examiner initially notes that consistent with
Appellant’s Specification (see Spec. para. [00024]), (1) Gold discloses a low
viscosity polymer 20 that “forms a thin layer, and fills the available space
in the interior of the coils 18 as well as bridging the space between adjacent
coils;” and (2) Deem discloses a high viscosity polymer 30 that “forms a
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thick layer (see figs. 2 and 2A), and a smooth outer surface despite a rippled
substrate 28.” Ans. 29. As such, as far as we understand, the Examiner
appears to take the position that despite both Gold and Deem being silent as
to the “conformance” characteristics of its respective polymers, because the
polymer of Gold is a low viscosity polymer that forms a thin, rippled layer
and the polymer of Deem is a high viscosity polymer that forms a thick
layer, and similarly Appellant’s polymers include a low viscosity polymer
that forms a thin layer and a high viscosity polymer that forms a thick layer,
the polymer of Gold has a high conformance and the polymer of Deem has a
low conformance. See Ans. 30.
We agree with the Examiner’s position. It is well settled that the
USPTO has the initial burden of providing a basis in fact and/or technical
reasoning to reasonably support the determination that the allegedly inherent
characteristic reasonably flows from the teachings of the applied prior art.
See In re King, 801 F.2d 1324, 1327 (Fed. Cir. 1986). Once the USPTO
establishes a prima facie case of anticipation based on inherency, the
burden shifts to the applicant to prove that the prior art does not possess the
characteristic at issue. See Id. This is the case whether the rejection is
based on inherency under 35 U.S.C. § 102, prima facie obviousness under
35 U.S.C. § 103, or both jointly or alternatively. See In re Best, 562 F.2d
1252, 1255 (CCPA 1977). In this case, Appellant’s Specification states that:
The polymer selected for application to the distal
most section of the guide wire is selected for its
ability to conform to the underlying shape wherein
properties such[as] low viscosity and the ability to
form a thin layer are critical. The low viscosity
also allows the polymer to fill the available space
in the interior of the coils as well as bridging the
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space between adjacent coils. . . . The second
polymer is selected for its ability to be
applied in a relatively thick layer and for having a
sufficiently high viscosity to form a smooth outer
surface despite a rippled substrate.

Spec. 8, para. [00024]. Emphasis added.
Similarly, Gold specifically discloses that:
…because of the low viscocity (sic.) of the
lubricating coating 20, the [thin] coating passes
between adjacent turns of the coil spring 18 and
completely surrounds each of the turns of the coil
spring 18.

Gold, col. 3, ll. 22-25. See also Gold, fig. 2. Emphasis added.
Furthermore, Deem specifically discloses that:
An exemplary PVP coating solution has a
relatively high viscosity, . . . Viscosities in this
range help prevent penetration of the coating
material through the coil into the annular base
(sic.) between the coil and the core wire.
Additionally, . . . the coating solution [is applied]
at a controlled rate selected to provide for the
desired thickness of the coating material onto the
guidewire surface without penetration of
the coating material through the coil tip.

Deem, col. 4, ll. 39-40 and 42-49 and figs. 2 and 2A. Emphasis
added.
Hence, we find that Gold’s similar teaching of a low viscosity
polymer that forms a thin, rippled layer and Deem’s similar teaching of a
high viscosity polymer that forms a thick, smooth layer would suggest to
a person of ordinary skill in the art that Gold discloses a polymer having a
high conformance and Deem discloses a polymer having a low conformance,
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so as to shift the burden to Appellant to show that this is not the case.
Appellant has not come forward with any evidence to satisfy this burden.
Appellant further argues that Gold teaches away from a polymer
having a rippled shape. App. Br. 19. Specifically, Appellant argues that
“the object [of Gold] is to provide a smooth or ‘ultrasmooth’ exterior
surface.” Id. In other words, based on our understanding, it appears that
Appellant is arguing that Gold discloses a polymer having a flat or straight
surface texture. We disagree.
Gold specifically shows in Figure 2 polymer 20 having a rippled
surface texture. Although we appreciate that “smooth” may mean flat or
straight, as Appellant proposes, nonetheless, what a reference teaches or
suggests must be examined in the context of the knowledge, skill, and
reasoning ability of a skilled artisan. See Syntex (U.S.A.) LLC v. Apotex, Inc.
407 F.3d 1371, 1380 (Fed. Cir. 2005). In this case, Gold discloses that
the lubricating coating 20, which passes between adjacent turns of the coil
spring 18 and completely surrounds each of the turns of the coil spring 18,
creates “ this smooth lubricious coating of the coil spring 18, [such that] the
coating serves the function of reducing the formation of blood clots because
of the smooth outer surface of both the outer portion and inner portion of the
coil spring 18.” Gold col. 3, ll. 26-29. Thus, in contrast to Appellant’s
position, we find that in Gold, coating a coil spring with a polymer would
make the outer surface of the coil spring smooth, i.e., not rough, in order to
prevent injury to surrounding tissue during movement of the guide wire
through the vascular system. Therefore, Gold discloses a coiled structure
having an outer surface coated with a smooth (i.e., not rough) polymer,
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wherein the smooth (i.e., not rough) polymer assumes the rippled shape of
the outer surface of the underlying coiled structure. See Gold, fig. 1.
Lastly, Appellant argues that the Examiner has not provided an
adequate reasoning with rational underpinnings to combine the teachings
of Anderson, Gold, and Deem. App. Br. 20. However, the Examiner has
provided a reason with rational underpinning (“reduce the friction of the
coil”). See Ans. 19 and 20; In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)
(“[R]ejections on obviousness grounds [require] some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness”) (cited with approval in KSR, 550 U.S. 398, 418 (2007)).
In conclusion, for the foregoing reasons, the rejection of independent
claim 1, and its respective dependent claims 2 and 11, under 35 U.S.C.
§ 103(a) as unpatentable over Anderson, Gold, and Deem is sustained.

Rejection VI
With respect to dependent claims 3 and 4, Appellant does not present
any additional substantive arguments separate from those presented above
in reference to independent claim 1. See App. Br. 20-21. As such, we shall
also sustain the rejection of claims 3 and 4.

SUMMARY
The Examiner’s decision is affirmed as to claims 1-4 and 11 and
reversed as to claims 5-10, 12-15, 19 and 20.
No time period for taking any subsequent action in connection with
this appeal may be extended under C.F.R. § 1.136(a)(1)(iv).

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AFFIRMED-IN-PART

JRG