Ex Parte Jalisi et al

Board of Patent Appeals and Interferences

Jun 3, 2009

09470874 (B.P.A.I. Jun. 3, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MARC MEHRZAD JALISI, DAVID M. ANDERSON,
WAYNE E. CORNISH, NANCY A. NICOTRA,
and MARK T. RICHARDSON
__________

Appeal 2009-000802
Application 09/470,874
Technology Center 3700
__________

Decided:1 June 3, 2009
__________

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

FREDMAN, Administrative Patent Judge.

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).

Appeal 2009-000802
Application 09/470,874

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a heat
treated elongate member. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm-in-part.
Statement of the Case
Background
“Conventional guidewires for angioplasty and other vascular
procedures usually comprise an elongated core member with one or more
tapered sections near the distal end thereof and a flexible body such as a
helical coil disposed about the distal portion of the core member” (Spec. 1,
ll. 14-17). According to the Specification, a “shapeable member, which may
be the distal extremity of the core member or a separate shaping ribbon
which is secured to the distal extremity of the core member extends through
the flexible body and is secured to a rounded tip at the distal end of the
flexible body” (Spec. 1, l. 17 to 2, l. 3).
The Claims
Claims 1-15, 17, 19-27, and 29 are on appeal. We will focus on
claims 1, 8, 20, and 26, which are representative and read as follows:

1. A heat-treated elongate member, comprising:
a composite elongate core;
the composite elongate core including an inner core
formed of a precipitation hardened material and a layer
formed of a superelastic material; and
a second layer concentrically arranged about the layer
formed of the superelastic material;
wherein the layer is arranged concentrically about the
inner core.

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Application 09/470,874

8. A heat-treated elongate member, comprising:
a composite elongate core;
the composite elongate core including an inner core
formed of a precipitation hardened material concentrically
surrounded by a first layer formed of a superelastic material
and having a proximal section and distal section;
a flexible body distinct from the first layer at least
partially overlying the distal section; and
wherein the precipitation hardenable material
comprises at least two materials selected from the group
consisting of nickel, cobalt, molybdenum, chromium,
tungsten, and iron.

20. The elongate member [wherein the inner core and the
first layer are independently formed and wherein the first
layer is formed from superelastic NITINOL and]
wherein the composite elongate core further includes
a second layer disposed at least in part concentrically about
the first layer and formed from a material similar to the inner
core material.

26. A guide wire, comprising:
a composite elongate core;
the composite elongate core including an inner core
formed of a precipitation hardened material concentrically
surrounded by a layer formed of a superelastic material and
having a proximal section and distal section;
a flexible coil disposed at a distal end of the distal
section;
wherein the precipitation hardened material and
superelastic material extend from the proximal section to at
least through a part of a length of the flexible coil.

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Application 09/470,874

The prior art
The Examiner relies on the following prior art references to show
unpatentability:
Thome et al. US 5,776,080 Jul. 7, 1998
Fagan et al. WO 96/25969 Aug. 29, 1996

The issue
The Examiner rejected claims 1-15, 17, 19-27, and 29 under 35
U.S.C. § 103(a) as being obvious over Thome and Fagan (Ans. 3).
The Examiner finds that
Thome teaches a medical guidewire having a heat-treated
elongate member comprising a composite core (150), the
composite core section including an inner core (154) formed
of Hiperco (Col 13 line 50) wire, and a layer formed of a
superelastic material (178, Nitinol), and a second layer
concentrically arranged about the layer formed of
superelastic material (176), wherein the layer is arranged
about the inner core . . . Thome does not teach that the inner
core is formed of a precipitation hardened material. Fagan
teaches a precipitation hardened material (stainless steel) for
use in a medical guide wire (Abstract). It would have been
obvious to one of ordinary skill in the art at the time the
invention was made to use the precipitation hardened
material of Fagan with the guide wire of Thome as an
alternate material

(Ans. 3).
Appellants contend that the “Thome et al. patent does not teach [the
claimed] structure since the metallic layer 178 forms the outermost surface
of the Thome et al. device and thus, Thome et al. does not disclose or even
contemplate a second layer concentrically arranged about a layer formed of
superelastic material” (App. Br. 6). Appellants also contend that the
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“Examiner has not demonstrated . . . that the layer of resin 176 at least
partially overlays a first layer formed of a superelastic material as is recited
in the claims” (App. Br. 7).
In view of these conflicting positions, we frame the obviousness
issues before us as follows:
(i) Did the Examiner err in finding that Thome and Fagan teach “a
second layer concentrically arranged about the layer formed of the
superelastic material” as required by claim 1?
(ii) Did the Examiner err in finding that Thome and Fagan teach a
“composite elongate core including an inner core formed of a precipitation
hardened material concentrically surrounded by a first layer formed of a
superelastic material and having a proximal section and distal section” as
required by claim 8?
Findings of Fact (FF)
1. The Specification teaches that “the composite elongate core
member further includes a second layer portion disposed at least in part
about the first layer portion and formed of a material similar to the inner
core element material” (Spec. 7, ll. 2-5).
2. Figure 2 of the Specification is reproduced below:
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Application 09/470,874

“FIG. 2 is a transverse cross sectional view of the guidewire” (Spec. 8, l. 7).
3. The Specification teaches that the
elongate core member 11 has an inner core element 31
formed from a precipitation hardenable material, a first layer
portion 37 formed from a superelastic material disposed on
an outer surface 43 of the inner core element 31, and a
second layer portion 46 formed from precipitation
hardenable material disposed on an outer surface 52 of the
first layer portion 37.

(Spec. 9, ll. 7-12.)
4. Thome teaches a guide wire in figure 25, reproduced below:

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“FIG. 25 is a detailed sectional view of an operative segment of a guide
wire” (Thome, col. 5, ll. 15-16).
5. Thome teaches a guidewire with a composite elongate core
where “[c]ore 154 is formed of a highly paramagnetic material relative to the
rest of operative segment 150” (Thome, col. 13, ll. 46-47; Fig. 25). Thome
also teaches an alternative where “core 154 is formed of solid stainless steel,
having a uniform outside diameter” (Thome, col. 16, ll. 32-33).
6. Thome teaches that “a thin walled tubular member 158 is
placed over the core 154. In a preferred embodiment, the thin walled tubular
member 158 is formed of a 304 stainless steel hypotube, which is secured to
the core 154 by an adhesive layer 162” (Thome, col. 16, ll. 49-52).
7. Thome teaches that the “thin walled tubular member 158 is
coated with a metallic layer 178” (Thome, col. 16, ll. 52-53).
8. Thome teaches that “the metallic layer 178 is formed of a
material having superelastic properties, such as Nitinol” (Thome, col. 16, ll.
54-56).
9. Thome teaches that “[n]otched segments 160 are filled with a
material 176, such as epoxy resin” (Thome, col. 17, ll. 10-11).
10. Thome teaches that “operative segment 150 includes multiple
layers of strands 182 tightly wrapped around core 154. In a preferred
embodiment, the strands 182 are formed of stainless steel ribbons or
composite fibers filled with epoxy ribbon” (Thome, col. 17, ll. 14-17).
11. Figure 26 of Thome is reproduced below:
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“FIG. 26 is a fragmented perspective view of an operative segment of a
guide wire” (Thome, col. 5, ll. 18-19).
12. Fagan teaches that the “guidewire shaft may be formed from a
precipitation hardenable alloy such as an alloy of nickel, cobalt,
molybdenum and chromium (MP35N and Elgiloy), 455PH stainless steel or
stainless steel alloy 1RK91” (Fagan, abstract).
13. The Examiner finds that “[i]t would have been obvious to one
of ordinary skill in the art at the time the invention was made to use the
precipitation hardened material of Fagan with the guide wire of Thome as an
alternate material” (Ans. 3).
Principles of Law
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) the level of ordinary skill in the art; (3) the differences between the
claimed invention and the prior art; and (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
The Supreme Court has recently emphasized that “the [obviousness] analysis
need not seek out precise teachings directed to the specific subject matter of
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the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” KSR
Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
Id. at 416. “If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability.” Id. at 417.
Moreover, an “[e]xpress 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). As noted by the Court in KSR, “[a] person
of ordinary skill is also a person of ordinary creativity, not an automaton.”
550 U.S. at 421.
Claim terms are interpreted using the broadest reasonable
interpretation in light of the Specification. See, e.g., In re Hyatt, 211 F.3d
1367, 1372 (Fed. Cir. 2000) (“[D]uring examination proceedings, claims are
given their broadest reasonable interpretation consistent with the
specification.”). Also see In re Morris, 127 F.3d 1048, 1054-56 (Fed. Cir.
1997). (“Absent an express definition in their specification, the fact that
appellants can point to definitions or usages that conform to their
interpretation does not make the PTO's definition unreasonable when the
PTO can point to other sources that support its interpretation.”)

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Analysis
Claim 1
Whether the combination of Thome and Fagan render claim 1 obvious
depends upon the interpretation of “a second layer concentrically arranged
about the layer” (see Claim 1). The Examiner finds that the “term ‘arranged
about’ does not have to mean outside or exterior” (Ans. 5).
We disagree with the Examiner’s understanding of the term “arranged
about” in this instance. The Specification only teaches the situation where
the second layer is placed outside the first layer (FF 1-3). The broadest
reasonable interpretation consistent with the Specification of “a second layer
concentrically arranged about the layer formed of the superelastic material”
is that the layer is on the outside of the first layer.
However, even relying solely upon the language of the claim, the
phraseology used requires an order. The claim requires an inner core, which
being “inner” is necessarily surrounded by the first layer of a superelastic
material (Claim 1). The claim then requires a “second layer” (Claim 1).
The broadest reasonable interpretation of a “second layer” that is “arranged
about” the first layer, is that the second layer is exterior to the first layer. If
the “second layer” was interior to the first layer, it would necessarily be
termed the first layer, and not the second layer.
We therefore agree with Appellants that the “layer of resin 176 does
not meet the claim language of being arranged about the superelastic layer
178. The Fagan reference does not disclosed [sic] the claimed structure”
(App. Br. 6).

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Claims 8, 26, and 27
Thome teaches a composite elongate core with an inner core
surrounded by a layer of superelastic material where the layer of resin 176 is
a flexible body which partially overlies the composite elongate core (FF 4-
9). Fagan teaches the use of precipitation hardened material comprising
material such as nickel, cobalt, and molybdenum (FF 12). The Examiner
finds that “[i]t would have been obvious to one of ordinary skill in the art at
the time the invention was made to use the precipitation hardened material
of Fagan with the guide wire of Thome as an alternate material” (Ans. 3; FF
13). See KSR, 550 U.S. at 416 (“The combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results.”)
Claims 8, 26, and 27 do not expressly require the same order as claim
1, since the “flexible body distinct from the first layer” (Claim 8), the
“flexible coil disposed at a distal end of the distal section” (Claim 26) and
the “flexible body disposed at a distal end” (Claim 27) are not identified as
second layers unlike the “second layer” claim 1.
Therefore, in analyzing claim 8, the issue is whether the phrase
“having a proximal section and distal section” necessarily refers to the “first
layer formed of a superelastic material” or whether the phrase can also be
interpreted to modify the “composite elongate core.”
Under the broadest reasonable interpretation rubric, we find that the
Examiner has reasonably interpreted the phrase “having a proximal section
and distal section” in claim 8 as broadly applying to either the composite
elongate core or the first layer formed of a superelastic material. See In re
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Zletz, 893 F.2d 319, 321-322 (Fed. Cir. 1989) (“[D]uring patent prosecution
when claims can be amended, ambiguities should be recognized, scope and
breadth of language explored, and clarification imposed.... An essential
purpose of patent examination is to fashion claims that are precise, clear,
correct, and unambiguous. Only in this way can uncertainties of claim scope
be removed, as much as possible, during the administrative process.”).
Appellants had, and still have, opportunities to clarify this claim
language to limit which element in claims 8, 26, and 27 is intended by
“having a proximal section and a distal section” (see Claim 8).
We are not persuaded by Appellants’ argument that the “Examiner has
not demonstrated, however, that the layer of resin 176 at least partially
overlays a first layer formed of a superelastic material as is recited in the
claims” (App. Br. 7). Since we agree with the Examiner that the “flexible”
layer may overlay either the core or the first layer, layer 176 satisfies this
limitation since layer 176 is clearly shown by Thome to overlay the core.
We also are not convinced by Appellants’ argument regarding claims
26 and 27 that “multi-layered strands 182 are described in Thome . . . as the
proximal most portion of guide wire 36 . . . Increased pushability and
torqueability are usually associated with components located at the
proximal, not the distal portion of a guide wire” (App. Br. 8).
In analyzing the meanings of the claim terms “proximal” and “distal,”
we begin by reviewing the language of claims 26 and 27, which simply
require “a proximal section and distal section” (Claim 26). Claims 26 and 27
do not identify or require a particular end of the elongate member to function
as the proximal end or as the distal end. Consequently, the Examiner
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reasonably interprets the strands 182 as placed at the distal end, satisfying
the requirements of claims 26 and 27 (FF 10-11).
Appellants point to no limitation in claim 26 and 27 which imposes a
requirement or identifies which end of the elongate member is the “proximal
end” and which is the “distal end.” Here, we decline to read an orientation
limitation regarding distal and proximal into claims 26 and 27 that is not
currently required by the plain language of the claim. “[L]imitations are not
to be read into the claims from the specification.” In re Van Geuns, 988 F.2d
1181, 1184 (Fed. Cir. 1993) (citing In re Zletz, 893 F.2d 319, 321 (Fed. Cir.
1989)).
Claims 20 and 21
Appellants contend that “the cited art does not teach the subject matter
recited in at least dependent claims 20 and 21 which require a second layer
disposed at least in part about the first layer (formed form superelastic
material), the second layer formed from material similar to the core element
material” (App. Br. 7).
For the reasons given in analyzing claim 1, we agree with Appellants
that Thome and Fagan do not teach a “second layer” as required by claims
20 and 21.
Conclusions of Law
(i) The Examiner erred in finding that Thome and Fagan teach “a
second layer concentrically arranged about the layer formed of the
superelastic material” as required by claims 1, 20, and 21?
(ii) The Examiner did not err in finding that Thome and Fagan teach a
“composite elongate core including an inner core formed of a precipitation
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hardened material concentrically surrounded by a first layer formed of a
superelastic material and having a proximal section and distal section” as
required by claim 8.
SUMMARY
In summary, we reverse the rejection of claims 1-7, 9-12, 20, 21, and
29 under 35 U.S.C. § 103(a) as obvious over Thome and Fagan.
We affirm rejection of claims 8, 26, and 27 under 35 U.S.C. § 103(a)
as obvious over Thome and Fagan. Pursuant to 37 C.F.R. §
41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 13-15, 17, 19,
and 22-25 as these claims were not argued separately.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).

AFFIRMED-IN-PART

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