Ex Parte Ye et al

Board of Patent Appeals and Interferences

Apr 1, 2009

09945225 (B.P.A.I. Apr. 1, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte TING TINA YE and GREGORY E. MIRIGIAN
__________

Appeal 2008-6320
Application 09/945,225
Technology Center 3700
__________

Decided:1 April 1, 2009
__________

Before TONI R. SCHEINER, DONALD E. ADAMS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, 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).

Appeal 2008-6320
Application 09/945,225

This is an appeal under 35 U.S.C. § 134 involving a claim to an
intravascular catheter. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.

Statement of the Case
Background
“Intravascular catheters are used in a wide variety of relatively non-
invasive medical procedures” (Spec. 1, ll. 11-12). The Specification teaches
that “[i]n order for the catheter to navigate a patient's tortuous vascular
system, it is desirable that intravascular catheters be very flexible,
particularly near the distal end” (Spec. 2, ll. 2-4).
The Claim
Claims 1-21 are on appeal. Independent claim 1 is representative and
reads as follows:
1. An intravascular catheter, comprising:
an elongate shaft having a proximal end, a distal end,
and a distal tip having a shapable length that is shapeable by
thermoforming techniques, the elongate shaft including:
an inner liner;
a second layer disposed over the inner liner, the
second layer including a first segment and a second
segment, the first segment extending to a distal terminus and
the second segment extending from the distal terminus to a
radiopaque marker band disposed proximal of the distal end
of the shaft, wherein the distal terminus is set back from the
distal end of the shaft a distance equal to or greater than the
shapable length;
a third layer disposed over the second layer; and
a fourth layer disposed over the third layer, the fourth
layer including a proximal end and a distal end.

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Application 09/945,225

The prior art
The Examiner relies on the following prior art references to show
unpatentability:
Nita et al. US Patent 5,951,539 Sep. 14, 1999
Samson et al. US Patent 6,090,099 Jul. 18, 2000

The issues
A. The Examiner rejected claim 1 under 35 U.S.C. § 102(e) as
anticipated by Samson (Final Rej. 2-3).
B. The Examiner rejected claims 1-5, 7-10, 12, and 13 under 35 U.S.C. §
103(a) as being obvious over Samson (Final Rej. 3-4).
C. The Examiner rejected claims 1-21 under 35 U.S.C. § 103(a) as being
obvious over Samson and Nita (Final Rej. 4-5).
A. 35 U.S.C. § 102(e) over Samson
The Examiner found that
Samson . . . discloses a catheter comprising an elongated
shaft, having a proximal end, a distal end and a distal tip,
wherein the shaft includes an inner liner, a second layer
disposed on the inner layer, a third layer disposed on the
second layer and a fourth layer disposed on the third layer
and wherein the first segment extends to a distal terminus
and the second segment extending from the distal terminus
to a radiopaque marker disposed proximal of the distal end
of the shaft.

(Final Rej. 2.)
Appellants contend that the “limitation that the tip is ‘shapable’ means
that it can be shaped, but is not necessarily shaped. This limitation describes
a structural characteristic of the product, not a process step” (App. Br. 9).
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Application 09/945,225

“Appellants do assert that their product differs structurally from the product
of the prior art” (App. Br. 10).
Appellants contend that the “recited claim element of a ‘shapeable
length that is shapeable by thermoforming techniques’ has been expressly
ignored by the Examiner . . . . The phrase clearly does not recite how the
catheter was formed, and is not a product by process recitation. Therefore, a
prima facie position has not been established” (App. Br. 11).
In view of these conflicting positions, we frame the anticipation issue
before us as follows:
Did the Examiner err in finding that the catheter of Samson comprises
a “distal tip having a shapeable length that is shapeable by thermoforming
techniques”?
Findings of Fact (FF)
1. Samson teaches “a catheter section made up, desirably, of an
outer tubing component and at least one inner stiffener component placed
coaxially within that outer tubing component. Between the at least one inner
stiffener component and the outer tubing component is a metallic braided
tubing member” (Samson, col. 4, ll. 33-38).
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Application 09/945,225

2. Samson teaches a catheter of Figure 2 as reproduced below:

Figure 2 shows “fragmentary cross-sections of catheter sections” (Samson,
col. 4, l.l. 65-66).
3. Samson teaches that a “catheter body or section (200) has a pair
of inner tubing stiffener members (202 and 204), an optional lubricious
sheath (206), and the outer polymeric layer (208)” (Samson, col. 5, ll. 59-
61).
4. Samson teaches that the catheter also comprises “a pair of
radio-opaque bands, the proximal band is (210) and the distal band is (212.)”
(Samson, col. 5, ll. 62-63).
5. Samson teaches that the catheter also comprises a “braided
tubing member (214). The inner tubing stiffening members or inner
stiffening tubing sections (202 and 204) desirably are simple sections of
tubing which have been cut to length for placement in the catheter section”
(Samson, col. 5, ll. 65-67).
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Application 09/945,225

6. Samson teaches that a catheter “must be sufficiently flexible at
the distal end to allow passage of the catheter tip through the loops and
increasingly smaller blood vessels” (Samson, col. 1, ll. 40-42).
7. The distal tip of the catheter of Samson shown in Figure 2 is
composed of the lubricious sheath 206 and the stiffener member 202 (FF 2-
3).
8. Samson teaches that the “‘lubricious sheath’ (206) may be of
any of a variety of lubricious polymers, e.g., polytetrafluoroethylene, FEP,
or other fluorocarbon polymers or polysulfones” (Samson, col. 6, ll. 16-20).
9. Samson teaches that the “inner stiffener members sections, or
layers (202 and 204) may be of a wide variety of materials but preferably are
LLDPE or LDPE, perhaps containing a small amount of ethylene vinyl
acetate (EVA)” (Samson, col. 6, ll. 11-15).
10. Figure 2 of the Specification is reproduced below:

“Figure 2 is an enlarged view of a shaft of the intravascular catheter” (Spec.
4, l. 11).
11. The Specification teaches that “[s]haft 12 comprises multiple
layers including an inner liner 24” (Spec. 5, l. 13).
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Application 09/945,225

12. The Specification teaches that “[p]referably, inner liner 24
comprises polytetrafluoroethylene (PTFE) . . . inner liner 24 may comprise
materials including . . . fluorinated ethylene proprylene (FEP) . . .
polysu[l]fone” (Spec. 5, ll. 13-21).
13. The Specification teaches that “fourth layer 44 may be
comprised of materials similar to those disclosed above, including polymers
and metals” (Spec. 8, ll. 5-7). The Specification teaches polymers including
“polyethylene (PE), polypropylene (PP), polyvinylchloride (PVC)” (Spec. 5,
ll. 18-19).
14. The Specification teaches that “[a]t distal end 48, the preferred
material is a low durometer polymer (e.g., PEBAX 2533) to maintain a soft,
atraumatic tip” (Spec. 8, ll. 11-12).
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.
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“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
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).
Analysis
Samson teaches an intravascular catheter with an elongate shaft (FF 1-
2) which includes an inner liner, lubricious sheath 206 (FF 2-3), a second
layer that is set back from the distal end of the shaft which is the inner tube
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stiffening layer 204, (FF 2-3), a third layer comprising a braided tubing
member 214 (FF 5) and a fourth layer comprising stiffening layer 202 which
extends to the distal end of the shaft (FF 2-5). Samson teaches that the distal
tip is flexible and is composed of layers 202 and 206 (FF 6-7).
The dispute centers on whether the distal tip is “shapeable by
thermoforming techniques” (Claim 1). Claim 1 and the Specification do not
require any particular degree of “shapeability” (FF 10-11).
We agree with Appellants that the “shapeable” limitation is not a
product by process limitation (App. Br. 8).
We agree with Appellants that the “word ‘shapeable’ should be
understood as meaning ‘capable of being shaped’. Thus, it is a material
property of a portion of the recited device” (Reply Br. 4).
However, the catheter of Samson is structurally identical to the
catheter of claim 1, including all of the claimed layers (FF 2-5, 10).
Additionally, Samson teaches that the first of the two layers which compose
the distal end, the lubricious sheath 206, can be composed of
polytetrafluoroethylene (FF 8). This is identical to the material identified as
preferred by the Specification for the inner layer (FF 12). Samson teaches
that the second layer of the distal end may be composed of a variety of
materials, including LLDPE or LDPE (FF 9). While the Specification
prefers PEBAX 2533 (FF 14), the Specification states that “fourth layer 44
may be comprised of materials similar to those disclosed above, including
polymers and metals” (Spec. 8, ll. 5-7; FF 13). One of those materials listed
above in the Specification is polyethylene, which is the material taught by
Samson (FF 9, 13).
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Since Samson is structurally identical to Appellants catheter, and may
be composed of virtually identical materials to those disclosed by
Appellants, the only question is whether the distal tip is “shapeable by
thermoforming techniques” (Claim 1).
The Examiner has reasonably established a prima facie case of
unpatentability at least based on inherency, thereby shifting to Appellants
the burden of proving that the distal tip of Samson would not have been
“shapeable.” See In re Best, 562 F.2d 1252, 1255 (CCPA 1977)(“Whether
the rejection is based on ‘inherency’ under 35 U.S.C. § 102, on ‘prima facie
obviousness' under 35 U.S.C. § 103, jointly or alternatively, the burden of
proof is the same, and its fairness is evidenced by the PTO's inability to
manufacture products or to obtain and compare prior art products”) (footnote
omitted). On this record, Appellants have proffered no such proof.
We are not persuaded by Appellants’ argument that regarding the
distal terminus of Samson that “[n]o such sections are included in the
catheter as shown” (Reply Br. 6). In fact, Samson clearly shows a distal
region composed of the inner lubricious layer and the outermost layer which
is distal to the second layer (FF 2). This region is the “shapeable length” of
the Samson catheter.
We agree with Appellants that “a portion of the catheter, and not just
disassembled components” must be shapeable (Reply Br. 7). However, the
region of Samson identified above represents a portion of the catheter and
that portion is reasonably interpreted as inherently satisfying the “shapeable”
limitation since it is composed of the materials identical to those disclosed in
the Specification for the distal tip (FF 8-9, 11-14).
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Conclusion of Law
The Examiner did not err in finding that the catheter of Samson
comprises a “distal tip having a shapeable length that is shapeable by
thermoforming techniques.”
B. 35 U.S.C. § 103(a) over Samson
The Examiner rejected claims 1-5, 7-10, 12, and 13 under 35 U.S.C. §
103(a) as being obvious over Samson (Final Rej. 3-4).
Claims 2, 5, 7-10, 12, and 13 depend from claim 1. As we have
affirmed the rejection of claim 1 over Samson, and Appellants do not
identify how Samson fails to teach the dependent claim limitations, we also
affirm the rejections of these claims as well.
Appellants separately argue claims 3 and 4, but the argument is that
Samson does not teach that “the shape of the distal tip can be heat set . . .[or]
that the shape of the distal tip can be heat set by steam” (App. Br. 11). We
are not convinced by these arguments for the reasons already discussed, that
based upon the evidence of record the distal tip of Samson inherently
satisfies these functional recitations. See 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 . . .Whether the rejection is based on
‘inherency’ under 35 U.S.C. § 102, on ‘prima facie obviousness' under 35
U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its
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fairness is evidenced by the PTO's inability to manufacture products or to
obtain and compare prior art products.”).
C. 35 U.S.C. § 103(a) over Samson and Nita
The Examiner rejected claims 1-21 under 35 U.S.C. § 103(a) as being
obvious over Samson and Nita (Final Rej. 4-5).
As above, claims 2 and 5-13 depend from claim 1. Claims 14 is
argued using the same argument as claim 1, which was addressed above.
Claims 15 and 18-21 depend from claim 14 and are not separately argued.
Appellants rely upon the same argument regarding the “shapeability” of the
distal tip to overcome the obviousness case over Samson and Nita. We note
that Nita teaches and prefers the use of PEBAX in the outer polymeric layer
(Nita, col. 12, l. 63 to col. 13, l. 1).
As we have affirmed the rejection of claim 1 over Samson, and
Appellants do not identify how Samson and Nita fail to teach any other
limitations of independent claim 14 or any of the dependent claim
limitations, we also affirm the rejections of these claims.
As above, Appellants separately argue claims 3, 4, 16, and 17, but the
argument is that “these thermoforming, heat set, and heat set by steam
features are neither disclosed nor suggested in either reference” (App. Br.
13). We are not convinced by these arguments for the reasons already
discussed, that the distal tip of Samson inherently satisfies these functional
recitations. See 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
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necessarily or inherently possess the characteristics of his claimed product . .
.Whether the rejection is based on ‘inherency’ under 35 U.S.C. § 102, on
‘prima facie obviousness' under 35 U.S.C. § 103, jointly or alternatively, the
burden of proof is the same, and its fairness is evidenced by the PTO's
inability to manufacture products or to obtain and compare prior art
products.”).
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C. §
102(e) over Samson. We affirm the rejection of claim 1, 3, and 4 under 35
U.S.C. § 103(a) over Samson. Pursuant to 37 C.F.R. §
41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 2, 5, 7-10, 12,
and 13 as these claims were not argued separately. We affirm the rejection
of claims 1, 3, 4, 14, 16, and 17 under 35 U.S.C. § 103(a) over Samson and
Nita. Pursuant to 37 C.F.R. § 41.37(c)(1)(vii)(2006), we also affirm the
rejection of claims 2, 5-13, 15, and 18-21 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

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