Ex Parte Stevens

Board of Patent Appeals and Interferences

Jan 15, 2009

10075053 (B.P.A.I. Jan. 15, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte ROBERT C. STEVENS
____________

Appeal 2008-4426
Application 10/075,053
Technology Center 3700
____________

Decided: January 15, 2009
____________

Before ERIC GRIMES, LORA M. GREEN, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal from the Examiner’s final rejection of
claims 1, 3-11, 24, 26-28, 41, 43-61, and 63-65. Jurisdiction is under 35
U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The claims are drawn to a reinforced catheter having a continuous coil
reinforcement member carried on an elongate flexible tube. A first flexible
Appeal 2008-4426
Application 10/075,053

2
outer coating covers the coil reinforcement member. A second flexible
coating covers the first coating at the proximal end, but not the distal end, of
the catheter. The first coating is softer than the second coating, providing a
soft distal tip to the catheter.
Claims 1, 3-11, 24, 26-28, 41, 43-61, and 63-65 stand rejected by the
Examiner as follows:
1. Claims 1, 3, 6-11, 24, 26-28, 41, 43, 46-53, 56-61, and 63-65 under
35 U.S.C. § 103(a) as obvious in view of Nita (US 5,951,539, Sep. 14, 1999)
(Ans. 3).
2. Claims 1, 3, 6-11, 24, 26-28, 41, 43, 46-53, 56-61, and 63-65 under
35 U.S.C. § 103(a) as obvious in view of Nita and Landuyt (US
2003/0109851, Jun. 12, 2003) (Ans. 7).
3. Claims 4, 5, 44, 45, 54, and 55 under 35 U.S.C. § 103(a) as
obvious in view of Nita and Follmer (US 5,728,065, Mar. 17, 1998) (Ans.
11).
4. Claims 4, 5, 44, 45, 54, and 55 under 35 U.S.C. § 103(a) as
obvious in view of Nita, Landuyt, and Follmer (Ans. 12).
Claim 1 is representative of the appealed subject matter and reads as
follows:
1. A reinforced catheter comprising:
an elongate flexible tubular member defining a lumen of
the catheter, the tubular member having a first end defining a
proximal end of the catheter and a second end defining a distal
end of the catheter;
a continuous coil reinforcement member carried on the
elongate flexible tubular member and extending from the
proximal end of the catheter and terminating at the second end
of the tubular member;
Appeal 2008-4426
Application 10/075,053

3
a first flexible outer coating covering the coil
reinforcement member and the tubular member substantially
entirely between the proximal end of the catheter and the distal
end of the catheter; and,
a second flexible outer coating covering a first portion of
the first outer coating between a first transition area of the
catheter and said proximal end of the catheter, a second portion
of the first outer coating between said first transition area and
said distal end of the catheter being uncovered by said second
outer coating and defining a flexible distal tip of said catheter,
the first coating being softer than said second coating.

1. OBVIOUSNESS OVER NITA
Claims 1, 3, 6-11, 24, 26-28, 41, 43, 46-53, 56-61, and 63-65 stand
rejected under 35 U.S.C. § 103(a) as obvious in view of Nita (Ans. 3).
Issue
The principal issues in this rejection are as follows:
Does Nita describe a catheter comprising a continuous coil
reinforcement member carried on a tubular member in which the
reinforcement member is “extending” from the first proximal “end” to the
second distal “end” of the tubular member as in claim 1?
Does Nita describe a catheter comprising a first and second outer
coating in which the first coating covers the catheter’s distal end and is
“softer than said second coating” as recited in claim 1?

Findings of Fact (FF)
The Nita patent
1. Nita describes a catheter having two or more spirally wound
reinforcement ribbons or wires (Nita, at col. 7, ll. 42-43).
Appeal 2008-4426
Application 10/075,053

4
2. Appellant does not dispute the Examiner’s findings that Nita’s reinforced
catheter comprises an elongate flexible tubular member around which are
wound reinforcement ribbons, a first flexible outer coating, and a second
flexible outer coating as in claim 1.
3. Fig. 5 of Nita, as reproduced below, shows a catheter with wound coils
307 and 309 (depicted in cross-section as broken lines) (Nita, at col. 15, ll.
1-5).

Fig. 5 is said to show “a variation of the inventive catheter with an
additional helically wound coil located proximally” (Nita, at col. 8, ll. 23-
24).
4. Nita states that a “small ‘nose’ or distal tip (311) of polymer remains
distal of the distal-most extension of the coil windings” (Nita, at col. 15, ll.
5-7).
5. Nita also states that “[u]se of layers of coil in excess of the preferred dual
layer distal-to-proximal layers is a feature independent of the presence or
absence of other features, e.g., the distal nose tip section (311), shown in this
Figure [5] or in others” (Nita, at col. 15, ll. 7-11).
6. Fig. 9 of Nita, as reproduced below, “shows a distal portion (520) of the
inventive catheter in which both helically wound coils (522, 524) extend
distally to a tip or bumper (526)” (Nita, at col. 15, ll. 53-55).
Appeal 2008-4426
Application 10/075,053

5

Fig. 9 is said to show “in cross-section, a highly preferred variation of
the distal tip of the inventive catheter” (Nita, at col. 8, ll. 30-31).
7. Nita states that “[f]or the purposes of describing this invention, a short
bumper tip (526) is considered to have a negligible effect on the operation of
the catheter assembly (other than to protect the intima of the arteries from
damage by the coil members)” (Nita, at col. 15, ll. 61-65).
8. Nita also states:
When we note that a coil extends to the distal end of the
catheter, we intend such a statement nevertheless to include the
presence of such a bumper tip (526). It is specifically noted
that, however, the short distal tip (526) shown in FIG. 9 is not
the same structural feature as is the comparatively lengthy
most-distal section (502) in FIG. 5 [sic, FIG. 8] which, in
practice, may be 2.5 cm. or longer. Indeed, the bumper tip (526)
may be used in conjunction with most-distal section (502).
(Nita, at col. 15, l. 65 to col. 16, l. 6).
9. In Example 1, Nita describes construction of “an intravascular catheter
using the concepts of [its] invention” (Nita, at col. 19, ll. 3-4). The catheter
is described as having a coiled reinforcing member attached to both ends of
the catheter tubular member:
10. Nita states that the “reinforcing member . . . was secured to the distal
end [of the tubing member] using a platinum band” (Nita, at col. 19, ll. 13-
15) (emphasis added).
Appeal 2008-4426
Application 10/075,053

6
11. “The assembly was rotated in the coil-winder to wind the ribbon from
the distal end to the proximal end. At the proximal end, the direction of the
ribbon wind was changed so that the ribbon was being wound towards the
distal end. The ribbon was wound to the end of the catheter so that a double
layer of ribbon was found from distal end to proximal end” (Nita, at col. 19,
ll. 16-23) (emphases added).
12. Nita does not describe a nose or bumper tip at the end of the
intravascular catheter of Example 1.
13. In Example 2, Nita describes construction of intravascular catheters with
two coils (Nita, at col. 19, ll. 35-39).
14. Nita states that “two ribbons on the inventive catheter (one wound
clockwise and one wound counterclockwise) extended from the proximal
end to the distal end” (Nita, at col. 19, ll. 48-51).
15. Nita expressly states that “[a] short bumper tip without coil was left on
each distal end” (Nita, at col. 19, ll. 54-55).
16. Nita teaches that the distal catheter end must be flexible to allow the
tip’s passage through blood vessels (Nita, at col. 2, ll. 10-14) and describes a
prior art tip which is “’flexible, soft, and floppy’” (id. at col. 5, ll. 43-45).
Nita’s own catheter is said to have a distal section which “is flexible and soft
to allow deep penetration . . . without trauma (id. at col. 9, ll. 59-61). Nita
also states that the “distal-most section” of the covering “is typically the
softest and most flexible” (id. at col. 12, ll. 48-49; see Fig. 2F, 212).
17. Figure 3D of Nita shows a catheter with “four regions of polymer outer
covering (240, 242, 244, and 246)” (Nita, at col. 14, ll. 37-38). The most
proximal portion 240 is comprised of a material which is “most preferably
Appeal 2008-4426
Application 10/075,053

7
. . . having a durometer value between 65D and 80D, most preferably 72D”
(id. at col. 14, ll. 43-44). “Finally, segment (246) is located at the most
distal end of the catheter and . . . is most flexible, preferably of a material
having a durometer value between 20D and 40D, most preferably 25D” (id.
at col. 14, ll. 51-55).
Analysis
Independent claims 1, 24, 41, 52, 61, and 65 are directed to catheters
that carry a coil reinforcement member extending from the proximal end to
the distal end of a tubular member. Although the wording in the
independent claims varies, Appellant appears to interpret each of the claims
to require that the coil member extends and terminates at the ends of the
tubular member (Reply Br. 4). Appellant contends that Nita does not meet
this limitation. Appellant states:
Rather, the coil reinforcement member as disclosed in Nita is
carried in the catheter along the length thereof. It extends to a
point near the distal end of the catheter but not to a point fully
at the distal end. Essentially, in each of the embodiments of the
catheter taught in Nita, some amount of catheter body not
containing the coil reinforcement member is present at the tip
area.
(Reply Br. 4).
Appellant argues that Nita specifically states that “[w]hen we note that
a coil extends to the distal end of the catheter, we intend such a statement
nevertheless to include the presence of such a bumper tip” (FF8). Thus,
Appellant asserts that “the presence of a bumper tip is specifically included
in each of the embodiments of the catheters described in Nita” (App. Br. 16;
see also FF3-9; Nita, 311 of Fig. 5 and 526 of Fig. 9).
Appeal 2008-4426
Application 10/075,053

8
The Examiner contends that Nita teaches embodiments in which the
coil extends from the proximal to the distal end (Ans. 3-5; 15). In reaching
this conclusion, the Examiner relies on the statement by Nita that the use of
coils “in excess of the preferred dual layer distal-to-proximal layers is a
feature independent of the presence or absence of other features, e.g., the
distal nose tip section (311), shown in this Figure [5] or in others” (Nita, at
col. 15, ll. 7-11; FF5). The Examiner asserts that this sentence establishes
that the distal nose tip section is an optional feature that may be present or
absent from Nita’s catheter. When absent, the Examiner contends that
Nita’s catheter would meet the claimed limitation of a reinforcement
member “extending” from the first proximal “end” to the second distal “end”
of the tubular member.
The Examiner has the better argument. Consistent with the
Examiner’s interpretation of Nita to refer to the distal nose section as
optional (Ans. 15), Example 1 describes a catheter in which “a double layer
of ribbon was found from distal end to proximal end” (Nita, at col. 19, ll. 21-
23; FF11). Nita does not describe a nose or bumper tip at the end of the
intravascular catheter of Example 1 (FF12). In contrast, Nita’s Example 2
expressly describes a catheter having a distal bumper tip without coil
(FF15). Thus, the preponderance of the evidence supports the Examiner’s
position that Nita describes a catheter that carries an end-to-end coil
reinforcement member as required by claim 1.
Appellant argues that the portion of Nita at column 15, lines 7-11,
referred to by the Examiner
when properly read in context, means that the use of additional
coil layers is a feature independent of the presence or absence
of other features, e.g., the particular/specific distal nose tip
Appeal 2008-4426
Application 10/075,053

9
section (311), shown in this Figure or the particular/specific
distal nose tip sections shown in other Figures. (emphasis
added). The applicants in Nita wanted to be sure to not restrict
the use of the additional coil layers on catheters of the type
having the distal nose section as shown in Figure 5, but to
extend its use to all of the disclosed catheters, regardless of the
particular distal nose tip section (or any other feature) present.
(Reply Br. 6.) As Example 1 of Nita expressly describes construction of a
catheter which lacks the distal nose section (FF12), we find Appellant’s
interpretation of what Nita intended to say at column 15, lines 7-11,
inconsistent with what the patent as a whole would have taught persons of
ordinary skill in the art.
Appellant also contends that the Nita patent does not teach, suggest,
or fairly disclose a first coating which is softer than a second coating as
recited in claim 1 (App. Br. 20). To the contrary, Nita expressly discloses
that the distal section of its catheter, which would correspond to the first
coating, is typically the softest section covering the catheter (FF16; see also
FF17).
For the foregoing reasons, we affirm the rejection of claim 1.
Appellant makes the same arguments for independent claims 24, 41,
52, 61, and 65 as he did for claim 1. We thus, affirm the rejection of these
claims for same reasons as for claim 1.
Appellant argues that the specific limitations recited in claims 6-11,
27, 28, 46-51, 54-60, 63, and 64 are not described by Nita (App. Br. 21-24,
26, 30-31,and 34-38). However, the Examiner explicitly identified on pages
5-6 of the Answer where such limitations could be found in Nita. We find
no defect in the Examiner’s findings and Appellant does not point to any.
Thus, we affirm these rejections, as well.
Appeal 2008-4426
Application 10/075,053

10

Claims 3, 26, 43, and 53
Claims 3, 26, 43, and 53 specify that the catheter’s first outer coating
has a Shore hardness of about 40D and the second of about 70D. Appellant
argues that
there is no teaching or suggestion in Nita that the layered
structure would benefit in any way by providing layers of
materials, each having a different Shore hardness as suggested
by the Examiner. To the contrary, the problem of providing a
stiff proximal end while having a flexible distal end is solved in
the banded-type construction by providing “a third layer of
ribbon (311)” (col. 15, ln. 2).
(App. Br. 21, 25-26).
This argument is not persuasive. Nita clearly teaches providing distal
and proximal sections of its catheter with coatings that meet the claimed
limitations of about 40D (distal segment 246) and 70D (proximal portion of
“most preferably 72D”) (FF17). Appellant does not challenge the
Examiner’s finding that Nita’s distal and proximal sections correspond to the
first and second covering, respectively (see Ans. 5). Nita provides a clear
reason as to why the distal section should be more flexible and thus have a
lower Shore hardness: to allow deep penetration without trauma to the tissue
(FF16). Thus, contrary to Appellant’s position, Nita does provide a reason
as to why there would be a benefit of using layers with differing hardnesses.
2. NITA AND LANDUYT
Claims 1, 3, 6-11, 24, 26-28, 41, 43, 46-53, 56-61, and 63-65 stand
rejected under 35 U.S.C. § 103(a) as obvious in view of Nita and Landuyt
(Ans. 7).
Appeal 2008-4426
Application 10/075,053

11
The Examiner relies further on Landuyt for its teaching of “a catheter
having a first coating (11) and a second coating (12) covering a first portion
of the first coating between a first transition area of the catheter and the
proximal end of the catheter” (emphasis removed) (Ans. 11). The Examiner
concludes that it
would have been obvious . . . to choose the first coating of Nita
et al to be softer than the second coating as taught by Landuyt
as both Nita et al and Landuyt disclose that it is desirable to
have the proximal portion of the catheter be more stiffer
than the distal portion and Landuyt teach the use of a
harder material for the second coating to achieve the
desired stiffness while still maintaining a softer distal
portion.
(Id.)
Appellant contends that the rejection is improper for the same reason
as for Nita alone (App. Br. 18-19). As we did not find these arguments
persuasive for Nita, and Appellant does not identify any deficiency in the
Examiner’s rejection of the claims over the combination of Nita and
Landuyt, we affirm the rejection for the reasons stated by the Examiner.

3, 4. NITA, FOLLMER, AND LANDUYT
Claims 4, 5, 44, 45, 54, and 55 stand rejected under 35 U.S.C. §
103(a) as obvious in view of Nita and Follmer (Ans. 11).
Claims 4, 5, 44, 45, 54, and 55 stand rejected under 35 U.S.C.
§ 103(a) as obvious in view of Nita, Landuyt, and Follmer (Ans. 12).
Claim 4 is directed to the reinforced catheter of claim 1 further
comprising “a marker band disposed adjacent the distal end of the catheter
on the first flexible outer coating.” Claim 5 is drawn to the “reinforced
Appeal 2008-4426
Application 10/075,053

12
catheter according to claim 4, wherein the marker band is formed of a one of
gold material and platinum material.”
The Examiner states that, in view of the teachings of Nita and
Follmer, it “would have been obvious to . . . place the marker band of Nita et
al on the outer coating as taught by Follmer et al as both Nita et al and
Follmer et al teach that it is desirable to provide catheters with marker bands
and Follmer et al teach that the marker bands can be placed on the outer
coating of the catheter” (Ans. 12-13). We agree with the Examiner’s
reasoning, and as Appellant does not identify any defect in it, we affirm the
rejection of claims 4 and 5 for the reasons stated by the Examiner.
Appellant argues that the specific limitations recited in claims 44, 45,
54, and 55 are not described by Nita or Nita in combination with the cited
references (App. Br. 29-34). However, the Examiner explicitly identified on
pages 5-6 of the Answer where such limitations could be found in Nita. We
find no defect in the Examiner’s findings and Appellant does not point to
any.
CONCLUSION OF LAW
Nita describes a catheter comprising a continuous coil reinforcement
member carried on a tubular member in which the reinforcement member is
“extending” from the first proximal “end” to the second distal “end” of the
tubular member as in claim 1, and independent claims 24, 41, 52, 61, and 65.
Nita also describes a catheter comprising a first and second outer coating in
which the first coating covers the catheter’s distal end and is “softer than”
the second coating as in claim 1, and independent claims 24, 41, 52, 61, and
65. We affirm the rejection of claims 1, 24, 41, 52, 61, and 65 in view of
Nita, alone, and Nita in combination with Landuyt.
Appeal 2008-4426
Application 10/075,053

13
Appellant did not distinguish the specific limitations recited in claims
3, 6-11, 26-28, 43, 46-51, 53-60, 63, and 64 from Nita, alone, or Nita in
combination with Landuyt. We affirm the rejection of these claims.
Appellant also did not distinguish the specific limitations recited in
claims 4, 5, 44, 45, 54, and 55 from Nita and Follmer or Nita, Landuyt, and
Follmer. We affirm the rejection of these claims.

TIME PERIOD
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

LP

TUCKER ELLIS & WEST LLP
1150 HUNTINGTON BUILDING
925 EUCLID AVENUE
CLEVELAND OH 44115-1414