Ex Parte Latini

Board of Patent Appeals and Interferences

Jan 31, 2008

10406647 (B.P.A.I. Jan. 31, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte LUCAS LATINI
____________

Appeal 2007-4167
Application 10/406,647
Technology Center 3700
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Decided: January 30, 2008
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Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, FRANCISCO
C. PRATS, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal from the final rejection of claims 1-6, 8,
9, and 11-15. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

Appeal 2007-4167
Application 10/406,647

STATEMENT OF THE CASE
The claims are directed to microcatheter having a tip relief region
with spiral cuts in its distal end. Claims 1-6, 8, 9, and 11-15 are pending
(Appeal Br. 1). Appellant appeals the following rejections:
1) claims 1-4, 6, 8, 9, and 11-15 as obvious under 35 U.S.C. § 103(a)
over Jones (U.S. Pat. No. 5,843,050, Dec. 1, 1998) (Answer 3); and
2) claims 1-6, 8, 9, and 11-15 as obvious under 35 U.S.C. § 103(a)
over Okajima (U.S. Pat. No. 5,554,139, Sep. 10, 1996) in view of Griffin
(U.S. Pat. No. 6,652,508 B2, Nov. 25, 2003) (Answer 3-4).
We select the following claims as representative of the appealed
rejections:
1. A microcatheter having an elongate tubular body, a distal
portion, a proximal portion, and a tip relief region within the
distal end portion, wherein the tip relief region comprises one
or more spiral cuts having a progressive pitch towards the distal
end of the tip relief region, and wherein the pitch is between
about 30 and 60 C/mm at the distal end of the tip relief region.

8. The microcatheter of claim 1, wherein the pitch of the one or
more spiral cuts on the tip relief region ranges between about
0.05 and 60 C/mm.

9. The microcatheter of claim 1, wherein the pitch is between
about 0.05 and 0.10 C/mm at the proximal end of the tip relief
region.

12. The microcatheter of claim 1, wherein the tip relief region
is coated.

13. The microcatheter of claim 12, wherein the tip relief region
is coated by shrink wrapping.

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14. A coaxial dual lumen microcatheter assembly formed by
inserting the microcatheter of claim 1 coaxially within a second
catheter.

15. The microcatheter of claim 1, having a size below about
1.5 Fr.

ISSUE ON APPEAL
The Jones, Okajima, and Griffin patents are cited by the Examiner for
teaching microcatheters. These catheters differ from the claimed invention
in the dimensions of the pitch of spiral cuts in the catheter’s tip relief region
and in the catheter diameter. The issue in this appeal is whether the claimed
dimensional limitations distinguish the claimed invention over the prior art.

OBVIOUSNESS OVER JONES
Findings of Fact
Scope and contents of the prior art
1. Jones describes “a microcatheter for negotiating small tortuous vessels”
(Jones, at col. 2, ll. 34-36).
2. The microcatheter has a distal section 32 of a tubular element 30 which is
provided with a spiral cut to modify the flexibility of the catheter (Jones, at
col. 5, ll. 19-21; at col. 6, l. 53 to col. 7, l. 2; Fig. 3; Answer 3). Thus,
persons of skill in the art would have known from Jones that varying pitch
adjusts the catheter’s flexibility.
3. “The spiral cut generally has a pitch within the range of from about 0.01
inches to about 0.125 inches” (Jones, at col. 5, ll. 25-27).
4. In one embodiment, “the distal section 32 comprises a first spiral cut
section having . . . a pitch of about 0.06, and a second, distal section having
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. . . a pitch of about 0.030” (Jones, at col. 5, ll. 28-32).
5. “The precise pitch of the spiral cut and axial spacing of adjacent windings
can be varied widely while still accomplishing the purposes . . . , and can be
optimized for any particular application” (Jones, at col. 5, ll. 35-40).
6. Jones does not state that the disclosed pitch is critical to achieve the
desired flexibility.
7. The pitch can be of continuous or variable spirals, or multizone spiral
sections in which each zone has a unique pitch (Jones, at col. 7, ll. 35-41;
Answer 3).
8. The microcatheter “will generally have an outside diameter within the
range of from about 0.5 mm to about 1.5 mm” (Jones, at col. 3, ll. 60-62)
which corresponds to 1.5 to 4.5 Fr (Appeal Br. 4).
9. “Other dimensions than these disclosed above and recited elsewhere
herein can be readily utilized by those of ordinary skill in the art in view of
the disclosure herein to suit particular intended uses of the microcatheter”
(Jones, at col. 3, ll. 64-67).
10. The catheter can have a heat shrinkable outer jacket 42 which is
“exposed to a source of heat to shrink the jacket” around the catheter body
(Jones, at col. 7, ll. 48-53; at col. 6, ll. 35-40; Fig. 3; Answer 3).
11. The outer jacket 42 “preferably extends beyond the distal end of the …
tubular element 30” (Jones, at col. 6, ll. 40-45; Fig. 3).
12. The microcatheter can have a balloon catheter placed around it (Jones,
at col. 12, ll. 23-42; Fig. 14).

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Differences between the prior art and the claimed invention
13. Jones describes a microcatheter having a tubular body 30, meeting the
limitation of “an elongate tubular body” as recited in claim 1 (FF 1-2; Jones
at col. 2. ll. 34-36; Jones, at col. 5, ll. 19-21; Fig. 3).
14. The distal section 32 of Jones’s microcatheter – which corresponds to
the “tip relief region” of the microcatheter of claim 1 – has spiral cuts (FF 2;
Jones, at col. 5, ll. 19-21; at col. 6, l. 53 to col. 7, l. 2; Fig. 3; Answer 3) as
does the microcatheter of claim 1.
15. Jones states that its distal section can be continuous or variable (FF 7;
Jones, at col. 7, ll. 35-41) – and thus teaches a “progressive pitch” as recited
in claim 1.
16. The pitch of the cuts in Jones’s microcatheter is “generally . . . from
about 0.01 inches to about 0.125 inches” (FF 3; Jones, at col. 5, ll. 25-27)
which corresponds to about 0.254-3.175 mm per cut (Appeal Br. 4).
17. Claim 1’s microcatheter has a pitch “between about 30 and 60 C/mm at
the distal end of the tip relief region” which corresponds to 0.017-0.333 mm
per cut (Appeal Br. 3-4).
18. Thus, Jones does not describe a catheter having a pitch at its distal end
of 0.017-0.333 mm per cut as required by claim 1 (FF 17; Appeal Br. 4), but
its disclosed pitch of from about 0.254-3.175 mm per cut (FF 16; Appeal Br.
4) overlaps with the claimed pitch.
19. Claim 8’s microcatheter has a pitch at its tip relief region which “ranges
between about 0.05 and 60 C/mm” which corresponds to 0.017-20 mm per
cut (Appeal Br. 4).
20. Jones does not describe a catheter having a pitch at its distal end of
0.017-20 mm per cut as required by claim 1 (FF 17; Appeal Br. 4), but its
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disclosed pitch of from about 0.254-3.175 mm per cut (FF 19; Appeal Br. 4)
overlaps with the claimed pitch.
21. Claim 9’s microcatheter has a pitch of claim 1 at its distal end and a
pitch “between about 0.05 and 0.10 C/mm at the proximal end of the tip
relief region” which corresponds to 10-20 mm per cut (Appeal Br. 4).
22. Jones does not describe a catheter with a pitch at its proximal end of 10-
20 mm per cut (FF 21) as required by claim 9.
23. Jones describes a microcatheter which is coated by shrink wrapping as
recited in claims 12 and 13 (FF 10; Jones, at col. 7, ll. 48-53; at col. 6, ll. 35-
40; Answer 3).
24. Jones describes a balloon catheter around a microcatheter (FF 12; Jones,
at col. 12, ll. 23-42; Fig. 14), meeting the limitations of claim 14 of a coaxial
dual lumen catheter.
25. Jones describes a microcatheter having a diameter of about 1.5 to 4.5 Fr
(FF 8; Appeal Br. 4), but not “having a size below about 1.5 Fr” as in the
microcatheter of claim 15.
Level of ordinary skill in the art
26. Persons of ordinary skill in the art knew to optimize the pitch and
diameter of Jones’s microcatheter to make it suitable for its particular
intended use (FF 5, 9; Jones, at col. 5, ll. 35-40; at col. 3, ll. 64-67).
Reason to modify the prior art
27. Persons of ordinary skill in the art would have been prompted to modify
the dimensions of Jones’s microcatheter to fit into a vessel of smaller size
than could be reached with Jones’s microcatheter and to achieve a different
flexibility to optimize it for this particular intended use (see Answer 3; FF
24).
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Analysis
In making an obvious determination, the Examiner must first identify
the scope and contents of the prior art and then ascertain the differences
between the prior art and the claimed invention. Graham v. John Deere Co.,
383 U.S. 1, 17 (1966). The next step is to identify a reason why persons of
skill in the art would have been prompted to combine the prior art to have
made the claimed invention. KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727,
1741 (2007).
In this case, Jones describes a microcatheter which meets all elements
of claim 1 (and dependent claims 8 and 9) (FF 13-15), but not the
specifically recited pitch of the spiral cuts at its distal end (see FF 16-20).
However, Jones teaches that the pitch of the spiral cuts modifies the
flexibility of the microcatheter (FF 2; Jones, at col. 5, ll. 19-21; col. 6, l. 53
to col. 7, l. 2). Jones also teaches that the “precise pitch of the spiral cut and
axial spacing of adjacent windings can be varied widely while still
accomplishing the purposes . . . , and can be optimized for any particular
application” (FF 5; Jones, at col. 5, ll. 35-40). Thus, we agree with the
Examiner that persons of ordinary skill in the art would have been prompted
to modify the pitch of Jones’s catheter to vary the microcatheter’s flexibility
(FF 25). Making such modifications to the pitch of Jones’s microcatheter
would have been within the ordinary level of skill in the art (FF 24).
With respect to claims 1 and 8 which are directed to pitch ranges that
overlap with the pitch of Jones (FF 18, 20), it is well-established that even a
slight overlap in ranges establishes prima facie obviousness. In re Peterson,
315 F.3d 1325, 1329 (Fed. Cir. 2003). In such cases, it must be shown “that
the particular range is critical, generally by showing that the claimed range
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achieves unexpected results relative to the prior art range.” In re Woodruff,
919 F.2d 1575, 1578 (Fed. Cir. 1990). Appellant has not provided rebuttal
evidence of unexpected results.
While Jones does not specifically describe a range that overlaps with
the pitch of claim 9 at the proximal end (FF 21), Jones does not limit the
pitch to those which are disclosed (the “spiral cut generally has a pitch” (FF
3; Jones, at col. 5, ll. 25-27)) nor does it state that these ranges are critical
(FF 6). To the contrary, Jones states that the pitch can be “varied widely
while still accomplishing” its purpose to confer flexibility on the catheter
(FF 5; Jones, at col. 5, ll. 35-40). Thus, while the claimed range differs from
the range disclosed in Jones, it is reasonably suggested by Jones’s
acknowledgement that pitch can be “varied widely.”
Jones’s microcatheter has a diameter of about 1.5 to 4.5 Fr (FF 7;
Appeal Br. 4), but not “below about 1.5 Fr” as in the microcatheter of claim
15 (FF 25). However, persons of skill would have been motivated to reduce
the catheter diameter to accommodate vessels of smaller size (FF 27) – a
modification within the scope of ordinary skill in the art (FF 26).
In sum, we conclude that Examiner has provided sufficient evidence
to establish that the claims are prima facie obvious over Jones. Once prima
facie obviousness has been established, it is Appellant’s burden to provide
rebuttal evidence or arguments. Hyatt v. Dudas, 492 F.3d 1365, 1369-70
(Fed. Cir. 2007).
Appellant argues that “there is no suggestion in Jones to modify the
pitch to this extent . . . . Jones does say the pitch can be varied – but that
should be interpreted to be within the range of pitches taught by Jones – 0.01
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to 0.125 inches” (Appeal Br. 4). We are not persuaded by Appellant’s
argument that the Examiner erred.
Firstly, as discussed above, Jones states that the pitch can be “varied
widely” (FF 5; Jones, at col. 5, ll. 35-40), and varies it (FF 7; Jones, at col. 7,
ll. 35-41), providing a reason to go outside the specifically disclosed range.
Secondly, absent unexpected results, we do not agree that the claimed
dimensional limitations are sufficient to distinguish over the prior art. In
Gardner v. TEC Systems, Inc., 725 F.2d 1338 (Fed. Cir. 1984), cert. denied,
469 U.S. 830 (1984), the patentability of a device for drying ink was at
issue. The differences between the prior art and the claimed invention were,
inter alia, the distance between a suppression plate and a web, the nozzle
slot width, and the width of the suppression plate. Gardner, 725 F.2d at
1345-46. The court held that such “dimensional limitations” did not
distinguish the claimed invention over the prior art because they did not
cause the device to perform any differently than the prior art device.
Gardner, 725 F.2d at 1399.
Here, Appellant attempts to distinguish the claimed invention over the
same type of dimensional limitation that the court in Gardner found
inadequate by itself to establish a basis for patentability. Persons of skill in
the art would have known from Jones that varying pitch adjusts the
catheter’s flexibility (FF 2). There is no evidence that the claimed range of
pitch does anything more than adjust the catheter’s flexibility as expected.
Because Appellant has not shown that a microcatheter with the recited
dimensions performs any differently than the prior art microcatheter, we
conclude – based on the legal principles enunciated in Gardner – that claims
1, 8, and 9 are not patentably distinct from the cited prior art.
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With regard to claim 15, Appellant argues that Jones does not suggest
a microcatheter having a size less than about 1.5 Fr and that such catheter
“would perform different from one above 1.5 Fr – for the simple reason that
it can access smaller vessels” (Appeal Br. 4).
This argument is not persuasive. Jones explicitly suggests using
dimensions other than those disclosed “to suit particular intended uses of the
microcatheter” (FF 9; Jones, at col. 3, ll. 64-67). This reasonably suggests
other diameters than those disclosed by Jones when the intended use would
so demand it. A smaller diameter catheter performs the same way as any
catheter – by having a size “for negotiating small tortuous vessels” (FF 1;
Jones, at col. 2, ll. 34-36). Thus, we conclude that the diameter size of the
microcatheter does not distinguish the claimed invention over the prior art –
for similar reasons set forth above for the spiral cut.
Appellant also contends that Jones “does not teach that the spiral cut
region specifically is coated” (Appeal Br. 5) as recited in claims 12 and 13.
We do not agree. Jones states that the outer jacket 42 – which can be heat
shrunk around the catheter body (FF 10; Jones, at col. 7, ll. 48-53; at col. 6,
ll. 35-40; Fig. 3; Answer 3) – extends beyond the distal end of the catheter
and shows it extending past the spiral cut region (FF 11; Jones, at col. 6, ll.
40-45; Fig. 3).
For the foregoing reasons, we affirm the rejections of claims 1, 8, 9,
and 12-15. Claims 2-4, 6, and 11 were not argued separately and therefore
fall with the other claims. See 37 C.F.R. § 41.37(c)(1)(vii).
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OBVIOUSNESS OVER OKAJIMA IN VIEW OF GRIFFIN
Scope and contents of the prior art
28. Okajima describes an intravascular catheter (Okajima, at col. 1, ll. 5-10)
which has spiral shaped slits that decrease gradually in the direction toward
the distal tip portion to gradually reduce the rigidity of the metal to prevent it
from kinking (Okajima, at col. 16, ll. 40-49; Answer 4).
29. The slits may change pitch continuously or step-wise (Okajima, at col.
7, ll. 35-37).
30. The distal region has the largest flexibility (Okajima, Abstract).
31. Griffin describes a catheter having helical or spiral slots 22 that are cut
with a pitch which varies linearly from proximal to distal to gradually reduce
the tube stiffness (Griffin, at col. 2, ll. 29-39; Fig. 2).
32. The slot can have a width of about 0.0002 inches or more and a pitch
that gradually reduces from about 0.10 inches to about 0.0001 inches
(Griffin, at col. 2, ll. 39-45).
33. “Those skilled in the art will recognize that the voids 22 may comprise a
variety of geometries” (Griffin, at col. 2, ll. 49-51).
34. The flexibility of the distal portion allows it “to navigate through
tortuous vasculature to remove vascular sites” (Griffin, at col. 1, ll. 32-34).
35. Neither Okajima nor Griffin describes the pitch as critical to achieve the
purpose of the disclosed catheter (see FF 33).
Differences between the prior art and the claimed invention
36. Okajima and Griffin describe a microcatheter with a progressive pitch
(FF 28-32) as recited in claim 1, but do not describe a microcatheter with a
spiral cut having a pitch “between about 30 and 60 C/mm at the distal end of
the tip relief region” as required by claim 1 (Appeal Br. 6).
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Level of ordinary skill in the art
37. Okajima does not describe the particular pitch size necessary to achieve
the desired flexibility, indicating that it was within the scope of ordinary
skill in the art to make such a determination. See also FF 33, for Griffin’s
teaching that the geometry of the catheter can be varied.
Reason to modify the prior art
38. Persons of ordinary skill in the art would have had reason to change the
pitch of the spiral cuts in the distal end of the catheter to modify its
flexibility to navigate remote vascular sites (see FF 34).

Analysis
In making an obvious determination, the Examiner must first identify
the scope and contents of the prior art and then ascertain the differences
between the prior art and the claimed invention. Graham, 383 U.S. at 17.
Here, Appellant acknowledges that the difference between the prior
art and the claimed invention is that the prior art catheters do not disclose a
microcatheter with a spiral cut having a pitch “between about 30 and 60
C/mm at the distal end of the tip relief region” as required by claim 11 (FF
34; Appeal Br. 6). Appellant contends that this difference in pitch makes the
claimed invention patentable over the prior art (Appeal Br. 6). We do not
agree.

1 Appellant also takes the position that the Griffin’s use of the term “pitch”
does not correspond to “pitch” as defined in the Specification and as
instantly claimed (Appeal Br. 5). The Examiner does not respond to
Appellant’s argument and thus we accept Appellant’s position as correct.

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Appellant is distinguishing the claimed invention over the same type
of dimensional limitation that the court in Gardner (see supra at p. 9) found
inadequate by itself to establish a basis for patentability. Neither Okajima
nor Griffin describes the pitch of the spiral cut as critical to achieve the
purpose of the disclosed catheter (FF 35). Modifying the spiral cut was
within the scope of ordinary skill in the art (FF 37) and there was reason to
do it – to change its flexibility (FF 38). Thus, because Appellant has not
shown that a microcatheter with the recited dimensions performs any
differently than the prior art microcatheter, we conclude – based on the legal
principles in Gardner – that claim 1 is not patentably distinct from the cited
prior art.
For the foregoing reasons, we affirm the rejection of claim 1. Claims
2-6, 8, 9, and 11-15 fall with claim 1 because separate reasons for their
patentability were not provided. See 37 C.F.R. § 41.37(c)(1)(vii).

CONCLUSION
We affirm the rejections of claims 1-4, 6, 8, 9, and 11-15 as obvious
under 35 U.S.C. § 103(a) over Jones; and claims 1-6, 8, 9, and 11-15 as
obvious over Okajima in view of Griffin.

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

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LAW OFFICE OF COLLEN A. BEARD, LLC
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