Ex Parte Provost-Tine et al

Board of Patent Appeals and Interferences

Jun 29, 2012

11259004 (B.P.A.I. Jun. 29, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte MICHELLE PROVOST-TINE, LEE CORE, MICHAEL PAPA,
and MICHAEL RIOPEL
____________

Appeal 2010-004908
Application 11/259,004
Technology Center 3700
____________

Before LINDA E. HORNER, MICHAEL C. ASTORINO, and
JOHN W. MORRISON, Administrative Patent Judges.

ASTORINO, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
The Appellants appeal under 35 U.S.C. § 134 from the Examiner’s
decision rejecting claims 1-14. Claims 15-20 have been withdrawn. We
have jurisdiction over the appeal under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
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REJECTIONS
Claim 11 is rejected under 35 U.S.C. § 112, second paragraph, as
indefinite.
Claims 1-9 and 11-14 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Bagaoisan (US 2002/0177800 A1, published Nov. 28,
2002), Mahurkar (US 5,378,230, issued Jan. 3, 1995) and Scribner
(US 6,053,904, issued Apr. 25, 2000).
Claim 10 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Bagaoisan, Mahurkar, Scribner and Gardeski (US 2004/0116848 A1,
published Jun. 17, 2004).

CLAIMED SUBJECT MATTER
Claim 1 is the sole independent claim on appeal, is representative of
the subject matter on appeal, and recites with emphasis added:
1. In combination, an elongate flexible
aspiration catheter for removing emboli or other
particles from a blood vessel and a guiding
catheter, the combination comprising:
an intravascular guiding catheter having
proximal and distal ends and a lumen of circular
cross-section extending between the ends;
a wire-guidable aspiration catheter
comprising an aspiration tube having only one
aspiration lumen, the lumen defined by a tube wall
and fluidly connecting a first fluid port disposed at
the proximal end of the tube and with a second
fluid port disposed at the distal end of the tube, a
reinforcement layer encapsulated within the tube
wall, and a deformed portion of the aspiration tube
having an oval transverse cross-section defining
major and minor axes, that portion of the catheter
that includes the deformed portion of the
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aspiration tube being noncircular in external
cross-section;
the aspiration catheter having a guidewire
tube extending externally of and alongside only the
deformed portion of the aspiration tube and being
secured thereto such that the minor axis extends
transversely through the guidewire tube, the
guidewire tube having a round lumen extending
longitudinally therethrough and being open at the
proximal and distal ends thereof for slidably
receiving a medical guidewire;
the combined deformed portion of the
aspiration tube and guidewire tube having external
dimensions adapted to be slidably received within
and through the circular lumen of the guide
catheter; and
a fitting mounted at the aspiration tube
proximal end in fluid communication with the first
fluid port.

OPINION
Indefiniteness
Claim 11 recites “[t]he aspiration catheter and guide catheter of claim
9 wherein the jacket comprises two or more materials having different
moduli along the catheter.” The Examiner determines “[c]laim 11 recites
both the aspiration catheter and guide catheter and it is confusing as exactly
to which catheter is being referred to when the claim recites ‘... having
different moduli along the catheter’.” Ans. 10; see Ans. 3.
The Appellants correctly contend that “the catheter” as recited in
claim 11 necessarily refers to the aspiration catheter. App. Br. 10. The
catheter of claim 11 is directed to a feature of the jacket as recited in claim 9,
and claim 9 requires that the jacket is part of the aspiration tube wall of the
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aspiration catheter. App. Br. 10-11. As such, “the catheter” of claim 11 has
antecedent basis to the aspiration catheter and is understandable to one of
ordinary skill in the art.
Thus, the rejection of claim 11 under 35 U.S.C. § 112, second
paragraph, as being indefinite is not sustained.

Obviousness
The rejection of claims 1-9 and 11-14 as unpatentable over Bagaoisan,
Mahurkar, and Scribner
The Appellants argue claims 1-9 and 11-14 as a group. App. Br. 7-8.
The Appellants provide additional arguments for claims 4 and 5. We select
claim 1 as the representative claim from the former group, and claim 4 as the
representative claim from the latter group. As such, claims 2, 3, 6-9 and 11-
14 stand or fall with claim 1, and claim 5 stands or falls with claim 4. See
37 C.F.R. § 41.37(c)(1)(vii) (2011).
Claim 1
Claim 1 recites “a deformed portion of the aspiration tube having an
oval transverse cross-section defining major and minor axes, that portion of
the catheter that includes the deformed portion of the aspiration tube being
noncircular in external cross-section.” The Examiner finds that Bagaoisan
discloses an aspiration lumen 434 defined by the interior wall of aspiration
shaft 426 (see Ans. 4; Bagaoisan, para. [0084], Figs. 9, 11A), but does not
specifically disclose a deformed portion of the aspiration tube (Ans. 4). To
cure this deficiency with respect to claim 1, the Examiner finds that
“Mahurkar teaches that oval lumens and circular lumens are equivalent
structures which provide the least flow resistance.” Ans. 4; Mahurkar, col.
2, ll. 29-31 (describing “[t]he present invention provides an efficient circular
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or elliptical flow geometry that offers the least flow resistance.”); see also
App. Br. 5. The Examiner concludes:
It would have been obvious to a person of ordinary
skill in the art at the time the invention was made
to use an oval aspiration lumen in the device of
Bagaoisan et al. because Mahurkar teaches that
circular and oval lumens are art recognized
equivalents and would yield a path of least flow
resistance for the aspirated material. Such would
provide the portion of the catheter with the
deformed portion of the aspiration tube to have a
non-circular external cross-section.
Ans. 5.
The Appellants acknowledge that “the [Examiner’s] rejection relies on
the oval cross-sectional shape of an internal lumen in one embodiment of
Mahurkar”, and asserts that the shape of internal lumen “is irrelevant to the
external configuration of the tube.” App. Br. 7 (emphasis added). The
Appellants contend that their “invention is directed to the oval cross-
sectional shape of the aspiration tube (i.e., its external shape).”
Claim 1, however, does not require the external shape of the
aspiration tube to be oval. See Ans. 8-9. Claim 1 recites “a deformed
portion of the aspiration tube having an oval transverse cross-section
defining major and minor axes.” Emphasis added. The claim does not
specify the portion of the aspiration tube that has an oval cross-section. The
Examiner’s finds that the interior walls of Mahurkar’s catheter that creates
an oval lumen. Ans. 4. The interior walls of the catheter are a portion of the
catheter. Furthermore, the Appellants acknowledge this understanding in the
Appeal Brief at page 9, “[t]he lumens, although defined by the tubes, are not
themselves the tubes”; and, also in claim 9, which recites in part “the
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aspiration tube wall further comprises: a liner having an inner surface
defining the aspiration tube lumen.” Hence, the Examiner correctly
determines that “[b]y using an oval lumen as in Mahurkar in the aspiration
tube of Bagaosian [sic] . . . the aspiration tube would have an interior oval
transverse cross-section.” Ans. 9; contra Reply Br. 1. Furthermore, as for
the recitation of claim 1 specifically directed to the external cross-section
being noncircular, i.e., “that portion of the catheter that includes the
deformed portion of the aspiration tube being noncircular in external cross-
section,” the Examiner determines that Bagaoisan’s aspiration catheter, as
modified by Mahurkar’s teaching of an oval lumen, “would provide the
portion of the catheter with the deformed portion of the aspiration tube to
have a non-circular external cross-section.” Ans. 5. The Appellants further
contend that the exterior cross-section of Mahurkar’s catheter tube is circular
(App. Br. 7); however, since the Examiner only relied upon Mahurkar to
modify the shape of Bagaoisan’s aspiration lumen 434 via the inner wall of
the aspiration tube 426, which does not include the Mahurkar’s tube wall
shape, the Appellants’ contention is not persuasive. Additionally, the
Examiner relies on Bagaoisan’s Figure 11A (Ans. 4) which depicts a
uniform cross-section of aspiration shaft 426. As such, the exterior cross-
section would mirror the shape of the interior lumen. In other words, the
Examiner’s modification of the Bagaoisan’s aspiration lumen 434 being oval
results in the exterior cross section of the aspiration shaft 426 being oval as
well as non-circular.
The Appellants also contend that neither Bagaoisan nor Mahurkar
disclose a deformed portion of the aspiration tube. App. Br. 7. The term
“deformed” in “a wire-guidable aspiration catheter comprising . . . a
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deformed portion of the aspiration tube having an oval transverse cross-
section defining major and minor axes”, as recited in claim 1, defines the
“wire-guidable aspiration catheter” in part in terms of the method or process
by which it is made. SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d
1312, 1315 (Fed. Cir. 2006) (citation omitted) (“A product-by-process claim
is ‘one in which the product is defined at least in part in terms of the method
or process by which it is made.’” .) More particularly, the term “deformed”
is directed to the manufacturing step described in Appellants’ Specification
at paragraph [0042] and shown in step 707 of Figure 7, of “compressing first
tube against second tube to deform first tube into oval shape,” which
specifies the manufacturing step involved in permanently deforming portion
36 of aspiration tube 31. See Spec. paras. [0015], [0039]-[0044], and fig. 6.
“Regardless of how broadly or narrowly one construes a product-by-process
claim, it is clear that such claims are always to a product, not a
process.” See id. at 1317. “Once a product is fully disclosed in the art,
future claims to that same product are precluded, even if that product is
claimed as made by a new process.” Id. at 1315. Thus, “[i]f the product in a
product-by-process claim is the same as or obvious from a product of the
prior art, the claim is unpatentable even though the prior product was made
by a different process.” In re Thorpe, 777 F.2d 695, 697. In other words,
“[t]he patentability of a product does not depend on its method of
production.” SmithKline, 439 F.3d at 1317. In this case, the term
“deformed” is directed to the method of manufacturing the aspiration
catheter’s shape, and construed as a product-by-process limitation. Since the
Examiner modified the shape of Bagaoisan’s lumen via the inner wall of the
aspiration tube 426 to be oval and the exterior of the aspiration tube to be
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non-circular, as discussed above, the step of deforming of the aspiration tube
does not structurally distinguish the product/apparatus claim 1 from the
modified Bagaoisan product. Hence, the Appellants’ contention is not
persuasive.
The Examiner’s rejection of claim 1 also includes the following:
Bagaosian [sic] et al. also does not teach using a
guiding catheter. However, the Appellant has
stated that it is well known in the field of
interventional catheters to use a guiding catheter to
facilitate navigation or exchange devices. Further,
Scribner et al. teach using catheter introducer
sheaths to reduce tissue damage and that it is
beneficial to use a sheath which will accommodate
the inserted member while still minimizing the
outer diameter (Col. 2 lines 21-26). The sheath
provided by Scribner et al. will receive the catheter
of Bagaosian [sic] et al. in a compact and slidable
manner (Col. 5 line 33, Bagaosian [sic] et al.
[0083] line 5, [0084] line 17). It would have been
obvious to a person of ordinary skill in the art at
the time the invention was made to use a guiding
catheter in the device of Bagaosian [sic] et al.
because the Appellant has admitted that it is well
known in the field of interventional catheters to
use a guiding catheter to facilitate navigation or
exchange devices and further Scribner et al. teach
that such are beneficial in reducing tissue damage.
Ans. 5.
To the extent that the Appellants’ provide comments concerning the
Examiner’s combination of Bagaoisan, Mahurkur, and Scribner, starting in
the Appeal Brief at page 7 beginning “[c]laim 1 is directed to the
combination . . .” and ending at the last line of page 8 “. . . for the same
reasons,” the comments do not add further contentions but merely reflect
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and reiterate the unpersuasive contentions discussed above. See App. Br. 7-
8. Furthermore, we note that the Appellants’ objective to downsize a guide
catheter “without adversely affecting the aspiration performance of an
aspiration catheter passable through the guide catheter” (App. Br. 8) is
irrelevant because the Examiner is not relying on that reason as the basis for
the combination with Scribner. See KSR Int’l Inc. v. Teleflex, Inc., 550 U.S.
398, 420 (2007) (holding it was error to limit the obviousness inquiry to the
problem the patentee was trying to solve and that “any need or problem
known in the field of endeavor at the time of invention and addressed by the
patent can provide a reason for combining the elements in the manner
claimed.”)
Claims 4-5
Claim 4 recites, “[t]he aspiration catheter and guide catheter of claim
1, in combination, wherein a dual lumen section of the catheter comprising
the deformed portion of the aspiration tube has a first outside dimension
measured along the major axis of the aspiration lumen cross section and a
second outside dimension measured along the minor axis of the aspiration
lumen cross section, the first outside dimension ranging from about 84% to
about 98% of the second outside dimension.” Emphasis added.
The Examiner determines that using Bagaoisan’s disclosed aspiration
lumen measurements “one can alter the diameter dimensions so as to achieve
the first outside dimension to be 84%-98% of the second outside
dimension.” Ans. 6. The Examiner concludes:
It would have been obvious to a person of ordinary
skill in the art at the time the invention was made
to alter the diameter of the aspiration and guide
lumens in the device of Bagaoisan et al. to have a
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first outside dimension which is 84%-98% of the
second outside dimension because appellant has
not disclosed that that having a first dimension
which is specifically 84%-98% of the second
outside dimension provides advantage or particular
purpose, or whether it solves a stated problem.
Ans. 6 (emphasis added); see also Ans. 9. The Appellants contend that the
Examiner’s reasoning is incorrect because the Examiner’s modification is
directed to the aspiration tube lumen, i.e., the interior oval transverse cross-
section, not the external dimensions aspiration tube. See App. Br. 9, Reply
Br. 1-2. However, the Examiner’s reasoning includes a modification of the
first and second outside dimensions of the deformed portion of the aspiration
tube. Further, the Appellants do not contend that the Examiner’s
modification of the first and second outside dimensions of the deformed
portion of the aspiration tube is unreasonable.
The level of ordinary skill in the art
The Appellants also contend that “[t]he rejections under 35 U.S.C.
§ 103(a) also are improper because they fail to resolve and articulate the
level of ordinary skill in the art that was applied.” App. Br. 11. The
Appellants further contend that “[w]hile applicants do not dispute that the
prior art of record may be some evidence of some level of skill in the art, it
does not necessarily follow that it is evidence of that level of skill that was
applied and on which the conclusion of obviousness is based. . . . Here, the
rejection fails to point out what parts of the prior art of record evidence the
level of skill that was applied in coming to the conclusion of obviousness of
applicants' claims.” App. Br. 11 (emphasis added); see Reply Br. 2.
The Examiner found, as discussed supra, as to the scope and content
of the prior art and differences between the prior art and the claimed
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invention under Graham v. John Deere Co., 383 U.S. 1 (1966). Though the
Examiner did not make a specific finding regarding the level of skill in the
art, the Appellants have not argued that the proposed modification was
beyond the level of skill in the art, and we consider the applied prior art, i.e.,
Bagaoisan, Mahurkar, Scribner, and Gardeski, to be reflective of the level of
skill in the art. See In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995)
(“The person of ordinary skill in the art is a hypothetical person who is
presumed to know the relevant prior art.” (citing Custom Accessories, Inc. v.
Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986)). See also
Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence
of specific findings on the level of skill in the art does not give rise to
reversible error where the prior art itself reflects an appropriate level and a
need for testimony is not shown.” [Internal quotation marks omitted]).
Against this background, the Examiner determined the obviousness of claim
1.1 Ans. 4-5; see also Ans. 10-11. Hence, contrary to Appellants’ assertion,
the Examiner analyzed claim 1 in light of the factual inquires set forth in
Graham.
Thus, the Examiner’s rejection of claims 1-9 and 11-14 as
unpatentable over Bagaoisan, Mahurkar, and Scribner is sustained.

The rejection of claim 10 as unpatentable over Bagaoisan, Mahurkar,
Scribner, and Gardeski
Claim 10 recites “[t]he aspiration catheter and guide catheter of claim
9, in combination, wherein the jacket is absent along the deformed portion
of the aspiration tube such that the guidewire tube is secured directly to the

1 The Appellants presented no evidence of secondary considerations.
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reinforcement layer and the liner.” Emphasis added. The Examiner finds
Gardeski
. . . teaches a catheter with a guidewire lumen (Fig.
2 lumen 26) and a delivery lumen (Fig. 2 lumen
24) in which the guidewire lumen is attached
directly to the liner 44 and the reinforcement layer
28 without the outer jacket 40/42, the jacket is
absent where members 46 and 44 are connected
and overlie one another, the jacket surrounds these
two member [sic] but is absent along their
intersection.
Ans. 8.
The Appellants contend that “Gardeski does not disclose a catheter
with a portion of the jacket being absent. The depiction of FIG. 2 in
Gardeski would be interpreted by one of ordinary skill as a fragmented
portion of a catheter arranged to illustrate the internal structure of the
catheter.” Reply. Br. 2. Gardeski describes that “FIG. 2 is a perspective
view of a section of the catheter body of FIG. 1 illustrating the internally
disposed wire braid overlying the side-by-side aligned deflection lumen and
delivery lumen.” Gardeski, para. [0027]. Additionally, Gardeski’s Figure 2
is based on Figure 1 illustrating a full length catheter wherein outer sheaths
34, 40, and 42 encase tubular wire braid 28 and lumen liners 44 and 46.
Gardeski, para. [0045]; App. Br. 10.
However, Gardeski also discloses that during fabrication “[a] distal
section of the wire braid 28 is typically left exposed to be embedded within
the distal sheath 34” (Gardeski, para. [0062]). As such, during fabrication
Gardeski’s catheter body 12 may have an appearance similar to the depiction
in Figure 2. However, the Examiner’s conclusion of obviousness is not
reflective of this disclosure in Gardeski. See Ans. 8. More importantly, it is
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unclear why the one of ordinary skill in the art would modify the combined
teachings of Bagaoisan, Mahurkar, and Scribner in view of Gardeski’s
catheter body 12 during fabrication.
Thus, the rejection of claim 10 as unpatentable over Bagaoisan,
Mahurkar, Scribner, and Gardeski is not sustained.

DECISION
We AFFIRM the rejections of claims 1-9, and 11-14 under 35 U.S.C.
§ 103(a) as being unpatentable over Bagaoisan, Mahurkar, and Scribner.
We REVERSE the rejection of claim 11 under 35 U.S.C. § 112,
second paragraph, as indefinite, and the rejection of claim 10 under 35
U.S.C. § 103(a) as unpatentable over Bagaoisan, Mahurkar, Scribner and
Gardeski.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED IN PART

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