Ex Parte Chappel

Patent Trial and Appeal Board

Jan 26, 2018

13022749 (P.T.A.B. Jan. 26, 2018)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/022,749 02/08/2011 Shlomit CHAPPEL 92077.092US1 7310
75004 7590 01/30/2018
CADWALADER, WICKERSHAM & TAFT LLP
ONE WORLD FINANCIAL CENTER
NEW YORK, NY 10281
EXAMINER
BOSWORTH, KAMI A
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
01/30/2018 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
DOROTHY. AUTH @ CWT.COM
DOCKETING@CWT.COM
JENNIFER.CHICK@CWT.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SHLOMIT CHAPPEL
Appeal 2016-004415
Application 13/022,749
Technology Center 3700
Before JENNIFER D. BAHR, WILLIAM A. CAPP, and
SEAN P. O’HANLON, Administrative Patent Judges.
BAHR, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Shlomit Chappel (Appellant)1 appeals under 35 U.S.C. § 134(a) from
the Examiner’s decision rejecting claims 1-36. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 The Appeal Brief identifies Medinol Ltd. as the real party in interest.
Appeal Br. 1.
Appeal 2016-004415
Application 13/022,749
THE CLAIMED SUBJECT MATTER
Claim 1, reproduced below, is illustrative of the claimed subject
matter.
1. A flexible and pushable catheter tip, comprising:
a longitudinally flexible tube having a luminal side and a
vessel wall side; and
a spring-like element, said spring-like element co­
extensive with said flexible tube, said spring-like element
located at a position selected from the group consisting of:
inside said flexible tube, and outside said flexible tube;
wherein said spring-like element provides longitudinal
flexibility and pushability to said catheter tip.
REJECTIONS
I. Claims 1-3, 5-10, 18, and 36 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Kline (US 4,044,765, iss. Aug. 30,
1977).
II. Claim 35 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Kline and Maahs (US 6,440,120 Bl, iss. Aug. 27, 2002).
III. Claim 4 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Kline and Von Oepen (US 2007/0260224 Al, pub. Nov. 8,
2007).
IV. Claims 11, 15, 18-21, 26, 30, 31, 33, and 34 stand rejected under
35 U.S.C. § 102(b) as anticipated by Von Oepen.
V. Claims 16, 17, and 27 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Von Oepen and Melsky (US 2003/0018318 Al,
pub. Jan. 23, 2003).
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VI. Claim 22 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Von Oepen and McGill (US 2002/0072730 Al, pub. June 13,
2002).
VII. Claims 12-14, 23, and 28 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Von Oepen.
VIII. Claims 24 and 25 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Von Oepen and Omaleki (US 6,500,147 B2, iss.
Dec. 31,2002).
IX. Claims 29 and 32 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Von Oepen and Kline.
DISCUSSION
Rejection I
Claims 1, 7, 9, 10, and 18
The issue raised is whether Kline’s spring 13 provides “pushability”
as called for in claim 1. Appeal Br. 6. In particular, Appellant argues that
Kline discloses that the I. V. tube can only provide rigidity when a puncture
needle is received therein, and, thus, teaches away from a device providing
both longitudinal flexibility and pushability. Id.
Appellant and the Examiner dispute the proper construction of
“pushability.” See id. at 7; Ans. 6-7. Citing paragraph 5 of the
Specification, Appellant asserts that “pushability” denotes “a force necessary
to avoid collapse of the distal edge of the tip and/or kinking of the proximal
neck of the catheter tip when obstacles are encountered.” Appeal Br. 7. The
Examiner counters that the language in paragraph 5 of the Specification
regarding avoiding collapse and/or kinking is directed to “radial rigidity,”
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and not “pushability.” Ans. 6. The Examiner also points out that the last
sentence of paragraph 5 “lists ‘pushability’ and ‘radial rigidity’ as two
different features.” Id.
Paragraph 5 of Appellant’s Specification conveys that “avoiding]
collapse of the distal edge of the tip and/or kinking of the proximal neck of
the catheter tip when obstacles are encountered” is desirable, and that “the
tip shape and its radial rigidity may be modified to” accomplish this
objective. However, Appellant’s Specification does not equate “radial
rigidity” with “pushability.” Rather, the Specification lists these parameters
separately. See Spec. ^ 5 (noting that “pushability and radial rigidity require
a thick or stiff material”), ^ 6 (noting “there is a need in the art for an
endovascular catheter tip that is longitudinally flexible and pushable and has
radial rigidity at its distal end”). In fact, the Specification at least implicitly
contemplates the possibility of pushability without radial rigidity.
See id. 19 (disclosing that the spring-like element “can provide pushability
to the catheter tip and may also have radial rigidity, meaning that it can
provide radial support to the catheter tip”). Consistent with Appellant’s
Specification, we construe “pushability” to mean the property of being
pushable, that is, capable of being pushed.
Kline discloses that the assembly “is relatively rigid at the time its
distal end is introduced into a vein though the initial penetration effected by
the puncture needle 21 and the distal tip 17” and that “the only time that the
assembly is in a relatively rigid state is when the puncture needle 21 is in
place.” Kline 5:14-17, 5:29-31 (boldface omitted). However, Kline also
discloses that “the needle is removed from the I.V. tube,. . . permitting the
further flexible introduction of the I.V. tube to the desired length of advance
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within the vein” and that “when the needle has been removed, the I. V. tube
can flex during its further advance into the vein.” Id. 5:21-26, 5:31-33
(emphasis added).
With the puncture needle removed, Kline’s I.V. tube is manipulated
from hub 5, in which the proximal end of the I.V. tube is permanently
received. Kline, Fig. 1,2:64-66. Thus, further introduction or advance of
the I.V. tube within the vein is effected by applying a pushing force on the
I.V. tube. In other words, without a puncture needle inserted therein, Kline’s
I.V. tube is both longitudinally flexible and pushable. See Ans. 7 (stating
that the cited passages of column 5 “provide support that the I.V. tube of
Kline is ‘pushable’ on its own and does not require a needle to impart
‘pushability’; rather, the I.V. tube is both flexible and pushable and the
spring-like element 13 provides longitudinal flexibility and pushability to
said catheter tip”).
Moreover, even assuming that radial rigidity is required for
pushability, Appellant’s Specification discloses that extension springs, that
is, springs having “a tightly packed coil that is conducive to flexion along
the longitudinal axis, without permitting spring compression or deformation”
are an example of a structure having “the desired properties of longitudinal
flexibility, radial rigidity and pushability.” Spec. ^ 31. Kline describes
spring 13 as “a continuously wound coil spring in which the helices thereof
are in mutual contact” and as “[a] close wound helical spring.” Kline 1:55-
56, 3:15. Thus, as described by Kline, spring 13 is a structure having the
desired properties for longitudinal flexibility, radial rigidity, and pushability.
For the above reasons, Appellant does not apprise us of error in the
Examiner’s finding that Kline anticipates the subject matter of claim 1.
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Accordingly, we sustain the rejection of claim 1, as well as claims 7, 9, 10,
and 18, for which Appellant does not present any separate arguments, as
anticipated by Kline.
Claim 2
Claim 2 depends from claim 1 and further recites that the “spring-like
element is an extension spring.” Appeal Br. 24 (Claims App.). Appellant
argues that “Kline describes the use of a compression spring that must be
retained in a compressed configuration, and therefore cannot be an extension
spring, as required by claim 2.” Id. at 7-8 (citing Kline 1:31-32, 3:61-62,
4:49-50); see also Reply Br. 5-6. According to Appellant, “[a]n extension
spring ... is formed with a tightly packed coil that does not allow for spring
compression.” Appeal Br. 8.
Kline describes spring 13 as “a continuously wound coil spring in
which the helices are in mutual contact” and as “[a] close wound helical
spring.” Kline 1:55-56, 5:15. Thus, as the Examiner points out, Kline
describes a spring having the structural characteristics set forth by Appellant
for an extension spring. See Ans. 7-8 (pointing out that because the coils
are in mutual contact, “one of ordinary skill in the art would recognize that
compression of these coils is not possible”).
Kline also discloses that “outer sheath 15 defines a hollow distal tip
17 that is necked down as at 18 to lock the distal end of the spring 13 against
axial elongation.” Kline 3:59-62 (boldface omitted). Kline’s disclosure of
providing positive means for ensuring against axial elongation does not
undermine the Examiner’s finding that Kline’s closely wound coil spring
having helices in mutual contact (thus rendering compression of these coils
impossible) is an extension spring, as called for in claim 2.
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Kline further discloses that one way of providing a sight zone for
visible observation of blood flow upon insertion of the puncture needle “is to
separate a plurality of the coils of the spring 13 in a zone indicated at A . . .
thus providing gaps between the separated coils through which blood flow
may be observed through the transparent outer sheath.” Kline 4:7-17
(boldface omitted); see id., Fig. 2. Appellant argues that this distinguishes
Kline’s structure from that recited in claim 2. Appeal Br. 8. This argument
is unavailing because this sight zone is a feature of the modification of
Kline’s Figure 2, not a feature of the embodiment of Kline’s Figure 1 relied
on by the Examiner. See Kline 4:7-17, 4:57-58 (referring to “the sight zone
A of the l.V. tube in the modification of FIG. 2”). Kline discloses that there
are also other ways of providing such a sight zone, such as constructing the
puncture needle with a hollow transparent needle or manipulating knob,
which may provide either a sole sight zone or supplement the sight zone
shown in the Figure 2 embodiment. Id. 4:18-20, 4:55-58.
For the above reasons, Appellant fails to apprise us of error in the
Examiner’s finding that Kline anticipates the subject matter of claim 2.
Accordingly, we sustain the rejection of claim 2 as anticipated by Kline.
Claim 3
Claim 3 depends from claim 1 and further recites that the “spring-like
element further provides radial rigidity to said catheter tip.” Appeal Br. 24
(Claims App.). In addressing this limitation, the Examiner finds that Kline’s
“spring-like element further provides radial rigidity to said catheter tip (since
the spring 13 is more rigid material than the outer sheath 15).” Final Act. 4.
Appellant submits that “Kline explicitly states that the assembly is
only relatively rigid when the needle 21 is inserted therethrough” and that
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“[t]he material construction of the spring 13 relative to the sheath 15 has no
bearing on whether the spring 13 is capable of providing radial rigidity in
absolute terms thereto.” Appeal Br. 8. Further, Appellant contends that
Kline does not suggest any need for radial rigidity when the needle is
removed and that such rigidity may be detrimental to Kline’s intent by
impeding advancement of the I.V. tube into a vein and possibly damaging
the vein or inflicting pain on the patient when the patient moves. Id. at 8-9.
In response, the Examiner explains:
Although needle 21 may provide rigidity to the assembly, the
spring 13 alone provides another (albeit different) degree of
rigidity to the sheath 15 since one of ordinary skill in the art
would understand that a tube formed of flexible, transparent
plastic material (Col 3, Lines 22-25) having a closely [wound]
helical spring (Col 3, Line 15) embedded therein is more
firm/rigid than a tube formed of the same flexible, transparent
plastic material that does not have a closely wound helical
spring embedded therein.
Ans. 8.
Notably, claim 3 does not specify any particular degree of radial
rigidity that must be provided by the spring-like element. According to
Appellant’s Specification, “radial rigidity” means “it can provide radial
support to the catheter tip.” Spec. ^] 19. The Examiner’s explanation
(Ans. 8) sets forth a reasonable basis to support the finding that the addition
of the closely wound helical structure of spring 13 provides radial support to
Kline’s I.V. tube.
For the above reasons, Appellant fails to apprise us of error in the
Examiner’s finding that Kline anticipates the subject matter of claim 3.
Accordingly, we sustain the rejection of claim 3 as anticipated by Kline.
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Claims 5 and 6
Claim 5 depends from claim 1 and further recites “a radially rigid
distal end section located distal of said spring-like element and contiguous
with” either the longitudinally flexible tube or the spring-like element.
Appeal Br. 24 (Claims App.). Claim 6 depends from claim 5 and, thus, also
incorporates this limitation. Id. The Examiner reads this radially rigid distal
end section limitation on Kline’s hollow distal tip 17. Final Act. 4. The
Examiner finds that tip 17 “is radially rigid when the insertion needle is
inserted therein.” Id.; see also Ans. 9. As such, the Examiner’s finding of
radial rigidity is a feature of the needle, and not tip 17. See Appeal Br. 9
(arguing same). Thus, the Examiner fails to establish by a preponderance of
the evidence that Kline’s tip 17 is radially rigid as required in claims 5
and 6. Accordingly, we do not sustain the rejection of claims 5 and 6.
Claim 8
Claim 8, which depends from claim 1, via claim 7, requires a spacer
portion, which “is an extension of said longitudinally flexible tube,” located
at a proximal end of the spring-like element. Appeal Br. 24 (Claims App.).
The Examiner reads the spacer portion on Kline’s sleeve 12, which is fully
bonded to outer sheath 15 (the structure on which the Examiner reads the
claimed longitudinally flexible tube). Final Act. 4; Kline 3:39 44.
Kline’s sleeve 12 is a metal sleeve or cannula, and, thus, is a different
material than flexible, plastic outer sheath 15. Kline 3:6, 3:22-23. At issue
is whether the language “extension of said longitudinally flexible tube”
requires the spacer portion to be “formed of the same construction of another
element” (i.e., of the longitudinally flexible tube), as Appellant contends
(Appeal Br. 11), or whether a discrete material directly connected to and
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extending from the flexible tube is sufficient to satisfy the “extension”
limitation, as the Examiner contends (Ans. 11-12).
Taking into account the full context of the limitation in question,
namely, “spacer portion is an extension of said longitudinally flexible tube”
(Appeal Br. 24 (Claims App.) (emphasis added)), we determine that
Appellant has the better argument. The term “portion” connotes that the
recited element is a portion of some other element in the claim. Further,
even accepting the Examiner’s proffered definitions of “extension”
(Ans. 11-12), we agree with Appellant that “[f]or the spacer to be an
‘extension of the longitudinally flexible tube,” thereby forming an
additional length or continuation of the longitudinally flexible tube, the
spacer portion “must essentially be a component of the longitudinally
flexible tube and . . . must be flexible.” Reply Br. 8. Notably, the Examiner
makes no finding that sleeve 12 is flexible. For the above reasons, the
Examiner fails to establish by a preponderance of evidence that Kline
anticipates the subject matter of claim 8. Accordingly, we do not sustain the
rejection of claim 8 as anticipated by Kline.
Claim 36
Claim 36, which depends from claim 1, further recites that “said
spring-like element provides simultaneous longitudinal flexibility and
pushability to said catheter tip.” Appeal Br. 27 (Claims App.). Appellant’s
arguments regarding simultaneous longitudinal flexibility and pushability
are essentially the same as those asserted for claim 1. See Appeal Br. 11.
Those arguments do not apprise us of error, for the reasons discussed above.
Accordingly, we also sustain the rejection of claim 36 as anticipated by
Kline.
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Rejection II
In contesting the rejection of claim 35, which depends from claim 1,
as unpatentable over Kline and Maahs, Appellant first argues that Maahs
does not cure the deficiencies of Kline, vis-a-vis claim 1. Appeal Br. 21.
Having been apprised of no such deficiencies, for the reasons discussed
above, this argument likewise fails to apprise us of error in the rejection of
claim 35.
Appellant also argues that flexible region 60 of Maahs is a corrugated
portion of cannula 10 and, thus, is not “a spring-like element located ‘inside
said flexible tube’ or ‘outside said flexible tube,’ as recited in claim 1.” Id.
This argument is unavailing because it attacks Maahs individually, rather
than in combination with Kline as set forth in the rejection. See Ans. 23
(stating that “[sjince the accordion tube of Maahs would replace the spring­
like element 13 of Kline, the accordion tube would reside within the flexible
tube 15 of Kline”); see also Final Act 13 (determining it would have been
obvious to modify Kline to include the spring-like element as an accordion
tube”).
Appellant presents additional arguments, for the first time, on page 19
of the Reply Brief, namely, that neither Kline nor Maahs teaches or suggests
a “catheter” having a spring-like element inside or outside the flexible tube
as recited in claim 1, that there is no teaching or suggestion in either Kline or
Maahs that flexible region 60 of Maahs would function as intended if placed
within Kline’s tube, and that the proposed modification would require undue
experimentation. These arguments are untimely, and Appellant does not
present any evidence or explanation to show good cause why it should be
considered by the Board at this time. See 37 C.F.R. § 41.41(b)(2) (“Any
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argument raised in the reply brief which was not raised in the appeal brief, or
is not responsive to an argument raised in the examiner’s answer . . . will not
be considered by the Board for purposes of the present appeal, unless good
cause is shown.”). Thus, we do not consider these arguments.
For the above reasons, Appellant fails to apprise us of error in the
rejection of claim 35 as unpatentable over Kline and Maahs, which we thus
sustain.
Rejection III
In contesting the rejection of claim 4, Appellant argues only that Von
Oepen does not cure the deficiencies of Kline, vis-a-vis claim 1. Appeal
Br. 14. Having been apprised of no such deficiencies in Kline, for the
reasons discussed above, we likewise are not apprised of error in the
rejection of claim 4 as unpatentable over Kline and Von Oepen, which we,
thus sustain.
Rejection IV
Claims 11, 15, 18, 20, and 34
Claim 11 requires, in pertinent part, an extension spring. Appeal Br.
25 (Claims App.). As described in Appellant’s Specification, “[ejxtension
springs have a tightly packed coil that is conducive to flexion along the
longitudinal axis, without permitting spring compression or deformation.”
Spec. ^ 31. Appellant argues that Von Oepen’s coil 20 in the Figure 8
embodiment relied on by the Examiner is not tightly packed, and prevented
by encapsulant 150 from expansion (i.e., not conducive to flexion along the
longitudinal axis) to the same degree as from compression, and, thus, coil 20
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is not an “extension spring.” Appeal Br. 12. Although we do not
necessarily agree that an “extension spring” requires a pitch space of zero, as
Appellant asserts (Reply Br. 10), at least body portion 12 of coil 20 is not a
tightly packed coil, nor is there any indication in Von Oepen that coil 20 is
conducive to flexion along the longitudinal axis without permitting spring
compression or deformation. Von Oepen does not support by a
preponderance of evidence the Examiner’s finding that coil 20 in Figure 8 is
an extension spring. Accordingly, we do not sustain the rejection of
claim 11, or claims 15, 18, and 34, which depend from claim 11 and are
grouped by Appellant with claim 11, as anticipated by Von Oepen. For the
same reasons, we do not sustain the rejection of claim 20, which requires “a
non-compressible extension spring,” as anticipated by Von Oepen. See
Appeal Br. 14, 26 (Claims App.).
Claims 19, 21, 26, 30, 31, and 33
Claim 19 recites, in pertinent part, a spring-like element providing
“longitudinal flexibility and pushability to said catheter.” Appeal Br. 26
(Claims App.). Appellant argues that Von Oepen does not describe coiled
wire 20 of the Figure 8 embodiment relied on in the rejection as flexible and
that, even if coiled wire 20 were flexible, encapsulant 150, in which the wire
is embedded, would render the wire inflexible. Id. at 13. This argument is
not well-founded, for the reasons set forth by the Examiner in the paragraph
bridging pages 14-15 of the Answer. Accordingly, we sustain the rejection
of claim 19, as well as claims 21, 26, 30, 31, and 33, which depend from
claim 19 and for which Appellant presents no separate arguments, as
anticipated by Von Oepen.
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Rejection V
Claims 16, 17, and 27 require the spring-like element to extend to a
distal edge of the catheter tip. Appeal Br. 25, 27. Even if the placement of
coil 20 of Von Oepen were modified as proposed by the Examiner “to match
the configuration of Melsky’s coil polymer composite subassembly (as seen
in Fig 6, in which the coil forms the distal-most end of the coil polymer
composite subassembly),” such that “spring 20 would form the distal edge of
the spring+encapsulant structure” (Ans. 17-18), this would not be a distal
edge of the catheter tip. See Reply Br. 13; Von Oepen, Fig. 8 (depicting
head 16A extending distally of the spring and encapsulant structure). Thus,
the Examiner fails to establish that the subject matter of claims 16, 17,
and 27 would have been obvious. Accordingly, we do not sustain the
rejection of claims 16, 17, and 27 as unpatentable over Von Oepen and
Melsky.
Rejection VI
Claim 22, which depends from claim 19, recites that “said spring-like
element abuts said distal shoulder of said balloon.” The Examiner finds that
Von Oepen discloses a spring-like element distal to a distal shoulder of the
balloon, but “does not disclose that it abuts the distal shoulder of the
balloon.” Final Act. 8 (citing Von Oepen, Figs. 4, 8). The Examiner finds
that McGill teaches a spring-like element (coils 356) abutting the distal
shoulder (adhesive taper 374) of balloon 312 for providing a spring force to
help guide the catheter. Id. (citing McGill, Fig. 25A, 109, 145). The
Examiner determines it would have been obvious to modify Von Oepen’s
catheter to include a “spring-like element so that it abuts the distal shoulder
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of the balloon, as taught by McGill. . ., for the purpose of providing a spring
force that can help guide the catheter.” Id. (citing McGill ^ 109).
The issue in dispute is whether McGill’s adhesive taper 374 can
reasonably be considered a “distal shoulder” of balloon 312. McGill
describes adhesive taper 374 as extending from the distal end of the balloon
to coils 356. McGill ^ 145. In describing the embodiment of Figure 25B,
McGill discloses that adhesive taper 374 is provided adjacent balloon 312 to
provide a transition region between balloon 312 and core wire 354. Id.
f 153. Appellant contends that taper 374 is not a component of the balloon.
Appeal Br. 17. According to Appellant, merely bordering the balloon is not
sufficient to justify the Examiner’s finding that adhesive taper 374 is an end
component of the balloon. Id. Construing “shoulder” according to a
dictionary definition as “‘an area adjacent to or along the edge of a higher,
more prominent, or more important part’ or ‘a rounded or sloping part where
the neck joins the body,”’ the Examiner finds that adhesive taper 374 slopes
to adjoin the balloon with coils 356 and, thus, is a “distal ‘shoulder’ of
balloon 312.” Ans. 18.
The “distal shoulder of said balloon” recitation of claim 22 denotes
that the shoulder is a component of the balloon itself, and the dictionary
definitions of “shoulder” cited by the Examiner do not support the
Examiner’s position that an element (the adhesive taper) distinct from a
structure (the balloon) is a component of the structure. McGill describes
adhesive taper 374 as extending from the distal end of or adjacent balloon
312, and, thus, not as a component of the balloon. Thus, adhesive taper 374
is not a distal shoulder of the balloon, as called for in claim 22.
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For the above reasons, Appellant’s argument apprises us of error in
the rejection of claim 22 as unpatentable over Von Oepen and McGill, which
we, thus, do not sustain.
Rejection VII
Claims 12—14
The rejection of claims 12-14, which depend, directly or indirectly,
from claim 11, under 35 U.S.C. § 103(a) as unpatentable over Von Oepen
suffers from the same deficiency as the rejection of claim 11 as anticipated
by Von Oepen. See Final Act. 8-9. Thus, we also do not sustain the
rejection of claims 12-14 as unpatentable over Von Oepen.
Claim 23
The Examiner finds that Von Oepen discloses all of the features of
claim 23, with the exception of the spring-like element being located at a
distance selected from 1 mm to 2 mm from the distal shoulder of the
balloon. Final Act. 9; see also Ans. 20 (pointing out that Von Oepen is
silent as to the location of coil 20 with respect to the distal shoulder of the
balloon as depicted in Figure 4). However, the Examiner reasons that such
spacing would have been obvious “since it has been held that rearranging
parts of an invention involves only routine skill in the art.” Final Act. 9
(citing In reJapikse, 181 F.2d 1019 (CCPA 1954)).
Appellant contends that the Examiner’s reliance on Japikse is
inapposite because “Japikse is concerned with the rearrangement of parts,
and not numerical limitations.” Appeal Br. 19. Von Oepen depicts coil 20
disposed distally relative to the distal shoulder of the balloon of balloon
catheter 40. Von Oepen, Fig. 4. In the modification proposed by the
Examiner, coil 20 would remain distal of the distal shoulder of the balloon.
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The only modification, if any, would involve the spacing between the distal
shoulder of the balloon and the coil.
Although the Examiner’s reliance on the principle of Japikse may not
be the most appropriate citation for this situation, we understand the
Examiner’s position to be that moving Von Oepen’s coil from where it is
placed to a location in which it is spaced from 1 mm to 2 mm from the distal
shoulder of the balloon, as claimed, would not change the overall operation
of the device, similar to the situation in Japikse, in which the court held that
moving a starter switch to a location different from the prior art was an
obvious variation because the overall operation of the device would not be
modified by such a change. Japikse, 181 F.2d at 1023. Likewise, absent
evidence that changes in size or position of the various features result in a
difference in effect or result, “[s]uch changes in design are no more than
obvious variations consistent with the principles known in that art.” In re
Rice, 341 F.2d 309, 314 (CCPA 1965).
Appellant argues that “[i]n the present application, the recited
measurements have been carefully selected to impart a specific combination
of longitudinal flexibility and pushability to the catheter tip” and that
“[bjased on the teachings of Von Oepen, one of skill in the art would require
undue experimentation to come to the measurements claimed in claim 23.”
Appeal Br. 19; see also Reply Br. 17.
Appellant fails to present any evidence showing any criticality to the
claimed spacing of the spring-like element from the distal balloon shoulder.
Appellant’s Specification does not attribute any significance to the relative
locations of the balloon shoulder and the spring-like element or associate
such relative locations to longitudinal flexibility or pushability. To the
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contrary, the Specification discloses that spring-like element 30 may abut the
balloon shoulder, be positioned a distance (“for example 1 or 2 mm”) from
the balloon shoulder in the distal direction, or in the proximal direction, up
to the middle of the balloon or the proximal bond. Spec. ^ 23. The
Specification gives no indication that any of these locations is preferable to
any of the others or has any impact on flexibility or pushability. Id.
For the above reasons, Appellant fails to apprise us of error in the
Examiner’s determination that locating Von Oepen’s coil relative to the
balloon shoulder with spacing as set forth in claim 23 is an obvious variation
of the arrangement disclosed in Von Oepen’s Figure 4 having no effect on
the overall operation of the device. Accordingly, we sustain the rejection of
claim 23 as unpatentable over Von Oepen.
Claim 28
Appellant does not present any arguments for claim 28, aside from its
dependence from claim 19. Appeal Br. 15-17; Reply Br. 15-17.
Accordingly, for the reasons set forth above in discussing claim 19, we also
sustain the rejection of claim 28.
Rejection VIII
In contesting the rejection of claims 24 and 25, which depend from
claim 19, Appellant argues that Omaleki does not cure the deficiencies of
Von Oepen vis-a-vis claim 19. Appeal Br. 19. Having been apprised of no
such deficiencies, for the reasons set forth above in discussing the rejection
of claim 19, Appellant’s argument likewise fails to apprise us of error in the
rejection of claims 24 and 25.
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Appellant adds that “[n]either Von Oepen nor Omaleki teach or
suggest a non-compressible spring-like element that provides longitudinal
flexibility and pushability to a catheter tip.” Id. This argument is not
commensurate in scope with claims 24 and 25, which do not recite that the
spring-like element is non-compressible. See In re Self, 671 F.2d 1344,
1348 (CCPA 1982) (limitations not appearing in the claims cannot be relied
upon for patentability).
For the above reasons, Appellant fails to apprise us of error in the
rejection of claims 24 and 25 as unpatentable over Von Oepen and Omaleki,
which we thus sustain.
Rejection IX
Claim 29
The Examiner’s rejection of claim 29 is grounded in part on the
Examiner’s finding that Kline’s hollow distal tip 17 is a radially rigid distal
end section. Final Act. 12. This finding is deficient, for the reasons set forth
above in addressing the rejection of claims 5 and 6. The Examiner
determines it would have been obvious “to include the radially distal end
section so that it tapers distally, as taught by Kline, for the purpose of
facilitating a smooth entry of the catheter into a vein.” Final Act. 12.
Appellant argues that Kline’s “distal tip 17 is not a ‘radially rigid
section.’” Appeal Br. 20. In response, the Examiner clarifies that the
modification in the rejection is not to replace Von Oepen’s section 16A with
Kline’s section 17, but, rather, to modify Von Oepen’s section 16A to have
the taper shape of Kline’s section 17. Ans. 22.
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In response to the Examiner’s clarification regarding the modification,
Appellant argues that Von Oepen’s tip head 16A assumes the shape
disclosed by Von Oepen to assist catheter advancement through a vessel
lumen, in contrast to tip 17 of Kline’s I.V. tube, which receives a needle to
permit advancement a short distance into a vein. Reply Br. 18. Thus,
according to Appellant, there is no reason a skilled artisan would look to
Kline’s I.V. tube for guidance in designing or modifying Von Oepen’s tip.
Id. Von Oepen’s tip head 16A assumes a bulbous shape to redirect the twist
of second guidewire 44 to enable the catheter to slide past and through the
twist without causing a tightening of the twists in the second guidewire.
Von Oepen 30, 42, 47, 55. There is no indication in either Von Oepen or
Kline that a tapered shape as taught by Kline would permit this function, and
the Examiner does not provide any technical reasoning to explain why this
would be the case. Thus, we agree with Appellant that a person having
ordinary skill in the art would not have been prompted to provide Von
Oepen’s tip head 16A with the tapered shape of Kline’s section 17. See
Reply Br. 18.
Accordingly, we do not sustain the rejection of claim 29 as
unpatentable over Von Oepen and Kline.
Claim 32
Appellant does not present any argument specifically addressing the
rejection of claim 32, aside from its dependence from claim 19. Appeal
Br. 20; Reply Br. 18. Thus, for the same reasons set forth above in
addressing claim 19, we also sustain the rejection of claim 32 as
unpatentable over Von Oepen and Kline.
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DECISION
The Examiner’s decision rejecting claims 1-3, 5-10, 18, and 36 under
35 U.S.C. § 102(b) as anticipated by Kline is AFFIRMED as to claims 1-3,
7, 9, 10, 18, and 36, and REVERSED as to claims 5, 6, and 8.
The Examiner’s decision rejecting claim 35 under 35 U.S.C. § 103(a)
as unpatentable over Kline and Maahs is AFFIRMED.
The Examiner’s decision rejecting claim 4 under 35 U.S.C. § 103(a)
as unpatentable over Kline and Von Oepen is AFFIRMED.
The Examiner’s decision rejecting claims 11, 15, 18-21, 26, 30, 31,
33, and 34 under 35 U.S.C. § 102(b) as anticipated by Von Oepen is
AFFIRMED as to claims 19, 21, 26, 30, 31, and 33, and REVERSED as to
claims 11, 15, 18, 20, and 34.
The Examiner’s decision rejecting claims 16, 17, and 27 as
unpatentable over under 35 U.S.C. § 103(a) Von Oepen and Melsky is
REVERSED.
The Examiner’s decision rejecting claim 22 under 35 U.S.C. § 103(a)
as unpatentable over Von Oepen and McGill is REVERSED.
The Examiner’s decision rejecting claims 12-14, 23, and 28 under
35 U.S.C. § 103(a) as unpatentable over Von Oepen is AFFIRMED as to
claims 23 and 28 and REVERSED as to claims 12-14.
The Examiner’s decision rejecting claims 24 and 25 under
35 U.S.C. § 103(a) as unpatentable over Von Oepen and Omaleki is
AFFIRMED.
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The Examiner’s decision rejecting claims 29 and 32 under
35 U.S.C. § 103(a) as unpatentable over Von Oepen and Kline is
AFFIRMED as to claim 32 and REVERSED as to claim 29.
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)(l)(iv).
AFFIRMED-IN-PART
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