Ex Parte Heck

Patent Trial and Appeal Board

Mar 1, 2016

12717766 (P.T.A.B. Mar. 1, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
121717,766 03/04/2010
20551 7590 03/03/2016
THORPE NORTH & WESTERN, LLP.
P.O. Box 1219
SANDY, UT 84091-1219
FIRST NAMED INVENTOR
Robert W. Heck
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
01261-33531.NP 3488
EXAMINER
MEHTA, BHISMA
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
03/03/2016 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):
patentdocket@tnw.com
rich@tnw.com
annette.fields@tnw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT W. HECK
Appeal2014-001706
Application 12/717,766
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a high-
flow tapered peripheral IV catheter with side outlets. The Examiner rejected
the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
reverse.
1 Appellant identifies the Real Party in Interest as the inventive entity,
Robert W. Heck (see App. Br. 3).
Appeal2014-001706
Application 12/717,766
Statement of the Case
Background
Appellant's invention relates to "a high-velocity, high-volume
peripheral intravenous (IV) catheter device with an elongate catheter having
an elongate lumen therein, an inlet port at a proximal end, and an outlet port
at a distal end opposite the inlet port" (Spec. 2:3-5).
The Claims
Claims 1, 2, 4--6, 13, 15, 18-24, 27, 28 and 30 are on appeal.
Independent claim 1 is representative and reads as follows:
1. A high-velocity, high-volume peripheral intravenous
(IV) catheter device, comprising:
a) an elongate flexible catheter with an elongate lumen
therein, an inlet port at a proximal end, and an outlet port at a
distal end opposite the inlet port;
b) the lumen having a proximal cylindrical shape from
the inlet port transitioning at a transition to an inner lumen
conical taper, and having a larger internal diameter at the inlet
port and a tapering smaller internal diameter bet\'l/een the
transition and the outlet port;
c) a plurality of side outlet ports formed laterally
through the catheter nearer the transition than the outlet port;
d) a cross-sectional area of the outlet port and the side
outlet ports together being equal to or greater than a cross-
sectional area of the inlet port;
e) a hub disposed at the inlet port of the catheter;
t) an elongate rigid stylet removably disposed in the
lumen of the catheter and insertable and removable through
the hub and the inlet port; and
g) the stylet having a beveled distal end forming a
piercing tip that protrudes from the outlet port of the catheter
when the stylet is completely inserted in the catheter.
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Appeal2014-001706
Application 12/717,766
The Issues
A. The Examiner rejected claims 1, 4---6, and 23 under 35 U.S.C. § 103(a)
as obvious over Tremulis,2 Bennett,3 and Magnusson4 (Ans. 4--9).
B. The Examiner rejected claim 2 under 35 U.S.C. § 103(a) as obvious
over Tremulis, Bennett, Magnusson, and Chiang5 (Ans. 9-10).
C. The Examiner rejected claim 24 under 35 U.S.C. § 103(a) as obvious
over Tremulis, Bennett, Magnusson, and Fonger6 (Ans. 10-11).
D. The Examiner rejected claim 27 under 35 U.S.C. § 103(a) as obvious
over Tremulis, Bennett, Magnusson, and Gross7 (Ans. 12-13).
E. The Examiner rejected claim 30 under 35 U.S.C. § 103(a) as obvious
over Tremulis, Bennett, Magnusson, and Holmes, Jr. 8 (Ans. 13-14).
F. The Examiner rejected claims 13, 15, and 18-21under35 U.S.C. §
103(a) as obvious over Tremulis, Bennett, Chiang, and Magnusson (Ans.
14--20).
G. The Examiner rejected claim 22 under 35 U.S.C. § 103(a) as obvious
over Tremulis, Bennett, Chiang, Magnusson, and Fonger (Ans. 20-21 ).
H. The Examiner rejected claim 28 under 35 U.S.C. § 103(a) as obvious
over Tremulis, Bennett, Chiang, Magnusson, and Gross (Ans. 21-22).
Because the same issue is dispositive for all eight rejections, we will
consider them together.
2 Tremulis, US 6,102,903, issued Aug. 15, 2000.
3 Bennett et al., US 3,670,729, issued June 20, 1972.
4 Magnusson, US 2007/0100299 Al, issued May 3, 2007.
5 Chiang et al., US 5,899,890, issued May 4, 1999.
6 Fonger et al., US 5,330,433, issued July 19, 1994.
7 Gross, US 5,002,535, issued Mar. 26, 1991.
8 Holmes, Jr. et al., US 6,569,129 Bl, issued May 27, 2003.
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Appeal2014-001706
Application 12/717,766
The Examiner acknowledges that
[ e ]ven though Tremulis discloses an elongate sty let where the
sty let has a distal end that protrudes from the outlet port of the
catheter when the stylet is completely inserted in the catheter,
Tremulis is silent as to the specifics of the distal end being a
beveled distal end forming a piercing tip that protrudes from
the outlet port of the catheter when the stylet is completely
inserted in the catheter.
(Ans. 5)
The Examiner finds that Bennett teaches "a catheter device having an
elongate catheter (10) with ... an elongate sty let (21) ... where the sty let
has a beveled distal end forming a piercing tip that protrudes from the outlet
port of the catheter when the sty let is completely inserted in the catheter"
(id. at 5---6).
The Examiner concludes that it would have been obvious to "provide
the distal end of the sty let of Tremulis as a beveled distal end forming a
piercing tip as taught by Bennett" "in order to insert the catheter device into
the desired location in the patient's body" (id. at 6).
The issue with respect to these rejections is: Does the evidence of
record support the Examiner's conclusion that Tremulis, Bennett, and
Magnusson render the claims obvious?
Findings of Fact
1. Tremulis teaches "a delivery catheter [] [that] is advanced over
a guide wire [] to a target location within fluid vessel, such as a restriction or
blockage" and that "[a]fter reaching the target location, therapeutic fluid is
supplied" (Tremulis, Abstract).
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Appeal2014-001706
Application 12/717,766
2. Trenmlis' Figure 2 is reproduced below:
Figure 2 shows that
[t]he delivery catheter 2 is introduced over the separate,
movable guide wire 30 in a conventional manner. Usually,
catheter 2 will be loaded over the proximal end of guide wire
30, after the guide wire 30 has been positioned within the
target body lumen. The delivery catheter 2 may then be
advanced over the guide wire so that catheter 2 also reaches
the target location.
(Id. at Fig. 2; 5:57---63.)
3. Bennett's Figure 3 is reproduced below:
n
~~~t1~G3~
: . ~#l.f1-..... ~':~'~~~'':':-'':~''Y-':~''..~{~~~~~~~0»;~;.~ =«"tX-"S»'!..:':».W"~~~----·
W-""""·"'·~"'<::~~~:Z:·:~~L:,::.l,~~i"~ ( ;.f:
>l
Figure 3 shows that
[an] introducing needle 20, with the device 10 mounted
thereon is inserted into the patient's vessel. When the device
is in position, that is when the sleeve 12 has been inserted into
the patient's tissue up to or adjacent the junction of the sleeve
12 with the body portion 11, the introducing needle 20 is
withdrawn from the device.
(Bennett Fig. 3; 2: 1---6.)
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Appeal2014-001706
Application 12/717,766
4. Bennett's Figure 4 is reproduced below:
Figure 4 shows that "after the introducing needle has been withdrawn,
a conventional catheter 22 is inserted in place of the introducing needle 20"
(id. at Fig. 4; 2:6-8).
Principles of Law
If the proposed modification would render the prior art invention
being modified unsatisfactory for its intended purpose, then there is no
suggestion or motivation to make the proposed modification. In re Fritch,
972 F.2d 1260, 1266 n.12 (Fed. Cir. 1992), citing In re Gordon, 733 F.2d
900, 902 (Fed. Cir. 1984).
Analysis
Appellant contends that
Tremulis states that the guide wire is a conventional guide
wire used in a conventional manner[]. A person of skill in the
art will readily recognize the difference between a guide wire
and a stylet. Guide wires are flexible guides inserted into the
patient typically through a small incision in the groin and then
maneuvered within the various arteries and vessels to the clot
or area of other vascular disease, and are round-tipped and
blunt[].
(App. Br. 19; citing Tremulis 5:29, 57-58.) Appellant contends that "[i]n
addition, a guide wire is used in place, i.e. it is not removed from the
catheter or the patient during use" (App. Br. 19). Appellant contends that
[a] piercing tip is not needed with Tremulis to insert the guide
wire into the patient's body because an incision is made to
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Appeal2014-001706
Application 12/717,766
insert the guide wire. Inclusion of a piercing tip on the
Trenmlis guide wire is not obvious and would not be
considered by one of ordinary skill in the art because the
guide wire would no longer be operable as a guide wire. At
the first instance of a bend in the artery where the current
Trenmlis round-tipped guide wire would tum and flex to
follow the artery toward the target location, the guide wire set
forth in the Office Action would pierce the artery and proceed
into some portion of the body outside of the artery and away
from the target location.
(Id. at 20.)
The Examiner finds that "[t]he elongate guide wire (30) disclosed by
Tremulis meets the structural limitations of the claimed sty let and thus, the
guide wire of Tremulis is considered to be a sty let" (Ans. 22). The
Examiner finds that "a piercing tip may be needed with the device of
Tremulis depending on the specific use of the device of Tremulis and the
inclusion of a piercing tip to the guide wire/sty let of Tremulis would still
allow the guide wire/stylet to be operable as a guide wire" (id. at 23-24).
We find that Appellant has the better position. We agree with
Appellant that the function of Tremulis' guide wire 30 (FF 1 ("a guide wire
[] to a target location within fluid vessel, such as a restriction or blockage"
and "after reaching the target location ... ")is different from Bennett's
introducing needle 20 (FF 3 ("[an] introducing needle 20 (emphasis
added))).
We also agree with Appellant that placing a piercing tip on Tremulis'
guide wire would render it inoperable as the piercing tip would pierce an
artery, or any locations or fluid vessels within the body. See In re Fritch,
972 F.2d at 1266 n.12 and In re Gordon, 733 F.2d at 902. Furthermore, on
this record, the Examiner failed to establish an evidentiary basis to support a
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Appeal2014-001706
Application 12/717,766
conclusion that there was an advantage or reason to place a piercing tip on
Trenmlis' guide wire which is used to guide a catheter to a target location
within a fluid vessel.
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that Tremulis, Bennett, and Magnusson render the claims obvious. The
Examiner does not rely on Magnusson, Chiang, Fonger, Gross, or Holmes,
Jr., to cure the deficiencies of the combination of Tremulis and Bennett as
discussed above. Therefore, we also reverse the rejections involving these
references as well.
SUMMARY
In sum, we reverse the rejection of claims 1, 4---6, and 23 under 35
U.S.C. § 103(a) as obvious over Tremulis, Bennett, and Magnusson.
We reverse the rejection of claim 2 under 35 U.S.C. § 103(a) as
obvious over Tremulis, Bennett, Magnusson, and Chiang.
We reverse the rejection of claim 24 under 35 U.S.C. § 103(a) as
obvious over Tremulis, Bennett, Magnusson, and Fonger.
We reverse the rejection of claim 27 under 35 U.S.C. § 103(a) as
obvious over Tremulis, Bennett, Magnusson, and Gross.
We reverse the rejection of claim 30 under 35 U.S.C. § 103(a) as
obvious over Tremulis, Bennett, Magnusson, and Holmes, Jr.
We reverse the rejection of claims 13, 15, and 18-21under35 U.S.C.
§ 103(a) as obvious over Tremulis, Bennett, Chiang, and Magnusson.
We reverse the rejection of claim 22 under 35 U.S.C. § 103(a) as
obvious over Tremulis, Bennett, Chiang, Magnusson, and Fonger.
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Appeal2014-001706
Application 12/717,766
We reverse the rejection of claim 28 under 35 U.S.C. § 103(a) as
obvious over Tremulis, Bennett, Chiang, Magnusson, and Gross.
REVERSED
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