Ex Parte Lee et al

Patent Trial and Appeal Board

Sep 28, 2016

12104247 (P.T.A.B. Sep. 28, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/104,247 04/16/2008
41838 7590 09/29/2016
GENERAL ELECTRIC COMPANY (PCPI)
C/O FLETCHER YODER
P. 0. BOX 692289
HOUSTON, TX 77269-2289
FIRST NAMED INVENTOR
Warren LEE
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.
226841-2 I GERD:0851 3526
EXAMINER
HOFFA, ANGELA MARIE
ART UNIT PAPER NUMBER
3768
MAILDATE DELIVERY MODE
09/29/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WARREN LEE, DOUGLAS GLENN WILDES, and
WESTON BLAINE GRIFFIN
Appeal2014-008939
Application 12/104,247
Technology Center 3700
Before ERIC B. GRIMES, ULRIKE W. JENKS, and
ROBERT A. POLLOCK, Administrative Patent Judges.
PERCURIAM
DECISION ON APPEAL
This is a decision on appeal 1 under 35 U.S.C. § 134 from the
Examiner's rejection of claims 1, 5-12, 25, and 31. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
The Specification discloses "ultrasound imaging catheters and ...
methods for packaging ... and for filling these imaging catheters with
acoustic coupling fluid at or near the time of use" (Spec. i-f 2).
1 Appellants identify the Real Party in Interest as General Electric Company
(App. Br. 2).
Appeal2014-008939
Application 12/104,247
Claims 1, 5, 7, and 31 are representative of the claims on appeal and
read as follows:
1. An imaging catheter assembly, comprising:
an imaging catheter comprising an imaging catheter tip;
and
an imaging catheter handle separate from the imaging
catheter and coupled to the imaging catheter via a flexible
shaft, wherein the imaging catheter handle comprises:
a fluid reservoir connected to the imaging catheter and
configured to deliver fluid through a proximal end of the
imaging catheter tip, wherein the proximal end of the imaging
catheter tip is an end of the imaging catheter tip that is closer
to the imaging catheter handle than an opposite distal end;
an actuatable release mechanism integrated into the
imaging catheter handle and configured to cause delivery of
the fluid to the imaging catheter tip when actuated with
respect to the imaging catheter handle;
a plunger configured to displace fluid from the fluid
reservoir; and
a biasing member configured to exert a predetermined
force against the plunger when the release mechanism is
actuated with respect to the imaging catheter handle, thereby
releasing the biasing member to bias against the plunger.
5. The imaging catheter assembly of claim 1, comprising
a box configured to hold the imaging catheter, the imaging
catheter handle, and the flexible shaft, wherein the box is
adapted to hold the imaging catheter tip in a downward
orientation when the release mechanism is actuated.
7. A packaging assembly, comprising:
an imaging catheter comprising an imaging catheter tip
and a fill mechanism; and
a box configured to hold the imaging catheter tip in a fill
orientation to facilitate filling the imaging catheter tip with
acoustic coupling fluid upon activation of the fill mechanism.
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Application 12/104,247
31. The packaging assembly of claim 7, wherein the box
holds the imaging catheter tip in the fill orientation without
being attached to a device external to the box.
The claims stand rejected as follows:
° Claim 31 under 35 U.S.C. § 112, first paragraph (written
description);
° Claims 1, 6, and 25 under 35 U.S.C. § 103(a) in view of Crowley2
and Prince;3
8 Claims 5 under 35 U.S.C. § 103(a) in view of Crowley, Prince, and
Prindle· 4
'
8 Claims 7-12 and 31 under 35 U.S.C. § 103(a) in view of Crowley
and Prindle.
I.
Issue
The Examiner has rejected claim 31 under 35 U.S.C. § 112, first
paragraph, for a lack of adequate written descriptive support in the
Specification (Ans. 2-3).
The issue presented is: Does the Specification provide adequate
written descriptive support for the claim 31 limitation that "the box holds the
imaging catheter tip in the fill orientation without being attached to a device
external to the box" (emphasis added)?
2 Crowley, US 6,572,553 B2, issued June 3, 2003.
3 Prince, US 2006/0264741 Al, published Nov. 23, 2006.
4 Prindle, US 7,434,686 B2, issued Oct. 14, 2008.
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Appeal2014-008939
Application 12/104,24 7
Findings of Fact
1. Figure 5 of the Specification is shown below:
Figure 5 is a side view of imaging catheter packaging (Spec. i-f 17). "[T]he
imaging catheter 14 may be packaged with a fluid reservoir 64 which has
been preloaded with sterile acoustic coupling fluid" (id. i-f 41 ). "[T]he
operator may remove the imaging catheter tip 26 from the packaging 72 and
place it in a tip holder 7 4 within the packaging 72" (id. i-f 42).
2. Figure 6 of the Specification is shown below:
·'' ''-. _,,····························································································::>-·'·, ?>·
/ / ~
i ! l ;f~ f~~\ ;_q,: .. ~~ ................ '-;. t ~~:~ ~~;. ~;~
I ~-':--~- I/
I rl·;-~~J
: -~~ ~ ~ ..... ) i - :... .......... ....,._,,"'"""'''~""""""""'"''''~.....,.,..,..-..:.. .... ~' / L _____________________________________________________________________________________________ v ....
Figure 6 is a side view of imaging catheter packaging (id. i-f 18). "[T]he
entire imaging catheter 14 ... may be packaged in a box 7 6 that is designed
or labeled to be stood on one end so that the distal end of the imaging
catheter tip 26 points downward within the box 76" (id. i-f 43).
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Appeal2014-008939
Application 12/104,247
Analysis
The Examiner finds that "the language of 'without being attached to
a device external to the box' is not taught or suggested. As such, the
limitation represents new matter" (Ans. 3).
Appellants argue that support for claim 31 may be found in the
Specification's disclosure that "'the box 76 is designed or labeled to be
stood on one end' .... Moreover, Figures 5 and 6 ... show a box
(packaging 72, box 76) without any attachment to external devices" (App.
Br. 8).
\Ve will reverse this reiection. We agree with Appellants that those of
ordinary skill in the art would recognize the Specification to show
possession of the packaging assembly of claim 31. Specifically, Figures 5
and 6 show ernbodiments of the clahned invention in which the imaging
catheter tip is held in the fill orientation "without being attached to a device
external to the box." We disagree with the Examiner's reasoning (Ans. 9-
10) that placing the box on a surface to accomplish the fill function is
attaching it to an external device. Simply placing a box on a surface does
not "attach" the box to that surface. Thus, we reverse the rejection of claim
31 under 35 U.S.C. § 112, first paragraph.
II.
Issue
The Examiner has rejected claims 1, 6, and 25 under 35 U.S.C.
§ 103(a) as obvious in view of Crowley and Prince (Ans. 4---6).
The main issue presented is: Would Crowley and Prince have made
obvious an imaging catheter assembly that comprises "a biasing member
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Appeal2014-008939
Application 12/104,24 7
configured to exert a predetermined force against the plunger when the
release mechanism is actuated" as required by claim 1 (emphasis added)?
Findings of Fact
3. Crowley discloses "acoustic imaging catheters" (Crowley,
col. 1, 11. 27-28).
4. Figures 7 and 7a of Crowley are shown below:
Figures 7 and 7 a show "the filling procedure used to prepare ultrasound
catheter sheath 12" (Crowley, col. 11, 11. 46-47). "A sterile, flexible filling
tube 1 7 attached to a syringe 19 is filled with sterile water. This filling
catheter is inserted into the ultrasound catheter sheath 12 .... The water is
then injected until it completely fills and the excess spills out of the
ultrasound catheter." (Id. at col. 11, 11. 49-54.) "A holding bracket 21 is
used to hold the catheter vertical during this procedure" (id. at col. 11, 11.
61---63).
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Appeal2014-008939
Application 12/104,247
5. Prince discloses an apparatus for use in "contrast agent
enhanced magnetic resonance angiography" (Prince i-f 2).
6. Prince discloses that an "injection device 12 ... is employed to
inject the magnetic resonance contrast agent" (id. i-f 105).
7. Figure 5B of Prince is shown below:
FIG.SS
Figure 5B shows a mechanical infusion device (id. i-f 28). "A plunger 24a of
the syringe 24 is engaged by a spring 40 which is housed in the block and
spring housing 30a. In operation, the spring 40 engages the plunger 24a to
pressurize the syringe 24" (id. i-f 121 ). To "obtain a constant ... rate of
infusion of the magnetic resonance contrast agent, the device 12 ... may
include a spring which has a constant width and thickness in order to exert a
constant force" (id. i-f 113). "[T]he infusion rate may be controlled to be
either constant or variable by design of the spring and, in effect, pre-
programmed by selection of the spring's design parameters" (id.).
Analysis
The Examiner finds that Crowley discloses an imaging catheter that
includes most of the limitations of claim 1 (Ans. 4), but does not disclose a
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Application 12/104,247
biasing member that is "configured to exert a predetermined amount of
force" (id. at 5). The Examiner finds that Prince discloses "a fluid injection
system wherein a syringe configuration may be regulated via manual or
spring loaded mechanisms ... as functional equivalents" (id.). "[A]n
actuatable release mechanism [is] integrated into the device (spring
adjustment mechanism 50, fig. 5B) to control a biasing member (a spring,
par. 0113) to exert a force onto a plunger (24a, fig. 5B)" (id.).
The Examiner concludes that it would have been obvious to one of
ordinary skill in the art to integrate Prince's spring-loaded mechanism
into the handle of the catheter device of Crowley in place of
the manual injection rate control mechanism of Crowley since
replacing a manual activity with a functionally equivalent
automated feature is considered routine in the art for lack of
critical or unexpected result. The expected benefits would be
to reduce human error and provide convenience to the user.
(Id.)
Appellants argue that the references do not teach or suggest that "the
biasing member exerts a predetermined force against the plunger," as
required by claim 1, and that Prince does not disclose "that the spring
adjustment mechanism 50 is configured to apply a predetermined force onto
a plunger" (App. Br. 12). Appellants argue that Prince discloses "adjusting
the rate of injection, but not that the rate adjustment mechanism 50 is
configured to apply a predetermined force to the plunger" (id.).
Appellants' argument is not persuasive. Prince discloses that the
infusion device can include a spring that has a constant width and thickness
in order to exert a constant force on the plunger (FF 7). Prince also discloses
that the infusion rate may be controlled, or pre-programmed, by design of
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Appeal2014-008939
Application 12/104,247
the spring (FF 7). Thus, Prince discloses that infusion rate is controlled by
applying a pre-programmed or predetermined force to the spring.
Appellants also argue that the references do not teach or suggest that
"activation of a release mechanism releases a biasing member to bias against
a plunger," as required by claim 1 (App. Br. 11 ). Appellants argue that
Prince discloses "an adjustment mechanism 50 to increase or decrease a rate
of injection ... [but] does not appear to indicate that the adjustment
mechanism 50 releases a biasing member to modify the rate of injection" (id.
at 12).
The Examiner responds that Prince teaches an automated release
mechanism for depressing a plunger of a syringe (Ans. 10-11). The
Examiner finds that Prince's spring loaded mechanism is "an actuatable
release mechanism integrated into the device (spring adjustment
mechanism 50, spring housing 30a, fig. 5b) to control/release a biasing
member (a spring 40, fig. 5b) to exert a force onto a plunger (24a, fig.
5b )" (id. at 11 ).
We agree with the Examiner's reasoning and conclusion. Prince
discloses that a spring 40, i.e. a biasing member, engages the plunger 24a to
pressurize the syringe (FF 7). Thus, Prince must inherently include a release
mechanism to actuate release of the spring 40 and begin pressurization of the
syringe. Prince also discloses that the rate adjustment mechanism 50 allows
a user to "increase or decrease the force applied to the plunger 24a" (Prince
i-f 141 ). Thus, by decreasing the force applied to the plunger to zero, rate
adjustment mechanism 50 allows a user to start and stop application of force
by the biasing member (spring 40).
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Appeal2014-008939
Application 12/104,247
We affirm the rejection of claim 1 under 35 U.S.C. § 103(a). Claim
25 has not been argued separately and therefore falls with claim 1. See 37
C.F.R. § 41.37(c)(l)(iv).
Appellants separately argue claim 6, which reads as follows:
6. The imaging catheter assembly of claim 1, wherein the
release mechanism comprises a mechanism for preventing
actuation of the release mechanism unless the imaging catheter
tip is pointing downward.
Appellants argue that the references do not teach or suggest the
additional limitation of claim 6 (App. Br. 13).
We agree with Appellants. The Examiner reasoned that Crowley's
holding bracket 21 meets the claim limitation because it holds the catheter
vertical (Ans. 5---6). The Examiner also responds that Crowley discloses
"visual inspection by the user to confirm that the catheter is in the desired
fill orientation (i.e. downward)" (id. at 11-12).
As pointed out by Appellants (Appeal Br. 13), however, the claimed
mechanism is a structural feature of the catheter assembly. The Examiner's
claim interpretation of "a mechanism for preventing actuation" as being
broad enough to include visual inspection by a user is not reasonable. In
addition, Crowley's holding bracket 21 does not correspond to the broadest
reasonable interpretation of "a mechanism for preventing actuation of the
release mechanism." Thus, we reverse the rejection of claim 6.
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Application 12/104,247
Issue
III.
The Examiner has rejected claim 5 under 35 U.S.C. § 103(a) as
obvious in view of Crowley, Prince, and Prindle (Ans. 6).
The issue presented is: Would it have been obvious to one of ordinary
skill in the art to combine the imaging catheter made obvious by Crowley
and Prince with the device storage system of Prindle?
Findings of Fact
8. Prindle discloses "a surface-mountable storage system for an
auto-injection device ... [which] protects the device from damage or
accidental use" (Prindle, Abstract). "The storage system includes a base
and a cover. The base has a back surface adapted to be mounted to a
generally vertical surface" (Prindle, Abstract).
9. Figure 3 of Prindle is shown below:
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Appeal2014-008939
Application 12/104,247
Figure 3 shows Prindk~s "storage system being in the open position to
provide access to the auto-injection device" (id. at col. 3, 11. 59----61).
10. Prindle discloses that, when unlatched, "the cover 110 naturally
assumes the open position~' when the unit is mounted to a \Vall or other
vertical service (id, at coL 5~ 1L 3-9}
Analysis
The Examiner finds that "the intended use of Crowley is [to] fill the
catheter tip in a vertical position (mounting bracket 21 ... )"(Ans. 6). The
Examiner finds that Prindle discloses "a box for storing and conveniently
accessing an injection device ... wherein the box is adapted to hold the
device in a downward orientation (the box is mounted to a vertical surface,
128 .. . )"(id.). The Examiner concludes that it would have been obvious to
one of ordinary skill in the art "to provide a box for storing the system of
Crowley in a vertical orientation in order to provide the predictable result
of storage and convenient access to the device as taught by Prindle" (id,).
Appellants argue that none of the cited references teaches or suggests
a box that "is adapted to hold an imaging catheter tip in a downward
orientation when a release mechanism is actuated" (App. Br. 14).
Appellants also argue that Prindle' s "storage unit 100 is designed to prevent
use of the auto-injection device 150 when in the storage unit 100" (id.).
The Examiner responds that "the bracket of Crowley (21, fig. 7)
could be replaced by the box of Prindle to accomplish the same function
of holding the device" (Ans. 13). The Examiner reasons that "the cradle,
base, and cover can all be interpreted to be components of a 'box"' (id. at
12). The Examiner also notes that Prindle's box "has a removable cover
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Appeal2014-008939
Application 12/104,247
110 (fig. 1-3) so as to allow access to the device," e.g., to actuate a release
mechanism (id. at 13).
We agree with the Examiner's reasoning and conclusion. Prindle
discloses a storage system that protects an auto-injection device from
accidental use or damage (FFs 8-10). Thus, it would have been obvious to
use such a storage system for the catheter assembly made obvious by
Crowley and Prince, in order to protect the catheter assembly from damage
or accidental use.
Incorporating a bracket for holding the catheter assembly and catheter
tip in downward orientation, as disclosed in Crowley (FF 4), into a wall-
mounted box, as disclosed in Prindle, would allow the box to hold the
catheter tip in a downward orientation. Appellants' argument that Prindle' s
box prevents use of the device is not persuasive because, as recognized by
the Examiner, Prindle discloses that the device has a cover that can be
opened to allow access to the device (FFs 9 and 10).
Thus, we affirm the rejection of claim 5 under 35 U.S.C. § 103(a) as
obvious in view of Crowley, Prince, and Prindle.
IV.
Issue
The Examiner has rejected claims 7-12 and 31under35 U.S.C.
§ 103(a) as obvious in view of Crowley and Prindle (Ans. 6-9).
Analysis
The Examiner relies on the teachings of Crowley and Prindle that are
discussed above (Ans. 7). The Examiner concludes that "it would have
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Application 12/104,247
been obvious to one of ordinary skill in the art ... to provide a box for
storing the system of Crowley in a vertical orientation in order to provide
the predictable result of storage and convenient access to the device as
taught by Prindle" (id.). We agree.
As with the rejection of claim 5, Appellants argue that Crowley and
Prindle do not teach or suggest "a box configured to hold the imaging
catheter tip in a fill orientation," as recited in claim 7 (App. Br. 15).
As discussed above with respect to claim 5, however, we agree with
the Examiner that one of ordinary skill in the art would have appreciated that
Prindle' s storage system for a medical device would also be useful to protect
Crowley's catheter assembly from damage or accidental use. And, as also
discussed above, incorporating a bracket for holding the catheter assembly
and catheter tip in downward orientation, as disclosed in Crowley (FF 4),
into a wall-mounted box, as disclosed in Prindle, would allow the box to
hold the catheter tip in a downward orientation.
Thus, we affirm the rejection of claim 7 under 35 U.S.C. § 103(a).
Claim 12 has not been argued separately and therefore falls with claim 7.
See 37 C.F.R. § 41.37(c)(l)(iv).
Appellants separately argue claims 8 and 9, which read as follows
(emphasis added):
8. The packaging assembly of claim 7, wherein the box
comprises rounded edges which prevent the box from being
placed in an orientation other than the fill orientation.
9. The packaging assembly of claim 7, wherein the box
comprises at least one label indicating an orientation of the box
which orients the imaging catheter tip in the fill orientation.
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Application 12/104,247
The Examiner finds that Prindle " does not expressly teach providing round
edges ... or providing a label indicating an orientation of the box" (Ans.
7), but concludes that "[p ]roviding rounded comers or labels indicating an
orientation of a box are functionally equivalent to the mounting bracket of
Crowley or the mounted box of Prindle for orienting the box in the desired
direction and well-known" (id. at 7-8), and therefore "an obvious matter of
design choice" (id. at 8).
Appellants argue that "the shapes of the edges of the storage unit 100
or labeling do not appear to have any effect on the mounting and/or
orientation of the storage unit 100. Rather, it is the holes 128 that orient the
storage unit 100 in a desired orientation" (App. Br. 17). Appellants argue
that "Crowley is similarly deficient" and, "[ f]or at least these reasons ... the
examiner's reliance on functional equivalency is entirely improper" (id.).
We agree with Appellants that the Examiner has not adequately
explained how the combination of Crowley and Prindle would have made
obvious the imaging catheter packaging assemblies of claims 8 and 9.
Prindle simply discloses a wall-mountable box for storing an injection
device. Crowley discloses a bracket that holds the catheter assembly in a
vertical orientation. The Examiner has not adequately explained how either
Crowley or Prindle, or the combination thereof, would have suggested the
packaging features recited in claims 8 and 9. Thus, we reverse the rejection
of those claims.
Appellants also separately argue claim 10, which reads as follows:
10. The packaging assembly of claim 7, wherein the fill
mechanism is configured to be activated only when the imaging
catheter tip is held in the fill orientation.
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Application 12/104,247
The Examiner finds that Crowley and Prindle disclose that the fill
mechanism is "actuated only when the imaging catheter tip is held in the
fill orientation (Crowley ... visual inspection, bracket 21 ... Prindle,
mounting brackets 128 ... )" (Ans. 8).
Appellants argue that "the structural features recited by dependent
claim 10 are clearly distinguishable from visual inspection of an imaging
catheter tip ... [because] visual inspection" is not part of a fill mechanism
(App. Br. 17-18).
We agree with Appellants. Although Crowley discloses a method of
filling a catheter tip, and suggests filling the catheter tip when it is pointed
down, Crowley does not disclose or suggest a fill mechanism that can only
be activated when the catheter tip is in any particular orientation. In
addition, as discussed above with regard to claim 6, the Examiner's reliance
on visual inspection does not meet the strt1ctural limitation of claim 10.
Thus, we reverse the rejection of claim 10 under 35 U.S.C. § 103(a).
Appellants also separately argue claim 11, which reads as follows:
11. The packaging assembly of claim 7, wherein the fill
mechanism is configured to be activated while the imaging
catheter tip is held by the box.
Appellants argue that Prindle' s device 150 "is not designed to be
activated while the auto-injection device 150 is in the storage unit 100.
Instead, the storage unit 100 merely holds the auto-injection device 150 for
later use," after removal (App. Br. 18).
As discussed above, however, with respect to claims 5 and 7,
incorporating a bracket for holding the catheter assembly and catheter tip in
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Application 12/104,247
downward orientation, as disclosed in Crowley (FF 4), into a wall-mounted
box, as disclosed in Prindle, would allow the box to hold the catheter tip in a
downward orientation and allow the fill mechanism to be activated while the
catheter tip is held by the box. Prindle discloses that the device can be
accessed by opening the cover of the device. Thus, we affirm the rejection
of claim 11 under 35 U.S.C. § 103(a).
With regard to claim 31, the Examiner finds that Prindle' s "box is not
required to be attached to the wall to provide the function of orienting the
catheter in a desired direction" (Ans. 8). "[T]he box can be placed on a
surface in a vertical orientation to maintain the catheter being stored in the
fill orientation" (id. at 8-9).
Appellants argue that Prindle' s storage unit 100 is "configured to be
mounted to a wall or vertical support" and "the structure of the storage unit
100 appears to indicate some type of support is necessary." (App. Br. 19).
Appellants argue that, if the storage unit 100 was "placed on a surface in a
vertical orientation, the cover 110 would not be able to open since the
rotation of the cover 110 would be blocked by the surface" and thus "the
storage unit 100 of Prindle does not hold an imaging catheter tip in a fill
orientation (or perform any meaningful function ... ) without being attached
to a device external to the storage unit 100" (id.).
The Examiner responds that claim 31 "does not require that the box be
opened while the box is in a specific orientation." (Ans. 16).
Appellants' arguments are not persuasive. Although Prindle' s box is
designed for attachment to a wall, it is shown in Prindle's Figure 1 as having
a flat bottom on the cover and reasonably appears capable of holding an
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imaging catheter with its tip in a vertical fill orientation without being
attached to an external device. Thus, we affirm the rejection of claim 31
under 35 U.S.C. § 103(a).
SUMMARY
We reverse the rejection of claim 31 under 35 U.S.C. § 112, first
paragraph.
We affirm the rejection of clairns 1, 5, 7 ~ l l 5 125 25, and 31 under
35 U.S.C. § 103(a).
We reverse the rejection of claims 6 and 8-10 under 35 U.S.C.
§ 103(a).
TIME PERIOD FOR RESPONSE
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-IN-PART
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