Ex Parte O

Patent Trials and Appeals Board

Jun 20, 2019

13017344 - (D) (P.T.A.B. Jun. 20, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/017,344 01/31/2011
23266 7590 06/24/2019
DAUGHERTY & DEL ZOPPO CO., LP.A.
38500 CHARDON ROAD
WILLOUGBY HILLS, OH 44094
FIRST NAMED INVENTOR
John P. O'CONNOR
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.
ANA1058-US
(ANA-10-7091)
CONFIRMATION NO.
6477
EXAMINER
SIRIPURAPU, RAJEEV P
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
06/24/2019 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):
adelzoppo@dd-iplaw.com
carole@dd-iplaw.com
mwheeler@dd-iplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN P. O'CONNOR1
Appeal2018-008232
Application 13/017,344
Technology Center 3700
Before ERIC B. GRIMES, ULRIKE W. JENKS, and
ROBERT A. POLLOCK, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a portable
ultrasound apparatus, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b ).
We reverse.
STATEMENT OF THE CASE
The Specification states that the failure rate for both venipunctures
and intravenous (IV) insertions is about 20%. Spec. 1. "[T]here is an
1 Appellants identify the Real Party in Interest as Analogic Corporation.
Appeal Br. 2.
Appeal2018-008232
Application 13/017,344
unresolved need for other approaches for performing venipunctures and IV
insertions." Id.
The Specification discloses "an apparatus [that] includes an
ultrasound portion configured to acquire an image of a region of interest of a
subject ... [ and] an instrument carrying portion configured to carry and
employ an instrument to perform a procedure at the region of interest based
on the image." Id. at 2. "[I]n one instance the instrument carrying portion
can be configured to carry a syringe with a hypodermic needle connected
thereto and the ultrasound portion can be used to locate a vein of a subject in
which to inject a substance into or draw blood from." Id. at 4. The
instrument carrier can include a drive system that moves the syringe toward
the subject and retracts the syringe after use. Id. at 11.
Claims 1-9, 11-14, 26-33, 38, and 39 are on appeal. Claim 1 is
illustrative and reads as follows ( emphasis added):
1. A portable ultrasound apparatus, comprising:
a single enclosure with at least two sides, including a first side and a
second side disposed opposite the first side across a gap there
between, the single enclosure housing:
a transducer array with a transducing area, wherein the
transducer array is disposed in the first side, and the first side includes
the transducing area and a non-transducing area;
an image processor disposed between the first and the second
sides;
a display with a display area, wherein the display is disposed in
the second side, and the second side includes the display area and a
nondisplay area, wherein the transducer array and the display are
disposed opposite each other across the gap; and
an instrument carrier disposed between the first and the second
sides and configured to carry an instrument,
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Application 13/017,344
wherein the instrument carrier includes an elongated
hollow shaft with first and second ends,
wherein at least one of the first and second ends is entirely
closed and another of the first and second ends includes at least
one opening at a central region of the corresponding end, and
wherein the instrument carrier further comprises a first
drive system that physically contacts a barrel of a syringe
installed in the instrument carrier and translates the barrel of
the syringe installed in the instrument carrier.
Claims 38 and 39 are also independent and are also directed to a
portable ultrasound apparatus comprising, among other things, a first drive
system that physically contacts a barrel of a syringe and either "pushes or
pulls the barrel of the syringe" ( claim 3 8) or "advances or retracts the barrel
of the syringe" ( claim 39).
The claims stand rejected as follows:
Claims 1, 2, 6, 8, 11, 26-33, 38, and 39 under 35 U.S.C. § 103(a) as
obvious based on Walker,2 Salcudean,3 Ridley,4 and Ritchart, 5 or
alternatively based on Walker, Salcudean, Ridley, Ritchart, and Chen6 (Final
Action7 3);
Claim 3 under 35 U.S.C. § 103(a) as obvious based on Walker,
Salcudean, Ridley, and Ritchart, or based on Walker, Salcudean, Ridley,
2 Walker et al., US 2005/0154303 Al, July 14, 2005.
3 Salcudean et al., US 2004/0133168 Al, July 8, 2004.
4 Ridley et al., US 7,244,234 B2, July 17, 2007.
5 Ritchart et al., US 5,769,086, June 23, 1998.
6 Chen et al., US 6,139,496, Oct. 31, 2000.
7 Office Action mailed Oct. 10, 2017.
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Application 13/017,344
Ritchart, and Chen, and further in view of Ritchie8 and W eiss9 (Final Action
9);
Claims 4 and 5 under 35 U.S.C. § 103(a) as obvious based on Walker,
Salcudean, Ridley, and Ritchart, or based on Walker, Salcudean, Ridley,
Ritchart, and Chen, and further in view of Hjertman 10 (Final Action 9-1 O);
Claim 6 under 35 U.S.C. § 103(a) as obvious based on Walker,
Salcudean, Ridley, and Ritchart, or based on Walker, Salcudean, Ridley,
Ritchart, and Chen, and further in view of Weiss (Final Action 11 );
Claim 7 under 35 U.S.C. § 103(a) as obvious based on Walker,
Salcudean, Ridley, Ritchart, and Weiss, or based on Walker, Salcudean,
Ridley, Ritchart, Weiss, and Chen, and further in view of Ritchie (Final
Action 12);
Claim 9 under 35 U.S.C. § 103(a) as obvious based on Walker,
Salcudean, Ridley, and Ritchart, or based on Walker, Salcudean, Ridley,
Ritchart, and Chen, and further in view of Batten11 and Hjertman (Final
Action 13-14);
Claims 12 and 14 under 35 U.S.C. § 103(a) as obvious based on
Walker, Salcudean, Ridley, and Ritchart, or based on Walker, Salcudean,
Ridley, Ritchart, and Chen, and further in view of Szczech 12 (Final Action
14); and
8 Ritchie et al., US 2008/0221443 Al, Sept. 11, 2008.
9 Weiss et al., US 6,527,731 B2, Mar. 4, 2003.
10 Hjertman et al., US 6,599,272 Bl, July 29, 2003.
11 Batten et al., US 5,398,690, Mar. 21, 1995.
12 Szczech et al., US 2004/0133111 Al, July 8, 2004.
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Application 13/017,344
Claim 13 under 35 U.S.C. § 103(a) as obvious based on Walker,
Salcudean, Ridley, Ritchart, and Szczech or based on Walker, Salcudean,
Ridley, Ritchart, Szczech, and Chen, and further in view of Soldner13 (Final
Action 15).
DISCUSSION
All of the rejections on appeal depend on the combination of Walker,
Salcudean, Ridley, and Ritchart, optionally further combined with Chen. The
same issue is dispositive for all of the rejections.
The Examiner finds that Walker discloses a portable ultrasound
apparatus comprising claim l's enclosure, transducer array, image processor,
and display, as well as an instrument carrier. Final Action 3. The Examiner
finds that Chen similarly discloses a hand-held ultrasound device comprising
a housing, a transducer array, an image processor, and a display. Id. at 4-5.
The Examiner finds that Salcudean discloses an ultrasound-guided
biopsy needle device comprising an instrument carrier that includes an
elongated hollow shaft with two ends, where one of the ends is closed, as
well as a drive system configured to translate an instrument in the instrument
carrier. Id. at 4. The Examiner concludes that it would have been obvious to
combine the teachings of Walker and Salcudean "because doing so would
have automated needle delivery as a predictable and obvious substitution for
the manual needle guide of Walker" and "would have reduced the burden on
the user to actuate and place the needle in the target." Id.
13 Soldner, US 4,058,114, Nov. 15, 1977.
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The Examiner finds that Ridley also discloses an ultrasound needle
guide apparatus, where the instrument is a syringe with a barrel, a needle,
and a plunger. Id. at 5. The Examiner concludes that it would have been
obvious to combine the teachings of Walker and Ridley "because doing so
would [have] predictabl[y] provided needle access to the body as suggested
in Walker." Id.
The Examiner finds, however, that none of these references disclose a
"drive system that translates the barrel and thereby the hypodermic needle in
the instrument carrier towards the subject[] and into the vein of the subject."
Id. The Examiner finds that Ritchart discloses a "biopsy and needle
controller automated device" comprising "a first drive system that physically
contacts a barrel of a syringe in the instrument carrier and that translates the
barrel of the syringe and thereby the hypodermic needle in the instrument
carrier towards the subject[] and into the vein of the subject ... (see Fig. 1
and col 5 ln 35-59)." Id. at 6.
Id.
The Examiner concludes that it would have been obvious
to have combined the device of Walker and Ridley with the
further automated teachings of Ritchart because it has been held
that automating a system requires mere routine skill in the art
and because the Ritchart system would yield a more repeatable
and efficient biopsy of the target disclosed in Walker and
Ridley. Moreover, an automated system would reduce the work
the load [sic] on a user. Also, the drive system of Ritchart has
the additional advantage of being compact and usable in a
single enclosure device.
Appellant argues that Ritchart does not disclose a drive system that
physically contacts a barrel of a syringe, as required by the claims. Appeal
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Application 13/017,344
Br. 6. Rather, Appellant argues, "Ritchart discloses a biopsy device 10
comprising a housing 12, out of which extends a needle assembly or probe
body 14 .... The probe body 14 includes an outer piercing needle 16 having
a point 88, an inner cutter 18 having a lumen 20, a probe housing 22, and a
tissue receiving notch 24," and it is the inner cutter of Ritchart's biopsy
device that is retracted and advanced. Id.
Appellant argues that the Specification "defines a syringe as including
a cylindrical barrel configured to hold a fluid, and a plunger configured to
slide through the barrel under pressure and push the fluid out of an end of
the barrel connected to a needle and through the needle." Id. Appellant
concludes that,
[b Jased on the definition in the instant application, the inner
cutter 18 of Ritchart does not read on the claimed barrel of a
syringe as Ritchart does not disclose or suggest that the inner
cutter 18 is configured to hold a fluid and includes a plunger
configured to slide in the inner cutter 18 under pressure and
push the fluid out of an end of the inner cutter 18 connected to
the needle 16 and through the needle 16. Hence, Ritchart does
not disclose or suggest a first drive system that physically
contacts a barrel of a syringe.
Id. at 6-7. Appellant also argues that the remaining references do not make
up for Ritchart's deficiency. Id. at 7.
We agree with Appellant that the rejections on appeal are based on an
unreasonably broad interpretation of the claim language. Each of the
independent claims requires a "drive system that physically contacts a barrel
of a syringe." Claims 1, 38, 39. The Specification describes an embodiment
in which syringe 502 is loaded or installed in an instrument carrier. Spec. 11.
"The syringe 502 includes a cylindrical barrel 504 configured to hold a fluid
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such as a liquid medicine, and a plunger 506 configured to slide through the
barrel 504 under pressure and push the fluid out of an end of the barrel 504
connected to the needle 118 and through the needle 118." Id.
This description is consistent with the established meaning of a
"syringe" as a device that has a cylindrical tube ("barrel") fitted with a
plunger that can be used to push fluid out of the barrel or to pull fluid into
the barrel. The Specification's description of the syringe-containing
embodiment is also consistent with its description of the problem that gave
rise to the invention. See Spec. 1 ("The care giver ... manually insert[ s] a
needle, which is attached to a syringe, ... into the vein .... The care giver
draws back the plunger of the syringe to confirm ... whether blood is drawn
into the syringe or not.").
Ritchart discloses "an automatic control system for a vacuum-assisted
automatic core biopsy device." Ritchart 2:41-42. The "biopsy instrument 10
comprises a housing 12, out of which extends a needle assembly or probe
body 14. The probe body 14 includes a hollow outer piercing needle 16, an
inner cutter 18 having a lumen 20 (FIG. 2), a probe housing 22, and a tissue
receiving notch 24." Id. at 5:5-10. The outer piercing needle 16 can be
rotated "for the purpose of obtaining a plurality of tissue samples." Id. at
5:30-32. "[T]he housing 12 [also] includes a carriage assembly 46 for
rotating, oscillating, retracting, and advancing the cutter 18." Id. at 5:35-37.
Thus, Ritchart's device includes an outer, cylindrical body (probe
body 14, which includes hollow piercing needle 16) but that body has cutter
18 inside it, rather than a plunger that can move fluid into or out of the
hollow body. Ritchart's device, in fact, is not designed to dispense and
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Application 13/017,344
collect fluids, but to obtain tissue samples; i.e., biopsies. Ritchart's device,
therefore, does not meet the broadest reasonable definition of a "syringe," as
that term would be read by a person of ordinary skill in the art in light of
Appellant's Specification.
The Examiner cites a dictionary definition of "syringe" as meaning "a
tube for collecting blood or other liquids or for putting liquids into the body
usually through a needle that can be put under the skin." Ans. 3. The
Examiner reasons that "a skilled artisan would clearly have found that
Ritchart discloses a fluid collection tube through a needle that can be placed
under the skin." Id.
The Examiner's reasoning, however, is contrary to Ritchart's
description of its device. Ritchart states that its device is designed to obtain
tissue samples, not body fluids. In addition, the Examiner's definition states
that a syringe can also be used to put liquids into a body; the Examiner
provides no explanation of how Ritchart's device meets this aspect of the
relied-on definition.
The Examiner also reasons that the cited references would have made
obvious the claimed device even under Appellant's definition, because
"Ritchart discloses a cylindrical barrel configured to hold fluid and Ridley
discloses a cylindrical barrel configured to hold fluid and a plunger
configured to slide through the barrel under pressure to push fluid out of the
barrel connected to the needle." Ans. 4.
We are not persuaded by this reasoning, because the Examiner does
not point to any disclosure in Ritchart to support the finding that its device is
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configured to hold fluid. As discussed above, Ritchart states that its device is
designed to obtain samples of tissue, not body fluids.
The Examiner also reasons that "Salcudean and Ridley in combination
with Ritchart teach[] to a skilled artisan that a needle, syringe, and barrel can
be automatically controlled and moved with a drive system" because
Salcudean "teaches automatic control and movement of a needle and
syringe" and Ridley "discloses control of a syringe with a barrel and
plunger." Id.
We are also unpersuaded by this reasoning. Ridley discloses a
manually operated syringe inserted into an opening in an ultrasound
transducer. The Examiner has not explained why Ridley's use of the well-
known manual syringe would have led a skilled worker to modify Walker's
device as required by the claims on appeal.
Salcudean discloses a needle guidance system that includes a needle
with a steerable tip. Salcudean ,-J 12. Salcudean's "invention relates to a
needle structure comprising a hollow, outer cannula ... and a longer stylet
... having a curved portion with a pre-defined curvature adjacent to [the]
leading end" so that the sty let can be extended out of the cannula, in which
position it assumes its curved shape. Id. ,-i 15. The curved shape of the
sty let's tip allows it to be steered toward a target past an obstacle that
prevents direct access to the target. See id. ,-i 62. Salcudean's device is
designed for use in"[ m ]inimally invasive, percutaneous procedures" such as
"[b ]iopsy, delivery of localized therapy, and anesthesia." Id. ,-i 2.
The Examiner has not pointed to a disclosure in Salcudean that the
needle of its device would have been understood to be part of a syringe,
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Application 13/017,344
under the broadest reasonable interpretation of that term as understood by
those of skill in the art. Thus, we do not agree with the Examiner that
Salcudean makes up for the deficiency of Ritchart.
In summary, we conclude that the Examiner has not persuasively
shown that the combination of Walker, Salcudean, Ridley, and Ritchart
(with or without Chen) would have made obvious the claim limitation
requiring a "drive system that physically contacts a barrel of a syringe" and
"translates" the syringe ( claim 1 ), "pushes or pulls" the syringe ( claim 3 8),
or "advances or retracts" the syringe ( claim 39). The cited references
therefore do not support a prima facie case of obviousness with respect to
the independent claims, or by extension the dependent claims, on appeal. All
of the rejections on appeal rely on the combination of Walker, Salcudean,
Ridley, and Ritchart (and optionally Chen), and all of the rejections are
therefore reversed for the reasons discussed above.
REVERSED
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