Ex Parte Maxwell et al

Patent Trial and Appeal Board

Jul 30, 2018

12358549 (P.T.A.B. Jul. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/358,549 01/23/2009
66854 7590
SHAY GLENN LLP
2755 CAMPUS DRIVE
SUITE 210
SAN MATEO, CA 94403
08/01/2018
FIRST NAMED INVENTOR
Adam Maxwell
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.
10860-508.200 I UM-3916 2726
EXAMINER
NGUYEN, HIEN NGOC
ART UNIT PAPER NUMBER
3737
NOTIFICATION DATE DELIVERY MODE
08/01/2018 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):
info@shayglenn.com
shayglenn_pair@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ADAM MAXWELL, ZHEN XU,
HITINDER S. GURM, and CHARLES A. CAIN
Appeal2017-005503
Application 12/358,549 1
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal2 under 35 U.S.C. § 134(a) involves claims 1-10, 20-22,
and 24 (App. Br. 2; see also Office Act. 3 1 ). Examiner entered a rejection
under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellants identify "The Regents of the University of Michigan" as the
real party in interest (App. Br. 2). In addition, Appellants state that "[t]he
Government also has certain rights in the invention by virtue of a
confirmatory license to the National Institutes of Health" (id.).
2 This Appeal is related to Appeal 2012-009485, Application 12/358,549,
Opinion affirming-in-part mailed August 13, 2015.
3 Non-Final Office Action mailed March 11, 2016.
Appeal2017-005503
Application 12/358,549
STATEMENT OF THE CASE
Appellants' disclosure relates "to ultrasound therapy and, more
particularly, [] to methods and apparatus for performing 'thrombolysis,' ...
in a safe, effective, noninvasive manner using direct image guidance" (Spec.
,r 2). Appellants' independent claims 1 and 20 are representative and
reproduced below:
1. A method for controlled mechanical fractionation of a
thrombus, said method comprising:
outputting an initiation ultrasound pulse sequence from a
therapy transducer resulting in cavitation forming a targeting
bubble cloud;
detecting a location of said targeting bubble cloud to
define a treatment region; and
aligning said therapy transducer such that said treatment
region is aligned with the thrombus.
(App. Br. 9.)
20. A method for acoustic manipulation of at least a fragment
of a thrombus, said method comprising:
outputting an initiation ultrasound pulse sequence from a
transducer resulting in cavitation forming a bubble cloud within
a predetermined volume;
detecting a location of the bubble cloud; and
actuating said transducer such that the fragment of the
thrombus is spatially positioned within said predetermined
volume in response to the location of said bubble cloud.
(Id. at 10.)
2
Appeal2017-005503
Application 12/358,549
The claims stand rejected as follows:
Claims 1-10, 20-22, and 244 stand rejected under 35 U.S.C. § I03(a)
as unpatentable over the combination of Xu, 5 Grandia, 6 Rabiner, 7 and
Appellants' Admitted Prior Art. 8
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
ANALYSIS
Examiner finds that Xu discloses Appellants' claimed invention, but
for, "detecting a location of said targeting bubble cloud to define a treatment
region; and aligning said therapy transducer such that said treatment region
is aligned with the thrombus" (Ans. 3). Examiner relies on Grandia,
Rabiner, and Appellants' Admitted Prior Art to make up for the foregoing
deficiencies in Xu (id.). Specifically, Examiner finds that:
Grandia discloses detecting a location of [a] targeting bubble
cloud to define a treatment region (see col. 3, lines 25-30 and
Fig. 3, the imaging means and hydrophone are used to detect
bubble cloud/cavitation to define a treatment region). Rabiner
discloses aligning [a] therapy transducer such that said
treatment region is aligned with the thrombus (see Fig. 8,
4 Examiner's statement of the rejection includes Appellants' canceled claim
23 (see Office Act. 3; cf App. Br. 11; Office Act. 1 ("Claims(s) 1-10, 20-22
and 24 is/are pending in the application")). We did not include canceled
claim 23 in our deliberations.
5 Xu et al., Controlled ultrasound tissue erosion: The role of dynamic
interaction between insonation and microbubble activity, 117 (1) J. Acoust.
Soc. Am. 424--435 (2005).
6 Grandia et al., US 5,827,204, issued Oct. 27, 1998.
7 Rabiner et al., US 2003/0236539 Al, published Dec. 25, 2003.
8 Examiner finds that Appellants admit that a "method of initiating,
maintaining and control[ing] cavitations has been developed" (Office Act. 3,
citing Spec. ,r 13).
3
Appeal2017-005503
Application 12/358,549
[0018], [0020], [0030] and [0075]; ultrasound probe 15 is
aligned with thrombus 16). Appellant's specification paragraph
[0013] admits that method of initiating, maintaining and control
cavitations had been developed.
(Office Act. 3 (alteration original).)
Based on the combination of Xu, Grandia, Rabiner, and Appellants'
Admitted Prior Art, Examiner concludes that, at the time Appellants'
invention was made, it would have been prima facie obvious "to modify Xu
to detect a location of [a] targeting bubble cloud to define a treatment region
and aligning [a] therapy transducer such that [a] treatment region is aligned
with the thrombus as taught by Grandia and Rabiner because this would
improve the efficiency of the treatment" (Office Act. 3). We are not
persuaded that the evidence, as relied upon by Examiner, makes obvious
Appellants' claimed invention or supports Examiner's conclusion.
Each of Appellants' independent claims 1 and 20 require: (1) the
initiation of an ultrasound pulse sequence from a transducer to form a bubble
cloud that defines a treatment region or has a predetermined volume; (2)
detecting the location of the bubble cloud; and (3) aligning, actuating, or
simply moving the transducer to align the treatment region or predetermined
volume with a thrombus (see App. Br. 9 and 10).
Examiner concedes that Xu fails to disclose "detecting a location of
[a] targeting bubble cloud to define a treatment region; and aligning [a]
therapy transducer such that said treatment region is aligned with the
thrombus" (Ans. 3). To make up for this deficiency, Examiner relies upon,
Grandia and Rabiner. Notwithstanding Examiner's assertion to the contrary,
however, neither Grandia nor Rabiner disclose the subject matter missing
from Xu.
4
Appeal2017-005503
Application 12/358,549
Examiner finds that Rabiner illustrates an ultrasound probe aligned
with a thrombus and, therefore, discloses that a device, such as a transducer,
may be moved to a location of interest (see Office Act. 3 ( citing Rabiner
,r 75 and FIG. 8); Ans. 3 and 9). Examiner, therefore, reasons that
"[m]oving [a] transducer to align the transducer with the treatment target to
improve treatment accuracy is a fundamental concept in the art that an
ordinary physician should have as common knowledge" (Ans. 9). We agree.
The issue on this record, therefore, distills down to how a person of
ordinary skill in this art would go about aligning a transducer with a
treatment target. Examiner addresses this issue by relying on Grandia'
Figure 3 and disclosure at column 3, lines 25-30 (see Office Act. 3; Ans. 3
and 8). Grandia's FIG. 3 is a block diagram representation
of a noninvasive surgical apparatus ... [that] includ[es] a
transmitter, used for transmitting a high power modulated
ultrasound wave into a medical target region, cavitation sensor
means for monitoring and optimizing formation of cavitation in
the target region and providing feedback to the transmitter, and
an imaging means for allowing visualization of the medical
target during treatment.
(Grandia 3: 35--42; id. at 11. 58-59; see also id. at 11. 25-30 ("Medical
apparatus in accordance with ... [Grandia's] invention preferably includes a
three part system comprising a high powered focusing transmitter, a
cavitation sensor and imaging means for allowing visualization of the
medical target area during treatment").)
Given the foregoing, Examiner reasons that "[i]t would make more
sense to see that Grandia discloses implicitly [ or even inherently with
knowledge of bubble cloud/ cavitation formation] the detection of
location/position of the bubble clouds since most physicians would more
than likely monitor the whereabouts of the bubble clouds as it focuses higher
5
Appeal2017-005503
Application 12/358,549
energy into a patient's body" (Ans. 8 (alteration original)). Even if
Examiner's reasoning were correct, Examiner failed to establish that the
combination of Xu, Grandia, Rabiner, and Appellants' Admitted Prior Art[9J,
makes obvious Appellants' claimed invention that requires: (1) the initiation
of an ultrasound pulse sequence from a transducer to form a bubble cloud
that defines a treatment region or has a predetermined volume; (2) detecting
the location of the bubble cloud; and (3) aligning, actuating, or simply
moving the transducer to align the treatment region or predetermined
volume with a thrombus (see App. Br. 9 and 10). To the contrary, Grandia
discloses that cavitation monitoring "is performed during positioning of the
focal zone in the target region, in other words, during the surgical
operation" (Grandia 7: 20-22 (emphasis added)).
Thus, Grandia discloses the use of cavitation monitoring to define a
focal zone after the transducer is located in a target region, which, absent
evidence to the contrary, is distinct from the requirements of Appellants'
claimed invention (see App. Br. 4--7; Reply Br. 2--4). In sum, Examiner
failed to establish an evidentiary basis to support a conclusion of
obviousness. In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) ("rejections on
obviousness grounds cannot be sustained by mere conclusory statements;
instead, there must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness").
9 Examiner finds that Appellants' admit that methods of initiating,
maintaining and controlling cavitation are known in the art (see Office Act.
3).
6
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Application 12/358,549
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness. The rejection of claims 1-10 and 20-
24 under 35 U.S.C. § 103(a) as unpatentable over the combination of Xu,
Grandia, Rabiner, and Appellants' Admitted Prior Art is reversed.
REVERSED
7