THE REGENTS OF THE UNIVERSITY OF MICHIGAN

Patent Trials and Appeals Board

Dec 30, 2020

2020003671 (P.T.A.B. Dec. 30, 2020)

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.
15/713,441 09/22/2017 Zhen XU 10860-513.300 / UM-5538 7025
66854 7590 12/30/2020
SHAY GLENN LLP
2929 CAMPUS DRIVE
SUITE 225
SAN MATEO, CA 94403
EXAMINER
KELLOGG, MICHAEL S
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
12/30/2020 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 ZHEN XU, RYAN M. MILLER,
ADAM D. MAXWELL, and CHARLES A. CAIN
____________

Appeal 2020-003671
Application 15/713,441
Technology Center 3700
____________

Before DANIEL S. SONG, BENJAMIN D. M. WOOD, and
WILLIAM A. CAPP, Administrative Patent Judges.

CAPP, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 seeks our review under 35 U.S.C. § 134(a) of the final
rejection of claims 1–6. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies The Regents of the University of
Michigan as the applicant and real party in interest. Appeal Br. 2.
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Application 15/713,441
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THE INVENTION
Appellant’s invention relates to therapeutic ultrasound. Spec. ¶ 4.
Claim 1, reproduced below, is illustrative of the subject matter on appeal.
1. A method of monitoring Doppler-based feedback during
Histotripsy treatment comprising the steps of:
transmitting Histotripsy pulses into a target tissue to
generate a cavitation bubble cloud in the target tissue, the
Histotripsy pulses having a pulse length less than 50 μsec, a
peak negative pressure greater than 10 MPa, and a duty cycle
less than 5%;
transmitting Doppler ultrasound imaging pulses into the
target tissue after the cavitation bubble cloud collapses;
monitoring a coherent motion along a direction of the
transmitted Histotripsy pulses with the Doppler ultrasound
imaging pulses;
analyzing a Doppler velocity of the Doppler ultrasound
imaging pulses to quantitatively predict a level of tissue
fractionation in the target tissue in real-time; and
displaying a Doppler velocity map to provide real-time
imaging feedback of the tissue fractionation in the target tissue.
THE REJECTIONS
The Examiner relies upon the following as evidence in support of the
rejections:
NAME REFERENCE DATE
Cain US 2008/0319356 A1 Dec. 25, 2008
Maxwell US 2009/0177085 A1 July 9, 2009
Xu Non-Patent Literature2 Feb. 16, 2010

2 Non-Invasive Creation of an Atrial Septal Defect by Histotripsy in a
Canine Model, NIH Public Access Author Manuscript.
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The following rejections are before us for review:
1. Claims 1 and 3–6 are rejected under 35 U.S.C. § 102(b) as
anticipated by Maxwell.
2. Claim 2 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Maxwell and Cain.
3. Claim 5 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Maxwell.
4. Claim 6 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Maxwell and Xu.
OPINION
Anticipation of Claims 1 and 3–6
by Maxwell
Claim 1.
The Examiner finds that Maxwell discloses each and every limitation
of the invention. Final Act. 4–6. In particular, the Examiner finds that
Maxwell discloses monitoring a coherent motion along a direction of
transmitted Histotripsy pulses with Doppler ultrasound imaging pulses. Id.
at 5.
Appellant argues, among other things, that Maxwell does not use
Doppler ultrasound imaging feedback to monitor coherent motion along a
direction transmitted Histotripsy pulses. Appeal Br. 4. Appellant argues
that Maxwell’s therapy transducer is oriented perpendicular to a blood vessel
and that, therefore, the direction of transmitted Histotripsy pulses is also
perpendicular to the blood vessel. Id. Appellant argues that Maxwell fails
to disclose using Doppler technology to monitor motion in the claimed
direction. Id.
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In response, the Examiner directs our attention to Figure 1 of Maxwell
and states that such drawing shows a therapy transducer and an ultrasound
imaging probe that appear to be oriented in substantially the same direction.
Ans. 9–12. The Examiner states that such orientation evidences that
Doppler monitoring occurs in the same direction as the Histotripsy pulses
from the therapy transducer. Id.
[T]he ultrasound imaging probe is centered and concentric
within the therapy transducer such that even if (arguendo, as
this is never stated in any portion of Maxwell) the focus of the
Doppler imaging pulses is slightly askew from the focus of the
Histotripsy pulses these will still be directed to the same area
(target vessel) which is along the same direction.
Id. at 10.
Determining whether claims are anticipated involves a two-step
analysis. In re Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012). The
first step involves construction of the claims of the patent at issue. Id.
“During examination, ‘claims ... are to be given their broadest reasonable
interpretation consistent with the specification, and ... claim language should
be read in light of the specification as it would be interpreted by one of
ordinary skill in the art.”’ Id. (quoting In re Am. Acad. of Sci. Tech. Ctr.,
367 F.3d 1359, 1364 (Fed. Cir. 2004)). The second step of an anticipation
analysis involves comparing the claims to prior art. Id. A prior art reference
anticipates a patent claim under 35 U.S.C. § 102(b) if it discloses every
claim limitation. Id.
Properly construed – “monitoring a coherent motion along a direction
of the transmitted Histotripsy pulses with the Doppler ultrasound imaging
pulses” – requires that the Doppler monitoring ultrasound imaging pulses are
oriented in the same direction as the Histotripsy therapy pulses. In that
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Application 15/713,441
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regard, the Examiner’s finding that Maxwell’s blood flow, being bounded by
a vessel, is “coherent” in the claimed direction is in error. Final Act. 5.
Maxwell is directed to the use of Histotripsy as therapy for blood
clots. Maxwell, Abstract. In a manner that is substantially similar to the
claimed invention, Maxwell employs a therapy transducer to place a high
intensity ultrasound beam on a blood clot. Id. Maxwell’s process employs
mechanisms that include cavitation, mechanical fractionation, or thermal
processes. Id. Maxwell’s Histotripsy process involves the creation and
maintenance of microbubbles in the form of a bubble cloud. Id. ¶¶ 31–33,
and 50. Maxwell uses Doppler ultrasound to provide feedback and confirm
restoration of blood flow. Id. ¶ 33.
Maxwell explains that feedback is important in determining if
initiation of cavitation has occurred. Id. ¶ 46. Maxwell teaches that
feedback and monitoring includes monitoring changes in (1) backscatter
from bubble clouds; (2) speckle reduction in backscatter; (3) acoustic
emissions, and (4) ultrasound Doppler. Id. ¶ 53. Maxwell teaches the use of
ultrasound Doppler to measure the blood flow in a vessel downstream of the
blot clot treatment location. Id. ¶ 56. Restoration of the blood flow is the
indication of treatment completion. Id.
We are unable to find any factual basis in the record to support the
Examiner’s finding that Maxwell monitors coherent motion in the claimed
direction. We agree with Appellant that the direction of blood flow in a
treated vessel is substantially perpendicular to Maxwell’s Histotripsy pulses.
Appeal Br. 4–5. There is no support in Maxwell’s Specification to support
the Examiner’s interpretation of Figure 1 whereby the Ultrasound Imaging
Probe purportedly uses Doppler technology to monitor coherent motion in
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the claimed direction. Ans. 10–12. A person of ordinary skill in the art
would understand that Doppler ultrasound can be used to detect movement
and, therefore, measure blood flow without necessarily monitoring motion
along a direction of substantially parallel Histotripsy pulses.3 Even if we
were to find that Maxwell’s Ultrasound Imaging Probe employs Doppler
technology to measure movement (we do not), we are not inclined to agree
with the Examiner’s finding that Maxwell’s Ultrasound probe measures
movement in the claimed direction.
In view of the foregoing, we determine that the Examiner’s findings
of fact are not supported by a preponderance of the evidence. Consequently,
we do not sustain the Examiner’s anticipation rejection of claim 1.
Claims 3–6
Claims 3–6 depend from claim 1. Claims App. The Examiner’s
rejection of these claims suffers from the same infirmity that we have
discussed above with respect to claim 1. For the same reason, we do not
sustain the rejection of claims 3–6.
Unpatentability of Claims 2, 5, and 6
These claims depend from claim 1 and are rejected over Maxwell,
either alone, or in combination with various other references. See Final
Act. 8–13. We have reviewed the additional cited art and the Examiner’s
findings and determine that these additional references do not cure the
deficiencies we have noted above with respect to the rejection of claim 1.

3 Even a lay person understands that you can discern an acoustic Doppler
shift from, for example, a moving train even though the listener is located
away from the train tracks and, therefore, is not receiving sound waves that
are traveling in precisely the same direction as the train.
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Moreover, the Examiner provides no persuasive reasoning to support
modifying the prior art to achieve the claimed invention for purposes of an
obviousness analysis. Id. Consequently, we do not sustain the rejection of
claims 2, 5, and 6.
CONCLUSION
Claims
Rejected
§ References Affirmed Reversed
1, 3-6 102(b) Maxwell 1, 3-6
2 103(a) Maxwell, Cain 2
5 103(a) Maxwell 5
6 103(a) Maxwell, Xu 6
Overall
Outcome
1-6

REVERSED