Guided Therapy Systems, LLC

Patent Trials and Appeals Board

Sep 25, 2020

2020000985 (P.T.A.B. Sep. 25, 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.
13/545,931 07/10/2012 Michael H. Slayton 148534.00109.GTS078USNP 7811
26710 7590 09/25/2020
QUARLES & BRADY LLP
ATTN: IP DOCKET
411 E. WISCONSIN AVENUE
SUITE 2350
MILWAUKEE, WI 53202-4426
EXAMINER
ROZANSKI, MICHAEL T
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
09/25/2020 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):
pat-dept@quarles.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MICHAEL H. SLAYTON and PETER G. BARTHE
____________

Appeal 2020-000985
Application 13/545,931
Technology Center 3700
____________

Before ANTON W. FETTING, AMEE A. SHAH, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

FETTING, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE1
Michael H. Slayton and Peter G. Barthe (Appellant2) seeks review
under 35 U.S.C. § 134 of a final rejection of claims 7–17 and 19–30, the

1 Our decision will make reference to the Appellant’s Appeal Brief (“Appeal
Br.,” filed July 8, 2019) and the Examiner’s Answer (“Ans.,” mailed August
29, 2019) and Final Action (“Final Act.,” mailed June 7, 2018).
2 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. The Appellant identifies the real party in interest as
Guided Therapy Systems, LLC (Appeal Br. 2).

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only claims pending in the application on appeal. We have jurisdiction over
the appeal pursuant to 35 U.S.C. § 6(b).
The Appellant invented a form of acoustic treatment of tissue.
Specification para. 5.
An understanding of the invention can be derived from a reading of
exemplary claim 7, which is reproduced below (some paragraphing added).
7. A method for providing acoustic treatment of a medium, said
method comprising:
a) localizing a region of interest in the medium;
b) computing, without feedback from monitoring
parameters, a spatio-temporal treatment function, e(x,y,z,t)
that produces a desired temperature function T(x,y,z,t) in
the region of interest,
the spatio-temporal treatment function e(x,y,z,t) defining
an ultrasound intensity at the time t at distinct locations
x,y,z in the region of interest;
c) delivering acoustic energy from an energy source into the
region of interest
by controlling the energy source with spatial and
temporal parameters derived from the spatio-temporal
treatment function e(x,y,z,t),
thereby producing the desired temperature function
T(x,y,z,t) in the region of interest,
thereby triggering an effect in the region of interest.
The Examiner relies upon the following prior art:
Name Reference Date
Truckai US 6,773,409 B2 Aug. 10, 2004
Moonen US 2009/0326420 A1 Dec. 31, 2009
Gustus US 2010/0076299 A1 Mar. 25, 2010

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Claims 7–17, 19–22, and 25–30 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Moonen and Gustus.
Claims 23 and 24 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Moonen, Gustus, and Truckai.
ISSUES
The issues of obviousness turn primarily on whether the prior art
describes the claim limitations.
FACTS PERTINENT TO THE ISSUES
The following enumerated Findings of Fact (FF) are believed to be
supported by a preponderance of the evidence.
Facts Related to Appellant’s Disclosure
01. “The spatial and/or temporal control can also be facilitated
through open-loop and closed-loop feedback arrangements,
such as through the monitoring of various spatial and temporal
characteristics. As a result, control of acoustical energy within six
degrees of freedom, e.g., spatially within the X, Y and Z domain,
as well as the axis of rotation within the XY, YZ, and XZ
domains, can be suitably achieved to generate conformal
distribution of elevated temperature of variable shape, size, and
orientation. For example, through such spatial and/or temporal
control, energy source can enable the regions of elevated
temperature distribution possess controlled [sic] that is based on
the function.” Spec. para. 32.
02. “[T]he acoustic energy source 102 may be programmable to
perform predictable and/or repeatable spatial and temporal energy
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transduction with or without feedback from a variety of
monitoring parameters, such as tissue parameters, pressure,
amplitude, energy absorption, and attenuation.” Spec. para. 64.
Facts Related to the Prior Art
Moonen
03. Moonen is directed to the treatment of biological tissue using
hyperthermia. Moonen para. 1.
04. Moonen describes therapies using local hyperthermia as locally
heating a target area or region of a biological tissue. When this
type of therapy is used for gene therapy, the heat may be used for
its action on a heat-sensitive promoter for example. Heat can also
be used to necrotize biological tissue and for tumor ablation.
Moonen para. 2.
05. Moonen describes a thermal treatment device as follows: the
spatial distribution of the treatment points is three-dimensional;
the control unit can determine the spatial and energy distribution
of the treatment points to be performed in relation to a spatial
distribution of required energy defined by a temperature
regulation system to treat the target region; the control unit can
determine the spatial distribution of required energy to treat the
target region according to a Proportional-Integral-Derivative
regulation system [such a system by definition incorporates
feedback]; determining the spatial and energy distribution of the
treatment points to be performed comprise deconvolution means
the spatial distribution of required energy to treat the target region,
using a spatial energy distribution characteristic of one treatment
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point; determining the spatial and energy distribution of the
treatment points to be performed comprise means to determine the
treatment point corresponding to the maximum spatial distribution
of remaining energy to treat the target region, the spatial
distribution of remaining energy corresponding to the spatial
distribution of required energy to treat the target region subtracted
by the spatial energy distributions characteristic of the previous
treatment points; the control unit can determine the spatial and
energy distribution of the treatment points to be performed, such
that

Moonen paras. 21–27.
06. Moonen describes
the control unit controlling the energy provided by the energy
generating means in relation to a time-shifted temperature regimen
for each treatment point. Moonen para. 29.
07. Moonen describes temperature mapping including the area to be
heated as carried out by MRI. This is particularly dedicated to the
monitoring of temperature maps and guiding of the ultrasound
system. On the basis of this data, the position and intensity of the
next focusing points are evaluated on the basis of the anatomical
and thermal maps. The coordinates and the power of the next
focal points are transmitted to energy generating means. A
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generator produces and amplifies the ultrasound electric signals
that are phase-shifted so that the matrix transducer connected
thereto emits an ultrasound wave focused on the chosen focal
point P. The rise in temperature induced inside the focusing point
therefore allows the thermal dose to be obtained that is needed to
achieve necrosis. Moonen paras. 75–77.
08. Moonen describes electronic shifting of the focal point, as
compared with mechanized shifting of the transducer, as most
useful for controlling temperature spatially, because it allows
travel over a large number of points to be heated per second. In
addition, since the transducer remains immobile, this movement of
the focal point does not create any imaging artefact related to
change in magnetic susceptibility. Electronic moving of the
focusing point does not have any limitations regarding speed but,
the electric signal generator used requires a certain time for data
transfer before switching all the paths to the new desired value.
Therefore, there is a minimum time between each change in the
position of the focal point. Moonen paras. 83–84.
09. Moonen describes testing the principle of electronic shifting of
the focal point and proper functioning of the matrix transducer by
moving the focusing point 4 points around a square with sides of 8
mm. This trajectory was repeated cyclically every 0.5 s by
changing the position of the focusing point every 125 ms with a
constant electric power of 200 W. By simultaneously conducting
5 slices of 4 mm (echo time 18 ms) every 3.9 s, the heating
observed in FIGS. 6a to 6b appears to derive from 4 focusing
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points simultaneously. This method of moving the focal point is
very rapid since there is no longer any maximum displacing speed
but just a minimum electronic signal switching time of 60 ms with
the generator used. This technique is also very accurate. Moonen
paras. 113–114.
10. Moonen describes the spatial distribution of the set temperature
as generally chosen to be uniform over the entire tumour, and zero
outside thereof, for the purpose of obtaining homogeneous
treatment of the target region whilst best protecting adjacent
tissues. Therefore, the temperature schedule is a square function
whose amplitude varies according to the previously defined set
time. Moonen para. 163.
Gustus
11. Gustus is directed to treatment for luminal diseases, particularly
for atherosclerotic plaque, vulnerable or “hot” plaque, and the
like. Gustus para. 4.
12. Gustus describes inducing desirable temperature effects on
body tissue using non-RF energy. The desirable temperature
effects include mildly heating the tissue for treating
atherosclerotic lesions and other disease states. Gustus para. 11.
13. Gustus describes using an ultrasound energy source. Gustus
para. 16.
14. Gustus describes adjusting the treatment energy in response to
feedback from the tissue analyzer during heating of the body
tissue. Gustus para. 21.
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15. Gustus describes adjusting or tuning the energy to gently heat
the atherosclerotic materials. Characteristics of the energy,
including the frequency, power, magnitude, delivery time,
delivery location, and/or patterns or combinations thereof may be
predetermined before diagnosis or treatment of a specific patient,
the energy characteristics being transmitted without feedback,
such as by employing open-loop dosimetry techniques. Such
predetermined characteristic tuning may be based on prior
treatment of atherosclerotic materials, prior clinical trials, and/or
other development work. Some embodiments may tune the
energy directed to a particular patient based on in situ feedback,
and many embodiments may employ some predetermined
characteristics with others being feedback-controlled. Gustus
para. 100.
ANALYSIS
Claims 7–17, 19–22, and 25–30 rejected under 35 U.S.C. § 103(a) as
unpatentable over Moonen and Gustus
Claims 7 and 25 are the only claims argued on their own merits. The
remaining claims are argued from the patentability of independent claim 7.
The issue surrounding claim 7 is whether the art describes or shows to be
predictable the “without feedback” limitation in step (b). We begin by
construing claim 7 and limitation (b).
Claim 7 recites three steps and a result. The steps are: (a) localizing a
region of interest; (b) computing, without feedback from monitoring
parameters, a spatio-temporal treatment function; and (c) delivering acoustic
energy from an energy source into the region of interest by controlling the
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energy source with spatial and temporal parameters derived from the spatio-
temporal treatment function. The result is producing the desired temperature
function T(x,y,z,t) in the region of interest, thereby triggering an effect in the
region of interest.
In particular, step (b)’s computing a treatment function is separate
from step (c)’s delivering the energy. It is step (b) that recites “without
feedback.” That is, the claim requires that the computation be done without
feedback. Step (c), i.e., the delivery of acoustic energy, itself is silent as to
feedback.
We know that the “without feedback” limitation modifies
“computing” because that phrase immediately follows the word
“computing.” The treatment function that is computed in step (b) provides
the spatial and temporal parameters recited in step (c) that are used in
controlling the energy source that delivers the acoustic energy. The claim is
silent as to the relationship between the parameters recited in step (c) and the
use of feedback in the control of the energy source to deliver energy in the
region of interest. Thus, for example the claim does not preclude monitoring
the energy intensity being delivered in the region of interest to provide
feedback so as to ensure an appropriate treatment. The Specification is of
little help as to construing the computing “without feedback” limitation, as it
only refers to feedback in paragraphs 28, 32, and 64, and there only to apply
feedback or lack thereof to the equivalent of step (c).3 The Specification
describes no particular benefit or unexpected result to either using or not

3 The “without feedback” limitation was added to claim 7 by amendment
filed May 22, 2015.
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using feedback. Thus, the Specification does no more than inform one that
either modality is possible.
Thus, step (b) is construed as computing a spatio-temporal treatment
function e(x,y,z,t) that produces a desired temperature function T(x,y,z,t) in
the region of interest which function is used to determine space and time
parameters for step (c). The spatio-temporal treatment function e(x,y,z,t)
defines an ultrasound intensity at the time t at distinct locations x,y,z in the
region of interest. The computation is performed without feedback from
monitoring parameters.
We also note for purposes of our analysis below, that the delivery in
step (c) is of a generalized acoustic energy to some unspecified medium, that
may be part of something living or non-living, to achieve some unspecified
effect. Although, the preamble recites that it is a method for providing
acoustic treatment of a medium, neither the preamble nor the body of the
clam specifies the treatment other than that it arises from acoustic energy
delivery.
The Examiner determines that Moonen describes all of claim 7 except
for the absence of feedback. The Examiner further determines that Gustus
describes similarly computing and applying an energy treatment function,
with the option of using or not using feedback. Final Act. 2–3. These
determinations are undisputed. Instead, the Appellant contends no one
would combine the two references in the manner the Examiner suggests
because the manner in which Moonen applies its energy relies on feedback
“to provide treatment of biological tissue without significantly heating
tissues adjacent to the focused area.” Appeal Br. 9. The Appellant
concludes that “the proposed modification would render Moonen
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unsatisfactory for its intended purpose and the proposed modification or
combination changes the principle of operation of Moonen.” Id. at 9–10.
We do not find this argument persuasive. Moonen’s principle of
operation is using the ability to electronically direct the focus of ultrasound
without moving the transducer, instead moving the focus of the emanated
energy using some function in space and time. The programming of such
movement is by definition of space and time a function of the form
e(x,y,z,t).
Moonen describes the application of the foregoing in the context of
using hyperthermia to necrotize tumors. In such a setting, feedback provides
a measure of protection to ensure only certain targeted tissue is treated.
However, Moonen describes proof of concept type testing to show
that the focal point can be electronically moved in some test medium
according to some space and time formula to achieve an effect in a region of
interest. FF 09. In such a setting, there is no safety concern as with
necrotizing tumors, and thus feedback is not required. Furthermore,
Appellant’s claim 7 broadly encompasses Moonen’s proof of concept testing
where feedback is not necessary.
In short, the problem with Appellant’s argument is that it does not
consider the full extent of the teachings in Moonen and does not take into
account the breadth of claim 7.
It is generally obvious to remove a step where the function of the step
is not needed. In re Kuhle, 526 F.2d 553, 555 (CCPA 1975) (deleting a
prior art switch member and thereby eliminating its function was an obvious
expedient). It would not be necessary to add the feedback equipment and
attendant cost to simply test the accuracy of applying Moonen’s function as
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Moonen does. All of claim 7’s limitations are met during such testing on
non-living target matter. Thus, we find the Appellant’s arguments
unpersuasive.
Dependent claim 25 additionally recites “the spatio-temporal
treatment function, e(x,y,z,t) is e = a(t) [u(x - x1) - u(x - x2)] [u(y - y1) -
u(y - y2)] [u(z - z1) - u(z - z2)] g(x,y,z), where u(y) is a step function, a(t)
represents the time excitation, and g(x,y,z) represents the spatial
modulation within the regions bound by [x1, x2}, [y1, y2], and [z1, z2].”
A step function is in general a constant non-zero value over some range and
zero elsewhere. Thus, it essentially masks some other function to which it is
applied to narrow the scope of that function. Although this formula is
expressed as an equality suggesting precision, the expression of both time
and spatial modulation as generalized functions of unrestricted scope means
this expression is ultimately that of masking these functions according to
spatial coordinates for each specific set of (x, y, z) coordinates.
The Examiner applies Moonen paragraph 163 (Final Action 6), to
which the Appellant correctly contends that this paragraph describes a
temperature function rather than a treatment function. Appeal Br. 21–22.
We agree with the Examiner’s answer that
the square function in [0163] is defined for a ‘temperature
schedule’ and this is in reference to the ‘spatial distribution of
the set temperature’, which is the treatment function. As such,
the Examiner understands that the temperature schedule is a
parameter that is a part of the treatment function, which is
defined by which an energy distribution reaches a temperature
[0029]. Any ‘temperature function’ would be defined as the
result of the energy distribution in tissue, which corresponds to
the claim 7 limitation that merely sets forth that the treatment
function f(x,y,z,t) produces a desired temperature function
T(x,y,z,t). Since the temperature function is a result or an
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application of a treatment function, the step function in [0163]
of Moonen relates to the treatment function.
Ans. 9.
Claims 23 and 24 rejected under 35 U.S.C. § 103(a) as unpatentable over
Moonen, Gustus, and Truckai
These claims are not separately argued.
CONCLUSIONS OF LAW
The rejection of claims 7–17, 19–22, and 25–30 under 35 U.S.C.
§ 103(a) as unpatentable over Moonen and Gustus is proper.
The rejection of claims 23 and 24 under 35 U.S.C. § 103(a) as
unpatentable over Moonen, Gustus, and Truckai is proper.
CONCLUSION
The rejection of claims 7–17 and 19–30 is affirmed.
In summary:
Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
7–17, 19–22,
25–30
103(a) Moonen,
Gustus
7–17, 19–22,
25–30

23, 24 103(a) Moonen,
Gustus,
Truckai
23, 24
Overall Outcome 7–17, 19–30

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2011).
AFFIRMED