Guided Therapy Systems, LLC

Patent Trials and Appeals Board

Dec 23, 2021

2020006310 (P.T.A.B. Dec. 23, 2021)

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.
15/094,774 04/08/2016 Peter G. Barthe 148534.00339.GTS114USNP 3537
26287 7590 12/23/2021
Quarles & Brady LLP/Guided Therapy Systems, LLC
Attn: IP Docket
411 E. WISCONSIN AVE
SUITE 2400
MILWAUKEE, WI 53202-4428
EXAMINER
CWERN, JONATHAN
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
12/23/2021 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):
l.ruggiero@guidedtherapy.com
pat-dept@quarles.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

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

Appeal 2020-006310
Application 15/094,774
Technology Center 3700
____________

Before CHARLES N. GREENHUT, BENJAMIN D. M. WOOD, and
GEORGE R. HOSKINS, Administrative Patent Judges.

HOSKINS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision rejecting claims 1–8 and 16–20 in this application.
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. The Appeal Brief identifies Guided Therapy Systems,
LLC as the real party in interest. Appeal Br. 2.
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CLAIMED SUBJECT MATTER
Claim 1 illustrates the claims on appeal, and it recites, with our
emphases added:
1. An ultrasound treatment system comprising:
an ultrasound probe having a transducer and a contact
surface, the ultrasound probe movable by a user along a
treatment surface in an arbitrary surface pattern while
maintaining contact between the contact surface and the
treatment surface;
a controller operably coupled to the ultrasound probe, the
controller, in use, controlling the emission of therapeutic
ultrasound energy from the ultrasound probe; and
a power supply operably coupled to the ultrasound probe
and that, in use, provides power to the ultrasound probe
sufficient for the emission of the therapeutic ultrasound energy,
the ultrasound probe transmitting the therapeutic
ultrasound energy into a treatment pattern beneath the
treatment surface that mimics the arbitrary surface pattern.
Appeal Br. 20 (Claims App.).
REJECTIONS ON APPEAL
Claims 1, 3–7, and 16–18 are rejected under 35 U.S.C. § 102(a)(1) as
anticipated by Slayton (US 2012/0165668 A1, pub. June 28, 2012). See
Final Act. (Aug. 6, 2019), 3.
Claims 2, 7, 8, 17, 19, and 20 are rejected under 35 U.S.C. § 103 as
unpatentable over Slayton alone. See Final Act. 4, 5.
Claims 7, 8, and 19 are rejected under 35 U.S.C. § 103 as
unpatentable over Slayton in view of Towe (US 2015/0306429 A1, pub.
Oct. 29, 2015) or Talish (US 5,003,965, iss. Apr. 2, 1991). See Final Act. 5.
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OPINION
A. Anticipation by Slayton
We summarize the disclosure of Slayton2, then we consider the
Examiner’s rejection of Appellant’s claims as anticipated by Slayton.
1. Slayton Disclosure
Slayton discloses methods of directing therapeutic ultrasound energy
to injured fibrous soft tissue to create a thermally induced biological effect.
Slayton, code (57). Figures 11 and 12 of Slayton are reproduced here:

Figures 11 and 12 are front views of two embodiments of a handheld
ultrasound probe 105, both of which comprise enclosure 78 that houses
transducer 75 for emitting therapeutic ultrasound energy, and position
sensor 107 for monitoring the position of probe 105. Id. ¶¶ 27–28, 186–187,
189. “[E]nclosure 78 is designed for comfort and control while used in an
operator’s hand” to move probe 105 across a subject’s skin surface
underneath tip 88 of probe 105. Id. ¶¶ 187, 189.

2 “Slayton is Appellant’s own prior art.” Appeal Br. 5; compare Slayton,
codes (73) & (75), with Application Data Sheet (filed Apr. 8, 2016) (naming
same two inventors, Michael H. Slayton and Peter G. Barthe, and same
assignee Guided Therapy Systems, LLC).
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Such movement is illustrated in Figure 7 of Slayton, reproduced here:

Figure 7 is a cross-sectional view of probe 105 disposed on skin surface 104
to emit therapeutic ultrasound energy 120 through tissue layers 102, 106,
108, 110 and into fibrous soft tissue layer 112. Id. ¶¶ 23, 150–152. “In
some embodiments, ultrasound probe 105 can be moved in at least one
direction 114 to provide a plurality of lesions 25 in fibrous soft tissue
layer 112.” Id. ¶ 152.
“[A] plurality of lesions 25 can be placed in a pattern in a portion of
fibrous soft tissue layer 112, such as, for example, a 1-D pattern, a 2-D
pattern, a 3-D pattern, or combinations thereof.” Id. Thus, “[i]n one
embodiment, ultrasound probe 105 comprises a single transducer
element [75] and while emitting therapeutic ultrasound energy 120 in a
pulsed matter, is moved in a linear motion along skin surface 104 to create a
1-D pattern of a plurality of lesions 25.” Id. ¶ 143. In another embodiment,
“probe 105 comprises a linear array of transducers [75] . . . moved along the
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linear vector of the array on skin surface 104 to create a 1-D pattern of a
plurality of lesions 25.” Id. In yet another embodiment, “probe 105
comprises a linear array of transducers [75] and . . . is moved along the
non-linear vector of the array on skin surface 104 to create a 2-D pattern of
a plurality of lesions 25.” Id. ¶ 144. As shown in Figure 10, probe 105 may
include motion mechanism 77 controlled by motor 86 and a controller to
move transducer(s) 75 within enclosure 78 in a similar fashion. Id. ¶ 171.
Appellant provides several illustrations to describe Appellant’s
understanding of the limited nature of these disclosures. See Appeal Br.
13–15 (discussing Slayton ¶¶ 143, 145, 171).
Slayton also contemplates “[a] variety of exemplary embodiments of
creating lesion[] patterns” (id. ¶ 152), some of which are illustrated in
Figure 8 (id. ¶ 158). Thus, probe 105 is controlled to “produce conformal
lesions 25 . . . through precise spatial and temporal control of acoustic
energy deposition.” Id. “[S]patial control may be realized through selection
of the type of one or more transducer configurations insonifying[3] [region
of interest (ROI)] 115, [and] selection of the placement and location of
ultrasound probe 105 for delivery of therapeutic ultrasound energy 120
relative to ROI 115.” Id. ¶¶ 86, 158. Temporal control may be achieved
“through adjustment and optimization of drive amplitude levels, frequency /
waveform selections, e.g., the types of pulses, bursts or continuous
waveforms, and timing sequences and other energy drive characteristics.”
Id. ¶ 158. In this way, “probe 105 can enable the regions of thermal injury

3 “Insonify” is a verb meaning “[t]o flood an area or an object with
carefully-controlled sound waves, typically as a part of sonar or ultrasound
imaging.” See https://en.wiktionary.org/wiki/insonify (accessed Dec. 13,
2021).
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to possess arbitrary shape and size,” such as cigar shapes, raindrop shapes,
flat planar shapes, round shapes, V shapes, and mushroom shapes, “in
various sizes and orientations.” Id. ¶ 159, Fig. 8. In one embodiment,
“probe 105 may be controlled and operated by controller 144” rather than by
hand to provide this treatment. Id. ¶ 161, Fig. 9.
Position sensor 107 “can calculate distance traveled along skin
surface 104” to “determine a speed of movement of ultrasound probe 105,”
and “if the speed is too fast, motion sensor [107] can signal an indicator to
slow the speed and/or can signal transducer [75] to stop emitting therapeutic
ultrasound energy 120.” Id. ¶ 152. In another embodiment, “position
sensor 107 may determine a distance 117 between pulses of therapeutic
ultrasound energy 120 to create a plurality of lesions 25 which are evenly
space[d],” “regardless of a speed that ultrasound probe 105 is move[d].” Id.
¶ 155.
2. Claim 1
i. The Examiner’s Rejection of Claim 1
The Examiner finds Slayton discloses an ultrasound treatment system
that anticipates claim 1. See Final Act. 3. As pertinent to Appellant’s
arguments on appeal, the Examiner finds Slayton’s probe 105 is “movable
by a user along a treatment surface in an arbitrary surface pattern,” to
transmit therapeutic energy into a treatment pattern that mimics the arbitrary
surface pattern. See id. (citing Slayton ¶¶ 158–162, Figs. 6–9). The
Examiner particularly finds “nothing in the structure of Slayton et al
precludes it from being moved in an arbitrary pattern[] along whatever
direction the user wants to move it,” and “there is no requirement in Slayton
et al that such scanning / movement is along a predetermined pattern,” so it
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“is therefore considered arbitrary.” Id. at 3, 6. Further according to the
Examiner, Slayton’s probe 105 “is capable of transmitting” therapeutic
energy when the probe is so moved arbitrarily. Id. (emphasis added). The
Examiner also explains that “the user” and “not the controller” controls
movement of probe 105 in arbitrary surface and treatment patterns. See
Interview Summary (Aug. 26, 2019).
ii. Appellant’s Argument Concerning Claim 1
Appellant contends the Examiner errs in the foregoing regards. See
Appeal Br. 4–15. Appellant argues Slayton’s probe 105 is not movable by a
user along a treatment surface in an arbitrary surface pattern, to transmit
therapeutic energy into a treatment pattern that mimics the arbitrary surface
pattern. See id. at 4. Appellant asserts Slayton’s disclosure is limited in two
different ways that contradict the Examiner’s findings.
Appellant firstly focuses on Slayton’s description of how probe 105
may be manipulated during delivery of therapeutic ultrasound energy. In
Appellant’s view, Slayton’s probe 105 “emits therapeutic ultrasound to
create precise linear arrays of microscopic ablation zones.” Id. at 5
(emphasis added) (citing Slayton ¶¶ 126, 130, 143, 149, 171). Appellant
asserts: “In all of these embodiments,” Slayton’s probe 105 “is configured to
realize the pre-planned linear path, by moving the ultrasound transducer
linearly along the path, and by ensuring that the ultrasound energy is under
precise spatial and temporal control.” Id. (emphasis added) (citing Slayton
¶¶ 74, 152). Appellant contends Slayton’s descriptions of moving probe 105
in “direction 114” shown in Figure 7 “are referencing linear movement . . .
which it should be apparent is not an arbitrary pattern by being defined as
linear.” Id. at 6 (emphasis added) (citing Slayton ¶¶ 141, 143, 149, 152,
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155). Appellant concludes “Slayton does not disclose any movement pattern
other than the linear pattern discussed above.” Id. (emphasis by Appellant).
Appellant also contends the arrangement of transducer(s) 75 within
Slayton’s probe 105 limits the treatment patterns that probe 105 may
generate, such that they “are all linear (in cases of rotation, there is no
translational movement of the ultrasound probe), and Slayton strictly follows
them.” Id. at 13–15 (emphasis by Appellant) (citing Slayton ¶¶ 143, 145,
171).
Appellant secondly focuses on Slayton’s description of “careful
planning of the desired path,” prior to delivery of therapeutic ultrasound
energy. Id. at 5 (emphasis added) (citing Slayton ¶¶ 126, 130, 149).
Appellant appears to acknowledge here that Slayton describes how
probe 105 might be manipulated in a non-linear “movement pattern,” but
insists “Slayton clearly contemplates that the movement pattern is
predetermined and thus is not arbitrary.” Id. at 64 (emphasis added) (citing
Slayton ¶ 154); see also id. at 7–8 (“The temporal and spatial control
described by Slayton is accurate, precise, and aligns entirely with a
predetermined (or premeditated) treatment strategy.”) (discussing Slayton
¶ 158). Appellant asserts Slayton further monitors the movement of
probe 105 as it delivers therapeutic energy to a subject, to assess
performance as a training tool, or to stop emitting energy if the delivery
pattern deviates too far from the predetermined pattern. Id. at 5–6, 8–9
(citing Slayton ¶¶ 152, 154, 158, 169). Appellant concludes “Slayton cannot
be said to teach an arbitrary path (e.g., subject to individual will or

4 See also Reply Br. 4–5 (“In the Appeal Brief, Appellant never asserted
that Slayton only describes linear paths and clearly described [Slayton’s]
non-linear embodiments.”) (citing Appeal Br. 6, first full paragraph).
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judgement without restriction), as the significant planning of the treatment
scheme is by definition restrictive.” Id. at 9 (emphasis by Appellant).
Appellant next attacks the Examiner’s finding that Slayton’s
probe 105 is capable of transmitting therapeutic energy as the probe is
moved by a user in an arbitrary surface pattern, as providing “no reasoned
explanation and no evidence to support this conclusory assertion.” See id.
at 9–10. Appellant’s view is that “the ultrasound systems of Slayton are all
configured to realize pre-planned and largely linear paths,” as discussed
above. Id. (emphasis by Appellant). Appellant concludes “Slayton does not
explicitly disclose what would have happened if a user had attempted to
adapt the device that it discloses to deviate from disclosed treatment plans.”
Id. at 5–6 (emphasis by Appellant).
Appellant finally contends Slayton does not inherently disclose that
probe 105 transmits therapeutic energy as the probe is moved by a user in an
arbitrary surface pattern. See id. at 10–15. Here, Appellant acknowledges
“Slayton mentions the term ‘arbitrary’ in two separate instances,” but
Appellant contends these disclosures reflect only that: “In the context of the
use of open- or closed-loop feedback [during execution of a predetermined
treatment pattern], spatial and/or temporal control of therapeutic ultrasound
emission from the ultrasound probe can be utilized to, if the feedback
determines that it is necessary, arbitrarily change the shape or size of the
regions of thermal injury in order to maintain controlled destruction of
tissue.” Id. at 11 (citing Slayton ¶¶ 133, 1595). Appellant also contends:
“Slayton does not disclose how the probe transmits therapeutic ultrasound

5 We understand Appellant’s citation in the Appeal Brief at page 11 (line 7)
to Slayton’s paragraph 157 to be a typographical error for paragraph 159.
See, e.g., Ans. 4; Reply Br. 4.
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in situations where the tracked movement of the ultrasound probe is different
from the predetermined movement pattern . . . ,” for example whether or
“how the system of Slayton would respond to movement of its ultrasound
probe in an arbitrary surface pattern.” Id. at 11–12 (emphases by
Appellant). Slayton does not necessarily disclose arbitrary surface pattern
movement, according to Appellant, because it expressly discloses stopping
therapeutic treatment as one option for responding to a deviation from the
predetermined pattern. Id. at 12–13, 15.
iii. The Examiner’s Answer to Appellant’s Argument Concerning Claim 1
In response to Appellant’s reliance on the claim term “arbitrary,” the
Examiner notes Appellant’s argument “define[s] the term ‘arbitrary’ as
‘subject to individual will or judgement without restriction.’” Ans. 4 (citing
Appeal Br. 9). The Examiner concludes Appellant’s claim construction is
inconsistent with Appellant’s Specification, which discloses “that an
‘arbitrary’ pattern may be a zig-zag or curvilinear pattern as examples
(non-linear patterns).” Id. (citing Spec. ¶ 68). Appellant’s Specification
further, according to the Examiner, “shows examples of an image of ‘linear,
arbitrary, and circular treatment patterns’, where the arbitrary pattern is
shown as a zigzag line as opposed to the linear or circular shapes.” Id.
(citing Spec. ¶ 19, Fig. 6). The Examiner concludes “the term ‘arbitrary’ as
used in [Appellant’s Specification] is not defined as referring to ‘planned’ or
‘unplanned’ treatment (or subject to individual will or judgement without
restriction), but rather to targeting the therapy in ‘non-linear’ patterns.” Id.
Turning to Slayton’s disclosure, the Examiner finds “Slayton also uses
the word ‘arbitrary’ when describing the types of thermal treatment patterns
which can be produced.” Id. (citing Slayton ¶¶ 133, 159). The Examiner
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finds Slayton indicates its probe 105 can create “various lesion shapes.” Id.
(citing Slayton ¶ 158, Fig. 8). The Examiner finds Slayton “teaches
movement along a ‘non-linear’ vector to create a 2D pattern of lesions,” so
“Slayton cannot be seen as being limited only to linear vectors as suggested
by [A]ppellant.” Id. (citing Slayton ¶¶ 143–144). The Examiner thus finds
“Slayton does teach a treatment surface in an arbitrary pattern.” Id. at 4–5.
The Examiner further disagrees with “[A]ppellant’s assertions that
Slayton only teaches moving the transducer along a pre-planned linear path.”
Id. at 5. The Examiner acknowledges “Slayton includes embodiments
directed towards a pre-planned linear path,” but finds “Slayton also
describes embodiments using a hand-held probe” in which “the user is
holding the probe and moving it over the patient’s body to provide treatment
in the desired pattern.” Id. (citing Slayton ¶¶ 51, 57, 70, 172, 187, 189).
Such a pattern can be “arbitrary” as claimed, according to the Examiner,
because “there is nothing in [Slayton] which would restrain the user from
moving the probe in any direction that they desire along the patient’s body.”
Id. (citing Slayton ¶¶ 133, 159, Fig. 8). Thus, the Examiner’s view is that
Slayton’s probe 105 may be moved in an arbitrary surface pattern to deliver
therapeutic energy, even applying Appellant’s claim construction, because
the user is free to deviate from any pre-planned treatment patterns. Id. at
5–6.
iv. Appellant’s Reply Concerning Claim 1
Appellant replies that the Examiner’s claim construction of the term
“arbitrary” as being restricted to include only non-linear surface patterns is
improper, because it is inconsistent with the ordinary and customary
meaning of this term. Reply Br. 2–3 (citing MPEP § 2111). Appellant cites
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two dictionary definitions of this term as meaning “existing or coming about
seemingly at random or by chance,” and “based on or determined by
individual preference or convenience rather than by necessity or the intrinsic
nature of something.” Id. (citing Merriam-Webster.com Dictionary).
Appellant concludes an “arbitrary surface pattern” should “be interpreted to
mean a surface pattern that is not known in advance (i.e., existing or coming
about seemingly at random or by chance . . . ) and/or which is selected by a
user based on their preference at the time of treatment.” Id. Appellant also
asserts the Specification disclosures cited by the Examiner do not support
the Examiner’s construction, because the Specification lacks an “explicit,
intentional attempt to define” the term “arbitrary to include only non-linear
paths.” Id. at 3 (discussing Spec. ¶¶ 19, 68, Fig. 6).
Turning to Slayton’s disclosure, Appellant dismisses the bulk of the
Examiner’s findings as resting on an improper claim construction. Id.
Specifically concerning Slayton’s two references to the term “arbitrary,”
Appellant submits: (1) “Slayton’s use of arbitrary is in relation to the
subcutaneous effects of its ultrasound beam” which “is different from
Appellant’s claimed arbitrary surface pattern”; and (2) Slayton is limited to
providing ablation “in a controlled manner” utilizing a feedback mechanism
to adjust the delivered energy “arbitrarily to maintain the desired ablation in
a controlled manner” which is unrelated to the term “arbitrary” as used in
claim 1 and Appellant’s Specification. Id. at 3–4 (emphases added) (citing
Slayton ¶¶ 133, 159).
Appellant also contends, in response to the Examiner’s findings
concerning Slayton’s probe 105 being freely manipulated by hand during
treatment, that “Appellant’s position is not whether or not the probe could be
moved . . . but rather, does Slayton teach or suggest it . . . and what does the
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system of Slayton do in response to it occurring . . . . [?]” Id. at 5–6.
Appellant asserts Slayton discloses “more than enough instances that
provide control to adhere to the pre-planned path” using feedback
mechanisms, thereby demonstrating that Slayton’s probe 105 cannot be
moved in an arbitrary surface pattern because, if Slayton’s probe were so
moved, Slayton would stop emitting ultrasound energy based on the
feedback. Id. at 5–6. Appellant’s position is that the Examiner’s findings in
this regard rely on an intrinsic disclosure being present in Slayton, which the
Examiner has not sufficiently established to sustain the rejection. See id.
at 6–7 (citing MPEP § 2163.07(a)).
Appellant particularly emphasizes that Slayton is limited to providing
“pre-planned treatment path[s],” which are therefore not arbitrary as
claimed. Id. at 4–6 (citing Slayton ¶¶ 144–145). According to Appellant:
“[A] person having ordinary skill in the art would appreciate that the
treatment plan, particularly those embodiments intended for use with a
human hand as the only motive and guiding force, would include buffers for
human error,” and “[n]one of this human error makes the original movement
pattern less planned or more arbitrary.” Id. at 6 (emphasis added).
v. Analysis Concerning Anticipation of Claim 1 by Slayton
Upon consideration of the foregoing, we sustain the Examiner’s
rejection of claim 1 as anticipated by Slayton, for the following reasons.
Claim Construction
First, as a matter of claim construction, we give claim 1 its broadest
reasonable construction that is consistent with Appellant’s Specification.
See, e.g., In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir.
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2004). Based on Appellant’s Specification, we construe the claim term
“arbitrary surface pattern” to mean a surface pattern having any shape the
user desires.
The Specification describes how “existing treatment devices are
limited by fixed treatment patterns, such as lines, patches, or other large
planar contours,” so one object of the invention is to provide the user
“increased control over the exact placement of energy.” Spec. ¶¶ 4–5
(emphasis added). The Specification describes this increased control as:
“The ultrasound probe can be movable by a user along a treatment surface in
an arbitrary surface pattern while maintaining contact between the contact
surface and the treatment surface,” to generate “a treatment pattern beneath
the treatment surface that mimics the arbitrary surface pattern.” Id. ¶ 7.
Examples of such arbitrary patterns are zig-zag patterns, curvilinear patterns,
circular patterns, and linear patterns. Id. ¶¶ 68–72, Figs. 3–6. In summary:
“A user can thereby generate treatment patterns 58 by moving the contact
surface 24 [of probe 10] along the treatment surface in a desired pattern.”
Id. ¶ 72 (emphasis added), Fig. 1 (illustrating probe 10 with contact
surface 24).
Thus, we disagree with the Examiner’s construction that would limit
“arbitrary” patterns to be any non-linear pattern (see Ans. 4), because it is
inconsistent with the Specification. The Specification discloses a linear
pattern as being within the scope of the claimed invention. See Spec. ¶ 71,
Fig. 6. We acknowledge that the Specification describes Figure 6 as
providing “an image of linear, arbitrary, and circular treatment patterns
generated by an ultrasound probe” (id. ¶ 19), which appears to differentiate
between linear and circular patterns on one hand, and arbitrary patterns on
the other hand. Nonetheless, there is nothing in the plain and ordinary
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meaning of the term “arbitrary” that would support this distinction, and the
balance of the Specification does not support this distinction. See id.
¶¶ 68–72.
We also disagree with Appellant’s construction that would limit
“arbitrary” patterns to exclude patterns that are determined prior to the
beginning of therapeutic treatment. See, e.g., Appeal Br. 9. This proposed
limitation lacks support in the plain and ordinary meaning of “arbitrary,” as
is evidenced by the dictionary definitions cited by Appellant. See Reply
Br. 2. Our construction of “arbitrary surface pattern” to mean a surface
pattern having any shape the user desires is consistent with the pattern
“existing or coming about seemingly at random or by chance,” and being
“based on or determined by individual preference or convenience rather than
by necessity.” Id. Thus, we agree with the portion of Appellant’s proposed
construction that defines “an arbitrary path” as being “subject to individual
will or judgement without restriction.” Appeal Br. 9 (emphasis by
Appellant). We disagree only with Appellant’s attempt to set a time period
in which the user must make this determination.
Slayton’s Disclosure
Next we apply our claim construction to the disclosure of Slayton.
We find Slayton discloses that a user may move probe 105 along the
subject’s skin surface in an arbitrary pattern, that is, a pattern having any
shape the user desires.
We find Slayton discloses one embodiment in which a user moves
probe 105 by hand, across the subject’s skin surface, to deliver therapeutic
ultrasound energy to the subject’s soft tissue underneath the skin surface.
Indeed, Appellant does not materially disagree with this finding. See, e.g.,
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Reply Br. 5–6. Slayton correspondingly describes probe 105 as “designed
for comfort and control while used in an operator’s hand.” Slayton,
Figs. 11–12, ¶¶ 187, 189. Slayton also discloses how probe 105 “can be
moved in at least one direction 114 to provide a plurality of lesions 25 in
fibrous soft tissue layer 112.” Id. at Fig. 7, ¶¶ 150–152. It is apparent from
Figure 7 that the user moves probe 105 by hand across the subject’s skin
surface 104 (e.g., from left to right in the Figure) to deliver therapeutic
ultrasound energy, based on the limited lateral extent of the probe’s
therapeutic energy beam 120 in relation to the lesions 25 created by the
beam, and the distance 117 between pulses of energy 120. Id. at Fig. 7,
¶¶ 152, 155.
We agree with the Examiner’s finding that Slayton does not place any
restrictions on this hand-directed movement of probe 105 to deliver
therapeutic ultrasound energy. Appellant’s contention that Slayton is limited
to linear movement of probe 105 in direction 114 shown in Figure 7 is not
supported by Slayton’s disclosure. Instead, Slayton states probe 105 “can be
moved in at least one direction 114 to provide a plurality of lesions 25,” and
then continues on to state “lesions 25 can be placed in a . . . 1-D pattern, a
2-D pattern, a 3-D pattern or combinations thereof.” Id. ¶ 152 (emphasis
added). As Slayton clearly ties the placement of lesions 25 to the surface
movement of the probe 105, the ability to create a 3-D pattern of lesions 25
implies probe 105 can also be moved in other directions across the subject’s
skin surface 104. Being movable along a treatment surface in a combination
of directions, as would necessarily be required to create a 3-D pattern, leads
directly to the reasonable conclusion that Slayton’s probe is “movable . . . in
an arbitrary surface pattern” as recited in claim 1. Appellant is in the best
position to enter argument or evidence to demonstrate this functional
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capacity is lacking in Slayton, because Slayton is Appellant’s own prior art,
but Appellant has not adequately done so.
Slayton further discloses that the subcutaneous treatment patterns may
be any one of a “variety” of 2-D or 3-D patterns, because the “ultrasound
probe 105 [is] configured for spatial control of therapeutic ultrasound energy
120 . . . e.g., spatially within the X, Y and Z domain” which allows for the
regions of thermal injury to have an “arbitrary shape and size.” Slayton
¶¶ 152, 158–159, Fig. 8. Exemplary 2-D patterns include cigar shapes,
raindrop shapes, flat planar shapes, round shapes, V shapes, and mushroom
shapes. Id. ¶ 159, Fig. 8. Thus, Slayton discloses that the probe 105 is
“movable by a user along a treatment surface in an arbitrary surface pattern”
resulting in a subcutaneous treatment pattern “that mimics the arbitrary
surface pattern.”
We acknowledge that claim 1’s “arbitrary surface pattern” and the
mimicking “treatment pattern” correspond to probe movement “along” the
treatment surface — e.g., along or parallel to the subject’s skin surface. See
Appeal Br. 20 (Claims App.). Slayton’s Figure 8, by contrast, illustrates
various 2-D treatment patterns that extend perpendicularly down into the
subject’s subcutaneous skin tissue 112, perpendicularly to the subject’s skin
surface 104. See Slayton, Figs. 7–8, ¶¶ 150, 152, 158–159. Nonetheless, a
person of ordinary skill in the art would understand from Slayton’s
disclosure of “a 2-D pattern, a 3-D pattern” and “degrees of freedom, e.g.,
spatially within the X, Y and Z domain,” that Slayton additionally
contemplates arbitrary treatment patterns being provided parallel to the
subject’s skin surface 104. See, e.g., id. ¶¶ 158–159.
Appellant also suggests Slayton’s disclosure of “a linear array of
transducers” limits the ability of probe 105 to transmit energy in a treatment
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pattern that mimics the arbitrary surface pattern, as required by claim 1. See
Appeal Br. 13–15. This position is not supported by Slayton’s disclosure.
Slayton discloses “one embodiment” in which “probe 105 comprises a single
transducer element,” in addition to the alternative embodiment in which
“probe 105 comprises a linear array of transducers” which is cited by
Appellant. Slayton ¶¶ 143–145, 171 (emphasis added). The single
transducer embodiment, combined with the freedom of movement of
probe 105 across the subject’s skin surface 104 impelled by the user’s hand,
provides a preponderance of evidence to support the Examiner’s anticipation
determination.
Finally, we are not persuaded by Appellant’s attempt to differentiate
Slayton from claim 1 based on various disclosures in Slayton directed to
predetermining a surface pattern for probe 105 to follow, prior to the
beginning of therapeutic treatment. As discussed above, there is no timing
requirement provided by the claim term “arbitrary surface pattern” to
support this differentiation. Thus, the use of feedback systems (Appeal
Br. 10) to ensure adherence to a pre-planned path does not undermine the
Examiner’s rejection.
Functional claiming, although permissible, “carries with it a risk.” In
re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997). When an Examiner has
reason to believe that a functional limitation asserted to be critical may in
fact be an inherent characteristic of the prior art, the Examiner possesses the
authority to shift the burden to the applicant to show otherwise. Id. The
Examiner may do this by establishing that the structure disclosed in the prior
art is capable of performing the recited function. Id. at 1478–79.
In this case, for all the reasons provided above, the Examiner has
established Slayton’s probe 105 is “movable by a user along a treatment
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surface in an arbitrary surface pattern,” to “transmit[] therapeutic ultrasound
energy into a treatment pattern beneath the treatment surface that mimics the
arbitrary surface pattern.” Appellant’s arguments to the contrary are not
persuasive, as discussed above. Thus, Appellant has not met its burden to
show error in the Examiner’s findings that Slayton’s probe is movable in the
manner recited in claim 1.
3. Claim 16
Independent claim 16 recites a “method of depositing therapeutic
ultrasound energy” that substantially corresponds to the functionality of the
apparatus of claim 1. Appeal Br. 22 (Claims App.).
The Examiner’s rejection relies on the analysis of claim 1 as discussed
above, and adds that the method of claim 16 “involve[s] an inherent use of
the ultrasound probe of Slayton,” “given that a user can move the probe
along any direction[.]” Final Act. 3–4; Interview Summary (Aug. 26, 2019).
Appellant likewise relies on its arguments concerning claim 1. See
Appeal Br. 4, 16–17. Appellant adds that these arguments “are even
stronger when presented with regard to” claim 16, because it “is directed to
a method.” Id. at 17 (emphasis by Appellant).
As discussed above in connection with claim 1, Slayton, at the very
least, implies probe 105 is movable, and transmits therapeutic energy, in the
manner recited in claim 1. Because this conclusion is based on how we
understand Slayton to operate in its normal and usual operation, we also
sustain the rejection of claim 16 as anticipated by Slayton. In re King,
801 F.2d 1324, 1326–27 (Fed. Cir. 1986).
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4. Claim 17
Claim 17 recites: “The method of claim 16, wherein the emission of
the therapeutic ultrasound energy is directed through a contact surface of the
ultrasound probe and into the target medium, the contact surface having a
maximum physical dimension of less than 2 cm.” Appeal Br. 22 (Claims
App.) (emphases added).
In rejecting claim 17 as anticipated by Slayton, the Examiner finds
“the method involves an inherent use of the device of Slayton” as discussed
in connection with claims 1 and 16 above, and also “notes that the size of the
contact surface fails to further limit the method.” Final Act. 4. The rejection
does not otherwise address the limitation of claim 17. See id. at 3–4.
Appellant argues the Examiner errs, because Slayton does not disclose
the limitation recited in claim 17. See Appeal Br. 17–18. Appellant asserts
“the Examiner is clearly wrong” in construing claim 17 as failing to add a
further limitation to claim 16, because claim 17 “requir[es] an ultrasound
probe to have a contact surface,” as well as a “specifically sized contact
surface.” Id. at 18.
In answer, “the [E]xaminer agrees that Slayton does not teach the
specific size” of the probe’s contact surface recited in claim 17. Ans. 6.
Upon review of the foregoing, we do not sustain the Examiner’s
anticipation rejection of claim 17. The Examiner does not provide any
discussion regarding why the specific structural limitation present in
claim 17 is not entitled to patentable weight. Although not cited by the
Examiner, we acknowledge the line of case law debating the issue of
whether a process is patentable because it employs some structure that may
be novel and unobvious. See In re Durden, 763 F.2d 1406, 1408–09
(Fed. Cir. 1985). In addressing the issue, our reviewing court,
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acknowledging that different cases may warrant different outcomes, has
rejected the notion that the PTO may rely upon some generalized rule for
such a situation. Id. at 1411. More recent cases reaffirm this principle. See
In re Dillon, 919 F.2d 688, 695 (Fed. Cir. 1990) (en banc); see also In re
Ochiai, 71 F.3d 1565, 1571–72 (Fed. Cir. 1995).
The Examiner’s anticipation analysis of claim 17 does not include any
discussion of the specific claim limitation involved, nor the specific facts
relied upon by the Examiner to reach a conclusion of anticipation. Rather,
the Examiner appears to have engaged in exactly the type of analysis that
was disapproved by our reviewing court in the context of an obviousness
rejection, in the decisions cited above. We cannot sustain the Examiner’s
anticipation rejection on this basis.
5. Claims 3–7 and 18
Appellant does not argue for the patentability of dependent claims 3–7
and 18 separately from their parent independent claims. See, e.g., Appeal
Br. 4, 15, 17. Therefore, we affirm the rejection of these claims as
anticipated by Slayton. See 37 C.F.R. § 41.37(c)(1)(iv).
B. Obviousness over Slayton
1. Claims 2 and 17
Claim 2 recites: “The ultrasound treatment system of claim 1, wherein
the contact surface [of the ultrasound probe] has a maximum physical
dimension of less than 2 cm.” Appeal Br. 20 (Claims App.); see also id. at
claim 1, line 2 (“an ultrasound probe having a transducer and a contact
surface”).
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In rejecting claims 2 and 17 as having been obvious over Slayton, the
Examiner finds Slayton anticipates the parent claims 1 and 16, but Slayton
“fail[s] to disclose the specific size of the contact surface as set forth” in
claims 2 and 17. Final Act. 4–5. The Examiner concludes: “It would have
been an obvious matter of design choice to provide a contact surface of less
than 2 cm, since such a modification would have involved a mere change in
the size of a component,” which “is generally recognized as being within the
level of ordinary skill in the art.” Id. at 5 (citing In re Rose, 220 F.2d 459
(CCPA 1955)).
Appellant asserts “the Examiner has failed to cite to any portion of
Slayton that describes the size of the contact surface.” Appeal Br. 15–16.
On that basis, Appellant argues the obviousness rejection is in error because
“it would be unclear for a person of skill in the art where or what size to
begin with, and why exactly a person of skill in the art would be motivated
to adjust the size” to correspond to the claim requirement. Id. at 16.
In answer, the Examiner finds “the size of the transducer in relation to
a patient’s body is shown in Figures 14–34 of Slayton, and the size of a
transducer is generally known by one of ordinary skill in the art (a size
sufficiently small enough to be placed on a specific region of the patient’s
body, while being hand-held manipulated).” Ans. 6.
In reply, Appellant states the Examiner’s points on claims 2 and 17
have merit, so “the specific arguments made with respect to claims 2 and 17
are withdrawn.” Reply Br. 7.
Upon review of the foregoing, we sustain the Examiner’s rejection of
claims 2 and 17 as having been obvious over Slayton, as no longer being
opposed by Appellant.
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2. Claim 7, 8, 19, and 20
Appellant does not argue for the patentability of dependent claims 7,
8, 19, and 20 separately from their parent independent claims. See, e.g.,
Appeal Br. 4, 15, 17. Therefore, we affirm the rejection of these claims as
having been obvious over Slayton. See 37 C.F.R. § 41.37(c)(1)(iv).
C. Obviousness over Slayton, and Towe or Talish
Appellant does not argue for the patentability of dependent claims 7,
8, and 19 separately from their parent independent claims. See, e.g., Appeal
Br. 4, 15, 17. Therefore, we affirm the rejection of these claims as having
been obvious over Slayton, and Towe or Talish. See 37 C.F.R.
§ 41.37(c)(1)(iv).
SUMMARY OF DECISION
In summary, we affirm the Examiner’s decision to reject claims 1–8
and 16–20, as set forth in this table:
Claims
Rejected
35 U.S.C.
§
Reference(s) Affirmed Reversed
1, 3–7,
16–18
102(a)(1) Slayton 1, 3–7,
16, 18
17
2, 7, 8,
17, 19, 20
103 Slayton 2, 7, 8,
17, 19, 20

7, 8, 19 103 Slayton, Towe,
Talish
7, 8, 19
Overall
Outcome
1–8,
16–20

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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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED