Guided Therapy Systems, LLC

Patent Trials and Appeals Board

Jul 2, 2021

2020001976 (P.T.A.B. Jul. 2, 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.
14/600,782 01/20/2015 Michael H. Slayton 148534.00306.GTS107USNP 6100
26710 7590 07/02/2021
QUARLES & BRADY LLP
ATTN: IP DOCKET
411 E. WISCONSIN AVENUE
SUITE 2400
MILWAUKEE, WI 53202-4428
EXAMINER
NGUYEN, HIEN NGOC
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
07/02/2021 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):
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 PAUL JAEGER

Appeal 2020-001976
Application 14/600,782
Technology Center 3700
____________

Before MICHAEL C. ASTORINO, CYNTHIA L. MURPHY, and
BRUCE T. WIEDER, Administrative Patent Judges.

ASTORINO, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the
Examiner’s decision to reject claims 1–15 and 17–28. 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. The Appellant identifies the real party in interest as
Guided Therapy Systems, LLC. Appeal Br. 2.
Appeal 2020-001976
Application 14/600,782

2

STATEMENT OF THE CASE
Claimed Subject Matter
Claims 1, 11, and 20–24 are the independent claims on appeal.
Claim 1, reproduced below, is illustrative of the claimed subject matter.
1. A method of inducing an acousto-mechanical effect in a
target zone of a medium, the method comprising:
a) coupling an ultrasound energy source to the target zone of
the medium, the ultrasound energy source configured to
produce a pulsed first ultrasound energy having a frequency of
between 100 kHz and 200 MHz and a pulse duration of
between 1 nanosecond and 1 millisecond;
b) initiating an acousto-mechanical effect in the target zone
by directing from 500 nJ to 5 J of the pulsed first ultrasound
energy from the ultrasound energy source into the target zone of
the medium.

References
The prior art relied upon by the Examiner is:
Name Reference Date
Lizzi et al. (“Lizzi”) US 6,488,626 B1 Dec. 3, 2002
Kaczkowski et al.
(“Kaczkowski”)
US 2007/0106157 A1 May 10, 2007
Capelli et al. (“Capelli”) US 2008/0009774 A1 Jan. 10, 2008
Canney et al. (“Canney”) US 2011/0251528 A1 Oct. 13, 2011
Slayton et al. (“Slayton”) US 2012/0143056 A1 June 7, 2012

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Rejections2
Claims 1–15 and 17–28 are provisionally rejected on the ground of
nonstatutory double patenting as unpatentable over claims 1–20 of
copending Application No. 14/751,349.
Claims 1–15 and 17–28 are provisionally rejected on the ground of
nonstatutory double patenting as unpatentable over claims 1–20 of
copending Application No. 15/001,712.
Claims 1–15 and 17–28 are provisionally rejected on the ground of
nonstatutory double patenting as being unpatentable over claims 1–20 of
copending Application No. 15/001,621.
Claims 1–15 and 17–28 are rejected under 35 U.S.C. § 112(a) as
failing to comply with the written description requirement.
Claims 1–15 and 17–28 are rejected under 35 U.S.C. § 112(a) as
failing to comply with the enablement requirement.
Claims 1–3, 9, 11–13, 18, 19, and 21–28 are rejected under 35 U.S.C.
§ 103 as unpatentable over Slayton, Capelli, and Canney.
Claims 4–8, 10, 14, 15, and 17 are rejected under 35 U.S.C. § 103 as
being unpatentable over Slayton, Capelli, Canney, and Lizzi.
Claim 20 is rejected under 35 U.S.C. § 103 as unpatentable over
Canney and Kaczkowski.

2 The Examiner has withdrawn the rejection of claims 21 and 22 under 35
U.S.C. § 101. Ans. 3.
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ANALYSIS
Double Patenting
The “Appellant respectfully requests that these provisional rejections
be held in abeyance until otherwise allowable subject matter is agreed upon -
Appellant will not address these provisional rejections elsewhere herein.”
Appeal Br. 4.
The Examiner’s provisional rejections of claims 1–15 and 17–28 on
the ground of nonstatutory double patenting as unpatentable over claims
1–20 of Application numbers 14/751,349 and 15/001,712 are dismissed as
moot because these applications are abandoned. Indeed, a Notice of
Abandonment was mailed for these applications on November 30, 2018 and
April 30, 2021, respectively.
As for the Examiner’s provisional rejection of claims 1–15 and 17–28
on the ground of nonstatutory double patenting as unpatentable over claims
1–20 of Application No. 15/001,621, we note that this application has been
issued a patent. Notice of Allowance, mailed Dec. 13, 2019; see Slayton
(US 10,624,660 B2, iss. Apr. 21, 2020). Since the Examiner’s original
provisional rejection on this ground, mailed on October 12, 2017, the claims
in present application and those of Application No. 15/001,621 have been
amended. Additionally, in Application No. 15/001,621 a Terminal
Disclaimer was filed on October 10, 2019 and approved on October 15,
2019 to overcome a provisional rejection on the ground of nonstatutory
double patenting as unpatentable over claims 1–24 of the present application
(Application No. 14/600,782, Non-Final Act. 3–4 (mailed Oct. 2, 2018)).
Due to the change in circumstances underlying the Examiner’s original
provisional rejection, we decline to reach this ground of rejection.
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Application 14/600,782

5

Written Description
Claims 1–15 and 17–28
The Examiner rejects claims 1–15 and 17–28 as failing to comply
with the written description requirement. Final Act. 7–8. The Examiner
finds that “claims include a very wide range of parameters 100 khz and
200 mhz, 1 ps (picosecond) and 1 ms (millisecond), 1 kw and 50 kw and
500 nj to 5 J” and “[o]ne of ordinary skill in the art does not know what
specific parameters to achieve acousto-mechanical . . . effect.” Final Act. 8.
The Examiner also finds that the Specification at “[p]aragraphs [0055–0065]
only disclose wide range treatment parameters without any selection
methodology.” Ans. 13.
The Appellant argues that the “[S]pecification as originally filed
specifically described to a person having ordinary skill in the art how to
compute the parameters necessary to achieve the claimed effect.” Appeal
Br. 9. The Appellant’s position is that the Examiner’s view “is an overly
simplistic view of ultrasound effects and ignores the multivariable nature of
ultrasound treatment . . . and the impact that the properties of the target
medium have on the desired effect.” Appeal Br. 8–9. Additionally, the
Appellant asserts the Specification shows an actual reduction of practice in
Examples 1–3. Appeal Br. 9 (citing Spec. ¶¶ 87–96). The Appellant’s
argument is persuasive.
We note that the Appellant asserts that “the level of ordinary skill in
the art is at least an advanced degree in physics or electrical engineering and
5 years of experience working with high-intensity acoustic devices (i.e., non-
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imaging applications of ultrasound and other acoustic energy).”3 Appeal
Br. 13. The Examiner agrees with the Appellant as to the level of skill in the
art. See Ans. 14.
In this case, we determine that the agreed upon level of skill in the art
–– i.e., an advanced degree in physics or electrical engineering and 5 years
of experience working with high-intensity acoustic devices (i.e., non-
imaging applications of ultrasound and other acoustic energy) –– supports
the Appellant’s positon that “a person having ordinary skill in the art would
. . . understand that the disclosed equations and other equations known to
those having ordinary skill in the acoustic arts would be used to determine
which parameters are necessary for achieving the desired effect.” Appeal
Br. 15 (citing Spec. ¶¶ 39–41, 62–66 (describing applications having an
acoustic-mechanical effect)); see Appeal Br. 9; Spec. ¶¶ 87–96).
Thus, we do not sustain the Examiner’s rejection of claims 1–7, 9–15,
and 17–28 which depend therefrom.

Claim 8
The Examiner separately rejects claim 8, which depends from
claims 1 and 7, as failing to comply with the written description requirement
because “there [are] many ways/methods to alter acoustic impedance of
tissue and cause impedance mismatch” and “[t]he [S]pecification does not
disclose the specific method in which the applicant alters acoustic
impedance of tissue and cause impedance mismatch.” Final Act. 7–8.

3 The Appellant’s assertion as to the level of skill in the art is discussed in
response to the Examiner’s rejection under 35 U.S.C. § 112(a) as failing to
comply with the enablement requirement.
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The Appellant argues that the method of claim 8 “is claiming a
specific way of altering an acoustic impedance of the target zone, namely by
executing step d) of claim 7, from which claim 8 depends.” Appeal Br. 10.
The Appellant submits that “[a] person having ordinary skill in the art would
at once envisage” the “finite number of ways to alter an acoustic impedance
of a target medium, thereby creating an acoustic impedance mismatch, by
way of an ultrasound energy having a pulse duration of at least 100 μs.”
Appeal Br. 10. The Appellant submits that the written description
requirement does not require the Specification to describe that which is
known to those having ordinary skill in the art. Appeal Br. 10.
The Examiner does not respond to the Appellant’s argument that
claim 8 complies with the written description requirement. For reasons
similar to those discussed above, we determine that the Appellant’s
argument is persuasive.
Thus, we do not sustain the Examiner’s rejection of claim 8.

Enablement
The Examiner rejects claims 1–15 and 17–28 as failing to comply
with the enablement requirement, which requires that “[t]he claim(s)
contains subject matter which was not described in the specification in such
a way as to enable one skilled in the art to which it pertains, or with which it
is most nearly connected, to make and/or use the invention.” Final Act. 8.
The Examiner determines “[t]he claims and specification do[] not
disclose the specific combination of parameters (frequency, duration, power
and energy) to enable one of ordinary skill in the art to initiate acousto-
mechanical . . . or thermal or cavitation effect.” Final Act. 8–9.
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When rejecting a claim for lack of enablement, the USPTO bears an
initial burden of setting forth a reasonable explanation as to why the
Examiner believes that the scope of protection provided by the claim is not
adequately enabled. In re Wright, 999 F.2d 1557, 1561–62 (Fed. Cir. 1993);
see Manual of Patent Examining Procedure (“MPEP”) § 2164.04, Burden on
the Examiner Under the Enablement Requirement (9th ed., rev. 10.2019, last
rev. June 2020). The test for compliance with the enablement requirement is
“whether one reasonably skilled in the art could make or use the invention
from the disclosures in the patent [application] coupled with information
known in the art without undue experimentation.” United States v.
Telectronics, Inc., 857 F.2d 778, 785 (Fed. Cir. 1988). Determining whether
any necessary experimentation is undue involves considering relevant
factors including, but not limited to: (1) the quantity of experimentation
necessary; (2) the amount of direction or guidance presented; (3) the
presence or absence of working examples; (4) the nature of the invention;
(5) the state of the prior art; (6) the relative skill of those in the art; (7) the
predictability or unpredictability of the art; and (8) the breadth of the claims.
In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988); see MPEP § 2164.01(a)
(Undue Experimentation Factors). “Whether undue experimentation is
needed is not a single, simple factual determination, but rather is a
conclusion reached by weighing many factual considerations.” Wands, 858
F.2d at 737.
The Appellant reviews the Wands factors and explains how
collectively they weigh in favor of enablement. See Appeal Br. 12–13
(citing Spec. ¶¶ 55–60, 87–92). The Examiner responds to the Appellant’s
argument and provides a separate review of the Wands factors. Ans. 14–15.
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The Examiner’s primary concern appears to be focused on the breadth of the
claims and the lack of guidance concerning selecting treatment parameters
and using disclosed and undisclosed equations. See Ans. 14–16.
We determine that one Wands factor –– namely, the relative skill of
those in the art –– stands out above others because the Examiner’s rejection
is based on the notion that “[t]here would be too many combination of
parameters for one of ordinary skill in the art to try” and therefore, “would
require an expert in the field to produce the specific effect.” Final Act. 9
(emphasis added). Notably, the Examiner’s analysis includes an agreement
with the Appellant that “the level of ordinary skill in the art is at least an
advanced degree in physics or electrical engineering and 5 years of
experience working with high-intensity acoustic devices (i.e., non-imaging
applications of ultrasound and other acoustic energy).” Ans. 14; Appeal
Br. 13. The Examiner, however, does not explain how the level of skill of
“an expert in the field” is distinct from the agreed upon level of ordinary
skill in the art. The failure to explain the difference between “an expert in
the field” and the agreed upon level of ordinary skill in the art undermines
the basis of the Examiner’s rejection.
Thus, we do not sustain the Examiner’s rejection of claims 1–15 and
17–28.

Obviousness
Claims 1–15, 17–19, and 21–28
The Examiner relies on Slayton for nearly all of the claim limitations
in independent claims 1, 11 and 21–24 except for a “pulse duration of
between 100 picosecond and 1 millisecond; treatment exceeds a
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fragmentation threshold of the object and a power of between 1 kW and
50 kW.” Final Act. 10. The Examiner relies on Capelli and Canney for
various teachings concerning pulse duration, fragmentation threshold, and
power. Final Act. 10–11. The Examiner reasons that the proposed
modification would have been obvious because the parameters “are common
effective treatment range[s] and fragmentation is one of effective way [sic]
of treating tissue.” Final Act. 11.
The Appellant finds fault with the Examiner’s rationale for why one
of ordinary skill in the art would have modified Slayton with the teachings in
Capelli or Canney. Appeal Br. 19–21. Specifically, the Appellant argues
that the Examiner’s rejection 1) “merely states in conclusory fashion that the
claimed parameters are a common effective treatment range and that
fragmentation is one effective way of treating tissue” and 2) “fails to explain
why a person having ordinary skill in the art would have modified the
teaching of Slayton to include the allegedly common effective treatment
range.” Appeal Br. 20. The Appellant’s argument is persuasive.
In this case, the Examiner’s rejection is based on the notion that one
of ordinary skill in the art could have used the combined teachings of Capelli
and Canney to modify the teachings of Slayton to result in the claimed
invention, but does not answer the question why one of ordinary skill in the
art would have done so. See Appeal Br. 20. In other words, the Examiner’s
rejection fails to be adequately supported with the necessary articulated
reasoning with some rational underpinning. See Appeal Br. 19; In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness
grounds . . . [require] some articulated reasoning with some rational
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underpinning to support the legal conclusion of obviousness.”) (cited with
approval in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)).
Thus, we do not sustain the Examiner’s rejection of claims 1–3, 9, 11–
13, 18, 19, and 21–28 under 35 U.S.C. § 103 as unpatentable over Slayton,
Capelli, and Canney. Further, the Examiner fails to rely on Lizzi in any
manner that would remedy the deficiency in the Examiner’s rejection as
discussed above. Therefore, we likewise do not sustain the Examiner’s
rejection of claims 4–8, 10, 14, 15, and 17 under 35 U.S.C. § 103 as
unpatentable over Slayton, Capelli, Canney, and Lizzi.

Claim 20
The Appellant again finds fault with the Examiner’s rejection because
of the lack of reasons for why one of ordinary skill in the art would have
modified Canney with the teachings of Kaczkowski. Appeal Br. 25. The
Appellant’s argument is persuasive. For reasons similar to those discussed
above, the Examiner’s rejection of claim 20 lacks the necessary articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness. See Final Act. 13–14; Ans. 18.
Thus, we do not sustain the Examiner’s rejection of claim 20 under
35 U.S.C. § 103 as unpatentable over Canney and Kaczkowski.

CONCLUSION
We DISMISS the rejection of claims 1–15 and 17–28 under the
ground of nonstatutory double patenting as unpatentable over claims 1–20 of
copending Application No. 14/751,349 and Application No. 15/001,712.
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12

We DECLINE to reach the rejection of claims 1–15 and 17–28 under
the ground of nonstatutory double patenting as unpatentable over claims
1–20 of copending Application No. 15/001,621.
We REVERSE the rejections of:
claims 1–15 and 17–28 under 35 U.S.C. § 112(a) as failing to
comply with the written description requirement;
claims 1–15 and 17–28 under 35 U.S.C. § 112(a) as failing to
comply with the enablement requirement;
claims 1–3, 9, 11–13, 18, 19, and 21–28 under 35 U.S.C. § 103
as unpatentable over Slayton, Capelli, and Canney;
claims 4–8, 10, 14, 15, and 17 under 35 U.S.C. § 103 as
unpatentable over Slayton, Capelli, Canney, and Lizzi; and
claim 20 under 35 U.S.C. § 103 as unpatentable over Canney
and Kaczkowski.
In summary:
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–15, 17–
28
Nonstatutory Double
Patenting

1–15, 17–
28
Nonstatutory Double
Patenting

1–15, 17–
28
Nonstatutory Double
Patenting4

1–15, 17–
28
112(a) Written Description 1–15, 17–
28

4 As discussed above, we do not reach this ground of rejection. See also
Ex parte Moncla, Appeal No. 2009-006448 (PTAB June 22, 2010) (holding
that it is premature to address a provisional rejection) (designated
precedential).
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13

Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–15, 17–
28
112(a) Enablement 1–15, 17–
28
1–3, 9,
11–13,
18, 19,
21–28
103 Slayton, Capelli,
Canney
1–3, 9, 11–
13, 18, 19,
21–28
4–8, 10,
14, 15, 17
103 Slayton, Capelli,
Canney, Lizzi
4–8, 10,
14, 15, 17
20 103 Canney, Kaczkowski 20
Overall
Outcome
1–15, 17–
28

REVERSED