Ex Parte Little

Patent Trial and Appeal Board

May 31, 2017

12729447 (P.T.A.B. May. 31, 2017)

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.
12/729,447 03/23/2010 Blake Little LSX-49US 7227
27805 7590 06/02/2017
THOMPSON HTNF T T P
EXAMINER
10050 Innovation Drive NGUYEN, HIEN NGOC
Suite 400
DAYTON, OH 45342-4934 ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
06/02/2017 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):
ipdocket @ thompsonhine. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BLAKE LITTLE
Appeal 2015-0082391
Application 12/729,4472
Technology Center 3700
Before ANTON W. FETTING, KENNETH G. SCHOPFER, and
ROBERT J. SILVERMAN, Administrative Patent Judges.
SCHOPFER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the rejection of
claims 8—27. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Our decision references the Appeal Brief (“Appeal Br.” filed Apr. 9, 2015)
and Reply Brief (“Reply Br.” filed Sept. 23, 2015), and the Examiner’s
Answer (“Ans.” mailed Aug. 3, 2015) and Final Office Action (“Final Act.”
mailed Oct. 29, 2014).
2 According to Appellant, “[t]he real party in interest is Valeant
Pharmaceuticals Inf 1, Inc., of Bridgewater, NJ, which is the parent entity of
Solta Medical, Inc., which is the successor entity to Liposonix, Inc., which is
the assignee of the present invention.” Appeal Br. 1.
Appeal 2015-008239
Application 12/729,447
BACKGROUND
According to Appellant, the Specification describes “a high intensity
focused ultrasound therapy system with a method for detecting a system
fault.” Spec. 14.
CLAIMS
Claims 8—27 are on appeal. Claim 8 is illustrative of the appealed
claims and recites:
8. A method for detecting a transducer fault in a high
intensity focused ultrasound therapy system, the method
comprising:
transmitting a burst of ultrasonic energy or a pulse of
ultrasonic energy from a high intensity focused ultrasound
transducer mounted in a therapy head;
after the burst of ultrasonic energy or the pulse of
ultrasonic energy is transmitted, applying an electrical clamp to
the transducer that provides an impedance across the transducer
and accelerates vibration dampening of the transducer after the
burst of ultrasonic energy or the pulse of ultrasonic energy;
after the application of the electrical clamp ends,
measuring a clamp waveform comprising residual electrical
voltage;
comparing the clamp waveform against a stored clamp
waveform profile; and
if the clamp waveform does not substantially match the
stored clamp waveform profile, generating a fault signal.
Appeal Br. 12.
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Appeal 2015-008239
Application 12/729,447
REJECTIONS
1. The Examiner rejects claims 8 and 9 under 35 U.S.C. § 103(a) as
unpatentable over Vitek3 in view of Lau,4 Thompson,5 and Wofford.6
2. The Examiner rejects claims 10-23 under 35 U.S.C. § 103(a) as
unpatentable over Vitek in view of Lau, Thompson, Wofford, and
Abdelghani.7
3. The Examiner rejects claims 24—27 under 35 U.S.C. § 103(a) as
unpatentable over Vitek in view of Lau and Abdelghani.
DISCUSSION
Claims 8—10
Regarding independent claim 8, the Examiner finds that Vitek
discloses a method as claimed except that Vitek does not teach the use of
high intensity focused ultrasound (“HIFU”) and Vitek does not teach
applying an electrical clamp, measuring a clamp waveform, and comparing
the measured and a stored waveform to determine if a fault signal should be
generated. Final Act. 2—3. With respect to these deficiencies, the Examiner
finds and concludes as follows:
In the same field of endeavor, which is ultrasound, Lau discloses
hifu transducer mounted in the therapy head (see [0062] and
[0065]). Thompson discloses apply electrical clamp to
accelerate vibration dampening of the transducer after the bust of
ultrasonic energy (col. 2, lines 28—60; dampening vibration by
using damping resistor to dissipate significant amount of driving
energy; the inductance and resistor are electrical impedance that
3 Vitek, US 6,543,272 Bl, iss. Apr. 8, 2003.
4 Lau et al., US 2009/0036773 Al, pub. Feb. 5, 2009.
5 Thompson, US 4,122,725, iss. Oct. 31, 1978.
6 Wofford et al., US 2005/0018453 Al, pub. Jan. 27, 2005.
7 Abdelghani, US 4,708,127, iss. Nov. 24, 1987.
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Appeal 2015-008239
Application 12/729,447
dissipate energy and dampening vibration; dampening vibration
could be mechanical or electrical or both). Wofford discloses
measuring and compare clamp waveform with stored clamp
waveform (see [0008], [0028], [0063], [0079], Fig. 11, claims 1
and 24). It would have been obvious to one of ordinary skill in
the art at the time of the invention to modify Vitek to include hifu
transducer mounted in the therapy head; apply electrical clamp
and measure/obtain clamp waveform after the bust of ultrasonic
energy is transmitted; compare clamp waveform with stored
clamp waveform as taught by Lau, Thompson and Wofford
because this enable precise; efficient therapeutic treatment of
tissue and prevent overload the system.
Id. at 3.
With respect to this rejection, we are persuaded by Appellant’s
argument that the Examiner has not provided an adequate reason with
appropriate rational underpinning to support the conclusion of obviousness.
See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (“[Rejections
on obviousness 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.”). In particular, we find that
the Examiner has not adequately explained how the proposed motivation to
“enable precise; efficient therapeutic treatment of tissue and prevent
overload [of] the system” would be achieved by modifying Vitek’s system
of fault detection to meet the claims. See Vitek Fig. 5.
As noted by Appellant, Wofford discloses a method for limiting the
maximum duty cycle of a signal in order to avoid damage or failure of a
power converter. See Wofford 14. Wofford achieves this goal by
comparing a voltage clamp waveform to a reference waveform to provide a
limiting signal. Id. at | 8. We agree with Appellant that this is done before
any signal is produced in Wofford’s system in order to limit the duty cycle
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Application 12/729,447
of the system to prevent overload, whereas the claim requires comparing a
clamping waveform to a reference waveform after a burst of energy is
transmitted and similarly Vitek’s method of fault detection requires
generating and transmitting a burst of energy toward a reflector. See Appeal
Br. 5; Vitek Fig. 5. At best, we find that one of ordinary skill in the art may
have recognized the benefits of adding Wofford’s teachings to limit the duty
cycle of Vitek’s system before ultrasonic energy is transmitted and when it
is used for therapeutic treatment. However, Vitek’s method of fault
detection is employed after a burst of ultrasonic energy is transmitted and is
performed with an acoustic reflector and is not performed while the system
is being used with a patient. See Vitek Fig. 5; col. 10,1. 47—col. 11,1. 20.
Thus, the Examiner’s rationale does not explain why Wofford’s teachings
would be employed to alter Vitek’s method of fault detection.
In the Answer, the Examiner further indicates that Thompson is relied
upon as the “link between the references” because “Thompson discloses
applying [an] electrical clamp after the burst of ultrasonic energy is
transmitted.” Ans. 10. However, we find that Thompson’s disclosure of
providing an electrical clamp after a burst of ultrasonic energy does not
provide a reason to employ Wofford’s comparison of clamping waveforms
in Vitek’s system of fault detection. We agree with Appellant’s statement
that:
A glaring deficiency of the Examiner’s articulated reasoning is
any explanation of why a person of ordinary skill in the art would
have modified Vitek and Wofford based upon Thompson to
apply the combined signal (containing the limiting signal) after
the transducer 12 in Vitek is caused to transmit the ultrasound,
instead of before ultrasound is transmitted as taught by Wofford
and used by the Examiner to modify Vitek.
Reply Br. 3.
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Application 12/729,447
For these reasons, we do not sustain the rejection of claim 8. For the
same reasons, we also do not sustain the rejections of claims 9 and 10, which
depend from claim 8.
Claims 11—23
With respect to independent claim 11, the rejection states:
Vitek measure amplitude and phase to obtain actual gain and
phase shift and compare this with expected gain and phase shift.
Vitek discloses determined functionality of a medical ultrasound
therapy head prior to beginning a medical treatment of a patient
(see col. 7, lines 21—44; test system before therapeutic treatment
by placing it in contact with the patient and transmit ultrasound
wave then analyze return echoes). The differences indicate there
is an error in the system. Abdelghani discloses disable the
device/system when signals do not match (see claim 17). Lau
discloses while a cap of the medical ultrasound therapy head is
in contact with the patient transmitting a burst of ultrasonic
energy via a transducer that is mounted in the medical ultrasound
therapy head (see Fig. 5, 78—8, [0070], and [0085-0086], element
180 is a cover or cap; the treatment device is in contact with the
tissue; the claim does not require direct contact between the
cap/cover with patient). Abdelghani discloses medical
ultrasound device head is in contact with the patient transmitting
a burst of ultrasonic energy via a transducer that is mounted in
the medical ultrasound device head (see Fig. 1). It would have
been obvious to one of ordinary skill in the art at the time of the
invention to modify Vitek to store in the system the expected
maximum, minimum, amplitude range, deviation/tolerance
range for comparing with the actual data and a cap of the medical
ultrasound therapy head is in contact with the patient transmitting
a burst of ultrasonic energy via a transducer that is mounted in
the medical ultrasound therapy head because this only require
routine skill in the art and allow the system to determine if there
is an error/failure in the system then disable the system. The
ultrasound device in contact with patient while transmitting
ultrasound is common in the field.
Final Act. 4—5.
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Application 12/729,447
Here, we are persuaded by Appellant’s argument that
the Examiner has failed to present any objective reasoning
supported by rational underpinning ... in the form of factual
findings that Vitek could be modified, as proposed, to replace the
acoustic reflector with the patient’s body. Accordingly, a person
of ordinary skill in the art would not have had an objective reason
to modify Vitek, for example in view of Lau and/or Abdelghani,
to reach the subject matter of claim 11.
Appeal Br. 9.
Claim 11 is directed to a method of determining functionality of a
medical ultrasound therapy head while a cap of the therapy head is in contact
with a patient. In contrast, Vitek discloses systems and methods for testing
the performance of an ultrasound transducer array using an acoustic
reflector, and not while the device is in contact with a patient. Vitek,
Abstract. The rejection indicates that modifying Vitek to test the transducer
array while in contact with a patient would have been obvious because it
would require only routine skill in the art and would “allow the system to
determine if there is an error/failure in the system [and] then disable the
system.” Final Act. 5. However, although it may be routine to provide
ultrasound therapy while a transducer is in contact with the patient, we are
not persuaded that this fact alone supports modifying Vitek’s testing method,
which uses a specific acoustic reflector designed to allow for the testing to
be performed before a therapeutic procedure is performed. See, e.g., Vitek
col. 7,11. 21 44. We find that the Examiner has not adequately shown that
modifying Vitek’s method such that it may be employed while the therapy
head is in contact with the patient would only require routine skill in the art.
See Appeal Br. 8—9. Thus, the Examiner reasoning lacks the required
rational underpinnings to support the conclusion of obviousness, and
accordingly, we do not sustain the rejection of claim 11. We also do not
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Application 12/729,447
sustain the rejection of claims 12—23, each of which ultimately depends from
claim 11.
Claims 24—27
Claim 24 is an apparatus claim that includes a program module
configured to perform a method of determining functionality of a medical
ultrasound therapy head including steps substantially the same as those
required by claim 11. See Appeal Br. 15. We are persuaded of reversible
error in the rejection of claim 24 for the same reasons provided above with
respect to claim 11. Accordingly, we do not sustain the rejection of claim
24, and we also do not sustain the rejection of claims 25—27, which depend
from claim 24.
CONCLUSION
We REVERSE the rejections of claims 8—27 for the reasons discussed
above.
REVERSED
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