Ex Parte Vitek et al

Patent Trials and Appeals Board

Mar 14, 2019

13323070 - (D) (P.T.A.B. Mar. 14, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/323,070 12/12/2011
23517 7590 03/18/2019
MORGAN, LEWIS & BOCKIUS LLP (BO)
1111 PENNSYLVANIA A VENUE, N.W.
WASHINGTON, DC 20004
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Shuki Vitek
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
INS-067 A/7306282001 1056
EXAMINER
COOK, CHRISTOPHER L
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
03/18/2019 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):
kcatalano@morganlewis.com
patents@morganlewis.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SHUKI VITEK, YOA V MEDAN, and YOA V LEVY
Appeal2018-002249
Application 13/323,070 1
Technology Center 3700
Before STEFAN STAICOVICI, BRETT C. MARTIN, and
LEE L. STEPINA, Administrative Patent Judges.
STAICOVICI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE-
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's
decision in the Final Office Action ( dated Mar. 14, 2017, hereinafter "Final
Act."), rejecting claims 1-13, 16-19, 3 7, and 39. 2 We have jurisdiction over
this appeal under 35 U.S.C. § 6(b ).
SUMMARY OF DECISION
We REVERSE.
1 Insightec Ltd. is identified as the real party in interest in Appellants'
Appeal Brief (filed Aug. 14, 2017, hereinafter "Appeal Br."). Appeal Br. 2.
2 Claims 20-36 and 40 are withdrawn from consideration and claims 14, 15,
and 38 are canceled. Appeal Br. 15-17 (Claims App.)
Appeal2018-002249
Application 13/323,070
INVENTION
Appellants' invention relates to a system and method for "preventing
damage to the ribs during focused ultrasound (FUS) treatment of visceral
tissue." Spec. para. 1.
Claims 1 and 19 are independent. Claim 1 is illustrative of the
claimed invention and reads as follows:
1. A method for transcostal ultrasound treatment of target
tissue, the method comprising:
(a) obtaining a generic model of a rib cage, the model
comprising a plurality of parameters;
(b) transmitting ultrasound waves to the target tissue;
( c) estimating values of the plurality of parameters
based on ultrasound reflections;
( d) determining whether the ultrasound reflections
associated with the estimated values of the parameters are
maximized; and
( e) if so, then based on the model of the rib cage and the
estimated values of the parameters, treating the target tissue by
focusing ultrasound into the target tissue without damaging
ribs;
if not, then,
(i)
(ii)
(iii)
updating the values of the parameters based
on (A) the ultrasound reflections and (B) the
estimated values of the parameters or
previously updated values of the parameters;
repeating the updating step until the
ultrasound reflections associated with the
updated values of the parameters are
maximized; and
based on the model of the rib cage and the
updated values of the parameters,
treating the target tissue by focusing
the ultrasound into the target tissue
without damaging the ribs.
2
Appeal2018-002249
Application 13/323,070
REJECTIONS
I. The Examiner rejects claims 1-13, 16-19, 37, and 39 under
35 U.S.C. § 112, second paragraph, as being indefinite.
II. The Examiner rejects claims 1-3, 6, 7, 10, 11, 16, 17, 19, and 37
under 35 U.S.C. § I03(a) as being unpatentable over Liu et al. (US
2008/0200806 Al, pub. Aug. 21, 2008, hereinafter "Liu"),
Linnenbank et al. (US 2012/0002840 Al, pub. Jan. 5, 2012,
hereinafter "Linnenbank"), and Lifsitz et al. (US 2011/0144462 Al,
pub. June 16, 2011, hereinafter "Lifsitz").
III. The Examiner rejects claims 4, 5, 8, 12, and 13 under 35 U.S.C.
§ I03(a) as being unpatentable over Liu, Linnenbank, Lifsitz, and
Takabayashi et al. (EP 1 964 518 Al, pub. Sept. 3, 2008, hereinafter
"Takabayashi"), as evidenced by Khokhlova et al., Focus Splitting
Associated with Propagation of Focused Ultrasound Through the Rib
Cage, Acoustic Physics, Vol. 56, No. 5, p. 665-674 (Sept.2010)
(hereinafter "Khokhlova").
IV. The Examiner rejects claims 8 and 9 under 35 U.S.C. § I03(a) as
being unpatentable over Liu, Linnenbank, Lifsitz, and Vortman et al.
(US 2010/0030076 Al, pub. Feb. 4, 2010, hereinafter "Vortman").
V. The Examiner rejects claim 12 under 35 U.S.C. § I03(a) as being
unpatentable over Liu, Linnenbank, Lifsitz, and Richard (US
2003/0187357 Al, pub. Oct. 2, 2003) or Stergiopoulos et al. (US
6,719,696 B2, iss. Apr. 13, 2004, hereinafter "Stergiopoulos").
VI. The Examiner rejects claims 16, 17, and 39 under 35 U.S.C. § I03(a)
as being unpatentable over Liu, Linnenbank, Lifsitz, and Tanter et al.,
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Application 13/323,070
Compensating For Bone Interfaces and Respiratory Motion in High-
Intensity Focused Ultrasound, Int. J. Hyperthennia, Vol. 23, No. 2, p.
141-151 (March 2007) (hereinafter "Tanter") or Chang et al. (US
2009/0112132 Al, pub. Apr. 30, 2009, hereinafter "Chang"). 3
VII. The Examiner rejects claim 18 under 35 U.S.C. § I03(a) as being
unpatentable over Liu, Linnenbank, Lifsitz, and Kang et al. (US
2008/0137482 Al, pub. June 12, 2008, hereinafter "Kang").
ANALYSIS
Rejection I
Independent claim 1 recites, inter alia, "the model comprising a
plurality of parameters ... transmitting ultrasound waves ... estimating
values of the plurality of parameters based on ultrasound reflections ...
determining whether the ultrasound reflections associated with the estimated
values of the parameters are maximized." Appeal Br. 14 (Claims App.).
Independent claim 19 recites similar limitations. See id. at 16.
The Examiner finds that it is unclear in both independent claims 1 and
19 "how parameters are determined to be maximized based on ultrasound
reflections." Final Act. 2 ( emphasis added). According to the Examiner, "it
is unclear how the parameters are determined to be maximized on a first
attempt ( e.g. steps a-e 'if so')." Id. The Examiner further finds that "it is
[also] unclear how values of parameters (e.g. model) are updated based on
iteratively acquiring ultrasound reflections." Id. 2.
3 As claim 3 8 is cancelled, we consider the inclusion of claim 3 8 in the body
of the rejection as a typographical error. See Appeal Br. 16 (Claims App.);
Final Act. 11.
4
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Application 13/323,070
Appellants argue that, "the Examiner is clearly confusing 'the
parameters of a rib-cage model' with 'ultrasound reflections."' Appeal Br.
6. According to Appellants, the Specification describes using an ultrasound
transducer to measure ultrasound reflections and a processor to determine
whether the ultrasound reflections are maximized. Id. (citing Spec., paras.
18, 44, 53).
In response, the Examiner "contends that [ c ]laim 1 is indefinite for the
use of the term 'maximized' with respect to the ultrasound reflections and
the estimated values of parameters." Examiner Answer 2 (dated Nov. 29,
201 7, hereinafter "Ans.") ( emphasis added). The Examiner explains that
such an interpretation is supported by paragraph 53 of Appellants'
Specification, which states that "the model includes parameters whose
values are estimated based on measured ultrasound reflection" and "the
method involves finding a set of values that maximizes ultrasound
reflections." Id. at 3 (emphasis omitted). Thus, according to the Examiner,
because ultrasound reflections are "represented as an amplitude or
magnitude" of the ultrasound wave, "there is simply not sufficient direction
to determine whether ultrasound reflections associated with the estimated
values (e.g. multiple data points) are 'maximized' (e.g. single data point
being the 'maximum')." Id. The Examiner asserts that "there is no link
between the relative terms [(]( e.g. higher and maximized) used in
[p ]aragraph [0053]) to provide any clarity for maximizing any claim
limitation." Id.
We agree with Appellants that in both independent claims 1 and 19
"what is maximized is the [ ultrasound] reflection, not the associated
parameters." Reply Brief 3 (filed Dec. 22, 2017, hereinafter "Reply Br.").
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Application 13/323,070
Paragraph 53 of Appellants' Specification describes obtaining a generic rib
cage model, wherein the model "includes one or more parameters (e.g.,
positional parameters of the ribs), whose values may be estimated based on
the measured ultrasonic reflections" ( emphasis added). Paragraph 53 further
describes finding a set of parameter values "that maximizes the reflection of
the ultrasound waves" ( emphasis added). Hence, the Specification is clear in
that the set of values of the model parameters are estimated based on
ultrasonic reflections and are eventually determined as the set of values that
maximize ultrasonic reflections, that is, the set of values that result in a
maximum amplitude or magnitude of the reflected ultrasound waves. Thus,
Appellants are correct "that only ... [a] single value - the reflection
magnitude - is maximized, and at that point the associated [ values of the]
parameters are used." Reply Br. 3--4. As such, we agree with Appellants
that "the present [S]pecification provides clear and sufficient direction for
one of ordinary skill in the art to determine whether the ultrasound
reflections are maximized." Appeal Br. 6.
Furthermore, we do not agree with the Examiner's position that "it is
unclear how values of parameters are updated based on ultrasound
reflections." Ans. 4. As Appellants correctly note, "[c]laims 1 and 19,
however, require updating the values of the parameter based on not only the
ultrasound reflections but based also on the estimated values of the
parameters or previously updated values of the parameters." Appeal Br. 7.
We agree with Appellants that "the parameter values in the current iteration
may be updated by changing the parameter values in the previous
iteration(s), and such a change may be based on the measured ultrasound
reflections associated therewith." Id. at 7-8. Stated differently, a skilled
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Application 13/323,070
artisan "can simply use reflection magnitudes ... associated with a
previously measured parameter value in order to estimate ... the next value
of that parameter." Reply Br. 4. Such an interpretation is supported by
Appellants' Specification, which describes an iterative process where "the
initial parameter values for the next measurement set are determined
based on the results of the previous measurements." Spec. para. 53.
In conclusion, for the foregoing reasons, we do not agree that
independent claims 1 and 19 are indefinite. Therefore, we do not sustain the
indefiniteness rejection of independent claims 1 and 19, and their respective
dependent claims 2-13, 16-18, 37, and 39.
Rejection II
As discussed supra, the Examiner finds that it is unclear in both
independent claims 1 and 19 "how parameters are determined to be
maximized based on ultrasound reflections." Final Act. 2. As such, the
Examiner construes the limitation of "determining whether the ultrasound
reflections associated with the estimated values of the parameters are
maximized" to mean that "a generic model is matched, aligned or 'morphed'
with individual patient ultrasound data." Id. at 2, 4. Thus, according to the
Examiner, "when the ultrasound image data matches the model parameters
( e.g. positions of anatomy), the parameters would be 'maximized' in its
broadest reasonable interpretation." Id.
In light of the Examiner's claim construction noted above, the
Examiner finds that Liu discloses most of the limitations of independent
claims 1 and 19, but fails to "disclose a starting step of obtaining a generic
model of a rib cage." Final Act. 3--4 ( citing Liu, Abstract, paras. 7, 53, 57).
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Thus, the Examiner finds that Linnenbank discloses a medical imaging
process where "a generic model is morphed with patient data ( e.g. MRI,
ultrasound, X-Ray) to generate a patient specific model," which "includes
steps of iteratively adjusting the boundaries of anatomical parts until they
satisfy [a] criterion (e.g. match/coincide)." Id. at 4 (citing Linnenbank,
paras. 1, 9--15, 17, 26-32, 80-86, 116, 117, 125, 126). The Examiner further
finds that although "Linnenbank morphs the model iteratively, Linnenbank
does not expressly disclose 'maximizing' model parameters (e.g. anatomical
positions) as now claimed." Id. at 5. As such, the Examiner then turns to
Lifsitz to disclose a medical image process for "aligning or matching at least
two images or models into one," "wherein images are considered to be
matched, aligned or in agreement when parameters are maximized." Id.
( citing Lifsitz, paras. 13, 14, 18, 22, 23) ( emphasis added). Thus, the
Examiner concludes that:
[I]t would have been obvious to a person skilled in the art to
have modified the transcostal ultrasound treatment system and
method described by Liu, particularly the "chest-rib distribution
model" generation to create a patient specific model of the ribs
as described by Linnenbank and Lifsitz comprising steps of
providing a generic model including parameters ( e.g. anatomy
position information) and morphing the model with patient
image data until parameters are maximized in order to enhance
( e.g. speed up/accuracy) the localization of rib locations for
individual patients.
Id. at 5---6.
We do not agree with the Examiner's claim construction in which
"when the ultrasound image data (received reflections) matches the model
parameters ( e.g. positions of anatomy), the parameters values with respect to
maximized ultrasound reflections would be matched in its broadest
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Application 13/323,070
reasonable interpretation." Ans. 4 ( emphasis added). Rather, for the reasons
discussed above, we agree with Appellants that in both independent claims 1
and 19 "what is maximized is the [ ultrasound] reflection, not the associated
parameters." Reply Br. 3.
Accordingly, Appellants are correct that the combined teachings of
Liu, Linnenbank, and Lifsitz have "nothing to do with maximizing the
ultrasound reflections associated with the estimated values of model
parameters." Appeal Br. 10. As correctly noted by Appellants,
Linnenback describes a method of linking coordinates of an
input image to coordinates in a reference model ... by
overlaying the input image and the reference model, and
adjusting at least one of them such that boundaries of the input
image and boundaries of the reference model coincide.
Id. (citing Linnenback, paras. 10-17, 80-86). Appellants are also correct
that Lifsitz merely discloses "several image registration approaches, one of
which is to find a transformation that maximizes the match of voxel
intensities between two images." Id. (citing Lifsitz, paras. 22, 23).
Although Linnenback discloses "performing boundary alignment" and
Lifsitz discloses matching images until parameters are maximized, neither
Linnenback nor Lifsitz discloses determining whether the ultrasound ( as per
claim 1) or acoustic ( as per claim 19) reflections, associated with the
estimated values of the parameters, are maximized. Id.
In conclusion, for the foregoing reasons, we do not sustain the
rejection under 35 U.S.C. § 103(a) of claims 1-3, 6, 7, 10, 11, 16, 17, 19,
and 37 as unpatentable over Liu, Linnenbank, and Lifsitz.
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Application 13/323,070
Rejections III-VII
The Examiner's use of the Takabayashi 4, Khokhlova, Vortman,
Richard, Stergiopoulos, Tanter, Chang, and Kang disclosures does not
remedy the deficiency of the Liu, Linnenbank, and Lifsitz combination
discussed supra. See Final Act. 7-13. Accordingly, for the foregoing
reasons, we also do not sustain Rejections III-VII.
SUMMARY
The Examiner's decision to reject claims 1-13, 16-19, 37, and 39 under
35 U.S.C. § 112, second paragraph, as being indefinite, is reversed.
The Examiner's decision to reject claims 1-13, 16-19, 3 7, and 3 9 under
35 U.S.C. § 103(a) is reversed.
REVERSED
4 We appreciate that Takabayashi discloses a thresholding method to locate a
bone structure, however, the Examiner does not adequately explain how
such thresholding constitutes "determining whether the ultrasound
reflections ... are maximized," as called for by each of independent claims
1 and 19. See Takabayashi, paras. 13, 14, 20, 24.
10