Ex Parte Kaufman et al

Patent Trial and Appeal Board

Mar 25, 2016

13177892 (P.T.A.B. Mar. 25, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/177,892 07/07/2011 Jonathan J. Kaufman
23399 7590 03/25/2016
REISING ETHINGTON P.C.
PO BOX4390
TROY, MI 48099-4390
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.
8386.3010.001 7367
EXAMINER
FERNANDEZ, KATHERINE L
ART UNIT PAPER NUMBER
3768
MAILDATE DELIVERY MODE
03/25/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JONATHAN J. KAUFMAN
and GANGMING LUO
Appeal2014-004327
Application 13/177,892
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
PERCURIAM
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to an
ultrasonic vertebral bone assessment apparatus and method. The Examiner
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 Appellants identify the Real Party in Interest as CyberLogic, Inc. (see App.
Br. 1).
Appeal2014-004327
Application 13/177,892
Statement of the Case
Background
Appellants' invention "relates generally to apparatus and method for
non-invasively and quantitatively evaluating bone tissue in vivo" (Spec. i-f 2).
The Claims
Claims 1-10, 21, and 22 are on appeal. Independent claim 1 is
representative and reads as follows (emphasis added):
1. A method of non-invasive and quantitative assessment of
the status of a lumbar vertebral body in a living being for at least
one of the quantities, bone-mineral density, bone mass, bone
mineral content, bone strength, bone fracture risk, bone
architecture and bone quality, comprising the steps of:
acoustically coupling a first transducer and a second
transducer to nearby skin on opposite sides of a torso of said
living being;
generating a first ultrasound signal and directing said first
ultrasound signal from said first transducer to said second
transducer through said torso, at least a first portion of said first
ultrasound signal passing through said lumbar vertebral body,
said second transducer generating a first output signal responsive
to receipt of said first ultrasound signal; and,
processing said first output signal to obtain an estimate of
said at least one of the quantities, bone-mineral density, bone
mass, bone mineral content, bone strength, bone fracture risk,
bone architecture and bone quality.
The Issue
The Examiner rejected claims 1-10, 21, and 22 under 35 U.S.C.
§ 103(a) as obvious over Luo2 and Ishii3 (Final Act. 2---6).
2 Luo et al., US 2008/0194952 Al, published Aug. 14, 2008.
3 Ishii et al., US 5,902,240, issued May 11, 1999.
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Application 13/177,892
The Examiner finds that Luo teaches "a method of non-invasive and
quantitative assessment of the status of a bone in a bony member in a living
being for at least one of the quantities, bone-mineral density, bone mass,
bone mineral content, bone strength, bone fracture risk, bone architecture
and bone quality" (Final Act. 2).
The Examiner concludes that it would have been obvious to "have the
method of Luo [] be applied to a lumbar vertebral body and thus have the
first and second transducers be acoustically coupled to a torso of said living
body, as taught by Ishii [] as a good site of ultrasonic measurements for bone
assessment is a lumbar vertebra" (id. at 3; citing Ishii 10:52-57).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner's conclusion that Luo and Ishii render the claims
prima facie obvious?
Findings of Fact
1. Luo teaches
[a] method for the assessment of various properties of bone[].
The method includes applying a pair of ultrasound transducers to
skin on opposite sides of a bony member and generating an
ultrasound signal and directing the signal through the bony
member to obtain a bone output signal. ... Two parameters are
disclosed, namely two net time delay (NTD) parameters.
The apparatus includes ... a means for establishing bone
mineralization through use of both ultrasound and x-ray
measurements.
(Luo Abstract; see also Final Act. 2-3.)
2. Luo teaches that "the bone tissue evaluation and the
osteoporosis diagnosis may be performed," and provides "more accurate and
precise estimates of bone mass, bone density, bone geometry, bone quality,
and bone strength" (Luo i-fi-f 14--15; see also Final Act. 2-3).
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Application 13/177,892
3. Luo teaches that "[i]n the presently preferred embodiment ...
the forearm 5 is measured and contains an ulna 21 and a radius 6" and that
"[i]t should be further understood that [an] alternative embodiment ... may
be used on any bone within a living body in which multi-directional
ultrasound measurements can be obtained, not just the phalanges" (Luo i-f 23,
52; see also Ans. 2-3).
4. Luo teaches that
[i]t should be appreciated that while this invention applies to
bony members generally in a living being, certain bones which
have shown to be well suited for ultrasound examination have
been identified. They include, for example, the calcaneus (the
heel bone), the phalanges (finger bones), the radius (wrist), and
any of the long bones for cortical bone assessment (for example,
the tibia and femur, particularly the proximal femur or hip).
(Luo i-f 69; see also Ans. 2-3.)
5. Luo teaches that
[ a]n additional embodiment [] is to operate a pair of transducers
in both through transmission and pulse-echo mode; in this way,
two sets of ultrasound parameters may be obtained, namely that
set associated with the transmission measurements, and that set
associated with the reflection measurements. It should be
understood that these data sets may be further processed, using
linear or nonlinear, univariate or multivariate regressions, to
obtain one or more of the aforementioned bone properties.
(Luo i-f 58; see also Ans. 4.)
6. Luo teaches that
It is useful to provide some additional background as to the
relationship between NTD and bone-mineral density. . . . For
this it is useful to model the bony member as consisting solely of
two layers, one bone layer of thickness db1, and another soft
tissue layer of thickness ds1; the thickness, d, where d=db1 + ds1
is equal to the overall thickness of the bony member. It should
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Appeal2014-004327
Application 13/177,892
be understood that the soft tissue layer includes not only the
overlying soft tissues but all the soft tissues located in the path
of an ultrasound wave, for example, including the soft tissues
within the marrow spaces of any trabecular bone that may be part
of the bony member. It should further be understood that the
bone tissue layer includes all of the bone located in the path of
an ultrasound wave, and that it has been effectively compressed
into a single layer. In this model, then, the time delay of the
bone-oriented signal is 'Cb, where 1;b= 'Cb1 + 'Cs1, and 'Cb1 is the time
for propagation through the pure bone layer, and 'Csi is the time
for propagation through the pure soft tissue layer. The
expression can then be written, using 'Cb1=dbi/Vb1, and 'Cs1= dsi/Vs1
where Vb1 and Vs1 are the speed of propagation of ultrasound
through bone and soft tissue, respectively, as d/vs1- 1;b=db1 (vb1 -
Vs1)/( Vb1 ·vs1). In this expression, db1 is the parameter of interest,
namely (directly proportional to) the total bone mass or bone-
mineral density (BMD) of the bony member and the other
parameters, namely Vb1 and Vs1 can, as the present inventors have
discovered, be treated as constants. Therefore, recognizing that
d/vs1- 'Cb is the net time delay, it should then be appreciated that
NTD is proportional to the BMD.
(Luo if 50).
7. Ishii teaches "[a Jn osteoporosis diagnosis [apparatus] provided
with a two-dimensional ultrasonic transducer array" in which "[t]he
ultrasonic transducer array (3) is applied to the skin covering a
predetermined bone of a subject, and ... sequentially emit[ s] a
predetermined number of ultrasonic pulses through the skin while receiving
echoes from the bone" (Ishii Abstract; see also Final Act. 3).
8. Ishii teaches "an ultrasonic pulse-echo type osteoporosis
diagnosing apparatus and method, which diagnoses osteoporosis by emitting
ultrasonic pulses towards a certain bone of an examinee and detecting the
echoes from the bone" (Ishii 1 :5-9; see also Final Act. 3).
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Application 13/177,892
9. Ishii teaches that "a bone Mb is selected as the site of
measurement which, although not necessarily very flat, has a sufficiently
large radius of curvature relative to the wavelength of the ultrasonic pulse"
and that "[g]ood sites of measurement include a lumbar vertebra, humerus,
tibia, calcaneus or neck of the femur" (Ishii 10:52-57; see also Final Act. 3,
Ans. 3).
Principles of Law
"[W]here the general conditions of a claim are disclosed in the prior
art, it is not inventive to discover the optimum or workable ranges by routine
experimentation." In re Aller, 220 F.2d 454, 456 (CCPA 1955).
"Only if the 'results of optimizing a variable' are 'unexpectedly good'
can a patent be obtained for the claimed critical range. In re Antonie, 559
F.2d 618, 620 ... (CCPA 1977)." In re Geisler, 116 F.3d 1465, 1469 (Fed.
Cir. 1997).
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 2-6; FF 1-9) and agree that the
claims are obvious over Luo and Ishii. We address Appellants' arguments
below.
Appellants contend that "[i]n contrast to the claimed invention and
Luo[], Ishii[] disclose[s] an ultrasound assessment method based on pulse-
echo ultrasound (i.e., ultrasound where the same transducer is used to send
and receive the reflected ultrasound wave)" (App. Br. 3). Appellants argue
that
[b ]ecause the stated benefit of using the lumbar vertebra is tied
specifically to the use of pulse-echo ultrasound techniques, one
of ordinary skill in the art would not have been led to combine
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Application 13/177,892
this teaching with the through-transmission ultrasound method
disclosed in Luo[]. [Appellants] further note[] in this regard that
Ishii [] specifically criticize[ s] through transmission diagnostic
methods as lacking in any theoretical basis thereby making it
even more unlikely that one of ordinary skill in the art would
combine the teachings of Luo [] and Ishii
(Id. at 3--4; citing Ishii 1 :35-2:2.) Appellants also argue that Ishii criticizes
reliance on attenuation in through transmission testing due to missing
established theoretic basis (Reply Br. 2-3; citing Ishii 1 :35--44). Appellants
then contend that Ishii relies on a signal that does not pass through the
cortical shell of the bone while Appellants employ a signal that does (App.
Br. 4).
We are not persuaded. While Ishii describes problems associated with
the assumption that the speed of sound is proportional to bone density when
diagnosing osteoporosis, the later filed and later published Luo4 recognizes
these concerns but nonetheless applies through transmission and establishes
a theoretical basis for that through transmission measurements "may be used
on any bone within a living body in which multi-directional ultrasound
measurements can be obtained" (FF 1, 3, 6, see also Ans. 5 (citing Ishii
i-fi-f 19-20, Luo i-fi-19-12)). The theoretical basis to which Appellants refer
relates to Ishii' s discussion of prior art that pre-dates Ishii, and does not
apply to the later invented, filed, and published Luo reference.
Further, as the Examiner points out, Luo teaches using through
transmission, in addition to pulse-echo, to measure and diagnose (Ans. 4; FF
4, 5). See W.L. Gore &Assoc., Inc. v. Garlock, Inc., 721F.2d1540, 1550
4 We note that Luo's publication date is August 14, 2008 while Ishii's
issuance date is May 11, 1999, or at least 9 years before Luo' s date.
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Application 13/177,892
(Fed. Cir. 1983) (A prior art reference must be considered in its entirety, i.e.,
as a whole, including portions that would lead away from the claimed
invention). Thus, to the extent that Ishii criticizes the use of through
transmission as a mode of analysis, the later published Luo demonstrates the
theoretical basis Ishii found lacking and provides detailed information on
calculating information regarding bone density and other parameters using
through transmission techniques (FF 6).
In addition, Appellants do not establish an evidentiary basis on this
record to support the conclusion that the lumbar vertebra is tied to pulse-
echo such that through transmission cannot be used. See In re Geisler, 116
F.3d 1465, 1470 (Fed. Cir. 1997) ("[A]ttomey argument [is] not the kind of
factual evidence that is required to rebut a prima facie case of obviousness").
Like our appellate reviewing court, "[ w ]e will not read into a reference a
teaching away from a process where no such language exists." DyStar
Textilfarben GmbH & Co. Deutschland KG v. CH Patrick Co., 464 F.3d
1356, 1364 (Fed. Cir. 2006).
Appellants contend that Ishii indicates that only pulse-echo is
appropriate for use with vertebral bones because the site is relatively flat
(App. Br. 4--5 (citing Ishii 10:52-57); see also Reply Br. 2).
We do not find this argument persuasive. As Examiner points out
both Ishii and Luo teach measuring other bones, beside the vertebral bones,
such as the tibia, calcaneus and femur (Ans. 2-3; FF 3--4, 8). Ishii merely
indicates that these bones are "good sites of measurements" and therefore,
does not restrict measurement to these bones only (Ans. 5---6; FF 8).
Therefore, Ishii does not suggest only the vertebral bones can be used for
testing. Appellants do not establish any evidence on this record to support
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Application 13/177,892
the conclusion that only vertebral bones are suited for through transmission
measurement, and Luo expressly suggests that the method "may be used on
any bone within a living body in which multi-directional ultrasound
measurements can be obtained" (FF 3). See In re Geisler, 116 F.3d at 1470.
See also In re Aller, 220 F.2d at 456 and In re Geisler, 116 F.3d at 1469.
Appellants contend that Ishii does not teach through transmission of
vertebral bones (Reply Br. 2). This argument is not persuasive because
Appellants fail to account for Luo' s contribution to the combination of Luo
and Ishii, as Luo teaches through transmission (FF 1, 5). "Non-obviousness
cannot be established by attacking references individually where the
rejection is based upon the teachings of a combination of references []. [The
reference] must be read, not in isolation, but for what it fairly teaches in
combination with the prior art as a whole. " In re Merck & Co., 800 F .2d
1091, 1097 (Fed. Cir. 1986).
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as obvious over Luo and Ishii. Claims 2-10, 21, and 22 fall with
claim 1.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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