Ex Parte Nakajima et al

Patent Trial and Appeal Board

Aug 24, 2016

12446144 (P.T.A.B. Aug. 24, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/446,144 12/22/2010
27896 7590 08/26/2016
EDELL, SHAPIRO & FINNAN, LLC
9801 Washingtonian Blvd.
Suite 750
Gaithersburg, MD 20878
FIRST NAMED INVENTOR
Toshiaki Nakajima
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.
2660.0007C 3683
EXAMINER
AGAHI,PUYA
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
08/26/2016 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):
epatent@usiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TOSHIAKI NAKAJIMA AND YOSHIAKI SATO
Appeal2014-008969
Application 12/446,144
Technology Center 3700
Before ERIC B. GRIMES, ULRIKE W. JENKS, and
ROBERT A. POLLOCK, Administrative Patent Judges.
PERCURIAM
DECISION ON APPEAL
This is a decision on appeal 1 under 35 U.S.C. § 134 from the
Examiner's rejection of claims 1-10. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We reverse.
STATEMENT OF THE CASE
The Specification discloses "a therapeutic device that can be applied
to ... [the] treatment of metabolic syndrome" (Spec. 1:6-7). The
Specification discloses that the device or system comprises a belt having a
1 Appellants identify the Real Party in Interest as Kaatsu Japan Co., Ltd
(App. Br. 3).
Appeal2014-008969
Application 12/446,144
"length that is enough to be wrapped around a predetermined range of
muscles of one of the limbs; fastening means for fastening said belt ... and a
gas bag provided in or on said belt" (Spec. 7:5-9). The Specification
discloses that the gas bag is "adapted to apply a predetermined compression
pressure to said predetermined range of muscles by means of compressing
said predetermined range of muscles when said gas bag is filled with gas"
(Spec. 7:9-13). The Specification discloses that the device comprises a
"pressure setting means which is capable of setting a gas pressure within
said gas bag to a predetermined pressure; [and] control means for controlling
said pressure setting means" (Spec. 7: 15-1 7).
Claims 1-10 are on appeal. Claim 1 is representative of the claims on
appeal and is reproduced in the Claims Appendix of the Appeal Brief. 2
Issue
The Examiner has rejected claims 1-10 under 35 U.S.C. § 103(a) as
obvious in view of Sato3 and Souma4 (Ans. 2, Fin. Rej. 5 3-7).6
2 Appellants' Appeal Brief, filed May 28, 2014, does not contain page
numbers. For reference purposes we consecutively count the pages starting
with the cover page as page one of the Appeal Brief.
3 Yoshiaki Sato et al., CA 2529808, published Dec. 29, 2004
4 Takahiro Souma, US 5,197,478, issued Mar. 30, 1993
5 Office Action mailed August 29, 2013.
6 The Final Rejection indicates that only claims 1-7, 9, and 10 are rejected
as obvious in view of Sato and Souma (Fin. Rej. 3). However, this
statement of the rejected claims appears to be in error because claims 1-10
are pending, and the summary sheet of the Final Rejection (p. 1) indicates
that claims 1-10 stand rejected. We note that Appellants appear to
understand that claims 1-10 have been rejected as being obvious in view of
Sato and Souma (see App. Br. 10).
2
Appeal2014-008969
Application 12/446,144
The issue presented is: Does the evidence of record support the
Examiner's conclusion that it would have been obvious to one of skill in the
art, in view of Souma, to modify the Sato' s therapeutic system to include a
control means that is adapted to execute both a preprocessing process and a
normal processing process, wherein a maximum pulse wave pressure (i.e.,
gas pressure within the gas bag at the time point at which the amplitude of
the pulse wave has reached its maximum) is determined during the
preprocessing process and wherein the "pressure setting means sets the gas
pressure within said gas bag to said maximum pulse wave pressure" during
the normal processing process, and thereby arrive at the therapeutic system
of claim 1?
Findings of Fact
1. Sato discloses "a muscle strength development apparatus
suitable for a pressure muscle strength increasing method" (Sato 1:9-13).
2. Sato discloses a tight fitting device that can encircle a limb.
"This tight fitting device 100 basically comprises a belt 110, a gas bag 120,
and a fastening member 130" (Sato 20:26-28).
3. Sato discloses that a "pressure setting segment 200 may have
any one of possible configurations as long as it can supply a gas to the gas
bag 120 and remove the gas from the gas bag 120" (Sato 23:23-25).
4. Sato discloses that a
quantification segment 300 is adapted to quantify, at a position
closer to the distal end of the limb, the quantification target that
is associated with the state of blood flow through the limb ...
[wherein] the quantification target varies depending on the
compression force applied by the tight fitting device ....
3
Appeal2014-008969
Application 12/446,144
[Q]uantification segment 300 ... can quantify at least one of
Korotkoff sounds, Swan sounds, and pulse waves.
(Sato 24: 10-27.) "[P]ulse waves are the waveforms over the body
surface representing volumetric changes in the blood vessels as blood pulses
through certain regions of body tissues. A sphygmograph is a device known
to be used for detecting pulse waves ... [and] it may be used as the
quantification segment 300" (Sato 25:5-10).
5. Souma discloses an automatic sphygmomanometer that is
arranged to predict, on the basis of the relationship between
cuff pressure and the amplitude of a pulse wave, maximal and
minimal blood pressures .... [I]t is possible to minimize the
discomfort inflicted upon the subject due to pressure and a
lengthy operation. Moreover, this ... eliminates the awkward
operation of setting a pressure which is approximately 30
mmHg higher than the expected maximal blood pressure.
(Souma, Abstract.)
6. Figure 2 of Souma is shown below:
;liiP.:; ,« i5i"f'2 'e O •;.;
·p~·t'{;~; ~;o.;5·0%
Figure 2 shows "a graphic representation showing the relationship between
time and the amplitude of a pulse wave signal when the rate of pressure-
increase is constant" (Souma, coL 3~ L 67----col. 4, L 2). Souma discloses that,
"[a]s the cuff pressure is increased, the amplitude of the pulse wave signal
gradually increases, and after this amplitude passes a peak point (Pl· P2), it
gradually decays" (Souma, coL Si lL 26-29). "[A]s shown in FIG. 2, if the
peak point of the amplitude of the pulse wave ... can be detected, it is
4
Appeal2014-008969
Application 12/446,144
possible to predict the maximal and minimal blood pressures of the subject"
(Souma, coL 5, lL 29-----32).
7. Souma discloses that
it is predicted that the minimal blood pressure is present in the
neighborhood of an amplitude ... which corresponds to 80% of
the amplitude of the peak position, that is, the peak point. ...
and that the maximal blood pressure is present in the
neighborhood of an amplitude . . . which corresponds to 50%
of the amplitude of the peak point. . . . [The] numerical values,
such as 80% and 50%, are not construed as restrictive values
since they may vary, depending upon the construction of the
hardware.
(Souma, col. 5, 11. 33--43).
8. Souma discloses that,
when the maximal blood pressure is to be measured, the
pressure within the cuff 102 may be increased at a relatively
high rate up to the instant of time slightly beyond the time
corresponding to the peak position of the pulse-wave signal. ...
[A ]fter the amplitude of the pulse-wave signal has reached the
limit, the rate of pressure-increase is slowed down to initiate
measurement of the maximal blood pressure. . . . [I]t is
possible to measure the maximal blood pressure without the
need to impose upon the arm of the subject a burden which is
30 mmHg greater than the expected maximal blood pressure as
in the case of prior art sphygmomanometers.
(Souma, col. 5, 11. 44---61.)
9. Souma discloses that a microprocessor "is affanged to operate
in accordance with the process procedure (program) shown in the flowchart
of FIGS. 4(a) to 4(cf' (Souma~ coL 4~ IL 19-24).
5
Appeal2014-008969
Application 12/446,144
10. Figures 4(a}-4(c) of Souma are shown below:
(~)
v
~--------------'-'""'""·-----;
-----'--- s~~ :
~~~~~~~:'.
~~;?1;;:;2'.1
L ________ ,,.::::~~~~~·:::::::J·----------·--...... ..-
' r-~;f;j·-~t;~\.~:;;~,~;~~1~------1---~-~~~~
~ ... '<:t-~~.;:_- M.:V ~«.,.;:.,.";$£ · .• '>'!-\.~,..,:~~
\ ..................... -.~~-.---.---·""""-
(=~~~:~~::~~~~~) FfG.4 fcl
Figures 4( a), 4(b ), and 4( c) "are flow charts which ... illustrate a process
procedure for measuring blood pressure" (Souma, coL 4, !L 6-8).
11. Souma discloses that "[a]fter the pulse-wave signal of
maximum amplitude has been measured, the process proceeds to Step S8,
where the pressure in the cuff 102 and the amplitude of the pulse-wave
signal which are obtained at this time are stored in RAM lOlb of the
memory 101" (Souma, coL 6, lL 53-57).
Analysis
The Examiner finds that Sato discloses a therapeutic system
comprising "a tight fitting device including a belt having the length that is
enough to be wrapped around a predetermined range of muscles of one of
the limbs ... [and] fastening means for fastening said belt" (Fin. Rej. 3,
citing Sato, 20 :21-21: 6). The Examiner finds that Sato does not disclose a
control means that is adapted to execute both a preprocessing process and a
normal processing process wherein the preprocessing process determines "a
6
Appeal2014-008969
Application 12/446,144
maximum pulse wave pressure that is a gas pressure within said gas bag at
the time point at which the amplitude of the pulse wave has reached its
maximum" and wherein, during the normal processing process, the "pressure
setting means sets the gas pressure within said gas bag to said maximum
pulse wave pressure" (Fin. Rej. 4).
The Examiner finds that Souma discloses "an automatic
sphygmomanometer for predictively measuring pressure by sampling pulse
wave signal" (Fin. Rej. 4, citing Souma, the title). The Examiner finds that
"Souma's process of determining the maximum pulse wave prior to storing
the obtained data value( s) in RAM 101 b reads on preprocessing.
Subsequently, applying the stored values so as to administer a new blood
pressure test reads on normal processing" (Fin. Rej. 5). The Examiner
concludes that one of ordinary skill in the art "would have had predictable
success incorporating Souma and Sato because doing so would reduce the
discomfort inflicted upon the arm of the subject" (Fin. Rej. 5, citing Souma,
col. 7, 11. 26-27).
Appellants argue that Souma discloses a device that allows for "an
expedited blood pressure measurement/test to enable a patient to endure the
least amount of discomfort during the test" (App. Br. 13, citing Souma, col.
2, 11. 45-51 ). Appellants argue that, in Souma, "the determination/use of the
maximum pulse wave pressure is for generating a predicted
maximum/minimum blood pressure for a subject" (App. Br. 13, citing
Souma, col. 5, 11. 26-43). Appellants argue that instant claim 1 "includes a
limitation as follows: 'control said pressure setting means during said
normal processing so that said pressure setting means sets the gas pressure
within said gas bag to said maximum pulse wave pressure"' (App. Br. 14).
7
Appeal2014-008969
Application 12/446,144
Appellants argue that "the determination of the maximum pulse wave
pressure during 'preprocessing' ultimately leads to the constant maintaining
[sic] the gas pressure to this level during processing" (App. Br. 14, citing the
Spec. 9-10). Appellants argue that Souma does not disclose setting "any
values, but rather stores the numerical value of the maximum wave pulse
measurement to use as a base-line predictor for the maximum and minimum
blood pressure measurement for a patient" (App. Br. 16). Appellants argue
that Souma does not disclose setting the maximum pulse wave pressure
because "the pressure in the system is constantly increasing to a value above
the maximum amplitude and then subsequently decrease [sic] to a value
below the maximum amplitude to measure a patient's maximum and
minimum blood pressure" (App. Br. 16). Appellants argue that Souma's
system "merely stores the numerical value [] as a bench mark in order to
change the rate of pressure increase/ decrease; the system does not set the
pressure to the maximum wave pulse as disclosed in applicant's pending
claim 1" (App. Br. 16-17). Appellants argue that "one of ordinary skill in
the art would not look to Souma with respect to usage of the maximum wave
pulse since Souma merely utilizes the maximum wave pulse calculation as a
base-line numerical comparison threshold that is stored in the memory to
allow for the adjustment in the rate of pressure increase during testing"
(App. Br. 17).
We agree with Appellants that the Examiner has not adequately
explained why one of ordinary skill in the art, in view of Souma, would have
modified the muscular strength enhancing system of Sato to set the gas
pressure in the gas bag to the maximum pulse wave pressure. "In rejecting
claims under 35 U.S.C. § 103, the examiner bears the initial burden of
8
Appeal2014-008969
Application 12/446,144
presenting a prima facie case of obviousness. Only if that burden is met,
does the burden of coming forward \vith evidence or argument shift to the
applicant" In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (citations
omitted). Although Sato discloses detecting and quantifying pulse waves
(FF 4), Sato does not disclose setting the pressure in the gas bag to the
maximum pulse wave pressure. Souma discloses an automatic
sphygmomanometer for measuring maximal and minimal blood pressures,
wherein the maximum pulse wave pressure is determined and then used to
estimate the maximal and minimal blood pressures (FFs 5-8). Souma
discloses that this process facilitates a quicker and more comfortable blood
pressure determination process (FF 5 and 8). The Examiner points to
Souma's disclosure that the value of the pressure in the cuff when the pulse
wave amplitude reaches a peak or maximum is stored in the memory
(Souma, Fig. 4( a); see FF 11 ). However, Souma makes clear that this value
is stored in the memory for the purposes of estimating the maximal and
minimal blood pressures (FF 9). Souma does not disclose that the pressure
in the cuff is set or maintained at this value. The Examiner asserts that one
of skill in the art would have modified Sato' s device to set the pressure in
the cuff to the maximum pulse wave pressure in order to make the device of
Sato more comfortable. However, missing from the Examiner's analysis is
evidence that an artisan would have a reason to choose the particular
pressure in the cuff, in this case the maximum pulse wave pressure, to make
the device more comfortable and still expect to achieve the muscle
strengthening goals disclosed by Sato. See KSR Int 'l Co. v. Teleflex
Inc., 550 U.S. 38, 418 (2007) (obviousness rejections require "some
articulated reasoning with some rational underpinning").
9
Appeal2014-008969
Application 12/446,144
Thus, we reverse the rejection of independent claim 1 and dependent
claims 2-8 under 35 U.S.C. § 103(a).
Like claim 1, independent claim 9 also recites that a control means
adapted to execute both a preprocessing process and a normal processing
process and to "control said pressure setting means during said normal
processing so that said pressure setting means sets the gas pressure within
said gas bag to said maximum pulse wave pressure" (emphasis added). 7
As discussed above for claim 1, the Examiner has not adequately
explained how the cited references would have made obvious a device that
sets the gas pressure within the gas bag to the maximum pulse wave
pressure. Thus, we also reverse the rejection of independent claim 9 under
35 U.S.C. § 103(a) for the reasons discussed above.
Independent claim 10 is directed to a control method that is carried
out by a therapeutic device, where the method comprises, among other steps,
the steps of:
controlling said pressure setting means with said control
means during said preprocessing so that said pressure setting
means changes the gas pressure within said gas bag, and
determines a maximum pulse wave pressure ... and
controlling said pressure setting means with said control
means during said normal processing so that said pressure
setting means sets the gas pressure within said gas bag to said
maximum pulse wave pressure. (emphasis added)8
7 The full text of claim 9 can be found in the Claims Appendix to the Appeal
Brief (App. Br. 26-27).
8 The full text of claim 10 can be found in the Claims Appendix to the
Appeal Brief (App. Br. 27-28).
10
Appeal2014-008969
Application 12/446,144
As discussed above for claim 1, the Examiner has not adequately explained
how the cited references would have made obvious a device that sets the gas
pressure within the gas bag to the maximum pulse wave pressure. Thus, we
also reverse the rejection of independent claim 10 under 35 U.S.C. § 103(a)
for the reasons discussed above.
SUMMARY
We reverse the rejection of claims 1-10 under 35 U.S.C. § 103(a).
REVERSED
11