Ex Parte Mao et al

Patent Trial and Appeal Board

Nov 10, 2016

12116013 (P.T.A.B. Nov. 10, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/116,013 05/06/2008
51111 7590
AKACHANLLP
Melvin Chan
900 LAFAYETTE STREET
SUITE 710
SANTA CLARA, CA 95050
11/15/2016
FIRST NAMED INVENTOR
Jimmy Jian-min Mao
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.
VIOPP015 6214
EXAMINER
LIU, CHU CHUAN
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
11/15/2016 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):
PTO-INBOX@AKACHANLAW.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JIMMY JIAN-MIN MAO and ROBERT E. LASH
Appeal2015-003054
Application 12/116,013
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
PERCURIAM
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a method
for measuring cerebral oxygen saturation. The Examiner rejected the claims
as obvious. 2 We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
1 Appellants identify the Real Party in Interest as ViOptix, Inc. (See App.
Br. 2.)
2 The rejection of claim 52 as being indefinite (see Final Act. 2-3) has been
withdrawn (see Ans. 15).
Appeal2015-003054
Application 12/116,013
Statement of the Case
Background
Appellants' "invention relates to patient monitoring devices and
methods" (Spec. i-f 2). Appellants' invention uses "a device including a first
source structure, a first near detector structure, a first far detector structure,
and a light diffusing layer, where the first near detector structure receives a
beam of light after the beam of light has been transmitted through a tissue
and the light diffusing layer" (id. i-f 9).
The Claims
Claims 16, 17, 19, 21-34, and 36-54 are on appeal. Independent
claim 16 is representative and reads as follows (emphasis added):
16. A method comprising:
positioning a sensor head of a tissue oximeter to face
toward a tissue, wherein the tissue oximeter can measure oxygen
saturation of the tissue without requiring a pulse, the sensor head
comprises a first source structure, a second source structure, a far
detector arrangement, a near detector arrangement, and a
semitranslucent film covering the near detector arrangement;
transmitting light through the first source structure and the
second source structure into a tissue;
receiving a first light transmitted through the tissue and
the semitranslucentfilm covering the near detector arrangement
at the near detector arrangement, the first received light at the
near detector arrangement including attenuation characteristics
due to the semitranslucent film;
receiving a second light transmitted through the tissue at
the far detector arrangement, the second received light not
passing through the semitranslucent film, and the second
received light at the far detector arrangement not including the
attenuation characteristics; and
processing the first and second received light using a
system unit.
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Application 12/116,013
The Issues
A. The Examiner rejected claims 16, 17, 19, 36, 46, 50, 51, and 53 under
35 U.S.C. § 103(a) as obvious over Chen3 and Cadell4 (Ans. 2-7).
B. The Examiner rejected claims 21-30, 31-34, 37, 40, and 43--45 under
35 U.S.C. § 103(a) as obvious over Chen (Ans. 7-9).
C. The Examiner rejected claim 38 under 35 U.S.C. § 103(a) as obvious
over Chen and O'Neil5 (Ans. 106).
D. The Examiner rejected claims 39, 41, and 42 under 35 U.S.C. § 103(a)
as obvious over Chen and Delonzor7 (Ans. 10-12).
E. The Examiner rejected claims 47--49 and 54 under 35 U.S.C. § 103(a)
as obvious over Chen, Cadell, and Delonzor (Ans. 12-15).
A. and E. 35 USC§ 103(a) over Chen and Cadell, and Chen, Cadell,
and Delonzor
Because the same issue is dispositive for these two rejections, we will
consider them together.
Appellants' independent claims 16 and 47 require "receiving a first
light transmitted through the tissue and the semitranslucent film covering the
near detector arrangement at the near detector arrangement" and "receiving a
second light transmitted through the tissue at the far detector arrangement,
the second received light not passing through the semitranslucent film."
3 Chen et al., US 7,072,701 B2, issued July 4, 2006 ("Chen").
4 Cadell et al., US 5,429,128, issued July 4, 1995 ("Cadell").
5 O'Neil et al., US 6,748,254 B2, issued June 8, 2004 ("O'Neil").
6 We note that the Examiner misidentified O'Neil as "O'Nell et al.," "USPN
6, 784,254" (see Ans. 10).
7 Delonzor et al., US 5,797,841, issued Aug. 25, 1998 ("Delonzor").
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Application 12/116,013
Independent claim 50 requires "receiving a first light transmitted through the
tissue and the semitranslucent film covering the first plurality of detectors at
the first plurality of detectors" and "receiving a second light transmitted
through the tissue at the second plurality of detectors, the second received
light not passing through the semitranslucent film."
The Examiner finds that
Chen discloses a method comprising: positioning a sensor head
of a tissue oximeter (abstract and Fig. 1) to face toward a tissue
(Fig. 1 ), wherein the tissue oximeter can measure oxygen
saturation of the tissue without requiring a pulse (NIRS, Col[.] 4
lines 28-52), the sensor head comprises a first source structure
(one or more laser diodes in 18, Fig. 1 and Col 6[.] lines 27-53),
a second source structure (one or more laser diodes in 18, Fig. 1
and Col[.] 6 lines 27-53), a far detector arrangement (element
20, Fig. 1) and a near detector arrangement (element 19, Fig. 1);
transmitting light through the first source structure and the
second source structure into a tissue (Fig. 1 ); receiving a first
light transmitted through the tissue (element 19, Fig. 1; Fig. 4 ),
the first received light at the near detector arrangement including
attenuation characteristics (Fig. 4 ); receiving a second light
transmitted through the tissue at the far detector arrangement
(element 20, Fig. 1; Fig. 4); and processing the first and second
received light using a system unit (elements 12 and 16, Fig. 2).
(Ans. 2-3; see also id. at 12.)
The Examiner acknowledges that "Chen does not specifically disclose
a semitranslucent film covering the near detector arrangement and the
second received light not passing through the semitranslucent film, and the
second received light at the far detector arrangement not including the
attenuation characteristics" (id. at 3; see also id. at 12).
The Examiner turns to Cadell and finds that it "teaches to prevent a
photodetector from saturating (i.e.[,] over-saturating), a neutral density filter
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Application 12/116,013
can be utilized and an OD of the filter can be added to obtain the absorbance
information (Col[.] 6 lines 40-59)" (id. at 3; see also id. at 12).
The Examiner asserts that because "[i]t is known that when
oversaturation happens, details of the detected signals above the dynamic
range of the detector may not reflect the true level correctly," it would have
been obvious to "modify the method (Chen) to incorporate a proper neutral
density filter (Cadell) to the near detector in order to obtain more accurate
optical measurements" (id. at 3--4; see also id. at 12).
The issue with respect to these rejections is: Does the evidence of
record support the Examiner's conclusion that Chen and Cadell render the
claims obvious?
Findings of Fact
1. Chen teaches
A method and apparatus for non-invasively determining the
blood oxygen saturation level within a subject's tissue is
provided that utilizes a near infrared spectrophotometric (NIRS)
sensor capable of transmitting a light signal into the tissue of a
subject and sensing the light signal once it has passed through
the tissue via transmittance or reflectance. The method includes
the steps of: (1) transmitting a light signal into the subject's
tissue, wherein the transmitted light signal includes a first
wavelength, a second wavelength, and a third wavelength; (2)
sensing a first intensity and a second intensity of the light signal,
along the first, second, and third wavelengths after the light
signal travels through the subject at a first and second
predetermined distance; (3) determining an attenuation of the
light signal for each of the first, second, and third wavelengths
using the sensed first intensity and sensed second intensity of the
first, second, and third wavelengths; (4) determining a difference
in attenuation of the light signal between the first wavelength and
the second wavelength, and between the first wavelength and the
third wavelength; and ( 5) determining the blood oxygen
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Application 12/116,013
saturation level within the subject's tissue using the difference in
attenuation between the first wavelength and the second
wavelength, and the difference in attenuation between the first
wavelength and the third wavelength.
(Chen Abstract; see also Ans. 2-3.)
2. Figure 1 of Cadell is reproduced below:
20
8 1""24
28 30
Figure 1
Figure 1 shows "a light source 8," "a finger 2," and "[a] neutral density filter
42 is mounted on a support 44," in which "light 22 passes through a sensor
focussing [sic] lens 32, which focusses the light onto a linear photo diode
array 34," and "[t]he array 34 is connected to a printed circuit board 36 for
processing of data obtained from the differences in light intensity as the light
passes through the finger" (Cadell 2:1-21, 36-38; see also Ans. 3).
3. Cadell teaches that "[ w ]hen it is desired to take a reference
measurement with the monitoring device, there is no finger in the receptor
and the motor ... rotates the shaft 38 to move the filter 42 so that it is in line
with the exit 16 and to move the lens 12 away from the entrance 14" (Cadell
2:39-43).
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4. Cadell teaches
Light entering the body is scattered and that light which emerges
radiates in virtually every direction. This light scattering means
that a limited proportion of the light can be captured by a lens
system placed at the point where light exits from the body part.
Further, the light that is captured for diffraction onto a diode
array must be collimated and this further reduces the useful light
available to the instrument. The result is that to measure the light
falling onto a diode array it is necessary to integrate the light over
a period of about 200 milliseconds. This period provides a useful
amount of light for measuring the transmitted light. To prevent
the array/detector from saturating during the reference scan it is
necessary to place a neutral density filter in the path of the
reference beam. Absorbance may be expressed in the usual
manner, and by adding the constant OD of the neutral density
filter at a given wavelength to the calculated absorbance it is
possible to indicate the total effective optical density due to both
absorbance and scattering.
(Cadell 6:40-59; see also Ans. 3.)
Principles of Law
A prima facie case of obviousness "requires a suggestion of all
limitations in a claim," CFMT, Inc. v. Yieldup Int'! Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and "a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
"[R ]ejections on obviousness grounds 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 re Kahn, 441F.3d977, 988 (Fed. Cir. 2006).
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Analysis
Appellants contend that "Chen and Cadell's devices and operation
techniques are very different" because "[t]he neutral density filter of the
Cadell finger system is used for calibrating the finger sensor and is not used
for taking measurements for analysis" (App. Br. 10).
The Examiner responds that
the rejection was made by incorporating a neutral density filter
taught by Cadell in the near detector taught by Chen in order to
prevent the detector from potential over-saturating. Examiner
indicated in the rejection ... that the near detector of the sensor
configuration taught by Chen would suffer over-saturating due
to shorter optical length and therefore reduces the accuracy of
optical measurements. The function of the neutral density filter
is to prevent a photodetector from saturating (i.e.[,] over-
saturating) (Col[.] 6 lines 40-59 ofCadell).
(Ans. 15-16.)
We find that Appellants have the better position. Cadell, at best,
teaches "[t]o prevent the array/detector from saturating during the reference
scan it is necessary to place a neutral density filter in the path of the
reference beam" (FF 4 (emphasis added)). Cadell teaches that "[w]hen it is
desired to take a reference measurement with the monitoring device, there is
no finger in the receptor and the motor ... rotates the shaft 38 to move the
filter 42 so that it is in line with the exit 16 and to move the lens 12 away
from the entrance 14" (FF 3 (emphasis added); see also FF 2).
As Appellants explain,
Chen never describes or suggests that either detector 19 or 20 of
the Chen device receives such an amount of light that these
detectors operate outside of their dynamic ranges. That is, there
is no description, suggestion, or motivation to modify Chen to
solve a problem with the Chen device that does not exist in the
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Application 12/116,013
device. The examiner's rational for identifying a problem with
the Chen device that does not exist in the Chen device is not a
reasonable motivation for modifying the Chen device as asserted
by the examiner.
(Reply Br. 5.) Appellants further point out that
because Chen does not describe or suggest that the Chen
detectors operate outside of their dynamic range, placing a
neutral density filter over one of these detectors would render the
Chen device entirely inoperable for its intended purpose because
the detector covered by the neutral density filter would not be
properly calibrated and would operate outside of its intended
operating range. Therefore, the Chen device with a neutral
density filter placed over the near detector when making a tissue
measurement would render unreliable tissue measurements.
(Id. at 5-6.) If the proposed modification would render the prior art
invention being modified unsatisfactory for its intended purpose, then there
is no suggestion or motivation to make the proposed modification. In re
Fritch, 972 F.2d 1260, 1265 n.12 (Fed. Cir. 1992), citing In re Gordon, 733
F.2d 900, 902 (Fed. Cir. 1984).
On this record, the Examiner failed to establish an evidentiary basis to
support a conclusion that there was an advantage or reason to receive a first
light transmitted through the tissue and the semitranslucent film covering the
near detector arrangement or the first plurality of detectors, and to receive a
second light transmitted through the tissue at the far detector arrangement or
the second plurality of detectors, "the second received light not passing
through the semi translucent film" as required by claims 16, 4 7, and 50.
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Application 12/116,013
B-D. 35 USC§ 103(a) over Chen, Chen and O;Neil, and Chen and
Delonzor
Because the same issue is dispositive for these three rejections, we
will consider them together.
The Examiner finds that
Chen discloses a method comprising: placing a sensor head on a
surface of a tissue to be measured (Fig. 1 ); transmitting light
through a plurality of sources of the sensor head into the tissue
(elements 18, Fig. 1 and associated descriptions); receiving light
transmitted through the tissue at a first detector structure
(element 19, Fig. 1) and at a third detector structure and a fourth
detector structure of a second plurality of detectors (elements 20,
Fig. 1; elements 20 comprises one or more photodiodes ), wherein
the first detector structure detects a first attenuated amount of
light (second block of Fig. 4), and the third detector structure
detects a second attenuated amount of light (second block Fig.
4 ); using the first attenuated amount, calculating a first
attenuation coefficient (third block of Fig. 4) for a shallow tissue
region having a depth of at most about X below the surface of
the tissue (Fig. 1 ); and using the second attenuated amount and
the first attenuation coefficient, calculating a second attenuation
coefficient for a deep tissue region (fourth block, Fig. 4 and
associated descriptions) having a depth of at least about Y below
the surface of the tissue (Fig. 1 ).
(Ans. 7.)
The Examiner acknowledges that "Chen does not specifically
disclose[] receiving light transmitted through the tissue at a first detector
structure and a second detector structure of a first plurality of detectors"
(id.).
The Examiner asserts that because "[i]t is known that wavelength-
specific photodetectors can facilitate detecting a particular wavelength or
wavelength band," it would have been obvious to "modify the sensor to
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Application 12/116,013
incorporate wavelength-specific photodetectors in both near and far detector
structures in order to obtain more accurate optical measurements of the
predetermined wavelengths" (id. at 7-8).
The issue with respect to these rejections is: Does the evidence of
record support the Examiner's conclusion that Chen renders the claims
obvious?
Findings of Fact
5. Figure 4 of Chen is reproduced below:
----· ---------~
Sensing o First !r.tensity and a Seco11d Intensity c,f
Hie Light Sf9nal After the light Signal Traveis
Thrct.1gh the Subject ot a First >'!"edetermlned
Dist<11'1Ce cmd o Se-cond Predeiermined Distance
Io.,-;.. ... ~ D';"'""" b~
of l'love!englh: i.e., Between the First arid the Second
Predetermined wa,-elenglhs, and 8etweer< the nrnt
and the Third Predetermined Wa>'l31engths
, .. ------·---······---····--·--·---·--···---1 ...... ----···-·-······--··-···
I
. EmpMcolly Determine Vo:tnot.Js B_lood Oxygen Saturot_ km Leve_ l
and Attm-io! Sl!:iod Oxygen Salul"atlon L"11e: ll><'ithln the l1ssue
-· -· ·---------·
I
r····-············--···--······-···-····:r-... ···········-····--······-······--·····-·
j DetenninE Calibrotlm Co:mstarits '1'Hc02 and 'i'HI:<
· Uslr1~ th<> Empirically Determined Venous ond
.
J Arterial Blood Oxyger. Sni.uration Levels, Li9ht
Signal Attenuotkm and Stol.istlcol Anol~-sis
FIG. 4
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Application 12/116,013
Figure 4 shows "a block diagram of the present methodology for calibrating
a NIRS sensor" (Chen 6:10-11; see also Ans. 7).
Analysis
Appellants contend that "the calculated attenuation of light is a
property of the light itself, whereas an attenuation coefficient [is] a property
of tissue being scanned," that "nowhere does Ch[ e Jn ever describe or
suggest using a first calculated attenuation coefficient for a first tissue region
for calculating a second attenuation coefficient for a second tissue region,"
and that "Chen uses an entirely different method for ultimately determining
oxygen saturation based on the use of different wavelengths travelling
th[rough] tissue as described at step four of figure 4" (App. Br. 19).
The Examiner responds that
[a]ccording to Col[.] 6 line 63 - Col[.] 8 line 50, the attenuation
parameter which comprises attenuation and energy loss in
shallow tissue is denoted by Ax, the attenuation parameter which
comprises attenuation and energy loss from both shallow and
deep tissue is denoted by Ab, and the attenuation parameter of
deep tissue only is denoted by A', wherein A= Ab-Ax and A' is
utilized in the calculation of oxygen saturation in the deep tissue
site (see equations 5-7 and 15-17 of Chen).
(Ans. 18; see also id. at 19.)
We find that Appellants have the better position. Chen, at best,
teaches "Determine the Difference in Attenuation as a Function of
Wavelength: i.e., Between the First and the Second Predetermined
Wavelengths, and Between the First and the Third Predetermined
Wavelengths" (FF 5).
As Appellants explain,
Equations 5, 6, and 7 of Chen describe the absorption of light,
and do not describe the attenuation coefficient of tissue ...
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Application 12/116,013
Light absorption and the attenuation coefficient of tissue are
entirely different physical properties as is well understood by
those of skill in the art. Light absorption describes the loss of
energy of light as the light propagates through a medium. The
attenuation coefficients of tissue describe a physical
characteristic of tissue that can attenuate light, i.e., cause the light
to [lose] energy as the light passes through the tissue. Light (i.e.,
electromagnetic waves) and the loss of light by absorption or
other attenuation are entirely different from tissue (i.e., a physical
medium) and an attenuation coefficient that describes a physical
characteristic of the tissue.
(Reply Br. 11.)
On this record, the Examiner failed to establish an evidentiary basis to
support a finding that Chen teaches "using the first attenuated amount,
calculating a first attenuation coefficient for a shallow tissue region having a
depth of at most about X below the surface of the tissue" and "using the
second attenuated amount and the first attenuation coefficient, calculating a
second attenuation coefficient for a deep tissue region having a depth of at
least about Y below the surface of the tissue" as required by claim 21.
SUMMARY
In summary, we reverse the rejection of claims 16, 17, 19, 36, 46, 50,
51, and 53 under 35 U.S.C. § 103(a) as obvious over Chen and Cadell.
We reverse the rejection of claims 21-30, 31-34, 37, 40, and 43--45
under 35 U.S.C. § 103(a) as obvious over Chen.
We reverse the rejection of claim 38 under 35 U.S.C. § 103(a) as
obvious over Chen and O'Neil.
We reverse the rejection of claims 39, 41, and 42 under 35 U.S.C.
§ 103(a) as obvious over Chen and Delonzor.
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We reverse the rejection of claims 47--49 and 54 under 35 U.S.C.
§ 103(a) as obvious over Chen, Cadell, and Delonzor.
REVERSED
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