Ex Parte SAITO

Patent Trial and Appeal Board

Nov 30, 2018

13538682 (P.T.A.B. Nov. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/538,682 06/29/2012
127226 7590 12/04/2018
BIRCH, STEW ART, KOLASCH & BIRCH, LLP
8110 Gatehouse Road
Suite 100 East
Falls Church, VA 22042-1248
Takaaki SAITO
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.
1259-0510PUS1 7595
EXAMINER
MEHL, PATRICK M
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
12/04/2018 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):
mailroom@bskb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TAKAAKI SAITO
Appeal2017---003442
Application 13/538,682
Technology Center 3700
Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
Appellant1 submits this appeal under 35 U.S.C. § 134(a) involving
claims to an endoscope system. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellant identifies the real parties in interest as FUJIFILM Corporation.
App. Br. 1.
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Application 13/538,682
STATEMENT OF THE CASE
Appellant's invention "relates to an endoscope system for obtaining
information of an oxygen saturation level of hemoglobin in blood in a blood
vessel of living tissue." Spec. 1:6-8.
"Examinations and acquisition of biological information, for example,
blood information, using endoscopes have been common in the medical
field." Id. at 1: 11-13. The Specification states that, with existing systems,
the information of the oxygen saturation level is obtained based on reference
data. See, e.g., id. at 2:6-10. According to the Specification, however,
"reference data is based on data of typical living tissue ... [and] [a]ctually
... the reference data varies depending on a characteristics of an internal
body part to be observed," such as vascular density, which characteristics
also vary depending on the body part involved. Id. at 2: 11-15. Thus, the
Specification explains, "when the oxygen saturation level of the living tissue
with an atypical characteristic is calculated using the typical reference data,
reliability of the calculation decreases." Id. at 2: 17-20.
In an effort to address the above-noted issues, the endoscope system
of the invention includes, inter alia, a "changing section [that] changes the
standard reference data [ correlating pixel values to oxygen saturation levels]
to corrected reference data in accordance with a characteristic of the internal
body part." Id. at 2:26-3:8. The system further includes a "calculation
section [ that then] calculates an oxygen saturation level of the internal body
part from the each color pixel value based on the corrected reference data."
Id. at 3:8-10.
2
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Application 13/538,682
Claims 1, 3-20, 24, and 25 are on appeal. Claim 1 is illustrative and
is reproduced below:
1. An endoscope system comprising:
a light source for applying measurement light to an internal body
part of a subject;
an imaging device for imaging the internal body part illuminated
with the measurement light to output a color pixel value of each
pixel;
a memory for storing standard reference data that defines a
correlation between the color pixel value and an oxygen
saturation level; and
a processor, the processor configured for:
calculating a pre-oxygen saturation level of the internal
body part based on the standard reference data and a pre-color
pixel value obtained from the imaging device during preliminary
1magmg;
changing the standard reference data to corrected
reference data in accordance with a difference between the pre-
oxygen saturation level and a predetermined standard value of
the oxygen saturation level; and
executing the preliminary imaging and main imaging,
wherein the imaging device images a normal internal body part
with no lesion being illuminated with the measurement light in
the preliminary imaging, and images an internal body part with
a lesion being illuminated with the measurement light in the main
imaging, and
wherein the processor calculates an oxygen saturation level of
the internal body part based on the corrected reference data and
a color pixel value obtained from the imaging device during the
mam 1magmg.
App. Br. 14 (Claims App'x).
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Application 13/538,682
The claims stand rejected under 35 U.S.C. § I03(a) for obviousness2
as follows:
I. Claims 1, 15, 20, and 24 over Maeda, 3 Schmitt, 4 Chen, 5 and
Pawluczyk6 ("Rejection I").
II. Claims 3, 6, and 11-14 over Maeda, Schmitt, Chen, Pawluczyk,
and Friedland7 ("Rejection II").
III. Claims 4 and 5 over Maeda, Schmitt, Chen, Pawluczyk,
Friedland, Matsuura, 8 and Fawzy9 ("Rejection III").
2 The Examiner's Answer expressly withdraws a rejection of claim 25 under
35 U.S.C. § 112(d) (§ 112, fourth paragraph). Ans. 15. The Answer
includes language related to a rejection of claim 23 under § 101. Id. at 2.
But claim 23 was canceled by amendment and the Examiner stated earlier
that "Applicant's reply has overcome the following rejection(s) via
amendments and arguments: claim rejection under 35 USC 101 regarding
claim 23 and under 35 USC 112(d) regarding claim 25." Adv. Act. (Feb. 19,
2016) 2; Reply Br. 1. Thus, the Answer's inclusion of a § 101 rejection of
claim 23 appears to be a mistake and is not considered further in this appeal.
3 Maeda et al., US 2009/0147999 Al, published June 11, 2009.
4 Joseph M. Schmitt et al., New Methods for Whole Blood Oximetry, 14
ANNALS OF BIOMEDICAL ENGINEERING 35-52 (1986).
5 P. Chen et al., Estimation of regional hemoglobin concentration in
biological tissues using diffuse reflectance spectroscopy with a novel
spectral interpretation algorithm, 56 PHYS. MED. BIOL. 3985--4000 (2011).
6 Pawluczyk et al., US 2006/0173266 Al, published Aug. 3, 2006.
7 Shai Friedland, MD et al., Measurement of mucosa! capillary hemoglobin
oxygen saturation in the colon by reflectance spectrophotometry, 57:4
GASTROINTESTINAL ENDOSCOPY 492--497 (2003).
8 Matsuura, US 2010/0063355 Al, published Mar. 11, 2010.
9 Yasser Fawzy, Quantification of mucosa oxygenation using three discrete
spectral bands of visible light, 2:12 J. BIOPHOTON 744--749 (2009).
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Application 13/538,682
IV. Claims 7-10 over Maeda, Schmitt, Chen, Pawluczyk,
Friedland, Foster, 10 and Kikuchi 11 ("Rejection IV").
V. Claim 16 over Maeda, Schmitt, Chen, Pawluczyk, and
Krotkov 12 ("Rejection V").
VI. Claim 17 over Maeda, Schmitt, Chen, Pawluczyk, and
Takasugi 13 ("Rejection VI").
VII. Claim 18 over Maeda, Schmitt, Chen, Pawluczyk, and
Sharma 14 ("Rejection VII").
VIII. Claim 19 over Maeda, Schmitt, Chen, Pawluczyk, Friedland,
and Fang 15 ("Rejection VIII").
IX. Claim 25 over Maeda, Schmitt, Chen, Pawluczyk, Parker, 16 and
Pratt 17 ("Rejection IX").
1° Foster et al., WO 2006/025940 A2, published Mar. 9, 2006.
11 Kikuchi, US 4,998,973, issued Mar. 12, 1991.
12 Krotkov et al., US 2004/0024296 Al, published Feb. 5, 2004.
13 Takasugi et al., US 5,512,940, issued Apr. 30, 1996.
14 Prateek Sharma, MD et al., The utility of a novel narrow band imaging
endoscopy system in patients with Barrett's esophagus, 64:2
GASTROINTESTINAL ENDOSCOPY 167-175 (2006).
15 Qiyin Fang et al., Time-domain laser-induced fluorescence spectroscopy
apparatus for clinical diagnostics, 7 5: 1 REVIEW OF SCIENTIFIC INSTRUMENTS
(2004).
16 Parker, US 7,236,813 B2, issued June 26, 2007.
17 Tabulated Molar Extinction Coefficient for Hemoglobin in Water,
available at http://omlc.org/spectra/hemoglobin/summary.html (1998)
("Pratt"). The seven-page document of record purporting to be "Pratt"
indicates that the data therein were compiled by "Scott Prahl," but we refer
to the reference as "Pratt" for consistency with the rejection on appeal.
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DISCUSSION
Issue
For Rejection I, the Examiner concludes that independent claims 1,
20, and 24 (as well as dependent claim 15) would have been obvious over
the combination of Maeda, Schmitt, Chen, and Pawluczyk. Ans. 4--7. 18
Rejections II-IX rely upon the findings and reasoning supporting Rejection I
and then add additional references to address limitations in the remaining
dependent claims. Ans. 8-15. Rejection II, for example, further relies on
Friedland as teaching the use of the average of multiple measurements in
order to reduce noise, which averaging the Examiner finds is not taught in
Maeda, Schmitt, Chen, and Pawluczyk. Ans. 8.
Because Rejections II-IX each rely on Rejection I for establishing the
obviousness of the independent claims, if Rejection I fails, so do all the other
rejections under § 103 on this record. As explained below, the dispositive
issue here is whether the Examiner established by a preponderance of the
evidence that the independent claims would have been obvious over Maeda,
Schmitt, Chen, and Pawluczyk.
Analysis
The Examiner addressed the patentability of independent claims 1, 20,
and 24 as a group. For purposes of our analysis in this appeal, we consider
claim 1 as representative of all the pending independent claims.
The Examiner finds that "Maeda discloses all the limitations of the
claims [1, 20, and 24] needed for the invention." Ans. 5. More specifically,
18 The Examiner also lists claim 23 as obvious, but claim 23 was canceled
via amendment as discussed above. See Adv. Act. (entering amendments).
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the Examiner finds that Maeda discloses an endoscope system for imaging
and processing information from internal tissues, which system includes a
light source, an imaging device, a memory, and a processor as claimed.
Ans. 4. According to the Examiner, Maeda discloses "a memory device for
storing standard reference data that defines a correlation between the color
pixel value and an oxygen saturation" and a processor, inter alia, "for
changing the standard reference data to corrected reference data ... if
measured concentration, such as oxygen saturation, is different from a stored
reference" and "for calculating an oxygen saturation level of the internal
body part from the each color pixel value based on the corrected reference
data." Id. at 4--5.
Although the Examiner finds that Maeda teaches all of claim 1 's
limitations, the Examiner states that "Maeda does not explicitly disclose
standard reference data for correction." Id. at 5. So, the Examiner turns to
Schmitt and Chen. Id. at 5-7. According to the Examiner, Schmitt teaches a
relationship between oxygen saturation and the ratio of reflectance of light at
certain wavelengths, along with related calibration curves. Id. at 5. The
Examiner finds that Chen teaches estimates for regional hemoglobin
concentrations in certain tissues, and that such concentrations are higher in
tumors versus normal tissues. Id.
The Examiner concludes it would have been obvious to adapt
Maeda's system with Schmitt's calibration curves "to better compare and
store the best measured and calculated S02 ... with the reference
information and identify any differences that will signalize the presence of
abnormalities in the tissues." Id. at 5. The Examiner further concludes it
would have been obvious to adapt Maeda's system with Chen's regional
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hemoglobin concentrations "to build reference standard values for the
normal tissues ... [and] for further identification of tumor and other
abnormal tissues due to their high regional hemoglobin content." Ans. 6.
According to the Examiner, the combination of Maeda, Schmitt, and
Chen "implicitly disclose[ s] the reference oxygen saturation and blood
volume curves ... which can be stored in memory for comparison with
measured and calculated values for normal tissues ... and changes in the
stored memory if the values are different within a present value." Id. at 6.
The Examiner asserts that this "implicitly indicates the tracking of
preliminary images for suitable normal part of the internal tissue for
calibration of the instrumentation." Id. Moreover, the Examiner asserts,
"[h ]aving the storage of the concentrations of the hemoglobin entities, with
the calculation and the possibility of storage of the resulting oxygen
saturation level, it will have been obvious ... to have used a color scale for
imaging the oxygen saturation level distribution for the regions of interest
having or not a tumor." Id.
Because the Examiner finds that none of Maeda, Schmitt, or Chen
"disclose explicitly the preliminary imaging and the control section for
executing these preliminary imaging," the Examiner cites Pawluczyk. Id.
According to the Examiner, Pawluczyk discloses an imaging device for
verifying a biopsy site and the diagnosis of lesions. Id. at 6. And, the
Examiner concludes, it would have been obvious to further adapt Maeda's
system "for proceeding initially with preliminary images for identifying the
right image location as taught by Pawluczyk in order to focus initially on
normal tissue for calibrating and validating and eventually updating the
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reference stored curves ... before scanning the remaining tissue for
identifying eventual abnormalities." Ans. 6-7.
We are unpersuaded the Examiner met the burden to show, by a
preponderance of the evidence on this record, that claim 1 would have been
obvious over the asserted prior art. In re Oetiker, 977 F.2d 1443, 1445 (Fed.
Cir. 1992) (The Examiner "bears the initial burden ... of presenting a prima
facie case of unpatentability.").
The processor of Maeda's system, as described in the reference, does
not calculate or change oxygen saturation levels ( or standard and corrected
reference data pertaining to the same). The Examiner's suggestion to the
contrary (Ans. 4--5) is unpersuasive. As pointed out by Appellant, Maeda's
system relates to the use of a "substance," exemplified by the luminescent
dye indo-cyanine green (ICG) injected into a subject, to calculate the relative
depth of blood-carrying vessels at the imaging site. App. Br. 4--5; see, e.g.,
Maeda, Abstract, ,r,r 8-10, 63, 72, 77-79, Figs. 3--4. Appellant explains,
consistent with Maeda, that calculating the depths of the blood vessels in this
way depends on the following principle:
These blood vessels are connected throughout the body, and the
blood component inside different blood vessels within the same
organism can be considered as being substantially constant
without regard to position, so that the ICG concentration can be
considered as being constant regardless of position of the blood
vessel.
Maeda ,r 58; App. Br. 4--5. 19 Blood oxygen saturation, on the other hand, is
a "ratio of the oxygen saturated hemoglobin to the total hemoglobin in the
19 Maeda teaches that once depth information for the respective vessels is
calculated, the concentration of the substance (e.g., ICG) can be calculated
and updated by calculating the concentration using the most shallow blood
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blood" (Ans. 15) and, as Appellant notes, "oxygen saturation varies
according to different blood vessels within the same organism (for example,
arteries and veins." App. Br. 5. Hence, as argued by Appellant, Maeda does
not and cannot use an oxygen saturation level as a "substance" for
calculating vessel depth. Id. at 4--5; Reply Br. 3--4. The Examiner fails to
provide a persuasive rebuttal to Appellant on these points.
The Examiner responds that Maeda's "substance" is not limited to the
dye ICG. Ans. 15. According to the Examiner, Maeda discloses that the
"substance" may include oxidized or reduced hemoglobin. Id. ( citing Maeda
,r 56). The Examiner is correct that Maeda is not so limited, but Maeda still
does not teach or suggest any specific calculation or use of oxygen
saturation levels with its system. Maeda does not disclose a processor that
calculates concentrations for both oxidized and reduced hemoglobin, and
from that calculates total hemoglobin or oxygen saturation levels, much less
that it is configured to calculate an oxygen saturation level in different ways
in preliminary and main imaging stages as required by claim 1. Neither does
Maeda disclose a processor configured for changing standard reference data
to corrected reference data based on "a difference between the pre-oxygen
saturation level and a predetermined standard value of the oxygen saturation
level" as required. The reference to devices that measure oxygen saturation
vessel image; then, updated substance concentration can be used to more
accurately calculate the depth of the deep blood vessels. See Maeda, ,r 90.
In this way, various "sections" ( depth calculating section, substance amount
updating section, and the substance amount calculating section) of Maeda's
system interact to provide progressively more accurate depth and
concentration information. See, e.g., id. ,r,r 85-92, Fig. 7.
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in Maeda's background does not, on this record, convince us that Maeda's
system is configured for calculating oxygen saturation levels. Ans. 15.
The Examiner responds further that Maeda's system is "capable to
calculate various 'substance' amounts including the hemoglobin species
amounts, from which an oxygen saturation and total hemoglobin would have
been obvious to deduce." Id. at 16. Thus, the Examiner asserts, "the
apparatus of Maeda is capable to perform the claimed functions." Id. And,
the Examiner notes, "claims directed to an apparatus must be distinguished
from the prior art in terms of structure rather than function." Id.
Claim 1 recites a system that includes a processor "configured for"
several operations. Although apparatus claims must be distinguished from
the prior art based on structure, not function, claim language such as
"configured to" or "configured for" can denote structure when used in the
context of an electronic circuit, processor, or programming. Typhoon Touch
Techs., Inc. v. Dell, Inc., 659 F.3d 1376, 1380 (Fed. Cir. 2011) (analyzing
Microprocessor Enhancement Corp. v. Texas Instruments, Inc., 520 F .3d
1367 (Fed. Cir. 2008)); In re Lowry, 32 F.3d 1579, 1583-84 (Fed. Cir.
1994).20
The phrase "configured for," when used as it is here, requires that "the
apparatus as provided must be 'capable' of performing the recited function,
not that it might later be modified to perform that function." Typhoon Touch
20 In re Noll, 545 F.2d 141, 148 (CCPA 1976) ("[T]he claimed invention ...
comprises physical structure, including storage devices and electrical
components uniquely configured to perform specified functions through the
physical properties of electrical circuits to achieve controlled results.
Appellant's programmed machine is structurally different from a machine
without that program.")
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659 F.3d at 1380. Further, when functional language is associated with
programming or some other structure required to perform the function - a
specially-programmed processor in claim 1 - that specific structure must be
present to meet the claim limitations. Id.; see also Ultramercial, LLC v.
Hulu, LLC, 657 F.3d 1323, 1328-29 (Fed. Cir. 2011) (holding that
programming may create a new machine programmed to perform particular
functions). The processor of claim 1 requires programming that causes the
processor to execute preliminary and main imaging operations, calculate a
pre-oxygen saturation level during preliminary imaging, change standard
reference data to corrected reference data based on differences between an
obtained pre-oxygen saturation level and a standard value, and calculate
oxygen saturation levels based on corrected reference data and pixel values
obtained as part of a main imaging operation. Yet the Examiner has not
established that Maeda's system includes a processor that is so configured.
That Maeda's system might be modified to carry out these operations, or that
a skilled person might "deduce" oxygen saturation levels from information
that Maeda's system optionally uses is not enough to demonstrate a teaching
of all the limitations of claim 1 in the cited prior art.
We are also unpersuaded that the relied-upon teachings in Schmitt,
Chen, and Pawluczyk make up for Maeda's deficiencies. The Examiner
cites Schmitt for teaching S02 calibration curves and Chen as teaching
regional hemoglobin concentrations, both of which the Examiner asserts
would have been used to provide "standard reference data" in Maeda's
system. Ans. 5---6. But the fact remains that Maeda's system does not
include a processor that calculates oxygen saturation levels or corrects
reference data based on differences in calculated saturation levels as
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required by the claims. And the Examiner has not, on this record, provided a
sufficient evidence-backed analysis explaining how and why the ordinarily
skilled person would have modified Maeda's system to include a processor
with all the claimed features that would still meet Maeda's objectives and
function as intended (i.e., be able to determine vessel depths). Pawluczyk is
cited for the limited purpose of showing that it was known in the art to detect
and diagnose lesions with contrast agents and an imaging modality ( e.g., X-
ray). Ans. 6-7; Pawluczyk ,r,r 2, 4. Pawluczyk is, however, unrelated to
oxygen saturation levels or calculations thereof and, thus, does not remedy
the problems with the rejection of claim 1 discussed above.
For the reasons above, the preponderance of the evidence on this
record does not support the Examiner's conclusion that independent claim 1
(and independent claims 20 and 24) would have been obvious over Maeda,
Schmitt, Chen, and Pawluczyk. The rejection of claims 1, 20, and 24 is,
therefore, reversed. Because the rejections of the dependent claims rely on
the same combination of Maeda, Schmitt, Chen, and Pawluczyk, with
additional references cited merely to address limitations of certain dependent
claims, those rejections are reversed as well. In re Fritch, 972 F.2d 1260,
1266 (Fed. Cir. 1992) ("[D]ependent claims are nonobvious if the
independent claims from which they depend are nonobvious.").
SUMMARY
We reverse the rejections for obviousness on appeal.
REVERSED
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