Ex Parte Song et al

Board of Patent Appeals and Interferences

Sep 21, 2010

11020647 (B.P.A.I. Sep. 21, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/020,647 12/22/2004 Xuedong Song KCX-904 (19942.3) 9214
22827 7590 09/22/2010
DORITY & MANNING, P.A.
POST OFFICE BOX 1449
GREENVILLE, SC 29602-1449
EXAMINER
SHIBUYA, MARK LANCE
ART UNIT PAPER NUMBER
1641
MAIL DATE DELIVERY MODE
09/22/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte XUEDONG SONG, MICHAEL KNOTTS,
DAVID SAMUEL COHEN, SHAWN RAY FEASTER,
and ZDRAVKO SAVOV ATANASSOV
__________

Appeal 2009-014155
Application 11/020,647
Technology Center 1600
__________

Before ERIC GRIMES, TONI R. SCHEINER, and DONALD E. ADAMS,
Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 1-14, 16-22, 24, and 31-38 on the ground of obviousness. We have
jurisdiction under 35 U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

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STATEMENT OF THE CASE
Claim 1 is representative of the subject matter on appeal:
1. A luminescent detection system for detecting the presence or
quantity of an analyte residing in a test sample, said system comprising:
an assay device that includes a chromatographic medium, said
chromatographic medium being in communication with luminescent
detection probes, said luminescent detection probes being capable of
emitting a detection signal;
an illumination source capable of providing electromagnetic radiation
that excites said luminescent detection probes to emit said detection signal;
and
a detector capable of registering said detection signal emitted by said
luminescent detection probes, wherein said illumination source and said
detector are positioned on opposing sides of said assay device so that said
chromatographic medium is positioned in the electromagnetic radiation path
defined between said illumination source and said detector, said illumination
source and said detector being positioned less than about 5 millimeters from
said assay device, said chromatographic medium being transmissive to said
electromagnetic radiation and said detection signal.

The Examiner rejected claims 1-10, 12-14, 16-20, 22, 24, and 31-38
under 35 U.S.C. § 103(a) as unpatentable over Catt,2 Badley,3 and
Potyrailo.4
In addition, the Examiner rejected claims 11 and 21 under 35 U.S.C.
§ 103(a) as unpatentable over Catt, Badley, Potyrailo, and Tanabe.5
We affirm.

2 US 2003/0044317 A1, published March 6, 2003 by Catt et al.
3 US 2004/0151632 A1, published August 5, 2004 by Badley et al.
4 US Patent 6,166,804, issued December 26, 2000 to Potyrailo et al.
5 US Patent 6,479,930 B1, issued November 12, 2002 to Tanabe et al.
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Issues
The issue raised by this appeal with respect to claims 1-10, 12-14,
16-20, 22, 24, and 31-38 is whether the evidence of record supports the
Examiner’s conclusions that it would have been obvious for one of ordinary
skill in the art to use a luminescent label in Catt’s assay device, and that it
would also have been obvious to place the assay device less than five
millimeters from an illumination source and a detector, given the teachings
of Catt, Badley, and Potyrailo.
The issue with respect to claims 11 and 21 is whether the evidence of
record supports the Examiner’s conclusion that it would have been further
obvious to use an electroluminescent light source in Catt’s device, given the
additional teachings of Tanabe.
Findings of Fact (FF)
1. The claims are directed to a luminescent detection system
comprising an assay device that includes a chromatographic medium in
communication with luminescent detection probes; an illumination source
capable of providing electromagnetic radiation to excite the probes; and a
detector capable of registering a signal emitted by the probes. The
chromatographic medium is positioned between the illumination source and
the detector, both of which are less than about 5 millimeters from the assay
device (e.g., claim 1). In use, electromagnetic radiation transmitted through
the chromatographic material by the illumination source excites the probes,
and signal from the probes is detected by the detector on the other side of the
chromatographic material.
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2. The chromatographic medium is “an optically diffuse porous
membrane formed from materials such as . . . nitrocellulose” (Spec. 7: 28-
32).
3. Catt “is particularly, although not exclusively, concerned with
assays which can be performed by comparatively untrained people and
especially in the home” (Catt ¶ 3). According to Catt:
Many assay devices are described in the technical
literature with suggestions that the assay result can be read
using optical equipment. The use of fluorescence emission, or
light reflectance, is often suggested. Such techniques are
mostly appropriate for use in sophisticated laboratories. . . .
[T]he suggestion is [also] made that a detectable signal
indicative of an assay result in [a signal concentrating] zone can
be measured by electromagnetic radiation, such as light,
transmitted through the zone. . . . However, no practical details
are provided to indicate how an accurate measurement might be
made using transmitted light.
(Id. at ¶ 8.)
4. Catt “found that quantitative information can be derived by
transmission reading of an assay strip . . . if the incident electromagnetic
radiation is uniform across a region of the test strip which encompasses and
extends beyond the test zone” (Catt ¶ 9).
5. In addition, Catt teaches that “[a] transmission design can be
made entirely from commercially-available . . . optoelectronic components,
facilitating the production of a monitor that is compact and relatively cheap”
(Catt ¶ 80), unlike “[a] reflectance measuring system [which] must all be
mounted on one side of a test strip . . . [and] require[s] the use of (relatively)
expensive custom components” (id.).

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6. Catt’s transmission-based system comprises
an assay device comprising a porous liquid-permeable carrier
strip or sheet [e.g., nitrocellulose] through the thickness of
which electromagnetic radiation is transmissible diffusely, said
carrier being within a casing, said carrier including at least one
detection zone in which an assay result is revealed by specific
binding of a detectable material directly or indirectly to a
binding agent immobilised in said detection zone, detection of
said material being effected as a response to said electro-
magnetic radiation, and said casing having electromagnetic
radiation transmitting regions enabling electromagnetic energy
from an external source to be passed through said device, said
detection zone lying in the electromagnetic radiation path
between said electromagnetic radiation transmitting regions.
(Catt ¶¶ 14, 15.)
7. According to Catt:
By ensuring precise interlocking between the testing
device and the reader, and also ensuring precise registration of
the location of the detection zone within the testing device
itself, the testing zone will be presented to the reader in a
constant pre-determined position every time a testing device is
inserted into the reader. The construction of the optical system
within the reader (light source and sensors) can therefore be
kept as simple as possible, because it is not essential for the
sensors to include any scanning facility, for example, which
would otherwise be required if the exact location of the
detection zone was not known. By avoiding the need for a
sophisticated optical reading system, the cost of the
reader/monitor may be reduced. Simplification of the optical
reading system may also enable the reader/monitor to be of
small size which will assist convenient and unobtrusive use in
the home.
(Catt ¶ 31.)

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8. As noted by the Examiner, Catt “fail[s] to teach that said
detectable labels comprise luminescent detection probes” (Ans. 4).
However, Catt teaches:
In principle, any electromagnetic radiation can be used to
effect the transmission measurement in the invention. . . .
Preferably the electromagnetic radiation is light in the visible or
near-visible range. This includes infra-red light and ultra-violet
light. It is generally envisaged that the detectable material used
as a label in the assay is one which will interact with light in the
visible or near-visible range, eg. by absorption. The
wavelength of the electromagnetic radiation chosen is
preferably at or near a wavelength which is strongly influenced,
eg. absorbed, by the label. For example, if the label is a
substance which is strongly coloured, ie. visible to the naked
human eye when the material is concentrated, the ideal
electromagnetic radiation is light of a complementary
wavelength. Particulate direct labels, for example, metallic (eg.
gold) sols . . . and coloured latex (polystyrene) particles are
ideal examples. For instance, in the case of blue-dyed latex
particles, the ideal electromagnetic radiaation [sic] is visible red
light which will be strongly absorbed by the blue particles.
(Catt ¶ 33.)
9. Badley teaches that:
Visually read qualitative assay systems incorporating
colored labels such as gold sol and blue latex particles provide
useful but limited sensitivity. This is primarily due to the
inherent insensitivity of light absorption, which is how color is
detected. Whilst this has allowed the development of rapid
user-friendly assay systems for the assessment of analytes such
as hCG (human chorionic gonadotrophin) in the urine of
pregnant women, there is a need for more sensitive assays in
order to detect other analytes in similar user-friendly formats.
(Badley ¶ 4.)
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10. Badley describes “luminescence-based assays that provide a
result which can be visually accessed by the user and which have
significantly greater sensitivity than conventional visually read color-based
assays” (Badley ¶ 5), without “bulky and/or expensive instruments” like an
excitation source, photodetector and processor (id. at ¶ 3).
11. Potyrailo discloses a fiber optic configuration that “provides
increased signal levels at significant distances from [a fluorescent] probe,”
as opposed to “the conventional configuration, . . . [which] does not lead to
an appreciable fluorescence signal at distances beyond several millimeters”
(Potyrailo, col. 5, ll. 32-47).
12. Tanabe describes an electroluminescence element “capable of
providing several kinds of luminescence colors . . . at a low cost” (Tanabe,
col. 3, ll. 58-59).
Discussion
The Examiner acknowledges that Catt “fail[s] to teach that said
detectable labels comprise luminescent detection probes, or that the light
(illumination) source and the detector are positioned less than about 5
millimeters from said assay device” (Ans. 4). However, the Examiner
concludes that it would have been obvious to use a luminescent label in
Catt’s system because Badley “teach[es] the benefit of using luminescent
labels, such as fluorescent labels, in order to allow for improved sensitivity .
. . as compared to traditional color detection methods” (id. at 5). In addition,
the Examiner concludes that it would have been obvious to position Catt’s
illumination source and detector “at a distance less than a few millimeters
from the assay device” (id. at 5-6) because Potyrailo teaches that an
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“illuminated sample does not create an appreciable fluorescence signal at
distances beyond several millimeters” (id. at 5).
With respect to claims 11 and 21, the Examiner acknowledges that
Catt, Badley, and Potyrailo “fail to teach that the light source can contain an
electroluminescent device” (Ans. 8). However, the Examiner concludes that
it would have been obvious to use an electroluminescent light source in
Catt’s system because Tanabe teaches such devices provide light in multiple
colors, conveniently and at low cost (id. at 8-9).
We agree with the Examiner’s rationale and conclusions, and are not
persuaded otherwise by Appellants’ arguments.
Appellants contend that Catt is concerned with simplifying assay
devices for use “by comparatively untrained people” and “describes an
optical system (light source and sensors) that are kept ‘as simple as
possible’” (App. Br. 7). Appellants contend that Catt’s “so-called remedy
for the deficiencies of fl[u]orescence emission does not in any way involve
the use of fl[u]orescence emission” (id.), and it wouldn’t have been obvious
to use Badley’s luminescent labels in Catt’s device because Catt teaches that
“the use of fl[u]orescence emission is ‘mostly appropriate for use in
sophisticated laboratories’” (id. (emphasis omitted)).
In addition, Appellants contend that Badley “eliminat[es] the ‘high
level of instrumentation required to detect and process the luminescent
signal’ and instead opt[s] for a viewing window that allows for direct
observation of a luminescent signal” (id. at 8). According to Appellants,
Badley “explicitly teaches away from the inclusion of luminescent labels
being used in connection with a system requiring a detector, such as that
described in Catt” (id. at 8-9 (emphasis omitted)).
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These arguments are not persuasive. Catt’s simplification strategy is
primarily based on the configuration of a transmission system (like that
presently claimed), as opposed to that of a reflectance measuring system
(FF3-5). Also, Catt teaches that “precise registration” between the light
source, the sensors, and the test device eliminates the need for a scanning
facility, therefore, “the optical system within the reader (light source and
sensors) can . . . be kept as simple as possible” (Catt ¶ 31; FF7). While it’s
true that Catt “generally envisage[s] that the detectable material used as a
label in the assay is one which will interact with light in the visible or near-
visible range, e.g. by absorption” (Catt ¶ 33; FF8), nothing in the reference
indicates that other conventional labels could not be used as well. In any
case, Badley provides evidence that one of skill in the assay art would
understand that a luminescent label provides greater sensitivity than a light
absorbing label, and that the choice of label often involves a trade-off
between sensitivity and convenience (FF9, 10).
Moreover, a reference is said to “teach away” from a claimed
invention when it “suggests that the line of development flowing from the
reference's disclosure is unlikely to be productive of the result sought by the
applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). That is not the
case here. Nothing in Badley indicates that luminescent labels wouldn’t
work in an assay device like Catt’s. In fact, Badley provides evidence that
luminescent signals are normally detected using optical instrumentation
(FF10). Nor, for that matter, have Appellants established, or even argued,
that Catt’s device would be incapable of exciting and/or detecting a
luminescent signal.
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Appellants further contend that Potyrailo “describes an apparatus for
increased signal levels at significant distances from the probe” (App. Br. 10
(emphasis omitted)), and thus, “actually teaches away from the limitations of
the presently pending claims” (id. at 11), which require the assay device to
be less than five millimeters from the illumination source and detector, and
especially claim 33, which requires “the illumination source, detector, or
both to contact the assay device” (id. at 13). In addition, Appellants contend
that Potyrailo “is completely silent regarding the position of an illumination
source” (id. at 11).
This argument is not persuasive. Potyrailo was cited as evidence that
one of ordinary skill in the art would have been aware that fluorescent
signals are not generally detectable at distance beyond a few millimeters
(FF11), and we agree with the Examiner that there is nothing unobvious
about empirically determining the optimal relative positions of the
illumination source, detector and assay device (Ans. 6).
Finally, with respect to claims 11 and 21, Appellants contend that the
Examiner “provides absolutely no explanation or justification for how
[Tanabe’s] plurality of different colors could function effectively” in Catt’s
device (App. Br. 13).
This argument is not persuasive. We agree with the Examiner that it
would have been obvious to include Tanabe’s conventional, convenient, and
inexpensive electroluminescence element in Catt’s device.

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CONCLUSION
The evidence of record supports the Examiner’s conclusions that it
would have been obvious for one of ordinary skill in the art to use a
luminescent label in Catt’s assay device, and that it would also have been
obvious to place the assay device less than five millimeters from an
illumination source and a detector, given the teachings of Catt, Badley, and
Potyrailo.
The evidence of record also supports the Examiner’s conclusion that it
would have been obvious to use an electroluminescent light source in Catt’s
device, given the additional teachings of Tanabe.

SUMMARY
The rejection of claims 1-10, 12-14, 16-20, 22, 24, and 31-38 under
35 U.S.C. § 103(a) as unpatentable over Catt, Badley, and Potyrailo is
affirmed.
The rejection of claims 11 and 21 under 35 U.S.C. § 103(a) as
unpatentable over Catt, Badley, Potyrailo, and Tanabe is affirmed.

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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).

AFFIRMED

cdc

DORITY & MANNING, P.A.
POST OFFICE BOX 1449
GREENVILLE, SC 29602-1449