Ex Parte Hodges et al

Patent Trial and Appeal Board

Nov 13, 2014

10105050 (P.T.A.B. Nov. 13, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ALASTAIR HODGES and RONALD CHATELIER
__________

Appeal 2012-006951
Application 10/105,050
Technology Center 1600
__________

Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a
disposable device for use in detecting a target antigen in a fluid sample. 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 Universal
Biosensors Pty Ltd (see App. Br. 3).
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Statement of the Case
Background
The Specification teaches that it would “be advantageous to develop a
device for performing an immunoassay that does not require any washing
steps and is suitable for a single use as a disposable device” (Spec. 1 ¶ 3).
The Claims
Claims 1, 2, 4–13, 15–18, 20, 29–35, 38, and 40–42 are on appeal.2
Independent claim 1 is representative and reads as follows:
1. A disposable device for use in detecting a target
antigen in a fluid sample, the device comprising
a reaction chamber having a first height;
an immobilized antibody positioned within the
reaction chamber;
a reporter complex comprising a probe and a reporter
complex antigen, wherein the probe is linked to the reporter
complex antigen, wherein the reporter complex antigen is
bound to the immobilized antibody, and wherein the reporter
complex antigen binds less strongly than the target antigen
to the immobilized antibody;
a detection chamber having a second height less than
the first height of the reaction chamber wherein air trapped
in the detection chamber prevents the detection chamber
from being filled with sample, and having a vent which is
initially closed;
a sample ingress to the reaction chamber; and

2 Claims 3, 14, 19, 21–28, 37, 39, and 43–52 have been withdrawn
from consideration (Office Action mailed Sept. 13, 2010, page 2).
While the Examiner has included all of claims 1–35 and 37–52 in
the provisional double patenting rejection (see Ans. 22–26), we
consider that to be a typographical error in view of the earlier
withdrawal of claims 3, 14, 19, 21–28, 37, 39, and 43–52 from
consideration.
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a sample passageway between the reaction chamber
and the detection chamber,
wherein the device is adapted to move the sample
from the reaction chamber to the detection chamber via
capillary action upon opening the vent in the detection
chamber to release trapped air.

The issues
A. The Examiner rejected claims 1, 2, 4, 6, 12, 15–18, 20, 29, 32, 34, 35,
40, and 41 under 35 U.S.C. § 103(a) as being obvious over Columbus,3
Freytag,4 and Gorin5 (Ans. 7–12).
B. The Examiner rejected claims 5, 7, and 8 under 35 U.S.C. § 103(a) as
being obvious over Columbus, Freytag, Gorin, and Rubenstein6 (Ans. 13–
15).
C. The Examiner rejected claims 9–11 under 35 U.S.C. § 103(a) as being
obvious over Columbus, Freytag, Gorin, and Jernigan7 (Ans. 15–16).
D. The Examiner rejected claim 13 under 35 U.S.C. § 103(a) as being
obvious over Columbus, Freytag, Gorin, and Vormbrock8 (Ans. 16–18).
E. The Examiner rejected claims 30 and 31 under 35 U.S.C. § 103(a) as
being obvious over Columbus, Freytag, Gorin, and Say9 (Ans. 18–19).
F. The Examiner rejected claim 33 under 35 U.S.C. § 103(a) as being
obvious over Columbus, Freytag, Gorin, and Uzan10 (Ans. 19–20).

3 Columbus, R.L., US 4,426,541, issued Jan. 17, 1984.
4 Freytag, J.W., US 4,434,236, issued Feb. 28, 1984.
5 Gorin et al., US 5,077,017, issued Dec. 31, 1991.
6 Rubenstein et al., US 4,376,825, issued Mar. 15, 1983.
7 Jernigan, W., US 5,434,055, issued July 18, 1995.
8 Vormbrock, R., US 5,258,315, issued Nov. 2, 1993.
9 Say et al., US 6,103,033, issued Aug. 15, 2000.
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G. The Examiner rejected claim 38 under 35 U.S.C. § 103(a) as being
obvious over Columbus, Freytag, Gorin, and Siegel11 (Ans. 20–21).
H. The Examiner rejected claim 42 under 35 U.S.C. § 103(a) as being
obvious over Columbus, Freytag, Gorin, and Boles12 (Ans. 21–22).
I. The Examiner provisionally rejected claims 1, 2, 4–13, 15–18, 20, 29–
35, 38, and 40–42 on the ground of nonstatutory obviousness–type double
patenting as unpatentable over claims 64 and 66–93 of US Application
10/830,841 (now issued as US 8,685,714, Apr. 1, 2014) (Ans. 22–26).
A. 35 U.S.C. § 103(a) over Columbus, Freytag, and Gorin
The Examiner finds that
Columbus teaches a test device (disposable device)
for use in detecting a target antigen in a fluid sample, said
device comprising . . .
a first zone 22 (reaction chamber) having a first height
h . . . a probe and a reporter complex antigen . . .
a second zone 24 (detection chamber) having a second
height h’ . . . and having an aperture 50 (vent) . . .
a liquid inlet aperture 46 (sample ingress) to the first
zone; and a sample passage way 60 between the first and
second zone, wherein the device is adapted to move a
sample from the first zone to the second zone via capillary
action.

(Ans. 8.)
The Examiner acknowledges that “Columbus fails to teach that the
labeled antigen analog is bound to the immobilized antibody and binds less
strongly than the target antigen to the immobilized antibody. Columbus

10 Uzan et al., US 5,849,247, issued Dec. 15, 1998.
11 Siegel et al., US 5,272,258, issued Dec. 21, 1993.
12 Boles et al., US 5,932,711, issued Aug. 3, 1999.
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further fails to teach that the aperture (vent) in the second zone (detection
chamber) is initially closed” (Ans. 8).
The Examiner finds that “Freytag teaches an anti-analyte antibody
that is displaceably bound to an analyte-analog, wherein the dissociation
constant between said antibody and the analyte–analog is greater than the
dissociation constant between said antibody and the analyte” (Ans. 9). The
Examiner finds that “Gorin teaches an apparatus with multiple chambers and
an external vent control to control the movement of fluid between the
chambers. . . . Moreover, Gorin teaches that the vent system is an alternative
to a meniscus flow stop” (Ans. 10).
The Examiner finds it obvious to modify the Columbus
antibody/antigen “by providing a labeled antigen analog (report complex
antigen) bound to the immobilized antibody. . . . This arrangement, as taught
by Freytag, provides for an efficient sensor that does not require a pre–
incubation step” (Ans. 9). The Examiner further finds it obvious “that
Columbus’s meniscus flow stop can be substituted by Gorin’s venting
system” (Ans. 11).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that the combination of Columbus,
Freytag, and Gorin renders the claims obvious?
Findings of Fact
1. Columbus teaches a
[R]eaction vessel comprising first and second fluidly
connected zones, inlet means permitting the introduction of
liquid into the first zone, and a passageway connecting the
zones. At least one of the zones contains a reagent capable
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of interacting with a material of the liquid, and the second
zone is adapted to receive the liquid from the first zone

(Columbus, col. 2, ll. 2–8).
2. Figure 2 of Columbus is reproduced below:

In Figure 2, “a reaction vessel 20 is provided, comprising means defining a
first zone 22 fluidly connected by passageway 60 to means defining an
adjacent zone 24 adapted to receive liquid flow from zone 22” (Columbus,
col. 4, ll. 55–59).
3. Columbus teaches that:
Surfaces 26 and 28, FIG. 2, are spaced apart a distance h in
zone 22, and distance h’ in zone 24, both of which are
selected to provide capillary flow of liquid. . . . To complete
the transfer of all the liquid into zone 24 following breach of
passageway 60, and to retain liquid in zone 24, distance h’ is
preferably less than distance h. . . . A quantity of liquid is to
be deposited at aperture 46, preferably in drop form.

(Columbus, col. 5, ll. 1–9.)
4. Columbus teaches that “[i]mmunoassays are possible using
such a device, wherein a labeled amount, that is, the analyte analog, is
included in the first zone, preferably to compete with the unlabeled analyte
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of the liquid for a bonding reaction with the reagent” (Columbus, col. 2, ll.
47–53).
5. Columbus teaches that to “permit air to be expelled from zones
22 and 24 ahead of an advancing liquid meniscus, apertures 50 are provided,
preferably through member 42 in the vicinity of zone 24” (Columbus, col. 5,
ll. 51–54).
6. Columbus teaches that in
[A]ccord with well–known principles of capillarity, the
smaller spacing of distance h’ insures that the liquid will
preferentially flow into zone 24 . . . . Additional processing
then takes place in zone 24, for example . . . measurement of
analyte in the liquid by an appropriate scan . . . using
electromagnetic radiation that passes through either member
44, as shown, or member 42 if exposed from above

(Columbus, col. 8, ll. 16–27).
7. Freytag teaches that “[t]here is a need for a heterogeneous
immunoassay which does not require a pre–incubation step and which is
readily adaptable to automated or semi–automated instrumentation”
(Freytag, col. 2, ll. 57–60).
8. Freytag teaches
(1) contacting a liquid sample suspected of containing
analyte with a solid phase having immobilized thereon an
analyte-analogue to which there is displaceably bound a
labeled, anti-analyte antibody in molar excess over the
analyte, wherein the dissociation constant between said
antibody and the analyte-analogue is greater than the
dissociation constant between said antibody and the analyte,
whereby said antibody is displaced from the immobilized
analyte-analogue as said antibody forms a complex with the
analyte from the liquid sample; (2) separating said complex
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from the solid phase; and (3) measuring the amount of said
complex which is related to the amount of analyte initially
present in the liquid sample.

(Freytag, col. 2, l. 65 to col. 3, l. 11.)
9. Gorin teaches that a “sample is a liquid and may be derived
from any source, such as a physiological fluid; e.g., blood, saliva, occular
lens fluid, cerebral spinal fluid, pus, sweat, exudate, urine, milk, or the like.
The liquid sample may be subjected to prior treatment” (Gorin, col. 4, ll. 23–
27).
10. Gorin teaches that “denatured blood/reagent mixture will then
be mixed and assayed for hemoglobin A1c by measurement of the change in
turbidity over about 30 seconds. Turbidity increases as a result of
agglutination of antibody-coated latex particles, the antibody being specific
for hemoglobin A1c” (Gorin, col. 18, ll. 33–37).
11. Figure 12B of Gorin is reproduced below:

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FIG. 12B discloses an embodiment comprising
Sample application site 730 is provided in an upper
face of block 790. Two channels lead away from the sample
application site. One channel is measuring chamber 732 . . .
a capillary pathway is provided for isolating a portion of the
mixture initially formed in mixing chamber 740. Channel
761 along the front face of block 790 leads to a capillary
space 762 to which a reagent can be applied before placing
cover plate 795 over base 790. The capillary path proceeds
to aperture 763, which traverses block 790. Capillary path
764 continues on the back face of block 790 and terminates
at vent space 765 through back plate 795. Actual venting
takes place through aperture 767 in back cover plate 797. A
solenoid-controlled vent seal (not shown) forms part of the
apparatus in which this embodiment is placed for controlling
entry and exit of liquids into this capillary pathway.

(Gorin, col. 17, ll. 1–36.)
12. Gorin teaches that “[c]apillary channels 761–764 provide the
measurement (mixture isolation) capillary with vent control occurring at
vent chamber 765” (Gorin, col. 18, ll. 45–47).
13. Gorin teaches “an apparatus and a method by which small
samples can easily be measured and diluted. . . . Valves are provided to
control the movement of fluid from chamber to chamber. . . . For some
operations, valves can consist of externally controlled vent covers to control
the flow of liquids in capillary spaces” (Gorin, col. 3, ll. 48–60).
14. Gorin teaches that “[v]alves consisting of external vent controls
can be used in any situation where flow occurs through a capillary pathway
(so that trapped air is effective to control flow of liquids) and where no
liquid is stored in the cartridge prior to use” (Gorin, col. 11, ll. 54–58).
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15. Gorin teaches “U.S. Pat. No. 4,426,451 . . . describes a number
of stop flow junctions that it refers to as ‘meniscus control means’ for use in
a device in which there is capillary flow from one zone to another. The stop
flow junctions described in that patent can be used in the apparatus of the
present invention” (Gorin, col. 7, ll. 11–16).
16. Gorin teaches that “[i]t is also possible to use a valve to control
flow of sample from the sample measuring chamber to the mixing chamber”
(Gorin, col. 8, ll. 27–29).
Principles of Law
“When a work is available in one field of endeavor, design incentives
and other market forces can prompt variations of it, either in the same field
or a different one. If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability.” KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 417 (2007).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 7–26; FF 1–15) and agree that claim
1 is obvious over Columbus, Freytag, and Gorin. We address Appellants’
arguments below.
Appellants contend that “Columbus is an improper reference for an
obviousness rejection because the allegedly obvious modification to
Columbus, to make it read upon the claims, would change the principle of
operation of Columbus” (App. Br. 7–8). Appellants rely upon the Hodges
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Declaration,13 which states that “it is my expert opinion that a meniscus
control and a vent control, when used to control a liquid flow in a system,
rely on two mechanisms and principles of operation that are not only
structurally different, but also structurally incompatible” (Hodges Decl. 5 ¶
5C; see also App. Br. 11).
The Examiner finds that “Gorin clearly indicates that the vent control
is used interchangeably with the meniscus control” (Ans. 29). The Examiner
further finds that the ordinary artisan “would have recognized that the two
controls are species of the same genus -they are distinct, but not so different
that altering one for the other would require a substantial reconstruction and
redesign . . . [and] would find it obvious to remove the meniscus control and
replace with a vent control” (id.).
We find that the Examiner has the better position. Columbus and
Gorin teach devices for analyzing biological samples using antibodies (FF 4,
9, 10). Both Columbus’ reaction chamber 20 (FF 2) and Gorin’s
mixing/reaction chamber 740 (FF 11) are connected to sample ingress
means, specifically aperture 46 in Columbus (FF 3) and sample application
site 730 in Gorin (FF 11). Columbus and Gorin teach passage to detection
chambers, specifically zone 24 in Columbus (FF 6) and capillaries 761–764
in Gorin (FF 12).
We recognize that structural changes, as identified by Dr. Hodges, are
necessary to modify the meniscus control of Columbus to the valve control
of Gorin (see Hodges Decl. 7–8 ¶¶ 7A–7C). We also have considered his
conclusion that “these two systems are not interchangeable or combinable”

13 Declaration of Dr. Alastair M. Hodges, filed Dec. 14, 2010.
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Hodges Decl. 8 ¶ 8B). Dr. Hodges relies upon a change in principle of
operation (see Hodges Decl. 8 ¶ 7C), but does not demonstrate that undue
experimentation, or indeed, any experimentation, would have been required
to substitute a valve as taught in Gorin for the vent and meniscus control of
Columbus (FF 1–16).
We contrast the Hodges Declaration against Gorin’s teaching that the
prior art was aware of a number of “‘meniscus control means’ for use in a
device in which there is capillary flow from one zone to another” (Gorin,
col. 7, ll. 10–15; FF 15). Gorin expressly suggests substituting valves for
these meniscus control means, teaching that “[i]t is also possible to use a
valve to control flow of sample from the sample measuring chamber to the
mixing chamber” (Gorin, col. 8, ll. 27–29; FF 16).
As we balance the teaching of Gorin that a valve may be substituted
for a meniscus control means (FF 15–16) in very structurally similar devices
with identical purposes as discussed above (FF 1–6, 9–14) against the
negative teaching of the Hodges Declaration (Hodges Decl. 8 ¶ 8B), we find
Gorin more persuasive. We also agree with the Examiner that In re Ratti,
270 F.2d 810 (CCPA 1959), does not mandate a different result (Ans. 27)
and that the “skilled artisan would have recognized that the two controls are
species of the same genus – they are distinct, but not so different that
altering one for the other would require a substantial reconstruction and
redesign” (Ans. 28).
Our position finds substantial support in the underlying facts of the
KSR decision itself, where the Supreme Court was not persuaded by the
Federal Circuit’s reliance upon a statement from an “expert that claim 4 was
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nonobvious because, unlike in Rixon, the sensor was mounted on the support
bracket rather than the pedal itself.” KSR, 550 U.S. at 415. That is, like the
current case, some reconstruction of the prior art elements amounting to a
change in the principle of operation of the pedal sensor would have been
required to arrive at the claimed invention. The Court, however, found that
“if a technique has been used to improve one device, and a person of
ordinary skill in the art would recognize that it would improve similar
devices in the same way, using the technique is obvious unless its actual
application is beyond his or her skill.” Id. at 417. We conclude that
substituting a valve for a vent and meniscus control is not beyond the skill of
Gorin’s ordinary artisan (FF 15–16), and we agree with the Examiner that
“Gorin teaches that using a valve in the form of a venting system is a
functional alternative to a meniscus flow stop. Accordingly, the skilled
artisan would have recognized that Columbus’s meniscus flow stop can be
substituted by Gorin’s venting system” (Ans. 11).
Appellants contend that “the Examiner has reconstructed the invention
not from the knowledge and motivations of a person of ordinary skill in the
art, but instead from the hindsight position of an Examiner with claims to
reject no matter how many references must be assembled, combined, and
modified to do so” (App. Br. 15).
We are not persuaded. While we are fully aware that hindsight bias
often plagues determinations of obviousness, Graham v. John Deere Co.,
383 U.S. 1, 36 (1966), we are also mindful that the Supreme Court has
clearly stated that the “combination of familiar elements according to known
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methods is likely to be obvious when it does no more than yield predictable
results.” KSR, 550 U.S. at 416.
As discussed above, we conclude that the person of ordinary skill
would have recognized the obviousness of modifying the meniscus flow
immunoassay method of Columbus to use the heterogeneous immunoassay
of Freytag “which does not require a pre–incubation step and which is
readily adaptable to automated or semi–automated instrumentation”
(Freytag, col. 2, ll. 57–60; FF 7) while also incorporating Gorin’s teaching
that rather than use meniscus control, “[i]t is also possible to use a valve to
control flow of sample from the sample measuring chamber to the mixing
chamber” (Gorin, col. 8, ll. 27–29).
We also note that it has been recognized that reliance on a “large
number of references” does not, without more, weigh against the
obviousness of the claimed invention. In re Gorman, 933 F.2d 982, 986
(Fed. Cir. 1991) (“The criterion, however, is not the number of references,
but what they would have meant to a person of ordinary skill in the field of
the invention.”).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
combination of Columbus, Freytag, and Gorin renders the claims obvious.
B.–H. 35 U.S.C. § 103(a) rejections
Appellants do not argue separately the claims in these obviousness
rejections. Having affirmed the obviousness rejection of claim 1 over
Columbus, Freytag, and Gorin for the reasons given above, we also find that
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the further obvious combinations render the remaining claims obvious for
the reasons given by the Examiner (see Ans. 13–22).
I. Double Patenting Rejection
We summarily affirm the provisional obviousness–type double
patenting rejection since no arguments were presented. See Manual of
Patent Examining Procedure § 1205.02 (“If a ground of rejection stated by
the examiner is not addressed in the appellant's brief, appellant has waived
any challenge to that ground of rejection and the Board may summarily
sustain it . . . .”).
When the appellant fails to contest a ground of rejection to
the Board, . . . the Board may treat any argument with
respect to that ground of rejection as waived. In the event of
such a waiver, the PTO may affirm the rejection of the
group of claims that the examiner rejected on that ground
without considering the merits of those rejections.

Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008).
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as being obvious over Columbus, Freytag, and Gorin. Pursuant to
37 C.F.R. § 41.37(c), we also affirm the rejection of claims 2, 4, 6, 12, 15–
18, 20, 29, 32, 34, 35, 40, and 41, as these claims were not argued
separately.
We affirm the rejection of claims 5, 7, and 8 under 35 U.S.C. § 103(a)
as being obvious over Columbus, Freytag, Gorin, and Rubenstein.
We affirm the rejection of claims 9–11 under 35 U.S.C. § 103(a) as
being obvious over Columbus, Freytag, Gorin, and Jernigan.
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We affirm the rejection of claim 13 under 35 U.S.C. § 103(a) as being
obvious over Columbus, Freytag, Gorin, and Vormbrock.
We affirm the rejection of claims 30 and 31 under 35 U.S.C. § 103(a)
as being obvious over Columbus, Freytag, Gorin, and Say.
We affirm the rejection of claim 33 under 35 U.S.C. § 103(a) as being
obvious over Columbus, Freytag, Gorin, and Uzan.
We affirm the rejection of claim 38 under 35 U.S.C. § 103(a) as being
obvious over Columbus, Freytag, Gorin, and Siegel.
We affirm the rejection of claim 42 under 35 U.S.C. § 103(a) as being
obvious over Columbus, Freytag, Gorin, and Boles.
We affirm the rejection of claims 1, 2, 4–13, 15–18, 20, 29–35, 38,
and 40–42 on the ground of nonstatutory obviousness–type double patenting
as unpatentable over claims 64 and 66–93 of US Application 10/830,841
(now issued as US 8,685,714, Apr. 1, 2014).

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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