Ex Parte Miles et al

Board of Patent Appeals and Interferences

Aug 25, 2010

11528286 (B.P.A.I. Aug. 25, 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.
11/528,286 09/26/2006 Robin R. Miles IL-11574 6687
24981 7590 08/26/2010
Lawrence Livermore National Security, LLC
LAWRENCE LIVERMORE NATIONAL LABORATORY
PO BOX 808, L-703
LIVERMORE, CA 94551-0808
EXAMINER
DIRAMIO, JACQUELINE A
ART UNIT PAPER NUMBER
1641
MAIL DATE DELIVERY MODE
08/26/2010 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 ROBIN R. MILES, WILLIAM J. BENETT,
MATTHEW A. COLEMAN, FRANCESCA S. PEARSON, and
SHANAVAZ L. NASARABADI
__________

Appeal 2010-003122
Application 11/528,286
Technology Center 1600
__________

Before CAROL A. SPIEGEL, TONI R. SCHEINER,
and STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
lateral flow strip assay apparatus for testing a sample. The Patent Examiner

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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rejected the claims as anticipated and obvious. We have jurisdiction under
35 U.S.C. § 6(b). We affirm-in-part.

STATEMENT OF THE CASE
The invention concerns a “simple-to-use sample collection and
processing package for lateral flow strip assays.” (Spec. [0022]). The
apparatus can be used “to interrogate saliva for protein or RNA markers to
determine the state of the person or animal being assayed.” (Id. at [0025]).
Claims 1, 3-5, 9-12, and 14-20 are on appeal. Claims 1, 4, 9, 11 and
15 are representative and read as follows:
1. A lateral flow strip assay apparatus for testing a sample,
comprising:
a housing, said housing having an end portion;
a lateral flow strip, said lateral flow strip positioned in said housing,
said lateral flow strip having a tip with a receiving portion on said tip with
said tip of said lateral flow strip extending outside of said housing from said
end portion of said housing;
a sample collection unit for collecting the sample; and
a reagent reservoir for receiving said tip of said lateral flow strip.

4. The lateral flow strip assay apparatus of claim 1 wherein said
reagent reservoir includes an entrance for receiving said sample collection
unit and a tapered portion for squeezing said sample collection unit.

9. The lateral flow strip assay apparatus of claim 1 wherein said
housing has a second end portion and said sample collection unit is attached
to said second end portion.

11. The lateral flow strip assay apparatus of claim 1 wherein said
sample collection unit includes a rubber chew bar.

15. The lateral flow strip assay apparatus of claim 1 wherein said
sample collection unit includes a colorimetric humidity indicator.

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The Examiner rejected the claims as follows:
• claims 1, 3, 5, 9, 16, 17, and 19 under 35 U.S.C. § 102(b) as being
anticipated by Aberl;2 and
• claims 4, 18, and 20 under 35 U.S.C. § 103(a) as being unpatentable
over Aberl and Eckermann;3
• claims 10 and 12 under 35 U.S.C. § 103(a) as being unpatentable
over Aberl and Mink;4
• claim 11 under 35 U.S.C. § 103(a) as being unpatentable over
Aberl, Mink, and Shoup;5
• claims 14 and 15 under 35 U.S.C. § 103(a) as being unpatentable
over Aberl and Slowey;6

ANTICIPATION
The Issues
The Examiner’s position is that Aberl taught a test kit that included a
lateral flow strip assay apparatus comprising a housing 6, said housing
having an end portion, a chromatographic test strip, i.e., a lateral flow strip,
positioned in said housing, and having an absorbent pad 1, i.e., tip, with a
receiving portion on said pad with said pad and test strip extending outside
of said housing from said end portion of said housing. (Ans. 3-4). The

2 Patent Application Publication No. US 2005/0175992 A1 by Franz Aberl
et al., published Aug. 11, 2005.
3 Patent Application Publication No. US 2004/0171173 A1 by Martine
Eckermann et al., published Sep. 2, 2004.
4 Patent No. 6,303,081 B1 issued to Ronald W. Mink et al., Oct. 16, 2001.
5 Patent No. 7,156,658 B2 issued to Randolph K. Shoup et al., Jan. 2, 2007.
6 Patent Application Publication No. US 2006/0018800 A1 by Paul D.
Slowey et al., published Jan. 26, 2006.
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Examiner found that Aberl taught that its apparatus also comprised a sample
collection device, an elution medium, i.e., reagent, reservoir for receiving
the absorbent pad and test strip. (Id. at 4). The Examiner also found that
Aberl taught that the housing includes a window 8 for viewing the test strip,
as recited in instant claims 3, 17, and 19. (Id.). Additionally, the Examiner
found that its sample collection device could comprise a sponge, as recited
in instant claim 5. (Id.). Regarding instant claim 9, the Examiner found that
Aberl disclosed that its housing has a second end portion and that its sample
collection device is attached to said second end portion. (Id.). Additionally,
the Examiner found, regarding instant claims 16 and 19, that Aberl disclosed
that its “housing includes a first end portion and a second end portion or an
upper end and a lower end, wherein said absorbent pad (receiving portion)
extends from said first portion or lower end of said housing, and said sample
collection device is connected to said second portion or upper end of said
housing.” (Id.).
Appellants contend that Aberl does not anticipate the rejected claims.
In particular, Appellants contend that Aberl did not disclose a “lateral flow
strip … having a tip with a receiving portion on said tip” nor a “reagent
reservoir,” as are recited in instant claims 1, 16 and 19. (App. Br. 14-17,
Reply Br. 4). According to Appellants, the recited “tip” should be
interpreted as receiving a sample for analysis and not for receiving an
elution medium, as is the case with Aberl’s absorbent pad. (Reply Br. 4-7).
Regarding instant claim 19, Appellants further assert that Aberl did not
disclose “a sample collection unit for collecting the sample, said sample
collection unit connected to said upper end of said housing.” (App. Br. 17).
Additionally, Appellants assert that Aberl did not disclose that its “sample
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collection unit is a sponge,” as recited in instant claim 5. (Id. at 17).
Regarding instant claim 9, Appellants also assert that Aberl did not disclose
that its “housing has a second end portion and said sample collection unit is
attached to said second end portion.” (Id. at 18).
The issues with respect to the anticipation rejection are:
1. Whether the instantly recited “tip with a receiving portion on
said tip,” should be interpreted as receiving a sample for analysis and not for
receiving an elution medium, as is the case with Aberl’s absorbent pad;
2. Whether Aberl disclosed an assay apparatus comprising (a) a
“lateral flow strip having a tip with a receiving portion on said tip,” (b) a
“reagent reservoir,” (c) “a sample collection unit for collecting the sample,
said sample collection unit connected to said upper end of said housing,” (d)
a “sample collection unit [that] is a sponge,” (e) a “housing [that] has a
second end portion [wherein the] sample collection unit is attached to said
second end portion.”

Findings of Fact
1. Aberl disclosed a sample analysis device for detecting “targets, e.g.
pathogens and/or allergy-associated components in a human body fluid
wherein a body fluid sample is collected with a swab member.” (Aberl
[0001]).
2. Aberl figure 1 is reproduced below:
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{Figure 1 shows a sample analysis device in the form of a chromatographic
test strip in accordance with Aberl’s invention. (Id. at [0022]).}

3. Aberl disclosed that its test strip comprises a plurality of different
strip materials arranged on an adhesive plastic backing (5), including an
absorbent pad (1), an application zone (2), a detection zone (3) and a waste
zone (4). (Id.).

4. Aberl figure 2 is reproduced below:

{Figure 2 shows a plastic housing (6) containing
the strip as shown in Fig. 1. (Id. at [0023]}.

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5. Aberl disclosed its test strip positioned in a plastic housing with the
portion of the test strip comprising the absorbent pad (1) extending outside
of said housing. (Id. at Fig. 2 and [0023]).
6. Aberl disclosed that its housing provides a sample application window
(7) for bringing a swab member into contact with the strip, and further
comprising a read out window (8) which displays the test result. (Id. at
[0023]).
7. Aberl disclosed that “an elution medium is applied by dipping the
absorbent pad into the chromatographic liquid.” (Id. at [0048]}.
8. Aberl disclosed that the elution medium may also be contained in a
reservoir which may be integrated with the analysis device. (Id. at [0049]).
9. Aberl disclosed that the absorbent pad is made of a well-absorbing
material which delivers the chromatographic liquid for the immunochemical
or enzymatic reactions. (Id. at [0048]).
10. Aberl figure 4 is reproduced below:

{Figure 4 shows a test kit comprising a sample analysis device according
to Figs. 1 and 2, along with a swab member/collection device of Aberl’s
invention. (Id. at [0025]}.

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11. Aberl disclosed that after a sample is collected, “the collection device
is fixed to the plastic housing containing the test strip….” (Id. at [0045]).
12. Aberl disclosed that the swab member/collection device comprises a
plastic body with a sample collection material fixed on it, which material
may consist of bibulous material such as highly purified cotton fibers or
alternative materials such as polyester, rayon, polyamide, or other fibrous
polymeric materials. (Id. at [0024], [0057]).

Principles of Law
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d
628, 631 (Fed. Cir. 1987). The test for anticipation “is not an ‘ipsissimis
verbis’ test.” In re Bond, 910 F.2d 831, 832 (Fed. Cir. 1990).
It is well settled that “claims in an application are to be given their
broadest reasonable interpretation consistent with the specification and that
claim language should be read in light of the specification as it would be
interpreted by one of ordinary skill in the art.” In re Sneed, 710 F.2d 1544,
1548 (Fed. Cir. 1983).

Analysis
A. Claim Interpretation
We turn to the Specification for clarification as to whether claim 1’s
“a receiving portion on said tip” requires the receiving portion to receive the
sample and not another simply any material, i.e., a reagent/elution medium.
See Sneed, 710 F.2d at 1548.
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Appellants assert that their “specification and drawings define the
claim element “a receiving portion on said tip” as “a receiving portion 13
that extends from the lateral flow strip housing 11.” (Reply Br. 4) (quoting
Spec.). Appellants assert that their “specification and drawing describe “a
receiving portion 13’ as follows: ‘The lateral flow strip 12 operates whereby
the sample is applied at the end 13.’” (Id.). However, neither of these
disclosures support interpreting the apparatus claim phrase “a receiving
portion on said tip” narrowly to mean the receiving portion receives only a
sample. While the Specification describes the intended use of the receiving
portion as receiving the sample, an intended use does not limit the apparatus
claim.
Consequently, in light of the Specification, we interpret the claim
phrase “a receiving portion on said tip” broadly as the portion on the tip of a
lateral flow strip that may receive any material, including an elution
medium.
B. Claims 1, 16, and 19
We are not persuaded that Aberl did not disclose a “lateral flow strip
having a tip with a receiving portion on said tip.” As the Examiner
explained (Ans. 11) Aberl disclosed an absorbent pad 1 located on the tip, or
end portion, of its test strip, which pad extends from the strip housing and
receives an elution medium. (FF-2, 3, 5, 7, 8, 9). The evidence supports the
Examiner’s finding.
We agree with the Examiner that Aberl disclosed a “reagent
reservoir,” as recited in the instant claims. Aberl expressly stated “an
elution medium is applied by dipping the absorbent pad into the
chromatographic liquid.” (FF-7). Additionally, Aberl disclosed that the
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elution medium may alternatively be contained in a reservoir which may be
integrated with the analysis device. (FF-8). This disclosure anticipates “a
reagent reservoir for receiving said tip of said lateral flow strip.” Appellants
have not separately argued claims 3 and 17, therefore claim 3 falls with its
independent claim 1 and claim 17 falls with its independent claim 16. See
37 C.F.R. § 41.37(c)(1)(vii).
Regarding Appellants’ further argument that claim 19 is not
anticipated because Aberl did not disclose “a sample collection unit for
collecting the sample, said sample collection unit connected to said upper
end of said housing” (App. Br. 17), Aberl specifically disclosed a sample
collection device (FF-12) and expressly stated that “the collection device is
fixed to the plastic housing containing the test strip….” (FF-11). Aberl’s
figure 4 illustrated the positioning and connection of the sample collection
device to the upper end of the housing. (FF-10). Therefore, Aberl
anticipated this element of claim 19.
C. Claim5
Appellants assert that Aberl did not disclose that its “sample
collection unit is a sponge,” as recited in instant claim 5. (App. Br. 17). We
disagree. Aberl disclosed that the swab member/collection device
comprised a plastic body with a sample collection material fixed on it, which
material may consist of bibulous material such as highly purified cotton
fibers or alternative materials such as polyester, rayon, polyamide, or other
fibrous polymeric materials. (FF-12). While the word “sponge” was not
used, a skilled artisan at the time of the invention would have understood
this disclosure as describing a sponge. See Bond, 910 F.2d at 832.
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D. Claim 9
We are unpersuaded by Appellants’ assertion that Aberl did not
disclose that its “housing has a second end portion and said sample
collection unit is attached to said second end portion” (App. Br. 18) for the
same reason discussed regarding 19. Aberl specifically disclosed a sample
collection device (FF-12) and expressly stated that “the collection device is
fixed to the plastic housing containing the test strip….” (FF-11). Aberl
figure 4 illustrated the positioning of the sample collection device to the
upper end of the housing. (FF-10). Therefore, Aberl also anticipated this
element of claim 9.

OBVIOUSNESS
The Issue
The Examiner’s position is that while Aberl taught the invention of
independent claims 1, 16 and 19, the reference did not teach that the
“reagent reservoir includes an entrance for receiving said sample collection
unit and a tapered portion for squeezing said sample collection unit,” as
recited in claims 4, 18 and 20. (Ans. 5). However, the Examiner found that
Eckermann taught a device for collecting and analyzing samples, which
device comprised a housing, an absorbent pad and a test strip. (Id.). The
Examiner found that Eckermann disclosed that the absorbent pad extends
from the housing and is used for collecting a sample solution. (Id.). The
Examiner also found that Eckermann disclosed that “[t]he absorbent pad and
the collected sample are brought into contact with the test strip by some type
of squeezing means.” (Id.). Additionally, the Examiner found that
Eckermann disclosed a storage chamber, i.e. reagent reservoir, “for storing a
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liquid can be included within the device, wherein the storage chamber is
arranged such that when the absorbent pad is positioned on one side of an
application zone of the test strip, the storage chamber is positioned on the
other side of the absorbent pad.” (Id. at 5-6). The Examiner found that
Eckermann disclosed that “[t]he storage chamber can act as a squeezing
arrangement, which can squeeze the sample out of the absorbent pad, while
at the same time emitting a liquid, such as a buffer solution, which
contributes to washing out the absorbent pad ….” (Id. at 6).
According to the Examiner “it would have been obvious to one of
ordinary skill in the art at the time of the invention was made to modify the
elution medium reservoir of Aberl … to allow for squeezing said sample
collection unit and/or absorbent pad as taught by Eckermann.” (Id.). The
Examiner reasoned that Eckermann taught the benefit of arranging a test
device that includes a housing, absorbent pad, and liquid storage chamber so
that the liquid storage chamber can squeeze the absorbent pad or sample
collection unit, while emitting a liquid to wash out the pad. (Id.).
Regarding claims 10, 11 and 12, the Examiner’s position is that Aberl
did not teach that its sample collection unit included a chew bar or a rubber
chew bar. (Id.). However, the Examiner found that Mink disclosed a device
for collecting and assaying oral fluids, which device included a capillary
matrix used to obtain a saliva sample from the mouth of a subject and then to
transfer the sample to the test strip. (Id. at 7). The Examiner found that
Mink disclosed that the device can include a bite plate, i.e., a chew bar,
coupled to the capillary matrix, that can be inserted in the mouth to position
the capillary matrix in place for collecting oral fluid. (Id.). According to the
Examiner it would have been obvious to include Mink’s bite plate in the
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device of Aberl because Mink taught the benefit of coupling a bite plate to a
capillary matrix, i.e., sample collection unit, to position the collection unit in
place for collecting an oral fluid sample. (Id.). Further, the Examiner found
that Shoup disclosed a dental device that included a mouthpiece having a
bite plate attached to it. (Id. at 8). The Examiner found that Shoup taught
that its mouthpiece is preferably fabricated out of rigid rubber or synthetic
rigid rubber, both of which are well known in the art. (Id.). According to
the Examiner, it would have been obvious for the skilled artisan to fabricate
Mink’s bite plate out of rubber as taught by Shoup because Shoup taught
that the well known material is preferable for a mouthpiece comprising a
bite plate that is situated in a patient’s oral cavity. (Id.).
Regarding claims 14 and 15, the Examiner found that Aberl did not
teach that its sample collection unit includes a colorimetric humidity
indicator. (Id. at 9). However, the Examiner found that Slowey disclosed a
sample collection device that included a handle having a sufficiency
indicator and an absorbent pad. (Id.). The Examiner found that Slowey
disclosed that its absorbent pad allows for the collection of a sample, e.g.,
saliva from a subject’s mouth. (Id.). The Examiner found that Slowey’s
sufficiency indicator can comprise a color indicator and is placed in contact
with the absorbent pad such that when the pad is saturated with sufficient
sample, the indicator changes color. (Id.). According to the Examiner, it
would have been obvious to a person of ordinary skill in the art at the time
the invention was made to include Slowey’s sufficiency indicator, i.e.,
colorimetric humidity indicator, in the device of Aberl because Slowey
taught the benefit of the indicator to indicate that an adequate volume of
sample has been obtained. (Id.).
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Appellants contend that none of the rejected claims are obvious
because Aberl does not teach or suggest a “lateral flow strip having a tip
with a receiving portion on said tip” nor a “reagent reservoir,” as recited in
the independent claims. (App. Br. 21, 26, 30-31, 34-35; Reply Br. 8, 14-15,
18, 21-22). Additionally, Appellants assert that none of the rejected claims
are obvious because the references relied upon by the Examiner, neither
alone or in combination, teach the limitations of the rejected dependent
claims. (App. Br. 20-37; Reply Br. 8-24). According to Appellants, because
the claim “elements are missing from [the] references, there could be no
combination of the … references that would have reasonable expectation of
success of providing Applicant’s invention of claims 4, 18, and 20.” (Id. at
23). For the same reason, Appellants assert that there would be no reason to
combine the references. (Id.).
The issues with respect to these rejections are:
whether the combination of Aberl and Eckermann taught or suggested
a “reagent reservoir includes an entrance for receiving said sample collection
unit and a tapered portion for squeezing said sample collection unit;”
whether the combination of Aberl and Mink taught or suggested a
sample collection unit including a chew bar;
whether the combination of Aberl, Mink and Shoup taught or
suggested a sample collection unit including a rubber chew bar; and
whether the combination of Aberl and Slowey taught or suggested a
sample collection unit including a colorimetric humidity indicator.

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Additional Findings of Fact
13. Eckermann disclosed a device for collecting samples of body fluids,
such as saliva, comprising an absorbent pad and two housing parts.
(Eckermann, Abstract).
14. Eckermann disclosed that the housing parts are arranged in a first
position wherein the absorbent pad can take up the fluid sample, and in a
second position, wherein the housing parts surround the absorbent pad. (Id.
at [0009]).
15. Eckermann disclosed that the device “can comprise a squeezing
arrangement which, when the housing parts are moved into their second
position in which they surround the absorbent pad, squeezes the fluid out of
the latter.” (Id. at [0025]).
16. Eckermann disclosed an embodiment in which one housing part
comprised a storage chamber for liquid “arranged in such a way that when
the housing parts are moved into second position … it is situated on one side
of the absorbent pad, and the application zone of the test strips on the other
side of the absorbent pad.” In this arrangement, the chamber acts as a
squeezing arrangement that can squeeze the sample out of the pad and emit
liquid for washing out the pad. (Id. at [0029]).
17. Mink disclosed a device for collecting and assaying oral fluids, which
device comprised a lateral flow chromatographic test strip and a capillary
matrix. (Mink Abstract; col. 8, ll. 5-7).
18. Mink disclosed that the capillary matrix acts as a receiving body or
pad that rapidly adsorbs (wicks up) oral fluid and delivers the fluid to the
test strip. (Id. at col. 8, ll. 21-24).
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19. Mink disclosed a bite plate is “coupled to the capillary matrix [and] is
insertable between the teeth of the patient to position the capillary matrix in
the oral cavity for receiving oral fluid.” (Id. at col. 8, ll. 10-13).
20. Shoup disclosed a dental measurement device that includes a
mouthpiece with an attached bite plate. (Shoup Abstract; col. 4, ll. 46-51).
21. Shoup disclosed that materials for fabrication of the mouthpiece (and
attached bite plate) include rigid rubber or synthetic rigid rubber compounds,
well know in the art. (Id. at col. 5, ll. 56-58).
22. Slowey disclosed “[a] specimen sample collection device includ[ing]
a handle having a sufficiency indicator and an absorbent pad partially
contained within said handle.” (Slowey, Abstract).
23. Slowey disclosed that the sufficiency indicator is preferably a shaped
light pipe with a color indicator on one end, which is placed in contact with
the absorbent pad. (Id. at [0058]).
24. Slowey disclosed that “when the absorbent pad is saturated with
sufficient sample, the reflectance of the pad changes causing a change in the
refractive properties of the light pipe, seen as an altering of the color or
indicator, which is seen as a line.” (Id.).

Principles of Law
“Section 103 forbids issuance of a patent when ‘the differences
between the subject matter sought to be patented and the prior art are such
that the subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said
subject matter pertains.’” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
(2007). “A combination of familiar elements according to known methods
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is likely to be obvious when it does no more than yield predictable results.”
Id. at 416.

Analysis
To the extent that Appellants contend that each of the rejected claims
are not obvious by asserting that Aberl failed to teach these elements of
independent claims 1, 16 and 19, we are not persuaded for the same reasons
discussed supra.
A. Claims 4, 18 and 20
We agree with Appellants that dependent claims 4, 18 and 20 would
not have been obvious over the combination of Aberl and Eckermann. In
particular, we do not find that Eckermann’s storage chamber and squeezing
arrangement (see FF- 13, 14, 15 and 16) taught or suggested a “reagent
reservoir includ[ing] an entrance for receiving said sample collection unit
and a tapered portion for squeezing said sample collection unit,” as recited in
the claims.
B. Claims 10, 11 and 12
Mink disclosed a device for collecting and assaying oral fluids, which
device comprised a lateral flow chromatographic test strip and a capillary
matrix. (FF-17). Mink also disclosed that the capillary matrix acts as a
receiving body or pad that rapidly adsorbs the oral fluid and delivers the
fluid to the test strip. (FF-18). Additionally, Mink disclosed that a bite
plate, i.e., a chew bar, is “coupled to the capillary matrix [and] is insertable
between the teeth of the patient to position the capillary matrix in the oral
cavity for receiving oral fluid.” (FF-19). We agree with the Examiner (Ans.
7) that a skilled artisan would have found it obvious to incorporate Mink’s
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bite plate in the device of Aberl because Mink taught the benefit of coupling
a bite plate to a sample collection device, i.e., to position the collection
device for collecting an oral fluid sample. See KSR Int’l Co., 550 U.S. at
406, 416.
We also agree that Shoup taught fabricating an oral device comprising
a bite plate out of rigid rubber or synthetic rigid rubber, both of which are
materials well known in the art. (FF-20, 21). We agree with the Examiner
(Ans. 8) that a skilled artisan would have found it obvious to fabricate
Mink’s bite plate using a well known rubber material, especially because
Shoup taught that such material was useful and effective in an oral device
comprising a bite plate. See KSR Int’l Co., 550 U.S. at 406, 416.
C. Claims 14 and 15
Slowey disclosed “[a] specimen sample collection device includ[ing]
a handle having a sufficiency indicator and an absorbent pad partially
contained within said handle.” (FF-22). Slowey also disclosed that the
sufficiency indicator is preferably a shaped light pipe with a color indicator
on one end, which is placed in contact with the absorbent pad. (FF-23).
Additionally, Slowey disclosed that “when the absorbent pad is saturated
with sufficient sample, the reflectance of the pad changes causing a change
in the refractive properties of the light pipe, seen as an altering of the color
or indicator, which is seen as a line.” (FF-24). Therefore, we find that
Slowey taught a colorimetric humidity indicator. We agree with the
Examiner (Ans. 9) that a person of ordinary skill in the art at the time the
invention was made would have found it obvious to incorporate Slowey’s
indicator in Aberl’s sample collection unit to gain the benefit of seeing when
and if an adequate volume of sample has been obtained from a test subject.
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See KSR Int’l Co., 550 U.S. at 406, 416. Appellants have not established
otherwise with persuasive evidence.

CONCLUSIONS OF LAW
Aberl disclosed each of the disputed elements of claims 1, 3, 5, 9, 16,
17, and 19.
A person of ordinary skill in the art at the time the invention was
made would have found it obvious to combine the elements of the prior art
to yield the inventions of claims 10-12, 14 and 15.
Claims 4, 18, and 20 would not have been obvious to the skilled
artisan over the combination of Aberl and Eckermann.

SUMMARY
We affirm the rejection of claims 1, 3, 5, 9, 16, 17, and 19 under 35
U.S.C. § 102(b) as being anticipated by Aberl;
we reverse the rejection of claims 4, 18, and 20 under 35 U.S.C.
§ 103(a) as being unpatentable over Aberl and Eckermann;
we affirm the rejection of claims 10 and 12 under 35 U.S.C. § 103(a)
as being unpatentable over Aberl and Mink;
we affirm the rejection of claim 11 under 35 U.S.C. § 103(a) as being
unpatentable over Aberl, Mink, and Shoup; and
we affirm the rejection of claims 14 and 15 under 35 U.S.C. § 103(a)
as being unpatentable over Aberl and Slowey.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
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AFFIRMED-IN-PART

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LAWRENCE LIVERMORE NATIONAL SECURITY, LLC
LAWRENCE LIVERMORE NATIONAL LABORATORY
PO BOX 808, L-703
LIVERMORE CA 94551-0808