Ex Parte Song

Patent Trial and Appeal Board

Jun 3, 2014

11741943 (P.T.A.B. Jun. 3, 2014)

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.
11/741,943 04/30/2007 Xuedong Song KCX-1346
(64347646US01)
3971
22827 7590 06/03/2014
DORITY & MANNING, P.A.
POST OFFICE BOX 1449
GREENVILLE, SC 29602-1449
EXAMINER
ANDERSON, CATHARINE L
ART UNIT PAPER NUMBER
3778
MAIL DATE DELIVERY MODE
06/03/2014 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte XUEDONG SONG
__________

Appeal 2012-003706
Application 11/741,943
Technology Center 3700
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

PER CURIAM.

DECISION ON APPEAL
This is a decision on appeal1 under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1-15 and 18-35. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.

1 The Real Party in Interest is Kimberly-Clark Worldwide, Inc. (App. Br. 1.)
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Application 11/741,943

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STATEMENT OF THE CASE
The claims are related to absorbent articles for testing bodily fluids for
analytes. Claim 1 is representative of the claims on appeal and reads as
follows:
1. An absorbent article for testing a bodily fluid suspected of
containing an analyte, the absorbent article comprising:
an outer cover;
a bodyside liner;
an absorbent core positioned between the outer cover and the
bodyside liner; and
an insert for testing a bodily fluid suspected of containing an analyte,
the insert comprising
a cover;
a lateral flow device encased within the cover, and
an attachment mechanism configured to attach a liquid permeable
back coversheet of the insert to the bodyside liner of the absorbent article,
wherein the lateral flow device is configured to perform a
heterogeneous assay to separate one species from another species prior to
detection and comprises a chromatographic medium that defines a detection
zone, the detection zone being configured for exhibiting a signal indicative
of the presence or absence of the analyte in the bodily fluid,
wherein the back coversheet of the insert is attached to the bodyside
liner of the absorbent article.

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Application 11/741,943

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Issue
The Examiner has rejected claims 1-7, 9, 10, 12-15, and 18-352 under
35 U.S.C. § 103(a) as obvious in view of Diehl3 and Dostoinov4 (Ans. 4-7).
The Examiner has also rejected claims 8 and 11 under 35 U.S.C. § 103(a) as
obvious in view of Diehl, Dostoinov, and Kaylor5 (Ans. 7-8). Because
Appellant does not separately argue that rejection, we will consider the
rejections together. We focus our initial analysis on independent claim 1.
The issue presented is: Has the Examiner established by a
preponderance of the evidence that Diehl and Dostoinov would have made
obvious the absorbent article of claim 1 with an insert comprising a lateral
flow device configured to perform a heterogeneous assay, wherein a back
coversheet of the insert is attached to the bodyside liner of the absorbent
article?
Findings of Fact
FF1. The Examiner finds that “Diehl discloses an absorbent article
comprising an outer cover 26, a bodyside liner 24, and an absorbent core 28
. . . [such that] [a]n insert 60 for testing a bodily fluid is attached to the
article” (Ans. 5 (citing Diehl, Figure 1)).

2 The initial statement of the rejection in the Answer (pg. 4) did not
reference claims 20-22, 25, and 33. On pages 6 and 7 of the Answer,
however, the Examiner discusses claim 20-22, 25, and 33 and thus it appears
that the omission of these claims from the statement of the rejection was an
inadvertent error.
3 Diehl et al., US 7,365,238 B2, issued Apr. 29, 2008.
4 Dostoinov et al., US 2004/0133090 A1, published Jul. 8, 2004.
5 Kaylor et al., US 2005/0131287 A1, published Jun. 16, 2005.
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Application 11/741,943

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FF2. The Examiner finds that the Diehl “insert 60 is attached to the
bodyside liner of the article by an attachment mechanism” (id. (citing Diehl,
col. 8, ll. 15-18)).
FF3. The Examiner finds that the Diehl “insert 60 comprises a cover
75, a lateral flow device 70, and a back coversheet 80 . . . [wherein the]
lateral flow device comprises a chromatographic medium defining a
detection zone” (id. (citing Diehl, col. 6, ll. 30-52)).
FF4. The Examiner finds that the Diehl “device 60, as shown in
figures 3 and 9, . . . comprises a substrate that transports fluid along the
length of the substrate by wicking” (id. at 8 (citing Diehl, col. 9, ll. 57-67)).
FF5. The Examiner finds that the “device 60 of Diehl therefore
creates the flow of liquid in a lateral direction of the article, and fulfills the
claim limitation of a lateral flow device” (id.).
FF6. Diehl discloses that, in one embodiment,

[T]he dehydration indicator 60 may be located in regions of the
article other than the urine loading zone. In these embodiments,
. . . at least a portion of the fluid transport element 160 is
located in, or adjacent to, the urine loading zone in order to
acquire fluid prior to transporting, e.g., wicking, fluid to the
dehydration indicator 60.

(Diehl, col. 9, ll. 54-64.)
FF7. The Examiner finds that the Diehl discloses a “lateral flow
device [that] detects the ionic strength of the user’s urine, but does not
disclose . . . a heterogeneous assay to separate one species from another
prior to detection” (Ans. 5).
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Application 11/741,943

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FF8. The Examiner finds that Dostoinov teaches “an absorbent article
having a lateral flow device . . . [that is] capable of separating a plurality of
species to be detected” (id. (citing Dostoinov, Figure 1; ¶ 0024)).
FF9. The Examiner finds that Dostoinov’s lateral flow device “allows
for the simultaneous detection of several species . . . [and] is useful in the
rapid detection and diagnosis of a patient” (id. (citing Dostoinov, ¶ 0016)).
FF10. Dostoinov discloses a sanitary-hygienic article comprising “a
liquid-permeable upper face layer, an impervious to liquid lower layer, an
absorbing core and a functional diagnostic means disposed between the
absorbing core and the lower layer” (Dostoinov 2, ¶ 0020).
FF11. Dostoinov discloses that the “functional diagnostic means can
be made in the form of at least one layer . . . divided into sections . . . [such
that] each section is a pocket with an indicating testing strip disposed in it”
(id. at 2, ¶ 0026).
FF12. Dostoinov discloses that “when the facing out . . . side of the
pocket is made from transparent material, the lower impervious to water
layer is also made transparent” (id. at 3, ¶ 0029).
FF13. Dostoinov discloses that if “the capsule [pocket] and the lower
water-impervious layer are made from transparent material or have
transparent windows, aligned relative to each other, the visual inspection [of
the test strip] can be made” without taking off the absorbent article (id. at 4,
¶ 0061).
FF14. The Examiner concludes that it would “have been obvious to
one of ordinary skill in the art . . . to configure the lateral flow device of
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Diehl to separate and detect a plurality of species, as taught by Dostoinov, to
provide for the rapid detection and diagnosis of a patient” (Ans. 5).
FF15. The Specification discloses that a “lateral flow assay device
generally includes a chromatographic medium (e.g., porous membrane) that
defines a detection zone for providing a signal indicative of the presence or
absence of an analyte” (Spec. 3:30-32).
FF16. The Specification discloses that the chromatographic medium
“may be made from any of a variety of materials through which the test
sample is capable of passing” (id. at 4:32-33).
FF17. The Specification discloses that a “heterogeneous assay is one
in which a species is separated from another species prior to detection” (id.
at 4:11-12).
FF18. The Specification discloses that, in one embodiment, the lateral
flow device
[I]s positioned on the bodyside liner 102 such that the
application zone 16 is located towards the crotch region . . . and
the absorbent material 18 is positioned towards the waist region
of the diaper 100. As such, the detection zone 20 and the
control zone 22 are positioned away from the crotch region of
the diaper, helping to inhibit any contamination from the urine
discharged by the wearer.

(Id. at 22:31-23:3.)
Principles of Law
The Supreme Court has emphasized that “the [obviousness] analysis
need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” KSR
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Int’l v. Teleflex Inc., 550 U.S. 398, 418 (2007). “If a person of ordinary skill
can implement a predictable variation, § 103 likely bars its patentability.”
(Id. at 417.)
Moreover:
The test for obviousness is not whether the features of a
secondary reference may be bodily incorporated into the
structure of the primary reference; nor is it that the claimed
invention must be expressly suggested in any one or all of the
references. Rather, the test is what the combined teachings of
the references would have suggested to those of ordinary skill
in the art.
In re Keller, 642 F.2d 413, 425 (CCPA 1981).
Analysis
Appellant argues that Diehl does not disclose or suggest “a lateral
flow device having a chromatographic medium that defines a detection
zone” (App. Br. 6). Appellant argues that the Diehl “indicator simply
indicates the ionic strength of the fluid” (id.). Appellant argues that the
Diehl “configuration is completely different than . . . [a] lateral flow device
configured to perform a heterogeneous assay to separate one species from
another species prior to detection and [that] comprises a chromatographic
medium that defines a detection zone” (id.).
These arguments are not persuasive. As recognized by the Examiner
(Ans. 8), Diehl discloses an ionic strength detection device that comprises a
detection zone and a substrate that transports fluid along the length of the
substrate by wicking, and thus Diehl discloses a lateral flow device that
comprises a chromatographic medium that defines a detection zone (FFs 6
and 7). Although, Diehl does not disclose a lateral flow device for
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performing a heterogeneous assay, Dostoinov does disclose an absorbent
article comprising a lateral flow device for performing a heterogeneous
assay (FF 8). We agree with the Examiner that these cited references would
have made obvious the incorporation of a lateral device for performing a
heterogeneous assay into an absorbent article by attaching the device to the
body liner surface of the article, and thereby arrive at the invention of claim
1, because Diehl discloses such an attachment location for lateral flow
devices (FFs 2 and 3).
Appellant argues that “one of ordinary skill in the art would not have
modified the dehydration indicator of Diehl, et al., configured[ ]to indicate
the ionic strength of a fluid, to be a lateral flow device configured to exhibit
a signal indicative of the presence or absence of the analyte in the bodily
fluid” (App. Br. 7 (emphasis removed)). Appellant argues that “[s]uch a
modification would render the dehydration indicator of Diehl, et al. to be
unsatisfactory for its intended purpose: i.e., to indicate the ionic strength of a
fluid” (id. (emphasis removed)).
These arguments are not persuasive. The arguments fail to recognize
that the obvious combination is the substitution of the tests of Dostoinov for
the test for dehydration of Diehl, and is not focused on the specific tests
being performed. Further, Dostoinov discloses that more than one
diagnostic test strip may be incorporated into an absorbent article, and thus a
single absorbent article could incorporate both a dehydration indicating
lateral flow device and heterogeneous assay device (FF 11). Additionally,
the combination of the references would have made obvious an alternative
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Application 11/741,943

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attachment location, i.e., attachment to the bodyside liner, for the Dostoinov
heterogeneous assay lateral flow device.
Appellant argues that the Dostoinov “diagnostic capsule is ‘joined
with the lower layer or with the absorbing layer’ . . . [and] [t]he ‘lower layer’
. . . is the liquid impermeable layer 7” (App. Br. 7-8). Appellant argues that,
“if one of ordinary skill in the art would have substituted the diagnostic
capsule of Dostoinov, et al. for the dehydration indicator of Diehl, et al., the
placement of the testing strip would necessarily be ‘joined with the lower
layer or with the absorbing layer,’” which would not result in the article of
claim 1 with the back cover sheet of the insert attached to the bodyside liner
(id. at 8 (emphasis removed)).
These arguments are not persuasive. The Examiner relies on Diehl for
disclosing the placement of an assay device attached to the bodyside liner of
an absorbent article (FFs 2 and 3). The Examiner relies on Dostoinov as
disclosing that a particular assay device, i.e., a device that is capable of
separating a plurality of species, is known for use in absorbent articles (FF
8). In accord with In re Keller, the test for obviousness is what the
combined teachings of the references would have suggested to an ordinary
artisan, and obviousness does not require the bodily incorporation of all of
the features of one reference into a second reference.
Appellant argues that Dostoinov “teaches away from the presently
claimed location of the insert” (App. Br. 8). Appellant argues that
Dostoinov discloses “placement of the testing strip ‘joined with the lower
layer or with the absorbing layer,’ . . . [which] is completely at odds with the
requirement of independent claim 1, which requires that the back coversheet
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of the insert be attached to the bodyside liner of the absorbent article” (id. at
9).
These arguments are not persuasive. Although Dostoinov discloses
that the testing strips are contained in a layer between the absorbent core and
the lower layer, the purpose of this particular placement appears to be so that
the diagnostic assay results can be viewed through a transparent window in
the lower layer (FFs 12 and 13). Thus, one of skill in the art would
understand that, if it is not necessary to view the strips through the absorbent
article, the test strips could be disposed on the body facing surface of the
absorbent article, as disclosed in Diehl (FFs 12 and 13).
Thus, we affirm the rejection of claim 1 as being obvious in view of
Diehl and Dostoinov. Claims 2-7, 9, 10, 12-15, and 18-35 have not been
argued separately from claim 1 and therefore fall with that claim. 37 C.F.R.
§ 41.37(c)(1)(vii).
The Examiner has also rejected claims 8 and 11 as obvious in view of
Diehl, Dostoinov, and Kaylor (Ans. 7-8). The Examiner relies on Diehl and
Dostoinov as discussed above and relies on Kaylor to supply dependent
claim limitations. Since Appellant has not argued this rejection separately,
we also affirm this rejection.
Conclusion of Law
The preponderance of the evidence supports the Examiner’s
conclusion that Diehl and Dostoinov would have made obvious the
absorbent article of claim 1 with an insert comprising a lateral flow device
configured to perform a heterogeneous assay, wherein a back coversheet of
the insert is attached to the bodyside liner of the absorbent article.
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SUMMARY
We affirm the rejection claims 1-15 and 18-35 under 35 U.S.C.
§ 103(a).
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).

AFFIRMED

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