Ex Parte Hindelang et al

Patent Trial and Appeal Board

Jan 16, 2013

12105304 (P.T.A.B. Jan. 16, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte FRITZ HINDELANG and KARIN SCHWIND
__________

Appeal 2012-002185
Application 12/105,304
Technology Center 3700
__________

Before STEPHEN WALSH, ULRIKE W. JENKS, and SHERIDAN K.
SNEDDEN, Administrative Patent Judges.

SNEDDEN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
analytical device and an analytical system. The Examiner has rejected the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
reverse.

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Application 12/105,304

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STATEMENT OF THE CASE
Appellants’ invention relates to an “analytical device . . . comprising
a lancet and a test element in an integrated arrangement.” (Spec., Abstract.)
A device of the invention may function as follows:
When the lancing process is triggered, the needle is moved
forwards and in doing so exits at high speed from the opening
through the protective cap. The entire lancing process occurs
within a few milliseconds. After the skin has been punctured
the needle is retracted again. In this process a catching device
which is located on the lancet pulls along the protective cap and
optionally additional seals. … The user (additionally) contacts
the opening of the device with his collection device so that the
suction opening (e.g. capillary) can take up a drop of blood. The
suction action of the means for sample liquid transport
transports the blood in the dispo to a site in the test chamber at
which a test element comprising a detection element is located.
(Id., 19-20.)
Claims 1-10 and 12 are on appeal. Claim 1 is representative and reads
as follows (emphasis added):
1. An analytical device comprising a lancet and a test element in
an integrated arrangement, the lancet comprising a lancet needle with
a tip and a protective cap which generally completely surrounds the
lancet needle at least in the area of the tip, wherein the lancet needle
can be displaced in at least one direction relative to the protective cap,
and wherein the lancet needle is configured to engage the protective
cap after displacement of the lancet needle in the at least one direction
and thereafter to pull the protective cap during displacement of the
lancet needle in a retracting direction, the test element comprising a
chamber containing a reagent system, the chamber having a first
opening configured to be generally sealed by the protective cap prior
to and during displacement of the lancet needle in the at least one
direction and configured thereafter to be generally opened upon
displacement of the lancet needle in the retracting direction.

Appeal 2012-002185
Application 12/105,304

3
The claims stand rejected as follows:
I. Claims 1-9 under 35 U.S.C. § 103(a) as being unpatentable over
the combination of Kuhr1 and Cohen.2
II. Claims 1-9 under 35 U.S.C. § 103(a) as being unpatentable over
the combination of Kuhr and Fritz.3
III. Claims 10 and 12 under 35 U.S.C. § 103(a) as being unpatentable
over the combination of Kuhr, Cohen and Uchigaki.4
IV. Claims 10 and 12 under 35 U.S.C. § 103(a) as being unpatentable
over the combination of Kuhr, Fritz and Uchigaki.
I.
Issue
The Examiner has rejected claims 1-9 under 35 U.S.C. § 103(a) as
being unpatentable over the combination of Kuhr and Cohen. The Examiner
finds that Kuhr does “not expressly disclose that the first opening of the
chamber of the test element is configured to be generally sealed by the
protective cap prior to and during displacement of the lancet needle.” (Final
Office Action, 3.) The Examiner finds that “Cohen teaches a lancet needle
(needle 14 Figures 1-3 and 5-7) configured to engage a protective cap (plug
30) after displacement of the lancet needle in the at least one direction
(needle 14 engages plug 30 after the needle moves in the distal direction,
Figures 1-3 and 5-7) and thereafter to pull the protective cap during

1 Kuhr et al, US 2003/0050573 A1, published Mar. 13, 2003.
2 Cohen et al, US 5,125,908, issued Jun. 30, 1992.
3 Fritz et al, US 2004/0034318 A1, published Feb. 19, 2004.
4 Uchigaki et al., US 6,830,551 B1, issued Dec. 14, 2004.
Appeal 2012-002185
Application 12/105,304

4
displacement of the lancet needle in a retracting direction (Figures 2-3 and
6-7).” (Id., 4.)
The Examiner finds that “[i]t would have been obvious to one having
ordinary skill in the art at the time the invention was made to combine the
pulling of the protective cap in a retracting direction as taught by Cohen with
the invention of Kuhr et al. to provide an obvious sign to a user that the
device has been used when they can no longer see the protective cap.”
(Final Office Action, 4; see also Ans. 11.)
Appellants contend that “there is no disclosure, nor is there any
suggestion in the combination of Kuhr and Cohen of claim 1’s specifically
recited ‘test element comprising a chamber […] having a first opening
configured to be generally sealed by the protective cap prior to and during
displacement of the lancet needle in the at least one direction and configured
thereafter to be generally opened upon displacement of the lancet needle in
the retracting direction.’” (App. Br. 23.)
The issue presented is: Does the evidence of record support the
Examiner’s conclusion that the cited prior art renders claim 1 obvious?
Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
FF1. Kuhr discloses “an analytical device containing a lancet
comprising a lancet needle and a lancet body, the lancet needle being
movable relative to the lancet body and the lancet body being composed, at
least in the area of the tip of the lancet needle, of an elastic material in which
App
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ip of the la
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FF2. Fi
e embodi
t needle (
11].) FIG
ic part (5)
t needle ti
ains a test
4D shows
ns (7, 7A
02185
/105,304
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nently con
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ment of FI
3) which i
. 4A show
and an ela
p.” (Id.)
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that “the
and 7B).”
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stic mater
In “FIGS.
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(Id., 7, ¶
5
ded, and a
the lancet
roduced b
mposed of
surrounde
et body (4
ial (6) whi
4B and 4C
to the lan
ap (7) can
[0110].) “
n analytic
body.” (K
elow.
a lancet (
d by a lanc
) … comp
ch in parti
, a test el
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be divide
FIG. 4E s
al test elem
uhr, Abst
2) which c
et body (4
osed of a
cular surro
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4).” (Id., 7
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).” (Id., 7
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, ¶[0112].
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,
)
f
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Application 12/105,304

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the outlet opening of the lancet of the analytical device (1).” (Id., 7,
¶[0114].) “FIG. 4F shows … that four capillary channels (7)[,] which
enable sample transport to the test element (9)[,] are present in the elastic
material (6) of the lancet body (4).” (Id., 7, ¶[0115].)
FF3. Kuhr discloses that
[t]he outlet opening of the lancet needle (3) is closed by a sealing foil
(11) in this embodiment. When the lancet is used the sealing foil (11)
can either be pierced by the lancet needle (3) or the sealing foil (11) is
removed manually before use.
(Id., 7, ¶[0113].)
FF4. Kuhr discloses that the “capillary gap (7) is worked into the
hard plastic part (5) of the lancet body (4) and is used to transport the sample
liquid.” (Id., 6, ¶[0096]; see also, Kuhr at Figure 1-3, element (7).)
FF5. Cohen discloses a “syringe that includes a protective holder to
prevent injury to the syringe user.” (Cohen, col. 1, ll. 9-10.)
FF6. Figures 1 and 3 of Cohen are reproduced below:
App
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64-6
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Figure 1
nt inventi
6.) Figure
cted into t
FF7. C
The
cylindric
aperture
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/105,304
is “a side
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view in pa
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rtial sectio
ge as stor
to FIG. 1
er use.” (I
lows:
d for slid
6. The sy
of the ne
n of one e
ed prior to
… showin
d., col. 2,
able move
ringe hol
edle 14 du
mbodimen
use.” (Id.
g the syri
ll. 1-2.)
ment insi
der 26 ha
ring use o

t of the
, col. 1, ll.
nge
de a
s an
f the

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Application 12/105,304

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syringe. A rubber plug 30 occludes the point of the needle,
further reducing the chance of accidental injury prior to use of
the syringe. Additionally, the plug 30 covers the aperture 28
and protects the needle 14 prior to use of the syringe.
…
The plug 30 continues to slide up the needle 14 until the
plunger is fully compressed, ultimately coming to rest against
the needle hub 12. Thus, displacement of the plug 30 to expose
the needle 14 requires no additional effort by the syringe user.
(Id., col. 2, ll. 33-38 and 50-54.)
Principles of Law
When determining whether a claim is obvious, an examiner must
make “a searching comparison of the claimed invention - - including all its
limitations - - with the teaching of the prior art.” In re Ochiai, 71 F.3d
1565, 1572 (Fed. Cir. 1995) (emphasis added). Thus, “obviousness requires
a suggestion of all limitations in a claim.” CFMT, Int’l. v. Yieldup Int’l
Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) (citing In re Royka, 490 F.2d
981, 985 (CCPA 1974)). Moreover, as the Supreme Court recently stated,
“there must be some articulated reasoning with some rational underpinning
to support the legal conclusion of obviousness.” KSR Int’l v. Teleflex Inc.,
127 S. Ct. 1727, 1741 (2007) (quoting In re Kahn, 441 F.3d 977, 988 (Fed.
Cir. 2006)).
Analysis
We agree with Appellants that the evidence of record does not support
the Examiner’s finding that the combination of Kuhr and Cohen would
achieve a device comprising a test chamber, where the chamber has an
opening that becomes “generally opened upon displacement of the lancet
needle in the retracting direction” as required by claim 1. (App. Br. 23.)
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9
The “protective cap” of Kuhr is described as protecting the “outlet opening
of the lancet needle”. (FF3.) The capillary channels (7) are not described by
Kuhr to be part of this outlet opening of the lancet needle protected with a
type of cap, but rather are described as being separately embedded into the
lancet body. (See e.g., FF2 and FF4.) Thus, modifying the “protective cap”
of Kuhr with the “protective cap” of Cohen (FF5-FF7) does not necessarily
achieve an arrangement where the capillary channels of Kuhr are protected.
See Continental Can Co. v. Monsanto Co., 948 F.2d 1264, 1269 (Fed. Cir.
1991) (“Inherency, however, may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from a given set of
circumstances is not sufficient.”). See also, In re Freed, 425 F.2d 785, 787
(CCPA 1970) (Deficiencies in the factual basis cannot be supplied by
resorting to speculation or unsupported generalizations.).
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that the combination of Kuhr and Cohen teaches or suggests all elements of
claim 1 or dependent claims thereto.
II.
Issue
The Examiner finds that Kuhr does “not expressly disclose that the
first opening of the chamber of the test element is configured to be generally
sealed by the protective cap prior to and during displacement of the lancet
needle in the at least one direction and configured thereafter to be generally
opened upon displacement of the lancet needle in the retracting direction,
and that lancet needle is configured to engage a protective cap after
Appeal 2012-002185
Application 12/105,304

10
displacement of the lancet needle in the at least one direction and thereafter
to pull the protective cap during displacement of the lancet needle in a
retracting direction.” (Ans. 7.) The Examiner relies on Fritz for this
element. Specifically, the Examiner finds that Fritz discloses “a lancet
needle (needle 31' Figures 9A-9C) configured to engage a protective cap
(material 35) after displacement of the lancet needle in the at least one
direction (needle 31' engages material 35 after the needle moves in the distal
direction, Figures 9A-9C) and thereafter to pull the protective cap during
displacement of the lancet needle in a retracting direction (Figures 9A-9C).”
(Id. at 7.)
In reaching a conclusion of obviousness, the Examiner finds that
Kuhr et al. as modified by Fritz et al. would have the first
opening of the chamber of the test element configured to be
generally sealed by the protective cap prior to and during
displacement of the lancet needle in the at least one direction
(Fritz et al. Figures 9A and 98) and configured thereafter to be
generally opened upon displacement of the lancet needle in the
retracting direction (Fritz et al. Figure 9C). In other words, as
combined, the protective cap/material of Fritz et al. would be at
the distal end of Kuhr et al. (see, for example, Figure 4D of
Kuhr et al.), and in this position would seal both the lancet and
the capillary channels of Kuhr et al.
(Ans. 8.) (Emphasis added.)
Appellants contend that the combination of Kuhr and Fritz fails to
disclose a test element comprising a chamber “having a first opening
configured to be generally sealed by the protective cap prior to and during
displacement of the lancet needle in the at least one direction and configured
thereafter to be generally opened upon displacement of the lancet needle in
the retracting direction” as required by claim 1. (App. Br. 29.)
App
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/105,304
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terile
¶ [0035].)

Appeal 2012-002185
Application 12/105,304

12
FF9. With regard to Figures 9A, 9B and 9C, Fritz discloses as
follows:
FIG. 9 also shows that the needle tip is arranged in a
material 35. This material 35 is preferably an elastomer which
tightly encloses the needle tip to effectively prevent
contamination of the needle tip. … The material 35 used to
prevent contamination of the needle tip …. In the initial
position shown in FIG. 9A, before lancing the needle tip is
located in the elastomer 35 which is pierced by the needle tip
when a puncture is carried out as shown in FIG. 9B. For this
purpose, the underside of the sleeve 40' has a plate 36 with a
central opening 37. The plate 36 prevents the elastomer 35 from
emerging through the opening 37 so that the elastomer 35 is
pierced when the needle 31' passes through the central opening
37. When the lancet 30' is retracted, the elastomer 35 remains
on the needle 31' and the needle tip is now exposed as shown in
FIG. 9C.
(Id. 6-7, ¶ [0059].)
Analysis
We agree with Appellants that the evidence of record does not support
the Examiner’s finding that the combination of Kuhr and Fritz would
achieve a device comprising a test chamber, where the chamber has an
opening that becomes “generally opened upon displacement of the lancet
needle in the retracting direction” as required by claim 1. (App. Br. 29.)
The “protective cap” of Kuhr is described as protecting the “outlet opening
of the lancet needle.” (FF3.) The capillary channels (7) are not described
by Kuhr to be part of this outlet opening of the lancet needle protected with a
type of cap, but rather are described as being separately embedded into the
lancet body. (See e.g., FF2 and FF4.) Thus, modifying the “protective cap”
of Kuhr with the “protective cap” of Fritz (FF8-FF9) does not necessarily
Appeal 2012-002185
Application 12/105,304

13
achieve an arrangement where the capillary channels of Kuhr are protected.
See Continental Can Co. v. Monsanto Co., 948 F.2d 1264, 1269 (Fed. Cir.
1991) (“Inherency, however, may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from a given set of
circumstances is not sufficient.”). See also, In re Freed, 425 F.2d 785, 787
(CCPA 1970) (Deficiencies in the factual basis cannot be supplied by
resorting to speculation or unsupported generalizations.).
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that the combination of Kuhr and Fritz fail to teach or suggest all elements
of claim 1 or dependent claims thereto.
III.
Claims 10 and 12 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over the combination of Kuhr, Cohen and Uchigaki. Having
reversed the rejection of claim 1 over the combination of Kuhr and Cohen,
we necessarily reverse this obviousness rejection further relying upon
Uchigaki because Uchigaki does not cure the deficiencies of Kuhr and
Cohen discussed above.
IV.
Claims 10 and 12 are also rejected under 35 U.S.C. § 103(a) as being
unpatentable over the combination of Kuhr, Fritz and Uchigaki. Having
reversed the rejection of claim 1 over the combination of Kuhr and Fritz, we
necessarily reverse this obviousness rejection further relying upon Uchigaki
because Uchigaki does not cure the deficiencies of Kuhr and Fritz discussed
above.
Appeal 2012-002185
Application 12/105,304

14

SUMMARY
We reverse the rejection of claims 1-9 under 35 U.S.C. § 103(a) as
being unpatentable over the combination of Kuhr and Cohen.
We reverse the rejection of claims 1-9 under 35 U.S.C. § 103(a) as
being unpatentable over the combination of Kuhr and Fritz.
We reverse the rejection of claims 10 and 12 under 35 U.S.C. § 103(a)
as being unpatentable over the combination of Kuhr, Cohen and Uchigaki.
We reverse the rejection of claims 10 and 12 under 35 U.S.C. § 103(a)
as being unpatentable over the combination of Kuhr, Fritz and Uchigaki.

REVERSED

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