Ex Parte Kuriger et al

Board of Patent Appeals and Interferences

Jul 20, 2012

10590531 (B.P.A.I. Jul. 20, 2012)

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.
10/590,531 08/24/2006 Rex J. Kuriger 247082-090USPX
(MSE-2685)
9794
71331 7590 07/23/2012
NIXON PEABODY LLP
300 S. Riverside Plaza, 16th Floor
CHICAGO, IL 60606-6613
EXAMINER
EISEMAN, ADAM JARED
ART UNIT PAPER NUMBER
3736
MAIL DATE DELIVERY MODE
07/23/2012 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 REX J. KURIGER and ANDREW J. DOSMANN
__________

Appeal 2011-004761
Application 10/590,531
Technology Center 3700
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF THE CASE
The following claims are representative and read as follows:
1. An apparatus for lancing the skin of a test subject, collecting a body fluid
sample from the lanced site on the skin of the test subject, the apparatus
comprising:
a body having an open end;
a hollow lancet having a tip adapted to puncture skin and to collect a
body fluid sample, the interior of the hollow lancet forming a channel for
moving a fluid sample from the tip to a reaction area;
a lancing mechanism disposed within the body, the lancing
mechanism coupled to the lancet at an end of the lancet opposite the tip, the
lancing mechanism being adapted to move the lancet between a retracted
position, a lancing position for puncturing the skin of a test subject, and a
collection position for collecting the body fluid sample;
an outer end cap having a first end coupled to the open end of the
body and a second end for contacting the skin of the test subject, the outer
end cap forming a first aperture therein that the tip of the lancet enters when
in the lancing position, the outer end cap having a wall extending to the
second end thereof; and
an inner end cap disposed within the outer end cap, the inner end cap
having a first end coupled to the open end of the body and a second end
forming a second aperture therein that the tip of the lancet enters when in the
lancing position, the second end being adapted to contact the skin of the test
subject when the lancet is in the collecting position, the inner end cap having
a wall extending to the second end thereof, the wall of the outer end cap
extending farther towards the skin than the wall of the inner end cap during
lancing such that the skin of the test subject is drawn inside of the outer end
cap and contacts the inner end cap,
wherein the second end of the outer end cap and the second end of the
inner end cap remain in contact with the skin in the lancing position to assist
in sample formation and collection.

12. A method for lancing the skin of a test subject and collecting a body
fluid sample from the lanced site on the skin of the test subject for
determining the concentration of an analyte in the body fluid sample with a
lancing and collection device, the lancing and collection device including a
hollow lancet having a tip for puncturing skin, the method comprising the
acts of:
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placing an outer end cap of the device against the skin of a test
subject;
puncturing the skin with the lancet in a lancing position;
positioning the punctured skin against an edge of an inner end cap of
the device, the inner end cap being disposed within the outer end cap;
disposing the tip of the lancet a predetermined distance from the skin
pulled against the edge of the inner end cap; and
collecting the body fluid sample from the puncture skin with the tip of
the lancet in a collection position,
wherein the outer end cap and the inner end cap remain in contact
with the skin in the lancing position to assist in sample formation and
collection.

Cited References

The Examiner relies on the following prior art references:

Douglas et al. US 5,951,492 Sep. 14, 1999
Dosmann US 2003/0171696 A1 Sep. 11, 2003
Roe et al. US 2004/0127818 A1 Jul. 1, 2004

Grounds of Rejection
 Claims 1-7 and 10-35 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Douglas in view of Dosmann and Roe.

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 3-
8. The following facts are highlighted.
1. Fig. 4 of the Specification is reproduced below.

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Fig. 4

Figure 4 shows apparatus outer end cap 30 and inner end cap 32,
skin S, which is drawn upward, and lancet 18 and blood B.
2. Figures, 1, 2 and 5 of Douglas are reproduced below.

Figure 1 of Douglas shows outer end cap 24. Figure 6 of Douglas
shows inner end cap 66.

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3. Roe, Figure 2 is reproduced below.

Roe, Figure 2 shows the “contact portion 84 of the reference member 82
extends through the expression opening 84 such that the skin contacting
surface 86 of the reference member 48 contacts and flattens the skin S
surrounding the lancet 50 as incision I is formed. (Roe, page 4, col. 2, para
[0068].

Discussion
ISSUE
The Examiner concludes that Douglas teaches an apparatus with each
element claim except,
Douglas does not disclose a hollow lancet for lancing and collecting
the fluid sample wherein the interior of the hollow lancet forms a
channel for moving the fluid sample from the tip to the reaction area;
that the lancing mechanism provides for a collecting position; or that
the outer and cap and the inner end cap remain in contact with the skin
in the lancing position to assist in sample formation and collection.
Dosmann teaches an optical format for lancing the skin for collecting
a body fluid sample from the lanced site comprising a hollow lancet
(element 10) having a tip adapted to puncture skin and collect body
fluid (paragraphs [0003]-[0004]; figures 1 and 2); the interior of the
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hollow lancet forming a channel (element 13) for moving a fluid
sample from the tip to a reaction area (paragraph [0014]). The body
fluid is drawn through the channel using capillary action or vacuum
assisted capillary action (paragraph [0014]). Furthermore this optical
format and integrated lance includes a viewing window to allow
optical analysis of the sample by transmission spectrometry by
passing a beam of light through the lance viewing windows to a
detector (paragraphs [0004] and [0014]). The lancet provides for
significantly less pain, high probability of blood harvesting and
improved overall test time by integrating the lance, harvest and
analysis operations (abstract).
Roe teaches a tip design comprising an outer end cap for contacting
the skin (element 46) and an inner end cap (element 82) disposed
within the outer end cap wherein the outer end cap and the inner end
cap remain in contact witht he [sic] skin in the lancing position in
order to assist in sample formation and collection (see figure 2, both
end caps are in contact with the skin during the lancing position).

(Ans. 4-5.)

The Examiner further argues that “Roe explicitly discloses in figures 2
and 3 showing that the outer sleeve still produces a droplet of body fluid by
creating a bulge in the skin using the outer sleeve (see figure 3) while using
the inner sleeve to contact the skin during lancing (figure 2).” (Ans. 10.)
Appellants argue that the rejection of the pending claims is improper
for the following reasons:
(1) Douglas states “that the inner sleeve 66 is in contact with the skin only
when the lacing is complete and the outer sleeve 24 is retracted.” (App.
Br. 10.)
(2) “Douglas teaches that the stimulator sleeve 24 (designated by the
Examiner as the “outer end cap”) depresses a ring of body tissue in
surrounding relationship to the incision, causing the incision to bulge while
spreading apart the sides of the incision, as seen in FIG. l. See Douglas, Col.
5, Ln. 51-54. The purported advantage to this design is that a drop of body
fluid is formed at the open end of the incision even if the incision is made in
a region of the body where the supply of body fluid is relatively low as
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compared to, for example, the fingertip region. See, id., Ln. 54-58.
Modifying Douglas such that the sleeves 24, 66 both remain in contact with
the skin during the lancing position, as proposed by the Examiner, would
eliminate this feature - i.e., the inner sleeve 66 would press down on the
patient's skin and eliminate the bulge of body tissue.” (App. Br. 11-12.)

The issues are: Does the cited prior art teach both that (1) “the wall
of the outer end cap extending farther towards the skin than the wall of the
inner end cap during lancing such that the skin of the test subject is drawn
inside of the outer end cap and contacts the inner end cap” and (2) that “the
second end of the outer end cap and the second end of the inner end
cap remain in contact with the skin in the lancing position to assist in sample
formation and collection,” as claimed.

PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007)
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ANALYSIS
Claim 1
We do not find that the Examiner has provided sufficient evidence to
support a prima facie case of obviousness. Claim 1 requires that (1) “the
wall of the outer end cap extending farther towards the skin than the wall of
the inner end cap during lancing such that the skin of the test subject is
drawn inside of the outer end cap and contacts the inner end cap” and (2)
that “the second end of the outer end cap and the second end of the inner end
cap remain in contact with the skin in the lancing position to assist in sample
formation and collection.”
As to the second limitation recited above for claim 1, Appellants
argue that Douglas states “that the inner sleeve 66 is in contact with the skin
only when the lancing is complete and the outer sleeve 24 is retracted.”
(App. Br. 10.) Thus, Appellants argue that Douglas does not teach “the
second end of the outer end cap and the second end of the inner end cap
remain in contact with the skin in the lancing position to assist in sample
formation and collection.” We agree.
The Examiner relies on Roe to make up for this deficiency of
Douglas. However, Roe, Figure 2 shows “the skin contacting surface 86 of
the reference member 48 contacts and flattens the skin S surrounding the
lancet 50 as incision I is formed.” (Roe, page 4, col. 2, para
[0068])(emphasis added). The flattening of the skin in Roe, does not meet
the claim requirement that “the wall of the outer end cap extending farther
towards the skin than the wall of the inner end cap during lancing such that
the skin of the test subject is drawn inside of the outer end cap and
contacts the inner end cap.” (Claim 1).
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Thus, the cited prior art does not teach or suggest both that (1) “the
wall of the outer end cap extending farther towards the skin than the wall of
the inner end cap during lancing such that the skin of the test subject is
drawn inside of the outer end cap and contacts the inner end cap” and (2)
that “the second end of the outer end cap and the second end of the inner end
cap remain in contact with the skin in the lancing position to assist in sample
formation and collection” as in claim 1. The rejection of claim 1 is reversed.

Claim 12
Claim 12 differs from claim 1 in that it only requires that “the outer
end cap and the inner end cap remain in contact with the skin in the lancing
position to assist in sample formation and collection.”
For the reasons stated by the Examiner in the Answer, we agree with
the Examiner that modifying the sampling device of Douglas with elements
of the lancing devices of Dosmann and Roe would arrive at this claimed
feature. Roe’s, Figure 2 shows outer endcap 46 and the inner end cap 82
remain in contact with the skin in the lancing position to assist in sample
formation and collection.
The rejection of claim 12, and its dependent claims 13-34, is affirmed.

CONCLUSION OF LAW
The obviousness rejection of claim 1-7, 10-11 and 35 is reversed. The
obviousness rejection of claim 12, and its dependent claims 13-34, is
affirmed.

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Application 10/590,531

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TIME PERIOD
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-IN-PART
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