Ex Parte Dosmann

Board of Patent Appeals and Interferences

Mar 23, 2009

10367690 (B.P.A.I. Mar. 23, 2009)

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.
10/367,690 02/19/2003 Andrew J. Dosmann MSE #2651 1935
71331 7590 03/23/2009
NIXON PEABODY LLP
161 N. CLARK STREET
48TH FLOOR
CHICAGO, IL 60601
EXAMINER
HOEKSTRA, JEFFREY GERBEN
ART UNIT PAPER NUMBER
3736
MAIL DATE DELIVERY MODE
03/23/2009 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 ANDREW J. DOSMANN

Appeal 2009-0561
Application 10/367,690
Technology Center 3700
__________

Decided:1 March 23, 2009
__________

Before TONI R. SCHEINER, DONALD E. ADAMS, and
LORA M. GREEN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s final rejection of claims 1-10, 12-17, and 25-27. We have
jurisdiction under 35 U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).
Appeal 2009-0561
Application 10/367,690

STATEMENT OF THE CASE
The claims are directed to a lance for harvesting a sample. Claims 1
and 10 are the independent claims on appeal, and read as follows:
1. A lance adapted to harvest a sample for an optical format, the lance
comprising:
a lance body, said lance body defined by a multisided tube wherein
each side is planar and of a material that allows transmission of light, said
multisided tube including a first end, said first end having a sharp point
adapted to pierce skin and harvest said sample.

10. An optical format with an integrated lance, comprising:
a housing, said housing having a first side and a second side, openings
in said first side and said second side for passage of light through said
housing, and
a lance defined by at least one flat surface, the lance being adapted to
harvest a sample and being mounted in said housing, said lance formed of
translucent material, said lance having a sharp end that is adapted to pierce
skin and harvest said sample.

The Examiner relies on the following evidence:
Meserol 5,029,583 Jul. 9, 1991
Gubinski 5,278,079 Jan. 11, 1994
Smart 5,801,057 Sep. 1, 1998
Comley 6,652,809 B1 Nov. 25, 2003
Raskas 6,922,576 Jul. 26, 2005

The Examiner makes the following grounds of rejection:
I. Claims 1-3, 7, and 9 stand rejected under 35 U.S.C. § 102(b) as being
anticipated by Gubinski.
II. Claim 4 stand rejected under 35 U.S.C. § 103(a) as being rendered
obvious by the combination of Gubinski and Raskas.
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III. Claims 5 and 6 stand rejected under 35 U.S.C. § 103(a) as being
obvious over the combination of Gubinski and Meserol.
IV. Claim 8 stands rejected under 35 U.S.C. § 103(a) as being obvious
over the combination of Gubinski and Comley.
V. Claims 10, 13, and 15-17 stand rejected under 35 U.S.C. § 103(a) as
being obvious over the combination of Smart and Gubinski.
VI. Claim 12 stands rejected under 35 U.S.C. § 103(a) as being obvious
over the combination of Smart and Gubinski as further combined with
Meserol.
VII. Claim 14 stands rejected under 35 U.S.C. § 103(a) as being obvious
over the combination of Smart and Gubinski as further combined with
Comley.
VIII. Claim 25 stands rejected under 35 U.S.C. § 103(a) as being obvious
over the combination of Gubinski and Meserol.
IX. Claim 26 stands rejected under 35 U.S.C. § 103(a) as being obvious
over the combination of Smart and Gubinski, as further combined with
Meserol.
X. Claim 27 stands rejected under 35 U.S.C. § 103(a) as being obvious
over the combination of Smart and Gubinski, as further combined with
Raskas.

We reverse all of the rejections of record.

Appeal 2009-0561
Application 10/367,690

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ISSUE
The Examiner finds that Gubinski anticipates claim 1, and renders
obvious claim 10.
Appellants assert that Gubinski, either alone, or in combination with
the other cited prior art, does not teach or suggest a lance defined by a
multisided tube or by at least one flat surface.
Thus, the issue on appeal is: Does Gubinski anticipate, or render
obvious either alone or as combined with the other cited prior art, a lance
defined by a multisided tube or by at least one flat surface?

PRINCIPLES OF LAW
To anticipate, every element and limitation of the claimed invention
must be found in a single prior art reference, arranged as in the claim.
Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383, 58
USPQ2d 1286, 1291 (Fed. Cir. 2001).
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) the level of ordinary skill in the art; (3) the differences between the
claimed invention and the prior art; and (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
“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, ___, 127 S. Ct. 1727, 1739
(2007).
If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability. For the same
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reason, 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 ___, 127 S. Ct. at 1740. It is proper to “take account of the inferences
and creative steps that a person of ordinary skill in the art would employ.”
Id. at ___, 127 S. Ct. at 1741. See also id. at ___, 127 S. Ct. at 1742 (“A
person of ordinary skill is also a person of ordinary creativity, not an
automaton.”). “In determining whether obviousness is established by
combining the teachings of the prior art, the test is what the combined
teachings of the references would have suggested to those of ordinary skill
in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal
quotations omitted).
While the analysis under 35 U.S.C. § 103 allows flexibility in
determining whether a claimed invention would have been obvious, KSR,
550 U.S. at ___, 127 S.Ct. at 1741, it still requires showing that “there was
an apparent reason to combine the known elements in the fashion claimed by
the patent at issue.” Id. “We must still be careful not to allow hindsight
reconstruction of references to reach the claimed invention without any
explanation as to how or why the references would be combined to produce
the claimed invention.” Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363,
1374 n.3 (Fed. Cir. 2008).

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FINDINGS OF FACT
FF1 According to the Specification, the “present invention relates to
minimum invasive techniques to determine compositions of body fluids,”
and more particularly, “an optical format with a square fused silica lance for
piercing skin of a user to harvest blood for testing.” (Spec. 1.)
FF2 Figure 1 of the instant disclosure is reproduced below:

Figure 1 is “a perspective view of a minimum invasive optical format with
an integrated lance.” (Id. at 2.)
FF3 According to the Specification:
To minimize pain when skin is pierced by the sharp point
16 of the lance 12, it is preferred that the outside dimension of
the lance 12 be small. By using a square fused silica tube for
the lance 12, the outside dimension of the lance 12 is 300 μm
which is smaller than a similar dimension of a typical 28 gauge
steel lance which has a diameter of 360 μm.

(Id. at 4.)
FF4 The Examiner rejects claims 1-3, 7, and 9 under 35 U.S.C. § 102(b) as
being anticipated by Gubinski (Ans. 3).
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FF5 The Examiner relies on Figure 5 of Gubinski, reproduced below.

Figure 5 is an end view of the capillary device of Gubinski (Gubinski, col. 4,
ll. 38-40).
FF6 The Examiner finds that Gubinski teaches a lance body, “wherein said
tube comprises a first end (the right tip as best seen Figure 5) having a sharp
point (the sharp edges of the right tip as best seen in Figure 5) that is capable
of piercing skin and harvesting blood.” (Ans. 4.)
FF7 Gubinski teaches
a sealable chamber device comprising a hollow chamber having
a sample intake port at a first end and a exhaust port at a second
end, said hollow chamber having a first chamber portion
extending from said intake port and terminating in a reduced
chamber portion having a cross-sectional area less than said
first chamber portion proximal said exhaust port and a
sufficient amount of expandable polymer in said reduced
chamber portion which forms a seal in said reduced chamber
portion upon contact of the polymer with an aqueous medium.

(Gubinski, col. 2, ll. 36-45.)
FF8 Figure 5 of Gubinski shows air exhaust port 18 of the capillary,
wherein a water-expandable polymer 32 is placed in the restricted or second
chamber portion, providing means of sealing the capillary (id. at col. 4, l. 59-
col. 5, l. 9).

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ANALYSIS
Appellant argues that “Gubinski is not a lance and does not have a
sharp end that is adapted to pierce the skin and harvest a sample.” (App. Br.
7.) According to Appellant, “[t]here is no disclosure, teaching, or suggestion
about a lance body having a first end that has ‘a sharp point adapted to
pierce skin and harvest said sample’ as recited in independent claim 1.” (Id.)
Appellant argues further that the lance of Gubinski is not capable of
performing the use of the present invention, and that “[t]he intended use of
the subject matter of claim 1—harvesting a sample by piercing the skin—
results in a structural difference between the subject matter of claim 1 and
Gubinski because the capillary of Gubinski does not include ‘a sharp point
adapted to pierce skin and harvest said sample’ (emphasis added).” (Id. at
8).
We find that Appellant has the better position. As can be seen in
Figure 5 (FF5), the end of the capillary of Gubinski that serves as the
exhaust port of Gubinski, while having a reduced area (FF8), has a flat
rectangular shape. The Examiner points to one of the corners as reading on
“a sharp point adapted to pierce skin and harvest said sample” (FF6), but we
find that while such a corner may be able to accidentally pierce the skin, it is
not a sharp point that the ordinary artisan would understand as one that is
“adapted to pierce skin and harvest said sample” (see, e.g., FF1, FF2).
Moreover, it is clear that Gubinski did not intend as it to be used as a sharp
point to harvest a sample, as the end of the capillary that the Examiner is
relying on to anticipate claim 1 is in fact the exhaust port of the capillary
device of Gubinski (FF8), sample in fact enters the sample intake port at the
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other end, and when it reaches the exhaust port at the end shown in Figure 5,
the sample hydrates the water expandable polymer to seal the device (FF7,
FF8).
We thus find that the Examiner has failed to set forth a prima facie
case of anticipation, and we are thus compelled to reverse the rejection.

FINDINGS OF FACT
FF9 The Examiner rejects claim 4 under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Gubinski and Raskas (Ans. 4).
FF10 Gubinski is relied upon as for the anticipation rejection (id.).
FF11 The Examiner finds that “Raskas teaches a micro optical sensor
device configured to puncture skin (column 3 lines 22-25) via a sharp point .
. . of an optical transmission member with a diameter less than 300 microns
(column 5 lines 19-23).” (Id.)
FF12 The Examiner concludes that “[i]t would have been obvious to one
having ordinary skill in the art at the time the invention was made to modify
the tube as disclosed by Gubinski . . . with the sharp point as taught by
Raskas, for the purpose of harvesting and/or analyzing blood for analytical
sampling.” (Ans. 4-5.)

ANALYSIS
Appellant argues that Raskas does not correct the deficiencies of
Gubinski (App. Br. 8-9).
Again, we conclude that Appellant has the better position. While we
agree with the Examiner that it would have been obvious to modify the
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capillary tube as disclosed by Gubinski with a sharp point as taught by
Raskas, for the purpose of harvesting and/or analyzing blood for analytical
sampling, the ordinary artisan would have been motivated to add it at the
inlet port of the device of Gubinski, not the outlet port. Moreover, the
Examiner has not provided any reason or evidence as to why it would have
been obvious to take the circular sharp point of Raskas (see, e.g., Raskas,
Figure 6) and make it a multi-sided tube wherein each side is planar.
Thus, as the Examiner has failed to set forth a prima facie case of
obviousness, we are compelled to reverse the rejection.

FINDINGS OF FACT
FF13 The Examiner also rejects claims 5, 6 and 25 under 35 U.S.C.
§ 103(a) as being obvious over the combination of Gubinski and Meserol
(Ans. 5, 8).
FF14 As to claims 5 and 6, Meserol is cited by the Examiner for teaching a
housing mounted around a portion of the tube allowing the passage of light
(Ans. 5).
FF15 As to claim 25, Meserol is relied upon for disclosing a sharp point of a
lance or needle (id. at 8)
FF16 The Examiner concludes for claim 25:
It would have been an obvious matter of design choice to a
person of ordinary skill in the art to modify the sharp lancet
point as taught by Meserol [ ] with the cleaved range of 30 to
60 degrees, because Applicant has not disclosed that cleaved
point provides an advantage, is used for a particular purpose, or
solve a stated problem. One of ordinary skill in the art,
furthermore, would have expected Applicant’s invention to
perform equally well with the blood harvesting sharp lancet
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point as taught by Meserol [ ], because it provides a sharp
lancet point configured to harvest blood and since it appears to
be an arbitrary design consideration which fails to patentably
distinguish over Meserol.

(Id.)

ANALYSIS
Appellant argues that Meserol fails to remedy the deficiencies of
Gubinski.
We agree. As noted above, while we agree with the Examiner that it
would have been obvious to modify the capillary device as disclosed by
Gubinski with a sharp point as taught by Meserol, the ordinary artisan would
have been motivated to add it at the inlet port of the device of Gubinski, not
the outlet port. Moreover, again the Examiner has not provided any reason
or evidence as to why it would have been obvious to take the circular sharp
point of Meserol (see, e.g., Meserol, Figure 1) and make it a multi-sided tube
wherein each side is planar.

FINDINGS OF FACT
FF17 In addition, the Examiner rejects claim 8 under 35 U.S.C. § 103(a) as
being rendered obvious by the combination of Gubinski and Comley (Ans.
5).
FF18 The Examiner relies on Comley for teaching the use of fused silica
material in a blood receiving member (id.).

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ANALYSIS
Appellants argue that Comley fails to remedy the deficiencies of
Gubinski (App. Br. 9). We agree, and reverse the rejection.

FINDINGS OF FACT
FF19 The Examiner rejects claims 10, 13, and 15-17 under 35 U.S.C.
§ 103(a) as being rendered obvious by the combination of Smart and
Gubinski (Ans. 6).
FF20 Figures 1 and 2A of Smart are reproduced below.

Figure 1 is an overall view of the microsampling device of smart, and Figure
2A is a top view (Smart, col. 3, ll. 58-60).
FF21 The Examiner finds that smart teaches “a housing (12) having first
and second sides . . . and a translucent lance (11 and 16) comprised of glass
(column 4 lines 9-13) . . . having a sharp point (as best seen in Figures 1 and
2A) that is capable of piercing skin and harvesting blood.” (Ans. 6.)
FF22 The Examiner notes that Smart “discloses the claimed invention
except a lance defined by at least one flat surface.” (Id.)
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FF23 Citing Figure 5 of Gubinski, the Examiner finds that Gubinski
discloses a lance defined by at least one flat surface (id.).
FF24 The Examiner concludes that it “would have been obvious . . . to
modify the blood-receiving member as taught by Smart . . . with the blood-
receiving member as taught by Gubinski . . . for the purpose of increasing
the efficacy of an optical-based analytical device to diagnose by configuring
it to detect a change in an optical transmission characteristic.” (Id. at 6-7.)

ANALYSIS
Appellant argues Smart discloses a circular needle, and that “neither
smart nor Gubinski discloses ‘a lance defined by at least one flat surface,’ as
recited by claim 10.” (App. Br. 9-10.)
Again, we conclude that Appellant has the better position. Smart
indeed discloses a circular needle (FF20, FF22). The Examiner concludes
that Gubinski discloses a lance defined by at least one flat surface (FF23),
but as discussed above with respect to the anticipation rejection, Gubinski
does not disclose such a lance. The end of the capillary device of Gubinski
as shown in Figure 5 (FF5) is in fact an exhaust port, and sample enters the
sample intake port at the other end, and when it reaches the exhaust port at
the end shown in Figure 5, the sample hydrates the water expandable
polymer to seal the device (FF7, FF8). Thus, we cannot agree with the
Examiner that it would have been obvious to use the end of the capillary
device of Gubinski as shown in Figure 5 as the lance in the device of Smart
because the water expandable polymer contained in the end would swell,
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and thus not allow sample to reach the sampling chamber of the
microsampling device of Smart.

FINDINGS OF FACT
FF25 The Examiner rejects claims 12 and 26 under 35 U.S.C. § 103(a) as
being obvious over the combination of Smart and Gubinski as further
combined with Meserol (Ans. 7).
FF26 As to claim 12, the Examiner relies on Meserol for teaching for
teaching a housing mounted around a portion of the tube allowing the
passage of light (id.).
FF27 As to claim 26, Meserol is relied upon for disclosing a sharp point of a
lance or needle (id. at 9)
FF28 The Examiner further rejects claim 14 under 35 U.S.C. § 103(a) as
being obvious over the combination of Smart and Gubinski as further
combined with Comley (id. at 7).
FF29 The Examiner relies on Comley for teaching the use of fused silica
material in a blood receiving member (id. at 7-8).
FF30 Finally, the Examiner rejects claim 27 over the combination of Smart
and Gubinski, as further combined with Raskas (id. at 9).
FF31 The Examiner relies on Raskas to address the limitation that the
outside tube has a diameter of less than 300 microns (id.)

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ANALYSIS
Appellant argues that neither Meserol, Comley, or Raskas remedies
the deficiencies of the combination of Smart and Gubinski (App. Br. 10).
We agree, and are compelled to reverse the rejections.

CONCLUSION(S) OF LAW
For the reasons set forth above, we conclude that Gubinski does not
anticipate, or render obvious, either alone or as combined with the other
cited prior art, a lance defined by a multisided tube or by at least one flat
surface.
We are thus compelled to reverse all of the rejections on appeal.

REVERSED

LP

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48TH FLOOR
CHICAGO, IL 60601