Ex Parte Patel et al

Board of Patent Appeals and Interferences

Aug 28, 2012

11466202 (B.P.A.I. Aug. 28, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PAUL PATEL and DANIEL WONG
__________

Appeal 2011-009203
Application 11/466,202
Technology Center 3700
__________

Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
ERICA A. FRANKLIN, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
device and method for expressing body fluid, e.g., blood, from an incision in
the skin. The Patent Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.

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STATEMENT OF THE CASE
The invention concerns an expression device for expressing body
fluid from an incision, for use in, for example, performing home diagnostics.
(Spec. 1, ll. 5-13.)
Claims 1, 3-8, 15, and 17-18 are on appeal. Independent claims 1, 8,
and 17 are representative and read as follows:
1. An expression device, comprising:
an expression cap defining a lancet opening;
the expression cap having a skin contacting surface that is generally
flat and positioned to face tissue during expression of body fluid;
the expression cap including an elastomeric ring extending around the
lancet opening from the skin contacting surface, wherein the elastomeric
ring includes elastomeric material, the elastomeric ring having a toroidal
shape with a circular cross-section;
the expression cap having a beveled surface between the lancet
opening and the elastomeric ring to enhance expression of the body fluid
when the expression cap is pressed around an incision site; and
wherein the beveled surface extends at a 20° to 30° angle relative to
the skin contacting surface.

8. A method, comprising:
forming an incision in skin;
expressing body fluid from the incision by pressing around the
incision in the skin an expression cap that includes an elastomeric ring made
from elastomeric material and a beveled surface located inside the
elastomeric ring;
wherein the expression cap has a generally flat skin contacting surface
that extends parallel to the skin when pressed against the skin;
wherein the beveled surface extends at a 20° angle relative to the skin
contacting surface;
wherein said expressing includes pressing the beveled surface against
the skin;
pushing the expression cap against the skin before said forming the
incision;
wherein said expressing includes pressing the expression cap against
the skin for at least 4 seconds;
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wherein said forming the incision includes lancing the skin to a depth
of 1.8 mm; and
wherein said expressing includes pressing the expression cap against
the skin until at least 0.1 μL of the body fluid is on the surface of the skin.

17. An expression device, comprising:
an expression cap defining a lancet opening, the expression cap including
a skin contacting surface that is generally flat and positioned to face
tissue during expression of body fluid,
an elastomeric ring extending around the lancet opening from the skin
contacting surface, the elastomeric ring being composed of elastomeric
material, the elastomeric ring having a toroidal shape with a circular cross-
section; and
a beveled surface between the lancet opening and the elastomeric ring
to enhance expression of the body fluid when the expression cap is pressed
around an incision site,
the beveled surface extending at a 20° angle relative to the skin
contacting surface.

The Examiner rejected the claims as follows:
• claims 1, 3-6, and 17 under 35 U.S.C. § 103(a) as unpatentable over
Schmelzeisen-Redeker;1
• claims 8 and 15 under 35 U.S.C. § 103(a) as unpatentable over
Schmelzeisen-Redeker; and
• claims 7 and 18 under 35 U.S.C. § 103(a) as unpatentable over
Schmelzeisen-Redeker and Moerman.2

1 Patent Application Publication No. US 2004/0030353 A1 by
Guenther Schmelzeisen-Redeker et al., published Feb. 12, 2004.
2 Patent No. US 6,706,049 B2, issued to Piet Moerman, Mar. 16, 2004.

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OBVIOUSNESS
I. Claims 1, 3-6, and 17
The Examiner’s position is that Schmelzeisen-Redeker disclosed an
expression device comprising an expression cap including an elastomeric
ring (10a/10b) in the shape of an “O” extending around the lancet opening
from the skin contacting surface, wherein the ring has a toroidal shape with a
circular cross-section (the toroidal compression unit 10a has a circular cross-
section along a plane parallel to the contacting surface 20). (Ans. 4.) The
Examiner also found that Schmelzeisen-Redeker disclosed that the
expression cap has a beveled surface between the lancet opening and the
elastomeric ring (Fig. 1B showing a beveled surface between 10a and 20).
(Id .)
However, the Examiner found that Schmelzeisen-Redeker did not
disclose (a) the expression cap having a beveled surface extending at a 20°
to 30° angle relative to the skin contacting surface; (b) the elastomeric ring
having an outer diameter of 10 mm; (c) the elastomeric ring having an inner
diameter of 7 mm; (d) the elastomeric ring having a height of 1.5 mm
relative to the skin contacting surface; and (e) the lancet opening having an
internal diameter of 6 mm. (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 have modified the prior art device to include these
specifications because doing so would have amounted to discovering the
optimum or workable ranges of disclosed general conditions, and would
have involved only routine skill in the art. (Id. at 5.)
Appellants contend that Schmelzeisen-Redeker “fails to disclose or
even suggest ‘the elastomeric ring having a toroidal shape with a circular
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cross-section’ as recited in claim 1.” (App. Br. 11.) According to
Appellants, in Schmelzeisen-Redeker the upper pressure-application region
10a and the lower region 10b are generally tapered and flat. (Id. at 11-12.)
Appellants also assert that it would not have been obvious to create
the beveled surface of the expression cap such that the beveled surface
extends 20° to 30° angle relative to the skin contacting surface by
discovering the optimum or workable ranges because “Schmelzeisen-
Redeker gave no indication that the angle of the beveled surface was a
critical parameter and no direction as to which of the many possible choices
is likely to be successful.” (Id. at 14.)
After considering all the evidence and arguments, we conclude that
the record supports a conclusion of prima facie obviousness. In particular,
we agree with the Examiner (Ans. 4, 7) that Schmelzeisen-Redeker
disclosed an elastomeric ring in the shape of an “O” extending around a
lancet opening from skin contacting surface, wherein the elastomeric ring
has a toroidal shape, i.e., it is an “O-ring” (see Spec. 7, ll. 13-14) and has a
circular cross-section along a place parallel to the contacting surface 20 (see
Schmelzeisen-Redeker Figs. 1A-B). Additionally, we agree with the
Examiner that a skilled artisan would have found it obvious to modify the
surface of Schmelzeisen-Redeker’s expression cap such that the beveled
surface extends 20° to 30° angle relative to the skin contacting surface by
discovering the optimum or workable ranges because the reference disclosed
the general feature of a beveled surface and a skilled artisan would have
understood that this feature contributed to increasing the internal pressure in
a region of the body part that is pressed against the surface which in turn
contributed to a sufficient amount of body fluid being expressed. (See
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Schmelzeisen-Redeker Abstract, Figs. 1A and B, [0010]-[0016], and
[0044].)
Appellants further assert that they “discovered unexpectedly that the
expression 32 cap with countersink angle 66 within the recited range was
able to produce over twice as much blood as compared to the control and o-
ring expression ring types.” (Id. at 14.) However, the evidence upon which
Appellants rely for this assertion relates to a comparison of the amount of
blood expression among (a) a control type expression member that was
generally rigid and ring-shaped with a contact surface that was generally
flat, (b) an O-ring type expression ring that “did not have a beveled surface,”
and (c) a concave type expression ring having a countersink angle of 20°.
(Spec. 9, l.8 - 10, l. 25.) Thus, Appellants’ asserted evidence of unexpected
results has not been shown to be unexpected compared to the closest prior
art which disclosed an O-ring type expression ring having a beveled surface.
See In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991).
Further, regarding independent claim 1, Appellants’ evidence is not
commensurate in scope with the breadth of the claims which recite a range,
i.e., 20° to 30°, at which the angle of the beveled surface extends. See In re
Grasselli, 713 F.2d 731, 743 (Fed. Cir. 1983).
Accordingly, we affirm the rejection of independent claims 1 and 17.
Appellants have not raised separate arguments for claims 3-6, therefore these
claims fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
II. Claims 8 and 15
The Examiner found that Schmelzeisen-Redeker disclosed the
claimed method, except that the reference did not teach (a) the expression
cap having a beveled surface extending at a 20° to 30° angle relative to the
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skin contacting surface; (b) expressing includes pressing the expression cap
against the skin for at least 4 seconds; (c) forming the incision including
lancing the skin to a depth of 1.8 mm; and (d) expressing includes pressing
the expression cap against the skin until at least 0.1 μL of the body fluid is
on the surface of the skin. (Id. at 6.) However, 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 have modified the prior art method to include
these steps because doing so would have amounted to discovering the
optimum or workable ranges of disclosed general conditions, and would
have involved only routine skill in the art. (Id.)
Appellants contend that these missing parameters would not have
been obvious because Schmelzeisen-Redeker “never identified, let alone
even recognized, any of these parameters.” (App. Br. 16.) According to
Appellants, “nothing in Schmelzeisen-Redeker … provides any suggestion
that these parameters are critical to anything, and thus, there would be no
reason to vary these parameters.” (Id.)
With respect to the beveled surface of the prior art, we agree with the
Examiner that optimizing this feature would have been obvious for the
reasons previously discussed. Further, we agree with the Examiner that an
artisan would also have found it obvious to optimize the recited parameters
in the claimed steps of pressing the expression cap against the skin and
forming the incision including lancing the skin, as a skilled artisan would
have recognized that the recited parameters relating to these steps disclosed
in the prior art were result effective variables. See In re Jacoby, 309 F.2d
513, 516 (CCPA 1962)( The question of obviousness cannot be approached
on the basis that an artisan having ordinary skill would have known only
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what was read in the references, because such artisan must be presumed to
know something about the art apart from what the references disclose.).
Further, Appellants assert the same evidence of unexpected results
discussed regarding the rejection of claims 1, 3-6 and 17. (Id. at 17-18.) For
the reasons previously discussed, this evidence is insufficient to overcome
prima facie obviousness.
Accordingly, we affirm the rejection of claims 8 and 15.
III. Claims 7 and 18
The Examiner found that Schmelzeisen-Redeker disclosed the
invention essentially as claimed, except that it did not disclose an over mold
layer covering the elastomeric ring. (Ans. 5.) However, the Examiner found
that Moerman disclosed an anti-slip over mold layer covering an elastomeric
ring. (Id.) According to the Examiner, it would have been obvious to a
person of ordinary skill in the art at the time of the invention to have
disposed Moerman’s anti-slip layer over Schmelzeisen-Redeker’s
elastomeric ring to provide more friction to prevent movement during blood
expression, as taught by Moerman. (Id.)
Appellants have not raised a separate argument for claims 7 and 18,
which both depend from independent claim 1. (App. Br. 11)(Claims 7 and
18 grouped with claims 1 and 3-6). Accordingly, we affirm the rejection of
dependent claims 7 and 18 for the same reasons discussed regarding the
rejection of independent claim 1.

SUMMARY
We affirm the Examiner’s rejections.

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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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