Ex Parte Sarstedt

Board of Patent Appeals and Interferences

Sep 18, 2009

10499747 (B.P.A.I. Sep. 18, 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.
10/499,747 08/12/2004 Walter Sarstedt 22980 3758
535 7590 09/21/2009
K.F. ROSS P.C.
5683 RIVERDALE AVENUE
SUITE 203 BOX 900
BRONX, NY 10471-0900
EXAMINER
PANI, JOHN
ART UNIT PAPER NUMBER
3736
MAIL DATE DELIVERY MODE
09/21/2009 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 WALTER SARSTEDT
__________

Appeal 2009-006917
Application 10/499,747
Technology Center 3700
__________

Decided: September 21, 2009
__________

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

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 7, 9, and 10-12, directed to a blood collection device. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
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Application 10/499,747

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STATEMENT OF THE CASE
The invention relates to a device for drawing body fluids,
having a specimen tube having at an outer end a tip with a
pierceable plug for a guide sleeve fittable on the tip and
provided on its side turned toward the tip with a needle and
with an elastomeric needle-shield tube and on the side turned
away from the tip with a connection fitting or the opposite end
of a double needle.

. . . In every case there is the problem that the elastomeric
needle-shield tube that surrounds the needle and that is
collapsed like a bellows when the guide sleeve is fitted to or
installed on the tip exerts a substantial sprin[g] return force
acting against the forces that retain the guide sleeve on the tip,
with the result that the guide sleeve is pushed off the tip.

(Spec. 1: 3-17.)
According to the Specification, this problem can be solved by the
“appropriate selection of materials and dimensioning with respect to [the
relative] size and elasticity” of the guide sleeve and the tip (Spec. 4: 22-23).
Claims 7 and 10 are representative of the subject matter on appeal:
7. A blood-drawing device comprising:
a specimen tube extending along an axis;
an end cap fitted axially over an end of the tube and provided with an
axially outwardly projecting pierceable small-diameter tip having a wall
forming a cylindrical outer surface and of a predetermined stiffness;
a small-diameter rigid guide sleeve fittable axially inward over the tip
and axially against the cap and having an inner side carrying a needle
piercing axially inwardly through the tip into the tube on fitting of the sleeve
to the tip and an axially outer side provided with a connection fitting or an
outer end of the needle, the sleeve being substantially radially inelastic and
so dimensioned that when fitted over the tip the sleeve bears radially
inwardly on and radially inwardly elastically deforms the tip wall to radially
inwardly grip the tip with a predetermined holding force; and
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an elastomeric needle-shield tube carried on the guide sleeve,
surrounding the needle, and pierceable by the needle on fitting of the sleeve
to the tip and piercing of the needle through the tip, the shield tube being
axially compressed on fitting of the sleeve over the tip and exerting on the
sleeve an axial outward force tending to push the sleeve off the tip, the
holding force exerted by the sleeve being sufficient to prevent the axially
compressed shield tube from pushing the sleeve off the tip.

10. A blood-drawing device comprising:
a specimen tube extending along an axis;
an end cap fitted axially over an end of the tube and provided with an
axially outwardly projecting pierceable small-diameter tip;
radially outwardly projecting and elastically deformable retaining ribs
formed on the tip;
a small-diameter rigid guide sleeve fittable axially inward over the tip
and axially against the cap and having an inner side carrying a needle for
piercing through the tip into the tube on fitting of the sleeve to the tip and an
outer side provided with a connection fitting or an outer end of the needle,
the rigid guide sleeve being substantially radially inextensible and having
such an inner diameter that when fitted over the tip the ribs are elastically
angularly folded and form a holding connection between the tip and the
guide sleeve; and
an elastomeric needle-shield tube carried on the guide sleeve,
surrounding the needle, and pierceable by the needle on fitting of the sleeve
to the tip and piercing of the needle through the tip, the shield tube being
axially compressed on fitting of the sleeve over the tip and exerting on the
sleeve an axial outward force tending to push the sleeve off the tip, the
holding connection between the sleeve and the tip being sufficient to prevent
the axially compressed shield tube from pushing the sleeve off the tip.

The Examiner relies on the following evidence:
O’Brien US 3,401,696 Sep. 17, 1968
Sarstedt US 4,449,539 May 22, 1984
Sarstedt US 5,755,701 May 26, 1998
Weiler US 6,068,148 May 30, 2000

Appeal 2009-006917
Application 10/499,747

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The Examiner rejected the claims as follows:
(A) Claims 7 and 12 under 35 U.S.C. § 103(a) as unpatentable over Sarstedt
‘539 and Weiler.

(B) Claim 9 under 35 U.S.C. § 103(a) as unpatentable over Sarstedt ‘539,
Weiler, and Sarstedt ‘701.

(C) Claims 10 and 11 under 35 U.S.C. § 103(a) as unpatentable over Sarstedt
‘539 and O’Brien.

ISSUE (A): Claims 7 and 12
The ultimate issue raised by this rejection is whether Appellant has
established that the Examiner erred in concluding that a blood-drawing
device with a rigid guide sleeve that fits over the pierceable tip of a
collection tube, and elastically deforms the tip to create a gripping force
between the sleeve and the tip, would have been obvious over the combined
teachings of Sarstedt ‘539 and Weiler.
The underlying issues, not necessarily in this order, are (1) whether
Weiler describes a coupling arrangement in which a guide sleeve fits over
and elastically deforms the tip of a collection tube, and (2) whether it would
have been obvious to incorporate Weiler’s coupling arrangement into
Sarstedt ‘539’s blood-drawing device.
Findings of Fact
FF1 Claim 7 is directed to a blood-drawing device with a rigid,
radially inelastic guide sleeve that fits over the pierceable tip of the end cap
of a specimen tube. The outer wall of the tip has “a predetermined stiffness”
and the radially inelastic sleeve is “so dimensioned that when fitted over the
tip the sleeve bears radially inwardly on and radially inwardly elastically
deforms the tip wall to radially inwardly grip the tip with a predetermined
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force” sufficient to keep the sleeve from being pushed off the tip by the
force exerted by a compressed elastomeric shield covering a needle that
pierces the tip when the sleeve and the tip are fitted together.
FF2 Figures 1 and 2 of the Specification, reproduced in part
immediately below, illustrate an embodiment of the blood-drawing device
that meets the limitations of claim 7:

“Fig. 1 is an exploded view of a specimen tube [1] with a guide sleeve [2];”
while “Fig. 2 is an overall view of a guide tube [sic, sleeve] [2] fitted over
the tip [7] of the specimen tube [1] of Fig. 1” (Spec. 5: 16-19).

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FF3
To draw blood the guide sleeve 2 and the specimen tube 1 are
pushed together, that is the rigid guide sleeve 2 is slid onto the
tip 7 of the cap 6. At first the end of the elastomeric shield tube
3 engages the plug set in the tip 6. On further pushing together,
the shield tube 3 collapses like a bellows (see FIG. 2) and is
pierced by the inner needle point 4 which then pokes through
the plug so that the point 4 is exposed inside the specimen tube.
Once the rigid guide sleeve 2 is in its end position of FIG. 2 . . .
the guide sleeve will bear radially inward . . . on the elastically
deformable wall of the tip 2 and deform it radially inward into a
waisted shape as shown in Fig. 2. The guide sleeve 2 is thus
held with prestress solidly on the tip 7 of the cap 6.

(Spec. 6: 24 to 7: 10.)
FF4 The Examiner found that Sarstedt ‘539 discloses a blood-
drawing device that meets all the limitations of the claimed device, except
that Sarstedt ‘539’s device uses a “bayonet fitting” to couple the guide
sleeve and the specimen tube (Ans. 4), and therefore, does not disclose a
coupling in which “the sleeve bears radially inwardly and radially inwardly
elastically deforms the tip wall to radially inwardly grip the tip with a
predetermined holding force or that the force is sufficient to prevent the
axially compressed shield tube from pushing the sleeve off the tip” (id. at
3-4). Appellant does not dispute this finding.
FF5 Weiler discloses a hermetically sealed, molded thermoplastic
dispensing container with a nozzle which defines a dispensing aperture
(Weiler, col. 1, ll. 44-47). “The nozzle is sized to receive a hub of a
dispensing assembly such as . . . a hypodermic needle assembly, in a mating
relationship therewith” (id. at col. 1, ll. 52-54).
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FF6 “A resilient annular bead about the periphery of the nozzle,
unitary therewith and spaced from the aperture, provides a liquid seal for a
dispensing needle or spike mounted thereto” (Weiler, col. 1, ll. 47-50).
FF7 Figures 1 and 2, showing Weiler’s hermetically sealed, molded
thermoplastic dispensing container and nozzle, are reproduced below:

Figures 1 and 2 illustrate Weiler’s hermetically sealed, molded thermoplastic
dispensing container 10, which includes body portion 12, neck portion 14,
and unitary nozzle 16 extending away from neck portion 14 and including an
upper end defining dispensing aperture 18. The aperture is temporarily
occluded by removable twist-off closure 20, delineated by frangible web 22
(Weiler, col. 2, ll. 59-67).
FF8 As shown in Weiler’s Figures 1 and 2, “nozzle 16 includes an
outer peripheral surface 24 and a resilient, unitary annular bead 26 extending
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circumferentially and radially outwardly about the outer peripheral surface
24” (Weiler, col. 3, ll. 28-31).
FF9 Weiler’s Figures 4 and 5, reproduced below, show nozzle 216,
including bead 226, before and after coupling with the hub 36:

Figure 4 shows nozzle 216 which includes outer nozzle surface 224 with
rounded annular bead 226. “As shown in FIG. 5, the container 10 . . . is
adapted to be used together with a dispensing assembly 34, such as [a]
hypodermic needle assembly, including a female hub 36 with a luer tapered
inner surface 38 which defines an interior hub cavity 40” (Weiler, col. 3, l.
66 to col. 4, l. 3).
FF10 “The resilient bead 26 is sized such that its diameter, combined
with the diameter of the nozzle 16, is slightly greater than the diameter of the
hub cavity 40 in the region of engagement” (Weiler, col. 4, ll. 8-11). When
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hub 36 is “fitted over the nozzle 16 . . . a portion of the inner surface 38 of
the hub 36 is in abutting and contiguous relationship with the outer surface
24 of the nozzle 16 and a portion of the inner surface 38 of the hub 36 is in
abutting and contiguous relationship with the compressed annular edge 32
and surfaces 28 and 30 of the bead 26” (Weiler, col. 4, ll. 25-31).
FF11 According to Weiler,
The resiliency and compressibility of the bead 26 and, more
particularly, the resiliency and compressibility of the molded
thermoplastic material comprising the same, allows the hub 36
to be pressed over the bead 26 which, in turn, comprises [sic,
compresses] the bead 26 and allows the bead 26 to exert a
sealing force against the inner surface 38 of the hub 36 to
provide both a secure friction fit and liquid seal between the
hub 36 and the nozzle 16.

(Weiler, col. 4, ll. 32-39.)
FF12 The nozzle 16, including the bead 26, is molded as one piece
(Weiler, col. 4, l. 46 to col. 5, l. 9). The bead is resilient and compressible
(FF11), therefore, the rest of the nozzle is resilient and compressible too.
FF13 The Examiner found that Weiler’s nozzle 16 is “a radially
inwardly elastically deformable tip . . . having a wall that is deformed
radially inwardly” (Ans. 4). In support of this finding, the Examiner notes
that the bead is resilient and compressible, and also points to Figure 2, in
which the hub and nozzle are not coupled, and Figure 5, in which they are.
The Examiner found that in Figure 2, “the walls of the nozzle 16 are flat
(with the exception of at the location of bead 26), but in Figure 5, “the outer
walls of nozzle 16 angle inwardly towards the point of contact between the
bead 26 and the inner walls of hub 36” (id. at 7). Appellant disputes the
Examiner’s finding, as discussed below.
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Principles of Law
“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). “[W]hen a patent
‘simply arranges old elements with each performing the same function it had
been known to perform’ and yields no more than one would expect from
such an arrangement, the combination is obvious.” Id. at 417 (quoting
Sakraida v. Ag Pro, Inc., 425 U.S. 273 (1976)).
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that is was obvious under § 103.

KSR, 550 at 421. 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 418.
See also id. at 421 (“A person of ordinary skill is also a person of ordinary
creativity, not an automaton.”).
Analysis
The Examiner rejected claims 7 and 12 as unpatentable over Sarstedt
‘539 and Weiler, concluding that “it would have been obvious to one having
ordinary skill in the art . . . to have substituted a friction fitting as taught by
Weiler for the bayonet fitting of Sarstedt [‘539] to achieve the predictable
result of providing a secure gripping connection that is easy to operate”
(Ans. 4), as both Sarstedt ‘539 and Weiler “are directed towards securely
attaching a cylindrical cap to a coaxial cylindrical tip” (id. at 8).
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Appellant contends that “it is not obvious to combine the teachings
of Sarstedt [‘539] and Weiler” (App. Br. 8) because “Weiler is not dealing
with the same problem as Sarstedt [‘539]” (id. at 7-8). According to
Appellant, the compressed needle shield in Sarstedt ‘539’s device exerts
outward axial pressure on the sleeve, and the sleeve is prevented from being
pushed off the tip by using a bayonet joint to couple the sleeve and the tip
(id. at 7). In contrast, Appellant contends, “there is really no structure that
tends to push off the cap” in Weiler (id. at 7), and “the sole function of the
bead 26 is to provide a seal” between nozzle 16 and female hub 36 (id. at 8).
This argument is not persuasive. As the Examiner points out, both
Sarstedt ‘539 and Weiler “are directed towards securely attaching a
cylindrical cap to a coaxial cylindrical tip” (Ans. 8), and moreover, “Weiler
expressly discloses that the bead 26 also provides a secure friction fit
between the sleeve 36 and the tip 16” (id.). We agree with the Examiner that
it would have been obvious to incorporate Weiler’s coupling arrangement
into Sarstedt ‘539’s blood-drawing device.
Appellant further contends that claims 7 and 12 require “radial inward
elastic deformation of the [tip] wall” (App. Br. 7) when the guide sleeve is
fitted to the tip, but the Examiner’s proposed combination of Sarstedt ‘539
and Weiler does not meet this limitation of the claims (id.). Appellant
contends that “[t]here is no radial inward elastic deformation of the wall” of
the nozzle in Weiler’s device (id.), and “at most the narrow bead 26 is
squashed when the massive cap 36 is fitted in place” (id.). This is in contrast
to the claimed invention, in which “there is more generalized contact so that
there is a solid gripping action and the two parts hold solidly together, in
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spite of the fact that the shield tube is constantly exerting an axial outward
pressure to push off the sleeve” (id. at 8).
Appellant’s argument is not persuasive. The Examiner’s finding that
Weiler’s nozzle 16 “a radially inwardly elastically deformable tip . . . having
a wall that is deformed radially inwardly” by the hub 36 (Ans. 4) is
supported by the record, given the fact that the entire nozzle, not just the
bead, is resilient and compressible (FF11, FF12), and the fact that Weiler
teaches that a portion of the hub “is in abutting and contiguous relationship
with the outer surface 24 of the nozzle 16 and . . . with the compressed
annular edge 32 and surfaces 28 and 30 of the bead 26” (FF10). Since the
entire nozzle is resilient and compressible, it follows that the walls of the
nozzle will be radially inwardly deformed in the vicinity of the radially
compressed annular bead. Therefore, we agree with the Examiner that
Weiler describes a friction fit coupling arrangement in which a guide sleeve
fits over and “bears radially inwardly on and radially inwardly elastically
deforms the tip wall to radially inwardly grip the tip” of the collection tube
as required by the claims.
Conclusions of Law
Appellant has not established that the Examiner erred in concluding
that a blood-drawing device with a rigid guide sleeve that fits over the
pierceable tip of a collection tube, and elastically deforms the tip to create a
gripping force between the sleeve and the tip, would have been obvious over
the combined teachings of Sarstedt ‘539 and Weiler.
The rejection of claims 7 and 12 as unpatentable over Sarstedt ‘539
and Weiler is affirmed.

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ISSUE (B): Claim 9
Issue
The issue raised by this rejection is whether Appellant has established
that the Examiner erred in concluding that a blood-drawing device with
radially outwardly projecting and axially extending ribs on the tip of the
collection tube, whereby a guide sleeve engages the ribs and radially
inwardly deforms the tip wall, would have been obvious over the teachings
of Sarstedt ‘539, Weiler, and Sarstedt ‘701.
Findings of Fact
FF14 Claim 9 requires that the tip “wall is formed with radially
outwardly projecting and axially extending ribs, whereby an inner surface of
the sleeve engages the ribs and radially inwardly deforms the tip wall.”
FF15 Sarstedt ‘701 describes a blood-drawing device in which
[T]he stopper cap . . . is constructed with at least one
prominence which at least indirectly deforms the stopper cap in
the collar region when this is pushed into the guide sleeve, and
the guide sleeve is constructed rigidly and at least the
prominence of the stopper cap is constructed non-rigidly,
preferably flexibly. A self-clamping location of the guide
sleeve directly on the collar of the stopper cap can thus be
achieved . . .

(Sarstedt ‘701, col. 2, ll. 31-38).
FF16 “The prominence can be constructed, for example, in the form
of . . . a longitudinal rib . . . If several prominences are provided, these
should be located in distribution over the circumference of the stopper cap”
(Sarstedt ‘701, col. 2, l. 65 to col. 3, l. 4).

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Analysis
The Examiner rejected claim 9 as unpatentable over Sarstedt ‘539,
Weiler, and Sarstedt ‘701, concluding that it would have been obvious for
one skilled in the art “to have used longitudinal ribs as taught by Sarstedt
‘701 in the invention of Sarstedt ‘539 as modified [by] Weiler in order to
provide a connection that has no jerky transitions during coupling or release”
(Ans. 5).
Appellant contends that “[n]o axially extending ribs are shown in
Sarstedt ‘539 o[r] Weiler. Similarly, the tiny ribs 17 in Sarstedt ‘701 are not
elastically deformable as recited in claim 9” (App. Br. 8).
This argument is not persuasive. Claim 9 does not require elastically
deformable ribs, it requires an elastically deformable tip wall (FF14). In any
case, Sarstedt ‘701 describes both a deformable stopper cap (i.e., tip), and
deformable longitudinal (i.e., axially extending) ribs (FF15, FF16).
Conclusions of Law
Appellant has not established that the Examiner erred in concluding
that a blood-drawing device with radially outwardly projecting and axially
extending ribs on the tip of the collection tube, whereby a guide sleeve
engages the ribs and radially inwardly deforms the tip wall, would have been
obvious over the teachings of Sarstedt ‘539, Weiler, and Sarstedt ‘701.
The rejection of claim 9 as unpatentable over Sarstedt ‘539, Weiler,
and Sarstedt ‘701 is affirmed.

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ISSUE (C): Claims 10 and 11
Issue
The issue raised by this rejection is whether Appellant has established
that the Examiner erred in concluding that a blood-drawing device with a
rigid guide sleeve that fits over the pierceable tip of a collection tube, and
elastically angularly deforms radially outwardly projecting and elastically
deformable retaining ribs on the tip to create a gripping force between the
sleeve and the tip, would have been obvious over the combined teachings of
Sarstedt ‘539 and O’Brien.
Findings of Fact
FF17 Claims 10 and 11 require a blood-drawing device with a rigid
guide sleeve that fits over the pierceable tip of a collection tube, and
elastically angularly deforms radially outwardly projecting and elastically
deformable ribs on the tip to form a holding connection between the sleeve
and the tip.
FF18 O’Brien describes “semen collection funnels having flexible
coupling vanes [i.e., fins] thereon for quick coupling to and release from
semen storage vials, each of which utililes [sic] a frictional coupling means”
(O’Brien, col. 2, ll. 28-32). When a funnel and storage vial are connected,
the ribs on the funnel are elastically angularly deformed, forming a friction
fit between the funnel and the storage vial (id. at col. 3, l. 19 to col. 4, l.21).
FF19 The Examiner found that “O’Brien and Sarstedt [‘539] are both
directed towards mechanisms for releasably attaching a cylindrical sleeve to
a coaxial cylindrical tip” (Ans. 10).

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Principles of Law
“Two criteria have evolved for determining whether prior art is
analogous: (1) whether the art is from the same field of endeavor, regardless
of the problem addressed, and (2) if the reference is not within the field of
the inventor’s endeavor, whether the reference still is reasonably pertinent to
the particular problem with which the inventor is involved.” In re Clay, 966
F.2d 656, 658-659 (Fed. Cir. 1992).
Analysis
The Examiner rejected claims 10 and 11 as unpatentable over Sarstedt
‘539 and O’Brien. The Examiner found that O’Brien teaches “an alternative
mechanism for releasably attaching a cylindrical sleeve to a cylindrical tip”
(Ans. 10; FF19), and concluded that it would have been obvious for one
skilled in the art to have “substituted elastic ribs as taught by O’Brien for the
bayonet fitting of Sarstedt [‘539] to achieve the predictable result of quick
coupling and easy releasing” (Ans. 6).
Appellant contends that “this rejection is purely retrospective and uses
two nonanalogous references” (App. Br. 9).
Appellant’s argument is not persuasive. The Examiner found that
both references are directed to “mechanisms for releasably attaching a
cylindrical sleeve to a coaxial cylindrical tip” (Ans. 10; FF19), and we agree
with the Examiner that “they are both reasonably pertinent to the particular
problem with which the [Appellant] was concerned” (Ans. 10).
Conclusions of Law
Appellant has not established that the Examiner erred in concluding
that a blood-drawing device with a rigid guide sleeve that fits over the
pierceable tip of a collection tube, and elastically angularly deforms radially
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outwardly projecting and elastically deformable retaining ribs on the tip to
create a gripping force between the sleeve and the tip, would have been
obvious over the combined teachings of Sarstedt ‘539 and O’Brien.
The rejection of claims 10 and 11 as unpatentable over Sarstedt ‘539
and O’Brien is affirmed.

SUMMARY
(A) The rejection of claims 7 and 12 under 35 U.S.C. § 103(a) as
unpatentable over Sarstedt ‘539 and Weiler is affirmed.

(B) The rejection of claim 9 under 35 U.S.C. § 103(a) as unpatentable over
Sarstedt ‘539, Weiler, and Sarstedt ‘701 is affirmed.

(C) The rejection of claims 10 and 11 under 35 U.S.C. § 103(a) as
unpatentable over Sarstedt ‘539 and O’Brien is affirmed.

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)(1)(iv)(2006).

AFFIRMED

lp

K.F. ROSS P.C.
5683 RIVERDALE AVENUE
SUITE 203 BOX 900
BRONX, NY 10471-0900