Ex Parte Woehr

Board of Patent Appeals and Interferences

Mar 16, 2009

10788127 (B.P.A.I. Mar. 16, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte KEVIN WOEHR
____________

Appeal 2008-47681
Application 10/788,127
Technology Center 3700
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Decided:2 March 16, 2009
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Before ERIC GRIMES, RICHARD M. LEBOVITZ, and
FRANCISCO C. PRATS, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL

1 Heard Feb. 11, 2009.
2 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 2008-4768
Application 10/788,127

This is a decision on appeal from the Examiner’s final rejection of
claims 1-40 as obvious over prior art. Jurisdiction for this appeal is under 35
U.S.C. § 6(b). We reverse.

STATEMENT OF THE CASE
According to the Specification, “[i]n an effort to reduce the transfer of
communicable diseases, safety features were added to commercially
available syringes to minimize accidental contact or sticking with used
needle tips” (Spec. ¶ 3). One type of safety feature involves “tip protector
technology” in which “a protective element is mounted over a needle and
configured to cover the needle tip . . . subsequent to an injection to block the
needle tip” (id. at ¶ 4). “The protective element may be activated manually
to cover the needle tip or automatically by way of releasing a spring to then
push the protective element over the needle tip” (id.).
The claimed invention is to a syringe assembly with a protective
sheath that slides over the syringe needle after injection to shield it from
accidental contact (id. at ¶¶ 103-104). The plunger tip has a gap to enable it
to completely expel or discharge fluid from the syringe barrel without
triggering the advancement of the slidable protective sheath (id. at ¶¶ 112-
113; see Specification Fig. 25).
Claims 1-40 are pending and appealed. The Examiner rejects the
claims under 35 U.S.C. § 103(a) as obvious in view of Restelli (EP 1 334
740 A1, Aug. 13, 2003) and Saito (US 6,196,997 B1, Mar. 6, 2001) (Ans. 3).
Independent claims 1, 25, and 35 are representative and read as
follows:
1. A syringe assembly comprising:
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a syringe comprising a barrel having an open proximal end and a
barrel end surface at a distal end, a plunger slidably disposed in the barrel
comprising a push flange, and a plunger tip comprising a plunger tip end
surface positioned on a distal end of the plunger; the push flange
being spaced apart from the plunger tip end surface by a first distance;
a sheath unit comprising a sheath cover telescopically disposed over
and removably secured to an inner shell; said inner shell comprising an
interior surface defining an interior cavity;
a spring compressed by a shoulder on the sheath cover and a shoulder
on the inner shell;
wherein the barrel is disposed, at least in part, in the cavity of the
inner shell; and
wherein the plunger comprises three plunger positions including a
first plunger position in which the plunger tip positioned on the plunger is
spaced apart from the barrel end surface; a second plunger position in which
the plunger tip contacts the barrel end surface; and a third plunger position in
which the push flange on the plunger moves a distal direction relative to the
plunger tip distal end surface such that the push flange is now spaced apart
from the plunger tip distal end surface by a second distance, which is less
than the first distance.

25. A syringe assembly comprising:
a syringe comprising a barrel and a plunger having a plunger tip
disposed inside the barrel; wherein the plunger comprises a tapered trigger
element disposed distal of a plunger push surface and the barrel comprising
a barrel end surface comprising an orifice;
a sheath unit comprising a sheath cover comprising at least one trigger
lever comprising a pivot point and a trigger tip; the sheath cover being
telescopically disposed over an inner shell and removably held thereto by a
detent engagement between the trigger lever and an engagement surface on
the inner shell;
a spring held in a compressed configuration by the detent engagement;
wherein the syringe is disposed, at least in part, inside the inner shell;
and
wherein the plunger tip abuts the barrel end surface and the tapered
trigger element on the plunger contacts the trigger lever but does not sever
the detent engagement.

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35. A syringe assembly comprising:
a syringe disposed, at least in part, inside an interior cavity of a sheath
unit;
the syringe comprising a barrel comprising an open proximal end and
a closed distal end comprising an orifice; a plunger comprising a push
flange, a tapered actuator, and a tip holder comprising a plunger tip mounted
thereon slidably disposed inside the barrel; the push flange being spaced
apart from a distal exterior wall surface of the plunger tip by a first distance;
the sheath unit comprising a spring and a sheath cover telescopically
disposed over an inner shell and held to the inner shell by an engagement
between a receptacle on a trigger lever located on the sheath cover engaging
an ear located on the inner shell; the spring being held in a compressed
configuration by the engagement;
wherein the tapered actuator disengages the ear from the receptacle
when the plunger moves distally and the push flange is spaced apart from the
distal exterior wall surface by a second distance, which is less than the first
distance.

ISSUES ON APPEAL
Does the combination of Restelli and Saito suggest a syringe assembly
with a plunger position in which the plunger tip distal end surface is spaced
apart from the plunger push flange by a first distance and another plunger
position in which the spacing between the plunger tip and push flange is less
than the first distance as recited in independent claims 1 and 35?
Does the combination of Restelli and Saito suggest a syringe assembly
in which “the plunger tip abuts the barrel end surface and the tapered trigger
element on the plunger contacts the trigger lever but does not sever the
detent engagement” between the plunger and sheath/cover as recited in
independent claim 25?
PRINCIPLES OF LAW
To establish obviousness under 35 U.S.C. § 103, the following factors
must be taken into consideration: (a) the scope and contents of the prior art;
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(b) the differences between the prior art and the claimed subject matter; (c)
the level of skill in the pertinent art; and (d) evidence of secondary
considerations. Graham v. John Deere Co., 383 U.S. 1, 17 (1966). In
making an obviousness determination, “there must be some articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006); see also KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, ___, 127 S. Ct. 1727, 1740-1741
(2007).
FINDINGS OF FACT
Scope and content of the prior art
Restelli
FF1. Restelli describes an automatic safety device for a glass syringe to
protect the needle once an injection has been performed (Restelli, at ¶ 1).
FF2. The safety device comprises a sheath mounted on the glass syringe
body and a sleeve movably mounted on the glass syringe body “to pass from
a retracted use position in which the needle protrudes forward from the
sleeve to be able to perform the injection” to a safety position in which the
needle is protected by the sleeve (Restelli, at ¶ 17).
FF3. Initially, the sleeve is locked into the retracted position by a locking
mechanism located at the rear part of the syringe plunger 2 (Restelli, at ¶¶
18, 19, 37). Once the lock is disengaged, the sleeve 4 is pushed forward
over the syringe body by spring 6 (id. at ¶ 39).
FF4. The glass syringe chamber is pre-filled with a solution to be injected
(Restelli, at ¶ 38). “[W]hen the injection is performed and the plunger 2 [of
the glass syringe] reaches the end of its stroke in the chamber of the syringe
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body, as shown in Figure 3,” the locking mechanism releases the sleeve and
the sleeve advances over the needle (id.).
FF5. Restelli’s Figure 3, reproduced below, shows the Restelli safety device
immediately after injection. Restelli’s Figure 4, reproduced below, shows
the safety device, after injection, with the sleeve 4 advanced over the syringe
body to protect the needle.

Figure 3 shows the safety device of Restelli immediately after injection;
Figure 4 shows the same safety device with the sleeve covering the needle.
FF6. The distance between the plunger tip 2 and the plunger flange 21
(Restelli, at ¶ 23-24) is not stated nor shown in Restelli to change during the
operation of the automatic safety device.
Saito
FF7. Saito describes a disposable syringe with needle, needle support with a
locking hole, and a piston with a locking projection (Saito, at col. 2, ll. 6-
44).
FF8. After the piston is pushed forward to empty the syringe, the locking
projection is inserted into the locking hole on the needle support and then the
support, along with the needle, is pulled inside of the syringe body (Saito, at
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col. 2, ll. 28-31; compare Saito’s Figs. 1, 2, and 6) to keep the needle from
being touched again (id. at col. 1, ll. 8-20).
FF9. The Examiner finds that the distance between the plunger (referred at
as a “piston” in Saito) flange and the plunger tip changes during operation of
the syringe (Ans. 3).

Differences between the prior art and the claimed subject matter
FF10. Independent claims 1, 25, and 35 are directed to a syringe assembly
comprising a sheath unit which fits over a syringe barrel and a spring
compressed on the sheath.
FF11. It is undisputed that Restelli describes an automatic safety syringe
which comprises a sheath unit (“sleeve”) and spring (FF1-5) which meet the
corresponding structural limitations of claims 1, 25, and 35.
FF12. Restelli’s safety device also operates similarly as does the claimed
syringe assembly, where the sleeve advances over the syringe body once the
plunger tip reaches the end of its stroke at the end of the syringe barrel. This
is illustrated in Figures 25 and 28 of the Specification reproduced below.

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Figures 25 and 28 show a syringe assembly described in the
Specification. Figure 25 shows the plunger at the barrel end; Figure 28
shows the syringe cover slid forward over the syringe needle.
FF13. Restelli does not describe an automatic safety device that meets the
following claimed limitations:
Claims 1 and 35: a plunger position with a first distance between a
plunger tip and plunger push flange and another position where the push
flange is spaced apart from the plunger tip by a second distance, which is
less than the first distance; and
Claim 25: “the plunger tip abuts the barrel end surface and the tapered
trigger element on the plunger contacts the trigger lever but does not sever
the detent engagement” between the plunger and sheath.

ANALYSIS
Claims 1 and 35
Claims 1 and 35 are directed to a syringe assembly comprising a
syringe with a plunger, a sheath unit covering the syringe body, and a spring
compressed on the sheath. The claims further recite that the assembly can
be placed into a configuration (a “position”) in which the distance between
the plunger tip and plunger push flange is less than the distance in another
position. That is, the assembly is required to comprise a structure which
permits the distance between the plunger tip and push flange to change
during operation. According to the Specification and as shown in the
figures, this structure involves a plunger disc 174 and plunger tip 462 – with
a gap (“trigger gap”) between the disc and tip (Spec. ¶¶ 112, 113; see Fig.
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25). The portion of Figure 25 of the Specification illustrating this feature is
reproduced below:

A portion of Specification Figure 25 is reproduced above showing the
trigger gap in the plunger tip. Numeral 472 of the drawing points to the
trigger gap.
The sheath 384 covering the syringe body is held in place by trigger
lever 390 which is engaged with the push flange 408. When the plunger tip
is pushed to the end of the syringe barrel, the push flange remains engaged
with the trigger lever. To disengage the trigger lever, the plunger is pushed
completely forward, closing the gap between the disc and plunger tip.
Portions of Figures 25 and 28 are reproduced below showing the open (472)
and closed trigger gap, respectively (compare 462 between Figures 25 and
28):

Fig. 25 Fig. 28
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Portions of Specification Figures 25 and 28 are reproduced above
showing the open and closed trigger gap in the plunger tip.
When the gap is closed, the sleeve around the syringe body is released
and the spring decompresses, advancing the sleeve forward over the needle.
Because the gap is closed, the distance between the tip and the flange
changes and is “less than the first distance” before the trigger lever was
disengaged.
It is undisputed that Restelli describes an automatic safety device for a
syringe that meets most of the limitations of claims 1 and 35 (FF11, 12), but
not that the distance between the plunger tip and push flange changes during
operation of the device (FF13). For this feature, the Examiner cites Saito
which the Examiner finds teaches a plunger in which the distance between
its tip and flange changes when the needle on the accompanying syringe is
pulled inside the syringe body (FF9). The Examiner states that it would
have been obvious “to combine the plunger tip assembly of Saito with the
trigger and sheath system of Restelli in order to provide a safety cover which
automatically prevents reuse of the syringe and accidental sticking of the
needle after use (Restelli)” (Ans. 4). The Examiner finds that Restelli’s
syringe needle could still be removed from the sleeve and reused (id. at 5).
The Examiner concludes that combining Restelli with Saito would solve the
problem of covering the needle and provide a mechanism to disable it from
reuse (id.).
Appellant contends that the Examiner erred in combining Restelli
with Saito. Appellant states that Saito describes a device in which the
needle is retracted into the syringe barrel, while Restelli’s device has a
sheath that is advanced forward to cover the needle (App. Br. 13-14).
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Appellant’s position is that since Saito already teaches a mechanism to
shield the needle, Restelli’s sheath/sleeve would be unnecessary and
redundant (App. Br. 14-15; Reply Br. 4, 7).
To establish obviousness, there must be “some rational underpinning
to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d at
988. In this case, the Examiner’s reason for using Saito’s plunger/syringe in
Restelli’s sleeve is to make Saito’s device automatically protect the needle
once the injection is finished – as taught for Restelli’s device (Ans. 4). As
we understand it, this would entail adding Restelli’s sheath/sleeve and
locking mechanism to Saito’s syringe. The flaw with this reasoning, as
pointed out by Appellant, is that Restelli’s sheath is for shielding the needle
by advancing a cover over the needle (FF4, 5), while Saito’s device
functions by withdrawing the needle inside the syringe body (FF8). The
mechanisms are different. Adding Restelli’s sleeve to Saito’s syringe would
put an entirely different mechanism for shielding a needle on top of one
which was already present. It would not make Saito’s needle retract
automatically, but would put a sleeve on an already retractable needle.
Because safety features are already present in each of Saito and Restelli, we
conclude that the Examiner improperly combined their disclosures.

Claim 25
Like claims 1 and 35, claim 25 is directed to a syringe assembly
comprising a syringe with a plunger, a sheath unit covering the syringe
body, and a spring compressed on the sheath. Claim 25 further comprises a
“trigger element” on the plunger and “trigger lever” on the sheath. The
claim recites that the “plunger tip abuts the barrel end surface and the
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tapered trigger element on the plunger contacts the trigger lever but does not
sever the detent engagement.” The Specification shows embodiments in
which a trigger lever 390 on the sheath is in contact with an actuator 404
(the “trigger element”) on the plunger (Spec. ¶ 106). As described above,
the plunger tip has a “trigger gap” defined by a distal plunger disc 174 and
the interior wall of the plunger tip 462. The gap allows the tip to abut the
barrel surface end without disengaging the engagement between the trigger
lever and trigger element on the plunger (id. at ¶¶ 112-115).
The Examiner does not separately address claim 25, instead relying on
the same rationale as for claims 1 and 35. Appellant contends that when the
plunger reaches the barrel end in Restelli’s device, the engagement between
the levers on the sheath and the plunger element become disengaged,
pushing the cover forward over the needle (App. Br. 16-17). Thus,
Appellant argues that Restelli does not meet the limitation of claim 25 that
the “plunger tip abuts the barrel end surface and the tapered trigger element
on the plunger contacts the trigger lever but does not sever the detent
engagement.” Appellant states that
Saito does not alter Restelli’s releasing mechanism at the
moment the plunger tip contacts the end of the barrel. Thus,
even if Saito’s plunger or entire syringe assembly is used with
the Restelli sheath mechanism, the combination does not teach
or suggest a syringe assembly wherein the plunger tip abuts the
barrel end surface and the tapered trigger element on the
plunger contacts the trigger lever but does not sever the detent
engagement.
(App. Br. 17.)
This argument is persuasive. Even if Saito’s plunger were utilized in
Restelli’s syringe, there is no “trigger gap” or analogous mechanism by
which the plunger tip would abut the barrel end and leave a gap which
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would allow the lever to still be in contact with the plunger as recited in
claim 25.
CONCLUSIONS OF LAW
The combination of Restelli and Saito does not suggest a syringe
assembly with a plunger position in which the plunger tip distal end surface
is spaced apart from plunger push flange by a first distance and another
plunger position in which the spacing between the plunger tip and flange is
less than the first distance as recited in independent claims 1 and 35. We
reverse the rejection of claims 1 and 35 and dependent claims 2-24 and 36-
40 which incorporate all their limitations.
The combination of Restelli and Saito does not suggest a syringe
assembly in which “the plunger tip abuts the barrel end surface and the
tapered trigger element on the plunger contacts the trigger lever but does not
sever the detent engagement” between the plunger and sheath as recited in
independent claim 25. We reverse the rejection of claim 25 and dependent
claims 26-34 which incorporate all its limitations.

REVERSED

cdc

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