Ex Parte Prais et al

Board of Patent Appeals and Interferences

Mar 16, 2012

11384759 (B.P.A.I. Mar. 16, 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.
11/384,759 03/20/2006 Alfred W. Prais 4133-082854-P-5532/1P1C1 8019
32182 7590 03/16/2012
David W. Highet, VP & Chief IP Counsel
Becton, Dickinson and Company
(The Webb Firm)
1 Becton Drive, MC 110
Franklin Lakes, NJ 07414-1880
EXAMINER
BOUCHELLE, LAURA A
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
03/16/2012 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 ALFRED W. PRAIS, RICHARD JAMES CAIZZA,
GARY HENNIGER, and ESPEN D. KARTERAAS
__________

Appeal 2010-004154
Application 11/384,759
Technology Center 3700
__________

Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
shieldable unit dose assembly. The 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
Background
“The present invention is directed to a shieldable unit dose assembly
for administering a unit dose of vaccine” (Spec. 3 ¶ 0003).
The Claims
Claims 1-21 are on appeal. Claims 1, 8, and 10 are representative and
read as follows:
1. A shieldable unit dose assembly, comprising:
a needle holding member having a proximal end and a
distal end, the distal end including a male tapering surface;
a unit dose needle assembly supported at the distal
end of the needle holding member, the unit dose needle
assembly comprising a solid elongated unit dose needle
having a patient end comprising a prong for containing a
unit dose of a vaccine and for administering the unit dose
directly from the prong to a patient, and a hub supporting the
unit dose needle, the hub including a female tapering surface
in engagement with the male tapering surface at the distal
end of the needle holding member; and
a telescoping safety shield member disposed around
the needle holding member and axially movable from a non-
shielding position surrounding at least a portion of the
needle holding member to a telescoped shielding position
encompassing the patient end of the unit dose needle.

8. The shieldable unit dose assembly of claim 1, further
comprising means for indicating that the safety shield
member is in the shielding position.

10. The shieldable unit dose assembly of claim 1, further
comprising structure for maintaining the safety shield
member in the non-shielding position prior to movement to
the shielded position.

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The issues
A. The Examiner rejected claims 1-7 and 9-21 under 35 U.S.C. § 103(a)
over Hausser
1
and Steiner
2
(Ans. 3-4).
B. The Examiner rejected claim 8 under 35 U.S.C. § 103(a) over
Hausser, Steiner, and Lewandowski
3
(Ans. 4).
A. 35 U.S.C. § 103(a) over Hausser and Steiner
The Examiner finds that Hausser teaches “a lockable safety shield for
a needle comprising a needle holding member 22 having a male tapering
surface and a threaded collar 34, a needle 32, a telescoping safety shield 12
movable from a non-shielding position to a shielding position, a groove 48
for receiving a deformable wedge 52” (Ans. 3). The Examiner finds that
Hauser teaches that the “device further comprises a removable cover 34”
(Ans. 3). The Examiner finds that Hauser does not teach a solid unit dose
needle (Ans. 3). The Examiner finds that “Steiner teaches a unit dose needle
comprising a solid needle bifurcated into two prongs having a U-shape there
between that allows for a single dose of a substance to be applied to the skin
of the patient” (Ans. 3).
The Examiner finds it obvious “to modify the device of Hausser to
deliver the agent using a unit dose needle as taught by Steiner instead of the
hypodermic needle because that delivery mechanism is known in the art and
suitable for delivery of certain medicaments” (Ans. 3).

1
Roderick J. Hausser, US 5,385,555, issued Jan. 31, 1995.
2
Dale C. Steiner, US 3,948,261, issued Apr. 6, 1976.
3
Raymond D. Lewandowski, US 5,338,310, issued Aug. 16, 1994.
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Appellants contend that “Hausser fails to teach or suggest a needle
assembly having a solid unit dose needle. Instead, Hausser teaches an
assembly for withdrawing or administering fluids including a safety syringe
and a hypodermic needle cannula which requires a passageway extending
between both ends for transfer of fluid therethrough” (App. Br. 12).
Appellants contend that the ordinary artisan “would not be motivated
to replace the needle cannula of Hausser, with the solid unit dose needle of
Steiner, which is an entirely different type of needle, because such a
suggestion/substitution would render Hausser unsatisfactory for its intended
purpose, and would change the principle of operation of Hausser” (App. Br.
12).
Appellants contend that “[n]owhere does Steiner teach or suggest that
the closure and needle may be used in combination with a needle hub or a
needle holding member. Nor does Steiner teach or suggest that the
closure/needle assembly can be affixed to a needle hub or needle holding
member” (App. Br. 13).
Appellants contend that to “simply remove just the closed needle of
Steiner and position such in the hub of Hausser would destroy the
functioning of the Steiner device as the needle is integrally joined with the
closure and the closure is necessary for sealing with the receptacle during
lyophilizing” (App. Br. 13; see Reply Br. 4).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that the combination of Hausser and
Steiner renders the claims obvious?

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Findings of Fact
1. Figure 10 of the Specification is reproduced below:

“FIG. 10 is a perspective view of the shieldable needle assembly showing
the safety shield member in a telescoped, shielding position” (Spec. 5).
2. Figure 3 of Hausser is reproduced below:

“FIG. 3 is a cross-sectional view” of the hypodermic syringe and safety
shield (Hausser, col. 3, ll. 53-54).
3. Hausser teaches “a hypodermic syringe having a sharp needle
cannula and a rigid safety shield. The safety shield is telescoped over the
syringe barrel, and may be slid from a proximal retracted position, where the
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needle cannula is exposed, to a distal position where the needle cannula is
substantially surrounded by the safety shield” (Hausser, col. 2, ll. 26-32).
4. Hausser teaches that “the distal end of syringe barrel 12 is
characterized by a tip 22 having a fluid passage 24 extending therethrough
and communicating with chamber 20” (Hausser, col. 4, ll. 17-19).
5. Hausser teaches that “distal end of syringe barrel 12 is further
characterized by a locking luer-type collar 28 disposed in spaced concentric
relationship around tip 22. Luer collar 28 includes an array of internal
threads to enable threaded mounting of a needle hub 30 between collar 28
and tip 22” (Hausser, col. 4, ll. 27-32).
6. Figure 3 and Hausser therefore teach a syringe barrel 12 which
has a male distal tapered tip 22 with a needle hub 30 composed of a female
surface that is luer locked to tip 28 (FF 3-5).
7. Hausser teaches that “safety shield 36 is frictionally retained in
a proximal position on syringe barrel 12 until hypodermic syringe 10 is
used” (Hausser, col. 6, ll. 27-29).
8. Figure 10 of Hausser is reproduced below:

“FIG. 10 is a side elevational view . . . showing the safety shield partly
section and in the distal locked position relative to the hypodermic syringe”
(Hausser, col. 3, ll. 66-68).
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9. Hausser teaches that “[n]eedle cannula 32 includes sharp tip 33.
To prevent accidental needle sticks prior to use of hypodermic syringe 10, a
needle shield 34 is removably mounted over needle cannula 32” (Hausser,
col. 4, ll. 35-38).
10. Figure 2 of Steiner is reproduced below:

“FIG. 2 is an elevational view, partly in section, of the container of the
present invention showing the closure lightly engaging the receptacle during
lyophilizing” (Steiner, col. 1, ll. 51-53).
11. Steiner teaches “a unit dose container in which a liquid vaccine
is retained on a bifurcated needle, lyophilized to a dry condition, and then
sealed in the container” (Steiner, col. 1, ll. 35-37).
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12. Steiner teaches that a “needle 40 having a bifurcated end 42 is
embedded at its opposite end 44 in the body portion 22 to a depth, typically
about two-thirds of the body portion, sufficient to firmly engage the closure
20 and needle 40 and support the needle 40, in fixed position “ (Steiner, col.
2, ll. 25-29).
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).
Analysis
Steiner teaches “a unit dose container in which a liquid vaccine is
retained on a bifurcated needle, lyophilized to a dry condition, and then
sealed in the container” (Steiner, col. 1, ll. 35-37; FF 11).
Hauser teaches a hypodermic syringe with a telescoping safety shield
which “may be slid from a proximal retracted position, where the needle
cannula is exposed, to a distal position where the needle cannula is
substantially surrounded by the safety shield” (Hausser, col. 2, ll. 26-32; FF
3). Hauser teaches that the needle is engaged to a female tapering hub by a
luer lock connection with a male surface at the end of the needle holding
member (FF 3-6).
Applying the KSR standard of obviousness to the findings of fact, we
agree with the Examiner that it would have been obvious “to deliver the
agent using a unit dose needle as taught by Steiner instead of the hypodermic
needle because that delivery mechanism is known in the art and suitable for
delivery of certain medicaments” (Ans. 3). Such a combination is merely a
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“predictable use of prior art elements according to their established
functions.” KSR, 550 U.S. at 417.
Appellants contend that the ordinary artisan “would not be motivated
to replace the needle cannula of Hausser, with the solid unit dose needle of
Steiner, which is an entirely different type of needle, because such a
suggestion/substitution would render Hausser unsatisfactory for its intended
purpose, and would change the principle of operation of Hausser” (App. Br.
12). Appellants rely on In re Gordon, 733 F.2d 900, 221 USPQ 1125 (Fed.
Cir. 1984) (App. Br. 12) for the proposition that “if the proposed
modification would render the prior art invention being modified
unsatisfactory for its intended purpose, then there is no suggestion or
motivation to make the proposed modification” (App. Br. 12).
In Gordon, the reference taught a gasoline liquid strainer which, under
the reasoning of the rejection at issue, needed to be turned upside down in
order to address the claims to a blood filter assembly, where turning the
liquid strainer upside down would be inoperable for filtering gasoline. See
Gordon, 733 F.2d at 901-902.
Gordon is a different fact pattern than the one presented in the instant
case. Unlike Gordon, where a gasoline strainer was used to address a blood
filter assembly, both Hauser and Steiner are interested in the delivery of
medicaments to patients using needles, a hypodermic needle in the case of
Hauser (FF 3) and a bifurcated unit dose vaccine needle in the case of
Steiner (FF 11). The focus of Hauser is that in order to “prevent accidental
needle sticks prior to use of hypodermic syringe 10, a needle shield 34 is
removably mounted over needle cannula 32” (Hausser, col. 4, ll. 35-38; FF
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9). Even simply substituting the Steiner needle, without other adjustments,
for the Hausser needle, would achieve Hausser’s goal of preventing
accidental needle sticks using the vaccine needle of Steiner. Thus, the
fundamental technological advance of Hauser, which was not the invention
of a hypodermic syringe, but rather the invention of a lockable safety shield
for needles, would not be rendered inoperable by the combination with
Steiner.
Our reasoning is consistent with KSR, where the court found that “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.” 550 U.S. at 417. Here, we agree with the Examiner
that the person of ordinary skill aware that the incorporation of a needle
shield improved the safety of the hypodermic syringe of Hauser would have
reasonably recognized that the same safety shield could be incorporated with
the vaccine needle of Steiner.
Appellants contend that to “simply remove just the closed needle of
Steiner and position such in the hub of Hausser would destroy the
functioning of the Steiner device as the needle is integrally joined with the
closure and the closure is necessary for sealing with the receptacle during
lyophilizing” (App. Br. 13; see Reply Br. 4).
We are not persuaded. As an initial matter, the needle of Steiner can
function whether the vaccine is lyophilized using the container of Steiner, or
lyophilized or prepared through some other means. Appellants’ literalist
approach to forming the combination of elements, also found in Appellants’
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arguments with regard to Hausser, is rejected by In re Sovish, 769 F.2d 738
(Fed. Cir. 1985). In Sovish, the court found that Appellants
argued at length about the “propriety” of “combining the
two references” as though the question is simply whether
the Esher patent suggests within its four corners using the
disclosed tubular, closed-end plug in a heat-recoverable
aperture member or conduit or whether Weagant similarly
suggests using an Esher type plug in place of his cork-like
plug 26

769 F.2d at 742. Sovish found that this “is not the proper approach to the
issue, which is whether the hypothetical person of ordinary skill in the
relevant art, familiar with all that Esher and Weagant disclose, would have
found it obvious to make a structure corresponding to what is claimed.” Id.
The same analysis applies in the instant case. The Sovish approach,
consistent with KSR, requires addressing the question of whether in light of
the teaching of a vaccine needle in Steiner (FF 11) and a safety shield for
hypodermic syringe needles in Hausser (FF 3), the hypothetical person of
ordinary skill in the art would have found the claimed structure obvious. We
conclude that just as Sovish found that the person of ordinary skill would
retain necessary components of the combination while removing
unnecessary components, so too, the ordinary artisan combining Hausser and
Steiner would have formed a combination which incorporated those
elements from Hausser necessary to form a safety shield for the vaccine
needle of Steiner. See Sovish, 769 F.2d at 743.
Claim 10
Appellants contend that “claim 10 requires that structure be provided
for maintaining the safety shield member in the non-shielding position prior
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to movement to the shielded position” (App. Br. 14). Appellants contend
that “Hausser does not disclose such an embodiment and further fails to
teach or even suggest structure that is provided to frictionally and releasably
maintain the safety shield member in a non-shielding position prior to
movement to the shielded position” (App. Br. 14).
We are not persuaded. Claim 10 requires a “structure” which has the
function of “maintaining the safety shield member in the non-shielding
position prior to movement to the shielded position” (Claim 10). No
particular type of structure is required, nor are there any limitations on the
“structure”. Hausser teaches that “safety shield 36 is frictionally retained in
a proximal position on syringe barrel 12 until hypodermic syringe 10 is
used” (Hausser, col. 6, ll. 27-29). Thus, Hausser reasonably satisfies the
functional requirement of claim 10 by the frictional retention on the syringe
barrel and the syringe barrel itself therefore serves as a structure which
satisfies the required “structure” of claim 10. See In re Zletz, 893 F.2d 319,
322 (Fed. Cir. 1989) (“[D]uring patent prosecution when claims can be
amended, ambiguities should be recognized, scope and breadth of language
explored, and clarification imposed.”)
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
combination of Hausser and Steiner renders the claims obvious.
B. 35 U.S.C. § 103(a) over Hausser, Steiner, and Lewandowski
The Examiner finds that “Lewandowski teaches a device similar to
that of Hausser but further including a safety indication to visually indicate
the shield in the locked position to assure that the needle is in the safety
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position to prevent accidental sticks” (Ans. 4). The Examiner finds it
obvious to “modify the device of Hausser to include a means for indicating
that the safety shield member is in the locked position as taught by
Lewandowski to assure that the needle is shielded to prevent accidental
sticks” (Ans. 4).
The Examiner provides sound fact-based reasoning for combining
Lewandowski with Hausser and Steiner. We adopt the fact finding and
analysis of the Examiner as our own. Appellants argue the underlying
obviousness rejection over Hausser and Steiner, but Appellants do not
identify any material defect in the Examiner's reasoning for combining
Lewandowski with Hausser and Steiner. Since Appellants only argue the
underlying rejection of Hausser and Steiner which we affirmed above, we
affirm this rejection for the reasons stated by the Examiner.
SUMMARY
In summary, we affirm the rejection of claims 1 and 10 under 35
U.S.C. § 103(a) over Hausser and Steiner. Pursuant to 37 C.F.R.
§ 41.37(c)(1), we also affirm the rejection of claims 2-7 and 9-21 as these
claims were not argued separately
We affirm the rejection of claim 8 under 35 U.S.C. § 103(a) over
Hausser, Steiner, and Lewandowski.

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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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